ML25030A177
| ML25030A177 | |
| Person / Time | |
|---|---|
| Issue date: | 02/26/2025 |
| From: | Tamara Bloomer NRC/NMSS/DMSST |
| To: | John Lubinski Office of Nuclear Material Safety and Safeguards |
| References | |
| Download: ML25030A177 (1) | |
Text
1 MEMORANDUM TO:
John Lubinski, Director Office of Nuclear Materials Safety and Safeguards FROM:
Tammy Bloomer, Acting Director Division of Materials Safety, Security, State/
and Tribal Programs Office of Nuclear Materials Safety and Safeguards
SUBJECT:
ASSESSMENT OF MATERIALS EVENT REPORTING CHECKLIST AND RECOMMENDED DISCONTINUATION The Division of Materials Safety, Security, State and Tribal Programs (MSST) recently identified a divisional procedure titled Annual Self-Assessment of Materials Event Reporting (ML18311A288). The staff had not been aware of this procedure as it was not included in the NMSS Procedure SharePoint List and it was not referenced in NMSS Policy and Procedure 7-06, Providing Annual Report to the Commission on Performance in the Nuclear Materials and Waste Safety Program, and Completing Office of Nuclear Material Safety and Safeguards (NMSS) Activities Associated with the Agency Action Review Meeting (AARM), Revision 2, dated January 28, 2020 (ML19309B868). This procedure provided instructions for staff to complete an annual assessment of the NRC materials event reporting program using a checklist. As the staff was unaware of the procedure, this checklist was not completed for Fiscal Years (FY) 19, 20, 21, or 22 event data.
After the staff discovered the divisional procedure, the staff completed the annual checklist for FY23, which corresponds to SECY-24-0034, Annual Report to the Commission on Licensee Performance in the Nuclear Materials and Waste Safety Program for Fiscal Year 2023 (ML24059A052), which was issued in April 2024 and briefed to the Commission on July 11, 2024. This completed checklist is included in Enclosure 1, Self-Assessment of Materials Event Reporting Checklist; FY23.
The checklist instructs staff to ask 5 questions on an annual basis.
- 1) Was the purpose of medical event reporting met?
CONTACT:
Jennifer Fisher, NMSS/MSST 301-415-1456 February 26, 2025 Signed by Bloomer, Tamara on 02/26/25
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- 2) Are there any indications of any problem with the NRCs reporting requirements for events?
- 3) Are there any adverse trends in event reporting?
- 4) Is there any indication of NRC policies discouraging event reporting based on trends or any other information?
- 5) Are there any indications of NRC policies affecting the practice of medicine?
In this assessment, the staff reviewed the history behind this procedure, interviewed staff involved in past and current work, and evaluated other programs in place to assess the NRC materials event reporting. Due to overlap with other programs, the MSST staff recommends discontinuation of the annual assessment and checklist as well as the withdrawal of this divisional procedure, Annual Self-Assessment of Materials Event Reporting.
History The Office of Inspector General (OIG) report, 16-A-02; Audit of NRCs Oversight of Medical Uses of Nuclear Material, dated October 8, 2015 (ML15281A331) included an observation that the NRC had not conducted a periodic self-assessment of its medical events reporting requirements to determine if medical event reporting requirements were effectively meeting their intended purpose. The OIG recommended that the NRC develop and implement policy and procedures that require periodic assessments of NRCs approach to medical event reporting.
The OIG further recommended that these assessments include whether the intended purpose of the reporting requirements were met as well as whether the thresholds of the reporting requirements were appropriate.
In the Status of Recommendations: Audit of NRCs Oversight of Medical Uses of Nuclear Material (OIG-16-A-02), dated July 29, 2016 (ML16211A033), the NRC staff described the division procedure that was newly created in response to the OIG recommendation. In the Status of Recommendations memo, the staff described the newly created procedure which established a self-assessment of the NRC event reporting program to be conducted each year using a checklist. In the Status of Recommendations memo, the staff noted that the self-assessment would be first conducted in 2017 to coincide with the FY16 AARM SECY paper.
The staff completed the annual checklist as part of the AARM program for FY16 (ML18311A287) and FY17 (ML18311A288) and found the medical event reporting program to be sufficient with no recommended actions identified. The annual checklist that was completed for FY18 (ML24129A207) also stated that the purpose of medical event reporting was met and detailed additional trending analysis work that was being done at that time. These analyses were:
The Advisory Committee for the Medical Uses of Isotopes (ACMUI) conducted and presented a study of medical events (FY14 to FY17) to identify common themes as a way to decrease the occurrence of future medical events (ML19038A495). The ACMUI had identified two overarching themes in their September 2018 briefing. First, the ACMUI noted that taking a time out prior to administering radioactive materials could have prevented some medical events. Second, it was noted that the lack of recent or
3 frequent experience may have contributed to the occurrence of some medical events.
The ACMUI had recommended that the NRC issue an information notice to share these insights and the NRC staff had agreed.
