ML23136A459

Advisory Committee on the Medical Uses of Isotopes (Acmui), Subcommittee on Training and Experience for All Modalities, Final Report, May 17, 2023

ML23136A459
Person / Time
Issue date:	05/17/2023
From:	Maryann Ayoade Advisory Committee on the Medical Uses of Isotopes, NRC/NMSS/DMSST/MSEB
To:
C Valentin-Rodriguez
References
Download: ML23136A459 (5)

Text

U.S. Nuclear Regulatory Commission Advisory Committee on the Medical Uses of Isotopes

Subcommittee on Training and Experience for All Modalities

Final Report Submitted on May 17, 2023

Subcommittee Members:

Hossein Jadvar, M.D., Ph.D. (Nuclear Medicine Physician; Chair)

Ronald Ennis, M.D. (Radiation Oncologist; term ended 3/17/2023)

Richard Harvey, Dr.Ph. (Radiation Safety Officer)

Darlene F. Metter, M.D. (Diagnostic Radiologist)

Megan L. Shober (Agreement State Representative)

Melissa C. Martin (Medical Physicist, Nuclear Medicine)

NRC Staff Resource: Maryann Ayoade Subcommittee Charge:

The T&E Subcommittee was re-established in 2022 by Dr. Darlene Metter, Chair of the Advisory Committee on the Medical Uses of Isotopes (ACMUI), with expanded charges to:

• Identify any potential impacts of ABRs request to terminate NRC recognition and other inactive boards identified during the staffs evaluation of specialty boards and provide recommendations to mitigate any potential impacts.

• Review and evaluate the NRCs current board recognition criteria and provide any recommendations for action.

The Subcommittee reviewed the relevant literature (see reference section) and met virtually several times to discuss the charge and propose several considerations in consultation with the NRC staff. The Subcommittee reported on the first charge above during the ACMUI meeting and the Commissioners meeting in December 2022. The second charge was further discussed during early 2023. The Subcommittees conclusions for both charges are included in this document.

==

Introduction:==

The American Board of Radiology (ABR, founded in 1934 as a non-for-profit organization and a member of the 24 certifying boards within the American Board of Medical Specialties, ABMS) announced in March 2022 that the board will no longer include Authorized User-Eligible (AU-E), Radiation Safety Officer-Eligible (RSO-E), and Authorized Medical Physicist-Eligible (AMP-E) designations on their certificates for all NRC-recognized ABR certification processes (for all specialty areas) starting on January 1, 2024, for individuals seeking authorization on NRC or Agreement State radioactive materials licenses:

1. AU-E designation for Diagnostic Radiology (DR), Interventional Radiology/Diagnostic Radiology (DR/IR), and Radiation Oncology (RO) certificates;

2. RSO-E designation for Diagnos tic Medical Physics and Nuclear Medical Physics certificates; and

3. AMP-E for Therapeutic Medi cal Physics certificates.

Prior to 2005, the ABR did not pro vide AU/RSO/AMP-Eligible designations on their certificates. During 2005-2023, after receiving NRC recognition, these designations were an option for candidates. T he ABR provided the following r eason for the decision to discontinue including these designations on the certificates (https://www.youtube.com/watch?v=hkRc9JzP2oA ):

• Not aligned with the core ABR m ission (to certify that our d iplomates demonstrate the requisite knowledge, skill, and understanding o f their disciplines to the benefit of patients); d iverts limited resources,

• ABR has never issued AU status ; most radiologists are not (and do not need to be) AUs,

• ABR merely passed along document ation of T&E and direct (alte rnate) pathway to becoming AU exists,

• AU requirement for 700h T&E in nuc lear radiology is an ACGME (residency) requirement,

• DR/IR (Form A - checklist related to the RC 80-h curriculum; Form B - I-131 documentation), RO (2-page veri fication form) need not to be su bmitted to ABR,

• Radioisotope Safety Exam (RI SE) questions will not be scored separately,

• Trainees and programs should co ntinue to keep T&E documentati on,

• T&E documentation needed for 16-m embedded NM-DR pathway and NR fellows to sit for NR CAQ exam,

• T&E documentation needed for Radi ation Oncology for AU status designation,

• ABR change is more cosmetic than substantive.

The ABR indicated that from 2024, the candidates should provide the relevant T&E documentation through their employers directly to the NRC or Agreement States in order to add the employee to the employers Radioactive Material (RAM) license.

Subcommittee Specific Comments:

Charge: To identify any potential impacts of ABRs request to terminate NRC recognition and other inactive boards identifie d during the staffs evaluation of specialty boards and provide recommendations to mitigate any potential impacts.

The subcommittee reviewed a num ber of relevant articles (see re ferences), gathered data from few states, and asked the ABRs Executive Director, Dr. Brent Wagner, to participate live with discussions and answer the subcommittees questions. The following conclusions were reached:

1) There may be, at in least in the short term, challenges with attaining AU status since AU-E designation on certificates was a rapid proof of AU eligibility and with the ABRs decision, the burden of proof is being placed on the applicants, preceptors, and training program directors to provide relevant documentation. It is plausible that in some cases the preceptors may be deceased or unwilling to sign off T&E documentation if there is >7 years window (per requirement in 10 CFR 35.59), or if the preceptor was not initially involved with applicants T&E.

