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ITEM 5: RADIOACTIVE MATERIAL

Any byproduct material Any As neededpermitted by 10 CFP. 35.100

ITEM 6: PURFPOSE(S) FOR WHICHLICENSED MATERIAL WILL BE USED

10 CFR 35.200 Medical Use of Unsealed Byproduct Material for Imaging and Localization Studiesfor Which a Written Directive is Not Required

Authorized. 1er UsJ-e

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NEW YORK STATE DEPARTMENT OF HEALTHRADIOACTIVE MATERIALS LICENSE

Pursuant to the Public Health Law and Part 16 of the New York State Sanitary Code, and inreliance on statements and representations heretofore made by the licensee designated below, a licenseis hereby issued authorizing radioactive material(s) for the purpose(s), and at the place(s) designatedbelow. The license is subject to all applicable rules, regulations, and orders now or hereafter in effectof all appropriate regulatory agencies and to any conditions specified below.

1. Name 3. License Number

Daniel E. Levy, M.D., P.C. 5168

2. Address 4. a. Effective Date

788 Franklin StreetValley Stream, New York 11580.

Attention: Ajay Agarwala, M.D.Radiation Safety Officer

January 26, 2005

b. Expiration Date

January 31, 2015

5. Reference NumberDH No. 04-530

6. Radioactive Materials(element & mass no.)

7. Chemical and/orPhysical Form

8. Maximum quantitylicensee may possessat one time

A.. Technetium 99mr A. Any A. 500 millicuries(all forms combined)

B. Thallium 201

C. Cobalt 57

D. Cesium 137

B. Thallous Chloride

C. Sealed Source

D. Sealed Source

* B. 50 millicuries

C. 20 millicuries

D. 500 microcuries

Doc:BOIL\CARD(52450) REV. 1/03

NEW YORK STATE DEPAR¶MENT OF HEALTHRADIOACTIVE MATERIALS LICENSE

CONDITIONSLicense No. 5168

9. Authorized use (unless otherwise specified, the authorized place of use is the licensee's addressstated in Item 2, above).

A. and B. Determination of cardiac function.

C. and D. Calibration of equipment.

10. A. Radioactive material listed in Item 6 shall only be used by:

Ajay Agarwala, M.D.

B. Radioactive materials listed in Item 6 shall be used by Ajay Agarwala, M.D.,as appropriate to fulfill the responsibilities of the Radiation Safety Officer.

11. Except as specifically provided otherwise by this license, the licensee shall possess and uselicensed material described in Items 6, 7, and 8 of this license, in accordance with statements,representations, and procedures contained in the documents (including any enclosures) listedbelow:

A. Application for New York State Department of Health Radioactive MaterialsLicense dlated November 23, 2004, signed by Daniel E. Levy, M.D.

B. Letter dated January 5, 2005, signed by Daniel E. Levy, M.D.

The New York State Department of Health's regulations shall govern the licensee's statementsin applications Cr letters unless the statements are more restrictive than the regulations.

12. A. Radioactive material shall be stored in a locked facility in the original shippingcontainer, or a container providing equivalent radiation protection. Such a facility maybe a cabinet, a safe, or a room, providing the facility is locked at all times when noactivities are in progress relating to the use of the radioactive material. This includesperiods of brief absence of personnel from a nuclear medicine department, laboratory,etc., where radioactive materials are used or stored.

B. Radioactive materials shall not be stored in the same facilities with materials whichmight substantially increase the fire or explosion hazard of the storage space and itsradioactive contents.

NEW YORK STATE DEPARTMENT OF HEALTHRADIOACTIVE MATERIALS LICENSE

CONDITIONSLicense No. 5168

13. A. Transportation of licensed radioactive material shall be subject to all regulations of theU.S. Department of Transportation and other agencies of the United States havingjurisdiction insofar as such regulations relate to the packaging of radioactive material,marking and labeling of the packages, loading and storage of packages, monitoringrequiremi nts, accident reporting, and shipping papers.

B. Transportation of low level radioactive waste shall be in accordance with theregulations of the New York State Department of Environmental Conservation ascontained in 6 NYCRR Part 381.

14. The licensee shall have available an appropriate survey meter which shall be maintainedoperational and.shall be calibrated before initial use and at subsequent intervals not exceedingtwelve months by person(s) specifically authorized by the U.S. Nuclear RegulatoryCommission or an Agreement State to perform such services. Records of all calibrations shallbe kept a minimum of five years.

