ML18099A381
| ML18099A381 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/2018 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| Holiday, Sophie | |
| References | |
| NRC-3567 | |
| Download: ML18099A381 (206) | |
Text
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
Advisory Committee on the Medical Uses of Isotopes Docket Number: N/A Location: Rockville, Maryland Date: March 7, 2018 Work Order No.: NRC-3567 Pages 1-205 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
1 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 + + + + +
4 ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES 5 + + + + +
6 MEETING 7 + + + + +
8 WEDNESDAY, 9 MARCH 7, 2018 10 + + + + +
11 The meeting was convened in room T2B3 12 of Two White Flint North, 11545 Rockville Pike, 13 Rockville, Maryland, at 8:30 a.m., Philip Alderson, 14 Chairman, presiding.
15 MEMBERS PRESENT:
16 PHILIP O. ALDERSON, M.D., Chairman 17 VASKEN DILSIZIAN, M.D., Nuclear Cardiologist 18 RONALD D. ENNIS, M.D., Radiation Oncologist 19 DARLENE F. METTER, M.D., Diagnostic Radiologist 20 MICHAEL OHARA, Ph.D., FDA Representative 21 CHRISTOPHER J. PALESTRO, M.D., Nuclear Medicine 22 Physician 23 JOHN J. SUH, M.D., Radiation Oncologist 24 LAURA M. WEIL, Patients Rights Advocate 25 PAT B. ZANZONICO, Ph.D., Vice Chairman NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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2 1 NON-VOTING MEMBERS PRESENT:
2 RICHARD GREEN 3 ZOUBIR OUHIB 4 MEGAN SHOBER 5
6 NRC STAFF PRESENT:
7 LINDA HOWELL, Acting Deputy Director, 8 Division of Materials Safety, Security, 9 States, and Tribal Programs (MSST) 10 DOUGLAS BOLLOCK, ACMUI Designated Federal 11 Officer 12 SOPHIE HOLIDAY, ACMUI Alternate Designated 13 Official and ACMUI Coordinator 14 MARYANN AYOADE, NMSS/MSTR/MSEB 15 JENNIFER BISHOP, R-III/DNMS 16 RUSSELL CHAZELL, SECY/RAS 17 SAID DAIBES, Ph.D., NMSS/MSST/MSEB 18 LISA DIMMICK, OEDO 19 SARA FORSTER, R-III/DNMS 20 ROBERT GALLAGHAR, R-I/DNMS 21 MICHELLE HAMMOND, R-IV/DNMS 22 LATISHCA HANSON, R-IV/DNMS 23 PATRICIA HOLAHAN, Ph.D., NMSS/DRM 24 VINCENT HOLAHAN, Ph.D., NMSS/MSST 25 ESTHER HOUSEMAN, OGC/GCLR/RMR 26 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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3 1 NRC STAFF PRESENT (CONT.):
2 DONNA-BETH HOWE, Ph.D., NMSS/MSST/MSEB 3 KEVIN NULL, R-III/DNMS 4 PATTY PELKE, R-III/DNMS 5 GRETCHEN RIVERA-CAPELLA, NMSS/MSST/MSEB 6 DIANE SIERACKI, OE/CRB 7 ZAHID SULAIMAN, R-III/DNMS 8 KATHERINE TAPP, Ph.D., NMSS/MSTR/MSEB 9 IRENE WU, NMSS/MSST/MSEB 10 SHIRLEY XU, NMSS/MSST/MSLB 11 12 MEMBERS OF THE PUBLIC PRESENT:
13 DAVE ADLER, American Society of Radiation 14 Oncology (ASTRO) 15 ROBERT DANSEREAU, New York State Department 16 of Health 17 MIGUEL DE LE GUARDIA, Cooks Children Medical 18 Center 19 LYNNE FAIROBENT, unaffiliated 20 CAITLIN KUBLER, Society of Nuclear Medicine 21 and Molecular Imaging 22 MELISSA MARTIN, American Association of 23 Physicists in Medicine (AAPM) 24 RICHARD MARTIN, AAPM 25 MICHAEL PETERS, American College of Radiology 26 JOSEPHINE PICCONE, unaffiliated NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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4 1 MEMBERS OF THE PUBLIC PRESENT (Cont.):
2 A. ROBERT SCHLEIPMAN, Partners Healthcare 3 CINDY TOMLINSON, ASTRO NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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5 1 TABLE OF CONTENTS 2 Opening ...........................................6 3 Old Business......................................17 4 Open Forum........................................57 5 Medical Related Events............................58 6 Staff Response to Medical Event 7 Reporting and its Impacts on Safety 8 Culture Subcommittee Report.................97 9 ACMUI Reporting Structure........................127 10 Worldwide Supply and the Domestic 11 Production of Molybdenum-99................135 12 Medical Projects on the Horizon..................170 13 Adjourn..........................................205 14 15 16 17 18 19 20 21 22 23 24 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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6 1 P R O C E E D I N G S 2 8:40 a.m.
3 CHAIRMAN ALDERSON: Welcome to this 4 meeting of the Advisory Committee on Medical Uses 5 of Isotopes. And to get the meeting agenda 6 started, I'll turn the program over to Mr. Bollock.
7 MR. BOLLOCK: All right. Thank you, 8 Dr. Alderson. Good morning, everyone. As the 9 Designated Federal Officer for this meeting, I'm 10 pleased to welcome you to this public meeting of 11 the Advisory Committee on Medical Uses of Isotopes.
12 My name is Doug Bollock. I'm the Branch Chief of 13 the Medical Safety and Event Assessment Branch, and 14 I have been designated as the federal officer for 15 this advisory committee in accordance with 10 CFR 16 Part 7.11.
17 Present today is the alternate 18 Designated Federal Officer, Ms. Sophie Holiday, our 19 ACMUI coordinator. This is an announced meeting of 20 the Committee. It's being held in accordance with 21 the rules and regulations of the Federal Advisory 22 Committee Act and the Nuclear Regulatory 23 Commission.
24 This meeting is being transcribed by 25 the NRC and may also be transcribed where recorded NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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7 1 by others. The meeting was announced in the 2 February 7th, 2018 edition of the Federal Register, 3 Volume 83, page 5465.
4 The function of the Committee is to 5 advise the staff on issues and questions that arise 6 in the medical use of byproduct material. The 7 Committee provides counsel to the staff but does 8 not determine or direct the actual decisions of the 9 staff or the Commission. The NRC solicits the 10 views of the Committee and values their opinions.
11 I request that, whenever possible, we 12 try to reach a consensus on the various issues we 13 will discuss today, but I also recognize there may 14 be minority or dissenting opinions. If you have 15 such opinions, please allow them to be read into 16 the record.
17 At this point, I'd like to perform roll 18 call on members participating today. Dr. Philip 19 Alderson.
20 CHAIRMAN ALDERSON: Here.
21 MR. BOLLOCK: Thank you. Dr. Pat 22 Zanzonico?
23 VICE CHAIRMAN ZANZONICO: Here.
24 MR. BOLLOCK: Thank you. Dr. Vasken 25 Dilsizian?
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8 1 MEMBER DILSIZIAN: Here.
2 MR. BOLLOCK: Thank you. Dr. Ronald 3 Ennis? Okay. I did see him, and it looks like he 4 stepped away for a moment. Dr. Darlene Metter?
5 MEMBER METTER: Here.
6 MR. BOLLOCK: Thank you. Dr. Michael 7 O'Hara?
8 MEMBER O'HARA: Here.
9 MR. BOLLOCK: Thank you. Dr.
10 Christopher Palestro?
11 MEMBER PALESTRO: Here.
12 MR. BOLLOCK: Thank you. Mr. Michael 13 Sheetz? Dr. John Suh?
14 MEMBER SUH: Here.
15 MR. BOLLOCK: Thank you. And Ms. Laura 16 Weil?
17 MEMBER WEIL: Here.
18 MR. BOLLOCK: Thank you. So we do have 19 a -- I confirm we do have a quorum of at least six 20 members. At the table, we also have Mr. Zoubir 21 Ouhib.
22 MR. OUHIB: Here.
23 MR. BOLLOCK: Mr. Richard Green?
24 MR. GREEN: Here.
25 MR. BOLLOCK: And Ms. Megan Shober?
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9 1 MS. SHOBER: Here.
2 MR. BOLLOCK: Mr. Green has been 3 selected as the ACMUI nuclear pharmacist. Mr.
4 Ouhib has been selected as the ACMUI therapy 5 medical physicist, and Ms. Shober has been selected 6 as the ACMUI agreement state representative. Mr.
7 Ouhib, Mr. Green, and Ms. Shober are pending 8 security clearances but may participate in the 9 meeting. However, they do not have voting rights 10 at this time.
11 I would also like to add that this 12 meeting is being webcast, so other individuals may 13 be watching online. We have a bridgeline 14 available, and the phone number is 888-790-6447.
15 The passcode to access the bridgeline is 79006 16 followed by the pound key.
17 Individuals who would like to ask a 18 question or make a comment regarding a specific 19 issue the Committee has discussed should request 20 permission to be recognized by the ACMUI 21 chairperson, Dr. Philip Alderson. Dr. Alderson, at 22 his option, may entertain comments or questions 23 from members of the public who are participating 24 with us today. Comments and questions are usually 25 addressed by the Committee near the end of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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10 1 presentation after the Committee has fully 2 discussed the topic.
3 We ask that one person speak at a time, 4 as this meeting is also closed captioned. I would 5 also like to add that handouts and agendas for this 6 meeting are available at the NRC's public Web site.
7 At this time, I'd ask that everyone on 8 the call who is not speaking to place their phones 9 on mute. If you don't have the capability to mute 10 your phone, please press *6 to utilize the 11 conference line mute and un-mute functions.
12 At this point, I'd like to turn the 13 meeting over to Ms. Linda Howell, Acting Deputy 14 Director of the Division of Material Safety, 15 Security, and State and Travel Programs, for some 16 opening remarks.
17 MS. HOWELL: Thank you, Doug. And good 18 morning, Committee members. As Doug noted, I'm the 19 Acting Deputy Division Director for a newly-named 20 division. It's Material Safety, Security, and 21 State and Travel Programs Division. In accordance 22 with a project that the agency initiated a couple 23 of years ago, we have removed rulemaking from our 24 division activities, so we decided to re-name 25 ourselves.
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11 1 First off, I'd like to thank all of the 2 Committee members not only for your attendance 3 today but your hard work and contributions over the 4 past year and several years prior to that. We do 5 truly value your contributions, your knowledge, and 6 your expertise, and the agency does need your input 7 in order to maintain an effective regulatory 8 oversight program.
9 Just so that you know, a few changes in 10 the last couple of months that may continue. Dan 11 Collins, whom most of you know as the division 12 director, is currently on rotation to Region I as 13 the Acting Deputy Regional Administrator. Kevin 14 Williams, his deputy whom I think you met at the 15 last meeting, is currently the Acting Division 16 Director, and then I've joined Kevin as part of the 17 management team for the division. And that will 18 extend over the next couple of months.
19 As I noted, we just recently changed 20 the name, so you will see in our correspondence and 21 communications with you, instead of MSTR, MSST.
22 Okay?
23 I'd also like to note a couple of 24 changes within ACMUI not only for the Committee 25 members but for the attendees here in the audience.
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12 1 This is Dr. Zanzonico's last meeting, as his term 2 on the ACMUI ends tomorrow. We are sorry to see 3 your departure, but we want to thank you for your 4 many contributions over the past eight years and we 5 anticipate making a selection for Dr. Zanzonico's 6 backfill shortly.
7 With your departure, we do anticipate 8 that Mark Dapas, the office director, will be 9 providing a tribute to Dr. Zanzonico tomorrow in 10 advance of the Commission meeting. So we look 11 forward to that.
12 As Doug noted, we have a new member 13 here at the table with Megan joining us. Thank you 14 very much for joining us as the Agreement State 15 Representative. We also need to note Dr. Alderson, 16 as the Chairman and Health Care Administrator, is 17 up for a second term on March 23rd, and you've 18 informed us that you do not plan to serve that full 19 second term, but will stay on board until your 20 replacement obtains his security clearance. And 21 Dr. Robert Schleipman has been selected as the next 22 Health Care Administrator representative. I think 23 he may be on with us this morning as webcast, but I 24 haven't had a chance to talk with him this morning.
25 So we look forward to him joining the Committee, as NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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13 1 well.
2 We do have to appoint a new Chairman 3 and Vice Chairman with the departure of two of our 4 senior members of the Committee. And it gives me 5 pleasure to inform you that we have appointed Dr.
6 Chris Palestro as the new ACMUI Chairman and Dr.
7 Darlene Metter as the Vice Chairman. Their 8 appointments will become effective on March 9th, so 9 we congratulate both of you in your new positions 10 and look forward to your leadership on the 11 Committee.
12 Dr. John Suh, our representative in 13 gamma stereotactic radiosurgery radiation oncology, 14 will complete his second and final term here 15 shortly. We've already issued a call for 16 nominations in the Federal Register, and those 17 nominations were due to be sent to Ms. Holiday by 18 April 3rd, 2018. So we look forward to keeping you 19 all informed on that process, and thank you very 20 much, sir, for your service. We do appreciate it.
21 Going on to a few other recent 22 activities at the Commission level, several things 23 have occurred since the last meeting, which was 24 fall of 2017, including issuance of a SECY paper 25 and the staff's evaluation of our program NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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14 1 regulating patient release following radioisotope 2 therapy. That paper was signed out at the end of 3 January this year.
4 The paper conveyed the staff's efforts 5 as they relate to evaluating whether significant 6 changes were warranted regarding our regulations 7 for patient release, and those are found under 8 Title 10, CFR 35.75. We determined that changes to 9 the rule text were not necessary, although we will 10 be forwarding some updated guidance to the staff on 11 that. But we do not anticipate making any further 12 rule changes at this time.
13 We do appreciate all of your insights 14 and input on that. It was a significant effort 15 over a prolonged period of time, and your insights 16 were very valuable to helping us arrive at a sound 17 conclusion on that.
18 Also, as most of you are aware, the 19 Commission has approved some final rule changes on 20 the medical use of byproduct material that went out 21 in August of 2017. The final rule is undergoing 22 OMB review and is due for publication in the 23 Federal Register in the short term, date yet to be 24 determined.
25 When the rule was voted on, the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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15 1 Commission directed the staff to evaluate whether 2 it would make sense for us to come up with a more 3 tailored training and experience approach for 4 different categories of radiopharmaceutical use.
5 We have not made a final determination in that 6 area. We are seeking your input on it. It will be 7 a topic for discussion and vote today and later 8 tomorrow in front of the Commission and probably 9 will receive review by the staff over the next 10 several months. But we are interested in your 11 input, so we hope that you will share your candid 12 opinions on that.
13 ACMUI, for the audience, has conducted 14 a couple of public teleconferences since the last 15 meeting. There was a public teleconference 16 conducted on February 15th to discuss nursing 17 guidelines and the physical presence requirements 18 for the Leksell Gamma Knife Icon'. Those reports 19 have been provided to the NRC staff for further 20 consideration. We will touch on those topics here 21 during the meeting today and possibly tomorrow.
22 The ACMUI also held a public 23 teleconference last week on March 1st to discuss 24 the interim report of the subcommittee on training 25 and experience requirements for various medical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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16 1 modalities. Again, we'll be discussing that later 2 today with core deliberations to follow in the next 3 few months.
4 And then other meeting items of high 5 interest for those of you in attendance in the 6 audience or on the phone, later on today we'll have 7 a presentation on the staff's response to 8 recommendations for medical event reporting and on 9 medical licensee patient safety culture, as well as 10 medical projects on the horizon to include the 11 status of molybdenum-99 production. There have 12 been some recent changes in that area.
13 And then, lastly, the ACMUI Committee 14 members will meet with the Commission at 10 a.m.
15 tomorrow in the Commission briefing room to discuss 16 ACMUI activities, ACMUI comments on training and 17 experience, the ACMUI's comments on changes to the 18 patient release program, and then ACMUI's comments 19 on medical event reporting and patient safety 20 culture.
21 So we look forward to active engagement 22 with you today, as well as with the Commission 23 tomorrow. And, again, as Doug indicated, we 24 recognize everybody has independent views, so we 25 welcome those views. We hope that you will put NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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17 1 them on the record if not everybody has consensus 2 and that we have an engaging dialogue today.
3 And with that, I'll turn it over to Ms.
4 Holiday.
5 MS. HOLIDAY: Good morning, ACMUI 6 members and members of the public who are joining 7 us. You know, I always say this for every meeting 8 and I'll continue to say this; this is the most 9 important presentation that you will hear at the 10 ACMUI meeting. It's your most favorite 11 presentation. I see that everybody is nodding in 12 agreement.
13 So this is the old business portion of 14 the meeting where we go over the recommendation and 15 action charts from the ACMUI previous meeting and 16 note if there are any status changes. For the last 17 several years, you've always heard me say that, for 18 several years of the charts, they're all tied up 19 with the expanded Part 35 rulemaking. So I'll 20 start off by saying we all were informed at the 21 September 2017 fall ACMUI meeting that the 22 Commission voted on the Part 35 rulemaking and 23 staff, as Ms. Howell indicated, we are still 24 waiting for the final rule to actually be published 25 in the Federal Register.
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18 1 But with that being said, all of the 2 items in the 2017 chart, with the exception of 3 items 30, 34, and 35, which are noted as delayed, 4 were included in the Part 35 expanded rulemaking.
5 So at this time, I would like to ask the Committee 6 if there's a motion to close these items.
7 MEMBER ENNIS: Is there any chance that 8 something could change between now and when it's 9 actually published?
10 MS. HOLIDAY: No. Since the Commission 11 did perform their vote in August of 2017, once the 12 Commission takes a vote, it's the final, done, 13 concluded deal. We're just, at this point, waiting 14 for the Office of Management and Budget to perform 15 their review, and then there are some 16 administrative checks before it actually gets 17 published in the Federal Register. But there will 18 be no additional changes to the rule text itself.
19 Yes, sir?
20 CHAIRMAN ALDERSON: This is Dr.
21 Alderson. I have a comment. Just as a point of 22 information for our later discussions, under item 23 number two on that first page, back from June of 24 '07, it has this statement which I just want to 25 remind us about. The rewritten attestation, and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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19 1 this was requirements for board-certified 2 individuals, should not include the word 3 "competency" but instead should read has met the 4 training and experience requirements. So I just 5 wanted to remind us, as we enter a meeting where I 6 think we may be talking about training and 7 experience requirements, that the word "competency" 8 has been cited here as one that is not to be used 9 widely. So I'm sure we'll use it many times, but I 10 just thought I should remind us that this was 11 there.
12 MS. HOLIDAY: Thank you. And thank you 13 for pointing that out, Dr. Alderson. What I'd also 14 like to offer is that this recommendation was made 15 11 years ago, and so none of the members on the 16 Committee now were a part of the Committee back 17 then. And the beauty of having rotating membership 18 terms is that opinions can change. And if the 19 Committee would like to make an amendment to this, 20 you know, that would be captured as a new 21 recommendation.
22 But I do recognize, since we do have a 23 subcommittee that is looking at training and 24 experience requirements, that this is something 25 that you should keep in mind going forward. So NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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20 1 thank you.
2 So, yes, I'd like to ask again.
3 Procedurally, this has to be a motion made by the 4 ACMUI.
5 CHAIRMAN ALDERSON: Is there a second?
6 Second.
7 MEMBER ENNIS: Second.
8 MS. HOLIDAY: Okay. Thank you.
9 CHAIRMAN ALDERSON: Are you going to 10 vote on it? All in favor?
11 (Chorus of ayes.)
12 CHAIRMAN ALDERSON: Opposed? None.
13 MS. HOLIDAY: Great. Thank you. So 14 then that takes us to the 2008 chart. So, again, 15 the majority of these are related to the Part 35 16 rulemaking. However, I will note that, for item 17 number 5 and item 22, these are related to yttrium-18 90 microspheres licensing guidance, and I said this 19 at the last meeting, of course, at previous 20 meetings where the Committee made a recommendation 21 that we should move the Perfexion guidance -- I'm 22 sorry. I'm mixing up names. Item number 5 has to 23 deal with the Perfexion guidance, and the Committee 24 at that time, in 2008, asked us to incorporate 25 their recommendations for future rulemaking. The NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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21 1 implications for item 5 are also relevant to item 2 22 in which the Committee had asked us to move 3 these modalities, these emerging technologies, to 4 be incorporated into the rule.
5 As I've said previously, some of these 6 technologies, such as Perfexion, such as yttrium-90 7 microspheres, are captured in 35.1000 licensing 8 guidance, and that's because they have unique 9 features in which they cannot meet all of the 10 requirements in the existing 10 CFR Part 35. As we 11 have also noted that having items captured in 12 35.1000 guidance allows us to be nimble and make 13 changes as necessary. For obvious reasons, the 14 yttrium-90 microspheres guidance has already been 15 on its ninth revision, with a tenth revision coming 16 out in the near future. So if this was to go into 17 rulemaking, we would not be able to incorporate 18 those changes.
19 Additionally, the Perfexion', we just 20 issued the guidance for the Perfexion' and the 21 Icon' unit two years ago. So in a similar 22 situation, if this was to have gone into 23 rulemaking, again, we would not have been able to 24 make these changes.
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22 1 they say delayed, but I would like to ask the 2 Committee if the Committee agrees that it should 3 remain as delayed or if you believe that they 4 should simply be closed. VICE CHAIRMAN 5 ZANZONICO: Sophie, this is Pat Zanzonico. Sophie, 6 could you remind us, remind me what the current 7 status of this is? Is it in guidance, and so the 8 idea would be to continue it basically indefinitely 9 in guidance, rather than leaving it delayed because 10 it can't be incorporated into the current 11 rulemaking? So I gather, if it were left delayed, 12 it wouldn't be fully resolved until the next round 13 of rulemaking? Is that basically correct?
14 MS. HOLIDAY: Correct. So the reason 15 that it is noted as delayed is that staff had 16 accepted the Committee's recommendations in terms 17 of saying that it was not being considered for the 18 current, I don't know if we should say current but 19 the Part 35 rulemaking that was just voted on last 20 year, but that, if this was truly a recommendation, 21 that the ACMUI still wanted staff to pursue, that's 22 why we have left it on the charts. Both the 23 Perfexion' and Icon' and the yttrium-90 microsphere 24 brachytherapy are captured in 35.1000 licensing 25 guidance.
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23 1 So what I'm asking for the Committee is 2 if you, as the Committee, do you agree that this 3 should still be considered for future rulemaking, 4 that is to bring it into the rule text under Part 5 35, or does the Committee agree that leaving these 6 modalities, these technologies, in 35.1000 space is 7 appropriate? If the Committee believes that it is 8 appropriate to remain in the licensing guidance 9 format, then the Committee would need to make that 10 motion.
11 VICE CHAIRMAN ZANZONICO: So this is 12 Pat Zanzonico. My suggestion, my personal 13 suggestion is that, since so many things may change 14 between now and the next round of rulemaking, which 15 will be many years in the future we've come to 16 learn, I think, rather than leaving these sort of 17 in limbo pending that, that they should just remain 18 as guidance. And then if and when new 19 technologies, new developments arise between now 20 and the next round of rulemaking, those could be 21 more appropriately addressed at those times, that 22 those issues related to these items could be more 23 appropriately addressed at those times. So my 24 personal suggestion would be to close them and 25 leave them as guidance.
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24 1 CHAIRMAN ALDERSON: This is Dr.
2 Alderson. I would ask a question then. Since 3 training and experience requirements are a major 4 issue in front of the Committee right now and this 5 is a training and experience issue, what 6 encumbrance would fall upon the Committee if this 7 were left in guidance and we wanted to bring it 8 back out because it fit into some training and 9 experience topic that we were discussing? Is there 10 an encumbrance?
11 MS. HOLIDAY: Sure. So if I'm 12 understanding correctly, the question is if the 13 Committee were to make recommendation and staff 14 were to adopt the recommendations or pursue other 15 venues with training and experience, how would that 16 affect these 35.1000 licensing guidance documents?
17 Essentially, licensing guidance under 35.1000 are 18 considered customizable licensing conditions, and 19 that simply means that what's in the guidance is 20 separate from what's under the Part 35 rule, since 21 they could not meet all of the provisions under 35.
22 So we could have different training and experience 23 requirements for these technologies that are 24 licensed under 35.1000.
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25 1 the radioactive seed localization guidance that was 2 recently issued a few years ago and the 3 subcommittee had provided recommendations. The 4 training and experience for that was very different 5 from what is captured under the rule for 6 brachytherapy users, and that is to say that we 7 also have a provision in there that notes the 8 ability for surgeons to perform, you know, the 9 extraction of the seeds under the supervision of 10 the AU. So for things like that, you would want 11 that to reside in 35.1000 space.
12 So we made changes in the rule to 13 accommodate, you know, training and experience.
14 However the Committee or the staff decides to move 15 forward, that would not affect the training and 16 experience in that guidance. It would not affect 17 the training and experience in the Y-90 guidance 18 and so on and so forth.