The Idaho National Laboratory (INL) contractors conducted an assessment of medical events from within the Nuclear Material Event Database (NMED) and issued a report; INL/LTD-19-52843, NMED; Review of Medical Events For Inadequate Training (Fiscal Year 2017-2018), dated February 2019 (ML19065A234). This is in addition to another INL contractor report from the previous year; INL/LTD-18-44325, NMED; Medical Events Involving Y-90 Microsphere Brachytherapy (Fiscal Year 2008-2017), dated January 2018 (ML18057A901).
Following these analyses, the NRC staff issued multiple information notices to raise the awareness of medical events as well as methods to prevent them. These information notices included the following:
IN-2019-12, Recent Reported Medical Events Involving the Administration of Yttrium-90 Microspheres for Therapeutic Medical Procedures, dated December 31, 2019 (ML19262G231).
IN-2019-11, Strontium-82/Rubidium-82 Generator Elution Events and Issues, dated December 23, 2019 (ML19281A220).
IN-2019-07, Methods to Prevent Medical Events, dated August 26, 2019 (ML19240A450).
IN-2019-06, Patient Skin Contamination Events Associated with I-131 Metaiodobenzylguanidine during Neuroblastoma Treatments, dated August 26, 2019 (ML19240A384).
In December 2024, it was identified that the annual self-assessment checklists were not completed for FY19, FY20, FY21, and FY22 event data, however both the AARM assessments and the Annual Nuclear Material Event Database Reports (NMED)1 were completed during this time.
The NRC staff provided a report on their annual review of medical events at every spring meeting of the ACMUI and the ACMUI provided its recommendation either every year or every other year, as they deemed appropriate. Both the MSST and ACMUI staff provide presentations on their review of medical events and the presentations were made available on the NRC public website.2 The frequency of these evaluations is described in NMSS Policy and Procedure 20-04 1 The Annual NMED Reports are included on the public-facing NMED Login website; https://nmed.inl.gov/default.
2 The Medical Uses Licensees Toolkit is an NRC public website, which includes a section titled Medical Events; https://www.nrc.gov/materials/miau/med-use-toolkit.html#events.
4 Administration of Advisory Committee on the Medical Uses of Isotopes (ML24207A233),
Section 3.3, ACMUI Meeting Management.
In addition, the medical team supported the NMSS Events Program by assessing event notifications as they were received by the NRC. The Medical Analysis and Trending Group (ATG) roles and responsibilities are established in the NMSS Office Procedure NMSS 06, NMSS Coordination of Events (ML21130A607). This adds value by ensuring that the medical team continues to be knowledgeable to the types of events that are occurring within the medical industry as well as determining whether any trends exist. During the time in which the annual checklist was not completed, the Medical ATG continued to review and trend events.
Evaluation During the assessment, the staff considered each question from the annual self-assessment checklist and whether the objective was completed by the staff during another process. With this review, the staff concluded that the failure to complete the annual self-assessment checklist did not impact the safety or security of medical licensees in the administration of medical radioisotopes.
Annual Self-Assessment of Materials Event Reporting Checklist Other NRC Work Processes
- 1) Was the purpose of medical event reporting met?
The routine presentations of medical events, by both the NRC staff and the ACMUI, at the ACMUI meetings provides an opportunity to reflect on purpose of medical event reporting is being met. In addition, the ACMUI has a standing subcommittee on medical events to provide recommendations to changes to medical event reporting as necessary.
- 2) Are there any indications of any problem with the NRCs reporting requirements for events?
The Medical ATG reviews event notifications as they are issued. This review allows for early identification of medical event trends as well as the identification of possible problems with the NRC event reporting criteria.
- 3) Are there any adverse trends in event reporting?
Both the NRC and ACMUI evaluate medical events over the past year(s) to discern any adverse trends in reporting. Both NRC and ACMUI present their findings at ACMUI meetings.
The Annual NMED Report looks at positive, negative, or neutral trends of events. In each Annual NMED Report, a section is dedicated to the review of medical event trends.
5 The AARM assessment provides an overview of the event data, as described in the Annual NMED Report. This overview focuses on adverse trends.
- 4) Is there any indication of NRC policies discouraging event reporting based on trends or any other information?
The medical team staff participates in several professional society committees and medical conferences so they could quickly hear industry concerns with medical event reporting.
In addition, the AARM provides a structured process to evaluate the effectiveness of the NRCs oversight processes during the preceding fiscal year and the appropriateness of NRC actions to address significant performance deficiencies. It is within this framework that NRC policies which discourage event reporting would be presented to NRC management.
- 5) Are there any indications of NRC policies affecting the practice of medicine?
The NRC and ACMUI presentations of medical events at the ACMUI meetings provides an opportunity to discuss real-world implications of NRC regulation, including medical event reporting, on the practice of medicine.
The staff noted that the good work being done in 2017-2019 was due to a cultural shift which occurred within the Medical Safety and Events Assessment Branch (MSEB) following the release of the OIG audit report. The positive culture in the branch has been maintained and continues to grow. Within the NMSS Events Program, the Medical ATG is very active in the review of events. The medical team is also very active in the identification of events that should be reported to Congress as abnormal occurrences.
