ML20207L373
| ML20207L373 | |
| Person / Time | |
|---|---|
| Issue date: | 02/17/1999 |
| From: | NRC |
| To: | |
| References | |
| RULE-PR-35-MISC NUDOCS 9903180101 | |
| Download: ML20207L373 (250) | |
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l 1 i ~ 1 UNITED. STATES OF AMERICA (. 2 NUCLEAR. REGULATORY COMMISSION 3 *** 4 PART 35 9UBLIC MEETING-WITH S REPRESENTATIVES OF THE MEDICAL BOARDS 6 *** 7 U.S. NRC 8 Two White Flint North, Room T2-B3 9 11545 Rockville Pike 10: Rockville, MD 11 Wednesday, February 17, 1999 12 The above-entitled workshop commenced, pursuant.to 13' notice, at 9:14 c.m.
-14 : PARTICIPANTS:
l 15 ED MAHER 16 FRANS WACKERS , 17 RICHARD FEJKA l 18 MIRIAM MILLER 19 ALAN H. MAURER 20 CHARLES ROSE 21 PETER MOORTOU
)
22 PHILIP O. ALDERSON
'23 MARK RAYMOND ,
24- WALLY AHLUWALI 25 DAVID COOPER l I t i - ANN RILEY & ASSOCIATES, LTD. I Court Reporters
'1025 Connecticut Avenue, NW, Suite 1014 i Washington,-D.C. 20036 l l (202) 842-0034 '
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2
-1 PARTICIPANTS: [ Continued)
() .2 N. SUNTHARALIGAM
'3- JACK BASKIN-4' 5
6 7 8 9 10 11 12 13 14 1 15 16-17-18 19 20 21 22 23
~ 24 '
l 25 t i i ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 2 84 b34
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___..___-.l l l l 3 l 1 PROCEEDINGS O, 2 [9:14 a.m.] l 3 MR. CAMERON: Good morning, everybody. I'd like 4 to welcome all of you to the NRC workshop on various aspects { 5 of the training and experience requirements in the proposed 6 revision to the NRC medical rules in 10 CFR Part 35. I want 1 7 to thank you all for sharing your time with us for the next 8 day and a half on these issues. 9 My name is Chip Cameron. I'm the Special Counsel 10 for Public Liaison here at the Commission and I'm going to 11 serve as your facilitator for the next day and a half. 12 Generally, my role is to try to help the group 13 have an effective discussion of the issues, and, 14 specifically, that means assisting you in trying to organize
- 15. the material for discussion, making sure that things stay 16 focused and coherent; and by that, I mean trying to, as much 17 as we can, develop what I call discussion threads, rather 18 than just unrelated monologues, and clarify any ambiguities 19 that might exist, and I think I probably have to do some 20 heavy liftin* in that regard, as may become obvious during 21 this session, but also make sure that everybody who wants to 22 speak has an opportunity to speak.
23 Originally, the topics for this workshop were the 24 NRC recognition -- and I'm using the word recognition, 25 trying to be politically correct, rather than saying NRC i "/^} b ANN RILEY & ASSOCIATES, LTD. l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 i l
l 4 l 1 approval of certifying boards -- but the NRC recognition of
- 2 certifying boards and also the role of the examination l
l 3 process.in establishing authorized users. i 4 You will see from the agenda that we're going to I l 5 get into detailed discussion of both the certifying board 6 issue and the examination issue, but our first discussion
'7 topic this morning at 11:00 is a context discussion. In 8 other words, what's the role of the various parameters in ,
9 the process for establishing authorized users. 10 That not only includes the examination, the 11 certifying board, the preceptor concept, but others as well. ; 12 I'm going to ask Cathy Haney, to my left, to sort of give us 13 a little bit of a ummary of that topic before we get to it ) rs 14 this morning, j N ,] ! 15 Now, the NRC staff, of necessity, has been 16 evaluating the public comments, written comments that have 4 17 come in on the prJposed rule, as well as the workshops that 18- we've had on these issues in the past. I 19 So they have been working on alternative 20 approaches perhaps to the provisions in the proposed rule ! 1 21 and we would not only like to have your comment and 22 discussion on the provisions relative to training and 23 experience that are in the proposed rule now, but also on l 24 the alternative approach that the staff is considering. 25 Cathy is going to talk about both the proposed and l [ t% l k_ l ANN RILEY & ASSOCIATES, LTD. l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
5 . 1 the alternative approcch this morning when she begins her :
- (N
(_) 2 d'iscussion, to sort of give us an overview of that, and then 3 we can play that back all throughout the remainder of the 4 workshop. ) 5 Because of that new material and because training 6 and experience is a very broad subject, I want to do an 7 agenda check, I have that on the agenda at 10:00 or 10:30 ; 8 today, to make sure that we're covering all of the issues 9 that are important to you and also we're covering them in 1 10- some sort of a logical sequence. 11 When I ask you in a minute or so to just go around 12 and introduce yourselves, I'm going to ask you to also state 13 one or two concerns that you have in this area and I will 14 use the flip-charts here to keep track of those. That will 15 also be a way that we can fill in the agenda with issues
-16 'that we might not have been thinking about.
17 Now, the ground rules for the workshop are fairly 18 simple. So that you don't need to worry about getting a 19 chance to speak, I'm just_ going to ask you to, if you have 1 1 20 something to say, just turn your name tent up like this and
-21 I will keep track of that and go to you when we're ready for 1 l
22 that. That will also help our court reporter keep a clean 13 transcript. l 24 We are transcribing this meeting and Jon will know i 12 5 who you are because he has a list of the people around the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1 i l J
6 _s 1 table. When we go to the audience for comment after each
.s 2 issue area, I would just ask those in the audience who want 3 to comment to just state your name and affiliation when you 4 speak, so that we have that for the transcript. And use the 5 microphone, please, it's back there somewhere. It's over 6 here.
7 In terms of the participants, I may not take the
-8 cards that are up in sequence, if we're trying to fra, low a 9 particular discussion thread, but we will get to you.
10 I'm going to ask the staff to put the transcript 11 and other relevant materials on the NRC web site. So that 12 if people want to know what happened during this session, 13 since we are in the middle of a rule-making here, if people 14 who are not here want to take a look at the transcript, 15 they'll kno.w what's going on and it may prompt a few of them 16 perhaps to send comments in to the NRC staff, which will be 17 graciously received, right, Cathy? 18 MS. HANEY: Of course. 19 MR. CAMERON: Again, thank you for sharing your 20 time and your ideas with the NRC. I would just urge all of 21 'you to participate and be candid, and this will be very 22 helpful for the NRC staff. 23 Now, what I'd like to do, before we bring Carl
- 24. Paperiello on, who is che Director of the Office of Nuclear 25 Material Safety and Safeguards, where this rule is being O
I ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 m
t I 7 4 1 developed and also those are the people who are in charge of \ l (g ' i (_/ 1 2 the licensing.in the medical area, he'll be down to join us l ! 3 soon. 1 4 But what I'd like to do is have everybody 5 introduce themselves and tell us a little bit about yourself 6 and, also, if you have one or two concerns that you think we l 7 should address during this workshop, please tell us. 8 I will start with my NRC colleagues. Cathy. 9 MS. HANEY: My name is Cathy Haney. I'm Chair of i 10 the Part 35 working group and also I'm a section leader in 11 the Division of Industrial Medical Nuclear Safety. ! 12 I'm basically here today because of my role as 13 chair of the working group and I have certain members of the 3 14 working group that are present here today to listen to some I 15 of your comments and the comments that I receive today I ! l l 16 will be taking back to the group. l 17 The specific topics that I'm interested in getting ( 18 information from are listed in the presentation that I do in l 19 a few minutes, so I'll wait till chat time to give you those 20 topics. l l 21 But basically, we're really interested in uhether, f 22 -if we go forward with a requirement for the exam in the j 23 rule, what will be the mechanism for having that 24 implemented, and then, also, if we go forward with a check l 25 of the certifying organizations, NRC approval or recognition 1 i a (_j ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l i
.- . _ - _ .. . .. . . ~ . . - _ . --. .. - . .
I 8 , 1 of the organizations, what are your ideas on what the input [b i
\~ # 2 of what'we should be looking at when we do get into ,
3 reviewing the boards. 4 MR. COOL: Good morning. I'm Donald Cool. I'm 5 ~ the Director of the Division of Industrial Medical Nuclear 1 6 Safety. Cathy and most of the folks in the working group
- 7 are part of my organization. 1 8 I chair the management steering group that +
9 provides some oversight and input to Cathy and the group and { 10 make recommendations to Carl, our Executive Director for 11 Operations, Bill Travers, and then the Commissioners 12 themselves. 13 This has been a major undertaking. I think most 14 of you have been following along in the process that we've ! 15 been going through and you're, therefore, clearly aware that 16 the issues with regard to training and experience, where I 17 that fits into the rule, the role that it plays with regard 18 to radiation safety, the role that it plays in terms of some 19 of the other aspects have become quite central to this whole 20 rule-making process and one of the key points of discussion i 21 that had been going on over the past now year and a half or j 22 so that this particular rule-making has been in process. 23 I do welcome eeth of you here today. I'm very 24 grateful that you take time away from your practices and 25 other activities to come and try and help us work through 1 v ANN RILEY & ASSOCIATES, LTD. 1 Court Reporters ' 1025 Connecticut Avenue, NW, Suite 1014 Whshington, D.C. 20036 (202) 842-0034
__ _ _ . . _ - - . . . . _ _ ~ .-._ .._ _ _ .. _ _ _ _ _ -_ 9 1 what has become a rather difficult issue, where there are a ' k( $sl 2 variety of views and interests, where there are a variety of 3 needs to try and accomplish those. 4 I'm in hopes that as we continue through this 5 process, that you can help us to devise a structure which I 6 will assure appropriate levels of training for the various 7 folks who are participating in the use of radioactive 8 materials in medicine, that's consistent with the t 9' Commission's mandate in terms of protecting public health 10 and safety, the safe uses of radioactive materials, but does 11 not get us over in the lines in terms of infringing upon the 12 practice of medicine or being involved in the various 13 aspects which you folks in the profession, in the various f-sg 14 societies need to work out in terms of the interactions with 15 your members.
'16 That gets to be, as we have discovered thus far, 17 sometimes a little bit of a fuzzy line to try and work 18 through.
19 I think those are my particular interests. I will 20 not be able to be with you the entire time' . There are some 21 other issues within the division that are also going to 22 require my attention, but I'm in hopes to be able to be in 23 and out of the meeting over the next day and a half and be 24 able to hear as many of the discussions as I can. 1 25 MR. ROSE: My name is Chuck Rose. I represent the l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
10 1 American Association for Nuclear Cardiology. We have , I
/ 2 approximately 2,000 members who are licensed nuclear 3 . cardiologists or are on nuclear licenses.
! 4 I also represent the Institute for Nuclear Medical l l 5 Education that's been training physicians and others in the 1 l 6 basics of radioisotope handling for about the last 20 years. ! 7 I had about almost 15 or 20 years of experience in the same l 8 area prior to that. 9 We've also been administering an examination of 10 the basics of radioisotope handling to the people who j 11 complete those programs for roughly the last 15 years. So l 12 we've had some experience in that area. 13 In addition to that, I'm here to represent the ! 7-~ 14 Council on Graduate Medical Education with regards to some ' kl 15 of-the terminology which is used in some of the regulations i 16 in reference to the ACGME. 17 Thank you. 18 DR. ALDERSON: I'm Phil Alderson. I'm here l 19 representing the American Board of Radiology. I am the 20 Chairman of Radiology at the Columbia Presbyterian Medical 21 Center in New York. 22 My subspecialty is in radiology. My career has 23 been developed and built through nuclear medicine and 24 nuclear radiology. l 25 I also happen to be currently the Chairman of the
/ ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l 1 .
l 11
~ 1 Commission on Nuclear Medicine of the American College of
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\s / 2 Radiology, but I am not officially here representing them at i 3 this time.
4 The sort of issues we hope we will discuss, the i 5 American Board of Radiology hopes we will discuss during 6- this meeting, have to do with the original proposal for 120 j 7 hours of education. We believe, and stated so in the letter 8 that we sent to the NRC that we believe that that is 9 insufficient alone; that you cannot learn safety and utilize i 10 the-ALARA concept outside the context of clinical medicine. 11 The new proposal that I recently received, a 12 four-month training period proposal, has potential, it's 13 interesting, and I look forward to discussing it at this f% 14 meeting. N ,)g , 15 We're also concerned about the testing process. f 16 It seems to be a very awkward process in some ways; how 17 would it be developed and administered? There is a very 18 diversified community out there that you would potentially 19 . propose to test. Who could do it, American Board of Medical 20 Specialty Boards, ACGME-approved organizations or anybody? 21 And when Ms. Haney spoke to the American College 22 of Radiology, was very kind to come and speak to them in 23 September, the proposal at that time was, well, anybody who 24 . applied that we thought, we the NRC thought was okay. And I 25 think we're a bit concerned about that idea and believe that I i _ 7001 RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 22 84 I b3
i 12 1 if there is going to be a test, then there's got to be some ;
/ 2 sort of a threshold of quality to allow organizations to be 3 involved in that process.
4 So those are some of the things that I think we'd 5 like to discuss in the next couple of days. 6 MR. CAMERON: Thank you. ! 7 DR. WACKERS: Frans Wackers. I'm representing the 8 Certification Board of Nuclear Cardiology. The 9 Certification Board is an independent organization. 10 Sometimes it's confused with the examination that's given by 11 the American Society of Nuclear Cardiology. That is not the i 12 case, this is an independent body. 13 The first exam was given in 1996 and we have had fs 14 every year well over 600 people who took the exam and it
\w d 15 will be a yearly exam, as far as I can see.
16 I have been involved in -- I'm a cardiologist, but i 17 I am Professor of Diagnostic Radiology and Medicine at Yale I l 18 University, and I've been involved in nuclear medicine for 19 well over 20 years now. I l 20 I've been involved as a clinical researcher, but ] 21 also I've been active in developing the image of nuclear 22 cardiology. I was the President of the Cardiovascular 23 Council and Society of Nuclear Medicine, and I was the 24 President of the American Society of Nuclear Cardiology. 25 Then I founded and was President of the 1 l 1 A ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
..._.._._.___.._..._,_______m -.. _ ....-_ _. ..-. ~ .
1 13 . 1 Certification Board of Nuclear Cardiology andlat the present 2 time lI~am President of the Accreditation Council for Nuclear
- 3 Medicine.
4- Our conccen is really that there will be ! 5 recognition of a group of specialized people who have been
~
l 6 contributing' tremendously to the field of nuclear medicine, 7 in particular, nuclear cardiology. 8- At the present time, more than 40-45 percent of 9 all. nuclear medicine studies are cardiac studies and the 10 majority of those studies are being performed and 11 interpreted by people who are trained cardiologists. 12 The' field, the literature really, if you look at , 13 those people who have contributed to the field, are all 14 trained in cardiology, they're all board-certified, they
- O' j 15 have advanced training, and have, one way or another, also
. 16 trained themselves or are being trained later in nuclear
- 17 medicine and, in particular, in radiation safety and 18 instrumentation.
,! 19 . So our concern is that this group will be { 20 recognized as an alternative pathway to training in 21 radiology or nuclear medicine that people have come through 22 five years of training in medicine and cardiology'and we i 23 support additional training and at least for to six months i 24 -training, we call level two training, in nuclear cardiology, 25 but' preferably a year training,.if you really want to make ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
14 1" .this your career.
\~s/' 2' Then we feel very strongly that the quality should 3 b'e assessed, and that's why we instituted the certification 4 -exam in nuclear' cardiology.
5 Again, our concern is that this alternative , 6. pathway will be recognized. 7 MR. CAMERCN: Okay. Thank you sary much, Frans, i 8 Peter. 9 DR. MOORTON: I'm Peter Moorton, representing the 10 American Osteopathic Board of Radiology. I'm the Chairman 11 of the Board. I'm practicing as a radiologist in : 12 Kirksville, Missouri. I do nuclear medicine. I have j 13 subspecialty training in magnetic resonance imaging.
/"' 14 Our concern is that we don't dilute the
(,)' i l 15 qualifications that we have already for training for nuclear 16 medicine. We feel that there should be a strong physics 17 background and there should be strong clinical experience. 18' We're opposed to extensive dilution of the program as it is. 19 As far as the testing in the future, we would also i 20 rather have the testing through the board apparatus than l 21 through the NRC, and that would be an item of discussion 22 here at this meeting. 23 MR. CAMERON: Thank you, Peter. Alan. ! 24 DR. MAURER: I'm Alan Maurer. I'm currently the i l 25- Director of Nuclear Medicine at Temple University Hospital I l l l ANN RILEY & ASSOCIATES, LTD. ! Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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I 15 1 in Philadelphia, and I'm here representing the American 2 Board of Nuclear Medicine, of which I'm a member. 3 My background in the field is somewhat mixed. I 4 began my training in internal medicine and cardiology. I 5 did additional fellowship training in nuclear medicine and i 6 'have been practicing full-time nuclear medicine, including 7 nuclear cardiology as part of that, for 17-18 years now. 8 Parenthetically, I'm also an active member for the 9 last several years of the Residency Review Committee for the 10 ACGME in nuclear medicine and have been very involved in 11 reviewing training programs that are certified to go on and 12 permit candida?.es to sit for the American Board of Nuclear 13 Medicine. 14 Overall, my concerns have to do with the quality
- 15. control or' assurance that we have on the training programs 16- and mechanisms. In the recent alternate proposals, I noted 17 that in the matrix we were given, there was still the option 18- for just a preceptor training program, as well as things l 19 which included participation in ACGME programs.
20 Myself, in discussing this with members of the i 21 boards, were really concerned that whatever mechanisms for 22 training are in place be somehow quality controlled, such as 23 the rigorous examinacion that takes place by the residency 24 review committees, where there are on-site inspections, and 25 we know what is involved in the actual training of the T- .,(w -ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
c ] i 16 i
,q 1 candidates.- The sites'are visited,.we know the material, ! -- 2 the lectures, who gives the lectures, requirements on 3 attending lectures, and documenting attendance.
l
'4 So one of.the key issues that I want.to bring up l
1 5 is that whatever mechanism for training is put in place or i 6 that is accepted by the NRC, is that we have some way to 7 assure that the candidates are getting the training and that ) 8 there is on-site inspection and very rigorous written 9 documentation of what's required. i 10 There are mechanisms in place right now and most 11 of the ACGME programs use these kind of rigorous controls by ) 12 committee review. So the greatest concern I think we have 13 is whatever mechanism of training is put in place, that we , 14 all feel comfortable that we know what's going on in the 15 training programs'and that that's well documented. I 16 If the examination is not one of the ultimate 17 requirements, I think that becomes an even more important 18 issue. If we do have an examination requirement, I think 19 the American Board of Nuclear Medicine also feels that the 20 current existing examining boards already have in place very 21- well established and certified examination techniques and 22 question preparation. 23 So that the American Board of Nuclear Medicine i 24 would like to maintain the status of being able to prepare
'25 and examine' candidates and would be willing to participate k- ANN RILEY & ASSOCIATES, LTD.
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17 1 in whatever process this group comes up with for an (_) 2 examination. 3 MR. CAMERON: Thank you all. I guess I would just 4 reiterate the one point that you made that obviously QA and 5 training programs is important in and of itself, but with an 6 elimination of an examination, it becomes even more - 7 important. { 8 All right. Jack. l 9 DR. BASKIN: I'm Jack Baskin. I'm immediate past J 10 President of the American Association of Clinical !
)
11 Endocrinologists. I'm here representing its 3,200 members 12 and also its patients. 13 Our concern is limited to the use of one single
~ 14 isotope, radioactive iodine-131, and its treatment of 15 thyroid disease,'primarily hyperthyroidism. About 90 to 95 16 percent of our use of it is for the treatment of 17 hyperthyroidism, the rest being the thyroid cancer.
18 We're concerned that our unique position is 19 perhaps going to be lost with these new rules. In the past, 20 NRC, for the pasts 50 years, had recognized the fact that 21 this is an integral part of ~ c practice of nedicine in 22 endocrinology and we simply don't want to put too many 23 barriers or onerous rules in that our members cannot 24 continue to be licensed to administer radioactive iodine, 25 particularly for hyperthyroid patients. l
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p 18 , gg 1 We're not opposed to a test, but we feel that if a (,,) 2 test is needed for this unique use of radio iodine, that it 3 he developed and administered by endocrinologists and that ; 4 we not be subject to taking a broad range of instrumentation ! 5 and testing of various isotopes in which we're not ' 6 interested in ever using. 7 We're also c'scerned that perhaps NRC rules are l 8 I sometimes being ined to create monopolies in medicine and we i 9 are opposed to that. 10 MR. CAMERON: Thank you, Jack. Wally? 11: DR. AHLUWALIA: My name is Wally Ahluwalia. I'm 12 representing American Board of Science and Nuclear Medicine. 13 I'm past President of the American College of Nuclear _s 14 Medicine and currently Chief of Radiation Oncology Physics
\~- 15 at the University of Oklahoma.
16 I've been practicing use of radioisotopes in 17 medicine for the last over 28 years and my background is 18 particularly in education, testing and training. 19 I feel that quality assurance of the training i 20 program is a very important aspect. Number two, examination 21 is also very important. However, if people pass the 22 examination, but they don't have a good background, where do i 23 we stand? 24 At this juncture, NRC is going to recognize 25 various boards. What I would like to see is that we should ! ANN RILEY & ASSOCIATES, LTD. l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
, . . . . . - . . . . . . - -. .. . - . ~ . .. . - . . . 19 l 1 1 definitely recognize the boards, but there should be a l
' k -} 2 common framework to see if all the boards fulfill the same t
3 baseline or common criteria. That's very important. 4 So I guess that there should be a common grid 5 which NRC should look at before approving all the boards. l 6 All the boards stress to different aspects, like l 7 I'm going to talk about later on. Board of Health Physics 8 and then American Board of Radiology, American Board of 1 9 Science of Nuclear Medicine, but I'm trying to underline ' 10 that there should be a common grid which we should all look l 11 at. 1 12 Thank you. 13 MR. CAMERON: Thank you, Wally. Mark. I 14 MR. RAYMOND: My name is Mark Raymond. I'm the l O. 15 Director of Psychometric Services for the American Registry 16 of Radiological Technologists, in St. Paul, Minnesota. l 17 Nuclear medicine and technology is one of several areas of ' 18 medical imaging that the ARRT offers voluntary certification l i 19 programs in. 20 I'm here to listen and learn and determine any 21 implications for nuclear medicine technology that the new 22 rules and regulations may have. 23 MR. CAMERON: I would note, also, because of 24 Mark's expertise in the psychometric aspects of this, that 25 he will be offering advice and information on that when we ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 i (202) 842-0034 '
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b l l l. 20 l i i talk about methodologies for preparing exams. j 2 Miriam. 3 MS. MILLER: I'm Miriam Miller and I'm past $ l ! 4 President of the Nuclear Medicine Technology Certification 1 l l 5 Board'and just recently retired from the faculty of George I 6 Washington University, where I conducted the nuclear ! I '
- 7. medicine technology program. I 8 !
I'm here also, similar to Mark, in the fact that l 9 we offer a certification examination for technologists. One 10 section of our examination is radiation safety and Nuclear : i 11 Regulatory Commission rules. 12 I'm here with the idea that'if there is to be a 13 separate examination, which we're not in favor of, we're in ! 14 favor of the boards, really, but if it turns out that we're ' c) b 15 offering our services because we have a computerized 1 i 16 examination which is offered daily with immediate results, ! i 17 and to offer our services and how that could be developed, 18 if it comes to that. ! I 19 Thank you. i
- 20. MR. CAMERON: Thank you, Miriam. Ed.
21 DR. MAHER: I'm'Ed Maher, of the American Board of 22 Health Physics. We are the examining, certifying and l 23 recertifying arm of the American Academy of Health Physics. I 24 We're the people that grant the diplomat status of certified i 25 health physicists. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 ! Washington, D.C. 20036 (202) 842-0034
21
,_ 1 Rather than to say I have a concern, I would say k-) 2 we're here to let the rest of the workshop members know that 3 if a' common radiation safety examination is the way things 4 end up, that we do have 38 years experience in examining 5 people in that area only and that we would be willing to 6 help in that regard.
l 7 Thank you. 8 MR. CAMERON: Thank you very much, Ed. I think 9 you can see that we have a wide range of interests, some i 10 perhaps in conflict on some of these issues, but also a lot j 11 of resources around the table on these issues. 12 Since Carl -- or because Carl isn't here yet, I l 13 think we have time to just have the people out in the 14 audience introduce themselves, so that everybody knows who i
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15 everybody is. Why don't we start with you? 16 I'm sorry. You know what? This is going to be a l'1 little bit difficult because of the microphone situation, I 18 but why don't we just do this. 19 MS. LOVELESS: I'm Vivian Loveless, with Syncor 20 International Corporation. 21 MR. CAMERON: Thanks, Vivian. 22 MR. VAIDYA: I'm Harish Vaidya, with Washington ; 23 Adventist Hospital and NMTCB. 24 MR. CAMERON: Would you want to tell us what that 25 acronym stands for? I ()
\s /
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e . 22 ) 1 MR. VAIDYA: Nuclear Medicine Technology l
-- [~T 4 is ,/ 2 Certification Board. )
3 I MR. CAMERON: All right. Good. ! 4 MR. CASHEN: Ray Cashen, on behalf of the American
- 5 Society of Radiological Tecanologists. )
i 6 MR. CAMERON: Thanks, Ray. I I 7 MR. KILLAR: I'm Felix Killar, with Nuclear Energy 8 Institute. 9 MR. SHOWALTER: Charles Showalter, with the 10 American College of Radiology. 11 MS. SCHLUETER: I'm Janet Schlueter, Technical 12 Ass.. cant to Commissioner McGaffigan at the NRC. 13 MR. CAMERON: Thanks, Janet. We'll swing over l 14 this way. l 15 MS. KOPPI: Susan Koppi, with the Endocrine l 16 Society, on the staff. 17 MR. FORREST: Rob Forrest, with the University of 18 Pennsylvania. 19 MR. CAMERON: Thanks, Rob. 20 MR. YOUNG: Good morning. I'm Thomas Young. I'm l 21 an inspector from the Region III office, on special ! 22 assignment here for the rule-making on Part 35. ; i 23 MR. CAMERON: And that's NRC's Region III. I 24 MS. PETRUZZELLO: My name is Pennie Petruzzello, l 25 and I'm here with Krueger-Gilbert Health Physics. J , l 3 %
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i 23 1 MS. MEYERS: My name is Laurie Meyers. I'm with 2 the American Association of Clinical Endocrinologists. 3 MR. CAMERON: Thanks, Laurie. Sam? 4 MR. JONES: I'm Sam Jones, with NRC headquarters, l 5 a member of the Part 35 working group, i 6 MS. FLACK: Diane Flack, I'm a member of the Part 7 35 working group. 8 MR. CAMERON: And you guys can use these 9 microphones, too. 10 MR. SIEGEL: I'm Barry Siegel. I'm a consultant 11 to the Part 35 working group. 12 MR. CAMERON: I think it's important to recognize 13 the people who are on the ground, so to speak, developing s 14 these rules for the NRC. It is the Part 35 working group 15 and we have several of them with us today. So that if you ! i 16 have questions or comments about anything, they'll be here. 17 I guess we still don't have Carl. 18 MS HANEY: I can start. There are a couple 19 breaking points in the presentation, if you want, if Carl l 20 comes in. 21 MR. CAMERON: Okay. Why don't we go ahead to the 22 9:30 overview of the proposed rule, and this will sort of 23 give us a context. When Carl gets here, we'll break and 2'4 have Carl welcome all of you and then we'll go on from
- 25. there.
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l l 24 i i 1 MS. HANEY: I'm just going to spend a couple of A. k, m 2 minutes going through a little bit about the background of : 3 the rule. Some people I recognize, familiar faces, have 4 heard this before, so I'll go a little bit quicker. But if , 5 I go too fast,Lplease stop me and I'll be happy to go back
-6 and give some more detailed information on the information.
7 Basically, what I'd like to cover in this part of 8 the presentation is the background to rule-making, why we're 9 where we are, the process and the approach that the Part 35 10 working group did use to come up with the rule, and then to 11 give you an idea of what information on training and 12 experience we need. 13 I alluded to that earlier, but I'll get into a 14 little bit more specific requests here. O- 15 Then I'd like to go over the current training and 16 experience requirements very briefly. The reason for that 17 is I want to highlight the boards that are currently 18 recognized in the rule; then talk a little bit about the 19 proposed rule, the training and experience requirements that 20 appear in there. Again, this aspect I'd like to focus more 21 on the alternative pathways as compared to the boards, and 22 then to describe what the working group is, where we are 23 right now. 24 That is definitely a works in progress. We 25 finished it-up on Friday, very quickly, so Chip could have ANN RILEY & ASSOCIATES, LTD. J Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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1 something to mail out to you, and it's continually changing. t i \/ 2 But, again, we wanted to stop the clock and at least give l 3 you something to talk about for the purposes of this l 4 meeting. 5 Back in March of 1997, the Commission gave us what l 6 they call an SRM, which is a staff requirements memorandum, 7 and in that document, they told us to go forward with the 8 rule-making and they gave us a couple of points that we 9 needed to consider during this process. They also said that 10 we needed to have the rule-making finalized by June of 1999. 11 The key things I highlighted on this viewgraph, 12 because as we're discussing the training and experience 13 requirements today, they need to all be able to be traced r~s 14 back to these items in the Commission's direction. ( )
\ 15 "ne first thing we want to do is focus Part 35 on 16 procedures that pose the highest risk, and this is looking 17 at really relatively between the diagnostic and the 18 therapeutic uses of byproduct material. Then as one step 19 down from that, we need to have oversight alternatives for 20 the diagnostic procedures consistent witn the risk.
