ML20217F729
| ML20217F729 | |
| Person / Time | |
|---|---|
| Issue date: | 09/26/1997 |
| From: | NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) |
| To: | |
| Shared Package | |
| ML20217F678 | List: |
| References | |
| NACMUI, NUDOCS 9710090039 | |
| Download: ML20217F729 (437) | |
Text
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Official Transcript of Proceedings O NUCLEAR REGULATORY COMMISSION
Title:
Advisory Committee on the Medical Uses of Isotopes Docket Number: (not applicable) >
l l
! Location: Rockville, Maryland O
Date: Friday, September 26,1997 i
1 Work Order No.: NRC-1246 Pages 311-600 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers ,.._. _. ,.
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This is an unofficial transcript of a subcommittee meeting of the Advisory Connittee of the Medical Uses of Isotopes, of the United States Nuclear Regulatory Commission. held on September 25 26. 1997, at the U.S. Nuclear Regulatory Commission. Two White Flint North.
Washington. 0.C. 20555. The meeting was open to the public with the exception of one closed session to provide an annual ethics briefing to the members. This transcript has not been reviewed, corrected or edited, and it may contain inaccuracies.
The transcript is intended solely for general informational purposes. As provided by l
10 CFR 9.103. it is not part of the formal or informal record of decision of the matters discussed. Expressions of opinion in this transcript do not necessarily reflect final determination or beliefs. No pleading or other paper may be filed with the Connission in any proceeding as the result of, or addressed to, any statement or argument contained herein, except as the Connission may authorize.
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3 311 1 UNITED STATES OF AMERICA
[,m) 2 NUCLEAR REGULATORY COMMISSION
. _)
3 + ++++
4 ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES 5 (ACMUI) 6 + ++++
7 FRIDAY B SEPTEMBER 26, 1997 9 OPEN SESSION 10 + ++++
11 ROCKVILLE, MARYLAND 12 The Advisory Committee met at the Nuclear p 13 Regulatory Commission, Two White Flint North, Room T2B3,
)
x) 14 11565 Rockville Pike, at 8:00 a.m., Judith Anne Stitt, 15 Chairman, presiding, 16 COMMITTEE MEMBERS:
17 JUDITH ANNE STITT, M.D. CHAIRMAN 18 DANIEL F. FLYNN, M.D. MEMBER 19 ANDREW KANG, M.D. MEMBER 20 WILLIAM B. NELP, M.D. MEMBER 21 DENNIS P. SWANSON, M.S.,B.C.N.P. MEMBER 22 LOUIS K. WAGNER, M.D. MEMBER 23 THERESA WALKUP, C.M.D. MEMBER 24 JEFFREY F. WILLIAMSON, PhD. MEMBER
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312 1- ACMUI INVITED GUESTS:
2 NAOMI ALAZRAKI, M.D.
3 MANUEL CERQUEIRA, M.D.
4 RUTH McBURNEY S CATHY RIBAUDO 6
7 ALSO PRESENT:
8 CATHY HANEY 9 DONNA-BETH HOWE, M.D.
10 SAM JONES 11 PENNY LANZISERA 12 MARJORIE ROTHSCHILD 13 BARRY SIEGEL, M.D.
14 15 16 17 18 39 20 21 22 23 i 24 l
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-313 1 -A-G-E-N-D-A l-
~2 Aaenda Item- Page 3 Discussion'of. Requirements for Training-and i
l =- 4 Experience, Penny Lanzisera- 314
-5 Discussion-of Requirements for Notification of 6 Patient-and-Related Definition of t-l-
7 Reportable Events
- 8 Cathy Haney. 382 9 Marjorie Rcathschild 462 10 Status Report on Rulemaking and Guidance 11 Cathy Haney 520 12
-13 14 15
, 17 10
-19 20 21.-
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l 314 1 P-R-O-C-E-E-D-2-N-G-S 2 (8:15 a.m.)
3 MS, HANEY: Good morning. We'11 go on the 4 record now. Before we get into the training and 5 experience I'd like to just follow up on one thing from 6 yesterday. Dennis Swanson had askea about his comments, 7 or the ACMUI comments on Regulatory Guide 8.39. What I 8 was able to find was a note from our staff person to File 9 about how those comments were resolved.
10 I provided Dennis a copy of that document this 11 morning and with the agreement that Dennis will go through 12 it, if he has questions about how the comments were 13 adopted or not adopted, he can come back to me and we'll 14 address it further and if necessary, bring it up at the 15 next meeting.
16 And with that, I guess we'll go into training 17 and experience if you're ready, Dr. Stitt. And Penny 18 Lanzisera is from our Region 1 office. Penny is a member 19 of the working group and she was responsible for this 20 particular area.
21 So Penny, if you're here, I hope?
22 MS. LANZISERA- We're going to start with the 23 authorized user and as time permits we'll move to the 24 radiation safety officer and physicist.
25 I do have one correction to make on the slide NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N.W.
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313 1 that I handed out to you. The third option on here, the !
[ ]
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2 third alternative, should say Training and Experience plus
%d 3 Exam. So if you'll correct it on the handout that I just 4 gave you that will help you further along.
5 Essentially, the authorized user alternatives 6 that we cane up with were thes'e; the first one being 7 status quo, which is M.D. plus Board certification or a 8 anecified number of hours. Now, 2 may look similar to 9 that but really what 2 is -- this is a summary of what's 10 written in your documents that you were given.
11 But what 2 really is, is the M.D. plus the 12 Board certification that will not be specifically listed s 13 in the regvlation, or a specified number of hours of
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\m l 14 training and experience. And the training and experience 15 we ha.e to focus more on radiation safety with this 16 op*
17 1 .s the M.D. plus Board certification or 18 a specified number of houro -- again focused on radiation 19 safety training -- plus an exam. And option 4 is M.D.
20 only. Option 5, M.D. plus exam. And option 6 was M.D.
21 plus exam plus clinical experience only.
22 I'm going to put up the next slide because I 23 think that will help you a little bit as we're going 24 through some of the major differences between the options.
/' ) 25 You'll find this on page 12 I believe, of your document, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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316 1 or the second handout that I gave you.
2 Essentially, the major differences are, you 3 know, if you believe that clinical experience is necessary 4 to list in the regulations then options 1, 2, 3, and 6 --
5 it's the last item on this slide. If you believe that 6 Board certification is necessary then options 1, 2, and 3.
7 If you think that an exam would be necessary to show 8 proficiency in radiation safety, then options 3, 5, and 6.
9 DR. WILLIAMSON: Could I ask a questica of 10 clarification? These options that you've written up here, 11 do you intend them for all modalities or simply for 12 nuclear medicine diagnostic and therapy?
12 MS. LANZISERA: Well actually, if you look at 14 your packet that we gave you on training and experience --
l l 15 DR. WILLIAMSON: Yes.
16 MS. LANZISERA: -- the second page was 17 something that we came up with in the working group that l
18 essentially went through and said, you know, which 19 alternatives do we think would fit which modality? So, l 20 does that halp?
21 MS. HANEY: Yes, the cnly thing I'd add to 22 that is, there were some alternatives that we did not feel 23 definitely would work for some of the modalities, but we 24 see training and experience going in the modality section 25 of the rule. It would not be in a general requirement.
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3171 1 So for example, if you went on an hour basis,
') 2 tha number of hours for e. raining for someone doing the low wJ 3 dose diagnostic may be very low, like 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />. But if 4 you had an individual that was into HDRs or the gamma 5 knives, then maybe that number would be increased to 200 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />. So there would be some variation within the 7 modalities for how they meet the requirement.
8 T!.is is intended really, to get at the level 9 of ( 11.'., do you think an exam is necessary, is clinical 20 experience necessary? Yea know, is just being a physician 11 only approcriate? And then we would go down to the next 12 tier whica is setting up the number of hours. And if we 13 get to that pe> int today that would be good, and if not,
')
C/ 14 we'll deal with it at another teme.
15 MS. L WZISERA: If you look at the rule text 16 as well, optionn 2 and 3, or alternatives 2 and 3 have 17 tried to get at that. That it may be different for each 18 modality that you're looking at on the required 19 training / experience hours.
20 And then the last thing to point out -- and 21 ag m . this is in the rule text --
is that for the 22 examination component of this, if it's important in the 23 rule text you'll see that the Medical Specialty Board 24 examinations would meet the requirement for the exam
} 25 required in those alternatives. So it's essentially
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318 1 option 3 versus options 5 and 6.
2 okay.
3 CHAIRMAN STITT: You're done?
4 MS. LANZISERA: That's it.
5 CHAIRMAN STITT: Okay. Is the group awake and 6 ready to jump in?
7 MS. LANZISERA: Which slide would you like me 9 to leave up? This one or the first one?
9 CHAIRMAN STITT: Folks prefer the matrix?
Worked for us before. Who wants to start?
10 l 11 DR. NELP: I have a question. Does the NRC 12 currently give examinations to licensees? Do they have 13 any experience at all in the examinations?
14 MS. HANEY: We do in the -- for reactor 15 operators on the other side of the house. We also 16 recently revised part 34 which is our radiography --
17 industrial radiography regulations -- and in that document 18 there's a requirement for certification by exam. And 19 Ruth, you probably know more about that than I do, se 20 maybe you can just take a few seconds and --
21 MS. McBURNEY: On this, Texas actually 22 implemented industrial radiography certification several 23 years ago. And their exam -- our exam is being used by the 24 American Society for Non-destructive Testing which is the 25 professional organization of industrial radiographers as NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS i 1323 RHoDE ISLAND AVE., N W.
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l 319 1 part of their certification program, as well as some other
[ ) 2 states have also contracted with us to use our exam, So a
3 we have quite a bit of experience in doing the 4 psychometrics and security and all that goes into test 5 development and so forth.
6 MS. HANEY: And 4 it -- you can correct me if 7 I'm wrong -- but my understanding is that under this rule, 8 NRC will certify a testing organization as having an 9 appropriate program, and then by NRC blessing the program 10 then, if someone takes that test then they meet the intent 11 of the rule. .
12 MS. McBURNEY: Right.
7-~ 13 MS. HANEY: So we allowed in the draft rule
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\- / 14 language that we put into the alternatives, we allowed for 15 both: either a test given by NRC or other approved 16 organization. Right now the staff for part 34 is in the 17 process of developing the evaluation criteria for the 18 itesting programs. So if we went this approach we would 19 probably be looking to what -- you know, they're a year 20 ahead of us so we'd probably be looking back to them to 21 see what sort of approach they took.
22 DR. NELP: Thank you.
23 CHAIRMAN STITT: The NRC is not involved in 24 approval of any of these programs that are available for
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( \ 25 other types of testing. The courses that folks can attend
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320 1
1 -- what, nuclear medicine, there's a fair number of those?
2 - MS. HANEY: We do not approve them but on 3 occasion we have gone out and looked at them, 4 CHAIRMAN STITT: Barry, you had a comment?
5 DR. SIEGEL: Just an amplification of this 6 testing question. I mean, this is obviously sotcething 7 that I've been talking about for a number of years as kind 8 of a paradigm shift in the training and experience 9 approach.
10 To reduce the -- at least if we think about 11 nuclear medicine for a moment -- to reduce the required 12 training and experience to the radiation safety component, 13 believing that the clinical component is largely a 14 function of other decisionmaking bodies: hospital 15 credentializing Boards, the certifying Boards, etc.
16 And that would thereby, in the case of nuclear 17 medicine, decrease the hours substantially. But in order 18 to provide that someone's really mastered it you need to 19 somehow validate the training; and examination is a way of 20 validating the training.
21 Board certification is one way to validate 22 that a person has mastered a certain body of knowledge.
23 Absent Board certification, an independent exam is another 24 way to achieve that. I think the NRC probably is not 25 eager to get into the business of examining physicians.
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331 1 But I suspect that there are plenty of organizations that m
/ i 2 might well be willing to jump in and fill the void.
() 3 For example, the National Board of Medical 4 Examiners might give such an exam on a contract basis.
5 They could make it readily available at many, many sites 6 throughout the United States -- probably in a computerized 7 format.
8 Modern examination technique says you don't 9 just prepare an exam with 100 questions and use it over 10 and over again, but you prepare an exam with 2,000 11 questions, have it on a computer, constantly jump to the 12 next level of difficulty when someone gets a question
-, 13 either right, or down when they get it wrong.
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'(. ,) 14 And an exam beetmes a randomized selection 15 from the large collection pool that's tailored to the 16 person sitting there at that moment in time, and yet test 17 the appropriate sample of the body of knowledge.
18 That's -- the SATs and ACTS are heading that 19 way and there's no reason why an exam like this couldn't 20 be designed that way with the help of a fairly large 21 amount of expertise that's already out there in the 22 various Boards that have put exams like this together over 23 the years.
24 So I personally think and have felt for a long
('~N., 25 time, that this is a very, very practical alternative to
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. J 322 1 relying en Board certification for validation of training Q
2 and experience.
3 I also would just add that if one reduceu the 4 required hours of training and experience to something 5 that is quite consistent with the radiation safety 6 component, then it is very likely that other Boards and 7 other Residency Review Committees will jump in and say 8 yes, we believe that we can require that our trainees in 9 our training programs have this training, and we will 10 examine in it so that our diplomates can be certified in 11 this.
L 12 And so that then, allows the Boards to come to 13 the NRC and say, we now provide thic, therefore let our 14 Board certification serve the role of the examination. So 15 I think it leads to a very logical approach where the NRC 16 focuses on radiation safety and lets the marketplace deal 17 with the rest of it.
18 CHAIRMAN STITT: So Barry, looking at 19 alternatives 1 through 6, where does your opinion lie 20 amongst those?
21 DR. SIEGEL: I think when you adjust it 22 modality-specific I come down on number 3; that you are a 23 physician, that you are either Board certified by a Board 24 that has deemed status -- a Board that has come to the NRC 25 and says the following things: our trainees get the NEAL R. GROSS COURT REPORTERS AND TRANSCRIDERS 1323 RHODE ISt.AND AVE., N W.
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323 1 required training and'our examination includas testing of
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i 2 their knowledge base in the radiation safety areas of 3 concern.
4 Because of restraint of trade = issues you can't 5 just let Board certification be the only basis for 6 allowing people to become authorized users so you giva the
-? one alternate route which is, a certain number of hours 8 plus/minus a certain number of hours of experience, and 9 then plus the exam.
10 And if I can just make one additional comment !
11 about_ clinical experience. When Sam and I were-working on 12 this using 35,100, 200, and 300 as the mouels that we were i 13 working on, we actually had no clinical experience 3 14 associated with 100, 200; because really it's -- the -
15 clinical. experience arm of that is not relevant to the 16 radiation safety aspect of it.
17 We did put some specific " clinical experience" la in 35.300, radiopharmaceutical therapy, but we changed the 19 name of what we called it. We called it 20 radiopharmaceutical administration experience. Meaning 21 that the person who wac about to become an authorized user 22 needed some hands-on experience in cetually performing the 23 therapies so that-that individual-understood the mechanics 24 of giving a radiopharmaceutical therapy.
25 That's distinct from -- that's not addressing-NEAl.R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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l 384 1 the question whether or not that individual has the 2 clinical judgment to decide whether an individual patient 3 needs the therapy. I really personally believe that that 4 shouldn't be the NRC's problem; that should be the problem 5 of medical certifying Boards, hospital credentializing 6 Boards. and in the event of malfeasance, tort law.
7 CRAIRMAN STITT: Manuel?
8 DR. CERQUEIRA: I'd sort of like to make a few 9 comments. I think, you know, Barry's making some very 10 good points.
11 I think it's very important to sort of focus 12 this discussion on the radiation safety aspects and leave 13 some of the other issues of clinical competence and some 14 of the turf issues out of the iscue of radiation safety.
15 And I think if we just sort of focused on that it will I 16 think, help us to come to some conclusions.
17 Looking at the alternatives, I am a little 18 concerned about setting up an examination and the 19 logistics of how to basically do it. The program that 20 you've established in Texas and that you're developing, 21 how many pupils a year approximately, take the 22 examination? Do you anticipate?
23 MS, McBURNEY: . think that in our state, plus 24 those that we do under contract, we're probably doing --
25 let's see --
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325 1 DR. CERQUEIRA: Just a ballpark.
2 MS. McBURNEY: Nearly a thousand a year. About 3 1,000 a year.
4' MS. RANEY: And what percentage of the United 5 States are you probably-testing? Maybe --
6 MS. McBURNEY: Probably --
7 MS. RANEY: -- 25 percent maybe?
8 MS. McBURNEY: More than that. Because we're 9 getting -- I mean, most of the radiographers are located 10 in the-Southwest -- in the South and Southwest, just due 11 to the oil and gas industry. Plus we're doing Illinois 12 and of course the AS&T program which is nationwide.
13 MS. RANEY: So probably in the 1,000 to 2,000
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14 range?
15 MS McBURNEY: Right.
16 MR. CERQUEIRA: And how often -- are you doing 17 this repeatedly or is itfjust a_one-time _--
18 MS McBURNEY: Monthly. Monthly in our state 19 and then probably once every two to three months in each '
20 of the entities that have contracted with us, which are --
21 there are seven.
22 DR. CERQUEIRA: That's a lot of testing. I 23 think just if-you look-at the radiologists, nuclear 24 medicine positions, and cardiologists, and pathologists 25- that are coming out, we're talking about a fairly large NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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326 l 1 number of people that would be taking this examination. I l 2 don't think it would have to be repeated, but -- so I 3 think that the issue of separation between radiation :
l 4 safety and clinical competence is important. )
l 5 I also worry a little bit in some of the 6 options in terms of Board certification. I think !
7 cardiologists traditionally have been excluded in the past 8 from having Boards. I think some of the newer 9 requirements for training programs have included 10 information on radiation safety as part of it in terms of 11 the number of hours in the clinical experience as well.
12 And I think that needs to be taken into 13 consideration in terms of the changes. I think when these 14 regs were written originally that wasn't the case, but 15 with time and evolution it has been included as part of i
16 the training. And I think probably radiation therapy and 17 radiation oncology are similar.
18 So there would be some issues about which 19 Boards would be acceptable. So I think we would be in 20 favor probably of option number 2 as the one that would 21 help to identify the amount of training that's required, 22 and I think the logistics of doing an examination is quite 23 difficult. I know Barry has some ideas and there are 24 alternative ways, but I think there would probably be some 25 problems.
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327 1 (8:30 a.m.)
,x 2 CHAIRMAN STITT: Thank you.
(v) Barry, you have a 3 follow-up on that?
4 DR. SIEGEL: Yes. Understand the issue of 5 what it takes for a Board to currently appear in Part 35 6 and at least the proposal in part is that specific Boards 7 would no longer be listed but rather they would be j 8 independently available in some separate guidance i
9 document.
10 But currently, the way the American Board of 11 Radiology is listed in Part 35 as -- its certification 12 constituting the basis for licensure, is because the 7s 13 American Board of Radiology came to the NRC and said, we I i
's_/ 14 certify that our trainees will get six month's of 15 training, and that our trainees will get the required 16 radiation safety training and that our examination will 17 include components of the NRC's knowledge base there.
18 If the American Board of Internal Medicine had 19 been willing to come forward and make the same statement 20 for training in cardiology any time in the last ten years, 21 cardiology could be right there on that same list.
22 Under this new proposal, or under a new 23 proposal where the number of hours is markedly reduced and 24 focused on radiatien safety, I suspect that the American
[ ) 25 Board of Internal Medicine will have its letter drafted N._,l NEAL R. GROSS COURT REPORTERS AND TRANSCRIDERS 1323 RHODE ISLAND AVE., N W.
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320 1 the same day that the new regulations appear, and it will 2 be on the list and that solves the problem for 95 percent 3 of the people who might have to take an examination who 4 are not Board certified.
5 Yet there still has to be an alternative route 6 for those people who, for whatever reason, choose not to 7 become Board certified, who are not eligible to become 8 Board certified, and yet still potentially can meet 9 radiation safety requirements in order to conduct this 10 component of the practice of medicine.
11 CHAIRMAN STITT: Member of the public and then 12 Naomi.
13 MR. BROSIUS: Yes, I'm Roger Brosius. I work 14 with the Radiation Safety Committee at the National 15 Institutes of Health. And the two alternatives that are 16 getting th; most attention here leave one area uncovered.
17 It's a small niche area, but we have I suspect that 18 other institutions also have physicians who are doing 19 research -- they're not doing diagnosis, they're not doing 20 therapy -- may be using one or two radiopharmaceuticals or 21 radioactive research drugs.
22 And the way the current regulations are 23 written and the two considerations that are on the floor 24 are written, these particular physicians are sort of 25 blocked out of the system. And so my point is, there NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RH005 ISLAND AVE., N W.
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329 1 needs to be a little bit of flexibility similar to the 2 diacussion for the-low dose diagnostic area _to allow a 3 mechanism for authorization of physicians who are doing 4 these research procedures.
l 5 CHAIRMAN STITT: Darry, you have a comment on 6 that?
- 7 DR. SIEGEL: Just that if you consider that 8 many of those would fall under 35.100 type application --
9 many would -- and that they'd be doing metabolism studies 10 with tritiated drugs and things like that, I think 11 depending on what one does with the hours for 35.100, it-12 might well be very straightforward for someone to achieve 13 those hours in an appropriate, institutional training-14 course,.and then sit for this exam in radiation safety and 15 then it would be very easy for a licensee to name such an 16 individual as an authorized user.
-17 I actually see this as a simplifying 18 mechanism, aside from the fact that it gets NRC out of the 19 turf battle once and for all.
20 CHAIRMAN STITT: Barry, why do you see it as 21 simplifying? Certainly 2 or 3 have more words'than the 22 status quo _does, but why-is it --
23 DR. SIEGEL: I think it levels the playing 24 field and it avoids some of the fractious disagreements O 25 about who's really doing.what. It reouces -- again, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1373 RHoDE GLAND AVE., N W.
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330 1 focusing on nuclear medicine -- it reduces the amount of l
2 training to that which is really essential to protect 3 workers and the members of the general public, with very I l
4 little focus on patients and consistent with what we're i
S recommending with respect to the medical policy statement.
6 And then it provides two roughly equivalent 7 mechanisms. It says you've got a certain amount of 8 training, and it's validated. And you either have it 9 validated by a Board or you have it validated by some 10 independent testing agency if you choose not to or not 11 eligible to take a Board exam.
12 And the bar then, can be set in terms of the 13 number of hours, and the need for supervised 14 administration experience based on the assessment of the 15 risk. So again, that is entirely consistent with the 16 approach in the medical policy statement.
17 And 35.100 type applications either in the 18 clinical setting or in the research setting are really low 19 risk. And so one microcurie of C-14 urea doesn't need a 20 whole lot of training and experience, and most of the 21 other things that are done with 35.100 type applications 22 could be done with minimal radiation safety training and 23 experience.
24 CHAIRMAN STITT: Naomi, you're next.
25 DR. ALAZRAKI: I'd like to just address the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE.. N W.
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331 1 issue of the clinical experience as it relates to 2 radiation safoty, since we're focusing on relating to (G')
3 radiation safety and I think that's appropriate. Just 4 going to lectures and reading the text on radiation safety 5 and the sciences surrounding the radiation safety world, I 6 think is not a substitute for practical handling of 7 radiation in the clinical setting -- any more than reading 8 . textbook on physical diagnosis is a substitute for 9 getting in there and doing physical diagnosis.
10 So my point is that some clinical experience 11 and application, practical handling of radioactive 12 materials, of drawing doses, of measuring doses -- which 13 you may have to do at two in the morning -- some practical
(,_s\
(_,) 14 experience and training is essential for really being able 15 to handle radioactive materials safely with confidence, 16 and protecting the public, the rooms, the space where 17 you're working.
18 We've had several experiences with physicians 19 coming in who have not had that kind of practical 20 training, who may have had the lecture and text reading; 21 physicians who have been either cardiologists or radiation 22 oncologists who are not trained in handling unsealed 23 sources, coming into the department, and we have to close 24 down a room when they finish because they don't understand
[~'} 25 how to use these materials safely.
S._ /
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l
332 l
1 And so 2 think that simply talking about t
2 radiation safety, you can't divorce totally the clinical 3 experiences. It's part of the radiation safety 4 erperience.
)
1 5 CHAIRMAN STITT: I want to ask Cathy a point 6 of clarification. Number 1, which is described as the 7 status quo, number 2 and number 3 in corryarison, does a number -- the things they have in common -- describe 9 specified hours of training and experience, and then 2 and 10 3 both contain the clause, " minimal requirements for 11 clinical experience".
12 Status quo does not have minimal requirements 13 currently */
14 MS. HANEY: No, it does have requirements for 15 clinical --
16 CHAIRMAN STITT: Okay, just --
so one of the i
17 major differences then for 1 and 2 --
18 MS. HANEY: Okay, f or 1 and 2, the differences 19 would be that in -- the Board by name would no longer be 20 listed. Under 2 it would basically say, if the Board, in 21 order to get the Board certification you get x number of 22 hours2.546296e-4 days <br />0.00611 hours <br />3.637566e-5 weeks <br />8.371e-6 months <br /> of training. Then that's an approved -- basically, 1
{ 23 that's an approved Board.
24 Two would significantly reduce the number of 25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />. For example, the status quo now is a 500-hour.
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333 l
1 The specified number of hours under 2 would be modality- l 2 specific, and I think at least what was just shown in the 3 proposal of what's in your package, we were saying -- we 4 just picked 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> as compared to the previous 500, 5 RNow, che 80 is certainly up for discussion --
6 you know, whether it's 80 or 200 it doesn't matter -- but 7 what we're saying is, it would be a reduced 1, umber of a hours that would just be focused on safety.
9 CRAIRMAN'STITT Okay. Let's go ahead -- more 10 over here and then we'll get that side going.
11 DR. FLYNN: Okay, speaking with someone who's .
12 on the Residency Review Committee ..,d who examines en the 13 oral Boards and proctors the written Boards, in fact we 14 are revising the radiation oncology Residency Review 15 Committee requirements, and it takes -- it's a 2-year 16 process and radiation safety will_be a component of that -
17 - and regulatory aspects in a general sense, not 18 specifically quotin5 one agency or a state or another.
19 In terms of the ABR though, I think the 20 missing thing - there's something that I'd like to say.
21 On the oral exam -- I don't know if you've examined the
- 22. oral exams, too -- radiation safety is'really not a focus 23 of the oral-Board'exami that's a clinical exam.
24_ In the written exam -- I've proctored in the 25 written exams a number of times, and looking specifically NEAL R. GROS 5 CoVRT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N W.
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i 334 1 at the written exam recently to look to see what's 2 radiation safety on the exam, there's a lot of material on 3 the exam and -- there's a separate Physics exam as you 4 know -- there's a lot of material on that -- I mean, 5 isotopes half-life, you know, half-value layers, doing a 6 lot of things like that.
7 There's a little bit on wipe tests on the 8 exam, a little bit on what needs to be done and what 9 degree of periodicity - like how often do you calibrate 10 this, how often do you check that - but there's not a lot 11 of radiation safety on the exam.
12 Now, my question is, sure the ABR has come to 13 the NRC wit.h a proposal and they have done it to some 14 degree. I'm not sure if it's to enough of a degree. In 15 other words, is there a communication between the NRC and 16 the ABR? I somehow doubt it.
17 In terms of the specifics of changes that are 18 occurring and what the NRC is obtaining in terms of 19 lessons learned from the kinds of problems that occurred 20 let's say, in the last ten years, and does that material 21 get organized and does the NRC relate as to what they see 22 are major safety concerns, and does that get translated to 23 the ABR and does the ABR respond to that? I somehow doubt 24 that happens because it's not reflected in the written 25 exam right now.
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1
1 i
335 l 1 CHAIRMAN STITT Let me come in on that also.
- ') 2 I write questions for the written exam. Do you, Jeff, LJ 3 write some physical questions for the ABR? l l
4 DR. WILLIAMSON: No, 7 haven't; not for 5 physician exams.
6 CHAIRMAN STITT: And I examine for oral 7 Boards, and the field is nue-oncology, one of the places 8 where we use radioactive resources the most. And I agree 9 with you Dan, that on the written exam are questions 10 about, kind of classic medical physics type of questions, 11 and certainly the oral exam is purely, purely clinical:
12 what is the stage; how do you manage this case?
,x s
13 We could have the NRC write Board questions
/
m- 14 for the written exam. I don't think that that has been 15 covered very well by our field. Now, maybe it is in nug 16 medicir.e in a better ferm, or --
17 DR. FLYNN: There are come radiation safety 18 questions, cut there's a small number of them. I don't 19 think it's by intent. I think there needs to be some more 20 of a periodic coa.munication between some NRC liaison and a 21 Board liaison -- no matter what Bbard it might be -- to 22 relate to the Board, number one, what are the major issues 23 -- broad scope, broad issues in radiation safety that you 24 see based on your nationwide experience -- and then let
/)
s w/
a 25 the Board write the questions, HEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHoDE IS'.AND AVE , N W.
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.s
336 i But they don't know what that is. They're 2 assuming it is and they may be writing questions that 3 .could have been relevant ten years ago. But there are 4 questions, but --
and they'll tell you -- if you ask them 7 7they'll say yes., there are -- but there are probably not t
6 enougS *cd nsy cyc probably not focused on some of the 7 key things t!. int need cc. be focused on.
8 CHAIRMAN ST.tTT: Let me throw out one other 9 isrue. In the practice of radiation oncology, the vast le m4crity of Board certified physicians who have practiced 11 in radiation m : ology are not using isotopes in any way, 12 shape or form.
13 Those who do probably have a fair amount of 14 experience and do it reasonably well. So you know, I 15 think that the Boards do nCt address that. I think you 16 a.id I both agree to that an.d that most practitioners in 17 our field are not using sources.
18 All right. We've got the group awake. Let's 19 see who -- Jeff, you've been waving for a while. Let's do 20 this and Barry, I'll come back to you.
21 DR. WILLIAMSON: I wanted to follow up on the 22 comments made by Dan and Judy. I mean, that may be true 23 about the content of the physician ABR exam, but I think 24 that the, you know, at least in radiation oncology there's 25 sort of the assumption being made here that the authorized NEAL R. GROSS COURT REPORTER $ AND TRANSCRIBERS 1323 RHODE ISLAND AVE , N W.
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337' 1 user, the practicing physician, is the one that in fact,
/x
/' i 2 controls, maintains, and needs to be knowledgeable about ;
i L) 3 the details of the radiation safety infrastructure.
4 I chink the paradigm that in fact, ir. most 5 closely followed throughout the country in radiation 6 oncology is that the medical physicist is actually the 7 person who puts together the radiation safety and quality 8 assurance infrastructure that the physician uses, and that 9 in practice, the locust of knowledge and experience is in 10 the physicist.
11 And most often one of the physicist's role is 12 to develop a procedure, explain to the authorized user and
,_s -
13 resident users of the material, this is what you have to i
\_- 14 do and take steps to ensure that the individuals doing 15 these activities, insofar as they relate to technical and 16 safety issues, are properly trained and able to do it.
17 So I'm a little concerned here that the 18 regulations are being written on the basis of a paradigm 19 or model that, you know, may not be widely applicable.
20 Mainly that there is one specialist, the physician, that 21 in supposed to be the source of knowledge of everything 22 relating to safety is simply not true.
23 The other question I have relates to the 44 nuclear medicine discussion which I'm not an expert in,
(
25 but is there some perceived deficiency in simply L.))
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338 1 requiring, you know, a fixed number of hours of experience 2 and/or training; that there has to be an examination?
3 Why have the added complication of requiring I 4 an examination? !
5 CllAIRMAN STITT: I know Lou and Dennis both 6 have comments. Lou, go ahead.
1 7 DR. WAGNER: Well, I guess I have -- excuse me l 8 for the sunglasses. I have a headache and that's the 9 reason I'm wearing them; I'm light sensitive.
10 The first question is, can the NRC give me any 11 information regarding the potential number of-physicians 12 or authorized users or licensees who have licenses but are 13 not Board certified? Who have obtained their training 14 from outside agencies?
15 MS, RANEY: I guess to answer the question, in 16 our docket file -- in the actual licensee's files -- we do 17 have that information but we don't have a database that I la could go to and say, this is the number. I might have to 19 go in and do a case-by-case review of files.
20 DR. WAGNER: Dan, did you have something to 21 add to that?
22 DR. FLYNN: I can tell you for radiation 23 oncology it's just under ten percent, nationwide. Of 3400 l
24 physicians, ten percent are not Board certified. Many of 25 them are in the examination process who have failed one or NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1MO RHODE ISMND A\E, N W.
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339 1 two times, but some are not. Some are not in the
) 2 examination process.
R.j 3 DR. WAGNER: My concern is this. With regard 4 -- and this gets a little bit over to Naomi's question --
5 with those individuals who have not had a training that is 6 specifically oriented to clinical experience, if that 7 exists I worry a little bit about radiation safety 9 training from organizations that are not necessarily 9 directly associated with a medical facility or something 10 of that nature.
11 And the reason I worry about that is because I 12 have not a tremendous amount of experience but a little rx 13 bit of experience on individuals who obtain their training i r i /
N- ' 14 in that way, and I don't feel it's adequate. I don't feel 15 it is supervised or approved adequately by the NRC or any 16 other individual.
17 So what I would be a little bit concerned 18 about would be the ability to obtain training outside of a 19 direct medical facility where you could get the direct 20 clinical experience. Some of these courses -- I spoke 21 with some individuals -- some of these courses run either 22 10 to 14 hours1.62037e-4 days <br />0.00389 hours <br />2.314815e-5 weeks <br />5.327e-6 months <br /> a day in order to get enough hours in, etc.
23 People get fatigued, you don't learn a whole lot, you know 24 that people are sleeping during many of the lectures, r~N 25 I worry a little bit about that kind of a
( )
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7 340 i situation that can develop if you have an opportunity for 2 these kinds of training programL'to develop. Not to say 3 that all of them are that way, but some of them sometimes 4 have such situations and I would like to see a little more 5 policing of those situations rather than just going ahead 6 and saying okay, they're approved.
7 Barry has a question back there.
8 CHAIRMAN STITT Barry?
9 DR. SIEGEL: Yes, several points. First, just 10 to respond to you. I think you need -- it's important to 11 understand that those courses are a free market response 12 to a barrier that the NRC has put up, largely encouraged 13 by the radiologists and the nuclear medicine physicians of 14 the world to make it difficult fc,r non-card-carrying 15 radiologists and nuclear medicine physicians to 16 participate in diagnostic imaging.
17 And conseq)tently, courses like that have a 18 reason as a solution. If you redace the amount of 19 training that is required -- training and experience that 20 is required -- to the amount that is consistent with what 21 is really needed to protect members of the general public 22 and the workers, that it will be quite easy for medical 23 institutions to provide the kind of training that people 24 need and that these freestanding courses will have much 25 less of a market available to them. That's point one.
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4
! 341 E
- 1 If you think in term of the paradigm shift 2 again, remember-that the paradigm shift is from the focus
, 3 largely on the patients -- which is where the NRC rules 1
l 4 have -- whether we believe it or not and no matter what a
j
~
5 the policy statement says ---that's really where the J 6 training and experience has been up to now.
. 7 If the focus moves from the patient to the '
- i 8 occupational worker and to the general public and focuses 9 on radiation safety, then it is quite possible to go back 1
- 10 to all of the Boards and say -- in partial response to f 11- what Dan raised -- and say, you've got to make sure that t
]
12 your training programs and your examinations include what 13- we're now interested in and convince us that you've done :
\m,/ 14 so, or simple -- we won't accept your Board as the basis 15 for deemed status, and people who have your-Board i .
j 16 examination can come and take the other exam that we give, !
17 which we know will be focused on radiation safety, 18 So paradigm shift doesn't mean that you just f
f 19 assume that the American Board of Radiology is going a i
20 good job. The American Board of Radiology would have to j 21 come' forward under a new set of rules and convince the NRC 5
-22 that it's doing a good job.
2 i 23 In response to what Naomi said, the draft 4
- 24 language that Sam and I worked on included a. substantial 25 amount-of hands-on doing the things in the laboratory in
( )
( ~,
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348 1 addition to just sitting in a classroom. And you've got i
2 to have that kind of experience.
l 3 However, I don't believe that the experience 1
4 with radiation safety tasks has to be conducted as part of 5 a 6-month training program that is primarily focused on 6 clinice.1 experience. It can be a freostanding component I
7 of the training.
8 CRAIRMAN STITT: I think Dennis was in line --
9 unless you forgot what you wanted to say.
10 DR. SWANSON: No. I strongly believe that you 11 need to validate the training experience with an exam 12 simply because there's no way to evaluate the quality for 13 the training experience program. You know, I can have 14 people that meet the number of hours, but the quality of 15 that training may or may not be good, and there's really 16 no mechanism to do that other the.a validating their 17 training experience by an examination.
18 So the way I would see this working actually 19 is, I think there needs to be within the Board 20 certification process, there needs to be a radiation 21 safety module exam. That radiation module exam needs to 22 be developed with the input of tne practitioners in that 23 modality.
24 Because I agree with you -- there are probably 25 certain clinical aspects that relate to radiation safety NEAL R. GROSS CoVRT REPORTERS AND TRANGCR DERS 1323 RHODE ISLAND AVE., N W.
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343 1 and I think the best people to detine those clinical
( ) 2 aspects that relate to radiation safety are the people Q
3 that are practicing that modality. So let them define 4 that and put that into a radiation module exam that ought l 5 to be done in cooperation with the NRC.
6 The NRC then recoghizes that radiation safety l
7 exam module as being appropriate and by so doing that, 8 that's how they certify that Board as meeting the 9 qualifications. You can basically then, the NRC, take 10 that same radiation safety exam module out of the 11 certification process and use it as the alternative to 19 Board certification.
,q 13 And in fact, if the NRC was smart, they would i \
'v/ 14 simply contract back with that certification body to give 15 that exam independent of the certification process, which 16 would then keep the NRC out of having developed their own 17 exam.
18 DR. ALAZRAKI: You still, just diverting a 19 minute to comment directly on what Dennis just said, you l
20 still have the group of people wh.: don't have the l 21 qualifications for a given Board .xam. You know, the 22 radiologist, the nuclear medicine docs, the radiation 23 orcologists have direct lines to their Boards for 24 examination.
s
/
i i/ 25 The cardiologists use internal medicine,
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344 1 because they don't have their own Board level 2 certification that they can go to or which can be approved 3 so to speak, except for internal medicine which it seems 4 to me, I don't know that internal med. cine --
5 DR. SIEGEL: Well, cardiology subspecialty 6 exam could take this one just the way the diagnostic 7 radiology exam has chosen to incorporate this.
8 DR. CERQUEIRA: That could be done, yes, 9 that's -
10 DR. SWANSON: Or if the nuclear cardiology 11 doesn't want to do it through a Board certification 12 process, they could go take this same radiation exam 13 module administered by the NRC who simply contracts it 14 back, giving that exam module to the Society of Nuclear 15 Medicine.
16 All the cardiologists have to take to fulfill 17 the NRC requirements would be the radiation safety exam 18 module. They wouldn't have to take the other 19 certification part which addresses the clinical needs of 20 nuclear medicine physicians. Yet it's keeping the 21 emphasis on radiation safety which is the purview of the 22 NRC, and that's the problem we need to discuss here.
23 CHAIRMAN STITT: Lou, go ahead.
24 DR. ALAZRAKI: Well, I didn't make my 25 comments. I was just --
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. ~ . . -. - . ~ _ . . . - . - - . . . - ~ . - . - ---- - -. ..-.~.--- ._.
!l i' ! 345 L :
l 1 CHAIRMAN STITT: I'm sorry,-Naomi..
u i:
- b
-2 :DR. ALAZRAKI: I was just saying something 3' about Dennis. -2 wanted to comment, first of all, about r
what Lou brought up and then Barry commented on about the,
. 5- sort of fly-by-night,-quick path to-licensing courses that 6 exist.
f
{ 7 Not the nuclear medicine community and not the 8 radiology-community. None of those communities is happy -
-9 about thoPe Courses and Would like to see them disappear,
[ 10 and for much more credible instruction and training in-1 11 radiation safety be available to those who really want to i
12 get it. And I think that's what we're trying to develop i
13 here, too.
14- Part of the practical experience in order to i
15 achieve that has to be in good centers. One of the
! 16' problems that exist right now in addition to these quick
.17- courses that squeeze in the hours to satisfy the p 18 requirements for licensure, right now what many physicians
'. 9 wind up doing, since the NRC says yes, you need clinical
)
.20 experience and just any authorized user can sign for that
- 21 clinical experience -- their good friends, their buddies, n
22 simply sign on;the: bottom line for them and they haven't 23 gotten the-clinical experience, the practical handling j l24- experience which is so essential to good radiation L \
- f 25: practice.
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346 1 So that's another aspect of the unsuccessful 2 situation which we have right now. Another aspect which 3 we can correct right now, which means that there has to be 4 some component here which relates to a clinical experience 5 in a -- it would have to be pretty much in an academic or 6 some credible training institution.
7 CHAIRMAN STITT: Go ahead, and . Barry.
9 DR. SWANSON: think that that relates back 9 exactly to what I said earlier, i don't think you can 10 evaluate the quality, and there's no mechanism to evaluate 11 the quality of a training experience program, other than 12 validating that training with an examination.
13 I fundamentally -- and I realize this probably 14 won't happen -- I'm not sure I'd even put a training 15 experience requirement -- the hours of training experience
.6 -- in the regulations. If you ask me, my option would be 17 Board certification with a radiation exam that's 18 recognized by the NRC, or an exam. Okay?
19 DR. ALAZRAKI: The exam alone doesn't reflect 20 that there has been some practical, hands-on experience --
21 which I think is really necessary --
22 DR, SWANSON: Well, maybe you could develop an 23 exam that does reflect that.
24 DR. ALAZRAKI: That would be very hard. Go 25 ahead --
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347 s
1 -1 DR._ SWANSON: Like I said, I realizei you-know 2~ --
l 3 MS. McBURNEY: What an exam would do is level 4- the_ playing field and take the regulatory agencies out of 5 having to evaluate-training, csther than that that is i
6 received in a residency program. So I know we're I 7 constantly _ faced with having to evaluate other training, i
-8 other than that which is an ACGME accredited program, and i -9 have actually changed our rules to say that it has to be
- 10 training _that is received within an ACGME f iram.
i
-11 But by adding an exam on radiation safety for .
[ 12 those that aren't Board certified, would level the playing j -1 field on: evaluating those-courses. And'then the clinical
.- -14. experience-part of it would be in addition, and as long as 15 that was received under. supervision of an authorized user, 16 that would probably -- in that modality -- probably be
-17 sufficient.
18- CHAIRMAN STITT: Barry?
19 DR. SIEGEL: Naomi, again, back to the issue 20 of_ paradigm shift-and clinical experience.
I= suspect that 21 you're comfortable with the mechanism your hospital has
-22 for deciding which neurosurgeons can be appointed to the 23 staff, and can have privileges to perform neurosurgery.
24- There is no government agency that decides
-25 whether that neurosurgeon has adequate, clinical
(
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348 1 experience. There doesn't need to be a government agency 2 to decide whether a nuclear medicine physician has 3 adequate clinical experience in order to be an authorized 4 user. What the government agency -- given the Atomic 5 Energy Act -- needs to decide, is whether that individual 6 has adequate radiation safety experience.
7 Now, you would argue that outside of a 8 hospital setting where you have credentialing activities 9 in the hospital, you have the practice setting. And there 10 an individual doesn't have to be credentialed. And I 11 would cite the following theoretical example.
12 Someone could easily set himself up as a 13 neurosurgeon in a private office with no training. The 14 courts would catch up with that individual eventually, 15 because that individual would probably run into 16 difficulties, and I would think the exact same thing 17 happens with circumstances where someone chooses to 18 practice a specialty outside of a credentialing setting 19 waere they have no training. They'll get into trouble.
20 And there are mechanisms that work in the 21 states for dealing with such individuals. I don't have 22 any problem with it at all. I think the NRC needs to 23 focus on radiation safety, on the practical, hands-on 24 experience that relates to radiation safety, and the 25 judgments about individual's clinical competence should be NFAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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349 1 made by physicians and by physician licensing Boards, and
[ ') 2 by hospital credentialing Boards, and by the standards of LJ 3 practice in the community. Not by the NRC.
4 CRAIRMAN STITT: We'll do some more discussion 5 and then I want to get to the matrix up tl.ere because it 6 relates to what we're discussing. Lou and then -- Naomi, 7 go ahead and rebut.
8 DR. ALAZRAKI: Yes. I don't disagree with 9 most of what you're saying. I just think that when you 10 say the NRC is concerned only with radiation safetv, I 11 don't see how you can divorce good training in radiation 12 safety from the clinical setting.
,_s 13 I think the consequences -- I think you don't
/ \
w_ / 14 want to give the opportunity for this non-neurosurgeon to 15 set up a shingle outside saying neurosurgery and wait for 16 him to kill off a few people before the courts get to him.
17 That's not what we want to see happen here.
18 We don't want to see someone cause a hospital 19 to close down a main corridor or close down an ICU or 20 close down something else because someone has come up and 21 sprayed radioactivity all over the place. I mean, these 22 are extremes I'm using, examples, but nonetheless, similar 23 things can happen.
24 So I think we want to make sure that people
[~') 25 who get licensed by NRC to use radioactive materials in
()
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l f 350 1 human -- set in patients -- that those people not only 2 understand and know radiation protection and radiation 3 safety and radiation safety sciences, but also know how to 4 handle it in the clinical situation, whether it be at two 5 in the morning -- which happens more and more with chest 6 pain clinics and emergency room injections of materials, 7 with ICU injections, with CCU injections.
8 We even have an epilepsy ward where they have 9 to be injected on the epilepsy ward. Radiation is 10 traveling all over the medical centers these days, and I 11 think you want to make sure that people in charge, people 12 who are called authorized users, really have had training 13 in the use of this material in the clinical setting.
14 CHAIRMAN STITT: Lou Wagner.
15 DR. WAGNER: I'd just like to speak in favor 16 of the exam from the following experience. I've been 17 training residents now for 20 years, and I can tell you 18 there is no bigger incentive for them to knuckle down and 19 understand that material that they're learning, than to 20 face them with an exam.
21 I've been training residents for these 20 22 years and usually in the first year when I get them their 23 attitude toward looking at the material is one of boredom, 24 and they really don't understand why we're teaching e. hem 25 this material until senior year comes around and they say, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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1 351 1- gee-I wish I had paid attention in the first year.
2 Well, now the Board exam is being'given in
-3 their'tirst year or in their second year. And boy, do-4- they' flock to my_ classes. So I think this is an 5- experience that I've had which says, you've got to have 6 the exam. This.really is the incentive and the motivation 7 for them to get-the job done.
8- CHAIRMAN STITT: Let me tell you where I think I 9 we are here. Just listening to the discussion and looking
,10 - at the alternatives 1 through 6 -- not that ue've honed 11 down on anything, but we're coming close -- the major --
12 if you group 1, 2, 3 and then you group 4, 5, 6, the major 13 difference-in -- if you were to draw a line between those 14 groups, is easy to use, Board certified.
15 That is,-status quo plus 2 and 3 have Board 16 certification as a component; 4, 5, and 6-do not. -I think 17 we're looking at something that lies in 1, 2, or 3.
18 Anybody want to -- is that fair? Naomi.
19 DR. ALAZRAKI: I would be comfortable with 3, 20 just that -- let me make sure I understand the exam part' 21 of it and the Board part - of it. The Board certification =
22= would -- my understanding is that the Board certification 23 would substitute-for an NRC authorized or run exam, so 24 that those individuals =who had Board certification by 25 Board which had examined _in radiation safety, would not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS -
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352' 1 have to take an NRC authorized exam; only those who didn't 2 have access to a Board exam would. Is that correct?
3 MS. HANEY: That's correct. And the key to 4 that is, that as part of the Board there would be an exam 5 that would test the items that we were looking at under --
6 if you went the alternative approach.
7 DR. ALAZRAKI: Or the Board could simply show 8 that they had questions -- sufficient questions covering 9 the scope of radiation safety on their exam?
10 MS. HANEY: Correct. And that would do it, 11 yes.
12 DR ALAZRAKI: Yes, and that would do it. And 13 also in number 3 there was a clinical experience component 14 as well which is not defined in terms of time or anything.
15 But nonetheless, there is a clinical experience component.
16 MS. HANEY: I would suggest that you might 17 want to look at page 8 of the alternatives paper -- 7 and 13 8. At the bottom of 7 it starts you into at least the 19 draft rule text, but where you're really looking at is 20 more on page 8.
21 If you look under 2 -- 1 is the classroom and 22 laboratory training included and it gets into your basics 23 there -- but 2, the supervised work experience shall 24 include -- and this is where, at least how we were 25 defining the key radiation safety things to come up.
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9 353 1 And then under 3 you do have this little bit
,n 2 of clinical experience.
( j ) Now realize this is not etched in 3 stone and changes can be made to this, but it was just a 4 first attempt. So what you're seeing here is what we 5 would be looking for to bring out the radiation safety in 6 a clinical setting.
7 CHAIRMAN STITT: Okay. Cathy, how is 2 and 3 8 different regarding clinical experience? It looks like 9 alternative 2, draft rule text is on page 5 -- starts on 10 page 5. I can probably read it myself if I look hard 11 enough.
12 DR, SIEGEL: It's identified.
',,- s 13 DR. ALAZRAKI: You have different things under l
'N_) 14 2 on page 8, than what's under 3. Shouldn't everything 15 that's under 2 also be under 3?
16 CHAIRMAN STITT: That's what I'm trying to 17 check. Cathy, do you know that right off the bat?
18 MS. HANEY: No , I need to just double-check.
19 CHAIRMAN STITT: Okay, if everybody can look 20 at those two things --
21 DR. ALAZRAKI: Should be, everything under 2 22 is also under 3, and then you have some other things under 23 3?
24 DR. SIEGEL: Then you have an exam.
g.
[ h 25 DR. ALAZRAKI: No, no, no -- just a list of N._,,
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354 1 things that are considered supervised work experience, 2 MS. HANEY: Yes, I think the key Barry brought 3 out --
the only difference between 2 and 3 in the rule 4 text that you're going to see is the exam. Everything 5 else is -- or should be the same.
6 CHAIRMAN STITT: That's what I was trying to 7 clarify, whetter group --
8 DR. ALAZRAKI: Well, under 3 -- unless the 9 administration's relating to therapeutic unsealed source 10 procedures.
11 MS. HANEY: It's under 2, also.
12 DR. ALAZRAKI: It's under 2, also?
13 MS. HANEY: Yes.
14 DR. ALAZRAKI: So what happens with a 15 cardiologist, say?
16 DR. CERQUEIRA: It's sort of the single organ 17 user. I think there, the hourly requirements if anything, 18 should be decreased, because you are not going to be doing 19 administrative --
20 MS. HANEY: Yes, this is where you get into 21 the modality specific. What's written here would fall 22 under the 300. Cardiologists would be more under the 200, j 23 and you would see a different listing of hours, I would 24 suspect, and you would see a different listing of the
, 25 clinical experience.
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355
.1 DR. CERQUEIRA: I'm confused by the 200 and 2_ 300, What is that referring to?
v 3 MS, HANEY: Okay. It's referring to the 4 current-Part 35 in that 300 is more your therapeutic use 5 of unsealed n.sterial. The 200 is your diagnostic where 6 the nuclear cardiology would be done.
7 DR. ALAZRAKI: Well also, in radiologists, 8 some are -- the diagnostic' radiologists may have training 9 in the therapeutic and may not.
10 MS. HANEY: I think that will come out under 11 the modalities. _Like for example, if we go with the 12 approach for 35 that we're talking about, where the 13 training and_ experience would fall under the modality, if
.' (D 14 your hospital was using multiple modalities.you would just
'15 have to make sure that you were covered for the training is and experience in each different section.
17 Now, you may end up having to take multiple 18 exams or -- we'd have to be careful how the wording went 19 bect.use-we're trying-to pull out a differentiation for the 20 radiation safety that someone in just doing diagnostic 21 studies would need; where someone that was doing 22 therapeutic HDR would need to know a-little bit more about 23 radiation safety.
t 6
24 Maybe there'd be two levels of an exam, that 25 if you took the higher level it qualif.tes you for
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356 1 everything else. Or to have a smaller exam that --
those 2 are the fine details we'd have to work out.
3 DR. ALAZRAKI: Well also, in terms of working 4 out those fine details, it's important I think,to 5 coordinate those with the clinical experience. For 6 example --
7 MS. HANEY: Oh, definitely, yes.
8 DR. ALAZRAKI: For example, the administration 9 of therapeutic radionuclides, definitely the clinical 10 component there would apply only to -- needs to apply to 11 the group who become licensed to do this.
12 MS, HANEY: That's right, yes.
13 CHAIRMAN STITT: Barry's got a comment and 14 then Dan.
15 DR. SIEGEL: Just to clarify what's in this
. 16 document so that the committee understands it better -- if 17 I understand what the staff did.
la The therapeutic module for radionuclides is 19 the one that's -- for which draft rule text is listed 20 here. The diagncstic imaging draft rule text is not 21 included here; the orachytherapy draft rule text is not i 22 included here; the teletherap*, draft rule text is not 23 included here. i 24 This is specific &lly an example of what it 25 would look like for radiopharmaceutical therapy. There is NEAL R. GROS $
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f 357 1 some draftirule text for diagnostic' imaging that's buried C
t 2 in Sam Jones' computer. I would actually suggest that for 3 the facilitated public meetings, that you might-want to j 4- consider including the 35.200 draft rule text, at least-5 because it's the area that is likely to generate the most 4
6 discussion. As you can see, it's generated the most 7 discussion this morning.
8 MS. HANE : Yes, that's fine. And when --
l-9 again, when we get further on the line, we would be coming 10 to the ACMUI for, do we havt the right number of clinical
- 11 hours for this modality, do we have the right number of --
l 12 the right type of clinical experience? -That would be i
13 something we would be looking to this group to tell us.
< -- (
, \s_ 14 CHAIRMAN STITT: But we're not going to settle i
15 that part today, so don't try. Dan.
16 DR. FLYNN: Okay. You refer to page 8, Cathy, 17 and'I'll-just read off just very briefly: classroom and b 18 laboratory training shall include radiation physics.and 19 instrumentation, radiation protection, mathematics
[
4 20 pertaining to use and. measurement of radioactivity, and 21 radiation biology.
22 And I think for me, the key thing that is
'23 missina -- there's four things listed. The fifth thing I 24 believe should be something like this: medical response I
['h d
25 to incidents involving radiation safety. And I can tell i
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358 1 you that I agree with Jeff in terms of, the physicist is 2 the key parson.
3 The problem is that the incidents and events 4 and problems that have occurred, I'm sure you'd agree, are 5 not involving problems that were created by a physicist; 6 they're problems that --
accidents or incidents or events 7 that have occurred because of a physician, basically. An 8 error happening or a problem happening the physician 9 didn't recognize or didn't respond appropriately.
10 And I can give you an example. Right now --
11 and this could happen the next --
sooner or later there's 12 going to be a medical event whereby a, let's say a 13 brachytherapy patient on the floor on a Satuiday night, 14 develops severe chest pain and shortness of breath.
15 And that hospital or licensee hasn't thcught 16 through what they need to do or should do, in response to 17 -- do they take the implant out, do they remove the entire
- 18 device, do they just remove the radioactive sources and 1
19 put it in the lead peak -- which by the way, should be in 20 the room.
21 I think the medical response to incidences 22 involving radiation safety is missing here, and that's 23 what you're trying to get at. The problems are not 24 occurring because the physicists are not well trained.
l 25 The physicists are very well trained in this country.
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359 1 -. There-are very few incidents that involve a medical r 2 radiaticn physicist. It's because of the overlap of j 3 clinical and radiation safety;.that's where the problems 4 occur.
5 CHAIRMAN STITT: I'd like to comment. I 6 support your suggestion completely that mock training is 7 one of the things -- I'm the co-Director of the' school of 9 brachytherapy, and we have essentially every meeting, a' '
9 session that's a mock emergency where people are in a .
10 simulated room with an HDR unit and it's very, very, very 11 effective.
12 The other comment, I agree with you.that most 13 misadministrations do not involve the physicists directly.
14 When you're talking about radiation oncology and lose dose 15 rate sources, that's really changed dramatically with 16 remote afterloading -- be it low or high dose rate --
17 because it's so procedural for so much hardware and t
18- software that most of these incidents have co do with what 19 took place during treatment planning or the physics and 20 dosimetry staff.
21 Okay. Other comments?
22 DR. SWANSON: I have-a couple of comments.
23 First of all,-as it gets to testing, handling, etc., don't 24 think today in terms of traditional testing techniques.
25 There.are ways to do testing today where you can test
\
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.,. , ,--ty-
. -
- v F 'T- *- ' -~
l 360 1 knowledge and handling, etc, 2 mean, 2 can think of I
2 several ways to do that which would be pretty interesting, 3 actua.lly .
4 The comment on what's written here on page 8 -
5 - a word of caution about getting too specific in the 6 regulations. For example, if you go down to the therapy, 7 you've listed a specific number of administrations of 8 specific therapy agents, and the problem I see with that 9 is, as we add other therapeutic radiopharmaceuticals, and 10 we're going to have to be constantly modifying the 11 regulations to include those, okay.
12 So if there's some more general way that you 13 can get the training, experience, requirements in there 14 without decignating specific numbers or specific 15 radiopharmaceuticals, I would advise that we do that.
16 CHAIRMAN STITT: Cathy, are you listening?
17 It's in the minutes, and it's a very good comment and in 18 fact, a lot of things that we're seeing, I think taking 19 the -- if we select something that includes Board 20 certification the reason to move that out is so that you 21 don't have to change the regs every time there's a new 22 Board that's been approved.
23 We'll continue down this line. Jeff?
24 DR. WILLIAMSON: Yes, Are we supposed to be 25 commenting on brachytherapy and teletherapy in this NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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l
361 i
l' discussion? Or is this discussion just confined to 100, ;
I h 2- 200,-and 300 level?- -
3 CHAIRMAN STITT: I think it's -- somebody's i
- 1. .
4' shaking their head.-- I:think it's general, but there are
. 5 specifics that will be addressed as more development of 1
6 these guidelines take place. Go ahead, 7 DR. WILLIAMSON:- Well, all right. I guess
}
8 then I would maybe-like to comment-about this :regarding 9 brachytherapy and teletherapy, and I have some serious
}- 10- questions whether this paradigm-would be applicable, i- .
11 mainly because as our proposed regulation development is 1
12 doing, it seems that patient safety and quality of 13 treatment is going to remain a regulatm y endpoint.
! A 14 And I. don't know if there-is any way-to sort 1
- 15. of= separate the training that a radiation oncologist and a
-16 physicist in radiation oncology get, that allows one to do 17 accurate treatment calculations, appropriate treatment 18 planning, appropriately-and correctly proceduralizing a
- 19- complicated treatment celivery process so 20 misadministrations don't occur.
21 I don't know'how to separate that from the-1 22 clinical training experience that a Board certified h 23 physicist and-radiation.oncologist get.
24 DR. SIEGEL: May I respond to that?-
- i. -
O' 25 CHAIRMAN STITT: Yes, Barry?
k 4
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i 362 1 DR. SIEGEL: Yes, f think -- again, let me 2 point out that I think that by having only 35.300 here an 3 example, it actually has confused the discussion.
4 My understanding of thinking up to this point 5 is that the clinical experience arm for brachytherapy and 6 teletherapy would largely remain unchanged from where they 7 currently stand, and it was in the very low risk 8 diagnostic imaging that the clinical experience largely 9 dropped out and the radiation safety and handling 10 experience was reduced to a level that's consistent with 11 reality.
12 In the case of radiopharmaceutical therapy 13 there actually is relatively little change from current 14 regulations consistent with the medium level of risk, and 15 I think for the things you're concerned about that things 16 would be very close to the way they are now, although 17 that's still open for considerable discussion.
18 So again, Cathy, I guess I would urge draft 19 rule text for more than just 300 in facilitated public 20 meetings if it's at all possible.
