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NRC FORM 313 US NUCLEAR REGULATORY COMMISSION (05-2012) 10 CFR 30 32 33 34 35 36 39 and 40
APPLICATION FOR MATERIALS LICENSE
APPROVED BY OMB NO 31500120 EXPIRES (05312015)
Estimated burden per response to comply with this mandatory collection request 43 hours Submittal of the application is necessary to determine that the applicant is qualified and that adequate procedures exist to protect the public health and safety Send comments regarding burden estimate to the Information Services Branch (T-5 F53) Us Nuclear Regulatcry Commission Washington DC 20555-0001 or by internet e-mail to InfocoliectsResourcenrcgov and to the Desk Officer Office of Information and Regulatory Affairs NEOBmiddot10202 (3150-0120) Office of Management and Budget Washington DC 20503 If a means used to impose an information collection does not display a currently valid OMS control number the NRC may not conduct or sponsor and a person is not required to respond to the information collection
INSTRUCTIONS SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW
APPLICATION FOR DISTRIBUTION OF EXEMPT PRODUCTS FILE APPLICATIONS WITH
OFFICE OF FEDERAL amp STATE MATERIALS AND ENVIRONMENTAL MANAGEMENT PROGRAMS DIVISION OF MATERIALS SAFETY AND STATE AGREEMENTS US NUCLEAR REGULATORY COMMISSION WASHINGTON DC 20555-0001
ALL OTHER PERSONS FILE APPLICATIONS AS FOLLOWS
IF YOU ARE LOCATED IN
ALABAMA CONNECTICUT DELAWARE DISTRICT OF COLUMBIA FLORIDA GEORGIA KENTUCKY MAINE MARYLAND MASSACHUSETTS NEW HAMPSHIRE NEW JERSEY NEW YORK NORTH CAROLINA PENNSYLVANIA PUERTO RICO RHODE ISLAND SOUTH
ROU ~ ~J SEND APPUCATIONSTO (OlD - 31Lj K-C I
LICENSING ASSISTANCE TEAM DIVISION OF NUCLEAR MATERIALS SAFETY US NUCLEAR REGULATORY COMMISSION REGION I 2100 RENAISSANCE BOULEVARD SUITE 100 KING OF PRUSSIA PA 19406-2713
IF YOU ARE LOCATED IN
ILLINOIS INDIANA IOWA MICHIGAN MINNESOTA MISSOURI OHIO OR WISCONSIN SEND APPLICATIONS TO
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION REGION III 2443 WARRENVILLE ROAD SUITE 210 amp f LISLE IL 60532-4352
ALASKA ARIZONA ARKANSAS CALIFORNIA COLORADO HAWAII IDAHO KANSAS LOUISIANA MISSISSIPPI MONTANA NEBRASKA NEVADA NEW MEXICO NORTH DAKOTA OKLAHOMA OREGON PACIFIC TIRUST TERRITORIES SOUTH DAKOTA TEXAS UTAH WASHINGTON OR WYOMING LL 3fS1SEND APPLICATIONS TO
NUCLEAR MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION REGION IV 1600 E LAMAR BOULEVARD AIltLlNGTON TX 76011-4511 03 03 ~S-82
PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE US NUCLEAR REGULATORY COMMISSION ONt+Jf THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO USNUCLEAR REGULATORY COMMISSION JURI~CTIONS
1 THIS IS AN APPLICATION FOR (Check appropriate Item) 2 NAME AND MAILING ADDRESS OF APPLICANT (Include ZIP code)
ITmiddot A NEW LICENSE ~J NovaMed Corporation
W B AMENDMENT TO LICENSE NUMBER 30 Nutmeg Drive 0 ~
Trumbull CT 06611 C RENEWAL OF LICENSE NUMBER 03LLfo ~~
3 ADDRESS WHERE LICENSED MATERIAL VVlLL BE USED OR POSSESSED 4 NAME OF PERSON TO BE CONTACTED ABOUT THIS APPLICATION -Robert M Constantine President _
CA
BUSINESS TELEPHONE NUMBER JBUSINESS CELLULAR TELE~E NUMBERPossession at temporary job sites only which are licensed
(203) 380-6682 (860) 944-3045 hospitals and blood banks requiring blood irradiator maintenance
BUSINESS EMAIL ADDRESS
rconstantinenovamedcorpcom SUBMIT ITEMS 5 THROUGH 11 ON 8-12 X 11 PAPER THE TYPE AND SCOPE OF INFORMATION TO BE PROVIDED IS DESCRIBED IN THE LICENSE APPLICATION GUIDE
5 RADIOACTIVE MATERIAL a Element and mass number b chemical andlor physical form and c maiximum amount 6 PURPOSE(S) FOR WHICH LICENSED MATERIAL VVlLL BE USED
which will be possessed at anyone time
7 INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR S TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREASTRAINING EXPERIENCE
9 FACILITIES AND EQUIPMENT 10 RADIATION SAFETY PROGRAM
12 LICENSE FEES (See 10 CFR 170 and Section 17031) 11 WASTE MANAGEMENT AMOUNT
FEE CATEGORY New Licence App $ 640000ENCLOSED
13 CERTIFICATION (Must be completed by applicant) THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATlONS MADE IN THIS APPLICATION ARE BINDING UPON THE APPLICANT
THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT NAMED IN ITEM 2 CERTIFY THAT THIS APPLICATION is PREPARED IN CONFORMITY VVlTH TITLE 10 CODE OF FEDERAL REGULATIONS PARTS 30 32 33 34 353639 AND 40 AND THAT ALL INFORMATION CONTANED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AND BELIEF WARNiNG 18 USC SECTION 1001 ACT OF JUNE 25194862 STAT 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A VVlLLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER VVlTHIN ITS JURISDICTION ~~~~~~~~-~----------~~~ ~--~~---CERTIFYING OFFICER - TYPEDIPRINTED NAME AND TITLE IDATE
Robert M Constantine President ~c~~~- i lJ1l
FOR NRC USE ONLY TYPE OF FEE IFEE LOG IFEE IgtVIlt IMOUNT RECEIVED ICHECK NUMBER 1 vVMrv
i I APPROVED BY IDATE~~I
NRC FORM 313 (05-2012)
S7117shyNMSSAGN1 MATERIALS-002
i
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
This is an application for a new license
Preface
NovaMed Corporation is purchasing the blood irradiator service business line from Pharmalucence Inc on or about October 15 2012 and seeks a new materials license to continue to operate the business line in the same manner as operated by Pharmalucence which is currently licensed by the NRC
llovaMed Corporation provides medical and research equipment maintenance service parts and sales After the purchase of the blood irradiator business line from Pharmalucence NovaMed will employ the two individuals currently trained and authorized to provide the service along with continuing to use the various radiation safety procedures currently in place
Thank you in advance for your consideration of this application
middot bull 1 lt
Appendix C
Suggested Format for Providing Information Requested in Items 5
through 11 of NRC Form 313
APPENDIXC
Suggested Format for Providing Information Requested in Items 5 through 11 of NRC Form 313
Appendix C is designed to be used for all types of applicants requesting a service license Because of the varied types of service applications it is necessary to make this appendix sufficiently broad in scope to handle most applications Services such as commercial nuclear laundries and waste management applicants may need to provide additional information once the necessary pre-licensing visit(s) are completed Maintaining close coordination during the early licensing phalte with the NRC licensing staff can be beneficial to both the NRC staff and applicant
Using this appendix successfully requires the applicant to do an initial review of the NUREG and preplan its answers We suggest that applicants read the entire appendix from beginning to end The next step is to select the individual elements that apply to the individual types of service(s) requested Highlight or circle Item Nos or in some other way identifY the areas that require specific information Provide the information on the specific elements that you identified as requiring input for obtaining authorization for the requested services
After selecting the applicable items that need to be addressed in Appendix C refer to the corresponding sections in the NUREG It is only necessary for applicants to provide the level of detail required for the individual types of service(s) requested in the application Note that providing information for very limited licenses eg leak test service provider requires less information than would be required for a commercial nuclear laundry or a waste management license Applicants for service licenses requiring authorization for types and quantities ofmaterial specific for broad scope licenses should refer to NUREG-1556 Vol 11 Consolidated Guidance About Material Licenses Program-Specific Guidance About Licenses of Broad Scope and NUREG-1556 Vol 7 Consolidated Guidance About Material Licenses Program-Specific Guidance About Academic Research and Development and Other Licenses of Limited Scope
Item Title and Criteria Use Description No Table(s) Attached
Below
C-I NUREG 1556 Vo1l8
5
APPENDIXC
RADIOACTIVE MATERIAL
Sealed Sources and Devices
bull Identify each radionuclide that will be used in each sealed sourcedevice
bull Identify the manufacturer or distributor and model number of each sealed sourcedevice
bull Confinn that each sealed sourcedevice combination is listed and approved in the SSD registIy for the purpose intended
bull Confinn that the activity per sourcemaximum activity per device specified in the SSD registration certificate will not be exceeded
Radioisotope
Cesium-137
o Depleted Uranium
o Uranium-238
o Thorium-232
o Other Specify
Radioisotope
Sealed Sources
Manufacturer Model No
CIS biointernational Model CSL-15 sealed source housed within Irradiator Model IBL-437C maximum 3 sources II
Quantity
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Source Material
Kilograms
Kilograms
_____ Kilograms
Kilograms
Special Nuclear Material
Manufacturer Quantity Model No
o
o
o
o
IYes INo
L2J 0
0 0
0 0
Yes No
NUREG 1556 Vol 18 C-2
APPENDIXC
0
0
0
Uranium-234
Uranium-235
Plutonium-238
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
0 0
0 Plutonium-239
0 Other SpecifY
C-3 NUREG 1556 Vo118
APPENDIXC
Unsealed or Uncontained Materials
Identify each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
OR
Identify your request for Type B or Type C quantities of material by filling out the table below
Radioisotope IYes INo
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I (Type B o 0 License of Broad Scope)
OR o [] bull Any radioisotope identified in lO CFR 33lO0 Schedule A Column II - (Type C
License of Broad Scope)
AND IF APPLICABLE
Identify individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
J Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Sol1d [] Other Specify
o Gas J Liquid o Solid [] Other Speci ty
o Gas 0 Liquid o Solid o Other Specify
AND
NUREG - 1556 Vol 18 C-4
APPENDIXC
NUREG - 1556 Vo1l8 C-5
APPENDIXC
IdentifY any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services on sealed sourcesdevices and will be required to take possession ofmaterials incident to providing services
Sealed SourcesDevices Possessed Incident to Providing Services
Radioisotope Manufacturerl Quantity Yes No Model No
CIS Not to exceed the maximum activity per m 0Cesium-137 biointernational sourcedevice as specified in the Sealed Model CSL-15 Source and Device Registration Sheet sealed source
Not to exceed the maximum activity per 0 0housed within
sourcedevice as specified in the Sealed Irradiator Model Source and Device Registration Sheet bull - v
Surce Material
o Uranium-238 Kilograms
o Thorium-232 Grams
o Other Grams
o Depleted Uranium Kilograms
NUREG - 1556 Vol 18 C-6
APPENDIXC
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services involving unsealed or uncontained material and will be required to take possession of these materials incident to providing services
Unsealed or Uncontained Materials
IdentifY each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid 0 Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
OR
IdentifY your request for Type B or Type C quantities of materials by filling out the table below
Radioisotope I Yes I No
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I - (Type B o o License of Broad Scope)
OR
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column IT - (Type C o oLicense of Broad Scope)
C-7 NUREG - 1556 Vo118
APPENDIXC
AND IF APPLICABLE
IdentifY individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
o Solid 0 Other Specify
o Solid 0 Other Specify
o Solid 0 Other SpecifY
o Solid 0 Other SpecifY
A~D
Identify any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
NUREG 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
5 RADIOACTIVE MATERIAL
Financial Assurance and Recordkeeping For Decommissioning
bull Pursuant to 10 CFR 3035(g) we shaH maintain drawings and records important to decommissioning and transfer these records to a new licensee before licensed activities are transferred or assign the records to the appropriate NRC Regional Office before the license is terminated
121 D
Company does not possess radioactive material at any of its facilities A decommissioning plan is not required
OR
bull If financial assurance is required submit evidence D
C-9 NUREG - 1556 Voll8
APPENDlXC
Item Title and Criteria No
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
6
bull Leak Test Analysis bull Environmental Sample Analysis bull InstrumentIDosimeter Calibration bull Instruction
Possession Incident to Performing the FoUowing Services on Sealed Sources and Devices
bull Installation bull Radiation Surveys bull Removal bull Disposal bull Relocation bull Repair bull Source Exchange bull Routine Maintenance bull Non-routine Maintenance bull Source Retrieval bull Transportation bull Packaging bull Leak Test Sample Acquisition bull Customer Training bull Other Services not identified above excluding activities
involving critical mass quantities ofspecial nuclear material Specity
Yes
I2J 0 0 0
IZI ~
0 0
(lJ 0 QJ
0 121 I2J I2J IZI CJ
No NA Description Attached
0 IZI I2J I2J
0
0 0 0 0 ~ 0
J 0 0 0 0 IZI 0 0 0 0 0 121 0 0 0 0 0 0 0 0 0 0 (]
NUREG - 1556 Vol 18 C-lO
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
Peabody(pm lFTE yScott Comenzo j H
EngmeerRSO
f---
ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
ByIMAI t-- Special~
ii DePina I Robert Morin I ltopengt BMETI Imaging EngllValentin Boyo - I-shy
I MIlitary Leave I (Mway-LOA) ~ FS BMET- Biomed Tech ell Eng Inlem FS BMETIII thru OcU NOli(Sterlhzersl (FS-CT)BaystateMAj 2012
Tell1Pi~e~I11i1 PtT
y --
pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
pharmaLucence -~ii-~)
PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
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Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
Page 1 of 6
2
2
2
3
5
6
7
7
i
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Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
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Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
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Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
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Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
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Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
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Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
2
2
2
Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
wwwnovamcdcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
wwwuovamcdcorpcom
Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
wwwnovamcdcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
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Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
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Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
2
2
2
3
3
3
Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
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Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
![Page 2: NovaMed Corporation, New License Application dated …](https://reader031.vdocuments.site/reader031/viewer/2022012515/618f6471660b103f1b603183/html5/thumbnails/2.jpg)
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
This is an application for a new license
Preface
NovaMed Corporation is purchasing the blood irradiator service business line from Pharmalucence Inc on or about October 15 2012 and seeks a new materials license to continue to operate the business line in the same manner as operated by Pharmalucence which is currently licensed by the NRC
llovaMed Corporation provides medical and research equipment maintenance service parts and sales After the purchase of the blood irradiator business line from Pharmalucence NovaMed will employ the two individuals currently trained and authorized to provide the service along with continuing to use the various radiation safety procedures currently in place
Thank you in advance for your consideration of this application
middot bull 1 lt
Appendix C
Suggested Format for Providing Information Requested in Items 5
through 11 of NRC Form 313
APPENDIXC
Suggested Format for Providing Information Requested in Items 5 through 11 of NRC Form 313
Appendix C is designed to be used for all types of applicants requesting a service license Because of the varied types of service applications it is necessary to make this appendix sufficiently broad in scope to handle most applications Services such as commercial nuclear laundries and waste management applicants may need to provide additional information once the necessary pre-licensing visit(s) are completed Maintaining close coordination during the early licensing phalte with the NRC licensing staff can be beneficial to both the NRC staff and applicant
Using this appendix successfully requires the applicant to do an initial review of the NUREG and preplan its answers We suggest that applicants read the entire appendix from beginning to end The next step is to select the individual elements that apply to the individual types of service(s) requested Highlight or circle Item Nos or in some other way identifY the areas that require specific information Provide the information on the specific elements that you identified as requiring input for obtaining authorization for the requested services
After selecting the applicable items that need to be addressed in Appendix C refer to the corresponding sections in the NUREG It is only necessary for applicants to provide the level of detail required for the individual types of service(s) requested in the application Note that providing information for very limited licenses eg leak test service provider requires less information than would be required for a commercial nuclear laundry or a waste management license Applicants for service licenses requiring authorization for types and quantities ofmaterial specific for broad scope licenses should refer to NUREG-1556 Vol 11 Consolidated Guidance About Material Licenses Program-Specific Guidance About Licenses of Broad Scope and NUREG-1556 Vol 7 Consolidated Guidance About Material Licenses Program-Specific Guidance About Academic Research and Development and Other Licenses of Limited Scope
Item Title and Criteria Use Description No Table(s) Attached
Below
C-I NUREG 1556 Vo1l8
5
APPENDIXC
RADIOACTIVE MATERIAL
Sealed Sources and Devices
bull Identify each radionuclide that will be used in each sealed sourcedevice
bull Identify the manufacturer or distributor and model number of each sealed sourcedevice
bull Confinn that each sealed sourcedevice combination is listed and approved in the SSD registIy for the purpose intended
bull Confinn that the activity per sourcemaximum activity per device specified in the SSD registration certificate will not be exceeded
Radioisotope
Cesium-137
o Depleted Uranium
o Uranium-238
o Thorium-232
o Other Specify
Radioisotope
Sealed Sources
Manufacturer Model No
CIS biointernational Model CSL-15 sealed source housed within Irradiator Model IBL-437C maximum 3 sources II
Quantity
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Source Material
Kilograms
Kilograms
_____ Kilograms
Kilograms
Special Nuclear Material
Manufacturer Quantity Model No
o
o
o
o
IYes INo
L2J 0
0 0
0 0
Yes No
NUREG 1556 Vol 18 C-2
APPENDIXC
0
0
0
Uranium-234
Uranium-235
Plutonium-238
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
0 0
0 Plutonium-239
0 Other SpecifY
C-3 NUREG 1556 Vo118
APPENDIXC
Unsealed or Uncontained Materials
Identify each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
OR
Identify your request for Type B or Type C quantities of material by filling out the table below
Radioisotope IYes INo
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I (Type B o 0 License of Broad Scope)
OR o [] bull Any radioisotope identified in lO CFR 33lO0 Schedule A Column II - (Type C
License of Broad Scope)
AND IF APPLICABLE
Identify individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
J Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Sol1d [] Other Specify
o Gas J Liquid o Solid [] Other Speci ty
o Gas 0 Liquid o Solid o Other Specify
AND
NUREG - 1556 Vol 18 C-4
APPENDIXC
NUREG - 1556 Vo1l8 C-5
APPENDIXC
IdentifY any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services on sealed sourcesdevices and will be required to take possession ofmaterials incident to providing services
Sealed SourcesDevices Possessed Incident to Providing Services
Radioisotope Manufacturerl Quantity Yes No Model No
CIS Not to exceed the maximum activity per m 0Cesium-137 biointernational sourcedevice as specified in the Sealed Model CSL-15 Source and Device Registration Sheet sealed source
Not to exceed the maximum activity per 0 0housed within
sourcedevice as specified in the Sealed Irradiator Model Source and Device Registration Sheet bull - v
Surce Material
o Uranium-238 Kilograms
o Thorium-232 Grams
o Other Grams
o Depleted Uranium Kilograms
NUREG - 1556 Vol 18 C-6
APPENDIXC
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services involving unsealed or uncontained material and will be required to take possession of these materials incident to providing services
Unsealed or Uncontained Materials
IdentifY each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid 0 Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
OR
IdentifY your request for Type B or Type C quantities of materials by filling out the table below
Radioisotope I Yes I No
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I - (Type B o o License of Broad Scope)
OR
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column IT - (Type C o oLicense of Broad Scope)
C-7 NUREG - 1556 Vo118
APPENDIXC
AND IF APPLICABLE
IdentifY individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
o Solid 0 Other Specify
o Solid 0 Other Specify
o Solid 0 Other SpecifY
o Solid 0 Other SpecifY
A~D
Identify any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
NUREG 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
5 RADIOACTIVE MATERIAL
Financial Assurance and Recordkeeping For Decommissioning
bull Pursuant to 10 CFR 3035(g) we shaH maintain drawings and records important to decommissioning and transfer these records to a new licensee before licensed activities are transferred or assign the records to the appropriate NRC Regional Office before the license is terminated
121 D
Company does not possess radioactive material at any of its facilities A decommissioning plan is not required
OR
bull If financial assurance is required submit evidence D
C-9 NUREG - 1556 Voll8
APPENDlXC
Item Title and Criteria No
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
6
bull Leak Test Analysis bull Environmental Sample Analysis bull InstrumentIDosimeter Calibration bull Instruction
Possession Incident to Performing the FoUowing Services on Sealed Sources and Devices
bull Installation bull Radiation Surveys bull Removal bull Disposal bull Relocation bull Repair bull Source Exchange bull Routine Maintenance bull Non-routine Maintenance bull Source Retrieval bull Transportation bull Packaging bull Leak Test Sample Acquisition bull Customer Training bull Other Services not identified above excluding activities
involving critical mass quantities ofspecial nuclear material Specity
Yes
I2J 0 0 0
IZI ~
0 0
(lJ 0 QJ
0 121 I2J I2J IZI CJ
No NA Description Attached
0 IZI I2J I2J
0
0 0 0 0 ~ 0
J 0 0 0 0 IZI 0 0 0 0 0 121 0 0 0 0 0 0 0 0 0 0 (]
NUREG - 1556 Vol 18 C-lO
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
Peabody(pm lFTE yScott Comenzo j H
EngmeerRSO
f---
ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
ByIMAI t-- Special~
ii DePina I Robert Morin I ltopengt BMETI Imaging EngllValentin Boyo - I-shy
I MIlitary Leave I (Mway-LOA) ~ FS BMET- Biomed Tech ell Eng Inlem FS BMETIII thru OcU NOli(Sterlhzersl (FS-CT)BaystateMAj 2012
Tell1Pi~e~I11i1 PtT
y --
pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
pharmaLucence -~ii-~)
PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
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Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
Page 1 of 6
2
2
2
3
5
6
7
7
i
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Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
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Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
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Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
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Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
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Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
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Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
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Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
2
2
2
Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
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Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
wwwIlovamedcorpcom
Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
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Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
2
2
2
3
3
3
Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