Due to these other work processes which review medical events, the staff believes the annual checklist is redundant and does not add value to the review of the medical event program. The analyses that were documented in the FY18 checklist was already underway and was not initiated by the assessment or the completion of the checklist. The staff who performed the assessments in 2017-2019, stated that the annual checklist was seen as a paperwork burden.
Starting in Spring 2020, the annual self-assessment checklist was not completed. During this time, other methods of reviewing medical events were done, including the routine review of event notifications by the Medical ATG, the Annual NMED Report, the AARM assessment, and the medical event presentations at the ACMUI meetings.
6 The INL contractors performed an assessment of medical events,3 and the NRC issued an information notice regarding similar medical events. In addition, the NRC is creating guidance to comprehensively explain and illustrate the evaluating and reporting criteria for all medical events to support licensees in reporting events. These documents are here:
INL/RPT-22-70530, Medical Events Involving Radiopharmaceuticals; Fiscal Year 2013-2022, dated February 2023 (ML23054A176).
IN-2024-04, Recent Medical Events Involving Administration of Therapeutic Radiopharmaceuticals, dated August 9, 2024 (ML24138A129).
Draft Regulatory Guide (DG)-8062, Medical Event Evaluation and Reporting, dated August 2024 (ML24016A109).
Recommendation MSST recommends the discontinuation of the annual self-assessment checklist as well as the withdrawal of the divisional procedure, Annual Self-Assessment of Materials Event Reporting.
ADAMS ACCESSION NO.: ML25030A177 OFFICE NMSS/MSST/MSEB NMSS/MSST/MSEB NMSS/MSST/MSEB NAME JFisher KTapp CEinberg DATE 1/30/2025 2/1/2025 2/11/2025 OFFICE NMSS/MSST NAME TBloomer DATE OFFICIAL RECORD COPY 3 Once a year, the INL contractors perform a special study of material events within NMED, as requested by the staff. This service supports the Nuclear Materials Users business line and is not always specific to medical.
2/26/25
Encl. 1 - 1 Self-Assessment of Materials Event Reporting Checklist Fiscal Year 2023 Fiscal Year Reviewed: __FY2023_____
During the review and assessment of all the events from the previous year, including review and analysis of the Nuclear Material Events Database (NMED) annual report, trend analysis and feedback from any NMED special review project, or any other event reporting and operational experience Trending and Analysis Groups:
- 1) Was the purpose of medical event reporting met? Yes _x__ No ____
If No, provide an explanation: _____________________________________________
- 2) Are there any indications of any problem with the NRCs reporting requirements for events? Yes ____ No __x__
If Yes, provide the indications: On August 27, 2024, the staff provided the Commission with a proposed rule to include reporting of nuclear medicine injections extravasations as medical events. This proposed rule would require reporting of administration of byproduct material that results or has the potential to result in a radiation injury from an extravasation, as determined by a physician. This recommendation was made following staff review of a petition to require reporting of radiopharmaceutical extravasations (ML20157A266) as all extravasations, including those that could result in harm, are currently excluded from medical event reporting. In addition, in accordance with direction in SRM-SECY-22-0043, staff has developed a draft regulatory guide that comprehensively explains and illustrates medical event reporting criteria for all medical events to provide clarity in reporting requirements. Finally, staff continues to evaluate medical event reporting for emerging medical technologies as part of the ongoing emerging medical technology rulemaking.
- 3) Are there any adverse trends in event reporting? Yes _x__ No ____
If Yes, provide the trends: While overall number of medical events appears constant, the NRC Medical ATG identified an increase in Y-90 microsphere GI deposition medical events being reported over FY24. NRC staff has requested additional information from the States on each event, but we have yet to identify common root cause as to why we have had an increase in events reported. Therefore, the NRC has requested the ACMUI
Encl. 1 - 2 form a subcommittee to evaluate these events to see if they could determine a common route cause and to provide recommendations to minimize these types of events in the future.
- 4) Is there any indication of NRC policies discouraging event reporting based on trends or any other information? Yes ____ No _x__
If Yes, provide the indications: ____________________________________________
- 5) Are there any indications of NRC policies affecting the practice of medicine (check with the Medical Radiation Safety Team Trending and Analysis Group)? Yes ____ No _x__
If Yes, provide the indications: ____________________________________________
Branch Chief Notes:
Actions Going Forward:
AARM Project Manager: Jennifer Fisher ____JEF_______________ 1/29/25 Name Signature Date MSEB Branch Chief: Chris Einberg ___CEE_______________ 2/11/25 Name Signature Date
Ltr ML25030A177 OFFICE NMSS/MSST/MSEB NMSS/MSST
/MSEB NMSS/MSST/MSEB RES/DSA/AAB NAME JFisher KTapp CEinberg TBloomer DATE Jan 30, 2025 Feb 3, 2025 Feb 11, 2025 Feb 26, 2025