21 So this is, again, looking at risk. We are using 22 a risk-informed approach to the rule-making, as compared to 23 a risk-based approach to the rule-making, but you will, if 24 you've gotten an opportunity to look at the rule in-depth, 25 you should see a difference between the prescriptiveness of p (_,/ 1004 RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034 l
r 26 1 the rules in the diagnostic area versus that in the 7s
~
- 2 therapeutic areas.
l 3' ~The other thing, in 1997, that the Commission 1 l 1 4 asked us to do was to capture relative safety issues and l 5: ' precursor events. As the rule-making went on, we went back 6 to the Commission and gave them some alternatives rather 7 .than putting a requirement in Part 35 or capturing these 8 sort of' events. .The Commission agreed with the staff's ! 9 approach,-.so we did not go forward with this particular 10 bullet. 11 Another thing they said was to go ahead and give I 12 us permission to change the term " misadministration" to 13 " medical event" or any other title that we would like to (~' 14 propose for use. Medical event seemed to capture, by title V) 15 or by name, the' sorts of events that we were trying to 16 identify and because.of that, we did go forward with medical 17 event. 18 They also asked that we redesign Part 35 to allow 19 for timely incorporation of new modalities. The best 20 example here is when remote afterloaders came into use 21 several years ago, there was no specific place where they 22 could be licensed in Part 35. .What typically happened -- 23 what did happened was we tended to license more by exemption 24 to the requirements for teletherapy units. 25 By having a spot in the rule for this what's been l rT L -
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27 1 coined emerging technologies, it would be easy to put that O k/m 2 sort of licensure requirements into that section of the rule 3 as compared to doing a significant number of licensing 4 exemptions. 5 This is a particular area where the training and 6 experience comes into play, because it's basically what 7 we're looking to capture is uses of material that we have 8- not, at the present time, discussed in the rule, and, 9 therefore, it's very hard for us to say what would the 10 training requirements be for this type of use. 11 In this case, I think we're going to have to do it a 12 on a case-by-case basis, using ACMUI, which is our Advisory 13 Committee on Medical Uses of Isotopes, for help. p)
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14 But why I bring it up in this meeting is that 15 whatever approach we end up taking in the final rule for 16 training and experience, it needs to be an approach such 17 that we could tailor it very easily to any use of emerging 18 technologies. 19 Then, also, we would revise the quality management 20 progrem to focus on patient safety. There are some changes 21 in the proposed rule. Again, I can go into it in-depth if 22 .you want, but since we're mostly focused on training, I'm 23 not going to go too far into depth on it. 24 Then the last item is using available industry 25 guidance and standards, when possible. Another key area
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y--- -- 28 e,_T 1 possibly for the training and experience, because while some k s/ - 2 of the boards, you could say, are not necessarily an 3 industry standard from the standpoint of something like an 4- ANSI standard, per se, but they are a standard that is 5 commonly accepted in the profession and how can we use that 6 'in this rule-making. 7 I did mention the time-frame thEt we were working 8 in and, hence, the importance of this meeting. We did get 9 the direction in March of 1997. Several months after that, 10 we went back with the staff's plan for revising Part 35. 11 That plan was approved by the Commission and that particular 12 plan had staff submitting a proposed rule to the Commission 13 in May of 1998 and then with a final rule going to them in 14 June of 1999. O 15 We did go to the Commis on in May. The rule was 16 published for ccmment in August of this year, and that is 17 the Federal Register Notice that you either received in the
- u3 mail or you picked up a copy when you came in, and, if not, 19- we can give you one at the break.
20 That also included the medical policy statement. 21 So there were actually two notices that were in the bound 22 version that you got. 23 The comment period, the rule was initially put out 24 for a 90-day comment period. Based on public comments that 25 we received, we did extend that another 30 days, and the n\_/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 ? (202) 842-0034
l i i 29
- 1 comment period closed in December. So now we're working i 7,)
l!Ass / 2 very frantically to come up with a final rule to give to the 1 3 Commission in the June 1999 time-frame, i l 4 I kind of alluded to this already. We did use a i-1 5 working group and steering group approach to developing the ! 6 rule, the rule text, revisions to the medical policy I l 7 statements, and then we are working on a guidance document 8 that's associated with this rule-making. 9 As I said earlier, I'm chair of the working group. 10 Don Cool is chair of the steering group. We have tried to 11 involve as many people as possible in these groups. We have 12 representatives from all the different NRC offices that have 13 some interest in this rule-making; specifically, the Office (g; 14 of Enforcement, the Office of our General Counsel, as well l 15 as regional input. 16 We also brought in representatives from the , 17 states. We have two members on the working group, Dave 18 Walter from the State of Alabama, and Marsha Howard from the 19 State of Ohio, because we are trying to do what we refer to 20 sometimes as parallel rule-making. The Council -- CRCPD is 21 Council on Radiation Control and Program Directors -- it's 22 terrible being up at a microphona and trying to remember 23 those long acronyms. 24 But CRCPD is working on a rule that would parallel l 25 Part -- or it's a' medical rule and we are trying to make ' Oh s ANN RILEY & ASSOCIATES, LTD. i Court Reporters 1025 Connecticut Avenue, NW, Suite 1074 Washington, D.C. 20036 (202) 842-0034
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30 i _ 1 them as consistent as possible. So Dave has been i k-s 2 representing the CRCPD interests on the working group. 3 On the steering group, Tom Hill is a member from 4 the State of Georgia. Basically, what happens is the 5 working group comes up with a drtft. If we run into any l 6 sticky issues, we go to the steering group and ask them for , 7 some assistance on how to' resolve those particular items. ; 8 Generally speaking, the approach that we used to l 9 this rule-making was to start with the identification and 10 diccussion of key crosscutting issues. One of the 11 l crosscJing issues was training and experience. Since it 12 was identified as a key crosscutting issue, we did receive a 13 ' lot of comment from the public, either written comment or 14 comments during some facilitated public meetings that we had ( ~), 15 ear 3y in the process. These were very useful to us. j I 16 The other thing that pertains to, again, the 1 l 17 training and experience is the. proposed change in licensing ) l 18 philosophy that we're putting forward with this rule. Under l ! 19 the current situation, under the current rule, in order to 20 get a license, you submit to NRC information on your l 21 training and experience, but then you also submit to us 22 various procedures, operating procedures, telling us how 23 you're going to do things, and then we tie you to that via 24 your license. And by tying it to it, I mean that when we go 25 out to inspect, we would look to see that you are using i N
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31
,_ 1 those procedures in your day-to-day operation.
I l \- 2 Under the proposal that accompanies this rule, we 1 3 would no longer review procedures up front and we would no l 4 longer tie you to them. So in essence, we're putting the j 5 responsibility on the licensee to develop procedures that 6 meet the intent of the rule and then to implement those 7 procedures. So that the tie to training and experience is 8 that the individuals that are using the material have to 9 have the proper training and experience to identify what 10 needs to be in that procedure and then also to go forward 11 with implementing that procedure. 12 We did develop a guidance document that goes with 13 this rule-making and we did not bring down copies now, but 14 we will bring down some copies at the break time, if anyone 15 would like a copy of the draft document. 16 This particular document tells you what you need 17 to submit to NRC in order to get your license. It goes into 18 some of the training and experience aspects, but it also 19 goes into some of these procedures. While you don't need to ; 20 submit the procedures, it just gives you an idea of what a 21 .model procedure would look like. It does not tie you to 22 following these procedures. They're merely there for 23 someone's information. l 24 The other thing that we did with this rule-making 25 is that if a particular requirement appeared in another i
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32 i 1 -portion of the rule, we did not maintain it in Part 20, ' (~~)
\s / 2 unless there was a specific need, from a radiation safety i
3 standpoint, that we believed that it was appropriate to , 4 maintain that requirement in the Part 35 rule. 5 Chip mentioned it, I believe, and I alluded to it, 6 we have done some rounds of facilitated public meetings ! 7 before. We'll call this one round three. 8 The first round was held to discuss the rule 9 alternatives that I mentioned earlier. The second round was 10 held during the'public comment period. These comments we l 11 took into consideration in developing this, the staff 12 working document. A lot of the focus of all these meetings ' l 13 was the training and experience requirements. So we do have i l 14 a rather large base of information when we looked into i
/~'}
15 preparing the TNE. l 16 Now, why are we here today? When we went forward 17 to the Commission with the staff's pr: 2posal for the final 18 rule, they came back to us with another staff requirements 19 memtrandum that said go forth and publish the rule, make a 20 couple of changes in it, but you can pretty much go out with 21 the way that you have it. 22 But they were a little bit concerned about the 23 requirement for an exam and NRC approvel that had been ! 24 inserted into the proposed rule. So they said to us that 25 when you come back with a final rule, that you need to L ! ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034 l 0
I 33 1 provide the Commission with more detailed information on the 2 FTE, as in the full-time equivalent effort, that would be 3 needed to implement this third-party examination, and then 4 they go on a little bit into the process for the adequacy of 5 the licensee training and asked us to solicit specific 6 public comment on the exam. 7 We did solicit specific public comment on the exam ! 8 in the Federal Register Notice. We did get a significant
- l. 4 9 number of comments on this particular area. I 10 But as I said, really what we're here for today is 11 hopefully that you can give me enough information that when 12 we go forward with a final rule, a proposal for a final 13 rule, that I can answer this question.
-. 14 Now, I know you can't tell me what my FTE efforts ) '# 15 are going to need to be, but by helping me at least scope 16 out what the process for NRC approval of boards would be and 17 what the NRC process for the exam, if we were to keep it in, l 18 would be, that would give me the needed information for me l
- 19. to calculate what sort of FTE resources from NRC's 20 standpoint we'd also need to do it.
- 21 At the same time, while we're interested in NRC i
I 22 resources, the Commission I'm sure would be interested in 1 l 23 information on the resources needed for the industry to l 24 implement this. Again, if we went with the third-party l 25 approval and the resources it would take for the boards to_
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34 _ 1 put'a package together to submit to NRC so that we would 2 recognize them. 3 So I'm looking for resource information on both 4 sides. Now, in one aspect, .it would be very easy if I just' 5 deleted the exam from the rule, as you see in the final, 6 where'the staff.is right now on the proposal for the final 7 rule, but now that I'm kind of this far into the examination 8 process, since I've deleted the exam from the rule, now I 9 need to go back to the Commission and say why I deleted it. 10 Of course, one of the considerations for deletion 11 is the FTE resources. So whether it's in or out, I still 12 need the information, is what it boils down to. 13 Now, I thought it would be worthwhile to take a 14 couple of minutes to go through the training that's required fS b 15 in the current 35 and then go on into the other two 16 documents that are out in the public domain at this point. 17 The current Part 35 has recognition of boards 18 actually in the rule and then it also has alternative 19 pathways for training and experience requirements. So, for 20 example, if you wanted to become an authorized user under 21 35.200, which is for imaging and localization, use of 22 byproduct material in imaging and localization, if you were 23 certified by the'American Board of Nuclear Medicine in 24 nuclear medicine, you are automatically qualified, and it 25 lists several other boards that you would fall under. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 e
35 , 1 If you were not certified by one of those boards, 2 there is an alternative training pathway, and that's what 3 Dr. Alde; son referred to earlier. It would be 200 hours of I 4 didactic training, 500 hours of practical experience, and 5 then 500 hours of clinical experience. I'll go on and focus 6 on that alternative pathway in a few minutes. ! 7 But in the proposed rule, we deleted the boards by 8 name from the rule, for a couple of reasons. One is that as , 9 new boards come along, it's very hard to do or it's a long process to do a rule-making to get them into the rule, and, i 10 11 therefore, anyone that was not coming in under board 12 certification would have to come in under this alternative 13 pathway. i 1 i 14 So they were almost -- they were trying to meet
\
I 15 the alternative pathway to make NRC happy, but at the same 16 time, they were becoming board-certified from a standpoint I 17 of their medical practice. We felt that it was maybe not I 18 appropriate to have the boards in the rule; however, to go ; I 19 forward with a process where NRC would approve the boards, ' 20 and then we would maintain this list of approved boards, 21 approved or recognition, we would maintain that on a web 22 site, make it very available to the public. 23 What I did see when I compiled this chart is that 24 the different boards are in the rule various different ways. I 25 In one part of the rule, it says certified in nuclear ; ANN RILEY & ASSOCIATES, LTD. i Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i l l i 36 ; i
,s 1 medicine by whatever board. In other portion, it says board ,
I \~/ 2 of, certified in. There is not consistency in the way the ! 3 current requirements are in the current rule. 4 I just put this -- I have the two pages, I won't L 5 put the second page up there, but you do have a copy of it, 6 just to show the various ways that the boards do appear in 7 the-rule based on their subspecialties. 8 When we.went into revising the training and ; 9 experience requirements, the first process that we did, we 10 went back to the staff requirements memorandum that said 11 that the T&E requirements -- or it didn't say the T&E ; 12 requirements, but the rule should be risk-informed, if i 13 possible. 14 So one of the working group's objectives was to 15 make the requirements for T&E risk-informed. Our thinking i 16 here was that there would be more requirements for the i 17 therapeutic uses as compared to the diagnostic uses of j 18 byproduct material, and that we would focus the training and 19 experience solely on radiation safety and NRC licensure 20 would not be equivalent to clinical competency. j 21 We heard that at a lot of the meetings. They are 22 two separate things. They should not be confused and you 23 should make it quite clear that they are two separate things 24 in any documents that we published, and the Federal Register ; 25 Notices that we did issue made that distinction, I believe. l q-
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i Court Reporters l' 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 i i
s j 37 1 The other thing that working group went out with I,_h V 2 is that you should complete a structured educational program l 3 and the program would have two components. One is didactic 4 training and the other is practical experience. 5 Again, we've gotten away from any reference to the 6 clinical competency. 7 Then with the changes in the requirements, the 8 hours to become an authorized user, we believed that an 9 examination should be given. So in other words, it was 10 somewhat of a three-pronged approach; that you would have a 11 structured educational program, you would have a preceptor 12 for your training, and then you would have an exam to assess 13 the competency, and all those things, those three items 14 together, would give NRC assurance that an individual would 15 be able to use byproduct material safely. 16 Now, I do throw in the implementaticn schedule at I 17 this point. Because of the significant changes that we were l 18 putting forth in some of the training and experience 19 requirements and because of NRC's approval of boards and 20 NRC's approval of the exam, we knew that that all couldn't 21 be put into place within six months of the rule becoming I 22 final. 23 So we did propose that the Part 35 would become 24 effective six months after it was published in the Federal 1 Register, with the exception of the training and experience 25 . ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202)' 842-0034
t 38 l . . _s 1 requirements, and that we were proposing we would take out
> 4 l
\_/ 2 to two years.
3 During the two years, from when the rule is -- 4 well, actually two years after the rule is published in the 5 Federal Register, an individual would have the alternative 6 of becoming an cuthorized whatever, authorized user, 7 radiation safety officer, medical physicist, whatever, by 8 either completing the requirements that are currently in 9 subpart J,.which is the area that lists the boards and then 10 the alternative training pathway that I alluded to earlier, 11 or they would be able to come in and comply with the revised 12 requirements. 13 That way, it would allow us time to approve g-^g 14 organizations and, at the same time, approve the boards or ' (_'l 15 any examining organizations, give them time to get a package
'16 in to us and then for us to approve it.
17 So some of the things today, if we focus on them, 18 depending upon which way it looks like we're going forward, 19 if you can give me an idea of whether you think two years is 20 an adequate time period for implementing something of the 21 nature that we are proposing. 22 There are a couple of questions that I think would 23 be worthwhile for us to focus on and these are the questions 24 that appeared in the Federal Register Notice, and I think 25 probably what's best is for me.to -- well, for you to know i i p i . '\ ) ANN RILEY & ASSOCIATES, LTD. ! Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washingt7n, D.C. 20036 (202) 842-0034
'39
-s 1 that they're in the document.
\ 2 Maybe when we get to the 11:00 session, Chip, we 3 can focus a little bit more on answering some of these 4 questions.
5- But,'again, to give you an. idea of what 6 information I'm looking for from you during this meeting. 7 Then the last three viewgraphs you have I think 8 get progressively harder to read, if you want to know the 9 truth. The particular one that's up on the screen now are ' 10 _the training and experience requirements that were proposed 11 that actually were contained in the proposed rule. i 12 You can see down the other column is that for all 13 types of users, with the exception of use under 35.500, ; I rg 14 which is your sealed sources for diagnosis, an exam would be (y , 15 required. So this is the exam that we're talking about l
-16 today.
i 17 But then recognize the alternative pathway to this 18 ~ is certification by a board that NRC has recognized. So 1 19 we'?.l.need to talk about what criteria NRC should use in 20 order to recognize this board. I can put this viewgraph up 21 as we go on later in'the' day. ! 22- Then the next thing that you see is the staff's 23 draft final rule as it existed on Friday and you will see 24 that we have deleted the requirement for an examination, but 1 25 we have included an approval of NRC of the training and
,/~N i 'w- ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 , (202) 842-0034 ' u
r? : i-l 40 , 1 l s 1 experience program, the training program tha'c would b-( 2- required, and you see that in column three. 1 3 I would propose even possibly a simplificaticn in~ i 1 4 'that third column and that is that rather than calling out' 1 5 ACGME or the AOA specifically, that we would, in rule text, f 6 we would just call it out as an equivalent program approved 7 by NRC. 8 This is where, Alan, you mentioned that you had 9 had some experience with looking at the quality assurance 10 that we would have and when we were reviewing these programs 11 gnd approving them. So-I'd.like the information from the 12 group on'if we were starting to -- if we took this approach j 13 and we're reviewing and approving these structured
's 14 educational programs, what sort of information does NRC need i i
15 and how labor-intensive is this particular proposal. 16 Then the next viewgraph goes on to some of the j i 17 other users, and then your radiation safety officer, your ! 18 medical physicist and your pharmacist at the end. 19 So, Chip, that's a quick overview of everything, I 20 believe. 21 MR. CAMERON: Great, Cathy, that was very concise ; 22 and very helpful. 23 Before we go into questions for you, I guess I 24 would ask the panel to keep the questions to clarifying 25 questions about what Cathy has presented. We'll have plenty C i\ ANN RILEY & ASSOCIATES, LTD. ! Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 84: 3034
41 7-s, 1 of opportunity to discuss the substantive comments on these
'- 2 issues. So let's keep it to clarifying questions.
3 Before we go there, though, one thing. Carl 4 Paperiello has been called downtown, so he won't be with us, 5 so we'll just have to try to make do with Carl. 6 I also wanted to give Rich Fejka a chance to 7 introduce himself. He's joined us. Rich, would you just 8 introduce yourself, please? 9 MR. FEJKA: My name is Rich Fejka. I'm 10 representing the Board of Pharmaceutical Sp<ecialties. I 11 apologize for being late, but I had to get my chores done 12 this morning before I could get up here. 13 MR. CAMERON: All right. Thank you, Rich. Before 14 we go to clarifying questions, I just want to emphasize that 15 the fact that the staff is thinking about a new approach 16 does not minimize the importance for both the staff and the 17 Commission of getting your comments on the approach that's 18 in the proposed rule. 19 So we're looking for discussion on not just new 20 approach, but also the approach that's in the proposed rule,
-21 because all of that information will be presented to the 22 Commission for their consideration in deciding what approach 23 should be taken on these particular issues.
24 I guess I would ask the panel, are there any 25 clarifying questions about what Cathy has presented? Try to
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42 (_ 1 use your cards, but you don't necessarily -- we don't have l \_/ 2 to slavishly adhere to that. Go ahead, Chuck.
'3- 'MR. ROSE: Because the staff's proposal'now is, in
,4 my opinion, very different than was the proposal that wae 5 subject to the seven meetings which have already occurred 6 across the_ country, if you go with this new proposed rule, 7 this significant change,_ do you intend on.having a series, 8 again, of national meetings to discuss this, published in 9 the Federal Register, et cetera?
10 If the answer is yes, won't that put it past the 11 six-month period? Gotcha. 12 MS. HANEY: It will. See, I've been looking for !
)
13 something'to get me past June anyway. fw 14 MR. ROSE: Well, I think this would do it.
~
15 MS. HANEY: As of right now, this really has been ; 16 reviewed no higher than me. It has not seen management at 17 Don's' level, steering group level, or Carl's review. 18 They do know the approach that we were going to 19 try to put down on paper and they said go ahead with it. 20 I can answer that question today, but the answer 21 could change, so just don't hold me to it. If we went l 22 forward with this, since we are doing these changes based on !
-23 public comment, because we did not do anything in here that 24 we-did not 1eceive in comment, I do not believe that we 25 'would need to go ahead and repost it and, therefore, we I
i: i l "%
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43 i's\ 1 would probably not go ahead with another round of public kl 2' meetings. 3 Now, why I'm saying it., this is my answer, because 4 obviously if this were to become firmer and truly the 5 approach we were looking at, we would have to review that
.6 with our Office of General Counsel to make sure that we were 7 still in adherence with the Administrative-Procedures Act.
8 If we had gone to the point where it was s. 9 significant enough change that-we would start tripping on 10 the Administrative Procedures Act, then, yes, we would have 11 to follow what the law says and go forward with possibly 12 reposting it. 13 So we are aware of that and without the law degree
,g
, 14 that I don't have, I think we're still okay, because we are
~'
15 doing it based on public comments. 16 MR. CAMERON: And I guess I would suggest that in 17 addition to what we hear going through the next day and a 1 18 half, that when we get to the final session tomorrow, that's ; 19- called summary and next steps, if there are process concerns l 20 such as Chuck brought up, let's make sure that we revisit 21 those tomorrow in terms of need for additional comment time, 22 whatever. 23 Alan. 24 DR. MAURER: One of the last things that you went 25 through was the implementation schedule and how that was put j i (/ l' ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
~ - . _ - . . ~. .- - . - .
v. 44 l j-q 1 in place. I'm not clear whether, I guess, the question
's- 2 comes up about grandfathering.
3 Does this apply only to new future license issues 4 or would existing licensees maintain their license or would 5 they go through the process and would we have to clarify? i 6 MS. HANEY: No. Anyone'that would be qualified 7 now as an authorized. user or radiation safety officer or 8 teletherapy physicist-would maintain their status. They 9 would not have to go back and comply with these new i 10 requirements. So in other words, we would be 11 grandfathering. j 12 MR. CAMERON: Perhaps one related issue that you 13 might want to address is the implementation schedule that
<-' 14 you put up was based on the provisions in the proposed rule.
b] 15 If the alternative approach was adopted, would 16 there be any difference in the implementation schedule? 17 MS. HANEY: There could possibly be, because one 18 of the reasons we went out two years was because of this 19 implementing the examination process, we thought it would 20 take that long. 4 21 But if we did go forward with the staff's 22 proposal, we would still be approving the-certifying boards 23 or recognizing the certifying boards and we would also be 24 recognizing the educational prograns, and that would take 25 some tir.- to do. i [d l T ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I i 45
'l.
Now,-whether it would actually take the two years (\ 1\_/ 2 or whether we could do it in one year is open for f 3 . discussion. I
~ 4L I think'the key here is how'much time does this j 1
'5 group think'it'would take for us to do that type of a j 6 review,. basically, and to bless that particular program as a ,
7 structured educational program that could be used'to meet i 8- the requirements. I 9 If you think that -- you know, given the number of ! I 10 . boards that we have, you could see from the list that it is i 11 a finite number right now, could we get it done in a year 12 and then we would implement it quicker. i 13 So'those are some questions. So I'think'the 11 4 implementation schedule is open to possible change. + O- 15 MR. . CAMERON: So just to reiterate some of the l l 16 needs that the staff and the Commission have, what are the f 17 resource implications for both the NRC and the medical i i 18 profession of the approach in the proposed rule and what are !
-19 the resource implications of the alternative approach that's 20 being suggested, as well as what are the schedule l l
21 implications of both of those approaches. ! I 22~ DR. ALDERSON: . I'll take the opportunity at this ! 23 time to officially make the comment that I made in the 24 opening,cwhich is pertinent to what you've asked us to do, . { 25 and that is the comment that the original approach prior to 1 1 O. ANN RILEY.& ASSOCIATES, LTD. J Court Reporters i 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 (
'(202) 842-0034 j i
k: I
4
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l 46 i 1 this modification, I believe and the American Board of (3 2 Radiology believes, is insufficient. l 3 It's insufficient for public safety. It's l i 4 insufficient for training. 5- We believe that the new proposal that you've made 6 is much more -- speaks much more to what we believe is 7 needed in the community. It's a great improvement; that is 8 to say, it's perfect as it stands, but it's a great l 9 improvement. 10 With respect to the FTE requirement that you just I 11 spoke of, I think there is' going to -- if the NRC decides to 12 get into the business of approving educational programs and 13 approving tests,.I think it's virtually like opening j
\ /) 14 Pandora's box. We have other people who do this now.
l
'\_) l 15 We have many organizations who get involved and 1 16 organizations, all the boards that are involved,-and the 17 American Board of Medical Specialty societies. They are of 18 known and demonstrated quality. They are under periodic ;
19 external review. So you know that they're solid, you know { 20 that-their programs are solid, because there are residency ! l 21 review committees that are reviewing those programs. ! 22 If you put another layer of review, re-review on 23 top of all that review, it's going to be a significant 24 effort. Among other things, you have a finite number of 25 boards now, .but it's a controversy in organized medicine. l lf '\ ' ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 l (202) 842-0034 1
47 1 There are something like 23 boards that are approved by the
- (~h
\_) _ 2 American Board of Medical Specialties, but there are 3 something like 125 boards. I mean, anybody can have a 4 board.
5 Any group can get together tomorrow and say we're 6 the board of this and that and we create an exam and so now 7 we're going to go to the NRC and say that we want to be 8 involved in this. I think there will just be an endless i 9 cavalcade of these people coming through your doors. 10 I think it's a mistake to go in that direction. I 11 think that the time resources are also of great concern and 12 I guess my personal concern was heightened when I heard you i 13 discuss the issue, the obvious issue of agreement states. I
,~ 14 thought of the convoluted process that we go through in our ws -15 agreement state, New York City, in order to get things 16 approved and how one Commissioner after another has looked 17 at us across the table and say it is our goal to be at least 18 as rigorous as the NRC and generally more.
19 So they've put us through all the hoops and more 20 hoops and it's taken enormous amounts of time to get 21 anything done through that agreement state process. 22 So if, in fact, individual organizations and 23 groups are having to work through that layer, as well, I 24 think it will be a very difficult process. And although I 25 initially thought that two years was a reasonable time, I'm l l l l p-h ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i l l 48 I 1 not sure that it is a reasonable time, and you're always 2 going to.have, as I say, these new boards popping up from 3- somewhere. 4 I think, therefore, you're much better off to rely 5 on proven organizations that other parts of our society and 6 the public have given their blessing through these various 7 processes. I don't think that that keeps other groups out. 8 I don't think that that is trying to restrain or, as someone 9 used the term, unionization or a monopolistic practice. I 10 ' don't believe that's true, because I believe that there are 4 11 a lot of other newer organizations, and I'll use the example ! 12 of ASNC, if I could, that -- l 13 ASNC, as a newer organization, has an examination, j i s 14 It's a very credible group, and the statistics that Dr.
\/ 15 Wackers gave you are accurate about the amount of people 16 doing nuclear medicine, nuclear cardiology. That group 17 could easily come in under the banner, under the aegis of 18 the American Board of Internal Medicine, they are interns, 19 _in this sort of a process.
20 So that by staying within the bounds -- and so for 21 the endocrinologists, for that matter, I presume. So by I 22 staying within the bounds of organizations that are already 23 approved, you could eliminate from the NRC the requirement 24 to get involved in a whole new layer of bureaucracy and go 25 through established processes to allow a broad base of
5 to'give us the benefit of these thoughts again when we get 6 to the discussion of these substantive issues and everybody 7 will get a chance to respond to some of the comments that 8 ~ Phil made.
- 9 But I would just ask you, during this period, to .
10' just -- if you want to clarify something with Cathy -- in 11 other words, to give us the information base to proceed with , 12 for the rest of the workshop, do that now and then we're 13 going to come back for substantive discussions of these 14 issues. 15 Wally. 16 DR. AHLUWALIA: Yes, sir. I have a comment on l l 17 this slide. This pertains to specialty boards listed. When 18 we go to the item third from the bottom, there should be 19 another X in the last column. 20 MR. CAMERON: We'll get that up there so everybody 21 can see that. 22 DR. AHLUWALIA: This is pertaining to the American 23 Board of Radiology,.subspecialty therapeutic physics. 24- MS. HANEY: Talk slow, go slow. 25 DR. AHLUWALIA: Okay. I l ANN RILEY & ASSOCIATES, LTD. ! Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 i (202) 842-0034
r-50 l l 1 MS. HANEY: Are you on the second one? i . [\-s}- 2 DR. AHLUWALIA: First page. I will bring the l 3 second comment in a second. The third item from the bottom, 1 4 there should be an X in the last column because-the 5 physicists train to observe the radiation safety, also. l 1 6 MR. CAMERON: Can you point out where you think ! l 7 this is supposed to go, Cathy, so that everybody ) 8 understands? I 9 DR. AHLUWALIA: The last column, RSO. The third 10 -- Board of Radiology. 11 MS. HANEY: So that one right there. 12 DR. AHLUWALIA: Yes. And another item should be 13 added, medical nuclear physics under American Board of 14 Radiology. So that X should'go under only RSO. There is 15 another board, subspecialty of American Board of Radiology 16 called medical nuclear physics. Dr. Alderson. l 17 MS. HANEY: Wally, is that in the current 35? I 18 Because what this shows us just what's in the current rule 19 text right now. 1 20 DR. AHLUWALIA: But that should be recognized, 21 too, you know. 1 22 MS. HANEY: No, I'm not saying it shouldn't be. 23 What I was showing here was more that the current rule does I 24 not recognize everyone, and that's part of the problem with 25 the current rule. l 1 ANN RILEY & ASSOCIATES, LTD. i Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034
l 1 51
- p- 1 DR. AHLUWALIA
- Let's go to the last grid, the i
2- second page of this -- you have another page. The last item 3~ is American Board of Science in Nuclear Medicine. That's 4 "in" Nuclear Medicine, the X is right there. They have l 5 another specialty called radiopharmaceutical. l 6 MS. HANEY: I know for sure that that one is not 7 in the rule. See, this is -- and the key here is that in 8 order to get them into the rule, we would need to do a 9 rule-making. So anyone that is currently certified or 10 approved by those organizations would not be able to come in i l 11 through the first route, but they would have to come in ; l 12 through the alternative training route, and that's what l 13 we're trying to fix. i
/~ 14 DR. AHLUWALIA: Okay. American Nuclear aspect of N
15 the American Board of Radiology is one of the oldest board 16 exams. I don't know why it's not recognized. 17 MR. CAMERON: Does everybody understand that 18 Cathy's slides only reflect what is in the existing Part 35 19 now? Which is not necessarily any type of a statement on 20 the legitimacy of other boards. It's just the status quo 21 and part of the proposal here is to find a way to recognize 22 new boards. 23 Cathy, I did have one question for you and it may 24 not be an important distinction, but you made a distinction 25 between the approach to this rule being risk-informed as i b ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014
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l 1 1 l 52 ( 1 opposed to risk-based. I'm not sure people understand. !
\_ ,/ 2 That may be a little metaphysical, but maybe you could l
3 explain that to us. l l l 4' Are you glad _I'm here asking you these questions? ' 5- MS. HANEY: _Wasn't it break time about two minutes
'6 ago? That's a Carl question. Wait till Don is here.