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Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
![Page 3: NovaMed Corporation, New License Application dated …](https://reader031.vdocuments.site/reader031/viewer/2022012515/618f6471660b103f1b603183/html5/thumbnails/3.jpg)
middot bull 1 lt
Appendix C
Suggested Format for Providing Information Requested in Items 5
through 11 of NRC Form 313
APPENDIXC
Suggested Format for Providing Information Requested in Items 5 through 11 of NRC Form 313
Appendix C is designed to be used for all types of applicants requesting a service license Because of the varied types of service applications it is necessary to make this appendix sufficiently broad in scope to handle most applications Services such as commercial nuclear laundries and waste management applicants may need to provide additional information once the necessary pre-licensing visit(s) are completed Maintaining close coordination during the early licensing phalte with the NRC licensing staff can be beneficial to both the NRC staff and applicant
Using this appendix successfully requires the applicant to do an initial review of the NUREG and preplan its answers We suggest that applicants read the entire appendix from beginning to end The next step is to select the individual elements that apply to the individual types of service(s) requested Highlight or circle Item Nos or in some other way identifY the areas that require specific information Provide the information on the specific elements that you identified as requiring input for obtaining authorization for the requested services
After selecting the applicable items that need to be addressed in Appendix C refer to the corresponding sections in the NUREG It is only necessary for applicants to provide the level of detail required for the individual types of service(s) requested in the application Note that providing information for very limited licenses eg leak test service provider requires less information than would be required for a commercial nuclear laundry or a waste management license Applicants for service licenses requiring authorization for types and quantities ofmaterial specific for broad scope licenses should refer to NUREG-1556 Vol 11 Consolidated Guidance About Material Licenses Program-Specific Guidance About Licenses of Broad Scope and NUREG-1556 Vol 7 Consolidated Guidance About Material Licenses Program-Specific Guidance About Academic Research and Development and Other Licenses of Limited Scope
Item Title and Criteria Use Description No Table(s) Attached
Below
C-I NUREG 1556 Vo1l8
5
APPENDIXC
RADIOACTIVE MATERIAL
Sealed Sources and Devices
bull Identify each radionuclide that will be used in each sealed sourcedevice
bull Identify the manufacturer or distributor and model number of each sealed sourcedevice
bull Confinn that each sealed sourcedevice combination is listed and approved in the SSD registIy for the purpose intended
bull Confinn that the activity per sourcemaximum activity per device specified in the SSD registration certificate will not be exceeded
Radioisotope
Cesium-137
o Depleted Uranium
o Uranium-238
o Thorium-232
o Other Specify
Radioisotope
Sealed Sources
Manufacturer Model No
CIS biointernational Model CSL-15 sealed source housed within Irradiator Model IBL-437C maximum 3 sources II
Quantity
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Source Material
Kilograms
Kilograms
_____ Kilograms
Kilograms
Special Nuclear Material
Manufacturer Quantity Model No
o
o
o
o
IYes INo
L2J 0
0 0
0 0
Yes No
NUREG 1556 Vol 18 C-2
APPENDIXC
0
0
0
Uranium-234
Uranium-235
Plutonium-238
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
0 0
0 Plutonium-239
0 Other SpecifY
C-3 NUREG 1556 Vo118
APPENDIXC
Unsealed or Uncontained Materials
Identify each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
OR
Identify your request for Type B or Type C quantities of material by filling out the table below
Radioisotope IYes INo
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I (Type B o 0 License of Broad Scope)
OR o [] bull Any radioisotope identified in lO CFR 33lO0 Schedule A Column II - (Type C
License of Broad Scope)
AND IF APPLICABLE
Identify individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
J Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Sol1d [] Other Specify
o Gas J Liquid o Solid [] Other Speci ty
o Gas 0 Liquid o Solid o Other Specify
AND
NUREG - 1556 Vol 18 C-4
APPENDIXC
NUREG - 1556 Vo1l8 C-5
APPENDIXC
IdentifY any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services on sealed sourcesdevices and will be required to take possession ofmaterials incident to providing services
Sealed SourcesDevices Possessed Incident to Providing Services
Radioisotope Manufacturerl Quantity Yes No Model No
CIS Not to exceed the maximum activity per m 0Cesium-137 biointernational sourcedevice as specified in the Sealed Model CSL-15 Source and Device Registration Sheet sealed source
Not to exceed the maximum activity per 0 0housed within
sourcedevice as specified in the Sealed Irradiator Model Source and Device Registration Sheet bull - v
Surce Material
o Uranium-238 Kilograms
o Thorium-232 Grams
o Other Grams
o Depleted Uranium Kilograms
NUREG - 1556 Vol 18 C-6
APPENDIXC
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services involving unsealed or uncontained material and will be required to take possession of these materials incident to providing services
Unsealed or Uncontained Materials
IdentifY each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid 0 Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
OR
IdentifY your request for Type B or Type C quantities of materials by filling out the table below
Radioisotope I Yes I No
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I - (Type B o o License of Broad Scope)
OR
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column IT - (Type C o oLicense of Broad Scope)
C-7 NUREG - 1556 Vo118
APPENDIXC
AND IF APPLICABLE
IdentifY individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
o Solid 0 Other Specify
o Solid 0 Other Specify
o Solid 0 Other SpecifY
o Solid 0 Other SpecifY
A~D
Identify any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
NUREG 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
5 RADIOACTIVE MATERIAL
Financial Assurance and Recordkeeping For Decommissioning
bull Pursuant to 10 CFR 3035(g) we shaH maintain drawings and records important to decommissioning and transfer these records to a new licensee before licensed activities are transferred or assign the records to the appropriate NRC Regional Office before the license is terminated
121 D
Company does not possess radioactive material at any of its facilities A decommissioning plan is not required
OR
bull If financial assurance is required submit evidence D
C-9 NUREG - 1556 Voll8
APPENDlXC
Item Title and Criteria No
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
6
bull Leak Test Analysis bull Environmental Sample Analysis bull InstrumentIDosimeter Calibration bull Instruction
Possession Incident to Performing the FoUowing Services on Sealed Sources and Devices
bull Installation bull Radiation Surveys bull Removal bull Disposal bull Relocation bull Repair bull Source Exchange bull Routine Maintenance bull Non-routine Maintenance bull Source Retrieval bull Transportation bull Packaging bull Leak Test Sample Acquisition bull Customer Training bull Other Services not identified above excluding activities
involving critical mass quantities ofspecial nuclear material Specity
Yes
I2J 0 0 0
IZI ~
0 0
(lJ 0 QJ
0 121 I2J I2J IZI CJ
No NA Description Attached
0 IZI I2J I2J
0
0 0 0 0 ~ 0
J 0 0 0 0 IZI 0 0 0 0 0 121 0 0 0 0 0 0 0 0 0 0 (]
NUREG - 1556 Vol 18 C-lO
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
Peabody(pm lFTE yScott Comenzo j H
EngmeerRSO
f---
ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
ByIMAI t-- Special~
ii DePina I Robert Morin I ltopengt BMETI Imaging EngllValentin Boyo - I-shy
I MIlitary Leave I (Mway-LOA) ~ FS BMET- Biomed Tech ell Eng Inlem FS BMETIII thru OcU NOli(Sterlhzersl (FS-CT)BaystateMAj 2012
Tell1Pi~e~I11i1 PtT
y --
pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
pharmaLucence -~ii-~)
PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
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Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
Page 1 of 6
2
2
2
3
5
6
7
7
i
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Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
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Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
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Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
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Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
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Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
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Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
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Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
2
2
2
Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
wwwnovamcdcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
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Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
wwwIlovamedcorpcom
Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
wwwllovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
wwruovamedcorpcom
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
2
2
2
3
3
3
Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
![Page 4: NovaMed Corporation, New License Application dated …](https://reader031.vdocuments.site/reader031/viewer/2022012515/618f6471660b103f1b603183/html5/thumbnails/4.jpg)
APPENDIXC
Suggested Format for Providing Information Requested in Items 5 through 11 of NRC Form 313
Appendix C is designed to be used for all types of applicants requesting a service license Because of the varied types of service applications it is necessary to make this appendix sufficiently broad in scope to handle most applications Services such as commercial nuclear laundries and waste management applicants may need to provide additional information once the necessary pre-licensing visit(s) are completed Maintaining close coordination during the early licensing phalte with the NRC licensing staff can be beneficial to both the NRC staff and applicant
Using this appendix successfully requires the applicant to do an initial review of the NUREG and preplan its answers We suggest that applicants read the entire appendix from beginning to end The next step is to select the individual elements that apply to the individual types of service(s) requested Highlight or circle Item Nos or in some other way identifY the areas that require specific information Provide the information on the specific elements that you identified as requiring input for obtaining authorization for the requested services
After selecting the applicable items that need to be addressed in Appendix C refer to the corresponding sections in the NUREG It is only necessary for applicants to provide the level of detail required for the individual types of service(s) requested in the application Note that providing information for very limited licenses eg leak test service provider requires less information than would be required for a commercial nuclear laundry or a waste management license Applicants for service licenses requiring authorization for types and quantities ofmaterial specific for broad scope licenses should refer to NUREG-1556 Vol 11 Consolidated Guidance About Material Licenses Program-Specific Guidance About Licenses of Broad Scope and NUREG-1556 Vol 7 Consolidated Guidance About Material Licenses Program-Specific Guidance About Academic Research and Development and Other Licenses of Limited Scope
Item Title and Criteria Use Description No Table(s) Attached
Below
C-I NUREG 1556 Vo1l8
5
APPENDIXC
RADIOACTIVE MATERIAL
Sealed Sources and Devices
bull Identify each radionuclide that will be used in each sealed sourcedevice
bull Identify the manufacturer or distributor and model number of each sealed sourcedevice
bull Confinn that each sealed sourcedevice combination is listed and approved in the SSD registIy for the purpose intended
bull Confinn that the activity per sourcemaximum activity per device specified in the SSD registration certificate will not be exceeded
Radioisotope
Cesium-137
o Depleted Uranium
o Uranium-238
o Thorium-232
o Other Specify
Radioisotope
Sealed Sources
Manufacturer Model No
CIS biointernational Model CSL-15 sealed source housed within Irradiator Model IBL-437C maximum 3 sources II
Quantity
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Source Material
Kilograms
Kilograms
_____ Kilograms
Kilograms
Special Nuclear Material
Manufacturer Quantity Model No
o
o
o
o
IYes INo
L2J 0
0 0
0 0
Yes No
NUREG 1556 Vol 18 C-2
APPENDIXC
0
0
0
Uranium-234
Uranium-235
Plutonium-238
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
0 0
0 Plutonium-239
0 Other SpecifY
C-3 NUREG 1556 Vo118
APPENDIXC
Unsealed or Uncontained Materials
Identify each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
OR
Identify your request for Type B or Type C quantities of material by filling out the table below
Radioisotope IYes INo
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I (Type B o 0 License of Broad Scope)
OR o [] bull Any radioisotope identified in lO CFR 33lO0 Schedule A Column II - (Type C
License of Broad Scope)
AND IF APPLICABLE
Identify individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
J Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Sol1d [] Other Specify
o Gas J Liquid o Solid [] Other Speci ty
o Gas 0 Liquid o Solid o Other Specify
AND
NUREG - 1556 Vol 18 C-4
APPENDIXC
NUREG - 1556 Vo1l8 C-5
APPENDIXC
IdentifY any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services on sealed sourcesdevices and will be required to take possession ofmaterials incident to providing services
Sealed SourcesDevices Possessed Incident to Providing Services
Radioisotope Manufacturerl Quantity Yes No Model No
CIS Not to exceed the maximum activity per m 0Cesium-137 biointernational sourcedevice as specified in the Sealed Model CSL-15 Source and Device Registration Sheet sealed source
Not to exceed the maximum activity per 0 0housed within
sourcedevice as specified in the Sealed Irradiator Model Source and Device Registration Sheet bull - v
Surce Material
o Uranium-238 Kilograms
o Thorium-232 Grams
o Other Grams
o Depleted Uranium Kilograms
NUREG - 1556 Vol 18 C-6
APPENDIXC
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services involving unsealed or uncontained material and will be required to take possession of these materials incident to providing services
Unsealed or Uncontained Materials
IdentifY each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid 0 Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
OR
IdentifY your request for Type B or Type C quantities of materials by filling out the table below
Radioisotope I Yes I No
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I - (Type B o o License of Broad Scope)
OR
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column IT - (Type C o oLicense of Broad Scope)
C-7 NUREG - 1556 Vo118
APPENDIXC
AND IF APPLICABLE
IdentifY individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
o Solid 0 Other Specify
o Solid 0 Other Specify
o Solid 0 Other SpecifY
o Solid 0 Other SpecifY
A~D
Identify any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
NUREG 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
5 RADIOACTIVE MATERIAL
Financial Assurance and Recordkeeping For Decommissioning
bull Pursuant to 10 CFR 3035(g) we shaH maintain drawings and records important to decommissioning and transfer these records to a new licensee before licensed activities are transferred or assign the records to the appropriate NRC Regional Office before the license is terminated
121 D
Company does not possess radioactive material at any of its facilities A decommissioning plan is not required
OR
bull If financial assurance is required submit evidence D
C-9 NUREG - 1556 Voll8
APPENDlXC
Item Title and Criteria No
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
6
bull Leak Test Analysis bull Environmental Sample Analysis bull InstrumentIDosimeter Calibration bull Instruction
Possession Incident to Performing the FoUowing Services on Sealed Sources and Devices
bull Installation bull Radiation Surveys bull Removal bull Disposal bull Relocation bull Repair bull Source Exchange bull Routine Maintenance bull Non-routine Maintenance bull Source Retrieval bull Transportation bull Packaging bull Leak Test Sample Acquisition bull Customer Training bull Other Services not identified above excluding activities
involving critical mass quantities ofspecial nuclear material Specity
Yes
I2J 0 0 0
IZI ~
0 0
(lJ 0 QJ
0 121 I2J I2J IZI CJ
No NA Description Attached
0 IZI I2J I2J
0
0 0 0 0 ~ 0
J 0 0 0 0 IZI 0 0 0 0 0 121 0 0 0 0 0 0 0 0 0 0 (]
NUREG - 1556 Vol 18 C-lO
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
Peabody(pm lFTE yScott Comenzo j H
EngmeerRSO
f---
ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
ByIMAI t-- Special~
ii DePina I Robert Morin I ltopengt BMETI Imaging EngllValentin Boyo - I-shy
I MIlitary Leave I (Mway-LOA) ~ FS BMET- Biomed Tech ell Eng Inlem FS BMETIII thru OcU NOli(Sterlhzersl (FS-CT)BaystateMAj 2012
Tell1Pi~e~I11i1 PtT
y --
pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
pharmaLucence -~ii-~)
PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
Page 1 of 6
2
2
2
3
5
6
7
7
i
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Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
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Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
wwwnovamedcorpcom
Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
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Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
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Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
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Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
2
2
2
Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
wwwnovamcdcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
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Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
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Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
wwwllovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
wwruovamedcorpcom
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
2
2
2
3
3
3
Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
![Page 5: NovaMed Corporation, New License Application dated …](https://reader031.vdocuments.site/reader031/viewer/2022012515/618f6471660b103f1b603183/html5/thumbnails/5.jpg)
5
APPENDIXC
RADIOACTIVE MATERIAL
Sealed Sources and Devices
bull Identify each radionuclide that will be used in each sealed sourcedevice
bull Identify the manufacturer or distributor and model number of each sealed sourcedevice
bull Confinn that each sealed sourcedevice combination is listed and approved in the SSD registIy for the purpose intended
bull Confinn that the activity per sourcemaximum activity per device specified in the SSD registration certificate will not be exceeded
Radioisotope
Cesium-137
o Depleted Uranium
o Uranium-238
o Thorium-232
o Other Specify
Radioisotope
Sealed Sources
Manufacturer Model No
CIS biointernational Model CSL-15 sealed source housed within Irradiator Model IBL-437C maximum 3 sources II
Quantity
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
Source Material
Kilograms
Kilograms
_____ Kilograms
Kilograms
Special Nuclear Material
Manufacturer Quantity Model No
o
o
o
o
IYes INo
L2J 0
0 0
0 0
Yes No
NUREG 1556 Vol 18 C-2
APPENDIXC
0
0
0
Uranium-234
Uranium-235
Plutonium-238
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
0 0
0 Plutonium-239
0 Other SpecifY
C-3 NUREG 1556 Vo118
APPENDIXC
Unsealed or Uncontained Materials
Identify each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
OR
Identify your request for Type B or Type C quantities of material by filling out the table below
Radioisotope IYes INo
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I (Type B o 0 License of Broad Scope)
OR o [] bull Any radioisotope identified in lO CFR 33lO0 Schedule A Column II - (Type C
License of Broad Scope)
AND IF APPLICABLE
Identify individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
J Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Sol1d [] Other Specify
o Gas J Liquid o Solid [] Other Speci ty
o Gas 0 Liquid o Solid o Other Specify
AND
NUREG - 1556 Vol 18 C-4
APPENDIXC
NUREG - 1556 Vo1l8 C-5
APPENDIXC
IdentifY any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services on sealed sourcesdevices and will be required to take possession ofmaterials incident to providing services
Sealed SourcesDevices Possessed Incident to Providing Services
Radioisotope Manufacturerl Quantity Yes No Model No
CIS Not to exceed the maximum activity per m 0Cesium-137 biointernational sourcedevice as specified in the Sealed Model CSL-15 Source and Device Registration Sheet sealed source
Not to exceed the maximum activity per 0 0housed within
sourcedevice as specified in the Sealed Irradiator Model Source and Device Registration Sheet bull - v
Surce Material
o Uranium-238 Kilograms
o Thorium-232 Grams
o Other Grams
o Depleted Uranium Kilograms
NUREG - 1556 Vol 18 C-6
APPENDIXC
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services involving unsealed or uncontained material and will be required to take possession of these materials incident to providing services
Unsealed or Uncontained Materials
IdentifY each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid 0 Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
OR
IdentifY your request for Type B or Type C quantities of materials by filling out the table below
Radioisotope I Yes I No
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I - (Type B o o License of Broad Scope)
OR
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column IT - (Type C o oLicense of Broad Scope)
C-7 NUREG - 1556 Vo118
APPENDIXC
AND IF APPLICABLE
IdentifY individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
o Solid 0 Other Specify
o Solid 0 Other Specify
o Solid 0 Other SpecifY
o Solid 0 Other SpecifY
A~D
Identify any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
NUREG 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
5 RADIOACTIVE MATERIAL
Financial Assurance and Recordkeeping For Decommissioning
bull Pursuant to 10 CFR 3035(g) we shaH maintain drawings and records important to decommissioning and transfer these records to a new licensee before licensed activities are transferred or assign the records to the appropriate NRC Regional Office before the license is terminated
121 D
Company does not possess radioactive material at any of its facilities A decommissioning plan is not required
OR
bull If financial assurance is required submit evidence D
C-9 NUREG - 1556 Voll8
APPENDlXC
Item Title and Criteria No
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
6
bull Leak Test Analysis bull Environmental Sample Analysis bull InstrumentIDosimeter Calibration bull Instruction
Possession Incident to Performing the FoUowing Services on Sealed Sources and Devices
bull Installation bull Radiation Surveys bull Removal bull Disposal bull Relocation bull Repair bull Source Exchange bull Routine Maintenance bull Non-routine Maintenance bull Source Retrieval bull Transportation bull Packaging bull Leak Test Sample Acquisition bull Customer Training bull Other Services not identified above excluding activities
involving critical mass quantities ofspecial nuclear material Specity
Yes
I2J 0 0 0
IZI ~
0 0
(lJ 0 QJ
0 121 I2J I2J IZI CJ
No NA Description Attached
0 IZI I2J I2J
0
0 0 0 0 ~ 0
J 0 0 0 0 IZI 0 0 0 0 0 121 0 0 0 0 0 0 0 0 0 0 (]
NUREG - 1556 Vol 18 C-lO
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
Peabody(pm lFTE yScott Comenzo j H
EngmeerRSO
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ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
ByIMAI t-- Special~
ii DePina I Robert Morin I ltopengt BMETI Imaging EngllValentin Boyo - I-shy
I MIlitary Leave I (Mway-LOA) ~ FS BMET- Biomed Tech ell Eng Inlem FS BMETIII thru OcU NOli(Sterlhzersl (FS-CT)BaystateMAj 2012
Tell1Pi~e~I11i1 PtT
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pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
pharmaLucence -~ii-~)
PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
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Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
Page 1 of 6
2
2
2
3
5
6
7
7
i
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Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
wwwnovamedcorpcom
Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
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Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
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Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
2
2
2
Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
wwwnov~lmedcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
wwwnovamcdcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
Wlwnovamcdcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
wwwuovamcdcorpcom
Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
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Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
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Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
2
2
2
3
3
3
Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
![Page 6: NovaMed Corporation, New License Application dated …](https://reader031.vdocuments.site/reader031/viewer/2022012515/618f6471660b103f1b603183/html5/thumbnails/6.jpg)
APPENDIXC
0
0
0
Uranium-234
Uranium-235
Plutonium-238
Not to exceed the maximum activity per sourcedevice as specified in the Sealed Source and Device Registration Sheet
0 0
0 Plutonium-239
0 Other SpecifY
C-3 NUREG 1556 Vo118
APPENDIXC
Unsealed or Uncontained Materials
Identify each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
OR
Identify your request for Type B or Type C quantities of material by filling out the table below
Radioisotope IYes INo
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I (Type B o 0 License of Broad Scope)
OR o [] bull Any radioisotope identified in lO CFR 33lO0 Schedule A Column II - (Type C
License of Broad Scope)
AND IF APPLICABLE
Identify individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
J Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Sol1d [] Other Specify
o Gas J Liquid o Solid [] Other Speci ty
o Gas 0 Liquid o Solid o Other Specify
AND
NUREG - 1556 Vol 18 C-4
APPENDIXC
NUREG - 1556 Vo1l8 C-5
APPENDIXC
IdentifY any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services on sealed sourcesdevices and will be required to take possession ofmaterials incident to providing services
Sealed SourcesDevices Possessed Incident to Providing Services
Radioisotope Manufacturerl Quantity Yes No Model No
CIS Not to exceed the maximum activity per m 0Cesium-137 biointernational sourcedevice as specified in the Sealed Model CSL-15 Source and Device Registration Sheet sealed source
Not to exceed the maximum activity per 0 0housed within
sourcedevice as specified in the Sealed Irradiator Model Source and Device Registration Sheet bull - v
Surce Material
o Uranium-238 Kilograms
o Thorium-232 Grams
o Other Grams
o Depleted Uranium Kilograms
NUREG - 1556 Vol 18 C-6
APPENDIXC
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services involving unsealed or uncontained material and will be required to take possession of these materials incident to providing services
Unsealed or Uncontained Materials
IdentifY each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid 0 Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
OR
IdentifY your request for Type B or Type C quantities of materials by filling out the table below
Radioisotope I Yes I No
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I - (Type B o o License of Broad Scope)
OR
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column IT - (Type C o oLicense of Broad Scope)
C-7 NUREG - 1556 Vo118
APPENDIXC
AND IF APPLICABLE
IdentifY individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
o Solid 0 Other Specify
o Solid 0 Other Specify
o Solid 0 Other SpecifY
o Solid 0 Other SpecifY
A~D
Identify any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
NUREG 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
5 RADIOACTIVE MATERIAL
Financial Assurance and Recordkeeping For Decommissioning
bull Pursuant to 10 CFR 3035(g) we shaH maintain drawings and records important to decommissioning and transfer these records to a new licensee before licensed activities are transferred or assign the records to the appropriate NRC Regional Office before the license is terminated
121 D
Company does not possess radioactive material at any of its facilities A decommissioning plan is not required
OR
bull If financial assurance is required submit evidence D
C-9 NUREG - 1556 Voll8
APPENDlXC
Item Title and Criteria No
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
6
bull Leak Test Analysis bull Environmental Sample Analysis bull InstrumentIDosimeter Calibration bull Instruction
Possession Incident to Performing the FoUowing Services on Sealed Sources and Devices
bull Installation bull Radiation Surveys bull Removal bull Disposal bull Relocation bull Repair bull Source Exchange bull Routine Maintenance bull Non-routine Maintenance bull Source Retrieval bull Transportation bull Packaging bull Leak Test Sample Acquisition bull Customer Training bull Other Services not identified above excluding activities
involving critical mass quantities ofspecial nuclear material Specity
Yes
I2J 0 0 0
IZI ~
0 0
(lJ 0 QJ
0 121 I2J I2J IZI CJ
No NA Description Attached
0 IZI I2J I2J
0
0 0 0 0 ~ 0
J 0 0 0 0 IZI 0 0 0 0 0 121 0 0 0 0 0 0 0 0 0 0 (]
NUREG - 1556 Vol 18 C-lO
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
Peabody(pm lFTE yScott Comenzo j H
EngmeerRSO
f---
ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
ByIMAI t-- Special~
ii DePina I Robert Morin I ltopengt BMETI Imaging EngllValentin Boyo - I-shy
I MIlitary Leave I (Mway-LOA) ~ FS BMET- Biomed Tech ell Eng Inlem FS BMETIII thru OcU NOli(Sterlhzersl (FS-CT)BaystateMAj 2012
Tell1Pi~e~I11i1 PtT
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pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
pharmaLucence -~ii-~)
PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
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Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
Page 1 of 6
2
2
2
3
5
6
7
7
i
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Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
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Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
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Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
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Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
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Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
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Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
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Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
2
2
2
Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
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Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
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Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
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Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
2
2
2
3
3
3
Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
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Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
![Page 7: NovaMed Corporation, New License Application dated …](https://reader031.vdocuments.site/reader031/viewer/2022012515/618f6471660b103f1b603183/html5/thumbnails/7.jpg)
APPENDIXC
Unsealed or Uncontained Materials
Identify each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Solid o Other Specify
o Gas 0 Liquid o Solid o Other Specify
OR
Identify your request for Type B or Type C quantities of material by filling out the table below
Radioisotope IYes INo
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I (Type B o 0 License of Broad Scope)
OR o [] bull Any radioisotope identified in lO CFR 33lO0 Schedule A Column II - (Type C
License of Broad Scope)
AND IF APPLICABLE
Identify individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
J Gas 0 Liquid o Solid o Other Specify
o Gas 0 Liquid 0 Sol1d [] Other Specify
o Gas J Liquid o Solid [] Other Speci ty
o Gas 0 Liquid o Solid o Other Specify
AND
NUREG - 1556 Vol 18 C-4
APPENDIXC
NUREG - 1556 Vo1l8 C-5
APPENDIXC
IdentifY any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services on sealed sourcesdevices and will be required to take possession ofmaterials incident to providing services
Sealed SourcesDevices Possessed Incident to Providing Services
Radioisotope Manufacturerl Quantity Yes No Model No
CIS Not to exceed the maximum activity per m 0Cesium-137 biointernational sourcedevice as specified in the Sealed Model CSL-15 Source and Device Registration Sheet sealed source
Not to exceed the maximum activity per 0 0housed within
sourcedevice as specified in the Sealed Irradiator Model Source and Device Registration Sheet bull - v
Surce Material
o Uranium-238 Kilograms
o Thorium-232 Grams
o Other Grams
o Depleted Uranium Kilograms
NUREG - 1556 Vol 18 C-6
APPENDIXC
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services involving unsealed or uncontained material and will be required to take possession of these materials incident to providing services
Unsealed or Uncontained Materials
IdentifY each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid 0 Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
OR
IdentifY your request for Type B or Type C quantities of materials by filling out the table below
Radioisotope I Yes I No
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I - (Type B o o License of Broad Scope)
OR
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column IT - (Type C o oLicense of Broad Scope)
C-7 NUREG - 1556 Vo118
APPENDIXC
AND IF APPLICABLE
IdentifY individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
o Solid 0 Other Specify
o Solid 0 Other Specify
o Solid 0 Other SpecifY
o Solid 0 Other SpecifY
A~D
Identify any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
NUREG 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
5 RADIOACTIVE MATERIAL
Financial Assurance and Recordkeeping For Decommissioning
bull Pursuant to 10 CFR 3035(g) we shaH maintain drawings and records important to decommissioning and transfer these records to a new licensee before licensed activities are transferred or assign the records to the appropriate NRC Regional Office before the license is terminated
121 D
Company does not possess radioactive material at any of its facilities A decommissioning plan is not required
OR
bull If financial assurance is required submit evidence D
C-9 NUREG - 1556 Voll8
APPENDlXC
Item Title and Criteria No
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
6
bull Leak Test Analysis bull Environmental Sample Analysis bull InstrumentIDosimeter Calibration bull Instruction
Possession Incident to Performing the FoUowing Services on Sealed Sources and Devices
bull Installation bull Radiation Surveys bull Removal bull Disposal bull Relocation bull Repair bull Source Exchange bull Routine Maintenance bull Non-routine Maintenance bull Source Retrieval bull Transportation bull Packaging bull Leak Test Sample Acquisition bull Customer Training bull Other Services not identified above excluding activities
involving critical mass quantities ofspecial nuclear material Specity
Yes
I2J 0 0 0
IZI ~
0 0
(lJ 0 QJ
0 121 I2J I2J IZI CJ
No NA Description Attached
0 IZI I2J I2J
0
0 0 0 0 ~ 0
J 0 0 0 0 IZI 0 0 0 0 0 121 0 0 0 0 0 0 0 0 0 0 (]
NUREG - 1556 Vol 18 C-lO
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
Peabody(pm lFTE yScott Comenzo j H
EngmeerRSO
f---
ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
ByIMAI t-- Special~
ii DePina I Robert Morin I ltopengt BMETI Imaging EngllValentin Boyo - I-shy
I MIlitary Leave I (Mway-LOA) ~ FS BMET- Biomed Tech ell Eng Inlem FS BMETIII thru OcU NOli(Sterlhzersl (FS-CT)BaystateMAj 2012
Tell1Pi~e~I11i1 PtT
y --
pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
pharmaLucence -~ii-~)
PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
wwwnonunedcorpcom 2
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
wwwnovamedcorJlcom
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
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Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
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Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
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Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
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Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
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Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
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Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
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Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
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Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
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Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
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Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
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Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
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Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
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Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
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Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
![Page 8: NovaMed Corporation, New License Application dated …](https://reader031.vdocuments.site/reader031/viewer/2022012515/618f6471660b103f1b603183/html5/thumbnails/8.jpg)
APPENDIXC
NUREG - 1556 Vo1l8 C-5
APPENDIXC
IdentifY any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services on sealed sourcesdevices and will be required to take possession ofmaterials incident to providing services
Sealed SourcesDevices Possessed Incident to Providing Services
Radioisotope Manufacturerl Quantity Yes No Model No
CIS Not to exceed the maximum activity per m 0Cesium-137 biointernational sourcedevice as specified in the Sealed Model CSL-15 Source and Device Registration Sheet sealed source
Not to exceed the maximum activity per 0 0housed within
sourcedevice as specified in the Sealed Irradiator Model Source and Device Registration Sheet bull - v
Surce Material
o Uranium-238 Kilograms
o Thorium-232 Grams
o Other Grams
o Depleted Uranium Kilograms
NUREG - 1556 Vol 18 C-6
APPENDIXC
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services involving unsealed or uncontained material and will be required to take possession of these materials incident to providing services
Unsealed or Uncontained Materials
IdentifY each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid 0 Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
OR
IdentifY your request for Type B or Type C quantities of materials by filling out the table below
Radioisotope I Yes I No
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I - (Type B o o License of Broad Scope)
OR
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column IT - (Type C o oLicense of Broad Scope)
C-7 NUREG - 1556 Vo118
APPENDIXC
AND IF APPLICABLE
IdentifY individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
o Solid 0 Other Specify
o Solid 0 Other Specify
o Solid 0 Other SpecifY
o Solid 0 Other SpecifY
A~D
Identify any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
NUREG 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
5 RADIOACTIVE MATERIAL
Financial Assurance and Recordkeeping For Decommissioning
bull Pursuant to 10 CFR 3035(g) we shaH maintain drawings and records important to decommissioning and transfer these records to a new licensee before licensed activities are transferred or assign the records to the appropriate NRC Regional Office before the license is terminated
121 D
Company does not possess radioactive material at any of its facilities A decommissioning plan is not required
OR
bull If financial assurance is required submit evidence D
C-9 NUREG - 1556 Voll8
APPENDlXC
Item Title and Criteria No
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
6
bull Leak Test Analysis bull Environmental Sample Analysis bull InstrumentIDosimeter Calibration bull Instruction
Possession Incident to Performing the FoUowing Services on Sealed Sources and Devices
bull Installation bull Radiation Surveys bull Removal bull Disposal bull Relocation bull Repair bull Source Exchange bull Routine Maintenance bull Non-routine Maintenance bull Source Retrieval bull Transportation bull Packaging bull Leak Test Sample Acquisition bull Customer Training bull Other Services not identified above excluding activities
involving critical mass quantities ofspecial nuclear material Specity
Yes
I2J 0 0 0
IZI ~
0 0
(lJ 0 QJ
0 121 I2J I2J IZI CJ
No NA Description Attached
0 IZI I2J I2J
0
0 0 0 0 ~ 0
J 0 0 0 0 IZI 0 0 0 0 0 121 0 0 0 0 0 0 0 0 0 0 (]
NUREG - 1556 Vol 18 C-lO
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
Peabody(pm lFTE yScott Comenzo j H
EngmeerRSO
f---
ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
ByIMAI t-- Special~
ii DePina I Robert Morin I ltopengt BMETI Imaging EngllValentin Boyo - I-shy
I MIlitary Leave I (Mway-LOA) ~ FS BMET- Biomed Tech ell Eng Inlem FS BMETIII thru OcU NOli(Sterlhzersl (FS-CT)BaystateMAj 2012
Tell1Pi~e~I11i1 PtT
y --
pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
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PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
wwwnonunedcorpcom 2
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
wwwnovamedcorJlcom
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
Page 1 of 6
2
2
2
3
5
6
7
7
i
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
wwwnovamedcorpcom
Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
wwwnovamedcOImiddotpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
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Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
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Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
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Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
2
2
2
Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
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Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
wwwIlovamedcorpcom
Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
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Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
2
2
2
3
3
3
Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
![Page 9: NovaMed Corporation, New License Application dated …](https://reader031.vdocuments.site/reader031/viewer/2022012515/618f6471660b103f1b603183/html5/thumbnails/9.jpg)
APPENDIXC
IdentifY any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services on sealed sourcesdevices and will be required to take possession ofmaterials incident to providing services
Sealed SourcesDevices Possessed Incident to Providing Services
Radioisotope Manufacturerl Quantity Yes No Model No
CIS Not to exceed the maximum activity per m 0Cesium-137 biointernational sourcedevice as specified in the Sealed Model CSL-15 Source and Device Registration Sheet sealed source
Not to exceed the maximum activity per 0 0housed within
sourcedevice as specified in the Sealed Irradiator Model Source and Device Registration Sheet bull - v
Surce Material
o Uranium-238 Kilograms
o Thorium-232 Grams
o Other Grams
o Depleted Uranium Kilograms
NUREG - 1556 Vol 18 C-6
APPENDIXC
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services involving unsealed or uncontained material and will be required to take possession of these materials incident to providing services
Unsealed or Uncontained Materials
IdentifY each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid 0 Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
OR
IdentifY your request for Type B or Type C quantities of materials by filling out the table below
Radioisotope I Yes I No
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I - (Type B o o License of Broad Scope)
OR
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column IT - (Type C o oLicense of Broad Scope)
C-7 NUREG - 1556 Vo118
APPENDIXC
AND IF APPLICABLE
IdentifY individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
o Solid 0 Other Specify
o Solid 0 Other Specify
o Solid 0 Other SpecifY
o Solid 0 Other SpecifY
A~D
Identify any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
NUREG 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
5 RADIOACTIVE MATERIAL
Financial Assurance and Recordkeeping For Decommissioning
bull Pursuant to 10 CFR 3035(g) we shaH maintain drawings and records important to decommissioning and transfer these records to a new licensee before licensed activities are transferred or assign the records to the appropriate NRC Regional Office before the license is terminated
121 D
Company does not possess radioactive material at any of its facilities A decommissioning plan is not required
OR
bull If financial assurance is required submit evidence D
C-9 NUREG - 1556 Voll8
APPENDlXC
Item Title and Criteria No
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
6
bull Leak Test Analysis bull Environmental Sample Analysis bull InstrumentIDosimeter Calibration bull Instruction
Possession Incident to Performing the FoUowing Services on Sealed Sources and Devices
bull Installation bull Radiation Surveys bull Removal bull Disposal bull Relocation bull Repair bull Source Exchange bull Routine Maintenance bull Non-routine Maintenance bull Source Retrieval bull Transportation bull Packaging bull Leak Test Sample Acquisition bull Customer Training bull Other Services not identified above excluding activities
involving critical mass quantities ofspecial nuclear material Specity
Yes
I2J 0 0 0
IZI ~
0 0
(lJ 0 QJ
0 121 I2J I2J IZI CJ
No NA Description Attached
0 IZI I2J I2J
0
0 0 0 0 ~ 0
J 0 0 0 0 IZI 0 0 0 0 0 121 0 0 0 0 0 0 0 0 0 0 (]
NUREG - 1556 Vol 18 C-lO
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
Peabody(pm lFTE yScott Comenzo j H
EngmeerRSO
f---
ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
ByIMAI t-- Special~
ii DePina I Robert Morin I ltopengt BMETI Imaging EngllValentin Boyo - I-shy
I MIlitary Leave I (Mway-LOA) ~ FS BMET- Biomed Tech ell Eng Inlem FS BMETIII thru OcU NOli(Sterlhzersl (FS-CT)BaystateMAj 2012
Tell1Pi~e~I11i1 PtT
y --
pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
pharmaLucence -~ii-~)
PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
wwwnonunedcorpcom 2
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
Page 1 of 6
2
2
2
3
5
6
7
7
i
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
wwwnovamedcorpcom
Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
wwwnovamedcOImiddotpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
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Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
2
2
2
Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
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Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
wwwIlovamedcorpcom
Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
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Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
2
2
2
3
3
3
Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
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Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
![Page 10: NovaMed Corporation, New License Application dated …](https://reader031.vdocuments.site/reader031/viewer/2022012515/618f6471660b103f1b603183/html5/thumbnails/10.jpg)
APPENDIXC
Special Nuclear Material Less than Critical Mass Quantities
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
For those individuals who will provide commercial services involving unsealed or uncontained material and will be required to take possession of these materials incident to providing services
Unsealed or Uncontained Materials
IdentifY each individual isotope requested
Radioisotope Chemical or Physical Form Total Activity Requested
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid 0 Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
o Gas 0 Liquid o Solid o Other Speciry
OR
IdentifY your request for Type B or Type C quantities of materials by filling out the table below
Radioisotope I Yes I No
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column I - (Type B o o License of Broad Scope)
OR
bull Any radioisotope identified in 10 CFR 33100 Schedule A Column IT - (Type C o oLicense of Broad Scope)
C-7 NUREG - 1556 Vo118
APPENDIXC
AND IF APPLICABLE
IdentifY individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
o Solid 0 Other Specify
o Solid 0 Other Specify
o Solid 0 Other SpecifY
o Solid 0 Other SpecifY
A~D
Identify any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
NUREG 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
5 RADIOACTIVE MATERIAL
Financial Assurance and Recordkeeping For Decommissioning
bull Pursuant to 10 CFR 3035(g) we shaH maintain drawings and records important to decommissioning and transfer these records to a new licensee before licensed activities are transferred or assign the records to the appropriate NRC Regional Office before the license is terminated
121 D
Company does not possess radioactive material at any of its facilities A decommissioning plan is not required
OR
bull If financial assurance is required submit evidence D
C-9 NUREG - 1556 Voll8
APPENDlXC
Item Title and Criteria No