19 If we were to agree to make the changes 20 for those particular technologies, then another 21 revision to the guidance would occur, and we'd be 22 on say revision 11 of the Y-90 guidance.
23 CHAIRMAN ALDERSON: So if I can 24 rephrase that into the words I used, there would 25 really be no encumbrance to approving this as it is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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26 1 and leaving it in guidance.
2 MS. HOLIDAY: Yes. I see a hand.
3 DR. HOWE: This is Dr. Howe. If you 4 change the guidance and that guidance in training 5 and experience now covers what's in a particular 6 35.1000, the 35.1000 guidance could be revised to 7 remove the specific training requirements that are 8 now incorporated in the rule. Now, training and 9 experience is a very important part of the 35.1000 10 uses, but it's not the only part. So you still 11 would have, you still may have different parts of 12 the guidance that would stay if the training and 13 experience might go into the rule if you make 14 changes.
15 CHAIRMAN ALDERSON: Yes, good. So it 16 doesn't seem to provide any problem but some 17 latitude for practitioners.
18 MS. HOLIDAY: Correct.
19 CHAIRMAN ALDERSON: Good. Okay. So 20 can we hear the motion again, or are there further 21 questions or comments? The motion again is that --
22 MS. HOLIDAY: I believe the motion is 23 to close items 5 and 22.
24 CHAIRMAN ALDERSON: Yes.
25 MS. HOLIDAY: So the motion was made by NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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27 1 Dr. Zanzonico.
2 CHAIRMAN ALDERSON: And moved and 3 seconded. Okay. Further discussion? Yes, Dr.
4 Palestro?
5 MEMBER PALESTRO: Yes, I have a 6 question. If these items are closed out, let's see 7 if I can figure out how to phrase it properly, if 8 they're closed out, they essentially disappear from 9 the log and we're not going to review them again.
10 So going forward in the future, all of us are gone 11 from this Committee, how will future members 12 recognize that these were items of concern at one 13 time?
14 MS. HOLIDAY: Well, unfortunately, they 15 would have to go through many years of transcripts, 16 not that that's the most wonderful task either.
17 But, essentially, they would not know that these 18 were past items because we don't, once we close 19 them on the charts, again, they do disappear off 20 the charts, just like how you know we have a two 21 and then a five but there's no one, three, or four.
22 MEMBER PALESTRO: So that would be my 23 concern then. If we leave it as is, where it says 24 open and delayed, in the future they can be flagged 25 as areas to be revisited.
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28 1 MS. HOLIDAY: Yes, it could be 2 revisited in the future if that's what, if that's 3 what the Committee wishes for future members to be 4 able to do. But the Committee now has the 5 opportunity, as members on the existing Committee, 6 to make a decision. If you feel like this does 7 need to stay as a delayed for future members to 8 consider, it's at your discretion.
9 Mr. Green?
10 MR. GREEN: So this is from the 2008 11 year, so the guidance has been static for a decade?
12 And if there are ever changes in the technology, I 13 think we can go back and change the guidance. I'm 14 not sure if there's a need to keep it currently on 15 the list to remind us it hasn't been changed in a 16 decade. But we can go back and change that 17 guidance, could we not?
18 MS. HOLIDAY: That's true, just as the 19 ACMUI formed a subcommittee, and I think Dr. Metter 20 chaired that subcommittee to review the staff's 21 draft revisions to the guidance, again, once the 22 guidance comes up for another revision or if the 23 Committee identifies that other things need to 24 change in the guidance, just with any other 25 recommendation, the Committee is able to make that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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29 1 recommendation at the meeting and it's captured on 2 the charts going forward. CHAIRMAN 3 ALDERSON: With respect to Dr. Palestro's comment, 4 I would think that, I understand your point 5 exactly, but if, in fact, this is a practice issue, 6 if practitioners are concerned about this, it will 7 be known to us. They will bring it up. If no one 8 is concerned, we may forget about it, but then we 9 don't need to worry about it. But if there are 10 issues in practice, they could bring it back and we 11 just heard that we would have the ability to change 12 this or do whatever we want. So I think that the 13 motion to close is not inappropriate at this time.
14 MEMBER WEIL: Laura Weil. I think what 15 Dr. Palestro is getting to is something that 16 concerns me, as well, is the lack of institutional 17 memory on this Committee. We don't really have an 18 accessible history. And given the nature of 19 rotation, perhaps this is not the place for that 20 history to be maintained, but transcripts are an 21 extremely unwieldy way to access that history. And 22 we struggle in subcommittee work sometimes to 23 figure out, well, why 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, why, you know, any 24 number of things that come up. And I think we need 25 some sort of record, that I'm not aware of anything NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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30 1 exists other than transcripts, in order for us to 2 do our work more efficiently.
3 MS. HOLIDAY: So I understand the crux 4 of what you're trying to say. So if I may offer 5 this, I will take this as an action item that I 6 will -- because I don't delete, I don't delete past 7 recommendations. They're just hidden on the Excel 8 spreadsheet. So what I will do is I will open up 9 all of the last 11 years of charts, and I will 10 capture them, I will add them to the ACMUI's 11 history web page on the ACMUI website so that both 12 ACMUI members and members of the public will be 13 able to access past committees' recommendations, if 14 the Committee will accept that action.
15 MEMBER PALESTRO: Yes, I just want to 16 say that I share Ms. Weil's concerns. And we found 17 the problems with institutional history in the 18 Training and Experience Subcommittee, and I think 19 your suggestion is a good one, as long as there a 20 way for someone or some committee to go back in the 21 future and look things over and have a sense of 22 what went on and so forth, and what was considered 23 important may or may not still be. So I think --
24 MS. HOWELL: And we appreciate your 25 input on that. So it's not really that the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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31 1 information is lost. It may not be as transparent 2 to you, as Committee members that you would like.
3 But I think certainly what Ms. Holiday just 4 proposed would satisfy that concern so that it 5 would be readily capture-able by all the Committee 6 members.
7 CHAIRMAN ALDERSON: Does the NRC need a 8 vote on this suggestion, or can this just go 9 forward?
10 MS. HOLIDAY: No. NRC doesn't need a 11 vote for me to take the action. What I'm still 12 waiting for is, given this action, does the ACMUI 13 still second Dr. Zanzonico's motion to close these 14 two items.
15 CHAIRMAN ALDERSON: Right. So we still 16 have the motion on the table to close these two 17 items. Is there further discussion on that?
18 Hearing none, we'll vote. All those in favor?
19 (Chorus of ayes.)
20 CHAIRMAN ALDERSON: Any opposed? None.
21 It passes.
22 MS. HOLIDAY: Thank you. Okay. So, 23 again, for items 2, 19 -- no, 2 and 28, 29, 30, 24 those are all related to the Part 35 expanded 25 rulemaking. Very similar to the 2007 chart, I'd NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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32 1 like to ask if there's a motion to close those 2 items, not the ones that say delayed but items 2, 3 28, 29, and 30.
4 CHAIRMAN ALDERSON: Is there a motion 5 to that effect?
6 MEMBER PALESTRO: So moved.
7 CHAIRMAN ALDERSON: Dr. Palestro. Is 8 there a second? Is there discussion? All in 9 favor? Any opposed? No opposition.
10 MS. HOLIDAY: Thank you. Again, so for 11 the ones that do say delayed, such as number 19, 12 number 26, and number 27, those were delayed, so I 13 will keep those on the chart because they were not 14 included in the Part 35 expanded rulemaking.
15 Okay. So that brings us to 2009.
16 There are only two items on this chart. Again, 17 these were included in the current Part 35 expanded 18 rulemaking. I will note, of course, that number 19 two has to deal with the 35.390 written directive, 20 not the training and experience. But I know, since 21 35.390 is something that's being considered by the 22 Committee now, I would like to point that out.
23 But, again, similar to the 2007 and 24 2008 chart, these are tied with the Part 35 25 expanded rulemaking. So is there a motion from the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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33 1 Committee to close these two items?
2 CHAIRMAN ALDERSON: Do I see a motion?
3 VICE CHAIRMAN ZANZONICO: So moved.
4 CHAIRMAN ALDERSON: Second?
5 MEMBER PALESTRO: Second.
6 CHAIRMAN ALDERSON: There is a second.
7 Is there discussion? All in favor?
8 (Chorus of ayes.)
9 MS. HOLIDAY: Thank you. Okay. Again, 10 the 2010 chart, all the items were closed on that, 11 so that's not included in this packet. For year 12 2011, item 1 has to deal with the patient release 13 criteria. As you heard from Ms. Howell earlier in 14 her remarks, staff issued its patient release paper 15 to the Commission on January 29th, so this is not 16 an open item anymore. The ACMUI's recommendations 17 as it relates to patient release was captured in 18 the subcommittee report that was unanimously 19 endorsed by the Committee included as Enclosure 4 20 for that patient release SECY paper. So I would 21 like to ask at this time if there's a motion to 22 close item 1.
23 CHAIRMAN ALDERSON: Is there a motion?
24 VICE CHAIRMAN ZANZONICO: So moved.
25 CHAIRMAN ALDERSON: And a second? Any NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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34 1 discussion? All in favor?
2 (Chorus of ayes.)
3 CHAIRMAN ALDERSON: It passes 4 unanimously.
5 VICE CHAIRMAN ZANZONICO: Sophie, I 6 have a parliamentary question. Can the Chair and 7 Vice Chair make motions? On some committees they 8 can't. On this committee can we?
9 MS. HOLIDAY: NRC does not preclude you 10 from making motions. Okay. Item 6 is an item 11 that's open indefinitely. This is where staff will 12 review the reporting structure with the Committee 13 on an annual basis. You'll hear that presentation 14 from me later on this morning.
15 Items 11 through 15 are all related to 16 the expanded Part 35 rulemaking. So, again, I'd 17 like to ask if there's a motion from the Committee 18 to close items 11 through 15.
19 CHAIRMAN ALDERSON: And is there a 20 second? Is there discussion? All in favor?
21 (Chorus of ayes.)
22 CHAIRMAN ALDERSON: Unanimous.
23 MS. HOLIDAY: Thank you. Item 16 again 24 has to deal with patient release criteria similar 25 to item 1. The patient release Commission paper NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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35 1 was provided to the Commission on January 29th, and 2 is there a motion to close item 16?
3 VICE CHAIRMAN ZANZONICO: I make a 4 motion.
5 CHAIRMAN ALDERSON: Is there a second?
6 MEMBER DILSIZIAN: Second.
7 CHAIRMAN ALDERSON: Is there 8 discussion? All in favor?
9 (Chorus of ayes.)
10 CHAIRMAN ALDERSON: It passes 11 unanimously.
12 MS. HOLIDAY: Thank you. All the items 13 on the 2012 chart were closed, so that chart is not 14 included. For the 2013 chart, all of these were 15 related to the Part 35 expanded rulemaking. That 16 was the time that the ACMUI was provided with the 17 draft proposed rule, so all of these items again 18 are related to the Part 35 expanded rulemaking. Is 19 there a motion to close all of these items?
20 CHAIRMAN ALDERSON: There's a motion 21 and a second. Is there a discussion? Hearing 22 none, all in favor?
23 (Chorus of ayes.)
24 CHAIRMAN ALDERSON: Unanimous.
25 MS. HOLIDAY: Thank you. Okay.
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36 1 There's no 2014 chart because all of those items 2 were closed. So that brings us to the 2015 chart.
3 I apologize if it's very hard to see. Item 7 has 4 to deal with the abnormal occurrence criteria. I 5 believe I informed the Committee at the meeting in 6 September that the NRC issued its revised abnormal 7 occurrence policy, so this item should have been 8 closed, but I do not believe that we made a motion 9 during the September meeting to close it. So at 10 this time, I'd like to ask if there's a motion to 11 close item 7.
12 CHAIRMAN ALDERSON: So is there a 13 motion to close? There is a motion. Is there a 14 second? There's a second. Discussion? Seeing 15 none, all in favor?
16 (Chorus of ayes.)
17 CHAIRMAN ALDERSON: It passes 18 unanimously.
19 MS. HOLIDAY: Thank you. Items 12, 13, 20 and 15 are related to the Patient Intervention 21 Subcommittee. As you'll recall during the 22 September 2017 ACMUI fall meeting, the Patient 23 Intervention Subcommittee provided a revised report 24 which was incorporated into the medical event 25 reporting and its impact on Medical Licensee NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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37 1 Patient Safety Culture Subcommittee report as an 2 addendum, I believe, or an appendix. So at this 3 time, I would like to ask the ACMUI if there's a 4 motion to close items 12, 13, and 15 as they were 5 superseded by the subcommittee's report provided in 6 2017.
7 CHAIRMAN ALDERSON: Is there a motion?
8 And a second? Is there discussion? All in favor?
9 (Chorus of ayes.)
10 CHAIRMAN ALDERSON: Unanimous.
11 MS. HOLIDAY: Thank you. Again, item 12 22 is related to the abnormal occurrence criteria 13 that was revised last year, similar to item 7. Is 14 there a motion from the Committee to close item 22?
15 CHAIRMAN ALDERSON: Is there a motion?
16 MS. HOLIDAY: Dr. Suh.
17 CHAIRMAN ALDERSON: And there is a 18 second. Thank you. We have a motion and a second.
19 Is there discussion? Hearing none, all in favor.
20 (Chorus of ayes.)
21 CHAIRMAN ALDERSON: Unanimous.
22 MS. HOLIDAY: Thank you. Okay. For 23 2016, this, of course, was when the Committee was 24 provided with the draft final Part 35 expanded 25 rulemaking, so items 1 through 15 are related to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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38 1 the ACMUI's recommendations as it relates to the 2 Part 35 expanded rulemaking. Is there a motion 3 from the Committee to close these items?
4 CHAIRMAN ALDERSON: Is there a second?
5 Is there discussion? Hearing none, all in favor?
6 (Chorus of ayes.)
7 CHAIRMAN ALDERSON: Unanimous.
8 MS. HOLIDAY: Thank you. Item 16, Dr.
9 Alderson formed a subcommittee to review the 10 training and experience requirements for all 11 modalities under 10 CFR Part 35. This I will leave 12 open since that subcommittee is still performing 13 its reviews and currently is reviewing the 14 requirements for 35.300 users.
15 CHAIRMAN ALDERSON: So I would, I think 16 that's appropriate. I would suggest possibly, I 17 noted back on item number 6 in the year 2011 it 18 contained the words open indefinitely, so it just 19 kept coming back. And that was one of the things 20 that we proposed and talked about when we created 21 this Committee, the idea that, as medicine evolves, 22 the world evolves, that it was always important to 23 be re-evaluating training and experience 24 requirements. So I would suggest perhaps that we 25 include not just open but open indefinitely under NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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39 1 that as a phrase in this particular handout. Yes, 2 Ms. Weil?
3 MEMBER WEIL: Thank you. In support of 4 that, I'd say that we called it a standing 5 subcommittee, rather than simply a subcommittee.
6 MS. HOLIDAY: Yes. So my understanding 7 is that it was originally named standing 8 subcommittee, but, as noted in the ACMUI charter, 9 ACMUI does not have any standing subcommittees.
10 And I believe the idea was that this subcommittee 11 would review the training and experience 12 requirement on a as-needed basis, maybe every five 13 years or so, however long it took to get through 14 it, because you didn't want to continuously have to 15 look at the training and experience requirements 16 every year. I wasn't involved with the meeting at 17 that time, so I'm not very sure if that was the 18 intent of the subcommittee.
19 CHAIRMAN ALDERSON: Well, Dr. Palestro 20 can speak. I will say that my intention in talking 21 about it was that it would be reviewed on an almost 22 continuous basis so that we were keeping up with 23 what was happening in the field. Dr. Palestro?
24 MEMBER PALESTRO: Yes. The concept was 25 not necessarily that it would be a yearly review or NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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40 1 a monthly review but that it would be an ongoing 2 review every X number of years and whenever it was 3 deemed necessary, perhaps the introduction of a new 4 technique, a new radiopharmaceutical, that sort of 5 thing. And so that was the concept of forming a 6 standing subcommittee, in essence that its work was 7 never really complete.
8 MS. HOLIDAY: Okay. So I will offer 9 that I am not opposed to this being open 10 indefinitely. I would like to say, while we called 11 it a standing subcommittee, I would make this 12 similar to our Medical Events Subcommittee that 13 reviews medical events on an annual basis. We 14 don't refer to that as a standing subcommittee, but 15 that review is performed on an annual basis. So I 16 would like to refrain calling it a standing 17 subcommittee, but I will note that the Committee 18 will review this on a continual basis. Is that 19 amenable to the Committee?
20 MEMBER PALESTRO: It is to me, yes.
21 CHAIRMAN ALDERSON: All in favor?
22 That's a consensus if that would be true. There 23 are comments, though, however.
24 MS. HOLIDAY: I agree.
25 CHAIRMAN ALDERSON: All in favor of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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41 1 that?
2 (Chorus of ayes.)
3 CHAIRMAN ALDERSON: Yes, everyone is.
4 So, yes, that's fine. Thank you.
5 MS. HOLIDAY: Okay. Item 24 has to do 6 with the Committee reaching out to their respective 7 professional organizations to enhance the 8 communications between the ACMUI, the NRC, and the 9 medical community. I've left this open because I 10 believe that this is one of those open indefinite 11 items that the Committee put forward as a 12 recommendation.
13 CHAIRMAN ALDERSON: It did.
14 MS. HOLIDAY: So if it's okay, is there 15 a motion to amend this to say open indefinitely?
16 MEMBER PALESTRO: So moved.
17 CHAIRMAN ALDERSON: Is there a second?
18 VICE CHAIRMAN ZANZONICO: Second.
19 CHAIRMAN ALDERSON: Any discussion?
20 All in favor?
21 (Chorus of ayes.)
22 CHAIRMAN ALDERSON: It's unanimous.
23 MS. HOLIDAY: Okay, great. Items 39, 24 42, and 43 are related to the yttrium-90 25 microspheres licensing guidance. I suggest leaving NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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42 1 this as open because staff has not issued its 2 revision to the Y-90 guidance. As you may be 3 aware, we issued the guidance for public comment 4 and that public comment period ended earlier this 5 year. Just this month. So when the next draft 6 revision of the guidance is ready, it will be 7 provided to the ACMUI for its review and comment at 8 that time. So I will leave items 39, 42, and 43 on 9 the chart as is.
10 Okay. Items 44 through 52 are related 11 to the Committee's recommendations for the 12 NorthStar's licensing guidance. I have these noted 13 in red, and I wrote closed, although this has not 14 been put forth as a motion to the Committee yet.
15 Staff issued this licensing guidance last month on 16 February 8th. It was sent out on the medical list 17 server. I will provide it to the Committee hard 18 copy before you leave for the meeting.
19 Since that guidance was issued, staff 20 will, in the near future, issue a memorandum to the 21 Committee to explain which recommendations from the 22 Committee were accepted and were not accepted or 23 partially accepted to explain what staff did in 24 response to your recommendation.
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43 1 there's a motion from the Committee to close items 2 44 through 52.
3 MEMBER ENNIS: It seems to me we should 4 wait and see that document before we close it.
5 MS. HOLIDAY: The guidance has already 6 been issued, so, similar to, like, the AO criteria 7 being revised by the Commission or the Part 35 8 expanded rulemaking, it's already been issued. So 9 staff has already addressed the ACMUI's 10 recommendations. All that staff has to do at this 11 point is simply issue the memorandum to explain 12 what we did with your recommendations. Ms. Weil?
13 MEMBER WEIL: I support the suggestion 14 that we wait. If this is inconvenient for you, 15 perhaps you should have communicated all that stuff 16 to us prior to asking us to close it.
17 MS. HOLIDAY: Sure. That's not a 18 problem. Is there further discussion from the 19 Committee?
20 MEMBER PALESTRO: Just a question. In 21 terms of the ACMUI recommendations, were they all 22 accepted in their entirety or were some of them 23 accepted partially and so forth, the way we see in 24 some of the other --
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44 1 that to Dr. Howe or Ms. Ayoade, as that was their 2 working group.
3 DR. HOWE: This is Dr. Howe. I'm not 4 prepared right now to give you an answer to that 5 question.
6 CHAIRMAN ALDERSON: So I think the 7 sense of the Committee is that we're not ready to 8 close all these items and Dr. Howe isn't ready to 9 comment to us on our questions. So I think these 10 items should remain open. Does anyone wish to say 11 otherwise on the Committee? The Committee's 12 recommendation is that they remain open.
13 MS. HOLIDAY: Okay.
14 MR. BOLLOCK: This is Doug Bollock.
15 And I'll just add, whether you close it or not, if 16 you are not satisfied with our responses, whether 17 we accept it partially, fully, or not at all, and 18 when you see those responses, that doesn't preclude 19 you from, in the future, giving other 20 recommendations for future updates, revisions, to 21 the guidance.
22 VICE CHAIRMAN ZANZONICO: So this is 23 Pat Zanzonico. So this is the guidance that was 24 issued in February?
25 MS. HOLIDAY: Yes.
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45 1 VICE CHAIRMAN ZANZONICO: That's 2 considered final and presumably has addressed, but 3 we can't definitively say at the moment, but 4 presumably has addressed the ACMUI comments. But 5 that's the document we're referring to, the 6 February guidance.
7 MS. HOLIDAY: Correct, correct.
8 MEMBER DILSIZIAN: Just to reassure 9 you, I mean, I was responsible for this document 10 and all the comments in the red are the ones we 11 recommended but cannot firmly state that all of 12 them weren't adopted. I just wanted to show you 13 that these are correct.
14 CHAIRMAN ALDERSON: This is Dr.
15 Alderson. Administratively speaking, I understand 16 that it's an efficient action now to potentially 17 close these because some of this has already 18 happened. On the other hand, from the point of 19 view of the public and we, as an advisory 20 committee, represent the public to the agency, it 21 looks as if we close something before we know what 22 happened and perhaps we don't really, aren't really 23 caring about it that much.
24 So I think, from the standpoint of the 25 Committee's representation of the public, that it's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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46 1 reasonable to keep these items open.
2 MS. HOLIDAY: Sure. I accept that.
3 Are there any other comments for these items?
4 Okay. So then we can move on to the 2017 chart.
5 Okay. For the very first item, this is where the 6 Committee requested that we review staff's response 7 to all the Committee's past recommendations and 8 actions as it related to the Part 35 rulemaking 9 during the fall 2017 meeting. As I stated earlier, 10 we were closing the items related to the rulemaking 11 efforts earlier.
12 NRC has not issued the final rule yet.
13 However, in 2018, because the rule will have 14 already been published by the next meeting, staff 15 will have an agenda item to go through each of the 16 recommendations from the ACMUI from 2007 and 17 forward, including the reports from 2013 and 2016, 18 to give you that detailed review.
19 So at this time, I would leave item 1 20 as pending to be discussed at the fall 2018 21 meeting. Is that okay with the Committee?
22 CHAIRMAN ALDERSON: It seems so.
23 MS. HOLIDAY: Okay. Item 8 has to deal 24 with the Patient Intervention Subcommittee amending 25 their report and providing it during the fall of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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47 1 2017. And as I discussed earlier, that report was 2 provided in a presentation and included in the 3 reporting and its impacts on Medical Licensee 4 Patient Safety Culture Subcommittee report. So I 5 would like to ask if there's a motion to close this 6 item since the item itself is just saying that they 7 will amend their report and present it, which has 8 already occurred during the September meeting.
9 CHAIRMAN ALDERSON: Is there a motion 10 to that effect? A second? Several seconds. Is 11 there further discussion? Hearing none, all in 12 favor?
13 (Chorus of ayes.)
14 CHAIRMAN ALDERSON: Unanimous.
15 MS. HOLIDAY: Okay. Item 12. This was 16 the item where the ACMUI asked staff to engage with 17 the Organization of Agreement States to find a way 18 to centralize reporting from the agreement states.
19 This was noted during Dr. Ennis's report where the 20 Committee conducts their annual review of medical 21 events reported on a fiscal year basis, and the 22 Committee noted that there were discrepancies 23 between how various agreement states report their 24 information and how some events do not provide 25 timely updates.
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48 1 So at this time, I would like to inform 2 the Committee that, during our monthly phone call 3 with the Organization of Agreement of States and 4 the Conference for Radiation Control Program 5 directors, I gave a presentation or I made a note 6 to the agreement states that this was an issue that 7 was recognized by the ACMUI and that we are 8 reminding the agreement states that they need to 9 report their medical events in accordance with FA-10 300, which is the procedure that informs the 11 agreement states how they have to report medical 12 events. In addition to that, I informed the states 13 that they need to ensure that they provide timely 14 updates so that the information may be 15 appropriately captured in that.
16 So at this time, I would like to 17 propose or ask the ACMUI if there's a motion to 18 close item 12. CHAIRMAN ALDERSON: Is 19 there such a motion?
