ML20254A179
| ML20254A179 | |
| Person / Time | |
|---|---|
| Issue date: | 09/14/2020 |
| From: | Christian Einberg NRC/NMSS/DMSST/MSEB |
| To: | Metter D Advisory Committee on the Medical Uses of Isotopes |
| Jamerson K L/NMSS/MSST | |
| References | |
| Download: ML20254A179 (9) | |
Text
September 14, 2020 MEMORANDUM TO:
Darlene F. Metter, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes FROM:
Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
U.S. NUCLEAR REGULATORY COMMISSION RESPONSES TO OPEN RECOMMENDATIONS AND ACTION ITEMS FROM THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES Below are the U.S. Nuclear Regulatory Commission (NRC) staff responses to open recommendations and action items from the Advisory Committee on the Medical Uses of Isotopes (ACMUI) from 2019 to 2020.
- 1. ACMUI Recommendation/Action Item from 2019, #17: The ACMUI endorsed the Appropriateness of Medical Event Reporting Subcommittee report and the recommendations provided therein. [The final subcommittee report (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19297E791) dated October 23, 2019, is available on the ACMUI Subcommittee Reports webpage1.] The Subcommittee recommended the following enhancements to the Nuclear Materials Events Database (NMED) to increase the value of information in the database:
- a. The NMED programmers should add a narrative field to the root cause and corrective action sections, in addition to the existing pick lists. This new narrative field should be a searchable free text section. (At a subcommittee meeting, an NMED representative has assured the subcommittee that this can be done.)
Staff Response: Not Accepted. The NRC staff assessed the recommendations to enhance NMED. An overview of the functionality of NMED was provided during the spring 2020 meeting.
CONTACT:
Kellee Jamerson, NMSS/MSST (301) 415-7408 1 The ACMUI Subcommittee reports can be accessed here: https://www.nrc.gov/reading-rm/doc-collections/acmui/reports/
Christia n
Einberg Digitally signed by Christian Einberg Date:
2020.09.14 09:52:47 -04'00'
D. Metter 2
Staff determined that the ACMUIs specific findings were generally outside the scope of NMEDs intended function. For this reason, the NRC recommends that this item be closed.
- b. NRC, in coordination with the ACMUI, should provide additional information to NMED users on best practices for writing NMED reports for medical events, such as develop educational materials to be shared with the regulator and user communities regarding what constitutes an optimal NMED report along with the rationale for why this is important. Further, this information could be promulgated via (1) an Informational Notice from the NRC and (2) presentations at OAS, CRCPD, and medical professional society meetings.
Staff Response: Accepted. The NRC staff plans to share best practices for preparing NMED reports. This specific recommendation will remain open, with an anticipated completion date of Spring 2021.
- 2. ACMUI Recommendation/Action Item from 2019, #20: The ACMUI endorsed the Institutional Memory Subcommittee report, as amended, to include the recommendation that a complete list of ACMUI members be updated and added to the listing of historical membership on the webpage. The subcommittee membership was amended to add Dr. Harvey Wolkov. [The final subcommittee report (ADAMS Accession No. ML19296D246) dated October 23, 2019, is available on the ACMUI Subcommittee Reports webpage.]
Staff Response: Accepted. As discussed during the 2020 spring ACMUI meeting2, the NRC staff updated the ACMUI historical membership to reflect the recent term endings for Dr. Chris Palestro and Laura Weil. The historical membership is current and will continue to be updated as ACMUI members rotate off the Committee. In response to other recommendations, the NRC staff has drafted a desk guide for new members. The utilization of this desk guide will be discussed with the ACMUI members during the closed session of the fall 2020 meeting. For this reason, the NRC recommends that this item be closed.
- 3. ACMUI Recommendation/Action Item from 2020, #1: The ACMUI endorsed the Regulatory Guide 8.39, Release of Patients Administered Radioactive Material Subcommittee Report regarding the draft final Revision 1, Phase 1 and the recommendations provided therein. [The final subcommittee report (ADAMS Accession No. ML20085H267) dated March 25, 2020, is available on the ACMUI Subcommittee Reports webpage.]