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
6
bull Leak Test Analysis bull Environmental Sample Analysis bull InstrumentIDosimeter Calibration bull Instruction
Possession Incident to Performing the FoUowing Services on Sealed Sources and Devices
bull Installation bull Radiation Surveys bull Removal bull Disposal bull Relocation bull Repair bull Source Exchange bull Routine Maintenance bull Non-routine Maintenance bull Source Retrieval bull Transportation bull Packaging bull Leak Test Sample Acquisition bull Customer Training bull Other Services not identified above excluding activities
involving critical mass quantities ofspecial nuclear material Specity
Yes
I2J 0 0 0
IZI ~
0 0
(lJ 0 QJ
0 121 I2J I2J IZI CJ
No NA Description Attached
0 IZI I2J I2J
0
0 0 0 0 ~ 0
J 0 0 0 0 IZI 0 0 0 0 0 121 0 0 0 0 0 0 0 0 0 0 (]
NUREG - 1556 Vol 18 C-lO
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
Peabody(pm lFTE yScott Comenzo j H
EngmeerRSO
f---
ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
ByIMAI t-- Special~
ii DePina I Robert Morin I ltopengt BMETI Imaging EngllValentin Boyo - I-shy
I MIlitary Leave I (Mway-LOA) ~ FS BMET- Biomed Tech ell Eng Inlem FS BMETIII thru OcU NOli(Sterlhzersl (FS-CT)BaystateMAj 2012
Tell1Pi~e~I11i1 PtT
y --
pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
pharmaLucence -~ii-~)
PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
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Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
Page 1 of 6
2
2
2
3
5
6
7
7
i
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Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
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Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
wwwnovamedcorpcom
Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
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Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
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Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
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Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
2
2
2
Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
wwwnovamcdcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
wwwuovamcdcorpcom
Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
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Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
wwwllovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
wwruovamedcorpcom
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
2
2
2
3
3
3
Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
![Page 11: NovaMed Corporation, New License Application dated …](https://reader031.vdocuments.site/reader031/viewer/2022012515/618f6471660b103f1b603183/html5/thumbnails/11.jpg)
APPENDIXC
AND IF APPLICABLE
IdentifY individual isotopes identified in 10 CFR 33100 Schedule A Column I or II that requested quantities exceeding amounts authorized in Column I or II
Radioisotope Chemical or Physical Form Total Activity Requested
o Solid 0 Other Specify
o Solid 0 Other Specify
o Solid 0 Other SpecifY
o Solid 0 Other SpecifY
A~D
Identify any uncontained source or special nuclear materials that should be included in the license
Source Material
o Depleted Uranium Kilograms
o Uranium-238 Grams
o Thorium-232 Grams
o Other Grams
Special Nuclear Material
o Uranium-234 Grams
o Uranium-235 Grams
o Plutonium-238 Grams
o Plutonium-239 Grams
NUREG 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
5 RADIOACTIVE MATERIAL
Financial Assurance and Recordkeeping For Decommissioning
bull Pursuant to 10 CFR 3035(g) we shaH maintain drawings and records important to decommissioning and transfer these records to a new licensee before licensed activities are transferred or assign the records to the appropriate NRC Regional Office before the license is terminated
121 D
Company does not possess radioactive material at any of its facilities A decommissioning plan is not required
OR
bull If financial assurance is required submit evidence D
C-9 NUREG - 1556 Voll8
APPENDlXC
Item Title and Criteria No
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
6
bull Leak Test Analysis bull Environmental Sample Analysis bull InstrumentIDosimeter Calibration bull Instruction
Possession Incident to Performing the FoUowing Services on Sealed Sources and Devices
bull Installation bull Radiation Surveys bull Removal bull Disposal bull Relocation bull Repair bull Source Exchange bull Routine Maintenance bull Non-routine Maintenance bull Source Retrieval bull Transportation bull Packaging bull Leak Test Sample Acquisition bull Customer Training bull Other Services not identified above excluding activities
involving critical mass quantities ofspecial nuclear material Specity
Yes
I2J 0 0 0
IZI ~
0 0
(lJ 0 QJ
0 121 I2J I2J IZI CJ
No NA Description Attached
0 IZI I2J I2J
0
0 0 0 0 ~ 0
J 0 0 0 0 IZI 0 0 0 0 0 121 0 0 0 0 0 0 0 0 0 0 (]
NUREG - 1556 Vol 18 C-lO
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
Peabody(pm lFTE yScott Comenzo j H
EngmeerRSO
f---
ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
ByIMAI t-- Special~
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pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
pharmaLucence -~ii-~)
PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
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Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
Page 1 of 6
2
2
2
3
5
6
7
7
i
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Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
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Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
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Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
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Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
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Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
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Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
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Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
2
2
2
Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
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Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
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Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
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Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
2
2
2
3
3
3
Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
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Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
![Page 12: NovaMed Corporation, New License Application dated …](https://reader031.vdocuments.site/reader031/viewer/2022012515/618f6471660b103f1b603183/html5/thumbnails/12.jpg)
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
5 RADIOACTIVE MATERIAL
Financial Assurance and Recordkeeping For Decommissioning
bull Pursuant to 10 CFR 3035(g) we shaH maintain drawings and records important to decommissioning and transfer these records to a new licensee before licensed activities are transferred or assign the records to the appropriate NRC Regional Office before the license is terminated
121 D
Company does not possess radioactive material at any of its facilities A decommissioning plan is not required
OR
bull If financial assurance is required submit evidence D
C-9 NUREG - 1556 Voll8
APPENDlXC
Item Title and Criteria No
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
6
bull Leak Test Analysis bull Environmental Sample Analysis bull InstrumentIDosimeter Calibration bull Instruction
Possession Incident to Performing the FoUowing Services on Sealed Sources and Devices
bull Installation bull Radiation Surveys bull Removal bull Disposal bull Relocation bull Repair bull Source Exchange bull Routine Maintenance bull Non-routine Maintenance bull Source Retrieval bull Transportation bull Packaging bull Leak Test Sample Acquisition bull Customer Training bull Other Services not identified above excluding activities
involving critical mass quantities ofspecial nuclear material Specity
Yes
I2J 0 0 0
IZI ~
0 0
(lJ 0 QJ
0 121 I2J I2J IZI CJ
No NA Description Attached
0 IZI I2J I2J
0
0 0 0 0 ~ 0
J 0 0 0 0 IZI 0 0 0 0 0 121 0 0 0 0 0 0 0 0 0 0 (]
NUREG - 1556 Vol 18 C-lO
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
Peabody(pm lFTE yScott Comenzo j H
EngmeerRSO
f---
ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
ByIMAI t-- Special~
ii DePina I Robert Morin I ltopengt BMETI Imaging EngllValentin Boyo - I-shy
I MIlitary Leave I (Mway-LOA) ~ FS BMET- Biomed Tech ell Eng Inlem FS BMETIII thru OcU NOli(Sterlhzersl (FS-CT)BaystateMAj 2012
Tell1Pi~e~I11i1 PtT
y --
pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
pharmaLucence -~ii-~)
PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
wwwnonunedcorpcom 2
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
wwwnovamedcorJlcom
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
Page 1 of 6
2
2
2
3
5
6
7
7
i
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
wwwnovamedcorpcom
Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
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Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
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Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
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Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
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Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
2
2
2
Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
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Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
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Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
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Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
2
2
2
3
3
3
Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
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Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
![Page 13: NovaMed Corporation, New License Application dated …](https://reader031.vdocuments.site/reader031/viewer/2022012515/618f6471660b103f1b603183/html5/thumbnails/13.jpg)
APPENDlXC
Item Title and Criteria No
PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED
6
bull Leak Test Analysis bull Environmental Sample Analysis bull InstrumentIDosimeter Calibration bull Instruction
Possession Incident to Performing the FoUowing Services on Sealed Sources and Devices
bull Installation bull Radiation Surveys bull Removal bull Disposal bull Relocation bull Repair bull Source Exchange bull Routine Maintenance bull Non-routine Maintenance bull Source Retrieval bull Transportation bull Packaging bull Leak Test Sample Acquisition bull Customer Training bull Other Services not identified above excluding activities
involving critical mass quantities ofspecial nuclear material Specity
Yes
I2J 0 0 0
IZI ~
0 0
(lJ 0 QJ
0 121 I2J I2J IZI CJ
No NA Description Attached
0 IZI I2J I2J
0
0 0 0 0 ~ 0
J 0 0 0 0 IZI 0 0 0 0 0 121 0 0 0 0 0 0 0 0 0 0 (]
NUREG - 1556 Vol 18 C-lO
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
Peabody(pm lFTE yScott Comenzo j H
EngmeerRSO
f---
ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
ByIMAI t-- Special~
ii DePina I Robert Morin I ltopengt BMETI Imaging EngllValentin Boyo - I-shy
I MIlitary Leave I (Mway-LOA) ~ FS BMET- Biomed Tech ell Eng Inlem FS BMETIII thru OcU NOli(Sterlhzersl (FS-CT)BaystateMAj 2012
Tell1Pi~e~I11i1 PtT
y --
pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
pharmaLucence -~ii-~)
PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
wwwnonunedcorpcom 2
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
wwwnovamedcorJlcom
Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
Page 1 of 6
2
2
2
3
5
6
7
7
i
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
wwwnovamedcorpcom
Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
wwwnovamedcOImiddotpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
wwwnovamedcorpcom
Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
2
2
2
Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
wwwnov~lmedcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
wwwnovamcdcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
Wlwnovamcdcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
wwwuovamcdcorpcom
Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
wwwnovamcdcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
wwwIlovamedcorpcom
Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
wwwllovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
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Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
2
2
2
3
3
3
Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
![Page 14: NovaMed Corporation, New License Application dated …](https://reader031.vdocuments.site/reader031/viewer/2022012515/618f6471660b103f1b603183/html5/thumbnails/14.jpg)
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (Contd)
Possession Incident to Performing Commercial Services Utilizing Unsealed or Uncontained Licensed Material
QJ
Nuclear Laundry 0 0
Waste Management Services
bull Commercial Incineration bull Commercial CompactionSuper Compaction bull Commercial SolidificationIVitrification bull Packaging Repackaging and Transportation of
Radioactive Waste bull Decontamination bull Decommissioning bull Site Characterization bull Radiation protection or health physics training and
instruction bull Other Services not identified above excluding activities
involving critical mass quantities of special nuclear material SpecifYshy
0 0 0 0
0 0 0 0
0 0 0 0
1 0 1 0
0
C-lI NUREG 1556 Vo1l8
7
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
Radiation Safety Officer
bull The name of the QroQosed RSO IMichael Thomson I
AND EITHER
bull The specific training and experience of the RSO 0
OR
bull Alternative infonnation demonstrating that the proposed RSO is qualified by training and experience eg listed ~
by name as an authorized user or the RSO on an NRC or Agreement State license that requires a mdiation safety progmm of compamble size and scope
NUREG - 1556 Vol 18 C-12
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Authorized Users
bull Before using licensed material authorized users will receive the training described in Appendix H of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
III 0
OR
bull A description of the training and experience for proposed authorized users
iii
Ancillary Personnel
bull Before using licensed materials ancillat) personnel will have successfully completed the classroom training portion of the training course described in Appendix H ofNlJREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0
OR
bull A description of the radiation safety training program including topics covered groups ofworkers assessment oftraining qualifications of instl1lctors and the method and frequency oftraining
0
C-13 NUREG 1556 Voll8
APPENDIXC
Item Title and Criteria No
9 FACILITIES A~D EQUIPMENT
Permanent Facilities Specifically Identified on the License
bull Leak Test and Environmental Sample Analysis Providers No response required for facilities (Equipment is discussed in Item 10 Radiation Safety Program)
bull Instrument Calibration If only sealed sources are possessed in registered devices designed to emit a collimated beam for the purpose of instrument calibration no response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources in a shielded container No response required (Equipment is discussed in Item 10 Radiation Safety Program)
bull Services that involve handling of sealed sources outside a shielded container
Submit a drawing or sketch of the proposed permanent facility identifYing areas where radioactive materials including radioactive wastes will be used or stored
- Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas
- SpecifY in the drawings shielding materials (concrete lead etc) and means for securing radioactive materials from unauthorized removal
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or sketch Describe engineered safety systems eg area monitors interlocks alarms etc
Yes No NA Description Attached
No Response is Necessary for this Section
No Response is Necessary for this Section
No Response is Necessary for this Section
0 [)
0
0
0
0
0
I
NUREG - 1556 Vol 18 C-14
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES MD EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material
bull Leak Test and Environmental Sample Analysis No Response is Necessary for Providers No response required for facilities this Section (Equipment is discussed in Item 10 Radiation Safety Program)
bull Other services that involve handling of unsealed 0 III radioactive material at pennanent facilities or field stations identified on the license - Describe the pennanent facilities and equipment to 0 0
be made available at each location where unsealed radioactive material will be used or handled
- Include a description of the area(s) assigned for the receipt storage security preparation handling 0 0 waste storage and measurement ofradioactive materials
- Submit a mcility diagram showing the proximity of licensed materials to unrestricted areas 0 0 0 0
- Drawings sketches diagrams etc should indicate the scale or include dimensions on each drawing or 0 sketch
- Submit a diagram sketch or drawing when applicable that identifies areas where radioactive 0 0 materials may become airborne The diagram should contain descriptions of the ventilation systems with pertinent airflow rates filtration equipment sample collection points and monitoring systems
- Submit a diagram of radioactive waste handling equipment that includes incinerators compactors 0 0 solidification equipment hold-up tanks sample collection points etc
C-15 NUREG 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
9 FACILITIES AND EQUIPMENT (Contd)
Permanent Facilities Specifically Identified on the License Requesting the Use of Unsealed or Uncontained Material (Contd)
- Describe proposed lalll1dry facilities if applicable 0 0 used for contaminated protective equipment and clothing SpecifY how the contaminated waste water from the lalll1dry machines or sinks is disposed Operating and emergency procedures should address decontamination ofthe laundry area and equipment Describe protective clothing (such as rubber gloves coveralls respirators and face shields) auxiliary 0 0 shielding absorbent materials secondary containers for waste water storage for decontamination purposes plastic bags for storing contaminated items etc that will be available
- IdentifY specialized handling tools facility interlocks designed to prevent operation of systems in the event that operation of the system could result in 0 0 accidental exposure or release ofmaterial (eg HEPA filters ventilation system etc) or equipment
Temporary Job Site Locations
bull No facility description is required for use of materials at Need Not Be Submitted With temporary job sites Application
Customers (hospitals and licensed blood banks eg Aml~rican Red Cross) are temporary job sites in IlirPI1ltpri friitip~
NUREG - 1556 VoL 18 C-16
19
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
to RADIATION SAFETY PROGRAM
The applicant is required to establish and submit its radiation protection program Each item listed below should be addressed in the corresponding sections of this guide
bull Development and implementation of an ALARA QJ 0 0 0 program
bull Description of equipment and facilities adequate to protect personnel the public and the environment
bull Confmnation that licensed activities are conducted only by individuals qualified by training and experience
bull Development and maintenance ofwritten operating and emergency procedures
bull hnplementation of an audit program to ensure that at least annually the radiation safety program is reviewed
bull Description of organization structure and individuals responsible for ensuring day-to-day oversight of the radiation safety program
bull Establishment and management of a radiation safety and decommissioning records system
bull Methods or procedures for preventing the release of contaminated material and equipment
bull Methods or procedures for preventing personnel contamination Radiation safety procedures and the authorized users responsibilities unique to (ach type of service operation requested in the application
bull Radiation safety procedures bull Equipment techniques and corresponding radiation
safety procedures associated with providing services involving either sealed sources or unsealed materials
I2J
121
I2J
121
121
I2J
I2J
121
WJ
I2J
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0 0
0
0
1
0
0
0
0
0
0 0
Audit Program Need Not Be Submitted With Application
C-17 NUREG - 1556 VoLl8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vo1 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be used to
perform required surveys We will use instruments that meet the radiation monitoring instrument specifications published in Appendix J of NUREGshy1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
121 0 0
OR
bull A description of the instrumentation described in Section 8102 ofNUREG-1556 Vol 18 ConsoHdated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 that will be ll)ed to perform required surveys We will use instrument) that meet the radiation monitoring instrument specifications published in Appendix J ofNUREGshy1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 Additionally we will implement the model survey meter calibration program published in Appendix J of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 We reserve the right to upgrade our survey instruments as necessary
0
NUREG - 1556 Vol 18 C-8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Radiation Monitoring Instruments (Contd)
OR
bull A description of alternative equipment andor procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be perfonned The statement We reserve the right to upgrade our survey instrument as necessary should be added to the response
0
Material Receipt and Accountability
bull Ordering licensed material and package receipt and opening will follow the model procedures in Appendix K ofNUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 121
OR
bull Submit a description ofprocedure(s) for ordering licensed material and package receipt and opening
0
AND
bull For unsealed licensed material submit a description of procedure(s) for ensuring material accountability
0
C-19 NUREG - 1556 Vo1l8
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry
bull We will have a prospective evaluation and deteITIline QJ 0 that unmonitored individuals are not likely to receive in one year a radiation dose in excess of 10 of the allowable limits in 10 CFR Part 20 or we will monitor individuals in accordance with the criteria in the section entitled Occupational Dose in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull A description of an alternate method for demonstrating compliance with the referenced regulations 0
ANDOR
bull Provide a bioassay program when using unsealed radioactive materials If an applicant elects to provide a bioassay program that is less conservative than 0 recommended in Regulatory Guide 820 its rationale should be stated
AND
bull Bioassay programs must include what the applicant considers and acceptable interval or schedule for conducting bioassays identifY action levels or 0 guidelines and describe specific actions to be taken when action levels are exceeded Because of the complex nature ofbioassay and corresponding data analysis it is acceptable for applicants to make reference to the procedures in NRC guidance documents
NUREG - 1556 Vol 18 C-20
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Occupational Dosimetry (Contd)
OR
bull Contract with an outside group for bioassay services 0 Provide a commitment that each vendor is licensed or otherwise authorized by NRC or Agreement State to provide required bioassay services
Public Dose Need Not Be Submitted With Application
The applicant is not required to and should not submit a response to the public dose section during the licensing phase This matter will be addressed during an inspection
Operating and Emergency Procedures
bull Procedure for obtaining an agreement with customers I2J 0 0 0 outlining the responsibilities of both the customer and service provider when performing service operations at a customers facility
bull Instructions for handling and using licensed materials liZ 0 0 0 bull Instructions for maintaining security during storage and
transportation I2J 0 0 0 bull Instructions to keep licensed material under control and
immediate surveillance during use IZI 0 0 bull Steps to take to keep radiation exposures ALARA bull Steps to maintain accountability during use 0 0 (2J 0 bull Steps to control access to work sites 0 0 IZl 0 bull Steps to take and whom to contact when an emergency 13 0 0 0
occurs 0 0 0 0 bull Instructions for using remote handling tools when
handling sealed sources except low-activity calibration 0 0 liZ 0 sources
bull Methods and occasions for conducting radiation surveys including surveys for detecting contamination aJ 0 0 0