21 MS. HANEY: Yes, I think for the public 22 meetings I think that's an excellent thing and we will do 23 that. What I would say, depending upon how our time 24 allotment goes today, if we do have time this morning it 25 might be a good time for us to just run down the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W. l (202) 234-4433 WASHINGTON. O C. 20005-3701 (202) 234-4433 l
363 1 modalities and let me know what you think the hour
( ) 2 requirements should be for each one of the modalities,
't) 3 Just, you know, ud knowing that this is a 4 first shot at it, and then also some of the, what you Sr wculd put into the clinical sections. But again, that's 6 very time dependent, but it wo'uld be nice for the 7 diagnostics and we'll have something for the public 8 meetings, 9 CHAIRMAN STITT: Let's do some more discussion 10 and then -- I don't know if the group was in a mood to 11 make a motion, I'm not sure if I can tell where we're 12 sitting on that. We'll go this way and then we'll go that
,-~
, 13 way, ,
l <
N_ / 14 DR. SWANSON: Just a quick comment to Jeff's 15 remarks. I think that's why it's important that, from an 16 exam perspective that you have the people actively 17 involved in the modality involved in developing exams, 18 Because as I said before, there's no doubt in my mind that 19 there are clinical decisions that are important to 20 radiation safety, and it's important as these radiation 21 safety module exams get developed that the people from 22 those areas are going to be the most familiar with what 23 those clinical decisions are; that those get incorporated 24 into the radiation safety exam.
/ ') 25 So it's important that you have people from i
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364 1 brachytherapy involved in the development of that 2 radiation safety module. And I think you can --
then you 3 get hit on the clinical decisionmaking that'r pertinent to 4 radiation safety issues by doing that.
5 CHAIRMAN STITT: Anybody else over here?
6 Okay, Naomi and then --
7 DR. ALAZRAKI: Just another comment about the 8 differences even within radionuclide therapy. There's a 9 big difference between treating a patient for 10 hyperthyroidism, or even strontium-89, or samarium for 11 bone pain -- a big difference between treating an 12 outpatient and treating someone with so much radioactivity 13 that it requires an admission. There's a big, big 14 difference in what you need to know radiation safety-wise 15 in those two.
16 And you need to know a lot of radiation safety 17 just for the outpatient, but in other words, you might 18 have enough clinical experience for example, if you're a 19 radiologist and you do the radiology, nuclear medicine 20 type of training, to do hyperthyroidism type of therapy 21 with regard to your experience in radiation safety, but 22 not enough with regard tc your experience in radiation 23 safety to admit someone and give them 200 millicuries of 24 I-131. There's a difference.
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365 g -I and then you-do have the mike.
1 j -OR. SIEGEL:- Naomi, we did exactly in draft
-t 2:
' k
-3 language what.you're talking about. It's the therapeutic-4- --
the'radionuclide therapy module is structured much the .
4
! 5 same way it is now except that it's -- the hours and 6 things are slightly adjusted. There is a blanket 7 radiopharmaceutical therapy module which includes all l
5 8 three of those types of radiopharmaceutical administration I
_9 experience. It's not' called clinical experience.
i 10 And then there are submodules that would be i 11 limited to hyperthyroidism, limited to thyroid cancer, i
- 12 limited'to bone agent. Unfortunately, I think the 1
, 13 regulations, Dennis, probably really do need to'be I( '
14 changed.
i 15 At some point when millicurie doses of 16 monoclonal antibodies are being used for therapy there's 17 going to be a different set of safety requirements and a la different set of administration requirements that are 19 going to go with that, that you can't necessarily 20- anticipate in a generic regulation.
21 'And it's hard to make a regulation for them 22 now since there aren't any FDA-approved drugs. It's a 23 little_ premature to write a reg that says what the safety 24 experience needs to be to use that drug. So the 25 structure's there to accommodate your concern and we o NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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366 1 worked hard on it and thought carefully about it.
2 DR. ALAZRAKI: You call it radiopharmaceutical 3 administration, not clinical experience, but it really is 4 again, clinical, because unless you've had that training 5 and doing it, you don't know exactly what to tell the 6 patient and the patient's family regarding radiation 7 safety, because they had on board whatever it is that they 9 have on board, and how to take care of it when they get 9 home.
l' DR. CERQUEIRA: Just a comment about the 11 examination. If the decision is made to go with a 12 separate examination for those people who aren't Board 13 certified, I think we need to make it as easy to take it 14 as possible. And you know, I've got three different 15 Boards and to have to think about traveling for another 16 one would be an issue.
17 And Barry, we were talking yesterday, was 18 talking about sort of a computerized system where people 19 could go at any given time in any -- you know, in a 20 limited number of locations to be able to do that sort of 21 an axamination. I think that would be ideal.
22 To require people to go to one or two areas at 23 a given time to take the examination I think would be too 24 much of a demand and really wouldn't meet the purposes.
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3 367 1 would I think, be ideal, 2 CHAIRMAN STITT: Dan?
s _
3-- DR. FLYNN: In radiation oncology, the
.4 recertification exam process is going to be done exactly 5 that way. It's planned that it's done remotely by 6 computer after proper identification, to take a 7' recertification exam. It won't be another oral exam; it 8 will be a recertification exam. It would be too hard to 9 administer oral exam to all practitioners.
10 But also, if the NRC was to then contract back 11 - to-some agency or Board to administer the radiation safety .
12 module that Dennis was talking about -- for example, s .13 written exams are being done right now, actually today I
\ 14 believe -- today -- in various parts of the country --
15 there's one in Boston, there's one in New York - whereby e 16 if NRC did contract back then for example,-at that exam 17 site so many radiation safety exam modules are set aside, 18' the1same proctors who are proctoring the' exam, there's no 19- increased cost at all.
20 The individuals taking that exam are sitting 21 over here,-and the proctors have administered the module 22 to these people while they have 300 other people who are 23' taking-the clinical. exam in the same room. - It's a doable 24 thing.
25- CHAIRMAN STITT: Let me try something -- see V['h.
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368 1 if you guys are in the mood for this. We've lost our 2 rudder nere. John Graham who was the glib person with the 3 worde and was willing to make motions is not with us today 4 -- at a Board meeting at his hospitals.
5 I'm wondering if anybody wants to entertain a 6 motion with a second and then we can continue discussion 7 to start focusing down here. Am I pushing the system too 8 soon?
9 DR. ALAZRAKI: Whar kind of a motion are you 10 thinking about?
11 CHAIRMAN STITT: To try to focus in on one of 12 these alternatives.
13 DR. WILLIAMSON: Well, I think it's -- I would 14 suggest, Madam Chairman, that you know, we limit the 15 selection of option to the 100, 200, and 300 series of 16 uses because we haven't had an adequate opportunity to 17 discuss brachytherapy or teletherapy.
18 DR. SIEGEL: Jeff, that still misses the 19 point. It misses the point of even assuming that the 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> for brachytherapy and teletherapy were set, where 21 the professional standards think they should be set, then 22 you still can choose among the options. I mean, I suspect 23 you would not recommend M.D. only as the basis for 24 performing teletherapy, so you're prepared to discard that 25 option in all likelihood.
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- 369
-1 And so really the_ question is, if you'see
[ 2 where this-discussion has-been,_it's largely been between 3- either. status quo, or 2 versus 3, and the key difference 4- is whether or nc.,t for those circumstances where training 5 is not validated by'a Board certification, should;it be 6 independently-validated by_an exam? That's really_the key
-7 question. Assume that the rest of the language will come 8 out correct.
9 DR. WILLIAMSON: Well, there's an additional 10-
~
consideration. I think you're dealing with a set of
.11 mediccl applications where a case can be made -- you know, 12 one can-argue both sides of it ---but nonetheless-the case 13 can-be made that radiation safety issues and the issue of V- 14 clinical competence to use the agent can be separated.
15 So I accept that you can make that case in the 16 - 100 and 200 series of applications. I'm concerned that we 17 would be implicitly endorsing the same concept for 18 brachytherapy-and teletherapy without a discussion-of it.
I 19 CHAIRMAN STITT: Any response-to that?
20 DR. SIEGEL: Yes.
21 -CHAIRMAN STITT: Who'said yes?- Of course, 22 DR. SIEGEL: I don't think you're explicitly __
23 endorsing _it at all and I think if you go to the 24 components of the medical policy statement, the driving uh 25- concept of how much clinical part ties into the radiation NEAL R. GROS $
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370 1 safety issue is driving by the medical policy statement.
2 And my guess is, you would come down and say that for 3 teletherapy, the training needs to be pretty much close to 4 what it is right now. And my guess io, I would agree with 5 you completely, and I think --
6 DR. WILLIAMSON: Well, it's a pretty fair 7 guess.
8 DR. SIEGEL: -- most other practitioners would 9 agree with you completely. The controversy really has 10 never been focused in this area on the training for 11 radiation oncology; the controversy has been nuclear 12 medicine.
13 Now, there's an emerging controversy with 14 brachytherapy related to endovascular brachytherapy, and 15 that will be a point worthy of discussion. But I don't 16 think the concept espoused in number 3 in any way mean 17 that you'd have to relax your standard with respect to 18 what it takes to be a good teletherapist or a good 19 brachytherapist.
20 CHAIRMAN STITT: I agree with that. I'm just 21 trying to keep my tongue to myself to see if anybody else 22 has any opinions. Dennis?
23 DR. SWANSON: I think one of the problems with 24 alternative 3 that may address Jeff's concern is that it 25 says M.D. plus Board certification or specified number of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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371 i- hours of training, with a change in the number of hours to
[
\
2 focus on radiation safety with minimal requirements for 3- clinical experience.
4 Maybe in the other areas we can't have minimal' 5- requirements for clinical experience is what that's 6 saying. 1So maybe what alternative 3 just needs to be 7 changed to is M.D. plus Board certification or specified 8 number,of hours of training with a focus on radiation 9 safety'plus exam.
10 That way the radiation safety could -
11 incorporate the clinical training for those areas where 12 extensive clinical training is associated with radiation 13 safetv-14 So I will make a motion that this committee 15 support alternative 3 as modified to state, M.D. plus
?.c Board certification or specified number of hours of 17- training (with a focus on radiation safety) p3us exam.
--18 DR. ALAZRAKI: What happened to-the clinical?
19 DR. SWANSON: Excuse me. Plus experience, 2 01 plus exam. Well, it says~ number of hours of training with-21 a focus on radiation safety.
22 CHAIRMAN STITT: Would you explain'how it's 23 essentially different than 3 right now? -The words are a
.24 little different but there --
I~' 25- DR. SWANSON: Well, I think you need to take J
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-- w-.- - -- , .. = w~m.-- r - --
372 1 out, "with minimal requirements for clinical experience" -
2 -
3 CHAIRMAN STITT: Okay, all right. So that's 4 the --
5 DR. ALAZRAKI: And what did you put in instead 6 of that?
7 DR. FLYNN: Appropriate requirements.
8 DR. SWANSON: With appropriate requirements.
9 DR. ALAZRAKI: That's leaves it more general.
10 DR. FLYNN: Should be appropriate modality, 11 specific requirements? Or just appropriate requirements?
12 DR. WILLIAMSON: Appropriate modalities, 13 specific requirements.
14 DR. SWANSON: It's a given, but I add it in 15 there.
16 DR. WILLIAMSON: Oh, then that's much better.
17 Appropriate modality, specific requirements.
18 CHAIRMAN STITT: And you're writing this down 19 so when I ask you to read it back you can, right? All 20 right, and Will seconded that. Let me bring up one cheap 21 comment here. M.D. is not to ignore the D.O.s or those 22 returning to the Canadian system with a different degree, 23 correct?
24 MS. HANEY: That was not the intent.
25 CHAIRMAN STITT: I presumed it wasn't. I just HEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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373 1 want to make sure it hits the public record. All right.
,m
( ') 2 Will?
G' 3 DR. NELP: I'd like to point out that I dor.'t 4 have an objection to this, but Barry today, if I wanted to 5 take a colleague in and train him to treat hyperthyroidism 6 if he were an endocrinologist, he doesn't have to take an 7 examination, he has to have 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of experience in my 9 laboratory, and he only has to supervise or be involved in 9 the treatment of three patients.
10 DR. SIEGEL: Ten.
11 DR. NELP: No, three. No, no, for thyroid 12 cancer. He'd only have to be involved in the treatment of
,_s 13 three patients with thyroid cancer, so we're really
/ \
/
'\ m / 14 changing the regulation now so that he would uave to be 10 also examined?
16 DR. SIEGEL: Correct.
17 DR NELP: I anted to point this out to Naomi 28 that at the current level things worked pretty well, but 19 now we' re adding an examinatj en. And the same thing for 20 hyperthyroidism. The guy has to tee ten patients but now 21 he also has to receive an examination administered by the 22 National Regulatory Commission who approves thereby, 23 DR. ALAZRAKI: Just to do thyroid cancer 24 therapy and nothing else.
j 25 DR. N1'LP : Yes, if he's an endocr4.lologist, (G NEAL R. GROSS
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374 1 which is an unusual but it's not a - well, it's not an 2 unusual --
3 CHAIRMAN STITT: Let's continue discussion 4 then.
5 DR. CERQUEIRA: Just a clarification. The way 6 we've changed this, so that if you're an M.D. and Board 7 certified you do not have to meet any of the subsequent 8 requirements which includes the exam, right? So that if 9 you're --
10 DR. SIEGEL: You've met them.
11 MS. HANEY: Yes, you've met with the 12 understanding that the Board that you're taking would have 13 a component on radiation safety. My understanding is that 14 under the current system, the current Boards, you would 15 not meet the requirement -- I mean, not -- there would be 16 grandfathering for everybody that's already out there.
17 But if -- you could not maintain the status 18 quo on your Board, what they're taught under the Board and 19 the testing under the Board and meet this requirement.
20 That board would need to change and have a certain 21 component focused on radiation safety.
22 DR. CERQUEIRA: And so currently the Boards 23 that you recognize are the Nuclear Medicine and Radiology 24 Boards, correct?
25 MS. HANEY: Right.
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i 375 1 DR. CERQUEIRA: But again, it comes back to
,m
[ ') 2 the questions that were asked before. You have not had
%s' 3 any direct input into what is included and not included, 4 correct?
5 MS. HANEY: ! Jot -- to my knowledge we have 6 not.
7 DR. CERQUEIRA: So how would that change in 8 the future?
9 MS. HANEY: We would probably have to get more 10 involved, we would -- as this alternative would develop if 11 ' this was the chosen one, I'ni sure we would have to enter 12 into some type of discussion with the organizations that
-m 13 we would eventually approve as meeting the requirements.
( \
/ 14 DR. CERQUEIRA: So I guess my point is that, 15 you know, historically those two Boards have been accepted 16 I think, with the ABIM and the Cardiovascular 17 Subspeciality Boards. There have been enough changes that 18 -- you knew, I think you have to basically look at it de 19 novo in terms of all the players and set some other 20 guidelines.
21 MS. HANEY: That's right, yes. It would be a 22 whole, you kncw, a relook at everything.
23 '
DR. CERQUEIRA: I think tnat would be l
24 important you know, 'J us t logistically, if you look at the (m
k i 25 amount of information that people are being tested on.
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376 1 I'm just not sure how much of a component you're going to 2 be able to include, say, into the radiology Boards where 3 you've got all this technology and all this clinical 4 material. But in fact, you know, again, I would really 5 champion the cause that you need to look at all the Boards 6 de novo.
7 CHAIRMAN STITT: Naomi?
8 DR. ALAZRAKI Well, I think that the group, 9 in general, is probably going to be pretty much, it sounds 10 to me, in agreement with the number 3 as it has been, but 11 the dicagreements are going to come when you get down to 12 the nitty gritty.
13 DR. SIEGEL: The devil is in the details.
14 CHAIRMAN STITT: Yes, I think fou're right.
15 That's a very good summary.
16 Other comments? Or do people want to vote?
17 We have to vote if you don't have something to say.
18 MEMBER NELP: Well, I would like to make one 19 more comment, that in the field of nuclear medicine this 20 is going to be a much more stringent requirement, but the l 21 average person is not Board trained, with the exception --
22 well, insofar as they'll have to take an examination, 23 which they don't have to do now, if they're not Board 24 certified.
25 DR. ALAZRAKI: For single -- or again, users i NEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N W.
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377 1 or for single procedural --
?. MEMBER NELP: Right. But those are the j
3 endocrinologists and the cardiologists that then I presume 1 4 also have to be examined if they don't - depending on how
,5 the Boards, revise or don't revise their training..
6 CHAIRMAN STITT: Dan?
? MEMBER-FLYNN: Yes, but I think it is time 8 that that is done, because I remember hearing comments a 9 few years ago where -- well, why does the ophthalmologist 10 have to take -- have any radiation safety training at all?
11 He is only treating pytergia with this superficial source.
l
-12 And now we have incidents involving hundreds '
13 and hundreds o,f patients in Puerto Rico and Hawaii, where 14 the two practitioners in Hawaii and the one in Puerto Rico ,
is hadn't a clue what the term half-life means. And as a
'I
- 16. result, they were giving doses with miscalculations as to 17 what the source strength was. And so I think that it's-18 time for having basic principlea tested.
r 19 MEMBER NELP: I just-wanted to point this out.
20 That's where the flack is going to come, basically.
21 CHAIRMAN STITT I don't think the number of ,
-22 individua1R comes close to the folks that are covered 23 under this.
24 Jeffrey?
25 MEMBER WILLIAMSON: Well, if the sort of -- >
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__ . - . . . _ , . . . _ , ~ _ , , , . , . , -
370 1 the issue that is most controversial here are single agent 2 or sort of single procedure / single organ system imaging 3 physicians, maybe there ought to be a generic category for 4 single procedures, single organ imaging studies and sort 5 of a common pathway for doing that.
6 CHAIRMAN STITT: Naomi'l 7 DR. ALAZRAKI: Single organ is now almost 8 extinct, limited just to the endocrinologist, because the 9 cardiologists do pet work, and they're using thalium, 10 they're using technetium in various forms, in addition to 11 a lot of the cyclotron general -- well, that doesn't come 12 under NRC. Excuse me.
13 DR. SIEGEL: It's still a aingle organ, 14 though.
15 DR. ALAZRAKI: It's still a single organ.
16 (Laught e r. )
17 DR. SIEGEL: But if you reduce the training 18 for diagnostic imaging uses, if you reduce the training 19 and experience and handling experience to that which is 20 really necessary related to the radiation safety issues, 21 and not the clinical experience, the argument disappears, 22 because basically single organ and multiple organs are 23 effectively the same in terms of laboratory radiation l
24 safety practice. They really don't differ. And that's 25 exactly the way the draft language that we laid out reads.
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379 1 In therapy, there are some differences with (y,/ ) 2 radionuclide therapy, depending on whether you are having 3 to bar at hyperthyroidism or strontium-89 or thyroid 4 ca- er or monoclonal antibodies.
l 5 CHAIRMAN STITT: Other comments? Ruth?
6 MS. McBURNEY: Yes. I don't think that the 7 rules can get so specific that they go to ningle organs, 8 single isotope, because as has been mentioned we're 9 talking about all sorts of new modalities that --
and it 10 is possible that, for example, cardiologists may want to 11 g 't involved with the restenosis use of stints and that 12 nort of thing.
- 13 And so we've got to be able to have the rules U 14 specific for whether it's diagnostic or therapeutic and 15 sealed source and unsealed sources, but to get it any more 16 specific than that I don't think is necessary.
17 CHAIRMAN STITT: Naomi?
18 DR. ALAZRAKI: And the other -- in line with 19 what Dan said a little bit ago, in the diagnostic area the 20 use of radioactive materials in medicine has changed 21 tremendously from 20 or 30 years ago, and so it is more 22 than time for changes in the way in which NRC approaches 23 radiation safety. But the changes have meant that the 24 need for the clinical radiation safety integration into
[D) 25 the training has increased.
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380 1 CHAIRMAN STITT: We discussed for some length 2 of time yesterday -- and it will come up again today --
3 precursor events, and just in some informal discussions I 4 think that the radiation safety training of individuals is 5 a precursor event if it's done poorly or not done at all.
6 And it is really directly related to why some of these 1
7 misadministrations occur.
9 I find that we're seeing a lot of -- we're 9 supporting ourselves in a number of the comments that are .
I 10 being made. Let's call a vote on this. )
11 Those in favor -- let me ask you to read that 12 again.
13 MEMBER SWANSON: I have a motion that the 14 ACMUI accept the approach addressed under alternative 3, 15 with the following changes, "M.D. plus Board 16 certification, or specified number of hours of appropriate 17 modality-specific training and clinical experience, which 18 focuses on radiation safety, plus an exam."
19 MEMBER WILLIAMSON: Can you say " including 20 radiation safety," because the way you've stated it makes 21 it sound like the clinical experience is exhausted by or 22 must focus on radiation safety. And whereas for 23 brachytherapy and teletherapy it actually -- you know, it 24 wouldn't be appropriate that classical radiation safety be 25 the only or even the main focus of that experience.
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381 1 So I would sui; gest you rephrase it to make 2 clinical experience as appropriate for the specific (G) 3 modality kind of stand alone and not attach that phrase to 4 the modifier "which focuses on radiation safety," making 5 it sound like the clinical experience is completely 6 focused on radiation safety events.
7 CHAIRMAN STITT: I'm confused. We've got a i
8 motion that we've been t.alking about. We can't change it 9 without a motion. Let's hear the motion again.
10 MEMBER SWANSON: Well, I had a motion that we 11 accept the approach addressed under alternative 3 with the 12 following modification that was expressed. "M.D. plus 7
13 Board certification, or a specified number of hours of I )
( ,/ 14 appropriate modality-specific training and clinical 15 experience which focuses on radiation safety, plus an 16 examination."
17 CHAIRMAN STITT: I think that's the intent of 18 -- I think if we quibble too much on semantics we won't 19 get this finished.
20 MEMBER WILLIAMSON: Do you think for 21 brachytherapy and teletherapy that sounds okay?
22 CHAIRMAN STITT: I think that sounds okay.
23 Let's vote. Everybody in favor of that one? Those who 24 are voting members?
[]
\ !
25 Okay. Those who are opposed?
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l
302 1 okay. Let's take a break. We're a li*.tle bit 2 ahead. You need to he back here at five after.
3 (Whereupon, ts. proceedi'igs in the foregoing 4 matter went off the record at 9:50 a.m. and 5 went back on the record at 10:19 a.m.)
6 CHAIRMAN STITT: All right. This is the 7 surprise part of the agenda. We are going to stop the 8 morning and move to this afternoon.
9 We need to discuss patient notification, but 10 the patient representative will not be here until the 11 afternoon. I have this burning desire to continue 12 discussion of reportable / recordable misadministration, 13 abnormal occurrence, and feel that we can do this separate 14 from patient notification. They're related, but only 15 related. So that's what we're going to start with.
16 Cathy, do you want to just --
17 MS. HANEY: What I've put up there is just the 18 overhead from yesterday that gives all of the options that 19 we have. For your information, we handed out a copy of 20 the abnormal occurrence reporting procedure. We also gave 21 you a copy of the Federal Register notice that gives the 22 policy statement on the Ao reporting. And we gave you 23 just the Commission paper that forwarded the Federal 24 Register notice. Probably of that package the important 25 aspect is just the first couple of pages, because I guess NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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l 383 j 1
1 Jeffrey had asked for a copy of the documentation on the 7
/ ) 2 AO criteria. !
\s / l 3 And I think we -- besides what's up there on 4 the viewgraph, just remember those couple of questions 5 from the SRM that we discussed, and I'll just summarize 6 them -- being that what is the best process for reporting 7 of events to ensure NRC is aware of potential or generic 8 issues? Again, that's really key into the precursor 9 events. What the thresholds ought to be, which is keyed 10 in with our overhead. And once the threshold is set, how 11 would it be implemented?
12 So with that, I think we'll just pick up where
,3 13 we were discussing yesterday.
I \
i /s- 14 CHAIRMAN STITT: I'm still trying to find the 15 page that I want. This is a topic that people have a lot 16 of opinions. So, Jeffrey, we're just going to start with 17 you. You got called on without raising your hand, so say 18 something.
19 MEMBER WILLIAMSON: Okay. Well, I guess I 20 have -- my sort of general opinion on this matter is is 21 that it's difficult to assess what are the appropriate 22 criteria to attach to each of these categories, unless one 23 knows what their associated reporting requirements are for 24 these criteria.
[' ')! 25 So my sort of broad outline of what I would
'\~
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384 1 suggest to NRC -- and it could fit in I think at least one 1
2 of these options -- is that probably there ought to be 3 three levels of events, I would suggest --
submit to you.
1 4 I think there ought to be maybe -- th+ highest level of l 5 event ought to be one that has in its definition some kind 6 of requirement that there be a'n actual injury to the 1
7 patient or high probability thereof.
1 i 8 And that would be perhaps associated not only 9 with reporting to the agency, but if there were going to 10 continue to be a reporting requirement to patients and 11 their referring physicians, and so on, that would be the 12 level there. I think the second event would be something 13 perhaps that could be -- have, again, a dose threshold or 14 something.
15 Anyway, it would involve a technical error on 16 the part of the caregiver that would be considered serious 17 enough that it would have generic safety implications, or 18 at least implications for the quality of that program, and 19 that would be the kind that would be reported to NRC but 20 would not necessarily trigger a requirement for a report 21 to the patient unless it were associated with an injury to 22 the patient.
23 And I think the third level of event would be 24 something that is like the recordable event or precursor 25 event, which is something that is collected and maybe the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE IGLAND AVE., N W.
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-l 385 i 1 institution is expected to respond to in_its own way in 2 terms of their quality improvement program, and would also 3 satisfy the information accumulation regarding precursor 4 events that the Commission has asked you to implement, but 5 would be essentially non -- would not trigger a punitive 6 action on~the part of the agency.
7 So that would sort of be my suggested outline 8- of preferences.
9 CHAIRMAN STITT: Let's keep talking along this 11 0 -- the table, to my left. Theresa, Lou, Dennis, Ruth's 11 Personal _ opinions? -Professional opinions about 12 reportable / recordable, the old misadministration?
~~s 13 MEMBER SWANSON: I think there needs to be 14 certainly reportable events to the NRC. I don't think 15 that --
I don't want to see any limits for recordable-16 events, though. I think it's -- there ought not be
-17 regulatory limits for recordable events. I think as I 18- stated yesterday, I'd rather see some type of performance 19- requirement _where instu utions-are required to evaluate --
20 to set up a reporting and evaluation system for all 21 abnormal events, okay,.and then the reporting of those, if 22 they want to collect information on those non-reporCable 23 events, ought to be in a voluntary type of scenario.
24 I think Barry discussed this briefly
/s
- t 25 yesterday. One of my recommendations to the working NEAL R. GROS 5 COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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386 1 groups is that they ought to really have representatives 2 from the United States Pharmacopeia come down here and i 3 discuss with them their medication error reporting program 4 and discuss basically what the USP is. They're right up 5 the road nere, and I think they would give you come pretty l
j 6 good infermation about this voluntary reporting program.
l 7 CHAIRMAN STITT: Go ahead, Jeff.
8 MEMEER WILLIAMSON: Yes. To be more specific, 9 I guess the kind of event that I think under good 10 standards of practice would -- I'm sure any physician 11 would report to the patient would be one that had some 12 likelihood of causing complications, adversely affecting 13 their clinical outcome, or increasing, you know, the 14 patient's cost for having a successful treatment, 15 whatever.
16 I think, you know, the Ao definition, if I 17 understand it properly, much more closely approximates 18 that. So I think that's a much better definition than the 19 current definition of misadministration as the trigger for 20 activating the reporting requirement to patients, because 21 one of the big -- you know, some of the deficiencies of 22 the current misadministration criterion are that, one, 23 there is -- one of the worst is there is no lower 24 threshold for wrong site applications, which opens the 25 door to a whole host of sort of small technical errors NEAL R. GROSS COURT REPORTERS AND TRANSCR$ERS 1323 RHODE ISLAND AVE., N W.
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1 1
307 1 that have no medical consequences at all.
,s 2 And secondly, depending upon, you know, what (J) 3 kind of a procedure it is, not even a 20 percent dose 4 delivery error, if that's what it involved, may 5 necessarily have -- be associated with any kind of a 6 patient inju*.y or probability thereof, especially if in 7 the course of carrying out the remaining procedures it can 9 be compensated for.
9 So I think that's -- AO is a good idea in that 10 sense. An alternative would be to incorporate, you know, 11 some sort of an element of expert judgment in evaluating 12 the event. So that's, you know, a suggested alternative.
g' 13 CHAIRMAN STITT Dennis?
(
\m- 14 MEMBEh SWANSON: Point of clarification from 15 the chairperson. Are we discussing -- right now, when we 16 talk about reportable event, are ve discucsing what we 17 want to report to the NRC versits -- you know, reporting to 18 the NRC versus capturing precurscr events? Or are we 19 mixing this together with patient notification 20 requirements? It's actually my recommendation that we P1 woald discuss reportable events to the NRC and precursor 22 events, and then take on the issue of patient notification 23 at some other time.
24 CHAIRMAN STITT: That's my intent, beca'tse
( ) 25 they do not have to be the same in any way, shape, or G
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388 1 form.
2 The other thing is let me throw out for you --
3 I think it would make sense for us to look at page 3, 4 because on page 3 our old friends -- recordable event and 5 misadministration -- are there, along with terms 6 reportable and recordable. And abnormal occurrence is 7 defined at the bottom, so there are some definitions that 8 we have been using in the past. Those may be things that 9 we want to be talking about for the future.
10 Another comment that comes to my mind is when 11 you look at the siternatives -- and there is a big matrix 12 in the back -- it's page 13 -- very complicated, and all 13 of the boxes look about the same. It is entirely possible 14 we may want to come up with something today that is not 15 any of these, and so I want to keep your minds open.
16 DR. ALAZRAKI: Which section are we in?
17 CHAIRMAN STITT: Well, it was a handout from 18 yesterday, Naomi. It is not in the book. That is what I 19 was --
20 MS. RANEY: Yes. You got it by e-mail 21 probably on Monday or Tuesday or so.
22 DR. ALAZRAKI: Yes, I remember now.
23 CHAIRMAN STITT: Yes.
24 DR. ALAZRAKI: Thank you.
25 CHAIRMAN STITT: The other thing I'd like to NEA!. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE-, N W.
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389 I
1 say is that I, after our discussion yesterday, think we '
( ) 2 have to be very careful. We can box ourselves into a
'w / {
i 3 corner. If you look at page 1 of this handout called l l
4 Recommendation for Threshold of Reportable Event, each one l 5 of them ties into precursor events. I am not opposed to 6 studying precursor events. I think it's -- because of our 7 discussion yesterday, our summary was it's a very 8 difficult topic.
9 In many people's eyes, it is a research event 10 or a topic, and to hook that into what are we going to 11 report to the NRC, I just want to caution us on that. So 12 it's certainly possible we can make a statement about 7~ 23 precursor events. I'm not sure that it could be folded
\
i b 14 into e motion.
15 So I'm making a list here of things that 16 people are bringing up, and right now it has got 17 dissociate -- possibly dissociate precursor events, wrong 18 site keeps coming up as a specific issue. So what I would 19 like to ask you folks to do is turn to page 3. Let's just 20 start looking at that sort cf thing, seeing if we --
I'll 21 take notes and we'll see if we can hone in on some parts 22 of this.
23 MEMBER WILLIAMSON: The other general issue 24 that has oeen raised is by Dennis, and I agree completely, 25 It's dissociating reporting to NRC and reporting to (V} '
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390 1 patients.
2 CHAIRMAN STITT: That's the ground rule that 3 we're going to operate under right now.
4 MEMBER WILLIAMSON: Right.
5 CRAIRMAN STITT: Okay. Anybody want to make 6 comments about the recordable event? This is page 3.
7 There is a whole listing, starting at the top with all 8 diagnostic radiopharmaceuticals, going through 9 teletherapy, brachytherapy, gamma stereotactic.
10 Dennis?
11 MEMBER SWANSON: Yes. I think it's extremely 12 confusing. I've said this before. I can't remember all 13 of those definitions as many times as I've looked at them.
14 You could simplify this a lot by simply making a 15 reportable event -
let me -- is an event that results in 16 an unintended radiation dose that is equal to or greater 17 than -- and let me put a limit here, my limit, okay --
18 five rems effective dose equivalent, or, two, equal to or 19 greater than 50 rads to any other organ. That definition, 20 by itself, would cover wrong patient, wrong route of 21 administration -
22 CHAIRMAN STITT: Would you repeat it? I've 23 got part of it. Reportable event is equal to an 24 unintended radiation dose resulting in --
25 MEMBER SWANSON: It's an event that results in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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l 391 1 an unintended radiation dose that io, one, equal to or
(
- (m)
V' 2 greater than five remo effective dose equivalent, or, two, 3 equal to or greater than 50 rads to any other organ.
4 MEMBER WAGNER: Define this to all of these 1
5 topics here?
6 MEMBER SWANSON: Yes.
7 MEMBER WILLIAMSON: I don't think that can 8 apply to therapy, because if you have a prescribed dose of 9 50 gray in 25 fractions, you know, 50 centrigray is one 10 percent. That is not --
that is half the margin of error 11 in calibrating a beam, which is pl.s or minus two percent.
12 So it has to be more modality-specific.
13 CHAIRMAN STITT: Naoml? -
\_s 14 DR. ALAZRAKI: Yes. Well, the definition of 15 the abnormal occurrence is one gray or 100 rad. So I 16 presume that means the unintended dose of 100 rad to a 17 major portion of the bone marrow is what is also included 18 in that definition, to the lens of the eye or to the 19 gonads, or equal to or greater than 1,000 rads or 10 gray 20 to any other organ, and represents either a doce that is 21 at 2 east 50 percent greater than that prescribed in the 22 written directive, or a prescribed dose or dosage that is 23 wrong pharmaceutical, delivered by wrong route of 24 administration, delivered to the wrong treatment site,
[~S 25 delivered by wrong treatment mode, or from a leaking
\v )
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398 1 source.
2 CHAIRMAN STITT: So what are your feelings 3 about what you just read to us? She is getting all choked 4 up.
5 DR. ALAZRAKI: Yes, right.
6 CRAIRMAN STITT: Pretty strongly.
7 DR. ALAZRAKI: Well, it would eliminate --
8 certainly, this definition would eliminars any of the 9 diagnostic stuff, because I can't imagine -- unless you 10 gave a therapy dose by mistake, when a diagnostic dose was 11 what was intended, you're not going to get into this 12 unless you're dealing with a therapy dose.
13 And we could narrow it, but I vouldn't be 14 unhappy if we didn't. And if we didn't, what I would say 15 would be that the recordable -- instead of a recordable 16 event, which everyone seems to be very negative about --
17 that we have some sort of guideline for radiation safety 18 committees in terms of -- or that they develop their own 19 plan, not prescriptive again -- performance -- that they 20 develop their own plan to review near misses, in other 21 words, things which didn't quite fall into that category
!!2 of reportable, but which they recognize were errors. And 23 let them write up their own plan of how to review that for
~4 their own improvement, for their can quality improvement.
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393 1 comment. Do you still?
t
/ I 2 DR SIEGEL: I still do.
l I don't think that 3 it is practical to believe that the reportable event 4 threshold can be set to be equal to the abnormal 5 occurrence reporting threshold, becaure the Commission is 6 nc going to accept that all licensees would have to tell l 7 them is what they have to tell Congress. There needs to 8 be a .ifferential threshold for reporting to the l
l 9 Commission than the Commission's requirement for reporting l
10 to Congress.
11 In order to simplify this, you then need to 12 decide where you want to set the threshold. Do you want
,s 13 to set the threshold essentially where it is now, which is
[ )
\_ / 14 largely predicated on the occupational worker exposure 15 reporting requirements, or do you believe that for medical 16 reesor.s there is svme logic to setting it somewhat higher 17 than that?
18 So one way to simplify it might be to take the 19 abnormal occurrence evant criteria that you see at the 20 bottom of page 3 and to change th7 numbers in there so 21 that it comes cut something like -- pick a number -- 50 22 percent, 25 percent, 20 percent of the threshold that the 23 NRC has to reporting to Corgress, so that NRC would be 24 capturing a substantially larger number of events for ito
,' 's i
25 investigation and catabase than it ultimately has to
%.J NEAL R. GROSS COURT REPORTERS AND TRANSCR$ERS 1323 RHODE ISLAND AVE , N W.
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394 1 report to Congress.
2 So let me just read you a suggested example.
3 If you look at the bottom of page 3 -- I'll just throw out 4 some words here, and then we can argue about the numbers.
5 Results in a dose that is, one, equal to or greater than 6 20 rad to a major portion of the bone marrow, to the lens 7 of the eye, or to the gonads, or, two, equal to or greater R than 200 rad to any other organ and -- and, Jeff, I'm 9 going to fix your problem as we go here -- represents 10 either a dose or dosage that is at least 20 percent 11 greater -- so I'm going back to the current 12 misadministration concept -- than that prescribed in a 13 written directive, or, two a prescribed dose or dosage 14 that is the wrong pharmaceutical, delivered by the wrong 15 route of administration, delivered to the wrong treatment 16 site, and is at least 20 percent greater than that 17 prescribed in a written directive, or delivered by the 18 wrong treatment mode, or, five, from a leaking source.
19 So that is sort of about -- it's a hybrid of 10 and 20 percent of what is in the abnormal occurrence.
21 It solves the wrong treatment site problem. It has to be 22 a big error in order to be reportable. It sets the bar 23 lower than the bar is set for the NRC to report to 24 Congress, but it is higher than current misadministration 25 reporting, assuming we believe that that is capturing more l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l
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195 1 events than need to be captured, g
2 CHAIRMAN STITT: I need to have you read the B 3 clause again.
4 DR. SIEGEL: Okay. B was represents either --
5 well, there is only one change. The change in B is that, 6 nunber 1, I drop the 50 percent to 20 percent, and then in 7 number Roman numeral III, I added delivered to the wrong 8 treatment site and is at least 20 percent greater than 9 that prescribed in a written directive.
10 MEMBER WILLIAMSON: And that's added to clause 11 Roman numeral III? .
12 DR. SIEGEL: III, yes. Because in the case of
! 13 brachytherapy, even though the five is not a treatment 14 site, the five does get a radiation dose as part of the
~;
15 brachytherapy procedure.
16 MS. ROTHSCHILD: I have two questions about 17 this. In tying the threshold to a dose that is only i
i
!a l greater than what is prescribed,.do you definitely want to 19 exclude -- or I think the current reporting, and certainly 20 the predecessor to that, it was more than 20 percent 21 different, with the idea being that even though 22 theoretically that might not result in patient harm, if 23 you end up with that big a difference between what is i
24 prescribed and what is administered, that is.something 25 'that you want to know about..
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396 1 And the second thing, would this -- these 2 criteris ce/er for f ractionated -- treatment that you've 3 got fractionated -- in a situation where you were supposed 4 to get a dose in key fractions, instead get the entire 5 dose in the first fraction, so that unless the written 6 directives are separate for each one of those, 7 theoretically you could end up with a situation where it l e is not a reportable event because there wasn't that 9 difference in the dose, even though the entire dose was 10 given in one fraction which certainly could, you know, 11 have undesirable effects.
i l
12 So I had those two questions about whether l
l 13 Barry's proposed criteria cover those two situations, t
14 CHAIRMAN STITT: Let's discuss those, i
15 DR. SIEGEL: Well, actually, two things.
16 First, in A, results in a dose, I think to clarify it 1
17 probably needs to be results in an unintended dose to go 18 along with Dennis' concept. I just would add that.
19 And I'm easy on the other stuff. I mean, I 20 think it's a question of what you want to capture. And it l 21 depends how you choose to capture precursor events, or i
22 other events. If you develop a voluntary reporting sy, stem i
l 23 for thoce, then I would submit that you might be able to 24 capture underdoses by way of a voluntary reporting system 25 to find out if there are systematic errors occurring that l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N W.
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i i
399 l l
1 you need to know about. )
,~.
2 Certainly, in terms of patient safety issues,
[/T
\E 3 underdocing rarely -- underdosing that is correctable 4 rarely creates a problem. It is wanting to capture that 5 information because you want to understand, y:u want to do 6 a fault analysis. And if voluntary reporting solves your 7 fault analysis problem, then you could tie reportable 8 event to something that is more strictly -- that has a 9 dose that is likely to result in either stochastic or 10 deterministic effects.
11 CHAIRMAN "TITT: Jeff?
12 MEMBER WILLIAMSON: Well, I think to resolve 7-~ 13 these questions the purpose of the reportable event must I )
\~ / 14 be clearly defined. And if it represents something that 15 triggers a federally mandated intrusion into the 16 physician-patient relationship, that would be a different 17 set of criteria than if the purpose of the reportable 18 event is to sort of trigger an investigation on the part 19 of the agency as regards the technical quality of the 20 institutional program as opposed to the physician-patient 21 rela tior. ship .
22 I think there is sort of a lot of negotiating 23 room for deciding, you know, when an. institution is 24 federally mandated to sort of open up its operation to n
l ) 25 federal inspection and see if it is okay. And that would O'
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1 3b8 )
1 1 be potentially a very different set of requirements if the 2 goal of the reportable event is to trigger some sort of a 3 mandated action on the part of the physician with regard 4 to the patient.
5 At least I would think, you know, maybe the 6 raciation oncologists would hAve some comment on that. I 7 mean, from the sort of tedious level -- that is, the B institutional quality -- that would be, you know, 9 something the physicist is perhape more involved in 10 monitoring and collecting information about. And the sort 11 of second purpose is something that involves more the 12 interests and activities of the physician.
13 CHAIRMAN STITT: My general response -- and 14 then Dan -- is that this has always triggered - response 15 from the NRC that whatever the intention was, the outcome 16 war if you called in what you felt was a misadministration 17 you vera punished. That was the ultimate outcome.
18 So if you're trying to tell me that there is 19 some ulterior motive that is a research issue, a good-for-20 all kind of question that we're going to be answering by 21 having institutions send us data, I would be very suspect 22 of that intent, based on 20-something years of prior 23 experience.
24 Dan?
25 MEMBER FLYNN: I hu' a comment, and this one NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W (202) 234-4433 WASHINGTON. O C. 20005 3701 (202) 234 4433
399 1 is to Jeff also, that as -- Judith, as you know, when we l i 2 look at -- as consultants, as we look into V
3 misadministrations, we are asked to make a comment as to 4 we believe were the licensee acti is appropriate. Is 5 there any special followup or a./ special intervention 6 that is required to protect the patient? Usually the l 7 answer is no.
8 Usually the answer is this is a cancer patient 9 being followed by both the referring physician and the 10 radiation oncologist. They're both aware of X, Y, Z that 11 has happened. The patient is aware. And they are taking 12 the appropriate steps because all cancer patients receive I
f-~s i
13 followup. And most of the time thac is the answer.
\ )
14 Almost all of the time that is the answer.
15 In terms of the other questions raised, this 16 involves quite a few incidents, like, for example -- and 17 ycu can comment on this after -- on HDR. If a le prescription has been written, at least my interpretation 13 has been from major incidents that -- let's say an 20 example, 3,000 centigray in five fractions. If the 21 prescription is then signed in that manner, then it is 22 going to be X percentage of that total dose.
23 But many times a prescription is written on an 24 individual basis -- 500 centigray today, signature, and n
( ) 25 then another treatment, 500 centigray next Tuesday, a
\m /
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400 1 aignature. Then it's 20 percent of the prescribed dose 2 because that's where the signature occurred. least 3 that's how I interpreted it. Otherwise, it's going to be 4 a nightmare just to interpret 20 percent of what.
5 CHAIRMAN STITT: Well, and that has been 6 ongoing since HDR became popular, because now we're doing 7 fractionated brachytherapy and the question of how do you 8 handle fractionated treatment becomes important.
9 The practice on the part of the NRC most 10 recently has been to lock at the total course, but there 11 is noching written in print. It has sort ot been a casual 12 move to that from what was the original, s;hich was 20 13 percent of that particular fraction.
14 MEMBER FLYNN: Well, something -- I was going 15 to finish that. Sometimes the prescriptions are written 16 and the licensee may have a general plan to give "four to 17 six fractions,a but they haven't determined how many 18 fractions they're going to give. They're writing the 19 prescription on a day-by-day basis. Then you have to 20 interpret the -- let's say, if an error occurred as being 21 20 percent of that prescription.
22 For teletherapy, I think that the way it is 23 now where it's a -- the key concern is if it's 15 percent 24 more than the prescribed dose, not if it's 15 percent 25 less, because dosimetrists and medical physicists are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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401 .)
1 checking the charts on a weekly basis. If there is'an
-2 underdosingi it doesn't harm the patient because it is-3_
p wu 3 always corrected by_a sidghtly adjustment, So i v ere is no I 4 medical consequence to that. That happens with every 5 licensee every year,. and that's part of -- taat has been
_6 the practice of radiation oncology.
4 7 It's only if you overdose and if the total
- 9 dose at the end of treatment has deviated by -- we can 2
- 9 debate what the percentage in -- 20 percent -- there is a
{ 10 problem. But underdosing on a weekly basis isn't the
]
11 problem.
I 12. CHAIRMAN STITT: Naomi?
13 DR. ALAZRAKI: Yes. I just wanted to comment i
!. 14 on, you know, the arbitrary numbers that-we're sort of
.L
- 15 dealing with here. I think 20 percent is too narrow, and f 16 I could @ia you some practical examples of why.
17 'dAld?4AN STITT: Tell_me which 20 percent i.
4 18 you'rs referring to, would you?
- 19 DR. ALAZRAKI Well, Barry arbitrarily I --
- 20 CHAIRMAN STITT: Okay.
- 21 DR. ALAZRAKI
-- understood just plugged.in
- '22 20 rads, 200 rads,.20 percent greater than the prescribed--
23 dose. And I would -- I think a more workable number is
- 24 closer to the 50 percent level. Maybe it can be less, but
= 25 not 20 percent.
.' \s
^
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4 s y r-- ,-y- p,--,.vm v c , , , , - , - .
402 1 For example, if we prescribe 20 nillicuries of 2 I-131 to treat a patient with some sort of 3 hyperthyroidism, and we are giving it in capoules, it is 4 sometimes very difficult to come within 20 percent of the 5 prescribed dose when you get the capsule. And given the 6 biologic variabilities that we're dealing with, both in 7 radiation on: ology treatment and in the 8 radiopharmaceutical treatment, given the huge biologic 9 variabilities, our prescription dose cannot be interpreted 10 that narrowly, And I think 20 percent is a little too 11 narrow to be making it a reportable event.
12 CHAIRMAN STITT: Barry?
l 2' p DR. SIEGEL: I think you're missing a key l . ? point, though, which is that you want to give 20 15 millicuries. The pharmacy delivers 14, and you decide, 16 "I'm happy to give" --
l l 17 DR. ALAZRAKI: No.
l 18 LR. SIEGEL: No. Just listen. "I'm happy to 19 give 14," so you revise your prescription, as opposed to l
1 20 you want to give -- you write a prescription for 20, the 21 pharmacy delivers 32, and the technologist says, "That's l
- 22 close enough. I'll give it." You don't want the l
l 23 technologist to give 32 when you wrote a prescription for 24 20.
l 25 If the capsule comes as 32, you need to revise i NEAL R. GROSS l COURT REPORTERS AND TRANSCRIBERS I 1323 RHODE ISLAND AVE., N W.
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403
~ 1; the prescription before'it's given, e which point it is 2' no longer an event because--you've changed-the--
3 prescription. -The issue here is not what you write the 4- prescription for.--
5 DR. ALAZRAKI: So you're saying change the 6 prescription?
7- DR. SIEGEL: That's exactly what you should 8 do. But-you have to do it before it's given.
9 DR. ALAZRAKI: You may not be available before 10 it's_given.
11 DR. SIEGEL: You need -- that's why there is ,
l 12 an ability to revise a prescription orally, so long;as it ;
13 is followed up in written form if you're not immediately l
(
14 available, and it's available to go.
15 But you know-what? With fax machines'now, 16 you're at the VA, you need to treat someone at Emery --
17 DR. ALAZRAKI: I may.be in --
i 18 DR. SIEGEL: -- you can fax over --
19 DR. ALAZRAKI: I may be in a conference. -I
-20 may be out of town the next day after I prescribed it.
21 DR. SIEGEL: You're in a conference, the l
22 patient ---what? But then another authorized user can I 23 revise the prescription for you. I've got no problems ;
i 24 with that.
25 CHAIRMAN STITT: Dennis?
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404 1 MEMBER SWANSON: If we were to change clause 1 2 to results in an unintended radiation dose that is greater 3 than whatever numbers were picked, I still don't 4 understand why we need anything under B. And, in fact, it 5 doesn't make sense to me because if we're basing a 6 reportable event upon a certain unintended radiation dose 7 or risk to an organ, why would you want to qualify that by 8 saying a dose or dosages at least 50 percent greater?
9 It doesn't make any sense to me, okay, because 10 basically you could have something that delivered more 11 than 100 rads, an unintended dose of more than 100 rada, 12 which may not be greater than 50 percent greater and won't 13 get reported as a reportable event. Why? Why would you 14 want to do that?
15 CHAIRMAN STITT: Let's keep discussing that.
16 I think that's a --
17 DR. ALAZRAKI: So what you are saying is all 18 we need is A, and forget about B?
19 MEMBER SWANSON: We need A, and A needs to be 20 modified to say results in an unintended radiation dose. ,
21 DR. ALAZRAKI: Of greater than what number --
22 some number.
23 MEMBER SWANSON: Whatever numbers you orant to 24 pick. Okay?
25 CHAIRMAN STITT: It also needs a wrong site NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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. - . _ . _ . _ . . ._. . . _ . _ . . _ _ _ . _ . _ _ . - _ _ . . ._ _ _ . . ~ . - . _ _ . _ .
405
+- 1- som2whara.
2 MEMBER SWANSON: Jeff has a concern about
.t 3 that, and he needs to. explain it to me because it's coming 4 from-his area.
5 DR. ALAZRAKI: I have a concern, too.
6 MEMBER WILLIAMSON: I do, too.
4 7 CHAIRMAN STITT: .Go ahead, Jeff.
8 MEMBER WILLIAMSON: Okay. I don't think you 9 can just say a reportable event involves an unintended 10 delivery of an absolute dose of 200 centigray. As I said 11 before, doses in therapy can be as high as 10,000 or 12 30,000 centigray in some settings, and 200 centigray is a l
13 tiny percentage of that.
- \,,/ 14 I think, one, that the absolute dose amount P
l 15 should be changed'so it's some percentage of.the 16 prescribed dose, so it would scale up or down with'the 17 magnitude of dose that the procedure is intended to give.
18 I would suggest that first of all, t
19 Secondly, I think you have to specify, you 1
20 know, the circumstanceu under.which this happens, because 21 the idea behind an event is -- like this is not that there 22 is simply an unintended dose, but that somehow it is due 23 to an avoidable technical error on the part of a 24 caregiver, and not something like the patient's
[' 25 metabolism, for no reasons that are the fault of the A NEAL R. GROSS court REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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I 406 1 phycicien, didn't work lika tha phycicicn would havo 2 expected, or in a brachytherapy patient the patient didn't 3 cooperate with the physician's instructions and yanked the 4 applicator out, through no fault of the caregiver's. So I 5 think you have to have a clause B.
6 MS. ROTHSCHILD: One thing -- be careful of in 7 your language is distinguishing between a percentage 8 different from what is intended which is one way of 9 phrasing it, but I don't think you want to go that route, 10 because we have had cases where -- I think what you want 11 to do is tie it to percent different from what's in the 12 prescription or written directive.
13 Because if you start talking about difference 14 from intended dose, you get into situations where the 15 physician -- you could capture events where the physician 16 intended, you know, to write a written directive for 17 treatment to X site, but instead wrote .d t for Y. And 18 then, what you're going to end up doing when you tie the 19 percent different, or whatever your threshold is, you're 20 going to capture those kinds of events, which I'm not sure 21 you want to.
22 So that I think the language here on the 23 bottom of page 3, ar i the current rule, all talk, I 24 believe, in terms of different from what was prescribed.
25 Because if you start talking about difference from what NEAL R. GROSS COOHT REPORTEFS AND TRANSCRIBERS 133 RHODE ISMND AW., N W.
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407 1 w:0 intsndsd, that'o completely different.
2 MEMBER WILLIAMSON:~ I'd agree completely.
- O 3 CHAIRMAN STITT
- And intended can be rather 4 vague. A written directive is pretty specific.
5 MEMBER WILLIAMSON: Yes. I agree, yes, with 6 what you're saying.
7 CHAIRMAN STITT: Okay, 8 MEMBER WILLIAMSON: The concept of having it 9 scaled is the important point I was trying to make.
10 CRAIRMAN STITT: Let's keep going. Let's try 11 this side. Naomi?
12 DR. ALAZRAKI: The one thing about that, 13 defining it in terms of from what was prescribed, there 5
14 have been incidents,-although again they are -- all of 15 these incidents are remote, what we're talking about, 16 where the physician wrote the wrong patient's name on the-17 prescription, let's say, 18 MS. ROTHSCHILD- . But that is still covered by 19 -- that is-probably covered by wrong patient. 1 20 DR. ALAZRAKI: Well, the prescription said --
21 MS, ROTHSCHILD: A dosage to the wrong 22 patient.
23 DR. ALAZRAKI: -- Mr. Smith. The dose was 24 really intended for Mr. Y. Mr. Smith got a dose.
[} 25 MS. ROTHSCHILD: Well, I guess my point is is V
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408 1 that if you ctcrt tc1 king cbout difforcncos from what wn 2 intended, you are really expanding the scope of what 3 you're going to capture. And you're going to get into 4 situations where you're -- you know, you're trying to 5 figure out, well, what did the physician intend?
6 Because basically what we want, what our focus 7 is on, is what the physician directed saying as to what 8 was administered. That's what I think the focus is on, 9 versus trying to figure out intent -- what did the 10 physician intend.
11 MEMBER WILLIAMSON: I think yol're trying to 12 capture a set of events where the physician makes a 13 trivial error in writing the written prescription, but the 14 treatment is given properly from the point of view of the 15 physician despite that trivial error in writing. I think 16 that's --
17 MS. ROTHSCHILD: I'm not sure that's true. I 18 mean --
19 MEMBER WILLIAMSON: Isn't that what you meant, 20 or no?
21 DR. ALAZRAKI: No , it's not a -- well, it's a 22 trivial error in one sense, but it's a non-trivial error 23 in the other sense.
24 MS. ROTHSCHILD: But I think that's covered by 25 wrong patient. I don't think you look necessarily at NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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409 1 wrong patient and wrong tractment cito in tho sems way no I
2 you would the --
, 3 DR. SIEGEL: I believe wrong patient is other 4 than the patient specified in the written directive. So 5 I'm not sure that if a physician writes the prescription 6 for the wrong patient, and the technologist properly.
7 treats the wrong patient, that that is actually reportable i
e
! 8 to the NRC.
j 9 MS, ROTHSCHILD: I'm not sure.
10 CHAIRMAN STITT: Let me show you-where I-think 11 we are. I think we are discussing the definition of what 12 I'm going to call reportable event, and we have made the
,s 13 statement and a motion, but we made the statement that
\_ ,/ 14 recordable event is something that we're not particularly 15 interested in. We're sort of letting that one die.
16 And as reportable event, we are hashing over 17 the definition of abnormal occurrence and several
, 18 specifics that it includes, and are looking at some 19- portion or some percentage of the different components of 20 abnormal recurrence as what would be reportable to the 21 NRC.
22 All right. Let's keep going. We'll start 23 this way down this arm. Barry, Dan, Naomi.
24 DR. SIEGEL: Let me try one other suggestion, 25 which- is' that the current definition of misadministration NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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410 1 could ctend ca tha dafinition of a rcportcblo ovcnt if ths 2 wrong treatment site issue were fixed either in 3 appropriate guidance or were fixed by putting some 4 qualification on the definition in the rule.
5 And then frankly, if you think about the 6 number of events that are being reported, that is not an 7 excessive number. The dose limits are similar to those 8 tnat are related to occupational reporting for the most 9 part, except when you get into the radiation oncology 10 arena, and there the current limits do, in fact, pay 11 recognition to what fraction error is it of the total 12 treatment plan.
13 And I personally am not overwhelmingly 14 troubled by the current misadministration reporting 15 criteria. There are almost no diagnostic nuclear medicine 16 evente captuced, and the ones that are captured are quite 17 egregious. There are I-131 events, but they are 18 decreasing in number, because people have actually figured 19 out that they need to write written directives. And there 20 are fewer and fewer of those every year.
21 I think if you took those and fixed the wrong 22 treatment site, you actually would have a very workable 23 thing for reporteble event, while simultareously killing 24 recordable event.
25 CHAIRMAN STITT: Let me make a comment on NEAL R. GROSS court REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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411 1 thct. Since I'm the Chair, I can jump-in wharovar I want 2 to, and then you're next.
3 Ihit just reflecting on my narrow view of this 4 whole thing, and my narrow view is what I do clinically 5 and also what I do as a consultant just like Dan. And 6 within therapeutic -- well, within radiation oncology, the 7 places where I find frustration is the wrong site which we 8 keep talking about, and the newer nuances of fractionated 9 high dose rate. And the NRC has the same issues along 10 that line.
11 So in my view as to radiation oncology,-those 12 are two of the issues that keep coming up. And other than 13 that, the old misadministration term, which would turn
\ 14 into reportable, is not particularly onerous. It is just 15 in those two contexts is where I have my greatest 16 personal, professional, and consultative problems.
17 Dan?
18- MEMBER FLYNN: I'm glad you said that, because-19 that's what I was going to say.
20 CHAIRMAN STITT: Good.
21 MEMBER FLYNN: Except that I thought there 22 were three things.
23 CHAIRMAN STITT: All right.
24 MEMBER FLYNN: One is the wrong treatment
/~'N 25 site. One is the fractionated high dose rate has to be U NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 ctHODE ISLAND AVE., N.W.
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412 1 fix d. But co consultento, wa'ra ocked to ro pond to o 2 deviation of dose from a prescription, and we have no 3 control over whether the phyoician wrote each single HDR 4 fraction as separate prescriptions or one big 5 prescription. And that means it is not a problem with us, 6 it is a problem with I think the wrong treatment site has 7 to be fixed. But the definition, in terms of HDR, .n the 8 brachytherapy section has to be fixed also.
9 And then, the other thing that I think could 10 be fixed, keeping in mind being on the record, is the 11 patient notification part of it. And if those three 12 things are fixed, I would vote to keep the current 13 misadministration rule and just call it reportable event, 14 because I think some of our nuclear medicine colleagues I 15 don't think maybe appreciate that.
16 In teletherapy, for example, it is standard 17 practice for big licensees, small licensees, no matter how 18 small the licensee, that a physicist or a dosimetrist --
19 not 100 percent, but maybe 99.9 percent are checking the 20 charts on a periodic basis, usually weekly, and they 21 actually calculate, you know, the dose this week or the 22 dose is seven percent too low -- an error was made. So 23 then they'll adjust the dose the next week or consult with 24 -- am I right? Can you respond to that?
25 And so it is not onerous on us to look at NEAL R. GROSS COURT REPORTERS AND TRANSCR:8ERS 1323 RHODE ISLAND AVE., N W.
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~ .
413 1 parecntagne, and I think Jeffrcy is cxcctly right. In
.. , G 2 radiation oncology, that's what we do. That's part of our 3 oractice. That is part of everyone's practice, and not 4 just a big licensee. And I think so it's net onerous on I 5 us te look at percentages in teletherapy and in
! 6 brachytherapy.
i 7 CHAIRMAN STITT: And let me toss into that, if
- e you look under teletherapy -- this is page 3 -- under j 9 status quo reportable, the prior misadministration term, j 10 if you could find some way to incorporate the percentages 11 of the total dose or the weekly dose, or the percentages 12 if they are less than three fractioris, that mighC help 13 this fractionated high dose rate business. You could find
, O
~ k. 14 some language for fractionated high dose rate therapy that 15 correlates to-teletherapy.
16 Again, so you and I are making very similar 17 points about radiation oncology, and the patient 18 notification we will discuss, but that will be separate.
19 I'd like to keep the discussion going, 20 particularly focusing on the other modalities. Barry has 21 made a suggestion to us that-we look-at misadministration 22 with some changes, and I would like you to respond back.
23 Naomi?
24 DR. ALAZRAKI: So where we are at now is that 25 we're-looking at it at 20 percent increased over NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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414 i
I procerib:d dircetiva, or what?
