ML23192A046
| ML23192A046 | |
| Person / Time | |
|---|---|
| Issue date: | 05/15/2023 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| References | |
| NRC-2379 | |
| Download: ML23192A046 (1) | |
Text
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES Docket Number: N/A Location: teleconference Date: 05-15-2023 Work Order No.: NRC-2379 Pages 1-206 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1716 14th Street, N.W.
Washington, D.C. 20009 (202) 234-4433
1 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
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ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES
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OPEN SESSION
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MONDAY, MAY 15, 2023
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The meeting was convened via hybrid Video-Teleconference, at 8:30 a.m. EDT, Darlene F.
Metter, ACMUI Chairman, presiding.
MEMBERS PRESENT:
DARLENE F. METTER, M.D., Chair HOSSEIN JADVAR, M.D., Ph.D., Vice Chair REBECCA ALLEN, Member ANDREW EINSTEIN, M.D., Member RICHARD L. GREEN, Member RICHARD HARVEY, Ph.D., Member JOSH MAILMAN, Member MELISSA C. MARTIN, Member MICHAEL D. O'HARA, Ph.D., Member ZOUBIR OUHIB, Member NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
2 MEGAN L. SHOBER, Member HARVEY B. WOLKOV, M.D., Member NRC STAFF PRESENT:
CHRISTIAN EINBERG, Designated Federal Official, NMSS MARYANN AYOADE, NMSS DANIEL DiMARCO, NMSS EDWARD HARVEY, RES VINCE HOLAHAN, NMSS CHRISTINE PINEDA, NMSS DANIEL SHAW, NMSS KATHERINE TAPP, Ph.D., NMSS CELIMAR VALENTIN-RODRIGUEZ, Ph.D., NMSS KEVIN WILLIAMS, NMSS IRENE WU, NMSS ALSO PRESENT:
JOHN ANGLE, University of Virginia ASHLEY COCKERHAM, Public Participant RALPH LIETO, Public Participant STEVEN MARSH, Public Participant CINDY TOMLINSON, Public Participant NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
3 CONTENTS PAGE Opening Remarks....................................8 Old Business......................................21 Open Forum........................................27 Medical Related Events............................29 Revisions to the Abnormal Occurrence Criteria.......
Medical Team Updates................................
Training & Experience for All Modalities............
Extravasations Rulemaking...........................
ACMUI Reporting Structure...........................
Decommissioning Financial Assurance for Sealed and Unsealed Radioactive Materials......................
Open Forum..........................................
Administrative Closing..............................
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4 1 P R O C E E D I N G S 2 8:30 a.m.
3 CHAIR METTER: Well, thank you very 4 much and good morning and welcome to the 2023 5 Spring Meeting of the ACMUI. I'm Darlene Metter, 6 diagnostic radiologist and ACMUI Chair. I hope you 7 all are having a safe and productive 2023.
8 But before we begin, I would truly like 9 to acknowledge and thank the NRC staff for their 10 dedication and incredible work in the planning and 11 organization of this meeting.
12 For it helps the ACMUI to do their work 13 for the public, and the medical, and the safe 14 medical use of isotopes. So from the ACMUI, I 15 thank you for what you do.
16 So now turning to today's agenda, the 17 ACMUI will address certain ongoing topics that are 18 at the forefront of the committee's attention. And 19 I truly look forward to these presentations and 20 updates.
21 And now, I would like to turn the 22 meeting over to Mr. Chris Einberg and Mr. Kevin 23 Williams for opening comments.
24 MR. EINBERG: Thank you, Dr. Metter.
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5 1 Good morning. As the designated 2 federal officer for this meeting, I am pleased to 3 welcome you to this public meeting of the Advisory 4 Committee on the Medical Uses of Isotopes.
5 My name is Chris Einberg. I am the 6 chief of the Medical Safety and Events Assessment 7 Branch and have been designated as the federal 8 officer for this Advisory Committee, in accordance 9 with 10 CFR Part 7.11.
10 This is an announced meeting of the 11 committee. It is being held in accordance with the 12 rules and regulations of the Federal Advisory 13 Committee Act, and the Nuclear Regulatory 14 Commission.
15 This meeting is being transcribed by 16 the NRC and may also be transcribed or recorded by 17 others.
18 The meeting was announced in the May 5, 19 2023 edition of the Federal Register, volume 88, 20 page 29168.
21 The function of the ACMUI is to advise 22 the staff on issues and questions that arise on the 23 medical use of byproduct material. The committee 24 provides counsel to the staff but does not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
6 1 determine or direct the actual decisions of the 2 staff or the Commission.
3 The NRC solicits the views of the 4 committee and values their opinions. I request 5 that whenever possible we try to reach a consensus 6 on the various issues that we will discuss today.
7 But I also recognize there may be a minority or 8 dissenting opinions. If you have such opinions, 9 please allow them to be read into the record.
10 At this point, I would like to perform 11 a roll call of the ACMUI members participating 12 today.
13 Dr. Darlene Metter, Chair, Diagnostic 14 Radiologist.
15 CHAIR METTER: Present.
16 MR. EINBERG: Dr. Hossein Jadvar, Vice 17 Chair, Nuclear Medicine Physician.
18 The radiation oncologist position was 19 just filled by Mr. Michael Folkert. He may be 20 participating later today, but he is not a member 21 just yet, a full member. But he may be calling in 22 on Teams later this afternoon.
23 Mr. Richard Green, Nuclear Pharmacist?
24 MEMBER GREEN: Present.
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7 1 MR. EINBERG: Mr. Josh Mailman, 2 Patients Rights Advocate?
3 MEMBER MAILMAN: Present.
4 MR. EINBERG: Ms. Melissa Martin, 5 Nuclear Medicine Physicist?
6 MEMBER MARTIN: Present.
7 MR. EINBERG: Dr. Michael O'Hara, FDA 8 representative?
9 MEMBER O'HARA: Present.
10 MR. EINBERG: Mr. Zoubir Ouhib, 11 Radiation Therapy Physicist?
12 MEMBER OUHIB: Present.
13 MR. EINBERG: Ms. Megan Shober, State 14 Government Representative?
15 MEMBER SHOBER: Present.
16 MR. EINBERG: Dr. Harvey Wolkov, 17 Radiation Oncologist?
18 MEMBER WOLKOV: Present.
19 MR. EINBERG: Ms. Rebecca Allen, Health 20 Care Administrator?
21 MEMBER ALLEN: Present.
22 MR. EINBERG: Dr. Richard Harvey, 23 Radiation Safety Officer?
24 MEMBER HARVEY: Present.
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8 1 MR. EINBERG: Dr. Andrew Einstein, 2 Nuclear Cardiologist?
3 I confirm that we do have a quorum of 4 at least six members present. As you heard, Ms.
5 Megan Shober will be joining us via Microsoft 6 Teams, as she was unable to join us in person.
7 And as I mentioned, participating 8 online today we have Dr. Michael Folkert, who has 9 been selected as the ACMUI's brachytherapy 10 radiation oncologist. Dr. Folkert is pending his 11 security clearance but may participate later today, 12 and is welcome to make comments and ask questions 13 at the appropriate time. However, he will not have 14 voting rights for any actions requiring a vote.
15 All members of the ACMUI are subject to 16 the federal ethics laws and regulations and receive 17 annual training on these requirements.
18 If a member believes that they may have 19 a conflict, or a conflict of interest as that term 20 is broadly used in 5 CFR Part 2635, with regard to 21 an agenda item to be addressed by the ACMUI, this 22 member should divulge it to the chair and the DFO 23 as soon as possible, before the ACMUI discusses it 24 as an agenda item.
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9 1 ACMUI members must recuse themselves 2 from participating in any agenda item which they 3 have a conflict of interest, unless they received a 4 waiver or prior authorization from the appropriate 5 NRC official.
6 I would like to add that this is a 7 hybrid meeting of the ACMUI. We are in person, but 8 we all are also using Microsoft Teams, so that 9 members of the public and other individuals can 10 watch online or join via phone.
11 The phone number for this meeting is 12 301-576-2978. The phone conference ID is 571779324 13 pound sign.
14 The handouts and agenda for this 15 meeting are available on the NRC's ACMUI public 16 website.
17 I'm now going to discuss some of the 18 NRC staff members who are participating via 19 Microsoft Teams.
20 And Dr. Celimar Valentin-Rodriguez is 21 joining us online. And Mr. Daniel Shaw is joining 22 us online.
23 In the room today, we have Sarah 24 Spence, Daniel DiMarco, Cindy Flannery, Dr. Tapp, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
10 1 and Dr. Brenneman.
2 Members of the public who notified Dr.
3 Valentin-Rodriguez that they would be participating 4 via Microsoft Teams will be captured as 5 participants in the transcript.
6 Those of you who did not provide prior 7 notification, please contact Dr. Valentin-Rodriguez 8 by email at cvr2@nrc.gov at the conclusion of the 9 meeting.
10 Today's meeting is being transcribed by 11 a court reporter. We are utilizing Microsoft Teams 12 for the audio of today's meeting, and to view 13 presentation material in real time.
14 The meeting materials and agenda for 15 this meeting can be accessed from the NRC's public 16 meeting schedule.
17 For the purpose of this meeting, the 18 chat feature in Microsoft Teams has been disabled.
19 Dr. Metter, at her discretion, may 20 entertain comments or questions from members of the 21 public who are participating today.
22 Individuals who would like to ask a 23 question or make a comment regarding a specific 24 topic of the committee has discussed and are in the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
11 1 room, can come up to either of the microphones set 2 up in the room.
3 For those individuals on Microsoft 4 Teams, please use the raised hand function to 5 signal our Microsoft Teams host, Christine, that 6 you wish to speak.
7 If you have called in to the Microsoft 8 Teams using your phone, please ensure you have 9 unmuted your phone.
10 When you begin your comment, please 11 clearly state your first and last name for the 12 record. Comments and questions are typically 13 addressed by the committee near the end of a 14 presentation, after the committee has fully 15 discussed the topic.
16 We will announce when we are ready for 17 the public comment period portion of the meeting, 18 and Christine Pineda will assist in facilitating 19 public comments.
20 At this time, I ask that everyone who 21 is not speaking, to please mute your Teams 22 microphones or phone. And for those in the room, 23 please mute your phones.
24 I will now turn the meeting over to Mr.
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12 1 Kevin Williams, Director, Division of Material 2 Safety and Safety Security State and Tribal 3 Programs, for some opening remarks.
4 MR. WILLIAMS: All right, thank you, 5 Chris.
6 Good morning, everyone, and welcome to 7 the ACMUI 2023 Spring Meeting. It's always great 8 to see all of you, and all of the NRC people, as 9 well.
10 We haven't been, this is probably the 11 second time we've gotten together face-to-face, and 12 I think face-to-face is actually great 13 communications.
14 We were just talking about that prior 15 to the start of the meeting. So much you can, 16 conversations you can have off the margins. So 17 welcome and thank you.
18 So first, I'd like to begin thanking 19 ACMUI for all your hard work and support to the 20 NRC. We truly value your contributions and 21 expertise, as we continue to tackle new issues 22 related to the medical use of radioactive material.
23 As I previously stated, this is the 24 second in-person meeting since the fall of 2019, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
13 1 and we're definitely excited to continue our in-2 person interactions.
3 I'd like to highlight a few items that 4 may be of interest to the ACMUI, and the meeting 5 participants.
6 There are a number of Commission 7 related activities. One is reporting nuclear 8 medicine injections extravasations as medical 9 events, the rulemaking itself.
10 As you know, there is a lot of energy 11 surrounding this, with a lot of different inputs 12 from a variety of stakeholders.
13 Following the ACMUI Fall 2022 meeting, 14 the Commission issued its staff requirements 15 memorandum for the staff's rulemaking package, to 16 address the petition for rulemaking that we had 17 received, which was PRM-35-22.
18 The Commission unanimously approved the 19 staff's recommended option and SECY-22-0043, which 20 has to do with the petition for rulemaking, and the 21 rulemaking plan on reporting nuclear medicine 22 injection extravasations as a medical event.
23 And as part of that, we will be 24 amending 10 CFR Part 35 to require reporting of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
14 1 nuclear medicine extravasations that require 2 medical attention for suspected radiation injury.
3 Later today, Irene Wu, Project Manager 4 for the extravasation rulemaking, will discuss the 5 status of this rulemaking and ongoing NRC 6 activities.
7 The next item that has the Commission 8 interest is the proposed limited revision to the 9 policy statement on the criteria for reporting 10 abnormal occurrences, commonly referred to as AOs.
11 On March 29 of 2023, the Commission 12 issued a staff requirements memorandum for the 13 proposed limited revision to the policy statement 14 on criteria for reporting abnormal occurrences.
15 That was in SECY-22-0009.
16 An ACMUI subcommittee in 2021 reviewed 17 the staff's proposed changes to the AO medical 18 criteria in III.C, which is events involving the 19 medical use of radioactive materials in patients as 20 human research subjects.
21 Later today, Rigel Flora will discuss 22 the Commission's decision, and will provide a 23 status update on NRC activities related to the AO 24 criteria.
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15 1 So to provide a few inputs on NRC 2 activities, in regards to reporting extravasation 3 rulemaking, on May 9 we transmitted a package to 4 the Commission to recommend an approach to this 5 disposition. A petition for rulemaking received in 6 2020 and moved forward on extravasations.
7 The emerging medical technologies 8 rulemaking, the staff has developed a regulatory 9 base to this document for this rulemaking, and is 10 addressing comments from the NRC regions and 11 Agreement States, and will address comments from 12 the ACMUI that will be discussed today.
13 The regulatory basis will be 14 transmitted to the Commission in March of, is it 15 2023 or 2024? So I'll correct that. But the 16 regulatory basis, where's Celimar?
17 MS. VALENTIN-RODRIGUEZ: It's 2023, 18 Kevin.
19 MR. WILLIAMS: It was transmitted in 20 2023 and following Commission approval, will be 21 published in the Federal Register for a 90-day 22 public comment period.
23 The NRC staff will conduct stakeholder 24 workshops during that time to gather stakeholder NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
16 1 feedback on the proposed changes to Part 35, 2 including comments on the training and experience 3 requirements for emerging medical technologies.
4 Training and experience for unsealed 5 byproduct material, the staff is developing 6 implementation guidance for training and experience 7 requirements per direction of the Commission.
8 The draft implementation guidance will 9 be issued in August of 2024 as interim staff 10 guidance, and will address how a person seeking 11 authorized individual status under Part 35, can 12 fulfill training and experience requirements, as 13 well as clarify the roles and responsibility of 14 those persons involved in, and subject to training 15 and experience requirements.
16 Phase 2 for the revision of Reg Guide 17 8.39 regarding patient release. Approximately a 18 month ago we issued for public comment, a draft of 19 the Phase 2 revision to Regulatory Guide 8.39.
20 In December of 2021 the ACMUI 21 subcommittee provided comments to the staff on this 22 draft, and then the staff considered those comments 23 in concert with comments from the Agreement States, 24 and our NRC regions.
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17 1 Once the staff reviews any public 2 comments received and incorporates the comments 3 into the draft Guidance as appropriate, the ACMUI 4 will receive the final draft for review and comment 5 prior to final issuance.
6 Nothing to report since our Fall of 7 2022 meeting, ACMUI meeting. Organizational 8 changes, I think Chris did talk about that for 9 ACMUI.
10 But for the NRC, we welcome two new 11 staff members into the Medical Radiation Safety 12 Team. Mr. Daniel Shaw, and Ms. Sarah Spence.
13 In addition, we selected a new ACMUI 14 coordinator, Ms. Lillian Armstead. And, she starts 15 with the NRC later this month.
16 ACMUI changes since the Fall meeting.
17 Dr. Ronald Ennis completed a second term, and his 18 departure left a vacancy for the ACMUI 19 brachytherapy radiation oncologist.
20 And, Chris talked about Dr. Michael 21 Folkert has been appointed to serve as the 22 brachytherapy radiation oncologist. And Chris also 23 provided his credentials.
24 Items of interest for this meeting.
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18 1 The following presentations will be discussed 2 today. Mr. Daniel DiMarco will provide an overview 3 of the recent medical events. Mr. Flora will 4 provide an update on the NRC's limited revision of 5 our AO criteria. Ms. Irene Wu will provide an 6 update on the NRC extravasations. Dr. Celimar 7 Valentin-Rodriguez will provide an update on 8 medical team activities.
9 Thanks for this opportunity to open the 10 meeting. I wish you a productive session today.
11 And as far as my time goes, you will see me in and 12 out of the meeting.
13 I will have to do a quick side note.
14 Chris sent me a message are you coming? Yes, I am 15 just addressing a couple issues before I get down 16 here.
17 So there's never a dull moment in my 18 day. So I will be in and out, but I look forward 19 to hearing from you, and having conversations with 20 you.
21 At this time, I will turn it over to 22 Dr. Celimar Valentin-Rodriguez.
23 MS. VALENTIN-RODRIGUEZ: Thank you, 24 Kevin.
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19 1 Christine, can I get the next slide, 2 please?
3 Good morning ACMUI members, and I'm 4 saddened that I can't be there in person with you 5 today.
6 This morning I'm going to go through 7 the old business and action items from the ACMUI.
8 First off, we have a 2019 recommendation where the 9 ACMUI endorsed the evaluation of extravasations 10 subcommittee report to note that under future 11 revisions of Part 35 rulemakings, extravasations be 12 captured as a type of patient intervention in the 13 definition of patient intervention.
14 The NRC, we propose to close this item.
15 In SRM-22-0043, the Commission directed the staff 16 to amend Part 35 to require the reporting of 17 extravasations that require medical attention for 18 suspected radiation injury. The staff is currently 19 developing a proposed rule.
20 There are two additional old business 21 action items regarding extravasations, which later 22 on I will also propose to close with the same 23 justification.
24 The next recommendation comes from 2020 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
20 1 and it is the patient, and it is also related to 2 patient intervention. And this will be, we propose 3 to close this item with the same justification as 4 the previous item.
5 The next item is Item Number 11 from 6 2020. As part of the Non-Medical Events Report, 7 the ACMUI recommended to the NRC staff and to the 8 National Materials Program, to evaluate the issue 9 of detection of short-lived medical isotopes in 10 municipal waste, and provide some level of 11 guidance, best practices, or additional 12 recommendations.
13 We propose that this action item remain 14 open. The medical team presented to the OAS board, 15 and we've agreed to a survey.
16 This survey was transmitted to the 17 Agreement States earlier this year, and we've 18 extended that to allow enough time for Agreement 19 States to provide comments.
20 The new target for this action item 21 will be Fall 2023.
22 The next action item, thank you, 23 Christine. The next action item is the ACMUI's 24 endorsement of the extravasation subcommittees NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
21 1 report, which we also propose to close as we have a 2 staff requirements memorandum for that SECY 3 package, and the staff is currently working on the 4 extravasation rulemaking.
5 The next item, Item Number 7, we formed 6 a new subcommittee to evaluate the Liberty Vision 7 Y-90 manual brachytherapy source licensing 8 guidance, that the staff is currently developing.
9 We are proposing for this item to 10 remain open as the staff has had to prioritize work 11 in rulemakings, and others about this licensing 12 guidance.
13 Currently the licensing guidance is 14 being developed and so we hope to form, reform the 15 subcommittee in the next few months to address the 16 licensing guidance.
17 The next item, Number 10, the ACMUI 18 endorsed the radionuclide generator knowledge and 19 practice requirements subcommittee report, and the 20 recommendations in this report.
21 We are proposing that this item remain 22 open. We are addressing this item as part of the 23 emerging medical technologies / rubidium-82 24 generator rulemaking, that was approved by the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
22 1 Commission in January of 2022.
2 So we propose to close this item, or 3 the target completion date will be in March 2026 4 when the Commission issues the final rule for this 5 rulemaking.
6 The next item is Item Number 15, which 7 is the ACMUI Reg Guide 8.39 subcommittee report.
8 And that is for the CivaDerm licensing memo.
9 We are proposing that that action item 10 remain open. We considered the subcommittee's 11 comments in that memo, and we are currently 12 revising and very close to issuing that CivaDerm 13 memo concurrently with Reg Guide 8.39.
14 The next item which is related, is the 15 actual report on the Reg Guide 8.39. As Kevin has 16 mentioned, the Reg Guide 8.39 is out for public 17 comment.
18 Once we receive public comments on Reg 19 Guide 8.39 and address those, we will reform the 20 ACMUI, or reestablish the ACMUI subcommittee for an 21 additional review and comment of the final draft 22 licensing guidance. Therefore, Item 16 we propose 23 to close at this time.
24 Next slide, please. Thank you, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
23 1 Christine.
2 Next item is a suggestion from the 3 ACMUI members to review the rulemaking plan for the 4 ongoing NRC effort, and that's to be the rulemaking 5 or draft proposed rule, for the NRC effort to 6 revise Appendix B to Part 30.
7 We propose to close this item as the 8 ACMUI established a subcommittee to review the 9 proposed rule, and we will be providing a report 10 today.
11 The next item is Item Number 4 from 12 2022. The ACMUI endorsed a Y-90 microsphere 13 medical events subcommittee report, and the 14 recommendations therein.
15 We propose for this item to remain 16 open. The staff is currently addressing the 17 recommendations, including outreach, to the Society 18 of Interventional Radiology, to increase engagement 19 and communications.
20 Dr. Tapp of the medical team, will be 21 providing a webinar to SIR in June, to discuss 22 current Y-90 microsphere licensing guidance and 23 medical events.
24 We are also looking more closely at Y-NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
24 1 90 microsphere medical events for the next two 2 years, to evaluate if and how the use of vendor 3 tools play a role in these medical events.
4 There was also a recommendation about 5 issuing another information notice, which for the 6 time being, we will not do as we issued an 7 information notice with related topics in 2019.
8 So, we will continue to monitor Y-90 9 microsphere medical events and see if there is any 10 other trends that would necessitate further generic 11 communication with our licensees. Therefore, we 12 propose that this item Number 4 from 2022 remain 13 open.
14 Item Number 5 from 2023, the ACMUI 15 endorsed the emerging medical technologies 16 rubidium-82 generator rulemaking subcommittee 17 report on the draft regulatory basis, and their 18 recommendations therein.
19 We propose to close this item. The NRC 20 staff considered the subcommittee's comments and 21 the development of this draft regulatory basis, and 22 the draft regulatory basis is currently in 23 concurrence, and is close to being issued to the 24 Commission.
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25 1 So that's coming up in summer 2023, and 2 we'll have approximately a 120-day public comment 3 period at that time.
4 Item Number 6 from 2023 is that the 5 ACMUI establish two subcommittees. One to create 6 generic process checklists, and another to review 7 the decommissioning financial assurance draft 8 proposed rule, as well as reestablish the nursing 9 mothers' guidelines to update the 2019 guidelines.
10 We propose too, for this item to remain 11 open. We have established the decommissioning 12 finance assurance draft proposed rule, and are in 13 the process of establishing the other two 14 subcommittees to address those two items later this 15 year.
16 And finally, Item Number 7 from 2022, 17 which was the scheduling of this meeting today. We 18 propose to close this item. The meeting as we're 19 here now, is being held May 15 through the 16, 20 2023.
21 And with that, Dr. Metter, if the 22 members would like to take a vote on whether to 23 accept the NRC staff's recommendations on these 24 items.
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26 1 CHAIR METTER: Thank you, Dr. Valentin-2 Rodriguez on your presentation of the old business.
3 And do I have any questions or comments 4 from the ACMUI for what was just presented?
5 Seeing none, do I have a motion to 6 approve the report as written?
7 MEMBER WOLKOV: Harvey Wolkov. Move 8 approval.
9 CHAIR METTER: Thank you, do I have a 10 second?
11 MEMBER MARTIN: I would second that.
12 CHAIR METTER: Dr. Richard Harvey 13 second it. Any comments?
14 All in favor?
15 (Chorus of aye.)
16 CHAIR METTER: Any abstain or opposed?
17 Seeing none, thank you Dr. Valentin-18 Rodriguez. Your report has been unanimously 19 approved by the ACMUI.
20 Our next item on the agenda is the open 21 forum, which is to introduce new topics for 22 discussion for future review by the ACMUI.
23 Are there any topics that the committee 24 members would like to bring forward at this time?
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27 1 Okay, seeing none, are there any topics 2 that the NRC staff would like to bring forth at 3 this time?
4 MS. VALENTIN-RODRIGUEZ: Good morning, 5 Dr. Metter --
6 (Simultaneous speaking.)
7 MR. EINBERG: No.
8 MS. VALENTIN-RODRIGUEZ: -- this is 9 Celimar. We don't have any items at this time.
10 Sorry, Chris.
11 CHAIR METTER: Thank you.
12 MR. EINBERG: Yes, no problem.
13 CHAIR METTER: Thank you very much.
14 Okay, so at this time in the open 15 forum, if there are other comments that you would 16 like to bring up for future topics, please let me 17 know, or bring it up in one of our other 18 discussions.
19 So, our next item on the agenda is the 20 medical related events by NRC staff Daniel DiMarco.
21 (Pause.)
22 CHAIR METTER: Yes.
23 MR. DIMARCO: Yes, probably should turn 24 the mic on. Okay, hello, everyone. My name is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
28 1 Daniel DiMarco, I'm a health physicist here at the 2 NRC with the Medical Radiation Safety team and I'm 3 here to present on the status of a medical events 4 from FY22.
5 Next slide, please. Just a quick 6 overview. The dose threshold for diagnostic events 7 precludes reportable events for most years. And 8 each year there are approximately 150,000 9 therapeutic procedures performed utilizing 10 radioactive materials.
11 Probably need to update this sometime 12 soon. I'll get some information from you all later 13 today.
14 Next slide, please. So, here's a table 15 with the medical events from the past five, past 16 six fiscal years, 2017 to 2022.
17 In the parenthesis there, you can see 18 the total number of patients involved, if it was 19 greater than the number of reports.
20 So, for this year we've got a total of 21 56 medical events, which is a little bit less than 22 last year, but is about on par with what we've seen 23 from previous years.
24 Next slide, please. So going into the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
29 1 events themselves. This year we had no medical 2 events from the 35.200 uses of byproduct material.
3 Next slide, please. We had 10 medical 4 events from the 35.300 use of the byproduct 5 material, four of them involving lutetium-177; 6 three of them involving iodine-131; two from, of 7 radium-223 Xofigo.
8 And this was our first year with an actinium-225 9 medical event.
10 Next slide, please. This event was a 11 patient overdose involving iodine-131, where the 12 patient was intended to receive a 5.5 gigabecquerel 13 dose, which was signed into the medical record.
14 But unfortunately, the written 15 directive, there was an error in the computer-16 generated written directive where the patient was 17 technically prescribed .074 gigabecquerels.
18 For this event, no harm was seen 19 because the patient received the intended dose.
20 But this is a medical event because the dose that 21 was, that was administered was different, was 22 significantly over the dose that was on the written 23 directive.
24 And so corrective actions included NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
30 1 changes to the computer-generated written 2 directive, and procedure changes to the existing 3 time out process.
4 Next slide, please. This next one was 5 a patient overdose, where the patient was part of a 6 therapeutic portion of a sponsored study protocol, 7 using iodine-131.
8 They had a fixed activity to the 9 administration that was limited by the kidney dose, 10 and so they have no reliable dose estimates for the 11 prostate. And so, the root cause was determined to 12 be an inadequate training on this specific 13 protocol, where corrective actions included 14 additional training.
15 No adverse impacts were expected to the 16 patient and follow up doses were cancelled due to 17 the proximity to the kidney dose restraints for 18 this protocol.
19 Next slide, please. This event was a 20 patient underdose involving iodine-131. This 21 patient had been administered an iodine-131 capsule 22 but was unable to swallow it and the pill broke 23 down in the patient's mouth.
24 After removing this capsule and taking NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
31 1 the patient to a safe room, they noticed that some 2 of the removed pharmaceutical had leaked, leading 3 to a contamination incident. And so, the next day, 4 they re-tried administering this iodine-131, this 5 time in liquid form. But the patient also failed 6 to swallow this.
7 And so, they had to get a dose estimate 8 from the first administration by bioassay, which 9 led to the dose estimation there. And so 10 corrective actions included having patients swallow 11 a placebo pill prior to the administration, just to 12 make sure that they were actually able to swallow.