20 VICE CHAIRMAN ZANZONICO: This is Pat 21 Zanzonico. Is there any evidence since your 22 presentation if they are or are not reporting in a 23 more timely manner?
24 MS. HOLIDAY: Because medical events 25 are reported as the medical events happen, there's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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49 1 no way for me necessarily to double check all of 2 the 37 agreement states because events aren't 3 continuously reported. Some states have events, 4 and some do not. So I guess a turning analysis 5 will be able to tell by next year if that's the 6 case.
7 MR. BOLLOCK: This is Doug Bollock. So 8 we do a, we review NMED events for the previous 9 year every year, and we just did that for 2017. So 10 there wasn't time to see that or see any difference 11 in the reports or doing a review of NMED at this 12 time. There just hasn't been enough time to see 13 any gains from the discussion we had with the 14 agreement states.
15 MEMBER ENNIS: Another question is, and 16 I guess maybe this is for you, I think, has the 17 role of, okay, what do I do? And since you've done 18 that, it would make sense to come off. I think, 19 for me and maybe for us, it's a little bit of like, 20 all right, what are our active issues and help 21 refresh our memory in case, because we're busy 22 doing other things a lot of the time. And this 23 feels to me like still an active issue in my mind.
24 Okay, has this worked and this may become a bit of 25 an ongoing thing. So on that side, I'm inclined to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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50 1 prefer to have it still remaining on the list.
2 CHAIRMAN ALDERSON: Okay. So there's a 3 suggestion from Dr. Ennis, for those reasons, this 4 should remain open. We still don't really have a 5 motion to close it. Is there a motion?
6 VICE CHAIRMAN ZANZONICO: This is only 7 a comment. Obviously, we've had items open dating 8 back to 2008, so I think leaving a 2017 item open a 9 little bit longer isn't that onerous.
10 CHAIRMAN ALDERSON: Zoubir?
11 MR. OUHIB: Yes. I guess keeping it 12 open probably won't be very beneficial because it 13 will either confirm that the system is actually 14 working or maybe the ACMUI will have other 15 suggestions or recommendations perhaps to meet 16 whatever needs to be met, in my opinion.
17 CHAIRMAN ALDERSON: So it seems that 18 the sense of the Committee is to keep this recent 19 item open. Is that generally the feeling of the 20 Committee? The heads are nodding yes, so I believe 21 this will stay open. MS. HOLIDAY: Okay.
22 Then that brings us to items 13 through 20, and 23 they are related to the recommendations that came 24 out of the medical event reporting and its impacts 25 on medical licensee patient safety culture. We NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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51 1 should really come up with an acronym for this.
2 You will hear a presentation later on today from 3 Mr. Bollock to explain staff's response to some of 4 those recommendations. So at this time, I will 5 leave those items open on the charts.
6 Okay. So then that brings us to item 7 number 21. This has to deal with the Nursing 8 Mother Guidelines Subcommittee report. So the 9 initial report was discussed during the September 10 2017 fall ACMUI meeting with the suggestion that 11 some amendments be incorporated and that this be 12 discussed at a future date. So we did hold that 13 public teleconference on February 15th. So I have 14 this marked as a closed item because the action was 15 to hold a public teleconference, which we did do on 16 February 15th.
17 So, again, I prematurely marked closed, 18 so I would like to ask the Committee if there's a 19 motion to close this item.
20 MEMBER METTER: I meant to close that 21 item.
22 CHAIRMAN ALDERSON: Is there a second?
23 MEMBER O'HARA: Second.
24 CHAIRMAN ALDERSON: There's a second.
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52 1 in favor of closing this item?
2 (Chorus of ayes.)
3 CHAIRMAN ALDERSON: Unanimous.
4 MS. HOLIDAY: Okay. And item 22 5 through 28 are related to the Patient Release 6 Subcommittee's report. Again, staff issued its 7 paper to the Commission on January 29th. I 8 provided the ACMUI with a copy of that Commission 9 paper, as well, if you'd like to see it in hard 10 copy. Again, essentially, the subcommittee 11 endorsed by the full committee agreed with staff's 12 conclusions that no changes were warranted via 13 rulemaking under 3575. So I would like to ask the 14 Committee if there's a motion to close items 22 15 through 28 as they relate to the patient release 16 Commission paper.
17 VICE CHAIRMAN ZANZONICO: Motion. So 18 moved.
19 CHAIRMAN ALDERSON: Is there a second?
20 MEMBER ENNIS: Second.
21 CHAIRMAN ALDERSON: Discussion?
22 Hearing none, all in favor?
23 (Chorus of ayes.)
24 CHAIRMAN ALDERSON: Unanimous.
25 MS. HOLIDAY: Thank you. Okay. Item NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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53 1 29 has to deal with the physical presence 2 requirements for the Leksell Gamma Knife Icon' 3 Subcommittee report. Again, this item was to hold 4 a public teleconference in the near future to 5 discuss the amended report. Similar to the nursing 6 mother guidelines, we held that public 7 teleconference on February 15th, so I'd like to ask 8 if there's a motion to close this item as the 9 committee did hold its public teleconference on the 10 15th of February.
11 CHAIRMAN ALDERSON: Motion was made by 12 Dr. Suh. Is there a second? There are seconds.
13 Further discussion? Hearing none, all in favor?
14 (Chorus of ayes.)
15 CHAIRMAN ALDERSON: Unanimous.
16 MS. HOLIDAY: And then item 30 is that 17 we agree to hold the spring ACMUI meeting on March 18 1st and 2nd with a backup date of March 14th and 19 15th. We did not meet either of those dates, but 20 we are here on March 7th and 8th. So I'd like to 21 ask the Committee if there's a motion to close item 22 30.
23 CHAIRMAN ALDERSON: This one should be 24 easy. With seconds, yes. Further discussion?
25 Hearing none, approved.
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54 1 MS. HOLIDAY: Thank you. Okay. And 2 this brings us to the 2018 chart. These 3 recommendations come out from the February 15th 4 public teleconference. Items 1 through 2 are 5 related to the recommendations for the Nursing 6 Mother Guidelines Subcommittee report. However, I 7 have left them as open items as I believe the 8 intent of the ACMUI was that these recommendations 9 be considered for changes in Regulatory Guide 8.39, 10 which is the guidance for patient release.
11 So I don't see any shakes of heads. Is 12 the --
13 VICE CHAIRMAN ZANZONICO: This is Pat 14 Zanzonico. The Nursing Mother Guideline 15 Subcommittee report is going to be amended, is 16 going to be revised. MS. HOLIDAY:
17 Absolutely.
18 VICE CHAIRMAN ZANZONICO: So on that 19 basis alone, these items should be left open.
20 CHAIRMAN ALDERSON: Yes, that's right.
21 I agree.
22 MS. HOLIDAY: Okay. Mr. Green?
23 MR. GREEN: On number one, I see that 24 some references are made merely to nuclides, 25 carbon-11. Some references are made to compounds, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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55 1 I-123 sodium iodide. And then some, again, go back 2 to I-131 sodium iodide and -- so there's a blending 3 of nuclide and chemicals. But, for example, I-123, 4 iofetamine, not iofetamine, MIBG is not on the 5 list. Sodium iodide 123 is, but there are other 6 123 compounds that are omitted from this list.
7 VICE CHAIRMAN ZANZONICO: This is Pat 8 Zanzonico. I think this list may not reflect 9 completely the tabulation in the report. And 10 you're right. In some cases, the recommendations, 11 the guidelines were based, were radionuclide 12 specific. So for example, if the physical half-13 life was short enough that the biological half-life 14 of the radiopharmaceutical was irrelevant, then it 15 was a radionuclide specific guideline. On the 16 other hand, if the effective half-life was impacted 17 by both the physical and biological half-life, then 18 they were radiopharmaceutical specific guidelines.
19 So that's why there's a mix of guidelines, some 20 radionuclide specific, some radiopharmaceutical 21 specific. But I don't think this list in the table 22 reflects the report exactly.
23 MEMBER METTER: This is Darlene. I 24 think what happened is, like, these were the items 25 that were brought to the attention of the Committee NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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56 1 at the time and not the items that were on, the 2 other items that were on the list.
3 MS. HOLIDAY: Okay. So then if there's 4 no further discussion, we can move on to the next 5 items. Items 3, 4, and 5 are related to the 6 physical presence requirements for the Leksell 7 Gamma Knife Icon' Subcommittee report. These 8 recommendations were presented during the February 9 15th public teleconference. I've left these items 10 open on the agenda. As Ms. Howell indicated, this 11 report was provided to staff specifically. There's 12 an NRC/Agreement State working group. I'm the co-13 chair of that working group, and we are considering 14 the ACMUI's recommendations during our review and 15 evaluation to determine if there should be changes 16 to the physical presence requirements for either 17 the Perfexion' or the Icon' unit. So I've left 18 these items as open.
19 Okay. So these are all of my items on 20 the old business charts. Are there any additional 21 questions, comments, or concerns?
22 CHAIRMAN ALDERSON: Seeing none.
23 MS. HOLIDAY: Thank you.
24 CHAIRMAN ALDERSON: Thank you.
25 Excellent report. So that brings us to the open NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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57 1 forum, medical topics of interest for further 2 discussion. We've actually been discussing some of 3 those as we went through these items. And we're 4 already well behind time here. So are there any 5 other new medical topics of interest that people 6 would like to discuss further before we invite Dr.
7 Howe to come forward? Seeing none -- oh, Dr.
8 Palestro?
9 MEMBER PALESTRO: Very quickly. With 10 respect to communications with professional 11 organizations, we did submit a request for a 12 continuing education program at the annual meeting 13 of the Society for Nuclear Medicine and Molecular 14 Imaging, similar to what we did last year. We have 15 not yet heard back. The meeting is later in June 16 this year, so I would hope that we find out 17 shortly.
18 We also had intended to submit to the 19 ACR but the format of that meeting changed and this 20 type of program doesn't fit with what they're going 21 to do this year.
22 CHAIRMAN ALDERSON: That's good. We 23 have a comment from the audience.
24 MS. KUBLER: Hi. Caitlin Kubler with 25 the Society of Nuclear Medicine and Molecular NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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58 1 Imaging. I just heard from our meeting staff this 2 morning, we will be sending out those confirmation 3 notices next week.
4 CHAIRMAN ALDERSON: Thank you.
5 Hopefully, you'll get a positive one. Any other 6 comments? Hearing none, I think we're ready to 7 move forward to the next portion of the program, 8 the next agenda item, which is medical related 9 events. Dr. Howe.
10 DR. HOWE: All right. This is one of 11 my favorite parts of addressing the ACMUI. We'll 12 be talking about the medical events that happened 13 in fiscal year 2017. Not only will you have 14 slides, but members of the ACMUI will have the 15 printout from the NMED reports for this time frame.
16 This is just a reminder that there are 17 many more medical procedures given, and the number 18 of medical events that you see is just a very small 19 number of those procedures. So we also have a dose 20 threshold for diagnostic events, and that precludes 21 most diagnosis events that don't go as expected 22 from not meeting the threshold from that event.
23 And there are about 150,000 therapeutic procedures 24 performed using radioactive materials in a year.
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59 1 denominator.
2 The ACMUI wanted a perspective, how are 3 the medical events trending. And as you can see 4 for 2012, '13, '14, the number of medical events 5 was 48, 43, 46. That's not a very large number.
6 We're comparing that to 150,000 per year. And for 7 diagnostic, there's a million. But with our dose 8 limit, you see very few diagnostic.
9 And then I've broken down how those 10 medical events, what categories they fell into.
11 35.200 are the imaging and localization. Those are 12 your diagnostic events for the most part. 35.300 13 are your therapeutic or I-131 greater than 30 14 microcuries. All of those require a written 15 directive. 35.400 are your brachytherapy, 16 primarily manual, permanent implant, and temporary 17 implant. And 35.600 are your high dose remote 18 afterloaders, new teletherapy units, and your 19 original gamma stereotactic radiosurgery units.
20 And 35.1000 includes the things that we consider to 21 be other than 100 through 600. Most of the 22 35.1000s are going to be the yttrium-80 23 microspheres, but it may also include intervascular 24 brachytherapy, the Perfexion', the Icon', and a few 25 other devices.
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60 1 So next slide. So this is what we've 2 seen in the last three years. 57, 50, 43. Once 3 again, you're not seeing very large numbers. They 4 fluctuate, around the mid-40s and they go up into 5 the 57 sometimes, up in the 50s. And you can see 6 down below the change in the different modalities 7 that had medical events. The parentheses that I 8 provide are the number of patients, so we may have 9 had nine -- and the other thing is how do we count 10 medical events? We basically count them by 11 facility. If a facility has a medical event, they 12 report it to us. That medical event, because they 13 may have an event today and then they go back 14 through their records and they find out that they 15 didn't catch additional medical events earlier. So 16 we may have more than one patient for a medical 17 event, but most of our medical events are single 18 patient activities.
19 So you can see in 2015, we had nine 20 medical events for 35.400, which is brachytherapy.
21 We had ten patients, so one of those medical events 22 had two patients. And when you look at 2017, for 23 35.600, we had eight, I won't say there are eight 24 facilities because if a facility reports a medical 25 event today and then they report another medical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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61 1 event two months from now, we will count those as 2 separate reports. So in 2017, we had eight 3 reported medical events that ends up at one 4 facility had two different reports, and they had a 5 total of -- and then one location had five patients 6 and the other had four patients. So you see more 7 patients than you have events.
8 Next slide. So let's start looking at 9 the specific modalities. So we had no medical 10 events in 35-200, which are primarily the 11 diagnostic, technetium events. We had four in 12 35.300, which require written directives. Three of 13 those for iodine-131, and we had one for radium-14 223. And this looked specifically at the events.
15 Next. So for I-131, the first event 16 I'll be telling you about, the facility 17 administered two millicuries of I-131 when none was 18 prescribed. The physician asked for parathyroid 19 tests, but, instead, the facility gave a thyroid 20 scan. There was no written directive. We have 21 seen this in the past where activities that require 22 written directives are given without written 23 directives, and that goes back to the facility and 24 its being aware of what written directives require 25 and being able to, they should identify this before NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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62 1 they ever gave it because they should have said 2 where's the written directive. There was none.
3 Well, I shouldn't be giving I-131 in two millicurie 4 quantities if there is no written directive. So 5 these things should be caught earlier because they 6 should have triggers.
7 What they did was they did electronic 8 ordering, and the record system was used without 9 confirming the order prior to administration. And 10 the thyroid received 1600 centigray.
11 What have they done to corrective 12 actions? They've modified their procedures.
13 They're going to confirm the dosage orders, and 14 they are retraining personnel. Those are common 15 corrective actions that we see.
16 The next slide. In this case, they 17 administered 20 millicuries instead of 30 18 millicuries that was in the written directive. In 19 this particular case, the written directive was 20 incorrect. The written directive should have been 21 written for 20.2 millicuries, but, instead, they 22 wrote it for 30. So the intended dose was given.
23 And now, as a corrective action, they're requiring 24 more individuals to review the written directive 25 for accuracy before signing it and giving the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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63 1 administration.
2 Next slide. They administered 106 3 millicuries instead of 150. This is a typical 4 problem we see over and over again. The dosage was 5 delivered in two capsules. The patient shook the 6 vial into the mouth but only one capsule came back.
7 The other was left in the vial. And it wasn't 8 discovered until the vial was sent back to the 9 pharmacy and they did a measurement and determined 10 they still had I-131 inside.
11 Next slide. This is our radium-233 12 dichloride issue. In this case, they administered 13 more activity than they were supposed to. They 14 administered 176 microcuries instead of the 108 15 microcuries. How did this happen? They had two 16 patients they treated on the same day. They 17 correctly labeled with the patient names the lead 18 pigs and the syringes, but they gave the wrong 19 syringe to the physician when they were giving 20 administration or to the technologist when they 21 were giving administration. So this is a wrong 22 patient.
23 They've added a time out. They've now, 24 for corrective action, the dosing physician has to 25 verify the identity of the patient and the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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64 1 prescribed dose in the written directive. And 2 you'll see later, when I get to some of the 3 yttrium-90 microsphere medical events, that time 4 out doesn't always work. So it is a corrective 5 action that many licensees give, but it doesn't 6 always work.
7 Next slide. So now we'll move into the 8 35.400. These are the brachytherapy, both 9 permanent and temporary implants. So we had seven 10 medical events. All of them were prostate medical 11 events. And you'll see, as I go through, we had 12 one licensee with two reports. They had a human 13 error and one they attributed to anatomy. They had 14 a wrong site. They used a previous activity. And 15 then they had larger than the pre-plan or the 16 swelling and had three cases of those.
17 And now let's look at the individual 18 cases. Next slide. In the first one, the 19 licensee, they had one licensee but two separate 20 reports. In the first case, the patient received 21 62 percent of the dose. There was no root cause, 22 but they attributed it to human error. And they 23 made a statement that some seeds may have migrated, 24 but they didn't provide any additional verification 25 of why they believed that was true.
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65 1 Next slide. It's the second case. In 2 this case, the patient received 78 percent of the 3 prescribed dose, and they blamed it on patient 4 anatomy. They identified during post-implant CT 5 scan and subsequent dosimetry. It was identified 6 during the post CT scan and subsequent dosimetry 7 analysis. There was a delay in reporting to the 8 state due to communication breakdown and inadequate 9 procedures.
10 And the next slide. Now we go into the 11 patients, additional ones. In this particular 12 case, there's the wrong site. They said they 13 received 74 percent less than prescribed, but if 14 you look you'll see almost all of the dose went to 15 the penile bulb, so they delivered it to the wrong 16 site. And they attributed it to human error, and 17 they are providing additional training to personnel 18 and approved supervision.
19 CHAIRMAN ALDERSON: Is there a 20 typographic error on that slide?
21 DR. HOWE: There might be. Which --
22 CHAIRMAN ALDERSON: It says proceed 23 2,760 instead of 1100.
24 DR. HOWE: Oh, there should be another 25 zero there.
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66 1 CHAIRMAN ALDERSON: Right. There 2 should be another zero.
3 DR. HOWE: Yes.
4 CHAIRMAN ALDERSON: Let's note that and 5 we'll add that in.
6 DR. HOWE: Okay.
7 CHAIRMAN ALDERSON: Thank you.
8 DR. HOWE: Thank you. The next slide.
9 Okay. In this particular case, there was an over-10 dosage where the patient received 157 percent of 11 the prescribed dose, and how did this happen?
12 Well, they failed to enter the correct activity 13 proceed into the physics spreadsheet. They had a 14 value from the previous calculation, and they 15 didn't put the new value in. So they didn't 16 perform an independent verification of the 17 treatment data. The new action is a secondary hand 18 calculation. They're required to use a blank 19 spreadsheet, so they don't carry erroneous 20 information from previous calculation. And they 21 are going to have a verbal timeout to verify key 22 parameters prior to treatment.
23 Next slide. This is an underdose, and 24 they attributed the underdose to an 18-percent 25 increase in the prostate size compared to the pre-NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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67 1 plan and that the physician had planned to have a 2 cooler coverage at one part of the prostate, and 3 that led to an under-exposure. And it was 4 discovered during a routine audit conducted by the 5 medical physicist.
6 Next slide. They were prescribed 7 14,500. They received 10,000 centigray. It was 8 administered in December. It was discovered the 9 next day. The second treatment was planned for the 10 day after where they implanted eight more seeds, 11 and they attributed it to post-operative swelling 12 and seed migration. And they decided that a 13 corrective action was to perform the post-implant 14 imaging sooner than one day later to minimize the 15 effect of swelling of the prostate gland and 16 possible migration of seeds.
17 Next slide. In this one, they 18 prescribed 1400, 1450 centigray, and they received 19 10,353 centigray. They determined that they should 20 order additional seeds beyond what the pre-plan 21 requires. I think when they were inserting them, 22 they realized they needed more coverage. And then 23 they performed a post-implant x-ray and ultrasound 24 to determine if and where additional seeds could be 25 placed.
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68 1 In the next slide, now we're moving on 2 to the 35.600, which are the HDRs, the teletherapy 3 and the Gamma Knife. And in this case, we have 4 seven gynecological HDR events, and we have one 5 Gamma Knife event. And the gynecological ones, we 6 had more patients than we had reports and also we 7 had most of our additional patients came with a 8 software issue. And we also had wrong site before, 9 equipment failure for one.
10 So if we move to the next slide. This 11 was a generic software issue, and this is a generic 12 software issue that we shared with the FDA under 13 our NRC FDA MOU. In this particular case, we had 14 two licensees and we had a Part 20 report. And the 15 first licensee, there was a determination made that 16 the Oncentra software versions, both 4.5, 4.5.1, 17 and 4.5.2, had an issue with source step size when 18 you were using a ring. In this case, the 19 source step size of 5 millimeters was a default, 20 that if you put 2.5 millimeters in you were still 21 going to get 5 millimeters. And so licensees 22 weren't able to really see what was happening in 23 this case.
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69 1 from 2,800 centigrade to 1,400 centigray. The dose 2 to the unintended site was expected to be between 3 126 to 175 centigray per fraction. So we clearly 4 have a medical event for the wrong treatment site.
5 Elekta notified software users of the 6 problem with the ring. The initial software 7 problem was identified overseas in France, and then 8 Elekta put a notification out and this caused a 9 number of licensees to go back and check to see if 10 this was a problem for their particular patients 11 and if they had used the ring.
12 On the next slide, this is our second 13 licensee, and this particular licensee had five 14 patients. It was a problem with the Oncentra 15 software version 4.5.2. And it was, again, the 16 software step size with a ring of 5 millimeters 17 versus 2.5 millimeters. In this case, when you go 18 5 millimeters, you may actually go back over and 19 cover tissue that you had only intended to give one 20 dwell time. And then you have doses to another 21 side of the ring that you hadn't expected to give 22 dose.
23 In this case, the treatment site 24 received between, a reduction between 20 and 31 25 percent of what the intended dose was. The NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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70 1 licensee did not calculate a dose to the unintended 2 site. Some of the source paths extended beyond the 3 planned end point and started on their turn path.
4 And then some tissue protection was provided in the 5 fluid-filled sleeve that provided some shielding in 6 displacement, and the licensee said it was too 7 complicated to provide dose to the unintended site.
8 Next slide. Now we've got four wrong 9 sites. In the first one, we have a 5 centimeter 10 site that received 500 centigray. The wrong 11 software orientation was selected. This again was 12 an Oncentra but for a different problem. In the 13 treatment planning, you must chose if the treatment 14 catheters are modeled from the tip or the connector 15 end of the catheter. In this case, the licensee 16 selected the tip end mode, which was incorrect.
17 And they have corrective actions, provide 18 additional training to personnel.
19 The next slide. In this case, they 20 used a Capri applicator, and they inserted it into 21 the patient's rectum instead of the vagina for the 22 second of five fractions. It was interesting that 23 they had to call on the radiologist to determine if 24 they had put it in the wrong place. I think there 25 would have been other indications.
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71 1 The treatment site received a 2 prescribed dose of, they claim that the treatment 3 site received the prescribed dose during the second 4 treatment. And then, as I indicated, the 5 radiologist had to confirm that the rectum had been 6 treated.
7 Next slide. In this particular case, 8 the 5 centimeter site receiving 500 centigray 9 should be deleted. That's immaterial for this 10 case. There were two tandem treatments that were 11 delivered as prescribed, but then one of the 12 fractions, the incorrect tandem applicator length 13 was put in as 115 instead of 131. And so it went 14 to the wrong site.
15 Next slide. Okay. So in this 16 particular case, the wrong site received 700 17 centigray. A wire was inserted in the length of 18 the -- the transfer guide-to was 7 2 centimeters 19 shorter than intended. They used a wire to make 20 sure that the applicator was in the correct place.
21 They pulled the wire out. There was a problem with 22 the transfer guide-to. And so when they went to 23 put the source in, it wouldn't fully insert and 24 they didn't realize that until afterwards. So 25 they're counseling the staff on the event.
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72 1 The next slide. This was an equipment 2 failure. The patient received a very low 3 percentage of the intended dose. There were five 4 separate interlocks that tripped in the first 5 fraction. So the licensee stopped the procedure 6 and sent the patient home, and then what they found 7 was that there was fluid in the catheter that may 8 have contaminated the source in the afterloader 9 unit, and they did a decontamination and then they 10 were sending the source and the catheters off to 11 the manufacturer for evaluation.
12 The next slide. This is our Gamma 13 Knife Model C. They were anticipating five shots.
14 Three of them were delivered correctly. The couch 15 retracted from the treatment physician due to 16 clutch malfunction. The patient was released.
17 They made the repairs, but the patient decided not 18 to come back.
19 Next slide. So we've just gone through 20 about 50 percent of the events. The other 50 21 percent are primarily yttrium-90 microspheres, and 22 we did have one intervascular brachytherapy.