2 CHAIRMAN STITT: Or wrong route, wrong mode, 3 or wrong patient.
4 DR. ALAZRAKI: Right.
5 CHAIRMAN STITT: Just looking -- I'm reading 6 to you from the therapeutic radiopharmaceuticals.
7 DR. ALAZRAKI: And there is an and per Jeff, 8 right?
9 CHAIRMAN STITT: What's that?
10 DR ALAZRAKI: It would be Part B.
11 DR. SIEGEL: No. No, what I was just 12 suggesting is forcat now the stuff at the bottom. Gc back 13 up to the current misadministration reporting requirement, 14 change the name to reportable event, 11x the two problems 15 that have been addressed, and stick with what is already 16 in place, because frankly, what is already in place --
17 DR. ALAZRAKI: What's already in place is 20 18 percent greater than the prescribe dose?
19 DR. SIEGEL: Well, which category are you 20 looking at?
21 CHAIRMAN STITT: Let me do this. I'm going to 22 butt in here.
23 DR. SIEGEL: Not at the bottom.
24 CHAIRMAN STITT: I want to look at page 3. I 25 want to look at the reportable events, and I'm going to go NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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41b 1 down each: category -_- cli dicgnostic radiopharmscauticcio, i
1 s 2 wrong patient,rwrong -- go ahead. So comment on these j 3 first three.- Let's discuss the first three. Do you know-4 where I am? Okay. So counting on --
5- DR. ALAZRAKI: The first one is, 'All 6 diagnostic radiopharmaceuticals,a and it's including less 7 than 30 microcuries of sodium iodide I-131 or I-125.
8 DR. SIEGEL That's correct, because that's 9 the quantity-that does not require a written directive.
10 DR. ALAZRAKI: Does not require a written 11 directive.
12 DR. SIEGEL: And then you report it if you 13 exceed those dose thresholds. And it's very hard to do t
14 that.
15 DR. ALAZRAKI.* 20 percent?
16 DR. SIEGEL: No. No , five rem effective dose )
17 equivalent --
18 DR. ALAZRAKI: Oh , five rem, j 19 DR. SIEGEL: -- or 50 rem to an organ.
20 DR. ALAZRAKI: Or 50 rem. -
Okay.
21 DR. SIEGEL: It is hard to do that in 22 diagnostic nuclear medicine, especially hard to do it with 23 byproduct material. It's easier to do it with non-24 byproduct material. It's' India-111.
25 DR. ALAZRAKI: Yes, India 111 does it.
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415 1 DR. SIEGEL: In c fcw ccc20.
2 DR. ALAZRAKI: Okay. So you say that it's 3 very hard to do that with five rem effective dose 4 equivalent.
5 DR. SIEGEL: It's hard to do that with 6 technetium.
7 DR. i.LAZRAKI: You have a patient with renal 8 failure whom you give a technetium agent to.
9 DR. SIEGEL: It's wrong patient, wrong 10 radiopharmaceutical, wrong route of administration, or 11 wrong dose, and exceeded these dose thresholds. A patient 12 -- if you meant to give the patient and the dose 13 thresholds were exceeded, no error has been made. It is 14 only when something was done wrong and the dose thresholds 15 were exceeded.
16 CHAIRMAN STITT: All right Let's keep going 17 across that top line.
18 MS. McBURNEY: Just from a regulator's 19 perspective, we have found out of -- I guess we have about 20 between 450 and 500 medical licensees in our state, and we 21 only get a handful of misadministrations reported under 22 the current criteria each year. And we have not had any 23 really complaints about the reporting mechanism, and I 24 den't see any problem with -- especially on the first 25 three, of still keeping the same as a reportable event.
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~ -. - . - _ . ,. - -- . - - ..- . - . . _ ~ . _ .
417 l 1 CHAIRMAN STITT: Oksy. Dannie?
/ -
2 MEMBER SWANSON: I have no problems with the l
(
3 first category. Category 2 you could do away with, I
4 because we have redefined when you need a written l 5 directive ba-La upon a dose limit now. We did that 6 recommendation yesterday. We said he needed a written 7 directive because the dose could result in greater than 50 8 rems.
9 So fundamentally, you could_ change -- you l- 10 could do away with category 2 --
11 CHAIRMAN STITT: Which do ;,- mean by
- 12 category 2, sodjum iodide?
-s 13 MEMBER SWANSON: Yes. I mean, basically, I
-- 14 think you want to refer back to the written directive now.
15 So you could say wrong patient, wrong radiopharmaceutical, 16 administered dose differs by greater than 20 percent from
, 17 that prescribed in the written directive. .
18 CHAIRMAN STITT: So what are you altering?
19 Tell me specifically.
20 DR. ALAZRAKI: So you're saying that --
21 DR. SIEGEL: What he's doing is dividing the 22 three nuclear medicine things into two categories.
23 MEMBER SWANSON: Right.
24 DR. SIEGEL: Those that don't require a 25 written directive, which would be the same current
. [j~')
(
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418 1 dafinition, and thinga thct do rcquira e written 2 directive.
3 MEMBER SWANSON: And it's based upon that 4 we've changed our definition of written directive.
5 DR. ALAZRAKI: So if you don't require the a
6 written directive as you don't in less than 30 microcuries 7 sodium iodide, and all other agents we use -- technetium 8 -- then how would you relate -- you can't relate it to the 9 written directive.
10 DR. SIEGEL: It'e as is.
11 MEMBER SWANSON: It's as is.
12 DR. SIEGEL: It's unchanged.
13 MEMBER SWANSON: Those not requiring written 14 directive would be categcry 1, and the requirement would 15 be wrong patient., wrong radiopharmaceutical, route, 16 dosage, and dose greater than five rems EDE o.- 50 rems to 17 the organ. The second category would be those requiring 18 written directive, and the category would be w::cng 19 patient, wrong radiopharmaceutica.1, administered dose 20 differs by greater than 20 percent from that ' prescribed in
?
21 the written directive.
22 DR. ALAZRAKI: Well, my understanding is that 23 we only want to report events which are really harmful, 24 that we don't want to report events which are 25 insignificant in terms of causing any medical NEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE,. N W.
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419 1 con.plications .
/^x 2 MEMBER SWANSON: No different from now.
~'
)
3 DR. ALAZRAKI: Wrong route of administration, 4 that with a technetium dose you're not causing any --
5 MEMBER SWANSON: And has to' deliver a dose 6 greater than five rems EDE or 50 rems to an organ.
7 DR. ALAZRAKI: Okay.
8 MEMBER SWANSON: Okay?
9 DR. ALAZRAKI: Okay.
10 DR. SIEGEL: I'll take you out and beat you 11 over the head and try to explain this to you.
12 (Laughter.)
13 CHAIRMAN STITT: Yes? We ne.ed sone relief.
l I
'N / 14 These two ire getting to me. Go ahead..
15 MS, RIBAUDO: This might change the focus a 16 little bit. When there was some earlier discussion about 17 changing the definition of reportable co what was written 18 at the bottom for abnormal occurrenea, just changing the 19 bar, I got really excited because chat would have meant 20 that the misadrainistration we had would nc longer have met 21 the definition of a misadminiecration because of a rubtle 22 difference.
23 Below, using the abnormal occurrence criteria, 24 would require a dose or doses that is at least some
/'d
(
25 percentage -- debate t'ne number - <-rme percentage greater
)
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420 l 1 thnn that procerib;d. Abova it just enya th t tho do:rga i 2 differs. It doesn't say it has to be greater. It could 3 be 20 percent, 50 percent, plus or minus.
4 We had the case where there was a 5 misadministration that resulted in an underd_se. It met 6 the definition to be reportable as a misadministration, 7 and you raised that point earlier with the legal-ease.
8 MS. ROTHSCHILD: Yes, the point being that 9 currently I think the phrasing is " differs by" -- you 10 know, differs from a certain percentage from the 11 prescribed dose.
12 MS. RIBAUDO: And it doesn't say greater than.
13 MS. ROTHSCHILD: Related to greater, right.
14 MS. RIBAUDO: There could be debate on that.
15 CHAIRMAN STITT: All right. Go ahead.
16 DR. SIEGEL: The key to this whole discussion 17 is what the point is of a reportable event, and what it is 18 associated with. If it's associated with, in all 19 circumstances, irrespective of harm, patient notification, 20 then exceeds becomes more relevant than differs.
21 And also, if it's associated with virtual 22 assurance of reactive inspection and escalated
, 23 enforcement, then exceeds is better than differs. On the 24 other hand, if the purpose of reportable events is to 25 provide the NRC with information that it can use to help NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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L
421 1 im;. rove tha quality of radiation cofoty throughout ths If -t 2 United States, rather than to go out and kill individual
! 3 licensees, then having the thresholds at a.relatively low ,
level is.really quite useful.
f ;4' 4 5 And so there are two things that need to be 1
2 6 still de alt- with as part of this whole issue. One is the 7 patier.t notdication, and we've said that now 37 times.
!. ~8 And two is how this ties in with enforcement.
i 9- CHAIRMAN STITT: Well, there are a few other i
j 10 little items on list -- the fractionated -- and it comes 11 vp over and over and over again. Dan and I see it. The f
12- staff sees it -- patient intervention. Somebody pulls out
[ _13 _ a source. Where does~that fit into things?
t 14 I'd like ---does the group like the approach 15 that we have been taking the past few minutes which is t
l 16- sort of the -- well, not sort of, it's the modality 17 approach. We're marching down-this list looking at it,
]
18 and I think it --
_19 - MS. HANEY: Can I comment one thing on --
20 CHAIRMAN STITT: Cathy, go ahead, j 21- MS, HANEY: It might be useful if this group 22 came up with why you think reportable events are
- 23 important. Barry gave two great reasons.
1 24- CHAIRMAN STITT: What were those?
j f '2 5 - MS, HANEY: One, for NRC to take enforcement a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS I- 1323 RHODE ISLAND AVE., N.W, (202) 234 4433 WASHINGTON. D.C.- 20006 3701 (202) 234-4433
'r
422 1 cgninct a cpacific lican:co, cnd --
-2 CHAIRMAN STITT: That was the retribution 3 reason.
4 MS. HANEY: I know.
5 C1'. AIRMAN STITT: Okay.
6 MS. HANEY: The recribution reason. And the 7 se ond one, so that we can use this information to correct 8 programs, you know, for the good of the world. If --
9 CHAIRMAN STITT: I'm sure no one would agree 10 with the first reason, and if truly the second one is the 11 better reason, if the committee would at least start with 12 a -- I mean, it doesn't have to be a formal 13 recommendation, but agree that that is the better 14 approach, and then I think that keys you into what Cathy 15 was saying is, do you want to do it as a differ, or do you 16 want to do it as just a greater? Because a difference in 17 a dose really can lead to -- you start looking at the root 18 cause of that, and it could have just as easily been an 19 overdose.
20 MEMBER FLYNN: It's more than that. You know, 21 we debated this when we were debating the QM rule seven 22 years ago and had a working group then. And during the 23 week, during -- in teletherapy, if you wanted the dose, 24 you correct for it. But so it's only greater than.
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423
1 tho wookly doso, but it exceeds for tho total dose.
2 Because if you discover that you underdosed the patient
. [~')
N) 3 two years later when they come back with recurrent cancer 4- that they are dying from, that's a serious consequence if 5 the patient was underdosed three yeara ago, and they are 6 subsequently going to die from their ca.1cer because of, 7 let's say, an error.
8 Now, it may be an unavoidable -- a human error 9 that occurred, but if that licensee has many such errors I 10 think the public health and safety are at risk. So I 11 think underdosing is a serious concern, if'it is not 12 corrected during the course of the whole treatment period.
13 And that happens_in teletherapy, but not if you discover O
' (_ / 14 the error six months later. So.I don't think any licensee 15 should take comfort that they're not reporting something 16 that is underdosed when it could bring great harm to the 17 patient. .
18 CHA!RMAN STITT: There's a similar correlation 19 in brachytherapy. But again, if you start looking at 20 underdose in a fraction, you can drive everybody crazy, 21 including the NRC and yourself. But if you -- and there 22 have been cases that I have consulted on where the 23 computer program-was wrong, and so that the entire. course 24 of treatment -- in fact, handfuls of patients were
- /'~ 25 underdosed-leading to potential loss of' control, loss of
-\
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424 1 curo.
2 And had that been determined at the end of the 3 course, that there was a difference, either greater or i 4 less than, in this circumstance it couldn't have been 5 helped. But that leads into precursor and the sort of 5 reporting that might have been of some use -- I think has 7 been of some use now that it has been looked at 8 retrospectively. So the semantics do count.
9 MEMBER FLYNN: The other point I was going to 10 make is that maybe for -- and when the NRC looks at this 11 for HDR, I think really there should be a percentage 12 attached to the single fraction -- each single fraction, 13 and also a percentage attached to the total course of 14 treatment. It could be 20 percent for HDR fraction and 10 15 percent for the entire HDR course. But I think it has to 16 be broken out somehow, whatever the percentages are.
17 CHAIRMAN STITT: Maybe.
18 Cathy, do you feel that we have not made 19 enough statement as to why we -- what were you asking us 20 to do? Why we like -- why we think reportability --
21 MS. HANEY: Well, I guess why -- I think it's 22 a given that we're all looking for these reportables, such 23 that we could make appropriate changes in radiation safety 24 programs whether it's at a particular licensee or at all 25 licensees.
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425 1 1 So I gusoo whnt -- accuming that everyona 2 agrees with that statement, then I think in reviewing
(
3 these -- going down the column here and reviewing it that 4 we need to be careful that we're capturing the pluses and 5 when doses exceed and are less than. And I guess that's i
! 6 the only thing I'm really meant to bring up.
7 CHAIRMAN STITT: That was your second point.
8 We can get there and keep going. I want to i 9 keep going on this topic. We've got another 45 minutes.
10 I think we can get several of these picked off. Let's go 11 back to the top again.
12 Dennis, did I get the feeling that -- okay.
13 Box 1 is okay as it stands?
O) hss 14 MEMBER SWANSON: Well, Box 1 you would retitle 15 Radiopharmaceuticals: Not Requiring Wricten Directive. ;
16 CHAIRMAN STITT: Is somebody doing the 17 clerical work on this? Who?
l 18 MEMBER SWANSON: And then it would stay the 19 same in the far right box. Items 2 and 3 you would 20 combine under the title Radiopharmaceuticals: Requiring.
, 21 Written Directive, and the box on the far right would stay 22 the same.as it is currently under Box 3.
23 CHAIRMAN STITT: All right. Everybody have 12 4 _ that dose? Just repeat it one more time, because this is
/ 25 going into the minutes and I_want to make sure --
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426 1 MEMBER SWANSON: Okcy. Top row, for box to 2 the left would read "Radiopharmaceutical: Not Requiring 3 Written Directive," or colt'mn 1 -- excuse me, for row 1, 4 far right box, it would remain the same. For columns --
5 excuse me, rows 2 and 3, the title box in the far left 6 would be changed to "Radiopharmaceuticals: Requiring 7 Written Directive," and the box on the far righC woulc'.
8 stay the same as it is right now under row 3.
9 CHAIRMAN STITT: Okay.
10 MS. HANEY: Where would wrong 11 radiopharmaceutical be addressed under the last item that 12 the administrator differed?
13 MEMBER SWANSON: It needs to be included.
14 MS. HANEY: It needs to be added?
15 MEMBER SWANSON: It needs to be added.
16 CHAIRMAN STITT: Okay. So add wrong --
17 MEMBER SWANSON: Wrong patient, wrong 18 radiopharmaceutical, wrong route of administration.
19 MEMBER SWANSON: Wrong mode of transfer.
20 MEMBER WILLIAMSON: Wrong mode of transport 21 and wrong route of administration.
22 MEMBER SWANSON: They're the same.
23 MEMBER WILLIAMSON: Oh. So there's a 24 duplication here?
25 MEMBER SWANSON: How did that sneak in?
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427 l' MEMBER WILLIAMSON:- That*o o misteko.
p 2 MEMBER SWANSON: Yes.
'Q- 1
[.
MEMBER WILLIAMSON: That's not the-current 4 uregulation.
5' MEMBER SWANSON: Excuse me. The box in the
'6 far right for row 2 should read, a wrong patient, wrong 7 radicspharmaceutis11, wrong. route of administration, 8 administered dosage differs by greater than 20 percent 9 from prescribed dose.ge," which would be implied -- what 10 was in the written directive.
11 CHAIRMAN STITT: All right. Any discussion-12 about what we've heard twice? Lou?
13 MEMBER WAGNER: I'd like added to that the V 14 idea that the administrative dosage, instead of differs by.
15 greater than 20 percent, I'd like there to be some 16 adjustment so that-if you have an underdosage by mcre than 17 20 percent.that if it is corrected it still doesn't have 18 to be reported. I don't see why -- if it's corrected, why 19 it should have to be reported.
20 DR. SIEGEL: Well, it depends what the issue 21 is. Again, if the --
22 MEMBER WAGNER: Well, we're talking about the 23 first three.
24 DR. SIEGEL: I know. But the issue is whether 25 the NRC ought to know that an error has been made so that t .
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428 l 1 it ccn diccovar why cn arror hto bacn meda, cnd th n thors 2 is nothing wrong with reporting it just because an error 3 of potential significance was made, because the next time 4 it could be greater than instead of less than.
5 On the other hand, I agree with you 6 completely, if the minute you report that it means you're 7 in deep trouble and you're headed for escalated 8 enforcement. And if we can uncouple reporting with 9 criminal behavior, then we can potentially turn this into 10 something that is not so onerous.
11 MEMBER WILLIAMSON: Why don't we make that 12 motion?
13 DR. ALAZRAKI: Well, unfortunately, that is 14 not the history of the NRC and its enforcement and 15 inspection practices. And we had that kind of thing where 16 it was an underdosage by more than 20 percent, which was 17 corrected by just doing another dose almost within e,n 18 hour. We had to report it, and it was as if we had 19 committed the worst crime you can imagine.
20 And, you know, I just don't trust the agency 21 to realize that; and, therefore, I don't think that we 22 should put that in the regs. We should only be talking 23 about doses which potentially cause harm, and therefore 24 we're talking about dosages which exceed the directive.
25 CRAIRMAN STITT: And in that light, that would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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429 1 bo o chengo cdminictored do=e -
l 2 MEMBER SWANSON: Greater than 20 percent.
3 CHAIRMAN STITT: -- greater then 20 percent. !
4 MEMBER SWANSON: Right? ;
i b- MEMBER FLYNN: I would agree with that. :
6 CHAIRMAN STITT: Any other comments? Is l 7 that -- l 8 DR. SIEGEL: This is for therapeutic 9 radiopharmaceuticals also? ;
10 MEMBER WAGNER: Yes. This covers the first 4
-11 two items which encompass the present first three, the 12 ones that you're looking at there, the first -- what ,i 1; Dennis has altered now in 2, which encompasses the first r
14- tbree. .;
15 MEMBER SWANSON: So the column on the far t
16 right for the second row would read, "the wrong patient, l 17 wrong radiopharmaceutical,. wrong route-of administration, l
18 administered dose greater than 20 percent." i 19 MEMBER WAGNER: Prescribed dosage. l l 20 MEMBER SWANSON: Right. !
i 21 CHAIRMAN STITT Thank you, Lou.
22 Yes?
23 MS, RIBAUDO: From what you said earlier, Dan, 2f now I want to ask the question would there be patient l
- -25 harm if-you-underdose w therapy?
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- - , _ . . , _ . ~ _ . . . _ . -
430 1 MEMBER FLYNN: Yoc, if you didn't correct it 2 in a medically timely manner. You can't say, " Gee, I want 3 to avoid reporting it because next month I'm going to have 4 that patient come in and slip them another 20 percent."
5 Number 1, that would be really a terrible thin 7 to do.
6 But it would -- you would miss the clinical benefit.
7 Now, if you recognize the error right away, 8 aad you corrected it in a clinically effective, relevant 9 fashion, then there is no problem. But if the patient 10 comes back and they are dying of cancer because they were 11 underdosed, 1 think that's an issue, that's a problem.
12 CllAIRMAN STITT It's also true that what 13 Naomi has said -- we have all -- I mean, our history is 14 that the agency has been after us and it has been 15 punitive. And we can make our suggestions. They don't 16 have to be adopted. We also know that. So, I mean, you 17 become very distinterested in being real helpful, because .
10 you get punished over and over again. If there is a 19 different culture, we will have to see it.
20 Lou, and then Theresa, and then Jeff.
21 MEMBER WAGNER: In my comment, I did say that 22 it was an uncorrected dose. But I would aleo like to make 23 a subtle differentiation.
24 I believe that the underdosing that results in 25 a bad clinical outcome is a medical problem. It has NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE , N W.
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431 1 nothing to do with a radiction induced probicm. Ono that 2 is greater than involves radiatier,. That subtle 3 difference I would say splits where the NRC's purview is, 4 and I would say the NRC should only be involved with those 5 events regarding complications brought about by the 6 radiation, not by complications brought about by a bad 7 clinical outcome.
8 CRAIRMAN STITT: We see that all of the time 9 in external beam therapy for cancer. -There are places 10 that traditionally _ treat low, low, low, low, low, and most 11 of us would-say, "You're running the risk," and they do 12 have lower control rates. And that's not a regulated type 13 of environment at all. It's a practice of medicine issue.
14 MEMBER SWANSON: There are some places that 15 believe in high dose chemotherapy with bone marrow 16 replacement, and there are some places that don't. .You're 17 right. It's a medical decision.
18 MEMBER FLYNN: Can I read --
19 CRAIRMAN STITT: No, let me do -- I promised 20 these people to talk -- Theresa and then Jeff.
21 MEMBER WALKUP: Just real quick. In regards 22 to the precursor events and a way -- a mechanism of 23 gatherine that information, I have been-thinking -- I 24 think we all have CQI programs within our department.
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432 I whoro our prob 1cm3 cro -- to includa parh:po ono thing 2 that we are interested in working on, with the f
3 understanding that this is strictly our quality 4 irnprovement program, and that they -- I mean, to find a 5 way that they couldn't come back in and punish us for 6 that. I mean, because are voluntarily doing this. It is
! 7 separate. It is not a reporting thing. It's one way of 8 doing it.
9 CHAIRMAN STITT: Okay. Jeff?
10 MEMBER WILLIAMSON: Well, it looks like we 11 kind of have two choices. We could make a separate motion 12 and vote on it that would specify what the intended 13 purpose of the reporthble event is, and that all of our 14 recommendations follow, given the acceptance of that 15 assumption.
16 or I think we could amend what we've said so 17 far about the different boxes and put in that -- something 18 to the effect that underdoses greater than 20 percent 19 would be excluded if compensated for in a clinically 20 timely manner. So we have that choice.
21 I can go on if you think it's appropriate and 22 talk about some technical issues associated with the 23 teletherapy and high dose rate.
2 4 ': CHAIRMAN STITT: Okay. Hang on just a second.
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433 l l
1 of como othar diccuccion. I went to finich cny othsr l Q 2 commentary on what we now -- we turned the first three 3 rows into two, and I think we're all pretty clear on what j l
4 they are.
5 Dan?
6 MEMBER FLYNih can I just -- well, let me give 7 you a hypothetical situation, suppose we have a hospital 8 five years from now -- we won't call it -- we'll call it 9 Oceanside Hospital. And what they did is they have --
10 (Laughter.)-
11 -- Oceanside Hospital has now underdosed the -
12 last 500 patients by 33 percent. oceanside Hospital says, 13 "Well, it's not reportable. So what?a It indicates I 14 think a systematic error in the licensee that is extremely 15 serious. It could have easily been overdosed 33 percent.
16 But because they've underdosed 500 patients by 33 percent, 17 they may not be having severe radiation consequences.
18 They're just having severe consequences in terms of their 19 cancers coming back and them all dying, you know, from the 20 cancer.
21 But I think it's not -- the medical aspect is 22 not the NRC's purview, but it's the licensee's, let's say, 23 approach to calibration of their cobalt machine that 24 resulted in a major systematic error that could have O 25 easily been overdosed and wasn't -
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434 1 cnd proc;durca which cro atenderd w:ron't follow d by 2 Oceanside }{ospital.
3 So I think it is a concern. I think we have 4 to be the ones to promote the serious quality aspects of 5 the rule. And I think we have to work on the enforcement 6 part of it.
7 CHAIRMAN STITT Jeff, what is your comment?
8 The comment you juer stic would address that. Is that 9 right?
10 MEMBER WILLIAMSON: That's correct. I do not 11 accept, you know, what Lou said. I do think I agree I 12 agree with Dan that underdoses are potentially a serious 13 quality violation as overdoses. There is, of course, the, 14 you know, added provision that if an institution has a 15 mechanism for catching them and correcting for them in a 16 clinically timely manner, I would agree NRC punishment 17 should not be visited upon the institution solely --
18 CHAIRMAN STITT: But how do we put that in 19 print?
20 MEMBER WILLIAMSON: Well, that's what I was 21 saying. I think the discussion might be simplified if we 22 choose one of two courses. We can either make a separate 23 resolution that basically, in our minds, specifies the 24 purpose of reportable event to address our concerns about 25 NRC retribution being visited unfairly or unreasonably NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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- 435 4
i 1 upon individuc1 liconcaso, or if ws fool wo cennot, you i
' 2 know, " trust" NRC, no matter what-we say. We could build b _,
3 into the definitions themselves some provisions that would 4 protect institutions from sort of the worst excesses of 5 NRC retribution.
6 CHAIRMAN STITT I think Dennis or Lou, one of 7 the two of you, at least in one of your preliminary 8 versions, and I think 4t got altered, had a clause 1
9 " administered dose." '4here was something about t 10 uncorrected. Would you state that again? ,
,! I i 11 MEMBER WAGNER: My criginal proposal was that 12 would be an administered -- that it be an administered
]
j 13 dose greater than about 20 percent prescribed dose, or an
] 14 underdose greater than or less than 20 percent, which was i
15 not corrected. And that is what my original proposal was.
16 But I do have a problem when we come up with 17 bizarre examples to justify certain behaviors and certain 18 regulations, because we should not be regulating based 19 upon extremely bizarre examples. And if your Oceanside 20 Hospital has that problem, they should have had the 21 radiation safety committee reviewing those issues and 22 looking it over themselves and correcting that problem up 23 front.
24 There is something really wrong with the f\
U 25 entire program which goes back to our enforcement NEAL R. GROS $
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436 1 proc;duro. Wh;n tho NRC insp;cto com: body, they chould be 2 inspecting the adequacy of the program and not looking at ,
1 3 individual citations and events.
4 CRAIRMAN STITT: What do you think about the 5 clause "or underdose of less than" -- is it greater than 6 or less than 20 percent -- the underdose --
7 MEMBER WAGNER: Or an underdosage of 20 8 percent or more that is left uncorrected.
9 MEMBER WILLIAMSON: In a clinically timely 10 fashion.
11 MEMBER WAGNER: In a clinically timely 12 fashion.
13 CHAIRMAN STITT: Because that clause could cad 14 up being in all of these others that we have to get to.
15 That's why it's important here.
16 MEMBER WAGNER: Right. Bat I think it is 17 important that we at least leave the corrected -- the 18 underdosing that is corrected. That certainly is 19 something that I don't think should be a reportable event, 20 and that was my original proposal in the first place.
21 CHAIRPJJi STITT: All right. Getting some 22 heads --
23 MEMBER WILLIAMSON: So it's option B, then.
24 He build into the definition some protection, rather than 25 make a general statement.
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I 437 :
i 1 CHAIRMAN flTITT: I'm ignoring option B horo.
2 I am --
3 MEMBER WILLIAMSON: No, I meant by -- I 4 presented option A and B.
5 CRAIRMAN STITT Oh. Oh, okay.
6 MEMBER WILLIAMSON: We have a general
? resolution specifying the purpose of reportable event, or 8 B, build as much protection as possible into the 9 definitions assuming, you know,-they-wouldn't be used 10 according to the intent we had in mind.
11 CRAIRMAN STITT: Barry, what do you want?
-12 DR. SIEGEL: Who is going to determine if 13 something was in a clinically timely fashion?- put that in 14 regulation space. And that's the full employment act for 15 medical consultants, I suppose, but --
16 CHAIRMAN STITT: Well, I agree with you.
17 MEMBER FLYNN - That clinically timely fashion, .
18 number 1, it will happen about a dozen times during the 19 year.- Number 2, it doesn't T have to involve an NRC report, 20 a medical consultant report. It could involve a phone 21 callito Judith and'a phone call to Mr. Serig to see if 22 that's a reasonable answer by the medical consultant based
- 23 on the history of.tt.e database that --
24 CHAIRMAN STITT: _ We're asking the Ph.D's to 25 see if the M.D.'s are saying the right --
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438 1 MEMBER FLYNN: No. In tcrmJ of tho datcbaco, 2 whether it's a common problem and whether it's relevant 3 that --
4 CHAIRMAN STITT: Go ahead.
5 DR. SIEGEL: Just political reality. Wouldn't 6 it be better to just let the record reflect that what the
? ACMUI is really, really, really, really, really, really 8 encouraging the NRC to do is to uncouple reportable events 9 from punitive action and to use this more and more as a 10 source of information to try to make programmatic fixes in 11 the health of our society.
12 I think rather than try to use the reporting 13 terms to remove a few events here and there because wo 14 don't trust the NRC doesn't really get at the heart of the 15 matter. And the heart of the matter is is to change the 16 whole mindset related to inspection, enforcement, making 17 the bad apples better. We're warning the good players 18 appropriately and not going after individual events as if 19 they were felonies. That's really the key. And if you 20 get that point across, and say it strongly by the ACMUI, 21 that's probably more important than messing around with a 22 greater than sign versus an equal sign.
23 MEMBER WILLIAMSON: I agree. I like my 24 alternative A better than alternative B, as specified 25 right there.
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439 1 CHAIRMAN STITT: Neomi?
2 DR. ALAZRAKIn- I think we should say that, 3 everything that you just said, but I don't think we are 4 ready to continue to expose ourselves the way we have, if 5 we don't have to.
6 CHAIRMAN STITT But it's also true that I 7 know -- I mean, I do a lot of conversing with the staff, 8 and they would like.something to go by. Now, maybe this 9 wonderful culture change of oh, we're going to work 10 together -- Barry, you've been spending too much time here 11 I think is the problem.
12- That sounds good, but they deal with a phone 13 call that has come in to say there has been a something 14 percent underdose. What do we do with it? - And they look ,
15 for something fairly concrete to decide how to respond.
16 Now, if the new culture is going to say we're 17 all happy together, don't worry about that, that - - I 18 mean, I cannot disagree with what you say. I think 19 Naomi's point -- I also echo that. You know, show me the 20 money, 21 MEMBER SWANSON: Let me emphasize that I don't-22 think the NRC has treated everybody that way. I mean,-we 23 had an administration that - involved underdosing a patient, j 24 and because.they were supposed to be liquid, they set it :
25 in a capsule and they couldn*t suck it through a straw, i NEAL R. GROSS f COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N W.
(202) 2344433 WASHINGTON, O C. 20006 3701 (202) 2344433 ytwr- y- 7v w W '-
v- 'v7-+w --My y,-yw y *,-i-g ,-,y 9 g y,9-y y g ,yg w f y.y ,ng,,,m,yyp,.,g.9f.3,p.,
,,y,,. ,,# y 7 y,,,,,__.y .,,,,pp,c.._, g. ,p,,,,.. , , , , , , , ,y
440 1 Okcy?
i 2 How, fundamentally, we report it as a 1
3 misadministration, which it was, and the NRC said fine.
4 And there was no punitive actions whatsoever associated 5 with that.
6 DR. ALAZRAKI: Well, I guess it's very 7 variable, and it has to do with a combination of attitudes 8 and training perhaps of the inspectors who come out.
9 CRAIRMAN STITT: One more anecdote, and then I 10 want to move on. I want to go through teletherapy in a 11 half hour.
12 Since the NRC has been sending the same 13 investigator out to our place, we're making this 14 relationship. It has definitely improved. Our physicists 15 are telling me that. I feel that.
16 We had a fractionation issue just last week.
17 When you look at the dose difference in the total .ourse 18 of all of the fractions it was not a misadministration.
19 If you looked at it ir. relationship to one fraction it 20 was. We reported it as a misadministration. The t
21 inspector came and said, "You know, I think this is an 22 overall picture. We're going to look at it as a part of 23 the overall picture. This is not a misadministration."
24 So there are changes. They are variable by 25 the area, by the individual you are working with, and, you NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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441 1 know, it een ocho como of thoco moro positivo foolingo ;
2 that Barry is expressing. !
t ,
3 Let's jump into teletherapy. Those who do ,
4 teletherapy, wake up and read. ,
l 5 (Laughter.)
6 MEMBER FLYNN: Just to make sure I understand 7 about wrong mode of treatment, what was intended by that?
8 Are we talking to the NRC staff jump in to make sure I l 9 understand what they mean by wrong mode of treatment for !
10 teletherapy? ,
11 CHAIRMAN STITT: Mafbe. Is that cesium versus ,
12 cobalt teletherapy? That's the only thing I can think of.
13 MEMBER WILLIAMSON: Maybe linear accelerator l
V 14 instead of cobalt-60 would be more likely.
15 CHAIRMAN STITT: Cesium teletherapy, cobalt l 16 teletherapy?
17 MS. HANEY:- Yes. Unfortunately, I don't have 18 the history on it. ;
19 CHAIRMAN STITT: I don't think any of us are 20 old enough to know that.
21 MS. HANEY: Oh, thank you.
22 (Laughter.)
23 CHAIRMAN STITT: Maybe Barry is old-enough.
24 MEMBER FLYNN: I don't know if there are any 25 -- are there any_ clinically used cesium. teletherapy NEAL R. GROS $
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442 1 courc00 in tha country right now, co oppo: d to raccorch 1
2 sources? I don't think there are. They are not in any of 3 the emergency training programs, I can tell you that. 9 4 CHAIRMAN STITT: So it's possible that that l
5 could be axed.
6 MEMBER WILLIAMSON: Well, I have a generic 7 suggestion for the radiation oncology definitions, and I
B that would be that each of them should be, you know, 9 preceded by some statement that is like of the form of 10 provision A of the abnormal event occurrence that I think 11 involves wrongful administration of an unintended dose 12 equal to at least 10 percent of the prescribed total dose, 13 and -- and then dot, dot, dot, dot -- all of the things 14 that are here. That would automatically take care of the 15 problems associated with wrong site.
16 And in the sort of classic example where 17 you're, you know, giving a high dose in a course of 18 treatment and actually make a 20 percent over or underdose 19 it would, you know, not affect those events. But it would 20 only call out as not satisfying the definition those 21 events that involved a trivially small dose to some, you 22 know, small -- to scme tissue not intended to target --
23 CHAIRMAN STITT: What do other people think 24 about that? Other therapy f ol'.,s here?
25 MEMBER FLYNN: I'm not sure if I understand.
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443 1 Can you rGpoot that juct ons moro timo?
2 MEMBER WILLIAMSON: Okay. Yes, I'm trying to 3 get at the fact that sometimes when some of these 4 provisions that are listed down here under 5 misadministration for.brachytl.erapy and telethorapy are 6 met, the actual amount of dose delivered to, you know, 7 some tissue is very small.
8 And the classic example is the resident being 9 tired at night who is removing the radioactive sources at 10 the end of an implant, and drops it for three seconds 11 between the patient's legs and gives, say, 10 MR to the 12 patient's thigh, which maybe has already gotten 1,000 13 centigray from the treatment as deli -red.
14 That theoretically, under the existing rule, 15 is a misadministration because it wrongfully delivered a 16 dose -- it doesn't matter how small -- to an unintended 17 site. So I would like to preface all of the radiation 18 oncology definitions with the phrase " involves wrongful 19 administration of an unintended dose equal to at least 10 20 percent of,the prescribed dose." The prescribed, yes, 21 total dose.
22 CHAIRMAN STITT: And you're saying that you 23 think that would help us with this wrong site?
24 MEMBER WILLIAMSON: Yes. That would eliminate 25 trivial wrong site misadministrations, and it would allow NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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444 1 come cort of ccoling with tha m:gnituda of doco that 10 2 going to be delivered by the treatment.
3 MEMBER FLY!al: You could put that with the 4 wrong site section, but it might confuse people about the 5 total dose --
6 MEMBER WILLIAMSON: Well, and --
7 MEMBER FLYNN: -- by 20 percent of the a prescribed dose.
9 MEMBER WILLIAMSON: It would satisfy it. I 10 mean, if the -- let's say, you know, a course of cobalt-60 11 teletherapy were giving 40 gray in 20 fractions, something 12 like that. Okay. Ten percent would be 400 centigray, 13 okay, but, you know, a misadministration would have to be 14 400 centigray wrongfully administered, plus that 15 difference has to exceed 20 percent of the prescribed 16 dose. That's what it would mean.
27 You could also, I guess, build it into just 18 the wrong site sentence and leave it there.
19 MEMBER FLYNN: Have wrong treatment site and 20 greater than 10 percent of the total prescribed dose.
21 MEMBER WILLIAMSON: Wrong treatment site 22 involving when a wrongfully administered or an unintended 23 dose of at least 10 percent of the prescribed dose is 24 given. That would -- maybe that's simpler. I think 25 they're equivalent, in my mind, as I stated them.
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445
! 1 MEMBER FLYNN: I vould cgroo with ths,t. I
- 2 think wrong treatment site has to be fixed. I agree with 3 Jeff 100 percent. I think the rest of the --
i l l 4 CHAIRMAN STITT: And that's an inte' isting --
l.
5 MEMBER FLYNN: -- definition I think is -- I 6 think it's not unreasonable.
i 7 MEMBER WILLIAMSON: Ler. me make a comment
- 8 about fractionation. I did some work looking at, you i
know, using commonly used radiobiological models to-see
. 9
\
10 what sorts of -- how large errors in single fractions 11 compared to the biological effect of, you know, a certain i
) 12 dose error in the total prescribed dose. I was thinking j 13 of HDR specifically.
i
\ 14 And I found that if I said, okay, a variation f 15 in the total biological effect of a course of therapy for 1
- 16 a three-fractior regimen, that's unacceptable, that meant i
j 17 you could have as large a variation in a single fraction i
1 18 as 60 to 80 percent.
4 19 So when you say that the trigger level is a 20 biological-effect equivalent to 20-percent of the total 21 prescribed dose for a multi-fraction treatment, that 22 translates according to, you know, currently accepted 23 biological models, into a much greater tolerance for an 24- error in an individual fraction. So one might say it's 25 not a misadministre. tion for a single fraction unless it is NEAL R. GROS $
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446 l 1 liko doublo the critorio, cnd liko 40 or 50 parcont 1 2 would submit.
3 MS, ROTHSCHILD: On the question about what 4 does wrong mode of treatment mean, I have been thumbing 5 through the statements of consideration for this 6 provision. And what it says le -- and this is for the 7 final rule -- it said that wrong mode of treatment was 8 substituted for what was in the proposed rule, which was 9 wrong sealed source.
10 And then it stated, "This change is intended 11 to clarify that teletherapy misadministrations capture the 12 use of the wrong sealed source as well as such events as a 13 patient receiving cobalt-60 teletherapy when the linear 14 accelerator teletherapy was prescribed."
15 CRAIRMAN STITT: Great. Thank you. We came 16 close on our --
17 MEMBER WILLIAMSON: I don't know if thats 10 necessary if we have an adequate dose space criterion, and 19 if you substituted in a linear accelerator for a cobalt-60 20 machine, and it didn't make any difference to the dose 21 distribution.
22 DR. SIEGEL: Jeff, it matters because it means 23 that the people who were supposed to be following the 21 direction.s of the authorized user were not following the j 25 directions of the authorized user. And that is the fault l NEAL R. GROSS COURT REPORTERS AND TRANSCR:BERS 1323 RHODE ISLAND AVE., N W.
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447 1 in tha cyst.cm thet nsado fcult enclyoio. It'c not that 2 there is an effects it's that why did someone look at a !
3 prescription that clearly says use the cobalt machine, and 4 go over to the 250 KVP machine, which assuming anybody has .
5 one 'left.
6 CHAIRMAN STITT: Right.
7 DR. SIEGEL: Of other of thor,e.
8 MEMBER UILLIAMSON: All right. Well, we 9 really haven't decided what the purpose of this reportable ,
10 event is, and I -- given your very optimistic view, you 11 know, I would agree with that. Given Naomi's less than 12 optimistic view, I would disagree.
13 CHAIRMAN STITT: Under teletherapy, then, Jeff 14 has suggested an enhancement of the wrong treatment site.
15 Would you just read it again, since we kind of abandoned I
16 that a few moments ago? And I want to ask if there are 17 any other additions, changes, suggestions for teletherapy?
18 MEMBER WILLIAMSON: Okay. Treatment of -- you 19 know,-treatment of the wrong site that involves unintended 20 delivery of a dose equal to at-least 10 percent of the 21 total prescribed dose.
! '22 CHAIRMAN STITT: Okay. How about the other 23 facets of teletherapy? Those'who are using cobalt 24 machines are basically feeling that what we've been f
C V
25 working with is still working.
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i
- , , , - . _ . , . _ . . . . , . _ - . . _ . . , . . . _ , _ .-.m .._,m, , . . . - . - . .. . . - _ . . , _ . _ _ . _ , - , . ~ , , . , . .
440 1 MEMBER FLY!m I think tho 1 cat 'ano io vary 2 unusual, less than three fractions. But I had a case in 3 the midwest where an infant was being treated for 4 blastoma, and they just decided not to check the done.
5 They should have checked the dose in the first -- it was 6 only three fractions that were being prescribed, and they 7 actually checked the dose a week later when the treatments 8 were over.
9 So it's reasonable to put a little bit of 10 emphasis on when there is only three --
11 CHAIRMAN STITT: Right.
12 MEMBER FLYlm: See, what the people around the 13 table who don't work in radiation oncology don't realize 14 is that -- I think Jeff can speak out -- but usually, 15 there is a process involved where the dosimetry and 16 physicist, in a very professional way, are checking the 17 charts on a weekly basis.
18 But occasionally a patient, maybe one patient 19 per thousand, gets only three fractions or less 20 prescribed. So those kinds of cases should maybe be 21 doublechecked up front before the first administered dose, 22 but I think that's why that section is put in there.
23 CHAIRMAN STITT: I think it'a fine to be 24 there. It happens with external beam. Anything that's a 25 short course if just a higher risk for an error.
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) 449 i i
1 Bor'v hco o commant, end th:n Lou.
( 2 DR. LIEGEL: Jeff, I have a question about If you meant 3 your modification of wrong treatment site.
4 to try the right eye, and you treated the left eye, what
] 5 is the prescribed dose to the left eye?
I
. 6 MEMBER WILLIAMSON: It's the prescribed dose i 1 I
7 stated in the written directive. '
i
] 8 DR. SIEGEL: So under teletherapy, it strikes l
l 9 me that a wrong treatment site means you use the wrong
- 10 port; and, therefore, it is dose independent.
l 11 MEMBER WILLIAMSON: Well, then we're back to
! 12 the same problem. What if you leave the beam on for one 13 second and give a very tiny insignificant dose? You know, i
s 14 it's back to all these -- what if you mess up a port film, j
15 which is a mistake, and are forced to take a second port 16 film, which is giving dose outside the prescribed field?
17 Do you want that to be captured by this? You have to have 18 some sort of a threshold. We can argue -- if you don't 19 like 10 percent, put five percent then.
20 DR. SIEGEL: But there is no prescribed dose 21- to the wrong site. Therefore --
22 MEMBER WILLIAMSON: No, there isn't.
23 DR. SIEGEL. -- saying that it's percentage of 24 the prescribed dose to the wrong site is --
g 25 MEMBER WILLIAMSON: I didn't say prescribed NEAL R. GROSS CoVRT REPORTERS AND TRANSCRSERS 1323 RHoDE ISLAND AVE., N.W.
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450 1 dono to tho wrong cito. I ccid of tha pro crib:d dono, 2 period, which means the dose written in the written 3 directive, Barry. The written directive dose.
4 DR. SIEGEL: So you think it's okay to -- if 5 the total course of therapy is 4,000 rado to the right 6 eye, you think it's okay to give 400 rads to the left eye?
7 MEMBER WILLIAMSON: I don't think it's okay, 8 but I'm arguing there has to be some sort of a threshold 9 for reporting criteria to the NRC. Yes, I am saying that.
10 We can argue about the amount and try and titrate it.
11 CHAIRMAN STITT: Lou?
12 MEMBER WAGNER: I have a question. Under 13 these rules, you have a patient who is being treated and 14 the patient s, ;s into cardiac arrest or has some other 15 medical emergency in the middle of the treatment causing 16 them to have an underdose of more than 20 percent, or more 17 than 10 percent, or something. Is that a reportable i 18 event? Looks like it is under these rules.
19 And again, I guess I would say that urlean 20 there is an argument against this that I could -- ti.et I'm 21 not seeing, I would again say it should be modified that 22 the underdcaing of 20 percent -- more than 20 percent is 23 not reportable when it is either corrected or something i 24 else.
I 25 DR. ALAZRAKI: W' 4 ave that.
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451 1 MEMBER WAGNER: On cll of th30s throo, too?
2 on these three, too? on these last three? That's what g(N 3 I'm trying to say.
4 DR. ALAZRAKI: My understanding was it would 5 apply --
6 MEMBER WAGNER: Is that going to take place 7 across the --
8 CHAIRMAN STITT: Well, I think we have to 9 discuss it on each one of them, so you're bringing it up 10 for teletherapy.
11 MEMBER WAGNER: I'm just bringing it up for 12 teletherapy.
13 CHAIRMAN STITT: Does the Lou Wagner underdose 14 clause fit --
15 MEMBER WAGNER: For teletherapy.
16 CHAIRMAN STITT: -- for teletherapy? I would 17 say it does, and I think it helps to correct some .
'18 potential problems that we have seen.
19 MEMBER FLYNN: What Jeff and Barry were saying 20 -- I don't know if Jeff would agree with this, but wrong 21 treatment site and greater than 10 percent of the fraction 22 dose. So, therefore, what Barry was saying=is that if you 23 treat a wrong eye for two days, but you treat the right 24 eye for 25 other days, you don't report it. But if it's a
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452 l
1 dono, than if you did tract tha wrong cyo on Wadno dcy cnd 1
2 Tharsday, you do have to -- just Wednesday, you do have to l
l 3 report it.
4 MEMBER WILLIAMSON: What if you --
5 CHAIRMAN STITT: So it's a lower threshold 6 you're proposing.
7 MEMBER WILLIAMSON: What if you forget a 8 corner block on a whole pelvis field for one fraction?
9 Obviously, that tissue underneath the corner block is f
10 going to get, you know, a dose, maybe 75 percent of the 11 pr63cribed fractional dose. Do you want to report that?
12 MEMBER FLYNN: It doesn't apply because the 13 prescribed dose in that case is the central axis dose. It 14 is not the dose over the whole volume of the field.
15 MEMBER WILLIAMSON: Well, wait a minute. No.
16 I mean, you've now said that the trigger level for wrong 17 site is 10 percent of the fraction size. Isn't that 18 correct, Dan? But at least in that case, the site is in 19 continuum with the radiation field. It's the borders of 20 the field as opposed to the wrong eye.
21 The wrong eye is a good example because of the 22 fact that, you know, a 200 rad dose to the wrong eye is a 23 threshold for cataract formation in a single fraction. So 24 that's why it's relevant. I mean, in a bone or in the hip 25 it's not going to make a difference.
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453 1 CHAIRMAN STITT And th3t'o why I wented to 2 have this discussion before noon instead of after noon, 3 because of these people are peeling out here pretty soon, f 4 MEMBER WILLIAMSON: I just want to say, you 5 know, that I think it would be interpreted because we've 6- had this situation arise, or actually a block was -- not a l
7 block. Actually, a field was angled 15 degrees off out of l
l 8 a multi-field course of therapy for one fraction. That 9 was a misadministration, even though it treated a very :
10 tiny slice of contiguous tissue with the target volume 11 that had no clinical significance.
l 12 So I think given the sort of history of the 13 legalistic application of these criteria, you can't have l
14 it both ways, and we kind of have to strike a balance that-l 15 captures what we consider really sort of clinically l
l 16 serious events, plus protects practitioners from having to l
- 17 report an abnormally large number of events of a very le trivial sort, like leaving a corner block off of a whole l
19 pelvic field for one treatment.
l L 20 MEMBER FLYNN: The site in that case is a l
l 21 volume of tissue. It-happens -- I mean, still the dose is 22 prescribed to the central axis. You're not blocking the 23 tumor if a corner block is left off. It is still the same 24 region or volume of tissue.
25 MEMBER-(ILLIAMSON: Well, no, you're treating L NEAL R. GROS $
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454 1 ticcuo that tha phyoicien intend:d to protcet by tho 2 corner blocks wrongfully, and you're giving more than one-3 tenth of the fraction size to that rim of tissue that the 4 block was intended to protect I'm sure.
5 MEMBER FLYNN: In every radiation oncology i
facility in the country, they start off emergency l 6
7 treatments without the corner blocks to stop the bleeding, 8 to stop the pain, to stop -- to increase the improvement l
9 of breathing. Because they can't manufacture the blocks 10 within a matter of minutes, they have to treat open, and I 11 think the region in that case is the site. I think -- I 12 don't think that we teruld -- I think that's an acceptable 13 -- the corner blocks is something that I don't think we 14 should report as a deviation.
15 CRAIRMAN STITT: Let Ruth comment while we 16 have our side bar.
17 MS, McBURNEY: As it applies to wrong 18 treatment site, I think in the -- it would probably be 19 better to put in a minimum dose to an organ there.
20 Because if you look at the abnormal accurrence criteria, 21 if you're talking about the lens of the eye, anything 22 greater than 100 rad,that was delivered to the wrong 23 treatment site would be an abnormal occurrence, and, 24 therefore, would have to be reported.
25 MEMBER FLYNN: Right. The lens of the eye --
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455 1 tho throchold 10 thought to bo 200, but thoro hevo bocn 2 some rare reports in the literature of doses as low as
('
3 100, but that's -- I'm not sure if that's really real or f l
4 not. So 100 is actually a good figure I think there.
5 The footnote of paragraph A, for the lens, 6 maybe not for gonads or for the bone marrow, but for the 7 lens it's appropriate.
8 CRAIRMAN STITT: Okay. I'm going to stop you 9 guys. My turn.
10 We're getting close to lunch. This afternoon 11 we have patient notification. We can still continue 12 reportable events. I'm getting the whispering in my ear
,-s 13 that patient notification is going to take two hours. Or 14 more?
15 MS. HANEY: Well, it's either going to take --
16 CRAIRMAN STITT: Depends on whose view you're 17 looking at. Evidently, the person who is yet to come has 18 four hours worth of discussion of this. I suspect our --
19 MS. HANEY: I guess my only concern is that I 20 definitely want to allow enough time for patient 21 notification, and it will either take five minutes or two 22 hours, and maybe just the five minutes.
23 And then I would like to just get a read on 24 which way to proceed with radiation safety officer, as far
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456 1 you would liko. And I know coma p2oplo cro lonving ct 2 noon, and I think another group of people are leaving 3 around 3:00. So I just want to allow time for lunch and 4 notification.
5 And the finer details that we're getting into 6 we will need to do, but whether we do it at this meeting 7 or next meeting, it's not as important -- the timing on 8 this -- because what I'm hearing is you want no recordable 9 requirements in the rule, and that reportable stays at the 10 level of the current misadministration with some changes.
11 CRAIRMAN STITT: I'm wondering if we can make 12 a general statement. I think it would be very helpful, 13 because that's where we're working right now. The 14 thoughts would be that we want --
15 MEMBER WILLIAMSON: And A, we'd like it -- C, 16 we'd like it decoupled from patient reporting and from 17 punitive actions.
18 CHAIRMAN STITT: Let me make a comment here, 19 and then I want a motion, okay? Jeff gets excited. He 20 jumps in here.
l 21 Here is where I -- I'm taking notes on what 22 the committee is saying to me -- that we want to delete 23 recordable events, we want to keep reportable, that 24 basically our lining up is our prior misadministration 25 with specific discussion points that we have had on the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE , N W.
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i- 457 5
1- cdminiotored-do:::cga, spscifically' refcrring to undardosega
{ 2 as well-as to overdosage and wrong site.
The other points that we've made today and 3
4 yesterday were -- I don't know if I want to put this as a 5 separate motion relating to precursor events. I'm going 6 to leave that out. I'd like to have somebody make a 7 summary motion about what we've discussed today that may 8 not have -- it doesn't have to include the details, 9 DR. ALAZRAKI: I can make a stab at it, but 10 somebody else will have to make the motion.
11 CHAIRMAN STITT: Oh, Well, let's try somebody
- 12. else to make the motion. Dennia?
13 DR. ALAZRAKI: Well, we could almost take it V 14 from --
15 CHAIRMAN STITT: You have too many words,.
16 Jeff. I'm going to try somebody else --
17 MEMBER WILLIAMSON: Okay.
18 -- CHAIREN STITT: -- and then we'll see if you 19 can take -- rephrase it as a motion.
20 DR. ALAZRAKI What the committee did, if we 21 look at page 3 --
22 CHAIRMAN ETITT: Yes.
23 DR. ALAZRAKI: -- we could use that as the 24 model with some modifications of page 3. We are
[
5 25 recommending all diagnostic radiopharmaceuticala not NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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458 1 requiring writton directivco reporttblo cro wrong paticnt, 2 wrong radiopharmaceutical, route, dosage, and the dose 3 exceeding more than five rem total body or 50 rem to an 4 organ.
5 And then we combined 2 and 3, which are 6 radiopharmaceuticals requiring a written directive, and 7 the reportables there include wrong patient, wrong route 8 of administration, administered dosage grater than 20 9 percent, or less than 20 percent if not corrected in a 10 clinically timely manner -- wrong radiopharmaceutical, 11 too.
12 Then, in the teletherapy -- and we really --
13 I'm not sure we completed that discussion. Have we 14 completed the discussion on teletherapy?
15 CHAIRMAN STITT: I think we did in the sense 16 that it included the wrong treatment site with the same --
17 or with unintended dose. Well, no, we did not. We did 18 not.
19 MEMBER WILLIAMSON: We came up with the 20 general concept that it needed to be fixed with some sort 21 of a dose threshold. Let's put it that way.
22 CHAIRMAN STITT: Right. Ok3y. So that's 23 still part of the motion, then.
24 DR. ALAZRAKI: Right. And that's where we 25 are, I believe. That's where we're at.
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459 1 CHAIRMAN STITT: All right. So that'o n 4
2 motion that Jeffrey wants to make.
- -3 MEMBER WILLIAMSON
- Well, yes. We can -- I'm i 4 wondering if I-can suggest some additions. I think we 5 also suggested that both underdosages and overdosages 6 could be included in the reportable event category. I
, 7 think that was the consensus.
- B And I think it was also sort of the sense j 9 that, you know, we feel strongly that the reporting i
i 10 mechanism should be decoupled from patient reporting,
! 11 should be not used by NRC as an excuse for escalated i
j 12 enforcement, and C, should be used only by NRC to identify i
13 generic problems across the field or fixes that are needed 5 Something like that.
14 to the specific licensee.
[ 15 DR. ALAZRAKI: My impression was that what we i
16 agreed about underdosage was that it could be corrected in 17 a clinically timely manner and would not have to be 18 reported if such -- if so corrected.
19 MEMBER WILLIAMSON: Yes. Okay, 20 CHAIRMAN STITT: That's a motion.
1-21 MEMBER WILLIAMSON: That's a motion.
22 MEMBER FLYNN: I second it. I second the 23 motion.
24 CHAIRMAN STITT: I think we've had plenty of 3
h 25 discussion, unless there is something that really -- all NEAL R. GROS 5 COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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460 1 right. Baccusa w 've bacn doing thic cll morning. And 2 certainly the idea is to get something on the books, 3 understanding that it's not complete. It gives the folks 4 reading the minutes, as well as the staff and the 5 commissioners, an idea of where we were -- what we're 6 working on and what we're in agreement with.
7 All these in favor?
8 Those opposed?
9 Okay. Cathy, any comments?
10 An hour for lunch. Start back at 1:00.
11 MS. HANEY: Judith?
12 CHAIRMAN STITT: Start back at 12:30 maybe?
13 Let me ask the group. 12:30 for -- pardon?
14 MS. HANEY: I know some people are leaving at 15 noon. Will everybody else be here through 5:00 who are 16 expected to be here through 5:00?
17 CHAIRMAN STITT: Who is coming back for 1:00?
18 DR. ALAZRAKI: Well, I'll be here, but X'm 19 leaving at 2:30.
20 CHAIRMAN STITT: Who is leaving at 2:00?
21 2:30? You are, Lou? You're leaving at 2:30? Who is 22 leaving at 3:00?
23 MEMBER WAGNER: I don't know when I'm leaving.
24 I don't know what time my plane -- I have no idea. I 25 didn't get any ticket.
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461 1 CHAIRMAN STITT: Do you nsod halp?
.2 _ MEMBER WAGNER: Yes. Well, I'11 --
r 3: CHAIRMAN STITT: Do you need a' motion? Okay.
4 Who is here until 3:00? Everybody is. Okay.
5 MS. ROTHSCHILD: Judith, I --
!_ 6 CHAIRMAN STITT: Are you here until 3:00?
j 7 MS. ROTHSCHILD: Yes. Well, I'm here until
-8 3:45. So I just was' wondering _on patient notification, do 9- we have an order? In other words, is this person who is 10 coming going to go first? Do you want to hear from me 11 first?
i 12 MS. HANEY: Well, I think what the -- you can 13 go off the record for this.
1 O 14 (Whereupon, at 12:01 p.m., the proceedings in 15 the foregoing matter went off the record.and d
16 resumed at 12:45 p.m.)
17 MS '. HANEY: Okay, we'll go back on the record 18 if everybody's okay with that.
19 We're going to discuss patient notification at.
20 this point. I'd like-the record to show that Jim Anderson
'21 has joined us, and he'll be here for the session on-22 patient notification. Jim is representing patients' 23 rights.
24 And with that, Ifll turn it over to Marjorie 25 Rothschild, who is the member from the working group that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE. N.W.
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462 1 w;3 rocponsiblo for thic caction.
2 MS. ROTHSCHILD: Thank you, Cathy.
3 CHAIRMAN STITT: Cathy, while they're doing 4 that, would you tell the group what else you want to try 5 get to today? I think you were bringing up RSO --
6 MS. HANEY: Yeah, what I would like to -- if 7 we finish this section, and then maybe we'll go into the 8 RSO training and experience requirements. Again, it's a 9 similar approach to what we did for the physicians, so I 10 don't think it will take that long, but if we can just 11 review that.
12 The othe' two things, if we do have time for 13 them, one would be to mention a little bit about the need 14 for training and experience requirements for ancillary is personnel such as the technologists and radiation therapy, 16 as well as the nuclear medicine techs.
17 If you want to, we can discuss some options 18 there and if you think it should be considered in the 19 rule. And then we can speak some more to the recordable 20 event thresholds. And we'll need to spend some time 21 discussing the next meeting -- where the next meeting 22 should take place.
23 Marjorie, you're ready.
24 MS. ROTHSCHILD: Okay, thank you. And 25 everybody can hear me now.
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463 1 For those of you who mny-not know, I'm on 2 attorney in the-Office of General Counsel here at NRC.
( 3 I'd-like_to just note a few points by way of background 4 before we start on the various alternatives for patient 5 notification.
6 Over the years, various issues have been 7 raised, as people are obviously aware of, regarding the 8 NRC patient notification requirement. I did some 9 extensive legal research relating to these issues, 10 including consultation with the American Medical 11 Association, Office of General Counsel.
12 And there are a few points I'd like to note 13 with respect to ?he AMA principles of medical ethics and
\m / 14 their opinion specifically on the existing NRC l
15 requirement, j 16 There are some ethical standards that the AMA 17 has. They're called Principles of Medical Ethics. And 18 the AMA states that those were developed for the benefit 19 of the patient. And there are two of these principles 20- that are relevant to the question of patient notification. j 21 One is what AMA calls principle number three, 22 which is physicians shall respect the law and the rights 23 of patients. And then ethical principle four is 24 physicians shall guard patient confidences within the
-[h 25 constraints of the law.
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464 1 And whnt wa gat from this io thtt tha duty of 2 confidentiality is not absolute, and that that is subject 3 to the legal requirements, and that a duly enacted 4 regulation establishes a standard of conduct which has the 5 force of law. So that the confidential nature of 6 physician-patient relationship must yield when disclosure 7 is necessary either to protect an individual, including 8 the patient, or society as a whole.