2) Despite the concern expressed in item 1 above, the sampled environmental data indicated that, for example, in Wisconsin, only a minority of AU licenses were granted through ABR AU-E designation on board certification (majority were through the alternate pathway). The 2020-21 ABR data indicated that 67% of DR, 79% DR/IR, 97% of RO certificates had AU-E designations. The percentages for AMP-E and RSO-E were almost 100%. However, despite these high percentages of designations, it was unclear how many individuals holding AU-E designations on their certificates actually applied for and were declared AU, although it is presumed that the conversion fraction is relatively small.

3) In California, it was estimated that it takes approximately 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> per license amendment for documentation evaluation by the regulator and that there was no significant time difference in the evaluations of the ABR AU-E certificates and the alternate pathway. As for benchmark reference, SECY-20-0005, Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material 10 CFR Part 35 (ML19217A318) cost-benefit analysis, the time spent per applicant for documentation evaluations were 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br /> for NRC, 11 hours1.273148e-4 days <br />0.00306 hours <br />1.818783e-5 weeks <br />4.1855e-6 months <br /> for Agreement Sates, and 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> for licensees.

4) There was no credible indication that other NRC-recognized entities will follow the ABRs decision. Of note, the following boards are either dissolved or inactive and are currently listed on the NRC-recognized specialty board certifications webpage as no longer recognized by the NRC:

a. Certification Board of Nuclear Endocrinology

b. American Osteopathic Board of Nuclear Medicine

5) The subcommittee suggested that further discussions may be appropriate within the annual meetings of the Association of University Radiologists (AUR), Society of Chairs of Academic Radiology Departments (SCARD), Society of Chairs of Academic Radiation Oncology Programs (SCAROP), and Association of Program Directors in Radiology (APDR).

6) The subcommittee recommends publication of the subcommittee recommendations (approved by the ACMUI) in the AUR flagship journal, Academic Radiology.

Charge: To review and evaluate the NRCs current board recognition criteria and provide any recommendations for action.

The subcommittee discussed the current NRC board recognition criteria as outlined in NMSS Procedure MSST-70-03, Revision 2: Procedures for Recognizing, Monitoring, and Terminating the Certification Process of Specialty Boards (ML20351A389), 2022 Evaluation of NRC-Recognized Specialty Boards (ML22125A247), and NRC Form 313A (AUT): Authorized User Training, Experience, and Preceptor Attestation - for uses defined under 35.300 [10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396]

(ML12164A741). It was also noted and discussed that per the NRC final rule Medical Use of Byproduct Material - Medical event definitions, Training and Experience, and Clarifying Amendments published in the Federal Register on July 16, 2018 (83 FR 33046):

Training and experience requirements are amended in multiple sections to remove the requirement to obtain a written attestation for an individual who is certified by a specialty board whose certification process has been recognized by the NRC or an Agreement State. The NRC has determined that certification by a specialty board, coupled with meeting the recentness of training requirements, is sufficient to demonstrate that an individual seeking authorization on a license has met the T&E requirements and has the requisite current knowledge and, therefore, additional attestation by a preceptor is unnecessary. Individuals who are not board certified will still need to obtain a written attestation; however, the language of the attestation is modified. Additionally, residency program directors will be allowed to provide these written attestations.

It was agreed that board recognition criteria as described in these documents are sufficiently comprehensive and detailed. The Subcommittee does not recommend any changes to the NRC board recognition criteria.

References:

What you need to know about the recent ABR decision related to authorized user eligibility. https://orbitcme.com/blog/what-you-need-to-know-about-the-massive-abr-decision-on-authorized-user-eligibility/

Baldwin JA, et al. All you need to know as an authorized user. Am J Roentgenol 2015; 205:251-258.

10 CFR 35.50 - Training for radiation safety officer and associate radiation safety officer.

10 CFR 35.51 - Training for an authorized medical physicist 10 CFR 35.55 - Training for an authorized nuclear pharmacist 10 CFR 35.59 - Recentness of training 10 CFR 35.190 - Training for uptake, dilution, and excretion studies 10 CFR 35.290 - Training for imaging and localization studies 10 CFR 35.390 - Training for use of unsealed byproduct material for which a written directive is required 10 CFR 35.392 - Training for the oral administration of sodium iodide (I-131) requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries) 10 CFR 35.394 - Training for the oral administration of sodium iodide (I-131) requiring a written directive in quantities greater than or equal to 1.22 gigabecquerels (33 millicuries) 10 CFR 35.490 - Training for use of manual brachytherapy sources 10 CFR 35.690 - Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units

Respectfully Submitted on May 17, 2023,

Training and Experience for All Modalities Subcommittee Advisory Committee on the Medical Uses of Isotopes (ACMUI)

U.S. Nuclear Regulatory Commission (NRC)

The ACMUI unanimously approved this report as presented during its public meeting on May 15, 2023.