7 I hate answering those questions, but I will try. 8 Those are usually the ones where I defer to my management to 9 answer. 10 The Commission asked us to do a risk-informed rule 11 and that is where the staff would take into consideration 12 all the information that they have available to them based 13 on incidents that have happened. As you're all aware, we
~( 14 collect certain information on events that occur under Part
) :
15 35. 16 We collect them under Part 20,-even though they ; 17 may be related to.use of material in medical uses, and we 18 have a database. i 19 We would go and we would use the information on 20 events that have been submitted /,o us. We would use 1 21 information that we're aware of how the material is used in 22 the department. We would use information about just the 23 dosimetry associated with uso of radiopharmaceuticals, if 24 someone were to get an incorrect dose, what type of damage, 25 radiation exposure damage or whatever are we talking about ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i 53 ! 1 1- to the patient, is it something that would have essentially
\
l \ s/ 2 no effect or is it something that could lead to a patient's I i 3 death, using information such as that. '
'4 And then another source of information is where we 5 get.information from the different stakeholders from 6 meetings like this and using that information to form the I 7 basis for our rule.
8 A risk-based approach would be something more l l 9 along the line of where we're actually doing something like 10 a probabilistic risk assessment, where we're looking more at 11 using the information that I said before, but actually l 12 getting more into a numerical analysis of risk. 13 We're looking at the linear non-threshold dose and
-~g 14 that sort of approach, looking at the doses that you would 15 receive from an exam and coming out with something, a 16 number, a risk, and saying such that if the risk of 17 something happening is greater than, say, i 18 ten-to-the-minus-six, we would regulate; if it's less than 19 ten-to-the-minus-six, we would not regulate.
20 The Commission is not endorsing that sort of 21 approach for this rule-making. 22 So that's about the best -- and when Don comes 23 back,-we can ask him his answer. 24 MR. CAMERON: I think that people can see that 25 distinction. Chuck. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 54 l
-1 ! .y MR. ROSE: I'll make l't quick. In the proposed
( \'
- s' 2 rule-making, where you have listed both didactic and 3 supervised practical _in the proposed regulations, it has the
'4 -- in the proposed rule-making, have you also changed the 1
)
5 fact that this supervised practical is now' clinical or is 6 this back to still as was originally published, this is l 7 supervised practical experience in the handling of { 8' radioisotopes? 9 MS. HANEY: It's the latter. It's supervised I 10 experience handling the isotopes, but we're recognizing the j 11 comments that said that you really need to be in the 12 department four months or a longer period than 120 hours to 13 get an idea of all the things that could go wrong with
/g 14 handling radionuclides.
b 15 MR. ROSE: But still handling. It's not clinical 16 training and interpreting of films and things like that as a 17 -- in other words, it's not a clinical training program from 18 the medical standpoint. It is basics of radioisotope 19 handling in a clinical setting. 3 20 MS. HANEY: Yes, with the exception -- there's 21 always an exception -- of that into the therapeutic area, 22 where, if you remember back to some of the discussions on 23 the proposed rule, especially in the therapeutic, the 400 24 and 600 uses, where the argument was made very loudly that 25- you cannot separate clinical competency from radiation
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55 m i safety handling competency, and because of that, you needed
\- / 2 the length in the department; hence, we maintained the threc 3 year requirement for the therapeut3c aspects.
4 And a little bit of that has come into the use of 5 unsealed byproduct material, where a written directive would 6 be required or use of your iodine, say, in the thyroid 7 carcinoma or in the 35.300 uses, where that case work is 8 there. 9 So while we are saying there is case work, we're 10 looking at the handling of that material from a radiation 11 safety standpoint relative to that case work. It still has 12 nothing to do with reading scans, which some people could 13 say the current rule kind of hinges on that. g-sg 14 So it's not that sort, but there is some i'-) 15 experience that we want in direct contact in the clinical 16 environment. 17 MR. ROS3: Surely. So this is more -- I'm not 18 taking a giant leap here perhaps, but if I am, I need to be 19 shot down on it, and I know you will do it. 20 MR. CAMERON: It could be any -- there are several 21 others around. 22 MR. ROSE: I understand that also, but you don't 23- have to moderate that. 24 So this supervised practical experience here in 25 the proposed draft here is more like a technologist would be I (_/ ANN RILEY & ASSOCIATES, LTD. Court ?aporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
E - 56 73 1 doing in a department than it is more like a physician would
\- 2- be doing in a department, with the exception of actually 3 injecting patients, perhaps, using syringe shields, et 4 cetera. So these are technical things rather than, as you 5 said, interpretation of scans.
6 MS. HANEY: Right. And one of the things that we 7 think is important to maintain that requirement is that the 8 physicians, in the case of an authorized user, are actually, 9 from the NRC standpoint, supervising the technologist's use 10 of the material and, therefore, we if we have the physicians 11 in a supervisory role over the technologists, they need to 12 know how to do this, how to handle the material properly, so 13 hey know if the techs are handling it properly. 14 The other thing is recogniring that NRC licenses a 15 broad range of users, from your very large hospitals, where 11 6 they may have a dedicated physics staff, down to your single 17 physician office, where there may not be a technologist, and 18 the physician may be doing all the work himself. 19 And because of that' wide range, we need to make 20 sure everybody has the same basic understanding of radiation 21 safety. 22 MR. ROSE: Okay. 23 DR. WACKERS: Maybe I'm getting ahead, but it 24 seems like there is -- I'm a little confused where the 25 discussion will be going, but it seems like there's two p i b ANN RILEY & ASSOCIATES, LTD. Court Reporters 102" Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 L .. . . . . . . . . . . . . . . .
i r -- 57 l
.. -1 issues to be addressed. l
\s-) 2. One is the approval of a training program or the {
3 approval of an exam. It seems to me that it must be -- and l 4 I'm thinking in terms of the work and the logistics for the 5 NRC, that it must be much more involved and difficult to go I 6 to every single training program and see whether it really ] i 7 meets your requirements, than going to approving certain 8 boards. , 9 ' But I cannot imagine that even if you would -- I 10 cannot imagine that we, in our exam, for example, would not i 11 have. questions about radiation safety or instrumentation. j I 12 That would remain there. And I think that probably every ; 13 other exam will have always elements of radiation safety in (~g 14 there. l
\
15 So I think to keep that in the back of your mind, 16 that it seems to be much more logical to go to a ruling 17- where the exam will be done by the existing examinations. 18 It is also probably much more in the line of your 19 resources what you can do and your authority to approve 20 certain boards. So I'm saying to get into what Phil I 21 mentioned, to go and approve the training programs seems not 22 to be in.your line of expertise, in the first place, whereas l l 23 approving boards is our expertise, and I'm talking about the 24 experts who can give independent advice whether a certain i 25 . organization is valid or not. : A k- ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
58 I 1 MR. CAMERON: Frans, I'm going to ask you to, A k)ms 2 again, bring that back up when we have the substantive 3 discussion of that issue and we'll try to close out with 4 clarifying here. 5 Let's go to Jack and then to Alan. Jack. 6 DR. BASKIN: On clarity, that should be 98 up 7 there, or is that right? That's an old one, okay. 8 MS. HANEY: Thanks. 9 MR. CAMERON: You never can tell, there may be 10 another. Is that what you're thinking? 11 MS. HANEY: I was thinking that. This is one of 12 those last-minute things on Friday evening, because Chip is 13 saying you've got to give me something to fax out, i 14 DR. BASKIN: I would like to echo what Dr. c--) 15 Alderson said. I think that we would definitely feel that 16 the proposed rule from February 12 is an improvement over 17 that rule and we'd favor it. It gets rid of the examination l '18 for our group. Naturally, we would feel that that turns us 19 back essentially to what we've been doing all along, which l l 20 our record is quite good as far as safety among 21 endocrinologists. ! 22 MR. CAMERON: We're going to get a chance to l 23 discuss this issue and when we come back and do an agenda 1 l- 24 check, we can sort of try to determine where we want to 25 address this basic issue of the feasibility of the new l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 I (202) 842-0034
[E 59
.,., 1 approach versus the old approach.
(
\~ ') 2 It seems like a macro issue, but we'll figure out 3 when we want to do that. Alan.
4 DR. MAURER: I just wanted some clarification. In 5 this proposed matrix up here, I understand the difference 6 between separating clinical experience from practical 7 experience with radiopharmaceutical handling, but in the 8 diagnostic category, it seems that the practical experience 9 there is basically 40-hour, that's one week, which would be 10 direct handling and radiation safety principles. 11 That would be the total requirement? Is that up 12 for discussion? Because that says you work one week and 13 then you know everything. f-'g 14 .MS. HANEY: That is what the proposal was and the V 15 tradeoff there was with the examination. We felt that 16 ertween the time in the hospital setting, learning how to 17 handle the material safely, even if it was only 40 hours, 18 and the exam, and then the preceptor form, and realized the 19 preceptor form, under the new -- either of the proposed rule 20 or the staff's approach, would put a little bit more burden 21 on the preceptor, because the preceptor will be signing to 22 say that in his or her view, the individual is competent to 23 function as an authorized user for radiati'1 -- again, only 24 for radiation safety purposes. 25 So those things tied together would give us the n ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 1 60
\
. /_s\
'l assurance that someone was competent. But, again, this is
\s I 2- why we've -- for the points that you've brought up are ,
3 really why the staff is thinking about increasing this ! 4 amount from 40 hours to whether it's four months or 5 something other than four months, I don't know. 6 DR. MAURER: I would just say that I think one 7 week's experience, whether it's combined clinical and 8 practical, is really very minimal and I would think that 9 would be up for discussion. 10 MR. CAMERON: We will get there. Ed. 11 DR. MAHER: A point of clarification for myself l 12 and maybe some others. The exam you're talking about here 13 is the same exam. rx 14- MS. HANEY: It does not have to be. We spent some <
') 15 time talking about was it one exam, two exams, or eight 16 different exams. From our standpoint, if -- we probably see 17 it as two to three exams; one exam for the diagnostic uses l
18 of unsealed material, one exam for the therapeutic uses, and 19 then the one that where do you put it is the 35.300, because 20 it's a little bit more than diagnostic, but a little bit I 21 less than therapeutic. 22 Then, of course, your radiation safety officer, 23 you could almost make the argv.aent that the exam for the 24 radiation safety officer should be the one exam that 25 everybody has, because it's one baseline of information, if
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n l 61
,s 1 we are only focused on radiation safety.
t ) k_/ 2 So those are some of the questions we would ask 3 you today; again, if we went with the exam approach, is it 4 -one exam, is it three, is it two. But we left ourselves 5 wide open. 6 DR. MAHER: If I could follow up. If you're the 7 .RSO, you're responsible for. waste disposal, a number of 8 things that perhaps a physician would not be inclined to get - 9 involved with. So if you use the RSO exam as a baseline ' 10 exam, you may be asking clinical folks to be examined in 11 areas that maybe they won't get involved with. 12 MR. CAMERON: This all ties into the question 13 that's on the agenda for later on, the feasibility of one
/-sg! 14 exam, a few exams, what should it be on. So we will get to ;
V 15 those issues. 16 I'm going to propose that we take a break and come 17 back at 11:00. Chuck, did you have a real' quick question? l 18 MR. ROSE: No. It will wait. 19 MR.' CAMERON: Then let's start.off and just do an 20 agenda check then and we'll go on from there and get into 21 the substantive discussion. 22 The restores are out to the far corridor and then 23 to the left for men, to the right for women. Coffee, down 24 on the first floor in the cafeteria. So you have enough i i 25 time to get some coffee and we'll_see you at 11:00. ! i ! V ANN RILEY & ASSOCIATES, LTD. Court Reporters . 1025 Connecticut Avenue, NW, Suite 1014 ! Washington, D.C. 20036 l
-(202) 842-0034 '
62 , 1 (Recess.] !
'k_ 2 MR. CAMERON: I wanted to just make a proposal to 3 all of you in terms of the agenda. It seems that this 4 overarching issue of the approach of the proposed rule which 5 would rely on an-exam as part of this so-called equivalent 6 pathway and the new approach, which would eliminate an exam, 7 probably fits best into what you would see at the 11:00 time 8 slot, which was where I thought we could discuss some of 9 these overarching macro issues.
10 So I suggest that we will do that as our first . 11 topic and then what we can do for the rest of the time is j 12 assuming that we use the present approach in the proposed 13 nale, then we'12 go down and look at the detailed issues - 14 associated with that, and we'll also do the same thing for l 15 the alternative approach. 16 But I think that the 11:00 slot would be ; l l 17 appropriate for discussing the overarching issue. l l 18 Does anybody have any problems with that or any 19 comments on that?~ ! 20 [No response.] l l 21 MR. CAMERON: Okay. That's what we'll do. Before 22 we get into that, Chuck Rose was kind enough to offer to 23 just give us some infc mation from the state point of view 24 that I think will reflect in a lot of our discussions from i 25 this point on, and we'll try to do that fairly efficiently. 1
', j
(,j ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 i Washington, D.C. 20036 l (202) 842-0034 I i
63 1 Chuck, would you want to do your presentation now O' (_ l 2 for us? And you might, you know, at appropriate times, tell 3 us about if you see any -- if there is a clear implication 4 for all of this, from all of this, your material, for any of 5 our discussions, you might want to highlight that, too. 6 MR. ROSE: I can't really judge whether you think 7 there is a clear implication or not in some of these cases. B What I'm going to do is I'm going to spend just a few 9 minutes going through what currently occurs. 10 I think they can hear me without that. Can you 11 hear me back there? 12 MR. CAMERON: No. He needs that. So I'm turning
=13 it on for you.
() 14 MR. ROSE: What I'm going to do is I'm going to go
\~' l 15 through some of the potpourri that we have here in current i 16 licensing requirements, so we can all get an idea of really 17 what is going on now, other than simply the NRC 1
18 requirements, because I think we all really that there are i 19 more licenses being issued and more authorized users l 20 occurring on non-NRC licenses than on NRC licenses. 21 So what you have here is a summary table, anf I'll 22 show you the way it works here, if I can get this focused, I , 23 and you have them also in that package. Some of you h' ave a f l 24 package of material on this and then there is this i 25 additional sheet, which is also in the package. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034 ! l l
64
- 1 But what you see here is a summary of the
~-) 2 licensing requirements currently for physicians for imaging '
3 procedures. Now, this does not include therapy, this does 4 not include radiopharmacy, et cetera. This is for imaging 5 procedures in the various states, as well as at the bottom, 6 the NRC, and then also at the bottom, I have listed New 7 Jersey and Pennsylvania. ' 8 New Jersey and Pennsylvania here I've listed here 9 just as examples of non-agreement states that do also have 10 very specific regulations. So we don't have a situation 11 here of agreement state versus non-agrlement state. In some 12 cases, we have cases where states that a re not agreement 13 states also have very specific regulations; that to be i r^s) 14 licensed in those states, you have to meet two sets of t l
15 criteria if you're going to use both reactor byproducts and I i
16 then, of course, non-reactor byproduct radioactive l 17 materials; in other words, cyclotron linear accelerator 18 versus nuclear reactors. 19 Now, the first thing I'd like to point out to you ! 20 here, and there may be things here that you think are more l 21 important than this, but the first thing I'd like to point { 22 out to you is that there are several states that not only 23 have specific didactic requirements for training of the 200 24 hours, the 200 hours originally being established by the 25 NRC, but those states also break down that didactic training i V' ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
65 t I. t into the curriculum distribution that they require to meet 1 ' 7- 't 1- , \/ 2 the 200 hours. 3 You notice that those states that have those 4 requirements, those requirements are all the same. Now, 5 that's not due to some magical event here. The reason, for i 6 example, that they require 100 hours of nuclear and atomic 7 physics and 30 hours of radiation protection and 20 hours of ; 8 radiation math and 20 hours of radiation biology and 30 f 9 hours of-radiopharmaceutical chemistry is those are the ,
'10 regulations that the NRC established when the NRC i 11 established the 200 hour requirement.
' i2
~ ~ ~
Later, in revision of regulations, the NRC dropped 13 the actual curriculum distribution there, but maintained the p 14 200 hour requirement. V 15 Now, the NRC did not create these. These were 16 originally created through the nuclear medicine training 17 programa, and that's where that recommendation came from for l 18 this distribution. Or was it radiology? The NRC created ! 19 it. Thank you, Barry. 20 MR. SIEGEL: Barry Siegel. Those numbers came out 21 of discussions at the ACMUI. Neither the American Board of l 22 Nuclear Medicine nor the American Board of Radiology 23 promulgated those specific training numbers. 24 The ACMUI, in a series of public meetings a decade i 25 and a half ago, came up with those numbers. j t l l [\ . ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 l (202) 842-0034
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I 66 1 MR. ROSE: And then am I correct, then, please, t \ l L/ 2 Barry, that the nuclear medicine training programs have i 3 adopted this curriculum number? 4 MR. SIEGEL: They adopted it as a minimum because 5 otherwise you couldn't get deemed status from the NRC. 6 Everybody's chasing each other's tail. 7 MR. ROSE: Right. Then the tail started with the i 1 8 ACMUI, right? I'm not playing Carol Marcus here, t 1 9 Now, notice that most of the states have the 200 i 10 hour training requirement. Now, I think what's important i 11 here in a minute will be the exceptions. Then do states i 12 currently require a competency examination in the basics of 13 radioisotope handling? As you can see here, there are y s 14 states that do require completion of a written examination (' 15 in the basics of radioisotope handling as was proposed, and 16 still is proposed, in the current NRC regulations. Now, this is not a board exam. This is an exam that is an examination in the curriculum of the 200 hours. 19- '*his is a separate examination in the basics of radioisotope , 20 l handling. 21 And these states will not give a license unless 22 you have shown competency versus attendance. Now, these j 23 other states, the answer is no here on those, they do l 24 require what is called butt time or competence. This is on l 25 the. record, isn't it? l l i O) ( ANN RILEY & ASSOCIATES, LTD. 7 Court Reporters 1025 Connecticut Avenue, NW, Guite 1014 l 84 b3 [
l 67 1 They do require actual classroom participation for O'
\_s/ 2 this period of tima. So some of the states require 3 participation and proving that you. learned something. Other 4 states require only participation for the total of the 200 5 hours.
6 So there s two types of documentation which occur. 7 The similarities between this and the proposal from the NRC, 8 except for the hours, which, for this group of people, would 9 have been 80 hours under the current proposed regulation, 10 the similarity here is significant, I think. 11 Notice that in the State of Georgia, for an 12 example, the program hours are none and the distribution is 13 not applicable. I want to point that one out to you simply f-~g 14 because this is what I refer to as the ACGME issue. In the b 15 State of Georgia, as wull as in several other states, but 16 Georgia has handled it a little bit differently, their, 17 quote, new regulations say that you must participate in a 18 six-month approved training program, approved by the ACGME. 19 I'm here to tell you again, as the ACGME has told 20 the NRC and as all of these states have been told, there is 21 no such thing as a six-month approved training program. You 22 can have six months in an approved training program, but 23 there is no such thing as a six-month approved training 24 program. 25 That may sound like a moot difference, but there 1 1 1 \,s ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 2003G (202) 842-0034
68 l' l' is a big difference between that. Therefore, what the State > l (~~) i \s/ t 2_ of Georgia says now is that if you are not going through a 3 six-month approved training program, of which there are none, if you're not a nuclear. physician or if you're not a 1 4 ' 5 radiologist, then the way to get licensed is to get whatever i 6 training you want to get, get licensed in another state or ! 7 the NRC, and apply to Georgia, and they will recognize the 8 fact you have already been licensed. 9 That's why this none occurs here. So it doesn't l 10 mean that you have been cut off, but you have been cut off i 11 -- I don't mean you, but the people who are looking for some i 1 12 alternative way have, in essence, been cut off from getting 13 training in Gecrgia simply because the regulation is such f-- 14 that it is ir.ipossible to comply. with it. t (m,'/ ! 15 The State of Texas, I have listed here, also, with 16 a little footnote here, the State of Texas has also done' l 17- something different here and the State of Texas says that l 18 the training must be done in an institution that has an 19 ACGME approved training program. l 20 Now, it doesn't mean that you actually have to be 21 part of that program. You have to do it in that institution 22 and they also then have specific requirements on who can 23 preceptor 4:. So it has to be done under the guidance of an 24 institution cnat has that program. 25 Their regulation also says it's the institution A i V
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_ _ .- . . .~ - - - - -- 69
- 1 which is approved. That's not the case. It's the program \ 2 _w hich is approved, which I will get into in a moment.
l 3 Acceptable locations, and I will just skip through
- 4. this, you have the table. This just says whether or not 5 they'll accept clinical experience; not basics of 6 radioicciope handling, which we were just discussing here, 7 but clinical experience in a single specialty, 8 multi-specialty, any hospital or they require that training 9 be in a teaching hospital.
10 Obviously, the State of Texas would require that 11 it be in a teaching hospital, only because of the ACGME 12 . aspect, so that would be a no, no, no, and a yes. l 13 Then the course content, handling hours, clinical (~ 14 experience, and total experience.
-kJ 15 Now, with that as a summary, I'm sure that there 16 may be some discussion later on that, but I just wanted to .
I 17 give us an idea of where we are. I'd like to move on to
.18 looking at some other aspects of this that relate to what i I
19 we're ;alking about today in what's going on today in the ! 20 country.
- 21. First off, the NRC and you may not realize that l 22 some states, and I hope I've done a good job of crossing i
23 most of this out, some states actually require that to give 24 training in their state, you have to have a registration of 25 a certificate in that state to do training or else they ' (31 A/ ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 l-Washington, D.C. 20036 (202) 842-0034 l l
! 70 L7,_ -1: won't accept the training of physicians for licensing in
-- 2 that state.
t 3- I give you that one as an example, and here is ; 4 another one as an example. I give this to you, say, 5 . training in the use of radioactive material and radiation 6' protection. 7 -I give these to you as examples of what I think 8 should not be done because these states give these 9 certificates or licenses or approvals,.if you will, only to 10 the people who pay the fee. That's the requirement. Fill
'll out the application, which requires practically nothing i 12 {
else, pay the fee, and now you are licensed to do training 1 13 of physicians for our state. ex 14 Now, not necessarily in that state, but if the 15 physician was trained in another state and wants, therefore, 16 to go to that state to get a license, the training i 17 organization has to pay a fee to the state. This does not l 18- in any way, in my opinion, have any indication of the l 19 quality of training or anything else. It simply indicates 20 that you are known to the state, you have filed your fee, ; 21 and you are now licensed in that state. 22 Now, I have lots of examples of what I, again, 23 consider the ACGME issue. Here is an example from a state 24 regulation, and I've got about ten of these and I'm only ] 25 . going to give you one, because they all read about the same, i r ? C\ b ANN RILEY & ASSOCIATES, LTD.
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l l i 71 84 f
-s 1 but this is about the way it works. \- l 2 Teaching _ institution shall be approved by the 3 Accreditation Council for Continuing Medical Education, 4 ACGME, or the Committee on Post Doctoral Training of the i 5 American Osteopathic Association. This is the way a lot of 6 the states.have listed this. l l
7 Now, the reason the states have listed these i 8 things this way -- here is another one -- has successfully 1 i 9 completed a six-month training program in nuclear medicine 10 that has been approved by the Accreditation Council for l 11 Graduate Medical Education. l 12 You say, well, gee, how could all these states go 13 wrong. Well, we know how they went wrong, because they 14 copied what the NRC had put in their regulations, and that's {~}' v 15 the way it is still in the current regulation. 16 It's, again, an issue. Six months in an ACGME l 17 approved training program versus an approved six-month ACGME 18 training program. That-is that issue. 19 Now, to go on here for a second, realize that in 20 some states, and this is, I think, an issue that I don't 1 I 21 know if the NRC can solve it, in some states, in many 22 states, if you do.not want to use byproduct material, then 23 you have, of course -- not'of course, but you have different 24 . training requirements. L 25 For-example, if you want to use just thallium, l f~%
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E 72
- _ 1 gallium, and' cobalt --
in other words, if you want to use k) m 2 just cyclotron-produced radiopharmaceuticals, there is a i 3 state in.which all you have to do is start buying them, 4 There is no certification, there is no license, there is no 5 certificate, there is no inspection, _there are no 6 requirements or any policies or procedures. There are not ; 7 even requirements that are enforced for even a film badge in 8 that state. 9 But, of course, if you wanted to use technetium, 10 hey,.then you need, of course, to have an NRC license, 11 because this is a non-agreement state. But the state itself 12 has no regulations, versus New Jersey and Pennsylvania, l l 13 which, in my opinion, really go to the other extreme. 1 I gg 14 And in New Jersey and Pennsylvania, both of those j
'- 15 states have a license application, they have requirements 16 for licensure which are, in essence, very similar, if not 17 almost identical to the NRC, and if you wanted to use 18 thallium, gallium, cobalt, et cetera, in those states, you 19 have to have training, you have to have experience, they 20 have their_own policies and procedures, regulations, 21 operational procedures, et cetera, almost identical to what 22 the NRC currently has.
23 So we have -- the point I'm making here -- you 24 say, well, where are you going. The point I'm making here 25 so far is we have a real collage of potpourri of regulations ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington,- D.C. 20036 (202)'842-0034
1 73 1 out there and not everyone marches to the same drummer, by a (N
'b 2- .long shot.
-3 And I see this, because I get involved with the.
4 licensing people all across the country and training people 5 all across the country, I see this as a real issue, a lack 6 of uniformity, because a physician can be in one state, they 7 want to go to another state, they can't even get a J..:.snse 8 to do nuclear. work in that state. They can get a medical 9 practice license, et cetera, but they can't do it in that 10 state, or they will go on purpose to a state where there are ! 11 practically no regulations, like the one I mentioned, and 12 that way they can be, quote, if you will, a nuclear 13 cardiologist or a nuclear physician simply by buying a ] (x 14 camera, opening up an office and filling out a single piece (, / l 15 of paper. ' 16- -But there is no oversight, there's no inspections, ; 17 there'are no requirements for even a survey instrument or a 18 film badge. And I don't think, even though the NRC is not i 19 involved with a non-radioactive byproduct material, 20 radioactive non-byproduct material, I don't think that's in l 21 the interest of good public health and good radiation I I 22 safety. l 23 Now, real quickly, I would like to clarify two 24 other things that we should think about here; not that we 25 need them for. discussion, but just for terminology. Most ; l 1 ()N l (- ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut' Avenue, NW, Suite 1014 i Washington,-D.C. 20036 ' (202) 842-0034'
74
,, 1. accreditation processes, educational accreditation process,
-[ 2 let's say you have a college or a university or someone like 3 that,,they accredit the program and not the provider.
4 In other words, a university or a college or a 5 school or any training program, they accredit -- the 6 accreditation agencies accredit the program, the content of 7 the program. They don't, shall we say, lay hands on the 8 owner or the organization, the hospital or the university l 9 and say you can do any program you want to do because you I 10 are good educational people. 11 The whole object here is learning and the 12 institution may be the, shall we say, management of the 1 13 actual program itself is what ends up being accredited. l L fg 14 For example, in a university, every single class I b 15 is'part of an inspection process. The examination for that 16- class is part of that inspection process. The question here l 17 is, and we seem to have gone in that direction, we're 18 looking at the accrediting organizations, we're looking at 19 the test, and then maybe someday we'll look at what is 20 supposed to be learned. 21 This is backwards from what traditional learning 22 has always been, even in medicine. It's the content that 23 leads to an examination to see if you got the content. 24 And the last thing is who is giving the exam. 25 That becomes relatively insignificant compared to w!at is ,,-~ < k_ l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l I \ l l 75 l 1 1 your goal. Your goal is to have people learn something. 1 7_s k 2 m One other thing that, in the medical field, gets i 3 confused is education versus continuing education. We have, 4 of course, the Accrediting Council for Continuing Medical i 5 Education that looks at continuing education for physicians, l 6 for category one PRA awards of the American Medical 7 Association, and there's an equivalency, of course, for the 8 American' Osteopathic Association. L 9 That is continuing medical education. If you go j 10 back and you look at the IRS regulations on continuing l l 11 education versus education, the IRS will tell you that if i ! 12 you're training for a new license, a new certification, a ) 13 new skill or a new profession, it's not continuing gg 14 education. It's continuing education of that individual, ' N-, ' 15 i but this is new education, and it is well defined in the tax 16 code. 17 So understand that this'is not continuing -- when l 18 we're talking about licensing of physicians, pharmacists, 19 radiation safety officers -- by licensing, I mean putting 20 them on a license as an authorized user, we're not talking 21 about continuing education. We're talking about their 22 continued education perhaps, but we're talking about 23 education for a new skill, just like we would if we had a 24 ; technologist who now was going into a new area, they were 25 learning new skills, that's continuing their education, but L s_- ANN RILEY & ASSOCIATES, LTD. l Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 i Washington, D.C. 20036 l (202) 842-0034 1
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76 .
. - ~ . 1- it's not continuing education. ,
'- ! 2 .I looked around when I knew I was going to be :
'3 doing this little presentation and thought, you know, is
- 4. there some kind of precedent which has occurred here in the '
5 past related to the NRC or related to this whole
~
6 accreditation process,,is there any kind of a precedent 7 here,- other than the precedents that we all know about, 8 because this is a little bit different, because according to 9 the regulations, as Cathy explained this morning, it was my 10 question, this is not clinical training in the normal method 11 of clinical training. - 12 This is not reading scans, I think, is the way she 13 described it. This is training in radiation safety. This
/~ 14 is health physics. This is radiation protection.
b} 15 instrumentation. This is radiation mathematics. This is This'is 16 radiopharmaceutical chemistry. 17 So is there any precedent here? Well, actually, 18 there is some precedent and there are agencies and 19 organizations who have been involved in this in the past,
-20 and I'll get to those in a second. '
.21 But some of you have the -- about the ten or 22 12-page package I have here, and I'm sure that the people 23 here can get you more of the complete packages. But what I 24 did is I outlined very quickly what goes into an 25 accreditation process in an educational institution, not O]
ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
77 l 1 i ,_ \ 1 necessarily in hands-on practical experience type of l (s l 2 training. 3 But if somebody wanted to have an educational 4 program, what goes into the educational process. You have 5 to demonstrate the objectives of the program. You have to 6 have eligibility for accreditation, which includes much of 7 the same kind of eligibility as the NRC has already l 8 established for the exam. i 9 In other words, it has to be a legitimate l 10 organization. It has to have the funds and the resources 11 and the honesty and the integrity and the objectivity, et 12 cetera, necessary to carry on that educational program. 13- Then, of' course, you have to have an inquiry and
-~ 14 you have to fill out all the applications, the applications \' 15 forms, but-here is the key; there isn't a single legitimate 16 educational organization out there that approves educational 17 programs without an on-site review. In other words, they go L 18 in, they sit down, whether it be health physics people or 19 whether it be radiopharmacy people or whether it be a 20 college or a university. They need to see what's being 21 done.
l 22 Part of that is to talk to students. Part of that 23 is to look at the credentials of instructors. And, by the l 24 way, in most cases, the instructors are required themselves 25 to be licensed or certified to teach that material. l l 1
-Q
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78 1 You just can't grab somebody off the street and 2 have them come in and-teach. They have to be licensed. And ; 3 most states, by the way, most states do have in their 4 departments of education, they do have mechanisms for the 5 certification of instructors. Here, for an example, are 6 four certificates, maybe you can't see these. This is a 7 certificate for someone to teach nuclear medical technology-8 and medical radiation dosimetry. Here is another one for 9 science and chemistry and medical radiation dosimetry. Here 10 is one for radiological technology. Here is another one for 11 radiation dosimetry, computer operations, nuclear physics, 12 et cetera. 13 States have these mechanisms already in place. l g 14 It's called a certified teacher.