9 I'd also like to note that, in preparing for 10 today, I did look back on the regulatory history of the 11 NRC patient notification requirement which I traced. It 12 was in the very first proposed rule on misadministration 13 reporting, and that goes back to 1973 and 1978.
14 And that the Commission stated in the 15 statements of considerations for the final 16 misadministration rule -- this was 1980. And this 17 particular patient notification requirement has basically 18 been carried over through the years to our current rule.
19 The Commission explained why it wanted a 20 patient notification requirement. What it stated was its 21 views that such a requirement was necessary to protect 22 patients.
23 Also said that it acknowledged that the rule 24 does affect, to a certain degree, the nature of the 25 physician's obligation to his or her patient, but that, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 13D RHODE ISMND AW., N.W.
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, 465 1 according to tha Commission -- and this would basically ba
(
\
2- consistent with the AMA -- that the physician-patient 3 relationship was a concept developed to protect the needs
'4- of the patient.-
5 A i in the Commission's. view, there wasn't 6 anything in the rule that would detract from those duties.
7 My last item I'd like to note before we 1
8 reference the various alternatives is that there may be 9 federal legislation introduced on the subject of f
! 10 confidentiality of individually identifiable health l 11 information.
12 There was a report issued by the Federal 1
13 Department of Health, Education and Welfare earlier this I
j'i 14 month in addition to some testimony by HHS Secretary i
- 15 Shalala. And what possibly could be introduced in.the i 16 form of proposed legislation would establish standards to i
17 protect the privacy of individually identifiable health .
s 18 information.
19 However, there are certain exceptions that 20 permit access to patient records or dissemination of 21 health information without patient authorization. Now 22 this -- remember though, this isn't a law, it's not even
-23 proposed legislation; but it could be coming along fairly 24' soon.
25 And that there is a public health exception to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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466 1 tha racomm:ndttione in thic rtport on protceting 2 confidential patient information, and the exception
, 3 relates to public health. And in response to an NRC 4 comment, Secretary shalala noted that NRC's -- the kinds 5 of disclosures which are required to be made to NRC would 6 come under this public health exception.
7 At this point, you know, the Office of General l
8 Counsel and Office of Congressional Affairs is monitoring 9 these issues. And the administration hasn't made a l
l 10 decision yet whether to submit any proposed legislation, l
11 Based on the report, it doesn't look like the 12 recommendations would affect NRC requirements on patient 13 notification. But once the legislative process starts, 14 it's not possible to predict exactly where it would end 15 up.
16 And that basically is what I wanted to note by 17 way of either background or in addition to the materials 18 that we have provided. This statement does reflect the 19 five different alternatives for patient notification that 20 the working and steering group came up with.
21 I think it's fairly straightforward, as stated 22 above. And if anybody would like to start discussion now.
23 Is chere anything in addition, Cathy?
24 MS. HANEY: No, and we can, again, either 25 leave the patient notification -- the listing, the five NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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467 1 citernctivac, up there, or wa do hava the ovarview, tha
~(% 2- matrix. Whichever you'd prefer to work with.
t 3 MS. ROTHSCHILD: I think that's really helpful 4 to have-the matrix up here.
5 MS. HANEY: It's up to -- we can leave that.up 15 for now. And ir it gets to this point, I do have this --
7 recognize that when we developed - the working group 8 developed the patient notification package, the package on 9 reporting thresholds did not exist.
10 So there are some things in this document like 11 reference to it allows NRC to meet the AO -- you know, our 12 obligation to tell Congress of abnormal occurrences. This 13 is where you start getting the tie between the reporting 14 threshold and patient notification.
15 And with that, I'll turn it over.
16 CHAIRMAN STITT: Well, let's leave the options 17 up there. If we want to go to the matrix, which is very 18 complicated, we can. These are some-general philosophy 19 issues that we've been over for years.
3M) Lou has got his hand up.
21 MEMBER WAGNER: I just have a question 22 regarding the data that was presented here. Excuse me.
23 In one of your statements, you said that the -
24 --when the rule was initiated, the Commission had stated 25 that the -- they found it necessary, in order to, I guess NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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468 1 --
I can't rcm;mbar exactly what you cnid, but I think it 2 was protect the patient or something like that nature.
3 Could you tell me whether or not, in your 4 research, you have any data upon which to base that 5 finding? Was there problems -- was there history problems 6 reported? Is there anything that was available to justify 7 that statement that it was necesr.atf?
8 MS. ROTHSCHILD: I think what the Commission -
9 - what started the Commission down on this road was that I 10 guess there were comparable -- there were certain 11 requirements in an old Part --
I'm sorry, can people hear 12 me now?
13 What started the Commission down this road 14 were that there were some requirements in old Part 20, 15 which still may apply, about reporting to individuals when 16 they -- when a licensee is required to report to NRC 17 certain overexposures. And I believe there was, you know, 18 a specific incident involving 400 patients. I guess we're 19 all pretty familiar with it at Riverside.
20 And the Commission felt that it had -- because 21 of exceptions in Part 20 not applying to intentional 22 administration of byproduct material to patients, that the 23 Commission needed something - a separate requirement to i
24 capture for those kinds of administrations what was 25 comparable for members of the public and occupational NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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469 ,
1 workers.
O 2 .And:I guess as far as why did patients need co y 3 know, I think the Commission has articulated its view that 4 patients need this information in order to be able to make 5 timely decisions about their health care or remedial care.
6 MEMBER WAGNER: Did the -- brief me on that 7 Riverside incident. On that Riverside incident, were the 8 patients not notified?
9 MS. ROTHSCHILD: I don't think there was a 10 reporting -- I'm not sure there was an existing reporting 11 requirement at that time for that kind or incident.
12 MEMBER WAGNER: That's not my question. My 13 question is, is there any data with regard to whether or 14 not the patients were notified by the physician of the 15 occurrence? I'm not familiar with the -- familiar enough 16 with the incident to have knowledge on that.
17 CRAIRMAN STITT: Dan,-you know, don't you?
18 MEMBER FLYNN:. It involved a systematic error 19 whereby patients -- because of a systematic error, not 20 because of individual calculation mistakes. Received an 21 overdose. And my recollection is that the error, of 22 course, happened over a period of time, so-it wasn't known 23 that there was a-systematic error.
24 Juud so there was a great delay in the time of Of t
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470 1 tr ctcd quito com3 timo previoucly who m:y hava hnd oith3r 2 no problems or had complications or were no longer alive 3 by the time the accident was discovered -- or the 4 misadministration was discovered, 5 Dut I don't know the details. If there are 6 any NRC staff here who remember the -- 1977, is it, 1978 7 period, 1975?
8 MEMEER WAGNER: What I'm asking is, was there 9 a precedent set in that incident where they tried to cover
- 1) up the incident and didn't notify the patients or 11 something like that, which --
12 MS. ROTHSCHILD: Well, I think the problem is, 13 .'s that there was no reporting requirement even to the 14 NPC. So NRC was not in a position to even necessarily 15 knew what was actually occurring in terms of possible 16 misadministrations.
17 Pardon? The problems was is that there was a 18 recognition that, although NRC had requirements -- or at 19 that time, it would be AEC if you're talking about early 20 70's - . tor reporting overexposures to members of the 21 public and workers, there was not a comparable requirement 22 for patients that NRC needed te know about the incidents.
23 And when NRC had the information, NRC believed 24 that patientt had a right to know when they were involved 25 in the subject of -- if they were a subject of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., NM (202) 23444:D WASHINGTON D.C. 20005-3701 (202) 234-4433
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471 1 -- micedministrctions. And that tha comparablo requirem:nto 2- for members of the public and occupational workers 3 provided for notification of them if a report was required 4 to be made to the NRC.
5 So I think in answer to your question, simply 6 stated, there was no requirement to report it to the NRC i 7 in the-first place, even the incident. So NRC would not
- 8 be in a-position to know whether patients would be 9 notified, i
10 We weren't aware of what was going on 11 necessarily, or there-was no requirement.
12- CHAIRMAN STITT: I have a question of you.
13 What is the requirement for reporting to 14 workers?
15 MS, ROTHSCHILD: Cathy, if you don't mind, I'm 16 going to --
17 MS. HANEY: Okay, if you exceed the public --
18 I mean the occupational dose limits, it basically boils 19 down to if you tell NRC, you tell the worker also.
20 CHAIRMAN STITT: And that can be a quarter --
21 MS. HANEY: Well,-I mean, it's an annual 22 requirement right now. But if -- I mean, theoretically, 23 if someone in January exceeded the limit, they wouldn't 24 need to tell us until the following January. But there p 25 are some other requirements that throw in about G NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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472 1 timolin30s.
2 If it hits a certain level, then they have to 3 tell us within so many days or file a report --
a written 4 report within 30 days.
5 CHAIRMAN STITT: Jeff.
6 MEMBER WILLIAMSON: Well, I was wondering, 7 what --
is the reporting requirement for workers that if 8 you exceed the annual exposure limit by any amount at all 9 or double the amount, is there any additional threshold, 10 or is that just if you exceed?
11 MS. HANEY: No, it's -- yes, if you exceed it.
12 Cathy, you have a copy of Part 20, don't you?
13 Is that --
14 MEMBER WILLIAMSON: And then depending upon 15 the amount you exceed, the schedule for reporting it to 16 NRC and the worker is accelerated, something like that?
17 MS. HANEY: From Part 20, it's when a licensee .
18 is required to report pursuant -- it lists the Part 20.
l 19 Any exposure of an individual occupationally exposed or an 20 identified member of the public to radiation or 21 radioactive material, the licensee shall a2ca provide a i
l 22 copy of the report submitted to the Commission to the l
l 23 individual.
l 24 This report must be transmitted at a time no 25 later than the transmittal to the Commission. And as far NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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473 1- oc what it'o refersncing io reporto would como in in
% 2- excess of the occupational dose limits for an adult, for a 3 minor, for the embryo fetus, or for the public.
4 CHAIRMAN STITT: So Marjorie, I think you were 5 trying to tell us that historically, the patient 6 notification came up around -- potentially around some
? event, but it was being related --
8 MS. ROTHSCHILD: Well, I'm not sure if it was 9 ..
l 10 CHAIRMAN STITT: Yes, we won't --
I won't push 11 that becauee of -- I don't think we know. But it could 12 have. But they were then -- the folks working on that 13 were trying to reference the fact that there was 5 14 preexisting notification for workers and members of the 15 public, --
16 MS. ROTHSCHILD: Right.
17 CHAIRMAN STITT: --
and there was no 18 notification for patients.
19- MS. ROTHSCHILD: Right, that's what the 20 Commission noted, and that would have-been in the early 21 70's. That was in the early 70's. The very first notice 22 of proposed rule making referenced the requirements for 23 workers and members of the public and the lack of such a 24 requirement for what they called accidental or erroneous 25 exposures of patients.
5
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{
474 1 And pstient notification rcquircm:nt wao in 2 that very first --
3 CHAIRMAN STITT: Frame of reference probably 4 helps us to understand.
5 After lunch, the postprandial depression here 6 -- probably good for us after our morning.
7 Naomi.
8 DR. ALAZRAKI: Well, the status quo, licensee 9 to notify NRC, referring physician, and patient or 10 responsible relative unless referring physician personally 11 informs the licensee that he or she will inform *.he 12 patient; or that, based on medical judgement, that telling 13 the patient or a responsible relative would be harmful.
14 Am I missing something or is there something 15 wrong with that?
16 MEMBER FLYNN: No , there's something wrong 17 with it.
18 DR. ALAZRAKI: Okay.
19 MEMBER FLYNN: At least -- I can tell you at 20 least five different incidents that I've had to look into 21 whereby the radiation oncologist informed the referring 22 physician. The referring physician ie not under the 23 purview of the NRC.
24 The referring physician says something of the 25 following: I don't think it's worthwhile telling the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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475 1 patient, so I don't want you to tell the pntient. Now
(N i 1 2 when the referring physician has-told the radiation 3 oncologist not to inform his patient, he's also said that 4 I don't think it's worthwhile informing the patient, and 5 he's not under the -- well, the referring physician is not 6 licensed by the NRC.
7 I mean, you're leaving the judgement up to the 8 referring physician exclu=ively. I mean, I don't know 9 what -- which of these five are the_best, quite frankly.
10 But I think number five is better than number one.
11 Because number five, it says based on medical judgement, 12 but it doesn't say based on the referring physician's 13 medical judgement.
('_s\
'\._-) 14 DR. ALAZRAKI: I don't read that into number 15 one. It says that the licensee is to notify the NRC, the 16 referring physician, and the patient, or responsible 17 relative unless the referring physician personally says 18 that he or she is going to notify the patient.
19 MEMBER FLYNN: But my experience in five 20 different cases is the referring physician said that I 21 don't want the patient notified, it's not worth -- it's
-22 not going to be of any help. Not because it wasn't going 23 to -- not because it was going to be harmful to the 24 patient.
25 So the referring physician did not want the V
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476 1 pationt notified -- ho caid thara would ba no b nofit 2 obtained from notifying the patient. Not that it would be 3 harmful, but there would be no benefit to notifying the 4 patient.
5 DR. ALAZRAKI: According to the way I read 6 this, then it's the authorized user's responsibility to 7 notify the patient. If the referring physician doesn't 8 want to do it, then the authorized user has to do it.
9 That's the way I read this.
10 MEMBER FLYNN: Well, it gets -- that's the way 11 it's supposed to work, but that's the way -- not the way 12 it's worked on a number of incidents.
13 MS. HANEY: You run into a problem when the 14 referring physician, as Dr. Flynn said, says no, don't 15 tell the patient.
16 MEMBER FLYNN: That's right; that's what he 17 says. And then he's the --
18 DR. ALAZRAKI: I think then the answer is 19 well, I'm sorry, but -- and there's no reason not to tell 20 the patient.
21 MEMBER FLYNN: I've called the referring 22 physician and told him that the radiation oncologist is 23 under licensure -- under law must notify the patient, and 24 that this creates a problem here not for you because 25 you're not licensed by the NRC, but it creates a problem NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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477 1 whare tha phyoicion would-ba in violation of hio liccnco.
T 2 And then usually the referring physician --
3- usually they'll say well, okay, I'll notify the patient 4 then. Because how he notifies the patient, he doesn't 5 have to cause the patient to have great anxiety if it's a 6 minor event. He can notify the patient in a very positive 7 way.
8 I'm not saying that number one and number five 9 are the answer necessarily. I just think number five is 10 better because it takes -- number one, I thought it was 11 great when it first was written-in terms of if it had to 12 be, it had to be.
13 But just based on practical experience with
\ 14 these incidents, number one gives-too much discretion to 15 the referring physician who's not on the NRC license.
16 MS. HANEY: Another item to notice between the 17 status quo and four and five is the change of the term 18- from responsible relative to guardian. With number one, 19 there's been a lot of discussion about what the 20 responsible relative is, and that's come up in a lot of 21 the misadministration cases.
22 So the working group chose to use, at least 23 for now, the term. guardian. There's probably a better 24 term out there, but we mean the guardian to be-the power 25 of attorney or the next of kin.
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478 1 What wa' ra trying to do io gat cwny fron, und;r 2 number one what's been basically seen as you're down at 3 the fourth cousin on the brother-in-law's side that you 4 haven't seen in ten years, and he's the only responsible 5 relative you can find, and why should we bother telling 6 that person, 7 So that's the intent of using this term 8 guardian. So that's another difference between one and 9 four and five, and what's broken -- what may be broken 10 with one. '
11 CHAIRMAN STITT: Question to the -- to 12 counsel.
13 We have hashed this over and over again, and 14 it seems to me what we have to be cognizant of is what is 15 the proper legal format. I mean, am I --
can we -- we 16 can't really put in next door neighbor if we would want 17 to, right?
18 MS. ROTHSCHILD: Well, I think we may get some 19 help from these HHS recommendations because they recognize 20 that situation. They call it instances in which patients 21 have either formally authorized others to act for them or 22 are unable to act for themselves.
23 And the way their discussion of this goes, 24 they would recognize a situation where there may be others 25 acting for patients and they talk about these other NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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479
. 1 individuole ao eithsr one, a haalth -- comsono holding o
" /~T i
2 health care power of attorney for the patient; or, if 3 there is no such person, next of kin; or if-there-is no 4 next of kin, then they go to the health care provider l
5 actually.
I l 6 CHAIRMAN STITT: Well, I can see why the t
I l 7 working group chose to use guardian. But I understand 8 your clarification. And, I mean, certainly if you'take 9 the isotope issue out of it and are -- need to talk with-10 the patient or the person who is their -- you know, the l 11 legal guardian, power of attorney, no matter what the 12 medical health care issue is, there's certain things that 13 you are obligated to uphold.
D 14 And I think that's the kind of wordage that we 15 would want to end up with. It sounds like that's the 16 intent of the working group.
17 MS. HANEY: That's right. And we just -- -
18 CHAIRMAN STITT: Whatever that may be.
19 MS. HANEY: Yeah, and we just use the term 20 guardian for the sake of a term that --
21 CHAIRMAN STITT: It's a short --
02 MEMBER-FLYNN: Can 1 give one more example?
23 CHAIRMAN STITT: Yes, sir.
24 MEMBER FLYNN: I was also the consultant in 25 the Puerto Rico strontium case. And in that case, the NEAL R. GROS $
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480 1 patient cort of ccm3 to tha ophthnlmologict directly.
2 There was no referring physician of record. There were 3 hundreds of patients involved, and many of them never even 4 knew that there was an overdosage, and many of them still 5 don't.
6 Maybe if they knew now -- some of them do.
7 There was a difficulty tracking them down because of the 8 record keeping. So -- and there also was no follow up. I
) 9 mean, those patients were treated and then they're off 10 somewhere in Puerto Rico.
11 But -- so that's -- I'm not sure how you --
12 that's another example of cn incident where many, many 13 people at risk for cataract formation and other infections 14 of the sclera because the dosage was so high -- these were 15 like three or four times the dose that should have been.
16 And the record keeping wasn't good. He did 17 make some attempt to contact some people, but many people 18 --
most of the people, at least when I was involved, li hadn't been reached and claim that he could not find them.
20 CHAIRMAN STITT: And that's probably true for 21 a lot of people.
22 MEMBER FLYNN: Well, I talked to a senior 23 radiation oncologist in Puerto Rico, and he said it's not 24 true because Puerto Rico's a small community.
25 CHAIRMAN STITT: Okay, it's more confined.
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.. - - - . . _. . . . . - -. = . - . _ - . . . - .-. .. . - . - - _
l 481 1 MEMBER FLYNN: And yc,u can track psople down 2 if you make enough of an effort to do so.
4 3 MS. HANEY: They have been tracked down in 4 Puerto Rico.
5 MEM3ER FLYNN: All right.
d e
6 CHAIRMAN STITT: In the southwest, when we had 7 our last brachytherapy school, there was a lot of folks in i 8 the southwest who were being treated for the same medical 9 condition. But the borders are much more open, and it_can
- 10 be very difficult to track.
11 The other issue about referring physician, and j 12 depending on your viewpoint --
I mean, in my business as a 13 radiation oncologist, many times there is no referring fd i
-14 physician or they're very, very ' remote, and that's quite 15 different from, say, Naomi's practice where, you know, you-16 don't know the patient.
i 17 You're performing medical technique on behalf 18 of the referring physician.
19 DR. ALAZRAKI: Yes, sometimes we know the 20 patient and sometimes we don't know the patient.
I 21 CHAIRMAN STITT: Right.
- 22 DR. ALAZRAKI
- Usually for therapeutic things, 23 we know the patient. For the diagnostic tests, we may not 24 really know the patient.
25 CHAIRMAN STITT: So those are some of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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482 1 cubtlatico thnt wa all hnva to dac1 with in hora, 2 I think that five is easier, from my 3 viewpoint, based on a lot of the things that have come up 4 here.
5 All right, let's try the -- you'll find that 6 Judy's rule is you speak when you're spoken to, and we --
7 because if everybody kind of waves and we look one 8 direction or the other, I tend to do some side of the room 9 or the other. It allows you to sleep a little bit while 10 this side is working.
11 So let's go to my left here. Unless Dennis or 12 Ruth have a comment, we'll start with Lou and go on down.
13 MEMBER WAGNER: Just a comment to look at the 14 way things are worded. There's a problem in five, and 15 that says -- there's that qualifier "if". So what that 16 says -- I think that's in contradiction to the previous 17 discussion regarding recordable event -- or not 18 recordable, reportable event.
19 Because licensee would notify NRC if there are 20 or would be detrimental ffects to the patient to the 21 reportable event.
22 MS. HANEY: It's the guardian.
23 MEMBER WAGNER: But the "if" replies to the 24 whole sentence as it's worded. As it's worded, it applies 25 to the whole sentence.
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483 1 MS. HANEY: Tha intent of tha working' group 2 was that --
-- (
~'
3 MEMBER WAGNER: I know, I know; the intent --
-4 MS. HANEY: No, no; in this case, you're 5- right; the NRC would only care about it if there were 6 detrimental effects.
7 MEMBER WAGNER: Okay, so that is a 8 clarification then.
9 MS. HANEY: That was the --~now wt te there is 10 another alternative out there.
11 MEMBER WAGNER: So the point is, is that even 12 if it exceeds the level of the recordable event in the 13 previous discussion that we had -- reportable event, n\d 14 DR. ALAZRAKI: If it's reportable,. the NRC 15 gets -- it's reported to the NRC.
16 MEMBER WAGNER: But this rule would say-you 17 don't have to do it unless there's detrimental effects on 18- the patient due to the' reportable event.
19 MS. HANEY: This is where the tie in between 20 when these two alternatives were developed comes in and 21 how you really can't totally --
22 MEMBER WAGNER: Separate the two.
23 MS. HANEY: -- separate patient notification 24 from reportable.
25 MEMBER WAGNER: I'm just pointing out that
[j\
\
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484 1 tharo'o whnr3 thn conflict is cricing.
2 Okay, thank you.
3 MS. ROTHSCHILD: Cathy, I know that we don't 4 have the viewgraph or the chart. Is that interpretation 5 of five, is that reflected -- I guess it's in the 6 materials everybody --
7 CHAIRMAN STITT: Yes, it's page 12. The 8 matrix, is that what you're referring to?
9 MS. HANEY: Yes, I do have the matrix.
10 CHAIRMAN STITT: Which point under the matrix 11 then are you --
12 MS. ROTHSCHILD: Well, looking --
13 CHAIRMAN STITT: Enables NRC to identify 14 causes? Enables NRC to fulfill statutory obligation?
15 MS. HANEY: Okay, let me do what's missing 16 from up there and I think I misstated. The five that's up 17 there does not match the five that -- it should say 18 licensee would notify NRC and referring physician, but not 19 patient or guardian unless based on medical judgement.
20 MEMBER WAGNER: Ahh.
21 CHAIRMAN STITT: Repeat that again. That's 22 somewhat different.
23 MS. HANEY: Okay, so what I -- yes, it does.
24 So what I originally said was one of the thoughts of the 25 working group, but that's not what got put down on paper.
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d 485 l 1 So it.,rgivo ma for that.
2 CHAIRMAN STITT- Tell us number five. We will 3 ell -- get your pencils out, guys.
1 4 MS. HANEY: Actually, let me, on the l 5 viewgraph, do it.
1 j 6 CHAIRMAN STITT Good.
l i 7 MS. HANEY: If I can get a --
l 8 CHAIRMAN STITT: Thank you, Lou, for being i
9 with us this afternoon.
i 10 MEMBER WAGNER: That's a big difference, i
l 11 CHAIRMAN STITT: Yes.
12 I was going to bring up one thing, and the 13 n ix points it out. One, two, three, four -- under the 14 key items, it's the fourth from the bottom. Alternative 15 five will require definition of detrimental effect. Or 16 certainly if not requiring definitional, leave it open to 17 interpretation.
18 MEMBER WAGNER: That's a whole new 19 perspective.
20 CHAIRMAN STITT: Is there anything else you 21 want to change that we've been over the past couple of 22 days?
23 (Laughter.)
24 All right, do people want to comment on five 25 with a new twist on things? It still -- I mean, just a NEAL R. GROSS -
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486 1
1 cumm;ry comm:nt b:ccd on diffe,rcnt p;oplo'o parcpcetivco 2 they've been throwing out.
3 This means the licensee notifies the NRC and 4 the -- it takes some of that referring physician back 5 pedaling out of it -- some of the issues that Dan has 6 brought up from doing the consultations. Ar4 I've had a 7 similar experience in radiation oncology.
8 And it also givea some medical interpretation 9 to notification based on the nature, Lne severity, the 10 potential consequences. That's the first time we've seen 11 anything quite like that.
12 Ruth?
13 MS. McBURNEY: That certainly would not be 14 consistent with notification of members of the public or 15 workers of unnecessary radiation exposure. For example, 16 if you've got the wrong patient and they received a dose 17 that was over some limit and was not notified, number five la would not be consistent with that type of notification.
19 CRAIRMAN STITT: *Although. it's interesting; 20 when you look at the matrix, third from the bottom allows 21 physician discretion based on medical judgement in 22 deciding whether to inform the patient. The status quo 23 plus all alternatives except four have that marked as 24 quality that's present.
25 In fact, that is how the status quo reads.
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487 1 MS. HANEY: Right. But tho koy 10 wo uco tho 2 term physician very loosely here. Whether it was the l 3 authorized user or the referring physician, we didn't i
! 4 differentiate in the case of the matrix.
5 MEMBER WILLIAMSON: Could I say something in ;
s 6 reaction to the last comment?
7 CRAIRMAN STITT: Yes, go ahead.
i O MEMBER WILLIAMSON: Okay, I think if, you a
9 know, one had a patient who came in for some -- who was 4
l-10 supposed to have some procedure not involving a radiation ;
i 11 exposure, and mistakenly, that patient got either a 12 diagnostic imaging test or some therapeutic procedure that 13 involved radiation exposure to them, I think they would be i ,
1 14 covered under the Part 20.
i 15 Because, from the perspective of NRC, aince 16 they're not covered by a written directive, they are a l
- 17 member of the general public, and therefore would have to -
18 be handled that way, j 19 CHAIRMAN STITT: Lou?
20 MEMBER WAGNER: We had long discussions on
! 21 that from the administration to the wrong patient -- that 1
22 person is' considered to be a patient. It goes under Part 4
j 23 35, not under Part 20.
24 MS. HANEY:- There was a rule change probably 25 about.three years ago. We refer to it as the wrong NEAL R. GROSS 4 Count REPORTERS AND TRANSCRISERS 1323 RHODE ISLAND AVE., N.W.
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488 1 p tient rulo. Prior to that, thoro waro a lot of 2 discussions that it did -- that the person did fall under 3 Part 20, 4 But there was a case out in California that 5 prompted us to do that rule making to throw that 6 particular individual under the reporting criteria, 35, 7 and not 20.
8 CHAIRMAN STITT: Okay.
9 MEMBER WILLIAMSON: Again, it seems -- to 10 continue chis, then you've made a decision to not cover 11 this under Part 20, but under Part 35, so it need not 12 therefore be handled the same way.
13 MS. HANEY: Need not be, but then there is --
14 you know, we tend to like to be consistent between how we 15 handle different groups of people. And in fact, in 16 discussions on the working group on this, some people 17 started to go back and maybe revisit did we do the right 18 thing with that rule, should we have left them under Part 19 20.
20 And I said we're not discussing that now.
21 CHAIRMAN STITT: Naomi.
22 DR. ALAZRAKI: If the unintended 23 administration of the radioactive material meets the 24 criteria for a reportable event, as we discussed earlier 25 this morning, why in the world would we not notify the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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489 1 petiont?
2 CHAIRMAN STITT: Well, it's an interesting 3 point. I mean, our version of the detail that we were 4 looking at this morning under reportable event is becoming 5 fairly specific and honed down and is a draw to the other i
6 nomenclature that had to be reported to the NRC, the l l 7 recordable event.
8 MS. HANEY: I think the question is whether 9 there should be a federal requirement to notify the 10 patient, or should you -- we rely on the standard -- the 11 care of the standard operating care of the patient -- I i
12 mean of the physicians.
l Ethics.
13 Give me the right term.
i 14 The physician's ethics to notify the patient 15 versus a federal requirement to n>tify the patient.
16' That's what a lot of the controversy over the whole.
17 requirement over the years has been.
- 18. DR. ALAZRAKI: Well, I think the whole issue 19 of notification of patient is viewed as a medical practice 20 issue rather than an NRC issue. But if we are putting _in J
! 21 the regs notify the NRC, notify the referring physician, I 22 think you have to put in.there notify the pitient too for 23 a reportable event.
24 Either you put it in or you don't. Maybe NRC 4
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490 1 prcctico teko over tha r00t.
2 CHAIRMAN STITT: Well, that's number two.
3 ".' hat's alternative number two. That is that they notify 4 the NRC --
5 DR. ALAZRAKI- Well, I would just strike --
6 CHAIRMAN STITT: -- and then the rest is 7 medical practice.
8 DR. ALAZRAKI: Yes, then we don't have any 9 section dealing with patient notification at oil because 10 it is medical practice issue, and the ethics of it are you 11 have to notify the patient.
12 CHAIRMAN STITT: Lou.
13 MEMBER WAGNER: Sometimes I think it's 14 important that -- and maybe in future preparations we can 15 go back and revisit this. Because at these committee 16 meetings, we have lots of individuals who do not share the 17 experience of others in what has gone on before. This -
18 thing has been, discussed over and over again.
19 The issue on this is quite clear. The reason i
20 we don't want it to follow Part 20 is because sometimes 21 there could be the situation where informing the patient 22 is huardous to the patient in the physician's judgement 23 or emotional stress or for other reasons.
24 And that's why it's a medical issue. That's 25 why there was a lot of struggling going on with regarding NEAL R. GROSS COURT REPORTERS AND TMNSCRIBERS 1323 RHoDE ISLAND AVE., N.W.
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- v
_ _ . _ . _ _ _ _ _ . . _ _ _ _ - _ _ _ . _ . . _ _ _ _ _ .. _ _ _ . ~ . _ _ - _ _
491 1 o fcdarcl rulo rcquiring com body to notify the pctiont or j 2 guardian'or referring physician or whatever it is. And e
3 then the discussion got down to the issue of whether or i f
4 not this was an intrusion into medical practice.
5 Now, the way we have modified the medical 6 statement before was that the only time -- I believe the 7 way we recommended -- the only time the NRC would be 8 involved would be if the current standards of practice '
9 from other bodies would not be adequate to protect an 10 individual, something of that nature.
11 Now, I'm not sure what our current status is, 12 but that was where the discussion went. That's why it 13 went that way. But I think the NRC ha s to understand that 14 they should not get involved in certain issues involving 15 medical practice, and this is an area where clearly 16 there's an intrusion in the medical practice.
17 We need to protect the patient-physician 18 relationship as well. When we make these rules, the 19 problem with these rules is that they are universal and 20 they don't take into account the vagaries of the practice
-21 itself.
I 22 And when you start meddling wit.h medical ~
23 practice, you start putting restrictions on physicians and 24 putting handcuffs on them that don't permit them to 25 practice for the individual patient. That's where the NEAL R. GROS $
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492 1 wholo crgum:nt ecma from. That'o whoro it origincted.
2 And that's why this is treated differently than part 20.
3 DR. ALAZRAKI: Everything that Lou said makes 4 a lot of sense, and I --
with that background, I would 5 feel that it's probably not appropriate for NRC to have 6 anything about patient notification in the rego and leave 7 that to the medical practice.
8 Just as when you have a misadministration of 9 any drug, dangerous drugs, in medical practice, which 10 happens a lot, there's no federal regulation about you --
11 thou shalt --
it is ethical practice that the patient be 12 informed if it comes to the attention of the physician.
13 CRAIRMAN STITT: Jeffrey, go ahead.
14 MEMBER WILLIAMSON: Just to amplify on what 15 both Lou and Naomi have said, I think a lot of problems 16 were caused by the fact that the definition of the 17 reportable event captured a lot of events which had no 18 health significance for the patient at all.
19 I mean, you know, we've been talking about 20 sort of small -- what are in essence small, technical 21 errors which, you know, may have safety significtnce in 22 the program the licensee should respond to but really have 23 no implications for the future health or clinical outcome 24 of the patient.
25 And you have to then tell the patient, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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L
493 1
1 rogardleca of whct tha patient'o etete of mind cro. And l l
2 in some cases, at least in one case in our own institution i 3 where we had one of these -- what I call administrative I i
4 misadministrations, you know, it forced the physician to
- 5 have to really emotionally upset and distress a patient l
6 who was, you know, having a lot of psychological' struggles 7 getting through the treatment.
8 And it resulted in quite a big brouhaha. And l 9 what happened when the physician chose to say, well, it ,
l l 10 would be harmful under these conditions to have to, you 11 know, upset the patient over this sort of trivial thing.
12 Then the NRC came back and said you have to go pick i '
13 someone; anyone,.that the patient knows and tell them. -
14 So I think there's, you know, some problems 15 with that. I think, you know, if there is no sort of 16 legal -- somebody.who has legal responsibility for the 17 patient's medical care, and the patient is competent, you :
18 know, it should just end there too.
19 CHAIRMAN STITT: Dan.
20 MEMBER FLYNN: Continuing on with what Jeff j 21 said, that*c why I believe -- not saying which one I.think 22 is the best, but I do believe that number five is better 23 than number one.- The reason why referring physician-is in 24 there is because I think in the discussions a long time 25 ago that the licensee'-- at least the referring physician l NEAL R. GROSS i
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494 1 io com:on0 who'o et crm'a lcngth who mny b3 looking into 2 the best interest of the patient.
l l 3 Just like the licensee is. But unlike the
\
4 licensee, the referring physician doesn't have any medical 5 legal problem or lack of objectivity in terms of what the 6 referring physician might disclose to the patient. In 7 other words, the referring physician is looking after the 8 patient's interests in an independent manner at an arm's 9 length from whatever incident had occurred with the 10 radiation.
11 However, I'm still -- I've never -- I've 12 always been wavering between number five and number two 13 because I think number five at least -- I mean number five 14 is better.
15 Number five -- what I hear Jeffrey saying is 16 that unless, based on medical judgement, there would be 17 harmful effects, there would be no need to notify the 18 patient because you've notified the referring physician, 19 and the referring physician is sort of like one extra 20 person who's independent from the radiation oncologist in 21 our field to look out for the patient's interest, who's 22 seeing the patient in follow up.
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l 495 -
l 1 the problom. I
! 2 CHAIRMAN STITT: Naomi. !
3 DR. ALAZRM;I So, Dan, I gather from what !
4 you're saying that you think there should be a federal !
l 5 regulation requiring notification of the patient?
i 6 MEMBER FLYNN: No, I'm still struggling 7 between number five and number two. My problem is that if i 8 you go to number two -- if you go to number two, jumping 9 from the current rule, QM rule, to number two -- I don't 10 want to exaggerate, but some licensees will say okay, now l 11 I'm not going to notify the patient, you know, because the 12 NRC is r.ow saying that it's okay, it's ethical not to 13 notify the -- and now, some people interpret it that way V 14 that I don't have to notify the patient because the 15 Government's telling me I don't notify the patient now.
16 They use that as an excuse.
17 CHAIRMAN STITT: All right, there will be some 18 people who disagree with that.
19 Naomi and then -- ,
20 DR. ALAZRAKI: Number two should then just j 21 read licensee to notify NRC period with nothing about l
22 patient or anyone else, 23 MEMBER FLYNN: And then a footnote could say 24 the NRC has determined that notification of the patient is 25 an important aspect of the patient --
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_ _ , . _ . . _ , . . _ _ , _ . . . _ . . _ _ -. . _ _ . _ . , . . , _ _ _ _ , _ . . _ . _ . . _ _ . , _ _ . ~ _
496 1 CHAIR!GN STITT NRC hno to d3tormin3 th0t.
2 MEMBER FLYNN: -- will not interfere with that 3 relationship since that is expected to be happening anyway 4 as part of medical.
5 CHAIRMAN STITT: Number two could say licensee 6 to notify NRC and then have a second statement that said 7 notification of patient -- or discussion of patient's 8 medical condition is always in accordance with the ethics 9 of general medical practice. And she made a statement 10 that came from the AMA that supports that.
11 MEMBER FLYNN: Right. But it would be nice if 12 that was referred in kind of italicized footnote.
23 CHAIRMAN STITT: It wouldn't be a footnote.
14 It could be part of number two.
I 15 MEMBER FLYNN: Well, right in there, right.
16 CHAIRMAN STITT: Well, that's another 17 discussion regarding two.
18 Yes?
19 MS. HANEY: Let me just make a note. If we 20 took this to rule space, we couldn't -- we probably would 21 not be able to put in the --
22 CHAIRMAN STITT: The clause?
23 MS. HANEY: -- the clause in there. However, 24 if we were to change from status quo to option two, we 25 would certainly need in a statements of cont'deration to NEAL R. G ROSS court REPORTERS AN3 TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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497 1 put c rctionslizction down for that cheng3. And that'a 2 where all the items that both you and Dr. Alazraki said --
3 all'thope items would come into play.
4 CHAIRMAN STITT: Go ahead, our patier F rep.
5 MR. ANDERSON: If you don't tell the physician 6 that this error, misadministration happened, how's he 7 going to know to make the judgement of whether or not the 8 patient should be told? Is he going to know 9 automatically?
10 I'm looking at three and thinking three meets 11 what you're saying as far as protecting the right of the l 12 physician to talk to the patient and not have the 13 Government tell the physician what to do.
14 MEMBER FLYNN: I think what you're 15 misinterpreting though is the licensee is in fact the 16 physician who administered the radiation.
17 MR. ANDERSON: Okay. .
18 MEMBER FLYNN: So he knows because he's the 19 one that reported it to the NRC. The radiation doctor 20 does know. He is part-of the licensee.
21 MS. HANEY: But in the case of a nuclear 22 medicine operation where you're not as involved with the 23 patient, you're more in a referral-basis -- like take Dr.
24 Alstraki and some of the patients that she would be O 25 seeing. 9he might not have the relationship with the U - NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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498 1 patient that tha roforring phyoicien would hevo.
2 And in that case, the question would be 3 wouldn't it be better that you at least told the referring 4 physician and then let that individual decide whether the 5 patient should be told. Is that --
6 CHAIRMAN STITT: I think that's probably the 7 intent of the comment. That's right.
! 8 DR. ALAZRAKI: Although -- yes, and I have no l
9 problem with that. Although, in the area of the 10 diagnostic doses, very faw, if any, would ever meet the 11 reportable event threnhold.
12 MS. HANEY: That's right.
13 CHAIRMAN STITT: So therefcare, wouldn't come 14 under any of this?
15 DR. ALAZRAKI: So it wouldn't really be an 16 issue. But there's no problem with -- if you want to 17 include notifying the referring physician, 1 suppose, that 18 could be by law. I don't know.
19 CHAIRMAN STITT: Lou.
20 MEMBER WAGNER: I want to clarify again that 21 the discussion has nothing to do with whether or not the 22 referring physician or the patient should be notified.
23 DR. ALAZRAKI: Okay.
24 MEMBER WAGNER: That is a given. It is a 25 given that we ought to behave in ethical ways. So none of NEAL R. GROSS CoVRT REPORTERS AND TFRNSCRIBERS 1323 RHODE ISI.AND AVE., N W.
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499 1 thio diccuccion 10 trying to ocy that wa chould not notify ,
l 2 the appropriate people. That's it. l i
- 3 Now, the important thing that we have to i
4 address is where do we draw the line between the NRC i 3
5 making a federal law about medical practice versus the NRC i a
- 6 sticking with the protection of the public from radiation.
7 Notifying somebody doesn't protect them from the i
8 radiation. . Okay, we're into a medical _ ethics issue here, 9 not one that deals with actual trying to control, maintain 10 radiation exposure. '
11 Now the physician certainly should notify --
12 the licensee should certainly notify the referring 13 physician and perhaps the patient or guardian if there's 14 going to be some kind of a detrimental effect. And that i
15 should be discussed with the physician for appropriate 16 reaction and appropriate recourse.
17 There's no doubt about this. The whols 18 discussion now is one of where does the NRC belong in 19 this.
-20 CHAIRMAN STITT: You keep pulling us back to 21 the point, Lout thank you.
22 Ruth. ,
23 MS. McBURNEY: There are times, however, that 24 where there is'a severe overdose or the wrong patient in O 25 which that gets outside the realm __of what you're trying to O NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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500 1 do in medical practico. And tho -- cnd that parcon nO:d3 2 to be protected as much as any other member of the public.
3 And I would think that they would need to know 4 if there were detrimental effects or were going to be 5 detrimental effects.
6 MEMBER WAGNER: But that's not the point.
? CHAIRMAN STITT: That's the practice of 8 medicine.
9 MEMBER WAGNER: That's the practice of 10 medicine.
11 CHAIRMAN STITT: That person would --
12 MS. McBURNEY: Not if it's the wrong patient.
13 C'(AIRMAN STITT: Well, sure it is. You mean 14 you would not -- you would keep that from a patient if 15 it's not regulated, I mean, that you have to tell the 16 patient? That would be surprising.
17 Dennis, is it that bad?
18 MEMBER SWANSON: We've discussed this --
19 CHAIRMAN STITT: For years. I mean --
20 MEMBER SWANSON: -- n.any times before, --
21 CHAIRMAN STITT: That's right.
22 MEMBER SWANSON: -- and we're back to the same 23 issue.
24 MEMBER FLYNN: Can I say one thing?
25 Number two though could be modified. There's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHcDE ISLAND AVE., N W.
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501 1 ono thing wa nsvor really diocucced in a lot of dato11.
[N 2 The licensee to notify the NRC, but not the referring G 3 physician nor the patient unless, based on medical 4 judgement, there would be detrimental effects by not 5 intervening in the -- I'll give you an example -- two 6 examples:
7 overdose of iodine-131 -- licensee doesn't 8 know that he should start IV's, give Lasix, and give a 9 thyroid block. Incident number two happened in 10 Connecticut. prostate seed implants were ten times 11 stronger than they should be.
12 If that patient wcnt to surgery immediately 13 and those seeds were removed with a radical prostatectomy, 14 there would have been much less of a dose to the rectum 15 and surrounding organs and that would have resulted 16 because of.the immediate notification of less harm coming 17 to the patient.
18 So the example I'm giving you is that if you 19 take action at a time when you can still intervene to 20 lessen the harmful effects of what has happened'as opposed 21 to throw up your hands and do nothing -- so the 22 requirement to-intervene when intervening can result in 23 less detrimental effects.
24 CRAIRMAN STITT: But it still sounds like 25 practice of medicine. If somebody is having chest pain,
\
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502 ;
1 you intervena. I don't think it noodo o fcdcrol 2 regulation to discuss that. l I
3 The thing that -- Lou, I'll let you have the 4 stand in a second.
i 5 The thing that bothers me just looking at two 6 or three -- and it's just the way it's written, but it 7 comes across to me, just looiting at it, if I'd opened this 8 book to this page, that it sounds like you're not aupposed 9 to notify the physician.
10 MEMBER WAGNER: Yes, that's the problem.
11 CRAIRMAN STITT: And that's not what --
12 MS. HANEY: Again, I think that's just the way 13 -- you know, the options, the alternative papers 'iere 14 written. By no means was that the --
15 CHAIRMAN STITT: Right. But nonetheless, 16 anybody looking at that would make it sound like we have 27 banded together here as a group to hide something from 18 every referring physician and patient in the country. So 19 I do have a problem with the way that's written.
20 DR. ALAZRAKI: You know, according to what 21 we've said, there should be nothing about patient 22 notification in the regs.
23 MR. ANDERSON: There should be a period behind 24 "NRC."
25 MEMBER WAGNER: Right, right. And then that's NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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503 J
1 it. That's right.
- 2 DR. ALAZRAKI
- We've already said that, what i
- 3 reportable events are and when NRC has to be notified. We i 4 don't need this section.
f i 5 MEMBER WAGNER: That's right.
j 6 CHAIRMAN STITT: Right, i
j 7 MR. ANDERSON: That was the only point I -- I
$ 8 kept looking at-it and it's saying but not -- it implies 9 that --
i
) 10 MEMBER WAGNER: That's bothered everybody.
) 11 CHAIRMAN STITT: Keep it quiet. It implies it i
12 we.J --
13 MEMBER WAGNER: Believe me, that bothers 14 everybody, 15 CHAIRMAN STITT: Right.
16 Lou, go ahead.
17 MEMBER WAGNER: The only thing that I guess I 18 could live with as a compromise would be something like 19 licensee to notify the NRC and, in accordance with the 20 contempoF ry ethical practices of medicine, the physician 21 and the patient. Now, I could live with something --
22 CHAIRMAN STITT: What did you say?
23 DR. ALAZRAKI: But then you've put it into a 24 regulation, Lou.
25 MEMBER WAGNER: But-I haven't forced them to O NEAL R. GROS $
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504 1 1 do cnything. I'vo ocid conaictent with tho othical 2 practices -- current ethical practices of medicine. To 3 me, there's nothing wrong with that. That doesn't 4 intrude. That doesn't force anybody to do anything other 5 than what's right.
6 And what we've been saying is the right thing 7 to do. That's the only compromise I could live with other 8 than saying the preferred thing is just simply to say 9 licensee to notify NRC period because then it just keeps 10 it within the NRC's purview, and that's right.
11 CHAIRMAN STITT: That's a nico statement. Are 12 you telling us we can't do that? It's a much more 13 positive sounding statement than --
14 MS. ROTHSCHILD: You mean about tying it to 15 the ethical standards? The only thing is, is that it may 16 have the legal effect of going from a should to shall.
17 That's -- you know, that's -- you must do it in accordance.
18 with these ethical standards.
19 MEMBER FLYNN: In some states, it's not just 20 ethical standards. In some states, it's a requirement by 21 the Board of Registration and Medicine based on the 22 license, the physician's state license, that he must do 23 so.
24 MS. ROTHSCHILD: And you'd have -- I think the 25 NRC would have to specify whose -- you know, whose ethical NEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS IM2 RHODE ISuMD AW.. N W, (202) 234 4433 WASHINGTON, D C. 2000# 3701 (202) 2344433
505 1 ctendardo or whatovor, 2
MEMBER FLYNN: I'm just saying it's not just
(
V) 3 ethical standards; it's a requirement by law, state law, 4
in some states that there are -- and it varies from state 5 to state, I assume, the wording. But that the physician 6 notifies the patient of any adverse effect. And they 7 notify the Board of Registration in Massachusetts.
8 And if they don't, they're in trouble with 9 their license if they get discovered.
10 CHAIRhW1 STITT Well, we could go back to a 11 simple statement. Licensee notifies NRC of reportable 12 events, period. And then what sort of -- you said there 13 was some other mechanism for making a statement that --
I \
() 14 MS. HANEY: All of the -- what Lou had just 15 naid would probably do better in the statements of 16 consideration. I don't think you would want to put into 17 rule space, you know, and shall follow voluntary standards 18 of medical practice only because they vary from state to 19 state who's regulating them.
20 And it would be very hard for us to go in and 21 -- you know, we're not going to cite you against the fact i
22 that you didn't follow the voluntary standards. Someone 23 else is going to take care of that, not NRC, more than 24 likely.
,<~y 25
!.v) So we would put --
this is just rationale for NEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE , N W (202) 234 4433 WASHINGTON, P C 20005-3701 (202) 234 4433
506 1
why tha rulo chango if thic option ware tho way to go, 2 CHAIRMAN STITT: So we cou d --
3 MS. HANEY: For the sake of the presentation 4 here on a document such as this, I think it --
I agree, it 5 does look bad by not having the voluntary -- that 6 certainly wasn't our intent by having it here. So it 7
might be, you know, good that we would change the wording 8
here or just to highlight that for people that are using 9 this document in the future that we've already noted that.
10 MEMBER WILLIAMSON: Yes, I would recommend you 11 might want to put what Lou just said as the -- or 12 something equivalent to what Lou just said for the 13 modified number five so people understand that the intent 14 of this is to not have a federal regulation forcing 15 physicians to do something, and that the reason is because 16 it is considered that, you know, adherence to existing 17 ethical standards is pretty good, 18 MS. HANEYt And that information is contained 19 in the pro's and con's. Like if you go to the pro for 20 two, it will say that we're relying on the physician's 21 ethics. But it is buried in the text of this document and 22 not on the first page.
23 MEMBER WILLIAMSON: I think if you're showing 24 this as a slide at a public meeting, you've caused, even 25 here in a relatively expert audience, some misgivings and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE,, N W.
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507 1 micundorctendingo. And I think in e summery slido liko
,s 2 this, you should be real careful how you put it.
[ I
(.__sl 3 MS. HANEY: Right, yes; we will.
4 MEMBER WILLIAMSON: I understand this has no 5 legal force.
6 MS. HANEY: We will make appropriate changes.
l 7 MEMBER WILLIAMSON: Okay, 8 CHAIRFVdi STI"T: Thank you.
9 We're working over a couple of things here. {
10 Is there anybody bold enough to want to try a motion?
11 Loy, you're having a good afternoon, sir.
12 You've got your sunglasses -- I feel badly because every (3
13 time we meet, we cause this man terrible headaches,
() ,
14 MEMBER WAGNER: I feel better.
15 CHAIRMAN STITT: --
and I think it's our 16 fault.
17 Go ahead; you've got the show.
18 MEMBER WAGNER: 1 would move that the 19 cc nmittee support the motion that the patient notification 20 rule should be limited to the statement that the licensee 21 to notify the NRC, period; and by virtue of that, with tie 22 modifications to the current recordable event -- I'm 23 sorry, reportable event as proposed by this committee, 24 this whole section could be eliminated.
/%
(x.y ) 25 Barring that, the option would be to list the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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508 1
pctient notificction cc tho licencoo to notify tho NRC, 2 comma, and in accordance with the contemporary standards 3
of medical practice -- I'm sorry, in accordance with the 4
contemporary standards of ethical medical practice, to 5 notify also the physician and the patient as needed.
, 6 CHAIRMAN STITT: Well, I think that's 7 discussion rather than a motion, isn't it? I think you 1
l 8 actually hit two different things.
9 MEMBER WAGNER: I have identified both things.
10 I gave them an option on this one.
11 CHAIRMAN STITT: We11, --
12 MEMBER WAGNER: I gave them an option.
13 CHAIRMAN STITT: Why don't we kind of -- can 14 we -- let's ignore motions richt now. Let's reword two 15 and five.
16 MR. ANDERSON: Can I try to --
17 CHAIRMAN STITT: Yes, sir.
18 MR. ANDERSON: -- piggy back on -- I hear you.
19 Licensee to notify NRC --
20 MEMBER WAGNER: Period.
21 MR. ANDERSON: -- period. Any further 22 notification of patient to be done in accordance with 23 existing medical practices and ethics.
24 CHAIRMAN STITT: "o that's sentence two of the 25 motion?
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_ - - _ _ _ _ _ . - l
509 1
MR. ANDERSON: Right. It'o cort of locyoc NRC 2
/
, s,
\ in it's bailiwick and then recognizes that there's another s_- 3 bailiwick beyond the purview of NRC.
4 MEMBER WAGNER: Yes, and I have no problem 5
with recognizing that there's another bailiwick of medical 6
practice beyond the purview of the NRC with, at the same 7
time, supporting the idea that the physician must behave 8 in accordance with --
9 MR. ANDERSON: In accordance with normal, 10 ethical procedure.
11 MEMBER WAGNER: Sure, I've got no problem with 12 that. I don't know if the NRC can put that into a --
13
,_ CHAIRMAN STITT: Well, I think we're hearing
\
( ,/ 14 them say that they have a problem with it.
15 MEMBER WAGNER: Well, it's --
16 MS, HANEY: No, I don't think I would put that 17 in regulation space.
18 MEMBER WAGNER: Okay.
19 MS. HANEY: But I would put it in the 20 statements of consideration. So I don't distagree with it.
21 CHAIRMAN STITT: So we could act on that as a 22 motion. --
23 MS. HANEY: Yes.
l l 24 CRAIRMAN STITT: -- but we're not trying to
( /
) 25 make this a rule at this time?
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510 1 MS. WWEY : Yoc.
L 2 CHAIRMAN STITT: Okay. You said it very well.
3 Since you have --
why don't you repeat that 4 MR. ANDERSON: I'11 try.
5 CHAIRMAN STITT: Now, let's see --
1 l 6 MR. ANDERSON: Further notification of 7 patients of --
8 MEMBER WAGNER: Or physicians.
9 MR. ANDERSON: -- or physicians will be in l 10 accordance with existing medical standards and ethics 11 beyond the purview of NRC.
12 MEMBER FLYNN: Could I ask if you would modify 13 it by also adding "and also in accordance with existing 14 state law?"
15 MEMBER WAGNER: Yes, that would be fine.
16 MS. ROTHSCHILD: There's one, I think, legal 17 problem with that.
18 MEMBER WAGNER: We just said that that's what 19 we're supporting. That's the point of view that we're 20 supporting. And how it gets put into the regulatory 21 language is up to the NRC.
22 MS. ROTHSCHILD: Okay, and I guess what I'm 23 saying is it --
I would agree with Cathy; it probably 24 would not go into the actual rule language. And there may 25 be -- I think one thing to bear in mind, there could be NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N W, (202) 234-4433 WASHINGTON, D C. 200C$3701 (202) 234-4433
511 1
cituctiono in which NRC could fool an ethical obligntion es 2 to notify thece individuals.
[
V) 3 And in fact -- in other words, a situation in 4
which particularly, I think, if you have mu]tiple events.
5 And if there were no requirement that the patients be 6
notified or referring physiciens, NRC conceivably -- there 7 could be a situatien in which NRC felt compelled to ensure 8
that those individuals are notified.
9 Now, whether --
10 MEMBER WAGNER: But that would occur -- that 11 would occur just from the basis of the recordable event 12 and it would have nothing to do with this.
13 MS. ROTHSCHILD: Well, I'm saying as a I \
'Q 14 practical matter where you could end up.
15 MEMBER WAGNER: But I don't see how that has 16 bearing on this because that could be affected just from 17 the fact that it's a recordable event in the first place.
18 MS. ROTHSCHILD: True. I guess my point is 19 that it -- the notification --
20 MEMBER WAGNER: Reportable. Dang, I can't --
21 MS. ROTHSCHILD: Looking at the notification 22 strictly as a question of medical practice, there is --
23 there are theoretically situations, and maybe not even 1
24 theoretical, where you are getting into "NRC space" j 25 depending on the facts of the situation in which NRC might NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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512 1 fool compalled to eck thnt tha pctiento ba notified or 2 take some other action. !
l 3 MEMBER WAGNER: Then -- j 4 CHAIRMAN STITT: Why would the NRC feel i
5 compelled to do that?
{
l 6 MS, ROTHSCHILD: I guess there could be any 7 number of reasons. I think it's more likely if there are 8 multiple -- you know, multiple events depending on the 9 severity and NRC were aware that the appropriate 10 individuals were not notified.
11 I mean, I'm just saying that there are -- when 12 you think of trying to have the line between what's in NRC 13 space and what's in medical practice space, that it may 14 not always be so --
15 CHAIRMAN STITT: Well, NRC, you're saying, can 16 decide if they're going to be talking to patients or not.
17 "But if the patient were involved in something, they would 18 have been notified in accordance with the ethical medical 19 practice and state law.
20 MEMBER SWANSON: First of all, the NRC 21 couldn't contact directly the patient anyway because the 22 NRC doesn't know that patient's name. Because if you look 23 at the reporting requirements, it's supposed to be 24 exclusive of their name.
25 MS. ROTHSCHILD: No , but that's not correct if NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N W.
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l'~. 513
) 114 you're talking'about the status _ quo.- I believe there is >
J2 some information the licensee is required to maintain that
.- {
i 3
includes the names of-all the individuals involved. '
4- MEMBER SWANSON: But you would still have to j : 5 go-back to the licensee. ,
i 6 -MS. ROTHSCHILD: Possibly. I'm just saying 1
l 7 that --
e i
8 MEMBER FLYNN: No , there's another method.
And that is if -- supposing the licensee did something 9
- j. '10 very bad and didn't want to correct it,'the NRC gets l
11- consultants -- more than one consultant, two different 11 '
12 consultants independently look at an action and-say this 1 13- is very bad. The patient should know-additional harm b
4 d 14' could come.
15L The NRC could, I assume, on its own -- doesn't 16 require our permission -- contact.the Board of
-17 Regiatration and Medicine in that state like, for example, 18 Puerto Rico, and'ask for some -- just_as an advisory that 19' this -- we consider -- we have great concern over X, Y, Z.
20L It's--in your. purview.
21-- Then the: state may take it-up and than act on
'22 it.
g MR. ANDERSON: Well,-for all standard of 24 practices is that this is reportec to the patients anyway,
(
( 25 then.there's no problem- is there?
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514 1 MEMBER FLYNN: Whet if it waen't reported to 2 the patient?
3 MR. ANDERSON: Well, you can't -- you know, 4
you can't stand on one leg and say this is the standard of 5 practice and everybody's doing it, and then stand on 6 another leg and say it's not.
7 MEMBER FLYNN: Well, the really odd, unusual 8 case, it could be happening once every ten years. I mean, 9 I think it's more of a hypothetical. The NRC could step 10 in, I assume, Lad notify the state if they wish to. They 11 don't require our permission to do that, 12 CHAIRMAN STITT: The NRC may view that they 13 have their own sets of standards or ethics to follow. I 14 think we need to stick to what we know, which is medical 15 practice, and -- period.
16 Lou and Ruth.
17 MEMBER WAGNER: Well, then I would modify my 18 motion to say that the committee recommends that the 19 patient notification rule be dropped because, under 20 current standards -- or under current reportable events, 21 the events have to be reported to the NRC and -- NRC, 22 period.
1 23 The committee does support the notification of 24 physicians and patients, as appropriate, in accordance 25 with medical practice, but there does not need to be a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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. _ _ . _ _ _ _ _ . _ _ _ _ _ _ . _ . . _ . . _ . - _ ~ _ - _ _ . . .
'515 4
1 federal law stating thus.
i i
2- -CHAIRMAN STITT: Well,- so far we're talking ,
b 3 aboutla lot of stuff and we don't have anything that's 4
been seconded,- and we've got several things that are 4
L l 5 actually quite different.
6 DR. ALAZRAKI: Well, that's a very good 7 motion. Somebody should second it.
8 MEMBER FLYNN: Would you-modify it to add the 9 phrase "and state law?"
10 MEMBER WAGNER: Su.',- yes, 11 MEMBER FLYNN: Okay.
12 MEMBER WAGNER: Yes.
13 CHAIRMAN STITT: Can you repeat it?
, 14 MEMBER WAGNER: No.
15 (Laughter.)
16 CHAIRMAN STITT: .It started of a~little windy.
17 MEMBER WAGNER: Okay,'I' understand, --
18 CHAIRMAN'STITT: That's why I can't start it 19 again.
20' MEMBER-WAGNER: -- because I'm trying to think 21- about what I'm saying here.
22- CHAIRMAN STITT:' I thought you were Jeff'for a 23 moment.
+
-24 . MEMBER WAGNER: Okay, there -- the ACMUI does .
25 not-support any regulation specific to patient NEAL R. GROS $
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516 1 notification, pariod. The NRC doOc cupport notificction 2 of the physician or patient in accordance with ethical 3
medical practice, as well as in accordance with state 4
regulation or law, but does not support the introduction 5 of a federal regulation on this, period.
6 MS, ROTHSCHILD: Question. Do you mean to say 7 ACMUI supports notification, or are you --
8 MEMBER WAGNER: I'm sorry, that's what I --
9 MS, ROTHSCHILD: You said NRC.
10 MEMBER WAGNER: I'm sorry, the ACMUI supports 11 it. I'm sorry.
12 CHAIRMAN STITT: Very Freudian, very Freudian.
13 MEMBER WAGNER: Yes, the ACMUI supports it.
14 MEMBER FLYNN: And did you mean physician or 15 patient, or physician and patient?
16 MEMBER WAGNER: I'm sorry, --
17 MEMBER FLYNN: I was listening carefully to 18 what you said. You said physician or patient.
19 MEMBER WAGNER: I'm sorry, it should have been 20 physician or patient.
21 MEMBER FLYNN: Not physician and patient?
22 MEMBER WAGNER: Not physician and patient.
23 That's up to the -- it could be physician and/or patient.
24 MEMBER FLYNN: Okay, and/or patient.
25 MEMBER WAGNER: Physician and/or patient.
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r 517 l 1 CHAIRMAN STITT: We need our little power book 1 2 up:-there. That worked -- once we_got a swing of that g 3 yesterday, it was helpful.
