ACMUI Discussion of Part'35 Training and

Experience Requirem'entsDouglas F. Eggli, M.D.

Nuclear Medicine Physician

- -Background'* ACMUI reviewed the training

and experience requirementsfor Authorized Users (AUs),Authorized Nuclear Pharmacists(ANPs), Radiation SafetyOfficers (RSOs), and AuthorizedMedical Physicists (AMPs)

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Goals

* Make the requirementcommensurate with the risk

* Risk-Informedlperformancebased vs. prescriptive

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Initial Evaluation

ACMUI: T & E subcommitteeformed -

* Initial discussions:-describe elements of training-Training provider-Attest to training adequacy

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InitialRecommendations

* ACMUI: certifying boardsshould remain actively involved

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* An alternate pathway -

developed

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Training Pro'grams* ACMUI recommended that

training programs would beresponsible for developing a -curriculum that would satisfythe broad educational andexperience objectives requiredby the regulation

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Training Programs

* ACMUI did not recommend aspecific time allocation forindividual curriculum -

components, rather specifiedthe content to be mastered -(performance based regulation)

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Attestations

* Certifying boards: attest, notcertify -

* Certification of competence:legal ramifications

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AttestationRecommendation

Attestation be performed-by thetraining director, who Is :responsible for similar'attestations of trainingexperience to the certifyingboards

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Attestation

* The NRC-subsequently* 'determined that the publicinterest would be best servedby requiring an AuthorizedIndividual to supply theattestation of training andexperience.

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Part 35 Rule Making

* Recommendations were offered fortraining requirements for allcategories of Authorized Individuals

* The ACMUI recommendations werelargely adopted by the Commission

* Proposed rule based on ACMUIrecommendations

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OAS Concerns

* Organization of AgreementStates: concern over AU'training and experience'

* Concern hinged on specificity ofdidactic educationrequirements, not on 700 hrs

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'ACMUI Discussion

* Total hours-reduced from 1000to 700 is appropriate

* Distribution of training hours:%represented an area of concern

for ACMUI -

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Reasons for ACMUIConcern

* Most clinical Nuclear Medicinein the US (subpart 200 and 300uses) Is performed by- 'physicians trained and certifiedby the American Board ofRadiology (approximately 70%of clinical volume)

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Reasons for ACMUIConcern

* Because of competing demandsfor training time from newmodalities, DiagnosticRadiology training programs willtailor training time in NuclearMedicine to NRC requirements(700 hours)

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Reasons for ACMUIConcern

American Board of Radiology hasIndicated that It Intends to requireall Diagnostic Radiology residents betrained in subpart 300 uses- This means that subpart 390 T&E

requirements have to be the basisfor Radiology training

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Reasons for ACMUIConcern

* ACMUI: 200 hours of didactictraining was excessive

* Recommended 80 hours forsubpart 300 uses.

* Recommendation was based onACMUI members' experience

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Reasons for ACMUIConcern

* Since total experience willlikely be limited to 700 hours,practical and clinicalexperience time would bedisproportionately reduced toaccommodate a 200 hourdidactic training requirement

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Didactic Training

* Components of didactic(classroom and laboratory)training are not well defined

* Large didactic requirementleads to uncertainty (i.e., whatqualifies as didactic training?)

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Definition of Didactic

* Dorland's Medical Dictionarydefinition of didactic: "conveying.Instruction by lectures and booksrather than by practice"'

* Training directors need to be certainthat the programs they design meetthe Intent of the regulation

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Further Discussion withNRC Staff

* Because the T&E requirementfor subpart 200 and 300 usesare to be prescriptive-.(quantitative), provide enoughdetail so that training directorscan be certain of compliance

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Summary: MedicalEvent Reporting Issues

Jeffrey F. Williamson, Ph.D.--Chair, ACMUI Medical Event'

Subcommittee

Subcommittee Charge* Evaluate 20% Threshold in ME

rule* How best to communicate risk* Permanent interstitial

brachytherapy

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Medical Event Subcom'mittee(MESC) 'activities