13 And so, no persons were determined to 14 be contaminated from that previous contamination 15 incident, and the decontamination of all of the 16 surfaces was successful.
17 Next slide, please. This event was a 18 patient overdose involving Lutathera where the 19 patient had a kidney disease, which required a 20 smaller dose than the typical 200 millicurie dose, 21 dosage.
22 The administering tech did not receive 23 this written directive from the nuclear medicine 24 department, and so the pharmacy tech drew the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
32 1 typical 200 millicurie dose, without consulting 2 this written directive.
3 And so, the root cause was determined 4 to be a failure to follow established protocols, 5 and lack of communication inter-departmental 6 communication.
7 So, their corrective actions included a 8 daily huddle to communicate key information about 9 the therapy patients, and a secondary verification 10 which required a physical signature on the written 11 directive. And this patient will be followed to 12 assess for kidney damage.
13 Next slide, please. This one was 14 another patient overdose involving Lutathera. This 15 was the third of the four treatments, where 16 previous treatments also had prescribed a half dose 17 of 100 millicuries due to reduced creatinine 18 clearance in the patient.
19 There was a bit of a delay in treating 20 this patient due to the suspension of radioisotope 21 production of Lutathera, which resulted in 22 inadequate creatinine level for the treatment.
23 And so, the doses to the non-target 24 tissue was in line with parameters for a standard NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
33 1 treatment with this 200 millicurie administration.
2 So, this final treatment was planned to be either a 3 full or a half dose, depending on the patient 4 tolerance. And so, the written directive was 5 updated to improve verification process of this 6 dose measurement.
7 Next slide, please. This next one was 8 a patient underdose with Lutathera, where two 9 minutes after the infusion was started, a leak was 10 noticed in the line. The procedure was stopped and 11 the vial and tubing were assayed, which showed no 12 patient contamination.
13 The room was surveyed, appropriately 14 decontaminated, and the root cause was determined 15 to be equipment failure, where the corrective 16 actions were implemented for that. And there were 17 no clinical impact or risks to the patient from 18 this event.
19 Next slide, please. This next event 20 was a patent underdose also involving Lutathera 21 where the patient received much smaller, .052 22 gigabecquerels of the dose, where they noticed that 23 the vial had lost pressure during the treatment and 24 attempted to, attempted to regain this pressure, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
34 1 but all of those attempts failed. No contamination 2 was found, and no serious adverse effects were 3 noted.
4 Next slide, please. This event 5 involved a radium-223 Xofigo patient overdose, 6 where the patient was prescribed 2.13 7 megabecquerels, but received 6.84 megabecquerels.
8 Similar to one of the previous Lutathera events, 9 this was just a simple clerical error in the 10 written directive, and the patient received the 11 intended dose. The written directive had just 12 incorrectly prescribed 2.13 megabecquerels to this 13 patient.
14 Next slide, please. This event was a 15 radium-223 Xofigo underdose, where the patient, 16 where the physician noticed a leakage occurring in 17 that 3-way stopcock and the administration, they 18 estimated a dose given by measuring the leaked 19 radio pharmaceutical.
20 The root cause was determined to be an 21 incorrect cath used on the unused port of that soft 22 cock. And so, the corrective actions included 23 procedure revisions to prevent leakage, and 24 additional training, and no harm is expected to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
35 1 patient.
2 Next slide, please. This event is our 3 first actinium-225 event, a patient underdose.
4 This was for a clinical trial for prostate cancer, 5 where there was an accidental discharge of the 6 radio pharmaceutical into the absorbent pad.
7 The root cause was determined to be the 8 recession of a connection point into the tungsten 9 shield surrounding the vial, which hindered the 10 operation of a 3-way stopcock.
11 The AU had removed the connection 12 without the required three saline flushes, and so 13 the corrective actions included the retraining of 14 all AUs, refreshing training on written directives, 15 and then acquisition of an alpha detector to survey 16 for contamination.
17 Next slide, please. Okay, so for FY22, 18 there was only a single 35.400 medical event.
19 Next slide. This was a patient 20 underdose involving an iodine-125 eye plaque. This 21 plaque held 30 seeds, with an activity of 49.21 22 megabecquerels for each seed.
23 The plaque was dislodged while the 24 patient rubbed the eye. However, the plaque was NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
36 1 able to be placed into the lead pouch and returned 2 to the AU with no, no other events occurring. And 3 so no corrective actions were taken for this.
4 Next slide, please. This here we had 5 11 35.600 medical events.
6 Next slide. The first event was a 7 patient overdose involving an iridium-192 HDR unit.
8 This patient was prescribed 10 HDR treatments, but 9 following four of these treatments, they had 10 noticed that some of the catheters had been 11 mislabeled.
12 The planned skin dose was 26.5 Gray, 13 but after adjustments, this dose to the skin ended 14 up being 48.4 Gray. No adverse effects were 15 expected, but patient will be following up more 16 frequently.
17 The root cause was determined to be 18 human error, and a lack of proper catheter 19 identification. And so corrective actions included 20 procedure updates to emphasize catheter 21 identification, and modification of the planning 22 process to include an additional review by a second 23 physicist. The staff also received additional 24 training.
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
37 1 Next slide, please. This next event is 2 a patient underdose involving an iridium-192 unit, 3 where two patients were both prescribed four 4 fractions of 7 gray for a total of 28 gray.
5 The first patient had an underdose in 6 fraction two of four, where only 79 percent of the 7 fraction was delivered. And the second patient had 8 an underdose in fraction four of four, where only 9 54.4 percent of the fraction was delivered.
10 Additionally, the second patient 11 received the, a 48 percent greater dose to the 12 rectum for the fraction, resulting in an overall 13 15.4 percent greater dose to the rectum for the 14 full treatment.
15 Next slide, please. For this event, 16 the radiation therapist had replaced a catheter, 17 one that was an incorrect length at least for this 18 medical facility.
19 The procedures required a blue catheter 20 with 137 -- 1,377 millimeter length. But the new 21 blue catheters are slightly longer than this, and 22 had to be trimmed down to this correct length.
23 Which the radiation therapist had not done.
24 And so, the corrective actions for this NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
38 1 included procedure modifications to ensure that the 2 correct catheter is always of the appropriate 3 length, and additional training.
4 And so patient one had modifications to 5 the rest of the treatment to compensate for their 6 underdose; and patient two had no adverse effects.
7 Next slide, please. This event with 8 another HDR patient underdose where during the 9 treatment the error messages 8C.2-dummy part switch 10 or drive failure had displayed during the treatment 11 after the first 15 channels were delivered.
12 The field service engineer suggested a 13 reboot of the system, which was not successful.
14 And so, the AU had stopped treatment to avoid 15 leaving the patient under general anesthesia, which 16 left the remaining four channels untreated.
17 Next slide, please. Another patient 18 underdose with an iridium-192 unit, where the 19 patient was treated without issue through the first 20 channel but at the start of the second channel, 21 there was an error which indicated that the source 22 position had slipped at the zero centimeter mark.
23 The treatment was paused and a test 24 wire was run, which showed no errors. A second NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
39 1 treatment, attempt at the treatment however, 2 returned the same error and so the treatment had 3 been cancelled after that.
4 The source was verified to be in the 5 unit, and no additional dose was delivered to the 6 patient or the staff.
7 Afterwards, the service engineer 8 determined that there was a hardware issue with the 9 active sourcing coder, which serves as a tech and 10 check for the movement of the source. And so for 11 corrective actions, this encoder was replaced and 12 the HDR unit was determined operational.
13 The next event is a wrong site event 14 involving an HDR unit. The patient had been 15 intended to receive the 600 centigray to the lower 16 nasal dorsum. However, it was prescribed to the 17 right nasal sidewall.
18 This was, again, another written 19 directive incorrect event where the patient 20 received the, the dose in the treatment in the area 21 that was intended, but the written directive had 22 been incorrectly filled out. And so no adverse 23 effects were expected for this.
24 Next slide, please. This was another NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
40 1 wrong site HDR medical event where the patient was 2 prescribed 3,600 centigray to the skin of the left 3 scalp. However, the physician had misidentified 4 the treatment site where the photos were taken 5 after the biopsy of the treatment area, but had 6 healed over.
7 And so when trying to identify the same 8 area prior to treatment, they had misidentified 9 that area. And so potential consequences were 10 determined to be a potential for developing skin 11 cancer at the treated site in 20-30 years, and 12 possible recurrence of the cancer at the untreated 13 site.
14 Next slide, please. So the patient was 15 offered additional treatment to the carcinoma, but 16 chose only observation by the dermatologist going 17 forward.
18 Corrective actions included a creation 19 of a HDR planning policy for dermal brachytherapy, 20 an updated commitment to policy to state that the 21 HDR skin cancer sites will be reviewed at a peer 22 review meeting before treatment, and better 23 photographs of the treatment site taken, and 24 ambiguous information requiring additional NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
41 1 verification going forward.
2 Next slide, please. This event was 3 another wrong site with an HDR unit, where the 4 patient had two lesions on the lower right leg.
5 The first was treated using SBRT without incident.
6 And the second had been prescribed 4,000 centigray 7 over eight fractions.
8 However, the first fraction, that first 9 500 centigray fraction had been unintentionally 10 delivered to the first lesion, which was discovered 11 when the patient noticed that the planning circle 12 had been drawn over the first lesion, instead of 13 the second lesion for that second fraction, before 14 it was treated. And so no adverse effects are 15 expected.
16 Next slide, please. The root cause of 17 this was determined to be human error, particularly 18 failure to notice the change in positioning from 19 supine to prone.
20 Contributing to this was that the two 21 lesions were very close, about an inch and a half 22 apart, and the second lesion was not present during 23 the previous SBRT treatment.
24 And so corrective actions included NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
42 1 adding a pre-treatment step for multiple close 2 lesions, and asking the patient to point to the 3 treatment site, as well as using more verification 4 images of the treatment site.
5 Next slide, please. This event was 6 another wrong site involving an HDR source, where a 7 patient was prescribed 2,100 centigray. The first 8 fraction was delivered without incident. However, 9 at some point after that, the patient had 10 experienced complications from a hysterectomy, 11 which was treated at a different hospital. And so 12 did not return to the original hospital for their 13 other treatments.
14 The oncologist at the new hospital had 15 determined that that first treatment was off by 3 16 centimeter, and that the colon and bowel had 17 received a dose of 700 centigray. And so 18 corrective actions included procedure modification 19 to require CT imaging review after insertion of the 20 HDR applicators.
21 Next slide, please. This event was 22 another wrong site involving an iridium-192 HDR 23 unit, where the patient had received a single 24 fraction to the left hand instead of the right hand NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
43 1 as prescribed.
2 The corrective actions for this 3 included an immediate discussion with all clinical 4 staff to verify the correct anatomical treatment 5 site regarding all prescriptions going forward.
6 Next slide, please. This event was 7 another wrong site with an HDR treatment where 8 there was a deviation in the transfer tube by 2.9 9 centimeters. Unfortunately, this had affected 27 10 patients before this was, before this was 11 discovered.
12 The dose to the unintended tissue was 13 determined by recreating the intended plans and 14 comparing that to a shifted plan, which resulted in 15 267 centigray of additional dose to unintended 16 tissues per fraction.
17 The investigation for this event is 18 still ongoing, and so I have no updates for you as 19 of this time as to corrective actions.
20 For this treatment, this involved a PDR 21 unit where there was a patient underdose.
22 Specifically, three patients underdosed where you 23 can see the prescribed and delivered doses there.
24 For this, there was a discrepancy NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
44 1 between the measured treatment distance and the 2 treatment plan. And so the root cause was 3 determined to be an erroneous manual entry in the 4 reference tables. Specifically, they entered 1,248 5 millimeters versus the intended 1,448 millimeters.
6 The corrective actions included a root cause 7 analysis, procedure modification, and additional 8 reference table verification.
9 Next slide, please. So this year we 10 had 34 35.1000 medical events, two GSR unit medical 11 events, and 30 Y-90 microspheres, or 32 Y-90 12 microspheres medical events.
13 Next slide, please. The first one 14 involving a GSR unit was a wrong site where the 15 patient was being treated for four lesions in the 16 brain. However, post-treatment they had discovered 17 that the targeting had been off by half a 18 centimeter for all of these lesions. The delivered 19 dose to the lesions were between 8 and 15 gray, and 20 the max dose to the unintended healthy tissue was 21 21.82 to 27.09 gray.
22 Next slide, please. The root cause of 23 this was a shifting of the co-registration of 24 images between the intended target, and the 25 treatment parameters. This was discovered after NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
45 1 the surgery. No adverse effects are expected, but 2 the patient will be, will continue to be monitored.
3 And the corrective actions included an 4 updated treatment procedure to include review and 5 approval of treatment plan by two of the three team 6 members, for all events that involve co-7 registration of CT MRI images.
8 Next slide, please. The next Gamma 9 Knife event was another wrong site where the 10 patient was treated for 10 brain lesions but had 11 fallen asleep during the treatment of the first 12 four. During the fifth treatment, the patient had 13 woken up, but no sufficient movement was recorded 14 to stop or delay the treatment.
15 This treatment was later paused to 16 allow the patient to use the restroom, during which 17 the therapist had noticed that the frame had moved 18 from its original position. The remainder of the 19 treatment was cancelled. They took new CT images, 20 and a new treatment plan was developed for the 21 remaining four lesions, which were all treated 22 without incident.
23 The review of the initial treatment 24 indicated that the four lesions were treated, that 25 four of them were treated initially. Two following NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
46 1 the patient waking up, and the remaining four were 2 treated after the re-planning.
3 Next slide, please. This is another 4 event where the investigation is continuing to on 5 go. So they've drawn up two most likely or worst 6 case scenarios, one where only two lesions were 7 affected by the movement, and one where all six of 8 the initial lesions were affected by the movement.
9 In the most likely scenario, the two 10 lesions received slightly more dose due to the 11 higher volume of brain tissue, with no effect on 12 the other lesions. However, in the worst-case 13 scenario, the two lesions would be underdosed by 14 over 50 percent, and would have a significantly 15 high risk of occurrence.
16 This patient is continuing to be 17 followed and currently, has shown no detrimental 18 effects from the investigation from this event.
19 And as I said before, it's still under 20 investigation.
21 Next slide, please. So this first 22 event, Y-90 TheraSphere overdose where 23 administering, when administering the microspheres 24 to the three separate liver segments, it was 25 determined that these segments had been NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
47 1 misidentified, due to the varying anatomy of the 2 patient.
3 Specifically, segment 7 had received 4 more dose than expected, but all three targets had 5 received an appropriate segmentectomy dose.
6 The root cause was determined to be the 7 failure to identify the varying anatomy during 8 treatment, where the corrective actions included a 9 secondary review of pre-treatment mapping, and 10 angiography of any administration where the 11 location of the catheter is questioned. And if 12 this is not effective, the AU will perform a 3-D 13 cone beam CT to confirm the area to be treatment, 14 and no adverse effects were expected.
15 Next slide. Another Y-90 TheraSphere 16 overdose where the patient was prescribed two 17 administrations to separate segments of the liver, 18 where the doses had been ordered with an incorrect 19 calibration date. And so, these segments had been, 20 were administered a significantly higher dose than 21 intended.
22 The root cause was determined to be a 23 failure to confirm the calibration date, and a 24 failure to check that the prescribed dose matched 25 the measured dose during the pre-treatment checks.
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
48 1 The patient had been followed and no 2 adverse effects were noted. And corrective actions 3 included updating the Y-90 work sheets to add a new 4 verification of dose in hand, rather than versus 5 the written directive, and then updates to the dose 6 ordering process, which required a second person to 7 give their signature, and all of the personnel were 8 trained on these new procedures.
9 Next slide, please. This event 10 involved another Y-90 TheraSphere overdose, where 11 the patient was intended to receive two vials of 12 microspheres for the administered dose. However, 13 the written directive was incorrectly filled out, 14 and that only accounted for one vial.
15 And so, the administered activity was 16 within two percent of the planned activity, 17 however, it was a significant overdose, compared to 18 the written directive. And so, the root cause was 19 determined to be human error in filling out this 20 written directive. And the corrective actions 21 included personnel training and procedure updates.
22 Next slide. This event was another Y-23 90 TheraSphere overdose, where two patients were 24 due to receive Y-90 treatment on the same day.
25 Patient A with two vials, and Patient B with three NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
49 1 vials.
2 Patient A had one of their first vials 3 inadvertently swapped with one of Patient B's 4 vials. And so had been administered a 5 significantly higher dose of Y-90 microspheres than 6 intended.
7 And so, the segments two and three were 8 prescribed 1,200 centigray, but had received 73,660 9 centigray. 12,000 centigray, excuse me, was 10 prescribed.
11 And so, this dose was considered 12 clinically acceptable, and no adverse effects were 13 expected. However, Patient B's treatment was 14 cancelled considering that none of, that the vial 15 had been used in Patient A.
16 Next slide, please. The corrective 17 actions included requiring a signed verification of 18 dose activity by two techs, with a temporary 19 requirement that one be a supervisor or manager.
20 Additionally, all dose vials are 21 required to be reverified in the event of hand off 22 between certified nuclear medicine technicians.
23 The Y-90 standard operating procedure 24 was revised, and all staff and AUs were trained on 25 the updates.
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
50 1 Ninety days following this event, a 2 supervisor checked the cart, documentation, and 3 calibration instrumentation for accuracy prior to 4 the transport to the IR suite.
5 And these monthly audits occurred for 6 90 days to determine the effectiveness of these 7 actions, after which quarterly audits were 8 continued.
9 Next slide, please. This next event 10 was a Y-90 TheraSphere underdose, where the vial 11 septum failed under pressure during the 12 administration.
13 No effects were expected, and the root 14 cause was determined to be a failure to develop, 15 implement, and maintain procedures. The corrective 16 actions included a revision of procedures to 17 specify the correct needle gauge, and revision of 18 emergency procedures.
19 Next slide, please. This event was a 20 Y-90 TheraSphere underdose, where the physician 21 noted that there was a significantly greater 22 resistance during the administration, but no 23 stoppage had occurred due to intervention, or the 24 patient. The tubing and connections were checked 25 post-treatment, but there was, they had found no NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
51 1 cause for the resistance.
2 The overflow bottle did show some 3 overflow, but no activity was measured in this 4 bottle, and the dose rate at the vial was zero 5 after administration with no contamination found.
6 Next slide, please. Post-treatment 7 investigation found that microsphere to have built 8 up at the distal and proximal ends of the catheter, 9 but no reason could be found for this. And the 10 manufacturer noted that the catheter was actually 11 within the recommended size. And so corrective 12 actions for this event included more flushes, 13 adding more flushes during the treatment.
14 Next slide, please. This event was 15 another Y-90 TheraSphere underdose where the 16 treatment had proceeded without incident, but post-17 treatment survey of the waste revealed about .43 18 gigabecquerels of Y-90 remaining. And no 19 contamination was detected anywhere around, and no 20 adverse effects are expected.
21 Next slide, please. This event another 22 Y-90 TheraSphere underdose, where the treatment had 23 proceeded without incident. However, post-24 treatment surveys revealed that there was residual 25 activity, which gave an estimate of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
52 1 administered dose.
2 The root cause was determined to be a 3 flow issue in the microcatheter, which caused the 4 microspheres to precipitate out of the solution.
5 And no adverse effects to the patient are expected.
6 Next slide, please. This next event is 7 a Y-90 TheraSphere underdose, where the AU had 8 noticed a sluggish flow during the first saline 9 flush, which was possibly due to kinking at the 10 microcatheter, they determined. However, no 11 contamination was identified and the AU was 12 satisfied with the dose delivered.
13 The root cause was determined to be a 14 small treatment volume, with a small vessel being 15 treated. They noticed that more than 30 psi is 16 required to push microspheres into these small 17 vessels, but the built-in pressure valve did not 18 apply a pressure greater than psi, than 30 psi.
19 They were not able to get up to that pressure. And 20 so no adverse effects were expected.
21 Next slide, please. This event was 22 another Y-90 TheraSphere underdose, where the 23 patient received only 26 percent of the prescribed 24 dose. According to the AU, the treatment went 25 according to plan and, but post-treatment surveys NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
53 1 revealed that the microspheres did not come out of 2 the tubing as designed.
3 All the proper procedures were 4 followed. No kinks in the tubing could be 5 identified, and the AU had used actually a larger 6 catheter than required. However, over 70 percent of 7 the microspheres remained in the delivery device.
8 No root cause could be identified, but my 9 investigation has determined that the most likely 10 cause was equipment failure, and so no corrective 11 actions were identified for this event.
12 Next slide, please. This event was 13 another Y-90 TheraSphere underdose where during the 14 preparation, the oncology nurse had expelled some 15 liquid onto the gauze to remove bubbles from the 16 tube, from the treatment tubing. This loss of 17 activity resulted in a smaller delivered activity, 18 which resulted in this underdose.
19 No adverse effects were expected, and 20 no additional dose was needed. Investigation 21 determined that the proper procedure had been 22 followed, and was not clear whether the event was 23 caused by human error, or a product defect.
24 Next slide, please. This next event 25 was another Y-90 TheraSphere underdose, where the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
54 1 procedure was halted prematurely. And surveys of 2 the waste in the room were taken where no 3 contamination was found, but microspheres were 4 observed clustered in the hub.
5 The correct microcatheter was used, and 6 the waste survey was used to approximate the dose 7 delivered. The root cause was determined after 8 investigation, to be microsphere clumping between 9 the line, between lines E and D in the kit.
10 Next slide, please. This event was 11 another Y-90 TheraSphere underdose, where 12 microspheres were clumped in the catheter and the 13 AU was unable to administer the full dose. The 14 root cause was determined to be the use of a 15 microcatheter with a curve tip that ended up at the 16 vessel wall, which blocked the flow of the 17 microspheres through the catheter. The corrective 18 actions included discontinuing the use of that type 19 of microcatheter.
20 Next slide, please. This event was 21 another Y-90 TheraSphere underdose, where surveys 22 post-administration had noted that microspheres 23 were held up in the catheter. The root cause was 24 determined to be a clumping of microspheres in the 25 catheter, due to problems in the procedure.
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55 1 And so corrective actions included a 2 copy of IN 1912 being provided to understand the 3 issue, and to help prevent future incidents.
4 Next slide, please. This event was 5 another Y-90 TheraSphere underdose, where the 6 surveys of the container post-administration 7 revealed a higher-than-expected dose after the 8 administration in the kit.
9 This kit was shipped to the 10 manufacturer after the decay of the radioactivity.
11 And so the root cause was determined to be the 12 intentional use of a smaller catheter than 13 advertised, which resulted in microspheres being 14 held up in the line. The physician determined that 15 this, the dose delivered was effective and no 16 corrective actions were taken.
17 Next slide, please. This event was 18 another Y-90 TheraSphere underdose, specifically 19 one of four treatments to different lobes of the 20 liver. The three other treatments had no 21 complications, however, this treatment the 22 physician attempted to use a, this specific 23 microcatheter, the TruSelect microcatheter, for 24 over an hour to access the artery but was 25 unsuccessful.
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56 1 And so fell back on a smaller 2 microcatheter, where some microspheres were held up 3 in the smaller catheter. Other treatment options 4 were considered, but the decision to use a smaller 5 catheter was determined by the physician to be 6 medically necessary. No adverse effects were 7 expected, and no corrective actions were put in 8 place.
9 Next slide, please. This event was 10 another Y-90 TheraSphere underdose, where the 11 treatment was prematurely terminated due to the 12 unwinding of the male Leur lock connector. A 13 second written directive was created to compensate 14 for this underdose, and this following treatment 15 was successful.
16 The information of this event was 17 circulated to all of the impacted licensees, and 18 the root cause was determined to be a defective 19 Leur lock. This event was not reported initially 20 due to insufficient written directive procedures, 21 and so corrective actions also included casing the 22 use of the infected administration set.
23 Next slide, please. This event was a 24 Y-90 TheraSphere underdose, where the patient was 25 successfully administered two doses of a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
57 1 microsphere, but the third only administered about 2 5 percent of the dose where the microspheres were 3 determined to be caught up in the tubing from the 4 vial. Unfortunately, I was not able to find any 5 more updates on this event so this is all the 6 information I have.
7 Next slide, please. This event was 8 another Y-90 TheraSphere underdose, where the AU 9 had noticed some resistance during the 10 administration and halted the treatment.
11 The microspheres were observed clumped 12 in the first two inches of the delivery catheter.
13 A second dose was ordered and delivered 14 successfully. No contamination was identified in 15 that first treatment, and the root cause was 16 determined to be the use of a catheter smaller than 17 the recommended catheter by the manufacturer.
18 Corrective actions included a 19 discontinuation of these microcatheters, with a 20 smaller inner diameter in accordance with the 21 recommendations from the manufacturer. And no 22 adverse effects to the patient were expected.
23 Next slide, please. This event was 24 another Y-90 TheraSphere underdose, which was 25 discovered during a review of microsphere NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
58 1 procedures.
2 The licensee had incorrectly assumed 3 that this was not reportable, because they revised 4 the treatment plan and written directive after the 5 treatment. The root cause was determined to be a, 6 the use of a smaller than recommended catheter.
7 And the AU had stated that the dose was medically 8 satisfactory, and the smaller diameter catheter was 9 necessary to treat the patient. The corrective 10 actions for this included providing additional 11 training to staff.
12 Next slide, please. Similar to the 13 last event, this was discovered during a review of 14 microsphere procedures where they assumed that it 15 was not reportable, because they revised the 16 treatment plan and written directive.
17 Again, the root cause was determined to 18 be the use of a smaller than recommended catheter.
19 The dose was medically satisfactory, and the 20 smaller diameter catheter was necessary to treat 21 the patient.
22 And the corrective actions included 23 providing additional training to staff.
24 Next slide, please. This event was 25 another Y-90 TheraSphere underdose where -- stasis NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
59 1 was not reached, and no apparent cause was 2 identified for this underdose.
3 The AU specifically had written that 4 12,000 centigray was the desired dose on the 5 written directive, but the dose that was received 6 from the manufacturer had a maximum expected dose 7 of 11,000 centigray.
8 So if the written directive had been 9 updated with this 11,000 centigray dose, then the 10 administration would not have tripped the medical 11 event criteria. And so the corrective actions 12 included training to the written directive updates 13 for this.
14 Next slide, please. For this event, 15 this was a Y-90 TheraSphere to the wrong site, 16 where the patient was prescribed that it was to the 17 right lobe of the liver, but instead received the 18 dose to the left lobe of the liver. The root cause 19 was determined to be varying anatomy in the 20 patient, and so they were brought back in 21 afterwards to treat the correct lobe of the liver.
22 Next slide, please. Okay, and now 23 we're into the SIR-Spheres medical events. This 24 was as SIR-Spheres underdose medical event, where 25 the tech had and ordered a full unit-dose and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
60 1 mistakenly administered that full dose during the 2 treatment.
3 The dose was not verified prior to the 4 treatment, prior to the administration, and the 5 written directive had been incorrectly filled out 6 with both the received and the ordered doses. The 7 root cause was determined to be human error, and 8 the corrective action included an implementation of 9 new procedures.
10 Next slide, please. This event was 11 another Y-90 SIR-Spheres overdose, where there was 12 a calculational error when converting from 13 gigabecquerels to millicuries, which resulted in a 14 larger dose being administered. Being ordered and 15 administered.
16 The corrective actions included an 17 updated written directive that explicitly lists the 18 conversion factor from gigabecquerels to 19 millicuries, and the conversion to be performed by 20 the tech, not just the manufacturer or 21 representative. No adverse effects were identified 22 or expected for this administration.
23 Next slide, please. This event was a 24 Y-90 SIR-Spheres underdose, where the root cause 25 was determined to be a clogged catheter. The NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
61 1 corrective actions included an implementation of a 2 new quality management plan, and no adverse effects 3 are expected.
4 Next slide, please. This event was a 5 Y-90 SIR-Spheres underdose, where there was an 6 error discovered during post-treatment 7 calculations. Unfortunately, no root cause could be 8 determined, and no adverse effects were expected.
9 Next slide, please. This event was a 10 Y-90 SIR-Spheres underdose where prior to 11 treatment, no leakage was observed during a 12 contrast injection. However, during the 13 administration, the doctor had noted a small leak 14 at the Leur lock connection.
