ML20154A365
| ML20154A365 | |
| Person / Time | |
|---|---|
| Issue date: | 08/20/1998 |
| From: | NRC |
| To: | |
| References | |
| FRN-63FR43516, RULE-PR-20, RULE-PR-32, RULE-PR-35 ASB-300-410, NUDOCS 9810020285 | |
| Download: ML20154A365 (240) | |
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239 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 4 *** 5 PUBLIC MEETING: 6 PROPOSED REVISION ON PART 35 AND THE 7 NRC'S MEDICAL POLICY STATEMENT 8 4 9 Ana Hotel 10 50 Third Street 11 San Francisco, California 12 13 Thursday, August 20, 1998 : 14 (% q / 15 The public meeting commenced, pursuant to notice, ; 16 at 8:52 a.m. 17 PARTICIPANTS: 18 FRANCIS CAMERON, Facilitator 19 ROBERT J. LULL, M.D. 20 RICHARD HEUSER, M.D. FACC 21 MARY PAT MANNING 22 CHARLIE SHOWALTER 23 MELISSA C. MARTIN 24 DAVID NEBLETT 25 KATHY S. THOMAS, MHA, CNMT ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 4 (202) 842-0034
240 1 PARTICIPANTS: (Continued) W. A. EHMIG _2 ! 3 SUSAN MCLAUGHLIN 4 DAVID BELK l 5 DALE AUSTIN 6 NIKKI HOBSON 7 EDGAR D. BAILEY 8 TERRY FRAZEE 9 DR. DONALD A. COOL l10 CATHY HANEY 11 DIANE FLACK 12 ROY-BROWN
.13 DAVIS LARSON, M.D.
14 JAY W. MILLSON ,y
-{ 15 16 17 18 19 20 21 22 23 24
-25
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I i 241 1 1 PROCEEDINGS () 2 [8:52 a.m.] 3 MR. CAMERON: John Earle, if you could just give a 4 few words about who you are. That would be helpful. 5 MR. EARLE: John Earle, professor and chairman of 6 radiation oncology at UC Davis Medical Center,'formerly 7 professor and chair of radiation oncology at the Mayo 8 Clinic. In that. capacity served on a radiation safety
- 9. committee and chaired that committee for a number of years.
10 I have been the director of two training programs and 11 currently establishing a third training program. So, I'm 12 quite familiar with the issues at hand. 13 I represent ASTRO and the American College of 14 Radiology. (O ,/ 15 MR. CAMERON: And ASTRO is the American -- 16 MR. EARLE: -- Society of Therapeutic Radiology 17 and Oncology. 18 MR. CAMERON: Okay. Thank you very much. 19 Next to John Earle is Dr. Joseph Prendergast. Dr. 20 Prendergast, could you give us a few words of introductions? 21 DR. PRENDERGAST: I am chairman for ASTRO for 22 California. And in that regard I represent ASTRO in 11 23 western states, and the American Association of Oncologists. 24 I have a background in nuclear medicine, and in 25 that I'm board eligible. I've never taken the exam, and my
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242 l 1 career has been basically disease management area of 2 endocrinology. 3 MR. CAMERON: Great. Welcome. 4 And over here we have Dr. David Faxon. 5 DR. FAXON: Good morning. I'm in cardiology at 6 the University of Southern California. As an interventional 7 cardiologist who is involved in brachytherapy, intervascular 8 brachytherapy, I wear two hats. One of those hats is 9 representing the ACC, American College of Cardiology, and , 10 also the past president of the Society of Cardiology 11 Interventionists, which is the professional society for 12 interventional cardiologists. 13 MR. CAMERON: Okay. Thank you very much. And we 14 might as well pick up any body new in the audience.
- r3 I
g,,/ 15 Dr. Forester? 16 DR. FORESTER: I'm Dr. James Forester. I'm 17 chairman of the Technology and Practices Committee of the 18 American College of Cardiology and representing the Ataerican l 19 College of Cardiology at the committee as one that l 20 supervises the production of documents that are published by i 21 the ACC. I'm also past chairman of the division of I 22 cardiology at Cedar Sinai Medical Center. And Burns and 23 Allen professor of cardiology at Cedars. And professor of 24 medicine at UCLA. 25 MR. CAMERON: Great. Thanks, Dr. Forester. ANN RILEY & ASSOCIATES, LTD. [/T t b- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 i l 1 l
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243 ' 1 And I believe we have a few people who weren't i 2 with us yesterday. If you just want to introduce yourself 3 and affiliation, if appropriate. ! 4 1 MS. MALOTT: Jill Malott of Colter Pharmaceutical 5 which is in Palo Alto, California. And we're developing a 6 therapeutic agent for non-Hodgkins.lymphoma. 7 MR. MCBEATH: Randy McBeath, also from Colter 8 Pharmaceutical. Our agent is a radiotherapeutic agent 9 that's labeled 5131. ! 10 MR. CAMERON: Thank you very much. 11 Yesterday we had a fairly good discussion of risk 12 and we came up with some ideas for the Staff to consider in 13 terms of how Part 3d might deal with low risk situations. I 14 And we also talked about the availability of professional l 15 standards, standards of practice, keyed off by Dr. Dale 16 Austin of the Federation of State Medical Boards. 17 We did have a proposal yesterday on how the NRC 18 might more effectively be able to consider standards of 19 practice in these areas. 20 And what I'd like to do before we get into the 21 third justification and rationale issue, which is 22 compliance, I was going to have Charlie Showalter, who has 23 kindly agreed to coordinate this effort, to just talk a 24 little bit about what his sense is of what you might try to 25 do in this area and to get your -- your comments on that. f A ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202)-842-0034 e
244 1 And this would be something that would develop over the next (} 2 couple of months, as we get down this meeting process. 3 Charlie? 4 MR. SHOWALTER: Thank you, Chuck. 5 Chuck asked me to write down in a sentence, 6 preferably a short sentence, what accreditation would -- how 7 accreditation might be used in this area by the NRC. And 8 what I wrote down was: " Accreditation serves as initial 9 evidence of compliance with professional and governmental 10 standards." 11 This I'm -- I'm drawing on my experience with the 12 mammography program of the FDA and how accreditation is used
.13 in that program. This is basically the way it's used. FDA 14 has oversight of accreditation bodies, and indeed, according (n) 15 to_the statute, must approve accreditation bodies whose 16 standards and procedures are in compliance with the federal 17 requirements under -- under MPUSA. And the accreditation 18 bodies play a huge role in the implementation of MPUSA. And 19 judging facilities according to initial compliance with 20 standards. If a facility, at some point, is in trouble with 21 their accreditation body and looses their accreditation they 22 may well loose their certification from FDA and their 23 practice.
24' So there's a huge role there for accreditation , l 25 bodies under mammography. A similar role could be foreseen ANN RILEY & ASSOCIATES, LTD. f/ (_-
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245 1 under regulations, or Part 35. Not necessarily under the [} _2 regulations that have been proposed, but under a different 3 set of regulations. 4 MR. CAMERON: And how is -- I guess I have a 5 couple of questions for you on that. 6 How is it would we incorporate the standards of 7 practice, for example, that the Society of Nuclear Medicine 8 or other societies have. How would that be -- in other 9 words, does accreditation, does that cover a lot of 10 territory here or do you need to be more precise on this? 11 MR. SHOWALTER: Accreditation typically covers a 12 lot of territory. It covers personnel. It covers any 13 equipment that might be used. It covers procedures. So, it 14 can, and indeed in mammography does cover the entire range 15 of practice. 16 Now, there are a couple of extremes in a 17 mammography program that could be looked at. One, the 18 extreme, I would say, is for screening and diagnostic 19 mammography where FDA has spelled out a very comprehensive 20 set of standards. And in order to be approved as an 21 accreditation body the accreditation body has to have a set 22 of standards that are consistent with those FDA standards. 23 Another -- the extreme that FDA is discussing 24 right now but has not really taken the action on because 25 they're letting things play out, is in the stereotaxic area. P
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246 1~ Where, right now, stereotaxic, although technically covered
) 2 by the statute, has been exempted from coverage under the 3 regulations temporarily. Temporarily because there were 4 nonprofessional standards that FDA could draw upon, and what 5 they have decided to do, recently the ACR and the ACS, the 6 American College of Surgeons, have agreed upon an 7 accreditation program in stereotaxy, and what FDA has said 8 publicly is they are going to see how this progresses within 9 the community.
10 And if the community adopts this program and if 11- they get, essentially, 100 percent participation in the 12 program, FDA may not find it necessary to write any 13 regulations in the area. 14 Now, I personally don't think that will. happen and , () 15 I think that the FDA will have to write a regulation in the 16 area. The regulation could be, however, as simple as, "You 17 must be accredited by an approved accreditation body in 18 order to practice. That would assure participation in the 19 program that they desired without going out and having to 20 develop and write a whole set of regulations themselves. 21 So, those are kind of the extremes you see in 22 mammography. I think somewhere within that range one might 23 find a suitable fit for nuclear medicine. ' 24 MR. CAMERON: Okay. Well, let's explore this a 25 little bit more.
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247 1 Cathy? This Cathy. ( 2 MS. HANEY: I guess I would just like to take a 3 second and tell you a little bit about what's in the 4 proposed rule where we have used the industry standards. 5 And it comes about in the change we're proposing in 6 licensing philosophy. And it especially has implications in 7 the diagnostic area. 8 Under the current Part 35, in order to get a 9 license you need to come into us with the application. And 10 as part of that application you need to submit procedures to 11 us. Typically, the licensee is saying that they will follow 12 our NRC's model of procedures that we have, 10.8, for those 13 of you who are familiar with 10.8. 14 Under this approach, under what we are proposing, 15 and you see this when you review the SECY paper and the 1 16 orange document that you have. The NRC would no longer be 17 reviewing procedure. 18 There are a lot of places in the rule where it 19 says that the licensee should develop, implement and 20 maintain procedures for whatever. One of them may be doing C 21 surveys, radiation surveys. 22 And if that's the case where I believe the agency l 23 standards come into play. Because all the licensee or the 24 potential licensee would need to submit to bs is a statement 25 that says, "We're going to do what 35.70 says", which means ANN RILEY & ASSOCIATES, LTD. 4 Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
248 1 that we're going to develop and maintain procedures. () 2 The licensee will then have the option of I 3 developing their own procedures or looking to professional 4 organizations for the procedures. For example, Kathy 5 mentioned SNM have certain procedures. We did handle those 6 as part of the-process and we looked at them and we said { 7 that in most cases these procedures address this particular i 8 topic area and therefore we don't need to go beyond. We're 9 going to let the licensee come up with their own procedure. 10 If I were a licensee I would probably look at what
- 11 SNM wrote, I'd look at what ACNP wrote, I would look at what i 12 the Health Physics Society wrote and probably join all of 13 those together and come up with what would be a procedure 14 that would be unique for my facility.
() 15 So, what we are proposing actually does give the 16 licensee the flexibility of using industry standards. 17 Now, go a step further. There were scme cases 18 where we went through these industry standards and 19 identified some things that we thought were very important 20- to safety and that we would expect, at a minimum, the
- 21 licensee would have in their procedures. And in those cases 22 we took those requirements and we actually put them into the 23 rule.
( 24 A diagnostic area example would be dose 25 calibrators, calibration. We originally thought, Well , f 4 O ANN RILEY & ASSOCIATES, LTD. l 5- I Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1
249 1 let's just put it in the rule that you will calibrate dose 2 calibrators. I will use a calibrater, dose calibrater," and (} 3 we would stop there. But the next question came about is, 4 we don't want inspectors going out and going to the licensee 5 and saying, "Well, you said you were only going to constancy 15 checks once a month versus once a day." We don't think the 7 inspector making this judgement call, we don't think that's 3 appropriate. But yet, what do we really feel it needs to 9 be? In that case, we think constancy needs to be once a 10 day. So, rather than leaving it up to the licensee to 11 decide, we actually put it into the rule text that says 12 you're going to do it once a day. We're not telling you how l 13 to do it. In the how, you're going to turn to an industry l l 14 standard that says how we are going to do that. In the j r~' i 15 (_) absence of anything very prescriptive in the rule the 1 16 licensee does have the flexibility. 17 ~The current Part 35 says that you will do daily 18 surveys. They're just to get_an MR review and make sure 19 there's no contamination. The proposed rule does not 20 contain that requirement. So, if an inspector goes out and 21 looks and is doing an inspection and finds that the licensee 22 is not doing daily surveys, that's okay. The inspector 23 would walk away. However, if the licensee chose to put that 24 in their procedure that they were going to do daily surveys 25 and they were not doing it and there was a problem, the /) k/ ANN RILEY & ASSOCIATES, LTD. s Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
.. . .-. _- - _ . - _ _ - - _ - . . = . .. .- _.. - -
250 1 safety inspector goes in and finds tremendous radiation [] %-./ 2 levels -- due to this spell of technisium -- then we would 3 start looking a little bit further and say, "What do the 4 procedures say? What does the licensee feel is appropriate 5 for their program?" 6 In the therapeutic area, because we are now 7 looking at really a different sort of effect on the patient 8 safety, on occupational safety, on public safety. You'll 9 find that there are a lot more prescriptive requirements. 10 In this* case, we did go to the industry standards, 11 mostly looking at the AAPM standards, going through their 12 task group reports and saying, "What are the requirements in 13 this section that we feel are very important to safety?" In 14 that case, we put it into the rule. But there are a lot of (O j 15 places within the rule where we have said, ""Do these things 16 in accordance with nationally approved procedures or l 17 organizations' peer review groups. 18 So, that would allow the end user to go -- the 19 licensee to go back, look at AAPM. There are certain 20 international standards that they -- the medical physicist 21 or the radiation safety officer or the oncologist may choose 22 1 to use rather than using the standard, you know, rather than 23 using the national ones. 24 So, that's -- what I'm trying to say is we have, I 25 think, taken a step toward recognizing that there are l l ['2) ANN RILEY & ASSOCIATES, LTD. \s / Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 ; (202) 842-0034
251 1 industry standards out there and when we :ould, we relied on (v) 2 those. But we did review them and if there key things that 3 we felt were important, we wanted to make the licensee aware 4 of it up front because in the past we've been criticized for 5 regulating through regulatory guides, regulating through the 6 license. In other words, we're trying to be very up front 7 with what we think is very important. 8 MR. CAMERON: Thanks, Cathy. And that's an 9 extremely important point that we -- that the proposed rule 10 has already made some efforts towards incorporation in 11 consideration of professional standards. 12 And I guess with this broad sort of charge to all 13 of you about how can standards of practice be incorporated 14 into the rule that the -- that starting point would be to t, j 15 look at what the NRC has done in the proposed rule already. 16 Kathy? 17 MS. THOMAS: Well, along those same lines of 18 accreditation, the nuclear medicine community as a whole has 19 joined together. This includes ACNP, ACC, ASNC, Society of 2C Nuclear Medicine, the technology section. 21 And we have formed a group which is with the group 22 called Intersocietal Accreditation for Nuclear Laboratories. 23 This group currently has completed the accreditation 24 standards for nuclear cardiology. The next phase of that is 25 going to be nuclear medicine laboratories. b's / ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
252 1 What this incorporate is everything and actually /\ 2 more of what's in the regs currently, what's in the new
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3 part. 4' And what it's addressing is those laboratories, 5 not only those that are under JCHO standards, but also those 6 freestanding nuclear cardiology clinics. As we all know, in 7 the future we are going to see reimbursement tied to l 8 accreditation or standards or whatever. And anybody who 9 really wants to win those contracts is going to be able to i 10 demonstrate quality of their service. 11 And so what we have done is designed the program 12 that will allow, regardless of whether you're a freestanding 13 clinic or a hospital, to have an organization come in there, i i 14 assess when we do collect all of the procedures, we want at I /~T least five of everything you do. t vj 15 There is a group of 15 16 that will review everything. This procedures is a three 17 year accreditation standard. , 18 We mandate everything that JCHO requires in all 19 areas, including what's done with radiopharmacy, including 20 what's done with patient education, the whole gamut, which 21 would tie along with the same lines of that initial 22 sentence, " Accreditation serves as initial compliance." 23 Because there is an area that isn't mentioned here, that 24 isn't mentioned in these accreditation standards. And I can 25 see how we could really streamline this process of that kind /~T ANN RILEY & ASSOCIATES, LTD. (s,/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 , Washington, D.C. 20036 (202) 842-0034
253 1 of language could be incorporated. 2 It is to demonstrate that yes, I have passed this 3 and you'll be rated -- your compliances is either
.4 provisional or it's absolute compliance or whatever. If you 5
can demonstrate that then I think you would not have to jump 6 through_a lot of the hoops-that are required by the federal 7 regulations. 8 MR. CAMERON: That's good. That's interesting. I 9 think that also suggests that this might be a useful effort 10 just to identify people in the medical community, what 11 actually is going on, such things as that. I'm not sure if 12 everybody knows about all these efforts. i 13 So, that in and of itself, regardless of the
- 14 impact on the regulatory regime, could be -- could be 15 useful.
16 Bob?
- 17. DR. LULL: Yeah. I agree with the thrust of the 18 discussion here about utilizing already available 19 professional organizations accreditation processes. And 20 probably the NRC should look at reviewing all of those that 21 are available to see which meet their needs and their goals.
22 I would suggest that perhaps there are some -- at 23 least I know of one program, the ACP program, that does 24 actual on site inspections by an inspector which may go on 25 for a day or several days. I would suggest that the NRC O ANN RILEY &_ ASSOCIATES, LTD. V Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.-20036 (202) 842-0034
254 1 look at programs like that or others that develop along fD
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2 those lines where you actually have an on site professional 3 reviewing the operation. As a potential -- thing to avoid 4 duplicate inspections by the NRC inspectors for what's low 5 risk activity, such as diagnostic imagings technique. 2 6 So, I think there is a range of possibilities 7 whereby the national structure of the NRC could back off
- - 8 from something that I think we've all agreed is a'relatively 9 low risk operation.
- 10 MR. CAMERON
- Good. Thank you. It doesn't have
- 11 to just be exclusively focussed on licensing, but actually
.; 12 could be expanded into the inspection enforcement area. And 13 of course there may be legal problems with that, but I don't 14 know. Joe DelMedico is going to be up here in a few minutes l () 15' talking a little bit about the enforcement policy. We may 16 be able to get his views on something like that. But a 17 very, very useful suggestion. 18 Roy? 19 MR. BROWN: It sounds like we're getting very, 20 very close. We're talking about standard of practice, we're 21 talking about interdisciplinary certification, we're talking 22 about practice guidelines, about some of the societies. I 23 mean, it sounds like we're getting very close to where we 24 can bundle all this together and take a particular field, 25 like maybe nuclear cardiology, and say, "Okay. We have l [}
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ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
255 1 this. We have that. We have the certification. We have
~h
[b 2 all these things" and then approach NRC and say, "Can we get 3 our license?" As long as you meet all these guidelines you l 4 can go out and practice nuclear cardiology provided you have 5 all these things. 6 Cathy pointed out to me this morning that maybe 7 the approach-should be go after Part 30 and create a new 8 licensing category rather than attack Part 35. I'm just 9 curious to see if that would be a better approach, to try to ! 10 look at attacking Part 30 instead of 35? I mean, if we're l i 11 going to a new licensing or new type of license? 12 MR. CAMERON: Cathy? 13 MS. HANEY: Well, as I discussed with Roy this 14 morning, right now we're set up to issue a general license () 15 and a specific license. And then there's an exempt license, 16 but we really haven't done a category yet. And those flow 17 out of our Part 30 requirements. So, if we were going to 18 come up with a new category of license, it would require it 19 relate to Part 30 to create this other category. 20 One of the thoughts would be that with even what 21 Roy just proposed you could probably still do it under a 22 specific license and it would not need to go into a Part 30 i 23 rule making. You could do it under -- kind of just maybe go
.24 a little bit further than what we've done with this change 25 of licensing philosophy that I just laid out a little bit
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256 1 further. What I'm saying, you need to develop these
~
(] 'q./ 2 procedures. 3 Maybe we'd go a step further in the licensing 4 philosophy and say that if you are accredited by such and 5 such an organization that's all we need to know and we don't 6 even look at your -- what type of instruments you have on 7 hand or the training or your staff or the authorized users 8 or even look at any commitments to any of the Part 35 9 requirements. And then -- that's not going into a Part 30 10 rule making. 11 Don might want to add something to that. I'll do 12 the old toss to him now. 13 DR. COOL: That's a very interesting concept that 14 we're tossing around here. I think one of the things that
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(t ),i 15 we're rolling around as I've listened to the various pieces 16 of the discussion is how we reach agreement of what that set 17 of conditions, certifications, accreditations are. 18 Because there are a number of different ones 19 floating around and I'm really pleased to hear what Cathy 20 was talking about, that some of the societies were coming 21 together. Because a year or so ago when I was listening to 22 some of the discussions I was getting the feeling that each 23 society was zooming off, doing slightly different things and 24 creating something which would make it very difficult for 25 me , at this level, to go ahead and say, "There's all O ANN RILEY & ASSOCIATES, LTD. (_) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
- . -- -- - - - - _ _ _ - -- _ _ - = . . . - _ . .
257 1 comparability. They're all touching the same things", 2 because each would have a little bit different focuses. 3 Robert pointed out some of them do on site, some 4 of them do it by just by pulling the materials in. 5 So, I would like for us to explore it. We may not 6 be able to do it in the context of these discussions because
- 7. we've got to talk about some other topics, but if you go off 8 and think very carefully over the next few weeks about which 9 pieces of accreditation could come together. What were the 10 key components that we would write in that short list. And 11 then if we were moving in the direction of that serving 12 as -- and I'm not going to be able to quote back from 13 Charles Showalter, it was a good sentence -- the deemed 14 compliance status.
() 15 16 We write it in the regulation. How do I avoid tieing me and you in knots from having to go through a rule 17 making every time I want to adjust this with the society's 18 adjusted update. Because the other thing that's get into 19 these -- the recognition of standards is that the standards 20 process is constantly changing. The standards of practice 21 are constantly changing. The engineering disciplines. The 22 kinds of things that we're dealing with in the modalities. 23 So, you're always updating, as you should. 24 By it's very nature, the rule making process is a 25 slower process. It can't start until the standard is done. (} s,f ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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258 1 And by the time we finish the rule making process, the , fg 2 standard is moving again. V 3 So, there are some things that we need to explore 4 a little bit more, but it's a good -- it's good if we can 5 try and get some additional focus in on it. 6 MR. CAMERON: Okay. So, there's a number of 7 procedural angles on this once you identify what might be 8 done. There is a number of things that you have to consider 9 there. 10 David? 11 MR. NEBLETT: I salute your effort in moving the 12 regulations away from the prescriptive and more to the I 13 recommendations made in the .;Ly of procedures. Because the 14 prescriptive ties us in knots, so to speak. And some of the I) NJ 15 procedures -- out in this particular one tie to exact task 16 group studies. TG-21, for instance, which defines how to l 17 calibrat? an area, accelerator or et cetera. 18 That is a report that is, at this point, seven 19 years ago. And that report is somewhat out of date already 20 and will be replaced in the near future with another report. 21 We have lived with major parts of 35 for what, 25 22 years? To tie regulations, rules, to a technology is a 23 grave error in my humble opinion, and it will tie the 24 intastry in knots. We will have a situation wherein the 25 vast majority of equipment in the country, accelerators, ANN RILEY & ASSOCIATES, LTD. (A_,) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
d 259 1 will be calibrated.with a new technology and new technique,
. ( ~g 2 and the other equipment will be tied by rules back to an old N) 3'
' technology and an old technique and it's a very costly 4
expense to the user to, to the patient, to be tied to this. 5 To say that we will follow industry standards is a
.6 spectacular idea. To say that we will follow standard A is 7 Gordian knot that will be choking.
8 MR. CAMERON: Okay. Thank you for that. 9 Cathy, do you want to comment? 10 MS. HANEY: Yes. I would just say, when you're 11 reviewing the document in the Statements of Consideration 12 for the rule, we did make reference to some of the TG 13 reports. And it was as much as to let the public know that 14 that's where we were pulling these requirements that we put 15 [/)
%. .into the rule space and to -- if someone was just looking to 16 see where our -- how we got to the point in the rule text.
17 But the. rule text, what-the. licensees would be 18 tied to, does have the statement about the nationally 19 approved organizations. And it was done just for the reason 20 that David brought out. That it's been brought to our 21 attention several times that these tash group reports are 22 updated and, you know, we're still referencing the group 23 reports that are five years behind. 24 So, that was a step away and we may need to 25 address that problem. ANN RILEY & ASSOCIATES, LTD. Tg Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
260 1 MR. CAMERON: Okay. Thank you. () 2 3 Don, do you have something to. add? DR. COOL: I don't think so. 4 MR. CAMERON: Okay. Bob, do you still have your 5 comment? 6 DR. LULL: Actually, I wanted to -- I just wanted 7 to point out that many of the contents of these 8 accreditating processes are really related to practice 9 parameters and quality of practice, which are issueE that 10 the NRC is backing away from. And perhaps rather than 11 trying to keep up with revisions that are appropriately 12 ongoing as practice keeps improving, the NRC could do is 13 define the basic principles that they need covered. And as 14 long as those are covered in any revision, then the () 15 revisions wouldn't matter. And that's a fair standard 16 operation that many organizations go through. 17 So, if you've got some basics which are a 18 relatively small part of these total accreditation 19 processes, you can end up refining those. And as long'those
'20 continue to be met, then whatever other revisions are made 21- would be consequential to the goals of the NRC.
22 MR. CAMERON: Okay. Thank you. 23 Well, I think that if you -- t' ; could be very 24 helpful. And if you take a broad look at it. Charlie, 25 thank you for coordinating this. And if anybody who is O- \_ / ANN RILEY & ASSOCIATES,.LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washingtdn, D.C. 20036 (202) 842-0034
261 1 interested could work with Charlie, I don't know if there 2 might be some sort of just a framework or concept worked on 3 by the time we get to the Kansas City meeting, that's all 4 sort of up to you guys. But if that's possible, then we 5 can -- we can put that on the agenda as a presentation to 6 spark a continuing discussion of this. 7 Charlie do you have a final word on this? 8 MR. SHOhALTER: I would fully expect to have a 9 framework before the Kansas City meeting and one of our 10 members there to discuss it. 11 MR. CAMERON: Okay. And -- 12 MR. SHOWALTER: Let me just say, also, that I've 13 got plenty of business cards. If anybody's interested with 14 working cn this, if you see me around and just get my -- how () 15 16 to contact me, phone numbers and all of that. MR. CAMERON: Great. Thank you all for that. 17 Anybody in the audience have a comment on this I 18 i before we move on to our first major discussion topic? ! 19 Okay. We're going to go to the third 20 justification and rational issue, which is broadly labeled 21 " Compliance issues, costs, enforcement". And I think what
.22 we'll do is the -- the NRC Staff has some good information.
23 It is in the regulatory documents accompanying the proposed I 24 rule on cost considerations. l 25 And what I'd like to do is ask Cathy to lead off ANN RILEY & ASSOCIATES, LTD. {- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
262 1 with that. i Let's have a discussion on cost and let's move '
)
2 S (\ms/ to the issue of enforcement and have Joe DelMedico from our 3 enforcement staff give us a short presentation on that and ; 4 discuss enforcement.
]
5 We do have some scheduling problems in terms of a t 6 couple of people. And after this compliance discussion what 7 I'd like to do is put the issue of emerging technologies on
)
8 the table for -- for discussion, sometime before lunch. I 9 But let's go to compliance. Cathy, do you want to 10 do your presentation? 11 MS. HANEY: What I'd like to do is just to tell 12 you a couple of things, a little bit of information about 13 some of the places where we have calculated the cost of the 14 rule.
./-~s
(} 15. There are two documents that we needed to generate 16 relative to the costs effects of the rule. And they serve 17 different purposes. 18 One is a regulatory analysis. Another is an OMB 19 document. The OMB document looks only at the record keeping 20 and the reporting requirements associated with the rule. 21- The regulatory analysis looks at items beyond those 22 particular areas. 23 Now, when we did the regulatory analysis we were 24 only looking at the change of the implications in the 25 proposed rule. We didn't go back and say, "It's going to ANN RILEY & ASSOCIATES, LTD. A(,,) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
263 1 cost so much to comply with the roles." So, this really
; 2 gets to what Nikki was saying yesterday.
3 So, with the numbers that I'm going to give you, 4 this will be the decrease in the cost of the rule. Where -- 5 with the ONB numbers we'll be able to give you the total 6 impact of what we calculate it to be. Most of these 7 documents are available on the NRC web site. They are also 8 available if you want to give me a call and we'll may you 9 your own individual copy. 10 At the time that we were mailing out these books 11 the documents were still being finalized to match up with 12 the proposed rule because there were some changes in it l 13 after the Commission reviewed it. I i 14 For those of you going on to Kansas you'll have () 15 your own copy in the binder that you'll receive for that. 16 The regulatory analysis looked at Part 35 and Part j 17 20 changes. We needed to look at the Part 20 changes ! 1 18 because of a small rule making that got grouped under this 19 particular item. And Roy made reference to it yesterday, it 20 was the University of Cincinnati petition. And I'll tell 21 you about that in a minute. 22- When you do a regulatory analysis you look at what 23 were the alternatives to this rule making. There were three 24 items that we looked at. One obviously was continue Part 35 ; 25 with making no revision at all. The second was to
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264 1 promulgate new regulations, look at them, the risk-informed (~% '2 or performance-based. And then under that, where mostly 3 it's the -- the third topic really is a subset of that is 4 - what are the particular alternatives for each particular , 5 section. 6 For those of you who who were with us in Chicago 7 or Philadelphia we had about at least three if not six 8 alternatives for each one of the cross cutting issues. If 9 we go this way, what are the implications. And the 10 radiation safety committee, do we have a committee, do we 11 not have a committee, do we have it only for the high risk 12 areas, do we only require procedures for communication 13 between the departments. So, there were a lot of 14 sub-alternatives.
.( ) 15 But in looking at the regulatory analysis, to a 16 certain extent we were looking ac do we change the rule, do 17 we not change.the rule? And obviously we chose to change 18 the rule.
19 -In the Part 20, let me step back and tell you a 20 little bit about this. 21 Several years ago we received a request for rule 22 making from the University of Cincinnati. And this falls -- 23' basically the requirements said that we are required to c24 : hospitalize patients because they contain radioactive 25 material, like any area of the iodine 131 patients that have ANN RILEY & ASSOCIATES, LTD. O' Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
265 1 received 100 millicuries of iodine were hospitalized.
!( [ 2 But visitors to these patients, the dose range for 3 these individuals are controlled by Part 20. And when Part 4 20 changed years ago, that limit became 100 milligram. And 5 what's happening is that visitors' family members are 6 notable to go into these rooms and spend time with the 7 ' patient because they re limited to a 100 milligram does 8 range.
9 The University of Cincinnati came in and 10 said:"There are cases where there's a child and the parent 11 would want to be in there to lend support, emotional support 12 to the patient. Or in the case of an elderly patient where 13 it's very advantageous to have someone that they're familiar 14 in the room with the patient. We'd like to have the dose-p~ As :U5 limit raised to 500 milligram. Please do a rule making, l 16 NRC." 17 That fell under the Administrative Procedures Act 18 where we noticed the petition, we got comments on the 19 petition, and then a long story real short, they got it 20 moved under the Part 35 rule making. 21- Again, we had to look at alternatives for this 22 rule making. 23 We'could obviously deny the petition and just say, l 24 " Stick with the 100 milligram." 25 We cottld -- another alternative we considered was ! I g ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l l 266 1 to go to the 500 milligram range and require badging and (n) 2 informed consent and record keeping of what the doses these 3 patients would receive. 4 Or else we could just go to a 500 milligram level 5 and again say, " Licensee, it's up to you. Make whatever it 6 takes to assure that that visitor does not exceed 500 l 7 milligram. Do it and we will not dictate to you restrictive
]
8 requirements of how you're going to get there. 9 In the case of that particular item we chose to i 10 take the latter approach, which was to go with raising the l 11 limit to -- or propose that we raise the limit to 500 l 12 milligram and not require instructions or badging. l l 13 So, that was basically where we started. A 14 I want to just discuss what the underlying data () 15 and assumptions in a regulatory analysis are. Again, all 16 these statements are subject to comment. If you feel that 17 we have not used the right values, we've underestimated, 18 we've overestimated, we take comments on the right analysis 19 in the ONB also. 20 Our underlying data and assumption. We needed to 21 come up with a number of licensees that are effected by this 22 rule making. NRC has a database, we refer to it as a 23 licensee tracking system, and we have certain categories for 24 licensees, assigned as one program code. If you look at the 25 reg analysis you will see a four digit number, that's a rh ( i ANN RILEY & ASSOCIATES, LTD.
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267 1 program code. Me break our licensees into diagnostic or () 2 oncology management program. It's not required diagnostic 3 where everyone is. And RDR use. I mean, there are probably 4 about 15 to 20 different categories a medical-licensee could 5 fall into. So, we used that data to come up with a number. 6 We also need to account for the impact on the 7 agreement states. We used the assumption that there -- we 8 tool the NRC numbers and multiplied it by 2.5 to get the 3 9 number of agreement state licensees. i
- 10 The reg analysis goes section by section through l 11 Part 35. So, if you want to take the time to review it or 12 if there are only sections that you're very much interested i 13 in you can go to that particular section, focus in on that J l
14 and look at it to see if we captured the right information. l
/i I , ( j/ 15 Our analysis considered the cost impacts of the '
16 rule, health and safety implications and the benefits. 17 If you go to the last page of the reg analysis or 18 close to the last page, what you would see is where we l 19 believe that there's a cost savings for this rule. 20 We're estimating that there would be approximately 3 21 $8 million savings to licensees as a result of this rule 22 making. There would also be a cost savings to NRC of 23 approximately $1.6 million. 24 I did not give you a slide on all the details 25 because I didn't want to bog the conversation too much down
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268 1 on those items, but where -- I want to tell you where the 2 big changes are. 3 The first big change is in the quality management 4 program. And we'll discuss this later on today. But we 5 have mention that you're not going to be required -- the 6 quality management program any longer. We're looking at 7 approximately a $6 million savings there. 8 The requirement to not have a radiation safety 9 committee. We're estimating approximately $3 million. 10 In the diagnostic area, it's no longer -- we're 11 proposing that you would not test more than a break through 12 everyday that you'll do the generator. That's about a $1.1 13 million savings. And in the supervision area, for those of 14 you, it's 35.27, we're not requiring that the licensee do () 15 periodical reviews of the individual. That the staff -- we 16 figured that's up to them how they want to review the 17 people. It's roughly a $1.1 million savings in that 18 particular area. 19 Also, as I said, chere are some savings to NRC as i 20 a result of this rule making. The major savings in this 21 area of NRC is also in the quality management area from the 32 standpoint of us not reviewing documentacion at the level i 23 that.we've already been reviewing it.
