ML19011A463
| ML19011A463 | |
| Person / Time | |
|---|---|
| Issue date: | 01/11/2019 |
| From: | Sarah Lopas NRC/NMSS/DMSST/MSEB |
| To: | |
| Sarah Lopas | |
| References | |
| Download: ML19011A463 (1) | |
Text
Evaluation of Training and Experience for Radiopharmaceutical Use Office of Nuclear Material Safety and Safeguards Society of Nuclear Medicine Division of Materials Safety, Security, State, and Molecular Imaging 2019 Mid-Winter Meeting and Tribal Programs Palm Springs, CA 45907 Authorized User Why We Are Evaluating Protecting Health and Safety Training & Experience The NRCs T&E requirements describe the minimum training for The NRC is evaluating:
The NRCs training and experience (T&E) physicians to safely use radioactive materials protecting (1) whether it makes sense to requirements for physicians seeking to themselves, coworkers, patients, the public, and the environment.
establish tailored T&E become an Authorized User are listed in The NRC issues licenses to medical facilities and not specifically to requirements for different Title 10 of the Code of Federal individual physicians (physicians are listed as AUs on a license).
categories of Regulations (10 CFR) Part 35. The NRC does not license physicians.
radiopharmaceuticals; (2) how Specifically, the T&E requirements in those categories should be Subpart E of 10 CFR 35 provide three How You Can Participate determined (such as by risks ways that a physician can be authorized posed by groups of radionuclides to administer unsealed byproduct or by delivery method); (3) what The NRC is conducting more extensive outreach with the medical materials or radiopharmaceuticals the appropriate T&E requirements community focused on assessing options for tailoring the T&E requiring a written directive. An would be for each category; and requirements for medical uses authorized under 10 CFR 35.300.
attestation may be required to confirm (4) whether those requirements that these requirements are met.
- A Federal Register notice (83 FR 45380) was published on October should be based on hours of T&E or focused more on competency. 29, 2018 opening a three-month comment period on the NRCs
- 1. A physician can be certified by a T&E evaluation.
medical specialty board, whose
- Submit written comments by January 29, 2019 by going to certification process is recognized by Is 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> appropriate? How www.Regulations.gov and searching for docket NRC-2018-0230.
the NRC or an Agreement State. should competency be assessed?
- Participate in the NRCs January 22 webinar to discuss the T&E evaluation and provide oral comments on the T&E docket.
- Keep track of the NRCs evaluation at the T&E Web site:
- 2. A physician can complete a structured Do the current NRC requirements www.nrc.gov/materials/miau/med-use-toolkit/training-experience-educational program and supervised unnecessarily limit patient access to evaluation.html work experience under an Alternate procedures involving Pathway. The required 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> radiopharmaceuticals?
breaks down to a minimum of 200 References hours of classroom and laboratory training, and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised Should the NRC create tailored T&E SRM-M170817:
work experience. requirements for different categories (ADAMS Accession No. ML17229B283) of radiopharmaceuticals?
SECY-18-0084:
- 3. A physician can be authorized if (ADAMS Accession No. ML18135A276) previously identified as an Authorized What should the categories be and User (AU) on an NRC or Agreement how should the requirements be T&E Federal Register Notice:
State license or permit. applied? (83 FR 54380; October 29, 2018)