15 The radiation safety staff was 16 notified, and the doctor had tightened the 17 connector and continued the procedure after 18 changing the gloves. And so, the remainder of 19 these microspheres were administered without 20 incident.
21 The contaminated materials, which 22 included the gloves and anything else that had been 23 contaminated, were removed and surveyed to estimate 24 the dose that was not delivered. And so that's how 25 they got the underdose estimation.
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62 1 Next slide, please. Post-treatment, 2 they surveyed the room and found no contamination, 3 and root cause was determined to be a lack of clear 4 written instructions and procedures. The 5 corrective actions included an update to the 6 procedures, to include steps for checking the 7 connections to delivery system, and no adverse 8 effects were expected.
9 Next slide, please. This event was a 10 Y-90 SIR-Spheres underdose, which had an apparent 11 cause of complicated patient vascular, which 12 inhibited the flow of microspheres, which resulted 13 in an underdose. And no adverse effects were 14 expected to the patient.
15 Next slide, please. This event was a 16 Y-90 SIR-Sphere underdose, where the procedure was 17 halted due to the occlusion of microspheres in the 18 delivery line. Specifically for this medical 19 procedure, this treatment had been the largest ever 20 dose to date. And so, the vial was maximum volume, 21 and the fluid actually appeared highly viscous in 22 the vial.
23 The root cause was determined to be too 24 many microspheres in the vial to be properly 25 agitated, or possibly a dysfunctional stopcock.
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63 1 The corrective actions included modification of 2 procedures to split these, these large doses into 3 two separate vials. And so, the patient was 4 administered another dose to compensate for this 5 underdose, and no adverse effects were expected.
6 Next slide, please. This event was a 7 Y-90 SIR-Spheres underdose, where the procedure 8 occurred without incident. No stasis or anything 9 going on. However, investigations afterward 10 determined that a member of the staff had noticed a 11 blob of microspheres close to the vial, before the 12 delivery.
13 And so, the manufacturer was notified, 14 and recommended gentle shaking of the vial before 15 delivery, a little bit of agitation. The AU 16 determined that the dose delivered was effective, 17 however, the corrective actions included checking 18 the vial prior to delivery, and following 19 manufacturer recommendations to shake the vial 20 gently if accumulation is observed. So, no adverse 21 effects were expected.
22 Next slide, please. This event was 23 another Y-90 SIR-Spheres underdose, where the 24 remaining microspheres during the procedure had 25 been held up in the delivery system. The NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
64 1 investigation noted that this dose was unusually 2 small compared to previous procedures, and so the 3 amount remaining, the amount of remaining 4 microspheres was approximately the same as in 5 previous procedures. But because of the smaller 6 size of the initial dose, it resulted in a 7 reportable underdose.
8 The corrective actions included 9 additional saline flushes to minimize the residual 10 microspheres, and the addition of 20 percent or 11 more, of 20 percent more activity for low dose 12 prescriptions, specifically under the 10 13 millicuries, 370 megabecquerels, to account for the 14 anticipation of residual microspheres remaining in 15 the kit.
16 Additionally, the licensee implemented 17 more frequent monitoring of hands-on personnel to 18 identify potential contamination. No adverse 19 effects were expected, and no additional dose was 20 required.
21 Next slide, please. So that was all 22 the medical events that occurred this year in FY22, 23 and so I just wanted to give a little bit of a 24 summary for this year.
25 I'm not going to be talking about any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
65 1 trending, I'll just give a summary, a quick summary 2 of what I've seen just for the events from this 3 year.
4 So, for the 35.300, I've got a graph up 5 there on some of the root causes of these events.
6 Equipment error, written directive error, or human 7 error.
8 I saw that there were a lot of written 9 directive, or written directive errors this year 10 where the intended dose was delivered, but there 11 was an incorrect written directive, which is a 12 medical event, even if the dose intended was 13 delivered.
14 Additionally, there were a few full 15 dose administration of lutetium-177s, where they 16 had written a reduced dose on the written directive 17 using those half doses.
18 And so, this year we had our first 19 actinium-225 event which hopefully there will not 20 be more, but as this gains in popularity, I'm sure 21 we'll be seeing more of these.
22 Specifically, this one had difficulties 23 with that lead shielded syringe, which resulted in 24 leakage. And so, we'll be looking at that going 25 forward.
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66 1 Next slide, please. For the 35.600 2 events this year, there were a lot of misidentified 3 sites events this year, as well as the use of 4 incorrect tube, or catheter lengths.
5 And again, this year we had ones where 6 multiple patients were affected by the single 7 medical event. Specifically, by the catheter tube 8 length problems.
9 And so, this I think, shows that there 10 needs to be more, more attention to these pre-11 treatment checks, especially when you're using the 12 same catheter for multiple different patients.
13 Next slide, please. For the 35.1000s, 14 we see the same that we've been seeing so far, that 15 these are primarily Y-90 microspheres, which are 16 primarily TheraSpheres, and they're primarily 17 underdoses.
18 Four of these specifically called out 19 events due to use of smaller than recommended 20 catheters.
21 However, at least in these, this year 22 for these events, we've been seeing a lot more 23 information about physicians saying that these 24 smaller than recommended catheters are necessary 25 for, for treatment with patients with these varying NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
67 1 anatomies, or very small, very small arteries and 2 veins to get into.
3 Two events, again, were due -- called 4 out specifically for malfunctioning Leur locks, and 5 two events for unusually small doses, which I've 6 been seeing more and more frequently.
7 And, again, calling back to those 8 35.300 and 35.600. Three of the six overdose 9 events were due to an incorrect written directive 10 where the intended dose was delivered, but the 11 written directive was just filled out wrong.
12 And so those are medical events and 13 we're continuing to look at those.
14 Next slide, please. Yes, I think 15 that's everything, so here's some of the acronyms 16 that I used. I think I've got a question slide at 17 the end.
18 Next slide. Yes, questions?
19 CHAIR METTER: Well, thank you very 20 much, Mr. DiMarco, for your excellent presentation.
21 I really do appreciate those summary slides. That 22 kind of helps to kind of coalesce with the 23 information you have. Are there any questions from 24 the ACMUI regarding this report? Yes, Ms. Martin?
25 MEMBER MARTIN: I was just wondering, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
68 1 to help me put it into perspective at least, do you 2 have the total number of procedures done? So, in 3 other words, if we're looking at 30 incidents, is 4 it 30 out of 100, 30 out of 1,000? Do you know or 5 do you have the information that says how many 6 procedures they actually did?
7 MR. DIMARCO: No, we just have the 8 medical events and what the procedures were.
9 However, if we do have any information for events 10 that involve more than one patient, like for some 11 of the 35.600 events, one of them was a single 12 medical event which had a single root cause, but 13 that affected 27 patients, and so if it's -- in my 14 table at the very beginning, if there were more 15 patients that had been affected, that was in the 16 parentheses there.
17 MEMBER MARTIN: I do have a question 18 regarding just what you just stated. On that 19 medical event score 2017 to 2022, can you clarify 20 what you meant that the total number of patients 21 involved were greater than the number of reports?
22 Because that doesn't kind of fit. It doesn't make 23 sense to me.
24 MR. DIMARCO: Well, for the 600s, at 25 least specifically this year where it says there NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
69 1 were 11 medical events there, one of those medical 2 events involved 27 patients.
3 MEMBER MARTIN: Oh, I see, several 4 patients. I understand.
5 MR. DIMARCO: A couple more of those 6 involved more patients, and so that's where I get 7 that greater number of patients than medical 8 events, yes.
9 MEMBER MARTIN: So rather than counting 10 them as individual each, you just counted them as 11 one?
12 MR. DIMARCO: Yes.
13 MEMBER MARTIN: Okay.
14 MR. DIMARCO: When they have one root 15 cause like that. For those, specifically for that 16 one, there was one where the incorrect catheter 17 length was used for multiple patients over a span 18 of time.
19 CHAIR METTER: Okay, thank you very 20 much for explaining.
21 MR. DIMARCO: Yes.
22 CHAIR METTER: Any other -- yes, Dr.
23 Einstein?
24 MEMBER EINSTEIN: CMS had publicly 25 available data on the number of procedures. That NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
70 1 should be relatively obtained. I think the data 2 excludes sites or providers where there are less 3 than ten procedures. One can purchase that data as 4 well. So (audio interference).
5 CHAIR METTER: Thank you for that 6 information. Any other questions? Yes, Dr.
7 Jadvar?
8 VICE CHAIR JADVAR: Thank you for your 9 report. I noticed that there's a lot of clumping 10 issues with these TheraSpheres. Is this something 11 that industry can help with? Is there something 12 systematic going on here or is it --
13 Even though, you know, in some cases, 14 the catheter length was correct or properly used, 15 there was still the problem. Is that something 16 that you think can be addressed with them and see 17 if there's a systemic issue that can be resolved?
18 MR. DIMARCO: I hope that that's 19 something that we can help resolve with the 20 manufacturers going forward with the ACMUI Y-90 21 medical event subcommittee going forward with that, 22 as well as just the staff going forward to help 23 address that community.
24 So as for me personally, I don't know 25 if this is something that's more systematic or NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
71 1 something that we can do anything about, but we're 2 definitely looking to deal with that, and we've got 3 Dr. Tapp here.
4 CHAIR METTER: I think Dr. Tapp has a 5 comment to make. And I believe in the past, the 6 ACMUI did have two presentations by industry 7 regarding this issue, so we might have to have them 8 update that, and then after Dr. Tapp's comment, I'd 9 like to have Dr. Angle, our ACMUI interventional 10 radiologist, make comments on that. Dr. Tapp?
11 DR. TAPP: Oh, Dr. Angle could probably 12 speak to this better, but clumping issues with the 13 Yttrium-90 microspheres has been something that's 14 happened since the beginning, and as they become 15 more subsegmental and they're getting more, trying 16 to hit the target, getting very selective into the 17 treatment site, they're using smaller 18 microcatheters which is sometimes causing the 19 clumping.
20 So, there's a balance between trying to 21 get more into hitting that tumor versus the risk of 22 clumping, so it is something I know we are 23 tracking, the manufacturers are tracking, and the 24 Society of Interventional Radiology is tracking, 25 but Dr. Angle, if you have anything to add, it NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
72 1 would be great to hear it.
2 DR. ANGLE: I think it's a very 3 important insight. John Angle from the University 4 of Virginia. The field is definitely evolving.
5 The lobar treatments are being replaced with 6 multiple subsegmental injections in one session.
7 So, patients are having different 8 treatments, multiple treatments in one session, 9 often involving much smaller vessels, so this 10 increases the likelihood of these types of events 11 you refer to with plugging of microcatheters.
12 I think all of the operators are very 13 well aware of the problem with smaller catheters, 14 and as you saw, some adverse events here.
15 Sometimes they have to make a choice whether to try 16 and use an extra small microcatheter realizing it 17 may not deliver the dose and this is a judgment 18 that, you know, operators are having to make, but 19 it has, I guess, been a trend.
20 I don't want to comment officially on 21 it, but most of the events are underdosing and I 22 would fully expect, unfortunately, this is going to 23 continue. As a practitioner, I can tell you that 24 as we do more and more segmental treatments, you're 25 going to see more of this, so it is a problem.
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73 1 I am curious about written directive 2 errors and I wanted to ask you a question back. Is 3 there any trend in what the written directive 4 format is, how it's actually done at the 5 institutional level that you can comment on when 6 you see written directive errors just in regards to 7 Y-90?
8 MR. DIMARCO: So, I did want to say 9 this. I don't want to call this a trend because 10 this is something that I've noticed. I did the 11 previous year's presentation as well on this.
12 So, I haven't been able to see this all 13 the way, but this is something that I specifically 14 noticed this year for those written directive 15 errors, because last year, I noticed that there 16 were not nearly as many written directive errors in 17 the same ways that we've been seeing for this year.
18 So, I don't want to say it's a trend 19 right now. It's just something that happened this 20 year, but it's definitely something to keep an eye 21 on and I will be keeping an eye on, and going 22 forward, seeing maybe if we need some clarification 23 for written directives on what goes on there, or 24 maybe even if we need a subcommittee IN here or 25 something like that. So it's something that I'm NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
74 1 keeping an eye on, but no activity yet on it so 2 far, so.
3 CHAIR METTER: Are there any other 4 questions from the committee? Yes, Ms. Martin?
5 MEMBER MARTIN: Just a question. With 6 particularly the TheraSpheres and SIR-Spheres, is 7 there any way to identify or do you if these are 8 repeat happenings at the same institutions, and if 9 so, is there any follow-up with that institution to 10 see if the suggested changes have an effect?
11 MR. DIMARCO: I haven't done any of 12 that research. I would assume that that would 13 probably fall more under the purview of the 14 investigators going down there, the Agreement 15 States and the regions just for medical facility 16 specific problems on that.
17 But we also have the Y-90 INs that we 18 sent out, and so that goes to all of the facilities 19 there, and so that would have all of the 20 information that would be useful for these, you 21 know, commonly shown problems.
22 MEMBER MARTIN: Well, just a follow-up 23 question with that. The other part of that is are 24 we seeing a difference between institutions that 25 are very active that have like a very active NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
75 1 interventional program?
2 Would you expect to see more happenings 3 or more instances from that or are we seeing more 4 procedures from the isolated, smaller, newer users?
5 Are they the ones turning or having the events?
6 That's what I was trying to differentiate.
7 MR. DIMARCO: I haven't done any 8 specific research on that, but just from going on 9 the events and seeing where these events are coming 10 from, I would say that there's really no 11 correlation between the size or the amount of 12 procedures being done for the facility and whether 13 or not a medical event happens.
14 I mean, obviously, there are 15 differences in percentages there where one event 16 from a smaller facility versus one event from a 17 bigger facility, the percentages there at least are 18 different, but just raw numbers-wise, these are 19 coming from everywhere.
20 CHAIR METTER: Okay, thank you. So, 21 I'm going to go to -- this is regarding the current 22 topic? Okay, so let me have Mr. Josh Mailman, our 23 patient advocate, make a comment, and then we'll --
24 I'm sorry, who was the individual? Oh, Dr. Tapp?
25 DR. TAPP: I was just going to respond NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
76 1 to that comment and that question from Ms. Martin.
2 The events are kind of difficult to correlate to 3 see if its small institution, medium, or big just 4 because it is up to the reporting.
5 Everyone is required to report, but we 6 do know that the larger institutions, they are 7 tracking. They have procedures, so they do report, 8 I think, a little bit more than some of the smaller 9 ones.
10 But we do see the reports from across 11 the board, but Dr. Ennis, previously on the ACMUI, 12 did recommend - he noticed in medical events that 13 the more you use something, the less likely the 14 events were occurring.
15 So, he did see a trend in that, I 16 think, two years ago, so we did put out an IN in 17 2019 that recommended if you haven't done a 18 procedure or if you haven't done a procedure a lot, 19 to do a mock procedure to make sure you're familiar 20 with it before you perform it. So that was the 21 previous recommendation from the ACMUI.
22 CHAIR METTER: Thank you. And I 23 believe Josh -- Mr. Ouhib, go ahead.
24 MEMBER OUHIB: I think the other factor 25 that we don't seem to pay attention to is staff NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
77 1 rotation. You might very well have an institution 2 that's doing a lot of cases, but their staff leave 3 or are not available for whatever reason and 4 somebody else will step in and do the procedure.
5 The next thing you know is you have a problem and I 6 think that needs to be looked at carefully.
7 CHAIR METTER: Any other comments from 8 the ACMUI?
9 MEMBER MAILMAN: Sure, I think I have 10 three. You know, first of all, thank you for this 11 presentation. Looking through this and listening 12 to it is always a little disheartening for a 13 patient, listening to medical events that happen.
14 A few things, just in language, page 15 eight of the actual handout which was 21-0448, 16 trying to keep patient inclusion language.
17 Patients never fail anything. The second time it 18 mentioned that patients failed to swallow as 19 opposed to he was unable to swallow, so really 20 great to keep that language consistent. Patients 21 never fail anything, so that's the first thing I 22 noted.
23 We seem to have, whether it's a trend, 24 but as more and more of these get done with 25 lutetium being half-dose sometimes, is there -- and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
78 1 I noticed that we have corrective actions at the 2 institutions. Is this anything that is going, 3 making recommendations nationwide or some other 4 recommendations? Because we're going to see these 5 half-doses and seeing this issue as well.
6 And I note that this is obviously 7 through the end of fiscal year 2022, which I think 8 is October. Is that correct?
9 MR. DIMARCO: That's correct.
10 MEMBER MAILMAN: Because one of the 11 things that I think we need to discuss whether it's 12 going forward or not, I think your next year report 13 will have several Pluvicto, Lutathera 14 misadministrations where one was given the wrong --
15 several patients have been misdosed with the wrong 16 radiopharmaceutical.
17 And I don't know if you have any 18 comments on what you're seeing with that going 19 forward of if it's something that we should look at 20 earlier before your next year's report. Those were 21 my three comments.
22 CHAIR METTER: Thank you.
23 MR. DIMARCO: Thank you. First of all, 24 thank you for your first comment on more inclusive 25 language. That's something that I grapple with. I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
79 1 come from a technical background, so I'm used to 2 these kinds of languages, so thank you for 3 reminding me of that.
4 As for the Lutathera, this is something 5 that we're definitely keeping an eye on. I have a 6 feeling that we will probably have to end up giving 7 out some more information on these just because 8 they're getting so popular, and so they're going to 9 be having more and more misadministrations, 10 especially with the way you talked about the 11 Pluvicto, Lutathera mix-ups. That's all I really 12 had to -- Katie, did you have something to say on 13 that?
14 DR. TAPP: Yes, for the Lutathera and 15 the new radiopharmaceuticals, we are seeing those, 16 as you mentioned, in the new fiscal year, and we 17 are planning to issue an information notice and get 18 it out there on the events we've already seen 19 because they are coming quickly.
20 And as you know, the Pluvicto did get 21 FDA approval and we're seeing more patients, so 22 we're going to try to get out an information notice 23 of what we've seen already and keep an eye on it 24 going forward.
25 We are meeting with AAPM and having a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
80 1 summer school where we're going to discuss medical 2 events and how to prevent them. So I'm hoping to 3 use some of that information I gathered from lots 4 of members there to help us, but if you guys, you 5 know, want to take up actions and let us know, 6 you'll see the information notice and provide us 7 comments on that as well, I'm sure.
8 CHAIR METTER: Yes, Mr. Ouhib, do you 9 have a comment?
10 MEMBER OUHIB: Yeah, I think in 11 addition, it would be really helpful if the 12 manufacturers will actually have some sort of 13 information related to medical events that have 14 been recorded or whatnot and send it to all users.
15 Here is what we have seen for this past three 16 months or whatever. Warning, don't do this in the 17 event of that. Avoid doing this, and so on and so 18 forth.
19 I think that would connect directly 20 with the users because I agree regulators can help 21 with that, AAPM can help with that, but there's 22 nothing like the manufacturer communicating 23 directly with the users and provide them good 24 information related to those cases.
25 CHAIR METTER: Dr. Angle, you have a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
81 1 comment?
2 DR. ANGLE: Actually, just a question, 3 maybe respective analysis of the plugging events of 4 Y-90 over the last several years. When we 5 administer the Y-90, of course, by putting a higher 6 dose in, we introduce a mechanical problem.
7 We have to get more particles through 8 the catheter and we've talked about how a smaller 9 catheter is harder, but also just physically having 10 to put more particles in, and is it possible to 11 analyze your data looking at these adverse events?
12 Is there a correlation between the dose and 13 plugging events?
14 I guess without knowing the 15 denominator, it's hard to analyze, but I guess my 16 question is do we have any way to analyze are 17 plugging events happening at much higher rates when 18 we're putting a large dose in or is there really no 19 correlation there?
20 And the reason is because I think 21 there's a lot of theories about why we're having 22 these plugging events and we really have been not 23 making much progress it seems in answering this 24 question, and I thought maybe this would be one way 25 to dive into this a little deeper. So is that kind NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
82 1 of information available in the information that 2 you get on these adverse events?
3 MR. DIMARCO: I think that that would 4 be an interesting line of study. Just on first 5 blush on that, I would say I don't think there's 6 that much of a correlation. We see problems with 7 larger than expected doses and smaller than 8 expected doses where the smaller is usually just 9 greater than 20 percent held up, not usually due to 10 clumping.
11 But I think the clumping issue, as well 12 as being, you know, those kind of larger doses, I 13 think that's for all of the doses, as well as a lot 14 of the information, it's hard to get just because 15 sometimes they will split them into two vials and 16 not tell us on the medical event reporting.
17 They'll just report the bulk whatever 18 they administered, so I would have to go back to 19 every single one. So I think it's interesting to 20 think about that, but I don't know how I would be 21 able to get that information.
22 CHAIR METTER: I do see Ms. Ashley 23 Cockerham from industry here to answer some of 24 these queries.
25 MS. COCKERHAM: Sure, I'm Ashley NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
83 1 Cockerham with Orchestra Life Sciences. I do 2 regulatory consulting. As a little bit of context, 3 I'm formerly an NRC staff employee, so many 4 familiar faces. I also worked for Sirtex and I'm a 5 current consultant for Boston Scientific. So I 6 feel like I have a well-rounded view of these 7 things. I'm going to try to address three things 8 that I've heard.
9 One, the information is available on 10 the number of procedures each year. That 11 information is obtainable from both manufacturers.
12 That's something that I was able to obtain as an 13 NRC staff member. In industry, I've been able to 14 provide that information to the NRC.
15 So the denominator is available at 16 least for Y-90 microspheres from both manufacturers 17 to help put this into context. I have not done the 18 analysis for the trends on whether or not the 19 incident percentage has changed in the last couple 20 of years.
21 The second point, there was a comment 22 about written directives. Both manufacturers do 23 provide template written directives. Each facility 24 is responsible for developing their own procedures 25 and they may or may not implement the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
84 1 manufacturer's template written directive, so that 2 written directive can vary and does vary from site 3 to site.
4 The third one is for why medical events 5 are occurring and sort of how to prevent them.
6 This is something that I've worked on with Boston 7 Scientific over the last year.
8 So, for TheraSphere, the company does 9 and has always provided an administration 10 checklist, which is something that was talked about 11 at previous meetings as sort of a timeout, best 12 practices. You always have the same checklist.
13 Again, the manufacturer provides that.
14 What the facility decides to implement is 15 determined by their own internal procedures. As a 16 supplement to that, we took that checklist and then 17 said basically why do we do each one of these 18 things? We check the Leur lock on this checklist 19 because it prevents leaks. So there is a 20 supplementary document available for TheraSpheres 21 that's specific to how to prevent a medical event.
22 It's called the safety procedures document that's 23 provided to all representatives, and they're 24 intended to train all of their treatment sites on 25 that. Does that help?
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85 1 CHAIR METTER: Thank you very much for 2 that very concise update and answering some of our 3 questions here. Does anybody from the ACMUI have 4 questions for Ashley? Yes, Ms. Martin?
5 MEMBER MARTIN: Ashley, is that 6 document provided to all of the users or only to 7 your, the people providing the training? That 8 safety document that you were referencing there, is 9 that provided for the users?
10 MS. COCKERHAM: Yes, it would be for 11 each treatment site.
12 MEMBER OUHIB: Okay, so this is 13 provided to the users, but how can you guarantee 14 that the users actually have used that, looked at 15 it? And so, the reason I'm saying this, there were 16 other documents that were sent out to the users.
17 And I'll use the example of end of life 18 for devices, and I can guarantee you many of them 19 never looked at that document and they felt like 20 oh, I never received that document. I don't know 21 what you're talking about, and so on and so forth.
22 So, I think as a suggestion perhaps if 23 you're sending that, that you request that the 24 users should actually send a signed form that they 25 have actually used that information and they intend NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
86 1 to implement it.
2 CHAIR METTER: Thank you. And I 3 believe you probably do present these presentations 4 to the specialty societies like SIR and those 5 groups?
6 MS. COCKERHAM: I think that's Katie.
7 Yeah, I want to defer to Katie here.
8 DR. TAPP: We are establishing a 9 working relationship with the Society of 10 Interventional Radiology. We have not had a big 11 presence there in the past, but I do have a webinar 12 coming up, I think, middle of June that I plan to 13 go over some of the events we've seen and 14 precautions that we've recommended in the past, as 15 well as licensing guidance, but in the past, we 16 have not had a big presence at the Society of 17 Interventional Radiology. It would be more SNMMI 18 and AAPM and others, Astro.
19 CHAIR METTER: Dr. Angle?
20 DR. ANGLE: I just want to say that's 21 such a, I think, it's a great initiative and I 22 think we really should make that an ongoing 23 process. I think it's wonderful to hear. Thank 24 you.
25 CHAIR METTER: Thank you and thank you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
87 1 for those words. Yes, Dr. O'Hara?
2 MEMBER O'HARA: I have a question. I 3 may have missed it.
4 CHAIR METTER: Could you turn on your 5 microphone?
6 MEMBER O'HARA: I think it's on. On 7 page 75 on the table, I may have missed this, but 8 what does variant anatomy mean?
9 MR. DIMARCO: So variant anatomy is 10 something that we get from the event reporting.
11 This is typically when someone using, whether the 12 patient has either a vein that goes to a different 13 segment or some sort of unexpected part of their 14 anatomy where the medical event occurred because of 15 either like going through a smaller than normal 16 vein or something like that, and so we see that a 17 lot in shunting at least where if the facility does 18 not notice that beforehand, it can lead to a 19 medical event.
20 CHAIR METTER: Yes, so they do, before 21 the Y-90 mapping with MAA, and to look for any of 22 this, quote, variant anatomy, which, Dr. Angle, I'm 23 going to have him make a comment on, but sometimes 24 what I've noticed is that when they split the dose 25 for right lobe and left lobe, then between the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
88 1 treatment, you have revascularization of other 2 areas, and so you might have more shunting than 3 expected, but let me have Dr. Angle, because he 4 does the procedures and he's the expert on this.
5 DR. ANGLE: I don't have much to add to 6 that, but we do a planning procedure. You 7 catheterize the vessels that you're going to be 8 injecting into, and then on the day of the 9 procedure, you have to recreate that 10 catheterization. And usually, that goes very 11 smoothly, but there's no guarantees.
12 And so, to your point, some vessels 13 that maybe were small a month earlier are larger 14 and you have trouble getting the catheter into the 15 exact same position that's appropriate, so 16 different catheters and wires are sometimes 17 necessary for that follow-up procedure which is, I 18 think, an unavoidable change in the procedure, and 19 sometimes this leads to just the inability to put 20 the catheter in the exact same position for the 21 follow-up procedure.
22 CHAIR METTER: Thank you for that 23 clarification. Any other questions from the 24 committee? Yes, Dr. Wolkov?
25 MEMBER WOLKOV: Harvey Wolkov. I do NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
89 1 have a quick question for you. It's a process 2 issue. So on a minority of cases, in fact, very 3 few, you indicate there's no further data, and I'm 4 just wondering what's the typical follow-up for 5 those patients?
6 MR. DIMARCO: So at least personally 7 when I'm doing these presentations, there's only a 8 certain amount of information that I can ask for in 9 the regulations, and so for that, I usually go to 10 either the regional offices if it's an NRC state or 11 any of the Agreement States.
12 And so for that, if I don't have any 13 information, that's just something that I have not 14 been able to get an update from them. As for any 15 of the patient follow-up, I'm not privy to any of 16 that. I think that's just on the medical facility 17 themselves as to what the follow-up would be for 18 that, so that's the process that I use.
19 CHAIR METTER: Yes, Mr. Ouhib?
20 MEMBER OUHIB: Yeah, in a few cases, I 21 noticed that there's a refresher course or training 22 after a medical event, and I said it before and 23 I'll say it again, I'm not sure why we're waiting 24 for a medical event to have refresher training for 25 all users. It doesn't hurt and it might very well NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
90 1 prevent another event.
2 CHAIR METTER: Thank you for that 3 comment. I just wanted to say that, you know, as 4 far as the NRC and what our work does, we're here 5 as regulators to help protect the public against 6 radiation safety. We're not here in the practice 7 of medicine, which I think is sometimes a very fine 8 line, so we kind of have to remember that. Dr.