\ ,] 15 So an accreditation process, again, it's in part J 16 of that whole package, and, for the sake of time, I'm trying 17 to go really fast here. .You have a whole flowchart of I 18 things you have to do to have an accredited program. If the 19 NRC has accredited programs that are not -- you know, now 20 they're looking at a dual track here, where you could go 21 this direction or you could go through an NRC-approved 22 program.
23 It's all laid out already, because it's already 24 been established as to what goes into the steps for an, at l 25 least, other legitimate approved programs. ! s
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l 79 1 So where does that leave us? That leaves us that i T rO s/ 2 -- and I have some other sheets here on curriculum and ; 1 3 instructors, et cetera. It leaves us with the idea that 4 perhaps there is some precedent here. So I looked around l 5 and I found several types of precedents. 6 One of the precedents happens.to be in the United 7 States Department of Education. The United States 8 Department of Education has accrediting organizations and l 9 through those accrediting organizations, the schools, the ' 10 universities, the junior colleges, the medical schools, et 11 cetera, that all of us attended, that institution has been 12 approved by one of those agencies recognized by the United 13 States Department of Education and they have approved 1,173
- (~%, 14 associate degree programs, 738 bachelor degree programs, \_ / -
15 masters degree, doctorate degree, and other programs. i 16 They also have approved 4,000 programs, actually j 17 4,212 programs which are not degree-granting programs, 18 programs of less than two years in duration. And excuse me, 19 but that's what we're talking about when we talk about the 20 basics of radioisotope handling, we're talking about a j 21 program of less than two years duration. 22 Now, to be accredited by one of these 23 organizations, you have to meet all of these criteria. In 24 addition to that, just to give you an idea, you not only 25 have to file voluminous reports, you have to be bonded, l r~;. l i 1
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J 80 _ 1 because they have to know that you have the certification, .i ^_) 2 you now come under regulations that apply to all schools and 3 colleges and universities about confidentiality of records, 4 duration of records, qualifications of instructors; in 5 essence, a lot of politically correct things, and a lot of 6 other things that come as part of being an approved 7 organization. 8 State Departments of Education do the same thing. 1 9 Then there are regional accreditation organizations, middle l 10 stnLes, central, associations of colleges and schools, all 11 the way down. These are the people who, for the United 3 12 States Department of Education, actually accredit colleges J
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gn - 84 1 enough information? I
,_s You look at the educational program,
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2 not the provider, but the program. Then from that falls the 3 examination and from that falls the examining organizations. 4 Thank you. 5 MR. CAMERON: Thank you very much, Chuck. I would 6 hope that some of these -- it seems like some of these ideas 7 may be relevant to whatever option we're discussing, and by 8 option, I'm talking about the proposed rule versus the new 9 staff thinking on this. 10 It also gives us an idea about some of the 11 compatibility problems that Dr. Alderson referred to early 12 on. You note that those states that don't give an exam now 13 would be compatible with the new staff approach. r3 i 14 But let me ask if there are any comments or 4 15 questions from anybody around the table on the material that 16 Chuck presented. Phil? 17 DR. ALDERSON: My question is -- it's just really
~
18 a point of information. Would anything in the new 19 rule-making proposal, regardless of which of the paths 20 that's being considered you now took, would -- if that came 21 into being and were the final rule, would it make any of 22 these states agree with it? Could they still go on and do 23 the very things that are on this table or would they be 24 forced in some way to comply with what the NRC has 25 recommended? f3 V] I ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 L
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85 > 1 MS. HANEY: The issue of agreement state f~ k )/ s- 2 compatibility is an issue'that we have not resolved yet. 3 I'll tell you the current thinking is that the states would ; i 4 have~to match what NRC does, because we're very concerned ' 5 about the issue of a physician moving from state to state. 6 Like it's easy to go be an authorized user in , 7 Maryland, but if you want to go into Virginia, it's a whole 8 new set of criteria. We want to have some type of basic , 9 level that everyone agrees to, to make the practice easier, 10 DR. ALDERSON: That's theoretically appropriate, i 11 but what I'm asking is does the law allow you to do that. I i 12 mean, can you do that? You've changed this rule. Can you 13 make these people comply? That's what I'm asking. fs 14 MS. HANEY: If it is given -- wh'an NRC issues a 15 rule., we go through and assign a level of adequacy and 16 compatibility, a designation to the rule, and those 17 designations can range from this state has to have a l 18 regulation that is identical to ours.all the way down to 1 l 19 they don't need to even address the issue in their l 20 regulation. ! 21 And right -- so we do have the mechanism, from a i 22 policy standpoint, to make the states do exactly as NRC 23 wants them to. But in determining that level of 24 compatibility, you go through a certain series of questions, 25 so that there is some uniformity. So it's not an arbitrary n (_/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, iiW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
86 j3 1- . decision. , b 2 And you go through.this stepping stone and where 3 .the training and experience'would come out of that process . 4 :right now is still'under discussion with the states.
'5 MR. CAMERON: And it also is -- there are 1
-6 potential legal issues that flow'from that in termslof the 7 ultimate state compliance with the NRC's compatibility 8 designation for a particular rule.
9 It may take a while to get there and there are 10 judgment calls, whatever, but it's like ultimately at least' 11 there is some compliance authority that the NRC has 12 vis-A-vis agreement states. 13 DR. ALDERSON: Then this is also relevant with 14 respect to the temporal issues we were discussing earlier, 15 how long does a grace period have to be, if there's a grace 16 period, because it's conceivable that you might get into 17 disagreements with some of these states and that might 18 substantially lengthen the implementation time in these 19 particular venues. 20 Is that a true statement? ! 21 MS. HANEY: Yes, that's correct. 22 MR. CAMERON: And usually the typical -- I don't 23 want to get too much into talking about the agreement 24 states,'myself personally talking about agreement state 25 issues here, but usually the states have three years in ( t ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
U 87 1 which to come into compatibility with an NRC final rule. ' f^ (s-)' 2 So I'd question how that relates to the two-year + 3 deferment of that particular issue. Chuck? i 4 MR. ROSE: Currently, of course, the regulations 5 are not required, as you can see, to be compatible. So that 6 would be a change for the NRC in their compatibility level. 7 I also want to add, to support his comment, some 8 state legislatures only meet every other year and so they do 9 have three years to comply, but in the past we have seen 10 that in some states, with issues of compatibility, they 11 didn't comply in three years simply because they couldn't 12 get things through their legislature, tnrough their 13 legislative process in that length of time. 14 Also, we have examples in the past where states 15 who had matters of compatibility that drifted away from t 16 those matters of compatibility and for several years they 17 did that, until they were dragged, shall we say, back to ' 18 reasonable compatibility by the NRC. 19 So just because there is compatibility doesn't 20 mean that they're going to stick with it, even though the 21 regulations say that. The dose calibrator issue in Texas 22 was a classic example. That went on for nearly four years, 23 almost three years after it was called to the attention of 24 the NRC, before the State of Texas started requiring, again, 25 that they have dose. calibrators, and, in the interim, most ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 88 l 1 -- not most -- many places'had gotten rid of them.
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(_/ 2 MR. CAMERON: Thanks, Chuck. I just should put on i 3 the record, because I don't think anybody else will for the j 4 Commission's benefit, that we do have something called the i 5 IMPEP process, which-basically applies to agreement states J 6 and to the NRC regions, which is a systematic review of 7 agreement state programs to make sure that they are adequate l 8 and compatible with NRC regulations.
- 9. You may have deviations for certtin purposes and 10 this is a relatively new program, but thero is a systematic 11 review program on here.
12 Chuck, I would just thank you again for raising 13 these issues. And in terms of the national accrediting body 14 issues accrediting criteria, please throw those in as
15 suggestions when we get into the discussion of various 16 options, where you think they might be relevant.
17 MR. ROSE: 'Thank you for the offer. 18 MR. CAMERON: I knew you that you wouldn't take 19 advantage of it unless we did offer it. 20 MR. ROSE: I wouldn't have brought it up. 21 MR. CAMERON: Frans. 22 DR. WACKERS: Well, I don't agree -- I don't 23 disagree that training and teaching is the most iraportant 24 thing. It is more important, of course, than the exam. l 25' What I'm concerned about is that what I see is a l l js
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l l 89 j
- 1 specter now of a large body and I could see how this goes kl 2 way over my head. We're trying to make things more l l
3 realistic, simpler, and more adequate. 4 So I don't disagree with your last line. I 5 disagree because you're sort of suggesting that this is 6 really the standard, that anything that we will be doing in 7 the future in terms of training should be held up to. 8 It disturbs me that things will get more l l 9 complicated, more controlled, more regulated than we have at 10 the present time. 11 MR. CAMERON: And I think that that's -- we'll 12 have plenty of time to examine those issues, but I think 11 that it's important for people to realize that there are (~%g 14 drawbacks to any particular approach and that a particular l V 15 approach is not necessarily the best for a particular area. 16 So let's all keep that in mind and iring those 17 potential drawbacks out and potential benefits from using 18 some of these approaches. 19 ~ I'd like to, if -- if you all don't mind waiting 20 to break for lunch until 12:30, let's get into a discussion 21 of the two major avenues that we're looking at here, the ; 22 proposed rule approach and the current staff thinking.
.23 Cathy, do you just want to just give us a quick 24 summary and any clarifications that you think are necessary 25 before we have a discussion of this? What I will do is try
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.,,, 1 to keep track of pros and cons.
< 3
\~ / 2 If you don't like something or if you like '
l 3 something, please try to give us a rationale for doing that.
+
4 We're also asking Barry Siegel, who I'm sure all !
~5 of you know, to come up to the table for this discussion.
6 Barry has been serving as a consultant to the NRC state 7 working group on the development of this rule. 8 MS. HANEY: What I did during the break time was 9 to really break down the two options that we have available 10 to us right now to hopefully make it a little bit clearer 11 about what the distinction between the two options is, and 12 then based on this distinction, we can go forward to some of 13 the issues I'd like to get answered today.
, 14 If you look at the approach that we took in the p\]
15 proposed rule, the A route is where we would allow NRC 16 recognition of the boards. This would be we would not list 17 the boards in the rule, but we would have this -- we would 18 approve, recognize the board, and then we would make that 19 available to everyone so they knew whether the board was 20 approved or not. 21 The thought'is that we would recognize the board, 22- if, in order to sit for the board, the board -- in order to 23 sit for the board, you would have to have completed 24 eve < hing that was in the alternative route. In the 25 proposed rule, the' alternative route has the exam, this is i n i )
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I i l 91 , 1 where the exam comes from. !
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s/ 2 There would be a requirement for a structured L 1 3 educational. program, and this educational program would have i 4 .the didactic training and the practical training, and then l 5 the preceptor. 6 The staff's working draft from last week would 7 still have the same route for A. So we're still in the ! 8- board approval route. But the alternative, the B route, 1 changes such that NRC would give approval of the training l
'5F 10 program that was being given. 'There would still be a 11 requirement for a structured educational program, and there '
1 12 would still be the requirement for the preceptor. 13 So the real difference in the two routes is in the 14 proposed rule, we have the exam and we're approving the 15 examining organizations, and then one could argue are we 16 going to approve the examining organization, are we going to 17 approve the exam. So you can get that into a much finer ! 18 detailed discussion. 19 Versus, in the staff working draft, where we're 20 ; approving the training program and, in this case, are we 21 _ going to approve the provider or are we going.to approve the 22 course content. , 23 That's the distinction-that should be made bar7d 24 on'this morning's discussion. i r 25 MR. CAMERON: Just two points before we begin the t
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92 1 discussion. On the details of either the proposed rule ((,,)- 2 approach of the staff working draft approach, we will go 3 into a discussion of those specifically details and what 4 we'd like to do now, I think, is talk about the pros and 5 cons of the proposed rule approach versus the staff working 6 draft. 7 Maybe perhaps just more for my benefit, so I 8 understand the conversation, more than anybody else's, what 9 is the difference between the training program and the 10 structured -- what you call the structured educational 11 program? 12 MS. HANEY: What I'm calling the structured 13 educational program would be where the rule would say 7-s3 14 training of four months duration or 200 hours of didactic i'~'I 15 training or, in the case of therapy, where you're talking, 16 say, three years in a program, that's actually the specifics 17 of what -- what's the magic -- that's what's the magic 18 number, versus, in the first case, where in the case of the 19 approval of the training program, where NRC is actually 20 saying that the training, the didactic training and 21 practical training that you're getting is under the ) 22 direction of someone that NRC approves. 23 MR. CAMERON: So they have qualified instructors, l 24 not fly-by-night and all that type of thing. i 1 25 MS. HANEY: Right. l
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l-93 1 MR. CAMERON: That's what you mean by training I,__h V 2 program. 3 MS. HANEY: Right, i 4 MR. CAMERON: All right. Does anybody have any 5- questions for Cathy on this, before we start? Alan. 6 DR. MAURER: In the original matrix, there were 7 three columns, and under other, it included preceptor. 8 Preceptor is not an alternate approach. The preceptor is 9 somebody that's defined under that training program. 10 What does the preceptor mean? 11 MS. HANEY: I guess from the standpoint of the 12 matrix, I didn't mean that as an alternative approach, and 13 that might have been misleading in the matrix that te gave 14 you. 15 The preceptor would be an authorized user or 16 radiation safety officer or physicist, someone that's an 17 authorized user in the area that you're going to request 18 authorization. 19 DR. MAURER: Is that the same person responsible 20 for the training program or that could be -- 21 MS. HANEY: No , it could be a different one, under 22 the current setup. But again, if you think that it should 23 be the same person, that's something we would take into 24 consideration. 25 MR. SIEGEL: But in the case of the A route, where l l
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i 1 l 94 1 the board is taking on essentially all of the functions, the i
\_/ 2 -preceptor is the training program director who certifies to 3 the board that the individual has completed the training and i 4 should be admitted to sit for the board's examination.
5 DR. MAURER: I would say that under part B, the 6 preceptor would probably have the same -- should be the 7 director of the training program, who would certify that, 8 and -- 9 MR. SIEGEL: The only question is whether you ; 10 believe -- is how much you believe in a free market economy ' 1 11 you have to allow for various innovative approaches to 12 accomplish the B route, where you might not be able to say 13 that the preceptor is, quote, a training program director. 14 That's part of the whole problem with the B route. O>-~ 15 The B route is designed not to give the boards a # 16 monopoly. Rather, the B route is designed to say that there 17 needs to be a mechanism and there have been some past 18 interpretations by the NRC that there does need to be such a 19 mechanism to allow people to train by some way other than 20 this monopolistic approach. 21 DR. MAURER: I think that's a good option, but 22 there are sometimes difficulties between what a program 23 director certifies and maybe what a preceptor is actually 24 doing. 25 MR. CAMERON: Let me jump in here. If I
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l 95
/s i understand this right, this is a good example of what we l s- 2 discuss now versus what we discuss later on. The problems, 3 potential. problems that Barry raised in terms of a 4 preceptor, those problems exist under the proposed rule 1
5 approach,.as well as under the staff working draft approach. 6 So that although there may be some distinctions, '
. L 7 the preceptor issue, I think, would be one that perhaps we '
8 would leave for more detailed discussion. 9 Chuck. i 10 MR. ROSE: In.the proposed rule and the working 11 staff draft, you have A as the same. My question is, will 12 the NRC require specialty boards to give a new type of 13 specialty board that is given to people who have met the NRC (" 14 requirements, but not necessarily the board requirements? (' 15 The board requirements require the completion of, let's say, 1 16 a radiology residency program and yet that is well beyond i 17 what's required to sit for the NRC rule. 18 The NRC rule is 560, roughly, hours versus three 19 to four years. So will the NRC require that these boards 20 give a separate examination in the basics of radioisotope l l 21' handling or if it's in the hands of the radiology board, and ! 22 I don't think that's what.the proposal was, but if it was in 23 -- were the radiology boards to say, look, if you want to go 24 this route through us, then you have to sit -- you have to 25 do four years of residency -- in other words, you see where
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1 . I l 96 I ,. t 1 I'm coming from.
\. l i
[ f'~2
\- 2 That's not directed at the radiologists, because 3 they've certainly been in this business a lot longer than 4 everybody else, but the fact is, is there going to be a new, 1
5 separate examination by these' boards, because their board 6 requirement to sit for an examination is well'beyond the 7 requirements for licensure. They're two different things. 8 MR. CAMERON: Cathy. 9 MS. HANEY: Let me try, and then Barry can fill
-10 in.
- 11. MR. CAMERON: Do people understand the question 12 that's on the floor? To the extent that they don't, Cathy, 13- can you try to explain in answering? That's if you Q 14 understand it.
Q) 15 DR. WACKERS: Just to clarify. So for the CBNC 16 exam, we have eligibility criteria. You can only sit if you 17 have certain training. One of the requirements is that at 18 the present time, they meet the NRC requirements. 19 Now, they will be changing, so it will -- so you l 20 can't incorporate that. So you need to have, let's say, 21' radiology residency, but in the radiology residency, there ; 22 should be -- and it should be no problem -- the minimal new 23 NRC requirements. l 24 MR. ROSE: I understand that, but if the radiology I 25 residency requirement is three to four years, they meet the O' ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
- . ~ = - . . .- .. . . _ . .
l l l r 97 l. I r~h 1 requirements, could, probably wouldn't, but could meet the ' '(-) 2 requirements for the NRC requirements in four months. 3 Does that mean that the American Boards of 4 Radiology would allow them to sit for a portion, at least, 5 or something, because I hope -- I mean, obviously, they're 6 not going to sit for the whole radiology board after four 7 months. 8 MR. SIEGEL: .That would be ABR's choice, if they 9 chose to do it. 10 MR. ROSE: So there would be a new board. 11 MR. SIEGEL: There could be. There could be, but 12 there wouldn't be any requirement to be. Right now, the 13 current rule gives the ABR deemed status because it is '7s 14 acknowledged that ABR training in 100, 200, 300 and 400 and 15 600 meet the requirements of the NPC with respect to 16 training. 17 And right now, the board examines, but that's not 18 a component that the NRC requires. In the proposed rule, 19 the ABR would come in and say we want deemed status because 20 we meet your training requirements and we have an exam that 21 meets your examination requirements. 22 In the revised working draft, the ABR would come 23 in and say we want deemed status because we meet your 24 training requirements and we meet your preceptor i
'25 requirements. That's the difference i
i I s<
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i 98 l 1 Right now, the working draft is actually much I
\ 2 closer to the proposed rule -- the working draft is much 3 closer to current Part 35, with respect to what the boards 4 will have to attest to to the NRC than is the proposed rule.
5 But there is nothing that precludes a board from saying 6 we're not going to issue a certificate to anybody other than 7 people who fulfill our full clinical training requirements, 8 those are the only people who can get our certificate. 9 Then there does have to be an alternate route for i 10 people who might wish to meet a lower set of standards. 11 MR. CAMERON: Just to interrupt for a second. 12 This is another issue and I think that it's pretty much 13 going to be -- this issue is going to exist, the one you're ! e 14 raising, is going to exist whether we're talklng about the 15 proposed rule or the staff working draft. 16 So, again, those types of common -- what I will 17 call common issues, let's come back to those, and get to the 39- major options here. I just realized that Cathy can change 19 this on -- 20 MS. HANEY: On whim. 21- MR. CAMERON: On whim, and I would just ask her to 22 keep her hands off the keyboard. But at any rate, did you 23 want to say something? l 24_ MS. HANEY: Yes. I would like just one little bit i 25 of information, for those that aren't as familiar with the ! N ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
99 7 1 proposed rule. (3)
\' s 2 The reason,we have two separate routes gets into 3 the way we license. This philosophy is in the current 35, 4 as vell'as goes through into the proposed 35.
5 If you are a licensee and you want to bring a new 6 authorized user into your license, onto your license, if the 7 individual is certified by a board that's listed in the 8 rule, all you need to do is to notify NRC within 30 days. 9 You send us a letter and you say we've just added Dr. Smith, 10 he's certified by such-and-such a board, and that's it. 11 If the individual you want to bring onto your 12 license is not certified by one of the boards, then you have 13 to apply to NRC for a license amendment, which means that r~'sa ( 14 you have to pay around $660. You have to fill out an
15 application. You need to send us copies of the individual's 16 preceptor forms, their training forms, and you can't allow 17 that individual to start operating r.s an authorized user 18 until you've gotten an amendment back from NRC which could 19 take anywhere from two to three months.
20 So the A route is really in the rule for 21 convenience sake of the licensee. I mean, essentially, we 22 could delete A, forget completely about the boards, and just 23 say here are the training requirements. But we are trying 24 to make it a little bit easier on licensees and that's why l 25 .we're really trying to keep this board approach in the rule. F p~5 l i U/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 , Washington, D.C. 20036 i (202) 842-0034
t 100 l ~ 1 MR. CAMERON: But, again, that applies whether r
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2 you're talking -- i l 3 MS. HANEY: Either way. l 4 MR. CAMERON: -- proposed rule or staff working ' l l 5 draft. 6 MS. HANEY: Yes. 7 MR. CAMERON: So it's another common issue. Phil, 8 do you want to weigh in? ! l 9 DR. ALDERSON: I want-to ask a question, and it's, 20 in part, doing that. Having listened to this and listened > 1 11 to Dr. Rose, it's sounding more as if, as we said earlier, l 12 an examination would be really complex, extremely complex. > 13 And although when we wrote our comment letter, we 7-sg 14 the American Board of Radiology, we recommended a consortium ' \~,] 15 approach to an examination, We recommende;d that the people ! 16 sitting around this table sort of get together and create an 17 exam. 18 Hearing more and more about it and particularly 19 some of comments Dr. Rose nade, I'm not sure that an exam is 20 feasible, and that's one of the very questions you're 21- asking. 22 So the question I want to ask based on that new 23 look at this is how then does the NRC assure -- how will we
- 24 be assured of the quality of the alternate pathway people?
l l 25 There's not an exam. Let's say there's not an l ANN RILEY & ASSOCIATES, LTD.
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I ' l 101 , t 7.s .1 exam. So then obviously you've thought:that through, ) k-s 2 because you're proposing it. So how are we assured of the 3 quality of the alternate pathway people?
- 4. MS. HANEY: And that's one of the goals from l
5 today, is to get -- today and tomorrow's meeting, is to get , 6 from this collective group what sort of things should NRC be 7 looking for when we are giving that approval. 1 8 If we strictly to say if.the educational program l 1 9 was ACGME approved, we rubber-stamp it and that's fine. If i 10 it is not ACGME approved, how far do we look. 11 We also, at the same time, don't want to tie the 1 12 different. medical specialties to only ACGME. We do want to 13 allow for the free trade that Barry mentioned. { l f-'g 14 So it's more when we get into these other than l b 15 ACGME approved programs, what do we start to look for and 16 how rigorous is NRC's review. 17 Now you're not in ruli space, you're in NRC policy 18 space. 19 MR. CAMERON: Can I ask a question and can I have 20 -- can you just put a (1) next to proposed rule and a (2) 21 here? 22 MS. HANEY: Is it okay for me to touch the i 23 keyboard? 24 MR. CAMERON: Yes. If you can-do it without 25 touching the keyboard. The question I have that was raised , l
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p l l 102 I j, 1 by Phil's comment, is there any -- would there be any ! k s) m 2 difference in terms of what criteria were used to approve. ) 3 2.B versus 1.B? 4 In other words, the approval of'the examining 5 organization versus the -- and this would be a B. That's l 6' really an A, okay. l 7 Would there be any difference in the criteria that 8 were used -- I mean, I'm sure there would be some
.9 difference. Would there be any major difference between 10 criteria for approval of the examining organization, which I 11 think are set forth in Appendix B -- or Appendix A rather of 12 the proposed rule, versus the approval of the training 13 program. . 14 In other words, there would be different elements i 5 '
15 .that you would be looking for, but how different would the 16- ' criteria be? I
- 17. I'm just asking that'because I'm trying to see 18- what we can combine for discussion purposes. But I take it 19 that Phil's point is the worry is how do we assure of the B 20 pathway quality under the no exam route.
21 Does that mean, Phil, that you're more -- you
~2 would be more assured of the B pathway quality under the 23 exam route?
24 DR. ALDERSON: No. I started out by saying that l l 25 discussions today have led me to believe that, in fact, the l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
0 103 1 exam may not be feasible. So I wanted to hear what NRC had i s_/1 2. thought of in terms of the other route. 3 MR. CAMERON: Can we go to the question then of 4 comments from the staff, why did you -- why are you looking 5 at eliminating the examination? .I think it goes to the 6 feasibility issue. And then let's get comments on that. 7 MS. HANEY: I guess just from, again, our working 8 group conversations, implementation of the exam is one of 9 our biggest concerns, from a standpoint of resources. 10 We made some preliminary estimates in the 11 regulatory' analysis that went out with the proposed rule and 12 we did it in the space of dollar amounts as compared to 13 FTEs. g3 14 We were using numbers, saying it would take us 240 t 3 A' 15 hours to review an application for someone wishing to become 16 an examining entity. That number, I think, is high, but in 17 all honesty, it's based upon the amount of staff time that 18 it took to review a similar submittal in the area of 19 industrial radiography. 20 Several years ago, we changed Part 34, which are 21 requirements for industrial radiography, and in that there 22 was a requirement for an examining organization. 23 They've only reviewed one application. Of course, 24 the first one always takes the longest, and they spent 25 somewhere around, I think, 500 to 600 staff hours reviewing (y V ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202)-842-0034 m-
m , 1 i 104 , 1 1 the submittal. 7_
\- 2 I halved it, figuring that after we do the first
{ 3 one, it should.go quicker with the subsequent ones. We also j 4 estimated, for the reg analysis space, that it would take -- j you know, that we would get several submittals, I forget the
~
5 f 6 exact number, but'I think it was somewhere around 30 l 7 different submittals, because we were assuming that there 8 would not be overlap, and I actually think that an 9 organization would come in and say I want to.be approved to 10 give the exam for 100, 200 and 300. 11 But we counted that, for the sake of a reg 12 analysis, as three separate. 13 If you go through all these numbers, a rough 14 estimate comes out with five to six FTEs of NRC time to 15 implement this. NRC is in a situation where our resources 16 are being cut, just like everyone else's. So if we were -- , 17 so where -- how can I get that five FTE number down to 18 something that would be more reasonable to my upper 19 management, because I honestly think if I go in with a , i 20 request for five FTE to implement this rule, they're not ) 21 going to look real favorably on me. 22 So then you start backing off on, okay, what are l 23 some alternative routes. Well, maybe rather than 240 hours, j 24 we do a quicker review and do 120 hours. ' 25 From there we went to starting to take some ideas
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l l i l 105 i 1
. 1 that if the exam was given by an organization that was ACGME 2 approsed or some other organization that has a status in the 3 medical community, we would essentially rubber-stamp the 4 exam, say it's fine, we'd go out in six months and we'd look 5 at it.
6 .If it was by an organization that currently is not 7 recognized by a state, is not recognized by any of the well 8 known organizations or the more common organizations that 9 are referenced relative to this rule-making, then we would 10 maybe do a moderate review. ! 11 Appendix A had a lot of procedures in it. Maybe 12 all we ask for from the applicant is tell us that you have 13 those procedures and you don't -- and we don't look at the i l g-wg 14 procedures and then if we go out in six months and find out i d 15 you don't have the procedures, then we pull our approval. 16 So we looked at ways of cutting it down, but 17 basically one of the reasons we backed off from the exam was i 18 implementation issues. ! 19 Another thing is -- j! 20 MR. CAMERON: Cathy, can I just interrupt you, so l 21- we can keep a balance here? i 22 MS. HANEY: Okay. i 23 MR. CAMERON: You talked about five FTEs, 24 resource-intensive, approving the examination organization 25 and the exam. Now, approval of the training program, the i l l t(O jV ANN RILEY & ASSOCIATES, LTD. t
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l l ls l 106 u - 1 implication is that going this route, that a pro on the
.x/ 2 alternative would be it's less resource-intensive?
