ML19072A259
| ML19072A259 | |
| Person / Time | |
|---|---|
| Issue date: | 02/26/2019 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | |
| Jamerson, Kellee | |
| References | |
| Download: ML19072A259 (5) | |
Text
TELECONFERENCE MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES February 26, 2019 MEETING
SUMMARY
PURPOSE To discuss the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Training and Experience Requirements for All Modalities Subcommittees draft report on the recommendations for the training and experience (T&E) requirements for authorized users (AUs) under Title 10 of the Code of Federal Regulations (10 CFR) 35.300.
OUTCOME The ACMUI Training and Experience Requirements for All Modalities Subcommittee provided a draft report for discussion with the full Committee. Subcommittee members included: Dr.
Ronald Ennis, Dr. Darlene Metter (Chair), Dr. A. Robert Schleipman, Mr. Michael Sheetz, Ms.
Megan Shober, and Ms. Laura Weil. The NRC staff gained a better understanding of the views and opinions of the Committee. The NRC staff will consider the Committees comments in its evaluation of whether it makes sense to establish tailored T&E requirements for different categories of radiopharmaceuticals, how those categories should be determined (such as by risks posed by groups of radionuclides or by delivery method), what the appropriate T&E requirements would be for each category, and whether those requirements should be based on hours of T&E or focused more on competency.
A full transcript and handout for the ACMUI teleconference meeting can be found on the NRCs public web site at: http://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/.
The ACMUI Subcommittee final report is also available on the NRCs public web site at:
http://www.nrc.gov/reading-rm/doc-collections/acmui/reports/.
AGENDA TOPIC Discuss the ACMUI Training and Experience (T&E) Draft Subcommittee Report regarding the requirements for authorized users under 10 CFR 35.300, Use of unsealed byproduct material for which a written directive is required.
SUMMARY
The ACMUI Training and Experience Requirements for All Modalities Subcommittee discussed its draft report, which focused on the T&E requirements for individuals authorized for the medical use of unsealed byproduct material for which a written directive is required under 10 CFR 35.390. In its report, the Subcommittee reviewed the current pathways for AU certification; addressed the concerns of a potential AU shortage; explored the concept of a limited-scope AU pathway tailored for specific radionuclide therapies; and expressed the need for an AU competency assessment.
RECOMMENDATIONS AND ACTIONS The Training and Experience Requirements for All Modalities Subcommittee discussed the following recommendations in the draft subcommittee report:
- 1. The Subcommittee strongly supports maintaining the current and existing AU pathways (board certification and alternate pathway) as codified in the regulations, which are adequate for protecting public health and safety.
- 2. The Subcommittee concludes that there is no objective data available to confirm an AU shortage.
- 3. The Subcommittee does not recommend a limited-scope AU pathway for unsealed byproduct material for which a written directive is required under 10 CFR 35.390.
- 4. The Subcommittee unanimously agrees that if the NRC chooses to pursue the creation of a limited-scope AU pathway for unsealed byproduct material where a written directive is required, the AU candidate must acquire the basic knowledge topics in 10 CFR 35.390 and satisfactorily complete a formal competency assessment. Additionally, the individuals continued status as limited-scope AU is dependent on successfully maintaining a formal periodic reassessment of competency.
The ACMUI unanimously approved a modification to the report to note that if and when the NRC decides to pursue a limited-scope AU pathway for radionuclide therapy, the ACMUI endeavors to work with the NRC to develop the curriculum.
The draft Training and Experience Requirements for All Modalities Subcommittee Report (ML19039A113), with the aforementioned amendment, was approved by the full ACMUI, with one dissenting vote, during its public teleconference meeting on February 26, 2019.
The final report (ML19058A598) is posted on the ACMUI Subcommittee Reports webpage.