9 Jadvar, you have a comment?
10 VICE CHAIR JADVAR: A quick comment, 11 I'm going to play, you know, as patient advocate.
12 In these, you know, I understand the reporting, of 13 course, for regulation and all of that, but are the 14 patients, do you know if the patients are told what 15 happened in many of these cases or we just don't 16 care or we don't even follow that? We just kind of 17 see what the physicians or the admin, the facility 18 provides?
19 MR. DIMARCO: So in our regulations, 20 for every medical event, the patient is required to 21 be notified.
22 CHAIR METTER: Well, this has been a 23 very, very good discussion. Any other final 24 comments or questions from the ACMUI? NRC staff?
25 May we open it up to the public? So are there any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
91 1 public comments regarding the recent report by the 2 NRC on the medical-related events?
3 MS. PINEDA: Testing. If you're a 4 member of the public and you'd like to make a 5 comment, you can, if you have joined the meeting 6 using Teams, you can use the raise hand function on 7 Teams. That's the little hand icon.
8 Just click on that once and then I will 9 know, and I'll call your name and you can unmute 10 yourself, and everyone has access to their 11 microphones, but you do have to unmute yourself.
12 If you joined the meeting by telephone 13 today, you can just press *5 and that will show me 14 that your hand is raised on your phone, and then 15 you'll press *6 to unmute yourself, and you might 16 need to also unmute your cell phone. Thank you.
17 Okay, it looks like we have Steven 18 Marsh. Your hand is raised.
19 MR. MARSH: Good morning. Thank you 20 very much for this presentation and opening it to 21 the public. I just had one question. Is there a 22 possibility to get a copy of Mr. DiMarco's 23 presentation? I'd love to share that with the 24 Radiation Safety Committee, my staff, and the 25 authorized users of the synopsis of that PowerPoint NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
92 1 presentation, all of the different events, and the 2 root cause analysis and everything. I think that 3 would be very helpful, as one of the other speakers 4 alluded to, about having some refresher training.
5 CHAIR METTER: Yes, thank you for your 6 comments, and I'm sorry, where did you say you were 7 from?
8 MR. MARSH: Oh, Baystate Health, 9 Springfield, Massachusetts.
10 CHAIR METTER: Okay, yes, so after this 11 meeting, this whole meeting is transcribed by a 12 court reporter, and in about a month, it should be 13 available. Mr. Einberg, can you make a comment 14 regarding that?
15 MR. EINBERG: Yeah, thank you, Dr.
16 Metter. All of the slides right now are on the 17 public website, so they can access those slides 18 right now, and all of the medical events are on 19 there as well. And we will have a meeting summary 20 with the transcript about a month after this 21 meeting.
22 CHAIR METTER: Thank you very much.
23 MR. MARSH: Thank you.
24 CHAIR METTER: Any other questions from 25 the public? Okay, seeing none, let's go onto the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
93 1 next item on our agenda which is presented by NRC 2 staff, Mr. Flora, the revisions to the abnormal 3 occurrence criteria.
4 MR. EINBERG: Yeah, I believe there's 5 been a change to who is making the presentation.
6 It's going to be Ed Harvey.
7 CHAIR METTER: Oh, I'm sorry. Thank 8 you.
9 MR. HARVEY: All right, good morning, 10 everyone. I'll do a quick sound check. Can 11 everyone hear me in the room?
12 CHAIR METTER: Yes.
13 MR. HARVEY: All right, excellent. So 14 my name is Ed Harvey. I'm an abnormal occurrence 15 coordinator in the NRC Office of Nuclear Regulatory 16 Research. I do work closely alongside the stellar 17 staff and the NRC's medical radiation safety team 18 to evaluate medical events that are reported to the 19 NRC for abnormal occurrence considerations.
20 But today, I'm going to go over some of 21 the efforts that the NRC has been taking to revise 22 the abnormal occurrence reporting criteria, but 23 first, I'd also like to express my apologies for 24 the last-minute change to the speaker on the 25 agenda, so, but next slide, please.
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94 1 Okay, so here is the agenda for my 2 discussion. As you can see, I'm going to start 3 with a little bit of background, go into some of 4 the proposed changes that the staff made to the 5 abnormal occurrence criteria, talk a little bit 6 about the Commission's direction through a staff 7 requirements memorandum or SRM, and then go over 8 the path forward for our next steps.
9 I only have about ten slides to 10 present, and then after that, I'll do my best to 11 answer any questions that you might have.
12 Okay, so I'm going to start off by 13 going a little bit back to basics to give a little 14 background, so I do apologize if this is too 15 fundamental.
16 First off, just asking the general 17 question of what is an abnormal occurrence or AO as 18 the NRC abbreviates? Section 208 of the Energy 19 Reorganization Act of 1974 defines an abnormal 20 occurrence as an unscheduled incident or event that 21 the NRC determines to be significant from the 22 standpoint of public health and safety.
23 This sounds incredibly subjective in 24 nature. The NRC does have strict and objective 25 criteria to determine if an event meets the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
95 1 threshold of an AO.
2 The current AO criteria, and I 3 apologize for not putting it here on the slide, but 4 the current criteria are outlined in the Federal 5 Register and this was published, last published on 6 October 2, 2017.
7 So every year the NRC evaluates 8 reported events, including several of those events 9 that my colleague, Daniel DiMarco, just went over, 10 and we evaluate these events against these 11 criteria, and those that meet the threshold, we 12 then publish them into the annual report to 13 Congress on, I'm sorry, on abnormal occurrences.
14 This is actually consolidated into a 15 NUREG publication, and as you can see on the slide 16 here, this is just kind of a screenshot of the 17 cover of the NUREG, but it is NUREG-0090, and then 18 every subsequent year, the volume number kind of 19 just goes up on them. So next slide, please.
20 So how did we get here today to talk 21 about proposed changes to the AO criteria? So on 22 the slide, you'll see a few documents that I'm 23 going to briefly talk about here.
24 The story kind of starts back in 2019 25 when the staff issued SECY-19-0088, which is a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
96 1 paper to the Commission, and we recommended that 2 the NRC evaluate a potential revision to the 3 current AO reporting criteria. And when I say 4 current, I mean the criteria that are currently in 5 place published in 2017 that I went over on the 6 previous slide.
7 This recommendation came out of an 8 initial review that the staff undertook to 9 determine if the current criteria provided an 10 accurate threshold for determining if an event is 11 significant from the standpoint of public health or 12 safety.
13 The Commission then responded to this 14 SECY via an SRM, which is there in the middle 15 there, around SECY-19-0088, that directed the staff 16 to pursue a limited revision to the AO reporting 17 criteria within only, it was limited to the medical 18 event and source security areas of the current 19 criteria.
20 So, in response to that SRM, the staff 21 then issued another SECY paper back in 2022 which 22 contained our proposed limited revision to the 23 NRC's policy statement on reporting criteria for 24 abnormal occurrences. Next slide, please.
25 So just hopping right into it, overall NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
97 1 there were three, what I consider three substantive 2 changes that we recommended to the Commission back 3 in 2022, so I'll just go over the three of those.
4 The first one here was Criterion I.C.1 and this was 5 a proposed, we proposed to add an exception to 6 stolen, diverted, or abandoned sources.
7 So currently, any Category 1 or 2 8 material, excuse me, Category 1 or 2 quantity of 9 material that is stolen, or diverted, or abandoned 10 for any amount of time is considered an abnormal 11 occurrence, even if that source is subsequently 12 recovered.
13 So, the staff recommended to remove 14 reporting of these events where it was clear that 15 the intent wasn't to actually steal the material.
16 We put some language in the policy to basically 17 exclude those events involving sources that are 18 stolen, diverted, or abandoned where it was evident 19 that there was no intent to gain access to the 20 radioactive material and then the sources were 21 recovered with little or no risk to public health 22 or safety.
23 So, an example is if someone steals a 24 truck with a Category 2 quantity of material in the 25 back because they wanted the truck, but not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
98 1 necessarily the source. Unbeknownst to them, the 2 source was on the back.
3 They recover the stolen truck with the 4 source in there still or they recover the material 5 afterward, perhaps in a short amount of time. This 6 would then be excluded from reporting to Congress.
7 This change was not accepted by the 8 Commission, and therefore, in the proposed limited 9 revision, Criterion I.C.1 remains substantively 10 unchanged in the current revision. And I think --
11 did the slide move? Next slide, please.
12 Okay, all right, so the next change was 13 in Criterion 3.C.1 and this is the staff had 14 proposed to the Commission that we remove the need 15 for a written directive to qualify a medical event 16 as an AO.
17 So, this proposal was accomplished by 18 essentially striking out the language in Criterion, 19 it's actually in 3.C.1, a level down, B, that 20 references the written directive, and we just 21 replaced it with prescribed dose or dosage.
22 This gives the NRC the latitude to 23 consider significant medical events as abnormal 24 occurrences that involved procedures that don't 25 normally require a written directive as required by NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
99 1 10 CFR 35.3045.
2 This change was accepted by the 3 Commission in the SRM, and in the proposed limited 4 revision, we do include essentially that summarized 5 change. Next slide, please.
6 And the final substantive proposed 7 revision to the AO criteria is that in 3.C.2. This 8 is where the NRC proposed to shift to more of a 9 deterministic consequence-based reporting criteria 10 for reporting medical events as AOs.
11 So, under this shift, in order for a 12 medical event to qualify as an AO reported to 13 Congress, the patient would need to experience some 14 sort of radiation-induced injury causing permanent 15 damage or require medical attention to prevent 16 permanent damage to a radiation-based injury in 17 summary there.
18 This change was not accepted by the 19 Commission, and currently in the revised criteria, 20 proposed revised criteria, 3.C.2 remains 21 essentially unchanged from the current policy. And 22 then next slide, please.
23 So, I kind of spoiled a little bit 24 what's in the SRM by kind of telling you real time 25 what changes were accepted and weren't, but this NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
100 1 slide here is a high-level pictograph of some of 2 the information that is inside the staff 3 requirements memorandum for this, for our SECY 4 paper for our proposed changes.
5 This SRM was published March 29 of this 6 year, and as you saw, they approved and disapproved 7 some of the proposed changes that we put in front 8 of the Commission.
9 Further, the Commission had asked us to 10 evaluate the removal of Criterion 3.C.2 because 11 there are some redundancies in the language of the 12 AO reporting criteria and the criteria in 10 CFR 13 35.3045 for reporting medical events to the NRC.
14 So, they asked us to kind of take a 15 look at that and let them know if we want to still 16 keep those criteria inside of the current AO 17 policy.
18 And then lastly, the Commission 19 directed the staff to incorporate their comments on 20 the draft policy revision and then publish it for 21 comment, a 90-day comment period. So next slide, 22 please.
23 So where are we at now? Here is our 24 path forward. Number one here, we did respond to 25 the Commission in saying that we are proposing to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
101 1 maintain Criterion 3.C.2 as is. Some of the, I'll 2 say, I guess, confusion or reasons for the 3 redundancy is that we were kind of trying to shift 4 the paradigm into a deterministic-based criteria as 5 opposed to kind of tracing it back to the written 6 directive. Our current policy is that you need to 7 report as an AO any event that goes 50 percent or 8 greater than the prescribed dosage or, you know, a 9 smattering of other things, wrong treatment site, 10 wrong patient, so on and so forth.
11 So, the way that that's structured 12 versus the way that 35.3045 is structured, we need 13 those criteria in there to make sure that we're 14 capturing all of the safety significant events in 15 our AO policy and reporting them to Congress.
16 Number two, we will incorporate the 17 Commission comments and publish the proposed 18 limited changes to the Federal Register for a 90-19 day public comment period, and then once that's out 20 there, we will be consolidating, docketing, and 21 evaluating all of the public comments that do come 22 in, and then work towards a final publication.
23 I will say we are very, very close to 24 getting number two done. So, once it's out there, 25 we look forward to any and all comments that the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
102 1 public has on our limited revision.
2 And then, I think, next slide, please.
3 I think that's all I have as far as material to 4 discuss, but I'm happy to attempt to answer any 5 questions that you have for me.
6 CHAIR METTER: Well, thank you, Mr.
7 Harvey, for that nice review on the updates 8 regarding abnormal occurrence. Do I have any 9 questions from the ACMUI for Mr. Harvey? Any other 10 additional comments or questions from the NRC 11 staff?
12 MR. EINBERG: No.
13 CHAIR METTER: Then let me just open it 14 up to the public because this is a very interesting 15 topic in my opinion.
16 MS. PINEDA: Again, if you are a member 17 of the public and you joined by Teams, just use the 18 raise hand function in Teams, and if you called in 19 by phone, then press *5 to raise your hand and then 20 *6 to unmute yourself after I call your name.
21 Thank you.
22 We have Ralph, and I think the name is 23 Lieto. Go ahead.
24 MR. LIETO: Yes, that's correct.
25 Hello?
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103 1 CHAIR METTER: Go ahead. Go ahead, 2 Ralph. This is Darlene.
3 MR. LIETO: Thank you very much for the 4 opportunity to comment. My name is Ralph Lieto.
5 I'm a medical physicist from Michigan. I'm 6 presently pretty much retired.
7 But I was very interested in Mr.
8 Harvey's presentation in that this abnormal 9 occurrence criteria has been something that's been 10 addressed quite a bit in the past, and I'm very 11 surprised that this criteria that you're asking for 12 comments on, which I think needs to be commented 13 on, is that that criteria about deterministic 14 effects being taken out should remain.
15 I think this was something that the 16 ACMUI had recommended a number of years ago, and I 17 think it would have been helpful if you maybe in 18 the future would comment in that almost nearly, if 19 I'm not mistaken, for the past ten-plus years, the 20 AO criteria has only been exceeded by medical 21 events. There's very few commercial reactor events 22 that have been reported in this.
23 And the other point is that even though 24 almost all of these have been predominantly medical 25 events, I am not aware of anything that has ever NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
104 1 occurred as a result of this reporting in an AO 2 that's resulted in any change in either regulatory 3 or guidance regarding patient safety or health.
4 So, it seems that a tremendous number 5 of these events that meet these criteria would 6 really only fall into the, you know, the realm of 7 being of some significance if they produced some 8 type of deterministic or radiation-induced injury, 9 and even then, I'm sure that probably would only 10 number in the very, very few.
11 So, I guess the issue is are you then 12 stating that if we need to put this back in, we 13 being the regulated community, that we need to 14 comment and that the Commission would change their 15 mind on pulling this out?
16 MR. HARVEY: So, I'll start by saying I 17 encourage you to, once this is open for public 18 comment, to submit your comment. I cannot 19 guarantee or I cannot comment on whether or not the 20 Commission will take that and change their minds on 21 this.
22 I'm fairly new to this AO coordinator 23 position, but I do think there was a comment -- I 24 would imagine there was a public comment period 25 when these proposed revisions went up before a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
105 1 SECY, but I'm not 100 percent sure on that.
2 But long story short, I would encourage 3 you to submit your public comment to get your 4 thoughts expressed to the Commission because we 5 will be responding to the comments that we receive 6 if they're within scope.
7 MR. LIETO: A follow-up question, 8 please?
9 MR. HARVEY: Sure.
10 MR. LIETO: Could you verify my 11 recollection that this was a proposal from the 12 ACMUI originally to change this abnormal occurrence 13 or was this from NRC staff to put this proposed 14 criterion into the AO criteria but was rejected?
15 MR. HARVEY: I think I'd have to defer 16 to ACMUI on that. I will say the initial review, I 17 think, back on the slides, the initial SECY paper 18 where we evaluated the current AO criteria and 19 requested to make revisions, I do think that came 20 out of discussions with ACMUI back in 2019 I 21 believe it was, but if there's anyone sitting in 22 the room that might remember that or if folks from 23 the medical team recall that as well, I would defer 24 to them.
25 CHAIR METTER: Yes, Dr. Katie Tapp is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
106 1 here to make a comment on that.
2 DR. TAPP: Yeah, Ed, it was actually 3 farther back. The ACMUI made the recommendations 4 to change the abnormal occurrence criteria before 5 we sent it up in 2015, so this is going back even 6 farther than the 2019.
7 The 2019 was a staff-led initiative, 8 but was with support and agreement with the ACMUI, 9 so they did have comments, but it was, 2015 was the 10 initial request for this and it was based on a 11 recommendation from ACMUI.
12 CHAIR METTER: Thank you.
13 MR. HARVEY: Thank you, Dr. Tapp.
14 MR. LIETO: Just a final comment then.
15 I would encourage the ACMUI to at least make a 16 motion to the Commission to have them reinsert this 17 criterion into the AO, thresholds for reporting 18 abnormal occurrence events from medical events.
19 Thank you.
20 CHAIR METTER: Thank you for that 21 comment. We'll look into that and take things into 22 consideration. Any other comments from the public?
23 Seeing none, we'll go to our next item on the 24 agenda. Dr. Valentin-Rodriguez from the NRC will 25 be giving medical team updates.
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107 1 MS. VALENTN-RODRIGUEZ: Thank you, Dr.
2 Metter, and thank you, Christine. Today, I will 3 provide an update on medical-related rulemaking 4 efforts, regulatory guidance development efforts, 5 and other opportunities for engagement with the 6 medical team. Next slide, please, Christine.
7 And this is just what I just covered, 8 so, Christine, if I could get the next slide?
9 So, I wanted to give you just kind of 10 an update on what 10 CFR Part 35, how we've planned 11 to change it, the different rulemaking plans that 12 the staff has submitted throughout the years.
13 And Christine, I think if you can hit 14 the next button a few times, you'll get all of the 15 items on the slide. Thank you.
16 So back in 2018 was the last time that 17 we officially amended 10 CFR Part 35 and it became 18 effective in January 2019 for NRC licensees and in 19 2022 for Agreement States and Agreement State 20 licensees.
21 So back in 2018 in that rulemaking, we 22 revised medical event reporting and notification 23 requirements for permanent implant brachytherapy, 24 and we also amended requirements for measuring 25 moly-99 contamination and required reporting for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
108 1 failed technetium and rubidium generators.
2 We also made some generic changes to 3 our training and experience regulations. We 4 addressed a petition for rulemaking regarding 5 grandfathering of individuals who had been 6 diplomats from a certified board previously or 7 before October 2005, and we made changes to those 8 same regulations to include associate radiation 9 safety officers and medical licenses.
10 So, the last few years, as you see on 11 this slide, we've submitted three rulemaking plans 12 to the Commission, all of which the Commission had 13 voted on. The staff's T&E rulemaking plan was 14 disapproved by the Commission in January of 2022, 15 but we pursued other Commission-directed actions, 16 some of which have been completed and others that 17 are in process and I will discuss later today.
18 Regarding the emerging medical 19 technologies / rubidium-82 generator rulemaking, 20 the Commission approved the staff's recommendation 21 option and I'll be talking about that rulemaking a 22 little bit in later slides.
23 And then last, but not least, in 2022, 24 the Commission approved the NRC's path forward on 25 petition for rulemaking PRM-35-22, which requested NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
109 1 that nuclear medicine injection extravasations that 2 exceeded a localized dose equivalent of 50 rem be 3 reported as medical events.
4 As previously mentioned, Irene Wu of 5 the NRC staff will be providing a status update on 6 that rulemaking, so I won't cover that today. So 7 next slide, please, Christine. Yeah, there we go.
8 So, the ACMUI has already provided 9 feedback on this rulemaking back -- last year, we 10 provided the ACMUI with the regulatory basis for 11 the emerging medical technologies / rubidium-82 12 generator rulemaking, which is what's grayed out 13 sort of in this timeline here.
14 And the timeline really shows what's 15 going to be our schedule for this massive 16 rulemaking where we aim to include requirements for 17 calibration and dosage measurements for strontium-18 82, rubidium-82 generators, and to establish risk-19 informed, performance-based requirements to create 20 additional flexibility in Part 35 for the 21 regulation of existing and future emerging medical 22 technologies.
23 And so, as I mentioned, the ACMUI 24 already provided comment on the draft regulatory 25 basis, which the staff has already addressed, and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
110 1 we are really appreciative of those comments.
2 The regulatory basis is in concurrence 3 in the NRC and we are aiming to issue that in the 4 next few weeks actually to the Commission, and 5 after that, it will be published in the Federal 6 Register for a 120-day public comment period. We 7 hope to have public meetings during that time.
8 And then we've pushed out some of the 9 schedule that's on the screen here to winter 2026 10 for the proposed rule and winter 2027 for the final 11 rule, and this was a decision made by the NRC staff 12 to prioritize the extravasation rulemaking. Next 13 slide, please.
14 Another rulemaking effort that the NRC 15 medical team has undertaken has been the issue of 16 veterinary release. As you will know, 17 historically, most common veterinary uses of 18 byproduct material are sodium iodine-131 for the 19 treatment of hyperthyroidism in cats, and we have 20 limited guidance in NUREG-1556, Volume 7, Revision 21 1.
22 A few years ago, we issued a technical 23 report for the evaluation of a radiopharmaceutical 24 for the treatment of osteoarthritis in dogs using a 25 tin-117m colloid, and in that case, the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
111 1 manufacturer provided proposed release criteria for 2 the NRC that relied on prescreening criteria and 3 pet owners following instructions to a greater 4 extent than previous practiced by the NRC.
5 And at that time, we issued that 6 technical report, which is publicly available on 7 our public website. Following this report, we 8 established a joint NRC / Agreement State working 9 group in October 2021 to develop recommendations to 10 establish a framework to authorize veterinary 11 licensees to release animals following veterinary 12 procedures.
13 Right now, our regulatory framework 14 relies on the public dose limits in 10 CFR Part 20 15 for that veterinary release. That is another 16 rulemaking that we've kind of deferred for a little 17 while.
18 After we started working on this 19 rulemaking plan, the medical team received the 20 staff requirements memorandum for training and 21 experience for emerging medical technologies, as 22 well as extravasations.
23 We have received resources from the 24 Commission to develop a regulatory guidance for the 25 release of animals, and so we will be proceeding NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
112 1 with that and then we'll proceed with the 2 rulemaking plan as our resources, our staff 3 resources allow. Next slide, please.
4 So, in terms of emerging medical 5 technologies, we will continue to develop licensing 6 guidance as, you know, 35.1000 will not go away 7 after our rulemaking. On this slide here are three 8 different technologies that we've reviewed in the 9 last few years.
10 For example, the Elekta Esprit is an 11 advanced gamma stereotactic radiosurgery unit from 12 the manufacturers of the Leksell Gamma Knife 13 Perfexion and Leksell Gamma Knife Icon. These 14 units, as you all know, are licensed under 35.1000, 15 that they are not able to meet some of the 16 requirements because they have evolved in terms of 17 technology.
18 And so recently we've issued a revised 19 licensing guidance for the Perfexion, Icon, and 20 Elekta Esprit to include this new gamma 21 stereotactic radiosurgery unit.
22 The Liberty Vision Y-90 Discs 23 brachytherapy source is a new single-use temporary 24 eye applicator source that utilized Y-90 for the 25 treatment of eye tumors and benign growths.
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113 1 The ACMUI did establish a subcommittee 2 to review the licensing guidance which the staff is 3 still developing. We are very close to issuing 4 that guidance for Agreement State and ACMUI 5 comment, so we should be able to reestablish soon 6 that subcommittee.
7 An interesting thing about this Liberty 8 Vision brachytherapy source is that our regulations 9 are written mostly for the use of strontium-90 10 sources for ophthalmic use of byproduct material, 11 whereas Liberty Vision uses Y-90, and so that 12 introduces some issues with regards to treating 13 experience, authorized users.
14 And the last technology on this slide 15 is the Akesis Galaxy RTi, which is another new 16 gamma stereotactic radiosurgery unit for the 17 treatment of head and neck conditions. It should 18 be licensed under 10 CFR 35.1000. This particular 19 unit has rotating sources in a collimator carrier.
20 It also utilizes image-guided treatment, and it 21 allows for table movement during treatment.
22 This guidance is also in development, 23 and so in the next few months, we should be able to 24 produce a draft licensing guidance for Agreement 25 States and ACMUI comment on this technology. Next NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
114 1 slide, please. Thank you.
2 So back in 2018, we issued the results 3 of the NRC's patient release program evaluation in 4 SECY-18-0015 to the Commission.
5 In evaluating the NRC's patient release 6 program, we considered rulemaking in four areas and 7 performed dose modeling calculations, researched 8 published data and peer-reviewed literature, and 9 conducting extensive stakeholder outreach to really 10 evaluate our patient release program.
11 At that time, we concluded that our 12 current patient release regulations are protective 13 of public health and safety, but that we should 14 probably update Reg Guide 8.39.
15 And so, we proposed to do that in two 16 phases, the first of which was published in April 17 2020 and that is the current version of Regulatory 18 Guide 8.39 that licensees could use, and in that 19 revision, we updated the patient release 20 information to provide example patient 21 instructions.
22 Revision 2, which you all saw a draft 23 of back in late 2021, this has been published in 24 the Federal Register as a draft proposed regulatory 25 guide, and in this revision, we are proposing to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
115 1 update the dosimetry equation, methodologies and 2 tables used to calculate dose to members of the 3 public.
4 So that is out for public comment as we 5 speak for a 60-day comment period that closes 6 sometime in June, and so as Kevin stated this 7 morning, once the staff has received those public 8 comments and addressed them, the ACMUI will have an 9 opportunity to review that proposed final draft 10 before it's issued as final. Next slide, please.
11 One of the Commission-directed actions 12 that resulted from the training and experience 13 rulemaking plan that was just approved by the 14 Commission was the development of training and 15 experience implementation guidance.
16 The Commission directed us to produce 17 this guidance to clarify expectations on how 18 individuals who are subject to training and 19 experience requirements can fulfill those 20 requirements, as well as what is the role or what 21 is the role and responsibilities of those 22 individuals who are subject to those requirements 23 in 10 CFR Part 35.
24 Although we do have substantial 25 guidance on medical T&E criteria in NUREG-1556, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
116 1 Volume 9, which is currently in its third revision, 2 given the types of questions that we and Agreement 3 State staff receive routinely regarding T&E 4 requirements, we determined that supplemental 5 guidance would benefit those individuals who are 6 trying to apply for authorized user individual 7 status, as well as answer questions from our 8 licensees.
9 We established a joint NRC and 10 Agreement State working group to develop this 11 guidance, and on this slide here, you'll see some 12 of the topics that we'll aim to expand on in this 13 guidance, which include what's the purpose of T&E 14 requirements?
15 You'd be surprised that with some of 16 the questions we get is that fundamental question 17 of purpose. Expectations for individuals that are 18 subject to these requirements. For example, how we 19 do address 35.27 and the requirements for 20 supervision? What is expected of those individuals 21 who supervise under 35.27?
22 Training, for example, including 23 equivalency of hours, recentness of training under 24 35.59, vendor and device-specific training, 25 preceptors and their roles in T&E requirements, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
117 1 multiple authorizations, for example, our 2 regulations allow for AUs and authorized medical 3 physicists to also serve as RSOs, and also 4 documentation and provide further guidance on how 5 to complete the 313a forms.
6 So, we are currently drafting that 7 licensing guidance and we plan to provide the 8 guidance to the ACMUI for review and comment, I 9 believe, sometime early next year. Next slide, 10 please.
11 Another regulatory guidance effort that 12 we're currently undertaking is the reporting of 13 medical events. The development of comprehensive 14 reporting regulatory guidance for the reporting of 15 all medical events was something that was included 16 in the staff requirements' memorandum for the 17 extravasations rulemaking that we received in 18 December of last year.
19 And so we are developing this guidance 20 concurrently with the extravasation proposed rule, 21 and so we plan to issue this guidance as interim 22 staff guidance because what we are planning to do 23 is issue guidance on current regulatory 24 requirements for medical event reporting.
25 As you all know, some of those medical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
118 1 event reporting requirements will change as we move 2 some of those technologies out of 35.1000 into the 3 current Part 35, and therefore, once we promulgate 4 the final rule for the emerging medical 5 technologies / rubidium-82 generator rulemaking, we 6 will issue that rulemaking, that reporting of 7 medical events regulatory guidance as final.
8 But we plan to make that available to 9 the public as soon as the proposed rule comes out 10 for extravasations, and so the ACMUI will also have 11 a chance to look at that review and comment. Next 12 slide, please.
