ML25093A080
| ML25093A080 | |
| Person / Time | |
|---|---|
| Issue date: | 04/08/2025 |
| From: | NRC/OCM |
| To: | |
| Shared Package | |
| ML25064A503 | List: |
| References | |
| M250408B | |
| Download: ML25093A080 (1) | |
Text
Subcommittee on Training and Experience (T&E) for all Modalities Commission Meeting, April 8th, 2025
Discussion of T&E Recs
- Subcommittee Membership
- Michael Folkert, MD PhD (Chair)
- Richard Harvey, DrPH (Radiation Safety Officer)
- Hossein Jadvar, MD PhD (Nuclear Medicine Physician)
- Zoubir Ouhib MS (Medical Physicist, Radiation Oncology)
- Megan L. Shober MS (Agreement State Representative)
- NRC Staff Resource: Maryann Ayoade 2
T&E Charge
- The current charge of the subcommittee is to review and evaluate the training and experience (T&E) requirements for all modalities in 10 CFR Part 35.
- On August 20, 2024, the subcommittee received the expanded charge to provide recommendations to the NRC on knowledge topics encompassing the safety related characteristics of emerging medical technologies (EMTs) required for Authorized Users (AUs) to fulfill their radiation safety-related duties and supervision roles; the methods on how knowledge topics should be acquired; and consideration for continuing education, vendor training for new medical uses, and training on the NRC regulatory requirements.
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Introduction
-Continuing innovation in the uses of radioactive byproduct material has led to new applications and indications in areas such as gamma knife technology, ophthalmic treatments, diffusing radioactive particle implants, and an increasingly diverse array of diagnostic and therapeutic radiopharmaceuticals.
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Introduction
- Emerging medical technologies (EMTs) are generally classified under 35.1000, but development of new radiopharmaceuticals, brachytherapy applications, and other devices utilizing radioactive byproduct material normally regulated under 10 CFR 35.200, 35.300, 35.400, and 35.600, may incorporate novel ligand/radioisotope combinations and/or administration methods that may pose additional patient and radiation safety risks and require additional training.
- This is not limited only to therapeutic applications, but also potentially diagnostic applications as well, as an increasing array of diagnostic radioligands are integrated into the clinic.
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Introduction
- For each medical use modality, 10 CFR 35 regulations prescribe the minimum hours of classroom and laboratory training as well as supervised experience for proposed authorized users.
- Core knowledge areas include:
Classroom and laboratory training in:
radiation physics and instrumentation radiation protection calculations pertaining to the use and measurement of radioactivity chemistry of byproduct material for medical use radiation biology Work experience in:
managing and assaying radioactive materials performing surveys calibrating and maintaining assay and survey equipment assaying and preparing doses managing spills, waste, and contamination developing safe protocols for radioactive material management safely and appropriately delivering radioactive doses to patients 6
Introduction
- In addition to these core knowledge areas, there has been increasing complexity around aspects of patient selection, patient and caregiver education, interactions of radioactive material applications with other therapies and interventions, pre-and post-procedure dosimetry, patient monitoring and release, and reporting of adverse reactions and medical events.
- The subcommittee also recognizes that the authorized user (AU) may not be physically present in some applications (for example, the administration of radiopharmaceuticals by certified nuclear medicine technicians (CNMTs)) and may instead be monitoring the dose administration virtually.
- As such, the independent educational needs of the entire healthcare team are also a consideration that must also be met to ensure the safe utilization of EMTs using radioactive byproduct material.
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Background===
- For each medical use modality, 10 CFR 35 regulations detail the minimum hours of classroom and laboratory training as well as supervised experience for proposed AUs.
- T&E requirements for EMTs are described in 10 CFR 35.1000 licensing guidance.
- The current regulatory framework for authorized user training and experience was established in 2002 following a comprehensive overhaul of 10 CFR 35.
- Over the past two decades, the ACMUI has revisited AU T&E requirements regarding board certification pathways (2002, 2009, 2023), 10 CFR 35.300 radiopharmaceuticals (2013, 2016, 2019) and EMTs (2022).
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Background===
- With the rapid increase in development of novel radiopharmaceuticals in the late 2010s, stakeholders expressed concerns with the perceived burden of T&E requirements for AUs.
- NRC staff engaged stakeholders, the ACMUI, and Agreement States and explored options to reduce the regulatory burden for physicians seeking to become AUs while preserving training critical to radiation safety.
- This led NRC staff to submit a rulemaking proposal in 2020 (SECY-20-0005) to modify T&E requirements in 10 CFR 35, Subparts D and E for unsealed byproduct material.