- 4 Are people clear on the motion?
-c '
5- Okay, this side is. This side okay?
6 Is there a second?
4 MEMBER WAGNER:
4 7 CHAIRMAN STITT: I'll open it for discussion -
i d
8 - keep it open. Did somebody second that?-
9 MEMBER FLYNN: I second it.
i
[
q 10 CHAI."J4AN STITT: All~right, comnient ? <
[ 11 Ruth, you've had your hand up, 12 MS. McBURNEY: I.was just going to say there
- 13 have been situations that we have-found that -- where not O < 14 only was the licensee -- a medical licensee having a lot 3,
} -- 15- of violations against our regulations, but we found that 16 they were being untruthful and unethical in other ways.
t 17 And on those situations, we have referred them F
18 to the state medical board. And that would be a mechanism 4
.19 that NRC could use, right.
1 j 20 CHAIRMAN STITT: That's a mechanism that any 21 practice uses and should. _And that -- I think that's a 1 22 point that we*re trying to make here.
1-( 23 So you've found a way to do it.
24 Jeff, you're sitting in the dark. Do you have s.
f
\
- 25. your hand up?
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518 1 DR. ALAZRAK2: No.
2 CHAIRMAN STITT: Okay, you're just resting, 3 all right. I don't want tc ignore you. You're sinking in 4 your chair too.
5 Naomi.
6 DR. ALAZRAKI: You want a comment?
7 CHAIRMAN STITT: I'm just giving everybody a 8 final go here.
9 DR. ALAZRAKI: I like it. I like the last 10 motion. If I could vote, I'd vote for it.
11 CHAIRMAN STITT: Oh, that's right.
12 MEMBER FLYNN: Can we call for a vote?
13 CHAIRMAN STITT: Jim, any comments? Is it 14 looking -- you're working away there with your paper and 15 pencil. Is it looking like what we've been discussing?
10 MR. ANDERSON: I was trying to write down what 17 yo. said or as best I can.
18 MEMBER WAGNER: I think it's a John Lenncn 19 song.
20 MR. ANDERSON: May I read this back and see if 21 it's -- what we're saying is the ACMUI does not support 22 any regulation requiring notification of physician and 23 patients as redundant to existing state laws and medical 24 ethics in existence or words -- that's what we're trying 25 to get at?
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A
519 1 MEMBER WAGNER: That's essentially what wa'ra
'~~ x, 2 getting at. You've summarized it in a --
(
'~'
)
3 MR. ANDERSON: See, the thing that was missing 4 when I heard you before is what we're saying is it's silly 5 for us, as a federal agency, to add rules to what is 6 already there.
7 MEMBER WAGNER: Absolutely.
8 MR. ANDERSON: And that's not our intent.
9 MEMBER WAGNER: Absolutely.
10 MR. ANDERSON: And that's what we're trying to 11 say.
12 MEMBER WAGNER: Absolutely.
,. s 13 CHAIRMAN STITT: All those in favor? Those i \
l K2 14 opposed?
15 All right, you guys; I'm proud of you. Let's 16 go home.
17 Let's stand up and take a break. You deserve 18 a break today. And we'll figure out where we're headed, 19 okay?
20 (Whereupon, the foregoing matter went off the 21 record at 2:06 p.m. and went back on the 22 record at 2:26 p.m.)
23 CHAIRMAN STITT. We are -- a little success 24 goes to our head and we just get all fizzy and can't l p l 25 think. l l
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520 1 Cathy and I chatted a little bit about where 2 we go from here, and we want to talk about that. And then 3 we're going to try to hit RSO, We're going to start 4 losing members in another hour. We can continue some 5 discussions, but won't have a quorum for voting.
6 Why don't you talk about where we go from 7 here, and then we'll go to RSO and physicist.
8 MS. HANEY: What I would say is going to 9 happen is hopefully, by the end of the second week in 10 December, we'll have a rough outline of a rule minus some 11 of these key areas probably. But some of the other things 12 like dose calibrator and survey meter requirements and 13 that sort of thing will be roughed out.
14 By January, we'll start developing the 15 guidance. I want to make sure that we have input from the i
16 ACMUI on the proposed rule before it goes,to the 17 Commission. Which puts a need for the ACMUI to be looking 18 at these documents in around the February time frame.
19 What I was at least offering up was maybe it 20 might be good to split the rule into diagnostic and 21 therapeutic areas and form maybe a subcommittee to work 22 with members of the working group to review rule text and 23 guidance documents.
24 And maybe the subcommittee would come into 25 Washington one week, work with appropriate members from NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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521 1 the working group, then the working group would go back i
r-2 and' clean up the package,-get it'e-mailed out or get it
- -3 sent out to the members of the ACMUI, and then have a 1
4 formal meeting of the entire ACMUI in probably the March t
- - 5 time frame.
t 4
6 It would have to be probably the second or 7 third week in March.for us to meet our deadline. That 8 way, it.would allow everyone to have~the opportunity to 9 comment on the-rule. We'd be able to get back to you with 10 why we chose an alternative.
11 You know, maybe if we went with yours or if we 12 went with another one, the rationale for doing that, and 13 then give-you the opportunity to comment on other areas of 14 the.~ rule also.
15 CHAIRMAN STITT: So we'd have a pharmaceutical.
16 group and a non-pharmaceutical group?
17 MS. HANEY: Okay, if you want. Or I~was 18 thinking therapy, non-therapy, but you're probably right.
19 MEMBER FLYNN: I think it's better -- nuclear 20 medicine and radiation oncology would be better.
-21 CHAIRMAN STITT: Right, I think that's the --
22' MS. HANEY: Okay.
23 CHAIRMAN STITT: Because I don't understand 24 what those guys do.
fy g 25 She and I discussed that there's some other NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS
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l 522 1 options we locked et. I thought thct it had some virtua.
2 Does that sound doable?
3 MS. HANEY: What it really means is that 4 you'll be coming here for a meeting, unless you want to 5
invite tne working group out to your facilities, probably 6 a week in February and a week in March.
7 CHAIRMAN STITT: A whole week or parts?
8 MS. HANEY: Oh, I'm sorry; I'm so used to 9 thinking of weeks. I would say at least three days for 10 the subcommittee -- at the subcommittee level.
t And then 11 two days at the ccmmittee level.
12 CHAIRMAN STITT: And it's detailed stuff.
13 It's all those little sub a's with the little i's after 14 it. It is. That's why I thought it was best not to bore 15 those of us who do the important part of medicine with 16 stuff that you guys do.
17 MEMBER WAGNER: Wait a minute. I can't let 18 that go by.
19 CHAIRMAN STITT: All right, let's go to RSO.
20 MEMBER SWANSON: Cathy, a quick comment.
21 Have you talked to the dose calibrator 22 industry people about --
23 MS. HANEY: No, not yet; but we know we need 24 to.
25 MEMBER SWANSON: Yes, you need to do that. I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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523 1 hcd a brief convaraction with thtm and there are -- thay
'~ x 2 do have some considerations with regard to what needs to -
! )
J 3 -
4 MS. HANEY: Yes.
5 CHAIRMAN STITT: Okay. For those of you that 6 are lost, we are in the back part of training and 7 experience, I believe. Page 13.
8 MS. LANZISERA: I'll let you read them 9 yourselves. But essentially, the big differences are --
10 and this runs very similar to what we did with the 11 authorized user. But the main difference between one and 12 all of the other ones is that we've taken out authorized
,~ 13 user from those alternatives.
i i x_ / 14 The difference between the second and the 15 third one is that we've added an e xam. And the fourth 16 one, we obviously had exam only. And the fifth one 17 actually was -- we added after the meeting of the working 18 group -- we felt it was important to try to gather this 19 one year of full time experience under an RSO.
20 Also, in two and three, we tried to specify 21 that instead of listing, you know, radiation safety 22 officer tra:aing and experience, and if you have this 23 training and experience, you can be an RSO for any 24 activity, we've tried to separate it out and say for your
~
( ,) 25 institution, if you're only doing 100 and 200, maybe that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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524 1 trcining cnd experience for that RSO is different from if 2 you're an institution doing gamma knife.
3 MEMBER FLYNN: There's a mistake up on the 4 slide. Number three, the end of the parentheses should go 5 after exam. Because the board :ertified person doesn't 6 have to take an exam also.
7 MS. LANZISERA: Correct.
8 MEMBER WAGNER: You're going to be good on the 9 session with a's and i's.
10 MEMBER FLYNN: I know.
11 MS. LANZISERA: Well, again, we've done the 12 same thing with the board certification. If you take the 13 exam for the board certification, you have met this exam, 14 so I'd agree with that.
15 MS. HANEY: So that's -- just paren is wrong.
16 MS, LANZISERA: Okay?
17 CHAIRMAN STITT: Well, this is an interesting 18 circumstance here because there's nobody at this table 19 that's exclusively an RSO. So we can say -- well, 20 exclusively. So we can tell anybody what we think they 21 ought to do and not be offending our own practice.
22 MEMBER FLYNN: I'm an RSO now.
23 CHAIRMAN STITT: Right, but you're not 24 exclusively. I mean, you all are representing --
25 MEMBER WILLIAMSON: I'm 2.n associate RSO.
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525 l l
l 1 CHAIRMAN STITT: All right, jump in there. l i
fx 2 How do we want RSO's to look?
- )
3 MEMBER WILLIAMSON: Well, let's review who 4 can be an RSO just to -- because I laven't looked at this 5 for a long time. Who can be an RSO now under status quo?
6 MS. LANZISERA: Right now, the first one is 7 the status quo.
8 MEMBER WILLIAMSON: Yes, the status quo 9 includes a board certified health physicist, right?
10 MS. HANEY: Yes, if you look on page 14, 11 there's a list of the boards that we recognized. American 12 Board of Health Physics and Comprehensive Health Physics, p- 13 ABR, American Board of Nuclear Medicine, American Board of
( ')
A s- / 14 Society of Nuclear Medicine, and the list goes down.
15 There are nine of them that are arranged. Or 16 there's an option here, if you're not board certified, 17 that you have had classroom training -- 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of the 18 classroom training and one year of supervised work.
19 MEMBER WILLIAMSON: Lo if we summarize Part A 20 with the nine boaro;, it basically comes down to you have 21 to be a professional health physicist that's board 22 certified, or you have to be a physician with a 23 radiological sciences specialty certification of some kind 24 of another, or you can be a radiation oncology physicist.
(m ,JI 25 Have I left anyone out?
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526 1 MS. HANEY: Or we do have the C option, which 2 is an -- or be an authorized user.
3 MEMBER WILLIAMSON: Yes, just the A option.
4 The A option includes --
5 MS. HANEY: Oh, I'm sorry. Okay.
6 MEMBER WILLIAMSOM: -- physicians with board 7 certification in a radiologic specialty, professional 8 health physicist, and radiation oncology physicist. Is 9 that --
did I leave anyone out of the list?
10 MEMBER WAGNER: Yes, you did. What does this 11 apply to here? What -- when we're saying RSO, this is RSO 12 for any license? Well, then you left out board certified 13 diagnostic physicist.
14 CHAIRMAN STITT: Of which you are one.
15 MEMBER WAGNER: Which I am one.
16 CHAIRMAN STITT: I think you just offended 17 your colleague.
18 MEMBER WILLIAMSON: Well, I think --
19 CHAIRMAN STITT: Jeff, where do you want to go 20 with this?
21 MEMBER WILLIAMSON: I'd like to -- I . '
,sking 22 a question, a point of information. That's all. I'm 23 sorry.
24 MEMBER WAGNER: No , no, no.
25 MEMBER WILLIAMSON: It would really help me if NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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.- .._...._ _ . _ _ _ . _ __ _ _ .. _ _ _ _ _ . _ .q l
527 l
- j
.1- I -- -
I2 MEMBER WAGNER: You did not incul't me. ;
3 . MEMBER WILLIAMSON: ABR is on there, so that l
i ..
=4- includes'--
5 ' MEMBER WAGNER: Okay, he said -- you said l 6 radiation' oncology physicist.
7 MEMBER WILLIAMSON: I'm just trying to r
8 understand-it. LSo if someone could explain what kind of 4 9- people this complicated clause allows, my question would '
i --
F 10- be answered.
- 11 MS. LANZISERA
- Well, I think too if you look 12 ac two and three, we've done-it - --we're trying-to do the s 13 same thing that we did with authorized user and say-that
-14 we're not going to list the board certifications,-the 15 specific ones, in the regulation.
p 16 So in that way, the NRC could approve-them as !
17 they come along. Yes,.this list that we.have in the
' 18, regulation currently may-not be complete. It.probably 19 isn't complete. And I think we've recognized that.
20 MEMBER WILLIAMSON: So to' summarize the
-21 current. rule text, all physicians with board 22 certification, all physicists with. certification in a 23 radiological board, all he'alth physicists with
-24 certification Jr. a board are included, or you have 25' classroom and. laboratory, 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> plus one year full NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.
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528 2 timo experience.
2 And t',en Part C allows any authorized user, 3 including the -- you know, nowtone with 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of 4 training to do, what is it, therapeutic 5 radiopharmaceutical application. Okay.
6 MS. LANZISERA: Correct.
7 MS. HANEY: Status quo.
8 MEMBER WILLIAMSON: Thank you.
9 CHAIRMAN STITT: Okay, let's kaep going on the 10 alternatives. What we don't have is a matrix on thic. I 11 don't know if that's necessarily good nor bad, but does 12 anybody find an alternative that they like? Or , does 13 anybody find an alternative they don't like?
14 Can we eliminate something here?
15 Yes, sir?
16 MEMBER SWANSON: Well, I like alternative 17 three. And the principal reason why I like it is I think 18 when it comes to training and experience requirements, we 19 need to be consistent across all the training and 20 experience requirements. And so alternative three is 21 consistent with the training and experience requirements 22 that we just discussed for an authorized user.
23 CHAIRMAN STITT: All right, good.
24 How about other comments on three? And 25 there's more detail on three in your packet.
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529 1 MEMBER FLYNN: I support number three, and I
,e') 2 have great problems with being one year under an RSO,
\' ')
3 which is -- I would eliminate numboc one myself and number 4 five. I don't think it's practical. I don't think it's 5 enforceable. I think it will make a big problem for 6 people, 7 It may not result in the selection of the best 8 candidate to be RSO. It would be a major economic impact 9 to small licensues, which would be -- I think there's a 10 federal law that would be violated. So I think that it 11 should be two, three or four. I favor three.
12 CHAIRMAN STITT: Comments about --
,- 13 MEMBER FLYNN: Not four.
I )
() 14 CHAIRMAN S?'ITT: Okay, good. Thanks, Dan.
15 We're working effectively.
16 Go ahead, Lou; you're on a roll for the 17 afternoon.
18 MEMBER WAGNER: No, the only thing that I 19 would be concerned about is that there are some board 20 examinations that might apply -- certifications that might 21 apply only to specific forms. For example, I sure as heck 22 dor.' t want to be an RSO for a brachytherapy f acility. I 23 don't have the proper training.
24 I don't want to do that. My board
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530 1 board certified in radiation therapy. I'm only board 2 certified in diagnostic radiological physics. And 3 therefore, I would only qualify under diagnostic forms of 4 use plus some iodine-131, which obviously comes under the 5 purview of diagnostic situations, but not brachytherapy.
6 I wouldn't want to be brachytherapy radiation 7 safety officer, although I might qualify under this rule.
8 I wouldn't do it.
9 MEMBER FLY.it No, I disagree.
10 CHAIRMAN S71TT: First Ruth and then Jeff.
11 MS. McBURNE7: There's a difference in being 12 an RSO for therapy and .*.eir.g the medical physicist for a 13 therapy institution.
14 MEMBER WAGNER: Right, right.
15 MS. McBURNEY: So --
16 MEMBER WAGNER: That's the point. That's the 17 point I'm making.
18 MS. McBURNEY: You wouldn't even qualify as a 19 radiation safety officer for --
20 MEMBER WAGNER: We're talking about RSO, 21 aren't we?
22 MS. McBURNEY: Right.
23 MEMBER WAGNER: Yes.
24 MS. McBURNEY: Radiation safety, not the 25 medical physicist.
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531 1- MEMBER -- WA GNER : Right. I'm talking-about-i g 2- radiation safety. 1 e
3 MEMBER FLYNN: But Jeff Williamson is.your 4, - i 0 '
radiation oncology physicist who's working in your 4
- 5- hospital. You're just the RSO. .You~have him to help you.
4~
6 MS. McBURNEY: All you have to make sure is >
4-
, '71 that it's accounted for and'so forth, i-l 8 CHAIRMAN STITT: Dennis is laughing..
(
- 9 What's so funny, Dennis?
L i
10 MEMBER WAGNER: That's what I'm confused about-
-11 ..
- 12 CHAIRMAN STITT
- Jeff.
I i- 13- MEMBER %AGNER: --
is that if you take RSO and 4
14 medical physicist, you take the different definitions, how
]_ ,
l :15 are we : splitting those? Because I do both jobs.
i 16 ' MEMBER WILLIAMSON: Well, we're only-talking-
] '17' about RSO at-this point. And in institutions,-'. depending-1 -
p 18- upon their-size, these may be separate persons, the L 19 medical physicist versus'the RSO versus the authorized-l_
20 user. In a very' tiny institution,'there might be only an 21- authorizea user and a medical physicist, and one of them-
~
22- might have'to be the RSO.
23 MS. McBURNEY: And-in very small institutions
) - 24' where they're only doing diagnostic nuclear medicine, the.
, 25 authorized user is usually named as the RSO currently.
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532 1 And in -- I don't know if NRC does this. If a 2 technologist has had that training, sometimes could be, 3 but very rarely have we done that.
4 CHAIRMAN STITT: Jeff, you were next.
5 MEMBER WILLIAMSON: I guess I -- if I 6 understood it -- if I understand option three, which I'm 7 not sure I do. I think I support it. It says, as I 8 understand it, board certification with all of the 9 different boards we've talked about, which would allow 10 authorized users, physicists, and professional health 11 physicists to be -- serve in that role.
12 Plus, you know, there's a separate examination 13 that has to be taken regardless of your certification. Is 14 that --
15 MS. HANEY: No, no; that's where there's a 16 mistake on the viewgraph.
17 MEMBER WILLIAMSON: Okay.
18 MS. HANEY: Penny, can you go up and change 19 the paren maybe?
20 The board certification would stand alone if 21 you were board certified. Again, the thinking there is in 22 order to get certified, you've already taken an exam. The 23 same thing would hold true that we spoke this morning 24 about is that the current boards may need to change what's 25 included in that board just slightly to meet the intent of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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533 1 this new rule.
,e'~N., 2 But --
and we would not specify board as
)
'~
3 American Board c ' Health Physics. What we would -- again, j 4 similar to what we did this morning, we would say board 5 certified. And as part of this board, you would have 6 gotten the things that are in Section B.
7 MEMBER WILLIAMSON: I guess my concern 9)' ;
i I
8 be about the existing regulation. From time t' t '. u t i~'a j 9 come to my attention mayba -- well, I guese *
. -lear i
10 I'll put it this way. I think the leve3 an k ad 0;
{
11 radiation safety training that's need 'to ce - noRd 12 competent authorized user versus an 1 -;C 4n ;m te e r: .
7 13 main interface between NRC and the a t .. ' .x _ m e-l \
\~ / 14 different.
15 And I think that a typical physician -- you 16 guys can, you know, confirm this or not -- may be not well 17 prepared without some extra study to follow all of the 18 applicable federal regulations and keep the institution 19 out of trouble.
20 So I'm wondering if there kind of ought to be 21 not two categories, a category of person that's sort of 22 professionally trained to take on this role, in which case 23 the presumption would be that all of the -- this person 24 knows all of the techniques, all of the federal
,.m
\
!' / 25 regulations, and state regulations, all of the techniques.
'v' NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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n 534 ,
I 1 And a person with competenco in a related 2 field but who might not necessarily have all the training 3 and could benefit from some sort of a -- maybe an exam 4 tool or something to make sure they understand exactly 5 what their role is.
6 Does that make sense?
7 CHAIRMAN STITT: So is that a different --
is 8 that a different, additional --
9 MEMBER WILLIAMSON: I think it's maybe 10 different.
11 CHAIRMAN STITT: --
alternative that you're 12 proposing?
13 MEMBER WILLIAMSON: I guess.
14 CHAIRMAN STITT: And what is that?
15 MEMBER WILLIAMSON: It's a sort of two tier 16 system --
17 CHAIRMAN STITT: Board certified plus exam?
18 MEMBER WILLIAMSON: -- which is board 19 certification in a profession where learning to be --
20 learning RSO duties is a major, major component versus 21 having board certification or credentials in a related 22 area where knowing all of the RSO type things might not be 23 the major emphasis.
24 And in the second one, there might be some --
25 MS. HANEY: But if we established a base level NEAL R. GROSS COURT REPORTERS AND TRANSCRICERS 1323 RHODE ISLAND AVE., N.W.
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535 1 or a common level to both of those, could we eliminate the fN; 2 two tier?
/
3 MEMBER FLYNN: I would oppose the two tier.
4 And I --
before I accepted being an RSO, I checked with 5 the community hospitals in the region and there were 6 several nuclear medicine physicians who are RSO's. There 7 was actually a senior nuclear medicine technologist who is 8 extremely bright who is an RSO at another institution.
9 And it seemed like the people they selected 10 was appropriate for that institution. And to require them 11 to have a medical health physicist or medical physicist, I 12 thought, would have been very intrusive and again, could 7- 13 be in violation of a federal statute and requiring the --
( i
'_/)
\ 14 assessing the economic impact on the small licensee.
15 You know, I had gotten a masters degree in 16 medical radiation physics and never worked as a physicist.
17 But during that masters degree at Harvard School of Public 18 Health, which is a very health physics oriented program 19 also, I still didn't think they trained us to be a 20 radiation safety officer.
21 They trained us a lot about instrumentation.
22 That's one thing we got a lot -- honestly, a lot more of 23 than the physician training would be. But I don't think 24 that -- I think the institution wants to select the best (3
( ) 25 person that's appropriate for that institution. And it NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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536 1 wouldn't b2 appropriate that I ba RSO at Mallinckrodt, but 2 it might be appropriate that I, or someone else, be the 3 RSO at a small community hospital.
4 MEMBER WILLIAMSON: I wasn't saying it should 5 be excluded. I just was wondering if the need for an exam 6
shouldn't be conditioned on the basis of what kind of a 7 certification the person had. And it seems to be clear, 8 for any kind of an institution one would hope, that 9
somebody who's trained as a professional health physicist 10 would not need an exam.
11 CHAIRMAN STITT: But I think that's getting 12 really very prescriptive, which is something --
13 MEMBER WILLIAMSON: Okay, I'll withdraw my 14 suggestion.
15 CHAIRMAN STITT: You can -- you don't need to 16 withdraw your suggestion. It's not a motion.
17 Lou.
18 MEMBER WAGNER: I'm getting -- I'm becoming a 19 little confused. I can see a wide range of scenarios here 20 that have to be covered. Now, I'd like to just ask a 21 simple question. And I know it sounds really stupid, but 22 at this point, I think we have to visit it.
23 What are the responsibilities of the radiation 24 safety officer under the NRC according to the new 25 proposals that we're making?
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537 1 MS. HANEY: We have not defined those yet.
^
f ~'N 2 MEMBER WAGNER: Well, we haven't -- so we
'\' - '/
3 haven't defined what the radiation safety officer is or 4 what the responsibilities are?
5 MS. HANEY: Not under -- not in the new rule.
6 MEMBER WAGNER: Yeah, see I think we're 7 putting horse before the cart then.
8 MS, HANEY: Well, but I could say that they 9 will probably not be --
10 MEMBER WAGNER: Something.
11 MS. HANEY: -- that different from where they 12 are right now.
7-~ 13 And probably a good reference point is page 17
]
\ '
s_/ 14 of the package that you have where it lists that the 15 supervised work experience should include authorizing the 16 purchase of radioactive material, receiving and opening 17 packages, storing radioactive material, keeping an 18 inventory record, using radioactive material safely, 19 taking emergency action if warranted, performing periodic 20 radiation surveys, performing checks of survey 21 instruments, disposing of rad waste and training people.
22 It's not going to be much different from that.
23 And in essence, that's really not what is that different 24 from the current 35.21
,7 (v ) 25 MEMBER WAGNER: I'm playing both roles. I NEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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l 538 1 guoco I mix th:m cnd I don't separate them.
2 MEMBER FLYNN: I could tell you in a small 3 community hospital, that's why I called so many people to 4 find out what they were doing.
5 Typically, when the nuclear medicine 6 physicians and -- say a lot of physicians were taking on 7 the role of RSo, it was an unpaid position. They were, 8 however, having assistants.
9 They had a nuclear medicine technologist, 10 radiation oncology physicist -- were playing key roles 11 there that they would work with these individuals and 12 review the audits, the -- you know, equipment checks, the i
13 calibrations, the source inventory, all the things that 14 are done.
15 And during the radiation safety commu.tcc 16 meeting, the duties are really limited to, you know, 17 reviewing exposure records. There was very -- it's not --
18 it doesn't require to be a health physicist to do that 19 part of the job.
20 MEMBER WAGNER: Yes, and I agree entirely.
21 And therefore, the only thing that we can really do is to 22 have a really base line qualifications for RSO if we're 23 going to make it generic and not specify it to tue 24 practice for which it. is targeted. And there's a heck of 25 a spectrum out there.
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539 1 CHAIRMAN STITT: Ruth.
/ '~^; 2 MS. McBURNEY: What could be done -- of l
) l 3 course, a base line, and then based on the modality, the 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> of training and the exam could be slightly 5 different. That's going to be resource intensive to have 6 the exam -- have so many different exams. But that's one 7 way of doing it.
8 MEMBER WAGNER: Yes, I think you're going to 9 run into a problem with three for those very small 10 facilities.
11 MS. McBURNEY: Right.
12 MEMBER WAGNER: I mean, you know, if you've 7-~3 13 got the small facility that you're talking about, the
! \
\ /
'/ 14 decision, of course, could be RSO, If he's board 15 certified, I would presume they'll have the board 16 certification physicians in there.
17 But if he's not board certified, well then he 18 can't be an authorized user, so --
19 MS. McBURNEY: Right. He'll have to take an 20 exam on radiation safety anyway.
21 MEMBER WAGNER: Yes, so he's going to have to 22 -- so he'll have that. Well, maybe not. Maybe that will 23 help then. Because then the physician could always be the 24 RSO.
,a
/ \
( /
-! 25 Are there any facilities wherein they wouldn't NEAL R. GROSS COURT REPORTERS AND TRANSCR!BERS 1323 RHODE ISLAND AVE., N W.
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540 1 have a resident physician where they might have physicians 2 as not permanent or whatever that might be contracted out 3 or something where they --
4 MEMBER FLYNN: There are consultants who do a 5 full time job as an RSO. There are consultant --
6 consultant comes around to 15, 20 hospitals to assist the
~
7 RSO. The RSO's responsible though. But the consultant --
8 there are consultants there that, you know, kind of beef 9 up the program and help out the RSO.
10 MEMBER WILLIAMSON: So three years --
11 CHAIRMAN STITT: Wait, wait.
12 MEMBER WILLIAMSON: I'm sorry.
13 CHAIRMAN STITT: Ruth, go ahead.
14 MS. McBURNEY: I know in Texas we have several 15 rural hospitals that may be in an area that are served by 16 one radiologist. And he may be the RSO -- or she may be 17 the RSO on several licenses. We don't like to do that.
18 We want them to be available. But all of these are unit 19 dose type facilities, diagnostic only.
20 So there's very little chance for 21 contamination.
22 CHAIRMAN STITT: Dennis, did you have 23 something? Pass for now?
24 MEMBER SWANSON: I've got some, I guess, minor 25 comments with three. And I'm just bouncing some stuff NEAL R. GROSS OOURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE , N W.
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541 1 cround in my hocd acre.
,r ^] 2 CHAIRMAN STITT: Okay.
( )
3 MEMBER SWANSON: Under alternative three right 4 now, you have board certification or a specified number of 5 training hours to include experience with the types and 6 forms of radioactive materials. I just wonder how 7 realistic it is that you're going to have a indiation 8 safety officer who's going to have experience in every 9 area or every modality within the institution.
10 Certainly they need to be knowledgeable of 11 them and they need to be trainnd in the :.ifferent 12 modalities. To actually require experience in those 7, 13 different modalities is probably a litt.1.e unreasonacle.
( )
(_) 14 So you might want to consider something like 15 board certification or a specified amount of training 16 respective to the types and forms of radioactive material 17 to be used in the facility.
18 MS. McBURNEY: Yes.
19 CHAIRMAN STITT: Okay, so you're saying 20 exchange experience with knowledge?
21 MEMBER WILLIAMSON: That's what it says 22 already. I think it says that.
23 CHAIRMAN STITT: Well, they're summarized on 24 page 13. l 7
I
) 25 MS. HANEY: They should -- hopefully the same i v
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542 1 Ototem'into.
2 MEMBER SWANSON: Right now, three on page 13 3 says board certification or specified number of training 4 hours to include experience. And the problem I have is to 5 include experience. I think it's unreasonable that you're 6 going to have somebody that's experienced in all 7 modalities.
9 MS. McBURNE.:. But the draft rule text just 9 says had demonstrated knowledge in radiation safety 10 commensurate with the use --
11 MEMBER SWANSON. No, that's fine.
12 CHAIRMAN STITT: But if we changed experience 13 to knowledge, that would act.ually support what the rule 14 language says and be more appropriate to the -- do you 15 want to -- okay, we can stick that there as a possible 16 when we get to a motion.
17 ! EMBER SWANSON: Right. Then another thought 18 that crosses my head is what if you've got somebody who's 19 board -- I'll take me. Okay, I'm board certified in l
l 20 nuclear pharmacy. And technically under here, I could be l
l 2 :. an RSO. Okay, my board certification in nuclear pharmacy l
22 by itself I don't think qualifies me to be an RSO without 23 knowledge in the other area.
24 Okay, so do we think about board certification 25 plus a specified amount of training respective to the NEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE . N W.
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543 1 typoo of motoriclo being used, or cpecified amount of
(]
, 1 2 training respective to types being used plus an exam?
3 CHAIRMAN STITT: I think that's what Jeff was 4 bringing up.
5 MEMBER WAGNER: Your board certification 6 wouldn't qualify under that. The NRC wouldn't approve 7 that board certification because it doesn't have the 8 appropriate testing of your knowledge for the base line 9 performance part.
10 MEMBER SWANSON: Well, I disagree with that, 11 but let me -- that's the whole thing is that then, when 12 you go out as an NRC to review board certification, you're 7- 13 going to -- in order to have that meet the requirements
( )
V 14 for an RSO, that certification exam is going to have to 15 include questions over all the modality.
16 MEMBER WAGNER: That's the whole point. That 17 was my point on the discussion is that there is that wide 18 range of spectrum. So what are the responsibilities and 19 what are we testing? We're really testing a really base 20 line thing which only has to test on these different items 21 on page 19. What page was it? I forget what page it was.
22 But that's all it has to be. But it's very --
! 23 I came up with the same problem when I was discussing 24 that.
,~
(v ,
) 25 CHAIRMAN STITT: Right, NEAL R. GROSS COURT REPORTERS MD TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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544 1 MEMBER WAGNER: That was my issue.
2 CHAIRMAN STITT: I think we're over ascessing 3 it.
4 Ruth, comment? And then let's try to move to 5 a motion.
6 MS. McBURNEY: That's the point I was going to 7 make, that without putting the board certifications in the 8 rule, that in assessing -- that if NRC assecsed each of 9 the coard certifications, including all the medical ones 10 and the medical physics ones, to assure that the precursor 11 to that included enough training in radiation safety or 12 the board exam included enough in radiation safety, that 13 anyone certified by that could qualify as an RSO, then I 14 think that would be fine.
15 MEMBER WAGNER: Qualify as an RSO anywhere for 16 anything.
17 CHAIRMAN STITT: You got it.
18 Anybody in the mood to make a motion?
19 Jeffrey.
20 MEMBER WILLIAMSON: Can I ask a question of --
21 make a comment, --
22 CHAIRMAN STITT: Yes.
23 MEMBER WILLIAMSON: -- which isn't even a 24 criticism.
25 So the difference -- it's a question. The NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE , N W.
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545 1 dif foronco betw en numbar throe end tha otatuo quo effecto rs 2 only the non-board certified pathway. And what has been 3 changed is the -- one year under an RSO has been deleted 4 as a requirement. And there's now, in its place, a 5 requirement for 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of training with some suggestion 6 it should be specific to the activities of the proposed I
? licensee plus an exam.
, 8 That's the difference?
I 9 HS. IUWEY: Not quite.
L 10 MEMBER WILLIA! CON: Okay, I guess the first 11 thing is the difference between one and three is just 12 because you're an authorized user doesn't automatically 13 make you a radiation safety officer.
14 MEMBER WILLIAMSON: Okay, right.
15 MS. HANEY: The 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> is already in one.
16 That's the alternate route to board certification. So we 17 kept the number of hours the same. The difference is 18 there's an exam and the fact that the boards would no 19 longer be listed there by name. It would say a board that 20 meets or contains the training specified in B.
21 CHAIRMAN STITT: Lou.
22 MEMBER WAGNER: Discussion. I see a problem 23 with regard to alternative three and the idea that we're
/\
24 going to combine -- first we're saying it's generic,
[ \
() 25 applies across the board. This would qualify you to be an NEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE., N W.
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546 1 RSO for anything. But then, within the altornativo, wa '
! 2 write to include, and it currently says experience with 3 the types of forms of radioactive material to be used at 4 the facility.
l 5 I would suggest that, bar.d upon these two l
l 6 discussions, those are in conflicts and that really, if 7 we're doing what we said, we don't really need that at 8 all. Apparently that this exam would cover what you need 9 to know, no matter what you're doing. And you don't have 10 to have a specified number of training hours or experience 11 specific to the materials being used at the facility 12 because your exam's going to be generic, right?
13 MS. HANEY: Well, that's what I was going to 14 say.
15 MEMBER WAGNER: Unless you make it modality-16 based, but we haven't done that.
17 MS. HANEY: You have the option of making this 18 modality-based.
19 MEMBER WAGNER: Well, that's where I think 20 that --
I think that we're almost going to have to leave 21 it there at this point because --
22 MS. HANEY: Modality-based?
23 MEMBER WAGNER: No, no, no; my point is we're 24 going to have to leave it. The point is whether or not we 25 want to make it modality-based or don't want to make it NEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHODE ISL.AND AVE., N.W.
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547 1 modality-baced. Beccuso what I'm seeing is -- I'm not gs 2 sure where we're supposed to be headed, and I don't have
(
') 3 the guidance as to really what this -- what the RSO is 4 going to really end up doing in this new form.
5 If it's what you specify over here, this is 6 some pretty generic stuff. This is some pretty generic 7 stuff. This is not anything specific. And if that's what 8 we're saying is that everybody must have this generic 9 training no matter what you do, then of course -- then l
10 we're not modality-based, it's something very simple, and '
11 we can take that out --
that clause out of alternative 12 three.
,~- 13 If, on the other hand, we feel that the
\
\s' 14 handling of unit doses of diagnostic materials is quite 15 different than handling a brachytherapy source and that 16 there's difference RSO training for those two things, then 17 we've got to make it modality-based.
18 And it all depends on what the qualifications 19 are going to be for support services. If you have a 20 brachytherapy system, are you going to need, in addition 21 to an RSO, a medical physicist or someone else trained 22 specific to that kind of stuff?
23 Because I certainly don't want that RSO going 24 in there if he's not trained on how to handle (v ) 25 brachytherapy sources, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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548 1 MEMBER FLYNN: He'c not going to be doing 2 that.
3 MEMBER WAGNER: Yeah. And if that's the case, 4 then we're back to the generica. And then we can take the 5 clause out of alterative three to be specific because it 6 doesn't have to be specific anymore. The whole dang 7 thing's generic.
8 CHAIRMAN STITT: Theresa and then Jeff.
9 MEMBER WALKUP: I just want to make a point of 10 interest. Thin number two under superviced work 11 experience sounds like my job description when I was a 1 .
12 nuclear medicine technologist. I mean, this would have 13 been my day to day -- I mean, that's what I'm saying.
14 I'm wondering if you would be, in some 15 institutions, putting some nuclear medicine technologists 16 that might -- I mean, the management pushing them into 17 this job because this was my job description. I did this 18 every day.
19 CHAIRMAN STITT: Well, and there are RSO's who 20 --
21 MEMBER WALKUP: They are, but it's under 22 special -- right now, it's not real common.
23 CHAIRMAN STITT: Jeff, you had a comment?
24 MEMBER WILLIAMSON: Yes, I was just going to 25 say if you're going to have a modality specific RSO exam, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHoDE ISLAND AVE. N W.
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1
549 1 the numbar of combinations is quito 1crga. And I think i
,~ 2 this would be a very ungainly examination system because -
k_ 3 _
4 CHAIRMAN STITT: Are we making this too 5 complicated?
6 MEMBER WILLIAMSON: I think so.
7 CHAIRMAN STITT: Who said yes?
8 MEMBER FLYNN: Yes.
9 CHAIRMAN STITT: Talk to me.
10 MEMBER FLYNN: The institutions are selecting 11 the best person that's appropriate for the job. They're 12 not selecting people who would are going to get the 13 institution in trouble. You're not giving much credit to 7-s
( I
\_ / 14 the institution's management, quite reasonably.
15 And I think that if I was a nuclear medicine 16 person, there wouldn't be radiation oncology brachytherapy 17 at that institution without a radiation oncology 18 physicist. Someone has to program the computer. Someone 19 has to get all that work done.
20 It's like saying that I'm not authorized to be 21 an air traffic controller at Dulles if I can't actually 22 fly a C-141 as a pilot. It's not true. There are pilots 23 to fly the C-141's. I don't have to be a pilot also 24 besides being an air traffic controller.
7-( ) 25 I can actually, you know, juggle which planes v
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550 1 the runwayo cro on without cctually flying the jets varcus 2 the cargo plane versus the helicopter.
3 CHAIRMAN STITT: Dennis.
4 MEMBER SWANSON: I understand that, but you 5 need to know the different characteristics of the jets and 6 the cargo planes and how fast they fly, etc. All I'm 7 saying --
8 MEMBER FLYNN: That's why management is going 9 to want to select somebody who's going to take the trouble 10 to know the regulations and to count on his colleagues in 11 the radiation safety committee who must represent all the 12 modalities to contribute as a committee.
13 The more modalities that institution has, the 14 more members on the committee there will be. And they 15 will -- that's the purpose of having a radiation safety 16 committee.
17 CHAIRMAN STITT: I think we're in trouble with 18 the big picture. We get so caught up in the details of 19 some of the parts that we work on here. It's 3:00. I 20 want you guys to either come up with something you want to 21 vote on or we can just -- I mean, the text stands as it 22 stands because we need to talk about the physicist and 23 we've got at least -- we've got several in the crowd.
24 Lou and then Jeff.
25 MEMBER WAGNER: I'd just say I would support HEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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551 1
citornativa thrce if we exclude the phraco that scya "to
(% 2 include experience with the types and forms of radioactive
, i I U) 3 material to be used at the facility" because that's no 4 longer a relevant --
it's just superfluous. It's not l j
5 relevant and it's not important.
6 CHAIRMAN STITT: It can be rather confining, l
7 MEMBER WILLIAMSON: Second it.
8 MEMBER WAGNER: Yes.
9 CHAIRMAN STITT: Okay.
10 MEMBER WAGNER: So that's --
11 CHAIRMAN STITT: Lou, before we finish that 12 motion off, there was discussion we had to change
, 13 experience to knowledge at one point. Do you feel like
( )
'N J 14 your motion wants to --
15 MEMBER WAGNER: I'm dropping it. So that's 16 being dropped.
17 CHAIRMAN STITT: Oh, I'm sorry, you are.
18 Specified numbers of training hours.
19 MEMBER WAGNER: Yes.
20 CHAIR!iAN STITT Plus exam.
21 MEMBER WAGNER: Yes, it's just a matter that 22 you have to have a specified number of training hours plus 23 an exam.
24 CHAIRMAN STITT: Okay, so we've got a motion f
\ / 25 and a second, and I think that helps -- we ready to vote J
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552 1 or do you want to discuss some more? Any other -- let's 2 vote.
l 3 Number three, which is a board certification 4 by a board approved by the NRC or specified number of 5 training hours.
6 MEMBER WAGNER: Plus exam.
7 CHAIRMAN STITT: Plus exam.
l 8 All in favor? All opposed?
9 Okay, we've got a winner.
10 Let's go on to radiation physicist. And I 11 think what I'd like to do is to turn back to authorized 12 user.
13 Who's going to present this?
14 We can either use the matrix, which is pretty 15 complicated, or the six different alternatives.
16 MS. HANEY: Originally, when the working group 17 met, we didn't have a lot of time to talk about the 18 physicist and the authorized nuclear pharmacist. But we 19 went so far as to say that whatever approach is decided 20 for the radiation safety officer would probably be the 21 approach that we would look for -- the same sort of 22 approach as alternatives for the physicist or the AMP.
23 In talking with Jeffrey, he felt that the 24 choice was -- that we were better not to compare them to 25 the radiation safety officer, but to go back to the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE , N W.
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1 553 1 authorized ucor. So that's why Penny's put up the olida l
,7 ^3 2 that has the alternatives for the authorized user.
( /
3 I think in the case of the physicist where we ;
1 4 would be replacing the MD with maybe an MS or a BS 5 possibly, and the questien would be is do you need the !
6 degree. I think with the physicist, we recognize that it 7 would be modality specific. We would not be trying to 8 come up with one definition for all physicists.
9 We would probably have in the definitions a 10 Part 35, a definition for a physicist, a very generic 11 definition. And then under each modality, you would have 12 their responsibilities. That's where the responsibilities 7s 13 would go if they were going to go into the rule, as well
/ h k/ 14 as what the training requirements were for that 15 individual.
16 CHAIRMAN STITT: How about commenting on what 17 Cathy just said?
18 MEMBER SWANSON: Would you like me to reread 19 what we agreed upon for the authorized physician?
20 CRAIRMAN STITT: There you go.
21 MEMBER SWANSON: MD plus board certification 22 or specified number of hours of appropriate modality 23 specific training and experience which focus on radiation 24 safety plus exam.
(q) 25 CRAIRMAN STITT: That's interesting. In a lot U'
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f 554 1
1 of canreo, I cen't im:gina working with a phyciciet who'o 2 got some hours. I've only worked with physicists who's 3 got some very specific training and board certification.
4 Does that fit radiation physicist?
5 MEMBER WAGNER: That's the problem, I chink, 6 is it's -- with the board certification, I think the only 7
modification has to be that the board certification has to 8 be specific to the modality. It has to be modality 9 specific board certification.
10 MEMBER WILLIAMSON: Well, just a second.
11 CHAIRMAN STITT: Is somebody writing this 12 down?
13 Jeff.
14 MEMBER WILLIAMSON: There isn't any modality 15 specific board certification process in -- within 16 radiation oncology physics. The broad categories that you 17 can get certification --
18 MEMBER WAGNER: Yes, I'm not --
19 MEMBER WILLIAMSON: -- radiation oncology, 20 physics, diagnostic physics, nuclear medicine; and in one 21 case, hyperthermia physics, which is not of interest here.
22 But -- and all of the --
23 MEMBER WAGNER: Eut you've got diagnostic 24 versus therapy.
25 MEMBER WILLIAMSON: You've got diagnostic NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS j 1323 RHoDE ISt.AND AVE., N.W. '
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555 1 vercus thorapy vorouc --
~
f 'N 2 MEMBER WAGNER: And that's what I'm getting i )
C/ 3 at.
4 MEMBER WILLIAMSON: -- nuclear medicine.
5 MEMBER WAGNER: That's what I would get at 6 would be your modality specific.
7 MEMBER WILLIAMSON: So that's as modality 8 specific as you can be.
9 CRAIRMAN STITT: I think we have to be careful 10 about putting modality specific because it means something 11 in these construct of how the NRC is looking at these 12 monitors, and there's no such thing as a modality specific 7-~s 13 certified physicist. And then we're also developing
/ \
v i
\- ' 14 something that doesn't exist elaewhere in the practice.
15 I mean, you're a medical physicist who knows 16 how to do some other things. But there's not a 17 certification process that --
18 MEMBER WAGNER: Maybe it would have to read a 19 board certification appropriate to the uses specified in 20 the license. I mean, it has to be --
21 CHAIRMAN STITT: Hold on a second, Ruth. I'll 22 let you --
23 Jeff.
24 MEMBER WILLIAMSON: I think that maybe a good
,,n
() 25 starting point would be the current definition of NEAl. R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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l 556 1 telothorcpy phyoiciot. Juct reed -- and I think --
2 MS. HANEY: You have it in your books if it 3 would be easier.
4 MEMBER WILLIAMSON: It's on page --
5 MS. HANEY: It's under the tab of Part 35.
6 MEMBER WILLIAMSON: Thirty-five, page 29, 7 35.961. It says the teletherapy physicist should be an 8 individual who is certified by the American Board of 9 Radiology, and it lists the various other boards and su 10 on.
11 That's one pathway. Or, holds a masters or 12 doctors degree in physics, biophysics, radiological 13 physics, or health physics and has completed one year of 14 full time training and therapeutic radiological physics 15 and an additional year of full time work experience under 16 the supervision of a teletherapy physicist at a medical 17 institution that includes the tasks listed in the --
18 presumably having to do with quality assurance of 19 teletherapy, 20 And that's -- when you stop and think here 21 what are the differences between the authorized user 22 controversy we had this morning and what the medical 23 physicist in radiatica oncology has to do, there's really 24 not a counterpart for the medical physicist of having a 25 very narrow, limited range of procedures that you use only NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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557 1 for one organ.
2 You know, medical physicist and radiation
[^]
('~' /
3 oncology are trained to take on the sort of whole array of i
4 issues involved in, you know, designing and operating an 5 efficient treatment planning and delivery sort of 6 procedure that achieves, yot! know, the end points of 7 safety and quality of treatment, including those addressed 8 that are of concern to the NRC.
9 So there's no sort of way -- practical way to 10 create, you know, credentialing -- non-board pathway 11 credentialing, I think for a narrow modality.
.2 I think it would be reasonable to come up
,- 13 with, you know -- with some sort of a substitution for i
\
\ -) 14 board certification which is like the current one which 15 approximates the definition of board eligibility for ABP 16 and ABR, but generalizing the statement of tasks here so 17 that, you know, it is applicable to both all areas of 18 brachytherapy, teletherapy, and gamma steraotactic, you 1
19 know, that would list in general generic form issues of 20 quality assurance, source calibration, handling of 21 radioactive sources, maintenance of treatment records, so 22 on and so forth.
23 We could make some kind cf a list. I haven't 24 thought about it enough to make one, but certainly one
(~~ 's
!, ) 25 could do that.
v.-
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558 1 CHAIRMAN STZTT: Okay.
2 Ruth, you have a comment?
3 MS. McBURNEY: I just had a question for 4 Cathy.
5 In the change in the rules, you're still just 6 going to require the medical physicist in conjunction with 7 therapy?
8 MS. HANEY: Correct, right.
9 MS. McBURNEY: So we're only talking about 10 radiation oncology type physics -- physicist?
11 MS. HANEY: Right, probably. Yes, at this 12 point, I don't see anything other than that.
13 MS. McBURNEY: Okay.
14 CHAIRMAN STITT: All right. So Jeff, I think 15 that's a nice analogy that you drew there.
16 Dan.
17 MEMBER FLYNN: Just one question of the 18 physicist.
19 Do you have examples of small licensees that 20 may have a -- only teletherapy or ot.'ly some single 21 m.sdality like -- let's say just teletherapy with cobalt 22 and no brachytherapy, and a consultant comes in every so i
23 often and does all the physical dosimetry with the machine 24 calibrations.
25 And yet, the person who's there is the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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559
! 1 physiciet who, let's say, has a bachelors degree end io a
! , } 2 physicist. Or , is the consultant the person who is the
/
3 medical physicist for the license -- for the institution?
l 4 The one who comes once a week or twice a month. {
5 MS. HANEY: In NRC space, it's the consultant 6 that's the teletherapy physicist.
1 7 MS. McBURNEY: Right, that does all those --
8 CHAIRMAN STITT: I don't know if we need a 9 motion in -- I mean, I guess we can if we want to.
10 We've given you a lot of our -- what do you need? What 11 would be helpful?
12 MS. HANEY: Well, 1 guess it's my -- would we 13 leave the boards that are currently listed in 35.961 by
\ l K/ 14 name in the rule?
15 MEMBER WILLIAMSON: I think that, you know, if 16 you were going to -- if you were going to remove them for 17 the other official personages in Part 35, you might want 18 to handle physics in an analogous way.
19 MS. HANEY: Okay.
20 MEMBER WILLIAMSON: You know, perhaps it's a 21 little more stable and clear what boards offer appropriate 22 radiation oncology physics.
23 MS. HANEY: If I were to remove the board 24 names, would I then go to an alternative of a number of (a) 25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> plus experience in certain areas, and that's where NEAL R. GROSS COURT REPORTERS AND 1RANSCRIBERS 1323 RHON ISLAND AVE., N W.
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~n
560 1 your liet of inctrum nt epot chocka on tolothercpy and i 2 that laundry list of items that a physicist would need to 3 know what to do -- that's where that would go, right?
4 MEMBER WILLIAMSON: Well, I would think that 5 what you'd want is something very similar to what's here 6 and what's present for the definition of authorized user 7 for brachytherapy sources and teletherapy.
8 It basically says under the last paragraph, 9 first column, page 35.29, holds a masters degree or 10 doctors degree in physics, biophysics, radiological 11 physics, and health physics, and includes the sort of one 12 year of training and one year of experience with emphasis 13 on the following list of tasks, dot, dot, dot, dot.
14 MS. HANEY: Okay. And would you want an exam 15 for this individual? Again, following consistency between 16 authorized user, radiation safety officer, this individual 17 would have to take an exam if they were not board 18 certified.
19 MEMBER WILLIAMSON: You get into -- boy. I'd 20 say if the foccs of the exam were on radiation safety, an 21 outside organization, you know, might claim the competence 22 to give it. But, you know, if you're going -- you're in a 23 tricky position because in -- radiation oncology 24 procedures hr.ve been, by our previous discussions and your 25 decisions, classified as high risk procedures.
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561 1 So wo do hevo to teko on como iccuco thnt rN 2 aren't just safety oriented with res' act to the public and I ]
3 staff, but actually involve the r ity of treatment 4 delivered to patients. And so it 9 sort of analogous to 5 you saying you, NRC, are going to examine the fitness of 6 physicists to practice radiation oncology physics and 7 saying to physicians we are going to examine your clinical 8 fitness to practice radiation oncology physics.
9 You couldn't do that. I don't think you can 10 make a case you have the competence to examine physicists 11 and calibration techniques and so on. You can have a very 12 -- an exam which is limited strictly to safety, I think, 13 and that would be a reasonable requirement.
\~-) 14 I'm sorry I'm being so wordy. Am I clear what 15 my objection is?
16 CRAIRMAN STITT: No, I think you're being very 17 appropriate, Jeff. I would --
18 MS. RANEY: The only thing I would offer, and 19 this is kind of off the top of my head with that, is 20 because NRC does see this as a high risk area, we tend to 21 start looking a little bit more into depth upon the 22 treatment planning and the spot checks and the other 23 things associated with the treatment planning a little bit 24 further in depth than we would in, say, into the (w- ) 25 authorized use r role.
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562 1 Now yco, you know, ao NRC, we would not went 2 to start testing that. We're not set up to do that.
3 However, you know, we would -- could we, again, get into -
4 contracting with another organization to do this exam for 5 us, you know, like working with -- you know, similar to 6 what we would probably be doing with the authorized user 7 is going back to these boards and saying if you -- you 8 know, if you want to be blessed, then these are the sort 9 of questions you ask.
10 MEMBER SWANSON: I think you've got to have an 11 exam. Agair., your training and experience requirements 12 are going to have to be consistent across all areas. And 13 you know, one of the main arguments for an exam for the 14 authorized user is that you can't --
there's no way to 15 verify the quality of that person's training and 16 experience, so you validate that through an exam.
17 And I think you've got the same problem here.
18 Okay, you're going to have to validate it through an exam.
19 MEMBER WILLIAMSON: Yes, I'm not denying the 20 existence of an exam. I am concerned about the NRC taking 21 upon itself the role of trying to test clinical competence 22 -- not safety competence, but clinical competence of 23 physicists just as much as I would imagine --
24 MS. HANEY: Well, I think --
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563 1 to NRC trying to toct clinical compctenco of physicicnc.
l f' 2 CHAIRMAN STITT: The exams we've --
1 A ],]
3 MS. HANEY: The test --
the exams would have 4 to be very specific as far as where NRC's responsibility 5 begins and where it ends. And that would -- again, that's 6 something that would have to be worked out further on down 7 the line. You know, I recognize we can't get into, you 8 know, did you use the right treatment plan; you know, is 9 that the right software.
10 We're not going to go that far. But I could 11 see us just starting to touch the fringes of what the 12 physicist is doing.
,3 13 CHAIRMAN STITT: The exams we've called for in i I N ./ 14 our other segments that we've examined were really very 15 specific exams regarding safety.
16 MEMBER WILLIAMSON: That's what I'm saying.
17 MEMBER WAGNER: That's the difference.
18 CRAIRMAN STITT: And you have to be very --
19 the NRC cannot start doing clinical testing on the 20 physicist. But I think Jeffr y's point, if I understood 21 it right, was safety and physicist are synonymous. I 22 mean, it's almost --
it's a little bit of an affront 23 because this should be standard body of knowledge in this 24 training.
!. ) 25 Whereas, it may not be quite so standard if a NEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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564 1 physicicn in tha cuthorized usor cctegory -- wo woro 2 talking about. But still, we have to be cognizant of what 3 we -- the standards we've been adhering to greviously in 4 our meetings.
5 Lou and then Jeff.
6 MEMBER WAGNER: This is amazing how things 7 sort of come around. Because what you -- what we're 8 grappling with nere is the following issue: I l
9 The NRC would like to see the medical 10 physicist be competent because they know that the medical 11 physicist plays an important role in radiation delivery 12 and how well it's delivered and how well the patient is 13 managed.
14 Unfortunately, the question comes whether or O 15 not that's within NRC's purview because this is actually 16 within the practice of medical physics, which is something 17 separate, just as the practice of medicine and the 18 competency of the physician is within the practice of 19 medicine. So it's a different ball game here.
20 And the interesting thing is that in the State 21 of Texas, we did recognize that there was this problem.
22 And so in the State of Texas, we have licensure where a 23 medical physicist has to be licensed. And so that's one 24 of the few places. And other sta*.es are starting to come 25 that direction in order to try to have some measure of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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565 1 compotency with regard to a board specific to medical l
(~} 2 physics.
('
/
3 Now here we don't have that. Because if we 4 require an exam in medical physics, which is what I'd like l 5 to see, we don't have a body who's capable of giving that 6 exam except the board certification bodies. Okay, that's 7 the problem.
j 8 MS. McBURNEY: And the Texas Board of 9 Licensure for Medical Physicists.
10 MEMBER WAGNER: Then you've got the Texas 11 Board of Licensure, right.
12 So now you end up with this dilemma here. And
,, -- y 13 it is a dilemma. And it really hits right on the nose of
! i
's - 14 the problem. I think that in this case, the NRC again is 15 going to have to limit the scope of the requirement for 16 the testing to the same scope as required for the 17 physician and leave the competency of medical physics up 18 to the practice which currently is in a much younger state 19 than that of the physicians itself.
20 Because it's clear that in every state the 21 physicians have to be licensed. But in the United States, 22 there's only a few states where the physicist has to be 23 licensed.
24 CHAIRMAN STITT: Dennis and then Jeff.
,n.
) 25 MEMBER SWANSON: One other comment. I think NEAL R. GROSS court REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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566 1 right now you ceid the otatua quo -- cnd correct ma if I'm 2 wrong, Jeff -- referred to masters degree or PhD degree?
3 MEMBER WILLIAMSON: That's correct.
4 MEMBER SWANSON: I don't think that that 5 should appear in regulatory space. I don't think that you 6 should refer to masters degrees or PhD degrees because 7 certainly one could see in the future the development of 8 certification programs, for example, that would not be a 9 " academic" type of degree.
10 MEh,BER WILLIAMSON: Can I respond to that?
11 The two boards that offer radiation oncology 12 certification have now explicitly rejected undergraduate 13 degrees as adequate preparation for medical physics.
14 MEMBER SWANSON: That's fine. I have no
, 15 problem with that. I mean, we have the same types of l
16 requirements with our board certification exam in nuclear 17 pharmacy. Okay, that's your board certification. I'm la talking about here what appears in regulatory space.
19 MEMBER WAGNER: Well, does the NRC require 20 that the authorized user be a physician?
21 CHAIRMAN STITT: Yes, it does. It doesn't say i 22 MD, but it includes --
23 MEMBER WAGNER: Well, physician means that 24 they're an MD.
l 25 CHAIRMAN STITT: -- MDDO, the Canadian NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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567 1 d gress. So thoca are --
l f~'s 2 MEMBER WAGNER: But then that definitely means
( ]
l 3 that you're requiring an academic degree.
l l 4 MEMBER WILLIAMSON: I think that's l
5 appropriate.
l 6 MEMBER WAGNER: And I think it's appropriate.
l 7 MEMBER SWANSON: Professional is a j 8 professional degree, f
9 MEMBER WAGNER: Well, this is too.
10 MEMBER WILLIAMSON: Yes. And can I say that I 11 think your best shot, since there's this issue of there 12 not being licensure for medical physics and you're getting
~
,- 13 into some uncomfortable position of competing with the I )
/
'N_ 14 boards -- the certification boards that do exist, your 15 best shot is to sort of keep the beefed up credentials 16 that you have for the alternative pathway, which, you 17 know, is a pretty good approximation of what the two 18 boards require as eligibility to sit for their exams.
19 It's not an unreasonable list of 20 specifications if you were to generalize the list of tasks 21 so it would be applicable to any therapeutic application 22 of ionizing radiation.
23 MEMBER WAGNER: Yes, that's -- the whole idea
,-~
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568 1 MEMBER WILLIAMSON: That's right. I macn, you 2 know, the medical physicist matured enough as a profession 3 that it has been able to define some sort of base line l 4 credentials that are well accepted within the community 5 that you have to have to call yourself a medical 6 physicist.
7 And these are accepted by, you know, very 8 similar definitions that I think are pretty consistent 9 with what's written in Part 35 now are accepted by the two 10 boarding certifying organizations as well as all of -- the 11 two professional societies that have taken the trouble to 12 define qualified medical physicist in one way or another, 13 which is American College of Radiology and AAPM.
14 So I think it's kind of uncontroversial that 15 these are reasonable requirements.
10 MEMBER FLYNN: I don't think there's a 17 contingency out there that --
Dennis, that's objecting to 18 thic. I think that there's 1,600 radiation oncology 19 faci. 2es in the United States. There's not one facility 20 that'n going to propose that a baccalaureate physicist be 21 a nadical physicist, to my knowledge.
22 I don't think there's anyone out there that's 23 contesting this issue, as far as I know. At least in 24 radiation oncology.
25 MEMBER SWANSON: I've expressed my opinion.
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)
569 1 There may be future programs that fundcmentally are
(s, 2 certification type of programs that direct it towards x ')
3 this. And I don't think that you can negate their 4 participation tc the regulation. The same reason why you 5 give alternative pathways other than board certification.
6 You can't eliminate the involvement of 7 somebody because of certain criteria. Okay, that's all 8 I'm saying.
9 MEMBER WILLIAMSON: Sure you can.
10 MEMBER WAGNER: You come up with that 11 application and consider it an exception to the rule.
12 MEMBER SWANSON: You can, and that's what
, 13 you're doing. It would be interesting to get the legal y,3 i 14 perspective on that. But I've voiced my opinion and 15 that's your area.