- 24 Unfortunately, there are some cost increases to 25 licensees as a result of this rule making. And that's why ;
l ("N ANN RILEY & ASSOCIATES, LTD. l (s-) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 i Washington, D.C. 20036 ! (202) 842-0034
269 1 if you add all those numbers up you don't come up with the 2 number that you see up on the slide. 3 One of the biggest areas results from the changes 4 in the training and experience requirements. And this comes 5 about from the requirement for certifying organizations. 6 We also have a requirement that you develop 7 procedures now for the labeling of syringes. We spoke 8 briefly about that yesterday. We're not telling you have to 9 label them any longer, but licensee -- the procedure that 10 says when you are going to need to label them. That's 11 approximately $1 million. 12 There's -- for the organizations that we want to 13 come into NRC to get approval fcr giving an examination, 14 that's around $700,000. And then just in your radiation () 15 protection program, changes that need to be made in that . 16 area because or requirements on the radiation safety 17 officer, you're looking at around $500,000. 18 Looking at all those, if you group those numbers. J l J 19 I didn't bring up the $10,000 or the $60,000 here or there. 20 But it does lower down to the number that you see on the 23 graph. 22 MS. THOMAS: For the training and experience? 23 MS. HANEY: Training and experience approximately 24 $1 million. 25 And as I said, if you would like a detailed -- the O ' \m) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
270 1 documents. Just get to me or anyone on the staff that's 3 () 2 3 back'there, and we will get more detailed information to you. But they are up on the rule making web site associated i 4 with this rule. 4 5 The other item that I wanted to mention or that I
- 6 did mention is the OND package.
7 MR. BAILEY: Cathy, may I ask a question about 8 this -- this slide you have up there? 9 MS. HANEY: Okay. i 10 MR. BAILEY: If -- if it's going to cost NRC and 11 the agreement states $1.6 million less, could we anticipate, 12 then, that that would be a direct saving to the medical i 13 facilities by reduction of licensing fees? 14 MS. HANEY: I'm going to say it's possible. One ( ) 15 would think so. I don't want to say yes or no. But if we 16 can show in our -- that there is a reduction, it should 17 correspond with a reduction in licensing fees. I 18 MR. BAILEY: I would imagine that the agreement 19 states will want to take a close look if we're cutting 20 staff. 21 MS. HANEY: Well, I'll also say from the 22 standpoint of the assumptions. Again, obviously, you need 23 to start'with certain assumptions when you do a document 24 such as this. This assumes that the agreement states would 25 adopt every requirement that is in Part 35. And we know t#}
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271 1 they're not going to do that.
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t 2 So, but that was the basis. We could have gotten 3 into saying, you know, estimating, well 50 percent of the 4 agreement states are going to ask to take this, 50 are not. 5 And that goes beyond what I think we needed to do. So, this 6- is just assuming that NRC and agreement states would just i 7 have an identical Part 35. l 8 DR. LULL: I'm just wondering if these are annual 9 cost savings. What's the time frame? j 10 MS. HANEY: there is a high percentage, probably l 11 about 75 percent of these .90sts are annual savings. There 12 are some percentages of these costs that are a one time 13 shot, especially in the training and experience arena i 14 because, you know, once you come in and get on the NRC's i 15 approved list, you're not going to need to do that again. 16 So, that's why I'm saying that there are some that's a one I i i 17 time shot. 18 The savings for the radiation safety committee is 19 an annual cost. For quali ty management, again, that's one 20 of those ones that's a combination of two. Once you develop 21 the procedures, they're in place. But you're not going to 22 need to maintain records of your recordable procedures any 23 longer. And there's a lot of savings associated with that 24 and that is an annual. 25 MR. BAILEY: It might be nice to break it out as .( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I 272 1 one time versus annual cost savings from the rule. () 2 MR. CAMERON: Cathy, what was your response to the 3 one time versus annual? 4 MS. HANEY: Well, I think what we'll do for the
)
5 Kansas City meeting is break that out, what's one time and 6 what's not one time. The bulk of this is on an annual 7 basis, though. 8 MR. CAMERON: Okay. Are you ready for further 9 questions? 10 MS. HANEY: Let me just go over ONB and then we'll 11 do that. 12 Okay. Now, as I said earlier, the other document 13 we needed to prepare was information on record keeping and 14 reporting burdens on the licensee. l' ( ),/ 15 What we have estimated it to be is that the burden 16 for this rule is approximately $106 million. The current 17 burden -- the current rules burden is estimated to be about 18 $166 million. And that takes into account the burden from 19 QM. I know QM -- the Part associated with QM has been -- 20 generally a lot of discussion with that. So, that is the 21 total. When we had to look at the ONB pt tages to get to 22 that one for the current 35, one for the revision to 35.75 l' 23 and one for the QM. For those that have looked at those 24 documents over the years. 25 So, we're proposing -- what we have sent to ONB is ANN RILEY & ASSOCIATES, LTD.
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273-1 a document that says this rule results in $166 million, () 2 therefore roughly a savings of $60 million. 3 And the majority of the reductions, again, are due 4 to the deletion of the prescriptive requirements in the 5 quality management area and also the reduction of the 6 prescriptive requirements within the rule by giving the 7 licensee more flexibility on how they accomplish a certain 8 task. We are not -- we are not accounting for it in such a 9 high level in the ONB. 10 I know over the years we received a lot of 11 criticism about the numbers that we are using, the hourly. 12 rate, the dollar amount. Unfortunately, we don't have much i 13 flexibility in what the dollar per hour rate that we use to 14 calculate the ONBs as used, X dollars per hours as a rate to r i 15 document it. I think what they're looking at is an 16 averaging. In most cases a technologist is repairing these 17 records and making this report. There are a few that a 18 physician would get involved with. And I believe, in their 19- thinking, that it averages out to -- to this average number 20 -that we use. 21 Again, both of these documents are available and 22 we'll take comment on both of them. And the ONB package did 23 go to ONB and is with their desk officer now. 24 MR. CAMERON: Okay. Great. 25 Let's go to David. l ANN RILEY & ASSOCIATES, LTD. [/
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__-.__._.____________m_ ~ _ ----- - -- - - - - -- - - i l-274 i 1 MR. NEBLETT: I think you answered my question, (') 2 but I just want to make sure that on the web sire we can 3 find out how, for example, the estimated cost for the 4 savings from the radiation safety committee and how do you 5 come up with the costs for a committee meeting, that sort of 6_ thing? 7 MS. HANEY: Yeah. That is -- that's it's in the 8 document. And what you would do is just go to the web site, 9 download the document, look under the particular section, in 10 that case, 35.24. And you would -- you would find the cross 11 savings averaged out. 12 MR. CAMERON: Okay. Terry? 13 MR. FRAZEE: The $1.6 million savings to the NRC 14 and agreement states, what I heard you say was that a C\ 15 decrease in document review? Okay, is this the savings ( ,/ 16 for -- from the licensing review standpoint, or did you 17 include the inspection? 18 MS. HANEY: No, the majority of it is the 19 document -- or actually, all of it is from the licensing 20 review. 21 MR. FRAZEE: Okay. So, the proposed concept is 22 the licensing is not required to submit a procedures form, 23 but the license somehow is going to reflect that licensing 24 has to have the procedures, and therefore it's shifting the 25 burden of review to the inspector in the field. And so, it O ANN RILEY & ASSOCIATES, LTD. b Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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275 l' seems to me that we need to account for what is the cost to ( 2 the inspector in the field in looking at the procedures. 3 And since you're going from what has been a once every five 4 year review of the procedures in the audits and. licensing 5 review to a one, two or three year cycle when the inspector 6 comes through and looking at the program and the program 7 now, including the inspection program, has to include, well, 8 what procedures you have. Are these procedures adequate? 9 Do they meet what the license requires? And so, it's almost 10 you could, in fact, be increasing the burden just on the 11 inspector side. 12 MS. HANEY: Right. We considered that as far as 13 over the last year and we started talking about was this 14 going to result in a change in the enforcement -- I mean, f ( 15 the inspection program. And our current thinking, and 16 again, this is the philosophical approach that we are trying 17 throughout -- from the length of the rule making to the 18 licensing to the inspection -- is the performance-based. 19 We, at this point, see no change in the inspection 20 program as a result of the proposed rule. The inspectors 21 would not be expected to go out and review these procedures l 22 on site. The only time that they would get into looking at 23 procedures was if they sensed a problem in a licensee or if < I 24 they were out investigating a medical event or if they had l 25 an indication that something was wrong. O' ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 _ _ 1
7._. i i 276 ). 1 So, in other words, let me give you an example. i () 2 3 Sometimes that's the best way. l The licensee would have to have a procedure for , 4 daily surveys. The inspector is not going to go out and 5 .say, "Let me see your procedure" if everything looks fine. l 6 But if the inspector goes out and finds -- happens to do > 4 7 some. confirmatory surveys and finds high radiation levels of j' 8 iodine 131, the inspector is probably going to say, "Did you { ) 9 do an I-1_ patient today?" And the licensee is going to say, 2 10 "No. .The last we used iodine was a week ago." And then the j-11 inspector is going to say, "Well, let's look at your l 12 procedure." l 13 Now, if -- if the licensee is not at the point of 14 the iodine -- we're below the directive level on the use of J
-() 15 iodine because then that triggers into another item -- but 1 1
16 assuming that a licensees procedures, their procedures don't ' f- ] 17 say anything about daily surveys, we would walk away at that J ( 18 point. If the licensees procedures, however, say "We're j 19 going to daily surveys whenever iodine is used", then the i 20 inspector would start looking at the item to see if the l 21 procedure. i } 22 So, we are right now -- the philosophic -- again,
;23 I'm giving you a philosophy -- is that we would not change 24 _our inspection program at all.
25 MR. CAMERON: That still sends some skepticism on 1 1 ANN RILEY.& ASSOCIATES, LTD. s_- Court Reporters 1 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034 l l I
277 1 Terry's part. But perhaps that should be addressed in the r 2 division comments or a further discussion around the table. 4 -s( 3 Bob? 4 DR. LULL: Yeah. Just a comment on that. 5 I think that you ought to consider some kind of 6 shift, additional training criterion for inspectors. If you l 7 go to a non-prescriptive-based licensing, when the inspector 8 goes out he's not going to ever checklist, even go down. 9 Inspectors need to know more about what's going on in the 4 1 10 nuclear medical clinical operations and, typically, is found 11 to be the case. It's been about 10 years since I've had NRC
- 12 direct inspectors. But -- and there will be needing to make 1
13 judgement calls which, unless they get some training and 14 knowledge about that, they're not going to be in the (3%
\ ,[ 15 position to do that and I t's going to lead to lots of i
16 problems. And I think we can see some of it already as I
- 17 people are trying to go to non-prescriptive-based licensing 18 generalities, the inspectors aren't keeping up with that. !
19 And so, I think that there's a real need for major 20 changes and it will probably have a cost impact on the 21 organization, because the inspector is going to need to have 22 more generalized knowledge to be able to make judgement 23 calls. 24 Right now there's no need for judgement calls, 25- just coing down, looking at things prescriptively, checking (O
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278 1 off the boxes. () im 2 MS. HANEY: And we have spent a lot of time 3 discussing that at our headquarters office and also with our 4 regional offices about the need to just change the mind set, 5 if you want to call it that, with the license reviewers and 6 also with the inspectors. So, we are planning to do 7 training and education with the inspectors to have them 8 understand this approach. 9 DR. LULL: Beyond -- even more than training and 10 education, they really need to have a certain background 11 level of experience when you hire someone as an inspectol 12 Because, you know, if you had someone who doesn't have a 13 concept of what's going on in the medical facility, you're 14 just going to take an inordinate amount of training and O) (, 15 experience to get them where they can exercise appropriate 16 judgements and not create lots of problems. 17 MS. HANEY: Right, And we will be doing that. 18 The other thing, we've already really started, to 19 a certain extent, this change to go more performance-based 20 in oar inspection program. If you look at the inspection 21 program -- our inspection procedure about a year ago for the 22 medical program it was very much a checklist sort of thing. 23 We, within the last three months, I believe, have issued a 24 new inspection procedure for he medical which go -- which 25 really takes more of a performanca oriented. There are no O. 4%/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
279 1 checklists associated with it. There are about.eight major
.( ) 2 subject areas and that being things like administration, 3 management of the program, dose symmetry, radiation 4 protection program. And the inspectors are supposed to go 5 in at a higher tier and look at it.
6 And again, this is only about three months into 7 it. So, you may not be seeing it. But I think this 8 approach goes more into -- does go into effect into 9 medicine, we'll have to get out there and push the l i 10 performance-based even more. But wa are making slim steps 1 11 towards that now. l 12 MR. CAMERON: So, are we solving the problems that i 13 was raised yesterday and is being raised today that what j 14 good is a performance-based rule to you if the reg guy is n ( ,) 15 very, very detailed, the inspection procedures are very 16 detailed? It seems like from what you're saying, Cathy, is 17 that we have some -- we're trying to get a handle on that? 18 MS. HANEY: Right. We are. 19 MR. CAMERON: And are there any comments on that 20 particular issue? 21 Roy? 22 MS, BROWN: Just a question. If we're in a 23 situation where the regulation and the reg guy are vague and 24 performance oriented rather than very prescriptive, when we 25 get into the compliance portion of it is Joe DelMedico going ~ l\s ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
280 1 to talk about the difference between, you know, how do you [~N 2 expect to -- when you have a very, very vague 3 performance-based -- 4 MR. CAMERON: I was just wondering the came thing. 5 Joe was going to focus on the enforcement. Do you feel 6 ready to talk about this particular issue in terms of 7 inspection license review, or is that more appropriately 8 addressed by Cathy and Diane? It's a question for you, Joe. 9 I don't know what you plan to do in your discussion. 10 MR. DELMEDICO: I think between the three of us. 11 MR. CAMERON: Okay. Joe indicated that the three 12 of you would take care -- take care of that. So, are we 13 ready to -- well, let's go the audience and see if anybody 14 out there has any comments about the cost data that you just ( ) 15 heard about?
'16 Why don't you speak into the microphone?
17 MR. TAHMASSIAN: I really think that from my 18 personal experience of watching what happens when you go 19 from a prescriptive to a more performance-based, the cost 20 shifts from your licensing review to the inspection. And 21 generally it is a much higher cost to the in. ection program 22 then it was in the licensing. 23 And no matter -- I mean, I applaud your attempts 24 to go into the process of, you know, that you are. But , 25 still, there is a criteria that somebody has to reach, ANN RILEY & ASSOCIATES, LTD. l (. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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4 281 1 unless you're hiring somebody to be an inspector who is
) 2 . qualified to be an RSO and has the same qualification 3 criteria as RSO and----in the same basis. The person has to '
- 4. go over the procedures, has to get something, because 5
there's this issue of we're inspecting. And to inspect, I
-have to know what I'm inspecting.
6 So,~if there's something 7' whether you're complying with or not. So, inevitably, no matter how good your inspector 8 9 is,'the cost shifts. So, I think you need to take that into 10 consideration. 11 MS. HANEY: Okay. 12 MR. CAMERON: Okay. Thank you. Anybody else out 13 there in the audience want to make a comment about cost 14" before we get into the --
) 15 MR. HICKMAN: I just wanted to add that I think 16 again expresses what we were just talking about in the 17 previous section. We need to be able to use the -- society.
16 They are trainable. They no what to look at in a program. 39 And I think that needs to be thought of as a potential cost MO saving element before regulation, certainly. 21 MR. CAMERON: Okay. Thank you. David? Anybody? 22 All right. Bob? 23- DR. LULL: I just would point out that this in 24 also going to be a problem for the agreement states. As 25 they go from prescriptive to performance-based, as they O ANN RILEY-& ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
282 1 follow the NRC lead, they will need to deal with their 1 2 inspection program and the quality of the inspectors and 3 their experience. 4 MR. CAMERON: Okay. The quality of inspection, 5 the type of training seems to be an important issue. 6 Let's get Joe DelMedico up here to -- oh. Okay. 7 Roy. 8 MR. BROWN: I'm sorry. Just a brief comment on 9 the cost of inspection. 10 This came up a couple of years ago when the NRC 11 did the study -- and forgive me, I can't remember what the 12 name of it was -- looking at inspections as the byproduct of 13 material facilities. But I think it's important, especially with this change, that the inspection concentrates on 14 () 15 management systems and infrastructure of licensing, not 16 sitting there going through every single survey, every 17 single piece of' paper that goes in the file. 18 And I would be interested in getting Joe's 19 comments on that as well. Looking at management systems and : 20 structure during the inspection, rather than going through i i 21 the paperwork. i l 22 MR. CAMERON: Well, great. Then I think it's time 23 to hear from Joe. Ready? 24 MR. DELMEDICO: Good morning. I mentioned 25 yesterday that there may be a window of opportunity right i O
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283 1 now to effect some change in the enforcement policies. So, ( 2 I'll give a three minute or less overview on that and get 3 those matters out on the table and then perhaps we can 4 discuss some of the issues that have been raised this 5 morning as well. 6 The developments that I'm going to talk about so 7 far have been in the power reactor area, but it's possible 8 that they could be applied to the materials area as well. 9 EVI, which is a group representing owners and 10 operators of power reactors has taken issue with the number 11 and nature of severity level four violations which are being 12 issued. Just to get everyone on the same playing field, 13 severity level four violations are below the level of 14 escalated enforcement. They're defined as more than minor I 15 significance and if left uncorrected could become a 16 significant regulatory issue. 17 As a result of EVI's efforts, the Commission has 18 asked the Staff to examine their processes in this area and 19 to make changes as appropriate. And it's not exactly clear i 20 where these changes will lead. For example, one possibility 21 is that we may do away with severity level four violations 22 altogether. 23 So, I think the question for this group is if 24 these changes are made, should they apply to materials 25 licensees as well as power reactor licensees. And some ANN RILEY & ASSOCIATES, LTD. C) Court Reporters j 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
284 1 would argue not, because there are some significant () 2 3 differences between the reactor and the materials licensing programs. 4 For example, reactors have, by significant NRC 5 requirement, have formal corrective a'ction programs, in 6 which corrective action is generally effected without NRC 7 involvement. In contrast, materials licensees sometimes 8 ' loose track of their corrective action which results in our 9 finding that violations have occurred, have repeated. 10 Violations that we've seen previously on the next inspection 11 have occurred. 12 Another difference is that reactors have resident 13 inspectors and an inspection report is issued at least once 14 a month. And so that allows the inspection reports to (~N () 15 provide a formal retrospective look to assure that 16 corrective action has been effected. By contract, as you 17 know, materials licensees may be inspected more in he 18 frequency of four to five years, depending on the type of 19 program. 20 So, to summarize, the issue is should the 21- enforcement policies for the reactor and the materials area 22 diverge, or should materials licensees have the advantage of 23 any new enforcement policy that is set into place for power 24 reactors. 25 I'll give two practical examples for this. The O ANN RILEY & ASSOCIATES, LTD.
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285 1 first is that severity level four violations may not be , 2
) cited at all if.the licensee identified the issue and has 3 corrective action ~ underway with it in 30 days, post NRC 4- inspection.
5 For example, let's say that a licensee identifies 6 a medical event. .That may prompt a reactive NRC inspection. 7 In that case where the licensee both identified the event 8 and had corrective action in place post NRC inspection, 9 there may not be a citation issued. 10 Another example might be for violations that are 11 cited, that is for 'riolations for which a violation is 12 issued. A formal response to the violation may not be 13 necessary from the licensee if the corrective action is 14 already known to the NRC. () 15 Two examples would be the case of overexpocure or 16 a medical event where a report is required to be made to 17 NRC. The report -- part of the report would deal with 18 corrective action and always has. And so the question has 19 come up, why would ' , then require the liccnsee to go - 20 through the time and effort of preparing a second formal i 21 response to the notice of violation when we already have { 22 l documented information about corrective action. l 23 So, that is what I plan to talk about this l 24 morning. I think at this point, Chip. I 25 MR.. CAMERON: Good. That's -- a I think Cathy has l ANN RILEY & ASSOCIATES, LTD. O' Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 I
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286 1 something to add and we'll go to the group. 2 MS. HANEY:
) What I'd lika to add is that from a 3 specific standpoint. Joe was talking generalities.
4 One of the things that our 35 working group will 5 be doing is looking at the enforcement program for medical 6 licensees. There are -- there is a document called NUREG 7 1600 that describes the NRC's enforcement policy. And it 8 gives examples of what a severity level one, two, three, and 9 four violation would be. I've looked at that and because of 10 the proposed rule we will need to make changes in that 11 document. And that will be done during this next year. And 12 it will probably be following the same sort of philosophy 13 the current document has for things like this. The term 14' " misadministration" will need to go away. The term " quality () 15 management" would need to go away. And in the case where we 16 had deleted records to prescriptive requirements in the 17 rule, we would also need to delete that from the enforcement 18 policy. So, there will be corresponding changes made in 19 that document as a result of the proposed rule making. 20 MR. CAMERON: So, there's two major efforts that 21 we've heard about this morning. One is the -- looking at 22 what sort of qualifications we would have for our inspectors 23 in this area. And that is not something that the working 24 group is looking at. That is an effort that is sort of 25 being done in house in nuclear material safety and , i lT ANN RILEY & ASSOCIATES, LTD. (_,/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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287 1 safeguards? 2 MS. HANEY: Well, the working -- under the
\-s 3
auspices of the working group, we would not get into looking } 4- at the inspector qualifications or the inspection program. 5 .But if I take off my hat as the chair of the working group I 6- become the section leader and the inspection procedures fall 7 under me. j 8 So, in answer to your question, yes. It will get 9 done by the division. ! 1 10 Okay.
- MR. CAMERON: And then there's a second 11 initiative that you just mentioned. And the working group 1 .-
l 12 process in terms of open meetings. If people want to
- 13. observe and see what's being developed, that will continue? l l
F 14 MS. HANEY: Right. (D) 15 MR. CAMERON: Okay. Nell, that's good. 16 Let's start with questions for Joe about the 17 enforcement policy. 18 Bob? 19 DR. LULL: Lest we loose the opportunity to 20 stretch out this opening of licensing criteria which may 21 impact on inspection criteria I would just reaffirm in the 22 context that we established yesterday that what we're doing 23 is we're having the inspections activity that has never, in 24 its history, caused a single death or any injury. And one 25 should really question the need for inspections at all. ANN RILEY & ASSOCIATES, LTD. [~')\
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288 1 MR. CAMERON: Okay. Any comment from the Staff? ("'s 2 MS. HANEY: I guess to say that that's a very good U 3 comment and that we are considering the need for inspection. 4 Where we would probably be looking at it is, yes, is 5 inspection needed or not needed. And where I would expect 6 it to receive a change is more so rather than us coming out 7 every three years we might come out every five years. 8 Our current program allows for an inspector to go 9 out and to find -- if everything is fine and the particular 10 licensee is on a three year frequency they can extend it to l 11 'five or six years, depending on if we're in the low risk 12 area, like the diagnostic area. If you're augmenting using 13 HDRs you can probably only extend it to maybe a two year I 14 period. 15 But the headquarters is looking at the regional [%)\ 16 offices and making sure that they are implementing that 17 criteria of the inspection program. 18 So, again, we're making progress toward reducing 19 the inspection in the low risk areas. We're probably not to 20 the point where, you know, is an inspection needed or not. 21 But we are moving that way. 22 MR. CAMERON: And is that part of the working 23 group examination? 24 MS. HANEY: No. That again falls under -- if I 25 put my section leader hat on -- it falls under the -- just f Q (_f; ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Snite 1014 Washington, D.C. 20036 (202) 842-0034
m .x- .ma._ .m _ 2 m__ m - &a.2 m_ ._ _ m a. - 4 ,, _m. _._..m . a. . 2 4 l l 289 l 1 the overall management of the medical use program. , 1 2 MR. CAMEROM: Okay. ! 1( ) I think it's useful for i people to know what the initiatives are that are being undertaken and in what context. So, I think we've heard , 5 three today already. 6 Roy? 7 MR. BROWN: I have a couple comments, not a 8 question. ! 9 Really, the purpose of inspection and enforcement 10 is to protect the public and employees by getting a licensee 11 to either improve their program or correct the deficiencies. 12 And it really shouldn't be to necessarily penalize the 13 ' licensee. 14 So, I think it would be important to write into r 15 the enforcement policy, at least into the -- you know, in 16 your thinking to try to encourage cooperation. If you're 17 getting cooperation from the licensee to correct any 18 deficiency that you have. .Then enforcement would have the 19 option not to cite. And maybe another way to look at that 20 is to drop all of severity level four violations and take 21 those and instead either make them a comment or write them 22 into the body of inspection and enforcement. 23 MR. CAMERON: Joe, do you want to comment on that 24 either by analogue or -- 25 MR. DELMEDICO: Roy's suggestion is very much l l b\/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
_ _ __.__..______.__._._-._-._._.__.___..____m.._._ 290 1 along the lines of remarks that I was making. And this is () 2 more of the Staff's proposed'right now responses to the , 3 issues that EVI has raised. And so it certainly is on the 4 l table. Any further justification that I can take back to my 4 5 management is, of course, helpful. j 6 MR. BROWN: What is the timing of this? Can we 7 include this in our Part 35 comments or do you need comments 8 more quickly than that? 9 MR. DELMEDICO: Well, Part 35 has what j i 10 relationship to Kansas City? 4 11 MS. HANEY: Well, the comment period for Part 35 12 is open until November 12th. I guess I would question Joe 13 as to when you get into whether there should be severity 1 14 level four violations or not is really outside the world of
) 15 Part 35 rule making. And I would -- would those comments be 16 better directed to DelMedico?
17 MR. DELMEDICO: They certainly could be. CORR has i 18 commented on enforcement policy in the past. And any day 19 between -- starting today would be a fine day to get those 20 comments. 21 MR. BROWN: Who should they be addressed to? a 1 22 MR. DELMEDICO: Mr. Liebermann. 23 MR. CAMERON: Just so that -- for my own purposes, 24 so I can keep track of all of these thingr., we have 1 25 inspector training experience going on -- going on within -- ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1
291 1 in because that's nuclear material safety and safeguard. l p)
- 2 The office of enforcement, represented by Joe
%.) 3 DelMedico, is looking at the issue of whether changes that 1 4 are happening in the reactor area should be trans -- also I 5 translated to the material area. Is that right, Joe? And 6 that's sort of separate from the Part 35 rule making effort. l 7 Okay. i 8 And then we have a working group effort on the ' 9 inspection procedures. Is that the NUREG 1600? j 10 MS. HANEY: Yes, I guess, is the best answer. But 11 part of that is we will look at the enforcement policy from 1 12 the standpoint of how the proposed rule effects it. And in j 13 that we're looking at a specific example of what OE is doing 14 is in the policy level. You could say OE is looking at
/~.
Iy,) 15 policy, the working group is going to be looking at 16 prescriptive examples in the current policy. 17 MR. CAMERON: Okay. So, sort of looking at real 18 world, practical? 19 MS. HANEY: Yes. Yes. 20 MR. CAMERON: In terms of enforcement or 21 inspection? 22 MS. HANEY: Both. 23 MR. CAMERON: Okay. And then there was the -- the 24 other thing that you mentioned, Cathy, that was tied to how 25 often we should be out there? f~D ANN RILEY & ASSOCIATES, LTD. (/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
292 1 MS. HANEY: And that's -- and that's under -- on 2 the division, as compared to the working group. But it is 3 under assessment. 4 But I know one of the concerns would be is doing 5 all these things, and the disjoint that one group would be 6 doing something and an assessment that the other wouldn't be I 7 doing or know about. But, those things get -- l l 8 MR. CAMERON: It seems that they're all sort of ' i 9 tied together. ' 10 MS. HANEY: Yeah, It depends on what hat I wear 11 and what Don's looking at. 12 MR. CAMERON: Okay. Well, I think that if the 13 people in the community know what efforts are going on it 14 would probably help you to try to keep all of those efforts () 15 coordinated. 16 Let's go to Ed and then Melissa. l 17 MR. BAILEY: I guess I have a little bit of 18 concern. We're talking about having the inspectors make 19 essentially more independent judgement out of their own 20 facilities. And at the same time, we're talking about 21 increasing the inspection interval. 22 And I just looked at -- at our state, for 23 instance, where we have about 700 or so medical licensees 24 and we have seven effected regions. So, if we went to five 25 years, for instance, we would only have 20 medical /% ANN RILEY & ASSOCIATES, LTD. ' s/ \ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i 293 I 1 inspections per year in those regions. Now. I think a lot lT 2 of the agreement states would go below 20 medical w - 3 inspections'per year because they would have less than 500 ' 4 medical licensees. And that, to me, does seem to me we're L 5 going to be increasing the expertise of the inspector in 6 familiarity with how hospitals and medicine operate, but 7 having exactly the reverse effect. There is, I hope, some 8 benefit to inspectors going into many different facilities 9 and learning what goes on in a hospital or medical facility. 10 So, I'm a little weary of this idea of increasing L ;11 the length of time between inspections and at the same time 12 placing more independent judgement factors in the hand of I 13 .the inspector when they go to the facilities. I think it's i 14 going to be difficult to increase their level of training () 15 -and at the same time decrease the number of inspections. ! 16 MS. HANEY: Okay. I have a couple of comments on ) 17 that, if I can. 18 The agreement states -- along as the agreement 19 states are bare minimum for -- if you want to say our 20 baseline -- they would always have the option of inspecting 21- on.a more frequent basis. 22 And then the other comment would be is this idea 23 of increasing the inspection interval for good performers 24 has really been in NRC procedures for several years. What 25 we are really starting to look at because of the FTE -- how i f -ANN RILEY & ASSOCIATES, LTD. L . Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
294 1 people are looking at the FTEs and the materials program, () v 2 that is this actually being implemented in the regions and 3 to what extent is it being implemented. 4 So, the last, you know, maybe year -- and we can 5 probably provide a better time frame than that -- that we're 6 starting to look at this a little bit more closely. Are the 7 regions actually implementing this policy of extending for 8 good performance. 9 And then we do also have to counter it. That it 10 we do have a poor performer, we reduce the inspection. We 11 would go out more frequently. 12 But the comment that you brought up aPout if the 13 inspectors are not out there more frequently then, you know, 14 d.ey're not seeing as many sites, is a good comment. O) (, 15 MR. BAILEY: Just getting back to a little bit on 16 what you said. I know we can inspect more frequently than 17 you do, but I will tell you that there are people who count 18 dollars in beans who will say, "All you've got to do is meet 19 the NRC inspection interval. Why do you -- why do you want 20 to do it more frequently than they do it?" And it becomt 21 very difficult, in reality, to have a program that does more' 22 frequent inspections, just monetary standard. 23 MR. CAMERON: Melissa? 24 MS. MARTIN: I would just like to come back to I 25 think sort of an overall philosophy of what we talked about i I (} (_/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
295 1 this morning. You're talking -- I think we're eventually () 2 going to get-to these emerging technologies and if you're -- 3 what is coming out for discussion hopefully today is very 4 - important emerging technologies. You're talking about 5 training of inspectors. And I think it's going to be 6 absolutely crucial to identify what recognition of these 7 accreditation bodies standards, particularly when you're 8 dealing with new technologies. 9 I think -- I don't see how you're going to train 10 and inspect the agreement states to train all the inspectors 11 to the level of expertise that they would actually need to 12 inspect in etail some of these programs unless you can 13 absolutely 3 quire. I think somebody made the statement, 14 unless evt. inspector is qualified to be an RSO. O' 15 ( ,/ You're looking at a very different training. And 16 so I think you have to develop your philosophies on a 17 management review level and assume, at that point, your 18 inspection program at that point, that does the facility 19 have these programs in place. Not so much do -- does every 20 inspector have to know every detail of the program. But I 21 don't think it's going to happen. 22 MR. CAMERON: Okay. And that's a good point. j 23 Nikki? 24 MS. HOBSON: I've been sitting here kind of ; 25 hesitating to display my vast ignorance on these -- on these ANN RILEY & ASSOCIATES, LTD. \ Court Reporters 1025 Connecticut ~ Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 I
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I i 296 1 subjects. () 2 But just from -- enlighten me. On a historical
- 3. basis, did the regulation of the medical uses of isotopes, 4 did that come out of the power reactor regulation? That 5 scheme? Was it intended to kind of shadow that? And if so, I 6 why? It seems to me we're talking about two different 7 animals. I guess the answer to the question is did it come 1
1 8 out of power reactor regulation scheme? 9 MR. DELMEDICO: I don't believe that it did. When 10 you speak of regulation you're speaking of licensing and 11 rule making and so on. And those two have, you know, grown l 12 up together. The Commission has the responsibility for 13 both. 14 However, up until this point, as far as an 15 enforcement policy there has been one policy. Now, it's had 16 provisions in it for various types of activities. Fines, 17 for example, in the nuclear medicine area are in the $1,000 18 to $2,000 range whereas fines for a power reactor are in the 19 $100,000. And there are examples in the enforcement policy 20 of violations for different types of activities. There's a 21 .section that gives guidance to the staff on the severity 22 level of violations at a reactor facility. It's very 23 different from the section in the policy that gives guidance 24 to the staff on violation in, let's say, the nuclear 25 medicine. (# ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
297 1 MS. HOBSON: .I think you can -- you can kind of f) J 2 understand from a patient's perspective that if you are, you 3- know, imposing kind of the regulatory framework, even on a 4 lesser level, the power reactor industry -- the medical 5 activities, it seems sort of inappropriate and maybe 6 overkill. And that's -- and I understand it. I don't have 7 your expertise. But that's sort of my impression, what I 8 heard talked about. 9 MS. HANEY: I think when Joe and I referenced the 10 reactor program, at the Commission level they're looking for 11 consistency, a certain baseline of consistency between how 12 we can regulate and protect the public. And i'n the 13 radiation safety area you're looking at our requirements in 14 Part 20 which are the dose limits.
-() 15 The Commission is saying, "We don't care how the 16 public gets this 100 milligram, whether they're standing 17 outside a nuclear medicine department or they're standing 18 outside a reactor, the dose limit to that individual would 19 be 100 milligram."
20 And at that point, then we're looking at the 21 specifics of the program. The reactors have their world and 22 they look at the specifics of how they regulate a reactor. 23 Then you go to the materials program, which is where 24 inspection and enforcement and licensing and rule making for 25 the medical program falls under. i (
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298 1 And we have our own -- what we call just our ("'s 2 program for regulating the medical uses of isotopes. And O 3 there are -- we have separate procedures with separate 4 policies. And then we go to inspection procedures, 5 licensing procedures, guidance document. 6 But once you start hitting the high tier of the 7 policy, we want to -- there is some uniformity consistency 8 between the two programs. But in the level that we're 9 talking for the rule making and for how frequently we 10 inspect and for how we handle licensing and how we handle 11 inspection, it is solely the medical program. 12 MS, HOBSON: Well, if you're talking about level 13 four violation -- and I don't have a clue as to what it is, 14 although it sounds from your description, Joe, like at a f" V
) 15 nuclear power plant this might be something that would, you 16 know, lead to a nuclear meltdown, I don't know -- how --
17 would you ever find that similar situation in a medical 18 situation? 19 MS. HANEY: I guess, let me just say -- may I say 20 something? 21 From the standpoint of the policy, there are four 22 severity levels, one being the highest and four being the 23 lowest. The severity level four violations would not result 24 in a meltdown. 25 Where the similarities come about would be a ("'s ANN RILEY & ASSOCIATES, LTD. (,,) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 , (202) 842-0034
299 1 severity level one, where a death resulted from an event. (~} 2 You can have -- you could have a death resulting from a (_- 3 power plant, you can also have a death resulting from misuse 4 of material in a medical setting. It's much less -- it's 5 really unlikely that it's going to happen at a medical 6 environment, but the policy is set up such to address that 7 if it were to happen. 8 MR. CAMERON: Joe, do you want to elaborate on 9 that? I don't want -- maybe your -- to make too fine a I 10 point between thiF FCnnection between reactors and 11 materials. i
)
12 MR. DELMEDICO: Well, I guess I would only add l 13 that this is the reason that there are various activities l 14 down in the policy. There's guic'ance for the various ; .()- 15 activities as far as what types of violations constitute i 16 what severity levels. So that basically'chere is a 17 distinction being made. 18 MR. CAMERON: And since all of these issues that 19 we're talking about are all sort of a piece with the new 20 regulatory philosophy for Part 35, will there be any 21 discussion in the supplementary information of the final l 22 rule about how the inspection, enforcement, license review 23 policy may be -- may be changing to reflect all of this? 24 MS. HANEY: Yes, we will have some comment on 25 that. I would expect that we will be receiving a
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300 J 1 .significant number of public comments on enforcement,
~2 licensing, things like that in response to the proposed 3 rule. And just under our procedures we would need to 4 address-all those comments in the final rule making.