3 MS. HANEY: It could be less resource-intensive, 4 but, again, .t depends upon the feedback that we get from i 5 this. meeting about at what level are we doing the reviews. 6 It may actually be a wash, but you know, the 7 original' thought that got us down the path of not requiring 8' an exam was, in. fact, the resource implications for 9 implementing the exam. 10 MR. CAMERON: Even though you might -- you don't 11 have a real good handle on whether this is really going to 12 be less -- 13 MS. HANEY: Right. I don't have a good -- 14 MR. CAMERON: -- resource intensive. Okay. I 15 Barry ---and then we'll go on. 16 DR. SIEGEL: And that, in part, depends on how the 17 medical community responds to the -- number 2. 18 If, for - I mean, for radiology, nuclear 19 medicine, radiology oncology, it's a no-brainer. They keep 20 going exactly the way they are going. 21 If, with the working draft, if the American Board 22 of Internal Medicine, for both cardiology training programs 23 and endocrinology training programs, says -- changes the 24 special requirements so that there is now a required amount 25 of1 training equal to one of the various options in the-l
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i l Court Reporters I 1025 Connecticut Avenue, NW, Suite 1014 4 Washington, D.C. 20036 l (202) 842-0034 ' l i
l l 107 l 1 working draft, then that effectively becomes an approved --
~s I )
( ,/ 2 a component of an ACGME-approved training program and it's a , 3 no-brainer for the NRC. l 4 On the other hand, if every endocrinology comes ! 1 5 forward and proposes that his training is -- his or her 6 training is going to be in a uniquely -- in a unique 7 structured educational program that is equivalent to what 8 the NRC requires and the NRC has to sit down and a priori 9 look at 200 of those every year, then that will consume even 10 more resources. 11 My belief is that, if the bar is set at the right 12 level, that there will be a strong incentive for the 13 residency -- for the boards and the residency review 73 14 committee and the ACGME to all try to incorporate these into ; (s/ ) 15 I what we all believe, I think, is the absolute best mechanism ! 16 for ensuring the quality of the programs -- that is, that 17 they're approved either by the ACGME or that they're 18 approved by the AOA's equivalent operation. { l 19 MR. CAMERON: Before we go to Wally and Chuck, let 20 me just check with Alan and Phil and perhaps Miriam about -- 21 does anybody have a comment on Barry's last comment? 22 Chuck, did you -- 23 DR. ROSE: Yes. i 24 MR. CAMERON: Go ahead. 25 DR. ROSE: Barry, wouldn't that -- based on 1 i i I~'i i () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 108 1
,.s 1 current fellowship programs residency programs, etcetera,
( ' \. - 2 wouldn't ACGME approval then requira that the person had at 3 least a year of training? l 4 DR. SIEGEL: You have a year of training to be an 5 endocrine fellow. 6- DR. ROSE: Right. 7 DR. SIEGEL: But you may only need 80 hours of 8 training as a component of that year for the ACGME to be 4 9 able to claim that its training during the year meets the 10 NRC's requirement. 11 DR. ROSE: So, you're proposing a separate -- 12 DR. SIEGEL: Absolutely not. ! 13 DR. ROSE: -- fellowship or residency in nuclear 1 (~ 14 cardiology, nuclear endocrinology. ( )/ 15 DR. SIEGEL: And that's not the case currently in 16 radiology. l 17 Radiology trains for four years, but they claim, 18 correctly, that during those four years, residents get six 19 months of training in nuclear medicine and they get the 20 basic science and handling requirements that are required by 21 the NRC. 22 It's a component of the total training program. 4 23 Cardiology could do the same, endocrinology could do the 24 same, medical oncology, if they want to use strontium-89, 25 could do the same. g-ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
109
,,s 1 DR. ROSE: Okay. Thank you. ;
I\ -) 2 MR. CAMERON: Phil. l 1 3- DR. ALDERSON: I think that Barry's proposal is , i 4 fundamentally on target. There is, however, always going to ! 1 5 be that 5 percent, 2 percent, 3 percent group of outliers, 6 and you have to address the outliers, and so, one way that 7 you might address them that would not be terribly burdensome 8- on your requirements would be to -- using something that's 9 typical and you already alluded to, is if you-developed a -- 10 sort of a little self-study document for these people, which 11- was just a computer-graded, yes/no kind of a -- you know, so 12 that it's like a qualification' document, so the outlier has 1 13 to fill out a qualification document that you can grade -r- 14 without your staff doing it but a machine can grade it for C 15 you to determine whether they're in or out, and then the 16 people that are in -- now, this is the more complicated 17 part. 18 The people that qualified in this small outlier 19 group -- it would seem to me you would consider that they l 20 might need to be visited somehow, they might need to be 21 site-visited, but I think you.could delegate that. 22 I think you could delegate -- for this small group 23 of people, you could probably delegate that kind of issue to 24 groups that you would approve to do it, like certain 25 sub-specialty groups who would apply to you to do it and you
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i I _ L i 110 l l1j 1 would give them the' status to'go out and do that for those I 12 outlying people, i 3 You might be:able to get -- you know, take care of i
- 4. 'the-other 5 percent:without your own staff having to be ,
l
.5 involved,'and you'd still-have a mechanism for quality 6 control. !
l 7J MR. CAMERON: Okay:. That's a suggestion to deal 7 8~ 'withithe' outliers, and before we go to Wally and Jack, j
~9 ,Barry, could you sort of just give us a straw-man c10 description of what the most effective response of the 11' medical community would be on this? In other words, how 12 much uniformity.
v 13 .Is there a way to just -- I know you were talking 141 O $15: about it, but ist there a way-to describe that so'that people, you know, around the table will know what would be 16: t'he most~ optimum way from the NRC's point of view? { l
- 17 DR. SIEGEL: Well, I think, just to restate what I !
18 'said,-the most optimum approach would be for the established 19 bodies that oversee training programs to require -- to 20L incorporate whatever the NRC requires as the minimum amount
' 21 ' _of training in. established training programs as a component 22 of.those training programs.
i
.23. Then one can= reach the conclusion that an
'24 ihdividual who completed an established training program had 25 .the necessary, component.
l; [ .)UCT RILEY & ASSOCIATES, LTD. l' Court. Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034' x -
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F 111 1 Now, there's one otPar twist on that concept that 2 we talked about in the worVing group, and that is it's 3 conceP 4ble that an individual might not want to have the 4 training and that it might -- might want to have it as an 5 elective, and one -- and a way to deal with the elective is 6 for the residency review cominittee to say we approve -- 7 programs tell us whether or not they offer this elective. 8 If they offer it, it's part of the overall program approval 9 process, and the preceptor certifies whether or not the 10 individual completed the elective. 11 Now, the disadvantage if you get into the exam 12 concept is whether or not people are examined in that, but 13 if it's just based on training, then it can work even as an g 14 elective.
~
15 MR. CAMERON: Okay. Let's -- Frans, do you have a 16 comment on that? 17 DR. WACKERS: I think that, in general, it will 18 work well. 19 So, for cardiology, you have -- so, level two 1 20 training in nuclear cardiology is six months, and you have a 21 level three, which is a comp ~. ate year. That's no problem. 22 The people who do these six months -- often, they 23 have to take at least a couple of months in addition to the 24 regular fellowship. 25 The problem w3th that is that they get sufficient O V ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
112 p- 1 clinical experience in that six months, but the physics or . i l I \_/ 2 the NRC requirementr>, as they are now, it's not always l 3 possible to get it within a time period. 4 Like we have a year-long course for the nuclear 5 medicine residents, cardiology residents, but sometimes the
.6 timing is just not that way.
7 So, there is a need for people who can't do that 8 anymore in a shorter time period. ; 1 9 So, they go somewhere -- and Chuck is an example l 10 of that -- a short course where they get in a week time all 11 the required physics. 12 So, that will be a realistic alternative route for 13 these people, as well, so that they get the clinical
--) 14 experience, but for the physics, they may have to go
\" 15 somewhere else, and it also implies -- sometimes I sign off !
16 on people that have been in such a course, they come to me l 1 17 for the clinical experience, and I take the two together and 18 say, well, they have met the requirements. 19 But the physics parts may not always be possible i 20 to do in a shorter program. 21 DR. SIEGEL: But the counterbalance to that is 22 reducing the physics and hand'<ng experience to something 23 that experienced trainers believe is more realistic. 24 I mean I think there's been a consensus for quite 25 a long time that it's pretty hard to teach a 200-hour course C/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-3034
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'1 without being repetitive, and the 80-hour number was not
-- 2 pulled out of the air. '
i 3 The 80-hour number was based on a real curriculum 4 in -- or samples of curriculums in established training 5 programs, that that was something that was a workable ' l 6 number. 7 So, if the bar is lowered a little bit in that ; 8 area, it's easier for the ABIM and the residents review { 9 committee in medicine and then, ultimately, the ACGME to 10 incorporate that in established training programs, rather 11 than having to make that be something that's done outside of 12 the training program. 1 1 13 MR. CAMERON: Okay. Good. That's a good ! 1 14 discussion. l 15 Let's go to Wally and then Jack and then Miriam, 16 and we'll come back to Alan and Chuck. 17 Go ahead, Wally. l l 18 DR. AHLUWALIA: I think the alternate B is a good ! i 19 approach, but there are weaknesses to it. This means we're I 20 lowering the'bar. 21 From my past experience, as we see in the teaching 22 programs, we give exams year after year after year before 23 our residents go for the board exam. On the first exam, 20 ! 24 percent pass; second exam, 40 percent pass, eventually to l 25 pass the boards. l ) ! 4 (~) l i k_/ ANN RILEY & ASSOCIATES, LTD. Court Reporters i 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034
114 1 'So, basically, what I am saying, if there are no l[\ 2 ' examination, how do we establish the basic competency? We l 3 have given them training, good program, but how do we make 4 sure that they are competent or they have learned what they 5 need to do in real life? 6 DR. AHLUWALIA: Can I ask -- I don't know if you 7 want to talk to this, Mark, but I mean that's the whole -- I 8 guess that's the crux of the issue here, is how do you 9 assure that people have learned if you don't have the exam? 10 Mark, why don't you address that? 11 DR. AHLUWALIA: The basic competency, just like as 12 you've listed there, the quality. I think, along with the 13 quality, competency is the basic issue, and the board exams
/ 14 is a vehicle to establish that.
15 MR. CAMERON: Okay. 16 Let's go to Mark, and then we want to -- this is a 17 key issue on the exam. 18 MR. RAYMOND: I guess I did share Wally's concern 19 in that it sounds like opcion B would essentially open up 20 the avenue for people who have otherwise not taken a board 21 exam or who have taken a board exam and failed it, for 22 whatever reason, and I guess I would just raise the 23 question, is that desirable or is that undesirable? 24 MR. CAMERON: Okay. 25 Chuck, you want to respond to this exam issue? l "T (d ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I 115 1 DR. ROSE: Yes. Boy, I hate to -- no, I don't l 0
\_) 2 hate to muddy.the water, but I want to make you think I do.
3 The way this is written, the NRC recognition of 4 the board, if no exam is required, if no exam is required, 5 as in B, all right, and the requirements for licensure in A 6 is that you have met the criteria to sit for your board 7 exam, right, does that mean, if you sit for your board exam 8 and you fail the exam, you're still licensable? Because you 9 have met the criteria? 10 DR. SIEGEL: You are now. 11 DR. ROSE: That came out in one of the other 12 hearings. 13 DR. ROSE: You are now. 14 DR. SIEGEL: You are now, but would you be tnder 15 the new regs? In other words, are you saying that you have 16 to meet the criteria, all right, the board exam has to have 17 the criteria for licensing in it as a component, and then 18 you have to sit for the boards and you have to pass for -- 19 the boards, right? 20 Because that would mean that the exam is in, 2.A., 21 'actually C, but 2.A., but it's not in B, right? And perhaps l 22 it should be back in B, and that way, we end up back with 23 the proposed rule again, right?
)
l 24 There. I'm glad I clarified that. I 25 MS. HANEY: Yes. G) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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116 7-~.g i DR. SIEGEL: All right. Anything else I can do to V 2 help you? r
'3 MR. CAMERON: All right. Let's keep that in mind 4 as we go along here, and I want to get to Jack and Miriam, 5 and then we'll go back over this way, starting with Alan.
6 Jack, what do you think about all this? 7 DR. BASKIN: Well, I think it gets back to what we 8 said about this isn't a test of competency in radiology or 9 endocrinology, we don't want everybody who gives radiciodine 10 to have to.take the boards in endocrinology, certainly. 11 This is a test in radiation safety. 12 Now, for point of information, how we have handled 13 it is endocrinologists -- we're a small group, we're (~}
%.)
14 certainly in that outlier group. There are 160 new 15 endocrine fellows each year for 120 programs, so each 16 program averages a little over one fellow per year. It's 17 not practical, really, for us to put on an 80-hour didactic 18 program for one fellow. 19 The way we are handling this now -- and many of 20 these are going into research, may not even want a license-21 to give radiciodine, but the ones who wish to do that have a 22 two-week course given in Kansas City by the American College 23 of Endocrinology, which.is, we think, an excellent course, 24 it's credible, it fulfills all the requirements, and it j 25 concentrates on radiciodine. 1 s ANN RILEY & ASSOCIATES, LTD. ! Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 , Washington, D.C. 20036 j (202) 842-0034 i m_
l 117 1 We're not interested in instrumentation of gamma O k s/ 2 cameras or anything that doesn't have to do with the use of 3 I-131 for the treatment of thyroid disease, entirely. 4 We think it's a good course, and we think that 5 this is a credible way to do it and make sense. So, we've 6 got something practical, and it works, and we think it can 7 be used. 8 DR. SIEGEL: But what you're saying is not 9 mutually exclusive with what I said. Attendr.nce at that ) 10 course could become part of the special rec,uirements, making l 11 that course subject to ACGME approval ever, though it, right 12 now, is a freestanding course. 13 DR. BASKIN: That's right, yes. It would not be 14 in the same location as perhaps -- 15 DR. SIEGEL: That's okay. It's no different that 16 radiology residents going and spending two months at the 17 AFIP to get their pathology training as part of their l 18 radiology training program. i 19 It's an elective. As part of the training 20 program, it's an elective that is under -- it has been see l 21 by the RRC, the residency review committee, and then 22 ultimately gets the rubber-stamp of the ACGME. 23 MR. CAMERON: Barry, let me ask you a question, 24 and Cathy, also. In terms of Jack's concern and questions, 25 are the implications the same under approach 1 and approach ( ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Kashington, D.C. 20036 l (202) 842-0034
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i 118 l 1 2?
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' \_/ 2 DR. SIEGEL: With respect to what? i l 3 MR. CAMERON: To the short course, you know, the ; 4 need for -- this course is great for the endocrinologists, l 5 I mean,-in other words, does he have the same -- l 6 DR. SIEGEL: It's easier under 2. l l 7 MR. CAMERON: Okay. i 8 DR. SIEGEL: Under 1, he gave the short course and l 9 he had to find a place to go take an exam. Under 2, they 10 give the short course, and ideally, either the short course 11 is pre-approved by the NRC as a freestanding or, ideally, it 12 gets incorporated into endocrinology training a.d approved 13 by the ACGME. fw g 14 MR. CAMERON: So Jack, I don't want to pin you 15 down in terms of saying you're for one or the other ! 16 approach, but is this approach, assuming it works the way 17 that Barry suggested, is approach 2 -- would that be 18 something that would be better from your point of view, and i 19- do you have any worries that -- about an exam being a better 20 confirmation of competency? 21 DR. BASKIN: Well, we're dealing with a very 22 focused group. 23 We think that, by the time they finish our 24 two-week course, that they hopefully would pass an exam, and 25 we're not, as I said earlier, opposed to an exam, except N ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
u l 119 l L ,_ 1 again, it's a big expense on us to -- if we start to set up j s, 2 a board, a separate board to give an exam.
- ]
l We think that -- currently, there's only one 4 3 I 4 training program that it would not put an onerous burden on ! 5 the NRC to approve our program, that it would be much less I 6 expensive to do it that way than by adding another. exam. 7 It's not_ going to decrease our structured 8 educational program at all, but it is going to add another 9 level of requirements for our people to pass another exam. 1 10 MR. CAMERON: Okay. Thank you for that. I 11 Let's go to Miriam, and then I'm just going to go ) 12 this way with Peter, Frans, Phil, and Chuck. 13 Go ahead, Miriam. fS 14 MS MILLER: There's one component of this that l
\j l 15 nobody has recognized, and it's in the RSO training. Many i 16 . technologists are the RSO in many hospitals. Does that mean 17 that you would recognize the ART or the NMTCB exam as being 18 they're NRC-trained, because they've had this' handling and 19 pretty much the approved programs to take these examinations 1 I
20 have all had that' mandatory training. 21 MS. HANEY: We could accept a technology as the
- 22. RSO provided that they met all the other requirements of -- l 23 that are in the rule, the specific requirements for becoming
'24 an RSO, and we have not changed this, whether you're talking 25 current proposed or the staff's draft.
i l l l ANN RILEY & ASSOCIATES, LTD. ; l Court Reporters 1025 Connecticut Avenue,~!M, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
120 i O 1 It's still the 200 hours and the one yer er (V 2 experience under a radiation safety officer, doing radiation 3 safety officer type of functions, but if that were -- if a l 4 technologist were to meet those requirements and the E technologist board, whether -- you know, whatever board they 6 went through, if they -- that board was approved under 7 option 1 say if we were doing board approvals, then they 8 could become the RSO. 9 MR. CAMERON: Thanks, Miriam. 10 Peter. 11- DR. MOORTON: I'd like to address what Barry had 12 to say. 13 First is that I think, under the board 14 examinations and using the present standards, we have
' 15 written. tests and we also have the oral practical which I 16 think is as close to evaluating competency as you can get, 17 and when you say somebody is certified and put them out on 18 the public, that's basically our stamp of approval that they 19 are at a basic level of competence to perform what they're 20 supposed to be able to do. (
21 As far as the various facilities being unable to 22 .fn ;a program in in a period of time, there are plenty of 23 dedica. 1 programs at other institutions where you could 24 send your residents out, just as we do for additional 25 nuclear training or ultrasound or whatever the field may be ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
121 1 .that Barry also mentioned, and I just noticed there was a , k_,) 2 brochure over here fro.n the College of Nuclear Medicine or 3 College of Nuclear Ca-diology where they have four weekend i 4 courses in a row to get 200 hours of physics, 5 So, courses such as that are available and they 6 can be incorporated into the program. 7 MR. CAMERON: Okay. Thank you, Peter. 8 Frans? 9 DR. WACKERS: Let's go back to this apparent I 10 discordance or lack of agreement between 2.A. and B. 11 If 2.B. is valid, so you can just do the training 12 and that's it, then the exam.-- we have in our exam -- 10 l l 13 percent of the questions are safety and instrumentation. l
-s 14 Now, theoretically, you can pass the exam and have
! t {
\ /y 15 all those questions wrong.
l 16 So, if the training is just enough, then you l 17 cannot have more stringent criteria for the exam, at least 18 if you want to be equal-handed. l 19 I think we should talk about it. 20 If you incorporate safety in the exam, is that a 21 mandatory portion of the exam they should pass? If that's 22 the case, then you cannot just have a training that would be 23 sufficient. It is a inconsistency there, t 24 ~ DR. SIEGEL: Under the proposed rule, the exam 25 clearly had to include a separate identifiable radiation fy. (j e ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014
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1 122
- 1. safety component.
m
) 2 Under the working group draft, it's the training l
3- that's looked at, and the fact that the board gets named ) 4 under A and chooses to give an exam in overall clinical l
-5 competence is not relevant to this issue. I 6 The board has chosen to set its bar at a very high 7 level, and the.NRC is willing to accept that, if you jump L
8 over that bar, you clearly meet what we require. The board l 4 9 can be.as high as it wants. But that doesn't mean that 10 someone who can't pass the board exam can't meet the NRC's l 11 minimal radiation safety standards. 1 1 12 MR. CAMERON: Under the second approach, the board ! l 13 could have whatever exam that they wanted to, and that exam l 14 could include what we're calling physics or it could just be f}
\m/ 15 l
something else, but that exam would be irrelevant in terms 16 of whether someone was going to be an authorized user under 17 approach number 2. Il Phil? 19 DR. ALDERSON: I wanted to speak to the question 20 that was asked regarding competence and how do you assess 21 competence if there's not an exam? Obviously, you need to 22 do that. 23- One answer might be that the ultimate test of 24 competence is your performance in the field. I mean it's 25 the outcome. i g ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l l l
r 123 I
- 1. It's not whether you pass the test. It's not L
O i
\ ,/ 2 whether you went somewhere and crammed for the test and then l.
l 3 remembered it to put it down on a piece of paper but whether 4 you can go out in the field apply it and be a safe and ( 5 appropriate practitioner of this discipline. l 6 So, it is conceivable that one thing that you 7 could do for, again, this small -- I'm only talking about 8 the outliers now. I think that Dr. Siegel 's approach, you 9 know, is fine for the 95 to 97 percent -- and everybody 10 around this table fits into his approach. 11 I think that that covers them, but ultimately, the 12 NRC leaders are going-to ask you to address the outliers, 13 what about the rest, and if you can't figure out them, well, 14 then you've got a problem. (g f-15 I think, with respect to the others, that you 16 could, in fact, develop, again, some sort of a computerized
.17 annual practice report that they have to fill out that asks 18 questions that you want to know and they can fill it out on 19 a computer-graded sheet, so that you don't have to have your 20 staff reviewing it, and then you could have along with this 21 practice report that would give you insight -- or your l 22 agreement states into the insight of these small practices, l
23 you could also develop -- it may require some manpower but l 24 potentially not much or you potentially could even delegate 25 it -- you could have a random spot-check as appropriate. t ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
E t 124 1 I say random because the randomness takes -- you
) 2 don't have to do them all, but they are notified as part of l 3 the annual report that they have to complete that this 4 includes a random spot-check program, and this means, l
5 doctor, that your office could be visited by a 6' representative who will review all these records, you will 7 need to have these records on-site, so on and so forth, and 8 then, you know, at some periodicity that is statistically 9 acceptable, you know, 5 percent of those, 10 percent of 10 those, you do visit them, and you know, that's how you 11 assure that they are competent, and then, obviously, I 12 assume there are some guidelines about the fact that, if 13 there are a certain number of untoward events or problems in 14 a certain practice, that that would raise a red flag, also. 15 MR. CAMERON: Okay. Thanks, Phil. 16 I will redraw this in a more legible format for 17 your information, for later on, but I think I did capture 18 the outliers a couple of different ways to address that. 19 Let's go back to Mark and then over to Chuck on 20 this exam -- I take it -- exam issue. 21 MR. RAYMOND: It almost looks like the issue is 22 set up as one of education and training versus testing, and 23 I guess I'm inclined to think that both are truly important 24 in order to guarantee competence. 25 Many of us who are affiliated and have been i g ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 (202) 842-0034
L i i 125 l l 1 affiliated with certification boards recognize that
- (~,
I~)/ 2 certification boards exist because education isn't always l l 3 100-percent effective; occasionally, there are outliers, and 4- we rely on the certification or the testing and' examining 5 process to sort of pick up and detect those outliers, 6 however few that may be. 7 So, rather than, you know, construe it as testing 8 versus training, I guess I would be inclined to argue for 9 both processes to be involved. 10 MR. CAMERON: So, what you're saying is that 11 testing is really the best way to pick up the outliers. 12 MR. RAYMOND: Yes, I think that that's fair. 8 13 MR. CAMERON: Chuck? f-~g 14 MR. ROSE: Just two comments. k_ / 15 If you have to pass the boards in 1.A. and 2.A. in 4 l l 16 order to be licensed, if that is the criteria, then I think j i 17 that 2.B. should be combined with 1.B. and have just one set ! 1 18 of criteria, that if you have to take the boards, the boards )
- 19. aupposedly establish the criteria for education, and you 20 have to pass the boards, that's the test, then the ultimate 21 route ought to include the approval of the training program, 22 as in 2.B., and an exanination, as in 1.B., because the 23 other parts of 1.B. and 2.B. are the same. l 24 The other comment is we're all making the 25 assumption here, which I think most of us realize is not i
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! ) l ll 126 '
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1 totally valid, and that is our past experience with criteria ("% \ ( ,/ - 2 for' boards exams did not necessarily meet the criteria for l 1
- 3. NRC licensing, 4 Having passed the boards met the criteria, but 5 that.didn't necessarily mean that they'd had 200 hours of 5 6 experience in preparation for the boards, and that's one of i
7 the reasons, I think -- and Barry may want to add something 8 here, but that's one of the reasons for looking at less 9 training and experience to meet the licensing requirements, i i 10- because quite frankly, it isn't being done in many cases to 11 meet board exams. 12 So, you have a dichotomy here, where people who 13 took boards cn: had board qualifications didn't necessarily 14 get 200 hours. All right? 15 People who didn't meet board qualifications had to 16 get and have to get 200 hours, and I think most of us 17 recognize that those situations may occur, and so, I think 18 you also have to do due diligence with regards to looking at 19 the requirements and inspect boards, just like you would
~ 20 inspect other people to make sure they actually give the 21' training that they're supposed to give.
22 MR. CAMERON: And before Barry answers this, just 23 let me ask you for clarification on this. 24 You talk about there's going to be -- about these
- 25 board exams. Under 2.A., the fact that there is a board l
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l 127 exam, for purposes other than what the NRC is interested in, 1
)
l
) 2 is irrelevant as far as we're concerned.
1 3 So, is your point that, well, we know these boards 4 are going to give exan's in terms of -- and is clinical I 5 confidence a wrong phrase to use? In other words, these 6 exams thst.the boards give for clinical confidence -- are j 7 you saying that, since they're still going to be giving 8 those exams -- 9 MR. ROSE: In both cases. 10 -MR. CAMERON: -- well, yes, in both cases -- then 11 why don't we.just go with the proposed rule? ' 12 MR. ROSE: No. What I'm saying is, if you -- that 13 1.A. and 2.A. are the same. All right? And we're making 14' the aGSumption here that, if you meet the requirements to 15 sit for a board exam, whether you have to pass it or not to ; 16 get a license, which is another issue, you're assuming that 17 you have met the requirements for licensure by meeting those 18 requirements to sit for that exam. 19 MR. CAMERON: They're not the same, though. 20 MR. ROSE: 1.A. and 2.A. are not the same? 21 MR. CAMERON: No. 22 DR. SIEGEL: They're not identical. 23- MR. ROSE: They look identical. 24' DR. SIEGEL: They look identical, but they're not. 25 For a person to be approved under 1.A., they have l l ! ((j\ ' ANN RILEY & ASSOCIATES, LTD. l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1
ji a 128 , t 1 to have passed the board exam, and the NRC has to have x x_) 2- agreed that the exam addresses the thing it wants the exam 3 to address. l , 4 For a person to be approved under 2.A., the 5' individual has to have passed the board exam and the NRC has 6 to' agree that the person's training met the things the NRC 7 wanted to address. 8 One is. exam ~ driven, the other is training driven, 9 and to say you want to recombine them again is clearly 10 idealistic. I mean it's reasonable, but it's not what these 11 two things are designed to do. 12 MR. ROSE: Okay. I understand now. So, you see, 13 education does work. Thank you. 14 MR. CAMERON: Especially in the most recalcitrant 15 cases, it works sometimes. 16 MR. ROSE: Well, I had a good instructor. 17 MR. CAMERON: Peter. 18 DR. MOORTON: Point of clarification. The 19 radiology' residency includes the basic requirements, but I 20 got from your initial paperwork that was sent out, you're 21 looking to strive to make licensing by the NRC available to 22 anybody that wants to get it, basically. 23 So, if they meet X criteria, what's to stop 24 anybody that has a license to practice medicine to get a 25 license, not that.they're skilled in imaging or that they've ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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i l 129 ! 1 got a cardiology beckground or anything else, and basically, .; 2 what it looks like is, on one hand, you're driving to have 3 these basic requirements. 1 4 Say I was a general practitioner, I decided I just i 5 wanted to just open up my imaging lab. -All I have to do is 6 take the 200 hours of physics and do a preceptorship, and 7 I'm in business. 8 Now, if that's okay and you want to make it 9 available to everybody, that's fine, but from our 10 perspective in radiology, we think imaging is more important 11 and more involved than just to take some basic things and 12 just open up a business. 13 MR. CAMERON: Barry, I know you're going to 14 respond to that, but I guess I'm also curious about how much (_s 15 different is Peter's concern if you're operating under 1, 16 where there is this examination in physics, versus operating 17 in 2, where there's no examination buc you look at the 18 training program. 19 In other words, is that concern the same whether 20 you're operating under 1 or 2? 21 DR. SIEGEL: I don't think it's identical under 1 22 or 2, because at least with respect to 35.100, 200, and 300, 23 .both the proposed rule and the working group draft are 24 focusing on the radiation safety components of the activity, 25 not on the overall clinical' competence to perform the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
1 i 130 i 1 activity, and the whole reason for doing that is to make p.k
\ ,, 2 this rule more risk-informed.
3' If you look at the safety record of diagnostic 4 nuclear medicine and, frankly, even therapeutic nuclear 5 tmedicine, the safety record is so good that to-say that you 6 have.to be a board-certified practitioner in order to do l 7 this is viewed by some as being unreasonable, unreasonably 8 restrictive. 9 There are other mechanisms in the practice of
- 10. medicine for dealing with people who hang out a shingle that 11 says neurosurgeon and they've had no training for bei fa 12 neurosurgeon. Eventually, malpractice courts will catch up
)
13 with those people. i 14 All of us in this room who are physicians have a (s e i
's ' 15 license in our state that says physician surgeon'. We can do i 16 whatever we want, i 17' There are other things in society that constrain 18 us. The question is whether the Atomic Energy Act also has 19 to constrain us, and I've argued for a long, long time that 20 the Atomic Energy Act should concern itself with the very 21 narrow scope of things related to radiation safety and not 22 to the full issue of clinical competence to read an image or 23' to decide whether or not a particular patient ought to be 24 treated to-make sure that that can be -- whatever is done 25 'can be accomplished safely. i ' 8 ANN RILEY & ASSOCIATES, LTD.
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4.. 131 i 1 MR. CAMERON: All right. Thank you. 2 Alan. 3 DR. MAURER: At the beginning of this discussion, 4 I' thought I knew where we were, and I think I've gotten more 5 confused -- 6- MR. CAMERON: A successful discussion. 7 DR. MAURER: Yes. The education process reversed i i 8 itself here. 9 I'm not sure I understand some of the shades of i 10 gray we've gone through between 1 and 2. ' 11 I would just like to reiterate that I think the 12 core of the discussion has, to me, said not only do we need 13 training programs that have some qualifications behind them, ! i 14 i
;- but I think we do need an exam structure to validate that - 15 training program.
I 16 So, under 1 or 2, whichever one, I'would just like l l 17 to reiterate I think the training. program needs to be 18 validated, and I think there does need to be some :
- 19. examination process, and I think what I'm hearing is we're !
20 getting away from that. I i 21 MR. . CAMERON: Yes. 22 DR. MAURER: We're talking about just a training l l 23 pregram that's approved, but I think someone else said it -- 24 I'think we need to tie together to really say we've done our 25 ' job, a training program and an examination process. I I i g3 l-() ANN RILEY & ASSOCIATES, LTD. i Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l l 132 1 1 MR. CAMERON: And indeed, that comes down to the
. r") '( ) 2' philosophical difference between those who think that you 3 need a training program to -- I mean, I'm sorry, an exam to !
4 validate competency or whether there are other ways to 5 validate competency such as the ideas that Phil suggested. 6 DR. MAURER: Again, my original comments were 7 about some form'of quality assurance. I think we need to be l I 8- sure, whatever the NRC's minimal requirements are in terms j 9 of radiation safety, you know, and radiation protection, 10 that that's covered in the training program and that there l 11 is an examination. 12 Now, I understand struggling with how that 13 examination is going to be given, whether it's going to be 14 -- whether the NRC will assume responsibility for that or [sY
\/ 15 somehow a combined approach through the boards with l 16 sub-specialty competency and then the outliers.
17 I would just like to reiterate I think we need ' 1 18 both components. 19 MR. CAMERON: All right. Good. That's a useful 20 point for the NRC staff to understand where all of you are I 21 coming from on that particular issue, and I don't know how 22 you --.and it's easy to say we need an exam to -- as a QA 23 check on the training program or we can do that in some 24 other respect.