13 Household waste from nuclear medicine 14 patients, this is an effort that we're undertaking 15 in part due to a recommendation from the ACMUI. In 16 a non-medical events presentation a few years ago, 17 the ACMUI noted that there is a decline in the 18 number of events where alarms at waste facilities 19 or landfills are triggered.
20 And so, as a reminder, we don't have 21 reporting requirements for those types of incidents 22 at the NRC, but the ACMUI is concerned that due to 23 the resurgence or the use of new 24 radiopharmaceuticals that are short-lived but may 25 have long-lived impurities, that we may be seeing NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
119 1 an uptick in the instances of household waste that 2 end up at landfills, but they're not reported to 3 the NRC.
4 And so we issued a survey this year to 5 the Agreement States regarding how common these 6 types of incidents are, whether states have any 7 programs in place to handle these incidents, and 8 whether additional guidance or best practices are 9 needed.
10 We've extended the comment period on 11 that survey, and so we hope to have a presentation 12 for you all in the fall of this year to address 13 those comments and a final recommendation from the 14 NRC on this issue.
15 And then for my last slide, so we have 16 opportunities for engagement coming up with the 17 medical team as I've shown here, and you'll see 18 from other presentations today, the medical team is 19 very busy. We have a lot of efforts ongoing.
20 For example, we will have a public 21 meeting on the extravasation rulemaking and request 22 for information next week on May 24. The public 23 meeting notice is in the public meeting notice 24 schedule that's available on the NRC's public 25 website and Irene will probably be providing more NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
120 1 details later today.
2 As I mentioned, Reg Guide 8.39 has a 3 proposed draft revision out for comment, and I 4 believe we're having a government-to-government 5 meeting with Agreement States this week.
6 The regulatory basis for emerging 7 medical technologies rulemaking will be out in the 8 next few weeks hopefully, and then we'll also have 9 public engagements on that.
10 And last, but not least, we will be 11 holding a workshop/public meeting in September of 12 this year on the American Board of Radiology's 13 termination, as well as training and experience 14 pathways available to individuals who are seeking 15 authorized status with NRC and Agreement States.
16 So, with that, I turn it back to you, 17 Dr. Metter, to see if the ACMUI or the public have 18 any questions.
19 CHAIR METTER: Well, thank you very 20 much, Dr. Valentin-Rodriguez, for the very complete 21 report. And really, again, I'd like to acknowledge 22 and thank the NRC staff for their tremendous work.
23 As you can see, they are doing multiple hats in 24 different areas just for our work and to protect 25 the public safety in regards to the medical use of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
121 1 isotopes.
2 I open it up to any questions from the 3 ACMUI. Seeing none, do I have any other comments 4 from the NRC staff?
5 MR. EINBERG: No.
6 CHAIR METTER: Thank you. And now I 7 would like to open the comment period and questions 8 to the public.
9 MS. PINEDA: Once again, if you have 10 any questions and you're joined by Teams, just 11 click the little hand icon, and if you have joined 12 on your phone, just press *5 to raise your hand and 13 then *6 to unmute yourself after I call your name.
14 Thank you.
15 CHAIR METTER: I believe there are no 16 comments from the public?
17 MS. PINEDA: We do have a comment from 18 the ACMUI member Dr. Harvey.
19 MEMBER HARVEY: Yeah, Richard Harvey.
20 I've spoken with a number of people that have had 21 some confusion about 8.39 and one of the reports or 22 documents that came out from ACMUI about the 23 recommendation of the occupancy factor being 0.25.
24 My personal opinion is that the 25 occupancy factor should be flexible and up to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
122 1 licensee to decide with justification. I've had a 2 number of people reach out to me and say that why 3 doesn't the ACMUI let us use occupancy factors of 4 one?
5 And I've tried to explain to them that 6 they can use an occupancy factor of one and be more 7 conservative, but they are just recommending 0.25 8 because it's more realistic. So I just thought I'd 9 make that comment at this point.
10 CHAIR METTER: Thank you very much.
11 That is a very important comment and it just 12 changes a lot of factors too. Any other comments 13 or questions for the NRC presentation?
14 Okay, seeing none, I believe we're 15 ahead of schedule. We've been very efficient. Any 16 other final issues before we go to break and come 17 back for our afternoon sessions? Mr. Einberg, 18 anything from the NRC?
19 MR. EINBERG: Nothing from the NRC 20 here.
21 CHAIR METTER: Okay, so let me go ahead 22 and I'll adjourn the morning session and let's come 23 back at 1:00 for our afternoon presentations.
24 Thank you.
25 (Whereupon, the above-entitled matter NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
123 1 went off the record at 10:48 a.m. and resumed at 2 12:59 p.m.)
3 CHAIR METTER: Darlene Metter and I'd 4 like to invite you back to the 2023 Spring ACMUI 5 meeting. I'm Darlene Metter, Diagnostic 6 Radiologist and ACMUI Chair.
7 So we have a very exciting update and 8 presentation scheduled for the afternoon, and I'd 9 like to bring Dr. Jadvar, ACMUI Member, to give his 10 presentation on Training & Experience for all 11 modalities. Dr. Jadvar?
12 VICE CHAIR JADVAR: Thank you, Dr.
13 Metter. It's my pleasure to present the report for 14 the subcommittee who worked on this topic of 15 Training & Experience for all modalities. So 16 first, I want to thank all the subcommittee members 17 including Dr. Ron Ennis, who was with this 18 subcommittee, but his term ended in March of 2023; 19 Dr. Richard Harvey, Dr. Darlene Metter, Megan 20 Shober, Melissa Martin and also, I want to thank 21 Maryann Ayoade for -- NRC staff resource who helped 22 us throughout this process. Next slide, please.
23 These are the subcommittee -- the 24 expanded subcommittee charges. If you recall, I 25 did present the results of the first charge, but I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
124 1 repeat them here again. The charges are to 2 identify any potential impacts of the ABR's, 3 American Board of Radiology, requests to terminate 4 NRC recognition and other recognized boards 5 identified during the NRC's evaluation of its 6 specialty boards and provide recommendations to 7 mitigate any potential impacts.
8 Charge number 2 is -- was to review and 9 evaluate the NRC's current board recognition 10 criteria and provide any recommendations for 11 action. Next slide, please.
12 So, let's focus on charge one which I 13 just mentioned. Next slide. These are the list of 14 the NRC-recognized boards, so that certificate 15 holders of any of these boards can request NRC to -
16 - for them to be granted AU status. I'm not going 17 to read over the boards in here, but I want to 18 focus on the ones that are in red font. One is the 19 American Board of Radiology and then we talk about 20 the American Osteopathic Board of Nuclear Medicine 21 and also the Certification Board of Nuclear 22 Endocrinology. Next slide.
23 So, a little bit of a background about 24 ABR. ABR was founded in 1934 as a non-for-profit 25 organization and a member of the American Board of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
125 1 Medical Specialties, or ABMS. And ABR is one of 2 the 24 specialty certifying boards in medicine.
3 This ABR certifying board is for diagnostic 4 radiology, interventional radiology, medical 5 physics under diagnostic, nuclear, or therapeutic 6 as well as radiation oncology and also some 7 subspecialties of radiology including nuclear 8 radiology, neuroradiology and pediatric radiology.
9 The mission of ABR is to certify that 10 our diplomats demonstrate the requisite knowledge, 11 skill, and understanding of their disciplines to 12 the benefit of patients.
13 If you recall, in December of 2022, we 14 discussed this charge and our findings of the 15 subcommittee, and we had Dr. Brent Wagner, who is 16 the ABR Executive Director, also online and he 17 answered our questions. Next slide, please.
18 So, prior to 2005, ABR actually did not 19 provide AU AMP or RSO eligible designation on any 20 of these board certificates. But for some reason, 21 in 2005, they decided to do -- start doing that but 22 as you see here, they're discontinuing this 23 eligibility designation under boards -- you can see 24 an example of that on one of the diplomas on the 25 side -- in end of this year, on December 31, 2023.
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126 1 So doing this basically 18 years, this eligibility 2 designation was an option for candidates and again, 3 this is going to disappear based on the decision on 4 December 31, 2023. Beyond that, starting January 5 1, 2024, none of these designations will be 6 available and candidates should provide relevant 7 T&E documentation if they want to be AU directly 8 through their employers to NRC so that their names 9 can be added to their employer's RAM license.
10 These are the reasons that were put 11 forward by ABR for why they made this decision, and 12 this was published in a YouTube video that you have 13 the address there on March 30th of 2022. They 14 reasoned that this activity was not aligned with 15 the core ABR mission, and it diverted limited 16 resources that they had.
17 Also, they mentioned that ABR has never 18 issued AU status and most radiologists are not and 19 do not need to be AUs. ABR basically passed along 20 documentation of T&E and direct pathway to becoming 21 AU, which is the alternate pathway, already exists.
22 AU requirement for 700 hours of T&E nuclear 23 radiology is also an ACGME or a residency 24 requirement, so the candidate provides -- gets that 25 education through their residency training.
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127 1 They also mentioned that the IR/DR 2 Forms A and B are no longer needed. The two-page 3 verification form that they provided in the past 4 for radiation oncology is also not needed to be 5 submitted to ABR starting January 1, 2024.
6 Their RISE questions, which are the 7 radioisotope safety examination questions, are also 8 not - theyre still presented to the candidates.
9 They should know the material, but theyre not 10 going to be scored separately. And they advised 11 that trainees and programs should continue to keep 12 their T&E documentation. In the case of the 16 13 months embedded nuclear medicine diagnostic 14 radiology pathway and also for those folks who 15 finish their diagnostic radiology residency and are 16 interested in doing one year of fellowship in 17 neuroradiology, they do have to have - keep all 18 this T&E documentation so that they can sit for the 19 examination.
20 And finally, they mentioned that the 21 ABR change or decision is more cosmetic than 22 substantive. Next slide, please.
23 So what would be potential 24 ramifications for this ABRs decision? It was 25 discussed that this may cause potential confusion NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
128 1 and challenges with burden that is now basically 2 transmitted to the applicants and institutions for 3 securing AU, AMP, or RSO status for the new hires.
4 AU eligibility board certification was a rapid 5 proof for AU eligibility and possibly ABR may have 6 underestimated the burden that was being placed on 7 the applicants, preceptors, and program directors.
8 Some of these preceptors may be deceased or they 9 may be unwilling to sign off if there is more than 10 greater - greater than seven years window or if the 11 preceptor was not involved to begin with with the 12 applicants T&E. So they may not be willing to 13 sign off.
14 Despite those potential issues, we 15 looked at some of the data that was gathered by 16 some of the members from what the situation is 17 right now. In California, it turned out that it 18 takes four hours for license amendment for 19 examining if a person is eligible for AU, and there 20 are about 100 AUs that are added per year. There 21 was no time difference between those who had ABR 22 certification with that eligibility designation or 23 the person applied through the alternate pathway.
24 Megan Shober told us that in Wisconsin, 25 there was no apparent adverse impact on regulatory NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
129 1 agencies based on licensing databases that she went 2 through in 2020 and 2021.
3 And the SECY-20-0005 rulemaking plan 4 for Training & Experience requirements, also for 5 unsealed byproduct material, mentioned that it 6 takes about 15 hours for NRC to examine these 7 applications, 11 hours1.273148e-4 days <br />0.00306 hours <br />1.818783e-5 weeks <br />4.1855e-6 months <br /> for the Agreement States to 8 examine these applications, and 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> that the 9 licensees have to spend to prepare the application.
10 Next slide, please.
11 So, when talking with Dr. Wagner, it 12 turned out that somewhere between 67% and 95% and 13 on average, about 80 percent of the ABR 14 certifications actually included this AU 15 eligibility on their certificates. However, it was 16 unclear and he did not really provide us a specific 17 answer regarding what percentage of these folks who 18 have AU-E on their certificates actually eventually 19 end up on broad licenses. I think we found out 20 from Dr. Angle that the IR is estimated to be 21 around 50 percent.
22 Also, there is no indication that other 23 NRC-recognized entities will follow these 24 particular decisions by the ABR. The other two 25 boards that I mentioned I'm going to talk about is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
130 1 the CB&E, the Certification Board of Nuclear 2 Endocrinology. This board actually has dissolved 3 and is no longer recognized by NRC. The American 4 Osteopathic Board of Nuclear Medicine has been 5 inactive since March of 2019 and is no longer 6 recognized, and it was even small when they were 7 active.
8 Now there are a number of venues that 9 we suggested these could be still more discussed 10 and, in fact, followed up with what the 11 ramification is as we go into 2024 and beyond 12 regarding potential impact, but these are some of 13 the societies or organizations that we suggested 14 including Association of University Radiologists, 15 Society of Chairs of Academic Radiology 16 Departments, Society of Chairs of Academic 17 Radiation Oncology programs, and Association of 18 Program Directors in Radiology. And these meetings 19 can be helpful for discussion -- further discussion 20 on this topic as necessary. And also, a 21 recommendation was made to perhaps publish our 22 findings and any other issues regarding this in 23 Academic Radiology, which is the flagship journal 24 for AUR. Next slide, please.
25 So, this is charge number 2 that was NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
131 1 added: to review and evaluate the NRC's current 2 board recognition criteria and provide any 3 recommendations for action. So, we discussed this 4 through additional virtual meetings, and the 5 documentation that the subcommittee looked at are 6 listed on this page. I'm not going to read through 7 them, but the decision was made that the 8 certification by a specialty board coupled with 9 recentness of training, less than seven years, was 10 sufficient for receiving AU status on a RAM 11 license. And in those cases, attestation by a 12 preceptor is unnecessary. And subcommittee 13 unanimously agreed that these documents are 14 sufficiently -- the documents above are 15 sufficiently comprehensive and detailed in that 16 regard and no changes are really necessary at this 17 time. Next slide.
18 So, these are my references for this 19 report and next slides show the acronyms I believe.
20 Yes.
21 That concludes my subcommittee report.
22 Thank you.
23 CHAIR METTER: Well, thank you, Dr.
24 Jadvar, for that very nice and complete review of 25 those two very important questions posed to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
132 1 ACMUI. Do I have any comments or additions from 2 the ACMUI subcommittee on Training & Experience?
3 Any comments from the ACMUI? Mr. Green.
4 MEMBER GREEN: So, this American Board 5 of Radiology is no longer going to have a process 6 to have their graduates, their fellows come out 7 with AU eligible. And it just makes me step back 8 and think how that relates to nuclear pharmacists.
9 On slide 5, there is a listing of the Board of 10 Pharmaceutical Specialties as a recognized 11 specialty board that pharmacists can avail 12 themselves. But I want to point out to you that 13 100 percent of all nuclear pharmacists in America 14 have come through the alternate pathway, because 15 you have to work for two years as a nuclear 16 pharmacist before you can sit for board 17 certification. So ABR is becoming like nuclear, 18 nuclear pharmacists. You -- if you want, you come 19 in, you knock on the door, and you present your 20 paperwork. And apparently, California and 21 Wisconsin don't see any problems with it, so even 22 though we're losing one, it's really no different 23 than what's already happening today.
24 CHAIR METTER: Thank you very much.
25 That's very --
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133 1 MEMBER GREEN: And there's only 353 2 board-certified nuclear pharmacists in the world, 3 so the rest of them are all AUs, and they've all 4 come through the alternate pathway.
5 CHAIR METTER: Well, thank you for that 6 very important information. Ms. Martin?
7 MEMBER MARTIN: I would just like to --
8 I think it's really important that we recognize the 9 ABR is not changing the training that the residents 10 will get. What is changing is the documentation 11 method. And I don't know how we emphasize enough 12 to the graduates of the future or the graduate 13 program directors how important it is that they 14 maintain that documentation of the residents when 15 they're getting their training. I agree it's not 16 going to be a problem for those relatively recent 17 graduates that have their paperwork together.
18 The challenge is for that person that's 19 been out 10 to 15 years and doesn't have their 20 paperwork together. One question I haven't -- the 21 question is, is the preceptor going to be 22 acceptable -- is it acceptable to have another 23 colleague at, say I want to go to work at XYZ 24 facility, is it acceptable that the -- that one of 25 the interventional radiologists or the nuclear NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
134 1 medicine guy, can they sign off as preceptor, or 2 does it have to be the preceptor from the training 3 program.
4 CHAIR METTER: Thank you for that 5 question. So first of all, there is that issue of 6 recentness of training. So, the training has to be 7 less than seven years when you apply for authorized 8 user status. And since I've been in an academic 9 site with training residents and fellows for over 10 the last 20 -- more than 25 years, those 11 individuals who want to be authorized users will go 12 ahead and keep track of things before 2005. And 13 then now I think the ABR did make it easier for 14 them, but now they're reverting back to pre-2005.
15 So, in my opinion, if you want to be an authorized 16 user and you know you will want to do that for the 17 future, you will keep your training and experience 18 requirements to be sure you meet them for the 19 future. Any other comments?
20 MEMBER GREEN: And submit before seven 21 years is up; otherwise, youre behind the eight 22 ball.
23 CHAIR METTER: Yes, Dr. Harvey.
24 MEMBER HARVEY: Richard Harvey. I 25 would say that, you know, the burden has shifted.
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135 1 The alternate pathway, as Mr. Green says, it works 2 fine. It does work fine and we can do this, but 3 there will just be more of an onus placed on the 4 licensee and the individual themselves, but it 5 works. So, I think what we're doing make sense, 6 and I don't know -- to Melissa's comment, I don't 7 know if you could accept in lieu of a preceptor's 8 signature a colleague's. I wouldn't think that 9 that would be acceptable, but I -- that's really 10 not my decision to make, so that's the way I would 11 see it.
12 CHAIR METTER: I have another comment.
13 I know when I spoke to Dr. Wagner, they were 14 expending all these ABR resources on this AU 15 eligible designation, but the issue was what was 16 the conversion factor for those individuals who 17 actually had AU eligibility on their diplomate 18 certificate that the ABR actually converted to on a 19 license. And the number, at least in my 20 institution, is very small. We have over 50 21 faculty and we have maybe 4 or 5 of us that are 22 AUs.
23 VICE CHAIR JADVAR: So, to kind of 24 respond to Melissa's question, I actually want to 25 ask if somebody from NRC can tell us if -- do they NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
136 1 accept if the preceptor is not from the same 2 training program if it's more than seven years, and 3 is somebody else from some other -- you know, some 4 program they never -- no? Are there are any ideas 5 on that or is -- there may be a problem?
6 MS. AYOADE: Good afternoon. This is 7 Maryann Ayoade from the Nuclear Regulatory 8 Commission. Can you all hear me?
9 CHAIR METTER: Yes, we can.
10 MS. AYOADE: Okay. Great. I apologize 11 that I am not able to be there in person today, but 12 I'm still here and I'm following along with the 13 discussion. For the preceptor authorized user, or 14 the preceptor requirement is that that individual 15 has to be an authorized user that meets the 16 training and experience requirements that the 17 potential authorized user or authorizing individual 18 is requesting, so for the same types of uses. And 19 as far as -- I believe Dr. Metter mentioned this --
20 you know, if it's beyond the seven years, if it's 21 12 years, they have to show continuing education, 22 you know, as it relates to what it is that they've 23 been doing since that time. And the continuing 24 education has to be within the seven years along 25 with whatever supervised work experience that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
137 1 they're receiving from an individual that we also 2 accept as a supervising individual, which also has 3 to be an authorized user.
4 In the last rulemaking that was 5 finalized in the 2018 -- it was issued in 2018 and 6 was implemented since that timeframe, three years 7 for Agreement States, it did allow residency 8 program directors to act as preceptors as well, but 9 there is a caveat to that requirement where the 10 residency program director is affirming, you know, 11 that the attestation represents the consensus of 12 the residency program faculty, but at least one 13 faculty member has to be an authorized user that 14 meets the same requirements that that individual is 15 requesting. So that was another option for a 16 preceptor individual that was added in that last 17 rulemaking that was issued back in 2018-2019 18 timeframe.
19 CHAIR METTER: Thank you, Ms. Ayoade 20 for that clarification. Any other comments? Yes, 21 Dr. Harvey.
22 MEMBER HARVEY: I'm still slightly 23 confused, so I apologize. Can somebody else other 24 than the preceptor that the physician trained 25 under, can someone else act as their preceptor and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
138 1 sign off on the NRC 313A form, "yes" or "no?"
2 MS. AYOADE: The only individuals right 3 now that are able to act as a preceptor are the 4 authorized user and the residency program director 5 and that's it. And that's in the training and 6 experience requirements for each type of use. So, 7 if you go to, for example, radiopharmaceuticals, 10 8 CFR 35.390, 490, you'll see that there under the 9 alternate pathway.
10 MEMBER HARVEY: Richard Harvey. So, if 11 a physician comes to a new organization that, say, 12 director of nuclear medicine wants to sign off as 13 that person's preceptor, they can do that?
14 MS. AYOADE: If that individual that 15 wants to act as a preceptor is an authorized user 16 that meets the same requirements that that new 17 individual is requesting for, yes. And the thing 18 about it is, it's the - youre signing off on the 19 work experience. You have to get supervised work 20 experience, right, with the areas it is that 21 they're requesting for use. And so that is what, 22 you know, brings it into the NRC space as far as 23 supervised work experience.
24 MEMBER HARVEY: Thank you, Ms. Ayoade.
25 So, somebody that is -- was not their preceptor NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
139 1 during their residency or fellowship can act as a 2 preceptor and sign off for them?
3 MS. AYOADE: Thats correct. The 4 regulations don't preclude or limit it to the 5 authorized user that was at their previous, you 6 know, training program.
7 MEMBER HARVEY: Richard Harvey. Thank 8 you very much, very much appreciated that 9 clarification because it wasn't really clear to me, 10 and I think that we definitely need to understand 11 that going forward. So, thank you very much, Ms.
12 Ayoade.
13 MS. AYOADE: Any other questions from 14 members of the ACMUI? Yes, Ms. Martin.
15 MEMBER MARTIN: Just thank you, 16 Maryann, for that clarification, because Richard 17 and I had the same question, and it's particularly 18 coming in with the Y-90. You know, we've got 19 people coming in that did not know 10 years ago 20 they were going to want to use Y-90. They're 21 willing to go through the training from the 22 manufacturer. They're willing to do their three 23 cases under supervision. They -- we just need to 24 make sure that it was very clear that the current 25 staff member that is at Facility A that is already NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
140 1 approved to do Y-90 procedures can serve as 2 preceptor for the new applicant.
3 CHAIR METTER: Thank you. Yes, Dr.
4 Einstein.
5 MEMBER EINSTEIN: (Off microphone) --
6 fellowship program directors as well, if so should 7 probably state residency or fellowship program.
8 CHAIR METTER: Okay. Thank you very 9 much for that comment. Any other suggestions or 10 comments from the ACMUI members? NRC staff? Maybe 11 open up to the public for comments and questions.
12 I see Ms. Ashley Cockerham there standing at the 13 podium, so do you have any questions or comments?
14 MS. COCKERHAM: Sure. Ashley Cockerham 15 with Orchestra (phonetic) Life Sciences. And I 16 think the key word to clarify on which AU can sign 17 off is that it is an AU, not the AU. So, if you 18 are an AU for that type of use, you can sign off 19 for someone else. And for the example that Ms.
20 Martin gave as someone who's done well over 100 of 21 these amendments specifically for Y-90 over the 22 last several years, it is very often that you 23 cannot get the original AU to sign off on 24 something. They may or may not have done those 25 cases in that time period, and so it is "an" AU who NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
141 1 provides the attestation. You also have situations 2 where the training is provided piecemeal, right, so 3 maybe a certain number of hours is done in this 4 time period at this facility and then another 5 section here and typically, youre only going to 6 have one attestation at the end of all of that for 7 the cases, and that would be from an AU who is 8 authorized or a residency program director, as Ms.
9 Ayoade said, who is -- where at least one faculty 10 member is an AU for that type.
11 I also wanted to make a comment on one 12 of the slides where it said the number of 13 authorized users that are coming through the board 14 certification pathway specifically for 15 interventional -- right there, yes -- for 16 interventional radiologists where it says 17 "estimated at 50 percent," again, I've been working 18 in this space, I guess, since 2016 when I left the 19 agency, and I would say in the hundreds of 20 amendments that I have seen, there have been a 21 handful come through the alternate pathway 22 documenting the 80 hours. The documentation is 23 inconsistent at best, and it is very difficult to 24 obtain. I'm usually literally the person emailing 25 an RSO at a facility saying "can you connect me to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
142 1 the radiology department," saying, "can you connect 2 me to the nuclear medicine department" trying to 3 dig up these documents. It is extremely difficult 4 to pull the documentation together. It is doable.
5 Obviously, it's done in nuclear pharmacy. We've 6 seen it in other types of uses, but I feel like I 7 have a pretty good perspective on what it's like 8 for IR, and it's not an easy task either for the 9 RSO's who are trying to pull the documentation 10 together just to get a simple amendment through.
11 And then for the regulators who are receiving that 12 documentation, it also takes significant more time 13 to do that review from the perspective of the 14 applicant.
15 CHAIR METTER: Well, thank you very 16 much for that in real world practice challenges 17 that we have with authorized user status. Any 18 other comments from the public?
19 MS. PINEDA: Oh, okay. Looks like we 20 do have a comment or questions from Ralph Lieto.
21 Go ahead.
22 MR. LIETO: Thank you. Actually, 23 Ashley kind of stole a little bit of my thunder, 24 because I wanted to simply underscore her comments 25 about the process to get an AU on a license. I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
143 1 think it's kind of misleading in the time values 2 that were given because basically, what youre 3 asking is the keepers of the house how long it 4 takes them to do something. You -- I think it 5 would be more apropos to ask the licensees how long 6 it takes from the time period that they acknowledge 7 receipt by the regulator to the time that they get 8 the actual amendment, because it takes much, much 9 longer. It's measured in weeks. I experienced 10 that for decades as an RSO in getting AUs 11 authorized on a license simply because either due 12 to volumes of things that the license reviewer is 13 dealing with or whatever, that it is not a short 14 turnaround time for getting an AU authorized by the 15 alternate pathway. It is much longer than the time 16 periods that were given in these slides. So I 17 think that needs to be understood, and I think the 18 fact that now everybody that's going to probably be 19 submitting information for an AU is going to be 20 doing it via an alternate pathway mechanism, I 21 think it's important that we look at some ways of 22 expediting both the documentation methodology and 23 the approval process. Thank you.
24 CHAIR METTER: Thank you for your 25 comment on that. I do see another individual at NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
144 1 the mike. Go --
2 MS. TOMLINSON: Hi. Cindy Tomlinson 3 with ASTRO. So, a couple of things I wanted to 4 mention. One is ASTRO now has a page on our 5 website that's sort of outlining its very -- very -
6 - 30,000-foot level, very broad umbrella outlining 7 what programs can do and what trainees can do to 8 make sure that they're leaving their programs with 9 everything intact, so all of their paperwork, all 10 the forms.
11 The other thing I wanted to mention was 12 I do know that CRCPD did query the states on things 13 -- some of the questions were, "Will you accept the 14 NRC's 313A forms instead of your own state form" 15 which would -- as trainees are leaving their 16 programs, if they just have one form to fill out, 17 right, and it's all filled out and they're ready to 18 go, it doesn't matter if they're moving from 19 California to Idaho, you know, whatever, or from an 20 Agreement State to an NRC state if the current 21 states will accept those.
22 But they also did ask about time -- how 23 much time, and they asked a few other questions. I 24 would recommend the ACMUI get in touch with CRCPD 25 to get that data. I think -- I don't have it here NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
145 1 readily accessible. It wasn't a ton of states that 2 responded to the survey, but it is useful 3 information. And they did ask a few other 4 questions. Off the top of my head, I don't 5 remember what they are, but those were some of the 6 questions that they asked.
7 CHAIR METTER: Thank you for that.
8 Ashley Cockerham has another comment.
9 MS. COCKERHAM: Ashley Cockerham again.
10 I wanted to add one additional piece that ties back 11 to the AU verification. So when an AU does provide 12 an attestation for another physician who is the 13 applicant essentially, right, the Agreement States, 14 we've really seen an increase in the diligence.