23 So on the next slide. For the 24 intervascular brachytherapy, the prescribed dose 25 was to be given for in-stent re-stenosis and in two NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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73 1 dwell positions. They were able to successfully 2 give the first dwell position, but when they went 3 to give the second, when they retracted the 4 sources, the source got stuck in the train, in the 5 source train, and they couldn't retract it into the 6 afterloader. And they found out later that there 7 was a deformation, 7.3 centimeters distal to the 8 strain relief located outside the patient.
9 So there wasn't a treatment to the 10 wrong treatment site, but the patient only got 50 11 percent of the dose they were expected to get. And 12 they attributed it to compression of the catheter 13 during a challenging advancement into the commonly 14 torturous vessel, the left internal mammary artery.
15 Next slide. So now we get to the bulk 16 of the medical events, the yttrium-90 microspheres.
17 And the first group we'll look at are the 18 Theraspheres. And you'll see some pretty complex 19 reasons for medical events here.
20 We've got 15 events. Three are 21 overdoses. We don't normally see overdoses. We 22 have two wrong sites. We have four kinked 23 catheters. That seems to be continuing. And we 24 have one cracked catheter. We have a partial 25 obstruction, two leaking connections, slow NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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74 1 infusion, and reflux to other loads.
2 Next slide. So in this particular 3 case, we have an overdose. They used the wrong 4 calibration date. There was a -- there are two 5 dates. One is when you plan it and when you expect 6 to give the material, and they used a much later 7 calibration day than they should have. They used a 8 dose calibrator that should have tipped them off.
9 They did not question the results.
10 The written directive was not prepared, 11 and it was not signed before the administration.
12 And they had additional shunting to the lung with 13 2,000 centigrade to the lung and the intended was 14 500 centigrade. And they have looked at the 15 patient about six months later, and they haven't 16 seen clinically-significant complications.
17 And in this particular, the next 18 overdose, they prescribed 35,000 centigrade. They 19 administered 80,000 centigrade. They administered 20 before the microspheres had decayed to the 21 prescribed activity. The scheduling nurse used the 22 pre-treatment plan instead of the final treatment 23 plan, and the physician's pre-treatment 24 calculations in timeout failed. So as I told you 25 earlier in some of these things, many of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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75 1 corrective actions are a timeout. And in this 2 particular case, and I have another one, the 3 timeout failed to pick up the discrepancies.
4 Next slide. And to go into a little 5 more detail on this particular one, the spreadsheet 6 had calculated the patient dose and was modified.
7 And when they checked the administrative vial for 8 the calibrated activity date versus this is what 9 they're going to do, they're going to do a 10 spreadsheet to calculate the patient dose and 11 they're going to modify that so that they look at 12 the calibration activity versus the prescribed 13 activity and the procedure date. And their timeout 14 procedure was modified to confirm the proper 15 activity prior to administration. So they're 16 having to revise their timeout process.
17 Next slide. This is another overdose 18 where they gave about twice as much as they needed.
19 They considered it to be a human error in 20 converting from gigabecquerels to millicuries, so 21 their corrective action is to have a procedure 22 modification, have written directive revisions, and 23 software update to assist in the unit conversions.
24 Next slide. In this case, they were 25 prescribed -- we're going to the wrong site. They NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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76 1 were prescribed 6,000. They administered 4,860 to 2 the left lobe, and then they delivered 3,600 to the 3 right lobe. They claimed they had challenging 4 anatomy. They had a narrow window just distal to 5 the vascular supplying the right lobe. And so they 6 believed the microspheres refluxed back into the 7 right lobe.
8 They verified catheter position because 9 they knew they were in a very sensitive area that 10 they could get back flow multiple times before the 11 administration without any apparent complications 12 they could see. But when they looked at their 13 Bremsstrahlung images after the procedure, they 14 realized that they had microspheres in both lobes.
15 And they attributed it to movement of the catheter 16 from some unnoticed patient movement, probably 17 breathing, or angiographically undetected reflux 18 caused by the difference in the flow dynamics of 19 the microspheres, the contrasting agent, and the 20 macro-aggregated albumin. So they are saying that 21 we've got three different tests to see if we have 22 it in the right place and where the back flow is 23 going to be, and all of those tests have different 24 parameters, so they may not be equivalent.
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77 1 again. Two separate segments of the right lobe 2 were supposed to receive 25 millicuries to the 3 small segment and 64 millicuries to the large 4 segment. They discovered that they only ordered 10 5 millicuries for the large segment, so they had an 6 error in ordering. And each dose needed a 7 different calibration date. And then contrary to 8 the vendor guidance, the licensee used one order 9 sheet for the two doses with the one calibration 10 date. So that led to problems in filling the 11 order.
12 On the next slide, we'll see that this 13 was a very complicated licensee. They had several 14 hand-offs. There was radiation oncology that 15 determined how much activity, and the radiation 16 oncologist was an authorized user. They did it in 17 consultation with the interventional radiology 18 authorized user. The physicist calculated certain 19 things. The interventional radiologist did the 20 ordering. And then when it came back, they also 21 switched people again, so everybody signed off on 22 things, but it was just too complicated a handoff, 23 so there were many, many places where there could 24 be errors.
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78 1 the written directive, the order, and the assay 2 data. And none of that was identified prior to 3 patient treatment.
4 Next slide. They prescribed roughly 47 5 millicuries to the left lobe, and they administered 6 46 to the right lobe. In this case, the 7 interventional radiologist and the radiation 8 oncologist authorized users, both of them are 9 authorized users, signed off on the planned 10 activity for the left lobe and via the left hepatic 11 artery, and then the authorized user completed the 12 written directive. But the interventional 13 radiologist, when he put the catheter in, he put it 14 into the right hepatic artery instead of the left 15 hepatic artery and so delivered the dose to the 16 right lobe.
17 Next slide. So this is one of the 18 cases that I told you about where the operating 19 room timeout for all parties is now going to be 20 looked at more closely to confirm the procedure and 21 the treatment that was administered. So they re-22 modified their written directive timeout 23 procedures.
24 Okay. Next slide. Now we have four 25 kinking ones. They prescribed 146 millicuries.
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79 1 They administered 11. They had a slow injection.
2 So this is a fairly routine activity and, through 3 the slow injection, there was a dent in the outlook 4 tubing from a pinch-clamp where they thought they 5 had over-tightening of the Touhy-Borst Y adaptor, 6 causing sedimentation of the microspheres in the 7 delivery system.
8 They sent the catheter back to the 9 manufacturer, and the manufacturer didn't observe 10 any evidence of the Touhy fitting as being over-11 tight. And so they also saw there was a small mass 12 of microspheres inside the dose vial, so they never 13 got out of the dose vial, and within the outlet 14 tubing. They did see locations with kinks, but 15 they didn't see any fragments that came through.
16 The next slide. So I've got two cases 17 here. One is prescribed 1,200, and they 18 administered, 12,000, they administered 6,000.
19 They had a kinked delivery catheter which 20 prohibited the complete microsphere administration.
21 In the second one, the residual, they prescribed 51 22 millicuries and they administered 39. There was 23 residual activity remaining in the delivery device, 24 and they could visualize a kink at the hub of the 25 catheter.
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80 1 Next slide. They prescribed 46 2 millicuries. They administered 20. They had two 3 separate liver segments. They had two different 4 procedures, and they got through the first one and 5 they made a measurement and they decided everything 6 was fine. But when they got to through second one, 7 the acrylic jar, which is the waste area that they 8 measure, contained 56 percent of the microspheres 9 intended for the patient's second liver segment.
10 So they looked at their protocols for dose 11 preparation and the box construction, the dose 12 administration, and all of those were followed.
13 They found minor resistance during the flush of the 14 stretched-out micro-catheter. They thought the 15 micro-catheter had a kink and that they would be 16 able to flush the contrast and saline through it, 17 but the microspheres might still clog it even 18 though they got saline and contrast flushed through 19 the kink.
20 So next slide. We have a cracked 21 catheter. In this case, they had two doses with a 22 total of activity of 54 millicuries to the right 23 and left lobes. They only administered 21. The 24 first dose and the second administration through 25 the radial artery of the left hand using the first NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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81 1 and second were both through the radial artery, and 2 this is the first time we've had a micro-catheter 3 identified as a Marksman. Most of the others 4 either haven't been identified or have been 5 identified by a different brand name.
6 So the post-radiation surveys, both in 7 the microsphere vial, ended up with 5 mR per hour.
8 The first one, the authorized user assumed that it 9 was contamination from a cloth, but when he saw the 10 second 5 mR per hour on the second procedure, he 11 realized that they had two under-doses. So they 12 did a visual inspection of the micro-catheter and 13 it revealed a crack, and the crack was determined 14 to be the cause of the event.
15 Next slide. In this one, we have a 16 partial obstruction. So they were prescribing 47 17 millicuries, they administered 13. They believe 18 the treatment went as planned. They didn't believe 19 there were any issues with the flow before the 20 administration. There was no increased resistance, 21 and they could flush the line post-administration.
22 But then they discovered when they surveyed the 23 waste and were performing the dose assessment that 24 less than half of the microspheres went into the 25 patient.
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82 1 Next slide. So this is a continuation 2 of it. They thought there was a partial 3 obstruction in the catheter where the line 4 connecting the microsphere vial to the catheter and 5 they thought the vascular was complicated and may 6 have resulted in movement of the micro-catheter 7 slightly forward from the initial placement. But 8 they also identified they had an unusual amount of 9 saline in the overflow vial, so that should have 10 given them a hint that the procedure was not going 11 as intended.
12 Next slide. Leaking catheter 13 connection. So they were prescribing 11 14 millicuries and administering 8. And they had 15 liquid leaking from the connector between the e-16 line, and they give different letters for the 17 different lines within the microsphere delivery box 18 so that they know which ones to connect to which 19 area and what the flow is going to be. And so this 20 particular e-line and the catheter that was going 21 into the patient, there was a leak. They stopped 22 the treatment. They started decontamination. They 23 didn't think there was very much dose to the skin.
24 And the incident was due to human error and the 25 poor connection between the e-line and the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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83 1 patient's catheter.
2 And on the next slide, so, once again, 3 we have a leaking catheter. They were supposed to 4 give 25 millicuries. They only gave about 9. And 5 it occurred while connecting the infusion line from 6 the microsphere vial to the micro-catheter. And 7 the problem was that the physician simultaneously 8 unclamped the administration line while trying to 9 connect it to the micro-catheter. So the physician 10 assumed that the leaking fluid was only saline and 11 proceeded with the administration. They found out 12 later that there was an area of contamination from 13 the leaking catheter.
14 Next slide. Now I have one case of a 15 slow injection rate. As I move into the 16 SirSpheres, you'll see a lot of cases with a slow 17 injection rate or slow activity, a low activity.
18 So they prescribed 175 millicuries. They 19 administered 43. They had a slow injection rate 20 because they were worried about reflux into 21 adjacent gastric artery that they could not 22 embolize. And then they completed the 23 administration, they did their flushes, they 24 verified the digital dosimetry was reading zero, 25 indicated all the microspheres had left the vial, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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84 1 but the microspheres had collected in the catheter 2 outside the patient.
3 Next slide. Another slow injection 4 rate. Oh, this is continued. Okay. So they had 5 external experts that they talked to, and they 6 thought that a slow injection rate could result in 7 an event like this, and the RSO identified the 8 catheter backed up as another slow injection rate, 9 on another slow injection rate administration.
10 So the next slide, we're moving into 11 the SirSpheres. They had eight medical events, a 12 label vial shield, not the vial; a low activity 13 administration, three of those; and a high-activity 14 clogging, one of those; and then they had other 15 clogging issues with the needle and catheter and a 16 kink.
17 So proceed to next slide. So they 18 prescribed, and these are the low activity ones, 19 and they prescribed only 2 millicuries to a small 20 lesion and then 20 millicuries for a large lesion.
21 And so they prepared two vials. They labeled each 22 vial shield, but they didn't label the vials. So 23 they provided the wrong vial for the wrong 24 treatment. They provided the large activity for 25 the small lesion and they didn't realize it until NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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85 1 they went to do the large lesion and only had a 2 small activity.
3 So they're going to require timeouts.
4 They're going to label both the vial and the vial 5 shield. They're going to read the labels three 6 times before administration.
7 Next slide. In this one, there's a 8 low-activity administration where they're giving, 9 and there are three of these cases where they're 10 giving 6 millicuries to two segments, and they only 11 administered 4.4. The activity was in the residual 12 waste. Stasis wasn't reached, and there are 13 procedure modifications.
14 There are going to be four 15 modifications. There are going to be written 16 directives adjusted to tighten up the dose to match 17 100 percent of prescribed dose. And they're 18 committed to have the AMP physician -- this one 19 didn't make any sense -- the AMP physician, I think 20 that should have been "and physician," present to 21 observe low-activity administrations.
22 So the next slide. They prescribed 5 23 millicuries. They administered 4. The cause of 24 the event was the amount of, they believe the cause 25 of the event was the amount of activity delivered, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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86 1 that the relatively low prescribed dose made the 2 residue look relatively large. And they are going 3 to have another doctor supervise the remainder of 4 the administrating doctor's cases. Now, this one 5 made no sense because that should have already been 6 part of the requirement for obtaining authorized 7 user status, so it sounds, if they would have a 8 physician in training, but he would have to be 9 supervised for the rest of the tests anyway.
10 Next slide. Another low-activity one.
11 They prescribed 4, and they administered 3. The 12 radiation survey revealed that the residual 13 activity of 1 millicurie remained in the treatment 14 device. And they believe using small doses carried 15 out with greater scrutiny and review.
16 Next slide. And now we've got a 17 higher-activity clogging, and they prescribed 84 18 millicuries and they administered 59. They thought 19 the tubing became clogged because the entire 20 activity couldn't be administered, and they 21 attributed it to the large dose of microspheres 22 increasing the amount of microspheres in the system 23 and clogging the micro-catheter.
24 Next slide. Clogged needle. They 25 prescribed 32, and they administered 8 millicuries.
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87 1 There was an occlusion of the vial delivery C 2 needle due to clumping of the microspheres. They 3 intended to return the apparatus to the 4 manufacturer, but they discarded it, so it didn't 5 get evaluated. And the manufacturer believed that 6 educating the administrator on the microspheres and 7 how to clear the clogged needle was all that was 8 needed, so they provided training on reversing the 9 valve for flush purposes to unclog it.
10 The next slide. So in this one, they 11 were prescribing 12 millicuries. They administered 12 5. The AU and the interventional radiologist 13 noticed strong resistance. The micro-catheter was 14 pulled from the patient and a very small defect was 15 observed. The cause of the microsphere blockage 16 was a defect in the micro-catheter, and this one 17 was reported to FDA under the MedWatch program.
18 Next slide. We have a kinked catheter, 19 and they were prescribing 40 millicuries. They 20 administered half of that, 21 millicuries. They 21 think the patient inhaled deeply and created a kink 22 in the catheter. The first three or four aliquots 23 were delivered before the plunger met resistance.
24 The kinked catheter was confirmed by PET/CT imaging 25 of the administration set and vial.
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88 1 Next slide. And we have completed all 2 43 of the medical events.
3 CHAIRMAN ALDERSON: Thank you, Dr.
4 Howe, for that very complete report. I also want 5 to thank you for giving us, as we had asked for it 6 sometime ago, the year by trending of all these 7 medical events. I think it's very useful to see 8 that. I hope that will continue.
9 We are over time now, but I will point 10 out that most of that isn't because of Dr. Howe's 11 report. It's because we started late this morning.
12 So are there additional questions for Dr. Howe 13 before the next item, which will be taking a 15-14 minute break. Yes?
15 VICE CHAIRMAN ZANZONICO: Pat 16 Zanzonico. There were two in the 35.400, these 17 were the brachy implants, where one was attributed 18 to patient anatomy and the other was, I guess, an 19 under-dosing due to swelling and seed migration.
20 Those kind of strike me as patient intervention. I 21 mean, if everything were done correctly in terms of 22 planning and delivery of the treatment and then 23 subsequently happened within the patient beyond the 24 control of the physician, of the treating team, 25 that sort of strikes me more as patient NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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89 1 intervention, rather than a misadministration or a 2 medical event rather.
3 DR. HOWE: Well, our current definition 4 of patient intervention would not include those as 5 patient intervention. But the new revision of Part 6 35 would probably do a different evaluation of the 7 events, and they may or may not be a medical event 8 based on the new criteria.
9 I would like to point out that we do 10 get the NMED cases and we present them to you. But 11 you'll actually get a thicker document that has 12 each one of these in it. I have included an area 13 in the back which are not medical events. They're 14 the ones that came up when I searched NMED as 15 medical events, but they don't meet the NRC 16 criteria. And I've also included the Part 21 17 report for the Elekta software issue in there, too, 18 for your information. Yes, Richard?
19 MR. GREEN: So there are 23 Y-90 20 microsphere events. One brand had 15 events, the 21 other brand had 8. Do you attribute that to 22 physician preference or market share, or is there a 23 quality defect rate that you can attribute to one 24 or the other?
25 DR. HOWE: No. We noticed that when NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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90 1 you have Y-90 medical events it almost seems as if 2 the word gets out to one manufacturer that we're 3 having issues with a certain area. So the next 4 year, if we don't see very many for that 5 manufacturer but we see more for the other, so they 6 seem to trade back and forth. I'm not, I don't 7 have information on the division between which 8 manufacturer has which share of the market, but the 9 devices are very different because of the small 10 size of the Theraspheres and the larger size of the 11 SirSpheres.
12 We are getting more complicated medical 13 events on the Theraspheres. We're still seeing 14 simple medical events for the Theraspheres that 15 just don't seem to go away.
16 MR. BOLLOCK: This is Doug Bollock. I 17 can add a little bit to that. So looking back over 18 about 10 years, it does, as Donna said, it goes 19 back and forth between the two. And we haven't 20 seen a trend necessarily negative from one or the 21 other or because of any design or any practice 22 preference. We haven't seen anything with that 23 when you look for ten years.
24 MR. OUHIB: Just a general comment 25 here. Looking at these, you see that things are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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91 1 repeating again and again. We go back through 2 iodine-131 and you look at the microspheres, you'll 3 look at other -- and it seemed like, obviously, we 4 can report these, but if institutions or 5 manufacturers are not learning and providing some 6 action to actually avoid from repeating these, 7 we're not doing the right job in my opinion.
8 So I guess I can probably do a survey, 9 and I'm not really sure how many institutions have 10 actually gone on the NRC website to look and learn 11 from past events. We talk about learning from 12 others' unfortunate scenario, but I'm not really 13 sure if that's really happening.
14 So I guess I'm not sure who would be 15 sort of the leader in this. Would it be the 16 regulation, would it be the manufacturer or 17 somebody else, to actually create a good summary 18 that will reach every single institution. This is 19 what has actually happened, and this is, which is 20 more important, here's how you can actually avoid 21 that scenario.
22 I mean, I look at the iodine-131 23 scenario, I remember looking at 10 - 12 years 24 medical event, 2000 to 2012, and not seeing that 25 happen. And I'm looking at it in 2017 and I'm NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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92 1 like, wait a minute, something is not right here, 2 we've got to do something. You look at the 3 microspheres, treating the wrong site, we've seen 4 it before. It has been reported before.
5 So I think something has to be done in 6 order to avoid that. And that's just my opinion.
7 DR. HOWE: And I think one of the 8 things that you have to consider here is, one, we 9 get very few medical events compared to all of the 10 treatment. So most treatments appear to be going 11 okay. The second thing is most of our medical 12 events are caused by human error, people not paying 13 attention. When we did the written directive 14 requirements, at that point we called it the 15 quality management rule back in 1992, we really 16 attacked human error. We said you need to identify 17 the patient, and you need to make sure that what 18 you wrote down is what's ordered and that you need 19 to make sure that what you ordered and what you 20 wrote down is what's administered.
21 And then we put in 35.41, and we said you have to 22 have a program to assure with high confidence that 23 you've administered what you had in the written 24 directive.
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93 1 elements, and most of them are human error. But 2 one of the things that we're doing with the 3 revision to Part 35 is we're now making licensees 4 determine if they have a medical event. And we 5 think that will focus them more on, okay, I wrote 6 this, I gave it, oh, now I've got to go back and 7 look again and see if I gave them my intended and 8 see if there are errors in it.
9 And then every once in a while we'll 10 get a rash of these things, and if we get a rash of 11 them we will send out an information notice, and 12 the information notice goes to all of our NRC 13 licensees and goes to the agreement states and 14 they're asked to share them with their licensees.
15 So we try to do that, but many of these cases are 16 onsie-twosies over time. I mean, we can try to 17 keep telling people pay attention.
18 CHAIRMAN ALDERSON: Dr. Ennis has a 19 comment.
20 MEMBER ENNIS: Just following up on 21 Zoubir's comment, I think he's right, there would 22 be something advantageous about closing the loop a 23 little bit more. So you alluded that the NRC, from 24 time to time, will send out an information notice.
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94 1 kind of annual report that we come up with some or 2 you come up with some kind of summary of the themes 3 of the year or the themes of the last five years 4 that would go out as information to everyone, look 5 out for clogging tubing, cracking kind of things 6 because we consistently see that and it's not going 7 down. Look out for prostate bulb, penile bulb is 8 not prostate, we've seen that repeatedly. If you 9 could, maybe just alert people to the themes and 10 what to look for or, you know, you've alluded to a 11 theme, the checklist isn't the whole solution and, 12 you know, you've got to do it right or whatever.
13 So perhaps that would help close the 14 loop. You have a mechanism potentially and just 15 let everyone know what you think the themes are for 16 the last year or last few years as an alert.
17 MR. OUHIB: If I could just add to 18 that, I think the most important thing, which is 19 lacking sometimes in these reports, is corrective 20 action. You look at the reports and it says 21 corrective actions were implemented. Well, what 22 are they? What was done to avoid that particular 23 problem? It would be beneficial for people to 24 learn from that also. I think that has a value.
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95 1 corrective actions is retraining the staff. You 2 retrain the staff, you retrain the staff, you 3 retrain the staff. It doesn't seem to be 4 effective. So we do see the same corrective 5 actions over and over again.
6 Now we're seeing, because there's more 7 focus everywhere in medicine about timeouts, we're 8 seeing corrective action, timeout, timeout, 9 timeout. And we're seeing that some of these 10 timeouts, because the licensee has such a 11 complicated system of passing off to the radiation 12 oncologist to the interventional radiologist, and 13 both of them are authorized users, and back and 14 forth and back and forth.
15 MR. OUHIB: Yes, and I can think of 16 these timeouts. There's a timeout pre-procedure, 17 and there is a -- and it should be, and I hate to 18 say it because this might sound redundant, but 19 there's another final timeout source launching sort 20 of like before. And I'll give an example of the 21 case of the rectum, you know, vagina versus rectum.
22 I'll give you the example of right versus left 23 lobe. There is a final timeout, okay, we are 24 treating this. It's sort of like just a site, per 25 se. We are treating this. That would have been, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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96 1 no, we're treating the left lobe, we're not doing 2 the right lobe and, no, we're treating, you know, 3 the vaginal cuff, not the rectum or whatever.
4 You know, it's like, it's sort of, you 5 know, because in the preliminary timeout, this is 6 the patient, this is case number two, this is 7 fraction number whatever, this is this, this is 8 this, and all of that. But there is, I mean, event 9 thought they might mention the site prior to 10 launching the source, someone might say wait a 11 minute, you know, the only person who knows is the 12 interventional cardiologist who is looking at the 13 image and probably the radiation oncologist and can 14 say, turn around and say wait a minute, I'm putting 15 it in the right lobe, what are you talking about 16 left lobe here, whatever. And then that, at least 17 the source has not engaged yet. Just a thought.
18 CHAIRMAN ALDERSON: So as we are 19 getting further behind time and because the next 20 discussion after the break has to do with the 21 safety culture of this issue, I would suggest that 22 perhaps we defer those discussions which are part 23 of the feedback until we get in there. Vasken has 24 a brief comment.
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97 1 think that, based on this discussion, I agree that 2 there should be an educational component. And we 3 did mention that part of the role of ACMUI and NRC 4 is to scientific sessions. I would recommend that 5 to have recommendations how to catch these and how 6 to prevent it. I think that we are describing 7 right now but what we're not doing is the next 8 step. And I agree with Zoubir that we should 9 probably take that --
10 CHAIRMAN ALDERSON: So we should bring 11 that up during this next discussion. Are there any 12 other items right now? Hearing none, thank you, 13 Dr. Howe. We'll use that clock on the wall. We're 14 supposed to have a 15-minute break, so we'll 15 reconvene just prior, a couple of minutes prior to 16 11. Thank you.
17 (Whereupon, the above-entitled matter 18 went off the record at 10:40 a.m. and resumed at 19 10:56 a.m.)
20 MR. BOLLOCK: Okay, so, I'm going to be 21 going through our Staff Response to ACMUI Safety 22 Culture Recommendations from your Subcommittee 23 Report that we received last year.
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98 1 provide our staff responses.
2 So, on September 11th of last year, 3 ACMUI unanimously approved the ACMUI report, 4 "Medical Event Reporting and Impact on Medical 5 Licensee Patient Safety Culture" which included the 6 recommendations.