-25 I mean I don't know what quantitative data or 1
-w g 1
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133 1 qualitative data you can develop to prove that one way or i r~ {
- ( T/ 2 the other, and then, of course, there is the resource 3 question that we talked about, and although we had a 4 statement of what the resources would be from the NRC's 5 point of view on having the -- going the exam route, keep in 6 mind that the NRC.doesn't know whether it might be just as 7 resource-intensive to not have an exam.
8 We've heard resource issues from the user's point 9 of view. Although Jack said that we're not necessarily 10 against an exam, obviously it's more resource-intensive to ) l 11 have an exam. 12 Barry? 13 DR. SIEGEL: One validation step, Alan -- and I 14 know that there are reasons to believe that one should not '/~T '( / 15 be comfortable with it in every circumstance, but the 16 preceptor is -- the rule language raises what the preceptor { 1 17 does to a new level. 18 The preceptor is now required to certify, under 19 penalty of perjury, that the individual has c =pleted the 20 training and that the preceptor believes that individual is 21 capable to function independently as an authorized user for 22 the stated purpose, 100, 200, 300, 400, or 600. 23 DR. MAURER: We can wave the flag and -- if we're 24 doing our job to ensure that training is correct, I think 25 it's a little naive to put our full hope in that. r~N lj ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
134 1 DR. SIEGEL: I agree, full hope. () 2 Now, let me ask one more question, though, because , 3 most of us around the table, because of our involvement with 4 professional organization and boards, sometimes confuse best
'S practice with minimal standard necessary to ensure safety, 6 and I'm concerned that you may be arguing best practice, 7 that you want to do it in a way that you know will be the-8 best'the American people could ever get, and that would be 9 great.
10 You know, if everybody has the same kind of 11 medical care as the President, that would be wonderful, but 12 it isn't necessarily resource-appropriate or cost-effective 13 to ensure that we're operating at that level in a
,_ 14 risk-informed rule when we acknowledge that the use of these l %- 15 drugs for nuclear medicine is essentially the -- they are 16 essentially the safest drugs in medicine. Most other drugs 17 cause more problems than the things we use in nuclear 18 medicine.
19 DR. MAURER: I don't disagree with your last 20 statement. 21 I just think that whatever recommendations come 22 out of this committee -- we've had to live with these 23 rulings, and there are going to be constituents from 24 different areas that are going to come back and say you 25 didn't do it right, you didn't set the best guidelines, and l l p) ( ANN RILEY &-ASSOCIATES, LTD. ! Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
135
/ ~,
1 I think it is possible, as you said, with the resources (s,). 2 available, to do it right at minimal competency level, and I 3 that includes assuring the proper training and some form of ' 4 testing to be assured that what the NRC wanted accomplished 5 was accomplished in that training, because if we don't do it I i 6 right, people are going to be coming back here five or 10 l h 7 years from now, after all the constituents start complaining ( 8 about-the new rule and-that the preceptorship wasn't 9 working, so we've got to do it right, recognizing all the 10 limitations. I 11- MR. CAMERON: Okay. Thank you, Alan. 12 Let's have one last comment before lunch from 13 Frans. Let's come back and I'll do a reprise for us of
)
14 what's been said, and then we can see what else we need to t
\/ 15 say about this.
l 16- Go ahead, Frans. ! i 17 DR. WACKERS: I liked, actually, the comment that ' 1B Phil made. 19 You cannot necessarily test in the exam what you 20 want to test, but we are dealing here with safety, and so, 21 to have a annual record of what_really happened -- and the ! 22 problem is that this actually does not apply so much to the 23 individuals, unless you have a solo lab, but really you're 24 talking now about accreditation of laboratories, and I think 25 it is important, and that seems to be totally at the ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 136 i
/
1 prerogative of the NRC on the inspections to look at the i (,/ 2 medical events or the misadministrations, what happened in 3 the laboratory. 4 So, you have your statement by a preceptor that 5 the proper training was there, and then you have to look at 6 what is the outcome, and if the outcome is bad, then it 7 should be stopped. 8 I think, actually, we haven't talked about -- the 9 examination of individuals is one thing, but the quality 10 control of the laboratory is another thing, and actually, we 11 are working with the SNM now on an accreditation program of 12 laboratories. 13 MR. CAMERON: Okay. Thanks, Frans. We'll come r~s 14 back to that issue about the laboratories, i ) 15 Why don't we come back at two o' clock, okay? That 16 gives you an hour-and-five-minutes for lunch, and we'll do a 17 summary here and see if there's anything more that we can 18 add to it. I mean there's only so much, perhaps, that we 19 can squeeze out of this, and then we'll go on to some 20 specifics. 21 [Whereupon, at 12:55 p.m., the meeting was 22 recessed, to reconvene at 2:00 p.m., this same day.] 23 24 25 l
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137 1 AFTERNOON SESSION A is ,) 2 [2 :05 p.m.] 3 MR. CAMERON: I thought that I'd just give a 4 summary of what I think I heard from our discussion on which 5 basic -- what are the pros and cons of these basic 6 approaches, and I don't know if anybody -- and hear anything 7 else anybody has to say on this, and then we need to move B into some of the specific issues on the agenda and also 9 clarify something in regard to that. 10 But what I heard this morning in terms of the ! 11 proposed rule, radiation safety exam -- and I do want to 12 introduce Carl Paperiello, who is the Director of the Office 13 of Nuclear Material Safety and Safeguards.
,~, 14- DR. PAPERIELLO: I had to talk to a Senate budget t \ 15 . committee this morning. I wanted to be here.
16 MR. CAMERON: Well, your staff told us -- we found 17 out that, in August of 1s99, there's going to be another
-18 proposed rule on this.
19 At any rate, some pluses of having the exam -- we 20 heard exams are the best measure of competency, exams are a 21' mechanism to QA the effectiveness of the training program. 22 We heard a negative in that it's 23 resource-intensive for the NRC to approve examination 24 providers and exams. Cathy gave us a 5-FTE number for that. 25 Obviously, it's going to be more expensive for m
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l l L I 138 li users to take this exam, radiation safety, and all of these
]
(f 2 costs are exacerbated by'the need for recertification exams, 3 which is something that Phil Alderson brought up that we 4 didn't get on the record. 5 MS. MILLER: Chip, that first statement -- exams 6 do not measure competency. They measure knowledge. 1 7 MR. CAMERON: Oh, this is going to be fun. All 8 right. l
'9 DR. MAURER: They are a measure.
10 MR. CAMERON: A measure of knowledge? ! 11 DR. SIEGEL: Exams are one approach for validating 12 knowledge but by no means the only approach. i l 13 MR. CAMERON: All r'7ht. l
, 14 So, you see the fun we've been having, Carl.
k s/ m 15 DR. PAPERIELLO: I don't feel as bad about all the 16 spelling tests I did poorly in when I was in elementary 17 school, particularly since my word processor does it for me 18 now. 19 MR. CAMERON: All right. 20 Now, in going over to this side, okay, supposedly 21 a plus here would be that it's less resource-intensive for 22 NRC to approve the t.aining program rather than the 23 examination -- examining organization, but the staff has 24 stated they have no data on this, okay? 25 . So, in other words, we're not sure that this is a O j- ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i i 139 ; I wash, right? n. k_) 2 Risk information indicates that -- and I put -- we 3 heard the term "best practice," okay, and you know, I can 4 4 refine this any way you want, but the risk information 5 indicates that best practice isn't necessary. . 6 In other words -- and I was going on exams as-7 perhaps a best practice, that maybe you don't need a best i B practice in this area because of the risk that'e presented , 1 9 by the procedures, especially when there are other methods i 10 to provide a QA check or deal with what Phil called the 11 outliers -- annual practice report, site visit, preceptors. 1 12 A neutral point here that Barry made, established 13- training organizations would need to incorporate NRC i 14 requirements as part of their programs, but I suppose that 1 (Y /,s) 15 would be true.under the first approach, okay? 16 Do we have final comments on this particular 17 issue? 18 i (:No response.] i 19 MR. CAMERON: Okay. Because this is for you guys , 20 to consider and for the Commission to determine on the i 21 approach t hat might be taken. 22 We're going to go to specific issues, and I think { 23 this generic issue is going to resonate throughout, so we'll 24 be getting back into it. ! l 25 Frans.
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140 i 1 DR. WACKERS: You talk about exam for radiation g l V 2 safety officer, radiotherapy,' diagnostic imaging that I I' 3 think will be -- you should have different' levels. It would l 4 be a lot simpler, you know, go to the boards, say, okay, 5 'every board takes care of all -- the level of difficulty ) 6 that's appropriate for.that specialty. The disadvantage of 7 having one exam is that you have to cover a whole lot of 8 things. 9 MR. CAMERON: Well, that's -- the other point, j 10 when we go into -- now, we're going to explore the details, 11 each requirement that's associated with the approach, and 12 one of the issues that we're going to deal with under this 13 approach is the feasibility of one exam, if that's the issue l l 14 that you're raising, and as we heard from'Ed this morning, ' C 15 they're willing to try to help in terms of one exam. 16 We heard Phil talk about getting a consortium to 17 put together an exam, but I think we're ready to go into 18 looking at some of the details of each particular approach 19 now, and what we had on the agenda for one o' clock was the whole issue of the role of the certifying board, what i 20 l 21 criteria do the certifying boards need to meet for the NRC ! 22 to recogni::e them, and what process should the NRC use to ; 23 recognize the boards? 24 Now, Cathy, correct me if I'm wrong, but all of 25 those -- the same basic issues are going to apply to both r% V. ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenne, NW, Suite 1014 , Washington, D.C. 20036 l (202) 842-0034 I
[' 141 , i 1 1.A. and 2.A? 2 MS. HANEY: That's correct. 3 MR. CAMERON: All right. And we did have a ! 4 question of clarification from Frans which I'm trying to '< 5 figure.out how to articulate it, and I may let you do that, 6 but basically, what are the -- in either case, 1 or 2, what 7 are the implications -- what's the diffe.ence between the A 8 route and the B route? 9 One of the differences that you mentioned this 10 morning is that, if we recognize a board and someone is l 11 board-certified under either 1 or 2, then they're just 12 l placed on the license.
)
I 13 MS. HANEY: That's true. That's really the only
- 14 difference between A and B, is from the standpoint of an \~ 15 authorized user being able to go right into performing the 16 functions of an authorized user.
I 17 If they go the A route, all we get is a ' 18- notification from the licensee. If they go the B route, all 19 20 j 21 22 23 24 25 l A ANN RILEY &~ ASSOCIATES, LTD, Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
142 1 the individuals' credentials come into us, with -- under a (3 (s,) 2 request for a license amendment from the licensee, and now 3 you're talking about, upwards to maybe two months before the 4 individual can start practicing versus an immediate if they 5- go the A route.
-6 MR. CAMERON: Okay.
7 Another thing to recognize is that, for the NRC to 8 recognize a board under either 1 or 2, the board is going to 9 -- essentially, thAboardisgoingtohaveatraining 10 program that is satisfactory to the NRC, in this case a 11 structured educational program, a preceptor. 12 The question is, is it any easier for NRC to 13 recognize a board in either case 1 or 2 than it would be to es s 14 use B, if that's the right way of phrasing it?
\ 15 And I guess, Barry and Cathy, why don't you talk 16 to us about that?
17 DR. SIEGEL: Well, the only other advantage of A 18 from NRC's point of view is that, in one fell swoop, they 19 deal with a large component of the individuals who may be 20 applying by recognizing the board, because the board says, 21- in order to come and sit for our test, you have to have been 22 in an ACGME-approved training program, the ACGME-approved 23 training program contains the elements that the NRC wants in 24 B, and the program director submits a statement to the board 25 that says the individual is competent and prepared to take e ("h
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l 143 1 the test. (D ( ,) 2 So, everything in B is incorporated into A. The 3 board now did all the work that the NRC otherwise would have 4 had to have done, and the NRC is able to deal with a large 5 number of individuals by reviewing one set of documents 6 instead of hundreds of sets of documents. 7 MR. CAMERON: Okay. 8 From that perspective, is there any sense 9 examining the option of -- did anybody in the comments 10 suggest that A -- in either case, A would be the only route? 11 In other words, the equivalent -- did anybody say that we 12 should not have an equivalent pathway? Is that practical at 13 all?
- 14 MS. HANEY: I guess I don't remember seeing any, \/ 15 and Barry can address it. The only other statements that 16 _was made is that it would be the board or the alternative 17 pathway would only be for someone that was ACGME- or 18 ADA-approved and that there not be roor, tar someone that 19' didn't fall under either of those organizations to be 20 . recognized in the rule.
21 MR. CAMERON: Okay. So, that's an issue for
- 22' discussion, is how tightly should the equivalent pathway be 23 constrained by only certain equivalent pathways, right?
24 MS. HANEY: Right. And that kind of moves us into 25 something we'll get to during the meeting, which is when we ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington,HD.C. 20036 i (202) 842-0034 l
144 !
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I start approving these organizations, whether it's the -- in q,/ 2 A or B, as far as looking at the structured educational 3 programs, do we only allow for ACGME or AOA? 4 If it's either of those organizations, is it more 5 o- less just a rubber stamp and we say it's fine and we only 6 expend our resources in looking into those programs that are l { 7 not ACGME- or not AOA-blessed. 8 MR. CAMERON: Okay. 9 Let me ask all of you whether -- does it make 1 10 sense to you to go to this issue of what are the criteria ; 11 and process for NRC to recognize boards? l We're interested ! 12 in that issue as well as -- and also the resource 13 implications of that issue. 14 MS. HANEY: Right.
/}
s/ 15 MR. CAMERON: All right. 16 As Cathy pointed out, all the boards that are now 17 listed in the rule will eventually disappear, and in order !
-18 for a board to be recognized --
19- .MS. HANEY: From the rule. 20 MR. CAMERON: From the rule. Well, I don't know i l 21 if people know the full extent of NRC's authority, but I ' l 22 guess that goes with use of the word " approval" of the 23 board, you know, but -- 24- Anybody want to open up with criteria and/or 25 procedures that NRC would use to recognize the boards? And () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 i (202) 842-0034
145 1 1 I ovess we can.-- you know, we can deal with both the 1.A. 2 7':d the 2.A. 3 MS. RANEY: I can maybe give you a couple of ; 1 4 options that theoworking group considered, and that was --
- 5. .and some of this came from the comments -- that if the board l 6 is already listed in the rule, that we automatically approve 7 it and look no"further, i 8 That would be one option. Of course, the counter 9L is that we look at everything.
10 Another option is like one step down from that, is 11 .if it's improved in the rule, we go ahead and rubber-stamp ! 12 it but maybe look at it in six months or 12 months and pay i 13 more attention to the ones that are not currently in the l g 14 rule, and those were the big options that we considered. (/
\s- 15- '
When you got into the approval, this is where you 16 get into how thoroughly do you look at the board's 17 procedures, and this references back'to the Appendix A 18 criteria in the draft rule, and I can put that. criteria up 19 on the. screen if we get that far in the discussion, but that- !
-20 gets into do we look at bylaws, is it sufficient for you 21- just to say that you have bylaws?
22- It's one of those, how much information should we 23' ask for in order to feel comfortable with the boards, 24 : recognizing that we'll be dealing-possibly with the 25 better-known boards, but also there could be these new ANN RILEY & ASSOCIATES, LTD. i Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 . I i i
146 1 boards that came into being that would not necessarily be (O s/ 2 recognized as much as some of the others. 1 3 MR. CAMERON: So, there were some criteria put i 4 forth in terms of approval of boards? 5 MS. HANEY: The criteria that were put forth were i 6 really for approval of the examining organization, but by 7 default, they become criteria for review of the boards, 8 because the boards must meet the B. 9 So, it's one of those -- you know, you either get 10 it via the examining mechanism or you get it almost toward 11 what you could use as a back-door approach and say we get it 12 under category A. 13 MR. CAMERON: Okay. l 14 Well, let's get some -- we'll go to Frans, but l 15 let's get some comment on this proposal that, if it's in the 16 rule now, that basically that means that we're going to 17 recognize it, and I guess the question is, just because it's i 18_ in the rule now, does that mean that it's going to have 19 these components of the equivalent pathway either here or 20 .here?
;21 So, Frans?
22 DR. WACKERS: One thing I've learned being 23 involved in exams is that it's really -- it's a science, a 24 specialty, and there are experts, and I think you really 25 should use the counsel of experts who know about how to run i
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i I L 147 l 1 the appropriate exam, and in 1999, that is different than 2 perhaps in '94, when some of these boards were established, 3 and I think Mark probably is the person to speak to that. 1 4 There is a list of certain criteria I think that he can list 1 5 that we should look for. 6 i l MR. CAMERON: I guess you're going to the approval I 7 of the examining organization. l 8 DR. WACKERS: No, no, no, the board, as we're 9 sitting here. 10 MR. CAMERON: Right. 11 DR. WACKERS: We have used experts. I think that 12 would be a thing to do, to look at the technical aspects of 13 an examination. f- ; MR.~ CAMERON: Okay. I guess this maybe ties in
-- 15 with the point that Chuck raises all the time, is what's the i
16 objective of what we're trying to do here, and Chuck, do you 17 want to comment on that? 18 MR. ROSE: Yes. 19 You know, again, the reason we're here is that the 20- NRC has decided that they're not going to look at clinical 21 training, per se, right, and I think most of us recognize 22 that the system we have is -- in the past was not exactly 23 working the way it perhaps should, but when we talk about l 24 approving boards, I don't think our goal here is to approve 25 a board. A, j l h ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202)-.842-0034
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u i 148 t 1 I think we will approve boards, but what are we
/~
( %. j 2 approving the board for? The fact that a board stands for, 3 when you are able to sit for that board, you've had a j 4 certain degree of education -- that's what it's about, l 5 right? j ! 6 It's not about the board. It's the education that i I 7 goes into that board, right? Then it is the board giving an ; ? 8 examination, right? 9 So, by approving a board -- and I understand about ) 10 having the bylaws and independence and all those things -- 11 those are all good administrative things for a board which 12 also come out of the testing criteria that you develop, l 13 which I think is excellent, right? 14 But I think, when you look at boards, you have to
) 15 look at what is it that that board stands for, not the 16 group, not who is it or anything else. It's, when you're 17 eligible to sit for that board, our assumption is that 18 you're eligible to be licensed, all right, as an authorized L 19 user.
20 So, it's the criteria, it's the education that l 21 qualified you to sit for the boards, is the thing that we're 22 looking at here, right? And it just seems to me that those 23 organizations, those boards that meet good educational 24 standards now, if you looked at all the boards, even those 25 that are listed, it's going to be a piece of cake for them. O (t ) ANN RILEY & ASSOCIAT2S, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
_ - - - _ . , _ - . _ _ _ _ _ . - . . . _ ._ __- _ _ - - . ~_ 149 ; 1 They're done. I mean they don't have to do 1 f'N ( ,) 2 anything, because they're already in, and they can prove it, 3 right? But I think you look at them, you look at everybody. 4 And for example, the American Boards of Radiology, 5 if you looked at them, I mean it would be very low time 6 consumption on their part, very little resource expenditure j 7 upon the NRC to look at what the Americans. Boards of 8 Radiology do or maybe even the American Boards of Nuclear
,9 Medicine or others, but look at their criteria, look what 10 they require of their people, right, and then also require 11 that, if they change that or if they get more lax on that or 12 comething like that, they have to let the NRC know, right?
13 DR. WACKERS: With all respect, I think that's 14 totally wrong.
/~N .
k ,) m 15 MR. ROSE: Okay. I 16 DR. WACKERS: You can have all sort of eligibility 17 criteria and training you should have, but if you then make 18 questions that are bad that lead you straight to the right 19 answer or that are so confusing that nobody can answer them 20 right, there's a whole aspect to having a good exam that you 21 should -- taking an exam or giving an exam is a technical 22 procedure. l 23 MR. ROSE: I agree, but the questions come from 24 .the material, the questions come from the education. What
'25 are you testing them on? What should they have learned, /~N i
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4 l 1 150 ! 1 right? That's the criteria. And I think that's what the p) (, 2 boards stand for. 3 The boards say.you've had certain amount of ! 4 knowledge. Therefore, you're eligible to sit for these 5 boards, right? 6 From that flows the questions. That's where you 7 get the ideas of the questions that you establish, you 8 validate, and you do all the other things that you need to 9 get good questions, right?
. 10 So, I think the NRC -- if the NRC wanted to look i 11 at all of the boards, even those that are listed, right, and f 12 wanted to look at them, those boards that are already in the j 13 regulations, who have had experience in this field, l
14 etcetera, that wouldn't be much of a burden on either the
- 'i I (d 15 NRC or on those boards.
16 On the other hand, if new boards come along, 1 17 right, whether it be other groups -- I can't think of any at i 18 the moment, but if other groups came along, you know, they 19 would have to meet the same kind of inspection, but that 20 material wouldn't be there, that background wouldn't be 21 there, that knowledge wouldn't be there, right? 22 And so, I don't think it would be burdensome on 23 the NRC to look at the boards, right, and the boards that 24 we're all familiar with, piece of cake. The ones that might 25 be new boards would require more effort and more expenditure i l l l l Q). (,, ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l l 151 i l 1 to do it, and if necessary, have the NRC do what they do fN t \
\_ ,/ 2 now, right? They would charge for what they do, right, in 3 inspecting a board.
4 MR. CAMERON: Before we go to Barry and then Alan, l i 5 let me just make sure I know where you're coming from on 6 this. 7 Are you saying that there should be -- if a board 8 is in now, that -- 9 MR. ROSE: I'm saying, if the board is in now -- ; 10 MR. CAMERON: -- that we would -- 11 MR. ROSE: -- you still look at them. 12 MR. CAMERON: -- they should continue -- still 13 look at them. i l
,-s , s 14 MR. ROSE: -Sure.
15 MR. CAMERON: Okay. 16 MR. ROSE: Sure. Why not? { 17 MR. CAMERON: And that you would take a look at 18 the new organizations more carefully. I 19 MR. ROSE: Well, you probably could look at them 20 with the same diligence, but you wouldn't have any ! 21 background, they wouldn't have any -- necessarily a track , l
- 22. record, right? i 23 And so, for example, again, using, if I may, the 24 radiology board, we all know what the radiology board -- I !
i 25 think most of us know what the radiology board does and 1 ('N s
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I 152 1 their-criteria, etcetera. I. 2 New boards, you kuuw, it would be a little more 3 difficult for us or the NRC, as well as them, to show the 4 due diligence of.what they do, right, and I think it would 5 be much more cumbersome on their part to be approved, not 6 that you're using a different criteria, it's just that we 7 don't have a history, we don't have a background, right? 8~ And I think, in that way, you would look fairly at all 9 boards rather than just saying those that are listed now are 10 in, because we all know that, in the past, just being -- 11 having a board exam didn't necessarily mean that they met 12 the other licensing criteria, right, that other people had 13 to meet, for example the 200 hours. 14 MR. CAMERON: And would you -- last question for
. \-
O ). 15 you. 4 Would you use -- the criteria for looking at both i 16 existing and new boards would be the type of criteria that I 17 are now found in Appendix A or the rule? 18 MR. ROSE: You mean the examination criteria. 19 MR. CAMERON: Yes. 20 MR. ROSE: Because it really isn't board criteria,
'21 it's exam -- I think it's excellent. I think that's --
22 MR. CAMERON: It could be used for board -- 23 MR. ROSE: Yes, except I would add one thing to 24 it. There's nothing in that criteria for content. It all' 25 looks at the orgar.ization and how it's put together, but
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( 153 l 1 it's -- the orientation is not what do you want to () 2 accomplish. 1 3 In educational terms, what I'm referring to are l 4 goals and objectives, right, the same kind of things from 5 which you build test questions. 6 If you don't have educational goals and objectives 7 for each thing that you want to teach, you not only don't ; 8 know whether or not you've taught it, you don't have the i 9 ability to test for it. 10 MR. CAMERON: Okay. Thank you, Chuck. 11 Barry, did you want to ask a question, or should 12 we move on to Alan right now? Did you have a comment? 13 DR. SIEGEL: Just a comment on what Charlie said. 14 I think what the NRC has to do at the front end is easier [
\ 15 under 2.A. than it is under 1.A., and that's because -- at 16 least the thinking was that, under 1.A., the board is going 17 to have to be able to come to the NRC and say we have a
- 18. statistically valid pool of questions in our exam that we 19 can separately grade that address radiation safety, and that 20 is not a given with any of the boards sitting around the 21 table, including even the American Board of Nuclear I
-22 Medicine, and I can say that as past chairman of its l 23 -examination commi4 j 24 DR. MNsasR: I'll update you on that.
25 DR. SIEGEL: I know you're working on it, but l L ! l ANN RILEY & ASSOCIATES, LTD. l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
1 154 ! l' whether you're there -- okay, aaybe you're there. But it's (~)j q 2 been -- radiology has a great physics exam, but most of it l 3 .actually deals with image production rather than with -- and 4 how to make good images, rather than with radiation safety, 5 and I think every board would have to do some work to 6 satisfy the NRC, and in part, defining that is what makes 7' the 1.A. route more difficult and one of the reasons why I 8 trying to do'the 2 approach seemed appealing, in part, to 9 the working group. I i 10 MR. CAMERON: And the reason it's more difficult i 11 is because of the examination content. 12' DR. SIEGEL: And getting that exam pulled out and 13 clearly recognizable as separate from the rest of the exam, i 1
, 14 which is dealing with clinical competence and not dealing (x )-- 15 with the NRC's focused area of concern, radiation safety. I 16 Another comment, just a clarifying comment, the i' 17 notion of one exam -- I really don't think there can be one
'18 exam that would cover 35.100 and 200 and 300 users and 19 simultaneously cover 400 and 600.
20 At an absolute minimum, there have to be two 21 exams, there has to be an unsealed exam and a sealed exam 22 because of the radiation safety risks and the kind of things 23 you have to know are different, some common things but many 24 different things. 25 MR. ROSE: I agree with Barry, and I think that's
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l 155 , 1 the reason we have to look at the boards, is the fact that i i ('% a_)_ 2 they do not have.an exam in this material. So, I agree with 3' Barry, but I think that's the reason we have to look at , 4 them. 5 DR. SIEGEL: But they do have training. 6 Oh, yes, they do have training. S MR. ROSE: 7 MR. CAMERON: Alan? 8 DR. MAURER: One comment I was going to make was 9 on.the number of exams. I absolutely agree there cannot be-10 one exam that will cover all the different aspects of 11 training requirements that you've looked at. 12 Having been on the board now for several years and 13 being the exam committee chairman this year, I have no 14 problem at all saying to the NRC that the American Board of 15 Nuclear Medicine, certainly, is well -- is open to having -- 16 to submitting everything to the NRC. 17 There are published criteria, and I'm sure ABR has ; 18 .the same thing, in terms of what are the essentials for 19 requirements of training. It includes a long list of 1 20 ^ physics, radiation safety issues in the training 21 requirements, and that's published material that would be 22 ' easy for the NRC to review quickly, I think would be very 23 easy. , 24 The question about looking at the exams, I think, 25 is a critical one, and I think the NRC should look at all l 1
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156 1 the examining groups in a similar fashion.
.s
[x_)I 2 I think Frans even said, their exam, currently 3 only 10 percent of the questions deal with physics and 4 radiation safety. You can still pass that exam, and 10 i i 5 percent is a very small number. 6 The American Board of Nuclear Medicine has been 7 very aware of this issue coming up, just about a 8 year-and-a-half age changed its testing agency, so that in { 9 terms of a recent pool, we do have statistical validation on { 10 questions -- I think it's from -- actually, one -- l 11 one-and-a-half completed exams at this point with the new 12 . organization, but that pool is available and we'll -- would 13 easily be available to the NRC to look at. ! 14 So, I think both the American Board of Radiology 15 and the American Board of Nuclear Medicine have well-written ' 16 training criteria, have a large pool of questions which i 17- could be open. 18 The only question is, does the NRC want to specify 19 its own training requirements that the boards and everybody 20 else would have to' meet? 21 The American Board of Nuclear Medicine has 22 training requirements and ABR also has training 23 requirements. 24 The easiest thing for the boards would be for the 25 NRC to come and look at the current training requirements, l [
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l-l 157
'l look at the exam, and give them deemed status, and I think 2 that would be relatively quick and easy based upon the track l
3 record of prior testing and extensive documentation of 1 4 training requirements. i 5 But I agree that all the organizations should be L 6 looked similarly, and there is a question of whether the NRC 7 should come up with what they want in terms of a level one 8 exam, a level two exam, and a level three exam, and the ABN 9 has.a large pool of basic science and radiation protection 10 questions in a recently-updated computer database. 11 MR. CAMERON: So, I think Cathy -- I think we need 12 to answer. Alan's question about does NRC want to specify 13 training requirements, but just to summarize what I think 14 Alan said, is that, instead of just making an assumption i
\~/ 15 about what we're calling currently recognized boards, that 1
16 as Chuck said, all boards should be looked at according to 17 the same criteria. 18 It may be, in fact, easier, less l 19 resource-intensive for the NRC to look at an existing board 20 because they may be better prepared in this case. 21 Cathy, what about specifying training 22- requirements, and did you understand what Alan meant by 23 thr.c? 24 MS. HANEY: I think so. We'll see if I did if I 25 answer the question. l l l (% ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l (202) 842-0034 l l
158 1 I think NRC has, de facto, defined the training IA/ ) 2 requirements, and that being where we lay out in the rule 3 the actual hours. , 9 4 If you look at the August 1999 version of the 5 proposed rule, that gives the alternative hours. 6 Where we say the didactic and practical hours, 7 those are the elements of what we would be looking for when 8 we looked at the board. Working Group approach, when we 9 were talking about the proposed rule, was such that an 10 organization would come in to us and say that they requested 11 to be approved by NRC and as part of that -- and they would 12 say that in order to sit for our exam -- well, we want to be 13 approved for someone that was going to use unsealed material
-s 14 for uptake and dilution, which would put them in the \' 15 35-200 -- I'm sorry, for imaging and localization that would 16 put them under 35-200.
17 In order to sit for our board, a candidate must 18 have 80 hours of didactic training, 40 hours of practical, 19 they would be a physician and they would have a preceptor 20 statement. 21 Once they have done all those things they can sit 22 for our exam. Then they would go on to say that our exam 23 meets all the requirements in Appendix A of the proposed 24 rule. In particular, the radiation safety component of our 25 exam will be graded separately and they would get a separate f-s ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
c 159 1 grade. V L (, ,/ 2 If they gave all that information to us, then we 3 would say fine, you are an approved board, but then I go the 1 4 next step further is how far do I need to go.to verify that 5 what the board told me is true. Do I ask for curriculums -- _6 DR. MAURER: Well, the question I was asking was 7 more the American Board of Nuclear Medicine has a contents 8 manual.that specifies in' infinite detail experience with the 9 . dose calibrator or experience with the survey meter or 10 ionization chambers, Geiger-Muller counter -- I mean in 11 extensive detail. 12 Does the NRC want to examine each board to make 13 sure that certain content is covered? I mean we have a 14 statistical database on questions that are very detailed. I a
\m ' 15 Just to say 30 hours or 40 hours or 50 hours doesn't specify 16 content.