15 They're following up on the AU status of the 16 attester, and so not only do you need a copy of the 17 license of the individual who's providing 18 attestation, generally, that AU who's providing the 19 attestation is on a broad scope license. The broad 20 scope license does not name authorized users as 21 individuals. So now you need a second piece of 22 documentation, that is a letter from the RSO at the 23 facility of the AU who is providing the signature.
24 I regularly provide these and it's great due 25 diligence on the Agreement State part. I'm not --
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146 1 that's not the intent of my comment. I think I 2 want everyone to understand the level of 3 documentation and detail that's needed, and this 4 would be for the RSO who is trying to submit the 5 amendment. You're essentially going to your peers 6 saying "can I get a copy of your license because 7 your doctor is signing off on my doctor," and then 8 get an individual letter as well. So that was one 9 piece.
10 And then Cindy brought up a great point 11 on the NRC 313A and while it would be wonderful to 12 have a consistent form that worked for everyone, I 13 can say there are many Agreement States who do not 14 accept the NRC Form 313A and two, it is essentially 15 useless when it comes to Y-90 amendments. Nothing 16 on the NRC Form 313A is relevant to a Y-90 17 microsphere application. You need to create a 18 from-scratch letter that is custom to that IR 19 physician. So, a form is not always the answer, 20 and we're not always going to get consistency at 21 the Agreement State level.
22 CHAIR METTER: Well, thank you very 23 much for that very important several pieces of 24 information on that. Are there any other comments 25 from the public?
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147 1 MR. EINBERG: This is Chris. Maryann, 2 do you want to clarify or answer the question --
3 MS. AYOADE: Yes.
4 MR. EINBERG: -- that Dr. Einstein had 5 regarding the fellowship directors?
6 MS. AYOADE: Yes. Dr. Einstein, can 7 you again just say your question again for clarity 8 for everyone so that I don't -- I make sure I don't 9 say it incorrectly? Hello?
10 If Dr. Einstein is speaking, I cannot 11 hear him.
12 MEMBER EINSTEIN: Can you hear me now?
13 MS. AYOADE: I can hear you faintly.
14 MEMBER EINSTEIN: Test one, two, three.
15 I'm going to change microphones. I think this is 16 probably much better.
17 MS. AYOADE: Yes, much better.
18 MEMBER EINSTEIN: Okay. In 35 CFR 19 290(b)(2), for example, I think among other places, 20 there's the verbiage the attestation must be 21 obtained from either one, a preceptor authorized 22 user who meets the requirements in 35.57, 35.290, 23 or 35.390 and 35.290(c)(1)(2)(g) or equivalent 24 Agreement State requirements, or two, a residency 25 program director who affirms in writing that the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
148 1 attestation represents the consensus of the 2 residency program faculty, etcetera. In many 3 cases, individuals will be training not in the 4 context of a residency program but in the context 5 of a fellowship program. That would be applicable 6 for nuclear medicine fellows, you know, as 7 distinguished from radiology or nuclear medicine 8 residents. That would be the case for cardiology 9 fellows or for cardiac advanced imaging fellows.
10 And I'm sure there are other scenarios, too, but 11 the verbiage specifically uses the term residency 12 program director. Like a cardiology fellow who did 13 their internal medicine residency somewhere else, 14 the internal medicine residency director really has 15 nothing to say in regard to use of radioisotopes; 16 whereas the cardiology fellowship director and 17 particularly like an advanced imaging fellowship 18 would be a much more appropriate person to opine on 19 an individual's qualifications. I guess that was a 20 statement, not a question. So, the question is I 21 mean should one interpret the term "residency" in a 22 broad sense to incorporate fellowships, or should 23 the term "fellowship" be added to this regulation?
24 MS. AYOADE: Thank you for your 25 comment, Dr. Einstein, and I'm glad that you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
149 1 restated your question with the additional 2 information. So, that is a good comment that you 3 brought up. Our regulations, as far as the board 4 certification criteria, that's where you start to 5 see the introduction of residency programs that are 6 approved by the ACGME. That's the Accreditation 7 Council for Graduate Medical Education. And that 8 Accreditation Council, it's an organization that 9 credits, as you all are maybe aware, both residency 10 and fellowship programs. And so, we have received 11 this question as far as the attestation 12 requirement, and we have discussed with our legal 13 counsel, and they have said that as long as the 14 fellowship program meets the same requirements, so 15 meets our same NRC regulatory requirements for a 16 residency program, then we should be able to 17 recognize that fellowship program. And so that's 18 as far as that part of your comment.
19 MEMBER EINSTEIN: And what are those 20 requirements? Is being ACGME-accredited sufficient 21 for meeting NRC requirements, or there are 22 additional requirements? I point out that all 23 general cardiology fellowship programs -- I'd have 24 to look into whether that's the case for 25 osteopathic cardiology programs, I'm not sure, but NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
150 1 all allopathic cardiology programs are ACGME-2 accredited. Advanced cardiac imaging fellowships 3 which often provide, you know, up to two years of 4 training in use of radioisotopes are not ACGME-5 accredited currently.
6 ACGME has introduced a new category 7 called NST, I think, Non-Standard Training program, 8 which is used in the context -- and it's come up in 9 the context of who's eligible to get a J1 visa to -
10 - for non-U.S. citizens to participate in those 11 programs. So, they call programs nonstandard 12 programs, but theyre not ACGME-accredited programs 13 in cardiac imaging, for example.
14 So, it would be helpful to have 15 clarification as to what constitutes a program 16 meeting the standards for a residency program per 17 the NRC.
18 MS. AYOADE: Thank you, Dr. Einstein.
19 So, to respond to that, our requirements for the 20 board certification pathway, you know, it asks or 21 requires that all candidates that are going through 22 that certification have to successfully complete 23 their residency training in a related medical 24 specialty. But in addition to that, the residency 25 training program must meet all of our training and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
151 1 experience requirement, classroom and laboratory 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> and also our work experience hours. And that 3 is in addition to the training program being 4 approved by the ACGME.
5 And so, what we do when we receive an 6 application from a specialty board saying that they 7 want to be recognized for this specialty area, we 8 do, you know, confirm that their training program 9 is ACGME-approved. But we go through their 10 criteria and we make sure that -- just as it is --
11 and it's written in the regulations -- just as it 12 is in the regulations, we have to make sure that 13 their program has at least, if it's 35.390 for 14 radiopharmaceuticals, the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and 15 experience, both in the classroom and laboratory, 16 which requires a minimum of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom 17 and laboratory training as well as the work 18 experience. And so just having the ACGME-approved 19 training program doesn't just get you there.
20 MEMBER EINSTEIN: So, I would contend 21 that not all radiology residencies provide those 22 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> and certainly for cardiology fellowships, 23 it's -- there's different tracks which trainees can 24 take. Say someone wants to become a cardiac 25 electrophysiologist, which is an additional board NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
152 1 examination and ACGME-accredited specialty. In 2 general, they're not going to complete 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, 3 they're not going to have 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of coursework.
4 However, in the same fellowship training program, 5 you can have someone who's interested in pursuing 6 cardiac imaging, and they will do that. So it's 7 sort of an optional module within a training 8 program.
9 CHAIR METTER: Okay. This is Darlene.
10 Can I say a comment here as part of a residency 11 program for radiology? It is a radiology ACGME 12 program requirement for 35.290, which is that 700 13 hours1.50463e-4 days <br />0.00361 hours <br />2.149471e-5 weeks <br />4.9465e-6 months <br /> and 80 --
14 MEMBER EINSTEIN: I stand corrected 15 then on that point but certainly for cardiology 16 fellowships, it's not a requirement for the program 17 but something which a trainee who is pursuing a 18 career in noninvasive cardiology or cardiac imaging 19 will generally pursue. But there are colleagues 20 who are pursuing advanced heart failure or cardio 21 electrophysiology are not going to pursue that, so 22 it's not a mandatory part of the program, and it 23 would be a shame for that not to be recognized.
24 You know, you can have one training program which 25 fits the needs of different trainees and is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
153 1 rigorous. I'm happy to share, you know, the 2 requirements which we have in my program for 3 trainees to get my signature so that they can take 4 the CBNC exam, and that addresses American College 5 of Cardiology requirements, CBNC requirements as 6 well as NRC requirements, all of which are spelled 7 out in what we -- in writing for what we require of 8 our trainees who want to pursue that avenue within 9 the training program, but it's not a mandatory part 10 of the training program itself.
11 CHAIR METTER: Thank you so much for 12 that clarification.
13 MS. AYOADE: This is -- okay, I have 14 some more comments or clarification. Again, as I 15 mentioned, our regulations don't preclude, you 16 know, fellowship programs to be considered as a 17 type of residency program but again, as long as 18 that fellowship program meets our regulatory 19 requirements for a residency program. That 20 requirement to be an ACGME-approved residency 21 program is -- again, it's not the only requirement 22 but it's very important, and we've had some 23 discussions with some members of the ACMUI 24 including Dr. Metter about how during some of our 25 review process with specialty boards, they have NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
154 1 submitted the ACGME requirements and it didn't 2 include all of the topic areas that we require, 3 right, and so that's an example of how yes, it has 4 to be ACGME-approved, but the specialty board is 5 also responsible for meeting our training and 6 experience requirements. So they have to make sure 7 that all of the candidates that they're approving 8 have gone through all of the required classroom and 9 laboratory hours, work experience hours.
10 MEMBER EINSTEIN: That's an important 11 point you just raised. You said all of the 12 candidates they're approving, not all of the 13 candidates who -- not all of the trainees in that 14 program so --
15 MS. AYOADE: All of the candidates 16 they're approving for NRC-recognized specialty 17 boards. And I say that because ABR gives 18 certificates that don't include that AU-eligible 19 designation, correct? And so as long as it has 20 that AU-eligible designation, that lets the 21 candidate know that, oh, I can -- I have met NRC's 22 requirements and I can use my board certificate 23 through the board certification pathway because 24 this certification from ABR has guaranteed that I 25 have met all of NRC's training and experience NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
155 1 requirements.
2 CHAIR METTER: Thank you for that 3 clarification, Ms. Ayoade, and for your comments, 4 Dr. Einstein. I'd like to make one comment and 5 since I was on the Nuclear Medicine RRC for the 6 ACGME, you know, ACGME program requirements change.
7 And so, you know, they can change over time so then 8 if they decrease some of their training, they may 9 not meet the NRC recognition criteria. Just a 10 comment. Dr. Harvey has a comment.
11 MEMBER HARVEY: Richard Harvey. Thank 12 you. So, an RSO licensee, if somebody comes to me 13 with a preceptor signature for a residency or 14 fellowship program from Facility X, how do I know 15 that that location is compliant and certified and 16 they can sign off as this person's preceptor? How 17 do I know that?
18 MS. AYOADE: Is that question -- this 19 is Maryann Ayoade. Was that question for the NRC, 20 Dr. Harvey?
21 MEMBER HARVEY: Anybody, I guess, that 22 can answer it. So, you know, somebody comes from, 23 you know, Facility X and how do I know that they 24 meet your requirements?
25 MS. AYOADE: So one of the things if --
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156 1 I could start on NRC's end. You know, one of the 2 things that our license reviewers -- which is also 3 part of the 313 Form -- is it asks for the license 4 number where that individual is currently listed on 5 the license or the facility where they're acting as 6 the residency program director. You have to ask 7 for documentation showing all of the requirements 8 that are required.
9 MEMBER HARVEY: Richard Harvey. So 10 somebody comes to me and I have to go to that 11 residency or fellowship program and ask for that 12 documentation to prove that they're compliant with 13 the NRC's regulations in order to accept that 14 preceptor certification?
15 MS. AYOADE: Dr. Harvey, can you just 16 restate your last question?
17 MEMBER HARVEY: Yes. So, I have 18 somebody that comes to me that did a residency or 19 fellowship somewhere. They have a preceptor 20 signature from that location. I do not know if 21 that location is NRC compliant with your 22 regulations. How would I know that and how would I 23 know that I can accept the certification of that 24 residency or fellowship program director because 25 their program is compliant with the NRC's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
157 1 regulations? How do I know that, or do I have to 2 actually ask them for documentation to prove it?
3 Thank you.
4 MS. AYOADE: You have -- you should be 5 asking for documentation to prove it. As I 6 mentioned earlier, that requirement is not just for 7 the residency program director. He has to be, you 8 know, part of a program or faculty where at least 9 one other faculty members is an authorized user 10 that is listed on a license, whether it's NRC or 11 Agreement State, right. So, you should be able to 12 ask for documentation of the license that lists who 13 the authorized user is, who the residency program 14 director is saying this person is also part of our 15 faculty.
16 MEMBER HARVEY: Richard Harvey.
17 Maryann, thank you. So, I understand the whole 18 licensing aspect of it and the AU having to be 19 licensed for that and getting the license, and we 20 do that. But now I think what youre saying is 21 that I have to get proof that the residency or 22 fellowship program is compliant with NRC 23 regulations in order for me to accept that 24 preceptor certification. Do I misunderstand?
25 Thank you.
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158 1 MS. AYOADE: No. That is correct. So 2 that is what comes with the additional option of 3 having a preceptor other than what we used to have, 4 which was just the authorized user, right. Now we 5 have the option of the program -- or residency 6 program director. And so that, you have to verify 7 that as well.
8 CHAIR METTER: Well, thank you Ms.
9 Ayoade. I believe Ashley Cockerham has a comment 10 regarding this issue.
11 MS. COCKERHAM: This is Ashley 12 Cockerham. I was just going to give you the short 13 answer to that. Based on my experience, the answer 14 is yes, and I spend hundreds of hours every year, 15 me and my team of consultants, doing exactly that 16 because that is what is required.
17 CHAIR METTER: Thank you. Dr.
18 Einstein.
19 MEMBER EINSTEIN: What constitutes 20 sufficient evidence that this outside facility with 21 which youre not familiar at all meets NRC 22 regulations? I think that's the crux of the 23 matter, right? Like how do you prove it?
24 MS. COCKERHAM: Do you want the real 25 answer? It depends on your license reviewer, and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
159 1 it depends on your radiation safety committee. If 2 it's a broad scope license, then it's an internal 3 radiation safety committee. It's their decision so 4 it would come to the RSO and that radiation safety 5 committee. If it's an Agreement State, it is 6 absolutely their decision. And if it's the NRC, it 7 is their decision and it varies from license 8 reviewer to license reviewer.
9 CHAIR METTER: Yes, Dr. Harvey.
10 MEMBER HARVEY: Richard Harvey. Thank 11 you very much. So as a broad scope licensee RSO, 12 youre saying that we make that determination.
13 What if I make that determination and that 14 fellowship or residency program is not compliant 15 with the NRC? Then as an Agreement State, my 16 Agreement State regulator is going to find fault 17 with what I did. So I don't know if there could be 18 a listing somewhere of all of the compliant 19 residency-fellowship programs that would be easily 20 accessible for people to look at or something along 21 those lines. Thank you.
22 MR. EINBERG: Dr. Metter, this is Chris 23 Einberg. You know, this is all excellent feedback 24 and as Celimar pointed out earlier, we're 25 developing T&E implementation guidance, and all of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
160 1 this is great feedback for consideration during the 2 development of this guidance. And, you know, the 3 ACMUI will have an opportunity to review that, the 4 implementation guidance. And, you know, so the 5 target is to have interim guidance developed next 6 August, August in 2024. So (audio interference).
7 CHAIR METTER: Thank you --
8 MEMBER WOLKOV: Dr. Wolkov, second.
9 CHAIR METTER: And Dr. Wolkov is a 10 second. Any more discussion? All in favor, say 11 aye?
12 Oh, yes, I'm sorry.
13 MS. AYOADE: Hi, Dr. Metter. I 14 apologize. This is Maryann Ayoade from NRC and for 15 those of us that were virtual, the screen did cut 16 out for like maybe the last 45 seconds to a minute.
17 But I did want to just make an additional comment 18 and just to clarify a couple of things. The NRC 19 313 Form is something, as Chris mentioned, we are 20 also reviewing as a part of that training and 21 experience implementation guidance recognizing 22 that, again, that is a guide or a way for our 23 licenses and even our license reviewers to help 24 them in the process as they receive information for 25 license reviews. We are also -- there is -- as NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
161 1 Ashley mentioned, there isn't anything for the 2 Yttrium-90 training and experience under the 313 3 Forms, but it can be used as a starting guide.
4 The other thing I wanted to mention is 5 all of the information that individuals will be 6 submitting on the training and experience alternate 7 pathway is not different from what is being 8 submitted to the specialty boards with the 9 exception of the preceptor attestation really. As 10 some of you have mentioned during this 11 presentation, if people are encouraging their 12 physicians, their potential authorized individuals 13 to make sure that they're keeping track of their 14 training and experience as they go along and not 15 just wait until the last day to try to figure out, 16 you know, what documentation do I need, who's 17 supposed to sign off on this part of my work 18 experience, who's supposed to sign off on the 19 preceptor attestation. And so, we're encouraging 20 people to keep track of their training and 21 experience documentation as they go along, use the 22 313 Form in addition to guidance that we have in 23 our NUREG-1556, Volume 9. But again, that's 24 something that we are currently looking at 25 wholeheartedly as part of this working group, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
162 1 because we want to make sure that we're being clear 2 in how individuals may or should be able to meet 3 our training and experience requirements now and 4 moving forward.
5 CHAIR METTER: Thank you very much for 6 that clarification and update, Ms. Ayoade. Any 7 other issues, any other discussion on this topic?
8 Okay. All in favor for the report as presented, 9 say --
10 (Chorus of aye.)
11 CHAIR METTER: All opposed or 12 abstained?
13 Thank you very much. The ACMUI 14 Committee is unanimous in approving the report of 15 Dr. Jadvar on Training & Experience.
16 So, our next topic is extravasation and 17 rulemaking by the NRC staff, Irene Wu.
18 MS. WU: Hi, can you all hear me okay?
19 CHAIR METTER: Yes, we can.
20 MS. WU: Okay, great.
21 Well, good afternoon. Thank you to the 22 ACMUI for the opportunity to give you an update on 23 the extravasations rulemaking.
24 I'm Irene Wu, the Project Manager for 25 this rulemaking here at the NRC and, specifically, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
163 1 I'm in the Materials Rulemaking and Project 2 Management branch in the Division of Rulemaking, 3 Environmental, and Financial Support in the Office 4 of Nuclear Material Safety and Safeguards.
5 So next slide, please? So, this is the 6 agenda for my presentation today. First, I'll 7 give you some background on this rulemaking. And 8 when I went back to sort like the last ACMUI 9 meeting agendas where I saw extravasations on 10 there, it looked like it was back in the 2021 11 timeframe when there was a subcommittee reviewing 12 the NRC staff's evaluation of extravasations and 13 medical event reporting.
14 So, I'll briefly cover that and then, 15 focus more on the more recent activities including 16 the petition, the rulemaking plan, and the latest 17 Commission direction that we received.
18 And then, next on the agenda is the 19 information request and preliminary proposed rule 20 language which we published last month in the 21 Federal Register.
22 And then, after that, I'll talk a bit 23 about our next steps for this rulemaking.
24 So, we actually have a public meeting 25 next week on the information request, so I'll talk NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
164 1 a little bit about that and what the schedule looks 2 like for the proposed rule. And then lastly, I'll 3 answer any questions you have.
4 So, yes, next slide, please? So back 5 in 1980, the Commission amended Part 35 to require 6 quarterly reporting of diagnostic 7 misadministrations and prompt reporting of 8 therapeutic misadministrations.
9 And in that 1980 final rule, the 10 Commission had excluded radiopharmaceutical 11 extravasations from the reporting requirements 12 stating, in part that, extravasation frequently 13 occurs in otherwise normal intravenous or intra-14 arterial injections. It's virtually impossible to 15 avoid, and therefore, the Commission does not 16 consider extravasation to be a misadministration.
17 So since then, I know the ACMUI has, 18 over the years, looked at whether extravasations 19 should continue to be excluded from medical event 20 reporting. I think there was some look-see at the 21 2008, 2009 timeframe and then, again, more recently 22 in 2019.
23 Next slide, please? So, at that brings 24 us to the NRC staff evaluation. If you recall, 25 that was in the January 2020 timeframe where staff NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
165 1 began this independent evaluation of whether 2 extravasations should be reported as medical 3 events.
4 And as part of that independent 5 evaluation, we wanted to hear from the medical 6 community and other stakeholders.
7 So, we had a public meeting in December 8 of 2020 to provide information on the staff's 9 evaluation and I provided on the slide the ADAMS 10 accession number for the public meeting summary, 11 that being ML21005A436.
12 And then, staff had the opportunity to 13 provide its preliminary evaluation of reporting 14 extravasations as medical events to the ACMUI. And 15 at a high level, that evaluation contained, I 16 believe it was six options with a mixture of some 17 rulemaking options, non-rulemaking options, and 18 then, we always include the no change option.
19 And the recommendation by staff was 20 that extravasation events that require medical 21 attention be reported as medical events.
22 And all of the non-rulemaking options 23 were dismissed since staff determined that 24 extravasations don't fit into the current medical 25 event reporting criteria.
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166 1 So, I have here on the slide that the 2 ACMUI agreed with the staff recommendation during 3 their September 2021 public meeting. And the ADAMS 4 accession number for that September 2021 ACMUI 5 meeting is on this slide.
6 All right, so next slide, please? So 7 that brings us to the petition for rulemaking. So 8 while the NRC staff evaluation was going on and 9 progressing in 2020, we received a petition for 10 rulemaking from Lucerno Dynamics in May of 2020 11 requesting that NRC revise its regulations to 12 require medical event reporting of extravasations 13 that result in a localized dose equivalent 14 exceeding 50 rem.
15 And in the -- later that year, I think 16 it was in September, we published a Federal 17 Register Notice announcing the docketing of that 18 petition.
19 We had a 75-day comment period. And we 20 received close to I think 500 comment submissions 21 during that comment period.
22 Then, in the May 2022 timeframe, staff 23 then provided a rulemaking plan, that being SECY-24 22-0043 to the Commission that presented options 25 for amending Part 35.
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167 1 And in that rulemaking plan, staff 2 recommended including as reportable medical events 3 nuclear medicine injection extravasations that 4 require medical attention versus expected radiation 5 injury.
6 Staff, also in that rulemaking plan, 7 committed to developing regulatory guidance for the 8 reporting of extravasations, including the 9 development of a dosimetry model that the medical 10 community could use to help in characterizing 11 extravasations.
12 And then, in December of 2022, the 13 Commission issued its staff requirements 14 memorandum, SRM SECY-22-0043, directing NRC staff 15 to begin a rulemaking amending NRC's regulations to 16 mandate medical event reporting of extravasations 17 that require medical attention for a suspected 18 radiation injury.
19 The Commission also, in that staff 20 requirements memorandum, also directed staff to 21 explore approaches to reduce reliance on patient 22 reporting, develop regulatory guidance for all 23 medical events, and to look for opportunities to 24 accelerate the rulemaking schedule without 25 shortening or shortchanging the public comment NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
168 1 periods.
2 Next slide, please? So, that brings us 3 up to present day and the information request that 4 we published in the Federal Register last month.
5 So, I'll step back a moment and say 6 that, to gain efficiencies in the development of 7 this rule, staff decided to proceed directly into 8 the development of the proposed rule.
9 So, therefore, instead of developing a 10 regulatory basis, we decided to rely on this 11 information request to address the direction by the 12 Commission.
13 And again, this is the information 14 request that was published last month, 88 FR 24130, 15 with a 90-day public comment period, consistent 16 with the direction we got from the Commission to 17 not shorten the public comment periods.
18 And the notice made the preliminary 19 proposed rule language for the rulemaking available 20 and also posed questions to obtain input from the 21 stakeholders.
22 Next slide, please? All right, so the 23 preliminary proposed rule language includes updates 24 to two sections which I will step through in the 25 subsequent slides, and that being 35.2, the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
169 1 definition section, as well as 35.3045, which is 2 the report and notification of a medical event.
3 And then, we also added to -- the 4 preliminary proposed rule language includes the 5 addition of two new sections, one for procedures 6 for evaluating reporting extravasations, and then, 7 with that, another section for the records for 8 those procedures for evaluating and reporting 9 extravasations, all of that being in Part 35.
10 And then, as I mentioned before, the 11 information requests included not only made the 12 preliminary proposed rule language available, but 13 it also put forth a set of questions that we have 14 grouped into three topics, those topics being 15 definitions, procedures, and health care 16 inequities.
17 So, for the next set of slides, I'll go 18 through the preliminary proposed rule language for 19 that grouping, that topic, and then, discuss the 20 associated questions at a very high level that were 21 in the Federal Register Notice for that topic.
22 And I do want to say as a disclaimer, 23 which is on the previous slide, that the 24 preliminary proposed rule language does not 25 represent the final NRC staff position, nor has it NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
170 1 been reviewed by the Commission.
2 So, therefore, the preliminary proposed 3 rule language may undergo revision during the 4 rulemaking process.
5 Next slide, please? All right, so, 6 again, we're going to start with the topic of 7 definitions. And here is the preliminary proposed 8 rule language for -- in Section 35.2, definitions.
9 The text in red on the next set of 10 slides, including this one, show the new language 11 being considered in the regulations.
12 So, we are initially putting out there 13 three new definitions, as you see here, one for 14 extravasation, one for medical attention, and one 15 for suspected radiation injury.
16 Extravasation is sort of the word we're 17 as opposed to infiltration. And in this case, our 18 definition, or our proposed definition for 19 extravasation is very specific to 20 radiopharmaceuticals.
21 The medical attention definition, you 22 know, we debated this one a lot. And we're not too 23 sure if it's too broad or not, but that's why we're 24 seeking public input on this preliminary proposed 25 rule language.
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171 1 And then, the suspected radiation 2 injury definition needs to cover both notice and 3 unnoticed injuries. And so, we're looking 4 specifically at the lowest severity of skin 5 deterministic effects such as erythema.
6 Next slide, please? So, here are the 7 three questions that we have in the Federal 8 Register Notice related to the new definitions that 9 we included in the preliminary proposed rule 10 language.
11 The first question is about what term 12 is best for us to use when describing the leakage 13 of radiopharmaceuticals from a blood vessel or 14 artery into the surrounding issue.
15 Again, we -- we're using extravasation 16 right now, but we want to hear if perhaps a 17 different term would be better.
18 The second question is asking about the 19 criteria we should use to define suspected 20 radiation injury.
21 And the third question is getting at 22 what -- to reduce the chance, severity, or symptoms 23 should be included in the definition of medical 24 attention.
25 Next slide, please? All right, so, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
172 1 here again, is the second grouping which is 2 procedures.
3 So, here's the preliminary proposed 4 rule language for a new section, which is Section 5 35.42, procedures for evaluating and reporting 6 extravasations. So, we used 35.41, procedures for 7 administrations requiring a written directive sort 8 of as a template for developing this preliminary 9 proposed rule language. So, you should see it 10 structured quite similarly.
11 The procedures here are being used to 12 reduce the chance of an extravasation as well as 13 the severity of the symptoms.
14 And with this potential regulation, 15 licensees will need to have good techniques to be 16 able to identify whether or not a radiation 17 exposure will lead to an injury. So, this would 18 most likely be through our dosimetry model, but 19 we're leaving it up to the physicians themselves.
20 Next slide, please? Okay, and then, 21 here is the preliminary proposed rule language for 22 a new Section 35.2042 records for procedures for 23 evaluating and reporting extravasation.
24 So, again, this is trying to parallel 25 what was done in 35.41 and 35.2041, we're doing the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
173 1 same here for 35.42 and 35.2042.
2 Mainly, it's to keep the record 3 requirements in Subpart L of Part 35. So, we've 4 included the preliminary proposed rule language for 5 this new section for records for procedures for 6 evaluating and reporting extravasations.
7 Next slide, please? Okay, so I think 8 this is the last set of preliminary proposed rule 9 language. This is for 35.3045 report and 10 notification of a medical event.
11 This section currently has, you know, 12 the instances when a licensee shall report any 13 event as a medical events. So, we've -- we're 14 proposing to add a third instance here for when a 15 licensee shall report an event as a medical event, 16 which is in the -- which is the administration of 17 byproduct material that results in an extravasation 18 that requires medical attention for a suspected 19 radiation injury.