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- 2020 rulemaking proposal (SECY-20-0005):
- Goals were to establish high-level radiation safety training criteria in advance of expected new EMTs/novel radiopharmaceutical therapies and eliminate the case-by-case approval of AUs on radioactive byproduct materials licenses.
- The rulemaking would have eliminated the alternate pathway for unsealed byproduct material use and required AUs to be certified by a recognized specialty board.
- Medical specialty boards seeking NRC recognition would have needed to demonstrate that their training programs meet NRC training requirements for T&E.
- In 2022, the Commission voted to maintain the status quo.
- The Commission did recommend evaluation of current specialty board recognition criteria, and to evaluate knowledge topics required for AUs to fulfill their radiation safety-related duties and supervision roles; the methods on how knowledge topics should be acquired; consideration for continuing education, vendor training for new medical uses, and training on the NRC regulatory requirements.
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0 Background
Background
- In 2022, the Commission approved initiation of an EMT rulemaking (SECY-21-0013), which would move many EMTs from 10 CFR 35.1000 to other sections of Part 35.
- This rulemaking would codify T&E requirements for AU physicians for these technologies.
- In 2023, NRC staff published a draft regulatory basis for this rulemaking.
- The EMT rulemaking remains in the proposed rule phase.
- As a result, NRC staff are assessing ways to make the existing EMT T&E requirements more generalizable instead of having a customized set of T&E requirements for each 10 CFR 35.1000 licensing guidance document.
- The Subcommittees current charge to review knowledge topics for EMTs is connected to the EMT rulemaking in an effort to identify consistent T&E elements for AUs.
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Knowledge Acquisition and Maintenance While the final review and approval of authorized users is primarily the responsibility of the NRC and Agreement States, the subcommittee strongly feels that the acquisition of general safety content and continuing education should primarily be the responsibility of:
- Medical boards such as:
- The American Board of Radiology
- The American Board of Nuclear Medicine
- Accreditation councils such as
- The Accreditation Council for Graduate Medical Education
- The Commission on Accreditation of Medical Physics Education Programs; and
- Professional societies that are actively engaged in the training and certification of Authorized Users (AUs), Radiation Safety Officers (RSOs), Associate RSOs (ARSOs),
Authorized Nuclear Pharmacists (ANPs), Authorized Medical Physicists (AMPs), and Ophthalmic Physicists (OPs) 1 2
Knowledge Acquisition and Maintenance
- Professional societies actively engaged in providing educational content relevant to initial certification and maintenance of certification include but are not limited to:
Society of Nuclear Medicine and Molecular Imaging (SNMMI)
American Society for Radiation Oncology (ASTRO)
American Association of Physicists in Medicine (AAPM)
American College of Nuclear Medicine (ACNM)
American College of Medical Physics (ACMP)
American Association of Medical Dosimetrists (AAMD)
American College of Radiation Oncology (ACRO)
American Pharmacists Association (APhA) APhA-APPM Nuclear Pharmacy Practice Special Interest Group (SIG)
Health Physics Society (HPS)
American College of Radiology (ACR)
Radiological Society of North America (RSNA)
American Society of Nuclear Cardiology (ASNC)
American Brachytherapy Society (ABS)
American Radium Society (ARS) 1 3
Engagement In Radiation Safety Education
- There is demonstrated interest and engagement in radiation safety educational development by the professional societies.
- For example:
The SNMMI and ACNM are circulating a joint practice guideline for the use of radiopharmaceuticals.
ASTRO has been developing a radiopharmaceutical safety white paper.
The ABS is developing training objectives for radiopharmaceutical practice.
The ACR has partnered with multiple societies to develop practice parameter guidelines for a range of diagnostic and therapeutic applications involving radioisotopes, which are regularly updated in collaboration with multiple societies including SNMMI, ACNM, ASTRO, ABS, and ARS.
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NRC Evaluation of Content
- While the NRC cannot endorse or preferentially favor any specific training pathway, it is recommended that the NRC evaluate whether educational materials or a program meets requirements for initial certification with a technology or application to improve efficiency for evaluating potential AUs.
- It will likely be necessary that the NRC will have to develop a range of training scenarios for initial certification that will depend on the time that has elapsed since professional training was completed by the prospective AU, as well as which training pathway the prospective AU initially completed.
- This is in keeping with the request for case scenarios in the recent T&E report (https://www.nrc.gov/docs/ML2418/ML24185A268.pdf).
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Continuing Medical Education
- The subcommittee recognizes the role for ongoing continuing medical education (CME) in supporting quality of care and radiation safety.
- In terms of CME, the subcommittee recognizes that professional societies are actively developing and providing CME for practitioners administering existing and emerging technologies through recorded, virtual, and in-person offerings.
- The AU will need to maintain records of their CME.
- We recommend that professional societies develop guidelines for CME minimum contact hours; we would also recommend that the NRC explore the need to define minimum CME requirements for AUs.