Staff Response: Accepted. Regulatory Guide (RG) 8.39, Release of Patients Administered Radioactive Material, Revision 1, Phase 1 was published in April 2020 (ADAMS Accession No. ML19232A081). The NRC staff has fully or partially accepted the ACMUIs recommendations and specific comments. For this reason, the NRC recommends that this item be closed. The recommendations were dispositioned as follows:
2 Discussion begins on page 25 of the March 30, 2020 ACMUI meeting transcript (ADAMS Accession No. ML20141L630)
D. Metter 3
ACMUI Regulatory Guide 8.39 Subcommittee Recommendations:
a) ACMUI Recommendation: In the Patient Precautions and Instructions Sections, it should be emphasized that the major source of radiation dose to other individuals will be from external exposure from the patient. Therefore, the most important precautions to take are measures to reduce or avoid the external radiation exposure from the patient, especially in the early time period after administration of the radionuclide therapy. While the release instructions may also include measures to limit the transfer of radioactive contamination to others, they should not overshadow or detract from the external precautions, as the radiation doses from internal exposure have been demonstrated to be small or negligible.
Staff Response: Accepted. The NRC staff agrees with the ACMUI and updated the regulatory guide with the language proposed by the ACMUI concerning external exposure. In addition, the staff formatted the document in a manner to emphasize precautions to reduce external exposure.
b) ACMUI Recommendation: The patient instructions should be simple, clear, and concise. Consideration should be given to providing instructions at an 8th grade level of understanding and given in the patients native or primary language. Studies have shown that the primary factor for limiting radiation exposure to others is in influencing the patients behavior. As the IAEA noted, The success of a patient release program is critically dependent on the quality and specificity of the information provided to the patient, the skill with which it is communicated, and whether or not the patient believes the information provided.
Staff Response: Partially Accepted. The NRC staff agrees that instructions should be simple, clear and concise and updated the guidance to read that the instructions should be easy to follow to enable the patient to understand how to minimize radiation exposure to other individuals. Also, consideration should be given to providing instructions in the patients native or primary language. Staff updated RG 8.39 accordingly. The staff did not include the grade level of the instruction. The staff believes the grade level of instruction should be determined by the administering institution and consistent with their grade level for public communications.
c) ACMUI Recommendation: Discussions on the radionuclide therapy procedure and release instructions should also include a caregiver or family member, if possible.
Staff Response: Accepted. The NRC staff agrees that instructions should include a caregiver or family member, if possible. The staff included caregiver or family member throughout RG 8.39.
d) ACMUI Recommendation: Instructions should also be provided on how long the precautions should be followed. As a guideline, the licensee may consider using several (3-5) effective half-lives of the radionuclide therapy.
Staff Response: Accepted. The NRC staff agrees that instructions should include the duration the precautions should be followed. The staff accepted the ACMUIs suggestions of using several (3-5) effective half-lives of the radionuclide therapy and updated RG 8.39 accordingly.
D. Metter 4
e) ACMUI Recommendation: The Regulatory Guide should not include instructions that are excessive, likely to cause patient anxiety, and not likely to reduce public exposures.
Staff Response: Accepted. The NRC staff agrees that instructions that are excessive, likely to cause patient anxiety, and not likely to reduce public exposures should not be included in the regulatory guide. The staff incorporated the ACMUIs suggested edits.
f) ACMUI Recommendation: Tables 1, 2, and A1 should be updated to include the new and potential radionuclides used in medicine listed below.
Staff Response: Partially Accepted. The NRC staff agrees that Tables 1, 2, and A1 should be updated to include the new and potential radionuclides. However, these updates are deferred to the phase 2 update of Regulatory Guide 8.39, Release of Patients Administered Radioactive Material.
g) ACMUI Recommendation: In Table 3, Activities of Radiopharmaceuticals That Require Instructions and Records When Administered to Patients Who Are Breastfeeding an Infant or Child, the subcommittee supports the guidance for a standardized interruption time period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> for all Tc-99m radionuclides, and the recommended interruption period to limit the dose to the nursing infant to 1 mSv, and not the regulatory limit of 5 mSv.