20 Next slide, please? Okay, so this is -
21 - so now, for the procedures corresponding with the 22 procedures preliminary proposed rule language, we 23 have the most question here in the information 24 request and related to those procedures.
25 So, the next three slides, actually, go NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
174 1 through those questions in the information request.
2 The first question under the procedures 3 topic and the fourth question in the notice is 4 about minimizing the change of the -- minimizing 5 the chance of extravasations.
6 The next question, or question five in 7 the Federal Register Notice, is about the immediate 8 steps that should be taken after an extravasation 9 occurs.
10 And question six here is about how we 11 can determine if an extravasation occurred.
12 Next slide, please?
13 Continuing on to question seven, this 14 is about post extravasation activities, things that 15 a doctor can do following the event while the 16 patient is still in the hospital for care.
17 Question number eight is getting at 18 what should be included in sort of an informational 19 sheet for patients that can be handed out to help 20 identify possible injuries and where to go if they 21 experience them.
22 Question number nine is related to the 23 discovery of an event which then has a lot of 24 implications for the timing of reporting. And 25 you'll see we also have another question on timing.
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175 1 Next slide, please?
2 All right, I think these are the last 3 three for procedures.
4 So, question number ten is another 5 question on timing, specifically when licensees 6 should be required to provide notification of an 7 extravasation medical event to the referring 8 physician and individual.
9 Question number 11, we're trying to get 10 at what medical professional has the skills needed 11 to identify the severity of these extravasation.
12 And you see that as part of the 13 question, we included a few examples of who that 14 might be to help the public in answering the 15 question.
16 And question number 12 is about what 17 topics should be included in the guidance document 18 that we're developing along with the rule package.
19 Next slide, please? All right, so this 20 is the last slide on the information request 21 questions with the last two questions related to 22 the topic that we've labeled as health care 23 inequities.
24 Now, we don't have any preliminary 25 proposed rule language related to these questions, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
176 1 but we wanted to include them in the information 2 request because we had heard from some patient 3 safety groups with concerns about the inequities in 4 the health care community. And so, we're looking 5 for input on how this rulemaking can effectively 6 address these concerns.
7 Next slide, please? All right, so just 8 to highlight how the public is able to submit 9 comments on the Federal Register Notice for the 10 information request.
11 So, I mentioned earlier that this 12 information request Federal Register Notice was 13 published on April 19th with a 90-day comment 14 period.
15 And as outlined in the Federal Register 16 Notice, there are three methods for the public to 17 submit comments.
18 They can either go to regulations.gov 19 and go to our specific docket, Docket ID NRC-2022-20 0218 and submit a comment that way. They can also 21 email us with their comments.
22 And they can also put their mail --
23 post mail their comments to us as well on the --
24 the email and the address are both included in the 25 FRN as well as the docket ID for the regs.gov.
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177 1 Next slide, please? So here are our 2 next steps. We are having a public meeting, as I 3 said earlier. We're going to have it next week on 4 May 24th to facilitate feedback and answer 5 questions on the information request.
6 We won't be actually collecting 7 comments at the public meeting as we want the 8 comments to be on the rulemaking docket. So 9 they're going to be needed to be submitted via the 10 methods I talked about on that previous slide.
11 But the -- and if anybody is interested 12 in -- that's listening that wants to be --
13 participate in that public meeting, that 14 information is available on the NRC's public 15 meeting website.
16 As I've said a few times, the public 17 comment period for the information request ends on 18 July 18th.
19 And then, the proposed rule right now 20 is currently estimated to go to the Commission in 21 August of 2024.
22 So, what that means for the ACMUI is 23 we'll be planning to give the ACMUI an opportunity 24 to review the draft proposed rule before it goes to 25 the Commission. And right now, we're estimating NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
178 1 that time frame to be in the -- sort of the March 2 to May 2024 time frame.
3 And after the proposed rule goes to the 4 Commission, the Commission still has to vote and 5 provide direction for the staff in a staff 6 requirements memorandum, or SRM, before we can 7 publish the proposed rule for the -- in the Federal 8 Register.
9 And right now, again, just an 10 estimation that that would be around the December 11 2024 time frame.
12 So next slide, please? With that, that 13 is the end of my presentation. I'd be happy to 14 take any questions that you may have.
15 CHAIR METTER: Thank you, Ms. Wu, for 16 that very thorough and very in-depth presentation 17 on extravasations. And I really appreciate the NRC 18 staff on their work on this.
19 Do I have any questions from the ACMUI 20 for Ms. Wu?
21 We have -- okay, we'll go this way.
22 Dr. Harvey?
23 MEMBER HARVEY: Thank you, Richard 24 Harvey, apologize.
25 I guess I have the dissenting NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
179 1 viewpoint. I think extravasations are a very 2 important quality assurance issue for the hospital, 3 clinic, or licensee. But I don't feel it should be 4 an NRC medical event.
5 That's my comment.
6 CHAIR METTER: Thank you.
7 Mr. Green?
8 MEMBER GREEN: Thank you.
9 Appreciate the presentation, Ms. Wu.
10 I'm a little bit flustered by the use 11 of the term extravasation.
12 We're trying to get a drug into a 13 confined space and that space typically is in the 14 venous -- in the circulatory system. It could be 15 arterial or it could be venous.
16 And what we're looking at is stuff that 17 doesn't get in there or leaks out.
18 There are other confined spaces that 19 radiopharmaceuticals are injected into like 20 intrathecal for radionuclide cisternography with 21 indium-111 pentetate, or DTPA.
22 There are drugs that are no longer on 23 the market such as chromic phosphate P32 which was 24 instilled into cavities.
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180 1 where material is not depositing in the right 2 space?
3 So, I'm not sure that the E word, 4 extravasation is correct and maybe infiltration is 5 a better choice.
6 CHAIR METTER: Thank you, Mr. Green, 7 that's --
8 MS. WU: Yes.
9 Sorry, go ahead.
10 CHAIR METTER: No, go ahead. Go ahead, 11 Ms. Wu, go ahead and make a comment.
12 MS. WU: No, I was -- all I was going 13 to say was, you know, that is sort of the reason 14 behind that one question that we have in the 15 information request, if extravasations is the right 16 term or if infiltration or another term may be 17 better. That's all.
18 CHAIR METTER: Okay, thank you.
19 And Ms. Ouhib?
20 MEMBER OUHIB: Yes, thank you for a 21 great presentation.
22 I happen to share the opinion of the 23 two previous ACMUI members.
24 One good reason is that it's almost 25 like here we go again that, as we introduce another NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
181 1 area of medical events, I'm wondering what's going 2 to happen to the authorized users for such 3 practice.
4 That maybe that would be sort of like 5 discouraging. And it's all -- we learned that a 6 long time ago with prostate brachytherapy as 7 medical events started to pop left and right and 8 all that.
9 And then, next thing you know, is 10 prostate brachytherapy is not as common anymore, 11 even though there was an effort to make it less 12 difficult, we don't see much of it. So, I think 13 that could be an issue.
14 The other question that I have for you, 15 are there any exclusions for such medical events, 16 per se, for this type of procedures?
17 I'll give you an example, a patient had 18 an injection, left, had a physical injury in the 19 area of where the injection was. Now, the patient 20 reports that they're having an issue in that area.
21 Now, is that going to be qualified as a 22 medical event?
23 And that's just a basic case that I 24 thought of now. But there could be others that 25 might not quite qualify for that.
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182 1 Thank you.
2 CHAIR METTER: Thank you for that 3 observation. Dr. Jadvar?
4 VICE CHAIR JADVAR: Thank you. So, I 5 just want to remind people, as was mentioned before 6 by Mr. Green, that, you know, you're trying to 7 puncture a vein to get in there to get some stuff 8 inside. That is -- there's going to be a hole 9 there.
10 When you pull the needle out, it's 11 going to be leaving a beading. That's normal.
12 That's the body.
13 Which, you know, eventually we close 14 off the platelets going there and then, trying to 15 close it up. But there's going to be a small 16 amount of bleeding. There's going to be a small 17 amount of radiotracer, in some cases, in many 18 cases, in fact, that can be right there and can 19 show up on the scans like a small dot, but very hot 20 sometimes.
21 Is that extravasation? It's not. It's 22 a normal thing. You made hole, there was bleeding.
23 There's going to be some concentration radio tracer 24 activity there.
25 And therefore, you know, it really NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
183 1 depends on where it's infiltration or extravasation 2 and that activity at that moment of time may exceed 3 whatever threshold you want to use.
4 But because of the lymphatics, because 5 of the way the body clears it, it's going to have 6 no effect whatsoever, despite the fact that they're 7 going to be a little bit of higher activity at the 8 -- concentration of activity at that time.
9 But it will have no bearing on 10 diagnostic quality of their scan that you're 11 looking at.
12 I just want to also draw your attention 13 to a recent article that was just published a 14 couple of months in the journal from Washington 15 University.
16 They looked at almost 32,000 scans, 17 bone scans, which is a very common procedure, that 18 they have done over the years at Wash U.
19 And the extravasation rate that was 20 documented was 0.37 percent, very, very small 21 number of people. And none of them that they 22 looked into all their, you know, documentation that 23 was in the records, none of them had any long-term 24 local effects.
25 In fact, they -- it's interesting, if NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
184 1 you go to the paper itself, they show one image, 2 which is Figure Number 2 which looks horrible. I 3 mean, there is this very large area of very intense 4 activity. But that patient had no long-term 5 effects at all, just some warm pad and elevation of 6 arm. And the quality of the scan was excellent.
7 You could make a decision if this 8 patient has metastatic disease or not. So, I think 9 what I'm saying is, that I agree with my three 10 other colleagues around the table that you're -- I 11 think you're making too much of this, I personally 12 think.
13 CHAIR METTER: Thank you very much, Dr.
14 Jadvar. Any other comments from the committee?
15 Yes, Mr. Green?
16 MEMBER GREEN: Just want to point out, 17 the professionals that we work with that work with 18 the nuclear medicine physician that perform the 19 patient administrations are appropriately referred 20 to as nuclear medicine technologists. In question 21 11, they're referred to as technicians, and that 22 should be corrected.
23 CHAIR METTER: Thank you for that 24 suggestion.
25 VICE CHAIR JADVAR: Well, since he NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
185 1 mentioned technicians, there was one slide that 2 says blood vessel or artery. So, it should be the 3 vein or artery, because artery is a vessel.
4 So, you know, and we normally don't 5 really inject into artery unless it's Y-90, if 6 you're going to arterial system in the liver. But 7 normally, almost 100 percent of 8 radiopharmaceuticals are administered 9 intravenously.
10 CHAIR METTER: Yes, Mr. Green?
11 MEMBER GREEN: Because I'm a geek, I 12 have a list of the 55 FDA approved 13 radiopharmaceuticals that are currently approved.
14 Forty-five of them have indications for intravenous 15 administration, three are oral, one's inhaled, 16 one's intradermal, and one's intrathecal.
17 So, we've got to make sure that 18 whatever we're writing is not all 19 radiopharmaceuticals, but those that go into that 20 intravenous space.
21 CHAIR METTER: Thank you. Do I have 22 any other comments from the ACMUI or questions?
23 Any from the NRC staff? Mr. DiMarco?
24 MR. DIMARCO: Hi, Daniel DiMarco, 25 technical lead on the extravasation rulemaking.
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186 1 I just want to make a couple comments 2 for some of the comments from the ACMUI.
3 So, when we were determining what we 4 wanted the reportable for specifically an 5 extravasation -- for a medical event involving an 6 extravasation, we took all the comments because 7 we've been hearing this from the ACMUI and the 8 medical community for the entire time we've been 9 doing this, and we've been trying to take these 10 comments under consideration.
11 And so that's why we wanted to 12 determine this to be, one, to be a radiation 13 induced injury because we didn't want to see any of 14 these reportable events come from, say, like 15 someone using the -- an allergy to the tape being 16 used or any sort of local trauma because of -- an 17 injection is a traumatic event, at least for that 18 local area.
19 So that's why we have a couple of those 20 questions in there on specifically being a 21 radiation injury and what sort of medical 22 professionals should be able to consult to say that 23 this was a radiation injury versus any sort of 24 other local injury due to any other, you know, 25 these are sick patients, maybe there's something NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
187 1 going on in the local area that isn't due to the 2 radiation.
3 So that's one thing. As for another, 4 at least with the diagnostics, the NRC does not 5 regulate image quality on that. So, we didn't want 6 to step into that area at all. Image quality is 7 strictly a medical community metric and the NRC 8 does not regulate that.
9 And I believe that was all I had to 10 say. If anyone has any other comments or questions 11 for me.
12 MEMBER OUHIB: It's a question, but I 13 think I'd like to hear it from the users is that, 14 you know, those type of things might very well be 15 included in the consent form, that the patient 16 ought to expect certain things.
17 They're not out of the ordinary.
18 They're totally normal things that could occur.
19 And now, we're saying that things that 20 could potentially occur are medical events. It 21 just doesn't make any sense to me.
22 MEMBER HARVEY: I think the distinction 23 that we have to take into account is that we get to 24 a tissue reaction level. And until we get to that 25 dose, anything below that threshold is not included NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
188 1 as a medical event.
2 So, some of the normal routine things 3 would certainly not fall under this. And I think 4 what the NRC's done is come up with a great 5 compromise to try to make this work.
6 I still have the dissenting opinion 7 that it should not be a medical event. But I think 8 you have to meet that bar. You have to meet that 9 threshold to be included. So, I just wanted to put 10 that out there. Thank you.
11 MR. DIMARCO: Yes. And so, part of 12 that threshold, we can't set that line or we're not 13 trying to set that line for any facility with is 14 this an event something that could possibly be a 15 reportable extravasation.
16 But part of that is the dosimetry model 17 that we're formulating that will be part of the 18 guidance, an appendix in the guidance. And so that 19 will be of use to everyone.
20 And in that, we're trying to get a 21 conservative estimate of the dosimetry with the 22 addition of certain techniques like warming the 23 area or elevating the arm, and so how that changes 24 the dosimetry and how that changing dosimetry 25 changes the probability of a certain extravasation NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
189 1 and having some sort of erythema or patient harm 2 for that.
3 CHAIR METTER: Thank you.
4 Do I have any other questions or 5 comments?
6 Yes, Mr. Ouhib?
7 MEMBER OUHIB: Yes, just a comment.
8 So, let's just take a situation where the 9 authorized user might very well predetermine or see 10 that this patient might very well have an issue.
11 I'm not sure. Okay?
12 So, choosing between reporting a 13 medical event or simply saying to the patient, I'm 14 sorry, but I might not be able to do this and 15 here's what the issue is.
16 And I'm just speculating here, this 17 might not happen, but I'd like to hear it from the 18 authorized user if that's a possibility and the 19 patient is basically sent home and not provided a, 20 you know, proper care, per se, because of that.
21 MR. DIMARCO: Thank you for that 22 comment.
23 CHAIR METTER: Okay, any other comments 24 from the ACMUI or NRC staff?
25 MS. PINEDA: Dr. Metter, I think Megan NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
190 1 Shober may have a comment.
2 CHAIR METTER: Oh, I'm sorry.
3 Yes, Ms. Shober?
4 MEMBER SHOBER: Yes, can you hear me?
5 CHAIR METTER: Yes, we can, I'm sorry, 6 I didn't see your --
7 MEMBER SHOBER: That's all right.
8 I just wanted to point out that when we 9 had the extravasation subcommittee, a couple years 10 ago, one of the big concerns that we had was on the 11 therapeutic radiopharmaceuticals that were coming 12 on the market.
13 Our emphasis in the conclusions that we 14 -- when we got to the point of making the decision 15 about which recommendation to support for the 16 extravasation rulemaking, we were really concerned 17 about the potential for therapeutic extravasations.
18 So, I know that the study that Dr.
19 Jadvar was mentioning was bout bone scans, 20 obviously, that's diagnostic.
21 But the concern was that, even if they 22 don't happen very often, that those -- if you did 23 have a therapeutic extravasation, that you could 24 have some pretty significant consequences from 25 that. Thank you.
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191 1 CHAIR METTER: Thank you, Ms. Shober, 2 with that very important information. Do I have 3 any other comments from the staff or the ACMUI?
4 Okay, can we open up to the public?
5 MS. PINEDA: If you're a member of the 6 public and you'd like to make a comment, again, 7 just use the little hand icon to raise your hand if 8 you're on Teams.
9 And if you've called in by phone, just 10 press star five to raise your hand and then, star 11 six to unmute yourself after I call your name.
12 Thank you.
13 MS. PINEDA: It looks like we don't 14 have anyone.
15 CHAIR METTER: Okay, it looks like 16 there are no public comments.
17 So, thank you very much for that very 18 detailed and very in-depth and thoughtful 19 presentation on extravasation. I really appreciate 20 the NRC staff and you particularly, Irene Wu, 21 regarding this presentation.
22 So, let's go to the next item on the 23 agenda. This is the ACMUI reporting structure by 24 Dr. Valentin-Rodriguez of the NRC.
25 MS. VALENTIN-RODRIGUEZ: Good NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
192 1 afternoon, everyone. Again, as Dr. Metter 2 mentioned, I'll be providing the review of our 3 reporting structure, a discussion of our annual 4 review, and frequency of meetings, and then, I'll 5 open it up to the ACMUI for discussion.
6 Next slide, please?
7 Okay, next slide, please? So, the 8 graphic on the slide provides a graphic of the 9 current reporting structure. From the bottom up, 10 you'll see that the ACMUI reports directly to Mr.
11 Kevin Williams who you all saw this morning during 12 his opening remarks.
13 He is the Director of the Division of 14 Materials Safety, Security, State, and Tribal 15 Programs, otherwise known as MSST.
16 And reporting to Mr. Williams is Chris 17 Einberg, who's in the room today who is the Branch 18 Chief for the Medical Safety and Events Assessment 19 Branch.
20 In our division, MSST, we report to Mr.
21 John Lubinski in the Office of Nuclear Material 22 Safety and Safeguards.
23 And then, NMSS reports to the Executive 24 Director of Operations Office who is currently Mr.
25 Daniel Dorman and who reports to the Commission.
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193 1 So, the ACMUI does not report directly 2 to the Medical Safety and Events Assessment Branch, 3 however, within our branch resides the Medical 4 Radiation Safety Team who helps coordinate and 5 support the day to day activities of the committee.
6 During the presentation of the bylaws 7 in September 2012, the ACMUI recommended to having 8 an annual review in its reporting structure.
9 Christine, can I get the next slide, 10 please? Sorry, there we go.
11 And at that time, the ACMUI was 12 presented with an option to continue to report to 13 NMSS or to report directly to the Commission.
14 And the subcommittee report provided in 15 2012 stated that the working relationship with the 16 -- between the NRC and the ACMUI remained excellent 17 and the reporting structure through the staff 18 continued to work or function effectively.
19 And so, at that time, the subcommittee 20 and the ACMUI agreed that the associated logistics 21 with direct reporting to the Commission, such as 22 more frequent meetings, did not and does not 23 justify any change to the ACMUI's reporting 24 structure.
25 Next slide, please? So, we currently NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
194 1 hold two meetings each year. We started to hold 2 them in person again, which are our spring and fall 3 meetings.
4 I know our May and December meetings 5 have been a little bit out of the ordinary in terms 6 of time frame. We had to do a lot of adjustments 7 post-pandemic. And so, we'll also do 8 teleconferences on an as needed basis.
9 Next slide, please? So, at this time, 10 I'll turn it over to Dr. Metter and the ACMUI for 11 discussion on whether the committee continues to be 12 satisfied with this current reporting structure, 13 what's not working about the reporting structure, 14 and any recommendations for improvement. So, thank 15 you.
16 CHAIR METTER: Thank you very much for 17 that review and reminding us how the structure 18 works for the ACMUI and with the whole NRC.
19 So do I have any questions for Dr.
20 Valentin-Rodriguez regarding the ACMUI reporting 21 structure or any comments? Any suggestions?
22 Mr. Green?
23 MEMBER GREEN: Thank you, Dr. Metter.
24 I just wanted to echo, I think comments 25 you made at least twice today, you know, there has NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
195 1 not been a direct support person supporting the 2 ACMUI that Dr. Valentin-Rodriguez has taken that 3 upon herself personally in addition to all her 4 other activities.
5 And I think we've been very well 6 supported and assisted in our activities. And I 7 look forward to have a full-time person that can do 8 that for us. Not that we have been famished and 9 not supported.
10 But, you know, there are other things 11 that the medical staff have to do, but I think 12 they've done a great job in supporting us.
13 CHAIR METTER: Thank you.
14 MS. VALENTIN-RODRIGUEZ: Thank you, Mr.
15 Green.
16 And as I think Chris and Kevin Williams 17 said this morning, we have hired someone, but, you 18 know, the bureaucracy of the federal government 19 hiring processes can be a bit long in the tooth.
20 So we're hoping to have her in place in the next 21 few weeks.
22 And so hopefully Ms. Armstead will be 23 here to support you in our day-to-day activities 24 and we can resume more normal operations.
25 So, I appreciate your feedback.
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196 1 CHAIR METTER: And Dr. Valentin-2 Rodriguez, I personally would like to thank you 3 particularly for your work because I know you're 4 doing like double duty, but also the NRC staff.
5 They've been very -- they're very professional, 6 very knowledgeable and really very prompt in their 7 responses to our questions and our needs. And that 8 only helps to make our job easier to help the 9 public in the protection and the use and -- the 10 medical use of isotopes.
11 And thank you very much.
12 MS. VALENTIN-RODRIGUEZ: Thank you, Dr.
13 Metter. It's a pleasure and to be able to work 14 alongside all these esteemed professionals.
15 So, I don't know, Chris, if you wanted 16 to have some words? But we truly appreciate it 17 from the NRC side.
18 MR. EINBERG: Yes, thank you, Dr.
19 Metter.
20 I'm -- very kind words and, as Celimar 21 said, you know, it's our pleasure and, again, we 22 really do -- or, you know, from my perspective, I 23 think we have a great team supporting the ACMUI, 24 supporting the medical community.
25 And, of course, what an esteemed body NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
197 1 we have here. And so, I think there's very good 2 collaboration between the NRC staff and the ACMUI 3 members.
4 CHAIR METTER: So, the question still 5 stands, do we like the current plan as far as 6 having two meetings per year, one in the spring and 7 one in the fall, given these general time frames?
8 PARTICIPANT: Yes.
9 CHAIR METTER: Okay, given that, I see 10 lots of heads shaking, nodding up and down, that 11 means yes rather than sideways. So, do I have a 12 motion to approve?
13 (Off microphone comment.)
14 CHAIR METTER: I have a motion to 15 approve the current schedule for meetings. Do I 16 have a second?
17 MEMBER HARVEY: Richard Harvey, I will 18 second that motion.
19 CHAIR METTER: Great. Any other 20 discussion?
21 All in favor, say aye.
22 (Chorus of aye.)
23 CHAIR METTER: All opposed or abstain?
24 I hear crickets, so that means that it 25 has unanimously been approved by the committee.
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198 1 And thank you very, very much for all that you do 2 to help us.
3 So, I believe we have a break right 4 now, we're going to be a little early unless 5 there's anything else, Mr. Einberg, do we have to 6 cover before we go to break?
7 MR. EINBERG: Nothing -- sorry, nothing 8 at all. So, yes, let's go to break then. And then 9 we'll resume at 3:00.
10 CHAIR METTER: At 3:15, I believe is on 11 my schedule.
12 MR. EINBERG: I'm sorry, yes, at 3:15, 13 my apologies.
14 CHAIR METTER: So, we'll have a break 15 right now, and we'll go off the air and we'll be 16 back at 3:15.
17 (Whereupon, the above-entitled matter 18 went off the record at 2:38 p.m. and resumed at 19 3:14 p.m.)
20 CHAIR METTER: Well, good afternoon, 21 and welcome back to the 2023 Spring ACMUI Meeting.
22 And we're just about to start our last section of 23 today's meeting.
24 And I'm Darlene Metter, ACMUI Chair and 25 Diagnostic Radiologist. And I'd like to introduce NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
199 1 Dr. Richard Harvey, our ACMUI (audio interference) 2 for his presentation on the decommission financial 3 assurance for sealed and unsealed radioactive 4 materials.
5 MEMBER HARVEY: Thank you very much, 6 Dr. Metter.
7 Appreciate the opportunity to submit 8 the report and presentation today.
9 I guess we can go to the next slide.
10 And can go to the next one, no financial 11 disclosures.
12 Again, I just wanted to thank the 13 entire subcommittee for all their efforts to get 14 this done. And I very much appreciate that.
15 So, Ms. Allen, Dr. Jadvar, Mr. Mailman, 16 Ms. Martin, Ms. Shober, so, thank you.
17 I'd also like to thank the NRC staff 18 resource for their fantastic work. And Ms.
19 Flannery really did all the heavy lifting on this 20 and really made it very, very easy for us to get 21 through this. So, thank you very much, Ms.
22 Flannery.
23 And thank you to Dr. Valentin-Rodriguez 24 for all her help in the report, ready, thank you.
25 So next slide, please. Our NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
200 1 subcommittee charge was to review and comment on 2 the draft proposed rule for the rulemaking for 3 decommissioning financial assurance for sealed and 4 unsealed radioactive materials.
5 A quick background -- next slide, 6 please?
7 Quick background is U.S. Nuclear 8 Regulatory Commission, NRC, is proposing to amend 9 its regulations for decommissioning financial 10 assurance for sealed and unsealed radioactive 11 materials.
12 The rulemaking would revise NRC's 13 decommissioning funding requirements for 14 radioactive materials based in the relative risk to 15 the public health and safety from different 16 radioisotopes including naturally occurring and 17 accelerated produced radioactive material.
18 The potentially affected licensees are 19 those authorized to possess radioactive materials 20 licenses.
21 Next slide, please? So, the proposed 22 rule changes, the language in 10 CFR 30.35, 23 financial assurance and record keeping for 24 decommissioning will remain unchanged.
25 The only change is the values in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
201 1 Appendix B, okay, to Part 30, Appendix B to Part 30 2 which is entitled quantities of licensing material 3 requiring labeling will be updated.
4 The values in Appendix B will be 5 updated to those of Appendix C of 10 CFR Part 20 6 for radionuclides with half-lives greater than 120 7 days.
8 We don't see any significant impact to 9 the licensees with germanium-68 or gallium-68 10 generators.
11 The benefits of this proposed rule 12 change are to provide relief for previously 13 unlisted radionuclides and there doesn't seem to be 14 any expected negative impacts to the licensees.
15 Next slide, please? So, our 16 recommendation -- this subcommittee -- the ACMUI 17 subcommittee on the decommissioning of financial 18 assurance for sealed and unsealed radioactive 19 materials draft proposed rule recommends that the 20 proposed rule with the changes to the table in 21 Appendix B to Part 30 be accepted as proposed.
22 And then the next slide is just 23 acronyms and I can take -- or any questions that 24 you may have for simply changing a table.
25 CHAIR METTER: Thank you, Dr. Harvey, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
202 1 for your committee's -- subcommittee's work on 2 this. Do I have any other comments from Dr.
3 Harvey's subcommittee?
4 Any comments or questions from the 5 ACMUI?
6 Yes, Mr. Green?
7 MEMBER GREEN: Are we changing all the 8 values that are in Table C to now be in Table or 9 just those with half-lives over 120 days?
10 MEMBER HARVEY: Richard Harvey. We're 11 taking everything from the one table and putting it 12 in the other. And I don't remember off the top of 13 my head how much overlap there might be.
14 So, we don't really see any impact to 15 the group. So, I guess I don't really have a great 16 answer to your question, unfortunately.
17 But the significant focus was on those 18 greater than 120 days. Obviously, as you know, 19 things that are less than 120 days have less 20 stringent regulations and so most of those things 21 can be either stored on site and managed on site 22 and decommissioning and funding financial assurance 23 is not necessarily required.
24 So, what really is impacted is those 25 with half-lives greater than 120 days.
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203 1 MEMBER GREEN: Thank you.
2 MEMBER HARVEY: You're welcome, Mr.
3 Green.
4 CHAIR METTER: Any other questions for 5 Dr. Harvey or any comments?
6 Okay, any from the NRC staff?
7 Any questions from the public?
8 Yes, sir?
9 MR. HOLAHAN: Yes, good afternoon, Dr.
10 Vince Holahan. I'm Senior Level Advisor at NMSS.
11 To answer your question, when we 12 started, we had 180 isotopes in Appendix B to Part 13 30. 130 of those isotopes were removed because 14 their half-lives were 120 days or less.