C-21 NUREG - 1556 Vol 18
APPENDIXC
Item Title and Criteria No
to RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures to minimize personnel exposure during ~
routine use and in the event of an incident including exposures from inhalation and ingestion of licensed unsealed materials
bull Methods and occasions for locking and securing stored 0 licensed materiallt
bull Procedures for the implementation and adherence to good health physics practices while performing service operations
Minimization ofdistance to areas to the extent ~
practicable where licensed materials are used and stored Maximization of survey frequency within reason to I2J enhance detection of contamination Segregation of radioactive material in waltte storage 0 areas Segregation of sealed sources and tracer materials 0 to prevent cross-contamination Separation of radioactive material from explosives Separation of potentially contaminated areas from clean areas by barriers or other controls I2J
bull Personnel monitoring including bioassays and the use I2J ofpersonnel monitoring equipment
bull Transportation of licensed materials to temporary job I2J sites packaging of licensed materials for transport in vehicles placarding ofvehicles when needed and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss tampering or unauthorized removal
bull Procedures for picking up receiving and opening III packages containing licensed materials in accordance with 10 CFR 201906
bull Instructions for maintaining records in accordance with I2J the regulations and the license conditions
NA
0 0
0 121
0 0
0 0
0 I2J
0 II2J
0 0
0 0
0 0
0 0
0 0
0 0
Description Attached
0
0
Good health physics practices are 0 observed during service
0 provision irradiators
0 featu re fixed sealed sources
0 within high capacity
0 shielding system
0
0
0 Note Further research required
0
0
NlJREG -1556 Vol 18 C-22
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Operating and Emergency Procedures (Contd)
bull Procedures for identifYing and reporting to NRC defects and noncompliance as required by 10 CFR 2121(a) of this chapter
bull Procedures and actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments
bull Instructions for the proper storage and disposal of radioactive waste
bull Procedures to be followed in the event of uncontrolled release of radioactive unsealed licensed material to the environment including notification ofthe RSO NRC and other Federal and state agencies
bull Procedures for identifying and reporting to ~C defects and noncompliance See Table 84 which describes the typical incident notifications required by NRC regulations
m
rlI
IZJ
rlI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
C-23 NUREG - 1556 Vo1l8
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAM (Contd)
Surveys
bull We will survey our facility and maintain contamination levels in accordance with the survey frequencies and contamination levels published in NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
(2J 0
OR
bull Submit description of alternative method for demonstrating how to evaluate a radiological hazard 0
Leak Tests
bull Leak tests when required by the license will be performed at intervals approved by NRC or an Agreement State and specified in the Sealed Source and Device Registration Sheet Leak tests will be performed by an organization authorized by NRC or an Agreement State to provide leak testing services to other licensees or using a leak test kit supplied by an organization authorized by NRC or an Agreement State to provide leak test kits to other licensees and according to the kit suppliers instructions
0 0 0
OR
middot Leak testing will follow the model procedures in Appendix 0 ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
IJ 0
NUREG l556 Vol 18 C-24
APPENDIXC
Item No
Title and Criteria Yes No NA Description Attached
10 RADIATION SAFETY PROGRAlf (Contd)
Leak Tests (Contd)
OR
bull Leak testing procedures and analysis will be done by the applicant Provide the infonnation in supporting a request to perfonn leak testing Appendix 0 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 may serve as guidance
III LJ 0 121
OR
bull We will provide commercial leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
0 0 0
AND
bull We will provide leak test kits as described in the model leak test kit description in Section 898 of NUREG-1556 Vol 18
bull Provided is a sample of the leak test kits that will be distributed commercially for each type of sealed sourcedevice combination we plan to provide
0 0 0
0
C-25 NUREG - 1556 VoLl8
APPENDIXC
Item Title and Criteria No
10 RADIATION SAFETY PROGRAlVI (Contd)
Maintenance
bull We will implement and maintain procedures for conducting routine maintenance ofour device according to each manufacturers (or distributors) written recommendations and instructions
OR
bull Alternative procedures are provided for NRCs review bull We will have the device manufacturer (or distributor)
or other person authorized by NRC or an Agreement State to perform non-routine maintenance on our devices
OR
bull Information requested in Appendix P of NUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000 is provided to support requests to conduct non-routine maintenance procedures
Minimization of Contamination
middot NRC will consider that the criteria for minimization of contamination has been met if the applicants responses satisfY the criteria in the following sections Radioactive Material Unsealed andor Sealed Sources Facilities and Equipment Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures Radiation Safety Program - Surveys and Radiation Safety Program - Waste Management
Yes No NA Description Attached
I2J 0 0
0 0 0
0
No Response is Necessary for this Section
NUREG - 1556 Vol 18 C-26
APPENDIXC
Item Title and Criteria Yes No NA Description No Attached
10 RADIATION SAFETY PROGRAM (Contd)
Transportation No Response is Necessary for this Section
No response is needed from applicants during the licensing phase
Waste Management
bull We will use the model waste procedures published in 0 0 ~
Appendix N ofNUREG-1556 Vol 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
bull If the applicant wishes to use only selected model 0 0 121 procedures provide a statement that We will use the (specify either (1) Decay-In-Storage or (2) Disposal ofLiquids Into Sanitary Sewerage) model waste procedures that are published in Appendix N of NUREG-1556 VoL 18 Consolidated Guidance About Materials Licenses Program-Specific Guidance About Service Provider Licenses dated November 2000
OR
bull Provided are procedures for waste collection storage 0 and disposal by any of the authorized methods described in this section
OR
bull If access to a radioactive waste burial site is 0 0 I2J 0 unavailable the applicant should request authorization for extended interim storage ofwaste Applicant should refer to NRC IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees dated February 1990 for guidance if extended storage is required
C-27 NUREG - 1556 VoLl8
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPIICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 5 RADIOACTIVE MATERIAL
A Radioisotope - Cesium-137
B Chemical andor physical form - Sealed Source Manufacturer - CIS bio international Gif-sur-Yvette Saclay France Model- CSL-15
C Possession Limit - Not to exceed 1870 Ci692 TBq per source 11220 ci4151 TBq total
From one to three Model CSL-15 sources are permanently installed in a Model IBL 437C Irradiator Possession limits are defined to allow temporary possession of two (2) IBL 437C irradiators at a temporary job site requiring irradiator replacement (existing irradiator removal and replacement irradiator installation) The IBL 437C is a category I (self-contained dry source-storage) gamma irradiator See ANSI N4331-1977
Section 6 PURPOSES FOR WHICH LICENSED MATERIAL WILL BE USED
Possession of irradiators at temporary job sites only for possession incident to maintenance repair relocation (packaging and transportation at licensed site) and leak testing of Model IBL 437C irradiators Sealed radioactive sources wi not be installed replaced or disposed of The source shield will not be breached disassembled or modified at any time except for modification to secondary shielding for enhancement of ModellBL 437C irradiators consistent with designs established by Sandia National Laboratories and as described by US NRC regulatory Issue Summary 2008-17 Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
Section 7 INDIVIDUAL RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING EXPERIENCE
See attached NovaMed Organization Chart for RSO reporting
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Michael Thomson has held the role of Radiation Safety Officer under the MRCP license 20-9734 since 2008 and is qualified in this role per NUREG -1556 Vol 5 Appendix G Consolidated Guidance about Materials Licenses Program Specific Guidance about Self-shielded Irradiator Licenses dated June 1998 (See attached training record)
--
--------
Robert MJZiL~U~~-- Constantine
NovaMed President
I John JaKer
Joan Hall Melissa Bauer C Joseph Carbone Sue E Stanley Regional Director of
Human Resources Customer Support Director of ServiceVP amp CFO Service Ops
Manager Operations Mgr Operrlions(MidAtlantic)
Joseph McGillicuddyI r--shyTimothy Franklin Director of
Sr Imaging I- Business Dev Engineer Shurland Fields Paul Grammer MtdAtanttt SupervisorSupervisor )--
BlOffied SeflIlCe Ops RobertBIOmedIcal Service Ops Bndgeport DeFrancesco
Sales Account Theodore Kosinski Richard Klaff I-----shy
Equipment BMETIIIp0J-ICtr - David Green I-
Specialist ILabl 8ndgaport ~ecu~ rd George Mason U BMETIII I-- -f V Rozovsky J
MasonlCare 8 FTE Site Manager Flteld Svc 2 FTE Jeffrey Dlmitt
lawrence (NY) Thomas
esney Kevin Richir Hostetler Sales Account f-shySite Manager ExecutiveBMETIIIoord I-shyUVA Ma~ PA
---- Tushar Mitra I-- 4Dhr~iman Das J 1~~r~ortESite Manager 8MET t
Hackettstown (NJ) lawrence (NY) i Carol Koumbaros J Drew Sheppard David Reihl Sales amp MktingBMETII f-shy
UVA Philip Perdion EqUipment I- Ad~ni~tSpecialist
M~i~~Repair I-- BndoeportH Ks~drew poniro~w~K~n Tech Anthony COPPOlaJ Fernando Sr Imaging Eng Baystate ~MA SrteMgr Bridgeportin 2FTE Eastem Long I$ (NY) Abrego
BMET IIIIFS r (~L~l - Bridgeport amp SateiliteBMETHI FWilIQServlCe (lAAj Frulhlres vnares gl Field Service
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ITmiddot-Site Mgr Sr Iagirt Eng (MAl Southampion (NY) Jamil Thomas
BMETII f--shy------ Ernie Rau Bridgeport Ronald McCoy H HyunLee ~~aUI cOIi1~~jltopengt Sr Imaging Eng Field Service FS BMETIII FSBMETIII f--- (FS-MA)Field Service t-- iVents AnesthesIa) (Upstate New York) Engineer
Technician tNH ) BaySlale (MA) Marcus J-
ChapmanKeith Golmk MankusGeorge True 8METI AnarewI l~ FSBMET Bndgeport Sr Imagi~ Eng
Intem FS BMETIII f--shy~Mlford 4 ns 6)[-- y
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I MIlitary Leave I (Mway-LOA) ~ FS BMET- Biomed Tech ell Eng Inlem FS BMETIII thru OcU NOli(Sterlhzersl (FS-CT)BaystateMAj 2012
Tell1Pi~e~I11i1 PtT
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pharmalucence t ~ 1 ~ -bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation lOS Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmalucence -Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Attest Dated November 120]]liJJ 1n~ Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive BedfordMA01730 (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
alucencemiddot p~~r11 ~
lSI bullbullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
II II
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105
Applicable to Activities and responsibilities authorized ill Massachusetts Material License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 0441-middotReviewed and updated Operating Procedure Tcmporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency I Precautionary Procedures shy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest-LriwJJ~middot Dated November 7 2010 ~~7n~~~~--==shyMichael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 Fax (781) 275-5191
wwwcisusinccom
pharmalucence ~t 3 J 4l t
I bull-bullbullbullbullbullbull shyCERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per S~tion 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue ill Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Attest Dated November 30 20092tid-L 17 ---shyMichael M Thomson Radiation Safety Officer
CIS-US Inc lODe Angelo Drive bull BedfordMA01730 bull (781)275-7120 bull Fax (781) 275-5191
wwwcisusinccom
tr ph~rmaLucence - bullbullbullbullbullbullbullbullshy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening of Irradiators
Attest--21i-LI~~=----1J~~~~--===-_ Dated September 18 2008 Michael M Thomson Radiation Safety Officer
CIS-USInc 10 DeAngelo Drive bull BedfordMAOl730 bull 78l)275-7120 bull Fax781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Albequerque NM
Attest--~7~~-----17---=--~----=--=------=--_ Dated Marcb amp November 2007 Michael M Thomson Reciiation Safety Officer
CIS-US Inc bull 10 De Angelo Drive bull Bedford MA 01730 (781) 275-7120 Pax (781) 275-5191
wwwcisusinccom
pharmalucence -== -- =~-shy- RADIOLOGICAL TRAINING AND EXPERIENCE
Michael M Thomson Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY Field ofTrainin
a Radiation Physics amp Instrumentation
b Principles amp Practices of Radiation Protection
c Mathematics Pertaining to Use and Measurement of Radioactivity
Biological Effects of Ionizing Radiation ampRisks of Occupational Exposure
e Safety amp Regulatory Issues for IBL 437C Field Service
CIS-US Radiation Safety Course (695)
CIS-US Radiation Safety Training Course (695) 4 4
CIS-US Radiation Safety Training Course (6195)
CIS-US Radiation Safety Training Course (695)
CIS-US Radiation Safety Training Course (695)
USNRC Rgn IV Protective Measures Workshop 61504 NRC Increased RM Access ControlsMampD Orders CY2006 Auamented Annual Trainina Sessions (Last 3107 amp 1107)
2
8 8
60
EXPERIENCE WITH RADIATION (Actual use of Radionuclides or Equivalent Experience)
y
Guy Turqwt de Beauregard General Manager Emsll gturquetclsbocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
QLBf OJ07-361CDIID Saelay September 411gt 2007
Dear Mr AIIo
In response to the recent divestiture by CIS blo international of its company CIS-US Inc to the CISshyUS manapment team we hereby acknowledges that
bull CIS-US Ine 10 DeAngelo Drive Bedford MA 01730 continues tobe the xelus~ field service provider for the CIS bio international Modellel 437C blood irradiator systems WithIn the respective jurisdictions of the US NRC and its Agreement States
bull fltOllald G McCoy and Michael M Thomson employaea of CIS-US Inc have 8IlCIUed many years of field service experience since lheir factory-training at CIS blo International faeilltles in belay [FRANce in 1991 and 1996 NSpectively They have beensuceessfully evaluatecl and authorized through US NRC-ordered security cearences to rJeId-service the ModetlBl 437C Irradiators
CIS bIo international is pleased to support CIS-US Inc in its continuing commitment to maintain and operate under the guidance of NRC and Agreement state security polioy
Sincerely
4~ Guy TUAaUET de BEAUREGARD Ganeral Manager CIS bio international
CiS blo ifltemaWtull ~ SAS u Gapllwl tie 311)00 000 EU()$ 5111 Saelov(E bullbullOI1oe)middot RN 306 bull BP 32 - 911Q2 GlfmiddoturYWlI Cedex - __ - T 33 (0)1 1185 70 70 _ F -33 (0)1 698510 71 bull WWWClbiointe lioolfr
Res evry B 312 261 894 - N klOfIIIflcUon TVA PR ltl312 261 8114
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555middot0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositionfTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on AprH 3D 2003 provided additional information conceming the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from public release under the Freedom 01 Inlom1ation Act (5 USC 552)
Exemption number __2_ Nuclear Regulatol) Commission review required before public release
M 0 Layton NSIRIONSIMTWS Name and organization 01 person making determination
Oata of Determination ___1w112~512003=-___
OFFICIAL USE ONLY
-2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving SGI that may be included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive SGI If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to SGI you do not have to notify NRC We request that you keep at least one individual on this list as your pOint of contact for receiving SG
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mall at fcsnrcgov
Sincerely
~-4J~-k- Thomas H Essig Chief
Materials Safety and Inspeotion Branch Division of Industrial and Medical
Nudear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 72003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T-4D8 Washington DC 20555
Sub Registration to receive information re enhanced security of radioactive material in response to USNRC letter dated 31-0CT-03
Dear SirMadam
CIS-US Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service Engineer been authorized by the current MAlRCP and precedent USNRC since 23-JUN-9S
Ronald G McCoy Field Service Engineer authorized by the current MAlRCP and 29-APR-98
Ron has been licenses since
been the RS 0 for all of and Manages reciprocity arrangements for irradiator field service in other Agreement States and in NRC jurisdictions
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please fee free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyrcccisusinccom
PERSONAL INFORMATION WAS REMOVED ~y NRC NO COpy OF THIS INFORMATION VAS RETAINED BY THE NRC
phlilrmalucence ~~~~~i~~jl
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 2012
Title Field Service Engineer
Signed
~n~ Employee
Date
29 Duntmm itnCld bull Hill Mf 01R2 bull Phon 71l1~15721J Fax nn2iSH1 WIiliphllrlllaluccllcecon
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112011
Review Period 2010
Title Field Service Engineer
x
x No installationsRelocations
x
x
We no longer attend trade Attend trade shows and specific training programs as needed X shows Looking to attend
RSO soon
Performs duties of Radiation Safety Officer and works with office staff to obtain reciprocity and make appropriate X
)Z7L~ Employee Date I
-~----Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 shy 2010
Title Field Service Engineer
and appropriate spare parts inventory C0l1~j1ermQ availability lead time from equipment
Monitor service contract administration develop correspondence and reports as needed for customers or other V
Abo() Employee Date (
f7--Iu---__ Date
Fcommonhrcompetency evaluationyour title
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name Mike Thomson
Date 112010
Review Period 2009 -2010
Title Field Service Engineer
nn~ventltie maintenance and service for equipment CIS-US in the United States
Assist development projects related to equipment sold or specific after-sale services offered by the
iill and provide training classes
Maintain and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for customers or other More work needs 10 be done in this area
Sign~7L Employee
SUP~~S3 Date
Fcommonhrcompetency evaluationyour title
CIS-US COMPETENCY EVALUATION Employee Name Michael 1110mson Date 12709 Review Period 2108-13109 Title Field Service Engineer
PerfOffil preventative maintenance and service for equipment sold and serviced by CIS-US in the United States Assist In technical development projects related to equipment sold or specific after-sale services offered by Ithe
trammg classes Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer JVIpound1nmr service contract develop correspondence and reports as needed for customers or other cIr111mfmt~
programs as
Signed
~d~ Employee Date
Date
Fcommonhtcompetency evaluation your title
NRC FORM 313 US NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS
Michael M Thomson Field Service Engineer and Radiation Safety Officer
Michael Thomson has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since June 1995 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect
Ronald G McCoy Field Service Engineer
Ronald McCoy has been authorized to use licensed material in the provision of commercial service to Part 36 irradiators since May 1998 under NRC license 20-20973shy04 (terminated 82702) and Massachusetts Radiation Control Program license number 20-9734 currently in effect (See attached training record)
No Ancillary Personnel are associated with the purposes for which the licensed material will be used
pharmaLucenceI J 10 ~ bull bullbullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibility authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Pharmaluoenee-Reviewed and updated Field Service Engineers Compliance Book Reviewed and updated NRC and Agreement State notification procedures and forms and covered safety and
security procedures for irradiators Discussed CRCPD documentation (Radiological Dispersive Device Guide to First responders and handout) on radiation incidents Discussed FDA dose requirements and how to
address FDA questions with customers 175 Hours
Dated November I 2011 Michael M Thomson Radiation Safety Officer
Attest~~-6middot~--11~~~~~_
CISmiddotUSInc 10 De Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)275middot5191
wwwcisusinccom
bullbullbullbullbullbullbullbullbullbullbull bullbullbullbull bull lt pharmaLucence
bullbullbullbullbullbull~ it
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
I I Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilities authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue DL Flight 044I-Reviewed and updated Operating Procedure Temporary Job Site Field Service Operating Procedure Temporary Job Site Installation Emergency Precautionary Proceduresshy
Temporary Job Site and Reviewed Sealed Source Leak Test Procedure Also reviewed pertinent NRC Incident Reports
Attest~ 11 ~-c--c-- Dated November 7 20W Michael M Thomson Radiation Safety Officer
CISmiddotUSInc lODe Angelo Drive BedfordMAOl730 (781)275middot7120 Fax(781)27S-5191
wwwcisusinccom
pharmaLucence l J it ~ bull to bull bullbullbullbullbullbull shy
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code of Massachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue HI Hotel Richmond VA - Surveys leak testing and new jig associated with Voluntary Security Enhancement Reviewed and updated Field Service Engineers Field Book Reviewed Voluntary
Security Enhancement paperwork and security procedures
Altest--olJiJJ~middotlt===-_11----~~=-=--middot=--_ Dated November 30 2009 Michael M Thomson Radiation Safety Officer
CIS-US Inc 10 De Angelo Drive Bedford MA 01730 (781) 275-7120 bull Fax (781) 275middot5191
wwwcisusinccom
pharmalucence III bull II I gt bull bullbullbullbull
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMassachusetts Regulation 105 Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20-9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Memorial Sloan Cancer Center New York New York by Sandia National Laboratories Subject Hardening ofllTadiators
Dated September 18 2008 Michael M Thomson Radiation Safety Officer
Attest~ tJJtL--shy
CIS-USlnc bull 10 De Angelo Drive BedfurdMAOI730 (781)275-7120 Fax(781)275-5191
wwwcisusinccom
CISmiddotUS Inc ~ ----~
CERTIFICATE OF TRAINING
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Has completed AUGMENTED ANNUAL TRAINING per Section 120753 Code ofMlssachusetts Regulation lOS Applicable to Activities and responsibilitie authorized in
Massachusetts Material License No 20middot9734 to INSTALL amp SERVICE GAMMA IRRADIATORS
Training Venue Manufacturers Meetings Sandia National Laboratories Alblquerque NM
Dated March amp November 2007 Attest~~7~~---J17~~~7+~~Michael M TIlomson Radiation Safety Officer
crs-us Inc 10 De Angelo Drive Bedford 11-1A 01730 bull (781) 275-7120 Fax (781) 275middot5191
wwwcisusinccom
CIS-US Inc
CERTIFICATE TRAININGOF
RADIATION SAFETY AND
REGULATORY COMPLIANCE
Ronald G McCoy
Has completed AUGMENTED ANNUAL TRAINING per
Section 120753 Code of Massachusetts Regulation 105
Applicable to activities and responsibilities authorized in
Massachusetts Materials License No 20-9734 to
INSTALL amp SERVICE GAMMA IRRADIATORS [SC-DSSj
Dated November 28 2006Attest----~~__----___--shyPaul M Tyree Corporate RSO
ClS-USIHCbullbull 10 De Ango Drive bull Bedloro MA 01730 bull (781) 275-7120 bull Fall F8i) 275-5191 Wyvyi cisuSViccom
RADIOLOGICAL TRAINING AND E PERIENCE
Rna1I G McC Field Service Engineer
FORMAL TRAINING IN RADIATION SAFETY
I Field of Training I Localion(s) and Dales) ofTraining Type amp Len1ilh ofTraining lecture amp SuDetVised
Trainill(l~~ a Radiation Physics amp CISmiddotUS Radiation Safety Training Course (3198) 6 2
Instrumentallon
b Principles amp Practices CIS-US Radiation Safety Training Course (3198) 4 4 of RadiatiOn Protectlon
c MathematiCS Pertaining CISmiddotUS Radiation Safety Training Course (3198) 1 to Use and Measurement of Radioactivity
d Biological Effects of Ionizing CISmiddotUS Radiation Safety Training Course (3198) 1 Radiation amp RIsks of Occupational Exposures
e Safety amp Regulatory Issues CIS-US Radiation Safety Training Course (3198) 2 for Irradiator Field Service Augmented Annual Training Sessions (last 11(6) 36
CY 2006middotgt NRC Increased RM Access Controls Mamp 0 Orders 8
E PERIENCE IT RADIATION (Actual Use of Radionuclides or Equivalent Experience) Type I Source($ I Where Experience was Gained I Duratlon I Scope of Use