16 CHAIRMAN STITT: Are there other comments that 17 people want to make?
18 MS. HANEY: 2 was going to say and actually, 19 we are faced with that right now as we have an application 20 into NRC for a physicist that is a bachelors degree with a 21 considerable amount of experience and is not board 22 certified. But at least on a cursory review, looks like 23 he -- and it's not for teletherapy; it's for HDR. And we 24 run into a problem there because we don't have training a)
.~ a 25 requirements for the HDR physicist in the regulations.
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570 1 B' t the guy could just as easily be applying 2 to be a teletherapy physicist and he only has a ES.
3 MEMBER FLYNN: Would you agree that's a rare 4 thing?
5 MS. HANEY: Yes.
6 MEMBER FLYNN: Could it be a license 7 amendment?
8 MS. HANEY: In this case, since it is HDR, it 9 could be a license amendment. If the individual were 10 applying for a teletherapy, it would have to be an 11 exemption to the regulations.
12 MEMBER FLYNN: And there could be such an 13 exemption?
14 MS. HANEY: Yes, there could be, 15 MEMBER FLYNN: If it happens once every ten 16 years, it's not going to be a big problem.
17 MS. HANEY: Probably, right.
18 MEMBER FLYNN: Okay.
19 CHAIRMAN STITT: Okay, anything else along 20 this line of the physicist?
21 MEMBER WILLIAMSON: Well, I think -- just one 22 last comment on it. I think it would be helpful in the 23 course of developing tne regulations -- you know, probably 24 there will be some expansion of the -- what used to be i 25 called the QM Program, and maybe that's sort of a place to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
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1 571 J
^
_1 outline what it is from a regulatory _ perspective whatithe -
i lp 2 physicist is to'be used for.
Q -
3 CHAIRMAN STITT: Okay.
2 .
h 4 MEMBER WILLI.qMSON: And you know, there's -- I-L
. 5 don't know if this is the time to-get into it, but --
f L
1 6 MS. HANEY: I would say_next_ meeting or
[ 7 probably in the subcommittee-meetings that I mentioned, i
i 8 MEMBER WAGNER: Just-_one-point of
$ 9 clarification that this is only applying'to a medical -- a
]
10 medical physicist is only required for therapy. Now,-what I
=11 about iodine-131 therapy?
12- MS. HANEY: I do not see that at this point T
r 13- being a requirement.
14 MEMBER WAGNER: Okay, that's fine.
15 MS. HANEY: Right now -- well, let me say that 16 right now, the only physicist that the working group has 17 talked about are for HDR, gamma knife and teletherapy.
~
If 18 this. group would like to suggest that the working group 19 consider _it for iodine therapies, --
20 . MEMBER WAGNER: I'm not suggesting that they 21.- do. I-just wanted to. clarify.
22 MS. HANEY: No , I-know. No, now I'm -- so you 23; turned it to me. Now I'm going to turn it back to you.
24 Those are the only ones that we have g 25 considered so far. Should we be considering others?
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572 1 CHAIRMAN STITT: Dennis.
2 MEMBER SWANSON: I'm a little concerned. I 3 mean, are you going to define the requirements for these 4 individuals in the regulatory space? If that's the case, 5 then, you know, do we want to define that you have to have 6 --
I mean, I'll defend my area of practice. Then let's 7 say you have to have a nuclear pharmacy involvement for 8 I-131 therapy in the regulation.
9 Yo'u know, this comes back to yeah, I wouldn't 10 run an institution without a medical physicist. There's 11 no doubt. Okay, I wouldn't run an institution without an 12 RSO. But do I want to put that in the regulation?
13 MEMBER WAGNER: I don't think anybody's 14 suggesting that, Dennis, 15 MEMBER SWANSON: I thought that's what I just 16 heard.
17 MEMBER WAGNER: No, you didn't hear that. -
18 MS. HANEY: What I'm saying is so far, the 19 working group has considered it important to have a 20 physicist specified for HDR, gamma knife, brachytherapy --
21 well, that the -- their training and experience 22 requirements for this individual --
23 MEMBER SWANSON: Okay, okay.
24 MS. HANEY: -- be in the regulation and 25 possibly the responsibilities of the individual, but that NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHC,DE ISLAND AVE., N W.
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573 1 one is a little iffy. What I'm saying is should wo be
/~N 2 putting training and experience regulrements into the
\ ]
3 other modalities for a physicist; and if so, what ones?
4 MEMBER SWANSON: I misinterpret your term 5 specified.
6 MS. HANEY: Sorry.
7 CHAIRMAN STITT: Jeffrey.
8 MEMBER WILLIAMSON: Low dose rate 9 brachytherapy.
10 MS. HANEY: Okay.
11 MEMBER WILLIAMSON: There are forms of low 22 dose rate brachytherapy that are as complicated, you know,
,, 13 as any teletherapy, or more so, and, you know, would I ')
'd 14 require as much professional expertise from the physicist 15 to be well done as some HDR applications.
16 MS. HANEY: Okay.
17 CHAIRMAN STITT: Gee, we're running out of 18 things to argue about.
19 MEMBER WAGNER: Yes, the only gap that I see 20 that isn't covered in regard to this is where you have 21 your definition of your RSO and then you have your problem 22 where if you have inpatient iodine-131 or therapy, they're 23 treated in the normally conventional diagnostic facility.
24 Now you're going to want a little bit elevated
( ) 25 level for the RSO for that facility. But I think that
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574 1 whct Dan said baforo is very appliccble. There you hnvo 2 to trust the judgement of the facility to be able to hire 3 people who are competent in the area, and I think that's 4 adequate. ~
5 CHAIRMAN STITT: Go ahead.
6 MS. LANZISERA: I just wanted to say that one 7
of the things that we brought up in the working group was 8 the board certification or the specified number of hours.
9 Since the board certifications for physicists 10 are not specific to the area of physics that you practice, 11 we felt that sometimes -- and especially for HDR 12 physicists and the gamma knife, that it may be more of 13 something like board certification or specified number of 14 hours1.62037e-4 days <br />0.00389 hours <br />2.314815e-5 weeks <br />5.327e-6 months <br /> of training and experience, and you always require 15 some level of experience only for those higher areas.
16 MEMBER WILLIAMSON: On top of the board 17 certification requirement or for the alternative pathway?
18 MS. LANZISERA: On top of the board x
19 certification. Because the current board certifications, 20 as far as I'm aware anyway, do not cover things especially 21 like gamma knife. There may be some things with HDR in 22 them now.
23 MEMBER WAGNER: Boards do cover that wide 24 range.
25 MEMBER WILLIAMSON: Yes, the boards do cover a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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575 1 wide rangs of practice issues, f'~'N 2 CHAIRMAN STITT: I think you'd have a hard --
(s -
)
'~'
3 I think we would have a hard time accepting that sort of 4 thing because then you'd have to say that a radiation 5 oncologist has to have some additional level of hours or 6 testing. I mean, we keep talking about teletherapy 7 physicist. That's where it came from.
8 But the whole concept of a gamma knife 9 physicist is more of an NRC type of concept. It's a 10 physicist doing gamma knife therapy. It's a physicist 11 doing high dose rate brachytherapy. It's just a plain old 12 medical physicist.
,s 13 MEMBER WILLIAMSON. It's presumed that the i\
N- '). 14 medical physicist is a professional who has the capability 15 of accumulating the knowledge and experience that he or 16 she needs in order to take on a new modality because 17 that's our job. One of our main jobs is integrating new 18 things into our practices as they come up, and that's why 19 the extra credential for a masters or PhD degree is there.
20 It's sort of like expecting a physician to go 21 and get new training every time a new drug comes out. I 21 mean, they're professionals; they know how to get 23 continuing education to safely and effectively use new 24 modalities as they appear in their professions.
I \
25 CHAIRMAN STITT: Other comments? It's 3:30.
(x.s)
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576 1 I know wa're going to lose some people pretty quick.
2 Theresa, did you have somethi.3?
3 MEMBER WALKUP: I hope it's okay to bring this 4 up right now, but under consistency, I was wondering if 5 the working group -- or what is being done about bringing 6 in the requirements and training for medical dosimetrists, 7 radiation therapists, and nuclear medicine technologists?
8 MS. HANEY: That was going to be our next 9 topic after authorized nuclear pharmacist.
10 MEMBER WALKUP: We'll have time? Okay.
11 MS. HANEY: I think we'll have time.
12 MEMBER WAGNER: Today?
13 CHAIRMAN STITT- We've got three people 14 leaving at 3:30.
15 MS, HANEY: Three people leaving?
16 MEMBER WAGNER: Yes, we're going to leaving.
17 We've got about --
less than ten minutes.
18 CHAIRMAN STITT: Who's leaving now, you two?
19 MEMBER WAGNER: Yes.
20 CHAIRMAN STITT: Two people are leaving.
21 MEMBER WAGNER: Yes, we've both got planes to 22 catch.
23 CHAIRMAN STITT: Whure do you want to go?
24 MS. HANEY: Go ahead. Let Ruth --
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. . ~ . - . _ . - _ . . . . _ . . - - - . . ~ . . . . . . - _ . _ - - - - - -~.. - ~.- - _ _
l
- 577 ,
1 want to make theLpoint that I do think there needs to ba
+
something in_the rule of-radiation safety training for
[Q L
i- - - -
2
- 3' technologists consistent with what's;in Part 19 equipment U 4 -- that they have to be-trained consistent with what p
!: 5 they're using.
t
[. 6 MS. HANEY: So I guess that.would be useful 7 too,.some type'of feeling from the committee. Do.you
{
1.
8 think there is a place in Part 35 regulatory space for
[-
l 9 training and experience for the type of individuals that -
10 Theresa mentioned?
, 11 -Previously we have not gone there. Some of the states have, fa
-13 MS. McBURNEY: If it's_not in rule, certainly
\'
14 in the. guidance documents to give some idea.on what you-d 15 mean by appropriate training.
16 MSMBER WALKUP: You know, it could be --
17 excuse me.
18 ._It could be just as simple as saying you-have 19 to-pass the given board examinations. I mean, they're out 20 there.
21 Excuse me?
22 MS. McBURNEY: I'm sorry, go ahead.
23 MEMBER WALKUP: ART, NMTCB, MDCB -- I mean, 24- they're-out there. I mean, it could-just be that simple.
[\ 25 But I also want to --
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578 1 CHAIRMAN STITT: But it would htvo to bo moro 2 complicated than that too. It would have to have all the 3 alternative pathways.
4 MEMBER WALKUP: Well, okay.
5 CHAIRMAN STITT: It can't jttst be board 6 certification. So there's a lot -- I mean, is there 7 something for us to respond to or you just want a general 8 statement at this point?
9 MS. HANEY: Well, the general statement of 10 whether you think it should be in rule space or not. But 11 recognize, for it to actually go into the proposed rule, 12 we would get into doing cost benefit. And do you feel 13 that there is enough information out there for me to 14 justify the requirement for having specific training and 15 experience for these individuals in rule space?
16 Again, this is somewhat similar to what we 17 went through with radiographers in that, in trying to la justify the requirements that we were putting on them, we 19 had to justify that there was a risk to the public and 20 that that offset the expense to the facilities for having 21 to bring all their technologists up to this level.
22 CHAIRMAN STITT: What about nursing staff?
23 Those are people who are using the isotopes. How about 24 the housekeeping? How about a certified hospital 25 administrator user or something like that.
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579 y \
(Laughtcr.)
i
('*3 2 MEMBER WALKUP: The radiation therapists are i
)
\ ' ' 3 the ones directly treating the patients. They are the The nuclear medicine 4 ones pushing the buttons.
5 technologists are the one directly injecting the 6 radioisotope. That's diagnostic. But it is happening, 7 and you're not under direct supervision of the physician.
8 They are not standing behind you upon every 9 injection, upon every push of the button, I mean, there 10 has to be some sort of competency there. And I go along 11 with Ruth in what she said about listing radiation safety 12 issues that if you have a radiation therapist that's
,3 13 involved in brachytherapy, they need to be required to I )
' -/ 14 understand how to use a geiger counter, how a room survey 15 meter works.
16 I mean, there's certain things that go along -
17 - competencies that need to be met.
18 MEMBER WAGNER: I agree that if we -- I mean, 19 if it's important enough to have a representative here on 20 this committee, I tend to think that it's important enough 21 that we look at the credentials of the individuals who are 22 in these --
23 CHAIRMAN STITT: If we're going to do it, we 24 have to do it across all walks of life. There are some
,m s
25 places where the therapists don't handle any sources and (s s)
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580 1 they don't do any HDR. If there's a cobalt unit, they'ro 2 pushing a button there. But it's common that in many 3
institutions, it's the nurses that are doing these things.
4 So you can't just stop it with one branch.
5 MEMBER WILLIAMSON: Well, we can simplify it 6 somewhat by the fact that we've sort of divided into 7 diagnostic versus therapy. And so perhaps, since we --
8 well, I'm not sure.
9 There is certainly a radiation safety 10 component associated even with the delivery of diagnostic 11 imaging agents, but maybe une wouldn't have to -- could 12 sort of end the process there and consider, you know, 13 dosimetrists and therapists for --
14 CHAIRMAN STITT: Lou.
15 MEMBER WAGNER: I'm just going to ask would 16 you like me to change my flight arrangements? Or it's 17 time for me basically to leave, so I don't know --
18 CHAIRMAN STITT: Well, we could also tell the 19 NRC that we're interested in discussing this and that 20 there are several -- and if they'd like to look into what 21 this would involve and the groups involved, we can look at 22 the details at our next meeting and leave it as an 23 acknowledgement and as a statement of support --
24 MS. RANEY: That is something that we should 25 look into.
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581 1 MEMBER WAGNER: I think it's something that wa f] !
2 should look into.
3 MEMBER FLYNN: If you do that, can I add --
4 can you add on specifically nurses that handle 5 brachytherapy patients? This could be LDR, low dose rate l
6 inpatients. This is where a lot of -- there have been a
- 7 lot of individual incidents.
8 MEMBER SWANSON: Yes, I say from an authorized 9 nuclear pharmacist standpoint, you know, those are fairly 1
l 10 recent ragulations. My recommendation would be not to 11 mess around with them very much at all. I think we need l
l 12 to modify them to be consistent with the other approaches I
,. 13 in that it would be --
14 MS. HANEY: That's what I was going to say.
15 MEMRER SWANSON: -- it would be board 16 Icertification by the -- again, by the boards that are 17 included there, but you wouldn't want to list them. Okay, 18 specifically they'd be recognized by you for specified 19 number of training hours, which we just went through.
20 So you could probably use those plus an 21 examination.
22 MS. HANEY: Okay. So again, what I'm hearing 23 is, throughout the whole thing, it's the same approach?
24 MEMBER SWANSON: It's a consistent approach.
j 25 MEMBER WILLIAMSON: Well, I would say -- add NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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582 1 thic. I think that what would justify including, you 2 know, more people beyond the authorized user level is the 3 sort of issue of patient safety in the context of high 4 risk procedures.
5 So I think that one should not get into the 6 nurses on the nursing ward. That's just going to be sort 7 of an unbearably complex -- if we have to worry about --
8 we already have enough work on our hands, you know, 9 maintaining the training of inpatient nurses with existing 10 rules.
11 And I don't know how much further it would be 12 profitable to go in regulato: , space.
13 MEMBERFLYNN[ Well, I think the nurses don't 14 get much training in many institutions. Maybe an hour a 15 year. But I don't think that brachytherapy's a low risk 16 procedure comoared to a technetium for a n. Lear medicine 17 -- for a'diacnostic scan. I think brachytherapy is a high 18 risk procedure.
19 If you look at the number of incidents versus 20 the denominator, it's still not high; but it's more like 21 10-2 or -- probably 10 as opposed to 10-5 or six with 22 teletherapy. So it would be more in the high risk area.
23 And some of these incidents happen on a night 24 or a wcekend where the nurse is the only person with this 25 brachytherapy patient with these sources who end up NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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) i 583 l l
1 falling out or baing taped to their chest or taped to
' 2
,, ~3 their face or put in the rubbish or go down in the linin N ] 3 or down -- whoever knows where the sources go.
4 But there are problems that have happened.
5 The nurses generally get an hour a year in many licenses.
6 Sometimes they're on vacation when the training is given.
7 And I think that's the -- and it's not putting the nurses 8 down. They have a lot of work to do.
9 And they may only get a certain amount of 10 training to -- and in a big licensee, usually the -- I 11 don't know about Mallinckrodt, but a lot of big licensees, 12 the patients tend to go to a certain part of the hospital,
,_s 13 a certain floor, a certain wing of the floor.
s
/
i )
's- / 14 The nurses on that floor get trained, not all 15 the nurses in the whole hospital. And if this stimulates 16 some licensees to segregate their patients to one part of 17 the hospital, so be it. That will be to the benefit of 18 patient care if you -- if they realize that they should be 19 putting the patients in one floor or another where the 20 nurses get the training and not have to train the whole 21 hospital.
22 I mean, I think it's a -- has a benefit to it.
23 CHAIRMAN STITT: Yes, there are some places 24 where -- we're talking about low dose rate -- where
,~
25
( s) s sources are loaded either by, depending on the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVE., N.W.
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584 1 inatitution, the physicist, the doaimetrist, the RTT, or 2 the RN.
3 So source loading ought to be looked at no -
4 matter what the individual's degree is.
5 MEMBER WILLIAMSON: Well, Dan is addressing 6 the issue of nursing care --
7 CHAIRMAN STITT: Right.
8 MEMBER WILLIAMSON: --
in the inpatient 9 setting of low' dose rate implants. And I agree it's 10 important. But, you know, the more procedure frequency 11 they have, the less important formal training is in a way.
12 CHAIRMAN STITT: And I was looking more at the 13 source handling by whoever might be doing source handling.
14 There's several possibilities. We can ask the 15 staff to let us know what they think the important points 16 are.
17 MEMBER SWANSO:T: Certainly in the nuclear 18 medicine technology area, there are many nuclear medicine 19 technologists that are preparing doses, administrating 20 doses, just like nuclear pharmacists are in lieu of 21 nt.: lear pharmacy involvement .
22 So, you know, I think definitely you're going 23 to have to consider training and experience requirements 24 for those individuals.
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585
- 1) losing the: -- have we lost the quorum?
- 2 MS. HANEY:
No, you're still okay. But as
'3' soon'as'-
I think Jeffrey is packing up.
4- CHAIRMAN STITT: We're losing their attention.
5 MEMBER WILLIAMSON: No, I'm not necessarily 6 leaving. I'm just putting my --
7 MS. HANEY: Oh, I thought that -- as soon as 8_ we lose one more person, we've lost our quorum.
9 Well, I think we've covered everything that I 10 need to cover.
11 CHAIRMAN STITT: Plus some things'that we 12- hadn't planned on.
13 MS. HANEY: Plus some extra work.
14- CHAIRMAN STITT: Right.
15 MS.-HANEY: So, you know, unless anyone wants 16 to go further --
17 CHAIRMAN STITT: Other burning issues?
18 Bad choice of terms.
19- MEMBER SWANSON: I think we're creating-20 mountains out of mole hills in some ways.
21- CHAIRMAN STITT: That's the name of the game, isn't it?
That's what we're here for.
23 MS. HANEY: Right, I -- go ahead, Cathy.
24 MS, RIBAUDO: I was just curious. Before we t 25 broke =for lunch,.we were in the middle of one of these g
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586 1 pages. It was page three. We were reviewing a chart for 2 modalities. We got as far as teletherapy but didn't 3 finish the rest of it. Were we just going to leave it as 4 it was?
5 CHAIRMAN STITT: Good question. Because we've 6 kind of talked that over off the record, so to speak. Do 7 you want us to go back and try to complete --
8 MS. HANEY: It's fine.
9 CHAIRMAN STITT: I think we could as long as 10 we've still got a quorum because I believe that we -- what 11 page are we on?
12 MS. RIBAUDO: It didn't seem to me like there 13 would be very much remaining to cover.
14 CHAIRMAN STITT: We had to quit because of 15 lunch and to get started on patient notification.
16 MEMBER WILI.IAMSON: Which topic is this now?
17 MS. RIBAUDO: It was the topic -- it was under 18 the recommendations for a threshold of recordable events.
19 CHAIRMAN STITT: Which is the handout.
20 MS. RIBAUDO: And it was page five.
21 CHAIRMAN STITT: It's the big matrix. Page 22 three, isn't it? It's the big matrix. And to summarize 23 where we were, Dennis had made some -- we had nicely 24 tidied up the first three rows which turned into two rows.
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j 587 1 cctually cottled that related to dose greater than 20%,
^3 2 and then we had added some words regarding under dose.
N
] 3 MEMBER WILLIAMSON: Well, we had --
4 CHAIRMAN STITT: This also is not in the form 5 of a motion. So at this point, we've been discussing.
6 What?
7 MEMBER WILLIAMSON: I remember now. We were -
8 - had a dispute -- not a dispute, but we didn't come to a 9 consensus on the issue of what to do with wrong site. And 10 Dan had isolated an incident where you might treat the 11 wrong eye, and I pre.sented an incident at the opposite end 12 of the spectrum where you night leave a corner block off 13 of a field.
's )
s/ 14 And we were trying to come up with a criterion 15 that would capture clinically significant events like that 16 while excluding --
17 CHAIRMAN STITT: That's right.
18 MEMBER WILLIAMSON: -- a lot of trivial 19 events.
20 CHAIRMAN STITT: So the wrong site and the 21 under dose, while we have addressed those, we hadn't 22 achieved consensus. We could let those continue to flap 23 out there in the breeze and look at brachytherapy and 24 gamma stereotactic, understanding that wrong site and the
(.
) 25 under dose are still not clarified amongst the group, just
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588 1 to sea if those other -- these next two rows work in the 2 same matrix or not.
3 So since I'm running the meeting, that's what 4 we're going to do. Brachytherapy is the next category.
5 And we like the concept of reportable event, and it's 6 listed as wrong patient, wrong isotope, wrong treatment 7 site, which brings up the prior caveats: leaking source, 8 failure to remove source for a temporary implant, 9 calculated administration dose differs by greater than 20%
10 of the prescription dose.
11 Again, that still brings us back to if you 12 make up the under dose -- no, wait a minute; that's -- it 13 doesn't address under dose. That is differs by greater 14 than 20%. So there's no --
15 MEMBER WILLIAM 3ON: It just says it could go 16 either way.
17 MS. HANEY: Could go either way.
18 MEMBER SWANSON: It says differs though, not 19 exceeds.
20 MEMBER WILLIAMSON: Just difference, plus or 21 minus.
22 CHAIRMAN STITT: Mine says differs by greater 23 than 20%.
24 MS. HANEY: But it could be 20% higher or 20%
25 lower.
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. _ . - - - . - - . . . - . - _ . - - . . - - . - . . . - - - . -.-.~ -- - - . . _
l' 589 l 12 MEMBER SWANSON:- Plus or minus, as opposed to l
' 2' exceeds. Differs means plus or minus.
5 3 CHAIRMAN STITT: Differs, you're right.- ~Okay, l
5 4 so that's plus or minus. Okay.
5 Gamma -- I'm going to' move on. Gamma i- 6 stereotactic under reportable -- wrong patient, wrong i
k 7.
~
treatment site, same caveat, total administered dose 1
8 differs by ten percent, same-caveat. :So ignoring wrong i
-9 treatment site and the differs, are there other things i 10 that are either in there that we don't like-or should be.
i j -11 added to brachytherapy.or gamma stereotactic?
'i j _12 - MEMBER WILLIAMSON: Well, I have a -- go.
I E
- 13. ahead.
b0
\ 14 MEMBER FLYNN: I had one -- if the one that 15 says-failure to remove source from a-temporary implant --
16- I'm: just --- I'm only wondering if thatz;could be stricken 17 because, if you did that, then-the calculated administered 18 dose would differ.by-more-than 20%<of the prescribed dose.
19 Because the reason why - . f ailure: to rerove
- 20. the source from temporary implant, does-.that mean 21 permanent failure? In other words, a month, a year,~an 22 hour,-two hours? .I think it would be covered-by the-next 23 one. That one would be important provided the dose 24 differs by more than 20%.
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590 1 cleo. In tharo comathing that you know that --
2 MS. HANEY: I don't know of anything.
3 MEMBER FLYNN: I can give you incidents 4 whereby some -- the physician has a 72 hour8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> implant in.
5 On the way to the hospital, you know, they get delayed in 6 traffic. They're a half hour late. The temporary implant 7 comes out a half hour later than -- but the dose hasn't 8 exceeded 20%.
9 That's no -- that's not a misadministration.
10 But if someone sees in the radiation safety minutes that 11 Dr. Smith was a half hour late, the dose was six percent 12 more than -- four percent more than it should have been, 13 it's still not a failure to remove a temporary implant 14 because it's within the 20% and it's reasonable, I think.
15 Ton't you agree?
16 CHAIRMAN STITT: Jeff.
17 MEMBER WILLIAMSON: That was exactly the 18 comment I was going to make, so I think it seems a
19 appropriate to strike that out.
20 CHAIRMAN STITT: Okay.
, 21 MEMBER WILLIAMSON: Because it will either be 22 covered by the wrong site condition or the differs by more
)
23 than 20%.
24 The other thing I guess I might suggest is it 25 seems that it should be understood this is the total dose NEAL R. GROSS COURT REPCRTEAS AND TRANSCRIBERS 1323 RHODE ISLAND AVE.. N.W.
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591 1 cnd maybe thare should be some more generous specification f'"N 2 made up for an error in a single fraction that approaches 3 biological significance like 40% perhaps.
4 CHAIRMAN STITT: That's what we're missing 5 under brachytherapy is the concept of how to address 6 fractionated brachytherapy, which hasn't been part of our 7 thinking until we got to remote after loading with --
8 MEMBER FLYNN: Since you're the HDR clinical 1
9 expert, I'd like to ask you a question. Think of what 10 fractions are being given in the country in HDR. You know i 11 better than I do.
12 CHAIRMAN STITT: Yes.
,_s 13 MEMBER FLYNN: It's 500, 600.
l i Y/ 14 CHAIRMAN STITT: Five hundred is very, very 15 common, and there's some other --
16 MEMBER FLYNN: But then, in the next section, 17 think of what fractions are given in a single shot by a 18 stereotactic radiosurgery.
19 CHAIRMAN STITT: Right.
20 MEMBER FLYNN: It's 1,500, 2,000, 2,500. So 21 because it's such a high fraction with the chance of 22 having a problem, ten percent does not seem to be l 23 unreasonable for stereotactic. So therefore, maybe it 24 should be a little -- it should be higher for HDR single n
( ) 25 fraction. Maybe it should be 30 or 40% for a single x_/
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1 592 I 1 frcction end 15 or 20% for a total prescription.
2 CRAIRMAN STITT: Or you could just look at 3 total prescription.
4 I know you've brought up the issue of looking 5 at single and then having something that also was an 6 escape clause using total.
7 Jeff, you do -- you're fairly knowledgeable.
8 I lean more towards the total unless forced 9 11to also making a statement about a percentage of a 10 single --
11 MEMBER WILLIAMSON: Well, yes; I think the 12 main force of the regulation should be to address total.
13 And I think fer safety significant events, 20% is not 14 unreasonable.
15 CHAIRMAN STITT: For single?
16 MEMBER WILLIAMSON: No, for total dose.
17 I think that we could debate back and forth 18 and probably come up with some consensus what to do for a 19 s Ausc: fraction. I think it should be significantly 20 larger than 20%. I don't think I would -- I don't think 21 it's necessary to back down from the 20% for the total.
22 Currently, HER is governed -- the 23 understanding of the regulation in the community is that 24 it applies to total prescribed dose and not individual 25 fractions.
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- _. _ ._ ._ _ _ .. , - ~. _.__.._--m.__ _ _ _ _ _ _ _ _ .
(-
1 1
593 1 CHAIRMAN STITT: But that's really depending -
2 -
it ' may be an understanding 'luesday, but it may not- be ,
,- t 3 Friday,-and it~may differ from-region to region. I mean,
- 4'~ Ifd-like--- I'd prefer that, and I know that that's the i
5 custom.- The NRC has been behaving _that-way more recently 6 than not, but it's not black and white.
7 MEMBER WILLIAMSON: That's been, you know, my
-8 understanding from discussing it with them that that's 9 been the resolution. And it depends somewhat-on how one -
-10 writes the written directive. We. talked about -- someone l 11- mentioned - =maybe it was Dan earlier today.
1 12 If-you write-single fractions every day, then 13 yes, it will be single _ fraction. But that's within the
-r 14 control of the authorized user now and, to some extent,
$ 15 under the control of the licensee-in terms'of how they 16 write their written-QMP that's required.
17 You can actually have some influence on what 18 written directive means by how you phrase that document.
19 CHAIRMAN STITT: Well, we finished the list.
20 We still have these kind of outliers -- not outliers, but
-21 these issues that-we-haven *t resolved. I'm a little bit 22 reluctant to - even though we still have a quorum, I'm
- 23 reluctant to -- what?
24- -MEMBER SWANSON: Will you still have a quorum 25 after I leave?
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594 1 CHAIRMAN STITT: No. Maybe you should juct 2 leave.
3 MEMBER SWANSON: Bye.
4 MS. HANEY: No, we still do because we only 5 had nine appointed members that we started out with.
6 CHAIRMAN STITT: We have a lot of information 7 in the minutes about wrong sites and about the under dose.
8 And I don't know if we can -- want to try to clarify it 9 any further.
10 MEMBER WILLIAMSON: Here's a proposal to try 11 and address -- to make a compromise between Dan's case and 12 the case I brought up. If you recall, you know, you and 13 I worked on a proposal for ASTRO to redefine the concept 14 of misadministration.
l 15 And we came up with the compromise of 200 1
16 centrigray being the threshold for wrong site reporting 17 thinking that that's pretty close to the minimum dose to a 18 localized organ which we were thinking of, the lens of the 19 eye, that could cause a complication in a patient or be 20 likely to cause a complication in a patient.
21 And so that would be a compromise between ten 22 percent of the total prescribed dose, which could be as 23 much as 600, and Dan's suggestion we make it ten percent 24 of the fraction size, which would be about -- you know, 25 for HDR, would be, you know, 20 to 100 centigray.
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595 1
1 CHAIRMAN STITT: Dennis. !
l
,~ ~') 2 MEMBER SWANSON: Would you though want to l
3 actually use 100 rads because that's where your abnormal 4 occurrence levels are at? I mean, I think rather than 5 200, is 100 reasonable?
6 CHAIRMAN STITT: Is that more --
7 MEMBER SWANSON: No , I take that back, it's 8 not.
9 ' MEMBER WILLIAMSON: If it were the eye, maybe 10 we would want to say specific exemption for the lens of 11 the eye just because that's addressed in their abnormal --
12 MEMBER SWANSON: Yeah, it's 100 --
13 MEMBER WILLIAMSON: I think for other organ
'v' 14 systems, it should be higher.
15 MS. HANEY: So the AO criteria is 1,000 to any 16 other organ.
17 MEMBER WILLIAMSON: Yes, maybe we should just 18 say it should be the AO criterion -- the AO wrongful or 19 unintended dose delivery criteria.
20 MEMBER SWANSON: Thousand's getting pretty 21 well up there.
22 MEMBER WILLIAMSON: Yes.
23 MEMBER FLYNN: But if you gave --
if you're 24 giving 200 rad fractions, and for the entire first week of h
! 25 July you gave Ms. Jones five t eatments for 200 rad w.-)
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596 1 frcetions to har right hip; and then the next Monday you 2 said oh, wait, it was the left hip, and then you don't 3 think the five therapeutic treatments to the wrong hip 4 would be the wrong site?
5 It's only a thousand rads.
6 CHAIRMAN STITT: That's really tacky.
7 MEMBER FLYNN: This has happened though.
8 Right and left incidents have happened a lot. It's a lot 9 of AO's on right versus left.
10 CHAIRMAN STITT: Glad I'm not an orthopedist.
11 When you get right and left mixed up, it's more than just '
l 12 a dose of radiation.
13 MEMBER WALKUP: It depends. The prescription 14 written for the incorrect hip -- I mean --
15 MEMBER FLYNN: The physician made a mistake.
16 He meant to put left hip. He put right hip.
17 MEMBER WALKUP: Then it's not a 18 misadministration.
19 MEMBER WILLIAMSON: It's not a 20 misadministration.
21 MEMBER WALKUP: If you're following the 22 prescription --
23 MEMBER FLYNN: Or in one case, the patient was 24 flipped on the table. It was a therapist mistake because 25 the patient was prone and then he put right hip, but NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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_o
597 1 whetover it wcs, tha film uac labaled wrong, whctavor.
(3 2 CHAIRMAN STITT: Well, you know, the other 3 thing is we don't have to come to a consensus, a 4 conclusion on this. I mean, we keep bringing it up. We 5 have stieng opinions that these are issues that need to be C addressed. Wa're really honing in on it, so I --
7 MEMBER FLYNN: I think wrong site like this 8 creates a problem because Jeff's example was -- Jeff's 9 example that he brought up mar times was that the 10 resident drops the source and gives a couple of millirem 11 to the thigh which has already gotten a thousand rem. Now 12 it's quite a bit different.
,_s 13 We're talking about a -- you know, a million
/ N
'sm- ) 14 timet that dose to the wrong site, and we're still finding 15 it aces.pt able . I think this would indicate there could be 16 a problem with the licensee. Not to be punitive to them, 17 but this is sort of in line with the other things that 18 we're reporting as reportable events.
19 It's not any less serious if you treat the 20 wrong site to 200 centigray than some of the other 21 reporting requirements we hava. It eliminates the 22 examples Jeff's given before about the trivial wrong site. .
23 CHAIRMAN STITT: So what's your suggestio;4i l i
24 You've lost me. I f^N
( );i 25 MEMBER WILLIAMSON: What's the suggestion, NEAL R. GROSS I
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598 1 Dan, the critorion?
2 CRAIRMAN STITT: Yes.
3 MEMBER FLYNN: Well, the examples you gave i
4 before -- and there have been some incidents that have 5 been reported that we've had to look into as consultants 6 where the wrong site was a little bit on the trivial side.
? It was a very low dose, but it was the wreng site.
8 So it was the inner thighs typically of like 9 an HDR patient, whatever.
10 CHAIRFUui STITT: But what are you suggesting?
11 MEMBER FLYNN: I'm suggesting that it should 12 be higher than a thousand because it can be a reportable 13 event to the NRC without having it to be such a high dose.
14 CHAIR)Ud1 STITT: I don't know if we can 15 resolve this. I think we ought to do what we've done to 16 this matrix which works nicely, and there's lots of 17 discussion that we have concerns that wrong site needs to 18 be more -- to be flushed out or addressed more clearly.
'. 9 MEMBER WILLIAMSON: Yes, we need --
20 CHAIRMAN STITT: And that the issue of greater 21 or less than these percentages, that the under dosages you 22 can -~ also needs to have greater detail paid to it. And 23 let us thrash this out --
i 24 MEMBER FLYNN: It also goes against everything 25 we have agreed to before in the radiation oncology side NEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N W.
(202) 2344433 WASHINGTON, D C. 20005-3701 (202) 234-4433
I l 599 i
l 1 wao that we'd go by percontagas. The other way around f f^T 2 would be a dose plus a percent. Either a thousand rad or t )
3 -- and/or greater than 20% of the prescribed dose.
4 CHAIRMAN STITT: I think the important thing 5 that we've done here for the staff is that we have set up
( 6 some very specific criteria that we strongly are in favor 7 of, and now we're really trying to fine tune and hone in 8 on it.
9 I think that's the important statement that's 10 come out of this. And that we have -- you know, we really 11 have used -- what we have in print is different than --
12 the alternatives one through five are very general. We've
-s 13 already put in tremendous amount of detail into these k-s 14 alternatives for reportable event.
15 MEMBER WILLIAMSON: Do you want me to read the 16 ASTRO definition *. hat we suggested, or is it --
17 CRAIRMAN STITT I don't -- actually, Jeff, I 18 don't think I'm going to allow us to act on it. I think 19 the group's too small, it's too late in the day. I think 20 the points have been well made. We've made it through 21 every single modality, and I think we have identified the 22 issues that need further work.
23 So I would aolicit that any people can bring 24 other ideas, and we need to have the group respond to it.
(
) 25 Cathy, I'm going to turn it over to you.
NEAL R. GROSS CoVRT REPORTERS AND TRANSCRlBERS 1323 RHoDE ISLAND AVE., N.W.
(202) 234-4433 WASHINGTON, D.C. 200054 701 (202) 2244433
600 1 MS. }lANEY: All right then, I would just liko 2 to thank everyone. I think it's been a great meeting.
3 We've gotten a lot out of it from the standpoint of the 4 members of the working group that were. here and we 5 appreciate it. And as designated federal official, I 6 close the meeting.
l I 7 (Whereupon, the proceedings were adjourned at
(
8 3:57 p.m.)
9 10 11 32 2
13 14 15 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REFORTERS AND TRANSCR:BERS 1323 RHODE ISLAND AVE., N W.
(202) 234-4433 WASHINGTON, D C. 20005-3701 (202) 2344433
O CERTIFICATE This is to certify that the attached proceedings before the United States Nuclear Regulatory commission in the matter oft Name of Proceeding FALL 1997 ACMUI Docket Number N/A 1 Place of Proceeding ROCKVILLE, MARYLAND 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 reduccd to typewriting by me or under the direction of the ccurt reporting company, and that the transcript is a true and accurate record of the foregoing proceedings.
N 'lu "'
i CHRIS'BXMR official Reporter Neal R. Gross and Co., Inc.
O NEAL R. GROSS COUP.T REPORTERS AND TRANSCRIBER $
1323 RHODE ISLAND AVENLT, NW (202)234-4433 WASHINGTON, D C. 20005 (202)234 4433
1 MEMBERS OF THE PUBt.1C SIGN IN SHEET (DO NOT REMOVE THIS FORM)
ACMUl Meeting September 25 26,1997 U.S. Nuclear Regulatory Commission Two White Flint North, T283 Sign in over your name,if your name does not appear, print then sign.
Please print legibly, as this la a public document 1
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CHAPTER I FOOD AND DRUG .
ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (Continued) 1 SUBCilAl*TER ll-MEDICAL DEVICES Part l'090 800 General.................................................................... 5 801 Labeling.................................................................. 13 803 M ed ical d evice re por ti ng . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 804 Medical device distributor reportin'g ...................... 51 805 C ard i ac pace ma k e r registry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 807 Establishment registration and device listing for manufacturers and distributors of devices ........... 59 I 808 Exernptions from Federal preemption of State and local medical device requirements ....................... 74 809 In vitro diagnostic products for human use ............ 84 810 Medical device recall authority (Eff. May 19, 1997) 90 W 812 Investigational device exemptione .......................... 96 ?W 813 [ Reserved]
814 Promarket approval of medical devices .................. 111 820 Quality system regulation (Eff. June 3,1997) .......... 133 821 Medical device tracking requirements .................... 154 860 Medical device classification procedures ................ 160 861 Procedures for performance standards development 172 862 Clinical chemistry and clinical toxicology devices 176 ,
864 Hematology and pathology devices ......................... 207 866 Immunology and microbiology devices ................... 225 868 A n es th es101 ogy de v i c es . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259 870 Cardi ovasc ula r d e vi ces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278 872 D e n ta l d e v i c e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297 874 Ear, n ose, and th roat devices . .. . . . . . . . . . . . . . . .. . . . .. . . . . . . . . . . 319 876 G as t ro e n te rol ogy - u rology d e vices . . . . . . . . . . . . . . .'. . . . . . . . . . . 329 878 General and plastic surgery devices ........................ 344 880 General hospital and personal use devices .............. 355 882 N e u rol o gical d e vic es . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . .M 372 884 Obstetrica: and gynecological devices ....'.. .... .... . 386 3 ,
t .
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21 CFR Ch. I (4-1-97 Edmon)
Page Part 880 O p th a l m i c d e v i c e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 403 888 O r th o pe d i c d e v i c e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 424 000 Physical medici ne d ovicos .... ... ........ ................... .... . 444 892 Ra d i o l o gy d e v i c e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 459 895 B an n e d d e v i c e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 470 897 Cigarettes and smokeless tobacco (Eff. August 28, 1997)..................................................................... 476 SUBCHAPTER I-MAMMOGRAPHY QUALITY STANDARDS ACT l 900 M am m o g ra ph y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 481 SUBCHAPTER J-RADIOLOGICAL HEALTH 1000 G e n o ra l . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
492 1002 Re c o rd s an d re p o r ts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 501 1003 Notification of defects or failure to comply ............ 510 1004 Repurchase, repairs, or replacement of electronic products............................................................... 513 1005 Importation of electronic products ......................... 515 1010 Performance standards for electronic products:
g e n e ra l . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 519 1020 Performance standards for ionizing radiation emit-M ti n g p r o d u c ts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 524 RTN48 1030 Performance standards for microwave and radio frequ ency emitting products ............. .. .. ........... . . .. 553 1040 Performance standards for light-emitting products 556 1050 Performance standards for sonic, infrasonic, and ultrasonic radiation-emitting products ............... 580 SUBCHAPTER K [ RESERVED) i SUBCHAPTER L--REGULATIC N3 UNDER CERTAIN OTHER ACTS ADMINISTERED BY ThE FOOD AND DRUG ADMINIS-TRATION 1210 Regulations under the FederalImport Milk Act .... 584 1220 Regulations under the Tea Importation Act ........... 587 1230 Regulations under the Federal Caustic Polson Act 596 1240 Control of com m u nicable diseases ....... .......... ...... . .. 602 1250 Interstate conveyance sanitation ........................... 611
.r e 1251-1269 [ Reserved]
1270 Human tissue intended for transplantati'on . . .. . . 621 1271-1299 [Roseryed]
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i890.5880 Multi functi:n phy:Ical 6890.5950 P:wcred heating unit.
ther:py table.
(c) Identification. A powcred heating (n) Identification. A multi-function unit, is a devico intended for medical physical therapy t,ablo is a devico in- purposos that consista of an oncased tended for medical purposes t, hat, con- cabinot, containing hot water and that sists of a motorized t,ablo equipped to is intended to heat and maintain hot provido pation',,a with heat, traction, packs at an olevated t,emperaturo, and musclo rolaxation therapy. (b) Classification. Class I. The device (b) Classification. Class II (porform- la oxompt, from the promarket notifica-anco st.andards). tion proceduros in subpart, E of part 807 ;
of this chapt.cr.
6890.5900 Power traction equipment-148 FR 53047, Nov. 23,1983, as amended at 61 (a) Identification. Powered t.raction FR 1125, Jan.16,1996) equipment, consist,s of powered devices Intended for medical purposes for uso 6890.5975 Therapeutic vibrator.
in conjunction wi t.h t,raction acces- (a) /dentification. A therapoutic vibra-sories, such as belt,s and harnesses, to t,or is an electrically poworod device in-cxort, therapeutic pulling forces on the tended for medical purposes that incor-patient's body. porates various kinds of pads and that !
(b) Classification. Class II (perform- is hold in the hand or attached to the anco standards). hand or t,o a table. It is intended for various uses, such as relaxing muscles
$ 890.5925 Traction accessory. nnd relieving minor achos and pains, (a) Identification. A tract,lon acces- (b) Classification. Class I. The device tory is a nonpowered accessory device is exempt, from the premarket notifica-int, ended for medical purposes to be tion procedures in subpart E of part 807 of this chapter.
used with powered traction equipment to aid in ex^erting t.herapeutic pulling 148 FR 53047, Nov. 23.1983, as amended at 61 forces on the patient's bo<ly. This go- FR M .Jan M, W notic type of device includes the pul- g ley, strap, head halter, and pelvic belt. PART 892-RADIOI.OGY DEVICES (b) Classification. Class I. The device 3g is exempt from the premarket notifica- g, tion procedures in subpart, E of part 807 Sec.
of this chapter. The device is also ex- 892.1 Scope.
empt, from the current, good manufac. 892.3 Effective dat.cs of requirement for pre-turing practico regulations in part, 820 g "P{^[j of this chapter, wit.h the except,lon of 6820.180, with respect to general re- tion 510(k) of the Federal Food, Drug, quirements concerning records, and and cosmetic Act (the act).
$ 820.198, with respect to complaint Subport 8-Diagnostic Dovices files.
892.1000 Magnetic resonance diagnostic de-
[48 FR 53047, Nov. 23.1983, as amended at 61 vice.
FR 1125. Jan.16.1996) 892.1100 Scintillation (gamma) camera.
892.1110 Positron camera.
6890.59-10 Chilling uniL 892.1130 Nuclear whole body counter.
892.1170 Hone densitometer.
(a) Identification. A chilling unit. is a 892.1200 Emission computed tomography refrigerative device intended for medi- system.
cal purposes to chill and maintain cold 892.1220 Fluorescent scanner. m :.-
packs at a reduced temperature. 892.1 2 Nuclear rectilinear scanner.
892.1310 Nuclear tomokraphy system.
(b) Classification. Class I. The device 892.1320 Nuclear uptake probe is exempt from the premarket, notifica- 892.1330 Nuclear whole body scanner.
Lion procedures in subpart M of part,807 892 1350 Nuclear scanmng bed of t,hl3 chapter. 892 1360 Itadionuclide dose cahbrator. ,
892 1370 Nuclear anthropomorphic phantom.
- [48 FR 53017. Nov. 23.1983 as amended at. 61 892.1380 Nuclear flood source phantom.
FR 1125. Jan.16.1996] 8P rm Had or" ~ ha" "'"",'u"ee " ' " "
9j5JR. I 2I CFR CTI. I (eI-97 EWOA) 892.1400 Nuotoar sealed calibr; tion souros, 892.5650 Manu:1 ruilonuclids applic: tor syc-892.1419 Nuclear elect.rocardiograph syn- t.em, chroniser. 892.5700 Itemot,e controlled radionuclide ap- .
892.1420 Redlonuclide test, pattern phantom- plicator system.
892.1540 Nonfet,al ult.rasonic monitor. 892.57M Radiation therapy beam-shaping 892.1550 Ult.rasonic pulsed doppler imaging block nu achhapy source.
892.1 Itrasonic pulsed echo imaging sys- 892.5740 Radlonuclide teletherapy source.
t,e m' 892.1570 Diagnostic ultrasonic transducer. 892.5750 Radlonuclide radiation therapy sys.
892.1000 Angiographic x ray system, tem.
892.1610 Diagnostic x ray beam-limiting do. 892.5770 Powered radiation therapy patient vice, support assembly. P 892.1630 Cine or spot nuorographic x ray 892.5700 Light, beam patient position indica-camera. Lor.
892.1630 Electrostatic x-ray imaging system. 892.5840 Radiation therapy simulation sys-892.1640 Radiographic film marking system. Lem.
892.1650 Image intensified nuoroscopic x- 892.5900 X ray radiation therapy system.
ray syst.em. 892.5930 Therapeutic x ray tube housing as-892.1660 Non image intensined Ouoruscopic sembly.
x rav syst,em.
892.1670 Spotrfilm device. Subpart G-Miscelloneous Devices 892.1680 Stationary x ray syst,em.
892.1700 Diagnost,1c x ray high voltage gen
- 892.6500 Personnel protective shield.
erator.
892.1710 Mammographic x ray system. Atrruonrry: Secs 501, 510, 513, 515, 520, 701 892.1720 Mobile x-ray system. of the Federal Food, Drug, and Cosmetic Act e92.1730 enotonuorographic x ray system. (21 v.s.C. 351, 380. ac0c, ac0e, ac0j, 371).
892.1740 Tomographic x ray syst,em. SOURCE: 53 FR 15G7, Jan. 20,1988, unless 892.1750 Computed tomography x ray sys-t,em.
892.1700 Diagnostic x ray tube housing as-sembly. . Subport A-General Provisions 892.1770 Diagnostic x ray t,ube mount.
892.1820 Pneumoencephalographic chair. 68911 Scope.
8925 330 Radiologic patient cradle. N 892.1840 Radiographic film. (a) This part set.s forth the classifica-892.1850 Radiographic film cassette. tion of radiology devices int.cnded for 892.1860 Radiographic Olm/ cassette changer, human use that are in commercial dis-892.1870 Radiographic film /casset,te changer tribution.
programmer.
892.1880 Wall mount.ed radiographic cassette (b) The identification of a device in a holder. regulation in this part is not, a precise 892.1890 Radiographic film illuminator, description of every device that is, or 892.1900 Automatic radiographic film proc- will be, subject t.o the regulation. A manufacturer who submits a pro-892.19 0 Radiographic grid.
892.1920 Radiographic head holder. market notification submisalon s*0r a 892.1940 Radiologic quality assurance in. device under Part 807 cannot show strument, merely that the device is accurately 892.1950 Radiographic ant.hropomorphic described by the section title and iden-phantom. tification provision of a regulation in 892.1960 Radiographic int,ensifying screen, this part but shall state why the device 892.1970 Radiographic ECG/ respirator syn-chronizer. is subst.antially equivalent t,o other de-892.1980 Radiologic table. vices, as required by 6807.87.
892.1990 Transiliuminator for breast evalua- (c) To avoid duplicative listings, a ra-tion. diology device that has tg.or more . .. .
types of uses (e.g., use bot.h as a diag-Subparts C-E (Rosorved] nos' tic device and a therapeutic device)
Subparl F-Thoropoutic Devicos is listed in one subpart only.
(d) References in this part, to regu-892.5050 Mmilcal charged-particle radiation lat,ory sections of the Coie of Federal Regulations are to Chapter 1 of this y 892.f to a r eutron radiation t,herapy m.c ,u., Title 21, unless otherwise noted.
.c s urn un, s vi-s-w commeu laser beam rath:r than with a chnrp- (b) Classification. Class I.
cnod mot,al blad , cr cn in vit.ro ding.
nortio d:vicJ d:Locts or id:ntiflos in- IM PR 484H, N:v. 20,1990) ,
foot,lous agents by using a deoxyribonucloto acid (DNA) probo or 9892.1130 Nuclear whole hodY
- " " I"'
nucloto acid hybridir.ation technology rather than culturo or immunoansay (a) Identification. A nuclear whole technology. body counter is n devico intor.dod to (M FR 13831, Apr. 5,1989] meu o amoun of rmHouucMos in the entiro body. This gonoric t,ype of devico may includo signal analysic and Subport B-Diagnostic Dovicos display equipment, patient and equip.
i
$ 892.1000 Magnetic resonance din g. mont, support.s, component part,s, and nostic device. amasories.
(a) Identification. A magnetic reso- (b) Classification Class 1. The devico nat4co diagnostic device is intended for is xompt m o pmmadot n Wica- i general diagnostic use to present im. t,lon procedurcs in subpart, E of part 807 ages which reflect the spatial distribu- f this chapter, tion and/or magnetic resonance spectra (53 FR G7, Jan. 20,1988, as arnended at, 59 which reflect frequency and distribu. FR 0001o Dec. 7, IMI) tion of nuclei exhibiting nuclear mag- 12 FR m, How 20,1990) notic resonance. Other physical param-otors derived from the images and/or spectra may also be produced. The de- 6892.1170 Bone densitometer.
vice includes hydrogen-1 (proton) Imag. (a) Identification. A bono de wit,om-ing, sodium-23 imaging, hydrogen-1 eter is a device intended for medical spectroscopy, phosphorus-31 spectros, purposes to measure bone densit.y and copy, and chemical shift imaging (pre. mineral cont,ent, by x-ray or gamma serving simultaneous frequency and ray transmission measuremen t.s spatial information), through the bone and adjacent, tissues.
(b) Classi/Ication. Class II. This generic type of device may in- gg
[53 FR 5078. Feb.1,1989) ch 8%nal anahsis and WsNay @p-ment, patient and equipment supports, 5892.1100 Scintillation (gammn) cam. component parts, and accessories, cra. (b) Classification. Class II.
(a) Identification. A scintillation (gamma) camorn is a device intended 9892.1200 Emission computed tomog.
to image the distribution of radio- raphy system.
nuclides in the body by means of a pho. (a) Identification. An emission com-ton radiation detector. This generic puted tomography system is a device type of device may include signal anal- intended to detect the location and dis-ysis and display equipmen t , patien t tribution of gamma ray- and posit,ron-and equipment support.s, radionuclide emitting radionuclides in the body and anatomical markers, component parts, produce cross-sectional images through and accessories, computer reconstruct,lon of the data.
(b) Classification. Class I. This generic type of device may in-(55 PR 48413, Nov. 20,1990) clude signal analysis a,nd display equip-ment,, patient, and equipment, supports, 5892.1110 Positron camern. radionuclide anatomical markers, com-(a) Identification. A positron camera pon nt, paM.s, and amssmles.
is a device intended to image the dis- (b)' Classification. Chtss II. -
tribution of positron-emitting radio-nuclides h1 the body. I'his generic type 6892.'1220 Fluorescent scanner.
of device may include signal analysis (a) /dentification. A Guorescent, scan-and display equipment, pa t,ien t and nor is a device intended t,o measure the equipment supports, radionuclide ana- induced fluorescent, radiat,lon in the tomical markers, component part,s, and body by exposing the body t,o cert.nin x-g accessories, rays or low-energy gamma rays. This '
been oatablished of the requiremont, for 6870,35.35 Intwag>r4Le balloon and c:ntrol cy: tem premarket, approval. See $870.3.
[45 FR 7907-7971, Feb. 5,1980, na amended at (n) Identification. A intra-nortic bal- .
t loon and control system is a devico 52 FR 17736, May 11.1987) that conalats of an inunt.ablo balloon, 6870.3450 Vaacuhar graft prostheals of which !s placed in the nort.a to improvo less than 6 millimeters dLameter, cardiovascular functioning during cor-tain life threatening emergencies, and (a) Identification. A vascular graft a control syst.om for regulating the in-prostheals of less than 6 millimeters 0nd n and donadon of um bnHoon.
! (mm) diamotor is a devico used to re- ,l'ho control system, which monitors t l
I>1 ace sections of small arterf es. This and is synchronized with the elect,ro-prost, hosts is commonly constructed of cardiogram, provides a means for set-woven or knit,t,ed materials such as pol- ting the innation and donation of tho balloon with the cardiac cycle.
l yethylono torophthalato and polytetra-Duoroothyleno and is not made of ma- (b) Classification. Class III (premarket t
torints of animal origin, including approval).
human umbilical cords. (c) Date PMA or notice of completion of (b) Classification. Class III (premarket a PDP is required. No ofrectivo dato has approval). boon established of the requirement for (c) Date PMA or notice of completion of promarket approval. Soo 5870.3.
a PDP is required. No offect,1vo dato has (45 FR 7907-7971, Feb. 5,1980, as amended at b:en established of the requirement for 52 FR 17736, May 11,19871 promarket approval. Sco $870.3.
6870.3545 Ventricular bypass (assist)
(45 FR 7907-7971. Feb. 5,1980, as amended at device.
52 FR 17736, May 11,19871 (a) Identification. A ventricular by-6870.3460 Vascular graft prosthesis of pass (assist) device is a device that as-6 milllineters and greater diameter, sists the left or right ventricle in main-talning circulatory blood now. The do-(n) Identification. A vascular graft vice is either totally or partially im-prosthesis of 6 millimeters (mm) and planted in the body.
greater diameter is a device used to re . (b) Classification. Class III (premarket place sections of arteries. This pros- approval),
thesis is commonly constructed of (c) Date PMA or notiec of completion of woven or knitt,ed materials such as pol- a PDP is required. No effective date has yethyleno torophthalato and polytetra- boon established of the requirement for fluoroethylene and is not made of ma- premarket approval. Sco $ 870.3, t,crials of animal origin, including g human umbilical cords. 52 FR 17736. May 11.1987)
(b) Classification. Class II (perform-ance st.andards). 6870.3600 External pacemaker pulse generator.
6870.3470 Intracardiac patch or pledg- (a) Identification. An external pace-et made of polypropylene, poly- maker pulse generator is a device that ethylene terephthalate, or poly- has a power supply and electronic cir-
" # "' cuits that produce a perjodic electrical (a) Identification. An intracardiac pulse to stimulate the heart. This de-patch or pledget made of poly- vice, which is used outside the body, is propyleno, polyethylene t,crephthalate, used as a temporary substitute for the or polytetrafluoroethylene is a fabric heart's, intrinsic pacing sytenWntil a device placed in the heart that is used permanent pacemaker can be im-to repair septal defects, for patch graft- planted, or to control irregular heart-ing, to repair tissue, and to buttress au- beats in patients following cardiac sur-tu res, gery or a myocardial infarction. The device may have adjustment.s for im-(b) Classification. Clasa II (perform. pulse strength, duration, R-wave son-t ance standards). sitivity, and other pacing variables.
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. . 1 TRAINING AND EXPERIENCE Authorized User
- 1. Status Quo
- 2. M.D. + Board certification or specified number of hours of training and experience
- 3. M.D. + Board certification or specified number of hours of training .
I
- 4. M.D. only
- 5. M.D. + exam
- 6. M.D. + exam + clinical experience
l l
AUTHORIZED USER OVERVIEW ALTERNATIVES KEY ITEMS FOR CONSIDERATION 1 2 3 4 5 6 More than one means to meet training ard experience X X X criteria.
Modality specific. X. X X X X Easy to use if board certified. X X X Emphasis on radiation safety training when training and X X experience required. (i.e., risk based)
Board changes do not require rulemaking. X X Standardized method for testing a baseline of training and X X X experience.
Licensee given complete latitude to review and approve X users.
R: source intensive to develop and administer exam. X X X Added expense to person taking exam. X X X Ad.ied assurance that tested individual is aware of radiation X X X s fety issues.
Clinical experience component included. X X X X 9
0 h
n
- , . _ . . - - . - - - - , _ _ , _ ,c.. - __- ,-.--~-- ._ .---- -.- .s - . , , _ , ,
i
SUMMARY
OF ALTERNATIVES - RSO l 1. AUTHORIZED USER OR BOARD CERTIFIED (OR # .
! OF HOURS) AND ONE YEAR UNDER AN RSO
! 2. BOARD CERTIFIED (OR # OF HOURS SPECIFIC TO USE REQUESTED) i l' i
! 3. BOARD CERTIFIED (OR # OF HOURS SPECIFIC j TO USE REQUESTED) + EXAM i
l 4. EXAM ONLY
- 5. ONE YEAR UNDER AN RSO + EXAM
,---,,---,,,,,-m-w%,.,sm.--,,m%% -,-_y-p ..,ym.-.y,----.--.--...w~--,,w .-w. -..,w.< -, , , . , , - - .-- - . , . . - - m. - - . --.. ., - - . , .---.-- .-_____-___ - - _ _ . - - - - -- - - - - - - - - - - - - - -- - - - - - - - - - - - - - ----u --
i i
l DISCUSSION ITEMS FOR PREVIOUS
- RECOMMEXDATIONS OF THE ACMUI i
- 1. ACMUI recommended that Statements 2 and 3 of 1979 Medical Policy Statement be revised.
i
- 2. ACMUI recommended retention of the current regulatory approach for
- Part 33.
I i 3. ACMUI recommends the NRC modify the QM inspection procedures svith I
the intent to reflect the spirit of the Commission direction in the SRM l regarding DSI 7.
1 i
r .
1 l
WORKING SCHEDULE i
i i
l Proposed Rule (with guic ance) l to Commission May 1998 i
! Final Ru e (with guidance)
! to Commission May 1999 i
. _ . -_.._ ____.--,_ _-___-_._._.._---___. -___.__ ._,.._ -_-_.___ _ ,__ _ _~-...__- _-, -
j.
PART 35 REVISION WRITING GROUP Donna Beth Howe, NMSS i
Jenny Johansen, Region I
! Sam Jones, RES i
}
} Penny Lanzisera, Region I i
Myron Pollycove, NMSS l Torre Taylor, NMSS i
i
5 . .
- PART 35 REVISION WORKING GROUP j Cathy Haney, Chairperson, Office of Nuclear Material Safety i
and Safeguards Lloyd Bolling, Office of State Programs Diane Flack, NMSS
- Marcia Howard, State of Ohio Sam Jones, Office ofNuclear Regulatory Research
) Penny Lanzisera, Region I 4 Marjorie Rothschild, Office of the General Counsel David Walter, State of Alabama Susanne Woods, NMSS
September 9,1997.
CHARTER FOR PART 35 WORKING GROUP MEMBERS: Cathy Haney, NMSS. Chairperson Lloyd Bo!,ing, OSP __
Diane Flack, NMSS Marcia Howard, State of Ohio Sam Jones, RES Penny Lanzisera, Region l Marjorie Rothschild, OGC David Walter. State of Alabama Susanne Woods, NMSS TASKS:
- 1. Review draft rule text prepared by NRC staff and develop rule text alternatives for major regulatory issues associated with the medical use of byproduct material.