15. Leak tests of sealed sources shall be performed in accordance with Section 16.10 (a)(4),New York State Sanitary Code (10 NYCRR 16). Off-site analysis of leak test samples shall beperformed by persons specifically authorized by the U.S. Nuclear Regulatory Commission oran Agreement State to perform such services. On-site analysis of leak test samples shall be inaccordance with procedures approved by the Department.

16. The licensee is authorized to hold radioactive material with a physical half-life of less than65 days for decay-in-storage before disposal in ordinary trash, provided:

A. Affectel radioactive waste shall be held for decay a minimum of ten half-lives.

B. Prior to disposal as normal waste, radioactive waste shall be surveyed to determine thatits radioactivity cannot be distinguished from background. All radiation labels will beremoved or obliterated.

17. The licensee shall not administer technetium-99m to patients if the technetium-99m containsmore than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m.

NEW YORK STATE DEPARTMENT OF HEALTHRADIOACTIVE MATERIALS LICENSE

CONDITIONSLicense No. 5168

22. The licensee may receive, possess and use calibration and reference standards in accordancewith section 16.1.23(e) of 10 NYCRR Part 16.

23. Nuclear Medicine Technologists who meet the criteria of 10 NYCRR 16.123(a)(3)(i) mayperform parenteral injections of radioactive materials for diagnostic purposes under thesupervision of a physician on the premises. Prior to allowing parenteral administration by anuclear medicine technologist, the Radiation Safety Officer shall insure that the technologist iscompetent in the performance of parenteral administration. Records of this approval must beretained as long as the Nuclear Medicine Technologist is working under, the license.

FOR THE NEW YORK STATE DEPARTMENT OF HEALTH

Date: JAN 2 6 2005RD/AD:ks

By 2 &L S r\ X

Robert E. Dansereau, ChiefRadioactive-Materials SectionBureau of Environmental Radiation Protection

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State of New JerseyDepartment of EnvironmetalrProtectioc

Bureau of Eniirowneotl RdiationRadioactive Materials Section

P0 Nox 415, Trenton, NJ 08625-0415Phone (609) 9462

. rust No. NJSL-283210h1003AmsadmeS No.: 00

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New Jersey Radioactive Materials License

Radioactive material shall only be used at Inflitute for Better Breathing, Newark Liberty Inernational AMrport,Building 340, Necrk, byewJerty.

Badioacthe material listed in Conditions 6,7, and 8 iban be used by orun&r the supervision ofAjiY AgarwalPaul Verona, M.D. and Rloola M ,.

Licensed materials sball not be

Ms license is based on e a enSd iopresentatid izsed Ilcaton dated Aup.2004 SignedbyM Man< l .

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Item 8

MODEL PROGRAM Fdr Radiation Safety Training

Personnel will be Instructed:1. Before assuming duties with, or in the vicinity of, radioactive materials.2. During annual refresher training.

.3. Whenever there is.a significant change in duties, regulations, or the terms of the license.

Instruction for individuals in attendance will include the following-subjects:1. Applicable regulations and license conditions.2. Areas where radioactive material is used or stored.3. Potential hazards associated with radioactive material In'each area where the-employees

will work.4. Appropriate radiation safety procedures.5. Ucensee's In-h )use work rules.6. Each individual's obligation to report unsafe conditions to the Radiation Safety Officer.7. Appropriate response to emergencies or unsafe conditions.8. Worker's right ':o be Informed of occupational radiation exposure and bioassay results.9. Locations where the licensee has posted or made available notices, copies of pertinent

regulations, and copies of pertinent licenses and license conditions (including applicationsand applicable correspondence), as required by 10 CFR Part 19.

10 Question and answer period.

The following will be trained initially, and then annually:

Nuclear Medicine TechsEKG TechsNurses

ITEM 9

Radiation Monitoiing Instruments

(A) Radiation Survey Instruments will be calibrated yearly by a qualified person toperform such calibrations. ( We eill send out our meter to ourradiopharrnaceutical vendor, who sends it to a calibration laboratory that meetthe requirements in 10 CFR 20.1501 and of 10 CFR 35.61.)

(B) Radiation Well Counter will be calibrated yearly by our consulting physicist, whowill follow nationally recognized standards or the Manufacturersrecommendations.

The Survey meter is a Ludlum 14 with a 44-9 GM Pancake Probe. This unit will be usedfor Daily package surveys of incoming packages, daily area surveys, daily monitoring ofhands and feet, and for monitoring waste prior to disposal.

The Well Counter is a Capintec CRC 15 W with a Capintec Well. This unit will be usedfor daily wiping of Incoming and outgoing radioactive packages, and for weekly areawipe testing for contamination.