* Membership -

* Two closed conference calls;two noticed public calls''Consultant: Louis Potters, MD

* Recommendations: 'April 2005

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Outline* Review'ME issues in prostate

permanent seed brachytherapy* Review MESC consensusachievei to 'date

* Review issues still underdiscussion

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Image-Guided SourceInsertion Procedure

* 18 gauge (1.3 mm diameter).needle for seed placement

* Ultrasound probe In - .rectum for needle guidance

* TRUS = Trans-rectal ultrasoundImaging

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TRUS Image iGuidance7, r

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Prostate BrachytherapyProcedure Flow ;

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Preplanning* TRUS Imaging 2 wks before Implant* Dose calculations to find needle loadings

& seed strengths that deliver desireddose to clinical target volume (CTV)

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Seed Insertion Procedure

* Patient anatomy may differ frompreplan

* AU must be free to adapt preplanto anatomy imaged duringprocedure

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Post-Procedure DoseEvaluation

* CT imaging: 0-30 days later* Contour CTV and organs at risk

& calculate doses-* Post-Implant doses, e.g., D.,- most'

definitive estimate of delivered dose

Current ME Definition10 CFR 35.3045:

* ME = byproduct materialadministration, in which- Delivered - Prescribedl> 50 Rem AND

> 20% OR

-Dose to extra-target site >expected (planned) dose by 50Rem AND 50% :

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Is 20% Level Justifiable?MESC consensus

* For temporary implants, 20% is areasonable regulatory actionlevel

* Permanent Implants: No

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Rationale: ProstateVariability in Post-implant CT.vs.written directive dose comparisons-CT vs. US CTV:. 50% differences-Large CT contouring variations- Long/variable interval from

Implant to dose calculation-legitimate preplan modifications

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Other Permanent ImplantIssues

* WD: 35.40(b)(6)(ii) allows AUto specify No. sources anddose at any time post-Implant

^ Wrong site ME:unenforceable

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MESC Proposal

..,-^Define ME In terms of where'...,sources-'areimplanted rather. .' 'than dose delivered;: Recommendation i

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MESC Proposal

* Recommendation 2: Replacewrong site and target volumeME definitions

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MESC Proposal* Recommendation 3: For

permanent implants amend35.40(c) and (b)(6)(11i) to requirecompletion and any revision ofWD within I working day ofsource insertion

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Rationale:Recommendations 1-3

* Determining fraction of seeds* Determine seed fraction'

intraoperatively* Limiting WD revisions

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Risk CommunicationMESC proposals under discussion

Recommendation' 4: Treat MEstrictly as QA performancesurrogate divorced frompatient harm

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Rationale Rec 4:* ME reporting perception

* AU reporting dilemma

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Rationale Rec 4:Industry practice- Errors alone not grounds for. punishment-Error reports used to Improve

overall process-QA deliberations not

discoverable

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Unresolved Issues

.* Dose calculation errors* Williamson: Add dose-

calculation error ME pathwaylimited to preplanning-ME = any calculation => error

in source strength WD > 20%

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Other ME issues

* Is current wrong-site ME criterionworkable and justifiable for othertypes of brachytherapy andexternal beam treatments?

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ACMUI Review of ICRP2005 Recommendations

Richard J. Vetter, Ph.D.Radiation Safety Officer

Extent of Comments

* Comments limited to items ofgreatest interest to ACMUI

* No comments on environmentalrecommendations

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JustificationICRP 2005 on justification of :

medical exposure:* JustificatIon of practice* Justification of procedures* ACMUI agrees

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ICRP Constraints

* Restrictions on dose: constraints' Achieving constraints: obilgatory* Exceeding constraints: failure* ACMUI position

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Example of Constraint

ICRP recommended declaredpregnant worker constraint: *mSv

ACMUI view:* Current limit of 5 mSv is safe* 1 mSv may be appropriate ALARA

goal for some: not constraint

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Typical Doses to MedicalPersonnel

* Cardiac Lab* PET* Nuclear Medicine

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Public Dose Constraint

* ICRP: a few mSv reasonable butdon't be rigid

* NRC: limit of 5 mSv to member ofpublic from radioactive patient.