5 If your looking for information on this in the 6 packages and the binders that you have right now, if you'll 7 look at the SECY paper 98.128, it's just about five pages 4 8 long, you don't need to get into the closures, there's a 9 brief discussion there on this change in the licensing 4 10 philosophy. That ties into the NUREG document, the orange 11 document. If you start looking through that you'll see that 12 you don't need to be submitting as many documents to us. 13 There's not a whole lot of discussion in what you 14 have right now about the enforcement program, although we () 15 did receive comments on the enforcement program during the 16 early input stages. But I would expect in the final rule 17 that we will have some discussion on that. 18 MR. CAMERON: Okay. Good. 19 David? 20 MR. NEBLETT: May I make a comment to Nikki? 21 Unfortunately, I believe that there is an analogue of 22 nuclear power standards being applied in the medical 23 community. Because the medical community is not a single 24 community. The short term biological effects that occur in
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25 radiation oncology can lead to death and have in an ("'i ANN RILEY & ASSOCIATES, LTD.
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i l 301 1 embarrassing number of cases. Those regulations covering () 2 those situations are necessary for the public benefit. i
-3 Those regulations that cover short term biological events do 4- not apply to the long term genetic biologic effects of 5 diagnostic procedures. And it is really inconsistent to be L
l 6 saying that 10 percent of a dose in a therapeutic range and l 7 a regulation that was caused by a therapeutic event should l 8 apply as a misadministration in a diagnostic range. Because l ! 9 10 percent is inconsequential in that the incidents don't 10 even measure at that level, in fact. 11 So, this dichotomy of one set of rules applying i 12 for biological effects that can cause death do not apply in 13 this diagnostic range of what's going to happen to the next ! 14 generation. And risk, although it was yesterday's topic, () 15 needs to be quantified such so that these rules can be 16 applied to risk. And to be quantified means that somebody's 17 got to be brave enough to lay them on the table and say, 18 "This is an event of death. This is an event of morbidity. 19 And this is a biological, long term event" and separate the 20 regulations on that kind of risk separation. 21 MR. CAMERON: Thank you, David. 22 Cathy, do you have any comment on that particular 23 issue? 24 MS. HANEY: No. 25' MR. CAMERON: Okay. Don, did you want to add some l ANN RILEY & ASSOCIATES, LTD. l
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302 1 clarifications about what's happening at the Commission on
/"'T 2 some of these issues?
LJ 3 DR. COOL: Yeah. Having listened from the back of l 4 the room for a few minutes, I think a couple of things that ! 5 you need to focus on both in terms of what may look like 6 just an enormous number of things that are happening may or 7 may not be connected in some way and then some of the time 8 frames. l 9 We have a series of things that are happening l 10 related to the specific revisions of Part 35 medical 1 11 regulations. And we're looking at specific issues 12 associated with licensing and with the approach we take to 13 . licensing. And specific issues associated with inspection 14 and the approach we take to inspection for this particular g/~~N 15 category of licensees. 16 More generally, we have ongoing efforts to look at 17_ how we conduct licensing and how we conduct inspection, 18 which has resulted in the last year in some changes to the 19 various inspection procedures and inspections angles which I 20 have which provides flexibility in increasing or decreasing 21 inspection time, has looked at some of those issues. That's 22 the second thing we talked about. 23 The third thing which is happening, which is at 24 the one quarter or higher level, is that the Commission 25 itself is looking at trying to respond to some of the ANN RILEY & ASSOCIATES, LTD. O) 2 i \s, Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 2 (202) 842-0034
303 i i pressures it's been receiving in the industry and in 2 [ Congress. Most of that pressure has been from the reactor 3 side of the house, but nevertheless, any influences in terms . 4 of general program directions are going to influence, in 5 some respect, all these other kinds of issues. 6 And so as a result of the series of Congressional 7 hearings and actions that have happened over the last month
-8 or'two, there are a series of activities now underway with 9 the Commission and the Commission Staff. One of the 10 focusses, there are about seven major areas that the 1
11 chairman specifically directed the Staff to look at between I ^ 12 now and Christmas. 13 One of those areas is enforcement. And that is 14- what opens up the window of opportunity,-the medical was () 15 referring to. And some fundamental re-examinations of how I 16 we will write some of those violations. Whether or not 17 there will-be severity level four as a heading. Very basic, 18 programmatic issue Because the Commission has asked us tc 19 look fundamentally at the whole enforcement program as an 20 arena. And that has a much shorter time frame than this 21 revision of Part 35 because, quite frankly, the Commission 22 expects that we will have a fundamental change program in 23 place by the end of this year. 24 So comments and suggestions of some of the things 25 Roy's been looking at others, associated with the
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- 2 not incorporation into a licensees action tracking system or i
3 follow up. We really need to have those over a very short ' 4 period of time. If you wait until November it's going to be 5 .too late to influence those. Those will already be 6 hardening down, especially with the Commission expecting a 7 .that it will go back down to the capital building in } 8 January. We will be able to say, "This is the area we { [ 9 looked at,- Here are the changes that are in place. They are ! 10 now operational." 1 11 So, if you have comments on that broad topic in a 12 particular area of enforcement, that window of opportunity 13 is very small. I would suggest the next few weeks to really s i 4 14 have any significant influence. I know the office of , t s } 15 enforcement will be working with us and the reactor people 16 are moving very quickly about what an alternative policy l I 117 would look like. And I just wanted to make sure that the , 16 record was clear for each of you what the relationship was i [ 19 and the time frame. 4 !- 12 0 MR. CAMERON: How do people-get their comments to 21' the right place and what.do-they reference what.their i
- 4. 22 comment on?-
4 F 23 DR. COOL: I think that as Joe DelMedico , 1 j- 24 indicated, if you've got comments to rel.ay about this j
- = 25 enforcement program, address those to Mr. Jim Liebermann, 7
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305 1 who is the director of the office of enforcement. 1 ( 2
) Certainly feel free -- in fact, I think I would 3 encourage you to copy myself or Cathy so that we, as a I 4 program, also are aware of those and can then know what l
5 pieces of information are available. Because it helps if it l 6 does work closely with Mr. Liebermann or not, in terms of 7 trying to put together these programs. 8 In terms of referencing why did you get into this. 9 Reference the fact that it was discussed in this meeting and 10 reference the ongoing actions as the result of the 11 Congressional hearings in late July. That should be 12 sufficient. 13 The internal language would be a simple reference 14 to the current chairman's tasking memorandum. I -- that, I () 15 don't believe, is a public document. It's a work in j 16 progress and they will be considered as predecisional. But 17 just, for everyone's awareness, that whole series of 18 activities is going on. 19 I'm not sure that there was anyone from the 20 materials cype of community who participated in the 21 Commission open stakeholder meeting July 27th or the 28th, 22 8 where a number of these things were also discussed. That's 23 another point of reference. The transcript for that should 24 be publicly available if you wanted to go look into that. 25 Other questions I can help you with, f ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Seite 1014 Washington, D.C. 20036 (202) 842-0034
. ~. - - . . . . . . . _. . - . ~ . - - . . _ . l 306 , 1 MR. CAMERON: Okay. Thanks, Don. - O 2 Terry? O 3 MR. FRAZEE: It's my understanding that it's the 4 reactor side, the reactor folks that were really upset about , 5 is severity level four issue and a huge increase in the i l l 6 number of level four violations and that's sort of got us l 7 into it, or got them into it. 8 But I guess I'm still not clear on how that i 9 relates to the medical, the materials side. Was there a 10 similar increase in the number of severity fours that would, 11 you know, raise flags, or is this jurt an opportunity? And 12 if it's just an opportunity, what kind 13 of -- what would be the impact on the medical -- the 14 material side, given item one compliarice or somOthing, some () 15 issues that's been brought up? What would happen to it? 16 Would it just not be cited, would it be translated into a
-17 severity level three or why should we be concerned?
18 DR. COOL: You've got about four questions there. 19 Let me try. Hopefully, Joe was also listening, so he can 20 pick up the ones that I forget. 21 I do not believe that the same sort of trend in 22 terms of an escalation of the number of a particular 23 enforcement of a severity level fours has occurred in the 24 materials side of the house. 25 You are correct. This piece of it is being driven [\-') ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
307 1 by a specific comment put directly to the Commission -- into 2 Congress then reflecting into the Commission, from the power (v) 3 reactor committee, the nuclear power industry. 1 4 Therefore, this in one sense constitutes more of ' 5 an opportunity rather than a particular drive through I 6 (phonetic) on the medical program or the materials program 7 for all. 8 However, it's an opportunity to be careful of, 4 9 because any time you go to start to look at a fundamental ' 10 structure of the program, that will inevitably, sooner or 11 lator, to a great or lesser extent, have an influence on the 12 materials pr.rt of the program, because the Agency looks at a 13 consistent approach in the various arenas. 14 So, if this constitutes mischief for some () 15 particular reason that's also a very important comment, just 16 as much as, yes, we think you should do this. Again, the l 17 thing I mentioned yesterday, both sides of the house. If 18 walking away from it doesn't makes sense, and it might well 19 not make sense because it's driven in the context of our 20 reactors having specified the required licensee corrective 21 action systems, which forms an alternative not present for 22 the most part from materials in medical facilities. 23 But then that comment needs to be vague in order 24 for the mischief - I'd put that in quotes, if you would -- 25 of having do the likewise result in changes which might not h A ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 26036 (202) 842-0034
308 1 be appropriate.
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( ) 2 MR. CAMERON: Okay. Thanks. 'J 3 Joe, do you want to add anything to that? I think' 4 we probably need to close down for a break soon. 5 MR. DELMEDICO: Terry asked about the practical 6 effect and I think the two most important points I tried to 7 touch on. l 8 There would be a greater premium placed on ! l 9 licensee identification and corrective action. And in those l l 10 cases there is the possibility, at least, that severity j 11 level four violations would not be cited at all. 12 And then secondly, there may be additional types 1 13 of violations in which even though a Notice of Violation was 14 issued, a formal response from the licensee, which we t'n, !, ,) 15 understand to involve some resources, would not be required, 16 because corrective action is already known the through the 17 Agency in one form or another. 18 MR. CAMERON: Okay. Thank you. Before we wrap p 19 for a break, we might as well try to deal with this topic 20 that's in the paddock here and I'm going to be adding one 21 topic up here also, the situation where manual 22 brachytherapy, where the dose may differ from the 23 prescription by much more than 20 percent. We will get to a 24 discussion of that and I'll add it up here. 25 Joe, suggestion was made yesterday is there any fT '% I ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
309 1 room for peer review in the enforcement section? We sort of () 2 3 dabbled on the use of alternative dispute resolution in the enforcement area. I really haven't gotten much off the 4 ground there, but this idea sort of falls into that 5 category. What are your thoughts on this particular idehi 6 And also, I've heard something about using some of 7 the -- the professional societies in the inspection area. A 8 point Bob Lull made this morning. And I think that's going ; 9 to be -- before we get into Charles Showalter's efforts. 10 But that -- what about this peer review enforcement issue? 11 MR. DELMEDICO: I think the comment came up in the 12 context of a medical event. And there is, at present time, 13 some form of peer review in that -- in what are now called 14 misadministrations -- are lcoked at by an NRC medical (O) 15 consultant, an MD consultant. And part of the issue 16 yesterday was whether or not there might be some clinical 17 effect. And that's taken into account in the severity 18 levels in the enforcement policy. In general terms, an 19 isolated -- what is now called misadministration -- without 20 clinical effect would, if it were cited at all, would be 21 cited at the severity level four level, which is a level 22 below escalated enforcement. 23 I guess I also need to clarify that, of course, a 24 misadministration in and of itself is not a violation. At 25 some times there associated procedural violations that are f\ ANN RILEY & ASSOCIATES, LTD. s Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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310 1 cited, and that's how we get into the severity levels.
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2 I think on that subject of additional peer review 3 we should keep an open mind at this point and be open to 4 suggestions. I don't have any conclusions. 5 MR. CAMERON: And would it be appropriate if 6 people wanted to say just things like that? Don, that could 7 raise these comments in the -- comments on the proposal? 8 MR. DELMEDICO: Certainly. 9 MR. CAMERON: Okay. Great. 10 Anybody in the office, now? 11 Go ahead. Why don't you state your name again? 12 MR. TAHMASSIAN: My name is Ara Tahmassian. Now, 13 I can speak of this particular issue on behalf of myself and 14 about 28 campuses from the UC and California State 15 University systems. I think that you are wrongly thinking 16 that by decreasing the frequency of the inspections from t 17 four years to six years, you are addressing our problems. 18 It's not inspection frequency that we object to by is .large. It's the inspection, what happens during inspection. ] 20 Most of us annually call upon each other to go out' 21 and do peer reviews and sort of review each other's 22' programs. We want to find out the problems before it 23 becomes a major problem, l 24 What we object is when an inspector comes in -- 25 whether it's an NRC inspector, whether it's a state
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311 1 incpector it doesn't matter -- goes through the program -- 2
} Melissa talks about the philosophy of inspecting the 3 management. Do you have, say, an instrument calibration 4 program? Yes. What is it is? Describe it. How does it 5 work? How do ycu find that instrument in the past year?
6 How do you catch it? You go through all of it and there's t 7 nothing wrong with it. Then they go through 2,725 ' 8 inspection reports and issue three instances of violation 9 which were instruments -- three types -- 3,000 instruments \ 10 were late by one or two days. I And it now becomes three. l 11 That's what's wrong with it. 12 So, I think that to say that if we can do it in 2 13 three year instead of five year, it doesn't make any 14 difference to us. Instead, look at the management. You i g-sg 15 I ( ) know, the big picture. What happens if an instrument is 16 late by one day? Or what happens if instead of once a year i i 17 I take three measurements from a dose calibrater and average 18 that instead of if I take daily. You know, what is more 19 important for the safety? Do I have the methods? And I 20 think that is absolutely important. { 21 So, as we move into this new philosophy, you focus ! 22 on the management. Now, if you see the management is not 23 being there, then you dig into the next layer of, you know, 24 sort of detail. 25 MR. CAMERON: Okay. That sounds like -- is that ANN RILEY & ASSOCIATES, LTD. {)) s_ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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312 4 1 food for thought for the working group effort?
/~N 2 .Okay. Good. Let's take E. break and come back at 3 11:00 o' clock, So, that's a good long break so make sure 4 you're back here on time.
5 [ Discussion off the record.] 6 MR. CAMERON: As I mentioned before, we're going , 7 to move into a discussion of emerging technologies and how 8 the proposed rule deals with that. And in a minute I'm 9 going to ask Don Cool to tee that up, so to speak, for us. 10 He might play all 18 holes, unfortunately, but I'll stop him 11 if he tries to do more of anything than a tee up of it. ' 12 If you'd look at your agenda we were going to 13 start off with a discussion of the specific aspect of the 14 rule with medical policies statement. In order to get to 1
-15 the specific provisions of Part 35 we're going to do the --
16 we're going to save the medical policy statement and try to 17 get to it at the -- at the end of the day. We've already , 18 had some discussion of'it. And the previous issue, is it 19 consistent with the -- it may not be a good issue, but is it 20 consistent with the proposed rule which is related to the 21 whole idea of does the Agency adhere to the medical policy
)
22 statement? 23 We'll try to get to that later, but what I'd like 24 to do is do emerging technologies and then maybe we can get 25 started on' training, the experience. And we have a number
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l 313 i 1 of paddock issues, a few that we will get to today too. l 2 So, I'm trying to talk about sort of the context f')/
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3 for emerging technology. I 4 DR. COOL: Thank you, Chip. 5 When Chip told me he wanted me to tee this up I 6 j told him I brought along my big broken driver. 7 But just in very brief, the concept of an emerging 8 technology section in the regulation goes back several years 9 in our discussions, trying to figure out a way in which we 10 could build a more flexible rule, a rule that would allow us l 11 l to start looking at a new kind, a particular approach, 12 particular kinds of devices or activities. 13 Well, they were in the early stages of development 14 periods. Experimental. Everyone trying to figure out r~N i s_-) 15 exactly how it was going to be done, what were the critical 16 things related to safety in that particular arena. 17 So, what you have in the proposed rule is a i 18 specific subpart to deal with and has been titled, " Emerging 19 technologies." That is, I think, probably the only place in 20 the rule where there more things required to be submitted. 21 If we were to look for each individual case we would expect 22 the number of cases or applications to be small. 23 To address all the particular issues related to 24 radiation safety and control and critical factors because of 25 the experimental, more uncertainty, continually evolving and [ ANN RILEY 6 ASSOCIATES, LTD.
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l 314 1 changing nature of that particular -- in that particular (-) 2 area. l 3 Having said that and looked at that, that perhaps I 4 is kind of an attractive thing to propose. You have more ! 5 flexibility. The rules specify as having a more fundamental 6 level. And it leaves much more to the license application 7 and approval part of the process and particular details, e 8 That, of course, also has its downside. And
- 9 there's a little give and take. It might take a Jittle bit g 10 longer to try and sort those things out. Some of those 11 sorts of things.
12 And it raises a couple of questions which I would 13 like to set on the table as part of this. Because it's not 14 maybe only to me, obvious at exactly what point you would O
\ ,/ 15 transition from uses under emerging technology and a sort of 16 license specific consideration to use under either one of 17 the existing sections of the rule, dealing with a particular 18 category, or the creation of a rule, moving to a new arena.
19 For example, should it key to when things are 20- being done or not in the transition from FDA IND approval or 21 some other kinds of situations. To what extent should the 22 Commission use, in the review process of that general set of 23 criteria. The more specific sets of things that are 2 coked 24 for in similar kinds of activity, as it reviews the license 25 specific application. To what extent do you even consider [ ANN RILEY & ASSOCIATES, LTD.
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315 1 an emerging technology, that which is taking a somewhat ( 2 existing approach and simply applying it in a new way or to 3 a new' location? 4 So, those are at least three sorts of things that 5 I'm particularly interested in in this particular arena. 6 And I know we have a number of folks here who are 7 particularly interested in it because there is at least one 8 modality which some folks have suggested should perhaps, 9 possibly, be licensed under the emerging technology. That 10 is the intervascular brachytherapy developments that are 11 going on there. 12 The criteria I just talked about, well, yes, it's 13 still being done under IND, still investigational. Just a 14 number of things that are being looked at and some (G,) 15 differences. People sort of jockeying around. Even 16 figuring out what kinds of isotopes in any kind of formal 17 sources, what kind of transport mechanism, and a variety of 18 things. So, that maybe lends support to saying we should be 19 over in this category. 20 On the other hand, if you stand back and look at 4 21 it from another perspective, it sort of looks and cracks 22 like a brachytherapy, but using maybe a slightly different 23 system, but it still is a source of other point type 24 considerations. Maybe not a traditional HDR in terms of 25 being really high does, but fairly significant dose. It's ANN RILEY & ASSOCIATES, LTD. s- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
_ __ _ ___._ _._ __.______________.._.._-.._.________.m _. . 316 1 dependant upon positioning. It's dependant upon retraction.
- 2 So, there's a number of things which look very similar to 3 existing brachytherapy, so maybe it should just be looked at 4
within the context of existing regulations which are already 5 in place for brachytherapy. 6 With that as sort of the context and sort of the 7 dilemmas we're facing, I would be particularly interested in 8 people's views as.to how we both be into and out of an 9 emerging technology arena. What gets you into there, what 10 pulls you back out, and to what extent should the staff look 4 11 to things like, in this particular context, the regulations 12 and uses and industry standards already existing for 13 brachytherapy to review the license specific application if, 14 capital letters, it were to be applied, under emerging [)
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15 technology though. l 16 MR. CAMERON: Okay. Thanks, Don. 17 Before we get into the discussion, I would be 18 remiss if I didn't identify that we have one new addition to 19 the panel. And I would ask Dr. -- is it Botvinick -- if you 20 could just. tell us a little bit about yourself? 21 MR. BOTVINICK: First of all I just want to say 22 what a pleasure it is to be here to represent the American 23 Society of Nuclear Cardiology, and the American College of 24 Cardiology. And about me, I was initially in cardiology and 25 came to nuclear medicine when the field was kind of opening
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317 1 up as diagnostic imaging method applied to cardiology in the 2
) early '70s when I was doing my fellowship in cardiology.
3 I'm now fully trained in bo*.h areas and I'm 4 someone who is well versed in practices of both. So, on one 5 night I might be called upon to see somebody with ST 6 elevations and treatment -- and the next night I might be 7 called in to look at a GI bleed study with a nuclear 8 medicine imaging study. 9 And I think maybe one reason I was asked to come 10 was because I speak kind of with certain knowledge of both 11 sides of the issue. I was trained in both areas. 12 I have to say, one thing I want to be a part of. 13 About 10 or 15 years ago I was invited to be a 14 representative of the ACC at an NRC meeting back east. And () 15 I do remember going up to the building and asking my escort, 16 "What floor is the NRC is it on?" And he said, "No, it's 17 not one floor. It's the whole building." I said, "My 18 goodness. The whole building. These people really do a lot 19 of regulation." 20 And I felt especially in my area one of the real 21 needs was to get people who were enthusiastic and capable i l 22 into the practice of nuclear cardiology. And it was clearly ' 23 at that time that the regulations were very intrusive on 24 that. It was really difficult or impossible to get certain 25 people who were in certain specialties involved. And, in 1 (~' ANN RILEY & ASSOCIATES, LTD. ( Court Raporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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318 1 fact, I have to speak frankly, I think there are people with 2 vested interet;t that want it that way. 3 And so'I welcome this turn, this consideration of 1 4 the possibility of lessening the really paralytic training-l 5 requirements for clinical nuclear cardiology. And I'm . 6 basically here to support that proposed regulation to reduce 7 training requirements. And to tell you, we will in some 8 detail, but to tell you that both societies and all their 9 members support strongly, are very willing and able to 10 foster and support training physicians in nuclear cardiology 11 and, in fact, have already implemented. For many years, in 12 fact, the ACC has fostered training and regulation safety. 13 As you know, there's already radiation, use of radiation, 14 use of X-ray, particularly, work and that the new society, () 15 nuclear cardiology, has an examination that they give which 16 is about 25 percent radiation safety and nuclear medicine 17 physics, and can basically be expanded to accommodate any i i 18 further need. But it's something we take very seriously, i 19 that is, radiation safety and the knowledge of nuclear 20 medicine physics. 21 We just simply want to administer everything in a 22 practical way so that we can not only assure radiation 23 safety in practice, but deliver this methodology for the l 24 betterment of all patients. 25 I think maybe I'll stop there. 4 l ANN RILEY & ASSOCIATES, LTD. O- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.-20036 (202) 842-0034
_. __..-._._.;_,_____..._,__._____.......-. .____._.___m.__ < l 319 1 MR. CAMERON: Well, thank you for those thoughts. () 2 3' You probably could just make a note that we have two buildings. l t 4 I think you came at a very auspicious time in the l I
- 5 program. We are going to -- as Don laid out a talk about 2
6 emerging technologies and then move into the training and e
- 7 experience requirements.
l 8 I think, as you can see, people have turned their l 9 \ name tags -- tents up if they want to talk. That's the way l l 10 we've been doing it. Very simple ground rule. 11 And let's go to -- to Rich. 12 DR. HEUSER: Thanks. Basically I'm going to i' 13 reiterate what I mentioned yesterday. And I'd like-to also 14 have Doctors Faxon and Forester talk about the came issue. i (A,) 15 Because, again, I'm a practicing cardiologist and also I 16 . represent the American College of Cardiology. And in terms 17' of-angioplasty or brachytherapy we really feel it should be 18 in an-emerging technology section. 19 As I mentioned yesterday, it's -- I was a little 20- surprised that the NRC would be even considering guidelines 21 for something that's clearly investigational. 'And this is 22 an investigation study for two aspects. I mean, some of the 23 technology is still fairly new. Stint technology is still 24 fairly new. And_in terms of its application in the coronary 25 or master tree, we don't know. Some of the studies are very O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
320 l 1 encouraging. And certainly since recent analysis, as I I~ mentioned yesterday, is a continued problem. If this really
' v) 2 3 makes an impact it will make an impact that can be dramatic.
4 There are so many different -- forms for therapy, l 5 different sources, that we feel at this time it's a little 6 premature to establish any specific training and experience
'7 for a regulatory agency at this time.
)
S On the other hand, when we get further along in ! l 9 the approval process and it looks as if we could be more ' 10 focussed, absolutely this is the right forum, along with an 11 interested society, through the medical physicists, 12 radiation oncologists and American College as well as the 13 other societies, I think that this has got to be 14 established. (/ 15 I think that we have also been involved, as was 16 mentioned, about the training of radiation safety is 17 continuing through the American College and American Board, I . 18 internal medicine, through certain occasion for 19 interventional cardiology. And important part of that will 20 be radiation safety. So, it's not that we're neglecting it 21 now. But right now feel that vascular brachytherapy should
.2 be in emerging technology.
23 MR. CAMERON: Okay. Thank you. Let's go to your 24 colleague, David. 25 DR. FAXON: Thanks very much. O
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t 321 1 I'm not going to say a whole lot. I'll expand a (I') 2 little bit on a couple of points that Rich made. U 3 I have a list here and I don't know whether it's 4 appropriate to'give it to you all or have it part of the 5 record, which is a list of the ongoing and past settings in 6 intervascular brachytherapy. There are 27. Two are missing 7 from this lost. But I'll give you the ones we had. If you 8 can pass that down, if you'd like to have that. Great. 9 Thank you. 10 And it's a field that is moving so incredibly fast 11 that it's almost hard for those of us who are involved in
- 12 this to keep up. At the last meeting I was at there were 16
[ 13 different companies that are -- have the license. I expect 14 that at the next meeting that I go to that will be probably 3 15 double that. 4 16 And the devices range incredibly from one another. 17 Some devices are true aqualiters (phonetic) of high dose 18 sources or opthotabular (phonetic) sources. Others are 19 liquid balloons with 3188 as the source. So, you're going 20 from a very high dose source to extreme low dose source, 21 from beta to gamma. You're going from those removable 22 sources to stint technology with various radiation sources. 23 So, the myriad of things that are being studied 24 are enormous. And which one is going to be the right one or 25 the popular one is the best one is completely unknown. This 4 4 5 gG ANN RILEY & ASSOCIATES, LTD.
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322 1 1 is all a very experimental procedure at the moment. [;
%s 2 What we do know is that in 55 patients, randomized 3 trial, 26 in one group, 27 in the other, there was a 4 significant difference between them. That's our knowledge 5 base. Now, there is anecdotal experience in a registry of 6 about 200 patients that give us hope that this is a very 7 useful technique.
8 I think it's entirely possible and reasonable for 9 a scientist to say, "This may not work." That these 10 randamized trials right now won't work. So, to make a 11 regulation -- seems -- seems -- not reasonable at this 12 point. 13 The other side of the coin, as one might argue, 14 "Well, why don't we leave it the way the regulation is n (u/ ) 15 currently written because that's a safe way to go." The 16 fact of the matter is it may not be the best way to go. 17 Because if it does work and the source itself is a very 18 safe, low risk radiation source, a beta source, it may be 19 more practical, cost effective and efficient to have it 20 regulated in a different way then the way this regulation 21 is. I don't know if that's going to be the case. I just 22 don't know. And I think that we don't know, in my mind, it 23 perfectly fits in the definition of emerging technology. It 24 seems -- doesn't seem like not to put it in that category. 25 The training requirements in cardiology, you know, i 1 (- (_ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 i (202) 842-0034 j
323 1 are fairly strict. It's a three -- mandatory three year 2 fellowship, a one year interventional fellowship that now is 3 being board certified,.and part of that -- because I'm on 4 the committee that writes that exam -- part of that exam is 5 radiation protection and safety. In addition to that, in 6 the state of California, of course, you have to pass another 7 examination in use voracity which we worked on. 8 So, there is -- there is already in place ! 9 regulatory and standards for training of interventional
-10 cardiologists.
And this is an area where I would see those 11 regulatory bodies working with the NRC to develop the proper 1 12 standards. l 13 So, that-may change the complexity of the way the 14 regulations are in as well. So, I think that just to get () l 15 back to the beginning that we feel very strongly about -- 16 personally, for somebody who's actually involved in doing 17 this every day as well as representing the ACC and the i I 18 Society of Cardiology that this should be an emerging 19 technology. 20 MR. CAMERON: Okay. Thank you, 21 We're going to go to -- to Elias next and then l 22 jump back to Roy.
-23 Besides people talking about this issue and what 24 the downside of regulations are I think maybe we can use 25 this as sort of an illustration of the problems, generic
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324 1 problems, that need to be addressed in the whole area of 2 . emerging technologies. 3 And I feel that Roy may be taking us back out to 4 the generic issues. No, he's shaking his head. Okay. 5 Well, let's go to Elias. 6 MR. BOTVINICK: I don't know exactly whether this 7
- is a necessary statement. But I just want to simply say 8 that nuclear cardiology is not an emerging technology. It's 9 a very well established technology. So, I just want to --
10 while I support everything that's been said, it's kind of 11' two different issues here. Nuclear cardiology is very 12 widely applied on a daily basis in the' diagnosis and 13 -management of literally thousands of patients with -- heart ; 14 disease. l () 15- So, what we're talking about is basically the 16 training requirements, to become involved and to apply this i 17 established method. And there plenty of people out there in 18 training that really would find it extremely difficult to
- 19. qualify with the current 1200 hour requirement. And which 20 is not necessary, as well.
21 In fact, truthfully speaking, the only' people that 22 would qualify would be people who went out of their normal a 23 training and basically dropped what they did professionally i 24 to take a special program and special programs outside of 25 the. professional societies are really not very well ANN RILEY & ASSOCIATES, LTD. ~ ON Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 rm. - , - -"
- 325 1 ,
overseen. () 2 Or they find the training hours within the formal 3 . training in radiology and nuclear medicine. And actually, 4 being a member of the radiology department, I can tell you 5 that -- maybe I shouldn't tell you -- but those hours really ' 6 are probably not honored actually as they're written in 7 paper. That is there are a lot of radiologists in 8 training -- in training to learn and it may be that those 9 1200 hours, as specified, are difficult to honor even in 10 long term structured programs. i 11 So, they're really overly drawn, very restrictive, 12 and the main impact they've had on th' profession is they've 13 really kept people.out who really deserve to be in. That 14 is, the people who really have the primary duty in managing () 15 the patients and can adapt the technology and apply it 16 probably best, having the greatest difficulty complying'with 17 this 1200 regulation. 18 And just one last -- there was a time when, for 19 example, ultrasound was an area that was used exclusively by 20 radiologists, and not cardiologists do most of the cardiac 21 ultrasound. In fact, in the caplat (phonetic) the early 22 atriogophists (phonetic) were radiologists. The 23 cardiologists, and rightly so, felt this is their purview. 24 They treat patients. They tested basically to determine if 25 they had any skills in applying a tourniquet. And now this I \ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
326 1 movement, really, is -- of course nuclear cardiology is c. ( ) 2 really sweeping through the cardiology community. x_/ And there 3 are cardiologists that are very motivated to train in this 4 area, a number of them have in spite of the restrictions, 5 the restrictive training regulations, and they do very well. 6 And they apply the method safely. And, in fact, it's very 7 important to the survival and to the application of the 8 method that cardiologists, for example, specifically be 9 involved in the application and delivery of this technology. 10 So, again, this is not an investigational -- 11 there's an investigation going on of this fairly sure 12 technology, always looking to improve itself. And the 13 various societies, the American Society of Nuclear 14 Cardiology was particularly developed in the last five years (j 15 specifically to look into and better the interests of the 16 field, not any particular specialty group. It's the Society 17 of Nuclear Cardiology, not the Society of Nuclear 18 Cardiologists or Cardiologists or Radiologists. So, they've 19 done a lot for the field and I hope you know that they 20 really brought us to this day where we're considering 21 logical and practical regulations for training. 22 And again, the ACC and ASNC are very well equipped 23 to support oversee and deliver the required training. 24 MR. CAMERON: Okay. Thank you. I think that 25 people do understand the distinction and that those words b' ANN RILEY & ASSOCIATES, LTD. \- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
327 1 that you had for us will be a useful factor when we move a 2 into the specific discussion of training and experience. [G"') 3 That we're going to start after we look at this particular 4 example of what might be an emerging technology. 5 And we go to Roy for his comments. 6 MR. BROWN: Well, first of all I want to comment 7 on the NRC, in recognizing the fact that there are emerging 8 technologies out there, there are quite a few exciting new 9 products on the horizon, as Dr. Faxon mentioned, there are 1 i 10 several different types of products out there, stints, l 11 delivery balloons, low dose rate, high dose rates. So, 12 there's a wide variety of intervascular brachytherapy, l 13 I guess what we're going to do in Part 35, looking 14 at 35.1000 and 35.12, it's pretty clear that it's vague on (' ) 15 emerging technologies. And maybe it is premature to set up 16 a team to do requirements of this one. But for companies 17 working on these new products and new fields, it's very, 18 very difficult to send millions of dollars into clinical 19 research on this, having no idea what the regulatory 20 requirements are going to look like and what the regulatory 21 requirements might be. 22 Having said that, I guess I have a question. 23 Similar to the discussion we had earlier this morning and 24 yesterday. Will the NRC be open to a petition for rule 25 making from a group of companies or from an industry to say i i f ANN RILEY & ASSOCIATES, LTD.
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328 1 that we feel this is the appropriate way to license an 2 emerging technology, such as intervascular brachytherapy? 3 MR. CAMERON: Don? 4 DR. COOL: I think the shortest answer is yes. In 5 the general construct of things in the world, always open to 6 petitions for rule making ideas. 7 Let me step back a second because that may he a 8 veiled answer to one of the questions I asked, which is how 9 do you know when you move from one category into another 10 category? 11 And I suppose one of the best possible of all of 12 the -- all of the rules would be in a situation like this 13 where, as it developed, the industry itself said, "We are 14 now -- we feel we have a clear enough idea of how this is () 15 going to pay out, that it would be useful, and that these 16 are the things that because of all of the testing we have ; i 17 done, we now feel it fits in. Here's our petition for rule ) l 18 making to move this category into the structure system and ' 19 out of the case by case review." That would be an ideal 20 situation and ideal petition because ycu can provide me with 21 all of the baseline and all of the facts to construct the 22 rule. 23 MR. CAMERON: And what you might also think about, 24 I guess, is -- is there some other type of institutional 25 structure that could be used besides a petition for ruling i l
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329 i 1 each time you wanted to move something into the -- into the 3 2 mainstream framework that could be establiched?
} And I don't 3 know if anybody has any creative ideas on that, but that's I 4 i also a possibility. !
- i 5 Roy? j 6 MR. BROWN
- !