We reserve the right to upgrade our survey instruments as necessary as long as they areadequate to measure the type and level of radiation for which they are used.

Dose Calibrator

Equipment used to measure dosages will be calibrated in accordance with nationallyrecognized standards or the manufactures instructions.

Gamma Camera

We will perform all Quality Control and Calibrations that are in accordance withnationally recognized standards and manufacturers recommendations.

_ .

AttachmentFacilities and Equipment

Hot Lab:

The jot lab is the location where radiopharniacuticals are stored, prepared anddispensed. Lead bricks or lead fined storage modules are used to provide shielding wherenecessary. The hot lab has an."" block present. Additional lead shielding is used around the'I? block where. necessary. Absorbent, plastic backed paper is used to line the counter topsihere radioactive iateial is used.

DOT shipping cont;ietrs for the transport of. unit doses provide significant shielding.These will be used for storage of patient doses until their use unless a suitable alternaive cedsm

Storage of ]adioaetive.Material and Waste:

Ldlined ( inh) disposalcans are present iiathehot lab aras for thestorage of

Active waste. Lead lined (118 mich), or equivalent, storage modules arepreseont for thestorage of radioactive material

- Additional Safety Equipment:

The folowvitg yf4 eqdpnent is also present for use at th liceseen s facity ad atloiations vhere radiopa euticals are used.

syringe shields syringe carriers* : disp<)sable protective gloves. absorbent pads

-remct hadling devices lead equivalent Wbocklead shields for vial storage lead bricks (aselead lied storage modules lab coats

Ajay Agarwala, M.D.906 Oak Tree RoadSouth Plainfielel, NJ 07080

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1 L- Block: w lead shielding2 Lead Lined Storage3 Lead Lined Waste Container(s) A) Shaips B) 5 Gallon Non-sharps4 Treadmill5 Stress Ta-ble/ Chair/ Injection Area6 Imaging Camera I Imaging Chair7 Cameraf. Computer Control

Item 10

Occupational Dose

We will provide dosimetry that meets the requirements listed under criteria in NUREG1556, volume 9 " Consolidated Guidance about Materials License: Program SpecificGuidance about Medicla Use Licensees."

Area Surveys

We have developed and will implement and maintain written procedures for area surveysIn accordance with 10 CFR 20.1101 that meet the requirements of 10 CFR 20.1501 and10 CFR 35.70.

Safe Use of Unsealed Licensed Material

We have developed and will implement and maintain procedures for safe use of unsealedbyproduct that meets the requirements of 10 CFR 20.1101 and 10 CFR 20.1301.

Spill Procedure

We have developed and will implement and maintain written procedures for saferesponse to spills of licensed material in accordance with 10 CFR 20.1101 .

Item 11

Waste Management

We have developed and will implement and maintain written waste disposal proceduresfor licensed material in accordance with 10 CFR 20.1101, that also meet the requirementsof the applicable section of Subpart K to 10 CFR Part 20 and 10 CFR 35.92.

This is tc acknowledge the receipt of your letter/application dated

____ ____ _ _ ,and to inform you that the initial processing whichincludes an administrative review has been performed.

/ 'Alro 60/- /'Z { F> Cc on -77/pc91Ž1There were no administrative omissions. Your application was assigned to a

technical reviewer. Please note that the technical review may identify additionalomissions or require additional information.

Please provide to this office within 30 days of your receipt of this card

A copy oi your action has been forwarded to our License Fee & Accounts ReceivableBranch, who will contact you separately if there is a fee issue involved.

Your action has been assigned Mail Control Number /I 7 8 0 3.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 5:12 (RD Sincerely,(6-96) .Licensing Assistance Team Leader

(FOR LFMS USE)INFORMATION FROM LTS

BETWEEN:

License Fee Management Branch, ARM

andRegional Licensing Sections

: Program Code: 02201: Status Code: 3: Fee Category:: Exp. Date: 0: Fee Comments:: Decom Fin Assur Reqd: _

LICENSE FEE TRANSMITTAL

A. REGION -I

1. APPLICATION ATTACHED

Applicant/Licensee:Received Date:Docket No:Control No.:License No.:Action Type:

AGARWALA, AJAY, M.D.

200602173037144

138443Zf- -A>At/-of

New Licensee

2. FEE ATTACHEDAmount:Check No.:

3. COMMENTS

Signed -

Date .( Is 9 1

B. LICENSE FEE MANAGEMENT BRANCH (Check when milestone 03 is entered /_/)

1. Fee Category and Amount:

2. Correct Fee Paid. Application may be processed for:

AmendmentRenewalLicense

3. OTHER

SignedDate