7 So, those recommendations included that 8 the NRC establish a program allowing medical use 9 licensees to evaluate medical events as described 10 in 10 CFR 35.3045 and also in 10 CFR 35.1000 11 Licensing Guidance and 10 CFR 35.3047 with an 12 approved patient safety program.
13 They also recommended the NRC licensees 14 with an NRC approved patient safety program 15 continue to report medical events as required with 16 the following conditions.
17 That the NRC will not allow this event 18 notification in the event notification 19 posted on its website, so not making it publically 20 available.
21 But, the NRC will conduct -- will not 22 conduct a reactive inspection on medical events 23 unless the event results or will result in death, 24 untended permanent harm or unintended significant NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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99 1 temporary harm for which medical intervention was 2 or will be required to alleviate the harm or reduce 3 radiation effects.
4 The other condition was that medical 5 use licensee will write a report available for the 6 next NRC inspection describing the event, cause and 7 corrective action taken.
8 And, the NRC will develop with ACMUI 9 advice, new temporary inspection procedures for NRC 10 review, licensee patient safety event reports and 11 will evaluate with ACMUI advice the need to change 12 enforcement manual procedures regarding medical 13 events that support the tests of this program.
14 ACMUI also in the report also 15 recommended the NRC should test out this program 16 with a number of sites and duration to be 17 determined at a later date, evaluate medical events 18 reported or medical events reports with the ACMUI.
19 And, during this test period, the NRC 20 with the advice of ACMUI should do the following.
21 Develop minimum criteria for patient 22 safety program reviews, assess how this change to 23 medical event reporting impacts the NRC's ability 24 to protect patient health and to minimize dangers NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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100 1 to the patient's life and to evaluate the different 2 types of patient safety programs and how lessons 3 learned from the patient safety incident reviews 4 are shared with the medical community.
5 The ACMUI report also recommended that 6 after the completion of the test year, NRC should 7 consider opening programs at NRC to all NRC medical 8 use licensees who request approval of their patient 9 safety program and to agree with States who request 10 to implement the program with their medical 11 licensees.
12 They also recommend the NRC define its 13 -- redefine its perspective of patient safety to be 14 different from occupational safety and from public 15 safety.
16 It also recommended the NRC partner 17 with the Department of Health and Human Services, 18 specifically, the Agency of Healthcare and Research 19 and Quality and the ACMUI to develop a national 20 database taxonomy specific for reporting patient 21 events involving medical use of byproduct material.
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101 1 regulations for patient safety programs to verify 2 the active involvement of the licensee's patient 3 safety program review of medical errors and 4 reporting of reviews to the National Patient Safety 5 database.
6 So, there's a lot in that report.
7 Again, the report was unanimously endorsed by the 8 ACMUI. So, it was a lot of us to swallow and we've 9 -- so, it was a lot for us to look over and to 10 consider.
11 And, in our considerations, our 12 responses, we looked at and are these following 13 this recommendation or are they meeting the purpose 14 of medical event reporting and what limitations we 15 would have or are there to conducting a pilot 16 program utilizing the patient safety organizations.
17 And, what we'd have to do in changing 18 our criteria for NRC reactive inspection.
19 So, the -- again, we're looking at the 20 purpose of medical event reporting, which the 21 Commission established in 1980 back when medical 22 events were part of the administrations, but still 23 applies with medical events today.
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102 1 to identify the causes in order to correct them and 2 prevent their recurrence.
3 The Commission was able to notify other 4 licensees of their possibility they could become --
5 they could make the same errors. So, looking at 6 generic issues.
7 We feel we are -- staff is not sold, 8 but the patient safety organizations presently meet 9 that completely. And, again, I understand the 10 recommendations are that we would have to look into 11 that. But, right now, from the information we 12 have, they don't fully meet our -- the purpose of 13 the medical event reporting.
14 Our medical events allows the NRC to 15 follow up on incidents in terms if other licensees 16 might be making the same or similar mistakes or 17 experiencing some of the same or similar 18 challenges.
19 When we identify similarities in the 20 problems reported from multiple facilities, we 21 provide information that may help prevent 22 additional incidents.
23 Some of the things that Donna Beth had 24 mentioned through generic communications and other NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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103 1 -- and just the fact that our events are publically 2 available, shared on the public website.
3 And, the information collected by the 4 NRC is valuable in assessing trends and patterns, 5 identify generic issues and generic concerns and 6 recognize any inadequacies or unreliability of 7 specific equipment or procedures.
8 This could -- this goes to -- it's a 9 good segue into what Zoubir was talking about and 10 Dr. Ennis was bringing up about looking for those 11 hot topics for the year.
12 We actually do that on an annual basis.
13 So, we, each year, we report to the Commission 14 during an Agency Action Review meeting we call it, 15 but in that meeting, we look at all materials 16 events. But it is -- and the report from NMED.
17 There's so -- NMED runs the annual 18 report which is publically available. And, as part 19 of that, they do break it down to medical events 20 and they look at trends for the past ten years and 21 look -- and it will -- through that, we may be able 22 to identify any specific trends or patterns that we 23 may feel show a negative performance by licensees.
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104 1 major negative performance by licensees and they 2 report specifically to the Commission on that.
3 That is rare for medical events, so I cannot recall 4 when we've done a briefing of the Commission on 5 that.
6 However, we do, if we feel that or have 7 some indications that there may be a negative trend 8 or some sort of pattern or trend, we can take a 9 deeper dive and do a case study.
10 So, we ask the INL folks that control 11 the NMED database to do a specific look at one type 12 of either modality or specific type of material 13 events or medical events.
14 And, in fact, we just did one this year 15 on Y-90 looking at the tracks and trends and 16 Yttrium-90 events.
17 And so, we do have a good idea of what 18 has been happening over the past ten years, if we 19 are seeing any significant issues with them.
20 And, to go to some of the points with 21 the Yttrium-90 events, the number of events have 22 stayed at relatively -- have been about the same, 23 in the 20s over the past 10 years.
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105 1 incidents of the -- there is an increase in the use 2 of Y-90, so the rate of incidents is very low and 3 is actually slightly going down. And, that's using 4 -- we do have some information directly from the 5 manufacturers of microspheres to get that to kind 6 of give us that other information.
7 So, we do know we have -- there's, 8 again, the low rate of incidents. The low rate of 9 incidents for all medical events is actually a 10 factor in looking at the hot topics.
11 So, we do absolutely look for the hot 12 topics. Unfortunately, when there's one, you know, 13 we see something once one year and then maybe one 14 another year or two later out of the 100,000, 15 150,000 cases where therapy -- for therapeutic 16 uses. It's such a low rate of incidents, we may or 17 may not share that in an information notice or take 18 other actions. So, we do take that all into 19 consideration.
20 And, that's one of the main factors is 21 why you don't see information notices come out 22 every few months or every couple of years from us 23 necessarily, because just the low rate of incidents 24 is a factor.
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106 1 CHAIRMAN ALDERSON: So, do Dr. Ennis or 2 Dr. Dilsizian wish to comment? I mean, your 3 comments previously just a few minutes ago were to 4 communicate more and get things back out to the 5 user community in such a way that they were 6 energized or educated by it.
7 And so, now, we're hearing that the low 8 frequency of events is generally what has not, you 9 know, has caused that not to really happen.
10 But, what do you think? Would your 11 sort of communications still be useful even in a 12 situation where the events are only occurring on a 13 low, but repeated frequency?
14 MEMBER DILSIZIAN: Yes, I mean, it's, 15 you know, I think there's been studies done on this 16 at that human error factor of doing something 17 complicated is about 3 percent.
18 And, if you look at our event rates, 19 certainly less than 1 percent.
20 So, you could make the argument that 21 we're doing great compared to others. But, the 22 potential negative outcome of even a less than 1 23 percent event is great in medicine compared to some 24 tasks that are, you could say, you know, working on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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107 1 a car engine.
2 And so, I still think that, even though 3 it's low, what the whole scientific community 4 meetings that we attend, and if it's going to be a 5 special session on NRC, for example, if I'm in the 6 audience, besides learning what the rules and 7 regulations and the changes, I would be really 8 interested to know what kind of medical events 9 occurred that's particular to, let's say, nuclear 10 medicine or radiation oncology.
11 And, what are the root causes and how 12 it could be prevented?
13 I think, to me, that would be something 14 I would like to hear, even though it's a small 15 percentage.
16 MR. BOLLOCK: Yes, and we appreciate 17 that. And, we have listened to -- ACMUI was a big 18 part of why we do post both Dr. Howe's reports on 19 our public website and then Dr. Ennis's 20 Subcommittee group when he does another review that 21 we'll hear in the fall on the medical events.
22 We do post those -- the slides on the 23 public website.
24 Also, going back to something that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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108 1 Sophie had brought up in the opening comments about 2 our discussion with the Agreement States and your 3 recommendation to keep that open with getting that 4 good information from them that's from the events 5 and getting the root cause.
6 As Mr. Ouhib had also mentioned 7 earlier, you know, we do, you know, we agree with 8 you and we appreciate that feedback. And, we do 9 agree that, you know, it takes the better 10 information we have, the better we can respond to 11 it and the better our communications out to the 12 regulated community, I mean, this is, you know, the 13 NRC 100 percent agrees there, you know, that is a 14 good thing.
15 And, we'll continue to work to do that 16 as best we can. So, we do appreciate those 17 insights and the feedback from you all.
18 And, just because I say the incidents 19 of rates are low doesn't mean we're not continuing 20 to do this on an annual basis. We look for these, 21 when we do see significant trends, we do take 22 action.
23 I was actually just thinking from two 24 years ago, the Committee recommended that we put NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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109 1 out an information notice on the kinking for the 2 catheter kinking and tubing kinking for Y-90.
3 And, we did actually take a look at it 4 two years ago and there wasn't necessarily a trend.
5 However, you know, what, six events last year. So, 6 maybe we need to take another look.
7 And so, we do continually do that. And 8 so, we, you know, we are aligned and I think the 9 NRC is in alignment with that and we do strive to 10 pass on that good information where we can.
11 CHAIRMAN ALDERSON: You want to 12 comment, Dr. Ennis?
13 MEMBER ENNIS: I want to just say, I 14 think that even low rates, if they're steady and 15 they're not declining, is a reason to try and 16 further the education. And, whether that's 17 presenting at annual meetings that you're invited 18 to or whether it's sending out a special thing.
19 I do think it's great to publically 20 boast Dr. Howe and ACMUI's alternating six month 21 reports, but how many people actually are going to 22 do -- going to look? You know, everyone's really 23 busy.
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110 1 attention. So, it's just another way beyond just 2 reporting it there to get it out.
3 And, you know, although the rates are 4 low, we're seeing recurring themes over years and 5 they're not going away as severe kind of a lot.
6 And so, I think there's room for 7 additional education that would be helpful.
8 I also, you know, as we talked about 9 before, I have some concerns about how accurate the 10 rates exactly are and whether there's more events 11 that are flying under the radar, so there may be 12 more going on.
13 MR. BOLLOCK: Yes, we appreciate that.
14 And, we recognize that's one of the -- kind of a 15 theme of the ACMUI's report last fall on this.
16 We haven't seen that. We don't know 17 what we don't know, and we recognize that we also 18 can't take action on things we don't know.
19 And, you know, we have to, you know, 20 between the NRC and the Agreement States, we do go 21 out and inspect licensees periodically and ensure 22 that they have a program and, you know, understand 23 the regulations of the NRC or the state specific 24 regulations and report as required.
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111 1 CHAIRMAN ALDERSON: Mr. Ouhib?
2 MR. OUHIB: Yes, I guess in addition 3 and, forgive me for not being a full member, I 4 can't really make a motion here, but it would be 5 desirable to have a group of people perhaps looking 6 at these events and probably submit some sort of 7 recommendation.
8 They're not rules, they're simply 9 recommendations based on what we're seeing this 10 year.
11 Here's what we recommend users to look 12 at, pay attention, correct, whatever, if they have 13 not done it already at their institution.
14 I think that would be beneficial sort 15 of like because you're not just presenting the 16 problem, you're presenting some ideas there how you 17 can avoid these type things.
18 And then, welcome any others to actually 19 submit to the group. Says, if you have any other 20 recommendations, please send them to us and have 21 somebody who is going to collect that information.
22 And, we'll just revise that and put it out that at 23 some point.
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112 1 comment and then Sophie Holiday has a comment.
2 MEMBER ENNIS: I would just ask, I mean, 3 the Subcommittee that I've been running to report on 4 any events. We could take on an addition charge to 5 give recommendations to NRC about things that we 6 think might need some additional education if NRC 7 would welcome and want that.
8 MR. BOLLOCK: Yes, absolutely, we would 9 welcome that.
10 And, Sophie, if you have anything else 11 to add?
12 MS. HOLIDAY: Yes, actually, this is 13 exactly what I was planning to make the comment 14 about with Zoubir's request, this is something that 15 is totally within the scope for the Medical Event 16 Subcommittee to do.
17 I know a lot of the membership has 18 changed, but you may recall that, as a result of one 19 of the -- of one year, the Medical Event 20 Subcommittee had identified that there were a 21 significant number of Yttrium-90 microspheres 22 medical events that were reported.
23 So, as a result of that, a separate 24 subcommittee was created to specifically review NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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113 1 those medical events.
2 So, absolutely, if the Subcommittee 3 wants to review and make remarks about how they 4 think there could be improvements or that they have 5 noted, you know, some specific errors or trends with 6 medical events, that is all within the discretion of 7 the Subcommittee to do.
8 And, in fact, this is something that NRC 9 and the greater medical community will benefit from.
10 And, because you are the medical experts, the 11 physicians and the physicists, this is something 12 that you are doing every day and we do not have that 13 specific knowledge and expertise, which is the whole 14 crux of having this advisory committee.
15 So, this is who you can benefit and 16 advise the NRC staff so that we can ultimately 17 inform our policies, procedures and regulations for 18 the medical use of byproduct materials.
19 CHAIRMAN ALDERSON: Yes, Dr. Howe?
20 DR. HOWE: I want to support what Sophie 21 just said. Our original intent when I give the 22 medical event report is to provide you with an 23 organized view of how medical events occur during 24 the year.
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114 1 And, our hope is that when you do the 2 fall medical event presentation, you will take it 3 and maybe cut in a different direction and come up 4 with what you think is important out of these events 5 that I'm presenting to you.
6 I'm giving them to you by modality 7 because they come in by date and it's very hard to 8 see any trends that way. So, I do modality.
9 You may decide that, based on cutting 10 across the modalities, it's time to give something 11 about the time out, whether the time out appears 12 effective or not based on what we're seeing in 13 medical events.
14 But, that's our hope is that, in the 15 fall meeting, your group will take something -- take 16 what I presented to you in an organized fashion just 17 by modality and come up with something that is from 18 your perspective and different from what I've done.
19 CHAIRMAN ALDERSON: We have a comment 20 from the audience here.
21 MS. TOMLINSON: Yes, sure, Cindy 22 Tomlinson from ASTRO.
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115 1 system which is part of the PSO. So, on behalf of 2 both organizations, we are happy to come in and talk 3 to staff.
4 More specifically, I know we've done a 5 couple of presentations on RO-ILS, but to come in 6 and really talk about the nitty-gritty of PSOs and 7 of what the information that is within RO-ILS and 8 how maybe that could be beneficial to you.
9 So, feel free to reach out to me and we 10 can make that happen.
11 MR. BOLLOCK: Thank you.
12 CHAIRMAN ALDERSON: I think that when 13 you think about this idea, and I would -- I'd like 14 to suggest, Ron, that your Subcommittee do take this 15 up and bring it back for the fall agenda.
16 I hope, Zoubir, that you're on that 17 Committee. I don't know the Committee, but if 18 you're not, you're appointed.
19 (Laughter.)
20 CHAIRMAN ALDERSON: Because, and I'm 21 going to use a generic term here, but, if you could 22 figure out a good natured way, I mean, we're talking 23 about safety culture which is a positive, 24 affirmative culture based on the fact that some NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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116 1 things didn't go well.
2 A good natured educational way to get 3 information out that would get to the user 4 community, this is not easily solved when you think 5 about -- but, of course, we've got the internet and 6 we've got emails.
7 And so, it doesn't have to cost a lot.
8 It can totally be an electronic communication. And, 9 if it came out periodically, and just, and I 10 wouldn't call it hot topics. I mean, it'll make for 11 so many jokes, you know.
12 Anyway, but, you know, get it out so 13 that the people can hear that, well, these events 14 are uncommon, but when administering microspheres, a 15 kinked catheter is a frequent recurrent --
16 frequently recurs as one of the problems.
17 And so, then, it's just got a couple of 18 paragraphs and a little picture about, so, let's 19 everyone pay attention, you know, to catheter 20 safety.
21 I mean, you know, and that's all it is.
22 You know, and it goes out twice a year or whenever 23 it's appropriate in terms of the Committee.
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117 1 would be educational. It also would impact in, I 2 think, a positive way, the public's perception of 3 the NRC as a regulator, you know, because it would 4 be out there as a way to be involved with the 5 community in a very positive way that's not in any 6 way punitive.
7 I mean, here's information that we 8 pulled our records together and we're providing this 9 to you, you know, with the help of the ACMUI.
10 So, I think, Ron, if your Committee 11 could help us get towards something like that, I 12 think that would be a big plus.
13 Mr. Ouhib?
14 MR. OUHIB: I think as far as 15 transmitting the information to the users, I don't 16 see that as a big challenge. And, we have 17 representatives here from different organizations.
18 The AAPM will be happy to actually put 19 that in their newsletter and put the link there.
20 The ASTRO will be happy and I'm sure the ABS will be 21 more than happy to do that.
22 So, I think as far as getting that 23 information to the people will be -- and we can 24 label it in all three organizations as the patient NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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118 1 safety corner and that will be very catchy sort of 2 like. And, it will be common to all three.
3 I think the work is going to come in 4 getting -- and don't get me wrong, your data is 5 extremely valuable, we just have not dug enough into 6 it to make it very effective in changing what is 7 actually happening.
8 CHAIRMAN ALDERSON: Yes, Dr. Suh?
9 MEMBER SUH: So, I also highly support 10 trying to shift the culture from being somewhat of a 11 more reactive culture to more of a proactive 12 culture. And, I think that begins with education.
13 So, one suggestion I also would make is, 14 these what I call best practices to build a higher 15 reliability organization or culture is to also 16 include the trainees as well.
17 So, within radiation oncology, we have 18 the ARRO organization. And, I know as a trainee, 19 they would really learn a lot. Because, here's some 20 medical events that have occurred and here are best 21 practices to avoid medical events.
22 And, I think if you hear it over and 23 over, time outs are really essential. Time outs are 24 really essential. This is how you can avoid X NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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119 1 percent of medical events from occurring by doing a 2 proper time out, not doing a shortcut. Is it right?
3 Is it left? Is it superior? Is it inferior?
4 And, if you keep going over that, it 5 becomes part of a ritual habit for them rather than 6 making a kind of a one off. Well, I'm going to skip 7 this because I'm really busy right now.
8 And, I think it's very important to 9 really have that.
10 And, also, getting on point, even though 11 the number of medical events are really small, I 12 think all of us, you know, from the public 13 standpoint, from a professional standpoint, we 14 really want to strive to be zero. Right?
15 So, it would be great someday, we have a 16 report where the number of events were so small that 17 it's a very short item on our agenda. Right? That 18 should be the goal of the Committee.
19 I think a long-term is, I mean, it's a 20 very aspirational goal, but it has to start with 21 sharing this information.
22 And, I'll be very, you know, from my 23 perspective, even though these events are listed on 24 the NRC site, I would -- I'm not sure how many, just NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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120 1 to take radiation oncologists, for instance, how 2 many actually look at that?
3 And so, maybe one way if you have a best 4 practice that comes out from the ACMUI, that it goes 5 to like say the chairs of various departments.
6 Then, it's something you can disseminate to other 7 faculty and to ASTRO and other organizations as 8 well.
9 So, I think this is very important topic 10 because, if you're really going to learn best 11 practices, you have to share best practices. And, I 12 think as a group, we've -- I think there's room to 13 improve that.
14 CHAIRMAN ALDERSON: Yes, right, 15 excellent statement.
16 Dr. Zanzonico?
17 VICE CHAIRMAN ZANZONICO: And, we've 18 often cited around the table here, the excellent 19 safety record of the airline industry. And, I think 20 just about any industry practice aspires to their 21 low rate of error where the error rate is -- where 22 an error is pretty catastrophic, needless to say.
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121 1 organizations or whoever, needs to be an emphasis 2 that the time outs and the item cited in the time 3 out should be at every level of the care team from 4 the most junior technologist up to the attending 5 physician.
6 Because, items like vials mislabeled or 7 activities not calibrated or not labeled properly, 8 those can be identified often by the most junior 9 people who carry a dose from Point A to Point B and 10 so forth.
11 So, I think there should be an emphasis 12 on the intervention, so to speak, by all members of 13 the care team. And, we all know that hospitals, 14 there's a hierarchy structure which sometimes 15 inhibits that sort of thing.
16 And, I think especially in this case 17 where we've noticed a lot of medical events related 18 to what amount to clerical errors that that's sort 19 of intervention we encourage as part of this 20 communication.
21 CHAIRMAN ALDERSON: Good.
22 Well, I'll make one final comment. And 23 so, I think we've agreed that Dr. Ennis's Medical 24 Event Subcommittee will make recommendations NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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122 1 probably at the next meeting of the ACMUI. So, it 2 should be on the agenda of things like content, 3 style, how it's transmitted and so on to begin to 4 get these ideas out into the user community.
5 So, thanks very much. Thank you, Dr.
6 Ennis and all of you who made these excellent 7 comments.
8 Are there any further comments on Mr.
9 Bollock's report?
10 MR. BOLLOCK: Well, actually, I have a 11 couple more points.
12 CHAIRMAN ALDERSON: Okay.
13 MR. BOLLOCK: That's just gets kind of 14 the first part of the report.
15 (Laughter.)
16 MR. BOLLOCK: And, there's a --
17 CHAIRMAN ALDERSON: Carry on.
18 MR. BOLLOCK: Yes, I'll let Dr.
19 Dilsizian have a say and then I can go through a 20 couple more our --
21 MEMBER DILSIZIAN: I just had one 22 comment. The bullet number three, I didn't -- I may 23 have not heard you, what was your response whether 24 you would consider --
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123 1 MR. BOLLOCK: Yes, okay.
2 MEMBER DILSIZIAN: -- whether you would 3 -- you're going to address it?
4 MR. BOLLOCK: I'll get to that, yes.
5 So, yes, so, getting to the next bullet, 6 limitations to conducting the pilot program, the 7 PSOs and some of the limitations with the PSO as 8 being voluntary.
9 If we went to a system that was 10 voluntary, even if we had approved it, if people 11 decide to stop using it, right, reporting, because 12 it is voluntary, that cuts out. I don't know that 13 something that -- that's something that the NRC 14 right now is not willing to accept.
15 There are a couple points, I know the 16 Subcommittee had -- or the ACMUI's report to us 17 spoke an anonymous reporting.
18 You know, we, right now, that would, as 19 part of the regulations that what's got to be 20 reported and what has to be reported in medical 21 events in the regulations. So, it would take a 22 regulation change.
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124 1 negatives to that.
2 And, the only other limitation for us in 3 conducting the pilot besides some of things not, you 4 know, being outside of the regulations, and unless 5 we make changes to the regulations, we can't just 6 pilot something that goes -- that's not a course of 7 the regulations.
8 For us to review the PSOs, that is 9 resource intensive for us and it's just the -- so, 10 it's just a limiting factor for us. We would have 11 to go out and verify it.
12 And, right now, we already have our 13 structure in place and the Agreement States have 14 their structure in place where they go out and do 15 periodic inspections looking at their programs and 16 report the medical events.
17 Now, we would have to go and approve, 18 you know, the PSO at a site which is a different --
19 you know, it's a slightly different take.
20 And then, I do recognize that the ACMUI 21 said that they would help us with developing that 22 program, but it is resource intensive. So, that's 23 just one of our limitations.
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125 1 instance, or an individual institution that has 2 their own PSO program, I believe that was one of the 3 recommendations was not just do one of the five, I 4 think, approved PSOs, but if an institution has 5 their own, if we approve it. So, it's, again, it's 6 a different type of -- it's another type of 7 inspection that we would have to conduct, we, as the 8 NRC, would have to conduct.
9 So, there are some -- there are a lot of 10 limitations to that.
11 And, to that, I think some of the 12 discussion we just had earlier with things that are 13 good that can help sharing information, things that 14 we can do, maybe getting from your subcommittees 15 reports on medical events, any themes, we'll call 16 it, instead of hot topics, but that and sharing that 17 using the listserv or helping to inform if we do 18 decide to put out information notices to share the 19 information.