Just a follow up comment. I just want i 7 .to make sure you realize, I'm sure you do, that the 8 regulated community respects and deals with the protection 9 of the public and patients and the occupational workers, it 10 is as important as the NRC feels it is. 11 But you also have to recognize that in some cases ! i j 12 you can put so much regulatory burden on a new product that l 13 you essentially finally just kill the product with too long l l 14 a hospital stay required or too many safety constraints. I O) ( -15 So, the NRC always has to be cognizant about that. l 16- MR. CAMERON: Okay. And I guess at some point I 17 should check with all of you around the table about whether i a 18 there is general agreement that there has to be some sort of - i 1- \ 19 separate treatment for emerging technologies because of some { 20 of the disadvantageous or the down sides that have been i l 21 brought up. It's a question of what that regime should be 22 and what -- how do you define an emerging technology. o 23 Dave? 24 DR. LARSON: For those of you who weren't here ] 25 yesterday, I'm Dave Larson from the UCSP and I'm a professor ' l l l ()
- - (_/
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330 1 of radiation oncology and also neurosurgery for UCSF. And I (} '% ) 2 represent the ACRO, American College of Radiation Oncology. 3 It's less clear to me that we need a separate 4 section in the regulations for emerging technology. I hope 5 we have a lot of emerging technology in the future. The 6 reason I say that, however, has to do with historical 7 precedent. I'd like to just take a minute to describe 8 something that happened in the late '80s and on into the 9 '90s that perhaps would serve as a model for emerging 10 technology whereby it appears the patients benefitted, 11 physicians benefit, society benefits. It has to do with 12 gamma technology, which in the '80s was an emerging 13 technology. Nobody knew exactly where it was going to go 14 and what was going to happen, t( ) 15 In 1986, the first gammanizers were sold in the 16 United States. In 1987 and 1988 several plain air 17 accelerators, not in the purview of the NRC, were converted 18 that it would give similar sorts of treatment. 19 In 1989 was the first international conference of 20 radiosurgery in the US and there were subsequent meetings 21 that year and in the following one or two years in national 22 and international conferences, which were remarkable for 23 being acrimonious. Where specialists from radiation 24 oncology and neurosurgery, on several conferences, got into
.25 embarrassing arguments about who should push the button.
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331 1 Things that were pretty irrelevant to actual patient care, [p} 2 Who should be involved in selecting patients. Who should 3 follow patients. 4 Well, the American Society of Therapeutic I 5 Radiology and Oncology, ASTRO, convened a task force, I l 6 happened to be the chair of that task force, to help define 1 7 standards of radiosurgery. Simultaneously, the American 8 Association of Radiological Surgeons, which I also happened I 9 to be a member of, convened a task force which I was not on, 10 but which had the same mission, to try to define standards 11 for radiosurgery. And each of those groups separately and 12 independently worked for about a year and a half defining 13 who should do radiosurgery, how it should be done, how 14 patients should be selected, defining issues of training, () 15 education, et cetera. l 16 After about a year and a half, each task force has 17 developed a document. And at about that time the two task 18 forces decided to share their documents and the documents 19 were remarkably similar and they ended up merging their 20 documents and in 1983 they simultaneously published and 21 analysis of both professional organizations, and involved 22 authors from both specialists, simultaneously in two 23 journals, one radiation oncology journal and one 24 neurosurgery journal, the standards for performing 25 radiosurgery. Ih ANN RILEY & ASSOCIATES, LTD. 'As' Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
332 1 And those standards recommended a team approach in l (A) 2 which there was a neurosurgeon involved in every case,
- 3 _ radiation oncologists involved in every case, radiation 4 physicist in every case, nurse in ever case, an ancillary 5 support staff involved in every case, and issues of quality 6 of assurance training, patient watching and follow up were 7 addressed.
8 So, that covered what was at the time considered i 9 to be reasonable standards. That approach was since adopted I i 10 by every radiosurgery facility in the US, of which there are l l 11 now several dozen gammanite facilities and several hundred l 12 plain air accelerator facilities. 13 The bulk of treatments, it turns out, are carried 14 out by gammanite. Gammanized treatment location, per
) 15 facility, by far gammanite then accelerators. ;
16 What were the disadvantages of this approach? 7 , Well, the disadvantage, it turned out, is the patient -- in ; I 18 a sense, the patient had two coneultations prior to the 19 procedure, 1ccher than one. Most patients view thic as an 20 advantage, not a disadvantage. They're getting more 21 information. It's usually there on the some day, the same 22 visit. And another potential disadvantage is that the date 23 and time of the procedure has to be coordinated between two 24 physicians rather than one. Not at all an insurmountable 25 problem. I ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 642-0034 I
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l-333 1 There are several advantages to this. Patients 2 benefit from the experience of two specialists. Medicare, i b(\ . 3 HMOs, insurance companies are aware of the document that was 4 published in 1983 and consider that to be the standard so 5- that all specialists are reimbursed. 6 Some patients are rejected for treatment. They 7 see two consultants rather than one. Sometimes the 8 radiation oncologist will raise questions, sometimes the 9 neurosurgeon will raise questions. So, not every patient 10 that otherwise might have been treated is treated. The 11 complication is rate is extremely low. For all in the US 12 it's about three percent. It's much lower than in Europe. 13 It's much lower than in Japan or South America where 14 technically, one specialist does the treatment, either the () 15 neurosurgeon or the radiation oncologist. So, there's 16 probably benefit. 1 17 In addition, as an outgrowth of that, coopere".ive l l 18 venture (phonetic) developed something called the 19 International Stereostactical Radiosurgery Society, an 20 international group that meets once a year to compare 21 outcome and to ensure that standards are adhered tc. 22 The bottom line is that I think ACRO has the 23 concern that training standards be high, that they not be 24 relaxed. The reason for that has to do with impact on 25 patient care in the typical radiation oncology department. (~') (_;/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 ( 2 0 7. ) 842-0034
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334 1 Complications in radiation involving radiation sometimes 2 make the news. That effects a lot of patients' competence ()g u-3 in their ability to have safe, effective treatment. .I think 4 it's important that the regulations continue to ensure that l 5 the treatments are safe and effective, vnd it's hard for me 1 6 to think that if we had a cooperative treatment proposed 7 that there's much disadvantage. 8 MR. CAMERON: Okay. Thank you. And your last l 9 comment about patient competence perhaps takes us a little ! 10 back to the issue of perception that Susan McLaughlin and 11 other people raised yesterday. 12 I guess the question to try to tie some of the 13 discussion together, are there lessons from the gammanite 14 development that would -- that would be illustrative for the 15 interventionalist brachytherapy that we've been talking 16 about and/or for the framework of the new rule and some of 17 the issues that Don Cool raised on this. Anything to offer 18 on that? 19 DR. LARSON: Let me defer for now. I'll think , 1 20 about it. 21 MR. CAMERON: All right. Good. I think that's i 22 the type of thing that we should bring our joint experience 23 to bear on. We could have something productive here. 24 Melissa, you have been up and down and I guess 25 I'll just go to -- to David. Or do you want to go ahead ANN RILEY & ASSOCIATES, LTD. (~ Court Reporters l 1025 Connecticut Av: nee, NW, Suite 1014 Washington, D.C 20036 (202) 8th-0034
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F 335 1 Melissa?
'D 2 MS. MARTIN:
(O I kept putting it up or down because 3 'I thought it was probably going to come up as training 4 experience. 5 Speaking from the physicists perspective, at this 6 point we would just like to emphasize that we definitely 7 would like to have radiation safety training as part of the 8 requirement, which ever category this goes under. But we'd 9 also like to see some specification specific data for
- 3 training for radiation safety so that it doesn't just slip
, 11 through as a nice meeting in the light. But I don't think 12 we need to specify who does the training when it comes down 13 to the radiation safety in the use of these intervascular 14 wurses (phonetic). D) ( 15 And I would also like to emphasize that we think 16 it should be specified somewhere the requirement that an 17 accurate dese calculation be made for any type of these 18 procedures that are developed so that we're actually using 19 physicists with.the appropriate training to do the dose 20 symmetry for these patients. 21 MR. CAMERON: Okay. Thanks, Melissa. 22 Dave, do you have a similar concern? 23 MR. NEBLETT: Yes. But I'd like to take one more 24 step in that direction. 25 Brachytherapy is, in fact, the oldest form of
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336 1 radiation therapy, going back to 1906. And it is fairly (~N 2 well regulated. You've probably heard almost every isotope t) 3 with explicit directions in many places. And in my mind 4 this is not emerging technology, this is emerging technique. 5 And as a technique it's using the same isotopes and it has 6 the same health and safety problems that you have already 7 addressed q:. J e well . And therefore I don't understand the 8 justification for additional regulations on materials that 9 you are already controlling relatively well. 10 The second area is an area of training, And I 11 think that's been addressed. 12 MR. CAMERON: Can you perhaps expound a little bit 13 on how you would differentiate between emerging technique 14 and emerging technology, because that might get us to the (~) 15 criteria questiun that Don raised about how you deal with 16 it? 17 MR. NEBLETT: In the sense that we're dealing with 18 the same' radiation sources or the same biological effect 19 that we've been dealing with for a long time. And 20 therefore, in my mind, they present the same hazards -- 21 radiation safety hazards -- and those radiation safety 22 hazards are no different. And that's where I would say I 23 see this somewhat as a technique as opposed to something 24 that's generating a new source of radiation that we now need 25 to have measurements and history and no how to control. f"'h ANN RILEY & ASSOCIATES, LTD. (/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
337 wa know what to do with beta emitters. We know what ne realistic g emitters. These are just beta and gamma I U" " " g used on the same tissue in a different ttervascular .n. And I don't think that additional regulation itients with ha handling of these materials is necessary, a heart, which MR. CAMERON: Okay. We're going to go to Rich and sis. We're this side for opinions on it. I guess I have just the night.
- ion for the group, is under that definition, would die of de ar be something called an emerging technology? ty. We want Rich?
the most DR. HEUSER: Well, again I gurtss it is a bit -- a to consider sout our technique or our technology . And I agree #
- dealing with gammanite.
I think that that was a iast us. And y that really required just really a few fields ' **P"US* ge,'~ "r . And our opinion is that with this being
; :ation to the hihE'is an emerging technology, the societies have rk together to put this together in terms of what 1 it's only --
ag to finally recommend to the NRC and then : technologies, implement it. different. I think the gamma is a nice analogue in that if it ## # " tat there are a whole gamut radiation that -- types oing to be practiced, approve and practiced in the tand de i tes, ! I think the involvement is going to be a lot l siva then it would be if only, for instance, beta ' a n'" as going to be implemented, we start up i l l
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339 1 things with our physicist, the radiation oncologist, the i () 2 safety officer.. It's not unusual. We're doing these 3 procedures on patients that tend to have unstable syndromes. 4 They have unstable angina. We do the procedure, we can't do l 5 radiation. We've got to get everybody together. You can't 6 do that right now. 7 If this thing really works and the studies s 8 confirm, validate that it really is effective, there are 9 going to be a large number of patients that are going to 10 need that therapy, perhaps. And do we need to have that , 11 sort of involvement. From a practical standpoint, it 12 doesn't make a lot of sense in terms of the cost. Then, on 13 the other hand, it's just a rare patient that has a certain 14 specific implication, then I think that the cost and benefit O (,,/ 15 of all this different expertise is a little bit different. 16 That's all I'm saying from a practical standpoint. 17 MR. CAMERON: Okay. Thank you. 18 Dave? 19 DR. FAXON: Sort of similar. I'm definitely 20 attracted to the idea of the gammanite because I think 21 that'. 2 good model. But I actually think this technology 22 is prior.to the gammanite. The gammanite was a defined 23 technology and technique, and then the groups got together 24 and decided how best to apply it. We're not even at that 25 stage. We don't even know what the right technique is, yet,
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L l 340 1 What the right technology is. So, in one sense I think () 2 we're predating that. When we get to the point where we do l 1 3 understand that, and I think that's a very appropriate 4 mcdel. The industry ought to be involved, as was already 5 suggested. Somehow getting the groups that are important l 6 together is probably the right way to -- and I think 7 everybody is going to agree with that. 8 DR. HEUSER: We're already having meetings like 9 that right now. And they are because we -- with radiation 10 oncologists as well as the medical physicists and 11 cardiologists working together right now. But you're right. 12 We don't even know what cap we're on yet. 13 DR. FAXON: I'd also get back to the issues of i 14 understanding these -- we do understand the radicactive () 15 material, but I think we don't understand very well the l 16 biology of the effect of radiation in restenosis. Beca :tse 17 that's the treatment we're using it for. We don't what the 18 target is. He don't know where the depth of the dose should 19 be. We don't know what cell type we're going after. We 20 don't know whether a single dose or a -- dose is the right 21 to go, so -- and we don't know what the long term 22 consequences of that are on the vascular wall. So, I think 23 we know very little about half the biology of this effect. 24 So, I think the argument whether it's a technique 25 or a technology, I think we -- we need to know a lot more t ANN RILEY & ASSOCIATES, LTD. s Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
341 1 about it. 2 { The other aspect about it which I was going to 3 raise before and forgot to is, perhaps unlike -- getting 4 back to the question that is this just an extension of a 5 previously existing technology to a different orge.n system. 6 I just don't view it that way. Because the components of 7 doing this are intricately intertwined with interventional 8 cardiology, angioplasty. It's not taking a brachytherapy 9 radiation wire.and placing it in a solid tumor and deciding 10 how it works there. This is really threading a catheter 11 wire into your coronary artery and being very versed at 4 12 understanding all the complications and risks that occur 1 13 when you blow up a balloon and put a stint there. All the - 14 other technologies we use in interventional cardiology. () 15 Because these devices have those comp:ications as well as 16 the radiation complications. You have to understand both of 1 17 those, and they're intertwined, they're not separated. So, 18 it's a much more complicated, I think, situation, then just i i 19 an application. 20 MR. CAMERON: That sounds like useful information. 1 21 I guess we're going to go to Ed Bailey. 22 And I would -- there seems to be a number of 23 questions emerging here. I would ask, on this particular 24 technique or technology, what do you think should be the I 25 regulatory regime, including no regulatory regime at this l l A ANN RILEY & ASSOCIATES, LTD. 5%_) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 i (202) 842-0034 1
l 342
.1 point in time.
When does that shift into the need for 2 another regulatory regime? How do you view the proposed 3 rule in terms of those few questions? And are there other 4 emerging technologies besides this one that we should just 5 mention here that might be coming down the line? . 6 MR. BAILEY: I think gammanite is a good example 7 . to use because the original gammanites that were brought ] J 8 into the United States, there was an inordinate amount of concern from a regulatory standpoint about how they should 10 be treated, how -- what should be done. 11 We can look at the same thing and RC doesn't get 12 involved in it, but in the pet cyclotrons. The first 13- cyclotrons that came in we spent a lot of time looking at 14 how we're going to regulate those facilities. 15
% As the number of each of these has increased it's 16 become somewhat more standard of what happens. If we look 17 at th..gs like samarium -- eight nine, they weren't truly 18 new technologies, but there was this perception that we had 19 ventured into a usw regulatory realm in that these were not 20 designed essentially to cure anything. They were simply 21 designed for, in most cases, a powerful treatment. And we 22 struggled with licensing those eiterials because it was a 23 totally new concept to us.
24 We have a whole bunch ot these different things. 25 And I think the key -- key to having a reasonable regulatory ()
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343 1 scheme is that when these things first come in we already 2 have a regime to regulate. We authorize medical research. 3 And these -- as I've heard people talk about cardiology, 4 this is truly research. This is not something that's going 5 to be done by every facility next week. The same thing 6 happened with samarium in -- throughout the pet facility. 7 We have a mechanism in place right now to regulate 8 things when they're in the research stage. FDA has a 9 procedure for saying, "Okay. They're no longer in research. 10 They are -- they are an approved drug." And at that point 11 then they move out of, in my opinion, out of the research 12 phase and out of being limited to a few institutions, 13 normally fairly large institutions that are doing research 14 in a variety of ways. () 15 16 If you look at how many there are, studies going on, and you look where those are located, you'll notice that 17 it's unlikely that any regulatory body is going to have all 18 of them to draw from on their experience. And when we look 19 at where large medical centers, research centers, are 20 located, you would have at least one in let's say the five 21 largest agreement states. You have some in RC states. So, 22 we're going to be forced to share. I think it's very 23 important that we be informed of what's going on. We've got
- 24. to be proactive in going out and getting that information.
25 I don't think we can sit back and sort of expect it to be ()
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i 344 hand fed to us. 1
/ 2 We have gotten laws on the council that I've b) 3 mentionad before. And this is really one of the objectives 4 of that, to have -- to have these people and their 5 associates come in and describe what's going on. I mean, 6 we've already had a, what, a two or three hour presentation 7 on nuclear cardiology and stints and HDRs and all this, so 8
-- and our staff was there to hear it. And I think the 9 familiarity with it gives us some advantage when we come 10 down to finally going ahead and licensing some of these 11 processes. And I think it's pretty much what we're doing 12 right now. And I don't see that there's really a big need 13 for changing the research regime.
14 MR. CAMERON: I'd like the NCR staff to compare ( 15 our post-rule framework with Ed's suggestion that this is a 16 medical research application. And I also would just 17 underline what he said about it going to this institutional 18 mechanism. How do you keep up with emerging technologies? 19 I don't know if there is any way to sort of tie that type of 20 institutional mechanism in with -- with Roy's suggestion 21 from the petition for rule making. I'm not sure how that 22 would all operate. But maybe we can expand a little bit on 23 that. 24 But Cathy, could you comment on medical research? 25 MS. HANEY: The proposed rule -- a section for
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345 1 medical research under 35.6 So, if there's truly research at fE 2 -- with the NLL for under the 35.6 category which would d 3 require certain things, informed consent, institutional 4- review boards, and things like that which -- licensees where l 5 it interacts and increases being done primarily. And they I 6 have that in place already. 7 From the standpoint of if we were -- if the 8 proposed rule were in effect right now and we were presented 9 with emerging technology with the intervascular uses, 10 saying, "Where does this fit into the proposed rule?" The 11 first -- that we would really need to make is pretty much 12 what Dave said. Is it truly an emerging technology or does I 13 it fall under one of the categories that we're using now, l i' gm 14 say we're using the rate 192? Is it an HDR unit without the ( ,) 15 HDR tag? And if that's the case then we would, you know, i 16 say we should be regulating under the 35.600 category. If 17 the decision was nade, no, it's not, then we would be going 18 back to the applicant and saying, "Well, we think you fall 19 under the 35.1000, which is the emerging technology ) 1
.20 category. Now, if you give us information about what are )
21 your procedures?" And we'll be looking in this case -- l l 22 -we'll be looking tor procede es up front because this would ! 23 be something that was truly new to us. ! 24 The main thing we're discussing here is we're i 25 saying, "What are the training and experience requirements ! (~ ANN RILEY & ASSOCIATES, LTD.
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346 1- that you think licensing are needed for this type of use?" I' 2 And in that case, in that capacity come in and say, "We l Q) 3 think your accreditacion by the board, that I think the exam 4 is going to be given next year." That should be sufficient 5 for someone to be considered an authorized use for this use. 6 If we're truly an emerging technology, Staff would 7 probably take this to our advisory committee and say, "We 8 believe this to be an emerging technology for the following 9 reasons. This is what the particular user -- or the request 10 for a licensee, potential licensee has presented to us. Do 11 you believe that it adequately covers the radiation safety 12 aspects of this use of the material?" And then based on 13 that, the Staff would make a decision. 14 MR. CAMERON: Since the proposed rule sets up a rO 3(_) 15 framework for making these types of decisions, then perhaps 16 people might not have a problem with the framework but might 17 have a disagreement with how those criteria were applied to 18 a specific use. Is that fair to say that the framework in 19 the proposed rule is not so much the problem as how the 20 framework might be applied to a specific use? 21 Dave? 22 DR. LARSON: I'm just a little worried about the 23 possibility of having this taken care of in a research 24 framework because that may prevent reimbursement. Is that a 25 possibility? Do car . '.ogists know? Are people being [~')
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,.- . .- ~. _ -. -. . - - - - - . - . - _ - . . ~ . . - . --. .. . ~ . _ . . ~ . . I 34? 1 treated now as if it's investigational or does reimbursement 2 take place? ( 3' DR. FAXON: No. 4 DR. LARSON: No. So, research would be, at least ' 5 as a temporary issue, it would seem like an appropriate 6 framework. But in the long run, if it pans out it would 7 have to be a different kind. 8 MR. CAMERON: Bob? 9 DR. LULL: I just wanted to point that the -- when 10 we talk about emerging technologies, really what you'ra 11 [ talking about is a kind of definition of the risk in that 12 you're -- it's an emerging undefined risk. That's what 13 we're hearing, that we don't knou exact]y what the riska 14 a r e .. ( 15 Once the risk becomes clear, I think that through 16 the mechanism we talked about with the medical advisory 17 committee we can define the degree of regg.lation that's 18 needed for that, based on the new approach that's risk 19 oriented. And this is what we were talking yesterday about 20 catablishing a structured framework fer risk analysis and 21 analyzing the data about any technology, whether it's 22 emerging or established in terms of what are the risks, and 23 then get regulations that are appropriate to deal with those
- 24. risks,'to minimize them from the public and everyone.
1 25 MR. CAMERON: Okay. Thank you for tising us back [ ANN RILEY k ASSOCIATES, LTD.
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348 1 into risk. 2 Would Dr. Forester,.out in the audience -- Dr. 3 Forester, why don't you come up to the microphone? t-4 DR , FORESTER: I'm_ Jim Forester from UCLA Cedar ! 9 Sinai. And the reason I'm here is I'm representing the , 6 l ./.merican College of Cardio19gy and I'm chairman of the 7 technology and clinical practices of triminium A (phonetic), 8 member of the board of trustees. The committee that I 9f chaired -- this documents -- supervised the production of i 10 documents. Last rears -- one of th.em was radiation eafety 11 in cardiovascular o.sease. 12 And what I'd like to speak to is the -- what I i 13 think is the argument for putting-this technology in the 14 category for smerging technology. i () 15 16 As background, I'd like you to be clear that the ! ACC feels very strongly about radiation safety. And I don't 17 think I can produce this document, but I think you can 18 understand that as opposed to many other types of radiation, 19 the physician who is delivering radiation in the cat lab is 20 particularly exposed to it. And so he has a very personal 21 interest in the outcoce of issues relating to radiation 22 safety, as well as to investment in his colleagues, his 23 1 technicians and others. And finally, of course, the 24 interest of his patient who he follows long term. 25 So, I want to be sure that you understand that the f
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349 I 1 ACC feels very strongly about this issue and would favor a 2 ( stringent and aggressive approach to radiation safety. 3 We're not here to anything less than that. 4 In terms of background for this particular 5 technology, I think it's worthwhile to question what is 6 known and what is no known. What's known is that in animals e 7 and in man, external -- let me take animals first. 8 In external radiation and radiation delivered form 9 in the blood vessel, reduces interval hyperglacia 10 (phonetic), that is proliferation of cells of the inner 11 stretch of the blood vessel that causes restenosis. J , 1?. In man it is known, as David as suggested, in a ! 13 small number of casas that various types of radiation may -; - 1 , i 14 reduce restenosie o. n delivered from within the vessel. 15 That's -- and that's another thing we know is that it's very {) 16 likely that this radiation, if used, will be delivered at i 17 all times of day and night in emergency situations. That's 18 the thin (3 that we know. . i 19 In cerms of what we don't know, there is a great ! 20 deal. First of all, we don't know whether the radiation j 21 should be delivered externally or from within the blood 22 vessel. If it Enrms our, as I think it's not unlikely, it 23 would be delivered from within the vessel, we don't know a 24 number of things again. We don't know whether it should be i 25 delivered transiently with a head and then pulled out, or l i ANN RILEY & ASSOCIATES, LTD. O,, Court Reporters ) 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 j s (202) 842-0034 l t
350 1 whether it should be delivered with a stint that would
-2 remain permanently within the vessel.
3 Second, we don't know what isotope should be used. 4-We are currently in the search right now, using a large 5 number,- iridium, P32, gitrium (phonetic) , so as a function 6 of that we don't know several other things. We don't know , 7 whether.we're going-to be using a relatively high rick gamma 8 radiation source or a relatively low risk. beta radiation 9 source. And in addition, of course, we don't know the dose, 10 as David suggested. We don't know whether we should 11 traverse the vessel or only penetrate through the area 12- surface themselves. 13 Now, what's the relevance of that lack of 14 knowledge and-_ uncertainty to the issue at hand? There's a () 15 wonderful line from Alice in Wonderland, "If you don't know 16 where.you're going, any road will do." And that's about
-17 where we are right now with intervascular radiation. We 18 don't.know where we're going, yet.
19 And the reason that that's important, I think, is
- 20 that it impacts directly on the decision into what category 21 does it fall. I would submit that there is such grave 122 uncertainty with regard to what will be done, that one of 23: the lines that came out in terms of the resolutions here on 24 page 24 at the bottom. The first resolution says: "The 25_ requirements for training and experience should be
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i l 351 1 risk-based and focussed on radiation cafety." () 2 And the issue is we don't know what the risk is at 3 the present time because we don't know what type of approach 4 we will be using.
- 5 So, to summarize, I think the messages I'd like to 6 leave with you are we are very committed to radiation 7 safety. We know a lit'.le bit, enough to suggest that this 8 is a.very promising technology.
9 But one that we know -- that we don't a great 10 deal. And the major things we don't know are part of the 11 risk associated with this procedure will be because it will 12 vary enormously with the type of technology to choose. To 13 me that suggests that this is the quintessential definition 14 of emerging technology. And for that reason I think it's () 15 appropriate ,o put this in the category of emerging 16 technology rather than say, "There's the word brachytherapy 17 and everything that we do, as long as it fits into that 18 category, should be treated the same way." And in that way, 19 coming back to Alice, I suppose that once we know what we're 20 doing we'll know the right way to choose. 21 MR. CAMERON: Okay. Thank you very much, Dr. 22 Forester. 23 Let's go to Roy and then I want to do a reality 24 check with someone in terms of what LC would like to know on ' 25 this issue either today during our discussion or the l. () s_- ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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352
.1 . comments taking place on the proposed rule.
2 Roy? 3 -MR. BROWN: Let me first of all agree with Dr. 4 Forester on the emerging technology issue. Some of the 5 l things that are being looked at in clinical trials are much 6 much different than any types of brachytherapy that's 1 7 currently being done. So, I definitely agree that this is 8 an emerging technology and there should be a separate 9 section, as you guys proposed on a number of times. 10 I want to go back and address the question you
- 11. asked about half an hour ago about the regulatory machines'.
12 And I just jot down a few notes here. This is fcr -- this 13 would be for a specific type of product. And this would be L14 a liquid filled balloon catheter, typically filled with 300 () 15 millicuries of radium 186. This is the product of the -- l 16 . product I'm also working with. 17 I can see a regulatory regime where you would go 18 to the nuclear medicine department and see what the license 19 says there. It's most likely that the liquid portion of
.20 this product would be processed as nuclear medicine through 21 tt+ nuclear pharmacy or through the nuclear medicine 22 department. First of all, go there and see what the 23 possession lists are, see what isotopes are typically used 24' to working with, see if they have possession to handle the 25 . isotope and the different form you're coing to use. Nuclenr
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353 1 medicine will be responsible for preparing the dose, (~5 2 preparing the liquid reports and checking the catheter. And 3 l l-nuclear medicine would be responsible for disposing of waste l 4 product after you're done. 1 5 There would be some sort of a changing requirement 6 for the RSO. You have the -- in these particular type of 7 therapies and this particular of brachytherapy, not just a 8 generic RSO that's used to dealing with different medicines, 9 There would have to be a specific program, a teeny 10 (phonetic) program for this technology. 11 Third, you have to be in accreditation, obviously, 12 as a cardiologist. If there is -- I'm not familiar with 13 ACC's accreditations, whether there would be at some point 14 down the road a separate accreditation for intervascular 15 brachytherapy or what type of accreditation. But some sort 16 of accreditation from, most likely, the ACC, I would guess. 17- And lastly, I think there would have to be a 18 standard of practice for that different technology that 19 explains, typically, what is the practice that's being done, 20 how the radiation safety issue is being handled,' how the -- 21 what's the waste product, and what are the costs if you take 2:2 something like that. 23 I would say, if you could meet those fcur criteria 24 then you could pass the test and you could get this -- 25 license. I'd like to get comments on that if you think -- l l ~j e~ ANN RILEY & ASSOCIATES, LTD. ( Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
354
-1 to see what you guys feel would be -- what we're talking
- (~s 2- about --
3 MR. CAMERON: } Okay. =Thanks, Roy.
- 4~
Let me go to Don and I think we'll -- it might be
- 5 a useful time to take a break for lunch. Not only because 1
6 it's lunch time but our neighbors are going to be pretty I ' 7 active and enthusiastic over there until about 1:00 o' clock. 8 So, we can kill two birds with one stone, so to speak. 9 Don? 10 DR. COOL: Okay. Thank you, Chip. 11 To answer the last question, first. I think that 12 was an excellent list, at least as a starting point. I 13 don't know that I can or maybe even should sit here and say, 14 you've got them all or not. You've certainly identified a l\ 15
.Q number of key items. I'm not really sure that you've got 16 them all, but I think maybe " .'re close. Those are 17 certainly the kinds of things at would need to be looked at in order for people to go through this,
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18 l 19 The traditional licensing approach, which could
.20 possibly be up in the air, would state that for this type of 21 thing you would traditionally have an amendment. That might 22 well be necessary because you're entering into a new arena 23 and you would be picking up the different pieces of the 24 regulations from which you were drawing the authority. That 25 would be the right kinds of questions.
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355 1
;I think going from here and not necessarily today 2
because we need to talk about some other topics, but as you 3 start to develop' comments, start to think about things that 4 we would take back up in the next meetings, would be whether 5 or not that was a complete list or whether you would add to i 6 it. 7 And then to answer the question if that is the 8 right list, how do you as the developer of the technology 9 and Dr. Faxon as the administrator of the technology that is ! 10 used in the interventional testing or administrative 11 material, trv4.ng to determine whether this works or not, and ! 12 I as the regulator come to a mutual agreement that they have 13 each been identified and that the appropriate approach, 14 appropriate to any of these are agreed upon so that we can 1 () 15 issue your license, so that we can get you moving forward 16 without using a whole lot of resources going back and forth.
- 17. .Because one of the things that I desperately want to avoid 18 is setting ourselves up in a situation where we filled in an j 19 automatic dooboo (phonetic) that negates all the advantage 20 of attempting to do this and learn something about it.
21 Another quote, which is actually a great summary 22- of.what Dr. Forester raised, "You can tell it's research by
- 23. you don't know how much it's going to cost, you don't know 24
.what the benefit is going to be and you don't know how long 25 it's going to take." But for that very reason, you have to
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356 1 be careful because otherwise it will end up having to tell (} 2 me how long it's going to take, how much it's going to cost 3 and what the end point is referring to in your license, and 4 we end up going over it. 5 So, if the answers to those types of questions, as 6 we're ready for lunch, as you think about it, how can we ? 7 define -- we honestly can't define the specifics, but how 8 can we set up a couple of guide posts that will enable us to 9 walk down this path together to get to the end point? 10 MR. CAMERON: Okay. Thank, Don. 11 I should go to the audience to see if there's any 12 other comments from anybody out here on this emerging 13 technology issue. 14 Go ahead. () 15 MS. SCHWEYAR: Once again, my name is Jill 16 Schweyar. I'm from Isostint, Incorporated. And radioactive 17 stints, but can be used in actual multiple areas, not only 18 in the coronary artery. I just want to make that point. 19 And in emerging technology, actually currently in 20 the regulation, 1 would actually like the NRC to consider 21 the decent time constraints on the licensing side of things. 22 But I can see in the research phase that if you have an item 23 which you have approved from the USFDA and you went -- you 24 have all your patients to nationally conduct your research. 25 What I can perceive is that there is a difficulty in getting L ANN RILEY & ASSOCIATES, LTD. O. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
357l 1 licenses out to particular institutions that want to do this
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v) / 2 research. I would just like to suggest that there be a 3 frame time and some limitations there. 4 MR. CAMERON: Thank you for your comment. 15 Dave, do you have a final word? 6 DR. LARSON: Just very briefly. There should be 7 no inference that radiation oncologists, including 8 cardiologists, aren't interested in radiation safety and 9 efficacy, because I'm sure they are. They -- want the best 10 communications. We just heard an eloquent discussion about 11 'how little we know in terms of the particular emerging l 12 technology. And therefore it's hard to say what the minimum 13 training requirements should be. If this is in the 14 framework for emerging technology, then we must define ,O () 15 training. And I think that would be a difficult task, 16 whereas if it's not placed under emerging technology, we 17 already have the mechanism in place for training for 18 radiation oncologists or any nuclear medicine person, 19 depending on the devise is used and his involvement in that 20 case. 1 21 Finally, just parenthetically, I treat patients in 22 the middle of the night and many of my colleagues do. The i 23 standard is that the patients sometimes have to be treated 24 with this technology in the middle of the night. Methods 25 should exist for that to happen also. O ANN RILEY & ASSOCIATES, LTD. (m- Court Reporters i 25 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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358 1 MR. CAMERON: Okay. Thank you. I think this was () 2 a good discussion and good introduction to the topic that 3 we'll open with at 1:30, which will be the training 4 experience requirements of the rule. We'll start with that 5 and -- Ed?
- 6. MR. BAILEY: We're alking about emerging 7 technologies and I remember a decade or so ago there was a 8 great emerging technology, and the.t was nuclear powered 9 pacemakers. And I don't think we've seen many of them.
10 It's been three or four years since we've seen one recently. 11 And I think we ought to go back and look at what we did 12 during that process. There were certain facilities that 13 were licensed to do the research and then at a certain point 14 they became a sort of generally licensed activity of the () 15 cardiologists who implanted one of those under some sort of 16 institutional controls and then the patient was then -- you 17 weren't allowed to fly an aircraft. So, you know, that's an 18 American technology that emerged and then disappeared. And 19 I think the stints, if they work, we'll see more of them. 20 If they don't work, they'll go away. 21 MR. CAMERON: I think we've had some suggestions 22 that maybe we can learn from the past. That's another 23 example to the extent that the working group hasn't looked 24 at that particular type of approach. Maybe that would be 25 useful, i ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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l 359 I i 1 Was there someone -- one other person with a final \ f'N d 2 comment that I can blame for taking away your lunch? !
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3 MR. HICKMAN: John Hickman, State of California. 4 We have licensed facilities in emerging 5 technologies. Through the' process of working with medical 6 developers and evaluate what the radiation safety problems 7 are, the qualifications of the individuals are pretty well 8 established by the firm or the developers saying, you know, 9 we want to train these individuals -- so, it does -- a 10 radiation safety issue and I think that since we don't have 11 all these specifics in Part 35, we need to have one or the 12 other, qualifications of dealing with, the facilities, and 13 if we would be satisfied with those two issues in working 14 with the developer, which we have opened the door and ; ( 15 encouraged them and -- and we then had very little problems 16 with the licensing.
- 17 MR. CAMERON
- Okay. That's sort of in mind with 18 what Don was saying. It's not as if the developer, the l
19 administrator and the regulator work together on the 20 exact -- well, let's come back at around 1:30. That's 60 l 21 minutes plus. And then we'll get started with training and 22 experience. Thank you. l 23 [Whereupon, the public meeting was recessed, to 24 reconvene at 1:30 p.m., this same day.] 25 O ANN RILEY & ASSOCIATES, LTD.
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360 1 AFTERNOON SESSION () 2 3 (1:45 p.m.] MR. CAMERON: We thought we'd work on training and 4 evaluation for about an hour. And then go to the issue of 5 radiation safety committee until 3:30 and then take a break. 6 And then it's sort of up to you about what issue we take up j 7 next, notification, quality management, events reporting, 8- and we are going to deal with agreement state issues at the ! 9 end. 10 And then I find three of our paddock issues that 11 we definitely want to get in. One is this who institutional l 12 licensing framework that David Belk brought up. The wet 13 signature that Melissa talked about. And also this 20 14 percent deviation between this and the prescription for () 15 manual brachytherapy. We will get to those issues. 16 In terms of what we do after the 3:30 break. 17 What's the hot issue for people to discuss, out of 18 notification, quality managcment, event reporting? Anybody 19 have any particular feelings about how we go through those 20 issues? 21 Okay. Well, we'll see where we are after the 3:30 22 break. 23 Cathy, do you want to start with giving us a 24 context for training?