r Csmiddot137 Irradiators CISmiddotUS Inc Irradiator Field Service 519apresent 3 f Cs-137 irradiators CISmiddotUS amp CBI factory training SaClay FRANCE middot4198 12
Xmiddotray Xmiddotray machines medical General Electric 71 middot74 4
Ii~ 9f 11Ii -~~X 1 Field service trainee for installation and maintenance of se-oss Gamma Irraol8tors 2 Manufacturers service trainee for installation and maintenance of SCooSS Gamma irradiators 3 Ucenseauthorized Field Service Engineer 4 Installation amp Maintenance of medical X-rav equipment
R11106 - PMT
Guy Turquet de Beauregard General Manager Email gturquetcisblocom
Mr Glenn ALTO CIS-US Inc 10 DeAngelo Drive
Bedford Ma 01730 USA
2lBIf DJ07middot361CDIID Saclay September 4111 2007
Dear Mr Alto
In response to the recent divestiture by CIS bio International of Its company CIS-US Inc to the CISshyUS management team we hereby acknowledges that
bull CISmiddotUS Inc 10 DeAngelo DrIve Bedford MA 01730 continues to be the exelusive field service provider for the CIS bIo international MedallBL 437C blood Imldlator systems within the respective jurisdictions of the US NRC anlt its Agreement Stetes
bull Ronald G McCoy and Michael M Thomson employees of CIS-US loc have accrued many years of field service experience since their factory-training at CIS blo Intematlonal facilities In Sadey [FRANCE] in 1998 and 1995 respectively They have been successfully evaluated and authorized through US NRCordered security clearances to fleld-servlce the Medel IBL 437C irradiators
CIS blo International Is pleased to support CIS-US Inc In its continuing commitment to maintain and operate under the guidance of NRC and Ag~ment State security policy
Sincerely
~~ Guy TURQUET de BEAUREGARD General Manager CIS blo International
UNITED STATES NUCLEAR REGULATORY COMMISSION
WASHINGTON DC 20555-0001
OFFICIAL USE ONLY
November 25 2003
Paul M Tyree CIS-US Inc 10 Deangelo Drive Bedford MA 01730
SUBJECT INITIAL AUTHORIZATION FOR ACCESS TO SAFEGUARDS INFORMATION AND ISSUANCE OF ORDER IMPOSING REQUIREMENTS FOR PROTECTING CERTAIN SAFEGUARDS INFORMATION
Dear Mr Tyree
In order to facilitate enhancement of security at your facility in Bedford MA I am granting initial authorization for the following personnel to view discuss and receive material designated as Safeguards Information (SGI) This authorization is based on the information provided in the transmittal of November 19 2003 from Paul M Tyree Corporate Radiation Safety Officer regarding the trustworthiness and reliability of the named individuals
PositioniTitle
1 Michael M Thomson Field Service Engineer 2 Ronald G McCoy Field Service Engineer 3 Paul M Tyree Corporate Radiation Safety Officer
Safeguards Information must be protected from unauthorized disclosure in accordance with Section 147 Atomic Energy Act of 1954 as amended and handled in accordance with specific requirements that the Commission may impose The enclosed Regulatory Issue Summary (RIS) 2003-08 issued on April 30 2003 provided additional information concerning the importance of protecting SGI
OFFICIAL USE ONLY May be exempt from publlo mlease under the Freedom of Information Act (5 USC 552)
Exemption number __2 _ Nuclear Regulatory Commission review required before public release
M C Laylon NSIRIDNSlMTWS Name and organization of person making determination
Date of Determination 1112512003
OFFICIAL USE ONLY
10 DeAngelo Drive Bedford Massachusetts 01730 7812757125 (F) 7812755191
November 7 2003
US Nuclear Regulatory Commission Director Division of Nuclear Security Office of Nuclear Security and Incident Response Mail Stop T -4D8 Washington DC 20555
Sub Registration to receive information fe enhanced security of radioactive material in response to USN RC letter dated 31-0CT-03
Dear SirMadam
CISmiddotUS Inc hereby designates and vouches for the following key individuals to receive NRC authorized access to certain Safeguards Information
Michael M Thomson Field Service En ineer ike has been authorized by the current MNRCP and prece ent USNRC irradiator service licenses since 23middotJUNmiddot95
I~~ has been II licenses since
CISmiddotUS Inc affirms that all measures prescribed in Enclosure 2 of the subject NRC letter will be implemented to protect Safeguards Information that it may possess or control
Thank you for your consideration and timely confirmation of our actions in this matter Please feel free to contact me immediately with any questions or concerns
Sincerely Paul M Tyree Radiation Safety Officer X 3020 ptyreecisusinccom
PERSONAL INFORMATION WAS REMOVED BY NRC NO COPY OF THIS INFORMATION VAS RETAINED BY THE NRC
middot2shyOFFICIAL USE ONLY
The US Nuclear Regulatory Commission (NRC) will maintain these individuals as your points of contact for receiving S61 that may be Included in any future correspondence Please notify the Office of Nuclear Security and Incident Response (at the contact listed below) when any of these individuals are no longer authorized to receive S6 If you authorize a new point of contact as a replacement please provide the basis for your determination that the new individual has an established need to know and is trustworthy and reliable If you subsequently authorize other individuals to have access to S61 you do not have to notify NRC We request that you keep at least one individual on this list as your paint of contact for receiving S6
If you have any questions about this letter you can contact Fritz Sturz Office of Nuclear Security and Incident Response at the phone number 301-415-6678 or bye-mail at fcsnrcgov
Sincerely
~ltJ~or Thomas H Essig Chief
Materials Safety and Inspection Branch Division of Industrial and Medical
Nuclear Safety Office of Nuclear Material Safety
and Safeguards
Enclosure RIS 2003-08
MA License No 20-9734
OFFICIAL USE ONLY
_C~IS_-U_S_I_nc_______________________-lt~ Subsidiary of CIS bio intematlonal ~
o TRAINING CERTIFICATION FOR CIS-US FIELD ENGINEERS
IBL 437C PRODUCT IRRADIATOR
FUNCTION DATE LOCATION INSTRUCTORS SIGNATURE
IIntroduction of the operation and 112798 Hackensack Med CII aid ~~ component location ofthe IBL
2 Observation of a PM on the ISL 128198 Hackell$ack Med CII tZJ~tJN~according to the attached PM checklist
3 Perform a P M on the IBL model H 112998 Stamford Hospital ~ under the instructors guidance according to the attached checklist
4 Perform a PM on the IBL model G 3111198 Hudson Valley Blood Clr ~~~ o under the instructors guidance according to the attached checklist
5 Perform a PM on the IBL H without 112998 Stamford Hospital ~wcSbtc~direct instructors supervision according to the attached checklist
6 Observe and assist with an lBL 112198 Hackensack Moo Ctr ~M~ installation performed by the instructor according to the attached checklist
This is to certifY that Ronald G McCoy has completed the necessary training course and authorizes Ronald G McCoy to conduct PMs and emergency service on CIS-US IBL 437C
~QMC~ CSusInc authorized signature
Eie-(U S~4 elfpound Title
r Date
Cl8-USINC bull 100eAngeloDrive bull 8eofordMA 01730 bull (781)275-7120 bull Fax(781)27SmiddotS191 mail()is-usccmaiicompuservecom
c
o CIS bio international
We certifY the successful participation of
RONMCCOY CIS-US
to our technical training course From Feb 23th to Feb 26th 1998 in Sac1ay FRANCE
He is able to provide installation technical service preventive maintenance of the
IBL 437 C
He is able to loadunload IBL 437 C intofrom the transport container CC30
shy__ ~X-tifA
~~ Michel DEZANDEE - Yves LACROIX Course Instructor International Service Manager
o CIS bio international GloLJpeORIS
BP 32 91192 GIF-$UR-YVETT EDEX - ~ANCE - Telephone (1) 69857280 et 7281
pharmaLucence -~ii-~)
PHARMALUCENCE COMPETENCY EVAIUATION
Employee Name Ron McCoy
Date 2012
Tide Field Service Engineer
Date
29 Dunham Road Billerica MA 01821 bull Phone 7812757120 Fax 7812755191 wwwpharmalucencecom
PHARMALDCENCE COMPETENCY EVAIDATION
Employee Name Ron McCoy
Date 112011
Review Period 2010
Title Field Service Engineer
AssIst in technical development projects X equipment sold or specific after-sale services offered by the
eqluplnellt and provide training X
iVUll adequate and appropriate spare parts mvemorv considering availability lead time from equipment manufacturer Monitor service contract administration develop X correspondence and reports as needed for customers or other
Date
w4 Date
Fcommonhrcompetency evaluationyour tide
PHARMALUCENCE COMPETENCY EVALUATION
Employee Name
Date
Review Period
Ron McCoy
112010
2009 -2010
Tide Field Service Engineer
Has employee demonsttated competence in the following position responsibilities Perform preventative maintenance and service for equipment sold and serviced by CIS-US in the United States IAssist in technical development projects related to equipment sold or specific after-sale services offered by the
companraquo Perform installations of equipment and provide training classes on equipment operation Maintain adequate and appropriate spare parts inventory considering availability lead time from equipment manufacturer Monitor service contract administration develop correspondence and reports as needed for custcmers or other departments Attend trade shows and specific training programs as needed Additional Conmetlt11~~
gA1)O~3 0+
Yes No
1 y V y I
y I
YES=Optional NOzRecuires a comment
I
I
I
i
Date
Date
Fcommonhrcompetency evaluationyour title
NRC FORM 313 us NUCLEAR REGULATORY COMMISSION
APPLICATION FOR MATERIALS LICENCE
NovaMed Corporation
SECTION 9 FACILITIES AND EQUIPMENT
Per Appendix C NUREG - 1566 vol 18 no response is required for facilities defined as temporary job sites All activities under the requested license are performed at temporary job sites (licensed hospitals and blood banks) and are activities performed on sealed sources in a sealed container (irradiator)
SECTION 10 RADIATION SAFETY PROGRAM
See attached policies and procedures
SECTION 11 WASTE MANAGEMENT
No radioactive waste is generated in the provision of IBL 437C irradiator services
~~ NovaMed
Radiation Safety Program Manual Appendix A
EMPLOYEE RADIATION SAFETY TRAINING PROGRAM
10 General
11 Company employee radiation safety training program is at a minimum composed of a lecturedemonstration written information retention survey and on-the-job training These shall be conducted by the Radiation Safety Officer or his designee and the employees training supervisor
12 Individuals will be assigned to act in the capacity of an occupational worker when such individual has satisfactorily completed the appropriate training and qualification program described in this section
20 Occupational Worker Training and Qualification
21 An individual assigned as an Occupational Worker must complete the following training program Upon completion a written information retention survey shall be administered to monitor training effectiveness
22 On-the-job training shall be provided by the individuals training supervisor and the Radiation Safety Officer or his designee who are jointly responsible to ensure the effectiveness of initial and ongoing training
23 The subjects given in table 1 shall as a minimum be included in the occupational worker training program
T bl 1 (T t 0a e rammg or ccupatlOna I W k )or ers Classroom time (hr Olerational time Subject
[hrJ 4 0 Introduction
Course Requirements Fundamentals of Radiation
3 1 Biological Effects from Radiation Risks from Radiation Exposure Sources of Radiation Exposure ALARA Radiation Protection Personnel Dosimetry
Table 1 (continued)
IRadiation Detection
wwwnovamedcmmiddotpcom
~~ NovaMed
Survey Instruments Radiation Counting Systems Radiation Measurements Using Radiation Quantities Using Radiation Units
3 1 Radiation Protection Standards and Regulations Regulatory Compliance Issues Emergencies amp Accidents Information Retention Survey
30 Annual Refresher and Update Training
31 Each Occupational Worker must attend a minimum of one periodic training session each year These sessions shall be conducted by the Radiation Safety Officer or his designee The purpose and scope of this training may include one or all of the subjects listed in table 2
T ble 2 (A e res h JPC ate Tmiddotmiddota nnua1 R f erandUd rammg)
Classroom time Olerational time Subject (hrJ (hrJ
10 10 Radiation amp Radioactivity Survey Methods Specific Radioactivity Measurement Procedures
20 10 Radiation Protection- Problems and Methods ALARA Goals and Methods Review of Emergency Plans amp Procedures Review of LaboratoryArea Safety Instructions
20 00 RadiationlRadioactivity Units and Uses Statistics in radioactivity Measurements Shielding amp Distance Exposure Factors
10 00 New Regulatory Issues
I
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 1 of 3RSP-0011
Safe Use of Radionuclides
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Radioactive Material Storage 2
50 Personnel Monitoring 2
60 Surveys 3
70 Radiation Safety Equipment and Protective Apparel 3
80 General Instructions 3
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 2 of 3RSP-0011
10 Purpose
The purpose of this procedure is to ensure the safe use of radioactive materials and to ensure exposure to radioactive material (RAM) is minimized during performance of service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of all employees to adhere to this policy and to maintain safety in handling radioactive material
30 General
31 Only trained and authorized personnel are permitted to perform service activities on the IBL 437 C irradiator - Authorized Users (AUs)
32 Any untrained personnel who need to perform service as part of company training or for any reason must be accompanied by the RSOARSO or designee at all times while performing IBL 437 C service
33 Personnel working on the IBL 437 C and the area in which it is installed shall practice good hygiene Hands shall be thoroughly washed prior to leaving the area and prior to eating drinking or smoking
34 Eating drinking smoking or storing food in the laboratory or any area that contains radioactive material is strictly prohibited
35 Gloves must be worn as appropriate when performing IBL 437 C service to protect against any residual biohazard associated with blood handling Follow the same procedures as the facility personnel when working with the device
40 Radioactive Material Storage
Radioactive material possession or storage is not permitted under our license
50 Personnel Monitoring
51 All individuals approved and consenting to work or frequent restricted areas per sect 120226 criteria are assigned personal dosimeters (DOE SDE Landauer Type P1 Luxeltm OSL bimonthly reporting Visitor badges are issued to public members for RSO-approved temporary access Individuals who work in areas adjacent to those in which radioactive material is used may also receive a dosimeter to ensure that their annual exposure is lt100 millirem
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Radiation Safety Procedure ~~ Safe Use of Radionuclides NovaMed Page 3 of 3RSP-0011
52 See RSP-005 - Personnel Monitoring for further information and instruction
60 Surveys
61 See RSP-006 - Surveys for further information and instruction
70 Radiation Safety Equipment and Protective Apparel
71 Safety equipment and materials are to be available to facilitate safe use and to keep personnel exposures ALARA
To include
bull Survey Meters and Laboratory Monitors
72 Protective apparel includes lab coat disposable gloves shoe covers and safety glasses
80 General Instructions
81 A list of general instructions is contained in the Field Service Compliance Manual carried by every Field Service Engineer posted in restricted areas to supplement training by reminding trained personnel to use safety equipment and protective apparel and to practice monitoring and housekeeping procedures that have been demonstrated to be cardinal in safe handling of radioactive materials
82 See Form RSP-001-FR
11
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Radiation Safety Program
~~ Procedure RSP-0021 NovaMed Radiological Emergency Procedures
Radiological Emergency Procedures
Approved by Date
Michael M Thomson RSO 01Aug2012
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original Document
Table of Contents
10 Purpose
20 Responsibility
30 Background
40 Radioactive Material Leakage
50 Decontamination of Personnel
60 Documentation
70 Emergency Response Personnel
80 Theft or Loss of Radioactive Material
Page 1 of 6
2
2
2
3
5
6
7
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Radiation Safety Program
~~ Procedure RSP-0021 Page 2 of 6 NovaMed Radiological Emergency Procedures
10 Purpose
The purpose of this procedure is to outline the steps to be taken in the event of an emergency involving radioactive material derived from the IBL 437C irradiator
20 Responsibility
It is the responsibility of all personnel that service the IBL 437C irradiator to adhere to this procedure
30 Background
The company provides field service restricted to the purposes authorized under either NRC or Agreement State licensure All services provided are performed at temporary job sites which hold an NRC or Agreement State license All service operations are performed with recognition of the operational requirements of the temporary job sites license
The IBL 437C irradiator may contain between one to three sealed sources containing Cs-137 chloride within double stainless steel capsules Each source may contain activity up to 1870 Ci (761) The sealed sources are fixed in position and are fully shielded in all directions These sources are inaccessible to operators and field service personnel and may only be accessed by dismantling of the irradiator shielding using specialized equipment within a hot cell
The companys emergency procedures are designed to address the event of escape of radioactive Cs-137 chloride from a sealed source There are no other radioactive materials associated with the IBL 437C
There are a significant number of IBL 437C Blood Irradiators installed within the United States There has never been any incident of measurable quantities of Cs-137 chloride coming from an IBL 437C sealed source The company views its safety program within the context of Risk which is defined
Risk = Hazard X Exposure where
Hazard =the potential for adverse health effect
Exposure = frequency of contact with the hazardous material
Historical exposure events associated with Cs-137 escaping the doubly encapsulated fixed sealed sources in the IBL 437C Blood Irradiator is zero
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Radiation Safety Program
~~ Procedure RSP-0021 Page 3 of 6 NovaMed Radiological Emergency Procedures
When determining risk of radiation exposure we can calculate in retrospect that it is zero
Risk = High Hazard X 0 Exposures = Zero (0)
However due to the high hazard associated with high concentration Cs-137 chloride exposure we have implemented the following safety program
The principles of Time Distance and Shielding will form the basis of our response to any radiological event
40 Radioactive material leakage
41 Prior to performing IBL 437C irradiator field service the Field Service Engineer (FSE) will perform a radiation survey per RSP- 0061 If any reading is greater than historically expected for the number of sources in the device or greater than 25 mRh the facility RSO will be contacted immediately and informed of the readings
A reading below 01 rem (1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - No evacuation further study to determine the source using safe practices and PPE as appropriate
Above 01 rem(1 mSv) in 1 hour at 30 cm from the device (High Radiation Area) - Immediately evacuate all personnel to a safe distance and define the (High radiation Area) with postings and exclusion tape Note that depending on the level of contamination there may be a Very High radiation area contained within the (High Radiation Area)
Definitions
High radiation area means an area accessible to individuals in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 01 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates
Very high radiation area means an area accessible to individuals in
which radiation levels from radiation sources external to the body
could result in an individual receiving an absorbed dose in excess of
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Radiation Safety Program
Procedure RSP-0021 Page 4 of 6 ~fampJNovaMed Radiological Emergency Procedures
500 rads (5 grays) in 1 hour at 1 meter from a radiation source or 1
meter from any surface that the radiation penetrates
(Note At very high doses received at high dose rates units of
absorbed dose (eg rads and grays) are appropriate rather than
units of dose equivalent (eg rems and sieverts))
42 Notify all personnel in the area Carefully move all personnel out of the area using a survey meter to ascertain contamination Assure that no contamination is being brought out of the restricted area on clothing or shoe covers
43 Notify the RSO (Facility and NovaMed) and Supervision immediately Further management of the radioactive contamination event is to be addressed by the RSO of the licensed site Company FSE personnel will consult for and collaborate with the site RSO The facility RSO shall be responsible for timely notification of the appropriate regulatory authorities
44 Only a minimum crew of experienced qualified personnel necessary to deal with a radioactive contamination event should enterremain in the area Carefully monitor skin clothing shoes etc of all personnel leaving the contaminated area
45 Control and decontaminate the area as follows
451 Put on proper Personal Protective Equipment (PPE) as instructed by site RSO
452 Isolate the IBL 437 C irradiator with supplemental shielding material to limit exposure A Plastic barrier taped to the floor may be appropriate to prevent further dispersal of leaking source material
453 Mark off contaminated area and restrict traffic to that area
454 Do not allow anyone to leave the area of the leak without first being monitored for contamination
455 Begin decontamination procedures as soon as possible but not without direction of the RSO and Supervision Cs-137 chloride is a salt and is water soluble Aqueous cleaning agents should be used Begin at the outer most edge of the contaminated area and work inward reducing the contaminated area Personnel
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Radiation Safety Program
~~ Procedure RSP-0021 Page 5 of 6 NovaMed Radiological Emergency Procedures
specifically trained and qualified to address radioactive contamination should be employed to address decontamination
456 Isolate all contaminated cleaning materials and PPE into properly labeled plastic bags for transfer to radioactive waste Cs-137 has a half-life of -30 years and must be disposed as radioactive waste and not held for decay
457 Survey the area with a calibrated survey meter to monitor the effectiveness of the decontamination procedure and to ensure there is no spread of the contamination beyond the spill area Perform contamination surveys and count the wipes using an appropriate counter and continue decontamination until the removable contamination is below the limits set by the RSO If the spill is high in radiation field or extent the RSO may specify area closure
458 Repeat the spill area cleaning until the contamination is removed as evidenced by wipe testing
Note Areas may be covered with appropriate shielding in the event that non-removable contamination exists The RSO may opt to prohibit further work in the area until a decontamination strategy is in place
50 Decontamination of Personnel
51 Notify the RSO and Supervision
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
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Radiation Safety Program
~~ Procedure RSP-0021 Page 6 of 6 NovaMed Radiological Emergency Procedures
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary and under direction of the RSO and Supervision Cleansing methods in order of harshness are as follows
bull Using RadiacWash towelettes
bull Lifting off with sticky tape
bull Washing with soap and warm water
bull Washing with a mildly abrasive soap a soft brush and water
bull Washing with detergent
bull Using a mild organic acid (citric acid)
bull Using an exfoliating cream to gently remove the outer layer of skin
If contamination is in the area of a wound a physician should supervise the decontamination operation
Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to construct a dose equivalent exposure record will be determined by the RSO
If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
60 Documentation
61 The RSO and affectedinvolved individuals will document the incident including any corrective measures and other improvements identified to prevent a similar occurrence
62 Documentation of radiological emergency incidents (spills etc) shall be maintained for review at NRC inspections Incidents involving work
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Radiation Safety Program
~~ Procedure RSP-0021 Page 7 of 6 NovaMed Radiological Emergency Procedures
related injury or illness of employees must be reported in OSHA records maintained by the EHSHR Dept
70 Emergency Response Personnel