20 You know, those are all very not 21 resource intensive ways, I think. So, I, 22 absolutely, I think those are great. Those are good 23 things. It's always good to be able to find things 24 that make a positive effect, you know, getting the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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126 1 most bang for our buck.
2 And then, the last -- to the point, the 3 change in criteria for NRC reaction inspections, so 4 that is our Management Directive 8.10 is what 5 determines our criteria for when to set up a 6 reactive inspection at a medical facility.
7 For instance, if there is a medical 8 event with an exposure over -- greater than 20 9 percent overdose to the patient, we -- the NRC will 10 send out an inspection team within five days.
11 That Management Directive is up for a 12 periodic change coming out next year. So, we'll 13 start this year, we will start the process. So we 14 will consider the ACMUI's comments and read the 15 report and considerations for our update to that 16 procedure and potentially making it in the changes.
17 CHAIRMAN ALDERSON: Excellent.
18 Questions or comments?
19 All right, seeing none, well, we have an 20 action plan and so we look forward to hearing those 21 reports in the fall and thank you for working with 22 us on this important issue.
23 Okay? Well, that will take us to the 24 next item on the agenda which is Sophie Holiday and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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127 1 she's going to talk to us about the ACMUI reporting 2 structure.
3 MS. HOLIDAY: I realize we are 4 significantly over time, so I will try to make up 5 for it in my presentation.
6 So, I am before you to give you your 7 annual presentation to discuss the Committee's 8 reporting structure, as I stated earlier this 9 morning during my old business comments.
10 So, we will go over what the current 11 reporting structure is. This will be your annual 12 review, discuss how often we conduct our meetings 13 and then open it up for a discussion amongst the 14 Committee members.
15 So, this is a chart that looks very 16 familiar to everyone on this Committee with the 17 exception that I made a change to reflect our new 18 division name, MSST. Previously, it was MSTR, and 19 prior to that, it was MSSA. So, now we are MSST.
20 So, as this chart is trying to convey, 21 the ACMUI along with MSEB, which is the Medical 22 Safety and Events Assessment Branch, the branch that 23 Doug is the Branch Chief for, we both report to the 24 Division Director of MSST.
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128 1 Again, that's the Division of Materials 2 Safety, Security, States, and Trial Programs.
3 While our branch is responsible for 4 doing the day to day operations of the ACMUI, more 5 specifically, my responsibility, we both ultimately 6 report to who is now Kevin Williams as the Acting 7 Division Director.
8 But, we have the dotted lines on this 9 chart to simply indicate that, while you may report 10 directly to Kevin Williams or Dan Collins, whoever 11 is the Director at the time, this does not preclude 12 you from being able to reach out, communicate with, 13 interact with, have drop-in meetings with- the 14 Director for our office, Office of Nuclear Material 15 Safety and Safeguards.
16 Our Executive of Operations, Victor 17 McCree or to the Commission, we've had Dr. Alderson, 18 I believe, had a drop-in with the Commission before.
19 Dr. Thomadsen has had a drop-in with some of the 20 Commissioners previously.
21 So, this is simply is saying that any 22 member on the Committee has the ability to reach out 23 to you, anyone in this management chain should you 24 so wish to do so.
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129 1 So, in September 2012, as was indicated 2 on the old business chart, the ACMUI recommended to 3 have this annual review of the reporting structure 4 open indefinitely.
5 And so, the Subcommittee -- there was a 6 subcommittee that was formed to -- for the ACMUI 7 bylaws. And, Dr. Zanzonico presented to the 8 Committee during May 2014 for the Committee to 9 consider whether they want to continue reporting 10 within the NMSS structure or if you wanted to report 11 directly to the Commission, which is what our 12 counterpart, the Advisory Committee for Reactor 13 Safeguards, ACRS, does.
14 The Subcommittee report states, and I 15 quote, that the working relationship between the 16 NRC and the ACMUI remains excellent. The reporting 17 structure through NRC staff continues to function 18 effectively and the associated logistical overhead 19 associated with direct reporting to the Commission, 20 e.g., the need for more frequent meetings, did not 21 and does not now justify any change in the ACMUI's 22 reporting structure.
23 That's what was stated in May of 2014.
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130 1 continue to have this annual reporting review.
2 This is the eighth review that we are 3 conducting.
4 So, one of the items that were up for 5 consideration is how often does the Committee meet?
6 Whether that be meetings physically here at 7 headquarters or via teleconferences.
8 So, as we are aware, we conduct two in-9 person meetings here at NRC headquarters a year.
10 The spring meeting which takes place in either March 11 or April and the fall meeting which takes place in 12 either September or October.
13 Comparatively, ACRS meets here ten times 14 a year and they report directly to the Commission.
15 Subcommittee meetings also meet here, so they meet 16 more frequently, which is a bit over burdensome for 17 some of the members on the Committee, as was 18 communicated in previous presentations for this 19 topic.
20 We also hold approximately two to three 21 teleconferences a year on an ad hoc basis. We've 22 already had our two, last month on February 15th 23 and, of course, March 1st.
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131 1 later this summer once staff provides its review of 2 training and experience requirements to the 3 Committee for consideration.
4 So, again, the number of teleconferences 5 varies from year to year, depending on the needs of 6 the Committee and depending on the needs of staff 7 and the Commission.
8 So, at this point, I would like to open 9 it up for discussion to the Committee.
10 The questions for consideration are, do 11 you still agree with the current reporting structure 12 whereby you report to the NMSS management or would 13 you rather report directly to the Commission?
14 Are you satisfied with the frequency of 15 the meetings, that is the two in-person meetings 16 here at headquarters with ad hoc teleconferences?
17 And, are there any other changes that 18 you would like to see?
19 So, I turn it over to the Committee.
20 CHAIRMAN ALDERSON: Very good.
21 Okay, this -- these subjects are open 22 for discussion.
23 Dr. Zanzonico?
24 VICE CHAIRMAN ZANZONICO: Pat Zanzonico.
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132 1 So, when we originally considered this 2 way back and initiated these annual reviews, Sophie 3 put the fear of God in us that this -- what I think 4 was sort of an appealing notion that we report 5 directly to the Commission involved a lot more work 6 and a lot more time on everyone's part.
7 As you said, our counterpart in the 8 reactor business, the reactor side of the business, 9 meets many more times per year.
10 And, I think that convinced everyone on 11 the Committee at the time that what we were doing 12 was perfectly adequate. Two face-to-face meetings a 13 year, teleconferences as needed, plus, of course, 14 emails and telephone calls and so forth, really was 15 more than adequate to address our responsibilities.
16 And, you know, in the intervening years, 17 I haven't felt anything has changed in that respect.
18 That the frequency of face-to-face meetings, 19 scheduling of Subcommittee -- of Committee and 20 Subcommittee meetings as needed and electronic 21 communications were perfectly adequate to meet our 22 responsibilities.
23 So, personally, I don't see any need for 24 any change in the reporting structure at this time.
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133 1 MS. HOLIDAY: Thank you.
2 CHAIRMAN ALDERSON: Thank you, Dr.
3 Zanzonico. Other comments from the ACMUI on that 4 issue?
5 Seeing none, back to Ms. Holiday. I 6 think that the Committee is happy with this 7 structure. I think the fact that it has been 8 reported back to us on an annual basis is useful.
9 It reminds us all what it is and what the -- at 10 least our predecessors, if it were true in that 11 sense, that on this Committee voted to do, and Dr.
12 Zanzonico's comment, you know, summarizes all that 13 up.
14 Are there any issues related to any of 15 this that people would like to bring forward at this 16 time?
17 Yes, Ms. Weil?
18 MEMBER WEIL: Just another historical 19 perspective. There was a time in the past when the 20 Committee felt not inadequately supported by staff.
21 And, that was the reason why we wanted to keep this 22 live so that we could continue to reassess whether 23 or not we were content and felt effective with the 24 reporting structure.
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134 1 I'm sure all of us agree that, I mean, 2 we've had the best. So --
3 (Laughter.)
4 CHAIRMAN ALDERSON: Did you mean Sophie?
5 MEMBER WEIL: So, why would we change?
6 (Laughter.)
7 MS. HOLIDAY: Yes, I think we should 8 clarify for the record that.
9 (Laughter.)
10 CHAIRMAN ALDERSON: Are there any other 11 comments?
12 Well, hearing none, I think that this 13 report is concluded. Thank you very much.
14 And I believe that our agenda for the 15 morning is concluded ten minutes behind schedule and 16 that's about where we started. So, thank you all 17 for staying on that pseudo schedule.
18 The schedule shows us reconvening for 19 the afternoon session at 1:00 p.m. by that clock, an 20 hour2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> and 20 minutes from now.
21 Are there any final comments before we 22 adjourn for the morning?
23 Seeing none, I think we're adjourned for 24 the morning.
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135 1 (Whereupon, the above-entitled matter 2 went off the record at 11:38 a.m. and resumed at 3 1:03 p.m.)
4 CHAIRMAN ALDERSON: So, with that, the 5 next item on the agenda is Richard Green who is 6 going to tell us about the worldwide supply and 7 domestic production of Molybdenum-99.
8 MR. GREEN: Thank you, Dr. Alderson.
9 At the onset, I want to just provide the 10 caveat here that this -- I apologize, this may be a 11 simplistic presentation. I want to make sure it's 12 discernable, digestible for everybody. We can get 13 in the weeds and be real geeky later.
14 So, this is an update of a presentation 15 I made in September of 2016. At that time, it was 16 entitled, "The Worldwide Supply of Moly-99."
17 The change in the title recognizes the 18 fact that, for the first time in 30 years, we have 19 the domestic manufacturing of moly on U.S. soil.
20 So, moly-99 used in the U.S. the last 30 21 years has been produced solely through the fission 22 of uranium-235. Uranium-235 is a very rare in its 23 natural abundance. There's only 0.7 percent.
24 The degree of an enrichment is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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136 1 important. Below 20 percent is referred to as LEU 2 and above 20 percent is referred to as HEU, low-3 enriched and high-enriched uranium.
4 The production of fission moly-99 5 utilizes enriched uranium-235 targets either LEU or 6 HEU targets but are placed in a neutron flux in a 7 nuclear reactor that itself is fueled with enriched 8 uranium-235 fuel, either LEU or HEU.
9 For the sake of clarity, I have to 10 introduce a term, HSA, or high specific activity, 11 moly-99. Before, we never had to concern ourselves 12 with that term, but it's germane now because of the 13 new generator system that's on the market today.
14 So, I'll be speaking specifically about 15 high specific activity moly and low specific 16 activity moly because they're made by different 17 mechanisms.
18 In the fission production of moly-99, 19 neutrons strike a uranium-235 target and split that 20 uranium atom into pieces. Six percent of the result 21 from fission fragments are moly-99.
22 There are current six reactors worldwide 23 involved in the large-scale commercial manufacture 24 of moly-99 that ship their irradiated targets to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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137 1 four processors where they sort through the nuclear 2 bits to isolate and purify the moly-99.
3 There are three commercial manufacturers 4 of FDA approved high specific activity moly-99 5 generators utilizing fission moly in the U.S.
6 GE Healthcare's DRYTEC generator is made 7 is Amersham, United Kingdom and shipped across the 8 pond.
9 Lantheus Medical Imaging's TechneLite 10 generator is made in North Billerica, Massachusetts.
11 And, Curium, you might know them by 12 their old name, Mallinckrodt, their Technekow V4 13 generator is made is St. Louis, Missouri.
14 So, those are the three, I'll call them 15 legacy manufacturers of moly-99 generators in the 16 U.S. market.
17 All of these generator manufacturers use 18 high specific activity moly-99 which is loaded onto 19 a small alumina column and the sodium pertechnetate 20 is released when the unit is eluded with normal 21 saline.
22 Here are the current six reactors 23 worldwide involved in the large-scare commercial 24 manufacture of high specific activity fission moly-NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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138 1 99.
2 In the last few years, the Osiris 3 reactor in France and the National Research 4 Universal reactor in Canada, or the NRU, have ceased 5 production of moly-99, leaving us with just these 6 six reactors.
7 The LVR-15 in the Czech Republic and the 8 MARIA reactor in Poland joined the supply network 9 after the severe moly shortages the market suffered 10 through 2009/2010. Glad to have them join the 11 party.
12 The OPAL, Open Pool Australian Light-13 Water reactor is the youngest reactor on this list, 14 operated by the Australian Nuclear Science and 15 Technology organization, or ANSTO, in Sydney, 16 Australia.
17 ANSTO has invested considerable 18 resources in their Australian nuclear medicine 19 project that will enable ANSTO to triple production 20 of moly-99.
21 They have completed the construction 22 phase and are in the process of completing their 23 validation program.
24 The increased capacity will enable NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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139 1 Australia to meet their domestic demand as well as 2 be able to supply up to 25 to 30 percent of the 3 global high specific activity moly-99 demand.
4 It is of note, the progress made by the 5 industry in converting from HEU to LEU. You see 6 that column second from the right? Target type, as 7 well as the one next to it, fuel type.
8 In converting from HEU to LEU for both 9 fuel as well as targets.
10 Only the BR2 in Belgium and the LVR-15 11 in the Czech Republic remain to make that switch 12 from high-enriched to low-enriched uranium.
13 In February of this year, Curium 14 announced that they were supplying their customers 15 exclusively with 100 percent low-enriched uranium 16 moly-99 generators, making them the only North 17 American provider to do so up to this point.
18 More on the American Medical Isotope 19 Production Act, or AMIPA in a moment.
20 I've updated this slide to reflect the 21 dedicated reactor processor relationships direct 22 lines as well as the multiple reactor processor 23 relationships that exist in some cases.
24 So, you can see that MARIA feeds NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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140 1 exclusively to the Curium processor in the Petten, 2 Netherlands where the BR2 reactor could funnel its 3 targets that have been irradiated to either Curium 4 or IRE in Belgium.
5 Obviously, South Africa is insular, they 6 feed their NTP processor and the OPAL reactor feeds 7 their associated ANSTO processor in Australia.
8 On November 22nd last year, a halt to 9 production at the NTP Radioisotopes facility, a 10 subsidiary of the South African Nuclear Energy 11 Corporation, or NESCA, was ordered, after it was 12 discovered that procedural deviations related to a 13 set of standard operating procedures were not 14 followed.
15 There is concern about the -- I'm going 16 blank -- we talked about it this morning, the -- it 17 was not a radiological hazard, it was not a spill it 18 was a concern about safety culture.
19 So, they said, wait, time out. You had 20 an SOP, you weren't following the SOP, take a time 21 out, figure it out and get back all on the same 22 page. We need a safety culture.
23 So, NESCA, which is the nuclear license 24 holder said that after they reported that matter to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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141 1 their new national nuclear regulator that they 2 received notification from the NNR to cease all 3 operations in its active pharmaceutical ingredient 4 production facility at NTP immediately. So, they 5 called a time out.
6 NTP resumed production on February 21st 7 at its facility after what was ultimately a three-8 month shutdown. Safety culture is important.
9 Unfortunately, this South African outage 10 coincided with a scheduled maintenance period at the 11 OPAL reactor in Australia.
12 Other reactors put into play their 13 outage reserve capacity to increase the number of 14 targets being irradiated.
15 Despite these efforts, there was a very 16 rough week in December when supply fell 17 significantly below demand.
18 Some manufacturers, depending on, you'll 19 notice that if I go back a slide, that SAFARI is all 20 LEU and OPAL is all LEU. And, they had contracted 21 to provide one manufacturer on a certain day of the 22 week enough LEU moly to produce a batch of all LEU 23 generators.
24 As that manufacturer would say, the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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142 1 order at Tuesday CAL, for example, you can buy an 2 LEU generator and get additional benefit derived 3 from CMS by getting an addition $10 co-pay payment 4 on doses derived from LEU target material.
5 Well, both those reactors were down 6 concurrently, that generator production cycle did 7 not occur. Okay? So, it was a rough week in 8 December.
9 But, for three months, South Africa was 10 down.
11 Just yesterday, Curium informed the 12 industry that the moly-99 activity for their 13 Wednesday CAL, today, generator production was much 14 lower than expected. This was due to one of their 15 reactor partners and Curium can receive from BR2, 16 HFR on MARIA, they were not specific in their 17 announcement, was much lower than expected.
18 This was due to one of their reactor 19 partners having a delayed startup after a scheduled 20 maintenance cycle.
21 As a result of this issue, they had to 22 reduce many of their customers' existing Wednesday 23 calibrated generators today. So, there are already 24 pharmacies today working with less than a full a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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143 1 compliment of generators they would normally have.
2 After reviewing all of this not so 3 pleasant news regarding legacy producers of fission 4 moly-99, good news.
5 For the first time in 30 years, we now 6 have a U.S. manufacturer able to supply moly-99 to 7 the U.S. market.
8 This is occurring at the Missouri 9 University Research Reactor, or MURR, and I will add 10 that to the bottom of the list, in Columbia, 11 Missouri.
12 This is a low specific activity moly-99 13 that I'll discuss in greater length in just a 14 moment.
15 So, the top six reactor sources and 16 processes are making HSA that can go into legacy 17 generators. And this production source on the 18 bottom starting at MURR feeding to their MURR 19 factory in Columbia, Missouri where they fill source 20 vessels is a low specific activity which requires an 21 entirely different generator system to produce 22 sodium pertechnetate.
23 So, let's talk briefly about the 24 American Medical Isotope Production Act of 2009. It NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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144 1 was passed in 2009 and signed into law by President 2 Obama, it has provided some degree of funding for at 3 least two of the startup projects we'll be 4 discussing today, to develop domestic production of 5 moly-99.
6 It has also been the impetus behind that 7 conversion from a use of highly enriched uranium to 8 low-enriched uranium as a reactor fuel and as 9 fission target material.
10 The goal is to reduce the potential for 11 terroristic acts by taking and seizing HEU 12 shipments.
13 This legislation effectively mandates 14 the full conversion away from HEU as soon as 15 possible and no later than January 2020, which is 16 not that far away.
17 The moly-99 supply chain remains very 18 complex and, as we have seen firsthand, in those 19 last several months. And, we are still experiencing 20 this fact even this week.
21 While the issues at NTP did not involve 22 a radiological release or incident, it illustrates 23 the fragility of the supply chain.
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145 1 industry has taken multiple measures to hedge their 2 bets to ensure a consistent supply of moly-99 as 3 best as possible.
4 This includes sourcing moly-99 charters 5 from multiple charter manufacturers as well as 6 operational measures such as frequent elutions and 7 multiple deliveries to clinical sites.
8 You can't get any more joiners, you can 9 just squeeze them harder and get more out of them, 10 that works to an extent.
11 The association that imaging producers 12 and equipment suppliers, or AIPES, A-I-P-E-S, 13 coordinates a reactor maintenance schedules in an 14 effort to ensure that when one reactor is down for 15 scheduled maintenance, others are able to pick up 16 the slack to the medical community and patients 17 don't suffer.
18 The Nuclear Energy Agency, NEA, is a 19 specialized agency within the organization of 20 Economic Cooperation and Development, OECD, an 21 intergovernmental organization of industrialized 22 countries based in Paris, France.
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146 1 to LEU fuel and targets as well as transition to the 2 full cost recovery basis in these largely government 3 operated subsidized research reactors.
4 For the industry to be viable and 5 sustainable, we need to be on the same playing field 6 and we can't have a low cost operator putting out 7 HEU derived moly which would cost a lot less because 8 20 percent versus, you know, 90 percent enrichment, 9 you're going to have five times as much waste using 10 LEU versus HEU.
11 There is desirable reasons to go to LEU, 12 but there are costs. And, those costs have to be 13 uniform throughout the industry, otherwise, it's not 14 going to work.
15 On February 8, 2018, the U.S. FDA 16 approved the first domestically produced non-uranium 17 based moly-99. The NorthStar RadioGenix' system is 18 a device designed as a totally closed system to 19 contain, move and shield all of the moly-99 which is 20 a mixture or radioactive moly-99, Tech-99m, and non-21 radioactive moly-98, or in the future, moly-100.
22 During a computer driven process of 23 isolating technetium from moly before delivering 24 technetium 99M into an Elysium vial.
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147 1 The moly in this system is not derived 2 from the fission of uranium and requires a different 3 system to isolate and concentrate the Tech 99M than 4 in the existing fission 99 legacy generator systems.
5 The NRC has promulgated licensing 6 guidance for medical use licensees, medical use 7 permittees and commercial nuclear pharmacies that 8 was released in February of 2018 under the steady 9 hand of Dr. Donna-Beth Howe.
10 The current production method for this 11 moly-99 is through neutron capture of natural 12 enriched moly-98. They take moly-98, make it into a 13 solid metal target and put it down into their 14 neutron flux at the MURR reactor where a neutron is 15 added and it becomes moly-99.
16 But, a relative small number of atoms 17 are converted from 98 to 99. Let's just say 2 18 percent. So, you're going to get a solution once 19 you dissolve that target of radioactive moly-99, but 20 it's not high specific activity, it's a lot of moly 21 present, a very small percentage is radioactive 22 moly-99.
23 So, in using natural occurring abundance 24 moly-98, they can produce a source vessel, which is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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148 1 what is -- what we could call a generator, a source 2 vessel that is approximately 6 curies today.
3 Their next step to increase the activity 4 in a single source vessel by using enriched moly-98.
5 This will allow up to approximately 18 curies, or 6 the top end DOT Type A quantity that could be 7 shipped in the U.S., about 18 curies per source 8 vessel.
9 NorthStar has built and qualified a 10 source vessel filling facility near the MURR 11 reactor.
12 As it was related to me, they intend to 13 crawl, walk and then run. They intend to focus 14 initially on units, placing units near the Missouri 15 vicinity and adjoining states. They're not going to 16 put one in Spokane to start with.
17 And, once they validate their mechanics 18 and distribution and processing and retrieving 19 abilities, they're going to go beyond that and 20 enlarge their delivery radius.
21 I've heard from NorthStar, the longer 22 term goal for them is to produce moly-99 without a 23 reactor and that's by using a linear accelerator of 24 proton bombardment of enriched moly-100.
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149 1 Again, starting with stable moly by 2 using a proton, knocking one neutron off or sorry, 3 one proton off and making it moly-99 in that 4 fashion.
5 NorthStar has stated that they have a 6 goal to be able to provide 10 percent of all U.S.
7 moly-99 demand in their first year after approval.
8 Now, I'm going to purposely go back a 9 slide or two to give you the picture of the entire 10 unit.
11 The moly-99 technetium liquid is 12 received inside it's shielded radiation transport 13 vessel, called a source vessel, I call it a keg.
14 But, it looks about the size of a normal moly 15 generator system, but it's liquid. It has 16 approximately 30 milliliters of liquid potassium 17 molybdate.
18 It is placed in one of these four doors 19 on the middle row of that generator system. There's 20 two on the far left, two on the far right. There's 21 one in the middle which has a unique purpose.
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150 1 door. The service bay door is the top largest door 2 in the center of the unit.
3 The moly tech is moved by the primary 4 separation cartridge, cabinet where various chemical 5 solutions located handing on top of the unit. You 6 see in the IV bag type device which will react with 7 that moly tech solution and column to make that moly 8 pass through the column, but the technetium is 9 filtered and retained on the column.
10 So, in a computerized mechanical 11 process, it's going to pump 5 mils from the source 12 vessel through that filtration column, moly goes 13 through, tech gets captured.
14 You get the next 5 mils, repeat, next 5 15 mils, repeat until all 30 mils have been pushed 16 through that exchange column, that filtration 17 process.
18 And then, upon command, it will elute 19 that technetium through the chemical agents to that 20 far right door on the right hand side on the top 21 which is where the technetium will be delivered in a 22 tungsten shielded vial, much like we do today.
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151 1 and then through a second column into that product 2 cabinet into the collection vial.
3 The various chemical washes are pumped 4 through valves to one of those two discard material 5 containers. Those two doors at the very bottom of 6 the unit in the center are to contain waste liquids 7 used in generating during the elution process.
8 At the end of the process, the moly is 9 returned back to that source vessel from which it 10 came. So, they can have four generators or four 11 source vessels in those bays and you can elute one 12 at a time by pushing liquid through that column and 13 extracting the technetium.
14 So, because we're working with low 15 specific activity, it's an entirely different animal 16 than the high specific activity legacy generators 17 that we have today.
18 But, we're excited to have a new source 19 of moly-99. More moly is good, moly from non-HEU is 20 good and I would argue that domestically made moly 21 is good as well. Glad to have it.
22 There's an example of a source vessel in 23 this photograph here.
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152 1 reaches its expiration date, is returned to the 2 source transport vessel to be returned to the 3 manufacturer.
4 So, that was approved in February.
5 Another company that you may have heard of in the 6 January 15th of 2018, an article appeared in The New 7 York Times entitled, "Inside the Global Relay Race 8 to Deliver Moly-99."