* NCRP recommends 5 mSv; 50mSv if instructed & monitored.

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Public Dose Constraints

- ICRP: 0.3 mSv constraintproblematic; exorbitant cost

- NCRP: 0.25 in general; 1.0 formedical facilities shielded perNCRP recommendations

- ALARA still works

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Public Dose Limits

* NCRP Statement 10 (2004):- I mSv limit to members of public- 5 mSv recommended forcaregivers of radiation therapypatients- 50 mSv limit; trained & monitored

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Worker Dose Limits* Pregnant worker: I mSv per term

problematic, risk very low* Workers: 20 mSv problematic for

some* ACMUI supports NCRP

recommendation & current NRCannual limit of 50 mSv

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Conclusions

* ICRP proposed constraintsconfusing and problematic

* ICRP proposed occupationallimits problematic for somemodalities

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ACMUI Rep'ort o'n DoseReconstru'ction:.,.

Jeffrey F. Williamson, Ph.D.Chair, DRS Subcommittee

DRS SUBCOMMITTEE'

J. Williamson, PhD Chair 'D.1Egglii MD""N. Hobson 'L. Malmud, MD :0. Suleiman, PhD -S. Schwarz, RPh

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St. Joseph's Hospital'Incident'

* 285 mCi 1-131 orally::administered ;

* Daughter'sexposure-'Reg III: Daughtees exposure =

15 rem* SNM: too conservative

Subcommittee Charge* Independently review Region 3's

dose evaluation* Review the alternate dose,

reconstruction meth'odology* Make recommendations

regarding dose reconstruction

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ACMUI DRS SCInvestigations

* Review Reg IlIl calculations,* Review/critique Marcus/Siegel

article* Interview relevant parties and

review documents

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';Findings* 15 rem: most conservative

estimate possible that is nottotally implausible -

* Distance reconstruction* DRS estimate: 9 rem for Reg IlI's

dwell-time scenario

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Findings: continued

* SJH disputes Reg III dwell-timescenario

* DRS: reduces DDE to 4-6 rein* Inspection report improvement

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Siegel/Marcus Critique

* Use more sophisticated DR tools,e.g., distance reconstruction

* Use EDE, not DDE, as regulatoryendpoint'

* DRS: overly simplisticapproximations used

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SNM vs. ACMUI DR* Distance Reconstruction factor* EDE vs. DDE factor* Continuous decay factor* Various other factors

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ACMUI Recommendationsto NRC Staff

-Doses near regulatory limit;-Licensee disputes NRC DR- Plausibility of findings is

suspect- Usual approximations suspect

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ACMUI Recommendationsto NRC Staff

* Use EDE as DR regulatory' -endpoint for CFR 20 compliance

* Use EDE/DDE ranges and/or;-justify rejection of Licenseescenario

* Exempt caregivers

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ACRONYMS

ACMUI - Advisory Committee on the Medical Uses of Isotopes

ALARA - As Low As Reasonable Achievable

AMP - Authorized Medical Physicist

ANP - Authorized Nuclear Pharmacist

AU - Authorized User

CFR - Code of Federal Regulations

CT - Computed Tomography

CTV - Clinical Target Volume

DDE - Deep-dose Equivalent

DR - Dose Reconstruction

DRS - Dose Reconstruction Subcommittee

EDE - Effective Dose Equivalent

ICRP - International Commission on Radiological Protection

ME - Medical Event

MESC - Medical Event Subcommittee

NCRP - National Council on Radiation Protection and Measurements

OAS - Organization of Agreement States

PET - Positron Emission Tomography

QA - Quality Assurance

Rec - Recommendation

RSO - Radiation Safety Officer

SC - Subcommittee

SJH - St. Joseph's Hospital

SNM - Society of Nuclear Medicine

T & E - Training and Experience

TRUS - Trans-Rectal Ultrasound Imaging

WD - Written Directive