ML18099A351
| ML18099A351 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/2018 |
| From: | Advisory Committee on the Medical Uses of Isotopes, Office of Nuclear Material Safety and Safeguards |
| To: | |
| Holiday, Sophie | |
| References | |
| Download: ML18099A351 (6) | |
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2017 ACMUI RECOMMENDATIONS AND ACTION ITEMS ITEM DATE STATUS The Committee requested that the recommendations and actions pertaining to the Part 35 rulemaking be reviewed during 1 4/26/2017 NRC Action Pending the fall 2017 ACMUI neeting and that additional time be provided to review each item.
The Patient Intervention Subcommittee will amend its ACMUI Closed 8 Subcommittee Report and will report at the ACMUI fall 2017 4/27/2017 Action 3/7/18 meeting or by teleconference to discuss their amended report.
The NRC staff will engage in discussions with the OAS to find a 12 9/11/2017 NRC Action Open way to centralize event reporting from the Agreement States.
The ACMUI recommended that the NRC establish a program allowing a medical use licensee to evaluate MEs as described 13 in 10 CFR 35.3045, in NRC 10 CFR 35.1000 licensing 9/11/2017 NRC Action Open guidance, and in 10 CFR 35.3047 with an approved patient safety program.
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2017 ACMUI RECOMMENDATIONS AND ACTION ITEMS The ACMUI recommended that NRC licensees with an NRC-approved patient safety program will continue to report medical events as required with the following conditions: (1) The NRC will not include this event notification in the Event Notification Report posted on its website. If this is not possible, the ME notification posted on the website will leave the licensee information and location anonymous. (2) The NRC will not conduct a reactive inspection of the ME unless the event results or will result in death, unintended permanent harm, or unintended significant temporary harm for which medical 14 9/11/2017 NRC Action Open intervention was or will be required to alleviate the harm or reduce radiation effects. (3) The medical use licensee will write a report available for the next NRC inspection describing the event cause and corrective action taken. (4) NRC will develop, with ACMUI advice, new temporary inspection procedures for NRC review of licensee patient safety event reports, and will evaluate, with ACMUI advice, need to change enforcement manual procedures regarding MEs to support a test of this program.
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2017 ACMUI RECOMMENDATIONS AND ACTION ITEMS The ACMUI recommended that NRC should test out this program with two large medical centers, two community hospitals, two rural hospitals, and two patient clinics for a year, evaluating the ME reports with the ACMUI. During this test period, the NRC, with advice from the ACMUI, should do the following: (1) Develop the minimum criteria for patient safety 15 9/11/2017 NRC Action Open program reviews; (2) Assess how this change in ME reporting impacts the NRCs ability to protect patient health and to minimize danger to the patients life; and (3) Evaluate the different types of patient safety programs in how lessons learned from their patient safety incident reviews are shared with the medical community.
The ACMUI recommended that after completion of the test year, the NRC should consider opening the program to all NRC 16 medical use licensees who request approval of their patient 9/11/2017 NRC Action Open safety program, and to Agreement States who request to implement the program with their medical licensees.
The ACMUI recommended that the NRC redefine its 17 perspective of patient safety to be different from occupational 9/11/2017 NRC Action Open safety and from public safety.
The ACMUI recommended that NRC partner with the Department of Health and Human Services (HHS), specially the Agency for Healthcare and Research and Quality (AHRQ) , and 18 9/11/2017 NRC Action Open ACMUI to develop a national database taxonomy specific for reporting patient events involving medical use of byproduct material.
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2017 ACMUI RECOMMENDATIONS AND ACTION ITEMS The ACMUI recommended that the NRC Update its Medical Use Policy Statement and 10 CFR 35 event reporting regulations for patient safety programs to verify the active 19 9/11/2017 NRC Action Open involvement of the licensees patient safety program review of medical errors and reporting of reviews to the national patient safety database.
The ACMUI endorsed the Medical Event Reporting and Impact on Medical Licensee Patient Safety Culture Draft Report, as amended to support the concept of the pilot program with the ACMUI 20 9/11/2017 Open total number of sites and duration to be determined at a later Action date and to include the Patient Intervention Subcommittee recommendations as an addendum .
The ACMUI will hold a public teleconference in the near future to discuss the amended Nursing Mothers Guidelines Subcommittee Report. Amendments will include, but are not ACMUI Closed 21 limited to: (1) a suggested time frame for providing written and 9/11/17 Action 2/15/18 oral instructions to patients who will stop breastfeeding altogether and (2) consideration to revise the radionuclides to be non-pharmaceutical specific.
The ACMUI commented (1) that the literature review was thorough and the model calculations sound; and (2) the current ACMUI Closed 22 dose-based approach to assessing patient releasability 9/11/17 Action 3/7/18 validated as more protective of public safety than the activity-based approach.
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2017 ACMUI RECOMMENDATIONS AND ACTION ITEMS The ACMUI recommended that the current 5-mSv (500-mrem) and 1-mSv (100-mrem) projected dose limits for family members and the general public, respectively, should remain a Closed 23 9/11/17 NRC Action per-event limit and are appropriate for all potentially exposed 3/7/18 cohorts, including pregnant women and children, and all radionuclide administrations.
The ACMUI recommended that the 1-mSv (100-mrem) dose Closed 24 limit for requiring patient safety instructions should remain in 9/11/17 NRC Action 3/7/18 place.
The ACMUI commented that (1) the assumption in regulatory guidance that the internal dose contribution is negligible has been validated; (2) other assumptions and methods in regulatory guidance are excessively conservative NCRP Report ACMUI Closed 25 9/11/17 No 155; and (3) a patient staying at a hotel following Action 3/7/18 radionuclide therapy is not a widespread practice and is unlikely to result in doses to workers and others > 1 mSv (100 mrem).
The ACMUI recommended that instructions must be provided to the patient well in advance of a planned therapy (ie not on Closed 26 the day of administration), without compromising patient care. 9/11/17 NRC Action 3/7/18 Specification of a regulatory time interval for pre-therapy instructions is not recommended --> NCRP Report No 155.
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2017 ACMUI RECOMMENDATIONS AND ACTION ITEMS The NRC recommended that the NRC should consider updating Appendix U (NUREG 1556) to reference Regulatory Closed 27 9/11/17 NRC Action Guide 8.39 rather than eliminating 8.39 or maintaining two 3/7/18 separate guidance documents.
The ACMUI endorsed the Patient Release SECY Paper ACMUI Closed 28 9/11/17 Subcommittee Report. Action 3/7/18 The ACMUI will hold a public teleconference in the near future to discuss the amended Physical Presence Requirements for the Leksell Gamma Knife Icon Subcommittee Report.
Amendments will include (1) the distinction between "an" or "the" AU or AMP;" (2) AU presence for re-initiation of procedure ACMUI Closed 29 9/12/17 following interruption; (3) possible incorporation of changes to Action 2/15/18 the physical presence requirements for the Leksell Gamma Knife Perfexion; and (4) whether the physical presence requirements will be limited to the frame-based or frameless-based option for the Leksell Gamma Knife Icon.
The Committee tentatively scheduled the spring 2018 ACMUI meeting for March 1-2, 2018. The back-up dates are March 14- ACMUI 30 9/12/17 Closed 15, 2018. The final meeting date is subject to Commission Action availability.
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