9 This article is primarily focused on 10 another startup company, SHINE Medical Technologies.
11 SHINE is pursuing the manufacture of moly-99 via the 12 neutron bombardment of a liquid uranium salt 13 solution.
14 SHINE has completed the construction of 15 what they call Building 1 in Janesville, Wisconsin.
16 They will house their first integrated accelerator 17 production system.
18 Moly-99 produced via this method that's 19 being pursued by SHINE has been successfully made, 20 loaded into a GE DRYTEC generator and successfully 21 eluded and made commercially manufactured drug kits 22 today. So, we know this technology works.
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153 1 beyond. So, that's a future project.
2 I pestered my boss. He went to Paris, 3 France, poor guy, and attended the OECD meeting 4 earlier this year and he brought back this chart for 5 me to show you today.
6 This is from the recent OECD meeting 7 that was held in Paris February 19th through the 8 22nd. It shows current fission produced moly-99 9 production and projected demand.
10 So, the red line on the bottom is the 11 demand growth with no outage reserve capacity. This 12 is just standard targets that normally put in the 13 reactor.
14 Again, many reactors have what's called 15 outage reserve capacity so they have normally eight 16 slots they can occupy with targets. But, they've 17 rented space and they can put in 12 if they need to.
18 So, the red line is that standard demand 19 curve.
20 The green line is the demand growth with 21 that outage reserve capacity so they could very 22 easily bump up production to that level.
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154 1 processing capacity.
2 So, I don't want to paint a discouraging 3 picture, I think it's a promising picture. We have 4 moly.
5 Yes, we have two less producers, large 6 Canadian reactor is gone off the map and a French 7 reactor has gone off the map. But, they were each, 8 you know, older than I am. And, you know, bad knees 9 and bad hips, reactors get it, too.
10 But, we've got coordination, we've got 11 collaboration, we've got scheduling coordinations so 12 that we don't have two reactors hopefully, knock on 13 wood, down at the same time as we did for three 14 months in December, January and February.
15 And, then now, most of all, we have a 16 domestic manufacturer and others trying to get into 17 the game.
18 So, that's a status report on where we 19 stand today with moly. Today, we're still 20 suffering, literally, today we're suffering, but 21 we're doing the best we can within the resources.
22 Any questions?
23 Yes, Doctor?
24 VICE CHAIRMAN ZANZONICO: That was NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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155 1 terrific update.
2 I just have a technical question. So, 3 the fact that you're chemically isolating the tech, 4 the fact that it's being made from low specific 5 activity doesn't have any adverse effect of kit 6 production or any such thing as that?
7 MR. GREEN: In simplistic form, tech is 8 tech is tech.
9 VICE CHAIRMAN ZANZONICO: Right.
10 MR. GREEN: It's a different way to get 11 there. And, actually, they were rather ingenious.
12 They -- very early on in the '70s, there was a 13 commercial manufactured low specific activity 14 generator, I think that was put out by E. R. Squibb 15 & Sons which today we would call BROCO.
16 And so, they filed an ANDA with this 17 unit. They didn't have to forge a new path and file 18 an NDA. So, they took an easier route to the 19 approval process.
20 So, they've got an FDA approved product.
21 Today, they can make a 6 curie source vessel. Once 22 they amend applications with the FDA to swap out 23 natural enriched to natural abundance to enriched 24 moly-98, then they can get an 18 curie source NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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156 1 vessel. And, that still uses a reactor in MURR 2 which I think is a very utilitarian high uptime 3 reactor that we have access to here in America.
4 But, once they have an accelerated 5 production system in their own plant in Beloit, 6 Wisconsin, then they'll be able to produce it right 7 there.
8 It's my understanding that they'll keep 9 both systems viable. You don't want to put all your 10 eggs in one basket. But they'll have multiple ways 11 to make moly.
12 VICE CHAIRMAN ZANZONICO: Another 13 question.
14 So, would that, within that base 15 production, do you then what energy protons you need 16 for that? Just in terms of the sort of the 17 viability of that?
18 It becomes much more expensive as the 19 energies grow up.
20 MR. GREEN: Well, I'll be a smart aleck 21 and tell you, I'm not a business, but I work with 22 several. I'd have to ask them about the energy 23 levels required.
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157 1 their case, they're just knocking a proton off of 2 the 100 atom to make it 99.
3 The SHINE process is different because 4 they're actually making it from the accelerator 5 hitting a target material, making a neutron flux 6 which then causes fission in a liquid target uranium 7 solution that they're able to tap and extract the 8 moly and then put the material back in to use again.
9 VICE CHAIRMAN ZANZONICO: One last 10 question.
11 So, I mean, what they're envisioning is 12 that these systems would just go into regional 13 commercial radiopharmacies. These would not be 14 hospital based systems?
15 MR. GREEN: Well, the NRC guidance is 16 for both clinical hospital sites and commercial 17 radiopharmacies, if they elect to get one.
18 Now, it is a rather large footprint. I 19 believe it's approximately five feet. I think it 20 weighs 3,000 pounds. So, it's -- if you're a small 21 clinic, small site, I don't think you would likely 22 be in the market.
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158 1 generator A and then generator B and C and D, then 2 it may be more applicable to a commercial 3 radiopharmacy setting.
4 CHAIRMAN ALDERSON: I'd like to ask 5 about -- this is Dr. Alderson -- I'd like to ask 6 about -- maybe I should say I'd like to be reassured 7 further about this low specific activity idea.
8 So, I'm going to reflect my ancient, you 9 know, legacy in the field to say that I remember, 10 you know, when, you know, we would get our tech 11 generator made the old-fashioned way on Monday, you 12 know, and it was high specific, it was high, you 13 know, we could get out small doses.
14 But, by Wednesday, it wasn't so good 15 because the activity was declining and we had to get 16 a second generator delivered, you know, later. This 17 was at Milacron Institute which is, you know, was a 18 busy, and then, even a busy facility.
19 So, we had to get a second generator 20 delivered so we could get to higher specific 21 activity eluates.
22 So, we had a problem clinically. We 23 felt that with low specific activity eluates.
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159 1 low really means here, but why shouldn't be worried 2 about that?
3 MR. GREEN: Well, in your case, as 4 you're describing, you were using a fission 5 generator, where all the atoms of moly were 6 radioactive atoms of moly.
7 And, you could change the elution volume 8 to some degree to change the concentration.
9 CHAIRMAN ALDERSON: Right.
10 MR. GREEN: But, as always, high 11 specific activity moly, because there was no stable 12 moly in that column, the alumina column had nothing 13 but radioactive moly because it was broken pieces of 14 uranium, the bits they sorted out through the moly 15 pieces and put them on a column for you.
16 In this case, they take stable moly and 17 make some of them radioactive moly-99 and that's all 18 dissolved with acid into a liquid solution of 19 potassium molybdate in 3 milliliters and you're 20 pushing that mechanically through this filtration 21 process and extracting the tech -- holding the tech, 22 moly goes through, the tech is held.
23 And, once you've pushed all the moly 24 liquid through, then you chemically tell the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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160 1 computer system, okay, now, elute -- rinse all the 2 technetium off into my elution vial.
3 So, it's still going to be nothing but 4 tech-99M and tech 99.
5 CHAIRMAN ALDERSON: I see.
6 MR. GREEN: But, it's --
7 CHAIRMAN ALDERSON: So, what you elute 8 is high specific activity --
9 MR. GREEN: Correct.
10 CHAIRMAN ALDERSON: -- you know what's 11 in there is low --
12 (Simultaneous speaking.)
13 MR. GREEN: The moly was low but the 14 tech is high.
15 CHAIRMAN ALDERSON: I got you, okay.
16 MR. GREEN: It's quite an ingenious 17 system. And, it's -- they've had a long road to hoe 18 but I'm very pleased that they've made it thanks to 19 the FDA.
20 CHAIRMAN ALDERSON: Dr. Palestro?
21 MEMBER PALESTRO: A question, you may 22 have mentioned it and I didn't catch it, but what is 23 the cost differential for producing technetium-99M 24 through the conventional generators that we have now NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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161 1 versus NorthStar? If that data is available either 2 in terms of millicurie or curie or however you would 3 compare it.
4 MR. GREEN: I'm a clinical geek, I don't 5 have financial numbers. I don't do math. My dad 6 was a CPA, not me.
7 But, I can give you a couple guardrails.
8 We were enjoying 30-plus years of high specific 9 activity fission moly from cheap HEU fuel reactors 10 using HEU targets.
11 Well, now, we're going to be using LEU 12 targets.
13 So, to get the same number of curies, 14 I've got to use five times as many targets because 15 it's 20 percent and it may have been, say it was a 16 100 percent. So, now, it's going to have a lot --
17 five times as much radioactive waste as much 18 processing as my storage.
19 So, there's a lot more bits to sort 20 through to get them out of moly that I used to get 21 in one target. That cost has to come up.
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162 1 subsidize these. I know these reactors are not 2 solely there for making moly, they do other things.
3 They do moly on the side.
4 Well, they need to have full cost 5 recovery so they're not propped up and supported.
6 So, tech is not going to be cheap. Now, 7 SHINE and NorthStar who are not using fission to get 8 moly will tell you that they think theirs will be 9 economically viable because you don't have all of 10 that waste stream.
11 I'm not sorting through the bits to get 12 6 percent moly and 94 percent waste which has half-13 lives of who knows how long.
14 So, I don't know what the true economics 15 are, you know, per curie, but there's arguments that 16 the legacy systems are going to go up because the 17 LEU and there's more waste.
18 And, perhaps these other innovators may 19 have a cost advantage, I don't know yet. But, in my 20 mind, one moly is good, non-HEU is good, and I'm not 21 opposed to domestically made moly either.
22 CHAIRMAN ALDERSON: Yes, Ron?
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163 1 perspective is just what the community thinks, like 2 is that -- is it really a lot safer? Like, that 3 would be number one.
4 And then, number two, among the now the 5 different technologies that are available, just can 6 you share what like what the pros and cons are to 7 them, particularly from a safety perspective since 8 that's what we're mostly interested in hearing?
9 But, also, just a little more broadly?
10 MR. GREEN: Well, I think the document 11 that Donna-Beth Howe and her team has prepared that 12 was released last month, I mean, in the legacy 13 system, the moly is static. It's on a fixed alumina 14 column and I push water past it.
15 In this system, the liquid -- low 16 specific activity gets a liquid moly solution and 17 I'm pushing it around.
18 And so, there are requirements -- there 19 are certain doors on that locked cabinetry you don't 20 open, you know, unless NorthStar's on the phone 21 telling you what to do or they're physically 22 present.
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164 1 and processing moly, you've got a radiation flux 2 that's here for 10 minutes that won't be there 10 3 minutes from now. So, it's not static.
4 Your term, you said was safety. I don't 5 think any of these are unsafe. They're just 6 different. I've used both systems, both produce 7 technetium and Dr. Alderson's question, technetium 8 is technetium, glad to have it.
9 CHAIRMAN ALDERSON: But, the safety can 10 be looked at from different perspectives when you --
11 yes, the generator's safe for the patients, but the 12 reason that they want it to be low-enriched uranium 13 is because they don't want other people to get their 14 hands on the high-enriched uranium to pirate it.
15 And, that's where that safety comes in.
16 MR. GREEN: You've got an operator 17 making a dirty bomb.
18 CHAIRMAN ALDERSON: Right, exactly.
19 MR. GREEN: Yes.
20 CHAIRMAN ALDERSON: That's where another 21 aspect of the safety that I think the NRC will be 22 concerned by.
23 MR. GREEN: Global threat reduction at 24 issue.
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165 1 CHAIRMAN ALDERSON: Any -- yes, question 2 from Dr. Daibes?
3 DR. DAIBES: Mr. Green, do you see --
4 sorry, Said Daibes.
5 Do you see NorthStar supplying the 6 needed market, being something that is available 7 now? Do you see this as --
8 MR. GREEN: I think they envision 9 themselves to start with because they're working 10 with natural enrichment moly and they can only make 11 a 6 curie source vessel at the moment.
12 Until they get an amended application 13 with the FDA to use enriched moly-98, they are 14 limited to roughly 6 curies per source vessel, I 15 understand.
16 Today, in a legacy system, I can buy an 17 18 curie generator. Okay? So, they're not a one 18 for one swap. But, they're a producer so it may be 19 in the mix. It may be 10, 15, 20 percent of the 20 technetium consumed, it's not going to, I think, 21 replace all units in all facilities.
22 But, we had three manufacturers, now we 23 have four. I've got to look at my fingers when I 24 count.
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166 1 CHAIRMAN ALDERSON: Yes, other 2 questions?
3 DR. DAIBES: Just a general comment. I 4 mean, considering that there was a crisis at one 5 point and there is potential crises down the road, 6 is there anything in parallel as a possible 7 technology to actually overcome this crisis down the 8 road that you know of?
9 MR. GREEN: Well, I think they've done a 10 lot of things. I mean, we were -- it's not that we 11 were naive, we were unprepared in 2009/2010.
12 Community reactors got holes in the stainless steel 13 vessel, it's leaking all over the place. There's 14 problems with the cement, tubings in Holland.
15 The two biggest reactors that supplied 16 roughly 6 percent of the moly in the world went down 17 for almost a year. That was rough.
18 But, back then, we didn't have any 19 coordination. We didn't have France tell Australia, 20 hey, I'm going down for three weeks here to refuel 21 my machine. You stay up while I'm down. Now, we 22 have that coordination.
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167 1 bombarded for a 6-day curie production cycle, 2 they've rented the space and now they've got outage 3 reserve capacity, they can take that 8 and make it 4 12.
5 If you tell me, I'm going to be out 6 doing a maintenance cycle, I can pick up the slack.
7 The other generator -- the manufacturer can pick up 8 the slack by using those other slots and creating 9 more targets.
10 So, we've got the coordination, we've 11 got the outage reserve capacity. We've got more 12 alternatives today than we had. We were unprepared 13 in '09 and '10. We're better prepared.
14 DR. DAIBES: But, you always have the 15 unknown, though.
16 MR. GREEN: Who knew, I mean the article 17 in The New York Times said it was a baboon that got 18 into the reactor hull. I don't know if that's true 19 or not.
20 (Laughter.)
21 MR. GREEN: We can discuss their 22 validity as journalistic source. But, safety 23 culture, shutting down, not a spill, not a release, 24 not an exposure, safety culture issue shutting down NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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168 1 for three months. And there was -- the reactor was 2 not shutdown, it was the processor that sorts 3 through the bits.
4 And so, and then, it happened to be that 5 the OPAL reactor was down for maintenance in that 6 cycle. So, that really added the additional pain.
7 CHAIRMAN ALDERSON: So, Richard, 8 NorthStar is up now?
9 MR. GREEN: Their drug is FDA approved.
10 CHAIRMAN ALDERSON: FDA approved? It's 11 up there? I meant, they're selling the product now?
12 MR. GREEN: We have a representative 13 from the state of Wisconsin Agreement State who can 14 give us direct information on their license status.
15 MS. SHOBER: Yes, Wisconsin does have 16 the -- we have an application in for the 17 distribution license for that generator product.
18 The distribution license has not been 19 issued yet. We are still waiting, coordinating with 20 NRC on the safety evaluation report for the 21 generator.
22 CHAIRMAN ALDERSON: I see. So, pending 23 local approval, it's not really being distributed 24 yet?
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169 1 MR. GREEN: Not yet.
2 MS. SHOBER: Better not be.
3 (Laughter,)
4 MR. GREEN: We hope so.
5 MS. SHOBER: Yes, I mean, we're 6 expecting within the next several weeks or --
7 CHAIRMAN ALDERSON: Several weeks?
8 MS. SHOBER: -- you know, short 9 relatively short-term.
10 CHAIRMAN ALDERSON: And then, SHINE is 11 about two years?
12 MR. GREEN: Two or beyond.
13 CHAIRMAN ALDERSON: Yes, all right.
14 Well, Wisconsin's going to be the 15 important place to be.
16 MS. SHOBER: Well, SHINE has an NRC 17 license for their production facility. And, we're 18 just licensing their demonstration site.
19 CHAIRMAN ALDERSON: Oh, okay, all right, 20 very good.
21 MR. GREEN: But, who knew? Southern 22 Wisconsin.
23 MS. SHOBER: The place to be.
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170 1 for Richard?
2 Seeing none, thank you, thank you.
3 Excellent report bringing us up to date on this 4 future issue.
5 Okay, medical -- the next report is back 6 to Doug Bollock again on the medical projects on the 7 horizon.
8 MR. BOLLOCK: Good afternoon.
9 I'm just going to give a quick overview 10 of some of the major projects that the medical team 11 is working on. And, I'm Doug Bollock, I'm the Chief 12 of the Medical Safety Events Assessment Group.
13 All right, so, just a couple of major 14 projects that the medical team is working on right 15 now.
16 As you're all aware, Part 35 rule was 17 approved by the Commission last year. We are 18 awaiting OMB's final review for impact before that 19 rule to be published for the near future.
20 We've reached out to find out an 21 estimated time when we'll get it back. Have not 22 heard back yet on that. But we are engaged and 23 hoping that comes out shortly.
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171 1 lot of other things that have to happen.
2 So, NUREG-1556 Volumes 9 and 13 have to 3 be updated to reflect the changes in the rule. And, 4 Donna-Beth Howe is working with the NUREG-1556 5 working group to incorporate those.
6 Also, besides that, we are working on 7 the other NUREG-1556 Volume 9 and 13 updates. Katie 8 Tapp is working with -- Dr. Tapp is working on that 9 along with a working group including other NRC 10 employees representation.
11 Germanium Gallium generators, as we 12 know, last year, I guess two years ago now, we 13 approved the 35.1000 licensing guidance for the 14 Eckert Ziegler generators.
15 But, what we are working on, Dr. Daibes 16 is working on 35.1000 guidance for current and 17 future generators. So, a more generic licensing 18 guidance so we don't have to update it every time a 19 new generator comes out. We just have one that 20 covers all the generators. We think it's -- we have 21 a path in sight to be able to do that. So, we're 22 working on that right now.
23 Physical presence requirements for 24 Leksell Perfexion' and Icon', y'all had -- ACMUI had NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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172 1 a teleconference last month on this. And, Sophie 2 Holiday and the Agreement State working group are 3 working on changes to 35.1000 guidance and 4 considering the comments from the ACMUI in their 5 determinations for any changes there.
6 Yttrium-90 microspheres, the topic of 7 the day today, another -- as Katie Tapp indicated 8 earlier, there were -- we put out a Federal Register 9 Notice for public comments on the 35.1000 guidance.
10 So, we're Revision 10 to the 35.1000 guidance on the 11 Yttrium-90 microspheres went out for public comment.
12 The first time we've ever done that with 35.1000 13 guidance.
14 And, we understand and recognize it's 15 not the same as going through rulemaking in that 16 full, you know, all the public input from that.
17 However, it's a step and we believe it's a step in 18 the right direction to get some further insights 19 from the users and the public to inform us on our 20 next revision.
21 And, so, we've received all of our 22 comments over 100 comments were received by the 23 public. Some of them were, you know, we agree with 24 this standard letter, but so, I think it was 134 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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173 1 comments is the last number I had heard and we're 2 still in processing those comments as that just 3 closed a couple weeks ago.
4 And, once we get all the comments, Katie 5 will lead the Agreement State Working Group on going 6 through those comments and incorporating, or 7 potentially incorporate, anything into the next 8 revision to Y-90 microspheres.
9 Patient release, so, as you were all 10 informed this morning, we set the -- the staff sent 11 a SECY paper to the Commission on patient release 12 last month, or actually, the end of January.
13 However, our work is not done. We are 14 going to update our guidance on patient release 15 which is Reg Guide 839.
16 As I'm sure many of you all are aware, 17 NUREG-1556 Volume 9 Appendix U also provides 18 guidance.
19 What we're doing now is the Volume 9 20 Appendix U will refer to the Reg Guide. So, we will 21 just work on changing that one document and not have 22 dual documents with potentially different 23 information if we update them in the future. So, we 24 will just have the Reg Guide and be updating that.
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174 1 And, some of the things that will be 2 going into the updates include the best practices 3 and other information that we provided -- the NRC 4 provided in an information notice last year, May of 5 last year, that the ACMUI reviewed and gave us many, 6 many good comments.
7 We've actually seen a lot of kudos for 8 that information notice. And, a lot of that will be 9 included in the Reg Guide update.
10 And, last, but not least, training 11 experience paper. So, the staff was -- when the 12 Commission approved the Part 35 final rule, they 13 also in their SRM with the approval directed the 14 staff to evaluate training experience as we 15 discussed in the teleconference last week.
16 So, we owe the Commission our staff's 17 evaluation on our training experience requirements 18 specifically for 35.300 at the end of August of this 19 year.
20 So, we will be -- staff will be quickly 21 getting our recommendations thoughts on paper and 22 sharing it with the ACMUI later this spring.
23 So, that's some of the major projects 24 that the NRC is working on.
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175 1 We also -- we are reviewing potential 2 rulemaking that we received from the organization of 3 Agreement States to add isotopes to the 10 CFR 4 Appendix -- or 10 CFR Part 35 -- or Part 30 Appendix 5 B table, this is -- if y'all remember, this is the 6 table that was discussed many times because it did 7 not have germanium-69 in the table.
8 And, that's why we need an exemption for 9 the germanium gallium generators because the use of 10 those generators automatically kicked into requiring 11 a decommissioning funding plan.
12 So, there are a couple of isotopes that 13 were recommended by the Organization of Agreement 14 States.
15 Also, the staff put out a Federal 16 Register Notice soliciting for other isotopes. I 17 don't think we received many, so I don't know if 18 there are any others outside of what the original 19 petition had.
20 PARTICIPANT: Roughly 10.
21 MR. BOLLOCK: Ten? Okay, so there's 10 22 additional isotopes. So, the NRC is reviewing that 23 and Said is part of the petition review group for 24 that. So, that's another major project that we're NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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176 1 working on.
2 And, as Dr. O'Hara's well aware, we are 3 also working with the FDA in updating our FDA NRC 4 Memorandum of Understanding. And, that's just how 5 we are able to communicate and share information 6 between the two agencies.
7 And, those are all the major work. That 8 doesn't count all the day to day answering questions 9 that we receive from our regions, from the states 10 and from the general public on our regulations, our 11 practices and everything across the board.
12 There's a lot of work for a small group.
13 If you look around, there's only a couple people 14 sitting on the edges here. And, in fact, we 15 actually had to supplement our staff this year in 16 order to get the SECY papers that we needed to write 17 for the training experience and also for emergent 18 technologies.
19 I was able to add for this year, Irene 20 Wu to the medical team.
21 So, it's a lot of work. We've got a 22 very dedicated staff, thankfully, keeping us very 23 busy.
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177 1 aware of what's going on, you will be. There will 2 be multiple opportunities for us to share 3 information with you and seek your guidance on many 4 of these projects.
5 Any questions?
6 CHAIRMAN ALDERSON: Okay, yes, Laura 7 Weil?
8 MEMBER WEIL: So, when is your paper to 9 the Commission on training and experience going to 10 be finished?
11 MR. BOLLOCK: August, the end of August.
12 MEMBER WEIL: And, how does that mesh 13 with the work of our Subcommittee?
14 MR. BOLLOCK: So, it's -- it can go in 15 parallel. Now, we -- the staff was directed to 16 provide our staff evaluation to the Commission. So, 17 before any actions can happen, you know, before 18 anything -- any actual changes would occur, there is 19 a lot of other steps to get to that point.
20 We would seek a lot of other input to do 21 that. So, this is just one part of that and one 22 step in that process. But, it works in parallel 23 with -- but we, as staff, we have to respond to the 24 Commission.
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178 1 MS. HOLIDAY: Dr. Alderson? I'm sorry, 2 this is Sophie.
3 If I could maybe add a little bit of 4 information, I think what Ms. Weil is trying to ask 5 or ascertain is, is this going to expedite the 6 review that the Subcommittee is performing?
7 And, I think, as we explained during the 8 teleconference last week, similar to when we have 9 rulemaking changes or NUREG-1556 or other guidance 10 documents, staff will be providing its paper, its 11 draft paper to the Committee for their review and 12 their comment.
13 This does not necessarily mean that the 14 Subcommittee's overall review of training experience 15 comes to an end.
16 MR. BOLLOCK: Right, nor does that mean 17 that you have to -- we'll ask you to review our 18 evaluation. But, what your Subcommittee is working 19 on for any recommendations directly from the 20 Subcommittee does not -- that doesn't affect the 21 time line there. You can work that in parallel.
22 CHAIRMAN ALDERSON: Question from Dr.
23 Palestro on that?
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179 1 didn't follow what you just said.
2 MR. BOLLOCK: Our paper doesn't affect 3 the work that you're doing.
4 MEMBER PALESTRO: Well, the way you're 5 describing it sounds to me almost like it's 6 duplication of effort. In other words, why would we 7 both be working on the same topic separately?
8 I understand if you're going to prepare 9 a draft of a paper or a proposal for the 10 Subcommittee to review and to critique and to make 11 suggestions or vice versa, it doesn't really make 12 any difference to me.