Enclosures:
- 1. Meeting Attendees
- 2. Teleconference Agenda
MEETING ATTENDEES ACMUI Christopher J. Palestro, M.D. Chairman Darlene F. Metter, M.D. Vice Chairman Vasken Dilsizian, M.D. Member Ronald Ennis, M.D. Member Richard Green Member Melissa Martin Member Michael D. OHara, M.D. Member Zoubir Ouhib Member A. Robert Schleipman, M.D. Member Michael Sheetz Member Megan Shober Member Lisa Weil Member Harvey B. Wolkov, M.D. Non-Voting Member NRC Andrea Kock Director, Division of Materials Safety, Security, State, and Tribal Programs (MSST)
Christian Einberg Chief, Medical Safety and Events Assessment Branch (MSEB)/Designated Federal Officer Sophie Holiday Designated Federal Officer Kellee Jamerson Designated Federal Officer/ACMUI Coordinator Maryann Ayoade NMSS/MSST/MSEB Said Daibes, Ph.D. NMSS/MSST/MSEB Lisa Dimmick Medical Radiation Safety Team Leader, NMSS/MSST/MSEB Sara Forster R-III/DNMS/MLB Robert Gallaghar R-I/DNMS/MLAB Edward Harvey R-III/DNMS/MIB Esther Houseman OGC/GCLR/RMR Donna-Beth Howe, Ph.D. NMSS/MSST/MSEB Ian Irvin OGC/GCLR/RMR Donna Janda R-I/DNMS/MLAB Sarah Lopas NMSS/MSST/MSEB Kathy Modes NMSS/MSST/ASPB Janice Nguyen R-I/DNMS/MLAB Patty Pelke R-III/DNMS/MLB Zahid Sulaiman R-III/DNMS/MIB Katherine Tapp, Ph.D. NMSS/MSST/MSEB MEMBERS OF THE PUBLIC Michael Baxter American Pharmacists Association Kendall Berry Fox Chase Cancer Center Janet Bukovcan British Technology Group (BTG)
Mary Burkhart Illinois Emergency Management Agency (IEMA)
Enclosure 1
William Chen Unaffiliated John Chippo Pennsylvania Department of Environmental Protection (PDEP)
Thomas Conley University of Kansas Medical Center Whitney Cox IEMA David Crowley North Carolina Department of Health and Human Services, Radiation Protection Section Ariel Doucet Virtua Health Brian Erasmus BTG Lynne A. Fairobent Unaffiliated Sherrie Flaherty Minnesota Radioactive Materials Unit Mike Fuller Virginia Department of Health (VDH)
Sandy Gabriel Unaffiliated Wendy Galbraith University of Oklahoma Health Sciences Center Bennett Greenspan, M.D. Society of Nuclear Medicine and Molecular Imaging (SNMMI)
Miguel de la Guardia Cook Childrens Medical Center Michael Guastella Council on Radionuclides and Radiopharmaceuticals, Inc.
(CORAR)
Stanley Hampton Eli Lilly Dan Hill Cardinal Health Daniel Januseski Virtua Health Tracy Jue California Department of Public Health Sue Langhorst, Ph.D. Unaffiliated Ralph Lieto St. Joseph Mercy Health System Cindi Luckett-Gilbert Shertech Pharmacy Carol Marcus, Ph.D, M.D. University of California at Los Angeles (UCLA)
Richard Martin American Association of Physicists in Medicine (AAPM)
Samuel Mehr, M.D. Nebraska Cancer Specialists Ashley Mishoe University of California, San Francisco Mary Moore VDH Joshua Myers PDEP Christopher Ott PDEP Brandon Paterson Unaffiliated Richard Peros New Jersey Department of Environmental Protection (NJDEP)
Michael Peters American College of Radiology (ACR)
Carmine Plott Novant Health Aria Razmaria, M.D. UCLA Medical Center Gloria Romanelli ACR George Segall, M.D. American Board of Nuclear Medicine (ABNM)
Ben Seiber PDEP Beth Shelton Tennessee Department of Environment and Conservation Jeffry Siegel, Ph.D. Nuclear Physics Enterprises Daniel Strohmeyer Unaffiliated Cindy Tomlinson American Society of Radiation Oncology (ASTRO)
Michael Ujhelyi BTG Paul Wallner, M.D. 21st Century Oncology, Inc.
Matthew Williamson Memorial Sloan Kettering Cancer Center Melonie Wissing VDH John Witkowski United Pharmacy Partners (UPPI)
Advisory Committee on the Medical Uses of Isotopes TELECONFERENCE AGENDA Tuesday, February 26, 2019 10:00 AM - 12:00 PM (ET)
OPEN SESSION 10:00 am - 12:00 pm Discuss the ACMUI Training and Experience (T&E) Draft Subcommittee Report regarding the requirements for authorized users under Title 10 Code of Federal Regulations (10 CFR) 35.300, Use of unsealed byproduct material for which a written directive is required.
Enclosure 2