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Continuing Medical Education
- Verification of ongoing training/experience and CME must follow applicable state, local, and certification board requirements, as well as the authority of the hospital or practice clinical credentialing program.
- Credentialing is a process where medical facilities grant healthcare professionals (such as physicians, non-physician mid-level providers, medical physicists, nurses, medical dosimetrists, and medical technologists) the ability to practice medicine and supportive services in their clinical sites.
- Credentialing and maintenance of associated privileges is not regulated by the NRC.
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Application-Specific Knowledge Base In addition to the core knowledge areas, the practical knowledge base for EMTs must include application-specific content and documentation of training on:
patient assessment and eligibility patient and caregiver education on the procedure and radiation safety (verbally and in writing) how to develop site-specific protocols for administration and use of the medical technology radiation safety and quality control for all aspects of the procedure including ordering, preparation, administration, and disposal of contamination/waste (if present) components of the written directive for therapeutic administrations pre-procedure assay/dosimetry role of post-procedure dosimetry patient monitoring, discharge instructions, and release, including management of procedural events such as extravasations follow-up protocols for therapeutic interventions reporting of adverse reactions and medical events aspects of supervision of the healthcare team, including relevant NRC regulatory requirements 1
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Supervision
- The administration/use of EMTs may require the direct involvement of a range of other specialties including Certified Nuclear Medicine Technologists (CNMT), Registered Nurses (RN), RSOs, and Medical Physicists (MP), under remote supervision by the AU.
- Understanding of NRC regulatory requirements for these roles must also be required for the AU.
The educational needs of the entire healthcare team, including the licensee/administrator, CNMT, RN, RSO, and MP (if available/applicable), must also be met to ensure the safe utilization of EMTs using radioactive byproduct material.
The AU must have a clear understanding of the roles and limitations of each member of their team, and a documented plan for how they would interact with these members when physically present and when monitoring remotely.
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Role of Vendors
- For EMTs and new radiopharmaceutical applications, the application vendor has a significant role in recommending and providing the appropriate knowledge and technical training for the safe and effective use of their technology.
- Vendor training should cover all aspects of how to correctly use the new device/drug.
- Training should also include contraindications to use and remind trainees not to modify/substitute aspects of the device or procedure without the approval of the manufacturer.
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Hands-On, In-Person
- It is the recommendation of this subcommittee that hands-on training should be expected for any new therapeutic device/drug, or for any therapeutic application that has a unique delivery platform.
- This means that the prospective user would have to conduct mock use or supervised patient use of the device/drug using the actual device/drug or a model device that incorporates all practice aspects of the new technology.
- Any training must include opportunities for the prospective AU to ask questions about the training material and process and receive answers in real time.
- The trainer (vendor and/or current AU) must be able to directly assess prospective AU learning in the context of the training prior to unsupervised clinical implementation.
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Hands-On, In-Person
- It is the recommendation of this subcommittee that the trainer (either a vendor representative or an AU for the new technology) must be physically present (in-person) for the training of the prospective user and their team, even in situations where the standard-of-care administration or use of the technology may be performed with the AU supervising remotely.
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Medical Events
- The NRC should encourage licensees to include information in annual refresher training for appropriate individuals (AUs, CNMTs, etc) regarding medical events involving radiopharmaceuticals or devices used by the licensee.
- We recommend that information on known medical events should also be included in initial training for a new device/drug application.
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Summary of Recommendations
- 1. Core knowledge base topics should be supplemented with application-specific content for existing and future EMTs incorporating radioactive byproduct materials.
- 2. The NRC should enable the relevant professional societies to develop curricula for initial training, and should explore how best to evaluate these curricula on an ongoing basis and how these curricula may be incorporated into an efficient licensing process.
- 3. The NRC should explore the need to define minimum CME requirements for AUs.
- 4. Training for new therapeutic devices/drug or any therapeutic application that has a unique delivery platform should be both hands-on and in-person with a vendor representative and/or an AU for the new technology prior to unsupervised clinical implementation.
- 5. The NRC should encourage inclusion of information on known medical events in annual refresher training for drugs/devices used by the licensee, and in initial training for a new drug/device application.
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- 10 CFR: Title 10 of the Code of Federal Regulations
- T&E: Training and Experience
- AU: Authorized User
- EMT: Emerging Medical Technology
- RSO: Radiation Safety Officer
- ARSO: Associate RSO
- ANP: Authorized Nuclear Pharmacist
- AMP: Authorized Medical Physicist
- OP: Ophthalmic Physicist
- RN: Registered Nurse
- CNMT: Certified Nuclear Medicine Technician
- CME: Continuing Medical Education 2
5 Abbreviations