'25 MS. HANEY: Okay.
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361 l 1 MR. CAMERON: What the proposed rule is all about? 2 MS. HANEY: Dave, could we turn the slide { 3 projector on? 4 When the working group was deciding how we handle 5 the is.3ues of training and experience we came up with a 6 couple of things that we decided would be the guiding lines. 7 One would be that the training and experience requirements 8 would be risk-informed and focussed on radiation safety. 9 And that was going to be a case across the board, compared 10 to whether you're looking at the diagnostic area of the 11 therapeutic areas. l 12 The other thing that we thought was important was 13 that individuals would complete a structured educational ' 14 program and this program would consist of two things: one O (). 15 didactic training and the second practical. 16 By didactic training we're really talking about 17 some type of a formal training program in radiation biology, 18 in nuclear physics and radiation protection. Things like 19 that. And we would specify a number of hours for this 20 didactic training that would be required in older to obtain 21 a master's degree in nuclear physics to be an authorized 22 user. That some knowledge of physics is needed to in order 23 to understand and handle the materials safely. 24 After going to a couple of meetings, and hearing 25 that competency needed to be verified via some method, the i f~h; ANN RILEY & ASSOCIATES, LTD. (_/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
l-362 1 working group also came to the conclusion that we needed --
/~'\ 2 that we would like to have individuals requesting authorized O
3 user status, radiation safety officer status, medical I l 4 physicist or nuclear pharmacy status to verify their ! 5 competency by taking an exam. 6 When we presented these ideas to the Commission in 7 June of this year there were two things that came out of 8 that durin; . hat as well as -- two items that came out 9 during that presentation as well as two concerns that were 10 raised over the last couple of months from the profescional 11 communities once they saw our proposals that we were putting 12 out. And that had to do with the number of hours that would 13 be devoted to this practical, to the didactic training. 14 And then also, what would be this examination n () 15 process? We were using the term examination given by an 16 organization approved by the NRC and agreement state. 17 From the NRC standpoint we're very concerned about 18 the number of hours, FTE-wise, that it would take for NRC to 19 implement this program. L 20 We're also concerned about the burden that we're i 21 placing on the licensed community, because you're going to 22 have to come in with some type of application to us 23 requesting approval of your organization. l 24 The current rule has -- current 35 -- has two l i 25 pathways for becoming an authorized user. And I'm just l l l ANN RILEY & ASSOCIATES, LTD.
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363 1 going to use the term " authorized user", but realize it () 2 applies to the whole list of other people that are touched 3 by Part 35. And that is one that you have certification by 4 a board that's named by the regulation. And then the other 5 is that you get this approved hour. You have so many hours 6 of practical, so many hours of didactic. 7 We still wanted to maintain that framework a 8 certain extent. Because if you went the board route, the 9 certification route, it became very easy for a licensee to 10 have you operate under their license. They did not need to 11 come in with their men with all your credentials and say, 12 "Please let Dr. So and So as an authorized user." All they 13 needed to do was to make sure that the physician was 14 certified by one of the board's listed in the rule, and then .rh () 15 within 30 days notify NRC that this individual was now 16 practicing under the license. There was no amendment fee, 17 it was more just a notification to NRC. It was -- it's 18 pretty much a user friendly sort of regulation. 19 What the problem comes to be is that the boards, 12 0 once they got into the regulation, were never reviewed by 21 NRC. They just -- it was basically once you got in the rule 22 you were fine. And it also required that any time a new 23 board wanted to become -- to get status in the regulation, 24 we would have to go through a rule making process. As you 25 heard earlier today, a rule making process is not -- you get ,O ANN RILEY & ASSOCIATES, LTD. k/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
1 l 364 1 'it the rule in two months. You know, we're talking several
/~'N 2 months if not years to get a rule change.
V 3 So, we looking at ways of stepping away from this. l 4 And one of the ways was to just afford this alternative 5 path, this pathway, as to say that the individual was 1 6 certified by a board that was approved by NP.C. The board 7 will not be listed in the regulations. We dould have a list l 8 on the Internet. We would, you know, have it obviously in 9 enough locations that it would be easy to get to. If a 10 licensee hired a new physician all they'd have to go and say l l 11 is, "What board does NRC -- has NRC approved? And are you 12 on that board?" If the answer's yes, you can go ahead and 13 operate and just the licensee would tell us within 30 days. 14 So, that's the one pathway. () 15 Now, the question. Came up about is what criteria 16 would be used to approve these boards. So, that took us 17 into the alternative B. The alternative pathway. Bece.use 18 for us to approve a board we would expect the board -- in 19 order to sit for the board, you would need the same amount 20 of training in radiation safety that you would need if yo' 21 were coming in under this alternative pathway but didn't 22 have the certification. 23 You have a copy of this view graph that came up, 24 actually, first. And if you look at -- this is pretty much ! l 25 the world of the training and experience requirements. And l l
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l 365 1 what I'd like to do is just step you through it first and (; 2 then come back and ask a few questions and tell you where 3 some of our concerns are. 4' In the case of the 25.1000 users there are your 5 unsealed pharmaceuticals. Should be using them for uptake, 6 dilution and excretion. Again, low risk area. We'd be l L 7 looking for 40 hours of didactic training and 20 hours of 1 l 8 practical. The individual to take an exam. And then also 9 to have a preceptor form. The situation with the preceptor 10 form is that currently an individual needs a preceptor form. 11 But all the preceptor is doing under the current 35 is 1 12 signing it, "Yes, this individual participated in this 13 number of cases." What we would be proposing is a preceptor l 14 form that goes a little bit beyond that. The preceptor will ! l () 15 be signing to say, "Yes, this individual has completed X 16 numbers of practical hours. And if there is case work t 17 required for that particular use, they completed that case l 18 work." But in the preceptor's mind, this individual is able j 19 to function as an authorized user for this type of use. 20 That last phrase is what would be different under what -- ' l 21 under this proposal. 1 22 In the- case of the 35.200 uses, which is your 23 unsealed pharmaceuticals for imaging and localization, you 24 would be required to have 80 hours of didactic, 40 hours of 25 practical, and again the same thing. You need to be a 1 (~' ANN RILEY & ASSOCIATES, LTD. ' 1 Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
366 l l 1 physician, you need to have a preceptor say that you had an
/~'\ 2 exam. \ ,) '
3 I know the issue of nuclear cardiology came up. l 4 Just to give some examples of what would fit in. ' A nuclear 5 cardiologist, for the diagnostic uses, would fall under this 6 35.2000 scheme in this proposal. 7 The 35.300 is your unsealed uses of 8 radiopharmaceuticals for therapy. Here we're looking at 80 9 hours, again. Of didactic training, 40 hours. But because 10 we are starting to step up into larger amount of material 11 that could pose a greater hazard to the patient and to the 12 occupational workers, we're looking for some case work to be 13 involved here. 14 We have sent five cases. It's close to what the t'% i ) 15 current rule is in this area. But we're looking at under 16 these five cases would be selecting the patient, is this the 17 right treatment. And I know that that starts to border on 18 are we looking at physician competency, but in speaking with 19 the ACMUI and physicians at other meetings, they have said 20 that to a certain extent in this therapy area that is part 21 of the program and you should include some case work there. 22 For those -- the endocrinologists would be falling 23 into this category. Withou* trying to highlight the area, 24 the concerns that have been raised over the last year. So, 25 endocrinology would no longer have this stand alone category l- {} I ANN RILEY & ASSOCIATES, LTD. , s_f Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
_ . .. _ .. _ .- _. _ _._ _ ~. _ _ _ _ - . __- ._ 367 1 in the rule. It would be they -- if they were using (i - 2 material under 35.300, which would be aware -- a written i
\ ,) ~ i 3 directive would be required. They would be required to have 4 the 80 hours of didactic and the 40 hours of practical, as 5 well as the exams. l
)
6 The next category is the manual brachytherapy. t 7 The strawman rule that went out on the Internet 8 significantly reduces number of hours. Again,-we were
, 9 trying to focus solely on radiation safety. And what we l 10 were told in a very good letter writing campaign from the 11 endocrinologists, from the ACMUI, we received a lot of input 1 12 that basically said that in the area 35.400 -- and I'll just 13 jump in and discuss 35.600 at the same time -- that clinical i
14 competency was so closely interrelated with radiation safety i () 15 that you cannot separate them. And in order _to know how to l 16 handle these materials safely you need to keep the l 17 requirements the way they are now. 18 We considered that. And by the time we got the 19 proposal to the Commission we had taken the training hours 20 back up to where they currently are, with the two
'21 exceptions. One being the preceptor four would be slightly 22 different, and also we would throw in a requirement for an 23 exam to verify competency.
24 The 35.500 would be our sealed sources for l 25 diagnosis. This is the one case where we did not require
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l 368 1 the preceptor form or the exam because of the low risk l (,) 2 associated with the use of material in this area. l l 3 The last three categories, the radiation safety 4 officer, the authorized medical physicist and the authorized 5 nuclear pharmacist, the changes there, again, are the exam 6 and the difference in the preceptor form. Your actual l 7 training requirements as far as degree requirements for a l 8 medical physicist, we left it two years. And two years of 9 practical use. And also the master's degree. l 10 In looking at these particular - ';his proposal, 11 several things have come to light. One is we are going 12 to -- we are impacting two groups by raising their training 13 levels. And we are reducing the training levels for several
,_ 14 others.
l
\>- 15 The two that we will be increasing the training 16 requirements for, one is the endocrinologist, as I said 17 earlier, and also the users of -- that just have the 18 strontium-9si applications. Authorized users for l 19 strontium-90I applicators would be asked would be asked that 20 they go into the 35.400 area. So, this is a significant 21 change for them.
22 I would like to throw out a couple of questions 23 and then turn it over to Chip to just facilitate a 24 discussion. l 25 The questions that you see up on the screen are
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Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l l l
l 369 4 1 ones that are taken from the Federal Recister, in a training
) 2 area. As I said, the reqairement for an exam does effect a 3 lot of different groups. Both sides, really. The 4- government side and the user. And we have some requirements 5 in the rule for what the examining organization would need 6 to do. And one of the requirements is that if you are an 7 examining organization, we want you to be sure that you're 8 not examining people that you're also training. We're 9 looking for some independence there.
10 When this was going up through the management 11 training, the question came up about why does it matter, why 12 can't we just put into the rule assure that training is -- 13 or that competency is addressed and just leave it at that? 14 Why be so prescriptive in the rule? Hence, we've asked the 15 question and any input you give us on that would be very 16 good. 17 Then you could even step back a little bit further 18' and say, "Do we really need the exam to verify competency?" 19 One of my responses when asked that question is that in 20 diagnostic area we have significantly reduced the training 21 hours. We have gone from a 200 hour didactic down to 80 and 22 we've gone from basically 1,000 hours in a clinical setting 23 down to 40. And my response is if I'm -- if I'm comfortable 24 with reducing the training hours by that much, I want to 25 assess competency, hence the exam. But I'm interested in ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
_ . _ . . _ _ _ . _ _ _ _ . _ _ . . . . _ . _ . . . _ _ _ _ _ _ . . _ . _ _ _ .m_ 370 1 the input on is the exam the right way to do that.
) 2 Another thing that I would be looking for input 3 and it's probably -- since the rule's only been out for a 1
4 week and I know you haven't had a lot of time to look at it, : l 5 but probably we'll focus more on this in the Kansas City 6 meeting and at the Washington meeting, is that we have 7 projected a certain amount of time needed for boards to 8 prepare and to submit an application to NRC. And that's 9 some of the information that's contained on the regulatory 10 analysis that I mentioned earlier. That was our best guess 11 at what it would take for the boards to come into us with an i 12 application. And what we're saying, "Is this reasonable?" 13 Because we want to be estimating the cost of this rule as 14 accurately as we can. I know there are a lot of testing (_/ 15 organizations out there that have had a lot of experience 16 with this and the question is have we adequately asked this, 17 you know, estimated the impact on the industry by requiring 18 this examination? j i 19 Another question that's not on the view graph but i 20 I would like to throw out is let's say that e just say that 21 the competency is verified by an exam and NRC does not 22 approve that examining process. Let's say we allow the 23 industry to approve the board process. What do you see as 24 vulnerabilities in that area? An example would be there's 25 been a severe -- a medical event that has caused biologic A) ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
371 ! 1 damage- . We go out and we look and we say,- "What was the () ~2 training of this-individual?"- We find that the individual { 3 had 80 hours.of didactic training, had 40 hours of practice, ) 4_ he took an exam that was given by ACGME testing. ACGME 5 testing had been approved as -- 1 6 MR. CAMERON: Didn't I hear ACME at some time? , 1 7 MS. HANEY: Yeah. That was, I think, in Chicago. l 8 The ACGME's testing was peer reviewed by-their 9' buddy down the street. We, of course, have to respond to l 10 our Commission,_hence to the Congress, hence to the public. 11 .s I this a good way of doing it? Should that exam be 12 approved by NRC? And when I say, " Approved by the NRC", I 13 wouldn't want to be cutting the agreement states out because 14 you would be part of the approval also.
) 15 So the question, can we take those words out of 16 .the text of the ruling and what problem does that cause us?
17 And then one last question is in the case of the 18 35.300 users where we are saying that we want a certain 19 amount of practical experience. Rather than specifying an l i 20 hour amount could we just go ahead and say we want ] 21 experience with five cases and this experience would include 22 not only selecting the patient but ordering the dose, 23 receiving the dose, surveying the package when it comes in, 24 handling any patient issues that came up if the patient were 25 to contaminate an area of the facility before they left, and ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1 t _- .
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372 1 waste disposal. j 2 If we rathe than -- in other words, rather, 3 rather than specifying hours say what we were interested in 4 the individual knowing and then leaving it up to the 5 particular facility or the preceptor to say how many hours 6 they felt that was'necessary and by their sign off on the , 1 7 precepts report they are attesting to the fact that this 8 individual is knowledgeable. i 9 So, with all those questions on the table I think l 10 I'll turn it over to Chip to get answers. 11 MR. CAMERON: Thanks a lot, Cathy. ! 12 These new proposals will effect all of you in 13 different ways. And I know that you want to comment on the 14 particular provision that effects you. But as much as () 15 possible I'd also like to look at some of the generic
~6 issues. Is the basic approach that's being used the best i 17 way to do it? Is an exam necessary? I take it if you do 18 away with the exam then the need for applications from 19 specialty boards and examining room physicians would no 20 longer be necessary?
21 MS. HANEY: Well, I would still like to see the 22 specialty -- well, we would not need the applications to 23 come into us, but we still would need some type of mechanism 24 for approving the specialty boards unless we chose to 25 continue to name them in the rule.
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373 1 And the reason that I would -- would not want to
-[^h 2 just put up the training hour requirement is that I don't V 3 really want to put licensees in a position where they're 4 sitting there looking at Dr. Jones's qualifications and 5 saying, "Does he have 80 hours? Does he have 40 hours?
6 Has -- does he have a preceptor report that's completely ! 7 filled in?" I'm trying to make the rule more user friendly 8 where they could just say, "Oh, Dr. Do and Do is certified 9 by X organization and NRC has approved it, hence, you know, 10 you're in." And that's all the thought process that the 11 licensee needs to go through. i 12 MR. CAMERON: Okay. Does everybody understand the 1 L 13 basic -- the approach of the proposed rule? 14 . Well, why don't we go to Bob Lull? 15 DR. LULL: The Society of Nuclear Medicine and [(_-) 16 Nuclear College of Nuclear Physicians are generally agreed l 17 on the fact that people need to have a sufficient expertise . 18 from a radiation safety point of view before they should 19 become authorized. This should be documentable. The -- how 20 that is accomplished there was some division in our 21 organizations. l 22 The American College of Nuclear Physicians felt 23 that the current prior hours, as previously defined, had 24 this incredible safety record that we described yesterday 25 and that it shouldn't be changed. l tN ANN RILEY & ASSOCIATES, LTD. l (,,)- Court Reporters 1 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
374 1 The Society of Nuclear Medicine, on the other O) i s 2 hand, felt that -- that the number of hours is 3 inconsequential and that as long as someone achieves true 4 competence in these areas so that he can deal with the use 5 of the radioactive material safely. And that a -- that an 6 exam in all of the areas that they previously submitted this 7 to the NRC. You have this in your commentaries as to which 8 topics ought to be learned, and that an exam to document 9 that would be very important considering the reduction in 10 the number of hours. 11 My own personal feeling -- and I believe I might 12 also'be speaking on behalf of both of these organizations -- 13 is that when you talk about the five cases, in any
/3 14 implication that this is experience in selecting the k)s- 15 patients or doing something for deciding that this is 16 qualifying this person for the appropriate medicine in the 17 medical arena, for applying the radioisotope or the decision 18 about whether or not the active isotope should be applied to 19 the care of that patient is kind of bogus. Five cases is 20 not nearly enough for that. And the NRC should be yearly 21 talking about their use of those cases for practical 22 experience in radiation safety. Only the radiation safety 23 aspect of the care of that patient is what they learn about.
l 24 And that's under routine circumstances. It's unlikely 25 .they're going to actually have a spill in five cases, so l[ ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 : Washington, D.C. 20036 (202) 842-0034
L 375
- i. 1 that they're not going to learn how to deal with a spill in
() 2 that small number of cases. And hopefully dealing with a 3 spill would be either a created classroom exercise, 4 laboratory exercise, or it would be something -- because 5 spills should be fairly rare. They certainly ought to have 6 the theoretical basis for how they deal with it. And i 7 perhaps a classroom laboratory exercise as part of the l 8 radiation safety classes to learn how to practically deal 9 with a spill when they're dealing with unsealed radionuclide 10 sources. 11 But certainly those cases you should not be using 12 the term " selected cases", because that's not sufficient and 13 that's not what it's about. They -- whether they select the 14 cases is partly the credentialing process that would be done k, m 15 in the medical side of things. 16 MR. CAMERON: Do you have some questions on that 17 Cathy? 18 MS, HANEY: I guess I do have a couple of 19 questions, l 20 And we have statements in the proposed rule that 21 says -- that say that NRC status as an authorized user is 22 not to assess clinical competency. 23 The reason we have -- one of the reasons we have 24 the case work in there is because we have heard from, over i
.25 the last year, from ACMUI and from the other public meetings j
() ANN RILEY & ASSOCIATES, LTD. Court Reporters ! 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 i (202) 842-0034
376 1- as well as a lot of the read letters. I think we have about () 2 360 letters that have come in since we started this process 3 last year, probably 330 of those address the training and , 4 experience issue. The majority of those are in the therapy l 5 area, but we'do have'a lot in the diagnostic area. 6 But one of the things that we heard during most of 7 the -- I believe it was the ACMUI meeting'-- is that once 8 you get into the therapy areas, whether it is in the 400 and 9 600 areas, and even to a certain extent the 300, you're 10 starting to get to the point where you cannot separate l 11 clinical competency from knowledge of radiation safety. And L 12 because of that we should leave the five cases in there. I 13 Now, what I believe I'm hearing you say is that in 14 the requirements for 35.300 we should not even include'a 15 case work. We should just leave it practical. 16 DR. LULL: No, what I'm saying is that you should 17 include case work but realize that the case work is'not 18 adequate towards the clinical competency evaluation 19 whatsoever. That small number of cases. What it is 20 adequate for is learning the routine radiation safety 21 applications in a therapy setting. 22 MS. HANEY: Okay. 23 DR. LULL: And so, it's basically practical 24 experience in radiation safety, but not in clinical 25 application. J. ANN RILEY & ASSOCIATES, LTD. Court ~ Reporters .. 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 , (202) 842-0034 1 i 4
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377 1 MS. HANEY: Okay. (m) 2 DR. LULL: That's the distinction. And I hope I'm 3 really clear on that because I think it's a very important 4 point. We're talking about didactic work and practical 5 radiation safety work in a clinical circumstance, but it's 6 still radiation safety. 7 Five cases.should be adequate for covering the 8 radiation safety practical experience for routine 9 circumstances, but it's certainly not anywhere near as 10 sufficient for the decision process about whether or not you 11 should do the treatment. 12 MR. CAMERON: Okay. Thank you. 13 Dr. Prendergast? 14 DR. PRENDERGAST: Speaking from the endocrinology p(,,/ 15 side, as was alluded to in other areas, the safety issues 16 really have been quite good and there really hasn't been a 17 significant reason to say that it's a problem. 18 In terms of endocrinology we do have an increase 19 in the hours that should be needed to handle the isotopes. 20 We think that the endocrinologists have programs in the 21 present amounts that really do things very well. And our 22 organization does that. Historically, if you look at the 23 data on how to treat'the things we do, which are basically 24- hyperthyroidism and thyroid cancer, these are situations 25 where a long history and peer review journal review would rN ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
378 1 say that the endocrinologists are supremely skilled and do () 2 very well with the management of this. 3 The basic way that the endocrinologists approach 4 this is just like we have heard from our cardiology friends 5 here. It is these are our patients, the institution for 6 caring for that patient we go on with, we continue to 7 incorporate our skills and the personal things that we have 8 involved with the patients. To involve other aspects of the 9 thing doesn't seem to be needed at this particular time. 10 And I would say that given the safety history and our 11 special concerns over the period of time, I would say that 12 it would be appropriate to keep the methods of education the 13 way they were, for us at least. 14 MR. CAMERON: So, you're suggestion would be to O. (_,/ 15- maintain what's in the current rule? 16 DR. LULL: That's correct. 17 MR. CAMERON: All right. Okay. 18 Let's go tu the cardiologists. Rich? 19 DR. HEUSER: I'm sorry, because I've got to get 20 going. But I just wanted to -- I sound like a broken 21 record -- I agree with all of the proposals for training and 22 experience for what you have in place, particularly if the 23 specialty boards are the ones that through the NRC or in the 24 determination of competency rather than the NRC. NRC should 25 mainly be concerned with safety. (O
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379 ) 1 On the other hand, as we mentioned before, in the 2 area of intervascular brachytherapy, this is again why we 3 bring it up, why it should be in the new technologies. l 4 Because I don't-think.we're at a stage right now where we l' 5 can even discuss, at this stage, training experience in 6 intervascular brachytherapy. That's something that we need
-7 to-table at this time and hopefully, in the ensuing further 8 . meetings, be able to discuss that on a more practical level l 9 when we know a little bit more about that technology.
l l 10- MR. CAMERON: Okay. Thank you. 11 Elias? 12 MR. BOTVINICK: First.of all, the ort nizations ; 13 that I represent, American College of Cardiology and ASNC, 14 really supports this approach. I am personally very pleased 15 ~ to see it' coming. From my personal point of view at the 16- university center, I've ben unable to train cardiology 17 fellows in this practice, simply because we don't have 1200 18 hours. I mean, I teach them what I can I think it's 19 sufficient, but they certainly can't qualify in that time. 20- This will allow me.to get my arms around them. I 21 will be able to legitimately testify that these people , 22 underwent the training and they've gone through the various 23 steps and they qualify. I could be one of their preceptors, 24 which is thrilling to me. And that's going to be 25 proliferating around the country. There will be a lot of i l I h ANN RILEY & ASSOCIATES, LTD. , d Court Reporters
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380 l 1 legitimacy brought to this training, first of all. r" 2 (%) As has been said, the use of radionuclides in i 3 cardiology has been going on for 20 or 30 years now and very 4 safely. The organizations, again, that I speak for are very 5 much committed not only to radiation safety and the teaching 6 of nuclear medicine physics and the basic groundwork or the 7 clinical application, but they also have very legitimate 8 board certified or. qualifying type examinations that include 9 radiation safety. It's an important aspect. 10 And I'm told they're very willing to accommodate 11 if, for some reason, on inspection the amount or the content 12 doesn't exactly suit these new regulations, they're more l 1 13 than willing to alter the exams so that, in fact, there is 14 full agreement and compliance. And the Nuclear Cardiology
- s. ,
t (_) 15 Society han, in effect, has what they call an exam sponsored 16 by -- they're certifying counseling. It's not a board level 17 examination but, in fact, it's really designed to make sure 18 that people who practice the specialty are qualified, rather l l 19 than saying they have boards in nuclear medicine or boards l 20 in cardiology. And I think we have one because it's 21 specifically targeted to this application, and that would be 22 another venue to really implement the radiation safety and 23 physics aspects. And as I said before, 25 percent of that l l 24 exam is now based in radiation safety and nuclear medicine j 25 physics. So, for all those reasons, we're supportive. rN r ' /) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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381 1 The question I asked, should you do -- should you r" 2 not have an exam? Now, I know the 1200 hours, there's no 3 exam required for that, specifically. Isn't that right? l 4 They're just hours. I 5 MR. HANEY: Right. Just hours. 6 MR. BOTVINICK: In fact, I -- I don't really know 7 what the organizations would say, except I have papers in 8 front of me, basically, telling me that the ACC boards, the 9 ASNC certified exam would be wonderful ways to test the l 10 competency. So, I think they're very supportive of exams 1 11 and I really can't see how you can implement this change in .
)
12- regulation without some kind of formal examination 13 procedure.
-~ 14 So, I think you're going to have to have an exam. -
i
\_- 15 Exactly this number one point, who can give it and who -- I l 16 think if it's under the auspices of one of our professional 1
17 societies, I think there are regulations there to make sure 18 that there's no tampering and that the testing is entirely 19 legitimate and proper. I think that would be enough 20 validation for me. 21 So, suffice it to say, I'm thrilled by this 22- personally. And I think our organizations would be very, 23 very glad to support this approach for the training of l 24 physicians i. nuclear cardiology. 25 MR. CAMERON: Okay. Thank you. O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I l 382 1 Melissa? , /"N,
, / 2 MS. MARTIN: I guess I'd like to -- obviously I'm 3 going to speak for the medical physicists. I don't -- I'd 4 like one point of clarification. l
- At least I cam here with l S the assumption when I read this that for those physicists 6 that are already board certified by American -- in other 7 words, one of the boards already named, whether you name 8 them specifically or not, but ADR, ADLP. This is not an 9 additional exam. That this would be recognition of those 10 boards already.
-11 MR. CAMERON: That's a good question.
12 MS. HANEY: We would see that anyone that is 13 currently listed as an authorized user or as a medical rx 14 physicist on a license would not have this as an additional k-) m 15 requirement. 16 However, if this rule were to go into effect as 17 proposed and if the -- if the individual had taken that exam 18 by that board and that was one of our improved boards they 19 would not need an additional exam. But if that 20 wasn't -- if that board had not been approved, they would 21 need to take an exam. And that applies across the board 22 with anyone that is an authorized user, a medical physicist, 23 any one of those categories, when this rule goes into 24 effect. Therefore, they would not be subject to these new 25 training requirements. p i)'- ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 ! Washington, D.C. 20036 ! (202) 842-0034 l
l 383 1 MS. MARTIN: Based on that -- that premise -- () 2 that's what I wanted to cleared up, because I thought it 3 wasn't just a medical physics-question. 4 I would just strongly encourage you to realize 5 that the AAPM, the ADR, Commission on Physics, and the 6 American College of Medical Physics, all have developed very 7 similar, basically equivalent, definitions for what we 8 consider a qualified physicist. And those all require 9 certification by an independent board to be recognized.by 10 that. 11 So, I would be very much in favor that to be 12 qualified as an authorized medical physicist would require l 13 certification or certainly the equivalent thereof to be 14 board eligible, at least to be listed. So, I would speak
) 15 very much in favor of requiring the certification exam.
16 The other thing I'd like to speak to is I think 17 the first topic you said, "Who can give an exam for 18 qualifications for providing the training and experience?" 19 I have no problem with the professional 20 organizations giving credit. We , as a medical physicists, 21 have an accrediting organization that recognizes and 22 accredits all of our physics hours -- the recognized body 23 for all physics' continuing education hours. 24 I would strongly encourage all the organizations 25 to have something similar to that and not adopt -- I'm using ID ANN RILEY & ASSOCIATES, LTD. \~s# Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
384 1 one of the examples. There is a training course that's
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-O 2 offered by an X-ray technolonist for a two week, 40 hours of 3 training. That person hasn't operated in training of 4 radiation safety. They operate as a dude ranch in Colorado. 5 I do not think that should be accepted as education and 6 training for the 40 hours of radiation safety. 7 MR. CAMERON: Thank you, Melissa. 8 How do we deal with that? 9 MR. BOTVINICK: Can I just put my two cents in? 10 MR. CAMERON: Go ahead. 11 MR. BOTVINICK: Just in regards to that. The 1200 12 hours -- I'm aware of what you're saying, but the 1200 13 hours, you see, brought people to that situation. There was 14 no other recourse. They needed 1200 hours. There were (f 15 people out there, scrupulous, unscrupulous, well trained, 16 not well trained, who were giving a certificate that said 17 1200 hours. I couldn't give them that certificate. Other 18 people around this table couldn't. But we could give a 19 certificate that they're well trained in radiation safety 20 and nuclear medicine physics sufficient to meet these 21 requirements and, potentially, you can give them the 22 didactics that they need with this more limited and more 23 practical requirement. I think that many of this 24 organizations would then dry up. That's all I could hope. 25 MR. CAMERON: And would that be true across the ANN RILEY & ASSOCIATES, LTD. O) (. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
385 1 board, of all the different types of -- I hate to use the 2 word board -- but will that be true across all of the (} 3 various disciplines with this new proposed rule? Melissa? 4 MS. MARTIN: I can only speak for the physicists. 5 Our hours, in something like that, would not be good for 6 anything. We have to have to have campat (phonetic) 7 accredited hours. 8 MR. CAMERON: Okay. Well, let's go the agreement 9 stage representatives. Terry and then Ed. 10 MS. FRAZEE: Well, I like the comment Dr. Lull 11 was saying -- made about the -- the basic reason for having 12 five medical case studies, and that is the hands-on 13 experience, practical experience with dealing with actual 14 radioactive materials. And the hands-on aspect is also what () 15 leads me to look more towards the training experience for 16 the technologists. The technologists are really handling 17 the materials and we see to avoid that and look more towards 18 what these -- the special handling seems to be more really 19 based in clinical, the physicians of all the occasions to 20 select patients and so forth. And I know we're saying -- it 21 seems to be an underlying premise. 22 The ultimate for practical exam would be -- I 23 really don't care how many hours that you specify, I want to 24 give you the real practical exam, depending on what kind of 25 study you're going to be authorized for. ANN RILEY.& ASSOCIATES, LTD.
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386 1 If it's diagnostic nuclear medicine then you come
~T to me and say you're ready to come to take the test and the (d 2 j
3 test is I'm going to put you on a hotline and I'm going to 4 hand you a vial of some unknown, and just as you reach out 5 to take it I'm going to drop it at your feet and let you 1 6 deal with it. And you have a whole range of considerations ) 1 7 that you have to go through. And if you can pass the test, 8 that's fine. If you're into the more therapeutic range I 9 obviously the hazard is going to be increased, and likewise 10 what's being dropped at your feet will also increase. If 3 1 11 you can get through that then whether you're the physician ) 12 that's administering a therapeutic dose or a technician, 13 technologist who's administering the diagnostic 14 pharmaceutical, cool. All right. I'll have some confidence (') 15 that you really know what you're doing before I'm willing to 16 write the license for you. 17 MR.-CAMERON: Thanks Terry 18 Cathy, any response? 19 MS. HANEY: No.
- 20 MR. CAMERON
- All right.
21 Ed? 22 MR. BAILEY: I guess I probably am picking at 23 gnats right now, but when we're talking about either NRC or 24 an agreement state approving these course, what I -- or 25 could I assume that which organization did it would be based ANN RILEY & ASSOCIATES, LTD. Os Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
387 1 on where that organization was based? ( f 2 I mean, right now we've got a pretty much a 3 standard thing that if a company is physically based in one 4 state that's where they get their licenses to do things. I 5 think some -- and if the answer to that is yes,'that's fine. 6 If it's nc, then I would suggest that there may be shopping 7 around for approvals. So, that is a little bit 8 disconcerting to me on how we would go about approving. 9 If a state must approve it, then many states or-10 some states may run into a problem of actually not having 11 1 the authority, in their present law, to do it. And I would 12 give the example of Colorado which had a course that we all 13 tried to get them to review and approve. And they responded 14 back they did not have the authority to approve course. So, () 15' that's one issue. 16 I think the other thing that to me is missing from 17 this training and experience thing is the continuing 18 education requirements. I think they need to begin to be 19' looked at in this field, otherwise they're going to -- and 20 they may be already be done by specialty boards. By -- I 21 think in general we are not concerned as much about people f 22 who have gone ahead and been prudential about specialty 23 boards and so forth. But we're looking at those people who 24- are now down in that second tier who are going to short 25 courses or whatever to get their qualifications. ANN RILEY & ASSOCIATES, LTD.
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l l 388 l 1 I would suggest that when we're looking at these
) 2 courses, the didactic hours, that we would be looking at 3 some organizations such as ACGNE as being the accredited 4 program there.