17 MS. HANEY: And that is one of the questions i 18 today. If you were in.my position, would you be content 19 having someone say candidates get 80 hours of didactic 20- training'that covers physics, radiation, biology -- 21 DR. MAURER: And I can sit here with a strong 22 position because the American Board of Nuclear Medicine does 23 spe'cify A, B, C, D, E, F -- 24- MS. HANEY: Right, but -- 25 DR. MAURER: And I would say yes, I would think l ANN RILEY & ASSOCIATES, LTD. l- Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014
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1 160 1 you would wan to make sure that somebody knows the N_j 2 difference between an ionization chamber and a Geiger-Muller i 3 counter for surveying purposes, so that was my question. 4 Does the NRC want to -- I think we had talked about it -- 1 5 provide a syllabus of the core material and make sure all 1 6 the boards meet it. 7 It is easy for the American Board of Nuclear 8 Medicine to say yes because I.think we have already done l 9 that and I think the American Board of Radiology may be more 10 weighted towards imaging, but certainly could do that, but I 11 think it would be incumbent upon the NRC to make sure the 12 content is there. 13 MR. CAMERON: Can we just clearly spell out what 1 14 the two alternatives that you -- two scenarios are that you 15 are talking about in terms of, Cathy, we are talking about 16 80 hours of this, that and the other thing, and thuL is sort 17 of just a gross 80 hours versus the specifics, the content ; i 18 of what those 80 hours would address. i 1 19 Is that the distinction you are talking about? 20 DR. MAURER: I think if you are going to -- you 21- have several options The easiest things for the existing 22 boards would say, look, we'll show you what we have got, 23 take a look at it, if you are happy with it just give them 24 all deemed status, but particularly if you are looking at 25 new boards where there is no track record, you have got to D l \_s/ ANN RILEY & ASSOCIATES, LTD. I Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
?
I 161 ; l' tell people what you want in their training requirements and Od -2 what you'want them to test on. .It's-that simple. How'can I 3 .they guess at what you want to test them on? 4 I am'not surefI answered your question. 5 MR. CAMERON: No, I think you did, and let's keep 6 going with this. I know that Phil, you might want to chime
~
7 inLon this too. 'Go ahead. I 8 DR. ALDERSON: I think that the existing boards do i 9 have the training and we do know what the outcome has been. i 10 I mean.the American Board of Radiology has been examining 11 since I think 1935, and we know that the record of safety of 12 diplomats of the American Board is very high, so I think you 13 clearly have to have a two-phase process =for old boards and : 14 new board. I think it's just like the tax form -- you know, 15 there should be a'short form and a long form.
. 16~ I think every board, you know, you should 17? interrogate each and every board, even those who are already ;
18 mentioned in'your rule, but I think.that those of us who are ' 19 already there should be on the short form because we have
'20 .got a record of long term success and certainly you can-
. 21; decide what is on the short form -- you know, five, six,
'22 ~seven,.eight questions.that can almost be the -- our i 123. response can be in the form of:1. long letter, saying how we
'24 fulfill your needs.and requirements and I think.if the L25: . existing boards do'that, .they should be approved for a
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p l l l 162 > 1 period of time -- let's say the period of time is four
?s
( ,) 2 years -- and then new boards that come along, they should be , 3 on the long form. I am not about to specify exactly what 4 should be in the long form but a lot of the details that 5 other people have been mentioning now should be on the long 5' . form. 7 I think that they should initially get a shorter 8 time of approval, just like new training programs do in the 9 RRC, so they should'get two years, and then after -- that ic , 1 10 sort of like their first provisional accreditation and after 1 11 they have been approved for two years.then the second -- in 12 two years you send them the short form and ask them for some 13 specific follow-up to their experience, and if it fits then 14 they go on the four year cycle, and that is how you keep l bs)
\/ 15 . bringing everybody in down the line. l 16 MR. CAMERON: And in terms of the questions on the !
17 short form, can you give us an example of what they might ) 18 be? 19 DR. ALDERSON: Well, I think that you want to ask 20 them what their curriculum content is with regard to
'21 radiation safety, how they intend to verify that that has 22 been -- that the people know -- in other words, are they 23 going to test and what is their approach? Maybe it will be 24 something unique.
25 You might want to ask them what the track record
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163 i 1 is of their candidates in the field. You might want to ask
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( j 2 them what sort of process they have for recertification or 3 renewal or validation. Those are the types of questions. I I 4 haven't thought of any more specifics at this point. l 5 MR. CAMERON: I think that is helpful. Ed? 6 DR. MAHER: I guess a point of clarification 7 myself. Do you feel that the training or the examination or 8 whatever' option you take for the clinical user is sufficient 9 for the RSO requirements or is it going to be different 10 training, examining for the RSO? 11 DR. ALDERSON: I would think an RSO would have to 12 have much different -- I agree with Barry and everyone else , l 13 _that said you have got to have at least two. I thought you
,_s 14 were going to say at least three. I mean I think if you get / \ ; 4 ' w/ 15 in -- I mean that's why I like the new option actually, i 16 after all the discussions of the morning. I mean I think 17 the more you open up this exam issue, the more complicated 18 it gets, the more the details come, the more the problems l 19 become for the NRC to administer it and I think therefore 20 that the approach of some other way to validate is what you 21 have to try to come up with.
22 DR. SIEGEL: The proposed rule though does allow 23 an authorized -- a physician authorized user to be an RSO 24 for that category of use for which the individual is an 25 authorized user, so a nuclear medicine phyuician authorized 1
,.~
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b i 164 1 L 1 for 100, 200, and 300 could not be an authorized, could not \ l'\ (,,/ 2 be an RSO for a teletherapy unit, and a teletherapy 3 radiation oncologist couldn't be the RSO for a nuclear 4 medicine' department. 5 DR. MAHER: So you would feel that those, the 6 training that is received in the board specialties would be 7 sutficient in itself for the RSO responsibilities in those 8 F.reas? 9 DR. SIEGEL: That is the way the proposed rule 10 structure -- 11 DR. MAHER: I mean the boards -- do you have 12 examination questions that cover the job task analysis of an 13 RSO, for instance? -- for instance, DOT transportation laws, 14 shipping, waste management, those types of things, and would
\- l 15 you require a major renovation of your exams in order to 16 cover all those areas if you wanted to use it as an RSO 17 credential?
18 MR. CAMERON: What is the assumption that you are 19 making for RSOs in terms of either the training program or 20 the exams? Is that right? I am asking the staff. 21 DR. MAHER: Yes. Essentially do the boards now 22 have in their training programs sufficient breadth and depth 23 in the RSO areas to say we would be acceptable RSO for the 24 NRC. Does the NRC feel that way and also do the boards -- as 25 our responsibilities are -- and what a clinical user at A ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
165 1 least I think would need to know. (G) sm, 2 MS. HANEY: Just a. couple of things. Barry had 3 said that the proposed rule allowed for an authorized user 4 to also function as an RSO. 5 We added in there that if you were an authorized 6 medical physicist or an authorized nuclear pharmacist, so 7 any of those three could automatically qualify as the RSO. 8 We were really faced with a dilemma as far as what
'9 to do with this automatic granting of RSO position. The 10 current rule does allow for the authorized user to become 11 the Radiation Safety Officer but we added on the two extra 12 people as far as gracing them in there.
13 Under the current rule it really was you had the w 14 'same amount of training because the 200 hours of didactic 15 ' training were the same, and we reduced it in the proposed 16 rule, so one could argue _by reducing it there we were 17 actually' reducing ic by some of the knowledge that you 18 mentioned about the DOT regulations and things like that, 19 but from a practical standpoint we recognized that in some
- 20. offices where you have a private physician's office
-21 especially in more the rural settings that they don't really
'22 need the full-fledged RSO with the 200 hours and the l'
23 knowledge that the authorized user had would be sufficient 24 to handle the normal everyday radiation safety sort of 25 issues even up to, say, a spill or contamination, and hence
- - D .
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PU i l-166 1 the practical requirement. r~N
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2
,- We did recognize that there was a little bit of 3 discrepancy there, but from the standpoint of the real world 4 practice that it may be a discrepancy we just have to live 5 .with under this rule.
6 We did not-go so far as to look into the boards to
- 7. see if the. boards had issues that would address things like 8 DOT. I mean this is jus the start- of looking at the_ boards l 9 issue more in-~ depth, but at least I would expect that the 10 boards coming in to us, whether it is for approval as RSO, 11 for people to be an RSO or to be a user under 35.200, for 12 . example, that the radiation safety questions that were on 1 13 that test would have to be as rigorous as what you would
-~ 14 expect for the RSO because of this clause here that they \2 15'. would be allowed to function-as the RSO. l 16 Again, that kind of goes into the 100-200 users, 17 the sort of training that they would have to have for DOT is 18 fairly minimal, but if you are up into transporting ;
1 19 brachytherapy sources or bringing sealed sources in under 20 your 35.600 uses then you get into a whole other set of DOT 21 requirements that you would be subject to. 22 This could be brought out in the different level 23 of exams if we went that approach. 24 DR. ALDERSON: This doesn't say.that -- just 25 because you would do this doesn't say that you can be -- you ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
f 167 l 1 are just qualified to be the RSO. It isn't as if -- there
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(_,T/ 2 wouldn't be-other things you would have to do locally. I 3 mean I think that the NRC has to rely on local jurisdictions 4 to provide some common sense as to who does what. I mean
- 5 this is just sort of a basic qualifier. )
6 MS. HANEY: Well, it is a basic qualifier but you 1 7 could apply for a license as a private facility, a private j 8 doctor's office, saying I have the credentials to become a 9 35.200 authorized user, and I want to be the RSO, and we j 10 would say fine, so there would be no other requirements that { 11 would come into play. I 12 DR. SIEGEL: But you couldn't be the RSO in a i 13 broad scope license, because you don't meet those !
~3 14 credentials.
)
\s) 15 MS. HANEY: You could only be an authorized -- you 1
1 16 could only be an RSO in a facility that as far as you.are 17 covered for. 18 DR. SIEGEL: Yes, I see. 19 MR. CAMERON: Okay. Let's go to Franz and then 20 over to Chuck. 21 DR. WACKERS: Again, I would like to support that 22 idea that there would be different tiered exam, different 23 levels. 24 Back to what you-should look for. In our exam I l t 25 think we have an extensive bulletin that everybody who l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 . (202) 842-0034 l l l
168 1 applies gets and it describes what the exam is and it also (G,) 2 refers to radiation safety and at the same time we have a 3 course on the physics and radiation safety which really 4 itemizes, as Alan sort of mentioned, what the issues are so i
)
5 that is the information that we can supply and provide and 6 we have also different portions of the exam are separately 7 I
' graded so we actually get the feedback, that the people who j 8 pass and fail, they get you pass or you fail on the 9 radiation safety, so I think that is all important 10 information to look at. We can provide all that.
11 MR. CAMERON: You bring up a point that I wanted 12 to ask the group about. It seems to me that just from the I 13 standpoint is the physics exam graded separately specific 14 curriculum content? Wouldn't it be hard for the NRC to
. \~
15 just, as you called it, rubber stamp an existing board as 16 approved, as opposed to the short form, long form approach 17 that we have been talking about? l 18 MS. HANEY: Well, I think with some creative 19 writing you could probably justify the rubber stamp approach 20 from the standpoint that we have been allowing individuals 21 that have been approved by these board for years and years 22 and years and years and years and there has not been a 23 problem, so in the absence of a problem, why are you l l i 24 changing, NRC? So from that standpoint, I think we could l 25 make a policy call that we were just going to grandfather, [ ()\ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 j (202) 842-0034 i
169 1 and the question is is that the right approach? Should we d x_) 2 that? What I am hearing is no, not really. 3 I think that that is what we have heard, and I 4 guess I would just check with the group on that. t 5 MS. HANEY: Which is goud -- I mean which is one 6 of the things why, again why we are having this meeting is 7 throughout the whole rulemaking a lot of the things that we 9 have heard is why are you making a change? You don't have 9 evidence that anything is broken. 10 In this case we are making a very different change 11 in a philosophical approach to how we are going to give 12 someone authorized user status and there is not the history 13 to show in some of these cases that there has been a problem 14 with whether it is Board A, B or C, so why shouldn't we just O~- 15 bless it, and that would be a place that we-reduce NRC 16 resources on putting this approach into effect, and also 17 reduce the burden on the licensees but then is that tha 18 right thing, which is what I am asking. 19 DR. ALDERSON: What I was saying earlier, I mean j l 20 maybe you were thinking of the ABR among some ot the others, 21 but if you want to grandfather us, we are happy to be 22 grandfathered. No problem. ; i- 23 [ Laughter.] 24 DR. ALDERSON: It is not an issue, but we have a l 25 good board. We have a good training program. We have good l
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! i 170 1 criteria. If you want us to fill out particularly a short A(_,I 2 form, we are delighted to fill out a short form. We will 3 fill it_out every four years. I will have to fill one out. 4 It's okay, you know? So that is all I was saying. It is not 5 a problem. 6 MR. CAMERON: Yes. I think that is a good 17- clarification. It is not like the existing boards would ; 8- resist being grandfathered but they are amenable to 9 something else. Well,.let's hear what Chuck has to bay and 10 also I guess if anybody else has comments on the short form, 11 long form concept, that might be useful to hear them. 12 Chuck? 13 MR. ROSE: Well, I think we have come full circle.
' 14 I mean we started out by talking about should they be, shall I
{' 'T, i 15 we say, rubber stamped? And as you can see from the 16 conversation it appears that many people at least feel that 17 it shouldn't be, but they also feel that it shouldn't be a 18 burden. 19 The discussion we have had about DOT requirements 20 and the RSO requirements, et cetera, that leads us right 21 back to what we really are doing, and that is looking at 22 what knowledge we want people to know. I mean we are 23 -approving a board but we are approving a board simply 24 because they stand for a certain amount of knowledge and 25 give an exam. [/ (_, ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 ; Washington, D.C. 20036 > (202) 842-0034
m l 171 ) 1 l 1 I would like to have us -- at least me, myself -- 2 I have a hard time with the idea that there is something I 3 magical about approving the board. We will approve boards. 4 Don't get me wrong. But why? Why?. Because they stand for l 5 a certain amount of knowledge and then they test on that 6 knowledge, right? -- and so when we look at, as the example 7 you gave of 80 hours of didactic and the 40 hours of l 8 practical experience for the 35.200, right? -- I think the 9 NRC should establish what they expect to be done in that 80 10 hours. 11 They should establish what should be done in that 12 40 hours. Don't rely on each individual group to come up 13 with their ovr. idea of how to spend the 80 hours and how to 14 spend the 40 hours. Tell me how many hours of nuclear and ( 15 atomic physics do you want, how many hours of radiation-l 16 safety, how many hours of radiation biology? Right? 17- You can have goals and objectives. They have 18 already been written. I mean states have them, the NRC has 19 them from years ago -- goals and object _ves for all of those 20 criteria, right? -- and tell people that that is the heart i 21 or the intent of the curriculum and then when the board says 22 that you are met that curriculum, then you can take their 23 test, and get away from the idea that there is something -- 24 I mean the board becomes the focal point, that lies at the 25 focal point because people had to learn something in order ANN RILEY & ASSOCIATES, LTD. Court Reporters ! 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l l 172 , 1 to take the boards and then they passed the boards to prove
]"~h - (_) 2 hopefully.that they have learned it, so I think we have come 1 l
3- ! that full circle, but I do think the NRC should establish l 1 4 what goes into the 80 hours and what goes into the 40 hours. 5 It may be different for 35.100 certainly than it 6 would for training a Radiation Safety Officer. Certainly it 7 would be different for a radiopharmacist, right, even though 8 it's not reading scans but I would expect the RSO would have 9 a different distribution. Of course they have a different 10 ' number of hours. The radiopharmacy would be different, 11 right? Somebody who was being trained in neurology to do 12' brain scanning -- that would be different. 13 Also, just one other comment, and this one really
-~ 14 doesn't muddy the water, but we keep talking about all of
\' 15 these criteria for those of us here at the table who are l 16 medical people, and keep in mind that there are other people {
17 coming into this field -- for example, veterinarians and 18 dentists and others in this field. I know they.are the 19 non-traditional ones and they don't represent a large number 20 of people but even the ones who are not in the field of 21 human medicine are required to meet the same criteria to get 22 a license. 23 I mean if a veterinarian wants to do radiation i 24 therapy on pussycats, right, he still or she still has to l i 25 meet the criteria for radiation therapy that the NRC has for l n _, ANN RILEY & ASSOCIATES, LTD.
- Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I 173 ( 1 human beings in most cases, not that they treat human beings l f (3_,/ 2 but they have to have the same number of training, of cases, 3 et cetera, so by having an established radiation safety 4 criteria or curriculum then it can be applied across groups. d t 5 It is fair to.everyone, but there may have to be different 6 levels, just like there are different hours. j 7 MS. HANEY: Charlie, let me ask you a question, 8 While you were talking I pulled up the rule language for -- 9 'MR. ROSE: You weren't listening. 10 I MS. HANEY: Yes, I was. 11 MR. ROSE: Oh, okay. 12 MS. HANEY: You were talking about veterinarians. 13 MR. ROSE: Okay.
,- S 14 MR. CAMERON: Pussycats.
15 (Laughter.] 16 MS. HANEY: 'And pussycats and irradiating those 17 poor things. 18 Now we did specify in the rule a breakdown and I i 19 guess this was from the proposed rule and the 35.300 users. 20 Is this the level of detail that you think is sufficient or 21 from what you said we would need to break down even further? 22 MR. ROSE: Well, I mean it's a start. It is a 23 start. I would like to see it broken down even further but 24 I would be much happier with this than just 80 hours. I 25 mean this is a start but I would like to see how many hours O
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l l 1 i 174 ! 1 of physics. i rx l k ,) 2 You have topics here, right?- i 3 HMS . HANEY: Right. 3 4- MR. ROSE: But what is that curriculum 5 distr'ibution that you see? And again, this is not cutting 6 new territory. I mean I gave you a list of eight or 10 l 7 states that have this requirement now, and go back and look 8 at the old NRC requirements. They had this requirement. 9 They even had an outline-of curriculum back in the olden 10 days, 11 MS. HANEY: Right, but some of the issue too is we 12 are trying not to make this an overly prescriptive rule and 13 we are trying to give some flexibility and some performance i 14 < based aspect to this rule, so we are treading a very fine 7-s l 15 line here. 16 MR. ROSE: I understand and I can't believe I am
.17 asking the NRC to be more prescriptive --
18 (Laughter.] 19 MR. ROSE: -- but I apologize to myself in 20 advance -- 21 MS. HANEY: I think the meeting is finished -- l 1 22 shall we just go home. 23 MR. CAMERON: Alan, do you have any comments on u 24 this particular issue before we go to Ed, since you said l 25 something about it earlier? i i, ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 : Washington, D.C. 20036 l (202) 842-0034 j
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l 175 1 DR. MAURER: I think from the established board's { 2 point of view, we have taken that, interpreted it and broken 3 it down to more detail, so to leave it as is from our point 4 of view would be fine. 5- On the other hand, I can't believe I am saying it, 6 I think to new boards and for further training it is helpful 7 to be more prescriptive in terms of exactly what you are 8 looking for in terms of radiation protection, particularly 9 for the public and patients. 10 MR. CAMERON: We'll go to Ed now, but can we 11 also -- if there is anyone that can give us a perspective 12 from a new board, an up-and-coming board, whatever phrase we 13 want to use, that would be helpful here too. Ed? 14 DR. MAHER: I happen to agree with Chuck in what A/ 15 was said down here, that I think there are different 16 requirements for a user versus an RSO, a different set of i 17 skills that are necessary, and so I think there needs to be 18 a little more prescription as to what those skills are -- 19 you know, job task analysis for RSO I believe is different I 20 than a clinical user. l l 21 I think relying on end of the pipeline measures -- ' 22 well, we don't have any accidents -- is a very dangerous ' 23 position for the NRC to be in and one that I would find very l 24 difficult to defend to the public, that we haven't had any 25 problema therefore let's not mess with the system. Just
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V) ANN RILEY & ASGOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
(, 176 1 stick 80 hours up there and be happy with it -- I think that l k_[ 2 is a very dangerous position. 3 I understand NRC doesn't want to over-rule, but on j 4 the other hand, I would say then why are we here? We l 5 haven't had any accidents. Why do we have to change Part ! 6 35? Obviously someone must. feel there is a need to change j 7 Part 35. Now what is that reason? ' 8 MR. ROSE: Perhaps we didn't have any accidents 9 because we had better driver's training in those days. i 10 [ Laughter.) 11 MR. CAMERON: Well, we put that big codfish on the ! 12 table -- we'll let it lie there as sort of a rhetorical fish ! 13 but your point is well made. I gg. 14 DR. MAHER: It's dangerous. I mean it's very
15 dangerous.
16 MS. HANEY: That is a very good point. 17 DR. MAHER: And maybe that is the reason why we 18 are doing this and I applaud that. I think that is the 19 right approach to take and of course we have to ! 20 counter-balance that with getting way too much regulation 21 than is really necessary for the risk involved. 22 MR. CAMERON: Okay, thank you. Mark? 23 MR. RAYMOND: My comment doesn't pertain to what 24 is on the overhead now. It goes back to the criteria for 25 boards. t' .. (, ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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l 177 p_ 1 MR. CAMERON: Let's go back then. ! s- 2 MR. RAYMOND: I think that Appendix A did a nice 3 job of outlining both criteria for the examining 4 organizations as well as criteria for the examinations 5 themselves but I would add a few things to what I see in 6 Appendix A based on comments that I have heard just in the 7 last half hour or so as well as just my own personal 8 experience. 9 Some of those items would be, as someone said 10 earlier, use of qualified experts to help develop the exam, 11 have qualified experts involved in the examining process. 12 The existence of a test blueprint or table of 13 specifications for the exam, which specifies the' content of 14 the exam. Sort of related to that, the NRC may or may not 15 want to specify the number of questions that pertain to.the 16 different Lections. They may or may not want to get that 17 prescriptive, but a number of questions. It will come down 18 to that sooner or later, whether or not those questions are 19 graded separately, and there should also exist a mechanism 20 for determining the passing score on the exam as a whole as 21 well as on those separate sections, if that section is going 22 to be graded separately. 23 There are various ways to determine pass / fail 24 marks or pass / fail rates and some are better than others and 25 I think that there are psychometrically acceptable ways and l l Asm ANN RILEY & ASS 7CIATES, ITD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
r' ' 178 r"N 1 those that aren't, but either way I think that the NRC (,) 2 should be looking at the way that boards do set their cut 3 scores and also how they maintain those performance 4 standards over time. 5 As someone pointed out earlier, their test 6 questions are statistically validated. There are ways to do ; 7 statistical analyses on test questions to help determine if ! 8 they are reliably and validly assessing what you want them i 9 to assess and I think that that would be one good criteria
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10 by which an examination process could be evaluated. I 11 I think a good rigorous description of the item 12 development process -- are people writing test questions and 13 sending them in and do they show up on the exam or do they
/~N 14 undergo a rigorous evaluation process by an examination
-I 15 committee? I think that would be another important 16 criterion to look at.
17 There are other -- there is a document that I i 18 carry around in my briefcase called the Standards for 19 Educational and Psychological Testing, published by the ! 20 American Psychological Association, National Council on 21 Measurement in Education, and the American Educational 22 Research Association. 23 I think that some good ideas might be gotten from 24 a quick review of that book in terms of the features of the 25 testing programs. I (\ () ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202). 842-0034
__. ~- - . ._. . . . . . . . . . . .- . V 179 1 MR. CAMERON: Okay, thank you. That would be very A k_,) 2 helpful as all additions to Appendix A that deals with the 3 approval of the examining organization -- in other words, do 4 they have a process for all these? And I'm sorry, I didn't 5 catch the one before the rigorous -- between how they , 1 6 maintain performance over time and the rigorous description 7 of the evaluation of the questions. 8 MR. RAYMOND: Statistical validation of test 9 questions -- 10 MR. CAMERON: Okay. 11 MR. RAYMOND: Item analysis. 12 MR. ROSE: Okay. We sort of jumped into Item 1, 13 proposed rule, assuming that there'is an exam, and if you
,,_s 14 are going approve examining organizations, here's some -- 15 additional things to think about. All right. Thanks, Mark.
16 Phil? 17 DR. ALDERSON: I think that these past few minutes 18 of comments are very good comments from people who are 19 experienced in the sophistication that is required for an 20 appropriate testing operation. 21 This is probably the strongest argument that my 22 colleagues could make here for the fact that you should not 23 be in exam business at all. 24 This is a very tough business and the NRC doesn't 25 belong in this business. I think that not only should the O) q, ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 180 l; 1
/'No 1 exam not.be overly prescriptive, and clearly it shouldn't, I '
(s,) 2 think that the way the rule is written now is the i i 1 3- appropriate level of detail, but I think that to go anything ; 4 beyond that is just getting way in over your head and I mean 5 I can't talk in terms of -- I can't answer your question ! 6 abrat how many FTEs this would require, because it causes me 7 to have to develop a new acronym, the FTC. That is the 8 " Full Time Career" -- and that is going to take if you 1 l 9 develop this. You are going to have some full time careers l 10 doing nothing in NRC but this, and that's all they'll do and 11 it will get more and more complicated as time goes on, so I 12 would.just strongly urge you to move toward what is being 13 recommended now and in Part 2 rather than in Part 1.
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14 MR. CAMERON: Okay. I think -- yes, I think that 7-]q t
\- 15 the force of that point comes through when you hear people 16 who know about testing talk about all that goes into that, 1
17 and that has never been something that's necessarily been a I 18 career path at the NRC. 19 DR. ALDERSON: And there are some wonderful l l 20 examples in the Government of very important high risk 1 21 programs that are handled by Government agencies through J 22 delegation to other types of societies and special groups 23 that don't include testing that are highly successful, and 24 the most obvious one is the Mammographic Quality Standards l 25 Act and all the approach to mammography. l (~) (m,/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 o (202) 842-0034
i ; l- ; ! I l 181
,_s. 1 The FDA handles that. They delegate it out l
-- 2 through a number of other societies. It is a great success.
3 Everyone recognizes that it has improved breast health and 4 reduced the risk of breast cancer in this country. No one 5 said that all the people that are going to interpret the 6 mammograms have to pass a test every, you know -- a special ! 7 test in order to -- they have got their boards. 8 They went through a training. They have got a 9 certification. They have got ways to be qualified. They 10 have to show their CME and that is a great and successful l 11 program and it is a very high risk area. It's a lot higher 12 risk area than the clinical use of diagnostic radionuclides, i 13 and that has been very, very successful. rg 14 MR. CAMERON: So I am just going to put this back ! (< > 15 on our chart of pros and cons here. l Many other analogous 16 areas that do not use testing. Miriam? 17 MS. MILLER: I just wanted to say when you did 18 your resources, looking at it, what you did not look at -- 19 the cost of an examination, and I think the pharmacy group 20 and our nuclear medicine technology board, which is just ! 21 nuclear medicine as compared to ART, which does all the 22 other modalities, very, very, expensive to run an 23 examination for a few people. 24 We have, because of the closing of programs and 25 the decrease in job areas, our testing, we went down from n b ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 i
182 . 1 1400 a year taking our exam to about 900 a year, and that \ 0
\s l 2 has cost us, because we don't raise the cost of the exam. I 3 think we pay out about $120,000 before we start counting the
~4 number of individuals, and that is something just doing a ;
5 few people is going to be very, very expensive. 6 MR. CAMERON: Okay, thank you, Miriam. That 7 obviously is an important resource issue. Speaking about 8 I that, I think we are starting to validate the Staff's i
-9 assumption that implementing the proposed rule in terms of 10 both recognition of boards with a testing requirement and 11 approval of examination organizations, okay, obviously a 12 testing requirement is going to be more resource-intensive.
13 than this route, but I wanted to specifically check that q 14 with you. u 15 Obviously we wouldn't get into all of the types of 16 things that Mark brought up, okay, if there's no test, but 17 these specific hours devoted to specific subjects obviously
\
18 if you are going to look at the training program, you are 19 going to have to get into that, I would assume, but would 20 anybody have any comments one way or the other about the l 21 comparative resource requirements between the proposed rule 21 with the exam requirement in it and the Staff working draft 23 with no requirement for an exam? 24~ DR. ALDERSON: It's much, much lower for the -- 25 MR. CAMERON: Does everybody pretty much t r"% l h ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 183 1 instinctively or other empirically feel that it is going to (' As ,]/ 2 be much lower? l-3 MR, ROSE: Can you recap th, difference between ; 4 them real quickly again for me -- let's say between 1.B and 5 2.B -- well 1.A and 2.A Barry explained the difference was ' 6 what? Barry? 7 MR. CAMERON: There's been a number of questions
- 8 about, confusion about whether there really is any 9' difference between 1 and 2, and I know there is a difference 10 and I am going to let Barry explain it.