Staff Response: Accepted. The NRC staff accepted the ACMUIs recommendation for a standardized interruption time period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> for all Tc-99m radionuclides, and to modify the interruption period to limit the dose to the nursing infant in Table 3.
h) ACMUI Recommendation: In the Phase 2 revision to RG 8.39, where the dosimetric equations, methodologies, and tables used to calculate dose to members of the public from released patients will be updated, the following issues should be considered:
- i.
An occupancy factor of 0.75 to 1.0 is unrealistic and cannot be justified for routine application, even for radionuclides with a physical half-life less than one day. Dose calculations should be based on realistic assumptions, and not overly cautious worst-case scenarios.
ii.
The dosimetric models and calculations must consider an option that uses the effective half-life and/or other patient specific factors for the radionuclide therapy.
iii.
A dose-based model should be developed to provide guidance on when precautions or restrictions would be appropriate following the death of a patient administered a therapeutic quantity of radioactive material.
Staff Response: Accepted. The NRC staff accepted the ACMUIs recommendation and provided the above items to the contractor for the Phase 2 update. The Phase 2 revision will consider occupancy factors, effective half-life, and precautions for death of a patient. There will be future opportunities for the ACMUI to review and comment on the Phase 2 revisions.
- 4. ACMUI Recommendation/Action Item from 2020, #2: Dr. Metter formed a subcommittee to review the impacts that COVID-19 pandemic could have or is having on the medical use community and determine if potential impacts could help the NRC prepare for any regulatory impacts. Subcommittee membership includes: Dr. Vasken Dilsizian, Mr. Richard Green, Dr.
Hossein Jadvar (Chair), Ms. Melissa Martin, Ms. Megan Shober, and Dr. Harvey Wolkov.
D. Metter 5
Non-voting subcommittee consultants include Mr. Gary Bloom and Mr. Zoubir Ouhib. The NRC staff resource is Ms. Lisa Dimmick.
Staff Response: Accepted. As discussed during the spring 2020 ACMUI meeting3, Dr.
Metter formed a subcommittee to review the impacts that COVID-19 could have or is having on the nuclear medicine industry. The subcommittee presented its report during a public teleconference meeting on April 30, 2020 to discuss its recommendations for regulatory relief. For this reason, the NRC recommends that this item be closed.
- 5. ACMUI Recommendation/Action Item from 2020, #3: Dr. Metter amended the membership of the Training and Experience Requirements Subcommittee. Subcommittee membership now includes Dr. Ronald Ennis, Dr. Hossein Jadvar, Dr. Darlene Metter, Dr.
Robert Schleipman (Chair), Mr. Michael Sheetz, and Ms. Megan Shober. Mr. Gary Bloom will serve as a non-voting subcommittee consultant. Ms. Maryann Ayoade will remain the NRC staff resource.
Staff Response: Accepted. The subcommittee membership was amended on March 30, 2020, as shown on the ACMUI Subcommittees webpage4. For this reason, the NRC recommends that this item be closed.
- 6. ACMUI Recommendation/Action Item from 2020, #4: The ACMUI endorsed the Patient Intervention Subcommittee report, as presented, and the recommendations provided therein. [The final subcommittee report (ADAMS Accession No. ML20097F476) dated April 6, 2020, is available on the ACMUI Subcommittee Reports webpage.]
Staff Response: Accepted. The subcommittee was tasked with evaluating the definition of patient intervention and other actions and circumstances that are exclusive of medical events.
The NRC staff is continuing to evaluate the subcommittees recommendations related to extravasations and medical event reporting. For this reason, the NRC recommends that this item remain open.
- 7. ACMUI Recommendation/Action Item from 2020, #5: The ACMUI endorsed the Bylaws Subcommittee report, as presented, and the recommendations provided therein. [The final subcommittee report (ADAMS Accession No. ML20097F532) dated April 6, 2020, is available on the ACMUI Subcommittee Reports webpage.]
Staff Response: Accepted. As discussed during the spring 2020 ACMUI meeting, the Bylaws Subcommittee proposed no changes to the existing bylaws regarding term limits for the ACMUI Chair and Vice Chair. It is currently at the discretion of the Director of the Office of Nuclear Material Safety and Safeguards. The NRC staff accepts the subcommittees recommendations. For this reason, the NRC recommends that this item be closed.