Immediately notify the RSO (both NovaMed and Facility) a listed Emergency Coordinator andor Supervision emergency response personnel (police fire etc) if radioactive materials are involved in a fireexplosion or other release-event Be prepared to notify and inform arriving emergency response personnel of the nuclides activities and forms involved Assist the facility RSO with contacting the appropriate USNRC or Agreement State authorities in an appropriate and timely manner Emergency Notification numbers are posted near devices as well as in our Reciprocity Field Service Manual under the appropriate authority
80 Theft or Loss of Radioactive Material
Any missing radioactive material must be immediately reported to the RSO as soon as its absence becomes apparent
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Radiation Safety Procedure ~~ Material Receipt amp ShipmentNovaMed Page 1 of 2 RSP-0031
Material Receipt amp Shipment
Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 No Material Received
Date
01A~g2012
Date 01Aug2012
2
2
2
Radiation Safety Procedure ~~ Material Receipt amp Shipment
NovaMed Page 2 of 2 RSP-0031
10 Purpose
The purpose of this procedure is to ensure all incoming radioactive material is properly received and accounted for and all outgoing radioactive material is properly shipped
20 Responsibility
All authorized users and all personnel that may receive or ship radioactive material must comply with this procedure
30 NovaMed does not purchase or receive radioactive material with the exception of exempt calibrated sealed sources (approximately 1 microcurie CS-137) for the purposes of instrument checks and leak testing reference standards
Radiation Safety Procedure~~ Radiation Safety Audit ProgramNovaMed Page 1 of 5 RSP-00401
R dO f S f t Auda la Ion a e[y Ot ProgramI Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Dale
NovaMed Corporation Trumbull CT 01JULY2012
~ul2ersedei1 uodales Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Audit Procedures 3
50 Documentation 4
60 Enforcement of RAD Safety 4
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 2 of 5 RSP-0041
10 Purpose
This procedure is to outline the requirements of the Radiation Safety Audit Program The audit will ensure that compliance is maintained with the requirements of the USNRC regulations and the terms and conditions of the USNRC license The audit will also ensure that occupational doses and doses to the public are 8s bOw 8s is Reasonably 8chievable (ALARA)
20 Responsibility
It is the responsibility of the RSOARSO or qualified designee or outside contractor to perform the audit The radiation safety program will be evaluated and audited on an annual basis
30 General
31 During daily activities authorized users (AU) shall be aware of any nonshycompliance with the USNRC standards or the terms and conditions of the USNRC license Non-compliance shall be corrected immediately and reported to the RSOARSO
32 The RSOARSO or designee will perform audits of procedures where radioactive materials are used The audit will ascertain compliance levels with respect to the radiation safety program Non-compliance will be described and a corrective action plan implemented
33 Audit records will be maintained on file for a period of not less than three years from the date of the record Audit records shall include the following
bull Date of the audit bull Name of the person(s) conducting the audit bull Persons contacted by the auditor(s) bull Areas audited bull Audit findings bull Corrective actions and bull Follow-up
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Radiation Safety Procedure ~~ Radiation Safety Audit ProgramNovaMed Page 3 of 5 RSP-0041
40 Audit Procedures
The audit shall consist of the following
41 Audit history - date of the last audit deficiencies identified and corrective actions taken
42 Organization and Scope of the Program - brief description of organizational structure noting any personnel changes Description of the scope of the licensed activities at the location Ensure RSO is identified
43 Training Retraining and Instructions to Personnel- ensure that personnel working with radioactive material have received the required training Ensure that each AU has a copy of the procedures and that heshe can implement these procedures
44 Audits - verify audits fulfill the requirements of the USNRC and that they are properly conducted and properly documented
45 Materials - Not applicable The company does not possess radioactive material
46 Leak Tests - verify that leak testing is performed calculated and reported correctly by reviewing the results of leak tests performed at customer sites
47 Inventories - the company does not possess radioactive material except exempt quantities in calibrated check sources
48 Radiation Surveys - verify that surveys are performed according to standard operating procedure and operator training and that appropriate operable and calibrated survey instruments are available
49 Transportation - if transporting materials (Le relocation of the IBL 437C within or to another licensed site) determine compliance with DOT requirements Verify packages are prepared marked and labeled in accordance with DOT requirements and that proper shipping papers are prepared in accordance with requirements
410 Personnel Radiation Protection - determine that unmonitored personnel are not likely to receive more than 10 of allowable limits Review personnel monitoring records compare exposures of individuals doing similar work determine reasons for significant differences in exposure If any AU declares pregnancy in writing evaluate compliance with 10 CFR 201208 Check maintenance of records
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Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 4 of 5 RSP-0041
411 Notification and Reports - ensure compliance with the notification and reporting requirements of the USNRC (10 CFR 19 Notices Instructions and Reports to Workers Inspection and Investigation and 10 CFR 21 Reporting of Defects and Non-compliance) Ensure the telephone number of the USNRCs Emergency Telephone (301-816-51 00) is known
412 Posting and Labeling - verify compliance with the posting and labeling requirements of USIIRC and DOT for cases of IBL 437C relocation
413 Bulletins and Information Notices - verify that bulletins information notices and other correspondence from the USNRC are being received Verify that appropriate action is taken in response to US NRC mailings
414 Special License Conditions or Issues - verify compliance with any special conditions on the USNRC license
415 Problems or Deficiencies and Recommendations - note any problems or deficiencies with the program or any non-compliance with USNRC requirements Indicate the recommended corrective actions to correct these deficiencies
416 Evaluation of Other Factors - evaluate managements involvement with the radiation safety program and whether the RSO has sufficient resources to perform required duties to maintain compliance with regulatory requirements
50 Documentation
51 Annual audits are to be recorded The audits will detail the findings if any and the necessary corrective actions to be taken
52 Follow-up reports detailing corrective action(s) taken in response to an audit shall be provided to the RSOARSO
53 Records of audits shall be maintained for a minimum of three years
60 Enforcement of RAD Safety
61 During the audits of compliance with the safety program violations will result in the following
bull Verbal- verbal warning from the RSOARSO describing the infraction corrective action(s) and completion date for corrective action(s)
Wlwnovamcdcorpcom
Radiation Safety Procedure ~~ Radiation Safety Audit Program NovaMed Page 5 of 5 RSP-0041
bull Written - if the response to the first infraction is not satisfactory or the same violation is repeated within one year the RSOARSO will provide the warning in writing
bull Suspension - if the response continues to be unsatisfactory or if the violation is repeated within one year the user shall be prohibited from activities involving radioactive materials until the user demonstrates to the RSOARSO an understanding of the applicable procedures andor regulations The suspension remains in force during all appeals (to the RSO)
62 Retraining may also be provided to ensure there is an understanding of the RAD safety program
63 All warnings will be documented
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Radiation Safety Procedure ~~ Personnel Monitoring
NovaMed Page 1 of 5 RSP-OOS1
personne1Momtorlng Approved by Date
Michael M Thomson RSO 01JULY2012
Issued by Date
NovaMed Corporation Trumbull CT 01JULY2012
Supersedes updates
Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 General 2
40 Minimization of Exposure 3
50 Personnel Contamination 45
wwwnovamedcorpcom
Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 2 of 5 RSP-0051
10 Purpose
The purpose of this procedure is to ensure all personnel working with radioactive material (RAM) are properly monitored for exposure to radiation and to ensure that the dose rates specified by the USNRC are not exceeded
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others handling RAM to abide by this procedure
30 General
31 All individuals that come in contact with RAM must wear appropriate dosimeters (monitor badge)
32 Dosimeters used to monitor dose to workers will be evaluated through a NVLAP-accredited facility
33 If an exposure in excess of the regulatory limits is suspected at any time it must be reported immediately to the RSOARSO and the badge will be processed immediately
34 Whole Body Dosimeters should be worn and handled as follows
bull Wear on the outside of the outer garment bull Do not place the badges in pockets or under protective clothing bull Wear the badge on the area of the body that would potentially receive
the greatest exposure to radiation bull Do not place badges on contaminated surfaces or store near sources
of radiation bull Store badges away from sunlight and sources of heat keep dry bull Leave badges at work
35 Personal monitoring shall be performed upon suspicion of a leaking source using a proper calibrated survey instrument
36 Dosimeters will consist of a whole body monitor to be worn as described in 34
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 3 of 5 RSP-OOS1
37 Doses to embryolfetus are to be controlled by limiting the doses to declared pregnant women to 05 rem during the gestation period and ensuring that the dose is distributed uniformly during the gestation period See RSP-009 for more information
38 Any individual who receives more than 10 of the annual limit in one quarter shall be investigated by the RSOARSO
39 The RSOARSO shall advise users of their dose on a quarterly basis or when requested in writing pursuant to USNRC regulation Some Agreement States require quarterly results as a part of their conditions for granting reciprocity
310 Non-users who are not likely to receive 10 of their applicable annual limits may accompany an AU with a Visitors Badge
311 Doses in unrestricted areas will be limited such that no individual will receive gt2 mrem in anyone hour or 100 mrem in a given year from operations This shall be demonstrated by area monitoring andlor routine operating surveys
40 Minimization of Exposure
41 It is the policy of the company to maintain exposure to radioactive materials to 8s bOW 8s Reasonably 8chievable (ALARA) levels through proper handling of materials and through adherence to the rules and regulations of the USNRC and the requirements of the facility Radiation Safety Program The NovaMed guideline is to limit exposure to radioactive material to 10 of the dose limits specified by the USNRC in Regulatory Guide 813 as follows
05 reml r 15 reml r 50 reml r 50 reml r 50 reml r 01 reml estation eriod
Suggested in NRC Regulatory Guide 813
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Radiation Safety Procedure ~famp Personnel Monitoring NovaMed Page 4 of 5 RSP-OOS1
50 Personnel Contamination
51 Notify the RSOARSO
52 Identify the contaminated area(s) with a calibrated survey meter
53 Remove any contaminated clothing and place in a properly labeled plastic bag for disposal as long-lived radioactive waste
54 Decontamination of the skin should be attempted with the mildest methods first progressing to more harsh methods if necessary Cleansing methods in order of harshness are as follows
bull Using RadiacWash Towelettes bull Lifting off with sticky tape bull Washing with soap and warm water bull Washing with a mildly abrasive soap a soft brush and water bull Washing with detergent bull Using a mild organic acid (citric aCid)
Note Skin decontamination procedures should not increase penetration of the radioactivity into the body by excessive abrasion of the skin If contamination is in the area of a wound a physician should supervise the decontamination operation
55 Cleaning should be from the periphery of the contaminated area towards the center to avoid spreading the contamination
56 Repeat cleaning procedure several times continuously monitoring to determine effectiveness
Note All personnel contamination shall be documented The need to assign a shallow dose equivalent due to skin contamination will be determined on an individual basis by the RSOARSO
57 If the above methods are unable to remove all contamination from the skin then the area must be covered with gloves andor tape to prevent the spread of contamination due to contact or skin sloughing off until the contaminated area(s) are below background
58 The RSOARSO in conjunction with the individuals involved shall document the incident including any measures identified to prevent a similar occurrence
510 Documentation of incidents (spills etc) shall be maintained on file for the life of the US NRC license in compliance with the USNRC regulation
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Radiation Safety Procedure ~~ Personnel MonitoringNovaMed Page 5 of 5 RSP-OOS1
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Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 1 of 3
s Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovalVled Corporation Trumbull CT
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Area Surveys
50 Wipe Test Surveys
60 Contamination
urveys Date 01Jufy2012
Date 01July2012
2
2
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3
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3
Radiation Safety Procedure ~~ Surveys
Page20f3NovaMed RSP-0061
10 Purpose
The purpose of this procedure is to ensure areas where the IBL 437 C irradiator is used are properly and adequately surveyed prior to the performance of services to determine if there is presence of radioactive contamination
20 Responsibility
It is the responsibility of the Authorized Users (AUs) of RAM and others in the process of servicing the devices to perform appropriate surveys to maintain ALARA dosages
30 General
31 Surveys are to be performed on the device to be serviced at the beginning of the service event so as ascertain the presence of radioactive contamination if it were to be present A simple survey of all surfaces of the device is conducted and the highest reading is recorded Prior to turning the device over to a subcontractor for any relocation a more detailed survey is performed and recorded After placement of a relocated device and prior to retuning the device to service a detailed survey is performed and documented
311 Wipe tests are conducted using an appropriate solventabsorbent combination to wipe a 100 cm2 area The absorbent component is counted in a sufficiently sensitive and calibrated radioactivity measurement device to allow quantitation of the presence of any radioactive material (Cs-137)
32 The RSOARSO or designee on at least a quarterly basis will review results of these surveys
33 Documented surveys will be retained for a minimum of three years
40 Device Surveys
41 Device surveys are to be surveyed using an appropriate calibrated survey meter
42 If a reading of 25 mRlhr or greater is discovered notify RSOARSO immediately to assist in locating the source of the radioactive field
43 Surveys shall be documented and retained for a minimum of three years
Radiation Safety Procedure ~~ Surveys NovaMed RSP-0061 Page 3 of 3
44 Jote JovaMed does not possess materials nor have restricted areas Surveys are performed at licensed customer sites on the IBL-437C Blood Irradiator
50 Wipe Test Surveys
51 Wipe the internal and external surfaces of the device as appropriate
52 Use an appropriate solventabsorbent combination to wipe a 100 cm2
area and count the sample in a calibrated well counter
53 If a wipe measures 185 Bq (0005 microcuries) over background the device is contaminated Immediately notify the site licensee RSO and department management Engage procedures associated with radioactive materials contamination (RSP-0061)
54 Wipe test surveys shall be documented and retained for a minimum of three years per 10 CFR 202103(a)
60 Contamination
61 Contamination on surfaces must be addressed with respect to the site license procedures and coordinated with the site RSO and department management
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 1 of 2 RSP-0071
Approved by a loac Ive as e R d r w t Management
Date
Michael M Thomson Radiation Safety 01AUG2012
Officer Issued by
NovaMed Corporation Trumbull CT 06611 Sugersedes ugdates Original Document
Date 01AUG2012
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Radioactive Waste 2
Radiation Safety Procedure ~~ Radioactive Waste Management NovaMed Page 2 of 2 RSP-0071
10 Purpose
The purpose of this procedure is to outline the proper waste management practices for the storage and disposal of radioactive waste material
20 Responsibility
It is the responsibility of all authorized users (AUs) of RAM to adhere to this procedure and to properly manage radioactive waste material
30 Radioactive Waste - NovaMed does not generate store accept for storage or disposal any radioactive waste at its faCilities
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Radiation Safety Procedure ~~ Personnel Training NovaMed RSP~0081
personneITraining I Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose
20 Responsibility
30 General
40 Documentation
Page 1 of 4
2
2
2
3
Radiation Safety Procedure ~~ Personnel TrainingNovaMed Page 2 of 4RSP-OOS1
10 Purpose
The purpose of this procedure is to outline the training requirements for Field Service Engineers (FSE) performing service on the IBL 437 C irradiator
20 Responsibility
It is the responsibility of the RSOARSO to ensure all FSE receive the proper training prior to performing service on the IBL 437 C irradiator
It is the responsibility of the RSOARSO to ensure that all employees are notified of the potential risks to the embryofetus of exposure to radiation
30 General
31 All personnel that are to work with radioactive materials (Authorized Users) must undergo proper training prior to working with any radioactive material Topics included in the training are as follows
a) Radiation Safety i) Background Levels of Radiation ii) Radiation Exposure - Internal amp External iii) Radiation ampContamination iv) ALARA Concept v) Biological Effects of Radiation vi) Radiation Risks vii) Prenatal Radiation Exposure Risks
b) Regulatory Requirements i) Company license ii) US NRC Regulations iii) RSO iv) Material Control amp Accountability v) Personnel Dosimetry vi) Radiation Safety Program Audits vii) Transportation viii) Recordkeeping ix) Surveys x) Posting amp Labeling xi) Reporting Incidents xii) US NRC Licensing amp Inspections xiii) Employee Protection xiv) Deliberate Misconduct
32 IBL 437 C irradiator service may only be performed by trained and authorized personnel
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 3 of 4 RSP-OOS1
33 All FSE must complete the company training curriculum prior to performing independent IBL 437 C service
34 Annual refresher training will also be provided
35 Retraining will take place when the need arises as evidenced by procedural or policy deficiencies or when new procedures are put in place
40 Radiation Safety Officer Training
10 The Radiation Safety Officer (RSO) shall be trained in the following topics Training may be in the form of lecture videotape hands-on or self-study and emphasizes practical subjects important to the safe use of the self-shielded irradiator
Radiation Safety
Radiation vs contamination Internal vs external exposure Biological effects of radiation Types and relative hazards of radioactive material possessed ALARA concept Use of time distance and shielding to minimize exposure Use of radiation detection instruments
Regulatory Requirements
Locations of use and storage of radioactive materials Material control and accountability Annual audit of radiation safety program License conditions amendments renewals Transfer and disposal Recordkeeping Handling incidents Licensing and inspection by regulatory agency Need for complete and accurate information Employee protection Deliberate misconduct
Practical Explanation of the Theory and Operation for Each Irradiator Possessed by the Licensee
Routine vs non-routine maintenance Operating and emergency procedures Prior events involving self-shielded irradiators
Radiation Safety Procedure ~~ Personnel Training NovaMed Page 4 of 4 RSP-OOS1
Instructors Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training
Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensees irradiators This may be demonstrated by written or oral examination or by observation
50 Documentation
All training will be documented in accordance with the companys Radiation Safety Training Documentation
Radiation Safety Procedure ~~ Pregnant EmployeelFetal Dose
Page 1 of 6 NovaMed RSP-0091
pregnant EmployeeIFeta10ose Approved by Date
Michael M Thomson Radiation Safety 01Aug20012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Policy 2
40 Declared Pregnancy 3
50 Fetal Dose Control 3
60 Confidentiality 4
70 NRC Regulatory Guide 813 4
80 Rescinding Pregnancy 4
Pregnancy Declaration 5
ReSCinding Pregnancy Declaration 6
Radiation Safety Procedure Pregnant EmployeeFetal Dose~rampJ Page 2 of 6 NovaMecI RSP-0091
10 Purpose
The purpose of this procedure is to provide a means for controlling occupational dose to an embryofetus
20 Responsibility
21 It is the responsibility of the pregnant radiation worker to declare her pregnancy so that adequate precautions to prevent or minimize radiation exposure can be taken and so that the employee can be fully informed of potential risks
30 Policy
31 A pregnant female who chooses to declare pregnancy must notify the RSOARSO of her pregnancy in writing on the form provided (attached)
32 Meetings to discuss fetal dose will be scheduled with each radiation worker who declares her actual suspected or planned pregnancy These meetings are also available to any other employee upon request
33 The meeting will be with the RSOARSO or designee the employee and the employees supervisor
34 Safety aspects of the employees work will be reviewed There will also be a discussion of the following
bull risks of fetal exposure bull exposure limits bull methods to minimize exposure and bull company policy regarding declared pregnant females
35 An opportunity for questions will be provided The employees monitoring records as well as the current potential for radiation exposure will be reviewed
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 3 of 6 NovaMed RSP-0091
36 The company has no responsibility in accordance with NRC regulations to provide specific fetal radiation dose precautions until a radiation employee openly declares in writing her pregnancy status to the RSOARSO
40 Declared Pregnancy
41 When a radiation employee wishes the company to be involved in the protection of her fetus under the 05 rem and the 01 rem ALARA dose guideline (10 CFR 201208) she must declare her pregnancy to the RSOARSO This declaration must be in writing on the form provided by the RSOARSO A meeting will be sCheduled with the employee the RSOARSO and her supervisor
42 The radiation employee will be required to sign a training document in accordance with the company Radiation Safety Training Documentation confirming safety information was presented and understood
50 Fetal Dose Control
51 The radiation employee will be assigned a monthly radiation-monitoring badge if one is not currently assigned
52 The Companys responsibility to protect the embryofetus under the US NRC 05 rem limit and the ALARA 01 rem guideline begins only when the employee declares her pregnancy in writing to the RSOARSO Any dose must be evenly distributed over the course of the pregnancy
53 Control of fetal dose will be attained with the full cooperation of the employee and the employees supervisor without economic penalty or loss of job opportunity Work assignment changes consistent with company Human Resources Policies may be initiated if necessary
54 When the occupational radiation dose of a declared pregnant woman exceeds 01 rem since conception the radiation employee may request adjustments in work assignment that will mitigate further occupational radiation dose
The supervisor may elect to
a) change the employees work assignment b) select one of the available leave options until the
employee becomes eligible for or requests maternity leave
55 In conjunction with the 05 rem fetal dose limit the ALARA philosophy will be applied to maintain dose as low as practicable
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 4 of 6 NovaMed RSP-0091
56 Pregnant radiation workers should not participate in any task that may result in higher exposures as determined by the RSOARSO