13 But, for the two groups to be working on 14 the same topic independently, I'm not sure that that 15 works very well, especially when you have deadlines 16 to meet, unless I'm just not understanding what 17 you're going to do.
18 MR. BOLLOCK: We have our deadline --
19 right, we have our deadline and what we owe, you 20 know, the paper. So, we can discuss further the 21 offline or I'll say it right here.
22 Really, there's not -- if you feel it's 23 duplicative, I mean there is a sense that it is 24 duplicative, but we understand that. We do want to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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180 1 seek the ACMUI's Subcommittee view.
2 If you're doing other outreach and 3 things that we don't have access to, we don't work 4 in clinical settings, we don't have the same 5 connections to -- that you necessarily have.
6 We do it through you in a lot of cases, 7 right, but we don't necessarily have that. We just 8 -- what we owe the Commission is our staff 9 evaluation, so it's the staff's opinion on what we 10 are directed to do.
11 So, we can work that in parallel. And, 12 what we would ask for -- what staff would ask to do 13 is review our product or have the ACMUI to review 14 our product before it goes to the Commission.
15 MEMBER PALESTRO: Okay, so then the 16 staff is going to put together, if you describe it, 17 a product, and it'll come back to the Subcommittee 18 to review and to make comments on?
19 MR. BOLLOCK: Correct.
20 CHAIRMAN ALDERSON: Well, I think we're 21 going to have several comments now.
22 All right, Dr. Dilsizian's hand I saw 23 next.
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181 1 question that comes up is, would you have 2 information that the Subcommittee does not have?
3 What, you know, for example, whatever 4 the research that you're doing besides teaching and 5 training with the issues is where did 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> come 6 from?
7 I guess the question is, would you have 8 additional data that they may not have that you may 9 share with them as you're doing your work?
10 MR. BOLLOCK: Right now, I don't believe 11 we have anything -- any information that you don't 12 have or haven't had access to over the past couple 13 years of working this.
14 But, if we do find -- if we think we've 15 come upon some other background information, we can 16 share that through -- we have a staff resource for 17 your Subcommittee. I believe Maryann's the staff 18 resource. If we come across that, we'll -- Maryann 19 can share that with the Subcommittee, absolutely.
20 Yes, we don't intend to -- yes, this is 21 -- we don't have -- right now, we don't have any 22 really different information or new information that 23 the ACMUI doesn't have.
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182 1 recommendations to the Commission.
2 CHAIRMAN ALDERSON: I think Ron Ennis 3 had the next comment.
4 MEMBER ENNIS: So, I guess what -- I 5 don't know the words other people must, but I think 6 we're used to a little process where we've had kind 7 of had sort of given you advice and then you've kind 8 of digested that and come up with a position paper.
9 And, I think the tension here is like it 10 seems to not be following in that kind of a sequence 11 now. And, I don't want to put words in Chris's 12 mouth, but maybe Chris wants to know how his 13 Subcommittee can still impact your paper if you're 14 working in parallel instead of in sequence?
15 MR. BOLLOCK: It's a good question. We 16 have, I mean, we essentially have our time line, 17 it's coming up shortly. We've had a lot of other 18 projects that have taken precedence the whole way so 19 this is one we really have to focus to get this out.
20 And, we have heard and, you know, we do 21 from the interim report that we just heard last week 22 and the previous reports, the May or the March 2016 23 report and all the work on that. I mean, that'll 24 help -- that helps inform staff on our position.
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183 1 But, and we understand there's, you 2 know, things take time, but we are on a time -- we 3 are on a kind of a strict time line.
4 And, that's why we're, in this case, 5 we're driving -- it's our evaluation. It's staff's 6 evaluation. So, we're driving this a little bit 7 more so than things in the past that the Committee 8 has seen where you bring an issue to us and 9 recommend change and then we might take action with 10 that.
11 This is something that we've been 12 directed, staff's evaluation. So, we have, you 13 know, this is something we have to do.
14 Yes, I don't like to be duplicative in 15 the work. And, the Subcommittee, you know, like I 16 said, for anything to make any actual change that 17 the Commission decides to have us do, say, 18 hypothetically, they have us go the path of 19 rulemaking and we'll have to develop a regulatory 20 basis for that.
21 We'll have our part of it and there's 22 other parts that tie into it. And so, the 23 Subcommittee's work will tie into that and other 24 public comments will all tie into that process.
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184 1 So, it is duplicative, but it's -- we 2 will be seeking all that duplicative input or, you 3 know, opinions. We will be seeking all that for 4 anything going forward.
5 Yes, so, I mean, I understand. This is 6 a little bit different from what the Committee is 7 used to with projects we have. I guess something --
8 it is probably closest to what we did with the 9 patient release paper.
10 We had the patient release draft SECY 11 paper. We were driving that. I know the ACMUI had 12 years prior given presentation and that was part of 13 our staff's paper.
14 And then, we provided the Subcommittee 15 and the full Committee the draft paper. You 16 provided us your recommendations. That's closest to 17 what we're doing right now with this.
18 CHAIRMAN ALDERSON: Okay, Dr. Ennis, 19 again?
20 MEMBER ENNIS: So, just to close the 21 loop, so, it seems like the issue is that you have a 22 deadline from the Commission.
23 So, is it possible to share with the 24 Commission that this is a big deal and it needs more NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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185 1 time to kind of get things aligned rather than --
2 MR. BOLLOCK: They're aware. And, 3 they're aware that this is -- and this has evolved 4 even with the ACMUI and the discussions from March 5 2016 to now, right? There's new things happened, 6 you know, you hear new input, you get the new 7 information comes along. Right?
8 This is -- we have to be able to be 9 flexible with that. The Commission is aware and 10 they have been aware. I mean, I think, I believe, 11 Dr. Palestro, you've briefed them in March of 2016 12 on this topic.
13 MEMBER PALESTRO: And 2017.
14 MR. BOLLOCK: And 2017. And again 15 tomorrow.
16 MEMBER PALESTRO: And 2018.
17 MR. BOLLOCK: So, they have been aware.
18 It is just, you know, we owe the Commission. We 19 work for the -- we're staff, we work for the 20 Commission and we owe them this evaluation.
21 MR. OUHIB: I guess just along that same 22 line, are there, for better coordination and to 23 really resolve these issues, are there any target 24 dates for each one of these at this point?
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186 1 MR. BOLLOCK: So, the Part 35 rule 2 change implementation, that -- once the rule is --
3 there's not, again, this is -- right now, it's out 4 of our hands. When it comes back and it's actually 5 published, we'll have six months before it's 6 applicable.
7 And, in that time frame, we will have --
8 that's when we'll have to have the NUREG-1556 9 updates. But, I think we're very close on that 10 right now.
11 1556 updates that apply to the rule 12 change, I should be specific with that. The general 13 NUREG-1556 updates, that may take a little bit 14 longer. There's -- that may lag a couple months.
15 The -- so that'll all be done within the 16 six months before it's applicable.
17 We have to update our internal 18 procedures, our inspection manual chapters and 19 inspection procedures that may have to be changed.
20 I don't believe there's any major changes to those, 21 but Donna-Beth and Maryann are reviewing all of 22 those.
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187 1 requirements change in the rule which means our 2 headquarters operations officer who received the 3 emergency notifications, they have to change their 4 processes. They have to understand what they are 5 receiving.
6 We also plan on providing training to 7 NRC license reviewers on the spectrums on the 8 changes to the Agreement States as well. And then, 9 to the licensees. So, we'll be developing and 10 providing webinar training on the changes to the 11 rule. And, that'll all happen in the six months.
12 Essentially, we plan on having that.
13 Once the training's developed, start giving it 14 probably April, May, June and throughout the summer 15 through multiple times.
16 The Germanium/Gallium generators, that 17 update, I believe we have a draft update already.
18 We're just -- staff will do a peer review before 19 it'll come to me and then we'll send it to the 20 Agreement States for their review and our Office of 21 General Counsel review. So, that's kind of in 22 process now. And then, we'll share it with the 23 ACMUI when we share it with the Agreement States, I 24 believe. So, that may be coming out shortly.
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188 1 There's actually not a lot of changes to 2 that from what the guidance that was already 3 developed two years ago.
4 Sometimes when we have -- we'll have to 5 take a look at it. Sometimes we do request -- in 6 the past we have requested with 35.1000 guidance 7 where there's very, very small changes with -- after 8 speaking to a couple -- just a few of the ACMUI 9 members, if the changes are not significant and 10 we've checked with a couple of the ACMUI staff.
11 They said this isn't worth your time to do a full 12 review, full Committee comment.
13 This is actually maybe the case with the 14 Germanium Gallium generators. There's not a lot of 15 changes to make it generic, which is a good thing.
16 I mean, it makes it -- this makes it easier for 17 future generators and other companies that want to 18 develop future generators.
19 So, we do -- those are a couple things 20 that we know we'll see in the next couple months and 21 this year that may be coming to the Committee.
22 Our hard line dates, the only one -- the 23 only two that we really have hard line dates for is 24 the -- to have the rule change implementation in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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189 1 place and that's just once the SRM goes out before 2 it becomes -- before it's applicable then we'll have 3 to have those in.
4 And, you know, we feel we can -- we 5 should be able to easily do that.
6 The patient release, the Reg. Guide 8.39 7 update, we have a date for that. There is some time 8 frame with Reg. Guide updates, it has to go out for 9 public comment. So, that does delay it. But, it'll 10 be about two years from now when that's fully 11 completed.
12 And then, the training and experience 13 paper, that's -- that we know we owe at the end of 14 August.
15 CHAIRMAN ALDERSON: Yes? Dr. Zanzonico?
16 VICE CHAIRMAN ZANZONICO: So, Pat 17 Zanzonico.
18 So, regarding the Reg. Guide which you 19 just alluded to, so, I'm glad to see you probably 20 follow the ACMUI recommendations to maintain Reg.
21 Guide 8.39.
22 I think one advantage of Appendix U over 23 the Reg. Guide is that the Reg. Guide, at least the 24 original version, was largely I-131 focused.
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190 1 Whereas, the Appendix U was more general.
2 Are the anticipated revisions of Reg.
3 Guide 839 including generalizing it somewhat to 4 other isotopes, radiopharmaceuticals and so forth?
5 MR. BOLLOCK: Right now, I believe the 6 tables in there include other isotopes.
7 VICE CHAIRMAN ZANZONICO: I'm trying to 8 recollect that.
9 MR. BOLLOCK: Yes, in Reg. Guide 8.39.
10 And, originally, the Reg. Guide and the 11 NUREG-1556, Volume 9, Appendix U were identical at 12 one point. They did start out identical. We're 13 just hoping to get back to that.
14 It will be -- it will cover -- it is 15 intended to cover all isotopes or all uses and what 16 tool to be used.
17 VICE CHAIRMAN ZANZONICO: I guess what I 18 was thinking of was the kinetic models specifically 19 for I-131.
20 MR. BOLLOCK: Right. So, the modeling 21 that we use in our paper were specifically for I-22 131. That still is kind of the bounding isotope for 23 patient release, is still I-131. So, the -- I mean, 24 there is more information on that. So, the focus NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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191 1 can seem to be like that, it's not intended. The 2 guidance itself is for all patients.
3 VICE CHAIRMAN ZANZONICO: Okay. I was 4 just mis-remembering.
5 MR. BOLLOCK: Yes, no, it's --
6 VICE CHAIRMAN ZANZONICO: It's one of 7 those -- essentially one of those tables or the four 8 tables in Appendix U or essentially reproduced in 9 the Reg. Guide?
10 MR. BOLLOCK: They are, yes, they are 11 the same. In fact, I think they came from the Reg.
12 Guide originally in Appendix U.
13 The one thing of note, so the Reg.
14 Guide, we do understand that the calculations in the 15 tables are out of date. To do those updates, we 16 actually have to split the Reg. Guide updates into 17 two.
18 It will be one that's including -- one 19 will include the information that was the best 20 practices and all the information that we gathered, 21 staff gathered, ACMUI helped us with in reviewing 22 that.
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192 1 to do immediately in the next two years.
2 To do -- to update all those -- the 3 calculations in the tables, that's a lot of number 4 crunching that, frankly, the NRC doesn't do a lot of 5 frequently. So, we contract that out. We need 6 money to contract that out. So, that goes to our 7 budget.
8 We're planning on asking for the money 9 and that budget will be approved later this year.
10 So, I just can't tell for sure.
11 VICE CHAIRMAN ZANZONICO: Just a follow 12 up question on the updating the data. You mentioned 13 contracting that out, that generally is something 14 like Oak Ridge does it?
15 CHAIRMAN ALDERSON: Dr. Palestro?
16 MEMBER PALESTRO: Yes, I'd like to bring 17 the discussion back to training and experience 18 again. Because, I really want to try to get this 19 clarified for the Subcommittee.
20 And, again, I just want to go over the 21 concept that you have in mind. I don't know how far 22 along you are in the project, how much of a draft 23 you have, nor am I asking to discuss that with us at 24 the moment.
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193 1 But, it seems to me that this 2 Subcommittee can be most useful and most efficient 3 in two ways. One is when you put either the entire 4 draft or sections of it together, that would be 5 distributed among the members of the Subcommittee to 6 review and comment on.
7 And the second is, and you alluded to it 8 before, that if there is information that you may 9 not have ready access to or not know where to go 10 look that we could potentially have a better sense 11 of where to go look, then we could also be contacted 12 for that.
13 We're looking at -- we want information 14 on, for example, a number of authorized users 15 graduating nuclear medicine programs. We know how 16 to get that and get it quickly.
17 MR. BOLLOCK: Right.
18 MEMBER PALESTRO: So, that sort of 19 thing.
20 But, that's different than having the 21 Subcommittee work in parallel with you.
22 MR. BOLLOCK: Right. And, we understand 23 that and I think we have, and staff in the past has 24 reached out to either individual members or a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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194 1 Subcommittee when we're working out things. And, we 2 have found that work relationship very beneficial to 3 us in helping us in the development.
4 And, yes, we are not --
5 MEMBER PALESTRO: No, I just think 6 that's fine. And, I think, you know, I'm speaking 7 on behalf of the Subcommittee that we agree that 8 we're more than happy if that's the set up that 9 we're going to be reactive rather than, quote, 10 unquote, proactive in this endeavor, that's fine as 11 long as we all are on the same page and clear about 12 it up front.
13 MR. BOLLOCK: Absolutely. And, we 14 appreciate that. And, we will -- you will be 15 hearing from us and the Subcommittee will be hearing 16 from us.
17 MEMBER PALESTRO: Sure.
18 MR. BOLLOCK: Yes, because we understand 19 it. You know, we're -- this is a -- the training 20 and experience, as we heard last week in the public 21 meeting, there are multiple people with multiple 22 opinions and they're all -- they all have valid, 23 scientific, logical basis for everything they say.
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195 1 board all the different sides and ends of the 2 spectrum. And, they're all from professionals, 3 other physicians like yourselves, you know, medical 4 professionals that have a lot of experience in this 5 field.
6 So, we understand, there is a lot there.
7 We staff just have to come up with our -- what we 8 best can do with what we know and what we're, you 9 know, with our understanding of radiation 10 protection, radiation safety that we understand and 11 our experiences and experiences of regulators to 12 answer the questions and to the Commission what the 13 Commission's asked us to do.
14 So, we get -- this would -- to make any 15 real change would take -- we need to engage and 16 continue to engage our external stakeholders, the 17 ACMUI to make any final change. Like I said, you 18 know, hypothetically, just to same changes, we would 19 -- we understand, we would have to reach out and 20 there is a lot more information needed.
21 And, we're going to continue to hear 22 those different perspectives before we land on 23 whatever we're going to land on. And, this is just 24 one part of that is what the staff believes right NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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196 1 now.
2 CHAIRMAN ALDERSON: So, this is Dr.
3 Alderson.
4 I would like to make a comment and, at 5 the risk of oversimplification, it seems like the 6 two primary issues here, the one that should be 7 primary to all of us is we work within the NRC is 8 the safe and effective handling of these radioactive 9 sources. That's the number one thing that we have 10 to be worried about.
11 The thing that we have to balance off 12 against is that problem of patient access.
13 Those are the two sides of the equations 14 -- of the equation.
15 The pressures, and there are pressures 16 coming on both the medical side and the regulatory 17 side. But, could be extremely different, different 18 pressures for different reasons.
19 Accordingly, I would suggest that the 20 Committee not be reactive, that the Committee be 21 proactive, really get to work looking at those 22 issues, come up with what you think the medical, you 23 know, best solutions are.
24 And then, when you get access to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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197 1 draft from the NRC, you are already -- you've 2 already got a medical opinion ready.
3 I think what'll happen is that things 4 will often get rushed toward the end. And then, 5 suddenly, there will be not enough time or it won't 6 be easy to think it through and you shouldn't, I 7 think, just react to what comes out, but actually be 8 ready with a position of our own that we think is 9 both safe and effective and provides as much access 10 as possible, as possible, not universal access, as 11 much as possible within the context of safety.
12 And, I think it will take some work to 13 do that, but I would go ahead and do that 14 proactively, that would just be my suggestion.
15 Yes, yes?
16 MR. GREEN: I understand what you're 17 saying, Phil. And, I think it makes sense provided 18 that there is frequent interaction between staff and 19 the Subcommittee.
20 Rather than the Subcommittee preparing a 21 document in isolation and the two groups meeting, 22 say, three to four months down the road then they 23 could diametrically opposed.
24 CHAIRMAN ALDERSON: Yes.
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198 1 MR. GREEN: Better that there be 2 frequent communication either between, you know, 3 several members of the staff or the liaison on a 4 periodic basis to say, look, this is what we're 5 thinking, what are you thinking and vice versa.
6 CHAIRMAN ALDERSON: Good. I think that 7 would be served mutually proactive. I think that'd 8 be ideal. Yes.
9 Yes, Dr. Dilsizian?
10 MEMBER DILSIZIAN: I guess the time line 11 of August, end of August is interesting because 12 we're not going to meet as a group until September.
13 Which means that a lot of the dialogues happen 14 between the Subcommittee and the staff, but we who 15 are not in the Committee are going to be out of this 16 discussion.
17 I guess is, the question is, can we have 18 any conference calls in between so that we all are 19 informed?
20 MR. BOLLOCK: Yes, so, typically, we 21 would, you know, as we did with the patient release 22 paper earlier this year. The Subcommittee was 23 provided the paper, the Subcommittee reviewed, 24 shared -- and then, the entire Committee reviewed it NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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199 1 and discussed it in a public setting on a 2 teleconference. I believe it was a teleconference 3 earlier this year.
4 We would do the -- we would have to do 5 the same thing, you know, late spring or early 6 summer after you've had a chance to review it and 7 provide -- the Subcommittee provide the input and 8 then the rest of the Committee see it and discuss 9 it.
10 So, there would be another public 11 teleconference. And, we do recognize that that we 12 need to do that.
13 CHAIRMAN ALDERSON: Yes? Ms. Weil?
14 MEMBER WEIL: I think it would be a good 15 idea for this Committee to review the charge to the 16 Subcommittee and make sure that the role of the 17 Subcommittee is clear.
18 Because, I think this is quite different 19 from what we envisioned our charge to be.
20 And, you know, going forward, again, 21 there's this question of educational memory which 22 is, since it's an ongoing Subcommittee, it should 23 just be clarified.
24 CHAIRMAN ALDERSON: I think that's fine.
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200 1 MR. BOLLOCK: Yes, and we recognize the 2 -- right, and the original charge of the 3 Subcommittee was to look at all modalities and go 4 through a systematic approach going through every 5 one of the -- each section of Part 35.
6 And, this is a more specific task that 7 we would be asking the Subcommittee to review is our 8 -- and so we -- yes.
9 (Off-microphone comment.)
10 CHAIRMAN ALDERSON: Was that comment --
11 MR. BOLLOCK: At the time --
12 CHAIRMAN ALDERSON: I don't think the 13 transcriptionist heard that comment, Laura.
14 MEMBER WEIL: That's probably fine.
15 (Laughter.)
16 MR. BOLLOCK: Hindsight's 20/20, at the 17 time, I believe that the Subcommittee was formed 18 with all the best intentions and we're doing all the 19 right things.
20 CHAIRMAN ALDERSON: Yes, clearly the 21 current charge, whatever it is, I don't remember 22 exactly the charge, but right now, it's focused on 23 one particular set of radionuclide therapies, not 24 the broad concept. That's still there and should NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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201 1 ultimately be addressed.
2 But, this is aimed at a much more 3 specific target in part because it's come down that 4 way from the Commission. So, we can only -- we have 5 to respond.
6 And, we have a comment from the 7 audience.
8 MS. KUBLER: Hi, Caitlin Kubler with the 9 Society of Nuclear Medicine and Molecular Imaging 10 again.
11 I would ask that, if the ACMUI 12 Subcommittee is to have another conference call, if 13 the public would have a little more advanced notice 14 than a week or a few days to review the 15 Subcommittee's report.
16 Last time, we kind of scrambled to put 17 together some comments and it would be helpful if we 18 had a little bit more time to thoroughly review that 19 before the teleconference occurs.
20 Thank you.
21 MS. HOLIDAY: Hi, Caitlin, this is 22 Sophie.
23 If I could follow up with your comment, 24 per the ACMUI bylaws, meeting materials have to be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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202 1 distributed to the Committee no later than two weeks 2 in advance of the meeting.
3 Of course, that also means that, if I 4 was to receive it, you know, on that two week 5 deadline, I would have to send it out. But, I also 6 have to enter it into ADAMS and then it has to be 7 processed by the staff here in order to make it 8 publically available.
9 Then, once it's publically available, I 10 have to pass it on to the web contractors for them 11 to post on the website.
12 So, there is a little bit of lag time, 13 but I recognize that. So, how I take it, as lessons 14 learned from the February and the March 15 teleconference is that I will be proactive and I 16 will send out the report as soon as it's declared as 17 publically available in ADAMS.
18 Because, recognizing that there is a lag 19 time between the time it's declared in ADAMS to be 20 publically available and posted on the website, I 21 will distribute that at least to our typical 22 professional societal organizations that know will 23 be submitting comments.
24 And, quite possibly sending it out on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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203 1 the medical listserv announcement in time for the 2 meeting. But, generally, by the time it gets on the 3 medical listserv announcement, it's also 4 concurrently the time it's posted on the website as 5 well.
6 MS. KUBLER: Thank you, I appreciate 7 that.
8 MS. HOLIDAY: Thank you.
9 MR. BOLLOCK: Yes, we, unfortunately, 10 just we, you know, work the paper, we give it to you 11 for review. You provide us comments. And, it does 12 take time and we have to set up the meeting.
13 You know, we do our best, we recognize 14 that and we do try to get the information and share 15 it and be as transparent and as early in that 16 transparency as we can. We do our best, but, you 17 know, we do strive for that.
18 I know the staff strives for that. You 19 know, we do it all the time and sometimes we --
20 unfortunately, it doesn't get out until, you know, 21 right before the meeting or two weeks before the 22 meeting.
23 But, we do work to get it out as early 24 as possible.
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204 1 CHAIRMAN ALDERSON: Mr. Ouhib has 2 another comment.
3 MR. OUHIB: Yes, on the proactive 4 proposition, I would say perhaps, if you were to 5 identify certain items, let's say training and 6 experience papers, certain items that will probably 7 need to be looked at or reevaluated or whatever, I 8 think it would be probably valuable if the 9 Subcommittee were to know that ahead of time prior 10 to having a conference call and whatnot.
11 And, say, here are the things that you 12 might want to think about. This is what we're 13 looking at or whatever. So, that way, the 14 Subcommittee would prepare themselves or get 15 something to sort of propose or counter or whatnot.
16 CHAIRMAN ALDERSON: Do we have any other 17 comments on this subject at this particular time?
18 Seeing none, I think that we are at a 19 point where we will be adjourning for a break of --
20 Yes, Dr. Palestro would like to --
21 MEMBER PALESTRO: Yes, separate topic, 22 I'd just like to inform the Committee that I did 23 hear from the Society of Nuclear Medicine and 24 Molecular Imaging the ACMUI CE session was, in fact, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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205 1 approved and it'll be held on Monday, June 25th from 2 3:00 to 4:30 p.m.
3 CHAIRMAN ALDERSON: Good, well, that's 4 excellent news. Thank you very much. Are there any 5 other items that will need to be brought before us 6 before we take will amount about a half hour break.
7 Then, we're supposed to reconvene at 3:00 and it's 8 now, you know, 2:27 according to that clock. So, 9 we'll take a 33 minute break and that'll be a closed 10 session. This terminates the open session for 11 today. Is that not correct?
12 MR. BOLLOCK: That's correct.
13 CHAIRMAN ALDERSON: That is correct.
14 So, seeing no other comments in the 15 room, are there any comments from outside? I guess 16 there are not any at this particular point. So, we 17 will adjourn and we'll be back for the next closed 18 session starting at 3:00 p.m. Thank you.
19 (Whereupon, the above-entitled matter 20 went off the record at 2:25 p.m.)
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