- 8. ACMUI Recommendation/Action Item from 2020, #6: Dr. Metter formed a subcommittee to review the abnormal occurrence (AO) criteria and consider the following: (1) define patient harm in AO; (2) reassess the current AO criteria; (3) define the goals of AO criteria 3 Discussion begins on page 28 of the March 30, 2020 ACMUI meeting transcript (ADAMS Accession No. ML20141L630) 4 A listing of the ACMUI Subcommittees can be viewed here: https://www.nrc.gov/about-nrc/regulatory/advisory/acmui/subcommittee.html
D. Metter 6
and reporting; and (4) determine if the current AO criteria is sufficient in terms of public health? Subcommittee membership includes Mr. Gary Bloom, Dr. Ronald Ennis, Dr.
Hossein Jadvar, Mr. Zoubir Ouhib, Mr. Michael Sheetz (Chair), and Ms. Megan Shober. The NRC staff resource is Dr. Katie Tapp.
Staff Response: Accepted. As discussed during the spring 2020 ACMUI meeting5, Dr.
Metter formed a subcommittee to define patient harm in abnormal occurrences; reassess the current AO criteria; define the goals of the AO criteria and reporting; and determine if the current AO criteria are appropriate in regards to public health and safety. This subcommittee was placed on hold until further notice from NRC staff. For this reason, the NRC recommends that this item be closed.
- 9. ACMUI Recommendation/Action Item from 2020, #7: The ACMUI endorsed the Interventional Radiologist Subcommittee report, as presented, and its recommendations provided therein. [The final subcommittee report (ADAMS Accession No. ML20097F625) dated April 6, 2020, is available on the ACMUI Subcommittee Reports webpage.]
Staff Response: Accepted. This subcommittee was tasked with investigating the need for an Interventional Radiologist on the ACMUI and determining whether this position should serve as a non-voting consultant or a full Committee member. The subcommittee did not recommend adding an interventional radiologist as a full voting member at this time.
However, the subcommittee recommended to invite an interventional radiologist for a trial period of 2-3 years and reassess the need for permanent membership at a later time. The NRC staff is considering inviting an interventional radiologist to attend ACMUI meetings for a trial period. For this reason, the NRC recommends that this item be closed.
- 10. ACMUI Recommendation/Action Item from 2020, #8: The ACMUI tentatively scheduled its 2020 fall meeting for September 21-22, 2020. The alternate date is September 14-15, 2020.
Staff Response: Accepted. Given the availability of the ACMUI and NRC staff, the 2020 fall ACMUI meeting is scheduled for September 21-22, 2020. For this reason, the NRC recommends that this item be closed.
- 11. ACMUI Recommendation/Action Item from 2020, #9: The ACMUI endorsed the COVID-19 Subcommittee report, as presented, and its recommendations provided therein. [The final subcommittee report (ADAMS Accession No. ML20125A148) dated May 4, 2020, is available on the ACMUI Subcommittee Reports webpage.]
Staff Response: Accepted. As discussed during a public teleconference meeting on April 30, 2020, the ACMUI COVID-19 Subcommittee presented its recommendations for potential regulatory relief measures during the COVID-19 pandemic. On May 5, 2020, the staff issued NRC Planned Actions Related to Certain Requirements for Title 10 of the Code of Federal Regulations (10 CFR) 19, 20, 30, and 35 During the COVID-19 PHE, which includes a list of regulatory requirements from which temporary exemption may be suitable for expedited review (ADAMS Accession No. ML20126G386). The NRC staff has fully or partially accepted the ACMUIs COVID-19 recommendations. For this reason, the NRC recommends that this item be closed. The recommendations were dispositioned as follows:
5 Discussion begins on page 232 of the March 30, 2020 ACMUI meeting transcript (ADAMS Accession No. ML20141L630)
D. Metter 7
ACMUI COVID-19 Subcommittee Recommendations:
a) ACMUI Recommendation: The Subcommittee recommends a one-time modification of case experience requirements in 2020 for all COVID-19 related reasons. Additionally, when hands-on training or in person work experience is not feasible, the NRC should consider virtual training and work experience as viable alternatives.