5 One other question that I have is since right now 6 I can come into NRC and present my certificate and be 7 approved as an RSO, although I don't work at the facility as 8 an RSO right now, I might want to four years from now. So, 9 can I come in ahead of time, using today's standards and get 10 approved and can that continue as -- becauce I'd hate not to 11 know that and have to take another test. You know, if I'm 12 certified., I'm certified, so why should -- if I ever met it 13 during the time that rule was in effect it seems like that 14 would facilitate it, unless you have continuing education or b) g 15 some other way to prohibit it. But I will send you an 16 application to be approved as an RSO just in case. l 17 MS. CATHY: I have something to say. 18 MR. CAMERON: Go ahead, Cathy. i 19 -- MS. HANEY: Okay. For the first one, as far as 20 the -- would the accrediting -- or the organization wishing j 21 to be accredited have to go to the state in which they're 22 residing? We have had some discussions in the NRC about 23 this. At least the current position is no. We recognize 24 that that would result in shopping around from NRC to state, 25 and because of that we would probably end up assigning in [ ANN RILEY & ASSOCIATES, LTD. 1%_]/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
389 1 the -- compatibility of range a designation that would make 2 sure that everyone was looking at.t..e same things. 3 Again, we can talk about what level this is on, 4 but we are not, at this point, prepared to say that a state 5 must have a program in place to do this. If they chose not 6 to, that's fine. If they hapnen to have a professional 1 7 organization in their state, that professional 8 organization -- they come down to NRC and say, " Approve us." 9 And-also, the issue had come up about reciprocal 1 10 recognition too. And those are some of the things that 11 we'll need to work out at the states. And I suspect it will 12 be a key discussion point at the agreement state meeting in 13 October when we're discussing the rule with the states. 14 That was the answer to that. We did -- () 15 16 MR. BAILEY: Well, there's one shade of that. MS. HANEY: Okay. 17 MR. BAILEY: What if I did want to approve them, 18 but they didn't want to come to me, they wanted to go to 19 you? 20 MS. HANEY: That would be okay. Our thinking 21 right now is it's okay to. 22 MR. CAMERON: Before we go to Dr. Lull and Dr. 23 Forester I was just curious. Will the agreement states, 24 when they comment on the rule, is it likely that they'll 25' look at the individual categories that users, for example, i
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390 1 comment on what the requirements are for in cardiology or in () 2 other areas? Give us your opinions on whether we have those 3 right. 4 MR. BAILEY: My response would be that I think 5 that's going to be as varied as there are agreement states. ' 6 There are going to be some agreement states you're not going 7 to hear from at all. There are going to be some that will 8 have a particular bar about one thing or the other. And I ! 9 don't think you're going to get a unanimous opinion on any 10 part!.cular part of this section except maybe the title. And 11 maybe not even that. Because I don't think, in general, the ) 12 agreement states are -- are a unified organization that's 13 going to come with one position. There's always going to be 14 people that have different opinions about how you do things. ' O \s / 15 And so far it hasn't caused really any big 16 problems I'm aware. 17 MR. CAMERON: Okay. Dr. Forester? 18 DR. FORESTER: Well, I'm going to go back to the 19 brachytherapy issue with relation to training and education,. ; 20 And I think that we should start out by agreeing that your 21 principle number one that you showed on the previous slide, 22 which is that the requirements for training and experience 23 should be risk-based is one that we should all be able to 24 agren on and should be the guiding fundamental principle foi 25 decision I this area. () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
391 1 So, if we establish that -- that it's risk-based i 2 criteria, then what we find in brachytherapy is that we 3 immediately run into a conundrum. And that is, what's the 4 level of risk? And I'm going to give you three examples. 5 There's a Dr. Waxman at Washington Hospital in 6 Washington, D.C. who is using a gamma wire that -- with a 10 7 curie source. And the patient was taken to radiation 8 therapy and that has delivered -- can't be delivered in the 9 capthelat (phonetic). Dave Faxon, who was sitting here this 10 morning, is using a source that is one 20th that. It is a 11 gamma source that is self-contained. You crank it into the 12 vessel and you crank it out. It's a half a curie. And the 13 third approach that's being used is a balloon that is 14 manufactured by Malincroft that uses radium. And the n(_/ 15 quection -- to the question,'what happens if the balloon l 16 ruptures and this is sprayed down-the coronary artery. It 17 is alleged that this would be releasing a dose that would be 18 essentially comparable to a thallium stress test. Now, I 19 think that what that suggests is that it's very difficult to 20 write a -- at this time, a prescription that would cover 21 those three scenarios. 22 And if you said -- and that is the reason, I 23 believe that this is, as I said this morning, the , 1 24 quintessential example of emerging technology. And that is 25 where it belongs at the present time. {\ \- ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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392 l 1 As Don suggested this morning, sooner or later 2 we're going to have to make a decision. And I'm well from l 3 the era of Yogi Berra and I remember his quote about making 4 decisions. He said that when you come to a fork in the 5 road. Take it. And maybe that's what we ought to do. l 6 But the idea -- and I would add on this -- which l 7 is not an ACC position, but one that I think many 8 cardiologists would agree with thic. On the specific
- - 9 response to your question, at a time when it becomes 10 apparent, and it usually becomes apparent six. months to a 11 year before it's actually approved, the FDA is going to 12 . approve a technology or a device, one of these, and I think 13 it would be appropriate to have a group of experts 14 representing the people who are out in the table "te e, that 15 is, manual physicists, radiation oncologists, cardiologists, 16 and industry, get together to hammer out a set of criteria.
17 And Melissa, I really wouldn't move out Hawaii for this 18 conference. And that goes in -- and I believe that if we -- 19 Scilitating that discussion we'd be able to reach an 20 agreeme#., even though it n1ight be somewhat contentious. 21 Buc I think that wb:igj be a reasonable way, Don, 22 of developing the criteria that you need, using as our 23 standard that requirements of training experience must be 24 risk-based. 25 If it turns out that it is only a balloon with a l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 393 1 dose that is comparable to thallium, it may be that the 2 radiation oncologists don't have a role in that situation. [O) l 3 If it turns out to be a gamma wire with 10 curies, the 4 radiation oncologist certainly has a role. And I think 4 5 that -- I imagine that the radiation oncologist only might I 6 have a role in those situations in which they make a 7 significant and reasonable contribution. So, we don't know 8 at the present time where that will be. 9 In response -- so, in response to these three 10 questions specifically, I do think that the requirement for 11 examining organizations to ensure that examinations are not 12 given in the -- as instructed by the examining organization 13 is reasonable. Specifically, the ACC tends to shy away from 14 1 certification but seeks to provide information to certifying (~% , 15 organizations. (w) I think that would be the position we would 16 take in this particular case. We'd be delighted to advise 17 the public, but do not want to be a certifying organization. 18 It's a requirement for the examination to verify 19 competency. I tend to agree with Elias. I think the 20 examination is good. I don't see any great downside to it. 21 And especially if it turns out to be a relatively limited 22- risk, I think that that examination is worthwhile. 23 The third question I really don't know the answer 24 to and I'd have to take it to people who know more about 25 this and bring it back to you.
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394 1 So, in summary, with relationship to intervascular () 2 3 brachytherapy, I believe that the best decision at the present time is to designate it an emerging technology, to 4 develop a plan soon, as we see what starts to emerge as the 5 appropriate therapy,.which would involve the people around l 6 the table to develop proposals for the NRC. And those 7 proposal would, among other things, answer the questions 8 that you would ask. 9 MR. CAMERON: Thank you, Dr. Forester. 10 How about some comments on Dr. Forester's 11 suggestion about how to handle emerging technology issues, 12 particularly training experience? L 13 Dave, do you have comments on that? l , 14 DR. LARSON: Well, first of all, radiation () 15 oncologists only do things that are significant. 16 I think everything that was said was quite p 17 reasonable. My concern is what happens now? Between now l 18 and some future time when we know a little bit more. What i 19 1 l are the requirements now? If we put it under emerging i 20 technology we're p7 y much obligated to develop, as I 21 understand the regulacions, some statements regarding 22 training; whereas, if we didn't put it under emerging 23 technologies, it could be covered by the things I suggested 24 earlier in radiation oncology or nuclear medicine. A l 25 physician would be involved in our case until some time in
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395 1 the future when we know more about the technology. ( V) 2 MR. CAMERON: There is an issue of timing raised 3 there. 4 Any other comments on the suggestion? Kathy? 5 MS. THOMAS: Well, one of the aspects that I keep 6 turning to,.whether it's an emerging technology or whatever, 7 is what we're talking about here is out ability to handle 8 and understand radioactive materials. 9 We're not looking at competency to put the wire 1 10 in, we're not looking at all the other issues associated I 11- with doing that procedure which is -- goes into clinical 12 aspects. What we're looking at, from my perspective, is 13 understanding the radiobiology, understanding the spill, 14 understanding all the criteria associated with that i 15 Iq )\ radioactive material. And that's where the competency is 16 illustrated with an exam. 17 So, regardless of what you're going to do with 18 that radioactive material, whether it's an emerging 19 technology, whether it's something that's a known fact today 20 as long as you know how to handle that and you can 21 demonstrate that competency, that's what this is all about. 22 So, to me, anyone at any time should be able to 23 meet the 40 hours, 80 hours, whatever, demonstrate their
- 24. competency. And it's a mute point whether it's an emerging 25 technology with a new way of using brachytherapy or if it's l
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{ l-i i 396 i something else. So, I guess I'm a little confused. I l) 2 understand that's emerging technology and haven't got a clue 3 how it's going to turn out. But if you've demonstrated your 4 ability to handle the radioactive material, what else is 5 there really to worry about relating to the NRC? 6 DR. LARSON: ,Well, I suppose the issue, then, as I 7 understand what we're talking about, the -- perhaps the 8 three years of training for if we were to stick with the 9 established regulations, whereas that might not be the case 10 if we were to put it into the category of emerging 11 technology. l 12 I think that three years of training for a balloon l l 13 that ruptures and delivers thallium level doses would be 14 illogical and excessive. On the other hand, it wouldn't be p). ( -15 if it were the gamma wire. 16 If it was the -- if it was a device that was 17 normally under the purview of a nuclear medicine physician, 18 then it wouldn't be the three years. The three years would 19 only apply for somebody who normally be under the purview, 20 within the current regulations, a radiation oncologist.
-21 MR. CAMERON: Let's go to Bob Lull.
22 DR. LULL: I think the key here is not so much the 23 number of hours. The number of hours -- you can put in 1200
, 24 hours and come out an idiot, incapable of dealing with an 25 issue. What you want is to demonstrate competence. /~
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1 397 l n 1 Quite frankly, I think we need to continually ( ,) 2 emphasize -- what I've been hearing here is -- Ed, you're 3 talking about continuing education. Continuing education in 4 radiation safety -- once you learn radiation safety there's 5 not like a lot of new stuff happening in radiation safety. l 6 l Maybe from the radiation safety office in terms of ! 7 regulation applications. 1 8 But, I don't think the continuing education is l l 9 really on the clinical competence side. We're not talking 10 about clinical competence. Quite frankly, if we're talking 11 about clinical competence to do radionuclide therapies or to 12 do diagnostic imaging, my feeling is very strong that a 13 minimum of one year, and even that's minimum in terms of 14 really understanding the proper application of these (_) 15 techniques from a radiation safety point, which is what l 16 we're talking about here. l 17 There's a number of topics that need to be -- that 18 are -- that can be outlined that the Society has outlined 19 for the NRC in its statement on this, that people need to 20- demonstrate competence. And exams are the typical way of 21 demonstrating competence. I'm not sure I'd like to do this 22 in Washington state where he's going to toss the gauntlet 23 down in a glass vial at my feet, but it sounds like it would 24 be a practical way of doing it. And, quite frankly, people 2b in a few number of cases that are designated for the (~'\ ANN RILEY & ASSOCIATES, LTD. l ( ) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l l l
398 1 learning practical skills, radiation safety, are routine () -3 2 cases. They're not likely to be cases where you'll have a m&jor spill situation. So, even if those -- teach you how I 4 to deal with that. You know, if you're going to deal with 5' that that's where it_ takes experience and a lot of learning 6 and understanding. And basically, I would suggest that not 7 only can you end up coordinating with the board examines, 8 where they come to you and say, "Look, we want to make this 9 available to our people", but I would suggest that you ; 10 consider utilizing the Nuclear Medicine Technology 11 Certification Board. There's a test that certifies the i I 12 technologist. They could produce a test out of their 13 database of questions where they could end up being a 14 neutral organization not related to any physician group to () 15 work to sp) to the NRC to develop what would meet your needs 16 to make you feel comfortable. Because if you're not 17_ comfortable then there's -- then we have a problem. Because 18 I think you need to be comfortable with what's happening in 19 terms of the radiation safety viewpoint. And that could be 20 a technique that would be available for anyone, regardless 21 of whether their own specialty board is providing the 22 support that they need for that. 23 MR. CAMERON: So, that would be you -- that would 24- be your proposed dilution to -- to the scheme that's 25 focussed on in this third issue?
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I i l 399 1 DR. LULL: Yes. I think that that's certainly ! I Q,)1 2 one. And I think the emphasis isn't on the number of hours. 3 People are arguing about 40 versus 80 hours, 120 hours. You i 4 know, we don't really care about the number of hours. What 5 we care about is that people develop proven competence. 6 That when something bad happens they're able to deal with it 7 and not create a radiation safety issue that's going to make l 8 a media splash that's going to derail the whole process of l 9 risk-based regulation, which is what we're really all about. 10 And I think that will eventually solve the problem 11 for the brachytherapy thing. You know, I don't think you 12 probably need three years if you have one specific device 13 that has one specific action and you're learning how to deal 14 with that. You know, it's not going to take three years to O ( ,) 15 be able to learn how to deal with that safely. And it's a 16 different kind of issue from what radiation oncologists are 17 dealing with in terms of planning therapy doses. 18 So, I think that's something that NRC can look at. 19 Again, applying the basic concept of this space. I think -- 20 a major shift for the Society of Nuclear Medicine and 21 American College of Nuclear Physicians to adopt this. 22 You're all aware there are major turf and economic issues 23 that are out there that are playing on this. But we think 24 it's the appropriate thing. It's the right thing to do to 25 do risk-based approaches to regulation, and minimum ('~'l ANN RILEY & ASSOCIATES, LTD. i
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l 400 1 regulations so that we're not overregulating and 2 overspending when we could be applying the money to other
}
3 more useful things, like getting people to be more accepting 4 of nuclear power. 5 MR. CAMERON: Thank you. 6 Terry? 7 MR. FRAZEE: Going back to the risk-based -- risk 8 to the patient and risk to the public and the worker. I 9 think -- on the risk to the worker and the general public, 10 then get back to the more important thing would be the basic 11 health and safety aspects of any of the procedures. We've 12 been talking about whether they're standard or whether 13 experimental. Focussing on -- okay, if something goes wrong 14 you've got your patient to be worried about. But that's a p) g 15 different story. You've already blown Part 20 standards to 16 pieces. What happens to workers that are in the area, to 17 yourself as the physician, your personal exposure,. and 18 potentially to the general public. Can you deal with those? 19- That's really the basic radiation protection. It shouldabe 20 -pretty standard stuff. So, a minimal training experience 21 there ought to cover it. There is still the patient -- 22 concerned, but -- and that's maybe outside where we ought to 23 be, particularly in the experimental area, related to quite 24 a bit of this. 25 MR. CAMERON: So, with that viewpoint do you think l
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l 401 l 1 that the proposed rule goes to far in the training and
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( j 2 experience area? Do we go beyond the minimal radiation i N/ 3 safety -- radiation safety training? 4 MR. FRAZEE: Not too far. There's got to be a 5 certain amount of didactic and practical experience that you 6 have to have before you get to my test. Basic common level. 7 And 40 hours, 80 hours is inconceivable. 8 MR. CAMERON: All right. Ed? 9 MR. BAILEY: I just have a quick comment. 10 Somebody may have said it while I was out. 11 I think a very important component is left out of 12 the chart, and that is the technologist training. I would 13 suspect that there are more cont 7ct hours between the 14 technologist and the radioactive material then there are ( ,) 15 between the physician and the radioactive material. They 16 aren't so in the radioactive material. So, I think it's 17 very important to include training of those. 18 MS. THOMAS: The premise that we've gone through 19 throughout this whole thing is yes, the technologist who 20 handles this almost exclusively. Now, knowing and 21 understanding radiation safety is a very small component of 22 nuclear medicine technology totally. 23 And I would hate to see guidelines by the NRC that 24' only go as far as handling radiation safety practice. 25 Because then you're going to have nothing in place saying,
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402 1 "Oh, sure. We've got these competent, qualified, people. () 2 See, the NRC says they're okay." We're moving towards 3 national licensure and we're looking towards state 4 licensure, and we're not looking towards minimal standards 5 which only include handling the radioactive material. l I 6 You can have somebody -- I don't care whether it's 7 a doctor, a technologist, that knows everything there is to l l 8 know about handling that does, but once it's in the patient 9 you've got to know that next step. 10 And so there's just more to that. And we're 11 really not looking for limiting this entire thing to 12 handling the radioisotope because the technologist does so l l I l 13 much more than that. And I think there would be great harm l l 14 in the industry if you limited it just to handling f 15 radioactive materials. That's why it's been left out. l 16 MR. BAILEY: Yeah. But I guess my response is 17 that I am afraid that there are places where the only 18 training they receive is they need somebody to help that day 19 and they were the receptionist, the were the whatever, i l '20 MS. THOMAS: That's true, but if we're going to do 21 that, let's move to something a whole lot more, not a whole 22 lot less.
-23 MR. CAMERON: Let's go to Bob and then Dr.
24 Forester and see if anybody in the audience has anything to 25 say. i.
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403 1 DR. LULL: Well, this, you know, the technologist s
'w.J
) 2 issue is the same conundrum we have for physicians. .
I 3 I could see where you might for the technologists 4 who don't exist and say, well, there is licensure, put some 5 pressure on -- as we were talking about minimums. And quite 6 frankly, as I expressed yesterday, the concern is that l 7 people consider what here is being defined as minimum 8 radiation safety training and experience to equal clinical 9 competence. 10 And I think that it is very important that any 11 certificate or any license issued by the NRC, based on these 12 new minimal radiation safety, training and experience should 13 state, very clearly, that this is -- certifies that the 14 patient -- the individual has met minimum radiation safety (-~f 15 training experience and is not to be construed as 16 representing clinical competence in the application of 17 radioisotopes. 18 That's a battlefield that will be fought someplace 19 else, and -- in another area. It shouldn't be fought in 20 the -- at the NRC level. And that's the big shift that's 21 going on. Because -- because right now it's often times N 22 interpreted that way and it's a mistake and it's something 23 that we'll continue to have unless we make a very specific 24 clarification of that point. 25 MR. CAMERON: Cathy? j I~) ANN RILEY & ASSOCIATES, LTD. k_s/ Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1 l
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404 1 MS. HANEY: And this is a follow up to what Bob ( ) 2 had said, is that if the rule does go through as proposed, 3 we do reduce these hours, NRC does make statements that NRJ 4 credentialing is not a substitute for 11inical competency. l 5 We'd also be looking for the professional societies to carry 6 that to the public as well as for the representatives of the 7 American Hospital Association to carry that to their 8 hospitals and to their membership also, saying that just l 9 because someone has an NRC status does not mean they are l I
)
10 clinically competent. 11 So, the NRC has a responsibility in this area to 12 get to the message out. But also, I think, that 13 responsibility goes out to all of the other professional 14 societies that are touched by this rule making. () 15 MR. CAMERON: So does he. 16 MR. BAILEY: I think we've always -- we, as the 17 regulators, have always felt that.just as when we give 18 somebody's name on a radiography license, we're not claiming 19 that they're going to do -- make a good radiographical pipe. 20 But I think Bob's right, that some people 21 assume -- and I've seen it used where my name's on the 22 license and, therefore, I'm the one that's the expert who 23 can do it. And I'm qualified to do it because my name's on 24 that license. 25 DR. LULL: One of the concerns that you'll have , ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 405 1 will be, you know, because there is a tendency for people to () 2 take a short course someplace and then start doing this 3 without ever really getting real clinical competence. And j 4 I'm very opposed to that. I think that's the wrong thing. 5 But what's going to happen is it's going to lead to i 6 issues -- it's going to lead to problems that are going to 7 create public concern and we'll start the cycle of 8 overregulation over again because of a fear of radiation. 9 And it's important -- some people, when we start 10 talking about therapy, who may actually end up being really, 11 really harmed. 12 But frankly, whether someone takes out someone's 13 thyroid gland without, you know, good medical indication, no 14 one's requiring that surgeons aren't doing thyroidectomies () 15 without good indication either. So, I mean, when you look 16 at -- as we've talked about, the perspective of what else is 17 going on in medicine, you know, we still need to look at our 18 regulations in that perspective too. 19- MR. CAMERON: Okay. Let's go to Dr. Foraster and 20 then over to Elias and then we'll wrap this up. 21 DR. FORESTER: Well, I think you would not find 22 objections from the professional societies on the point 23 there is a clear distinction between competence in clinical 24 care and competence in radiation safety. 25 So, I believe that that's not going to be a [N
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406 l 1 problem. You would certaiuly have the support of the ACC. 2 I'll take on the i.ssue of -- that perhaps I should 3 l i clarify one other point. And that is at the present time, 4 i again with the intervascular brachytherapy, we are doing 5 this as a team approach. And the team currently involves 6 the cardiologist, a radiation or a medical physicist, a 7 radiation safety officer, and a -- a radiation oncologist. 8 And the research is being done around the country. j 9 At the same -- as Ed suggested, the issue 10 probably -- proportionately will come down to is the 11 radiation oncologist essential to that process. And I 12 believe that that will be determined by the level of risk 13 associated with the procedure. It's quite possible that we 14 could get away with just three of the four and not all four. [)
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~15 Very frankly, I don't know whether that's true or 16 not. I really don't know. But that's, I think, the --
17 the -- I hesitate to call it the turf issue, but it is the 18 issue that lies beneath much of the discussion between Dave 19 and I is what's the level of training necessary, and this is 20 so dependent upon what the level of risk is. But without 21' any question this has to be done as a team effort. And I 22 don't believe we'll be able to get away with any less than 23 three. 24 MR. CAMERON: Okay. Go ahead, David. 25 DR. LARSON: I'd just like to go record for ACRO ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 2 84 - b3 i
l 407 1 that we support entirely this notion that we're not l l-("') V 2 dogmatically saying radiation oncologists will, in the L 3 future, be involved. It depends very much on the kind of l l l 4 technology that develops. t 1 5 MR. CAMERON: Okay. John, did you have a similar 6 comment? 1 7 MR. EARLE: Yes, I do. I wanted to express my ! 8 delight at the position NRC is taking with regard to taking 9 risk into account in promulgating regulations. And I want 10 to.make that very clear. 11 I also appreciate the need to separate knowledge I 12 of radiation sink issue from clinical competence. But I 13 caution that if pushed to the extreme in that separation, 14 you're actually loosing something. And it's something that () 15 you may, in fact, need to keep in mind. I 16 The reason for having the radiation oncologist 17 amongst the four individuals in your team at the moment is 18 precisely because we don't know what we're going to wind up 19 using. And of the members of that team the radiation 20 oncologist is the only one that has the full knowledge of 21 the entire biological spectrum of effects of these agents, 22 this kind of treatment, on the tissues at risk. 23 And some of that experience is, in fact, clinical. 24 Some of it is experience gained in following patients over
-25 the years and watching for the perhaps even subtle l
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408 1 complications of radiation treatment that may occur.
) 2 So, although I agree with trying to keep a 3 separation in the competence in radiation safety, I caution 4 to you that radiation safety may be dictated by the clinical 5 events that occur and can occur quite --
6 MR. CAMERON: Great. Thank you, Dr. Earle. 7 Elias? 8 MR. BOTVINICK: I think it's already been said 9 about Dr. Forester, but again, it's perfectly appropriate, 10 and it seems to me that the NRC has never really intended, 11 as has been said, to certify the clinical abilities of 12 practitioners. But it was always focussing the regulation 13 on issues of radiatier safety and basic knowledge of the 14 radiopharmaceuticals in use. And that's why it's very
) 15 appropriate to put in these new regulations.
16 For the states to be handing over, in a very 17 formal way, to the appropriate organizations which remain 18 yet to be determined -- we kind of know who they are -- who 19 will oversee-clinical competence in this area. 20 And I think with the new regulations it's much 21 less likely of confusing the issue. We'll know, basically, 22 who's felt to be responsible and from which aspect of the 23 practice. The basic science, the radiation safety aspect, 24 and the delivery of the clinical care. 25 MR. CAMERON: Okay. Thank you, Elias. ! [- ' ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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409 I 1 We're going to go out here to David Nichols. l l () 2 MR. NICHOLS: Thank you. David Nichols, American l i 3 College of Nuclear Physicians and Society of Nuclear ) 4 Medicine. Speaking on behalf of the Society of Nuclear 5 Medicine at this point. 6 I just wanted to reemphasize an issue that Dr. 7 Lull raised when he had mentioned the types of areas that we 8 envision being in the core curriculum of basic radiation 9 sciences. And they're very similar to what is in the rule 10 making now. 11- If you feel that in this core curriculum of 12 classroom training that it needs to include radiation, 13 physics, and instrumentation, radiation protection, 14 mathematics pertaining to the use and measurement of 1 15 radioactivity, radiopharmaceu'tical chemistry, and radiology-16 biology. And that those subject area cross between all the 17 areas within nuclear medicine, at 35.100, 200 and 300. That 18 the radiation science does not change, regardless of the l 19 modality that you're using. There may be other practical 20 concerns that come into play, but that basic radiation 21 competency does not change. 22 And then getting into some of the practical areas 23 that you would have to have experience in, it would 24 include -- receiving and packing of the radioactive l 25 materials, the calibrated dose calibrators and diagnostic l l l I I~ ANN RILEY & ASSOCIATES, LTD. l \~- Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
--}l 410 1 instruments to check for proper operation, calculating and 2 safety preparing patient or human research doses, using l 3 administrative controls to prevent the misadministration, 4 using procedures to contain spill byproduct material, and 5 having an awareness of those practical areas of what's e l involved. And that that would pretty much go through all 7 -the areas of nuclear medicine as well, whether it's uptake 8 imaging or therapy.
9 And then to throw a number of 120 hours in there 10 to meet those qualifications seems, to us, as an arbitrary 11 figure. It could take someone who is a genius in radiation 12 physics two days to fully understand all of this and qualify 13 for the exam. It could take somebody six months to two 14 years to be ready to fully qualify to take this exam. l i 15 So, to require someone to sit in a classroom for
'16 120 hours just doesn't seem to make a lot of sense to us.
17 And we'd like to hear about some of the rationale for the i 18 120 hours being the designated number, as opposed to 44 or 19 75 or 200 or 600 or 1200. 20 MR. CAMERON: You seem to be saying that -- that 21 the exam should be the whole deal and that any number you 22 put on it is going to be more or less arbitrary, either as 23 too much or too little. Is that right? 24 MR. NICHOLS: And I think that the number of 25 comments at the Agency on this issue show the divisiveness O ANN RILEY & ASSOCIATES, LTD. Court Reporters r 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 411 1 between the number of hours between the specialist 2 societies, ranging from 55 hours to 1200 hours. And to just {} 3 pick 120 didn't seem to make a lot of sense to us when, in 4 fact, what every specialty society agrees upon is what that l l 5 core curriculum is. l 6 MR. CAMERON: Dr. Prendergast,.do you want to say 7 anything about that while that issue is on the floor? 8 DR. PRENDERGAST: Well, the issue is with l 9 endocrinology in that safety is clearly not a problem. That 10 the endocrinologists, in basic-terms, have spent there time 11 in the fellowship, the training, to be able to handle that. 12 So, that the extension in the practical experience goes on a 13 long time. 14 And then what we're talking about in terms of the
'oO 15 way it is set up for now, but the projection thing, seems to
( ,/ 16 be very accurate to be able to have that time of 17 treatment -- excuse me, time of picking a course that would 18 be especially designated to ascertain what is the proper way 19 to do it. 20 So, that interval of time is okay. We spend a lot 21 of our fellowship time in preparation. 22 MR. CAMERON: Okay. Thank you. 23_ David? From the state, NRC state working group, 24~ David Walter. 25 MR. WALTER: And I'm from one of the states that h\_/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
412 1 doesn't have any kind of training program requirement for () 2 3 technologists.. like that. No registration or licensure or anything The states that don't, I think there are 33 or 4 so, so the majority of the states don't. 5 I have a large number of rural hospitals, as a 6 number of states do. I've had to go through a situation 7 where the gift shop girl becomes the therapy technologist. 8 I don't like that. What I -- I mean, maybe what we're 9 saying is a stop at four is what you want to eventually get 10 to. But if you have a national licensure, but you don't 11 require licensure to be able to go in there and be a tech, 12 it really makes no difference. It becomer economics. It 13 doesn't become anything else. 14 And so, I -- I know that the working group has r 15 heard this from ma for a long time, but I want to put my two 16 cents in again to say that I am fully behind having some 17 type of a minimum qualification standard for radiation 18 safety. Not clinical competency, but a part of clinical 19 competency. Because I -- I look at them essentially as 20 being very closely tied together in my line of work in what 21 I'm doing. And would like to see board certification 22 requirements as a possible -- as one way of doing it. 23 And in going back to answering one other thing 24 about the number of hours and whether we should have numbers 25 in there or not, we could say, "No hours in here at all" and 59
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413 1 we'll get them through the board, saying, "Well, how many t 2 hours do we have to require and individual to have before we
}
3 can allow them to be more eligible?" To guys, let's just go 4 ahead and put it in the rule so you don't end up getting it 5 at a round about way, coming in it from the back door, which 6 is what we're trying to get away from in the first place. 7 MR. CAMERON: Okay. Thank you, David. 8 Susan? 9 MS. MCLAUGHLIN: Again separating the competency I 10 radiation safety from the clinical competency and in support 11 of the exam or some other type of competency assessment for 12 the radiation safety area, I think we can maybe draw some 13 parallels to what Joint Commission has done over the years 14 with their safety training requirements in health care in b Q 15 general. 16 And it used to be that Join Commission for safety 17 training required annual updates in certain courses and so 18 on and so forth. And as long as you had the attendance 19 lists of the people going to those courses, that you were 20 fine in their eyes and that you would meet the requirements. 21 Well, what they came to realize over the years is 22 you could have people sign in on this attendance list and 23 sleep through the class and learn nothing. 24 So, what they had gone to instead is a 25 determination of whether the Staff people can appropriately () s ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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l l' 414 l 1 respond to questions related to the safety. And in other (Oj 2 words, how competent are they? And I think that if you look 3 at that type of a model in terms of is a person really 4 competent in these safety issues rather than how many hours 5 that they have had, I think that's very appropriate. 6 MR. CAMERON: Okay. Thank you very much for that 7 information, Susan. 8 We really do need to move on here. If Kathy and 9 bob, I.could just ask you to try to be brief? 10 Kathy? 11 MS. THOMAS: One of the issues that we talked 12 about at the beginning of this whole -- not this meeting, 13 but previously -- was if we're looking at competency in 14 handling radioactive materials through the full gamut of
) 15 nuclear medicine that what we would like to see incorporated 16 which would address your needs is that technologists would 17 illustrate their competency by either passing national 18 registry or certification exam.
19 That was -- that has been incorporated with
'20 clinics who are looking for reimbursement from federal 21 agencies, but has not been incorporated into this. And we 22 were told, "Well, we're looking at the radiation safety 23 issue. We're not looking at full competency, such as you're 24' talking about with the physicians." However, in this case, 25 by requiring one or the ot um of the registries j l
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415 1 certification boards you will meet his needs and save f%Y 2 everybody a lot of money having to go after national 3 licensure which still has to be adopted by the different 4 states and may look a little different. Because then you 5 set a standard throughout the nation that ensures that 6 everybody who's handling those radioactive materials is 7 competent in every way? 8 MR. CAMERON: Okay. Thank you. 9 Bob? 10 DR. LULL: Yeah. I'll just support what Cathy I 11 says. That if you're going to do something about the 12 technologists, to take care of the states where they aren't 13 licensed, you should demand an MTCB certification. i 14 I just want to emphasize -- add on to when David O( ,/ 15 was giving his discussion of 'the topics and the conclusion 16 was that the exam is the most important thing. I wanted to 17 add not just the exam but also documentation of adequate -- 18 the experience in the radiation and safety. That is, 19 radiation and safety experience that's documented by the 20 preceptor, in addition to the exam. 21 Because the exam can't test for -- for practical 22 experience. That's comething you need someone to stand up 23 for them and say, "Yes, I've gone through this and shown 24 them all this. And we've done laboratories." I think the 25 details will be very important in terms of what is included ANN RILEY & ASSOCIATES, LTD. ['d~') Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l l Washington, D.C. 20036 I (202) 842-0034 l l 1 I
l 416 1 1 in these courses, what practical experience is actually () 2 given them, rather than just names of patients. I mean, you I 3 need to have -- we are looking at really defining what 4 practical experience they're going to get. And then I think 5 you have to be very careful about how you choose who is 6 going to be allowed to be a preceptor, so that you can't 7 just have people kind of cloning incompetence, one to 8 another. You need to have some criteria for who's a 9 preceptor, who can act as a preceptor to the document. 10 Someone who is known to be able to teach t fw se things, 11 rather than just someone who may have learned it. Because 12 just because you have passed the minimum standards doasn't 13 mean you're able to teach someone else up to minimum 14 standards. s) C'T 15 MR. CAMERON: Okay. Thank you. l l l 16 We need to go on to at least begin the radiation l 17 safety committee discussion. But one of the things that we 18 didn't spend much time on that I would ask you for purposes 19 of the future meetings in Kansas City and Washington and 1 20 also your comments, is this last issue not necessarily only 21 the projected amount of time, but the whole issue of the NRC l 22 approving boards and exams for purposes of this portion of 23 the rule. What would be the criteria for doing that? It is 1 24 a resource issue for the NRC. Is it appropriate for the NRC 25 to do this? How do you -- if you don't do this, how do you
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417 1 address the issue of the so-called dude ranch course that we I~'\ 2 heard about a number of times. O 3 So, I think that that's an important issue that we 4 need to put a final point on in future discussions. 5 Okay. Cathy, do you want to take us through the 6 radiation safety committee? 7 MS. HANEY: Sure. You're messing me up on my 8 order of slides. 9 MR. CAMERON: I guess you didn't say that you did 10 want to. 11 MS. HANEY: I did want to, but. 12 MR. CAMERON: Okay. 13 MS. HANEY: Okay. The issue of whether we have a 14- radiation safety committee in the rule or whether we don't believe it rates as one of the cross cutting issues. k 15 And we 16 spent a lot of time discussing it over the last year. 17 To cut through the story and make it real short. 18 The rule does not retain a requirement to have a radiation 19 safety committee. 20 Instead, what we have done is developed a Section 21 35.24 that deals with the authority and responsibility of 22 the radiation protection program. 23 What we have tried to do is give the licensee the 24 flexibility in how they manage their radiation protection , 25 program. I i [ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
418 1 There are ways that they can do it. They can () V 2 still maintain the radiation safety committee. They could 3 take the functions that were previously that of the 4 radiation safety committee and move them to a risk 5 committee. They could choose just to have the radiation 6 safety officer report directly to the chief executive 7 officer of the facility. There are various ways that the 8 issues, in this area, can be handled. But again, we wanted t 9 to give the licensee the flexibility in how they did this. 10 The. comments that we received in this area were 11 either, "Yes, it's a good idea to delete the radiation 12 safety committee and give us flexibility", or what we got l 13 from the Health Physics Society and the AAPM is that, "The 14 radiation safety committee should not be deleted from the TT ( j 15 rule. That the radiation safety committee is needed as a i 16 mechanism for raising radiation protection issues to the
)
17 level of hospital administration and facility management in i 18 getting things done. Without this committee, these 19 functions would get lost and the concerns of the radiation 20 safety officer as far as making the facility safer would not 21 really reach the attention of hospital management and there 22 may be some problems with the program because of this." 23 And in listening to all of those things, we did 24 decide to delete it. But we went through the list of what l 25 we currently require of the radiation safety committee and 1 1 O
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l 419 1 tried to identify, again, what were the key issues. What (s-') 2 were the things that we did not want to get lost? And what j 3 where the good things about the committee? l 4 And what came down was a requirement in the rule 5 that the licensing management had to approve a request for 6 licensing actions. In the current rule there are some l 7 actions that were improved at the radiation safety committee 8 level and just gone ahead and implemented. But if we don't 9 have a radiation safety committee we didn't want it getting 10 delegated down. We wanted this decision -- this decision 11 making point going up higher so that management must approve 12 these. 1 l 13 We also included the licensing management had to 14 improve minor changes in the radiation protection program. () 15 For those that are familiar with Part 35 previously, this 16 had been referred to as "administerial changes". We're not 17 using that term any longer because no one ever knew what
)
1 18 administerial change was anyway. So, we're just saying 19 minor changes to the program. 20 The other thing that we had added is that the 21 facility -- and this applies whether you are a university, 22 whether you are a small rural hospital, or you are a -- in 23 private practice and you happen to have two offices, one on 24 the east side of town, on on the west side of town. You 25 would need to have administrative procedures for hA/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
420 1 interdepartmental, interdisciplinary coordination. That was () 2 one of the items that we heard was -- the radiation safety 3 committee -- the great benefits of having tha committee, it 4 brought all these different specialties together, from the 5 nursing staff, from the different types of authorized users 6 from hospital administration. They'd sit down and talk for 7 at least a couple of minutes, four times a year 8 We don't want to loose that coordination. But 9 again, we don't want to dictate that you are going to 10 coordinate a committee. So, we're saying, " Licensee, come 11 up with some administrative procedures." We fully recognize 12 that the procedure for this small doctor's office that has I 13 one on, you know, the east and the west side, are going to 14 be vastly different from that at a hospital level. And I'm
) 15 not talking broad scope licensees, but we're one step from a 16 broad scope licensee.