60 Confidentiality
Radiation employees may wish to keep their pregnancy status confidential for a period of time Any employee may still obtain fetal dose and related radiation safety information at any time through the RSOARSO without officially declaring her pregnancy status
70 NRC Regulatory Guide
The NRC Regulatory Guide 813 -Instruction Concerning Prenatal Radiation Exposure - provides information regarding the expectations of the licensee when handling declared pregnant women This guide has been and will be consulted when handling issues concerning declared pregnant women
80 Rescinding Pregnancy
When the declared worker is no longer pregnant she will notify the RSOARSO of this in writing on the form provided (attached) This completed form will be placed in her records to show that she is able to resume unrestricted work
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 5 of 6 NovaMed RSP-0091
Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am (or may be)
pregnant The estimated month and year of conception is The expected delivery date is _______
I understand the radiation dose to my embryofetus during my entire pregnancy will not be allowed to exceed 05 rem (5 millisieverts) (unless that dose has already been exceeded between the time of conception and submitting this letter) I also understand that meeting the lower dose limit may require a change in job or job responsibilities during my pregnancy
Signature
Supervisor Signature
ASOARSO Signature
Radiation Safety Procedure ~~ Pregnant EmployeeFetal Dose
Page 6 of 6 NovaMed RSP-0091
Rescinding Pregnancy Declaration
Date _____ Department__________
I voluntarily declare that I am no longer pregnant I
am now able to resume unrestricted work in the RAM Lab
Signature
Supervisor Signature
RSOARSO Signature
Radiation Safety Procedure ~~ Survey Instrumentation
Page 1 of 3 NovaMed RSP-00101
Survey Instrumentation
I Approved by Date
Michael M Thomson Radiation Safety 01AUg2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Instrument Calibration 2
40 Instrument Use 2
50 Specific Instrumentation 3
Radiation Safety Procedure ~~ Survey Instrumentation
Page 2 of 3NovaMed RSP-00101
10 Purpose
The purpose of this procedure is to ensure all radioactive material (RAM) survey instrumentation is properly used and calibrated in accordance with manufacturers instructions and NRC or Agreement State regulations
20 Responsibility
21 It is the responsibility of the RSOARSO to maintain RAM survey instrumentation and to ensure its proper calibration at specified intervals
22 It is the responsibility of the Authorized Users (AUs) to properly use RAM survey instruments
30 Instrument Calibration
31 All RAM survey instrumentation must be calibrated on at least an annual basis
311 Special calibrations may be performed at any time there is reason to believe that the operating characteristics of an instrument have been changed by repair or alteration or whenever system performance is observed to have changed
32 Calibration must be performed by a qualified outside RAM instrument calibration service licensed by the NRC or agreement state to perform such services
33 Instruments must be calibrated in accordance with ANSI 323(a) -1999 Radiation Protection Instrumentation Test and Calibration standards and must be calibrated using NIST-traceable radioactive sources Note We only work with Cs-137therefore we have the instruments calibrated specifically for that radioactive material
34 Records of calibration must be maintained per 10 CFR 2021 03(a)
40 Instrument Use
41 Prior to using RAM survey instrumentation ensure the type of instrument is appropriate for the source to be measured and that the proper and appropriate probes are installed
42 Ensure the proper batteries are installed and perform a battery check
421 If the unit needs batteries install fresh batteries of the proper size and in the proper configuration
Radiation Safety Procedure Survey Instrumentation ~DampNovaMed RSP-00101 Page 3 of 3
43 If applicable check the response of the unit with a known radioactive source material
44 Check all cables for proper and tight connection
45 If the survey instrument does not properly respond to the instrument checks and a cause for unresponsiveness can not be found and corrected do not use the unit and mark it as inoperable and return the unit to the supplier for service
50 Specific Instrumentation
51 Instruments that meet the radiation monitoring instrument specifications published in Appendix J to NUREG-1556 vol 18 Consolidated Guidance about Materials Licenses Program-Specific Guidance about Service Provider Licenses dated November 2000 are used We reserve the right to upgrade our survey instruments as necessary
52 RAM survey instrumentation
521 SE International Modellnspector+ with Wipe Test Plate for use in surveys and to perform wipe test analysis (See attached Specifications sheet and User Manual)
522 The Inspector is a small handheld microprocessor-based instrument which offers excellent sensitivity to low levels of alpha beta gamma and x-rays The digital readout is displayed with a red count light and a beeper sounds with each count detected Other features include an adjustable timer external calibration controls and adjustable alert Note The adjustable alert will be set to alarm at a maximum of 25 mRh which is the maximum allowable dose at the device surface
523 All Field Service Engineers are equipped with a meter The company maintains a backup inventory of meters to allow substitution in case of failure at calibration end dates and to provide a second meter in jurisdictions (Maryland) which require two meters to be present on site
Radiation Safety Procedure ~~ Sealed Sources
Page 1 of 3 NovaMed RSP-0111
Sealed Sources Approved by
Michael M Thomson Radiation Safety Officer
Issued by
NovaMed Corporation Trumbull CT
Date 01AUG2012
Date
01AUG2012
Supersedesl updates
Original Document
Table of Contents
10
20
30
Purpose
Responsibility
General
2
2
2
Radiation Safety Procedure ~~ Sealed Sources
Page 2 of 3 NovaMed RSP-0112
10 Purpose
The purpose of this procedure is to ensure sealed radioactive sources contained in the IBL 437 C irradiator are properly maintained inventoried and tested for leakage
20 Responsibility
21 It is the responsibility of the Licensed Facility to properly maintain the IBL 437 C irradiator and to ensure its sealed sources are not compromised in any way that would cause the release of radioactivity The company provides IBL 437 C irradiator services at temporary job sites under a US NRC license and is only in possession of the irradiator as part of maintaining servicing relocating or upgrading (as defined in US NRC RIS 2008-17 Voluntary Security enhancements)
22 It is the responsibility of the Licensed Facility RSOARSO to maintain the sealed source inventory and to ensure that sealed sources are leak tested in accordance with US NRC regulatory requirements and requirements outlined in the facility radioactive materials license The company may assist the Licensed Facility RSO in compliance with National Source Tracking System (NSTS) and other regulatory issues
30 General
31 Only those sealed sources licensed or exempt by the US NRC may be possessed onsite
32 Sealed sources installed in the IBL 437 C are permanently fixed and inaccessible to irradiator users and service personnel No operation shall be performed on the IBL 437 C by any company field service engineer that could compromise the irradiator shielding or create access to the sealed sources
33 Sealed sources must be tested for leakage at a minimum of 6-month intervals Leak testing must be documented and records must be maintained on file On each visit to a Licensed facility by a company Field Service Engineer the engineer will verify that a leak test has been performed within the last 6 months If the interval is greater than 6-months the engineer shall immediately contact the Licensed facility RSO and will either have the RSO perform the leak test or perform a leak test prior to beginning work
34 An appropriate solventabsorbent combination to wipe the sealed source must be used
35 Leak tests of sealed sources may only be analyzed by organizations licensed by the NRC or agreement state to perform such services
36 The company license indicates that the company can be in posseSSion of a maximum of 6 sealed sources in a maximum of 2 devices This posseSSion is incident to performing work at temporary job site No inventory of sources is required
Radiation Safety Procedure ~~ Sealed Sources
Page 3 of 3 NovaMed RSP-0112
37 The sealed source leak test must be capable of detecting the presence of 185 Bq (0005 microcuries) of radioactive material on the test sample
38 If the test reveals the presence of 185 Ba (0005 microcuries) or more of removable contamination a report must be filed with the US NRC in accordance with US NRC regulation Immediate notification of the site RSO shall be made and procedures engaged in conformance with the sites radioactive contamination mitigation policies The IBL 437 C irradiator should be immediately removed from service and decontaminated repaired or disposed of in accordance with US NRC requirements
39 The RSO will be responsible for the filing of any report if necessary with the US NRC
Radiation Safety Procedure ~~ Radiation Safety Organization
ResponsibilitiesNovaMed RSP-0121
Radiation Safety Organization Responsibilities
Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates
Original document
Table of Contents
10 Purpose
20 RSOIARSO Designation
30 RSOIARSO Responsibilities
40 Radiation Worker Responsibilities
50 Requirements for Handlers of Radioactive Materials
Page 1 of 5
2
2
2
3
4
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 2 of 5 ResponsibilitiesNovaMed RSP-0121
Purpose
11 To describe radiation safety responsibilities within the organization to ensure the best practices of the safe handling and use of radioactive sources are used
12 Oversee site radiation safety activities
20 RSOARSO Designation
21 The RSO is appointed by the officer of the company responsible for the facility (herein after referred to as the Chief Officer or CO) The RSO shall have experience in the handling of radioisotopes and practice of radiation protection The RSO shall have training consistent with the requirements of NRC or Agreement State regulations and reflective of the purpose of the companys license
22 The RSO reports directly to the CO and may be overruled only by that position
23 Changing the RSO requires an amendment to the existing Radioactive Material License
24 RSO may have other duties however sufficient time must be devoted to fulfillment of RSO responsibilities and license conditions
25 In the absence of the RSO the Assistant RSO shall assume the responsibilities of the RSO The ARSO should have the same training as the RSO described in Section 21 above
30 RSOARSO Responsibilities
The RSOs duties and responsibilities include ensuring radiological safety and compliance with NRC Agreement State and DOT regulations and the conditions of the license see Figure 81 Typically these duties and responsibilities include ensuring the following
31 Activities involving licensed material that the RSO considers unsafe are
stopped
32 Radiation exposures are ALARA
33 Posting of required documents or a notice where the following documents
can be found
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 3 of 5ResponsibilitiesNovaMed RSP-0121
34 Development distribution implementation and maintenance of up-to-date
operating and emergency procedures
35 Possession installation relocation use storage repair and maintenance of
self-shielded irradiators are consistent with the limitations in the license the
SSD Registration Certificate(s) and manufacturers written recommendations
and instructions
36 Safety consequences are analyzed before conducting any activities involving
repair use maintenance installation or relocation of IBL 437 C irradiators
37 Individuals installing relocating using maintaining or repairing self-shielded
irradiators are trained and authorized (as described in the license application)
38 Prospective evaluations are performed demonstrating that individuals are not
likely to receive in one year a radiation dose in excess of 10 of the allowable
limits or personnel monitoring devices are provided
39 When necessary personnel monitoring devices are used and exchanged at the
proper intervals and records of the results of such monitoring are maintained
310 Self-shielded irradiators are properly secured
311 Documentation is maintained to demonstrate by measurement or calculation
that the radioactive dose to an individual member of the public likely to receive
the highest dose from the licensed operation does not exceed the annual limit
in 10 CFR 201301
312 Proper authorities are notified of incidents such as damage to or malfunction of
self-shielded irradiators fire or theft
313 Unusual occurrences involving the self-shielded irradiators (eg malfunctions
or damage) are investigated cause(s) and appropriate corrective action(s) are
identified and timely corrective action(s) are taken
314 Radiation safety program audits are performed at least annually and
documented
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 4 of 5 ResponsibilitiesNovaMed RSP-0121
315 When the licensee identifies violations of regulations or license conditions or
program weaknesses the licensee develops implements and documents
corrective actions
316 Licensed material is transported in accordance with all applicable DOT
requirements
317 Licensed material is disposed of properly
318 Appropriate records are maintained
319 Up-to-date license is maintained and amendment and renewal requests are
submitted in a timely manner
40 Radiation Worker Responsibilities
41 Government Regulations - all persons who receive possess use or transfer radioactive materials on site are subject to regulations issued by the US NRC
42 Company Policies
421 Employees must comply with company procedures for safe handling of radioactive materials (RSP-001) and practice ALARA concepts
422 Procedures must be adequately planned to ensure necessary safety precautions are taken
423 Employees must wear personal monitoring devices (supplied by the RSO) while in restricted areas as stated in RSP-OOS
424 Employees must maintain logs and perform surveys as required by the RSO as stated in RSP-006 and RSP-OO
425 Survey hands shoes body and clothing for radioactive contamination before leaving the restricted area If contamination is discovered follow RSP-OOS for decontamination procedures
50 Requirements for Handlers of Radioactive Materials
51 A prospective Authorized User must
Radiation Safety Procedure ~~ Radiation Safety Organization
Page 5 of 5 ResponsibilitiesNovaMed RSP-0121
511 Be over 18 years of age and provide RSO with prior exposure documentation and radioactive material use history
512 Receive training from RSOARSO on applicable US NRC and State regulations and Corporate Radiation Safety Procedures prior to being allowed to work with radioactive material This training will be documented in accordance with company Radiation Safety Program Training
513 Work in the field under the direct supervision of the RSOARSO When the Authorized Users techniques and knowledge of radiation safety procedures are deemed sufficient by the RSOARSO then the Authorized user may work unsupervised in the field
Radiation Safety Procedure ~~ Leak Test Procedure
Page 1 of 7 NovaMed
Sealed Sources Approved by Date
Michael M Thomson Radiation Safety 01Aug2012 Officer
Issued by Date
NovaMed Corporation Trumbull CT 01Aug2012
Supersedes updates Original Document
Table of Contents
10 Purpose 2
20 Responsibility 2
30 Discussion 2
40 Formulas 2
50 Leak Test Materials 4
60 Leak Test Procedure 4
70 Documentation 5
80 Record Retention 5
Example A (Leak test record 6
Radiation Safety Procedure ~~ leak Test Procedure NovaMed Page 2 of 7
10 Purpose
The purpose of this document is to ensure the procedure for testing sealed radioactive sources contained in the IBL 437 C is properly defined and understood by those performing the testing
20 Responsibility
21 It is the responsibility of the RSO to define review and update the procedure and to review the procedure with Authorized Users (AU) to verify it is being properly performed
22 It is the responsibility of the Authorized Users (AU) to perform the procedure as described and to report any errors or other issues to the RSO
30 Discussion
31 NovaMed performs leak testing as a part of relocation projects We do not solicit nor accept wipe smears sent in from customers and do not perform as commercial leak test service providers
32 The IBL-437C Blood Irradiator is a self-shielded device with the sealed sources inaccessible to our field engineers Thus evidence of radioactive contamination is not expected on a wipe test smear Results are categorized as either not contaminated or contaminated A minimum level of acceptable radioactive contamination is not defined In the event a wipe test provides results that are statistically above background the company will notify the facility RSO The presence of 185 Bq (0005 ~Ci) or more of removable contamination on any test sample shall be considered evidence that a sealed source is leaking
33 Our instrumentation efficiencies are capable of detecting a Minimal Discernable Activity (MDA) of 185 Bq (0005 microcuries) at a 95 confidence
40 Formulas
41 The calibrated check source must be decayed from its initial value
At =Aoemiddot693 () I tmiddothalf
Given At = Activity (current) Ao =Initial activity of the source 102 microcurie on 1211974 (example)
t-half for Cs-137 = 3015 years t = time years of decay of source
Example
If calculation made on 72712
~~ NovaMed
A(8142003)
A(842003)
A(842003)
A(842003)
A(842003)
Radiation Safety Procedure Leak Test Procedure
Page 3 of 7
=(102 IJCi) (emiddot693(3767 yrs) 1(3015 years)
Cmiddot) ( -693(123)=(102 IJ I e
=(102 IJCi) (e-middot866)
= (102 pCi) (4206)
=429 IJCi (1588 KBq)
42 The efficiency of the instrument is calculated
[(cpm from standard) - (cpm from bkgl] = efficiency in cpmBq Activity of std in Bq
Where
cpm = counts per minute std = standard bkg =background Bq = Becquerel
Example
Standard cpm = 64000 Countsmin Background = 42 Countsmin Standard Activity = 1588 KBq (04292 IJCi)
EFF = 64000 cpm(std) - 42 cpm(bkg) = 4027 cpmBq 15880 Bq
43 The Minimal Discernable Activity (MDA) also call Lower Limit of Detection (LLD) is calculated and must be at least 185 Bq (0005 microcuries)
The formula we use is the one for determining a measurement at the 95 confidence level The formula for this level is
Where
MDA = Minimum Discernable Activity in disintegrationsmin B =Background count (42 cpm) EFF =Efficiency in cpmBq (4027 cpmBq) T = Count time (1 minute)
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 4 of 7
271+465 vBt MDA= EFFt
MDA = 271 + 465 v42 1 = 271 + 465 6480 1 = 30132 7482 dpm 40271 4027 4027
MDA =7482 dpm =01247 8q (337E-6 microcuries)
43 The sample counting time and background counting time must be equal The counting efficiency must be determined by using a standard source of known activity that emits photons of approximately the same energy as the contaminant to be detected The counting rate for the standard is divided by the standard activity to determine the counting efficiency When dividing the two values must be in compatible units For example a standard activity in lCi must be converted to dpm by multiplying by a factor of 22E+6
45 For a copy of the full discussion of the theory and limitations of this test refer to pages 307-311 in NCRP Report No 58 A Handbook of Radioactivity Measurement Procedures issued Februaryl 1985 by the National Council on Radiation Protection and Measurements 7910 Woodmont Avenue Bethesda MD 20814
46 Leak testing formulas are part of a Microsoft Excel spreadsheet which is verified and protected to prevent corruption
50 Leak Test Materials
51 DEFENSAP leak test wipes or alcohol swabs or suitable substitutes
60 Leak Test Procedure
6 t Samples will be collected at appropriate locations and the date time locationidentification as well as the individual collecting the sample will be recorded on the package The data for the check source in use is confirmed in the spreadsheet as accurate which includes the original actual activity and date of measurement
62 The sample swab is checked with a survey meter to determine presence of any contamination
63 A suitable location to perform the analysis will be selected which is away from the device and other sources of radiation The sample tray will be used to
Radiation Safety Procedure Leak Test Procedure~fampNovaMed Page 5 of 7
position the samples to be counted as well as the calibrated check source assuring proper symmetry to the detector
64 The Inspector will be turned on and the calibration number displayed during POST (Power On Self-Test) will be viewed to confirm the meter is operating An instrument check with the appropriate check source will be performed to confirm proper instrument operation If the check source does not read within 20 of the expected value after calibration the meter will not be used
65 The meter will be placed into the Totalrrimer mode with the timer switch (on top) placed to the Set position The Set + and - buttons are used to set the count time to 1 minute
66 A background count will be performed with no check source and no wipe test in the sample tray in order to determine the background count The Timer switch is moved to the On position the meter beeps 3 times and an hourglass turns indicating that the 1 minute count has started while the count rises At the end of the 1 minute time the beeper again beeps in a pattern of 3 beeps a delay 3 beeps a delay and a final 3 beeps The hourglass is no longer moving and the display is steady The background count is entered into the spreadsheet
67 A source count is performed by placing the calibrated check source into the sample tray with the calibration sticker down (The window for the check source is on the back If the check source is placed incorrectly the count will not be sufficient to produce an acceptable MDA) The meter is again set for one minute per the above instructions and the count is performed for the one minute timed period The results are entered into the appropriate field in the spreadsheet The spreadsheet automatically calculates the decay of the cesium check source based on the original activity and date of measurement
68 The wipe test sample(s) are measured in the same manner for one minute and the results are recorded in the appropriately labeled gross count section for each wipe test performed
69 The spreadsheet is designed to calculate the MDA as well as the results of each wipe test If the results are appropriate and acceptable the fields will have a green background and if inappropriate or exceeding limits the cell backgrounds will be red
70 Documentation
71 The results of all leak testing will be recorded on the Leak Test Analysis form see attached example A
72 Review the data and sign and date the record
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 6 of 7
80 Record Retention
81 Retain records for 3 years (10 CPR 202103(araquo
Radiation Safety Procedure ~~ Leak Test Procedure NovaMed Page 7 of 7
EXAMPLE A
(See attached pdf file)
h rm lucence
Facility Name Facility Address
City State Zip Code
LEAK TEST ANALYSIS for SERIAL NUMBER 90middot323
Date of Test 27-Jul-12 Background 42
Date of Analysis 27Jul-12 Source Count 64000 Originsillei I 1020
Counter Inseector Efficiency 7 Cal date I 1-0ec-74
Serial 19974 Current Ci I 04292
Set-up (1) Standard MDA(3) 203E-04 Ci 753 Bq
Results
Gross Count 45 Sample Net CPM 3IBL Internal- Pre-Move Results Test Activity 201E-05 jJCi
Acceptable laquo0005 Ci) 074 Bq
Gross Count 750 Sample Net CPM --_708----IBL External- Pre-Move Results Test Activity
Acceptable laquo0005 Ci)
Gross Count 787 Sample Net CPM --_745----IBL Internal - Post-Move Results Test Activity 500E-03 jJCi
Acceptable laquo0005 Ci) 18485 Bq
Gross Count 788 Sample Net CPM --_746----IBL External - Post-Move Results Test Activity
Failed
(1) Sample geometrycounter set-up as appropriate to reproduce measurement (2) NIST traceable source used to derive measurement efficiency (3) Minimum Detectable Activity 95 confidence level (4) Minimum Detectable Activity when sample net CPM-Iower detection level (Ld) CPM
The Irradiator was found to be free of contamination andor leakage of Cs-137 at the above test sensitivity (MDA) The maximum level for acceptance of the Irradiator is 5E-03 jJCi [185 Bq]
Prepared by
Michael M Thomson Field Service Engineer Date
NovaMed Corporation - Drive bull TrumbulL GT vwvwpharmaucence com
M14-1-004A Effective 308 Rev 1
This is to acknowledge the receipt of your letteeuroplicatio~ated
g- 7 - h and to inform you that the initial processing which includes an administrative review has been performed
~erewe~ OsiOS ~o9a~i~i~W~~gned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information
o Please provide to this office within 30 days of your receipt of this card
A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved
Your action has been assigned Mail Control Number S 7 Cflll When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260
NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader
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