Staff Response: Partially Accepted. The NRC staff will consider options to temporarily modify or delay specific in-person training and work experience requirements. For example, the NRC would consider temporary exemption of some in-person work experience requirements for generator elution from medical specialty boards or licensees whose physicians are seeking authorized user status under the alternate pathway. The NRC staff evaluated a temporary exemption for generator elution training and experience under 10 CFR 35.290(a)(1) and 10 CFR 35.290(c)(1)(ii)(G). (ADAMS Accession No. ML20231A930) b) ACMUI Recommendation: The Subcommittee recommends a delay in non-urgent reporting requirements such as in 10 CFR 20.2206 (Reports of Individual Monitoring) for a proposed 90 days.
Staff Response: Accepted. The NRC agrees that non-urgent reporting requirements can be delayed due to the COVID-19 pandemic. The NRC staff included in its May 5, 2020, table of regulations some reporting requirements, the exemption from which may be suitable for expedited review6.
c) ACMUI Recommendation: Only if specifically requested by the licensee, it is reasonable to allow variance on written reporting requirements for an initial report and ameliorating plans of the incident to the NRC or regulatory agency within 15 days and the full incident report in 30 days (vs. 15 days). If further delays are anticipated, licensees should contact the NRC or regional regulatory office (via phone, email, or letter) in expressing their need for a temporary exemption request.
Staff Response: Accepted. The NRC staff agrees that reporting of a medical event can be delayed due to the COVID-19 pandemic on an event-by-event basis. The NRC staff included in its May 5, 2020, table of regulations a medical event reporting requirement, the exemption from which may be suitable for expedited review.
d) ACMUI Recommendation: The Subcommittee recommends a delay (proposed 90 days) in regular (non-urgent) radiation safety activities by the Radiation Safety Officers.
Additionally, any annual refresher trainings should be postponed (up to 90 days) during the public health crisis.
Staff Response: Accepted. The NRC agrees that some radiation safety activities such as leak tests, inventory, instrument calibrations, annual training, etc., can be delayed due to the COVID-19 pandemic. The NRC staff included in its May 5, 2020, table of 6 Table of Medical Use Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Public Health Emergency, Updated May 8, 2020 (ADAMS Accession No. ML20129K060)
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regulations several requirements, the exemption from which may be suitable for expedited review.
e) ACMUI Recommendation: The ACMUI recommends no change to the physical presence requirement for HDR or Gamma Knife Stereotactic Radiosurgery.
Staff Response: Partially Accepted. The NRC staff did not include in its May 5, 2020, table of regulations the physical presence requirement and therefore, physical presence is not suitable for an expedited review. The NRC staff, however, recognizes that specific licensees might have difficulties in safely bringing in the appropriate Authorized User or Authorized Medical Physicist to fulfill physical presence requirements. The NRC staff could consider an exemption for physical presence on a case-by-case basis.
f) ACMUI Recommendation: Any inspections that require inspectors and licensees to be physically present and/or in the same room should be postponed up to 90 days.
Staff Response: Accepted. On March 19, 2020, on-site materials inspections were suspended. On June 1, 2020, inspection activities resumed onsite, remotely, or a combination thereof.
g) ACMUI Recommendation: Due to significant decline in radiology practice volume, and other economic ramifications of COVID-19 pandemic, ACMUI supports delaying payment of all relevant fees for FY 2020 for a specified period (proposed 90 days).
Moreover, review of medical use licensees amendment requests related to COVID-19 can be considered for expedited review.
Staff Response: Accepted. In Letter to the Honorable John A. Barrasso from NRC Chairman Svinicki dated April 10, 2020 (ADAMS Accession No. ML20099B857), the NRC approved a 90-day deferral of all annual fee (10 C.F.R. Part 171) invoices that would have been issued in the third quarter of Fiscal Year 2020. The NRC staff is taking this action to temporarily mitigate the financial impacts and economic disruptions caused by the COVID-19 pandemic. The new billing date for annual fees that were scheduled to be billed in the third quarter (April, May, June) will be July 22, 2020.
- via email OFFICE MSST/MSEB MSST/MSEB MSST/MSEB NAME KJamerson*
LDimmick*LD CEinberg*
DATE 09/10/2020 09/10/2020 09/11/2020