15 When Appendix B to Part 20 was updated 16 in 1991, it was increased from 260 isotopes to 757.
17 Of those, we added back to the new Appendix B to 18 Part 30, 105 isotopes bringing it to 154.
19 What we find is, for the most part, 20 there were only changes in a couple of isotopes, 21 cadmium-109 actually went down by a factor of 10.
22 Most of the isotopes went up by a factor of either 23 10 to 100.
24 The only thing will be the default 25 values of those that aren't in the table already.
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204 1 Those will decrease by about a factor of 10. Thank 2 you, ma'am.
3 CHAIR METTER: Thank you very much for 4 that information. Did you have any other questions 5 of him, Dr. Harvey?
6 MEMBER HARVEY: I wanted to thank him 7 very much for his support. Thank you very much.
8 CHAIR METTER: Thank you. Do I have 9 any other comments from the public?
10 MS. PINEDA: If you're a member of the 11 public and you have a comment or a question, just 12 hit the little hand icon in Teams. Or on your 13 phone, press star five to raise your hand. Thank 14 you.
15 CHAIR METTER: It looks like there's no 16 questions from the public. Do I have a motion to 17 approve Dr. Harvey's report to the ACMUI?
18 Dr. Wolkov?
19 MEMBER WOLKOV: Harvey Wolkov, so 20 moved.
21 CHAIR METTER: Thank you. Do I have a 22 second for approval?
23 MEMBER O'HARA: Michael O'Hara, so 24 moved.
25 CHAIR METTER: Thank you, Dr. O'Hara.
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205 1 Any other discussion or comments?
2 All in favor of approving Dr. Harvey's 3 presentation, say aye.
4 (Chorus of aye.)
5 CHAIR METTER: Any abstention or 6 opposed?
7 Thank you very much, the report is 8 approved unanimously by the ACMUI.
9 So, our next item on the agenda is an 10 open forum where the ACMUI will discuss medical 11 topics of interest for the future. Do we have any 12 of those topics that anyone would like to bring up 13 at this time? Ms. Martin, yes?
14 MEMBER MARTIN: I seem to be good at 15 this today. I'm not sure I have all the details 16 that I should know before I bring this up, but 17 there was a fair amount of discussion in the 18 physics groups that there is a proposal that will 19 basically lower the limits requiring the increased 20 controls for HDR units.
21 And I was just wondering if that has 22 been brought to the hospitals' attention and what 23 impact that would have on the -- because it would 24 have a significant impact on many users that -- how 25 that's being considered if you have to add NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
206 1 increased controls for all the HDR units.
2 MEMBER HARVEY: Dr. Martin, can you 3 tell us what they're lowering the threshold to?
4 Will then it include all like single irradiators?
5 Because, currently, it's just more than 6 one co-located together and there were regulation 7 thresholds were set so that one HDR unit had less 8 stringent regulations. Are we now talking about 9 including individual HDRs?
10 MEMBER MARTIN: That was the talk. But 11 again, this was done at a physics group discussion 12 and I don't have enough details to give you the 13 information.
14 But that was the implication that all 15 of the single units would now have to have the 16 increased controls at all times.
17 And I was -- I'm really looking for 18 information if that's really a true statement or I 19 would love for someone from the NRC or someone else 20 to disprove that.
21 MR. EINBERG: I see that Dr. Valentin 22 has her hand up and maybe she can elaborate.
23 But I haven't heard of anything.
24 MS. VALENTIN-RODRIGUEZ: Thanks, Chris.
25 Yes, so if you'll remember in the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
207 1 December 2022 fall meeting, we had a presentation 2 from Dr. Andy Carrera on the radioactive source 3 security and accountability rulemaking.
4 That rulemaking looks -- puts further 5 controls on Category 3 sources of material.
6 So licensees who now possess Category 3 7 sources of material, in this case, for example, 8 those who have HDR units, will have further 9 controls, including if they, for example, submit an 10 application for a license or if they want to 11 increase their amount of material to receive 12 Category 3 sources, they would have to have pre-13 existing -- they would need to meet certain 14 conditions that would make them what we call a 15 known applicant which may subject them to, for 16 example, pre-licensing with this.
17 And there would be further requirements 18 for license verification.
19 But at this time, there would be no 20 requirement to implement what we call Part 37 or 21 what used to be called increased controls and is 22 now physical security requirements in 10 CFR Part 23 37.
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208 1 just be a few things that they would need to meet, 2 and that would be in order to ensure security of 3 Cat 3 sources.
4 I can share that presentation from Dr.
5 Carrera from the December fall meeting to kind of 6 give you more of an update or kind of a summary of 7 what that rule -- proposed rule will entail.
8 MEMBER MARTIN: That would be much 9 appreciated because I know the AAPM group's looking 10 for that information because it impacts so many of 11 our members.
12 CHAIR METTER: Okay, thank you.
13 Any other suggestions for topics?
14 Okay, any from the NRC staff?
15 MR. EINBERG: No.
16 CHAIR METTER: So, at this time, if 17 there are any that do come up in the future, just 18 go ahead and you can email Dr. Valentin-Rodriguez 19 or myself or Mr. Chris Einberg regarding that.
20 Thank you very much.
21 So let's go on to the final item on our 22 agenda, our administrative closing by Dr. Valentin-23 Rodriguez.
24 MS. VALENTIN-RODRIGUEZ: Thank you, Dr.
25 Metter.
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209 1 Today, we heard a great many topics.
2 And so, I wanted to thank the ACMUI members for 3 their thoughtful feedback as well as the presenters 4 from both NRC and the ACMUI, and also our public 5 for their input and feedback on the topics we 6 discussed today.
7 Just a brief overview of the topics 8 that were discussed, we had a very informative 9 presentation from Mr. DiMarco about our fiscal year 10 2022 medical events. We also had a presentation 11 and updates to the abnormal occurrence criteria, 12 specifically, to Medical AO criteria as well as an 13 update on ongoing medical team activities.
14 We heard from Dr. Jadvar, which turned 15 into a very lively discussion about training and 16 experience for all modalities.
17 And I wanted to assure the ACMUI 18 members as well as the public that we're working on 19 that implementation guidance that we've talked 20 about. And this is the sort of feedback that we 21 really want to hear from you all as to what are the 22 questions that you all have when implementing our 23 training experience requirements in 10 CFR Part 35.
24 We also heard the status of our 25 extravasations rulemaking, and we heard some NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
210 1 feedback on that.
2 And I want to remind everyone there's a 3 public meeting next week, May 24th, from 1:00 to 4 4:00 p.m. Eastern Standard -- Eastern Daylight Time 5 for that.
6 And we also had a review of our ACMUI 7 reporting structure and Dr. Harvey provided a 8 report on the decommissioning financial assurance 9 proposed rule.
10 So, with that, I didn't capture any 11 action items from the NRC or ACMUI. Dr. Metter, 12 did you capture any action items at this time?
13 CHAIR METTER: No, not at this time.
14 But thank you very much for that nice, very concise 15 review.
16 MS. VALENTIN-RODRIGUEZ: So, the next 17 topic for the administrative closing will then be 18 selecting a tentative or two dates for our fall 19 meeting.
20 I've provided in advance several 21 meetings that would work in concert with a proposed 22 Commission meeting in the September and November 23 time frame.
24 Right now, on this slide, you have 25 September -- you have a few September dates --
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211 1 thank you.
2 The first tentative date is September 3 11 and 12 which would be Monday, Tuesday. That 4 would accommodate a full meeting on Monday and the 5 Commission meeting on Tuesday.
6 Christine, can you go back to the next 7 -- can you go to the next slide? Thank you.
8 There are no available dates right now 9 in October for a Commission meeting. So, we 10 bypassed October.
11 And then, I also offered several 12 tentative dates in September -- in November, namely 13 November 1st and 2nd, 13th and 14th, with -- and 14 those would be Commission meeting on Thursday, the 15 2nd, Tuesday, November 14th, and then, a third date 16 Wednesday, Thursday, November 15 and 16, with the 17 Commission meeting on Thursday, November 16th.
18 So, I think the November dates look to 19 be more agreeable to those who contacted me 20 beforehand with the September 11th to 12th date a 21 little bit behind in terms of votes, but not by 22 much.
23 So ,I wanted to bring it up to you all 24 for discussion so that we can pick two dates and 25 then propose that to our Office of the Secretary to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
212 1 get on the Commission's books for the fall.
2 CHAIR METTER: Any comments from the 3 members regarding certain dates? Yes, Dr. Jadvar?
4 VICE CHAIR JADVAR: Well, 5 unfortunately, I'm personally not available for 6 13th to 16th, I'm traveling at that time. For me, 7 my best dates are in September and then one or two 8 in November, but not during the 13th through 16th.
9 CHAIR METTER: Any other comments? I 10 think we had initially -- the majority of the 11 members kind of wanted to do -- make it abutting a 12 weekend.
13 So, any other suggestions? Yes, 14 Melissa?
15 MEMBER MARTIN: Well, just realize that 16 if you have the meeting on November 1st and 2nd, 17 that requires us to travel on Halloween.
18 VICE CHAIR JADVAR: I second Darlene's 19 mentioning because during the week, at least for 20 us, we're coming from across the country, it really 21 have to take another day off from work on Tuesday 22 to be able to be here on a Wednesday. So that's 23 why I think, you know, a coupled to a weekend would 24 be better.
25 MEMBER HARVEY: November 13th is the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
213 1 American Heart Association scientific sessions.
2 MEMBER MAILMAN: Of course, the 3 September date is the European Nuclear Medicine 4 meeting which is E&M is that Monday and Tuesday as 5 well as I have multiple obligations in there and 6 one of their -- there's a patient -- the 7 International Patient Meeting in Italy. So, I'm --
8 it's a hard date, but they're all hard dates. So, 9 we'll figure it out.
10 CHAIR METTER: Any other comments?
11 Because if we don't do those Monday, 12 Tuesdays, then you're confined to November 1 and 2 13 and Halloween.
14 But you know what we could do? If 15 people are not opposed to it, perhaps just send out 16 another poll for those weeks, or is that going to 17 be difficult, Dr. Valentin-Rodriguez?
18 MS. VALENTIN-RODRIGUEZ: No, I can 19 certainly send out another poll.
20 So, these dates that I proposed to you 21 all ensure that we have a date that's available to 22 the Commission for a Commission briefing. That 23 way, we can reduce travel by not having to bring 24 you all in again for a, you know, a second trip for 25 a Commission meeting.
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214 1 So that's why I proposed these days 2 which I consulted with our Office of the Secretary 3 on.
4 If these don't work, then we can 5 certainly go back to the drawing board. But I 6 probably -- I think we'd probably be looking at a 7 December time frame meeting, then.
8 CHAIR METTER: Yes, Mr. Green?
9 MEMBER GREEN: Before COVID, we seemed 10 to do the meeting with the Commissioners live in 11 the spring. And because of COVID, it fell on to 12 the fall.
13 Is there any thought to put that back 14 into the spring and if we did that, would we miss 15 this year's or would we do this fall and this 16 spring? Are we going to stick with spring or fall 17 or just --
18 MS. VALENTIN-RODRIGUEZ: No, we can --
19 CHAIR METTER: That was -- yes.
20 MS. VALENTIN-RODRIGUEZ: Oh, I was 21 commenting --
22 CHAIR METTER: Thank you.
23 MS. VALENTIN-RODRIGUEZ: Yes, sorry, 24 Dr. Metter, for interrupting.
25 No, I was just going to say that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
215 1 certainly, within the committee's purview, that is 2 an option. We could forego a Commission meeting in 3 the September -- in the fall time frame and then 4 reach out to the Commission for a spring meeting 5 date. I think that would probably be easier to 6 book at this time. We just have to ensure to get 7 on their calendar early so that we can get 8 availability of dates.
9 Their October time frame is very busy 10 this year, so their calendar is filling up.
11 So that is certainly one option to 12 forego a meeting this year and then, get back to 13 them and have the Commission meeting in the spring.
14 MEMBER GREEN: Just to be clear, the 15 ACMUI would still meet, but we would not meet with 16 the Commissioners?
17 MS. VALENTIN-RODRIGUEZ: Correct.
18 MEMBER GREEN: So, we could plan a day, 19 a Monday and Tuesday adjacent to a weekend, perhaps 20 in October, where we don't have to meet with the 21 Commissioners this fall, we could plan that face to 22 face meeting with the Commissioners in the spring?
23 MS. VALENTIN-RODRIGUEZ: Correct, I 24 could open up the week of the 16th or the 23rd.
25 CHAIR METTER: Do I -- may I ask the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
216 1 ACMUI, is that a reasonable proposal for y'all to 2 have the fall meeting and then we meet with the 3 Commission in the spring?
4 (Off microphone comments.)
5 CHAIR METTER: Okay, so --
6 (Off microphone comments.)
7 CHAIR METTER: Unless there's any other 8 issues that come up.
9 So, can we have a motion for that?
10 MEMBER HARVEY: Motion, Richard Harvey, 11 I'll make the motion.
12 CHAIR METTER: All right, so the motion 13 is to have a fall meeting of the ACMUI without the 14 Commission and have a Commission meeting in the 15 spring. Do I have a second for that?
16 MEMBER MARTIN: Second.
17 CHAIR METTER: Okay, I have many people 18 seconding. So, we have many seconds.
19 So any other discussion?
20 All in favor, say aye.
21 (Chorus of aye.)
22 CHAIR METTER: All opposed or abstain?
23 So, we'll go ahead and proceed with 24 that. And we'll go ahead and have the -- a poll 25 sent out regarding the appropriate dates for the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
217 1 fall.
2 And then also find out when the 3 Commission is meeting in the spring and put out two 4 polls for that. Maybe the first one and then, we 5 can be sure that it's already clear that it's --
6 one is just for the ACMUI, the second is for the 7 Commission meeting.
8 Yes, Mr. Green?
9 MEMBER GREEN: And part of that poll, 10 let's make sure we capture the European meetings 11 that were not on the calendar so that we can avoid 12 those.
13 CHAIR METTER: Okay.
14 Josh, is you want, go ahead and give 15 that dates to Dr. Valentin so --
16 (Off microphone comments.)
17 (Simultaneous speaking.)
18 CHAIR METTER: Okay, thank you.
19 MEMBER OUHIB: It looks like there is 20 only November -- early November that works out 21 because of the American Heart Association's then in 22 November.
23 MEMBER HARVEY: November 13th, yes.
24 Is it worth discussing the two dates 25 which Mr. Green mentioned, the 16th and 17th and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
218 1 the 23rd and 24th right and see if we can come to a 2 time which would work for everyone?
3 MEMBER MARTIN: I think that sounds 4 great.
5 MEMBER HARVEY: Because both of those 6 would work for me.
7 MEMBER MARTIN: What month is it?
8 MEMBER HARVEY: October 16 and 17 or 9 October 23 and 24.
10 VICE CHAIR JADVAR: There are no 11 October dates yet.
12 MS. VALENTIN-RODRIGUEZ: No, so that --
13 those would have included the Commission meeting, 14 that's why they're not -- I didn't propose them, 15 but we can certainly discuss them at this time.
16 CHAIR METTER: Why don't we go ahead 17 and have you send out a poll so people can actually 18 look at their schedule so that they're not at a 19 short notice, maybe agreeing to something that they 20 may not be able to attend.
21 So, let's go ahead and, if you don't 22 mind, DR. Valentin-Rodriguez, if you can send out a 23 poll and then we can have everybody can look at the 24 schedule and have a date that they can be sure they 25 can attend.
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219 1 MS. VALENTIN-RODRIGUEZ: Yes, 2 definitely. I'll add more dates to the poll and 3 resend it. Of course.
4 CHAIR METTER: And I believe we would 5 either -- would you like a Monday, Tuesday, or 6 Thursday, Friday? Or it doesn't really matter just 7 as long as it --
8 (Off microphone discussion.)
9 CHAIR METTER: I mean, there's --
10 MS. VALENTIN-RODRIGUEZ: All right, we 11 can also do Thursday, Friday if you wanted.
12 CHAIR METTER: No, we'll go ahead and 13 stick with the Monday, Tuesday.
14 MS. VALENTIN-RODRIGUEZ: Okay.
15 VICE CHAIR JADVAR: Yes, Wednesday, you 16 have to travel.
17 MS. VALENTIN-RODRIGUEZ: I know, yes, 18 okay, okay.
19 CHAIR METTER: So, we'll go ahead and 20 do Monday, Tuesday. Any other items that we need 21 to cover?
22 MS. VALENTIN-RODRIGUEZ: No, that's all 23 I had, Dr. Metter, so I turn it back to you.
24 CHAIR METTER: Well, thank you very 25 much. Do I have any final comments before we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14TH ST., N.W., STE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com
220 1 adjourn this meeting from the committee or for the 2 NRC staff?
3 MR. EINBERG: Yes, Chris Einberg, 4 again.
5 Yes, I want to echo what Dr. Valentin 6 said regarding the hard work that the committee has 7 put in, especially the two subcommittees that 8 reported out.
9 We thank the subcommittees, all the 10 members of the ACMUI, and as well as the NRC staff, 11 and the public comments that we received.
12 So, a lot to think about and we're busy 13 and we appreciate -- and you're all very busy as 14 well, and so we appreciate all the hard work and 15 the thought you put into these discussions.
16 CHAIR METTER: Thank you very much, Mr.
17 Einberg.
18 So, at this point in time, thank you 19 very much for everybody's contribution and hard 20 work and the meeting is adjourned.
21 (Whereupon, the above-entitled matter 22 went off the record at 3:39 p.m.)
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May 9, 2023 Celimar Valentin-Rodriquez, PhD Medical Radiation Safety Team Leader Nuclear Regulatory Commission 11555 Rockville Pike Rockville, MD 20852
Dear Dr. Valentin-Rodriquez,
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) appreciates the Advisory Committee on the Medical Uses of Isotopes (ACMUI) including an overview of the current rulemaking regarding reporting of certain nuclear medicine injection extravasations on the May 15th meeting agenda.
We look forward to continuing to provide the medical expertise of SNMMIs 15,000 members to ensure patient access to nuclear medicine procedures providing personalized medicine optimizing patient treatment, as the rulemaking process moves forward.
This is a critical issue for the millions of patients receiving nuclear medicine procedures. We appreciate gaining additional information about the current rulemaking at the upcoming ACMUI meeting.
The safety of our patients and the highest quality of care are our top priorities. Patients must have access to valuable nuclear medicine procedures. We also must ensure that patients who would benefit from nuclear medicine procedures are not apprehensive or resistant to safe, often lifesaving procedures because of radiation paranoia or a chilling effect that can result from misinformation. We support a harm based, rather than dose-based approach, as has been recommended by the NRC.
We will be submitting comprehensive comments in response to the preliminary proposed rule, however there are two new important and relevant studies that we wanted to more immediately bring to your attention because you may not be aware of them.
These studies demonstrate both the rarity and lack of severity of extravasations in nuclear medicine. We support the NRC embarking on a thorough examination of this issue and we believe these studies provide useful new information.
- 1. In October 2022, the Journal of Nuclear Medicine, an independent highly regarded peer reviewed medical journal, published Adverse clinical events at the injection site are exceedingly rare following reported radiopharmaceutical extravasation in patients undergoing 99mTc-MDP whole body bone scintigraphy: A 12-year experience l Journal of Nuclear Medicine (snmjournals.org)
This study looked at 31,679 patient records retrospectively from 2010 to 2022.
Results: Retrospective review of the records of 31,679 99mTc-MDP WBBS showed RPE documented in 118 studies (0.37%). Medical records were not retrievable for 22 patients, yielding the final cohort of 96 patients with reported RPE. The median follow-up duration was 18.9 months (IQR: 7.8-45.7 months). Short-term events were noted in four patients, of whom one was asymptomatic. Of the three symptomatic patients, two experienced mild discomfort at the injection site, and one had a tender swelling. Three of the four events had a prior intravenous contrast extravasation for a contrast-enhanced computed tomography performed earlier during the day, and a 99mTc-MDP injection later at the same site likely leading to RPE.
None of the long-term local events had any plausible link with the RPE event.
==
Conclusion:==
Reported RPE were rare and short-term local symptoms were observed in three patients (0.009%), all of which were likely related to the prior higher volume intravenous contrast extravasation. The smaller volume diagnostic RP injections for WBBS are highly unlikely to cause local symptoms on their own. No patient had any long-term adverse event with a plausible link to the RPE.
- 2. The Journal of Nuclear Medicine (in press) Frequency and significance of injection infiltration and associated dosimetry in clinical PET/CT: A multi-center investigation.
The primary objective of this study was to gain data on the frequency and significance of injection infiltration events in clinical PET/CT practice through quantitative analysis of 1000 subjects from 10 US imaging sites. The secondary objective was to gauge the true risk associated with dose infiltrations through detailed, anatomically specific Monte Carlo estimates of radiation dose to the highly proliferative epidermis, and the less radiation sensitive dermal and subcutaneous hypodermal tissues.
Results: In a 1000 patient multi-center investigation into frequency of infiltration events in PET, no infiltrations of >1% injected dose were found. The majority of visualized activities at injection site were external contamination, or injection apparatus.
Only 6/1000 injections had activities in excess of 6 µCi, none > 50 µCi. Frequency appears very low when cannula injections are used.
A first of its kind, skin dosimetry Monte Carlo model was developed and tested that includes the actual skin anatomy, which turned out to be critical in terms of dose distribution.
==
Conclusion:==
The risk of actual skin injury is likely significantly lower than implied in current literature due to the magnitude of beta dose absorption in the relatively radiation resistant hypodermis and dermis and sparing of the sensitive epidermis. Additional study with higher energy beta emitters, and radiopharmaceutical therapy radionuclides is warranted.
For additional background information on previously submitted comments, below are links to SNMMIs comments from November 25, 2020, and August 31, 2022, in response to NRCs request for comments on this issue.
https://s3.amazonaws.com/rdcms-snmmi/files/production/public/NRC%20Extravasation%20Public%20Comment%20final%20signed%208-31-21.pdf https://s3.amazonaws.com/rdcms-snmmi/files/production/public/NRC%20Extravasation%20Comment%20Letter%20Final_signed%2011-25-20.pdf One paragraph to note:
The question of frequency, however, is perhaps not the most relevant question for purposes of providing comment. The more relevant question is: How often are patients harmed by nuclear medicine extravasations? There are approximately 20 million doses of radiopharmaceuticals administered intravenously each year in the United States.1 In a recent meta-analysis, van der Pol, et al. summarized 37 previously published reports of the consequences of radiopharmaceutical extravasation.2 Of a total of 3016 diagnostic radiopharmaceutical extravasations, only three (< 0.1%) were associated with adverse reactions.
In each case the adverse reaction was limited to the skin adjacent to the injection site and all were associated with relatively infrequently used radiopharmaceuticals. It must be emphasized that no adverse reactions were reported for the more than 3000 cases of extravasation of the commonly used 99mTc-, 123I-, 18F-, and 68Ga-labelled radiopharmaceuticals. In summary, there are no clinical data that support the Petitioners claim that extravasation of diagnostic radiopharmaceuticals is a patient safety issue.
Thank you for your consideration. Please contact me if you have questions or I can provide additional information.
Sincerely, Munir Ghesani, MD President, Society of Nuclear Medicine and Molecular Imaging
May 9, 2023 To: The ACMUI Committee Re: written statement for the May 15 ACMUI meeting for agenda item, Rulemaking for Extravasations On behalf of Patients for Safer Nuclear Medicine, a national coalition advocating for transparency in the administration of radioactive materials in healthcare, we have respectfully urged the Nuclear Regulatory Commission (NRC) to seriously consider the harm caused to patients by extravasation. Unfortunately, recent instructions by the Commissioners to the NRC medical staff will only make matters worse for patients. Patients should not be required to report extravasations. Nuclear medicine providers should be responsible for reporting these misadministrations.
By the NRCs own estimation, some 28,000 major extravasations occur annually in the United States.
These extravasations are large enough that they would warrant reporting to the NRC if not for an incorrect reporting exemption that has been in place for 43 years. But because of this blanket reporting exemption, no one knows for sure how many large or small extravasations occur. The Commissioners instructions to the medical staff will not improve visibility to this issue.
Extravasation has a serious economic, physical, and emotional impact on the patient and the healthcare system in general. In these 28,000 cases, no one knows the amount of radioactive material that was injected into the tissue. Consider the diagnostic flaws that result when a precisely measured amount of radioactive material is not properly administered. And what if the radiation dose to the patients tissue is extremely high? Beyond the expense of a delayed diagnosis of tissue damage and the harm that may cause the patient, the cost of catastrophic later stage treatment can be exorbitantly high.
The Commissioners decision places additional burdens on patients. The NRC is essentially creating rules that impose upon patients the responsibility of monitoring themselves for an indefinite period, which could range from weeks to months, or even years, to detect radiation injury, despite their inability to discern if they have been extravasated. The agency is initiating rulemaking that would place responsibility for identifying a large extravasation on the patient post-event, rather than emphasizing the need for providers to identify and mitigate extravasations when they occur.
There is another, underreported aspect to the extravasation issue: the erosion of trust in our medical professionals. How can a patient who is just starting their cancer treatment journey maintain trust in their care team when potential harm through extravasation is not disclosed immediately? By keeping critical information from a patient, medical professionals fail to act in the patients best interest. The medical communitys efforts to encourage the Commissions patient injury position actively undermines the patient/clinician relationship. With the NRC admitting that tens of thousands of patients are extravasated annually, why are the medical community and the NRC seemingly so invested in hiding extravasations from patients?
It can be inferred that medical societies endorse this course of action under the assumption that only a small fraction of patients will report, and they are banking on the patients' lack of awareness about the possible gravity of a large extravasation. A charitable reading of this position would suggest that the NRC and its nuclear medicine allies would rather protect the nuclear medicine community rather than patients.
Visit us at www.safernuclearmedicine.org
We have expressed our concerns in letters sent to the NRC in January and March. We believe that, instead of relying on patients who are generally not medical school-trained experts to assess extravasation, the NRC should simply reaffirm that nuclear medicine providers should be responsible for reporting large extravasations.
By using the existing objective dose threshold - as is used for all other medical event reporting, including an accidental spill on a patient - licensees would be required to take immediate steps, including determining the tissue dose. We believe radiation injected under the skin should be treated with the same level of concern as radiation spilled onto the skin, which IS currently considered a reportable medical event.
With all this in mind, we recommend that the NRC rulemaking should be focused on including the word extravasation in the current medical event reporting section. By following our recommendation, it would be difficult for anyone to attempt to influence the adoption of a different policy in order to evade reporting. The final regulation will then ensure that large extravasations are reportable, similar to other medical events. In addition, we believe all nuclear medicine licensees should be required to do the following:
- Be certified in gaining venous access if they have responsibility for administering these radioactive drugs.
- Monitor the injection to ensure that if there is an extravasation licensees will know immediately.
- If there is an extravasation, licensees should do everything they can to reduce the radiation dose to the patient tissue.
- If there is an extravasation, licensees should assess the amount of radiation and make sure it is documented in the patients record.
- Provide patients with information about extravasation, including symptoms to look out for.
- Inform the patients full care team about the extravasation, to determine next steps in the best interests of the patient.
To make our position abundantly clear: we reject NRC staffs current recommendation to create a unique reporting criterion that forces the patient to play doctor and detect ones own radiation injury rather than asking NRC licensees - the experts - to identify and monitor extravasations. We remain baffled that the NRC plans to make patients directly responsible for their own diagnosis and care for extravasation follow-up, rather than licensees charged with their care.
Please take the opportunity to focus on patients in your deliberations. Consider how the average patient is impacted by your decision: the potential effect to their treatment, the potential radiation damage to their tissue and skin, and the cost (both financial and emotional). Consider the wide-ranging consequence it has on the larger healthcare system: lost productivity, patient harm, higher costs, worse outcomes, and an erosion of trust. There is no better time than now to take patient-positive action.
Sincerely, Members of the Patients for Safer Nuclear Medicine Coalition Visit us at www.safernuclearmedicine.org