- 2. Prepare recommendation, including any proposed changes, to the Commission regarding changes to the 1979 Medical Policy Statement.
- 3. Participate in meetings held by NRC in the fall of 1997 to solicit public input on rule text alternatives and in the summer of 1998 to solicit public comments on the proposed rule and associated draft documents.
- 4. Bring major regulatory issues to the attention of the steering group and incorporate steering group recommendations into the rule text and associated guidance documents.
- 5. Prepare and/or review draft - and final rulemaking packages, including any associated guidance documents, for submittal to the Commission in accordance with the schedule established in SECY 97-131. Ensure that all documents address appropriate elements of SRM COMSECY 96 057, Materials / Medical
- Oversight (DSI 7).
- 6. Review, consider, and resolve, as appropriate, public comments on the rule and any other associated documents, i l 7. Prepare or review, as applicable, documents in support of the rulemaking package (e.g. regulatory analysis, environmental assessment, OMB clearance package). '
- 8. Review the Enforcement Policy to identify any changes needed to reflect the -
revisions made to Part 35 and make recommendations for any needed changes.
- - . - - . . - - - - . . . ~ _ . , - , , , - , . . . - . - . . . - , . , , - _ . - ~ , - , - , - - - - , . ,~ --
l- . .
l PART 35 REVISION STEERING GROUP l
l l
Don Cool, Chairperson, Office ofNuclear Material Safety
- and Safeguards
) Tom Hill, State of Georgia
! Jim Lieberman, Office of Enforcement ,
! Paul Lohaus, Office of State Programs 3
Stu Treby, Office of the General Counsel .
Cheryl Trottier, Office of Nuclear Regulatory Research I :
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- i i
i a
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PUBLIC AND PROFESSIONAL INPUT 1
l I
I i
I l 1. Meetings with Professional Societies i
i 2. Public Meeti: s i
- 3. Internet I
3 e
i t
4
- ~ -
i RECENT INTERACTIONS WITH l
i MEDICAL PROFESSIONAL SOCIETIES I
l American College of Medical Physicists American College of Radiology
- Oncology Nursing Services l American College of Radiation Oncology i
4
-_ _ . . _ . . . , - - . _ _ _ _ _ . . _ . _ , _ _ _ _ ~ . _ _ _ , . _ . . _ , . _ _ . . _ . . , . _ , _ . _ . _ _ _ . _ _ _ , _ _ _ . , ,- _
UPCO MING MEETINGS WITH MEDICAL PROFESSIONAL SOCIETIES l American Association of Clinical Endocrinologists American Hospital Association American Society of Therapeutic Radiology and Oneclogy American College of Cardiology American Society ofNuclear Cardiology American Heart Association Radiation Society ofNorth America American Board of Radiology American Association of Medical Dosimetrists
~
-, A 15 M
l l
l l PUBLIC MEETINGS i
October 18,1997 All Agreement States Meeting Los Angeles, CA I
Westin Suites Hotel
- October 28-30,1997 Philadelphia, PA Korman Suites Hotel .
l November 12-14,1997 Chicago, IL
! Ramada Congress Hotel 1
INTERNET Technical Conference Forum http:\\techeonf.lln1. gov /noframe.html .
e 4
1 RECOMMENDATION FOR REVISION TO
, NRC'S 1979 MEDICAL POLICY STATEMENT OPTION 1: Status Quo ,
i Current statement of general policy to guide regulation of medical uses of radioisotopes states:
I l
- 1. The NRC will continue to regulate the rhedical uses of radioisotopes as necessary to provide for the radiation. safety of workers and the general public. .i
- 2. The NRC will regulate the radiation safety of patients where l justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.
l 3. The NRC will minimize intrusion into medical judgments l affecting patients and into other areas traditionally considered to be a part of the practice of' medicine.
i
+
l OPTION 2: April 1997 recommendation of the Advisory Committee on the Medical Uses of isotopes (ACMUI)
ACMUI recommended statement of. general policy to guide regulation of medical uses of radioisotopes would be: j
- 1. [No change.]
- 2. The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary standards or compliance with these standards are inadequate. Assessment of the risks justifying such regulations will reference comparable risks and comparable modes of regulation for other types of medical practice.
- 3. The NRC will not intrude into medical judgments affecting l patients and into other areas traditionally considered to be a part of the practice of medicine.
i LOPTION 3: ;
t Revised statement of general policy to guide regulation of medical uses of radioisotopes would be:
i
- 1. [No change.] :
- 2. The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary standards or cumpliance with these standards are i inadequate. i
- 3. The NRC will continually strive to minimize involvement in niedical judgments affecting patients and into other areas traditionally considered to be a part of the practice of l medicine.
__ __ _. __ .__.._)
l l
l OPTION 4:
l Revised statement of general policy to guide regulation of medical uses of radioisotopes would be:
, I l i i 1. [No change.] :
l l
l 2. The NRC will regulate the radiation safety of patients consistent with the risk posed by the radioactive materials. In regulating the radiation safety of patients. NRC's role is to assure that the i
physician's prescription is accurately delivered to the correct oatient.
r
- 3. The NRC will not intrude into the medical judaement formina the basis of the physicians' prescription.
1 i
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- i. .
l l
l QUALITY MANAGEMENT PROGRAM l
l
- 1. Maintain current requirements; g35.32, sections (a)+(b)+(c)+(d)+(e)+(r).
- 2. Only require a written quality management program; 35.32, section (a).
- 3. Require written quality management program, audits, and retain each written directive and a record of each dosage requiring a written directive and perform audits; 35.32, Sections (a)+ (d)+(b with modifications).
- 4. Require written quality management program, retain each written directive and a record of each dosage requiring a written directive, and maintain a record of recordable events; e35.32, sections (a)+(d)+(c).
i
RADIATION SAFETY COMMITTEE
- 1. Status Quo
- 2. A RSC is required for a medical institution and all modalities, with the exception of diagnostic low dose sealed and unsealed byproduct material uses.
- 3. A RSC will not be required for any medical licensee.
- 4. A RSC will not be required, but medical licensees will be required to establish and implement a program for administrative and technical oversight of radiation safety.
TRAINING AND'EXPERTENCE Authorized User -
- 1. Status Quo t h
- 2. M.D. + Board certification or specified number of hours of training and experience i
- 3. M.D. + Board certification or specified number of hours of training
- 4. M.D. only
- 5. M.D. + exam
(
- 6. M.D. + exam + clinical experience l
F PATIENT NOTIFICATION
- 1. Status Quo
- 2. Licensee to notify NRC only but not referring physician or patient.
- 3. Licensee to notify NRC and referring physician but not patient.
- 4. Licensee would always notify NRC, referring physician, and patient or guardian.
- 5. Licensee would notify NRC and referring physician, and patient or guardian if, based on medical judgment, there are or would be detrimental effects on patient due to the reportable event.
4 i
RECOMMENDATION FOR THRESHOLD OF REPORTABLE EVENT
- 1. Status quo + precursor
- 2. Reportable raised to AO Criteria + precursor Recordable raised to current reportable
- 3. Reportable raised to AO criteria + precursor
- 4. Reportable lowered to current recordable + precursor
- 5. Alternative 1,2,3 or 4 with voluntary report of precursor 4
L______.___.
EVALUATION OF COMMITTEE AND COMM!TTEE MEMBERSHIP SEPTEMBER 25,1997 1
i i
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i 1
i COMSECY-96-028 i
l
- Reexamine role of ACMUI following determination of NRC ro!e for materials / medical program area 1
i
- Commission paper I
- ACMUI preliminary thoughts 1.
i 4
1 4
SECY 97-143 ACMUI NEAPPOINTMENT OF MEMBERS
- Brief performance evaluations for reappointments
- Allow ample lead time for Reappointment decisions
- Solicit input from RSO/HP in the interim for the Part 35 revision
- Reevaluate composition of ACMUi after Part 35
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, revision 3
SRM - ACMUI BRIEFING, DlS 7 AND PART 35
- Part 35. revision (including test casesD
- More risk-informed, performance-based regulatory program l
- - Address questions posed by Commission during briefing
- Industry Standards
- Positive enforcement program
- Criteria for events
- Establish threshold for evaluating errors
- OGC to provide analysis - risk in radiation medicine 4
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TRAINING AND EXPERIENCE Authorized User
- 1. Status Quo
- 2. M.D. + Board certification or specified number of hours of training and experience
- 3. M.D. + Board certification or specified number of hours of training
- 4. M.D. only
- 5. M.D. + exam
- 6. M.D. + exam + clinical experience
AUTHORIZED USER OVERVIEW ALTERNATIVES KEY ITEMS FOR CONSIDERATION 1 2 3 4 5- 6 More than one means to meet training ard experience X X X criteria.
Modality specific. X X X X X Easy to use if board certified. X X X Emphasir on radiation safety training when training and X X cxperience required. (i.e., riek based) _
Board changes do not require rulemaking. X X Standardized method for testing a baseline of training and X X X cxperience. _
Licensee given complete latitude to review and approve X E
users.
Resource intensive to develop and administer exam. X X X s
Added expense to person taking exam. X X X Added assurance that tested individual is aware of radiation X X X sr.fety issues.
1 Clinical experience component included. X X X X i l
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SUMMARY
OF ALTERNATIVES - RSO
OF HOURS) AND ONE YEAR UNDER AN RSO
- 2. . BOARD CERTIFIED (OR # OF HOURS SPECIFIC TO USE REQUESTED)
- 3. BOARD CERTIFIED (OR # OF HOURS SPECIFIC TO USE REQUESTED) + EXAM
- 4. EXAM ONLY
- 5. ONE YEAR UNDER AN RSO + EXAM
WORKING SCHEDULE Proposed Rule (with guic.ance) l to Commission May 1998 Final Ru e (with guidance)
.to Commission May 1999
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! PART 35 REVISION WRITING GROUP
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4 Donna Beth Howe, NMSS l Jeilny Johansen, Region I l Sam Jones, RES l
! Penny Lanzisera, Region I
! Myron Pollycove, NMSS l Torre Taylor, NMSS i
i Susanne Woods, NMSS l
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l PART 35 REVISION WORKING GROUP l
i Cathy Haney, Chairperson, Office of Nuclear Material Safety i and Safeguards Lloyd Bolling, Office of State Programs Diane Flack, NMSS l Marcia Howard, State of Ohio l Sam Jones, Office of Nuclear Regulatory Research Penny Lanzisera, Region I Marjorie Rothschild, Office of the General Counsel David Walter, State of Alabama Susanne Woods, NMSS
i e
September 9,1997 CHARTER FOR PART 35 WORKING GROUP MEMBERS: Cathy Haney, NMSS, Chairperson Lloyd Bolling, OSP Diane Flack, NMSS Marcia Howard, State of Ohio Sam Jones, RES Penny Lanzisera, Region i Marjorie Pcthschild, OGC
, David Waiter, State of Alabama Susanne Woods, NMSS TASKS:
- 1. Review draft rule text prepared by NRC statf and develop rule text alternatives for major r6gulatory issues associated with the medical use of bypm uct material,
- 2. Prepare recommendation, including any proposed changes, to the Commission regarding changes to the 1979 Medical Policy Statement.
- 3. Participate in meetings held by NRC in the fall of 1997 to solicit public input on rule text alternatives and in the summer of 1998 to solicit public comments on the proposed rule and associated draft documents.
- 4. Bring major regulatory issues to the attention of the steering group and incorporate steering group recommendations into the rule text and associated guidance documents.
- 5. Prepare and/or review draft and final rulemaking packages, including any associated guidance documents, for submittal to the Commission in accordance with the schedule established in SECY-97-131. Ensure that all documenta address appropriate elements of SRM - COMSECY-96-057, Materials / Medical Oversight (DSI 7).
- 6. Review, consider, and resolve, as eppropriate, public comments on the rule and any other associated documents.
- 7. Prepare or review, as applicable, documents in support of the rvemaking package (e g. regulatory analysis, environmental assessment, OMB clearance package).
- 8. Review the Enforcement Policy to identify any changes needed to reflect the revisions made to Part 35 and make recommendations for any needed changes.
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PART 35 REVISION STEERING GROUP l Don Cool, Chairperson, Office of Nuclear Material Safety l and Safeguards
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Tom Hill, State of Georgia Jim Lieberman, Office of Enforcement i Paul Lohaus, Office of State Programs
- Stu Treby, Office of the General Counsel Cheryl Trottier, Office of Nuclear Regulatory Research
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PUBLIC AND PROFESSIONAL INPUT 1
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1 i 1. Meetings with Professional Societies i
j 2. Public Meetings
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- 3. Internet
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RECENT INTERACTIONS WITH MEDICAL PROFESSIONAL SOCIETIES l
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! American College of Medical Physicists i
l American College of Radiology i
l Oncology Nursing Services j American College of Radiation Oncology 1
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i l UPCO MING MEETINGS WITH MEDICAL PROFESSIONAL SOCIETIES American Association of Clinical Endocrinologists American Hospital Association American Society of Therapeutic Radiology and Oncology
] American College of Cardiology 4 American Society ofNuclear Cardiology i American Heart Association l Radiation Society ofNorth America American Board of Radiology
- American Association of Medical Dosimetrists ;
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! PUBLIC MEETINGS i
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October 18,1997 All Agreement States Meeting
- Los Angeles, CA
- Westin Suites Hotel i
October 28-30,1997 Philadelphia, .PA Korman Suites Hotel November 12-14,1997 Chicago, IL Ramada Congress Hotel i
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- INTERNET l
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RECOMMENDATION FOR REVISION TO <
NRC'S 1979 MED CAL POLICY STATEMENT
-OPTION 1: Status Quo Current statement of general policy to guide regulation of medical uses of radioisotopes states:
- 1. The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public.
- 2. The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequete.
- 3. The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine.
OPTION 2: April 1997 recommen'dation of the Advisory. Committee,on the
' Medical Uses'of isotopes-(ACMUI)
ACMUI recommended statement of general policv to guide regulation of medical uses of radioisotopes would be:
- 1. [No change.]
- 2. The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary standards or compliance with these standards are inadequate. Assessment of the risks justifying such '
regulations will reference comparable risks and comparable modes of regulation for other types of medical practice.
- 3. The NRC will not intrude into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine.
\
OPTION 3:
Revised statement of general policy to guide regulation of medical uses of radioisotopes would be:-
- 1. [No change.]
- 2. The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary standards or compliance with these standards are inadequate.
- 3. The NRC will continually strive to minimize involvement in medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine.
)
OPTION 4: l Revised statement of general policy to' guide regulation of medical uses of radioisotopes would be:
- 1. [No change.]
- 2. The NRC will regulate the radiation safety of patients consistent with the risk posed by the radioactive materials. In regulating the radiation safety.of patients. NRC's role is to assure that the physician's prescription is accurately delivered to the correct patient.
- 3. The NRC will not intrude into the medical judgement forming the basis of the physicians' prescription.
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QUALITY MANAGEMENT PROGRAM l
- 1. Mamtain current requirements; {35.32, Sections (a)+(b)+(c)+(d)+(e)+(f).
- 2. Only require a written quality management program; 35.32, Section (a).
- 3. Require written quality management program, audits, and retain each written directive and a record of each dosage requiring a written directive and perform audits; 35.32, Sections (a)+ (d)+(b with modifications).
- 4. Require written quality management program, retain each written directive and a record of each dosage requiring a written directive, and maintain a record of recordable events; 35.32, Sections (a)+(d)+(c).
RADIATION SAFETY COMMITTEE
- 1. Status Quo
- 2. A RSC is required for a medical institution and all modalities, with the exception of diagnostic low dose sealed and unsealed byproduct material uses.
- 3. A RSC'will not be required for any medical licensee.
- 4. A RSC will not be required, but medical licensees will be required to establish and implement a program for administrative and technical oversight of radiation safety.
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I PATIENT NOTIFICATION
- 1. Status Quo
- 2. Licensee to notify NRC only but not referring physician or patient.
- 3. Licensee to notify NRC and referring physician but not patient.
- 4. Licensee would always notify NRC, referring physician, and patient or guardian.
- 5. Licensee would notify NRC and referring physician, and patient or-guardian if, based on medical judgment, there are or would be detrimental effects on patient due to the reportable event.
RECOMMENDATION FOR THRESHOLD OF REPORTABLE EVENT
- 1. Status quo + precursor
- 2. Reportable raised to AO Criteria + precursor Recordable raised to current reportable
- 3. Reportable raised to AO criteria + precursor
- 4. Reportable lowered to current recorda!; precursor
- 5. Alternative 1,2,3 or 4 with voluntary report of precursor
- 1. How should the NRC determine which industry standards, including voluntary ones, are adequate to meet the NRC's regulatory responsibility for patient, worker, and public safety?
To what extent should NRC allow the licensee flexibility in interpreting or selecting an industry standard?
- How should the concept of " quality. improvement" be incorporated into reliance on industry standards and an accre'ditation-type of approach.to licensing and l inspection?
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- 2. What'are the necessary transition steps the NRC.
should take in order to implement a more positive-enforcement program that, in.effect, encourages e or rewards good performance while addressing the outliers?
What metrics.should the NRC use.to decide whether the approach.is. working?
'3. In considering various events (e.g., misadministrations, equipment failures, or procedural errors), what criteria should the NRC use to determine that a particular event is isolated, rather than having program implications for that licensee or generic implications for other medical licensees?
.What is the best process for the reporting of events to ensure that the NRC is aware of potential generic-issues?
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- 4. In evaluating errors, should a threshold be established beneath which corrective action is not required?
How would.such a threshold be set, and how would it be -
implemented?
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" EXEMPT DISTRIBUTION OF A RADIOACTIVE DRUG CONTAINING ONE
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MICROCURIE OF CARBON-14 UREA" l
Proposed rule published June 16,1997 (62 FR 32552)
Comment period ended July 16,1997 Comments resolved and on way to Commission
RADIOPHARMACY RULE DRAFT REGULATORY GUIDES Published for public comment March 1997 l
Comment period ended July 31,1997 Public Workshop with Pharmacy and Pharmaceutical Industry Nov 21,1997 Projected finalization of the guides Spring-Summer 1998
i August 1997 SOMMARY OF MAJOR ETHICS RULES FOR SPECIAL GOVERNMENT EMPLOYEES Special Goverment egloyees (SGE)2. such as consultants, are subject to the laws and regulations on ethics that apply to full-time employees, unless specifically exempted. These laws and regulations include the criminal conflict-of-interest statutes and the government-wide regulations on employee conduct, financial disclosure, ethics training, and post-egloyment.
When appointed. SGEs are given a copy of the employee standards of conduct regulations, an analysis of the regulations by the Office of the General Counsel (OGC), and the NRC supplemental conduct regulations. An SGE who has a question about any ethics matter should contact an OGC Deputy Eth es counselor.
The following is a sumary of the major conflict-of-interest laws and L regulations that apply to special Government employees.
CRIMINAL STATUTES (18 U.S.C. 201-208) 1 Bribery 18 U.S.C. 201 prohibits an SGE from seeking, accepting, or agreeing to receive anything of value for being influenced in the performance or nonperformance of an official act.
Representations to the Government 18 U.S.C. 205 prohibits an SGE from representing a non-Federal party before any Federal agency or court on any "particular matter involving specific
- An NRC consultant is hired as a "special Government egloyee* (SGE),
which is legally defined as an officer or employee who is retained, designated, appointed, or employed to perform temporary duties on a full-time or intermittent basis, with or without compensation, for a period not to exceed 130 days during a period of 365 consecutive d6ys. 18 U.S.C.-
5 202(a)/ A art of a d is counted as a full day for purposes of
-determining tie number o days that an SGE has worked. including days spent in travel on Government business.
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parties"8 in which the SGE personally and substantially participated while a .
Federal employee or SGE. 18 U.S.C. 203 precludes an SGE. in some instances,
- from receiving cogensation from a party resulting from the activities of the SGE's business partner or colleague.
Examle: An SGE who morked on a license sendnent could not urge an NRC official. On behalf of the licensee, to approve the amendnent even if i the SGE did not receive any fee in return, l Examle: If the business partner of an SGE represents a licensee to the i agency on a license amendnent that the SGE reviewed for the agency, the !
V SGE could not receive a partner's share of the fee from the licensee for i 1
jI his partner's services before the agency on that amendnent.
I Inaddition,anSGEwhoservedtheNRCformorethan60dayswithinihe
- preceding 365 days is also barred from representing a non-Federal party (or
- accepting compensation for representational activities) on any "part%1ar matter involving specific parties" that is pendi before the agency.
- - including a particular matter that the SGE did work on for the NRC.
Examle: An SGE who served the NRC for more than 60 days during a year could not represent a licensee to the NRC even on a proposed license
- amendnent in which the SGE will not be involved in an official capacity
. as an NRC emloyee.
Post-Employment 18 U.S.C. 207 prohibits former SGEs from ever representing a non Federal party to a Federal agency or court on any "particular Government matter involving specific parties" in which the former SGE personally and substantially participated-as a Governmant employee.
EXEnple: A fonner NRC consultant who advised the agency about a
-proposed enforcement action could not later appear before the agency for ,
the licensee on that action.
Financial Interests Unless a written waiver is obtained,18 U.S.C. 208(a) prohibits an SGE from participating personally and substantially in any particular Government matter 8
A "particular matter involving specific parties" means a specific proceeding associated with identifiable parties in which the United States is-a party or has a direct and substantial interest. It includes a Government contract, grant. litigation, license application or amendnent, investigation,
-inspection, claim. or enforcement action. -It does not include general l rulemaking. legislation. or the formulation of general policy, objectives, or standards.
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}: (including a rulemaking) that could directly and predictably affect the SGE's
[ personal financial interest or the financial interest of any of the following:
i (a)- The SGE's spouse or minor child:
i (b) The SGE's general partner or an organization in which the SGE serves as an officer, director, trustee, general partner, or em)loyee: or l (c) An organization with which the SGE is negotiating or las an arrangement l for prospective employment.
[ However, government-wide regulationr(5 CFR Part 2640) permit SGEs to
!- participate in a Government "particular matter involving s1>ecific l>arties' if the value of their security holdings does not exceed EDM. If S3Es are
! working on a generic matter, such as a rulemaking, they can also partici > ate i if the value of their seucrity holdings in a single entity affected by t)e
! rulemaking does not exceed $25.000 or 150.000 in all affected entities.
l Exanple: An SGE any not Fork on a license amendnent if the licensee is l the SGE's enployer or private client or 1f the SGE owns stock in the i licensee exceeding $5.000 in value (unless the head of the NRC office i using the SGE's services issues a written waiver after consultation with DGC.) If the SGE is wrking on a rule that could affect a tuber of licensees, the SGE could wrk on the rule if the value of the SGE's
- stock in one of the affected licensees does not exceed $25,000; the SGE could also wrk on the rule if the value of the SGE's stocks in all j entities affected by t.he rule does not exceed $50.000.
l These regulations also allow SGEs to participate in matters affecting the
- holdings of a wtual fund which is diversified in its investments and certain diversiffed penston plans. (*01 versified' means that the fund does not have a l policy of concentrating its investments in a specific industry, business.
foreign country, or State.)
l L Exanple: An SGE who owns shares it, a 'diversifled* mtual fund can work
- on a license application even though the fund's portfolio contains stock i of the applicant, without regard to the value of the SGE's investment in V the fund. Nonver.1f the SGE owns more than $5,000 in a " sector *
\ mutual fund, such as XYZ Medical Technology Fund, the enployee could not i work on the application if the fund's portfolio contains securities of the aop11 cant and the applicant's business was in the medical technology field.
I STANDARDS OF CONDUCT REGULATIONS (6 CFR PART 2635) l l
NRC Title or Position -
, 5 CFR 2635.702 prohibits SGEs from using their NRC title or position for their i personal gain or the gain of anyone else. It also prohibits them in their NRC capacity from appearing to show preferential treatment to or endorsing anyone.
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s Nonpublic Information 5 CFR 2635.704 prohibits SGEs from engaging in a financial transaction using roper use of non>ublic infomation to nonpublic further theirinformation, interest orallowing the im's interest, or mating any unauthorized anyone else disclosure of such infomation. ("Non>ublic infomation" means information gained through Federci employment whic1 tas not been made available to the general public. It includes NRC plans, policies, reports, studies, financial plans or internal data protected by the rivacya Act or withholdable under the Freedom of Information Act.)- : -
NRC policy also prohibits SGEs from taking nonpublic NRC documents upon termination of NRC service or using nonpublic infomation in grant applications or contract bids (inc uding ag records the SaE wrote or reviewed that have not been released to the lic). NRC requests that SGEs neither comunicate nonpublic infomation t others after termination of service nor use nonpublic information in grant applications or contract bids submitted to the agency.
Examle: A former SGE should not give a client unreleased NRC information concerning an ongoing licensing proceeding that the SGE was involved in for the agency. The ex-SGE should also not provide the client with nonpublic information which would be part of the client's bid for an NRC contract.
Gifts from Outside Sources 5 CFR 2635 Subpart B prohibits SGEs from soliciting or accepting gifts given directly or indirectly from licensees, applicants, contractors, anyone seeking business with the agency, anyone with interests that the SGE could affect, or en organization with a majority of members who meet the above description.
They cannot accept gifts that are given because of their NRC position.
Exceptions to this prohibition include gifts given because of the SGE's non-Federal business or employment, coffee or refreshments provided at meetings, non-cash gifts valued at $20 or less from any one source (with a $50 limit during a year), gifts from friends or family members, and attendance at widely attended gatherings.
Examle: The cmparv that emloys the SGE is also a '11censee. There is
-no objection to the comany's granting the SGE a bonus for his work based on the comany's performance standards for all its arployees.
There would be an objection if the bonus was due to the fact that the SGE 1s an NRC consultant Gifts to Supervisors 5 CFR 2675 Subpart C prohibits SGEs from giving a gift to any em)loyee who directs or evaluates supervisors. their Exceptions performance, include including non-cash items of S suNriors or lessof ontwir an imediate
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8-occasional basis, refreshments shared in the office, and hospitality offered I at home, '
NRC Time and Property -
5 CFR 2635.704 705 prohibit SGEs from using duty time or any NRC property, such as telephones, photocopiers, fax machines, mail, or computers, for any purpose not in connection with NRC duties. It also prohibits SGEs from asking a subordinate to carry oct a nonofficial-task.
Outside Teaching, Speaking, or Writing 5 CFR 2635.8N prohibits SGEs who serve or are expected to serve more than 60 days during a 365-day >eriod from receiving comensation for outside teaching, speaking. or writing t1at relates to their NRC duties. This includes an activity where the subject matter of the outside activity deals in significant i
part with any matter that the NRC assigned the SGE or was assigned during the previous year. .
i Example: An SGE who is DQ1 expected to serve NRC for more than 60 days during the year could receive a fee for an article about proposed NRC regulations that the SGE reviewed for the NRC. (As stated in the last footnote, regulations are not "particular matters involving specific parties.")
If the SGE is act ex>ected to serve NRC for more than 60 davs during a one-year period, tie pro 11bition is only on "particular NRC matters involving specific parties" in which the SGE participated or is participating perronally and substantially.
Examle: An SGE who wrks for more than 60 days during a year cannot accept a fee for an article on MC regulations the SGE reviewd because the regulations are the subject of the SGE's MC assigrr3ent.
This restriction does nQi apply to teaching a regularly established course at an institution of higher learning, an elementary or secondary school, or a program sponsored and funded by the Federal, State, or local Government.
Examle: An SGE who is a professor at a university could continue to teach a regular college course that includes discussing the wrk that the SGE is directly involved in for the NRC. provided that the MC infonnation used is publicly available. .
Fundraising 5 CFR 2635.808 prohibits SGEs from fundraising from anyone the SGE knows has interests that could be substantially affected by the performance or nonperfonnance of the SGE's Government duties.
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4 Expert Witness ,
5 CFR 2635.805 prohibits SGEs who serve or are DD1 expected to serve more thaii
- 60 days during a 365 consecutive day period from serving as an expert witness, wit 1 or without cogensation, before a U.S. court or agency for a tion Federal party in a proceeding in which the U.S. is a party or has a direct and substantial interest if the SGE participated in the proceeding or the particular subject matter of the proceeding while a Federal egloyee unless authorized NRC s Genersi Counsel. -
An SGE who has served or is expected to serve gitt than 60 davs during a 365 consecutive day period cannot serve as an expert witness for a non Federal party, with or without co@ensation, in any proceeding before a U.S. agency or court ir, which the NPC is a party or has a direct and substantial interest unless authorized by NRC's General Counsel.
Impartiality Unless a waiver is granted. 5 CFR Subpart E prohibits SGEs from participating in any "particular NRC matter involving specific parties" which the SGE knows is likely to have a direct and predictable effect on the financial interests of a member of his or her household if a reasonable person would question the SGE's impartiality. T
" covered relationship"pis bari also if that person is orincludes representsanyone a party.with whom the SGE has a Examle: An SGE's involvement in an NRC inspection where the SGE's brother is an officer of a licensee would raise a question of imartiality. It could also raise a question if the SGE morkcd for or consulted the licensee within the past year.
Job Seeking 5 CFR 2635 Subpart F requires SGEs to disqualify themselves from participating in any particular NRC matter, including rulemaking and other generic matters, that will have a direct and predictable effect on the financial interest of a person with whom the SGE is negotiating or has any arrangement for future egloyment unless the SGE receives a waiver.
Examle: An SGE should not advise the hRC on a pronsed license amendnent if the SGE intends to apply for a positio'n with the licensee.
Before applying for that position, the SGE should be removed from any
. involvement with that amendnent.
8 " Covered relationship includes: anyone with whom the SGE has a a relative with whom business, contractual, or other financial relationship:he the SGE has a close personal relationship; and anyone t SGE has served '
during the cast year as officer, director, trustee, general partner, agent, attorney. consultant, contractor, or employee.
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PROCUREMENT RESTRICTIONS Procurement integrity Act (41 U.S.C.423)
SGEs who personally and substantially participate in an NRC procurement over f 00.000 must pronptly re> ort in writing to their supervisor and ethics o"ficial an contacts wit 1 or by a bidder or offeror regarding possible non-Federal emp oyment. They must then either reject the possibility of non-Federal enp oyment or disqualify themselves from furthsr participation in that procurement unless authorized in writing.
4 Former SGEs who wed in certa'in procurement positions or made certain decision on a p:ocure. cont exceeding 11a mil: 1on are prohibited from accepting i compensation from that contractor as an emp oyee, officer, director, or consultant for one year after ceasing perfomance on that procurement.
Current and former .%Es with access to contrator bid or pr sal or source
< selection infomation are prohibited from knowingly disclos this
' information before the award of the contract unless authoriz . This prohibition applies to anyone who is acting or has acted on behalf of the Government or who advised the Government on a procurement. In addition, the regulations prohibit anyone from knowingly obtaining this information prior to
- the award of the contract without authorization.
Noncompetitive Contracts (48 CFR 3009.101)
Under noncompeti its krocurement ive contractregulations. NRC willconditions:
under the follo4ng not award an SGE a sole source or i (1) the contract
- arose directly out of the SGE's activityinfluence the awerd the Contracting Office of the contract, or U()2) detemines that another conflict of interest exists if the SGE was employed by the NRC within two years of the date of the request for tha procurement action.
FOREIGN GOVERNMENTS -
Emoluments idause of the Constitution (Art. I 5 9, cl. 8) ,
This clause prohibits SGEs (including those who work for the NRC for even a few days a year) from engaging in any employment with a foreign government or the political subdivision of a foreign government including a public university or consnercial enterprise owned or operated by a foreign government.
. The ban does not apply to a foreign privately owned corporation or an international organization, such as the International Atomic Energy Agency.
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Forolyn Gifts and Decorations Act (5 U.S.C.7342,41 CFR Part 101-49)
The Act prohibits SGEs from accepting a gift exceeding $245 in value frce a foreign government or an international organization. A orohibited gift even includes travel ex>enses exceeding $245 in value unless the travel takes place entirei) outside tie United States. The restriction also extends to the spouse and dependents of the SGE. SGEs can accept travel and travel related ex.)enses from a foreign government to cover the costs of activities taken on :
behalf of that government as part of U.S. Government duties.'
FINANCIAL DISCLOSURE (5 CFR PART 2534) ,
Public Report SGEs who are paid above grade level GG-15 and who are expected to work more than 60 days during a year must file a public financial disclosure report (SF 278) within 30 days after beginning service, annually thereafter, and within 30 days after termination of service.
Confidential Report All other SGEs must file a confidential financial disclosure report (OGE Fom 450) within 30 days after beginning service and annually thereafter.
SECURITY OWNERSHIP RESTRICYlONS (5 CFR 5801.102)
SGEs who are members of the Advisory Comittee on Reactor Safety and Safeguards, tne Advisory Comittee on Nuclear Waste, and the Atomic Safety and Licensing Board Panel (as well as their s>ouses and minor children) are prohibited from owning securities issued )y nuclear industry entities on NRC's prohibited securities list.
POLITICAL RESTRICTIONS (HATCH ACT) ct to the Hatch Act restrictions on >artishit political SGEs areduring activities only sub>he t period they provide services to tie Government.
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6 4
9/23/97 RECOMMENDATION FOR THRESHOLD OF REPORTABLE EVENT Summary of Alternallyan
- 1. Thresholds for reportable event (misadministration) and recordable event remain as listed in the current $35.2, with the addition of a statement fr. the reportable definition to 6ddress precursor events that are outside the am! defined by the term
" misadministration."
- 2. Threshold for reportable event is raised to the level of the NilC abnormal occurrence reporting criteria. in addition, the definition for reportable event willinclude a statement to address precursor events that are outside the area currently defined by the term
" misadministration." Threshold for recordable event is raised to the current threshold for
- misadministration."
- 3. Threshold for reportable event is raised to the level of the NRC abnormal occurrence reporting criteria. In addition, tb definition for reportable event will include a statement to address precursor events that are outside tha area currently defined by the term
" misadministration." (No requirement for recordable event.)
- 4. Threshold for reportable event is lowered to the current level of recordable event, with the inclusion of items such as wrong patient, route, or dosage that are not covered by the current ' recordable event
- definition, in addition, the definition for reportable event will include a statement to address precursor events. (No requirement for reccrdable event.)
- 5. Thresholds for reportable event and recordable event, if applicable, would be set according to the outcome of discussions on Alternatives 1,2,3, and 4. Licensees would voluntarily report precursor events that are outside of the area currently defined by the term " misadministration.'
NOTE 1: The term " misadministration" has been replaced with ' reportable event' in this document.
NOTE 2: In the Staff Requirements Mernorandum dated March 20,1997, the Commission directed the staff to address how to capture not only relevant safety significant events, but also precursor uents. Staff is considering the development of a regulatory requirement designed to capture precursor events having programmatic implicatior;a for radiation safety. This requirement would be intended to identify events, incidents, and situations which have implications for that facility or implicatici a for similar facilities (generic incidents) that may adversely affect the dose to the patient or the public. The objective of this requirement is to identify information that would be useful to avoid potentially signiScant problems and to improve the radiation safety program at licensed facilities. Thit requirement should include, but not necessarily be limited to, incidents resulting from mechanical, structural or electrical malfunction of a system, as well as events resulting from procedural errors or human error, Examples of 1
0 l
- precursor events might include failure of an interlock system, malfunction of a timer system, i failure of a brachytherapy treatment device to contain a source, or mistabelling of a radiopharmaceutical.
.t 4
l i
4 e
2
a CURRENT DEFINITIONS / REQUIREMENTS l Status Quo Recordable Status Quo Reportable (Recordable Event $?5.2) (Misadministration 635.2) l All diagnostic radio . . Wrong patient, radiopharm ,
pharmaceuticals (including < 30pC route, or dosage and Nal.1125 or I 131). . Dose >5 rem EDE or 50 rem to organ.
Sodium lodido radio . Admin dosage differs oy >10% . Wrong patient.
pharmar'euticals (where $30 pCl prescr. dosage and >15pCl. . Wrong radiopharmaceutical.
Nal 125 or 1-131. . W/o wntten directive. . Admin. dosage differs by >20%
l . W/o daily dosage record. prescr. dosage and $30 pCl.
Therapeutic radio . Admin. dosage differs by >10% . Wrong patient-pharmaceuticals. prescr. dosage . . Wrong mode of transport.
. W/o written directive.. . . Wrong route of admin.
. W/o daily dosage record.. . Admin. dosa0e differs by >20%
prescr. dosage.
Teletherapy. . Calculated weekly dose 15% > . Wrong patient.
prescr. dose. . Wrong mode of treatment.
. W/o wntten directive. . Wrong treatment site.
. W/o daily dose record. . Calculated weekly dose 30% >
prescr. dose.
. Calculated total dose differs by
>20% total prescr. duse
. If <3 fractions calc. total dose differs by >10% total prescr.
dose.
Brachytherapy. . Calc. dose differs h >10% prescr. . Wrong patient.
dose. . Wrong radioisotope.
. W/o written directive. . Wrong treatment site.
. W/o daily dose record. . Leaking source.
. Failure to remove source for a temporary implant.
. Calculated admin. dose differs by
>20% prescr. dose.
Gamma stereotactic radiosurgery. . W/o wntten directive. . Wrong patient.
. W/o daily dose record. . Wrong treatment site.
. Calculated total admin, dose differs by >10% total prescr.
dose.
Abnormal occurrence event criteria - Misadministration (Management Directive 8,1):
- a. Results in a dose that is (1) equal to or greater than 1 gray (Gy)(100 rad) to a major portion of the bone marrow, to the lens of the eye, or to the gonads, gI(2) equal to or greater than 10 Gy (1000 rad) to any other organ; AND
- b. Represents either (1) a dose or dosage that is at least 50 percent greater than that prescribed in a written directive of (2) a presenbed dose or dosage tht.t is (i) the wrong pharmaceutical. (ii) delivered by the wrong route of administration. (iii) delivered to the wrong treatment site, (iv) delivered by the wrong treatment mode, or (v) from a leaking source (s).
3
...n . . . . . _ . . - . - . - - - . - ._ - . _ - . . _ _ . _ . . -
i f
I i
l ALTERNATIVE 1: Thresholds for reportable event (misadministration) and recordable event j remain as listed in the current $35.2, with the addition of a statement in the reportable definition ,
! to address precursor events that are outside the area defined by the term " misadministration."
- 1 l !
4 U
a j 1. Regulatory requirement for licensee to identify and/or report or record, as appropriate, events. This information may be used to increase the overall effectiveness of the radiation safety program.
- 2. Provides licensee with tiered approach to event repo ting or recording depending on the nature of the event,
- 3. Enables NRC to identify the causes of events and help identify precursor events (SRM DSl 7) in order to con ect them and prevent recurrence (Isolated incidents can reveal a generic problem when compared nationally).
- 4. Enables NRC to fulfill its statutory obligation (in Section 208 of The Energy i Reorganization Act of 1974) to report abnormal occurrences (AOs) to Congress.
- 5. Licensees are familiar with current definition, therefore it would only be necessary to change current operating procedures to identify and report precursor events.
Cons
- 1. Requirement for multiple action points (reportable and recordable) may be considered prescriptive.
- 2. Requirement may be considered as intruding into the area of patient confidentiality if the patient's name or identification is included in the report or record.
- 3. Reporting of precursor events may not be justified by risk associated with the potantial for exposure and may result in an increased burden on licensees.
- 4. Reporting of precursor events may result in a large volume of reports, requiring a significant expenditure of NRC resources for evaluation of low risk events.
- 5. Specific rule language and guidance (examples) will need to be developed to identify precursor events, 4
dugguted Rule Text Status Quo Recordable Status Quo Reportable (Recordable Event 635.2) (Misadministration 935.2) l All diagnostic radio . .. . . . Wrong patient, radiopharm..
pharmaceuticals (including < 30pC route, or dosage and Nat.1 125 or 1-131). . Dose >5 rem EDE or 50 rem to organ.
Soditim iodide radio . Admin dosage differs by $10% . Wrong patient.
pharmaceuticals (where >30 pCl prescr. dosage and >15pCl. . Wrong radiopharmaceutical.
Nal 125 or 1131. . W/o written dirceSve. . Admin dosage differs by >20%
. W/o daily dosage record. prescr. dosage and >30 pCl.
Then peutic radio . Admin dosage differa by $10% . Wrong patient.
pharmaceuticals, prescr. dosage . . Wrong mode of transport.
. W/o wntten directive. . Wrong route of admin.
. W/o daily dosage record. . Admin. dosage differs by >20%
prescr. dosage.
Teletherapy. . Calculated weekly dose 15% > . Wrong patient.
prescr. doso. . Wrong mode of treatment.
. W/o written directive. . Wrong treatment site.
. W/o daily dose record. . Calculated weekly dose 30% >
prescr. dose,
. Calculated total dose differs by
>20% total prescr. dose.
. If <3 fractions, calc, total dose differs by $10% total prescr.
dose.
. Brachytherapy. . Calc. dose differs by >10% prescr. . Wrong patient.
dose. . Wrong radioisotope.
. W/o wntten directive. . Wrong treatment site.
. W/o daily doce record. . Leaking source.
. Failure to remove source for a temporary implant.
. Calculated admin. dose differs by
>20% prescr. dose.
Gamma stereotactic radiosurgery. . W/o wntten directive. . Wrong patient.
. W/o daily dose record. . Wrong treatment site.
. Calculated total admin. dose differs by >10% total prescr.
dose.
Additional requirement for reportable events:
Statement to address precursor events (reference NOTE 2. page 1).
5
~
fj TERNATIVE 2: Threshold for reportable event is raised to the level of the NRC abnormal occurrence reporting criteria, in addition, the definition for reportable event will include a statement to address precursor events that are outside the area currently defined by the term
" misadministration." Threshold for recordable event is raised to the current threshold for
" misadministration."
Et9A
- 1. Regulatory requirement for licensee to identify and/or report or record, as appropriate, events. This information may be used to increase the overall effectiveness of the radiation safety program.
- 2. Provides licensee with tiered approach to event reporting and recording, depending on the nature of the event.
- 3. Enables NRC to identify the causes of events and help identify precursor events (SRM DSI 7) in order to correct them and prevent recurrence (isolated incidents can reveal a generic prcblem when compared nationally).
- 4. Enables NRC to fulfillits statutory obligatiori(in Section 208 of The Energy Reorganization Act of 1974) to report abnorrnal occurrences (AOs) to Congress.
S. Abnormal occurrence event reporting criteria are risk based.
CDM
- 1. Requirement for multiple action points (reportable and recordable) may be considered prescriptive.
2, Requirement may be considered as intruding into the area of patient confidentiality if the patient's name or identification is included in the report or record.
- 3. Reporting of precursor events may not be justified by risk associated with the potential for exposure and may result in an increased burden on licensees.
- 4. Reporting of precursor events may result in a large volume of reports, requiring a significant expenditure of NRC resources for evaluation of low risk events.
- 5. Specific rule language and guidance (examples) will need to be developed to identify precursor events.
- 6. Licenseet would have to change curren "Mrating procedures to identify and report precursor events.
6
Suggtsled Rule Text Recordable Event:
All diagnostic radio . Wrong patient, radiopharm., toute, or dosage pharmaceuticals (including < 30pC and Nal,1125 or I 131). . Dose >5 rem EDE or 50 rem to orgen.
Sodium lodide radio . Wrong patient.
pharmaceuticals (where >30 pCi . Wrong radiopharmaceutical, Nat 125 or 1131. . Administered dosage differs by >20%
prescribed dosage and $30 pCl.
Therapeutic radio . Wrong patient.
pharmaceuticals. . Wrong mode of transport.
. Wrong route of admin.
. Administered dosage differs by >20%
prescribed dosage.
Teletherapy. . Wrong patient.
. Wrong mode of tre.'tment.
. Wrong treatment site.
. Calculated weenty dose 30% > prescribed dose.
. Calet. fated total dose differs by >20% total prescribed dose.
. if <3 fractions, calculated total dose differs by
>10% total presenbed dose.
Brachytherapy. . Wrorg patient.
. Wrong radioisotope.
. Wrong treatment site.
. Leaking source.
. Failure to remove source for a temporary implant.
. Calculated administered dose differs by
>20% prescribed dose.
Gamma stereotactic radiosurgery. . Wrong patient.
, . Wrong treatment site.
. Calculated total administered dose differs by >10% total presenbed dose.
Reportable Event:
. a. Results in a dose that is (1) equal to or greater than 1 gray (Gy) (100 rad) to a major portion of the bone marrow, to the lens of the eye, or to the gonads, gI(2) equal to or greater than 10 Gy (1000 rad) to any other organ; AND
- b. Represents either (1) a dose or dosage that is at least 50 percent greater than that prescribed in a written directive gi (2) a prescribed dose or dosage that is (i) the wrong pharmaceutical. (ii) delsvered by the wrong route of administration, (iii) delivered to the wrong treatment site, (iv) delivered by the wrong treatment mode, or (v) from a leaking source (s).
- c. Statement to address precursor events (reference NOTE 2, page 1, 7
l ALTERNATIVE 3: Threshold for reportable event is raised to the level of the NRC abnormal occurrence reporting criteria. in addition, the definition for reportable event willinclude a statement to address precursor events that are outside the ares defined by the term
" misadministration." (No requirement for recordable event.)
ELQA
- 1. Regulatory requirement for licensee to identify and/or report, as appropriate, events.
This information may be used to increase the overall effectiveness of the radiation safety program.
- 2. Enables NRC to identify the causes of events and help identify procursor events (SRM DSI 7) in order to correct them and prevent recurrence (isolated incidents can reveal a generic problem when compared nationally).
- 3. Enables NRC to fulfillits statutory obligation (in Section 208 of The Energy Reorganization Act of 1974) to report abnormal occurrences (AOs) to Congress.
- 4. Abnormal occurrence event reporting criteria are risk based.
- 5. The regulation would be simplified because there would be only one paperwork requirement, i.e., only reportable events.
CQDA
- 1. Requirement may be considered as intruding into the area of patient confidentiality if the patient's name or identification is included in the report.
- 2. Reporting of precursor events may not be justified by risk associated with the potential for exposure and may result in an increased burden on licensees.
- 3. Reporting of precursor events may result in a large volume of reports, requiring a significant expenditure of NRC resources for evaluation of low-rist, events.
- 4. Misadministrations that do not meet the reporting criteria or the criteria for a precursor event will no longer be reported to NRC.
- 5. Specific rule language and guidance (examples) will need to be developed to identify precursor events.
- 6. Licensees would have to change current operating procedures to identify and report precursor events.
8
l 4* !
1 Suggested Rule Text: l 1
Reportable Event:- !
- a. Results in a dose that is (1) equal to or greater than i gray (Gy) (100 rad) to a major portion of the l bone rnarrow, to the lens of the eye, or to the gonads, gI (2) equal to or greater than 10 Gy (t000 rad) to any other organ; AND
. b. Represents either (1) a dose or dosage that is at least 50 percent greater than that prescribed in a written directive g[ (2) a prescribed dose or dosage that (1) is the wrong pharmaceutical, or (ii) is delivered by the wrong route of wdministration, or (iii) is delivered to the wrong treatment site, or (iv) is delivered by the wrong treatment mode, or (v)is from a leaking source (s),
- c. Statement to address precursor events (reference NOT E 2, page 1 ). j i
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, , , , ,-~r ,,---..,,.,-n -, , ,,,-n , , , , , , , -, --r,n- ,-,-,----.v-,-,.- ,-, , ,m-,,,,,,-wm,_,n-e- ,e-e ,
- . _ . - .-. -.- . - . -. - .-..~ __ - - -. . _ - - . . . . - - - - _ .
ALTERNATIVE 4: Threshold for reportable event is lowered to the current level of recordable '
event, with the inclusion of items such as wrong patient, route, or dosage that are currently not covered by the current ' recordable event" definition. In addition, the definition for reportable event willinclude a statoment to address precursor events. (No requirement for recordable event.)
ELQA
- 1. The regulation would be simplified because there would be only one paperwork requirement i.e., only reportable events.
- 2. Regulatory requirement for licensee to identify and/or report events. This information may be used to increase the overall effectiveness of the radiation safety program.
- 3. Enables NRC to identify the causes of events and help identify precursor events (SRM ,
DSI 7) in order to correct them and prevent recurrence (isolated incidents can reveal a generic problem when compared nationally).
- 4. Enables NRC to fulfillits statutory obligation (in Section 208 of The Energy Reorganization Act of 1974) to report abnormal occurrences (AOs) to Congress. ;
Cons
- 1. Requirement may be considered as intruding into the area of patient confidentiality if the patient's name or identification is included in the report.
- 2. Lowering the threshold for reporting events and reporting of precursor events may not be justified by risk associated with the potential for exposure and may result in an undue burden on licensees
- 3. Lowering the threshold for reporting events and reporting of precursor events may result in a large volume of reports, requiring a significant expenditure of NRC resources for evaluation of low risk events.
- 4. Specific rule language and guidance (examples) will need to be developed to identify precursor events.
- 5. Licensees would have to change current operating procedures to identify and report precursor events.
10
Suggested Rule Text Reportable Event:
All diagnostic radiopharm . Wrong patient, radiopharm . route, or dosage (including < 30pC Nal.1125 or I-131).
Sodium iodide radiopharm (where . Wrong patient.
>79 pCl Nal-125 or 1-131. . Wrong radiopharmaceutical.
. Admin dosage differs oy >10% prescr. dosage and $15pCl.
. W/o wntters directive.
. W/o daily dosage record.
Therapeutic radioparm . Wrong patient.
. Wrong mode of transport.
. Wrong route of administration.
. Admin, dos, age differs by >10% presenbed dosage.
. W/o wntten directive
. W/o daily dosage record.
Teletherapy. . Wrong patient.
l . Wrong mode of treatment.
. Wrong treatment site.
. Calculated total dose differs by >20% total prescribed dose.
. If <3 fractions, calculated total dose differs by >10% total prescribed dose.
. Calculated weekly dose 15% > presenbed dose.
. W/o wntten directive.
. W/o daily dose record.
Brachytherapy. . Wrong patient.
. Wrong radioisotope.
. Wrong treatment site.
. Leaking source.
. Failure to remove source for a temporary implant.
. Calc. dose differs by >10% prescribed dose.
. W/o wntten directive.
. W/o daily dose record.
Gamma stereotactic radiosurgery, . Wrong patient.
. Wrong treatment site.
. Calculated total admin. dose differs by >10% total prescribed dose.
. W/o wntten directive.
. W/o daily dose record.
Additional requirement for reportable events:
Statement to address precursor events (reference NOTE 2, page 1).
11
ALTERNATIV.ELi Thresholds for reportable event and recordable event, if applicable, would be set accord;ng to the outcome of discussions on Alternatives 1,2,3, and 4. Licenseca would voluntarily report precursor events that are outside of the area currently defined by the term
- misadministration."
E001
- 1. Relies on voluntary standard for reporting of precursor events that do not meet the dose threshold for reportable or recordable events.
- 2. Voluntary reporting system may permit NRC to capture precursor events reported to other agencies or organizations and thus reduce duplicative reporting by licensees.
! 3. Consistent with SRM on DSI 7 to rely on voluntary standards when ... .. appropriate.
l
- 1. NRC and licensee resources would be required to develop a mechanism to capture precursor events.
- 2. Inconsistent application of voluntary standard may result in NRC not being informed of some precursor events.
Suggested Rule Text The rule text would either be the suggested text in alternative 1,2,3, or 4, but with a statement to address voluntary reporting of precursor events.
12
i l
l OVERVIEW OF THRESHOLD FOR REPORTABLE EVENT
.i k
Key items for Consideration Alt. Alt. Alt. Alt. :
1 2 3 4 Regulatory requirement for licensee to identify and/or report or x x x x record, as appropriate, events.
Enables NRC to identify the causes of events and help identify x x x x precursor events (SRM DSI 7)in order to correct them and 4
prevent r~ cience (isolated incidents can revea! a generic ,
problem w..en compared nationally).
Enables NRC to fulfill its statutory obilgation (in Section 208 of x x x x The Energy Reorganization Act of 1974) to report abnormal
- occurrences (AOs) to Congress, Requirement for multiple action points (repodable and x x recordable) may be considered prescriptive.
Requirement may be considered as intruding into the area of x x x x patient confidentiality if the patient's name or identification is included in the repod or record. .
Reporting of precursor events may not be justified by risk x x x x ,
ass ociated with the potential for exposure and may result in an increased burden on licensees Reporting of precursor events may result in a large volume of x x x x reports, requiring a significant Jxpenditure of NRC resources for evaluation of low risk events.
Specific rule language and guidance (examples) will need to x x x x
. , be developed to identify precursor events.
- Key items are not identified for Alternative 5 because the exact pros & cons will depend on
- which Alternative is used with the voluntary reporting of precursor events.
i t
i 13
ss 6
9/15/97 PART 35 PATIENT NOTIFICATION OF REPORTABLE EVENT Summarv of AlternAlbf_t1 i
- 1. Status Quo : Licensee to notify NRC, referring physician, and patient or responsible relative, unless referring physician personally informs the licensee that he or she will
)
i inform the patient or that, based on medical judgment that telling the patient or a responsible relative would be harmful.
- 2. Licensee to notify NRC only but not referring physician or patient.
- 3. Licensee to notify NRC and referring physician but not patient.
- 4. Licensee would always notify NRC, referring physician, and patient or guardian.
S. Licensee would notify NRC and referring physician, and patient or guardian if based on medicaljudgment, there are or would be detrimental effects on patient due to the reportable event.
NQI]t item 4 of the SRM, March 20,1997, states:
(Staff should consider...)
Changing the nomenclature from
- misadministration' to ' medical event" or comparable terminology.
Use of term
- guardian"in Alternative 4 & 5 is intended to encompass guardian, individual having ' medical power of attorney
- or 'next-of kin' but not all individuals who have been considered to be
- responsible relative.'
1
ALTERNATIVE 1 : Status Quo : Licensee to notify NRC, referring physician, and patient or responsible relative, unless referring physician porsonally informs the licensee that he or she willinform the patient or that, based on medicaljudgment that telling the patient or a responsible relativo would be harmful.
i P.I.ns I
1.
Is consistent with other NRC requirements (e.g.,10 CFR $$ 19.13(d) and 20.2205) requiring licensees to provide reports to individuals receiving radiation exposure when licensees are required to report such exposure to ,NRC.
- 2. Is consistent with other Federallegislation (e.g., Privacy Act) recogn! ring the right of individuals to know information about themselves which is contained in records both inside and outside the Federal sector. See Statements of Consideration for misadministration rule at 45 Fed. Reg. 31701 (35 SC-10) and 55 Fed. Reg.1439, at 1444 (January 16,1990).
3.
Enables patients, in consultation with their personal physicians, to make timely decisions regarding remedial and prospective medical care. 56 Fed Reg. 23360.
- 4. Enables NRC to identify the r,auses of misadministrations and help identify precursor events (SRM DSI 7) in order to correct them and prevent recurrence (isolated incidents can reveal a generic problem when compared nationally) and preserves patients right to know.
- 5. Enables NRC to fulfillits statutory obligation (in Section 208 of The Energy l Reorganization Act of 1974) to report Abnormal Occurrences ('ANO's') to Congress. i
- 6. Is consistent with present NRC guidance regatding medical events (e g., Management .
Directive 8.10 Handbook regarding medical event reporting). !
C201
- 1. Current rule language lacks definition of ' responsible relative
- which rnay not be well understood by the medical community. Also, there appears to be multiple and sometimes conflicting interpretations of the extent to which and circumstances in which the ' responsible relative
- must be notified.
- 2. Patient notification requirement could be viewed as an unnecessary intrusion into the practice of medicine.
Current Rule Text (a) For a misadministration:
(1) The licensee shall notify by telephone the NRC Operations Center 1.! no later than the next calendar day after discovery of the misadininistration.
2
(2) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.0 within 15 days after discovery of the misadministration. The writton report must include the licensee's name; the prescribing physician's name; a brief description of the evem; why the event occurred; the effect on the individual who received the misadministration; what improvements are,needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the individual (or the individual's responsible relative or guardian),
and if not, why not; and if there was notification, what information was provided. The report must not contain the individual's name or any other information that could lead to identification of the individual. To meet the requirements of this section, the notification of the individual receiving the misadministration may be made instead to that individual's responsible relative or guardian, when appropriate.
(3) The licensee shall notify the referring physician and also notify the individual receiving the misadministration of the misadministration no loter than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery, unless the referring phy6l clan personally informs the licensee either that he will inform the individual or that, based on medicaljudgement, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or the individual receiving the misadministration cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the individual as soon as possible thereafter.
The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the misadministration, because of any delay in 4
notification.
(4) If the individual was notified, the licensee shall also fumish, within 15 days after discovery of the misadministration, a written report to the individual by sending either:
(1) A copy of the report that was submitted to the NRC; or (ii) A brief description of both the event and the consequences as they may affect the individual, provided a statement is included that the report submitted to the NRC can be obtained from the licensee.
(b) Each licensee shall retain a record of each misadministration for 5 years. The record must contain the names of allindividuals involved (including the prescribing physician, allied health personnel, the individual who received the misadministration, and that individual's referring physician, if applicable), the individual's social security number or other identification number if one has been assigned, a brief description of the misadministration, why it occurred, the effect on the individual, improvements needed to prevent recurrence, and the actions taken to prevent recurrence.
(c) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals re uving misadministrations, or to that individual's responsible relatives or guardians.
1_/ The commercial telephone number of the NRC Operations Center is (301) 810-5100, 3
ALTERNATIVE 2 : Licenst.e to notify NRC only but not referring physician or patient.
Ein!l 1.
Would not directly result in what some view as NRC intrusion la the practice of medicine.
2.
Enables NRC to identify the causes of reportable events and help identify precursor events (SRM DSI 7) in order to correct them and prevent recurrence (isolated incidents can reveal a generic problem when compared nationally) find preserves patient's right to know.
3.
Contiriues to enable NRC to fulfill statutory obligation to report 'ANO's" to Congress.
4.
Relies on ethical standard of care to present medical facts to patients. (SRM DSI 7) 4
- 5. May support more consistent compliance with the rule.
Conti 1.
Is not consistent with other NRC requirements in Parts 19 and 20 regarding reporting radiation exposures to individuals when such reports are made to NRC.
2.
NRC and licensee potentially aware of patient infoimation (e.g., potential consequences to patient health) when referring physician and patient are not aware for future informed decisions and medical histories by other physicians.
3.
Does not effectuate specific Commission determination that patients have a right to know when they have been involved in a misadministration. 55 Fed. Reg.1444 (Janua y 16,1990).
- 4. Recognizes inconsistent application of ethical standard of care.
5.
If patients are not notified and need follow-up care, NRC may have, at minimum, an ethical obligation to either notify patients itself or find another entity (such as a state) to do so.
6.
In order for NRC to comply with Section 208 of Energy Reorganization Act requirement to include " nature and probable consequences' in ANO reports, NRC action to ot,tain such information may inject NRC into patient physician relationship and result in patient notification without explicit notification requirement in regulations.
Draft Rule Text (a) For a reportable event :
(1) The licensee shall notify by telephone the NRC Operations Center2 no later than the next calendar day after discovery of the reportable event.
I 4
+
(2) The licensee shall submit a written report to the appropriate NRC Regional Office listed 'in 10 CFR 30.6 within 15 days after discovery of the reportable event. The written report musHnclude the licensee's name; the prescribing physician's name; a brief description of the event; why tha event occurred; the effect on the individual ; what improvements are needed to pre. vent recurrence; actions taker tn prevent recurrence. The report must not contain the indivik$s name or any other information that could lead to identification of the individual, (t3 Esch licenses shall ret.in a record of each reportable event for 5 years. The record must contah the r.ames of allindMduals involved (including the prescribing physician, allied ;
besith personnel, tm irvtbidksi, arid that individual's referring physician, if applicable), the !
Individual's social 6ecuaty juMer et other identification numoeilf one has been assigned, a I brief description of the reportdc event , why it occurred, the effect on tM individual, improvements needed to prevent recurrence, and the actions taken to prevent recurrence, (c) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals involved in the
'eportable event, or to that indiv! dual's responsible relatives or guardians.
- 2) The commercial telephone nur,,oer of the NRC Operations Center is (301) 816 5100.
5
, o ALTERNATIVE 3 : Licensee to notify NRC and refe~ing physician.
