ACMUI Discussion of Part' 35 Training and Experience Requirem'ents Douglas F. Eggli, M.D. Nuclear Medicine Physician - - Background' * ACMUI reviewed the training and experience requirements for Authorized Users (AUs), Authorized Nuclear Pharmacists (ANPs), Radiation Safety Officers (RSOs), and Authorized Medical Physicists (AMPs) pi 20. ACMU TA E Doe. 2 Goals * Make the requirement commensurate with the risk * Risk-Informedlperformance based vs. prescriptive Aprd20. =U ACIUIT&F D6.-.6. Ij II . t. Initial Evaluation ACMUI: T & E subcommittee formed - * Initial discussions: -describe elements of training -Training provider -Attest to training adequacy dole4 ACMTED * Initial Recommendations * ACMUI: certifying boards should remain actively involved - . . - . I............ * An alternate pathway - developed Aofl 2'. 2cO M UE D 6.o. 5 Training Pro'grams * ACMUI recommended that training programs would be responsible for developing a - curriculum that would satisfy the broad educational and experience objectives required by the regulation A"20.=4 A"UIT!DE..W. 1
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- -Background' ACMUI Discussion of Part' 35 Training and · based vs. prescriptive Aprd20. =U ACIUIT&F D6.-.6. Ij II. t. Initial Evaluation ACMUI: T & E subcommittee formed -* Initial
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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)
pi 20. ACMU TA E Doe. 2
Goals
* Make the requirementcommensurate with the risk
* Risk-Informedlperformancebased vs. prescriptive
Aprd20. =U ACIUIT&F D6.-.6.
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II. t.
Initial Evaluation
ACMUI: T & E subcommitteeformed -
* Initial discussions:-describe elements of training-Training provider-Attest to training adequacy
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
mACUI , 2 cam - i-
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
* 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
ACAUI M= . . 2
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
* 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