17 The procedure, as I said, does not have to be 18 elaborate. It can be as simple as when I decide to change 19 contractors for who's going to calibrate my survey 20 instruments I'm going to~ send an electronic message to 21 everyone that has a surveyor and tell'them that. That might 1 22 be okay for one level of licensee. For another level of 23 licensee they may choose to say that issues that pertain to 24 the radiation safety committee will be discussed at the risk 25 committee, and my risk committee will have members on it n N' ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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1 that will touch _all the disciplines. g e- ' (j 2 What we're looking for in this particular area --
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.l 3 'again, we're putting up a couple of questions, and I'm not '
4 sure the time will allow us to go through all of these 5 questions, but as the next -- well, we're probably down to 1
)
6 85' days now to go. We would like some input from the public 7 in these areas. 8 Our commission, when we briefed them back in June, 9 were very concerned about the reach of the radiation safety 10 committee. They felt that this might effect the radiation 11 safety program, negatively effect it. And hence, the first ! 12 question. It really boils down to will it impact the 13 licensees effected as it carries out its radiation 14- protection program. And that really boils into will we be 1
\ 15 reducing the effectiveness of'the program and the radiation 16 safety officer. Will the radiation safety officers now have 17 problems in getting their jobs done?
18 And then, as a separate item almost, is the 19 question, if we decide to put the radiation safety committee 20 back into the rule because we've heard from the public 21 comment that it is a good idea to have it in there, we would 22 probably not put it back in at the prescriptive level that 23 it is right'now where we tell you, " Meet four times per 24 year. Your minutes have to be done within X numbers of 25' days. You have to have this type of membership on it." l l () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l l 1
422
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1 l We'd probably just say, "Have a committee with a direct J gg l
) 2- report to management." Something -- that sort of ruling 3 which, I guess, is the best way to put it.
4 But the question is that if we do have that 5 committee requirement back in, should we go so far as to l 6 stipulate that the radiation safety officer must be a member l 7 of the committee? And, in fact, I'll go even further. If l 8 we do start specifying who should be a member of the 9 committee, what individr71s would you recommend be included? 10 MR. CAMixON: Okay. I take it from your remarks, 11 Cathy, that -- that the Commission's concerns is that this 12 would be one provision in the rule that, if you support the 13 deletion of the requirement of -- for the radiation safety 14 committee, that it would behoove you to express in your ("~ (,_)) 15 comments on the rule why the deletion of this requirement l l l 16 would not adversely effect safety at a particular facility. 17 And I would just remind people of that. And I 18 guess the simplest way to start this discussion is has the 19 NRC gone too far in deleting this requirement? Are we right 20 on target? 21 Bob? 22 DR. LULL: I'm speaking for myself because I don't 23 know exactly what the Society's position is on this. Maybe 24 David Nichols can give us that later. 25 MR. CAMERON: I'm sure that David will be -- O '\ / ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 423 I 1 DR. LULL: I'm sure he'd be happy to. And you r \'
-( ) 2 probably already have it in your records.
3 But my own personal feeling is that you're 4 deleting the requirement, and yet still having a requirement I 5 -for something akin to that. 6 But may be happening may be the same thing Ed
- 7. Bailey described earlier, and that is if there's no j l
8 regulatory requirement, it's difficult to get management to l 9 support the cost of maintaining what's really needed at an 10 institution. 11 So, institutions that really need a radiation 12 safety committee, it's going to be an uphill battle for them 13 to argue that they ought to have one, because it's not a 14 regulatory requirement, management's trying to cut costs
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(%,) 15 everywhere they can, and they're going to try to eliminate - 16 it. l 17 So, often times, you need the regulatory 18 requirem;nt to have it. I think making it less prescriptive 19 in terms of membership allows lots of flexibility. And so I i 1 20 think having a radiation safety focus, whether it be a 21 committee or not -- well, I think a committee is a good 22 focus -- where the discussion of the institution defines 23 who's on it. 24 But I do agree that the radiation safety officer 25 must be a member of that committee. They have to be there.
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424 l 1 They should be a member of that committee or their 2 associate, you know, substitute, alternate radiation safety 3 officer ought to be at the meetings. 4 I think that -- I feel you should -- may have gone 5 too far with this. You should maintain a committee l 6 structure. ! 7 MR. CAMERON: Okay. Thank you. 8 Did you have a -- 9 MS. HANEY: ,Yes. Let me just ask an additional 10 question, j 11 If you were going to support retention of the 12 radiation safety committee, would you like to draw a line 13- that says'that if.you're only using materials under 35.100, l 14 200 and-300 you don't need a committee, and if you're using g 15 materials under'400 and 600 you do? Would you want us to i 16 get-that specific or would you just, again, I mean, looking ) 1 17 'at the risk-based? l 18 DR. LULL: I think it depends on the
-19 circumstances. You may have people operating under some of l
L 20 those inside a large institution where they really should 21 have a committee controlling the total institutional 22 ; program. 23 And I think if someone's going to operate in a f 24~ single out patient office, well, it's hard for them to have 25 a radiation safety committee. They can end up having an
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l 425 1 RSO. They're probably going to be the RSO, the user, 2 authorized user and everything all wrapped up into one.
- 3 But, you know, so I think the circumstances 4 require some flexibility in the approach to this rule. But 1
5- I don't think that there may be a need to have something 6 there that -- that spells out the requirements so that 7 people, you know, can maintain -- forcing their institution 8 to give them that kind of support. Because otherwise the 9 support will evaporate. 10 MR. CAMERON: Okay. Then maybe we could get some 11 input from people such as David Belk on that issue and 12 perhaps Susan also. 13 David? 14 MR. BELK: Well, Bob and I were talking actually ()
,-~
15 here this morning about this issue. And Bob covered a 16 number of the issues that we were going to address. So, I 17 don't want to repeat it because of the time frame that we're 18 going after. 19 However, there's a couple of additional issues 20 that we think are important. 21 In real terms, a committee of peers has much more 22 influence on the internal enforcement of policies and 23 procedures then that of an administrator. I can speak from 24 personal experience on that. 25 Additionally, the existence of a radiation safety
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I i 426 l 1 committee is important in enhancing facility staff b) 2 interrelation and intercommunication, which is actually more l 3 critical to the administration and management -- such as i : 4 ours. We need to bridge the gap between staff, medical and I 5 administrative forms. So, this is one mechanism to do it. ) 6 Other than that, again, Bob covered a number of 7 the issues, as you did in your original explanation. Just 8 in general, we support the continuance of the radiation 9 safety committee. And perhaps we'll have to clarify that --- 10 written support later on. So, in the interest of saving 11 time I'll def'er to other people. 12 MR. . CAMERON: Well, that's great. Thank you for i 13 that. l 14 And Susan? () 15 MS. MCLAUGHLIN: Yes. I, once again, would like L 16 to draw aLparallel base don my previous experience on the 17 Joint Commission. l 18 Several years ago the Joint Commission went to the 19 non-prescriptive standards in terms of the safety committee, 20 which is exactly what I see you doing here. And I think 21 that there's some real pluses to doing that. 22 It used to be that the safety committee had a list 23 of certain people that had to be on the safety committee, L 24 how frequently they had to meet, how frequently they had to 25 send reports to the board and so forth. l-I
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427 l 1 The non-prescriptive standards did away with all () 3 2 of that, given the organization a lot more flexibility in terms of setting up their committee structure. They don't 4 need to call it a safety committee. The function can be t 5 combined with another committee or however the-organization 6 wants to do it. 7 Now, all of that is well and good giving them the L 8 flexibility. But in support of what Bob said previously, 9 -taking calls from the field about this, the Joint Commission 10 still required that that function that was previously known 11 as the safety committee to be there, although it wasn't in 12 such prescriptive terms. 13 Taking the calls from the field you would be 14 surprised at how many people called in and said, "Oh, I hear (G,) 15 we don't have to have a safety committee anymore and my i 16 management is looking to get rid of the committee meetings 17 that we don't need." l 18 So, I think that definitely the cross-factors in 19 committee meetings from a management -- a hospital 20 administration perspective are important. And I think, - i 21 though, that having said all of that, the non-prescriptive 22 nature would still be appropriate as long as it was 23 communicated very clearly that certain functions still have 24 to be there, we don't care where they're done, how they're l 25 done and by whom they're done, as long as the functions are l l l l I 'h ANN RILEY & ASSOCIATES, LTD.
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428 1 done.
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2 MR. CAMERON: Okay. Thank you. 3 It's, I guess, a little unclear to me about
- 4 whether the Joint Commission did the latter or whether they i
5 said, "Well, you do have to have some type of a committee, l 6 but we're very performanct-based, to use that term, in terms 7 of how the committee should function and who should be on 8 it." Or is it exactly -- is it an exact parallel to what 9 we're doing, saying, "You don't have to have a committee. j 10 But you do need to do these functions?" 11 MS. MCLAUGHLIN: Well, it's probably somewhere in L 12 between. While they say that you don't have to have a i 13 safety committee as such, it can be combined i .th another 14 group, like a QI committee or something lik- aat. It can
-() 15 be~ set up in a subcommittee structure. Whatever the case 16 may be. There's a lot of flexibility. Although in some l 17 sense you really -- they really -- they still call for a 18 multidisciplinary group. But they don't care how it's l
19 structured. I 20 So, I think that there's a lot of parallels that i 21 can be on here. 22 MR. CAMERON: Okay. And from what I hear Bob and 23 David saying, it's even though there's still some function 24 still specified in the rule, the requirement to have a j- 25 committee actually achieves a lot of benefit. l
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_ . - _ . . _.. . _ . . m. _ _ . _ _ _ . _ _ _ . . . _ _ . - _ _ . _ . . __ . _ _ . . _ . . _ 429 1 Okay. How about people-who -- who support the
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- \J 2 proposed rule and'think that the committee requirement is 3 either onerous or unnecessary or whatever? In other words, 4 the other side of the coin.
, 5 Ed, did you want to talk at'all about that or are l l 6 you going to make another -- 7 MR. BAILEY: No. I don't -- I don't want to be 8 put down on the side that supports the rule as presently 9 written. i 10~ In.the interest of time I want to say that to 11- reaffirm that the Health Physics Society wants the committee 12 maintained.
- 13 MR. CAMERON: So, the Health Physics Society does '
14 want the committee maintained? () 15 MR. BAILEY: Right. l 11 6 . MR. CAMERON: Do you want to give us a rationale 17 on that? l. l 18 MR. BAILEY: I think it's a lot of what's been 19 said already. 20 MR. CAMERON: All right. 21 MR. BAILEY: That without it it's going to go down 22 hill. It will not be funded, et cetera, et cetera. The L - 23. peer association and so forth. 24 Checking another hand, and based on the state of
- 25 California, I think we too see the value of having a l
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i 430 ! 1- radiation safety committee in that -- for a lot of the same (~ 2 reasons. We also find that it is quite often~ easier to deal l \m l 3 and get changes made when we are working with a radiation 4 safety committee in an institution rather than one strong 5 individual in that organization who says, "No, we're not 6 going to do that" or whatever. 7 And I think that's -- that's part of a peer i 8 pressure -- peer whatever you want to call it. That brings 9 about change for the good more rapidly, in many cases, then l 10 trying to do it through one person, whether they're called 11 the RSO or the authorized user or what. 12 MR. CAMERON: Okay. Thank you. 13 Let's go to Melissa, then to Mary Pat then back 14 over to Bob. Melissa?
,a
( ) 15 MS. MCLAUGHLIN: Well, I'd just like to reiterate 16 again why AAPM agrees with Health Physics Society. 17 I guess we came in with a -- Cathy was asking 18 where would we be willing to cut. For those hospitals that 19 are truly only in the 100 and 200 category we're not so 20 adamant that we would require a radiation safety committee. 21 But particularly as soon as you get into any of 22 the facilities that use therapeutic doses or sealed sources 23 in therapeutic modes, we definitely feel that we should 24 require a radiation safety committee. 25 And in answer to the last question, in addition to l ()
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431 1- the RSO we feel that it should be mandatory for at least a h 2 member of management.to be part of that committee, because , 3 that'is the only committee you have, sometimes, to allow 4 input to management. i 1 5' .And I would just leave it at that. 1 6 MR. CAMERON: Okay. Thank you. 7 Mary Pat? 8 MS. MANNING: I support, and I think the Oncology 9 Nursing Society, would support the benefit of having a l 10 committee. What may be variable is how often it meets. It 11 may be that in some settings it needs to meet quarterly. 12 Maybe it needs to meet twice a year. In other settings, 13 depending on if it's a new program, it may need monthly 14 meetings. And being able to set it up individually using
/)
( ,f 15 some specific criteria for what that committee would-do may 16 well resolve the issue, if it is, in fact, that the rule 17 goes forward, in having a committee or not having a 18 committee. 19 MR. CAMERON: Okay. Thank you. That's another 20 way to try to cut this, in terms of when you have a 21 committee. 22' I think it might be appropriate to deal with 23 David's issue that we have up on the paddock, in the 24 paddock, in terms of the institutional licensing framework. 25 At'this point, then, we will go to audience on !!#h sl ANN RILEY & ASSOCIATES, LTD. i Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l I i
. . - . =. -.- . . . .. . . - -.__ - _ .. .. .. . .. l 432 1 this general issue. But David, do you want to restate that ! () 2 issue for us? l 3 MR. BELK: Well, for particularly large 4 institutions that have multiple license through the state. . 5 For example, a university. An institutional license, I 6 think, would be beneficial. It would be more effective for l 7 our institution and for the regulated institution. ; 8 Repetitive administrative needs on the campus by 9 campus basis just isn't an efficient way to do it. I think i 10 as far as communication of issues and concerns would be as 11 quick or quicker to deal with one license for an 12 institution. 13 And if Ara has anything additional he'd like to 14 add, now's the time to do it.
,e~ 's 15 MR. TAHMASSIAN: I think as you move into this 16 concept of sort of performance-based, I think we need to 17 look at some of the other ways that we do business.
18 Especially for some of us who have large medical 19 institutions, to get a unified license where then you -- you 20 know, we can determine the sublicenses, helps tremendously. 21 Because we come up with policy, one procedures, one protocol 22 which is written and covers the entire spectrum of the 23 operations, regardless of physical location. 24 It's a different way of looking at it. Right now 25- you have to have seven or eight, nine different licenses -- ANN RILEY & ASSOCIATES, LTD. ['s~ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 _ ~
433 1 10 different licenses just in the UC system. And I think () 2 this is true. It could be extended to VAs, for example, l 3 where the VA had the discretion of getting their license -- 4 subs to individual licenses. 5 MR. CAMERON: Now, this seems to be, I think, 6 perhaps an issue that would be dealt with outside of the i 7 Part 35 framework and I guess I would ask Cathy to Don if L 8 there are mechanisms now which would try to achieve what 9 David and his colleague are espousing? I know there's 10 something called a master materials license. I don't know 11- if that's what this is all about. But if you guys could 12 comment? 13 MS. HANEY: Well, you always have the option of a 14 broad scope licensee which is, to a certain extent, what I 15 think you're getting at. In the case of a broad scope 16 licensee, the license goes to the administration and then 17 the administration or management approves users -- they 18 usually call them permits, or something like that. And l 19 they're doing a lot of regulation and inspection. The state 20 or NRC would come in and inspect management and they would 21 go out to the facilities. 22 One step down from that, at least in NRC's phase, 23 we have what's called a master material license. And it's 24 similar to a broad scope, it just doesn't go so far. 25 The Air Force is an example of one of the master ,I ANN RILEY & ASSOCIATES, LTD. l Court Reporters i 1025 Connecticut Avenue, NW, Suite 1014
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l l 434 l l 1 material licensees that we have where they have one j h O 2 radiation safety committee meeting four times a year. They 3 are doing the things that are the requirements of the l 4 management. 5 In the case of the VA that you mentioned, there is 6 an effort underway for the VA to do exactly that, which 7 would -- there would be one license issued to the VA. 8 Management then meeting would go from there as far as 9 authorizing the individual hospitals. Again, that doesn't j 10 mean that the NRC won't go into the specific hospitals. We 11 would go in and inspect, whether it's a VA hospital or 12 whether it's one of the military bases -- base hospitals.
- 13. We would go in under that master material license and 14 inspect it. l 15 So, there are some things already in place. Chip 16 is right, this is outside of the Part 35 arena, but it's 17 something that the NRC is able to do and the states can do 18 for the broad ~ scope.
19 MR. CAMERON: Okay. Don? 20 DR. COOL: Let me -- let me add one other 21 component to that, which is a little bit closer to the
'22 actual arena that we're dealing with.
23 Back a couple of years ago one of the big nuclear 24 pharmacy chain system came to NRC looking to see if they 25 could consolidate the licensing for their various pharmacies l f') ANN RILEY & ASSOCIATES, LTD. I N/ Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I I 435 1 in all of the NRC states. We, in fact, wer.t through a i fs 1 l t
} 2 process with them and issued that company a single i 3 consolidated license, which had certain additional !
4 requirements on it about their oversight of their various 5 individual programs, things that they were doing. 6 And that single license in the nuclear pharmacy 7 arena had something on the order of 35 or 40 individual 8 pharmacy locations which were administered all over across 9 the varicus NRC state jurisdictions, all under the same 10 license. 11 It proposed an advantage to that licensee in terms , 12 of the administration at a central point of contact at i 13 central control because they were doing very similar things ; 14 every single time. And that's one of the things that I I
'( ,, 15 think is -- where you could get some version of that kind of 16 approach. If you have a lot of replicated units that are 17 doing very similar things, it lends itself. When you have 18 highly adverse units and highly adverse kinds of activities 19 going on, as I would expect at the university system with 20 lots of different things and activities, that might be a 21 little less amenable to that process. That doesn't mean 22 we'd rule it out.
23 So, the NRC has, in fact, experience in several 24 different categories. However, the licenses -- where we 25 still do all the individual inspections. l h) ANN RILEY'& ASSOCIATES, LTD. l\? Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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I 436 1 Master material licenses where the master material L 2 licensee, in fact, has the first -- of permitting inspection ; 3 of their individual facilities. Random spot checks. And i 4 broad scopes of a particular institution who then controls-5 permitting within the various laboratories on a particular , I 6 campus or maybe a couple of campuses. ! 7 For example, the National Institute of Health, 8 NIH. That broad scope actually covers three campuses in the 9 ' local Maryland, D.C. arena. 10 So, that's some of the background that's out there 11 already. 12 MR. CAMERON: So, it seems that there doesn't need 13 to be -- that the mechanisms might exist for you to do what 14 you want to do, it's just a question of figuring out what () 15 would be most efficient for you and discussing this with the 16 NRC. Is that a correct summary, Don? 17 DR. COOL: Discussing for the NRC or the states. 18 MR. CAMERON: Oh. 19 DR. COOL: And one of the difficulties, of course, 20 is that if you have facilities in both NRC and the state,
- 21. that poses one set of problems. Or multiple states.
22 Anytime you cross a jurisdiction you come up with a real 23 difficulty. In the case of the coasolidated license that we 24 issued, we issued it only to cover those who were in NRC l 25 jurisdictions. They still have to deal with their i ANN RILEY & ASSOCIATES, LTD. a s-f '/ Court Reporters , 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 (202) 842-0034
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437 1 individual states. l
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b) 2 The other thing that I should mention is the NRC l 3 has not yet attempted to-go through something like a master 4 material license process for anything other than a federal 5 organization because there are some other issues associated ' l 6 with authority and validation. And things in terms of l 7 licensing inspection and violation. l 8 While we have thrown it around, we have to 9 actually seriously try and embark upon the process. We 10 haven't had anybody actually try to apply for one, so we ( 11 haven't tested the theory. 12 MR. CAMERON: Okay. Great. 13 Ed, do you want to comment? 14 MR. BAILEY: Yeah. When I worked in another state ' !} (,.
,f 15 we did combine much of the licenses. The highway department 16 had 126 licenses. We combined them and put them all on one 17 license with 126 locations.
( 18 Likewise, the Well Logging Company had 80, 40 or 19 something locations. And we did that all on one license. l 20 Somehow, David, I just can't see UC Berkeley and i 21 UCLA agreeing enough to lump all of the UC campuses on one 22 license. 23 MR. TAHMASSIAN: Berkeley is divorcing from -- 24 MR. BAILEY: But we would, I guess, in that case r 25 end up with nine medical licenses. We'd end up with UC, 6
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438 e 1 Stanford, USC, Kaiser, Cedar Sinai and then the two other f() 2 hospital groups and all the other hospitals in the state. 3 And nation wide, you'd only have two medical licenses plus 4 the universities, I guess. 5 Whereas it could occur, there are some entities l 6 that are so large that they definitely have a life of their ?
-7 own and I'm not sure that we could ever reach that level of 8 uniformity where I went into Ara's program and found 9 something and made him change it at UCLA. So, I --
that may 10 not be possible. It is certainly, as far as I know, legally 11 possible to do it.
-12 MR. CAMERON: David?
l l 13 DR. LARSON: It sounds like our first approach to 14 this would be.to come to you. And I'm speaking to Ed.
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- (,,) 15 MR. BAILEY: Yes. I guess the answer is yes.
16 MR. CAMERON: All right. We're going to take'a 17 break but if we have anybody out in the audience? Anybgdy 18 with red hair that would like to comment on radiation safety 19 committee issue? 20 David, do you want to comment? 21 MR. TAHMASSIAN: Can I make one recommendation in 22 response to Cathy's question? l 23 MR. CAMERON: Certainly. 1 24 MR. TAHMASSIAN: Just one recommendation with 25 regards to the smaller facilities, like the one using 100, f ANN RILEY & ASSOCIATES, LTD. l () Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
i i I i 439 l 1 200, might be that you could insert the language where
- o i t
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2 facilities have the right, under certain conditions, to give 3 you an alternative means of achieving the goals without a 4 radiation safety committee. l 5 So, this would be given right out of this -- for ! 6 -the smaller institutions, where the management or -- would 7 be a solution. 8 MR. CAMERON: All right. Thank you. Bob? l 9 DR. LULL: One -- I would like -- what happens is j 10 often times VA hospitals, which are under NRC, and 11 universities work together. But in an agreement state the 12 university is licensed by the agreement state, not by the 13 NRC, and it makes it very difficult for them to really 14 integrate their operations. A
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15 I would like to see'some discussion between the 16 agreement states and the NRC about circumstances where they 17- might transfer authority to one way or the other, to 18 consider that as a potential option to allow integration of 19 programs for a better cost effectiveness and delivery of 20 care. 21 It's just that it's kind of far out, I know. But 22 I'd like you to just put it in the back of your minds, when 23 you get a free moment to think about that. 24 The other point I wanted to make was regarding the 25 radiation safety committee. As we cut back the number of
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440 1 hours and the amount of experience that we're requiring for () 2 people from a radiation safety viewpoint, I think having 3 better local control over what's happening radiation safety 4 wise where they can change things and respond to things more 5 quickly by a committee make a committee even more important 6 rather than less important. 7 MR. CAMERON: Okay. Great. Another argument for 8 committees. ( 9 Let's come back at 4:00 o' clock and let's start 10 off talking about the manual brachytherapy dose prescription 11 issue. 12 [ Discussion off the record.] 13 MR. CAMERON: Well, we do want to discuss Nt 14 issue that David Larson raised. And since it ties in with () 15 reportable events, we'll move into reportable events after 16 we discuss that specific issue. And I think David's issue 17 woilld be a good lead in to that. 18 David, would you like to describe what the 19 particular problem is? 20 DR. LARSON: Well, it occurred to me just recently 21 that there is a situation that has arisen probably for at 22 least 20 years that doesn't seem to be covered by 23 regulations and certainly doesn't seem to be covered, from 24 my understanding of the regulation, with the new 25 regulations. b' \~- ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
441 1- Let me just be sure that I understand this rh 2 correctly. 3 My understanding of the regulations regarding 4 manual brachytherapy is that there should be a written 5 prescription prior to the procedure. That a prescription -- 6 a written prescription must be either dose or number of 7 seeds in strength, and that a misadministration or a medical 8 event would be some percentage -- 20 percent deviation 9 between the written prescription and the actual 10 . administration. 11 Now, if that's all correct, then there has been a 12 history of misadministrations possibly never reported, as a 13 general rule, and will be medical events. 14 And I think somehow this has to be taken into
-15 account.
16 Let me explain how this happens. If there will be 17 a situation where surgeon perhaps arranged in advance, 18 perhaps not typically arranged in advance, will call up and 19 say, "Okay. We have a patient up here in the operating room 20 and we have some residual tumor we can't remove. This is 21 not a candidate for some form of interruptive radiotherapy. 22 It's not going to be radiotherapy. He's going to bring up 23 radioactive seeds and we'll implant that." 24 Now, you don't know prior to doing this 25 implantation -- even when you're in the OR looking at it you .O> ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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t 442 ' I t 1 don't know am I going to do 10 seeds or 20, or it could be , 2 100 seeds or 120, 130. If it's more than 10 or 20 percent 3 deviation between your cstimate and the final number of - l 4 seeds, for examples. You would know the strength, but you l 5 l wouldn't know in advance the number of seeds that would be 6 used. l
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7 So, I think right now in the United States, just ! 8 . making my best estimate, there's somewhere between several 9 hundred and perhaps 1,000 of these procedures per year. And 10 I anticipate that that number is going to rise -- based on il some things that are happening for nervous system tumors. 12 There appears to be -- low toxicity appears to be effective, 13 yet it's not at all covered. 14 So, the way the technique works is once you've () 15 given the source -- the seed strength, the idea is to apply 16 the seeds with adhesive permanently to the surface of the 17 surgical section cavity. Now, the section cavity may be ; i 18 highly irregular. And you don't know what the shape of that l 19 cavity is in advance, no matter what imaging technology you 20 use, and the dosage of the surrounding structures and 21 surface cannot be predicted in advance. All we know is that 22 if you use Il-25 with -- with activities in the range of 23 typically 25, 29 per seed, with a density of about one per 24 square centimeter, tend rot to produce any microsis. It 25 seems to be quite safe. l l l l ! (~'N ANN RILEY & ASSOCIATES, LTD. (,,) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
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l I 443 1 So, it might be possible, in that situation, to
- (T 2 have a written prescription in advance that covered a range.
U 3 But given what currently is done, technically there is -- 4 there are misadministrations or medical events taking place 5 in' California. And that's a misdemeanor.
'6 MR. CAMERON: He remembered that.
7 Cathy, comment on that. The proposed rule was for 8 the medical event? 9 MS. HANEY: No. Actually, under the current rule 10 - and the proposed rule it would not he a medical event. 11 In the case of brachythe. py we are not -- we do 12 know that what you go into a procedure with thinking you're I 13- going to implant 10 seeds or whatever may not be what you 14 end up doing once you get inside, all right, or start {
. () 15 working with the patient.
16 So, what the rule allows you to do is to write --
-17 requires you to do is to write a written directive before i 18 you do the procedure that says exactly what you said, the L 19 number of seeds, the number. This is what you would expect.
l-20 So, your best estimate would be you're going to use X number 21- of seeds. But when the procedure is over you can go back, 1
'22 and in the case of brachytherapy as well as any other of the 23 procedures, make a written directive.
24 In the case -- 25 DR. LARSON: I misunderstood you. i
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444 1 MS. HANEY: Okay. In the case of -- sticking () 2 specifically to your example, you would write down that you 3 plan.-- or your intent is to 15, 10/15 seeds, what ever. 4 You go in, you only use 10 seeds. After the procedure is 5 finished, you do the implantation, you would go back and 6 revise the written directive and you would say, "Rather than 7 15 I inserted 10 and it is not an administration." 8 DR. LARSON: I don' t see that written down in the 9 proposed regulations. 10 MS. HANEY: It is. Page 190 of what -- it's under 11 35.40. 12 DR. LARSON: Thirty five forty? 13 MS. HANEY: Yes, it should be -- if we're matching 14 pages -- I may have a different version than you -- but it () 15 should be page 190 of the Federal Register Notice. On item l 16 six it says, "For all other brachytherapy." i i 17 DR. LARSON: Six dash two? !- 18 MS. HANEY: Right. Right. You have your prior to 19 implantation, you do what you -- you.would right down pretty l- 20 much what your intent is and what you think you're going l [ 21 into, but then after implementation but prior to f l 22 completion -- that's kind of the key, though. Prior to ! 1 23 completing it. We don't want you going back two weeks later i 24 and changing the written directive. In that case it would I 25 be a misadministration. But prior to completing the l a () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 I Washington, D.C. 20036 (202) 842-0034
I' l 445 1 treatment you would just put down in the written directive
/m 2 'what you actually implanted.
(V) 3 DR. LARSON: That sounds like that would cover it. 4 MR. CAMERON: If there is anything that's unclear 5 in the supplementary or that could perhaps be nailed down in 6 supplementary information that's fair game for comments on 7 the rule. Because you don't want to leave ambiguities like j 8 that out there. f 9 Well, this sort of -- Melissa? 10 MS. MARTIN: Well, I'm just following up on Dr. 11 Larson's comments because I do the symmetry on a fair number 12 of brachytherapy cases, but I'm really sitting here with the 13 expert on my left. 14 You've got up there that that represents total p) ( 15 dose or dosage differences by'20 percent. I can tell you 16 that after Dr. Larson gets through, according to his written i 17 directive, at least the way we've got most of our guys doing 4 I 18 it now, they may write in there, "We actually implanted 73 19 seeds at .52 millicuries each", which our planned dose is, 20 say, 10,000 centigrade. 21 When we actually run the dose symmetry, we could 22 very well be anywhere from two days to two weeks later, that 23 dose may come out 8,000 to 15,000. We don't -- it could 24 very well be differences by 20 percent or more routinely, 25 then what the intent was. Because again, it's irregular i ()
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446 1 surfaces. They're doing a volume implant. They're going to (~} V 2 make their best judgement and they're going to do what, 3 surgically, is necessary. But -- and they will do an 4 estimated dose. But there's many times where it's -- and 20 5 percent difference in a brachytherapy case can be two 6 millimeters. 7 MR. CAMERON: I'll have to look at this closer, 8 but I still believe that the proposed rule would cover it,. 9 because whdn Dr. Larson is writing the written directive he 10 will be writing down the number of sources. And assuming 11 that he goes back and revises it after he's done the 12 implantation, and that number of sources is the number of 13 sources that goes in the patient. You're not kicked into 14- the space of the medical event because you are still in the () .15 16 space of this is what the original directive said. MS. MARTIN: So, according -- my interpretation is 17 as long as the number of sources and the activity of the 18 sources used is correct, that gets rid of the 20 percent 1 19 dose differential? l
-20 DR. LARSON: Let me tell you, I think I understand 21 how to get around this now.
22 MR. CAMERON: This might still be a misdemeanor. 23 DR. LARSON: I think in the past what a lot of 24 people have done -- people have written a dose at so many 25 millimeters, it could be 20,000 to 5 millimeters or 1 I O ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034 I
447 1 something like that. And then a week later, once they've (} 2 'done their -- are -- inspecting the facility, you might find 3 that it's 40,000 to 5 millimeters. 4 An alternative to doing that at the time of ' 5 ~ implant is not to specify a dose, because it allows us to 6 just make a guess. I'm going to use 80 seedt; of this f 7 strength. And when I'm done I needed to know that I used 8 71, 112, and I write that in. And that satisfies 9 reSulations and it still allows me to do corrective symmetry 10 a week later. 11 MS. HANEY: Yes. 12 MS. MILLER: That was my point. So, we don't have 13 the dose part of the written prescriptive. 14 MS. HANEY: No. Because the rule allow for an or. O) ( 15 MS. MILLER: Okay. Thank you.
- 16. MR. CAMERON: That might be something -- I don't 17 know what the communication network is like among all of 18 you, but people who are here now might realize that. But
- 19. similarly situated people who aren't here might not have a 20 clue about that. I don't know if that's something we should 21 elaborate on in'the supplementary information or if this 22- should be shared in the community.
23 MR. BAILEY: But isn't this exactly the same 24 situation you get into if you're doing thyroid therapy or 25 residual thyroid therapy? I mean, you don't know -- you
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I: 448 1 don't know how much of the item is really going to be taken I (~ 2 up, so that you end up -- you really don't know what the
.k}J 3 dose is to that tissue necessarily? I mean, you give a dose i
4 in terms of X millicuries as he gives a dose in terms of X 5 seeds. 6 MS. HANEY: Right. And the rule does recognize 7 that there are things like some uncertainty, if you want to 8 call it that, when you're going into the procedure. And the l l i 9 operating surgeon always has the ability to revise the 10 written directive. 11 Now, in the case of the Il-31, again, if you 12 thought you were giving the patient 100 millicuries and then l 13 immediately afterwards you realized you may have done 60 but 14 you decided to go ahead, if there was a revised written l
-[v ) 15 directive you would probably be okay. If you wait a week to 16 revise that written directive then we would probably be 17 calling that a medical event.
18 Now, I can't say doing it in less than three hours 19 it's okay, but starting after three hours, it's not. The 20 rule doesn't give you that -- doesn't provide for that. l 21 But we have tried to do in the case of 22 brachytherapy, because we do know that has been a problem, 23 and as I said the current rule allows for that revision, 24 before implantation and after implantation, but we still do 25 have the caveats in there because of the nature of the ANN RILEY & ASSOCIATES, LTD.
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449 L l 1 patient, you can go ahead and teat without a written l' 2 directive as long as you follow up immediately with it and 3 that you can revise the written directive. 4 One of the big examples of when a written 5 directive is revised is that for some reason halfway into l 6 the treatment -- I mean, half way into the treatment, the l 7 patient pulls the implant out. 8 Now you've got the case of is this a 9 misadministration because now we're 50 percent under dose. 10 All the physician -- if the physician decides that that's 11 probably enough of a dose to treat this condition, I'm not 12 going to implant it again, you just document, revise the 13 written directive, to say, "I put it at day one, 24 hours 14 rather than 48 hours", and that's okay in the NRC states. () 15 16 DR. LULL: Can I comment? MS. HANEY: Sure. 17 DR. LULL: I really don't understand why you would 18 be concerned about an under dosage. Their concerns are -- 19 you're worried about if someone gets radiation they
-20 shouldn't have gotten, getting more radiation. You know, it 21 would seem to me that under dosage should not really -- it's 22 not a real safety issue. It's not a risk issue, big risk 23 ' issue.
24 MS, HANEY: We've been dealing with that question.
'25 It's been asked a lot of times over the last year.
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450 l 1 And where we are concerned is that even if the
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(s 2 dose is under that there was a breakdown or a potential -- 3 well, actually, I guess there was a breakdown in the 4 program. That in this case it was lucky it was a 50 percent S under dose. But the same problem that led to the 50 percent 6 under dose may have actually resulted in a 50 percent 7- overdose. 8 DR. LULL: Well, that's a good assumption. I 9 mean, but basically you're going to hear about any overdose. 10 You can analyze the overdoses. I don't think that the under 11 dose evaluation is something that you ought to be into. 12 Now, in addition to that comment which I don't 13 expect a definitive answer on now anyway. But am I to 14 understand that these dose thresholds apply to all of these
) 15 things under it represents? Like, if you give the wrong 16 pharmaceutical, but it produces less than the doses l 17 established up here, like 50 rems to an organ that it's not 18 reportable?