Etna
~
- 1. Does not involve NRC in what some view as intrusion in the practice of medicine.
- 2. Enables NRC to identify the causes of reportable events and help identify precursor events (SRM DSI 7) in order to correct them and prevent recurrence (isolated incidents can reveal a generic problem when compared nationally) and preserves patient's right to know.
3.
Continues to enable NRC to fulfill statutory obligation to report 'ANO's' to Conpress.
- 4. Less prescriptive than current rule by relying on ethical standard of care to present medical facts to patients.
i 5. May support more consistent compliance with the rule.
6.
Relies on ethical standard of care to present medical facts to patients. (SRM DSI-7)
C005 1.
is not consistent with other NRC requirements in Parts 19 and 20 regarding reporting radiation exposures to individuals when such reports are made to NRC. ,
- 2. Unless referring physician follows ethical standard to inform pa'.lents of medical facts, does not effectuate specific Commission determination that patients have a right to know when they have been involved in a misadministration. 55 Fed. Reg.1444 (January 16,1990).-
- 3. NRC actions to obtain information to comply with Section 208 of Energy Reorganization et of 1974, requirement to include " nature and probable consequences
- in ANO reports, could result in patient notification without explicit notification requirement in regulations.
- 4. Recognizes inconsistent application of ethical standard of care.
- 5. If patients'are not notified and need follow-up care, NRC may have, at minimum, an ethical obligation to either notify patients itself or find another entity (such as a state) to do so.
Draft Rule Text (a) For a reportable event:
") The licensee shat! notify by telephone the NRC Operations Center 8 no later than the next calendar day after discovery of the reportable event.
4 6
~ - - . -.
t (2) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after discovery of the reportable event. The written report must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the individual; what improvements are needed to prevent recurrence; actions taken to pretent recurrence. The report must not contain the individuars name or any other information that could lead to identification of the individual.
(3) The licensee shall notify the referring physician of the reportable event no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery. If the referring physician cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the referring physician as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the reportable event, because of any delay in notification.
(4) If the referring physician was notified, the licensee shall also furnish, within 15 days
) after discovery of the reportable event, a written report to the referring physician by sending i either:
(i) A copy of the report that was submitted to the NRC; or (ii) A brief description of both the event and the consequences as they may affect the
! Individual, provided a statement is included that the report submitted to the NRC can be l obtained from the licensee.
(b) Each licensee shall retain a record of each reportable event for 5 years. The record must contain the names of allindividuals involved (including the prescribing physician, allied health personnel, the individual, and that individuars referring physician, if applicable), the individuars social security number or other identification number if one has been assigned, a brief description of the reportable event, why it occurred, the effect on the individual, improvements needed to prevent recurrence, and the actions taken to prevent recurrence.
(c) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals involved in the reportable event, or to that individuars responsible relatives or guardians.
- 2) The commercial telephone number of the NRC Operations Center is (301) 816-5100.
' i 7
6LTERNATIVE 4 : Same as status quo but licensee must always notify patient or guardian (does not provide for licensee reliance on referring physician to do so, or no notification based on medicaljudgment),
Elmi 1.
Is consistent with other NRC requirements (e.g.,10 CFR SS 19.13(d) and 20.2205) requiring licensees to provide reports to individuals receiving radiation exposure when licensees are required to report such exposure to NRC.
2.
Is consistent with other Federallegislation (e.g., Privacy Act) recognizing the right of individuals to know information about themselves which is contained in records both inside and outside the Federal sector, See Statements of Consideration for misadministration rule at 45 Fed. Reg. 31701 (35-SC 10) and 55 Fed. Reg.1439, at 1444 (January 16,1990).
- 3. Enables patients or guardian in consultation with their personal pnysician, to make timely decisions regarding remedial and prospective medical care. 56 Fed. Reg. 23300.
- 4. Enables NRC to !dentify the causes of reportable event and help identify precursor events (SRM DSI-7)in order to correct them and prevent recurrence (isolated incidents can reveal a generic problem when compared nationally) .
- 5. Enables NRC to fulfillits statutory obligation (in Section 208 of The Energy Reorganization Act of 1974) to report Abnormal Occurrences ('ANO's") to Congress.
- 6. Patient or guardian would always be required to be notified because there is no provision for referring physician to inform patient in lieu of licensee doing so or for withholding notification based on medicaljudgment of harrn to patient.
CDs .
- 1. Determining who is ' guardian
- may be difficult without a definition.
- 2. Not consistent with ' therapeutic civilege" of physician to withhold certain information from the patient which could adversely affect the patient's condition.
- 3. Not consistent with Medical Policy Statement to minimite intrusion in the practice of medicine.
4, May not require notification of individual (responsible relative) who under current rule would have been notified.
8
Qtaft Rule Text (a) For a reportable event:
(1) The licensee shall notify by telephone the NRC Operations Center 2 ] no later than the next calendar day after discovery of the reportable event.
(2) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after discovery of the reportable event. The written report must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the individual; what improvements are needed to i
prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the '
individual (or guardian), and if not, why not; and if there was notification, what information was provided. The report must not contain the individual's name or any other information that could i lead to identification cf the individual. To meet the requirements of this section, the notification of the individual may be made instead to that individual's guardian, when appropriate.
(3) The licensee shall notify the referring physician and also notify the individual (or guardian)of the reportable event no it.ter than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery. If the referring physician or the individual cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the reportable event, because of any delay in notification.
(4) The licensee shall fumish, within 15 days after discovery of the reportable event , a written report to the individual by sending either:
(i) A copy of the report that was submitted to the NRC; or (ii) A brief description of both the event and the consequences as they may affect the individual, provided a statement is included that the report submitted to the NRC can be obtained from the licensee.
(b) Each licensee shall retain a record of each reportable event for 5 years. The record must contain the names of all individuals involved (including the prescribl.ng physician, allied health personnel, the individual, and that individual's -referring physician, if applicable), the individual's social security number or other identification number if one has been assigned, a brief description of the reportable event, why it occurred, the effect on the individual, improvements needed to prevent recurrence, and the. actions taken to prevent recurrence.
(c) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals involved in the reportable event , or to that individual's guardian.
- 2) The commercial telephone number of the NRC Operations Center is (301) 816-5100, 9
0 ALTERNATIVE 5 : 1.icensee to notify NRC, referring physician, but not patient or guardian (or responsible relative) unless based on medical judgement, there would be detrimental effects on patient due to a reportable event.
Ef21 1.
Enables NRC to identify the causes of reportable events and help identify precursor events (SRM DSI 7) in order to correct thern and prevent recurrence (isolated incidents can reveal a generic problem when compared nationally) .
2.
Continues to enable NRC to fulfill statutory obligation to report 'ANO's' to Congress.
3.
Is consistunt with Medical Policy statement to minimize intrusion into the practice of medicine.
4.
Is consistent with SRM direction to revise Part 35 to be risk based.
5.
Is consistent with SRM direction to rely on industry standard (here, ethical standard of care), except for required notification of reportable events causing ' detrimental' effects.
C9DS 1.
Not consistent with Parts 19 and 20 regarding reporting to individuals radiation exposure information fumished to NRC, which do not require threshold of
- detrimental' effects.
2.
Determining what is ' detrimental
- may be difficult without definition of this term (e.g.,
i some effects may be delayed in time).
3.
NRC has previousiy rejected threshold of " clinically detectable adverse effect"( for reporting misadministrations) as not well understood by the medical community and a
' moving target' for patient notification of misadministration. 45 Fed. Reg. 31701.
4 NRC and referring physician may possess information regarding patient's medical treatment and consequences of misadministration without patient being aware of that information, which is not consistent with patient's 'right to know" (55 Fed. Reg.14^4, January 16,1990).
5.
Recognizes inconsistent application of ethical standard of care for reportable events not having detrimental effects.
6.
May not require notification of all patient's (or guardians) who under current rule would have been notified.
- 7. Determining who is " guardian
- may be difficult without a definition.
l 10
Draft Rute Text (a) For a reportable event:
(1) The licensee shall notify by tele,. hone the NRC Operations Center 2_/ no later than the next calendar day after discovery of the reportable event.
(2) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after discovery of the reportable event.The written report must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the individual; wha *. improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the individual (or guardian), and if not, why not; and if there was notification, what information was '
provided. The report must not contain the individual's name or any other information that could lead to identification of the individual e o meet the requirements of this section, the notificction of the individual may be made instead to that individual's guardian, when appropriate.
(3) The licensee shall notify the referring physician and also notify the individual (or guardian) of the reportable event no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery if, based on medical judgment, there are or would be detrimental effects on the individual due to the reportable l
event. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or the individual (s) cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall noiny the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the reportable event, because of any delay in notification.
(4) If the individual was notified, the licensee shall also fumish, within 15 days after discovery of the reportable event, a written report to the individual by sending either:
(i) A copy of the report that was submitted to the NRC; or l (ii) A brief description of both the event and the consequences as they may affect the s
individual, provided a statement is included that the report submitted to the NRC can be obtained from the licensee.
(b) Each licensee shall retain a record of each reportable event for 5 years. The record must contain the names of allindividuals involved (including tne prescribing physician, allied health personnel, the individual, and that individual's referring physician, if app licable), the individual's social security number or other identification number if one has been assigned, a brief description of the, why it occurred, the effect on the individual, improvements needed to prevent recurrence, and the actions taken to prevent recurrence.
(c) Aside from the notification requirement, nothing in this section affects any nghts or duties of licensees and physicians in relation to each other, to individuals involved in the reportable event,_
or to that individual's guardian.
- 2) The commercialtelephone number of the NRC Operations Center is (301) 816-5100.
11
PATIENT NOTIFICATION OVERVIEW ALTERNATIVES KEY ITEMS FOR CONSIDERATION 1 2 3 4 5 Consistent with other NRC requirements (e.g.,10 CFR $$ j 19.13(d) and 20.2205) requiring licensees to pruride reports to individuals receiving radiation exposure when licensees are X X required to report such exposure to NRC.
l l
Consistent with other Federal legislation (e.g., Privacy Act) recognizing the right of individuals to know information .
1 about themselves which is contained in records both inside X X and outside the Federal sector. See Statements of Consideration for misadministration rule at 45 Fed. Reg. 31701 (35 SC-10) and 55 Fed. Reg.1439, at 1444 (1/16/90).
Rule clearly defines who must be informed X X X Requirement minimizes intrusion into medical judgements X X X X affecting patients.
Notification requirement enables patients, in consultation with their pemonal physicians, to make timely decisions regarding X X X remedial u id prospective medical care. 56 Fed. Reg. 23360.
Enables NRC to identify 'he causes of reportable events and help identify precursor events (SRM DSI 7) in order to correct X X X X X them and prevent recurrence (isolated incidents can reveal a generic problem when compared nationally).
Enables NRC to fulfill its statutory obligation (in Section 208 of X X X X X The Energy Reorganization Act of 1974) to report Abnormal Occurrences ('ANO's') to Congress.
Consistent with present NRC guidance regarding medical events (e.g., Management Directive 8.10 Handbook regarding X medical event reporting).
Relies solely on physician ethical standard of care to present X medical facts to patients. X Consistent with Commission SRM directive to rely on X X voluntary standards if such meets NRC needs.
Requires definition of " detrimental" effects. X Allows physiciar discretion, based on medicaljudgement, in X X X X deciding whether to inform patient of medical event.
Preserves pat;ect right to know X X Requires definition of " guardian
- or ' responsible relative' X X X 12
s d
9/15/97 PART 35 TRAINING AND EXPERIENCE Summarv of Alternatives - Autholinglunt 1.
Status quo (i.e., M.D. + Board certification or specified number of hours of training and experience).
2.
M.D + Board certification or specified number of hours of training and experience (with a change in the number of hours to focus on radiation safety, with minimal requirements for clinical experience). Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.
- 3. M.D. + Board certification or specified number of hours of training (with a change in the number of hours to focus on radiation safety, with minimal requirements for clinical j
experience) + exam. Note, the specific board certifications will not be listed in the rule, i but instead will be a certification that is approved by the NRC.
- 4. M.D. only.
- 5. M.D. + exam.
- 6. M.D. + exam + clinical experience.
NOTES The Altematives represent various tombinations of training and experience criteria that could be used to demonstrate that an authorized user can receive, possecs, use, and transfe r radioactive material consistent with radiation rnfoty practices and in accordance with the regu!ations.
These key elements are listed below with a reference to the Alternative that incorporates thL element.
- 1. Is it necessary to state the need for clinical experience in the training and experience requirement? If yes, age Alternatives 1,2,3, and 6.
- 2. How should a potential authorized user demonstrate that they have obtained knowledge about-the safe handling of radioactive material?
- a. If by industry certification (e.g., American Poard of Nuclear Medicine, American Board of Radiology, etc.), Egg Alternatives 1,2, and 3.
- b. If by radiation safety exam, age Altematives 3, 5, and 6.
t
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i 5
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. . - - -.- - ..-.=... .-. - _- . - . . - . - . . - - ~., _ - - - _ - . -
i
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N O
j' ALTERNATIVE '1: Status quo (i.e., M.D. + Board certification or specified number of hours of training and experience). l L P. rom I 1
4
- 1. More than one means to meet authorized user criteria.
- 2. Modality specific.
- 3. Easy to use if board certified by a board listed or if have completed -cing program.
] 4. Assures that user has radiation safety training if training hour option is pursusd.
V l 5.- Has a clinical experience component.
! U i
- 1. Reference to a training program that is not in existence [e.g.,35.910(c) - six month training
' program).
r 4
- 2. Umits approval to boards specifically listed and must amend regulations to add or delete a
[
board.
- 3. Training hours required may not accurately reflect the risk of the modality (i.e., not risk based).
- 4. - No process developed for periodic review and assurance of certifying boarJ standing.
4
- 5. NFC must review / accept any certifying boards not listed.
I i
! 6. Requiring hours in radiation safety training does not assure understanding of radiation
! . safety.
{
Current Rule Text t
The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician who:.
1 (a)is certified by:
(1) The American Board of Nuclear Medicine;
[ (2) The American Board of Radiology in radiology, therapeutic radiology, or radiation
!' oncology;
' (3) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or j (4) The American Osteopathic Board of Radiology after 1984; or -
4 4'
i 1
j 3 i l
4
(b) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals, and supervised clinical experience as follows:
(1) 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training that includes:
(1) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology; and (2) Supervised clinical experience under the supervision of an authorized user at a medical institution that includes:
(1) Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and
~
(ii) Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals.
\
4
l l
1 4
ALTERNATIVE 2:
M.D. + Board certification or specified number of hours of training (with a i change in the number of hours to focus on radiation safety, with minimal requirements for clinical experience). Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.
~
P_tos
- 1. More than one means to meet authorized user criteria.
- 2. Modality specific.
- 3. Easy to use if board certified or if have completed a training program.
4.
Emphasis on radiation safety for the number of hours of training required (i.e., risk based if the number of hours required increases as the risk of the modality increases).
- 5. Board changes do not require rulemaking.
- 6. Assures that user has radiation safety training if training hour option is pursued.
- 7. Clinical experience component is included.
Cons
- 1. NRC must review / accept certifying board.
- 2. A mechanism must be developed to notify the public of the NRC accepted boards.
- 3. No process developed for periodic review and assurance of certifying board standing.
4.
Requiring hours in radiation safety training does not assure understanding of radiation safety.
Draft Rule Text The licentee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician who:
(a) Is certified by a medical specialty board whose certification process includes all of the training and experience requirements in Section 35.930(b) and whose certification has been
)
accepted by the NRC; or (b) Has completed hours of training (e.g.,120 riours) that includes classroom and laboratory I training and supervised work experience, in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals; and has had supervised radiopharmaceutical administration experience.
(1) The classroom and laboratory training shall include:
5 l l
(1) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and l (iv) Radiation biology, (2) The supervised work experience under the supervision of an authorized user shall include:
(I) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters; (iii) Calculating and safely preparing patient or human research subject dosages; (iv) Using administrative controls to prevent the misadministration of byproduct material;
~
and A
(v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures.
(3) The supervised radio' pharmaceutical administration experience under the supervision of an authorized user at a medical institution shall include:
(l) Oral administration in 10 individuals of iodine-131 or diagnostic studies (involvino
' dosages of sodium iodide 1-131 in quantities greater than 30 microcuries) or for treatne at of -
hyperthyroidism or cardiac dysfunction; or (ii) Parenteral administration in 3 individuals of: phosphorus-32 for treatment of myeleproliferative disorders or intracavitary cancer; or strontium-89 or samarium-153 for treatment of bone metastasis; and (iii) Oral administration in 3 individuals of iodine-131 for treatment of thyroid carcinoma.
4 5
6
ALTERNATIVE 3:
M.D. + Board certification or specified number of hours of training (with a change in the number of hours to focus on radiation safety, with minimal requirements for clinical experience) + exam. Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.
Eros
- 1. More than one means to meet authorized user criteria.
- 2. Modality specific.
- 3. Easy to use if board certified.
4.
Emphasis on radiation safety for the number of hours of training required (i.e., risk based if the number of hours required increases as the .sk of the modality increases).
- 5. Board changes do not require rulemaking.
- 6. Standardized method for testing a baseline of awareness / knowledge.
- 7. Added assurance that tested individualis aware of radiation safety issues (i.e., baseline).
- 8. Clinical experience component is included.
Cons
- 1. NRC must review / accept certifying boad.
2, A mechanism must be developed to notify the public of the NRC accepted boards.
- 3. Process required for periodic review and assurance of certifying board requirements.
4.
Resource intensive to develop and administer exam and maintain testing program.
- 5. Added expense to person taking exam (e.g., cost to travel to exam location).
Draft Rule Text The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician who:
i (a) is certified by examination by a medical specialty board whose certification process includes all of the training and experience requirements in Section 35.930(b) and whose certification has been accepted by the NRC; or (b) Has completed hours of training (e.g.,120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br />) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable 7
to the use of therapeutic radiopharmaceuticals; has had supervised radiopharmaceutical
- administration experience; and has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.
(1) The classroom and laboratory training shall include:
(1) Radiation physics and instrumentation;
- (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and j (iv) Radiation biology. 4 (2) The supervised work experience under the supervision of an authorized user shall include:
(I) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters; l
(iii) Calculating and safely preparing patient or human research subject dosages; (iv) Using administrative controls to prevent the misadministration of byproduct material; and I (v) Using procedures to contain spil;ed byproduct material safely and using proper decontamination procedures.
(3) The supervised radiopharmaceutical administration experience under the supervision of an authorized user at a medical institution shall include:
(I) Oral administration in 10 individuals of iodine-131 or diagnostic studies (involving dosages of sodium lodide I-131 in quantities greater than 30 microcuries) or for treatment of
- hyperthyroidism or cardiac dysfunction; or (ii) Parenteral administration in 3 individuals of: phosphorus-32 for treatment of myeloproliferative disorders or intracavitary cancer; or strontium-89 or samarium-153 for treatment of bone metastasis; and (iii) Oral administration in 3 individuals of iodine-131 for treatment of thyroid carcinoma.
8
>+
ALTERNATIVE 4: M.D. only.
EIQ1
- 1. No NRC specified training required to practice medicine using radioactive material.
4
- 2. Easier to approve authorized users.
- 3. Licensee is given complete latitude to review and determine the radiation safety and modality specific qualifications of a practitioner.
4
- 4. Supports a highly performance based approach.
Cons
) 1. May not accurately reflect risk of modality (i.e., not risk-based).
- 2. No assurance that user has received radiation safety training.
- 3. No specific clinical experience required. This may not accurately reflect the risk of the modality (i.e., not risk based).
Draft Rule Text:
The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician.
9 J
4 ALTERNATIVE 5: M.D. + exam.
EIDE
- 1. - Modality specific if tailor test to each modality.
- 2. Standardized method for testing a baseline of awareness / knowledge.
- 3. Added assurance that tested individualis aware of radiation safety issues (i.e., baseline).
4
- 4. No NRC specified training required to proctice medicine using radioactive material.
- 1. Resource intensive to develop and administer exam and maintain testing program.
4
- 2. Added expense to person taking exam (e.g., cost to travel to exam location).
- 3. No specific clinical experience required. This may not accurately reflect the risk of the modality (i.e., not risk-based).
- 4. Relies on exam results to show that individual has received appropriate radiation safety
. training.
Draft Rule Text The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician and has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.
4 10
1 ALTERNATIVE 6: M.D. + exam + clinical experience.
Ecom
- 1. Modality specific if tailor test and experience to each modality.
- 2. Standardized method for testing a baseline of awareness / knowledge.
- 3. Added assurance that tested individual is aware of radiation safety issues (i.e., baseline).
- 4. Clinical experience component is included.
Cons
- 1. Resource intensive to develop and administer exam and maintain testing program.
- 2. Added expense to person taking exam (e.g., cost to travel to exam location).
- 3. Relies on exam results to show that individual has received appropriate radiation safety training.
Draft Rule Text The licensee shall require the authorized' user of radiopharmaceuticals in Section 35.300 to be a physician who:
(a) Has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission; and (b) Has had supervised radiopharmaceutical administration experience. The supervised radiopharmaceutical administration experience under the supervision of an authorized user at a medicalinstitution shallinclude:
(1) Oral administration in 10 individuals of iodine-131 or diagnostic studies (involving dosages of sodium iodide 1-131 in quantities greater than 30 microcuries) or for treatment of hyperthyroidism or cardiac dysfunction; or
~ (2) Parenteral administration in 3 individuals of: phosphorus-32 for treatment of myeloproliferative disorders or intracavitary cancer; or strontium-89 or samarium-153 for treatment of bone metastasis; and (3) Oral administration in 3 individuals of iodine-131 for treatment of thyroid carcinoma.
l 11
AUTHORIZED USER OVERVIEW ALTERNATIVES _
KEY ITEMS FOR CONSIDERATION 1 2 3 4 5 6 !
More than one means to meet training and experience X X X criteria.
Modality specific. X X X X X Easy to use if board certified. X X X Emphasis on radiation safety training when training and X X-experience required. (i.e., risk based)
Board changes do not require rulemaking. X X Standardized method for testing a baseline of training and X X X experience.
Licensee given complete latitude to review and approve X i users.
Resource intensive to develop and administer exam. X X X I
Added expense to person taking exam. X X X Added assurance that tested individual is aware of radiation X X X safety issues.
, Clinical experience component included. X X X X e
e W
12
Summarv of Alternatives - Radiation Safety Officer
- 1. Status quo (i.e., Board certification or specified number of training hours along with one year of training under an RSO or identified as an authorized user on a license).
- 2. Board certification by a board approved by the NRC or specified number of training hours to include experience with the types and forms of radioactive material to be used at the fecility.
Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.
- 3. Board certification by a board approved by the NRC or specified number of training hours to include experience with the types and forms of radioa'ctive material to be used at the facility
+ exam. Note, the specific board certifications will not be hsted in the rule, but instead will be a certification that is approved by the NRC.
- 4. Exam only.
- 5. One year of full time experience at a medical institution under the supervision of a radiation safety officer + exam.
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ALTERNATIVE 1:
Status quo (i.e., Board certification or specified number of training hours along with one year of training under an RSO or identified as an authorized user on a license).
ED28
- 1. More than one means to meet RSO criteria.
- 2. Easy to use if board certified by a board listed or il named as an authorized user on a license.
- 3. Assures that RSO has radiation safety training if training hour option is pursued.
Cons
- 1. Not risk-based. Same training requirement regardless oflevel of use.
- 2. Assumes that an authorized user has sufficient radiation safety training.
- 3. Limits ta specific boards listed in the rule and must amend regulations to add or delete boards.
- 4. Number of hours specified may not accurately reflect the risk of each modality.
- 5. NRC must review / accept any certifying boards not listed.
- 6. Requiring hours in radiation safety training does not assure understanding of radiation safety.
Current Rule Text:
The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in Section 35.32 to be an individual who:
(a) is certified by:
(1) American Board of Health Physics in Comprehensive Hesith Physics; (2) American Board of Radiology; (3) American Board of Nuclear Medicine; (4) American Board of Science in Nuclear Medicine; (5) Boardtf Pharmaceutical Specialties in Nuclear Pharmacy; (6) American Board of Medical Physics in radiation oncology physics; (7) Royal College of Physicians and Surgeons of Canada in nuclear medicine; (8) American Osteopathic Board of Radiology; or (9) American Osteopathic Board of Nuclear Medicine; or 14
)
. 1 4
1 .
' - (b) Has had classroom and laboratory training and experience as follows:
(1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of Cassroom and laboratory training that includes:
(I) Radiation physics and instrumentation;
. (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity;
. (lv) Radiation biology; and (v) Radiopharmaceutical charnistry; and (2) One year of full time experience as a radiation safety technologist at a medical institution under the supervision of the individual identified as the Radiation Safety Officer on a i Commission or Agreement State license that authorizes the medical use of byproduct material; or (c) Be an " authorized user identified on the licensee's license.
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k ;.- ALTERNATIVE 2: Board certification by a board approved by the NRC or specified number of training hours to_ include experience with the types and forms of radioactive material to be used at the _ facility. Note, the specific board certifications will not be listed in the rule, but instead will
! be a certification that is approved by the NRC.
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( 1. More than one means to meet RSO criteria.
- 2. Modality specific if experience and training hours are tailored for each modality.
i 3. Easy to use if board certified.
- 4c Board changes do not require rulemaking.
5.-
Assures that RSO has radiation safety training if training hour option is pursued, j Cons j 1. NRC must review / accept certifying board.
l
- 2. A mechanism must be developed for notifying the public of NRC accepted boards.
l
- 4. Requiring hours in radiation safety training does not assure understanding of radiation
! safety.
I Draft Rule Text:
i i The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety
. Officer as provided in Section 35.32 to be an individual who:
i
-(a) is certified by a specialty board whose certification process includes all of the training F
_ and experience requirements in Section 35.900(b) and whose certification has been accepted i by the NRC; or (b) Has completed hours of training (e.g., 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable i._
to the type and forms of radioactive material to be used.
(1) The classroom and laboratory training shall include:
(I) Radiation physics and instrumentation;
- -(ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity, (iv) Radiation biology; i
(v) Radiopharmaceutical chemistry.
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(2) The supervised work experience, under the supervision of a Radiation Safety Officer on a Commission or Agreement State license that authorizes the use of byproduct material similar to the use requested shallinclude:
(1) Authorizing the purchase of radioactive material; (ii) Receiving and opening packages of rudioactive materiat; (iii) Storing radioactive material; (iv) Keeping an inventory record of radioactive material; (v) Using radioactive material safely; .
(vi) Taking emergency action if control of radioactive material is lost; (vii) Performing periodic radiation surveys; (viii) Performing checks of survey instruments and other safety equipment; (ix) Disposing of radioactive material; and (x) Trainin'g personnel who work in or frequent areas where radioactive material is used or stored.
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ALTERNATIVE 3:
Board certification by a board approved by the NRC or specified number of training hours to include experience with the ty; as and forms of radioactive material to ba used at the facility + exam Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.
, E00.1
] 1. More than one means to meet RSO criteria.
- 2. Modality specific if experience and training hours are tailored for each modality.
- 3. Easy to use if board certified.
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- 4. Board changes do not require rulemaking.
i
- 5. Standardized method for testing a baseline of awareness / knowledge.
1
- 6. Added assurance that tested individualis aware of radiation safety issues (i.e., baseline).
Cons
{ 1. NRC must review / accept certifying board.
l 2. A mechanism must be developed for notifying the public of NRC a :cepted boards, i 3. To approve an authorized user to be RSO, the AU must meet the specified RSO criteria.
4 i
- 4. Resource intensive to develop and administer exam and maintain testing program.
- 5. Aded expense to person taking exam (e.g., cost to travel to exam location).
Draft Rule Text:
1 The licensee shall require an individual fulfilling the re*ponsibilities of the Radiation Safety Officer to be an individual who:
(a) is certified by examination by a specialty board whose certification process includes all
- of the training and experhance requirements in Section 35.900(b) and whose certification has been accepted by the NRC; or -
(b) Has completed hours of training (e.g.,200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable to the type and forms of radioactive material to be used; and has demonstrated sufficient t -
knowledge in radiation safety commensurate with the use requested by passing an examination i
given by the Commission or an organization or entity approved by the Commission.
(1) The classroom and laboratory training shall include:
18 4
(l) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Radiation biology; (v) Radiopharmaceutical chemistry.
(2) The supervised work experience, under the supervision of a Radiation Safety Officer on a Commission or Agreement State license that authorizes the use of byproduct material similar to the use requested shallinclude:
(i) Authorizing the purchase of radioactive mcterial; (ii) Receiving and opening packages of radioactive material; (iii) Storing radioactive material; (iv) Keeping an inventory record of radioactive material; (v) Using radioactive material safely; (vi) Taking omergency action if control of radioactive materialis lost; (vii) Performing periodic radiation surveys; (viii) Performing checks of survey instruments and other safety equipment; (ix) Disposing of radioactive material; and (x) Training personnel who work in or frequent areas where radioactive material is used or stored.
19
- . - _ -.- - - . ~ . . .~ - - . , . . ..
l 6LTERNATIVE 4: Exam only.
P.ms
- 1. Modality specific if tailor test to each modality.
- 2. Standardized method for testing a baseline of awareness / knowledge.
- 3. Added assurance that tested individual is aware of radiation safety issues (i.e., baseline).
CQQA
, 1. Resource' intensive to develop and administer exam and maintain testing program.
- 2. Added expense to person taking exam (e,g., cost to travel to exam location).
- 3. Relies on exam results to show that individual K received appropriate radiation safety training.
Draft Rule Text:
The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer to be an individual who has demonstrated sufficient knowledge in radiation safety comniensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.
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ALTERNATIVE 5. One year of full-time experience at a medicalinstitution under the supervision of a radiation safety officer + exam. q Ptos
- 1. Assures that RSO has radiation safety training at a medicalinstitution.
- 2. Standardized method for testing a baseline of awareness /kncwledge.
- 3. Added assurance that tested individualis aware of radiation safety issues.
C.QDS
- 1. Not risk-based. Same training requirement regardless of level of use.
- 2. Amount of time specified may not accurately reflect the risk of each modality.
l
- 3. Resource intensive to develop and administer exam and maintain testing program.
l 4. Added expense to person taking the exam.
Draft Rule Text:
The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer to be an individual who:
(a) Has completed one year of full time experience at a medical institution under the supervision of the individualidentified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material and, (b) Has demonstrated sufficient knowledge in the radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.
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+ - _ _
_ _ _ . _ _ _ _ . .. - . -- - -- - ~ - - - - - - -
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Summarv of Alternstives - Authorized Physicist and Authorized Nuclear Pharmacist Alternatives for training and experience are similar to the attematives provided for the radiation safety officer, except for the text discussing an authorized user requesting to be listed as a radia' ion safety officer, liowever, care must be taken to ensure that the training and experience for physicists is commensurate with the type of physics performed.
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'e 9/15/97-PART 35 - QUALITY MANAGEMENT PROGRAM Summatv of Alternatives 1.
Maintain current requirements; S35.32, Sections (a)+(b)+(c)+(d)+(e)+(f).
- 2.
Only require a written quality management program; $35.32, Section (a).
3.
Require written quality management program, retalia each written directive and a record of each dosage requiring a ..ritten directive, and perform audits; S35.32, Sections (a)+(d)+(b with modifications)) .
- 4. !
' Require written quality management program, retain each written directive and a record of each dosage requiring a written directive, and maintain a record of recordable
- vents; $35.32, Sections (a)+(d)+(c).
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( NOTE: Section 6 of the SRM dated, March 20,1997, states:
[ Staff should consider...]
The Quality Management Program provisions (10 CFR Part 35.32) should be re-evaluated and revised to focus on those requirements that are essential for patient safety, e.g. confirming patient identity, requiring written prescriptions and verifying dose.
To the maximum extent pos'.ible, the requirements should be revised to be risk informed. Given this objective, a mixed approach of performance-based rules and otherwise prescriptive reguiations should be pursued, Section 4 of the SRM dated, March 20,1997, states:
[ Staff should consider...]
Changing the nomenclature from " misadministration" to " medical event" or comparable terminology.
1
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' ALTERNATIVE 1
- Maintain current requirements; $35.32, Sections (a)+(b)+(c)+(d)+(e)+(f).*
PJ.D.!i
- 1. No additional regulatory burden to licensee's.
- 2. No additional NRC resources would be needed for modifications to licensing or inspection procedures.
3.
$35.32(a) would continue to require licensee to establish and maintain a written quality management program (QMP) to provide confidence that byproduct material or radiation therefrom will be administered as directed by the authorized user.
- 4. $35.32(b) would continue to require that licensees audit their QMP's to determine the effectiveness of their program and retain records of the audit.
5
~ $35.32(c) would continue the concept of " recordable event" to be used to identify precursor events.
- 6. $35.32(d) would continue to require licensees to retain each written dirdive and record each administered dose or dosage requiring a written directive.
Cons
- 1. Does not reduce regulatory burden to licensees.
- 2. Does not make the regulation more performance-based.
- 3. $35.32(e) would continue to require licensees to submit modifications of their QMP's to NRC, which continues regulatory burden.
- 4. 935.32(f) would continue to require licensees to submit their QMP's to the NRC, which continues regulatory burden.
5.
Rule is inconsistent with Commission direction (SRM on DSI 7) to focus on those requirements that are essential for patient safety e.g., confirming patient identity, requiring written prescriptions, and verifying dose.
2 i
Cunent Rule Te.11 Section 35.32 Qua'.ty management program. l
{
(a) Each hpplicant or licensee under this part, as applicable, shall establish and maintain a wntten quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The !
quality management program must include written policies and procedures to meet the following specific objectives:
(1) That, prior to administration, a written directive ' is prepared for:
(1) Any teletherapy radiation dose; (ii) Any gamma stereotactic radiosurgery radiation dose; (iii) An'y brachytherapy radiation dose; (iv) Any administration of quantities greater than 30 microcuries of either sodium iodide I 125 or I-131; or (v) Any therapeutic administration of a radiopharmaceutical, other than sodium iodide I 125 or I-131; (2) That, prior to each administration, the patien 's or human research subject's identity is verified by more than one method as the individual named in the written directive; (3) That final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives; (4) That each administration is in accordance with the written directive; and (5) That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.
(b) The licensee shall:
(1) Develop procedures for and conduct a review of the quality management program including, since the last review, an evaluation of:
(1) A representative sample of patient and human research subject administrations, (ii) All recordable events, anc' (iii) All misadministrations to verify compliance with all aspects of the quality management program; these reviews shall be conducted at intervals no greater than 12 months; (2) Evaluate each of these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the objectives of paragraph (a) of this section; and (3) Retain records of each review, including the evaluations and findings of the review, in an auditable form for three years.
(c) The licensee shall evaluate and respond, within 30 days after discovery of the recordable event, to each recordable event by:
(1) Assembling the relevant facts including the cause; (2) Identifying what, if any, corrective action is required to prevent recurrence; and (3) Retaining a record, in an auditable form, for three years, of the relevant facts and what corrective action, if any, was taken.
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(d) The licensee shall retain-(1) Each written directive; and )
(2) A record of each administered radiation dose or radiopharmaceutical dosage where t a written directive is required in paragraph (a)(1) above, in an auditable form, for three years
! after the date of administration.
2-(e) The licensee may make modifications to the quality management program to j
increase the program's efficiency provided the program'.s effectiveness is not decreased, The licensee shall fumish the modification to the appropriate NRC Regional Office within 30 days after the modification has been made.
l (f)(1) Each applicant for a new license, as applicablo shall submit to the appropriate NRC Regional Office in accordance with 10 CFR 30.6 a quality management program as part of the application for a license and implement the program upon issuance of the license by the NRC.
(2) Each existing licensee, as applicable, shall submit to the appropriate NRC Regional Office in accordance with 10 CFR 30.6 by January 27,1992 a written certification that the quality management program has been implemented along with a copy of the program.
' If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.
i Also, a written revision to an existing written directive may be made for any diagnostic or
- therapeutic procedure provided that the revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose.
If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an cral directive will be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a vaitten directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive.
[56 FR 34121,' July 25,1991, as amended at 59 FR 61783, Dec. 2,1994) i i
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ALTERNATIVE 2 Only require a written quality management program; $35.32, Section (a).*
- Etg.g - l l
1.
Reduces regulatory burden to licensees (no audits or records).
- 2. Makes the regulation performance-based. 1 l
3.
$35.32(a) would continue to require licensee to establish and maintain a written quality management program (QMP) to provide confidence that byproduct materiel or radiation therefrom will be administered as directed by the authorized user.
4.
$35.32(e) would be de;eted, discontinuing the requirement for licensees to submit -
modifications of their'OMPs to the NRC which would decrease regulat ary burden.
5.
$35.32(f) would be deleted, discontinuing of the requirement for licensees to submit their QMPs to the NRC which would decrease regulatory burden, i
j 6. Dose based rule.
L 7.-
Requirements in draft rule language is consistent with Commission direction (SRM on DSI 7) to focus on those requirements that are essential for patient safety, e.g.,
confirming patient identity, requiring written prescriptions, and verifying dose.
\
Cons 1.
Additional NRC resources would be needed for modifications to licensing or inspection procedures.
2.
May increase on-site inspection time (no audits or records of recordable events are available for inspector re slew).
- 3. No requirement ($35.32(b)) for licensees to audit their QMPs to determine the effectiveness of their program and retain records of the audit.
. 4.
935.32(c) would be deleted, discontinuing of the concept of " recordable event" which is used to identify precursor events.
5.
No requirement ($35.32(d)) for licenecc:, to retain each written directive and record each administered dose or dosage requiring a written directive, thus these records would net be available forinspection.
6.
Guidance would need to be developed to assist licensees in determining when a QMP/ written directive is necessary 3
e
. - - . - - _ - - _ . - -- ~ . . - . - _ - - - - - .
Draft Rule Text Section 35,32 Quality management program.
1 (a) Each applicant or licensee under this part, as applicable, shall establish and maintain a written quality management program to provide high confidence that byproduct material or
' radiation frorn byproduct material will be administered as directed by the authorized user. lhe quality management program must include written policies and procedures to meet the following specific objectives:
(1) That, prior to administration, a written directive ' is prepared when the dose to any organ or tissue exceeds 50 rem:
(2) That, prior to each administration, the patient's'or human research subject's identity is verified by more than one method as the individual named in the written directive;
- (3) That each administration is in accordance with the written directive; and (4) That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.
' If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.
Also, a written revision to an existing written directive may be made for any diagnostic or therapeutic procedure ph .,ided that the revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma
' stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose.
If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented immediately in the
- ,atter.!'c recaid and a written directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive.
1
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o ALTERNATIVE 3 Require written quality management program, retain each written directive and a record of each dosage requiring a written directive, and perform audits; $35.32, Sections (a)+(d)+(b with modifications)) .
ELQS
- 1. Reduces regulatory burden to licensees.
- 2. Makes the regulation more performance-based.
- 3. S35.32(a) would continue to require licensee to establish and maintain a written quality management program (QMP) to provide confidence that byproduct material or radiation therefrom will be administered as directed by the authorized user.
- 4. Retain a requirement (S35.32(b)) for licensees to audit their QMP to determine the effectiveness of their program and retain records of the audit.
- 5. Retains requirements (S35.32(d)) for licensees to retain each wntten directive and record of each administerert dose or dosage requiring a written directive.
- 6. 35.32(e) would be deleted, discontinuing the requirement for licensees to submit modifications of their QMP to the NRC.
- 7. 35.32(f) would be deleted, discontinuing of the requirement for licensees to submit their QMP's to the NRC.
- 8. Requirements in draft rule language is consistent with Commission direction (SRM on DSI 7) to focus on those requirements that are essential for patient safety, e.g.,
confirming patient identity, requiring written prescriptions, and verifying dose, with the exception of the requirement for an audit.
Cons
- 1. Additional NRC resources would be needed for modifications to licensing and inspection procedures.
- 2. S35.32(c) would be deleted, discontinuing of the concept of
- recordable event" to be used to identify precursor event.
- 3. Guidance would need to be developed to assist licensees in determining when a QMP/ written direc'.ive is necessary 7
i Draft Rule Teg Section 35.32 Quality management program.
(a) Each applicant or lic' see under this part, as applicable, shall establish and maintain a wntien quality management program to provide high confidence that the byproduct material or raciation front byproduct material will be administered as directed by the authorized user. The quality management program must include written policies and procedures to meet the Silowing specific objectives:
(1) That, prior to administration, a written directive ' is prepared when the dose to any organ or tissue exceeds 50 rem:
(2) That, prior to each administration, the patient's or human research subject's identity is verified by more than one method as the individual named in the wntten directive; (3) That each administration is in accordance with the wntten directive; and (4) That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.
(b) The licensee shall:
(1) Develop procedures for and conduct a review of the quality management program l at intervals no greater than 12 months.;
i and i
(2) Retaln records of each review, including the evaluations and find;ngs of the review, in an auditable form for three years.
(c) The licensee shall retain:
(1) Each written directive; and l
(2) A record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required in paragraph (a)(1) above, in an auditable form, for three years after the date of administration.
' If, because of the patient's condition, a delay in order to provide a written revision to an existing written dir3ctive would jeopardize the patient's health, an oral revision to na existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral ruvision.
Also, a written revision to an existing written directive, :"ay be made for any diagnostic or therapeutic procedure provided that the revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brach/ therapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose.
If, because of the emergent nature of the patient's condition,1 delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the ir. formation contained in the oral directive is documented immediately in the patient's record and a written directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive.
8
i 1
ALTERNATIVE 4 Require written quality management program, retain each written directive and a record of each dosage requiring a written directive, and maintain a record of recordable events; $35.32, Sections (a)+(d)+(c).
ELO.1
- 1. Reduces regulatory burden to licensees (no required audits).
- 2. Makes the regulation more performance based.
+ i
] 3.-
$35.32(a) would continue to require licensee to establish and maintain a written quality j management program (QMP) to provide confidence that byproduct material or radiation
} therefrom will be administered as directed by the authorized user, j 4. $35.32(c) would continue the concept of " recordable event" to be used to identify i precursor events, i 5. Retains requirements ($35.32(d)) for licensees to retain each written directive and ;
) records of each administered dose or dosage requiring a wntten directive.
1 l 6. $35.32(e) would be deleted, discontinuing the requirement for licensees to submit
! modifications of their QMP to the NRC, i
, 7. $35.32(f) would be deleted, discontinuing of the requirement for licensees to submit their QMP's to the NRC.
] 8. Requirements in draft rule language is consistent with Commission direction (SRM on i
DSl 7) to focus on those requirements that are essential for patient safety, e.g.,
4 confirminf. patient identity, requiring written prescriptions, and verifying dose.
- CDIl1 1
- 1. Additional NRC resources would be needed for modifications to licensing and inspection >
, procedures.
- 2. May increase on site inspection time, i- 3. $35.32(b) would be deleted, thus there would be no requirements for licensees to audit their QMP to determine the effectiveness of their program and retain records of the audit. '
- 4. Guidance would need to be developed to assist licensees in determining when a
! QMP/ written directive is necessary, i
1 9
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6 Draft Rule Text i
Section 35.32 Quality management program.
(a) Each applicant or licensee under this part, as applicabic, shall establish and maintain c written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The quality management prcgram must include written policies and procedures to meet the following specific objectives:
(1) That, prior to administration, a written directive ' is prepared when the dose to any organ or tissue exceeds 50 rem:
(2) That, prior to each administration, the patient's or human research subject's identity '
is verified by more than one method as the individual named in the written directive; (3) That each administration is in accordance with the written directive; and (4) That any unintended deviation from the written directive is identified and evaluated, and appropriate . action is taken.
(b) The licensee shall evaluate and respond, within 30 days after discovery of the recordable event, to each recordable event by:
(1) Assembling the relevant facts including the cause; (2) Identifying what, if any, corrective action is required to prevent recurrence; and (3) Retaining a record, in an auditable form, for three years, of the relevant facts and what corrective action, if any, was taken.
(c) The licensee shall retain:
(1) Each written directive; and (2) A record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required in paragraph (a)(1) above, in an auditable form, for three years after the date of administration,
' If, because of the patient's condition, a delay in order to provide a written revision to an i existing wntten directive would jeopardize the patient's health, an omi revision to an existing wntten directive will be acceptable, provided that the oral revision is documented immediately in the patkent's record and a rsvised written directive is signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.
Also, a written revision to an existing written directive may be made for any diagnostic or therapeutic procedure provided that Me revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the telatherapy done, or the next teletherapy fractional dose, if, because of the emergent nature ol the patient's condition, a delay in order to provide a wntien directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive.
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6 QUALITY MANAGEMENT OVERVIEWS ALTERNAT1VES KEY ITEMS FOR CONalDERATION 1 2 3 4 Licensee establish and maintain QMP X X X X
[ objectives identified in regulation)
Licensee required to perform audits X X and record resul's Licensee required to retain written X X X directives and records of administered doses Licensee required to submit QMP X modifications to NRC Licensee required to maintain X X recordable events 11
0 A
9/25/97 RECOMMENDATION FOR REVISION TO NRC'S 1979 MEDICAL POLICY STATEMENT OPTIOf(1: Status Quo Current statement of general policy to guide regulation of medical uses of radioisotopes states:
- 1. The NRC will contiaue to regulate the medical uses of radioisotopes as necessary to prov!de for the radiation safety of workers and the general public.
- 2. The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.
- 3. The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine.
ELOS
- 1. Consistent with NRC's authority in the Atomic Energy Act of 1954, as amended, to regulate domestically the uses of byproduct material, including medical use, to protect public health and minimize danger to life and property.
- 2. Recognizes that physicians have primary responsibility for protection of their patients, by stating that the NRC will minimize intrusion into medical judgments affecting safety.
- 3. Regulation of the radiation safety of patients is risk based.
- 4. For higher risk activities NRC may elect to circumscribe areas that might otherwise be regarded as within the discretion of the physician.
- 5. Current statement provides for balance between protection of the patient and avoiding intrusion into the practice of medicine.
C.Qnti
- 1. Allows for some, although minimal, NRC involvement in medical judgements affecting patients.
I
OPTION 2: April 1997 recommendation of the Adv;sory Committee on the Medical Uses of Isotopes (ACMUI)
ACMul recommended stetement of general policy to guido regulation of medical uses of radioisotopes would be' 1, [No change.] I
- 2. The NRC will regulate the radiation swfety of patleents only where justified by the risk to the patients, and only where voluntary standards or compliance with these standards are inadequate. Assessment of the risks justify!ng such regulations will reference comparable risks and comparable modes of regu!stion for other types of medical practice.
- 3. The NRC will not intrude into medical judgments affecting patients and into other areas traditionally considered to be a part of the practke of medicine.
EIns;
- 1. Regulation of the radiation safety of patients is risk based.
- 2. Acceptable level of risk associated with regulating the medical use of byproduct material may be lower than in other areas of medicine.
- 3. Clearly states that NRC will not be involved with the physician-patient interface.
- 4. Recognizes that physicians have primary responsibility for protection of their patients.
CQDR
- 1. Requires NRC to assess risks in other types of medical practices, which may be problematic.
- 2. Implementation of statements #2 and #3 could be in conflict when the level of risk justifics intrusion.
2
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OPTION 3: '
Revised statement of general policy to guide regulation of medical uses of radioisotopes would be:
l 1. [No change.] l 3 2. The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary standards or compliance with these t standards are inadequate.
- 3. The NRC will continually strive to minimize involvement in medical judgments
- affecting patients and into other areas traditionally considered to be a part of the practice of medicine.
l !
l l M 3
- 1. Consishnt with NRC's authority in the Atomic Energy Act of 1954, as amended, to regulate domestically the uses of byproduct material, induding medical use, to protect ;
public health and minimize danger to life and property. '
4
- 2. Regulation of the radiation safety of patients is risk based.
- 3. For higher risk activities, NRC may elect to circumscribe areas that might otherwise be regarded as within the diceretion of the physician.
- 4. Recognizes that physicians have primary responsibility for protection of their patients.
! 5. Provides additional emphasis that NRC's policy is to minimize intrusion into medical i
practice.
i
- 1. Acceptable level of risk associated with regulating the medical use of byproduct material may be lower tnan for other areas of medicine
- 2. Allows for some, although minimal, NRC involvement in medicaljudgements affecting patients.
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4 OPTION 4:
Revised statement of general policy to guide regulation of medical uses of radioisotopes would l be'
- 1. [No change.)
- 2. The NRC will regulate the radiation safely of patients consistent with the risk posed by the radioactive materials. In regulating the radiation safety of patients, NRC's role is to essure that the physician's prescription is accurately delivered to the correct patient.
- 3. The NRC will not intrude into the medical judgement forming the basis of the physicians' prescription. l
- 1. Consistent with NRCs authority in the Atomic Energy Act of 1954, as amended, to regulate domestically the uses of byproduct material, including medical use, to protect public health and minimize danger to life and property.
- 2. Recognizes that physicians have primary responsibility for protection of their patents, by stating that the NRC will not intrude into medicaljudgements forming the basis of the physicians' prescription.
- 3. Regulation of the radiation safety of patients is risk based.
Dans
- 1. NRC's role in regulating the radiation safety of patients is narrowly focused.
4
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e 9/15/97 PART 36. RADIATION 8AFETY COMMITTEE AMmmarv of Altatngityga
- 1. Status quo: A Radiation Safety Committee (RSC) is required for all modalities in a medicalinstitution.
- 2. A RSC is required fer a medical institution and all modalities, with the exception of diagnostic low dose sealed and unsealed byprod'uct material uses.
- 3. A RSC will not be required for any medical licensee.
- 4. A RSC will not be required, but medical licensees will be required to establish and implement a program for administrative and technical oversight of radiation safety.
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6LTERNATNI1 Status quo: A Radiation Safety Committee 6!9C)is required for all F.odalities in a medicalinstflution.
Ef.QS 1.
Licensee familiarity and continuation of established radiation safety programs.
2.
Provision for communication between disciplines & departments in a single committee, with a radiation safety focus.
3.
Requirements for approvals via multidisciplinary view points in a team approach.
- 4. Radioactive material use and users are under licensee persont al/ peer review and accountability.
- 5. Provisions for direct involvement of executive management (resource allocation, corporate policy, and interdepartmental coordination).
6.
A committee of varied representation is granted significant latitue and authority to develop & implement an appropriate radiation safety program & direct personnel.
CDI11
- 1. Need for RSC is not based on risk of modality.
- 2. May not be necessary for effective radiation safety management at small medical institutions.
3.
Radiation safety is not directed solely by an individual (s) (e.g., Radiation Safety Officer) whose role is independent of the authorized user role and interests.
Current Rule Text Each medical institution licensee shall establish a Radiation Safety Committee to oversee the use of byproduct material.
(a) Each Committee must meet the following administrative requirements:
(1) Membership must consist of at least three individuals and must include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a renresentative of the nursing service, and a representative of management who is neither an authorized user nor a Radiation Safety Officer. Other members may be included as the licensee deems appropriate.
(2) The Committee must meet at least quarterly.
2
_ _ _ _ _ _ _ . .= -- - - _. . --
o (3) To establish a quorum and to conduct business, at least one-half of the Committee's membership must be present, including the Radiation Safety Officer and the management's representative.
(4) The minutes of each Radiation Safety Committee meeting must include:
(i) The date of the meeting; (ii) Members present; (iii) Members absent; (iv) Summary of deliberations and discussions; i (v) Recommended actions and the numerical results of all ballots; and '
(vi) ALARA program reviews described in Section 35.20(c).
(5) The Committee must promptly provide each member with a copy of the meeting minutes, and retain one copy for the duration of the license.
(b) To oversee the use of licensed material, the Committee must:
(1) Review recommendations on ways to maintain individual and collective doses At. ARA:
(2)(i) Review, on the basis of safety and with regard to the training and experience standards in subpart J of this part, and approve or disapprove any individual who is to be listed as an authorized user, an authorized nuclear pharmacist, the Radiation Safety Officer, or a teletherapy physicist before submitting a license application or request for amendment or renewal; or (ii) Review, pursuant to Section 35.13 (b)(1) through (b)(4), on the basis of the board certification, the license, or the permit identifying an individual, and approve or disapprove any individual prior to allowing that individual to work as an authorized user or authorized nuclear pharmacist; (3) Review on the basis of safety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove minor changes in radiation safety procedures that are not potentially important to safety and are permitted under Section 35.31 of this part; (4) Review quarterly, with the assistance of the Radiation Safety Officer, a summary of the occupational radiation dose records of all personnel working with byproduct material; (5) Review quarterly, with the assistance of the Radiation Safety Officer, allincidents involving byproduct material with respect to cause and subsequent actions taken; and (6) Review annually, with the assistance of the Radiation Safety Officer, the radiation safety program.
[51 FR 36951, Oct.16,1986, as amended at 59 FR 61782, Dec. 2,1994) 3
ALTERNAINf,_2 A RSC is required for a medicalinstitution and all modalities, with the exception of diagnostic low dose sealed and unsealed byproduct material uses.
EM l
- 1. Risk based.
2.
Licensee familiarity and some continuation of established radiation safety programs.
3.
Provisions for communication between disciplines & departments in a single committee, with a radiation safety focus.
4.
Requirements for approvals via multidisciolinary view points in a team approach.
S.
Radioactive material use and users are under licensee personnel / peer review and accountability.
6.
Provide for direct involvement of executive management (resourco allocation, corporate policy, and interdepartmental coordination).
7.
A committee of varied representation is granted significant latitude and authority to develop & implement an appropriate radiation safety program & direct personnel.
CDM For institutions with an RSC:
1.
An RSC may not ce necessary for effective radiation safety managnment at small medicalinstitutions.
2.
Radiation safety is not solely directed by an individual (s) (e.g., Radiation Safety Officer) whose role is independent of the authorized user role and interests.
For diagnostic low-dose sealed and unsealed byproduct material uses:
1.
No provisions for licensee to establish interdepartmental / interdisciplinary communicatbn
&/or a_ committee with emphasis on radiation safety.
2, No collegial consensus assisting / representing executive management in oversight of radiation safety issues.
3.
Radiation safety is dependent upon only the RSO and executive management oversight.
4
4 4.
Current broad scope licensees & regulatory provisions for use & approvals (facilities &
use) will undergo significant change.
5.
Decreased potential for executive management involvement in the radiation safety program.
Draft Rule Text Section 35.XX Radiation Safety Committee Each medical in:titution licensee shall establish a Radiation Safety Committee to oversee the use of byproduct material, with the exception of diagnostic low-dose sealed and unsealed byproduct material use.
(a) Each Committee must meet the following administrative requirements:
(1) Membership must consist of at least four individuals and must include an authorized user of each type of use permitted by the license (s), appropriate modality specific physicist (f.)
(if applicable), the Radiation Safety Officer, a representative of the nursing service, and a representative of management who is neither an autherized user nor a Radiation Safety Officer.
Other members may be included as the licensee deems appropriate.
(2) To establish a quorum and to conduct business, at least one-half of the Committee's membership must be precent, including the Radiation Safety Officer and the management's representative.
(3) The committee must meet at least quarterly.
(4) The licensee shall prepare and maintain secords of the Committee meetings in accordance with $35.2022.
l (b) To oversee the use of licensed material, the Committee must:
(1) Review, on the basis of safety and with regard to the training and experience, and approve or disapprove any individual who is to be listed as an authorized user, authorized nuclear pharmacist, the Radiation Safety Officer, or an authorized modality specific physicist, before submitting a license application or request for amendment or renewal; or (2) Review, pursuant to Section 35.13, on the basis of the board certification, the license, or the permit identifying an individual, additional training and experience requirements, as applicable, to approve nr disapprove any individual prior to allowing that individual to work as an authorized user, nuclear pharmacist, or physicist; (3) Review on the basis of skfety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove minor changes in radiation safety procedures, provided tne changes do not affect the standard of safety established in applicable NRC regulations; (4) Review quarterly, with the assistance of the Radiation Safety Officer, allincidents involving byproduct material with respect to cause, and subsequent actions taken; and (5) Review the radiation safety program at least annually, with the assistance of the Radiation Sa'ety Officer.
5 e
l" ALTERNATIVE 3 A RSC will not be required for any medical licensee.
P_tos 1.
Supports a performance based approach and acknowledges the low risk of sealed and unsealed low-dose byproduct material uses.
- 2.
Licensee directs the structure and management of their own radiation safety program C9118
- 1. Not risk based 2.
No provisions for licensee to establish interdepartmental / interdisciplinary communication
& lor a commihee with emphasis on radiatl*,n safety.
3.
No collegial consensus assisting / representing executive management in oversight of radiation safety issues.
4.
Radiation safety is dependent upon only the RSO and executive management oversight.
5.
Current broad scope licensees & regulatory provisions for use & approvals (facilities &
use) will undergo significant change.
6.
Decreased potential for executive management involvement in the radiation safety program.
6 m
4 ALTERNATIVF.A A RSC will not be required, but medicallicensees will be required to establish and implement a program for administrative and technical oversight of radiation safety.
P.LQ3 1.
Consistent with a risk informed, performance based approach to regulations.
2 Provisions for direct involvement of executive management (e.g., resource allocation, corporate policy, and interdepartmental coordination.
3.
Licensee is granted significant latitude and authority to develop & implement an appropriate radiation safety program.
C201 1.
Radiation safety is dependent only upon executive management oversight.
2.
Resources devoted to management oversight of the radiation safety program may, at times, be impacted by the need to devote management resources to other program areas within the facility.
Draft rule text To oversee the use of licensed material, the licensee must establish a program that will do the following:
(a)(1) Approvo or disapprove any individual who is to be listed as an authorized user, an authorized nuclear pharmacist, the Radiation Safety Officer, or a teletherapy physicist before submitting a license application or request for amendment or renewal; or (2) Approve or disapprove any individual prior to allowing that individual to work as an authorized user or authorized nuclea' pharmacist; (b) Appro're or disarprove minor changas in radiation safety procedures that are not potentially important to safety and are permitted under Section 35.31 of this part, (c) Reviert allincidents involving byproduct material with respect to cause and subsequent attions taken; and (d) Review annually, with the assistance of the Radiation Safety Officer, the radiation safety program.
(e) Provide a rnecht.nism for interdepartmental / interdisciplinary communication, 7
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e Radiation Safety Committee Overview Attemative 1 Alternative 2 Alternative 3 Altemative 4 Key items for Consideration with RSC/ without RSC Risk basis xlx a
x Licensee familianty and continuation of x x/_
established radiation safety programs with minimal or no impact on corresponding regulatory oversight Provisions for communication between x x/_
disciplines & departments in a single committee with a radiation safety focus Approvals via tuultidisciplinary view points in x x/_
a team approach Radioactive material use and users are x x/_
under licensee personnel / peer review and accountability Provisions for direct involvement of x x/. x executive management (resource allocaton, corporate policy, and interdepartmentalcoordination)
A committee of varied representation is x x/.
granted significant latitude and authonty to develop & implement an appropriate radeten safety program & direct personnei May not be necessary for ef'ective radiation x x/ ,
safety management at small medical instit#1tions Collegial consensus representing executive x x/_
management in oversight of radiation safety issues Radiation safety and initial authori:ed user x x/,
approval directed by Radiation Safety Committee Radiation Safhty is dependent upon only the x x
_/x RSO and executive management oversighi Licensee direrts the structure of their own _/x x x radiv. ion safety program C
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- 1. How should the NRC determine which industry standards, including voluntary ones, are adequate :
! to meet the NRC's regulatory responsibility for patient, l
worker, and public safety?
i !
To what extent should NRC allow the licensee flexibility ,
in interpreting or selecting an industry standard? f f
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How should the concept of " quality improvement" be !
l incorporated into reliance on industry standards and l an accreditation-type of approach to licensing and l inspection?
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- 2. What are the necessary transition steps the NRC
! should take in order to implement a more positive :
l enforcement program that, in effect, encourages
! or rewards good performance while addressing the i
outliers?
l l What metrics should the NRC use to decide whether i l the approach is working?
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l 3. In considering various events (e.g., misadministrations, i equipment failures, or pro dural errors), what criteria l should the NRC use to determine that a particular event
- is isolated, rather than having program implications for that li nsee or generic implications for other medical j li nsees?
1
{ What is the best pro ss for the reporting of events to l ensure that the NRC is aware of potential generic
! issues? -
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l 4. In evaluating errors, should a threshold be established
) beneath which corrective action is not required?
j How would such a threshold be set, and how would it be i implemented?
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