19 MS. HANEY: That's right. Let me just take a 20 second and run through this slide, because we kind of jumped 21 into it. 22 What -- when we were looking to do with medical 23 events, misadministrations, we decided to get away from the 24 term " misadministration", because over the years NRC had 25 been criticized for using this term. [ \ ANN RILEY & ASSOCIATES, LTD. 5' Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l l 451 l' To people it meant more. To patients it was a 2 scary thing to hear the term " misadministration". And it's 3 n to really an appropriate use of the term. So, the 1 4 Commission gave us the okay to go ahead and change the term. 5 So, we had coined the term " medical event". If you don't 6 like the term " medical event", that's one thing you can l 7 comment on and say, " Change it to such and such." But we do 8 need, unfortunately, some type of label for this thing. Do , 9 for this sake, I'm now going to call it a medical event. 10 The other thing that we ran into with looking at 11 the current criteria is that there are no thresholds for 12 wrong treatment site. 13 If -- you know, we're trying to lock at 14 consistency between the diagnostic uses and the therapy 1 () 15 uses. Under the current rule ', if there were to be an 16 implant, and implant came out and laid next to the patient's 17 leg for X number of hours or minutes, whatever. You 18 delivered a dose of, say, one gram to the leg. That would 19 be classified as a wrong treatment site, because the leg was 20 not intended to receive any radiation at all. 21 We have had -- and we have medical consultants 22 come in and say, "Okay. It's true. It was wrong treatment 23 site, but one gram to the leg is no big deal. Why are you 24 worried about it? You don't need to know about it." l 25 So, we've attempted to fix the problem of this
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452 1 wrong treatment site. 2 The other thing that we tried to fix was the
)
3 problem of patient intervention. Again, it's really more 4 driven by therapy and the diagnostic arena. However, there 5' are some cases where the patient is just going to decide to 6' take the implant out and there wasn't anything that the 7 licensee could have done to prevent it. 8 And in that case we want the hospital to 9 investigate, to look at it from the standpoint of their own 10 internal procedures, buy, you know, we don't care about l 11 that. 12 What we're saying is if it was truly patient 13 intervention that you don't need -- it would not be i 14 classified as a medical event. So, those were the two () 15- things that we were really trying to fix with the current l i 16 misadministration criteria. I 17 To get at that, we have put a dose threshold on 18 the medical event such that you need to exceed the five -- 19- the .05 severt (phonetic) and the .5 severt to an organ or 20 tissue through a skin dose, because currently skin is not 21 addressed. 22 So, that's your.first criteria when you're looking 23 at if something's a medical event or not. Once you crossed 24 that then you also have to look at these other categories.
-25 Does the dose differ by more than 25 -- 20 percent. If J / ANN RILEY & ASSOCIATES, LTD.
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453 1 you're looking at fractionated doses, does it differ by 50 (}
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2 percent. Those percentages we have not changed from the l 3 current rule. And then you get into the wrong 4 pharmaceutical and the list there than you can read. 5 And then the kick out for all of those would be if 6 it was the result of patient intervention. You would not 7 need to tell us. l 8 I would sensitize you to the ruling and our j 9 ' commenting on it. Look at the discussion on patient l I 10 intervention. What, in your mind, is patient intervention? 11 Have we given enough information in the supporting 12 documentation that you feel that we've adequately addressed 13 this? i 14 A concern comes about from the licensee' side that ! I i( ) 15 are you going to be subject to seccnd guessing by an NRC i 16 inspection. What you may have called patient intervention 17 is an inspector going to come in and say, "No. That wasn't 18 patient intervention"? These are some areas that you need 19 to look at very closely in the rule to feel -- to decide 12 0 whether there's adequate justification to those items. 21 Sort of a long answer to your question is that in 22 the diagnostic arena is you deliver something by the 23 wrong -- the wrong pharmaceutical and it does not trigger 24 these dose thresholds in that first bullet it is not a 25 medical event, i l
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454 1 In the current rule, you may have triggered what (). 2 was referred to as a " recordable event". And then that was V 3 an internal procedure that NRC was dictating you go to. We 4 have stepped away from recordable events and deleted it i 5 entirely from the rule. So, we're not saying that you have 6 to do anything with that. 1 7 DR. LULL: The thresholds, I think, really help a I 8 lot. The misadministration rule -- and frankly I kind of 9 like the word " misadministration" as directing - but a 1 10 medical event, under these circumstances, I think is better ' 11 because of the thresholds now and because now you're talking 12 about significant, you know, reasonably significant 13 radiation exposures, either 5 rems dose equivalent or 50 14 rems to organ or skin. And so those are reasonable levels. I ([ 15 And so personally, I think that's much more acceptable. 16 We felt, from the Society viewpoint, however, that 17 the history of the misadministration rule'and -- real harms 18 that are produced make the whole thing, for diagnostic l 19 ~ doses, totally unnecessary and way out of line with what i 20 happens with other risky things that happen in medicine. 21 - So, I know you understand that. 22 MR. CAMERON: I'd like to know if anybody has any 23 bog problems besides the general one expressed by Bob with 24 the current medical event rule and -- why don't we go for David's comments? 25 I i (T s ,/ ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i 455 1 MR. NEBLETT: I think the entire thing needs to be
"'\ 2 reviewed because you people talk about dos.e as if you know
[D 3 what you're talking about and you don't. 4 There isn't anyone in this room who's smart enough 5 to calculate dose. We don't know what the dose is. We 6 estimate the dose under clinical experience and a lot of 7 simplifying assumptions. And that needs to be clearly 8 specified that we are estimating dose under clinical . l 9 assumptions to back up 30 years of clinical experience so 10 -that we have a consistency in what we do. 11 It doesn't do any good to calculate dose 12 accurately in a lump when it's been considered and estimated 13 as a soluble water organ for 30 years. It's a total ! 14 inconsistency. () 15 We should be talking about dose estimations made 16 under the same clinical assumption by a qualified expert. 17 l And that's what should be more than 10, 15 or 20 percent in 18 error. Not dose. 19 I feel really strong about that. 20 The next thing is this difference needs to be tied 21 to risk. And you sit up there and say "Ah" when I pull out 22 this therapeutic material that's laying next to his leg and 23 I'm going to set it next to a genetic effect with it is 24 fairly inconsistent because that patient has already a 25 higher dose from that from scatter. What you need to say is f\ s-) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 ! Washington, D.C. 20036 l (202) 842-0034 l
456 1 what's this 10 percent difference, and what is the risk
. ['} - 2 involved in that 10 percent difference?
v 3 If that risk is subclinical, then there is no risk. I think this whole 4 thing needs to be reviewed and I wish I had more time to 5 discuss it, but I don't. 6- MR. CAMERON: I'd like to hear what the Staff has 7 to say about the issue of estimation of dose and the issue i 8 of risk. 9 MS. HANEY: Well, I think that the understanding 10 is that this is an estimation. 11 MR. NEBLETT: It needs to say that. It's a 12 regulation. 13 MS. HANEY: Well, and I would say that when you 14 provide written comments that -- this goes back to what we () -15 had said yesterday -- we are looking to identify events 16 where there has been a significant deviation from what the 17 physician directed. And indicates that this -- if there is 18 alternative rule language to propose, you know, we're 19 certainly'open to it. We've gotten a lot of input from the 20- AAPM. And I guess it's pretty mush the AAPM on this 21 criteria. And they're going to be coming back to us because 22- I'm sure that we have not addressed it completely. 23 But we're very much open through the whole year to 24 input from the.different professional organizations on the 25 way to capture these events. l-ANN RILEY & ASSOCIATES, LTD. i Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 ( Washington, D.C. 20036 j (202) 842-0034
457 1 MR. CAMERON: How about the risk issue? 1 f"') v 2 MS HANEY: Again, I think it's very good. We are 3 trying to, you know, treat -- look at the risk across th- , 4 board and try to come up with a definition of medical event 5 that would apply to risk in different areas -- the whole l 6 world of Part 35. And if there is a better way of defining 7 this it's good. 8 We tried to get away from the standpoint of the 9 current rule that says if you're in brachytherapy this is 10 one set of criteria, if you're using sterectopic 11 radiosurgery this is another criteria, if you're diagnostic 12 it's another. And to try to simply that and take it to 13 this. 14 And maybe by doing that and -- what we thought was pm ( 15 simplifying the rule is, in f'act, not the way to go. And I 16 would go back to doing it under different categories. 17 MR. CAMERON: Now that the negative label of 18 " misadministration" has been changed, the fact that it's a 19 recordable medical event doesn't imply necessarily that 20 there's a violation of the regulation, is that true? 21 MS. HANEY: No. It's true that it doesn't apply, 22 that there is a violation of the regulations. However, when 23 there is a medical event it does trigger a what we refer to 24 as notification of the patient, notification following a 25 medical event. And that has been a big issue over time as l l ("'\ ANN RILEY & ASSOCIATES, LTD. i '\s-) Court Reporters L 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
458 i. 1 far'as notification goes, which gets us into a whole other 2 discussion. l /')(_/ 3 The other thing that does happen as a result of a 4 medical event is that if it is a significant one it triggers 5 an inspection. And the NRC will tend to allow, as also I'm 6 sure the states do in their investigation. We have other 7 requirements that say that you need procedures for this, 8 procedures for that. And what tends to happen is that 9 during this investigation we identified that there was a 10 breakdown in the procedures. 11 If it was a procedure that was required by the 12 regulation to be developed and implemented and it was not { 13 implemented, it may subject the facility to citation. 14 MR. CAMERON: I'd like to hear from Bob and also i -~, q,) 15 I'd like to hear from our agreement state representatives l 16 on -- on this topic. 17 And this side of the table won. I'd just like to 18 congratulate you. 19 Go ahead, Bob. 20 DR. LULL: Well, first of all, I think that this 21 thing, as a generic rule for tracking things that have a 22 significant edge, isn't bad, really. 23 You know, first of all, 5 rem for an effected' dose l 24 equivalent for a totally body, it's like that's the maximum 25 for a radiation worker or close to. And 50 rems to organ is l l. e J
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459 1 kind of the level at which you -- you really are getting up f-s 2 to where you might start seeing' organ effects. b) 3 to.the gonads, to the testicles, will result in a Fifty regs 4 demonstrable decrease in sperm count. So, we're talking 5 levels that are not inappropriate for sunning (phonetic) as 6 organ levels here. So, I don't think that I agree with the 7 concern. i t 8 And also the fact that these are dose estimates is i 9 very true. On the other hand, all of our biologic data. 10 relationship to radiation dose in humans at a baseline, dose l l 11 estimates done the same way. And so that's what our j 12 database is related to and we don't have any other database l 1 13 to'-- any other better measuring dose than that. I 14 understand the theoretical concerns, but I think the -- the 15 levels that as set here tend to resolve all of my concerns
;g'
'16
'about, you know, these are events that have been a huge pain 17 in the neck for people and there's been no real. risk. I 18 understand this concern about what is a real risk, and we've !
19 argued this ourselves. On the other hand, this is -- this 20 is going to ruin a lot of that pain in the diagnostic area. 21 MS. HANEY: And I was going to say, an the i 22 i therapeutic area. 23 In the diagnostic area what will tend to kick you 24 in or out of a medical event is the first bullet up there, 25 which.is the dose threshold. In the therapeutic area what ANN RILEY & ASSOCIATES, LTD. Court Reporters j 1025 Connecticut Avenue, NW, Suite 1014 i Washington, D.C. 20036 (202) 842-0034 i
_ .. -. m_ _ .......__ ..___._ __ _ _ _ _._ _ _ _ _ i 460 l 1 will kick you in or out of a medical event is more of are l 2 you differing by 50 percent from -- 50 or 20 percent from 3 what was prescribed? So, the argument there should be 4 really whether is 20 percent the accurate percentage and is 5 50 percent the accurate. 6 So, we've really got the kick to clauses for both 7 modalities -- well, for modalities or both areas. l-
'8 DR. LULL: Yeah. And by the way, I would -- you 9 were talking before and I feel strongly against, at least ;
- 10 . internally, people readjusting -- after they saw them -- did 1
{ ' L 11- something at a lower dose of a radiopharmaceutical, or a 12 higher dose then adjusting it afterwards and reassigning. 13 You know, I think that frustrates the very principle of 14 using these trigger events to look at your program and see '\).I 3 15 what's not working. 16 That principle, which is behind everything that i
. 17 professionally our organization strongly supports and should 18 be utilized internally for internal controls that everyone 19 who's practicing nuclear medicine should be doing.
l 20 They should be looking at each -- any time 21 something is not precisely the way it's supposed to be. And 22 it doesn't have to happen at the NRC level with penalties 23 and all of that sort of thing. It should be happening as 24- part of the professional competence. That's what we're . 25 talking about. i ~ ANN RILEY & ASSOCIATES, LTD.
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461 1 j 2 And-people who are adequately trained, with 3 adequate experience, will do these things automatically
'4 ' because that's the professional competence acting and it 5 doesn't need to have NRC regulations driving it.
6 MR. CAMERON: Terry? 7 MR. FRAZEE: The -- I like the threshold. I like 8 most of the changes. I'm a little unclear how the wrong 9 site is handled for therapy. 10~ MS. HANEY: The wrong site, in the example that I 11 gave where the source laid next to the leg before it was 12 detected. And let's say it wasn't due to patient 13 intervention'for some -- you know, it was not put in well 14 and it just fell out and laid next to the leg. It would get () 15 addressed to the standpoint of that if it was caught, if 16 this source was seen and corrected, the action was taken 17 before a dose was delivered to the leg, that would exceed
- 18. this threshold, then it would not be a medical event.
19 If it was not caught quick enough and the dose to
- 20 the leg would have exceeded these items, then we would --
21 the threshold -- then we would want to know about it, 22 because now we're starting to look at m ore a procedural
- 23 management of the care. I don't want to say management of 24 the care because that's not where want to me. But more from l 25 a radiation safety aspect. Maybe the nurse should have been l
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l 462 1 checking on the patient more frequently. () 2 3 You know, if it was caught within an hour, you know, Okay, fine, you haven't exceeded this. But let's say 4 the nurse or the physician or radiation safety officer, 5 whatever, didn't catch it until a day later. There's 6 something wrong at a problematic standpoint. Or maybe wrong 7 is not the right term. Maybe it's something that the 8 program could be made better by a change in this medical 9 event, which just highlighted the attention that something 10; needs to be done to look at addressing this problem. 11 But I'll tell you something. This -- that was the 12 only way that we could come up with addressing the wrong 13 treatment site. And we toyed around with trying to get into 14 treatment volumes and, you know, recognizing that when you ( 15 do a certain therapeutic procedure that there is some dose 16 that is delivered to the entire body as a result of the 17- treatment, you know. And where -- what's acceptable and l 18 what's not acceptable. And about the best way the group 19 could come up with was with setting this threshold. But 20 certainly if people come up with a better way of addressing 21 . wrong treatment site we're open to it. In fact, we put a 22 specific question in the Federal Register Notice of, you 23 .know, we tried to address wrong treatment site. If we 24 didn't, tell us and give us a solution. 25 MR. FRAZEE: The subtleties of shift in the (- i /) ANN RILEY & ASSOCIATES, LTD. fk/ Court Reporters i 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 t .. -
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463 1 positioning of a procedure -- and therefore, when is it far l (n) 2 enough away -- from one site -- or isn't. I'm not sure 3 exactly how to handle that one. ! 4 The requirement of written directive. We talked l 5 about prior to implantation this was required. The sources ) 6 or dose. You'll lead people down the garden path in the 7 sense that, you know, we're all -- okay, the reality is you t t 8 have every intention of doing one kind of implantation, but 9 when you get in there, something else happens. So, maybe 10 it's -- say, "Look, this is what we intended to do without a 11 dose. We intend to use a particular isotope and 12 afterwards -- after implementation here's what we actually 13 have." Whether it's immediately after or two weeks after, l l 14 or whenever. 15 MS. HANEY: Yeah. The intent, I believe, was to 16 give the licensee some flexibility by saying dose or the l 17 number of needles receipts or whatever. The number of. The 18 intent was not to mislead or trap the licensee. And I think 19 Dr. Larson brought up a good point that in his example that j 20 maybe we had done that and maybe we should delete that 21 reference in the rule. Because not everyone reads the 22 Statements of Considerations. Because we could write a long 23 explanation of, if you use dose, just realize you're in 24 jeopardy. 25- So, maybe one of the things in the final rule is A
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464 1 that we would delete " dose" in that basis and just go with 2 the number of sources. b' T 3 MR. CAMERON: Okay. Great. Ed, do you have some 4 comments on this one? 5 MR. BAILEY: I don't think I do. I presume that 6 these migrating seed that we hear about would not be 7 considered wrong site or whatever. 8 MS. HANEY: That's one of the areas that we'll 9 probably be exploring during the misconduct period. That 10 raises the question of is that patient intervention. You 11 know, assuming that the seed was implanted properly and due 12 to just the physiology of the body the source moved, should 13 that kick in as a medical event? One would think not, but 14 this gets into the grey zone of what is patient n (J $ 15 intervention. And I think we'll, you know, at subsequent 16 meetings and in public comment get a lot of questions raised 17 and hopefully some information on how we do deal with that. 18 But again, we're hoping the threshold would do it, 19 but I'm not sure, in that case, if the source were to 20 migrate and were to -- may not be done with it. You know, 21 maybe it might exceed the threshold, but should that really 22 be a medical event? The answer may be no. I mean, assuming 23 it was surgically implanted correctly. 24 MR. BAILEY: And I guess the other question I have 25 is water leaking source was put down there. I -- I mean, a l l l (~N ANN RILEY & ASSOCIATES, LTD.
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._ . _ - . ~. . . ~ . - ~ _ _ . . _ _ _ _ . _ . _ . . _ _ _ _ . . _ _ _ . _ m. __ _ _ m, 465 1 leaking source-is already a portable event.
(N 2 MS. HANEY: That's a good comment. I mean, the 3 leaking source was left over from the current criteria and t 4 we had no reason to delete it from, you know, the proposed ; 5 rules. So -- right, a water leaking source is a reportable l 6 event and it would be reported under 35.3047, I think -- 46? l 7 l It's 46 or 47. And if we heard that a brachytherapy source ' 8 was leaking in part of the bag and say, "Have you used it l 9 recently?" And if you said, you know, yes, then we'd start 10 looking a little bit further. How much was leaking and was 11 there a dose to the patient that wasn't captured. 12 MR. BAILEY: I guess thinking about leaking 13 sources, the only ones that I can think of probably have 14 been cleaned in some manner before they're put into the 15 patient. 16 MS. HANEY: Right. 17 MR. BAILEY: And I don't know how you -- they l 18 would be discovered to be leaking later or whatever during 19 the routine leak test I guess there's a possibility of going 20 back. 'But it seems there's already a mechanism to catch 21 that. 22 MS. HANEY: Right. 23- MR. CAMERON: How about people in the audience? l 24 David? 25 MR. NICHOLS: David Nichols, the American College l , 1
\
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_ _ . . . . _ _ ~ . _ - . . _ . - 466 1 of Nuclear Physicians and Society of Nuclear Medicine. 2 [ I wonder if there was any consideration to raise 3 the threshold even higher to be similar to what the FDA 4 requires, and they're reporting instances with a threshold 5- of morbidity or mortality involved. It still seems that 6 you've got to have events reported to you that have no 7 medical consequences to the patient. And then the question i I 8 is, well, why are you collecting information where there's i 9 no medical consequence to the patient? And even after
- 10 you've collected it then what are you dealing with it l l
l 11 because most of it's going to be an isolated event' You i . 12 already said that you have less than 30 misadministrations 13 or medical events a year out of thousands of procedures, j 14 And so, if these are isolated is there any purpose ( ) 15 in collecting it other than for enforcement against the 16 licensees? 1 17 MR. CAMERON: I guess to answer your first 18 question, yes, we did get consideration to other thresholds 19 or other type of definitions for medical events. 20 We especially looked at the FDA definition in the 21 case with precursor events and hopefully we'll get them in ! 22 there too to talk about what happened with precursor events. l 23 We have a requirement to report to Congress at 24 normal occurrences. And this falls under our authorization. 25 'NRC can come up with the criteria for defining what we ANN RILEY & ASSOCIATES, LTD. ( Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l' Washington, D.C. 20036 (202) 842-0034
1 l 467 1 report to congress and the public has the opportunity to 2 comment on what that criteria is. But the AR criteria right 3 now is set at 100. rems to a major bone marrow, lens of the 4 eye or gonads.or 1000 rems to any other organ. And then we 5 also kick in with a dose or dosage -- at 50 percent, that's 6 prescribed in a written directive. It kind of parallels the 7 definition'that you see here. 8 We thought about setting this criteria at the 9 point of the AO criteria. And we came back with it. We 10- thought that that was not a good idea because we wanted to 11 be hearing about events before we had to report them to 12 . Congress. So, it wasn't the licensee reports to us and then 13 we automatically enter a report to congress. 14 You know, our standpoint is not to go and take () 15' 16 enforcement action. events. That's not our objective from these Our objective is to receive notification when these 17 " events take place. Such that it heightens our awareness of 18 potential problems in the licensees programs, it brings a 1 i 19 certain attention to the radiation protection program at the l 20 licensee, such that they can take corrective action. I 21 A lot of time what we learn from these medical 22 events are information that we take out to other licensees l 1 23 with an information notice of, you know, this happened at a 24- licensee, and it may have generic implementations such that 12 5 we prevent further medical events at other licensees by just ("'s ANN RILEY & ASSOCIATES, LTD. ! Court Reporters i 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
468 1 getting this information out. O
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2 MR. CAMEROM: That's an interesting statement and 3 philosophy about the -- the intent is not to take 4 enforcement action on these. Is there any data on 5 percentages of what are now misadministrations where we do 6 not take enforcement action or take enforcement action? Not 7 that that proves anything. Just curious. 8 MS. HANEY: Yeah. Joe would have to comment as 9 far as whether there is -- I mean, the data is available. 10 We could go back and look at the number of the 11- misadministrations and then look through the enforcement 12 files to see whether there's a one-to-one correlation or
. 13 not.
14 I would say probably the greater benefit is the j 15 fact that by getting this information out to other licensees 16 we have prevented similar misadministrations or medical 17 events from happening in their facilities and that -- that, 18 in our eyes, that's a greater benefit. 19 MR. CAMERON: Okay. Good.
. 20 David?
21 MR. WALTER: David Walter from Alabama. We 22 have -- we know misadministration criteria is what some-23 people would say is ridiculously low, 500 milligrams whole
- 24. body and 2 grams or 2 rems to an organ. At which time maybe 25 we -- that's our point at which we call it a
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469 1 misadministration and they have to send in a written report _ 2 as to what happened, why it happened. 3 Virtually everything we have had and seen in the 4 past -- currently have all been a programmatic problem. And 5 we don't have medical events that reach anywhere need the 6 criteria that the NRC has set because if you go back to that 7 point you've got a major problem usually, except for those 8 occasional blips that occur. You have a major problem in 9 your program that has led to this and it has not been 10 corrected because it's never been brought to your attention. 11 And we don't go out and inspect people because 12 they notify us that they've got a misadministration. We 13 check when we go on our regular -- next regularly scheduled 14 inspection to make sure that they've taken care of what they () 15 16 said they were going to do for corrective actions. But it's still our experience that, simply stated, 17 these -- all of these things that you find in medical events 18 in the NRC are things that could have easily been stopped 19 long ago if hLought to the attention of the licensee. 20 And that's what we're doing is we're giving tt m a 21 friendly prod on the back and saying, " Check -- check your 22 program out. Make sure that you've got it going right and 23 that you don't have something escalating that's a real 24 problem." l 25 MR. CAMERON: Okay. Thank you, David, for that
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470 1 information. And maybe that's a good introduction to see if 2 we have any -- anything to say about the whole issue of 3 agreement states and compatibility. David was talking about 4 their trigger for misadministrations. 5 And Cathy, the -- what is the proposed level of I 6 compatibility for this rule? 7 MS. HANEY: I think we have a lot of everything. ! 8 MR. CAMERON: Oh, great. 9 MS. HANEY: So, actually -- it's a C. The 10 majority is a C. However, there are some components that ! 11 are greater than a C. There are some health and safety I l
~12 requirements.
13 MR. BAILEY: Those are sneaky. 14 MS. HANEY: You'll get your turn, Ed. l (f') 15 MR. CAMERON: Can you explain what that means in 16 layman's terms? In other words, what a C is? 17 MS. HANEY: A C is the agreement states, the 18 flexibility of taking our rule and putting into effect a 19 rule that they feel suits their need. They should go higher 20 up in the alphabet. The state would have to adopt our 21 regulation either verbatim or it would have to adopt it at 22 least as stringent if not more stringent than the NRC l-23 regulation. 24 We had a lot of discussions about the 25 compatibility. We had major input into where the levels ] []
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471' 1 i came out. The Federal Recister Notice goes through and jgs 2 explains it. We also do have a chart that may be easier. 3 It shows in chart form as compared in text form. Probably 4
'in the next few weeks we'll try to get the chart up on one i 5 of the web sites. If someone wants to go download it and 6
look at it it's a little bit easier to look at it.
- 7 Those sections -- our designation for the sections 8 are also up for public comment and for comments from the 1
9 state. 10 We will be having a meeting, a workshop at the all 11 agreement state meeting that's being held in October. The 12 discussion on Part 35 will be on October 31st in the 13 morning. And I suspect that at that meeting there will be a 14 lot of comment about the compatibility level as associated 15 with the rule. 16 For those licensees that are in agreement states 17 this is a key section for them because it, you know, they 18 can have another NRC regulation out there and not to feel 19 that you're touched by it, but if we're starting to talk 20 about section of the rule being designated with the health 21 and safety section, then the states are going to be in a 22 situation where they're going to have to adopt something 23 similar to this regulation and that it does have an impact 24 on them. So, hopefully people will be commenting, for the 25 NRC and from the agreement states. l l
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I 472 1 Also, I would stop there and just let Terry and Ed 2 make a comment. t 3 MR. CAMERON: Well, I would just want to emphasize 4 what you said, that it's not just an agreement state, NRC 5 issue, because it has big effects on licensees. It's not on 6 the agreement states, but in a specific agreement state, but 7 it could have, I guess, competitive ramifications, depending 8 on what state you were in. 9 Terry? 10 MR. FRAZEE: There were a couple here that I found 11 as I was reading this. I was reading through. What I 12 thought you were providing a particular designation. But 13 there were a couple ones, like, whoa, I don't understand 14 that one. And is there a listing of the essential A) (G 15 objectives for each section and why you gave a particular 16 designation? 17 MS. HANEY: I will look for a head shake from the 18 back. At this point I do not believe there is a listing of 19 the essential objectives in a section. 20 Some of -- in this chart that I mentioned, on some 21 of them we got down to this, like, 35. 24 (b) is the health 22 and safety section. The rest is designated as C. So, for 23- some of them we have identified I think what you would 24 consider the essential objectives. There are probably a 25 couple at this point that have not been identified. But I'm I l ("Ng ANN RILEY & ASSOCIATES, LTD. i (, ,/ Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
473 i 1 j sure over the next couple of weeks we will probably be doing
/~T 2 that.
3 MR. FRAZEE: Are we talking about the same thing? ) 4 Would you go down and identify the particular section and 5 subsection item? That's not what I'm talking about. It's 6 why did you pick a particular -- 7 MS. HANEY: Okay. I think the answer is no, there 8 is not a document that says that at this point. 9 MR. CAMERON: Can we -- should we have a l 10 commitment from the NRC to develop such a document so that 11 people can basically examine the rationale? I mean, isn't 12 that what it goes to, rationale? 13 MR. FRAZEE: Right. 14 MS. HANEY: I think before we make a commitment, (Av) 15 since I'm up here at the table by myself and we have a 16 representative from state programs sitting back there very 17 quietly, if there is anything that Lloyd might want to 18 address on this topic and, you know, where we stand or why 19 we would or wouldn't produce the essential objectives? 20 MR. BOLLING: Sure. 21 MR. CAMERON: Lloyd Bolling. 22 MR. BOLLING: It's Lloyd Bolling, state programs. 23 The assignment of compatibility categories to each 24 and every requirement of Part 35 is derived from the 25 adequacy and compatibility of the policy. On occasion there ANN RILEY c ASSOCIATES, LTD. ()N (,, Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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474 ; 1 wasn't a direct fit between.the compatibility categories and 2 the specific requirement. But if you look at the criteria , 3 for compatibility, A, B, C, D and H and S, you get -- when ; 4 you're down to C, in'the C area, it's -- it has to do with-l 5 compatibility. If you go to D, it's defined as being 6 something that is not a matter of compatibility, and 7 therefore, the states don't have to adopt it. But D, with-8 an-H and S, means that there are some -- safety concerns, 9 but they don't rise to the level of compatibility. ; 10- Now, it's been pointed out to us that when a 11 requirement has a D, H and S and a state does not adopt it , 12 then they are in jeopardy for being inadequate. So, that, I ' 13 know is your concern. And'we are going to be looking again ! E14 at those D, H and Ss. Ih 15 But as we developed the chart -- and I know that i [d.
~16 not everybody has seen the chart yet -- but it's kind of a
'17 cheat sheet that we're using to help us with the text. As 18 we look at that chart again it may, in fact, cause us to 19 make some other assignments.
20 But the assignments that are -- that you've seen 21 in the text and derived from the chart, come right out of 22 the compatibility and adequacy policy. ] i 23 MR. FRAZEE: Well, I think you need to take a look 24 at 35.100.and 35.200. Those are designated as H and S, and 25 yet these are clearly areas where generally we're saying l {% ANN RILEY & ASSOCIATES, LTD. g Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 ! Washington, D.C. 20036 (202) 842-0034
_ - . ~ . 475 1 these: are very low risk procedures. So, why do the states : ("% 2 have to -- 1 3 MR. CAMERON: ~ I think maybe the states can 4 understand -- look at the policy and understand what those. 5: designations mean. But I think the disconnect now perhaps
+
6 is that there's no. explanation of why a particular provision 7 fell into a particular category and, therefore, it would be 8 hard for anyone to -- to comment on that without that 9 explanation, i 10 Is that basically the point? 11 MR. BOLLING: Yes. 12 -MR. CAMERON: Ed? i t j 13 MR. BAILEY: I think certainly the designations l 14 are going to be important and the agreement states need to l [ 15. look at them very closely. 16 I have concern about the liberal use of the H and I 4 l 17 S category because I'm not sure, then, does that mean that 18 it rises to the level of an A or a B or not? And an example 19 of one of the ones that I believe was designated A and S is t 20 35.70(b) which is giving an exemption from doing a survey. 21 Now, I don't know how that's requiring them to give a survey 22 .or do a survey. It could be considered a health and safety. l 23 And there may be others in there like that. Because I'm not 24 sure, really, what health and safety means in terms of the 25' policy. i l 4- 7dD7 RILEY & ASSOCIATES, LTD. Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 3 Washington, D.C. 20036 (202) 842-0034 l
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476 l 1 MS. HANEY: I think I'll add to what we went ) [) 2 through this. This was our best attempt at taking the L/ 3 policy and putting it down. By no means are these l
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4 categorizations etched in stone at this point. I think by 5 an interactive process between some of the states we can 6 work through and come to a better understanding and 7 agreement on where these certain categories should fall 8 under the adequacy and compatibility policy. 9 MR. BAILEY: Now, I guess another example of it 10 where it gets a little confusing is under 35.63 (a) where 11 you're talking about each licensee shall determine and 12 record the activity of each dosage. But then there's no 13 direct revision. And that's marked as health and safety. 14 Whereas to me, that -- I would have thought that would have p. ( ,j 15 risen to some other -- I guess. And -- if you're giving 16 unit dosage you don't have to do that. 17 MS. HANEY: Yeah. I think that what we can do is 18 get out that chart where it actually lays it out. It's a 19 lot easier to read than the text. We thought about putting 20 the chart into the Federal Register Notice but it was about 21 10 to 15 pages long. 22 Maybe we can include that in the handout for the 23 Kansas City meeting as well as put it up on the net and then 24 it will be easier for us to go through and actually mark up 25 where this is question. And maybe outside the meeting, that [}
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'477 1 is something we need to do during the meeting. But we could
(^ meet with you over the breaks or whatever, whoever the state b} 2 3 representatives are, and pick out the ones where you have a 4 questions and then we can go back to the office of state 5 programs and talk to them about, you know, does this really 6 fall into this category, and if en, why? 7 And again, I would really guess that a large 8 percentage of the agreement state meeting will be to discuss 9 the levels assigned to the different sections. 10 MR. BAILEY: Can you have that mailed out? ) 11 MS. HANEY: Yes. No, we can, in fact, we can get 12 it mailed out to you, at least you and Ed next week. And if 13 you think it appropriate we can include it in the binder 14 when it goes out to the Kansas City members. () '15 MR. CAMERON: Okay. I think we're about done 16 here. 17 MR. BAILEY: Can we go through the suggestions 18 they raised and marked them where we think -- l 19 MR. CAMERON: There's no comment up here, I guess, 20 on that one. 21 Are there any other -- I just want to thank 22 everybody, particularly those of you who stuck around to the I 23 bitter end. I wish there was some sort of a report that we 24 had. 25 Thank you all for participating. Are there any -- ANN RILEY & ASSOCIATES, LTD. I f/) Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
478 l 1 .are there any other issues that anyone around the table or l)
\ms e 2'
those around the table or those in the audience would like ; 3 to' raise as a final' comment for us today? 4 We covered all provisions of the rule, obviously, i 5 but I think we did have some good discussions. We did 4 L 6 cover -- it's sort of an evolutionary process in terms of i { l l 7 moving through the meetings. I 8 Terry? 9 MR. FRAZEE: Keep in mind that tha base level in I 10 the current practice position in the reali ' d -- coverage 11 in the rural hospital setting. Much of what we dealt with
- 12. today has been several steps above that and also I 13 representatives here f,om major institutions, board 14 certified, no question as qualified, but in the state we l l
- 15 have to deal with individual physicians still. So, Part 35 I 16 needs to sort of baseline, cover those guys and then l 17 progress up from there. I think -- a broad scope license --
18 a type M for medical or something, that a lot of these guys l 19 are looking for. The certification yesterday -- so, I'm 20 certainly more into allow that as some sort of an option 21 where the large facilities do have -- to take the program -- l
.22 a broad scope type of origin.
23 MR. CAMERON: So, you're suggesting some -- 24 looking for some sort of an endorsement of a specific new 25 type of licensing arrangement that goes into the issue that r-i r l lO
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479 1 David Belk, I guess, had raised. ! 2 All right. Anybody else have a final comment? (} 3 All right. Well, thank you and we'll look forward ! 1 4 to your comments -- for the proposed medical policy ; 5 statement and the proposed rule. 6- If-you referenced this it will help to make it 7 into the right docket. But if you don't, it doesn't 8 necessarily mean that we won't see those comments, but 9 anyway, it's 63 Federal Register, this is the page number { 10 and that's the date. 11 [Whereupon, at 5:06 p.m., the public meeting was ' 1 12 concluded.] J 13
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REPORTER'S CERTIFICATE , es This is to certify that the attached proceedings I ( ) before the United States Nuclear Regulatory Commission in
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the matter of: NAME OF PROCEEDING: PUBLIC MEETING: PROPOSED REVISION.OF PART 35 AND THE NRC'S MEDICAL POLICY STATEMENT CASE NUMBER: l l l t PLACE OF PROCEEDING: ' San Francisco, CA f% (j). were held as herein appears, and that this is the original transcript thereof'for the file of the United States Nuclear Regulatory Commission taken by me and thereafter reduced to typewriting by me or under the direction of the court reporting company, and that the transcript is a true and l: accurate record of the forego proceedibgh. 1 nel 8 % udyJdkso Official Reporter Ann Riley & Associates, Ltd. LO
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