11 DR. SIEGEL: Okay. In both cases, A or B, "1" 12 focuses on the examination and "2" focuses on the training ! 13 program. The key thing to validate in "1" is that there's a l
-s 14 reliable exam in addition to requiring that people have met
\-) 15 some training before they can come to take the exam. The l l 16 key is the exam. ' 17 In "2" the key is that the training program 18 content and the conduct of the training program is performed 19 in such a way that it is satisfactory, and that is the key 20 thing, and the concept can be made that it is easier for the 21 vast majority of authorized users, just physicians we are 22 talking about now, to be encompassed in an easily-validated 23 ' training environment, namely one that is ACGME-approved or 24 AOA-approved under 2.A than it is for the boards to go and 25 require significant changes in their examinations under 1.A .rb Q ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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l l 184 1 and so in terms of getting this mobilized very quickly for a l (O 2 large number of authorized users, 2.A works faster. (_/ 3 Radiology is already there. The American Board of 4 Nuclear Medicine is already there. It is a relatively short 5 step.for cardiology and endocrinology to get 2.A 6 incorporated into the Green Book and the special 7 requirements for training in cardiology or endocrinology, 8 whether it is incorporated directly in the training program 9 or whether, as you propose, it is sending people to the 10 two-week course as part of the training program. That is a 11 shorter step than a big revision in your exam. l l 12 The "B" elements under "1" or "2" are more l
)
13 difficult because it means the NRC has to have a set of l l 14 criteria in advance that it will use to approve these i ( 15 independent examinations or these independent training ' 15 programs but given the program content that is already 1 l i 17 specified by various documents available from the boards 18 about'what needs to be in training under 2.A, the NRC I 19- think will have a much easier time looking at some l 20 independent training program and say, yes, we are satisfied 21 that the content of that program is in line with what the 22 qualified. experts say people should be trained in, and I am 23 using that term now to define the boards represent the I 24 qualified experts. 25 MR. CAMERON: Ed , did you have a comment? ! (O_,/ ANN RILEY & ASSOCIATES, LTD. Court Reporters. 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
l L 185
, l' DR. MAHER: Yes. I was going to say if you look ' 2 at the focus as just being radiation training, and if you '
3 strip out from the board examinations that you all 4 administer just the RSO part of it, would that still be l 5 true? , 6 Would your training programs have to be 7 significantly modified to cover the RSO responsibilities ' 8 versus giving a single exam that covers enough RSO that the > 9 NRC could look at one exam and say that exam covers all the . 10 areas of RSO radiation safety. Barring the fact that there 11 is a radiation safety side associated with the clinical 12 user, and that is probably a little easier area to test on, 13 and you probably know how to do that better than anyone for t 14 your specialty. O. 15 MR. CAMERON: Comments from -- Phil, do you have a 16 response? 17 DR. ALDERSON: I have a response to one part of 18 that. 19 It was the part when you said you strip out all 20 these other things and we have said a couple of times today , 21 around the table and Mr. Rose has said a couple of times i 22 about how a lot of things are stripped out. We are only ! 23 talking about radiation safety here. 24 I would like to make the point, a very strong
- 25. point, that was in the letter that the American Board wrote, t
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186 1 which I wrote, and we feel very strongly about it, that the (_sl 2 training, the safety is carried out in the context of 3 clinical practice. I mean that is where we use these things 4 and you cannot take radiation safety out of the clinical 5 . arena. l 6 I am not suggesting for a moment in any way that 7 the NRC is involved with the competence of the physician to 8 interpret the examination -- it's not in any way 1 1 9 whatsoever -- but in fact a lot of what I believe is 10 important in radiation safety has to do with components that { 11 relate to the clinical environment you are in, and the idea 12 of ALARA, which is also mentioned in our letter. I mean 13 part of that is choosing to use the right dose at the right f, 14 time for the right reason, and if you giving a lot of (' 15 radiation where there is no medical necessity, that is 16 direct and substantial overdosing of the public and that is 17 inappropriate, and that needs to be considered. 18 We can't just lift safety up out of this. I mean l 19 people have to know what to do when they drop a dose on the 20 floor, if they drop the dose on the floor when they are 21 carrying it from the radiopharmacy to the bedside or to the 22 table to make the injection, and it just can't be distracted 23 from that environment. I just wanted to make that statement 24 at least once, if I didn't make it any other time. 25 DR. MAHER: Well, I make a distinction between the ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l l l
187
,-s 1 radiation safety required of a clinical user, and that is %s) 2 between you and your patient and your staff, but an RSO has 3 another level of responsibility, and that could be the 4 general public, and I would doubt that the boards are !
5 testing in those areas as well as transportation, waste 6 management, other things that typically the clinical user 7 does not get involved with but when they become the RSO as 8 well maybe there is another level of training that is 9 required to make sure the NRC has the satisfaction that 10 things aren't going to go wrong, and that is the difference, 11 because I do realize that it is part and parcel -- the user 12 safety is absolutely part and parcel of the way you do your 13 work.
,-s 14 MR. CAMERON: There is, I think, two questions on ,
15 the floor here for the NRC and others, and one is the issue 16 in terms of the radiation safety officer. Are we either 17 under a testing approach or under the training program 18 approach, are we considering everything that we need to 19 consider in terms of training and experience for radiation 20 safety officers. 21 The second question is I think a little bit of a 22 broader question that Phil brought up is either under the 23 exam approach or under the training program focus approach, 24 how much are.we looking at the need to put the radiation 25 safety training in the clinical context? j i ; i l l (~) V ANN RILEY & ASSOCIATES, LTD.
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188 1 MS. HANEY: Let me address those a little bit. (m (,)- 2 I think from the standpoint of Ed's question about l 3 the training for the RSO, I would think under this approach, 4 since authorized user status would automatically grant you 5 the ability to be the radiation safety officer, when NRC i 6 started doing approval, whether it is of an exam or whether i I 7 it is of the training program, I think we would need some ' 8 assurance that the training program was actually covering 9 everything that the Radiation Safety Officer would need to 10 know for these certain components and that gets a little bit ! 11 of what Alan and Chuck said about we need to get down maybe 12 in a little bit next tier level of specificity about what 13 would be required from a syllabus or would be required in 14 the exam. i i
\~/) 15. I think in addressing Phil's concern, I would say 16 again the version of the rule as it existed on Friday and 17 what we are discussing today is that we are recognizing that I the training needs to be in the clinical setting and that is i
18 ' 19 really one of the main reasons why we increase the number of 4 20 training hours from the 120 hours for the imaging and ; I 21 localization up to recognizing that it needs to go up to l 1 22 that four-month program or something equivalent to that, so 23 again I don't want to say that that is what is going in the 24 final rule, because who knows what is going to happen, but I i 25 think you can be assured that the working group heard you ( ANN RILEY & ASSOCIATES, LTD. l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
F-l 189 i .. 1 and heard that it should be in that setting and at least we i fM ( ,) 2 are moving toward that rather than away from that. 3 Can I put one more question on the table? 4 MR. CAMERON: Absolutely. 5 MS. HANEY: And you can kind of fit it in. To go 6 back to the discussion we were having a few minutes ago on 7 Option 1 with the proposed rule, Phil indicated that kind of 8 for some of the reasons that we have been talking about, 9 especially the ones that Mark brought out, that NRC should 10 not be in or would not want to be in a position where we are 11 approving the examining organizations, but would those same 12 reasons flow through to why NRC should not give the exam, { 13 because we have heard from certain commenters that NRC _ 14 should go into the exam business and give the exam and, you sl 15 know, whether~it is 1, 2 or 3 or a 2, 3 or 4 exam sort of i 16' thing it doesn't matter, but I would tend to think that for 17 the same reasons that I don't want to approve an exam, I 18 don't want to be giving an exam either, and just -- is l 19 there -- am I making the log ical progression with this 20 discussion cnr are there some other items that you might want 21- to consider relative to NRC giving the exam? 22 I am asking mostly because we do have comments 23 .that say do that. In the statements of consideration I am i 24 going to have to go back and say why NRC is not in the exam 25 business. L ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
P 1 i i 190 t 1 MR. CAMERON: Okay. Now that is a good question ;
) 2 and maybe we should approach that, get into.the whole 3 examination question and approach that after the break, 4 okay?
5 I guess that before we leave this area of 6 recognizing the boards, I don't want to put anybody on the 7 spot but I just want to make sure Rich, Peter, Jack, 8 Wally -- any comments that you would like to make relative 9 to the discussion that we just had before we break? Jack? i 10 DR. BASKIN: Just one more thing, which you could ! l 11 add to that list of reasons not to exam -- what about I 12 recertification? This always follows. Are we going to then l i 13 recertify and what is that going to involve? It escalates l 1
._ 14 it.
N . 15 MR. CAMERON: Yes, that is a good point and one 16 that Phil also had a concern with is that it is not just the i 1 17 initial exam but I assume that if you give an initial exam 18 then you have to deal with the recertification issue. 19 DR. MAHER: Which could be just continuing 20 education credits. 21 DR. SIEGEL: Well, you don't know. Once an AU 22 now, always an AU, unless you stop for a very long period of 23 time. 1 I 24 MR. CAMERON: Miriam, what do you.think about the 25 recertification? i l O k ,) ANN RILEY & ASSOCIATES, LTD. Court' Reporters 1025 Connecticut Avenue, NM, Suite 1014 Washington, D.C. 20036 (202) 842-0034
191 1 MS. MILLER: Well, we have gone through this issue
'Ch
(_ / 2 of recertification and technologists threw up their hands 3 and screamed, but we recognize as a board, and we are trying t 4 to work it out, that actually like those in the year 2000 on 5 that take it should take it every seven years. 6 I am not in favor that continuing education keeps , 7 up your competency, because there's many cruises you can 8 take 100 hours and it doesn't mean you any more competent l 9 than what you have done, so I definitely am in favor of 10 recertification but we have had a tough time selling it to i 11 our constituents. ' l 12 MR. CAMERON: All right, go ahead. ' 13 DR. MAHER: I want to say we have, American Board f- 14 of Physics, has a recertification program where we approve 15 courses because we know there are some courses out there 16 that are generally done on a golf course or on a cruise, but 17 we do approve and we give CEs -- C credits -- for that 18 course, and we find that if we don't require that, then in 19 these times of cutting back, employers don't send people to 20 get retrained, refresher trained, and this is a good wedge 21 to keep people current, and I think that is very important, 22 to be current. 23 MR. CAMERON: All right. Anybody on either 24 recertification or -- Peter, go ahead. 25 DR. MOORTON: Well, we have got voluntary l l f~h h ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 i
192 1 J
./i recertification testing in' place. We have had that in for I \s,) 2 about six years now, and as the ABR has done as of 2000 or I
i 3 2001.all the candidates will have a time limited certificate 4 of 10 years and they will have to be recertified. l 5 The recertification test covers the same 10 areas 1 6 of radiology including nuclear medicine that the 7 certification test does, so the limiting factor would be can 8 a doctor practice in a hospital when he is not certified? j 9 There's a lot of pressure to be certified to practice in i 10 groups as well as on the hospital staff, so whether the I 11 nuclear license was ongoing or not, if he didn't have a 12 place to practice it would be a moot' point. I 13 MR. CAMERON: Okay. Comments on that from 14 anybody? n)
\- 15 (No response.]
16 MR. CAMERON: All right. Well, let's take a break 17 and be back at quarter to 4:00 and we'll go into our last l l 18 segment for today, 19 [ Recess.] l l 20 MR. CAMERON: We have covered a number of issues 1 21 'on the agenda. I guess first I would like to introduce Ken I 22 Burman or have him introduce himself. Ken? 23 DR. BURMAN: Thank you for the invitation. I'm j 24 sorry I could only be here for the last part today. The 25 Endocrine Society asked me to come and represent them for I 4 V ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 L (202) 842-0034 l i
193 1 today and I am Head of Endocrine at the Washington Hospital (Q,/ 2 Center here in Washington. 3 MR. CAMERON: Okay, great. We have discussed a 4 number of issues so far and I have put a number of remaining 5 issues up here, some broad, some narrow. I sort of wanted 6 to check with all of you whether these -- are there any 7 remaining issue that you-have that we want to address and 8 the sequence that we address these issues in. 9 The first one is just basically an information 10 question. How much attention does each board give now to 11 what we call radiation safety? It's also referred to as 12 physics, also referred to as the handling of radioactive 13 material. I think I have.seen all of those phrases in the 14 rule.
.IN-/)N 15 To finish up on the exam issue, this whole issue
{ 16 of can there be a common exam or exams, who develops that. 17 We have heard the consortium idea. We have heard from Ed on 18 the American Society of Health Physics' willingness to take 19' this on. A related question -- what is the NRC role in 20 either developing or approving the exams? I think that Mark 21' sort of started us down a path by giving us, I thought, some 22 excellent criteria that we could add to Appendix A in terms 23 of if we stay in the business of approving examining 24 organization -- what we should look for in terms of the 25 capability,-the process of that organization, but also ('~'l 1001 RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
194 1 perhaps convinced everybody that the NRC should not be I (q_)- 2 involved in it -- revisit that issue just so that we have 1 3 whatever we need or whatever anybody wants to offer on the ! 4 record on that issue. j l 5 There's been some requests for a straw poll on j 6 whether we approve Approach 1 or 2 or if you want to vote on 7 either of the Articles of Impeachment -- l I 8 [ Laughter.] i 9 MR. CAMERON: -- instead, feel free to do that. 30 Then the training -- perhaps some more substantive l 11 questions. What should NRC look for in approving training 12 programs? What attributes should we look for and request 13 from people who want to get a training program approved, and 1 s 14 these elements would either apply in A, looking at the i k/ 15 boards, or in B -- and a subset of that question, in 16 approving training programs, how much reliance should be 17 placed in ADA, ACGME stamp of approval, is that what it is? { i 18 What do people think -- you know, I would think i 19 maybe we could, if we could in the remaining half hour or so 20 perhaps get through the straw poll on this, what is the 21 feeling of the group in terms of the issues that remain and i 22 the sequence of. addressing them, and anybody -- any issues ' 23 anybody else wants to address, we will do that. l l 24 Phil and then Peter. 25 DR. ALDERSON: It seems that if the straw -- I
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l l 195 1 think you ought to take the straw poll first. We have been i" k ,)/ s 2 talking about these issues for hours. I mean if the straw , 3 poll is clear in one direction, then maybe the answers to a i 4 number one, two, three and four are less compelling or you 5- need them less. 6 MR. CAMERON: I think that is path we would all l l 7 like to go down and we can take the straw poll, and I 8 realize that it may be academic, for example, if the strsw 9 poll revealed that everybody -- that most people are in f i 10 favor of ditching the exam, but for purposes of -- we have j 11 to keep in mind that the Commission still needs to look at 12 these issues, so anything pro or con on these they are going 13 to be interested in. 7g 4 14 So it-may be so that we can maintain some level, t
\ >' 15 some appearance of interest in the examination issue, we'll 16 postpone the straw poll. Peter?
17 DR. MOORTON: Well, the way the AOBR arrived at ; 18 its criteria for examination was through the setup of the 19 American -- the College of Radiology which operated in a 20 similar fashion as AOCR. { 21 We knew what the requirements were for a nuclear 22 . license and we worked backwards. Originally it was three 23 months and then it went up to six months. We changed the 24 program at the College of Radiology level and we responded 25 at the board level to test at that accelerated level. _) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l l 196
.T 1 If the NRC changes the requirements, what will l
# 1
- 2' happen is the Colleges and the board will respond l 3 accordingly. If you lower the requirements we would alter 4 our requirements at the college level. If you increase the i 5 requirements we wou3d increase them, so-basically what we 6 are doing now is a direct reflection of what you have wanted 7- us to do in the past, su to say that you are rubber stamping 8 it, we are just doing what you have basically mandated in 9 the past right now. l 10 ' MR . CAMERON
- And I mean I think that is a good 11 reason why -- I think " rubber. stamp" is the wrong phrase. I 12 mean it is a negative phrase, first of all, and secondly, 13 that is a good point about where the circle begins on all of yg 14 this.
15 Other -- Rich? 16 MR. FEJKA: Yes. Throughout the afternoon and 17 morning I have been listening and trying to put in 18 perspective where as the Pharmaceutical Specialties 19 representing nuclear pharmacists how we all fit into this 20 situation here, and some of it seems to be ass-backwards to 1 l l 21 me until now, or at least an opportunity to comment on. ) 22 When I look at the requirements for us as 23 radiopharmacists to take the board exam, it's 4000 hours. 24 To take the board exam, which if we pass grants us the 25 oppc::tunity to be an authorized nuclear pharmacist -- well, O ANN RILEY & ASSOCIATES, LTD. Court Reporters ! 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l : f 197 i A 1 before you get to 4000 hours, you'll hit the 700 mark, and ~ k ,) m 2 you are probably going to work under some preceptor and it 3 gives you a chance to, if NRC chooses not to do the exam, 4 you submit the paperwork. Your preceptor will tell you that 5 you have met the requirements to be an authorized-nuclear 6 pharmacist. 7 I think to go higher, to become board certified in
- 8 nuclear pharmacy gives the individual the opportunity to 9 distinguish themself further -- maybe a more sincere 10 commitment to their career, something that they really want 11 to become, but as I sit and wonder about the examination 12 aspect, you know, it's possiblo -- in our exam it's 200 13 questions, 15 percent of which deals with radiation 3 14 safety issues, but if we take this test and don't -- you N-15 know, is NRC going to require a break-out? Well, not really 16 at first, because you are t.ying if you become 17- board-certified you meet the requirements to be an l 18 arthorized nuclear pharmacist. j 19 We have to look to the future that the majority of 20 the radiopharmacists who are now entering into the field of l
21 practice are probably newer graduates and not people who 22' have been around for awhile, the grandfathering part that 23 was in the regs, for previous to 1994, so all these people 24 are probably going to look to do it within the first 700 l 25 hours. If they meet that criteria and specifically if there s ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut-Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l l 198 1 is no NRC requirement for an exam, I think that they would 2 look at it as probably an easy thing to do. 3 I c'on't want to underestimate the fact I think j 4 that with 700 hours working on the job a radiopharmacist 5 will be exposed to'a lot of the radiation safety issues and 6 concerns that we specifically would deal with, and probably 7 even ume of the other things, depending on your practice 8 environment, but the separation, if you do get into the 9 examination aspect, you know, what is going to be required 10 in terms of is there going to be a requirement to separate 11 radiation safety issues from the rest of the exam? 12 If you do that, then that seems that the NRC is 13 now providing a wedge into an individual board's ability to em 14 examine its people. That would raise questions to me as to I D J 15 individuals saying who is ultimately responsible for this l 16 test and the granting of certification? j 17 So to me I am not sure that we have addressed i 18 issues of is a pnssing score required, what type of ; 19 questions will have to be dealt with. We have sort of 20 talked with regard to RSOs, uptake dilution and excretion, { 21 but there is a separate section for being the authorized ! 22 nuclear pharmacist which puts us in a different ballpark 23 that a lot of the things that deal with sealed sources, 24 brachytherapy sources -- maybe we would have to order some 25 of those to send on out to a local physician who is going to t
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l l 199 1 use them so we would have to know a lot of those issues, but i \ (m s (_s) 2 overall what would NRC's involvement if they choose to.go ! 3 down the path of requiring the teet. i 1 4 MR. CAMERON: Okay. I think that is a good point l l 5 that leads into the common exam issue and I will ask in a 6 minute, Cathy and Barry, about when are considering the 7 exam, can you talk a little bit about would there have to be l 1 8 a separate component on radiation safety? ! 9 Rich talked about 15 percent of their exam ) 1 10 questions, and I take it that they are not a separate 11 portion of the exam -- 12 MR. FEJKA: No, they are intermixed. 13 MR. CAMERON: Okay -- on radiation safety, it sort 14 of gets us to this question of how much -- you know, Rich tO 15 said 15 percent -- what do the other boards have on 16 radiation safety? Is it separated out? 17 We know that -- I don't know how the clinical -- 18 the context issue enters into this in terms of an exam, but i i 19 why don't we start with that,- and Frans, do you have any ; 20 comment on the issues or sequence or additional issues? 21 DR. WACKERS: Well, just one that's a little bit 22 different. I would like to make a statement. I really feel 23 very strongly after all the discussion we had that I think 24 that the NRC should not be in the business of either giving I 25 exams or looking at board exams.
/~N
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i 200 1 Really again I would like to repeat that I think
-{"T.
r l sl 2 it's mainly a technical issue that makes whether an exam is 1 3 good or not -- so that is the first point. 4 I think it should be, in other words then, go back 5 to existing boards and I think that the boards will test 6 what they deem to be appropriate, so like in nuclear j 7 cardiology I think we need to be tested about radiation 1 8 safety, in radiotherapy there's different things than l 9 radiopharmacy exams, so I think every professional society { 10 or professional discipline that has an exam will determine 11 what is appropriate. 12- The other thing I want to say and the last point 13 is what should the NRC look for in a tr..ining program, l
,- 14 actually what I did at some point when we were talking about
( 15 it is well, what should we really know? -- I went to 3 16 actually my Radiation Safety Officer and said, well, do you
-17 think now that a cardiologist really should know about 18 radiation safety so he doesn't blow up the whole hospital, 19 and I think that it is back from just giving a directive but 20 now he can go back to the practice, so what is really 21 important? So we got a list actually that is very close to 22 what the issues was for the 200 hours.
23 I don't think we should get into exams. I think 24 to look at training programs, look at what is really 25 important for the practice of that particular subspecialty. (D ,_ (_./ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
201 ; 1 MR. CAMERON: Okay. When we get to this specific I
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(_,T) 2 issue, I.am going to come back to you and ask you about l 3 that. The bright line means Friday morning -- or Thursday 4 morning, and we are going to go into this and I have been I 5 remiss in not asking people out in the audience to comment 6 on some of the issues that we are discussing, so I think 7 that I will go and ask Rob, since he is standing there, do l 8 you have a point on this? 9 MR. FORREST: Rob Forrest, University of 10 Pennsylvania. 11 I would like to ask the panel since we have 12 already decided that the authorized user status doesn't l l 13 really infer a clinical competency, what would be the effect f3 - 14 of the NRC, at least for the 100, 200, even perhaps 300 _(- 15 section, the NRC doing away with the authorized user status? 16 We have already determined that it is a low risk 17 kind of thing and we have already determined that hospitals 18 and places have other means of determining who should be 19 qualified to do certain procedures, so how about the NRC do 20 away with their authorized user status for those kinds of 21 modalities and what happens? l 22 MR. CAMERON: Okay, thanks. That's an intriguing l 23 question for perhaps Friday morning. 24 (Laughter.) 25 MR. CAMERON: I would say that perhaps -- are you !
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l 202 i 1 going to be here tomorrow? e (~) ; l l (_/ 2 MR. FORREST: Yes. ; 3 MR.' CAMERON: All right. Why don't we put that on I 4' the agenda for sort of a fun question for tomorrow, okay? I 5 am_ going to put that in here, and Ed, do you have -- you i 6 wanted to get right into this? I l 7 DR. MAHER: Well, I wanted to follow up with this 8 'I comment. If you look at the RSO's responsibility as being a i 9 mentor, a cheerleader for good radiation safety practices, 10 perhaps all the NRC needs to concern itself with is the 11 certification of RSOs, if they are going to do away with the 12 clinical user, because the RSO's responsibility is to make 13 sure the staff is adequately trained, stilled in radiation 14 safety procedures.
\#' 15 DR. SIEGEL: Except the authorized user is 16 responsible to make sure that the staff is properly trained 17 in the conduct of the clinical procedures --
18 DR. MAHER: Absolutely -- 19 DR. SIEGEL: -- that also have an impact on the 20 radiation safety, so it is a very interesting question that 21 has come up many times in the working group. j. 22 MR. CAMERON: Okay, and we will save that for 1 23 tomorrow. ) 24 . Wally, what did you have to say? 25 DR. AHLUWALIA: The first point is when you say (~3 i (m,/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
l 203 1 1 radiation safety aspect, this does include methodology and 2 instrumentation. Then this opens another question about the 3 training programs. 4 Most of the training programs not only concentrate 5 on radiation safety, they concentrate about 80 percent other 6 applications, and this opens the third question -- on the 7 board exams, examinations are only pertaining 10-15 percent 8 to radi~ tion safety. This makes the board questions not 9 suitable according to the NRC criteria for radiation safety. 10 MR. CAMERON: Let's do this. Let's jump into 11 this -- what I put status of board attention to radiation 12 safety, what percentage of the exam, and are the questions 13 on radiation safety separate, and I am assuming that we all 14 have pretty much the same understanding of the phrase 15 " radiation safety" and if'that is not correct, let's examine 16 that, and then have Cathy tell us about what the NRC expects 17 in terms of -- would expect in terms of how much attention 18 should be given to radiation safety and whether it would 19 need to be a separate exam. 20 I guess I.am just going to go around the~ table and 21 if the question about how much attention is given 22 separateness is relevant to you and your organization just 23 share that with us. Ed? 24 DR. MAHLER: I guess I would break radiation 25 safety into -- there's two practices. One is on the (\ - ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 (202) 842-0034
204 I clinical level, it protects your patient and you, maybe your ! (,) ("' 2 immediate staff. Then there's a whole other group out there 3 than we_need to protect and that is called the public, and I 4 their exposure pathways are the nuke medicine lab and other 5 areas in the Part 35 area which could expose the general 6 public. That could be shipping, transportation, emergency 7 recovery, whatever the case is. 8 And my question is -- or my comment would be is l 9 that, are these boards certifying'in those areas, or are l 10 they testing in those areas? It would seem to me -- now, I ! 11 haven't looked at all the exams -- that the radiation safety
-12 issue is confined to the administrat[on, the safety 13 involvement and the administration of the - 14 radiopharmaceuticai and not necessarily pathways to the \~- 15 public and protection of the public. Am I wrong on that 16 issue?
17 And if that is a correct assumption on my part, 18 then do we have adequate training. programs? Now, I could go 19 away from the examination part if I knew there was a 20 training program which covered the general public safety and 21 that there was a prescribed number of hours, and these were 22 the topics we need to follow. I can -- I can follow that. 23 I don't need to examine every one, although I think it is l 24 curious that all the certifying boards have an exam. I 25 guess if the exams weren't important, why does everyone
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i 1 205 1 examine people, if it is not a measure of competency? And I (,,) 2 think it is a measure a competency, not the only, though. l 3 MR. CAMERON: Okay. Well, then let's add this 4 public aspect of radiation safety as we go around the room. 5 Again, if it is -- if you have something appropriate to 6- offer on this, please do. Miriam. t 7- MS. MILLER: Well, looking at the NMTCB, the , h 8 Nuclear Medicine Technology Certification Board exam, 15 l i 9 percent is actually radiation safety practices. But if we ' 10 were asked to pull out questions on radiation safety, I 11 would also pull out our radiopharmacy, because many of that 12 is tne safe handling of radiopharmacy, and that is 25 13 percent, so that gives us almost 40 percent in handling of 7s i 14 radioactive materials for the nuclear medicine, which, as I e k/ 15 said before, many times are appointed an RSO in a small 16 . facility, i 17 DR. WACKERS: Of how many questions? 18 MS. MILLER: Actually, it is a computerized exam, 19 so it depends on the difficulty level they get them. It is 20 usually about 90 to 100. But it is -- the number, when you ! 21 have a computer-adaptive test, which we do, it depends on 22 the difficulty level of each question, okay, how many they 23 .get. In other words, they can answer 25 very difficult 24 questions and meet the criteria, but if they get some easy 25 questions, it might take up to a 100 to get their passing ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 206 1 level.
'x- / 2 MR. CAMERON: That raises -- I was going to ask '
3 you, is that -- are there separate portions? And I realize i 4 that no one has ever -- I haven't heard the rationale why is 5 a separate radiation safety component, as opposed, I 6 suppose, to having the questions mixed #n, why is that 7 important? 8 MS. MILLER: Well, ours are mixed in, but there is { 9 -- when the computer pulls questions from the pool, -- 10 MR. CAMERON: Yeah. 11 MS. MILLER: -- you have to tell them a certain ' 12 number to pull from each of these sections, and our main l 13 sections are clinical practice, radiopharmacy, ! i 14 instrumentation and radiation safety. So they pull, of the l 15 total exam they are going to give, 15 percent from radiation i 16 safety and 25 percent from radiopharmacy. 17 MR. CAMERON: I see. I 18 MS. MILLER: And then when we make up the exam, 19 when questions are put in it, we have to categorize them, 20 and, like Mark said, and look at their testing ability and 21 their psychometrics in that area. ' 22 MR. CAMERON: Okay. All right. Cathy, a quick 23 note on the separateness, the value of the separateness. 24 MS. HANEY: Well,'the value of the separateness 25 would be is that we could envision a situation where someone l ! .rh !k l m ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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207 L l
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I would pass an exam given by a certifying organization, pass
\s / ' 2 all the clinical-questions, and fail all the radiation 3 safety questions, and we would never know it, and this
- 4. persen would now be granted authorized user status because 5 of his knowledge of radiation safety; So the working 6 group's feeling was that if we were going to go that route, I i
7 that the radiation safety component of the exam would have 8 to be graded separately. 9 MR. CAMERON: Okay. All right. Well, let's 10 proceed to Mark. 11 MR. RAYMOND: The ART examination in nuclear 12 medicine technology has 22 questions of 200, that's 11 13 percent, specifically on radiation protection. However, 14 like the NMTCB exam, we also have questions on radiation 15 protection sprinkled out through other sections of the exam 16 on radiopharmaceutical preparation and instrumentation, j 17 quality control. So I would say that, you know, all in all, 18 that we are probably up in the neighborhood of two times 22 19 questions dealing with radiation protection issues, if not 20 more. 21 You know, kind of as a testimony to the importance 22 that we give radiation safety, we have a list of conventions 23 for our examination. Mostly they are terminology 24 conventions. However, for the nuclear medicine examination, 25 our conventions consist of something called Appendix B be
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l l l 208 1 contracted with a health physicist to draw up a document for
,h \_) 2 us based on the NRC regulations, which sort of abstracts the 3 NRC -- current NRC regulations,' puts them in a readily 4 interpretable format for all of our program directors and 5 our candidates to see, and that particular appendix'is 11 6 pages long, and it goes-into great detail about the 7 different aspects of radiation safety that we test on, and l B how we test on it, and so on and so forth. So we give a lot 9 of attention to it.
10 MR. CAMERON: Okay. And then do you think that -- 11 hearing what Cathy said about the rationale for the 12 separateness of the radiation safety issues, and I don't 13 know if everybody agrees with that rationale, but your
-- 14 particular exam would meet that objective? i
-- 15 MR. RAYMOND: Yes, I suppose it would, although we 16 have never put it to a rigorous test. But it would be, you {
17 know, pretty difficult, I would imagine, for someone to know l 18 very little about radiation protection and still be able to l 19 pass that examination. l 20 MR. CAMERON: All right. And I think, Miriam, you l 21 are affirming that, too, in terms -- 22 MS. MILLER: Yes, and our test is the same way. 23 MR. CAMERON: All right. Okay. Let's go to 24 Wally, and we are going to go around and then we will go 25 back.
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l l 209 1 DR. AHLUWALIA: I will speak for the American l 2 Board of Science and Nuclear Medicine. It consists of two
- 3 parts.
4 MR. CAMERON: Just swing the mike over towards 5 you, Wally. Thank you. 6 DR. AHLUWALIA: I speak for the American Board of
)
I 7 Science and Nuclear Medicine. It consists of two parts. I 8- Part 1 is a three-and-a-half hour exam, 180 questions, which 9 covers radiation safety,. instrumentation, pharmaceuticals, 10 physiology, and -- uptake clearance, three-and-a-half hours. 11 They must pass Part 1 and Part 2. Part 2 is 100 questions, 12 two-and-a-half hours, 100 percent safety. It 99 percent 13 fulfills the criteria of safety to be the RSO and other 14 criteria, wherever you need to fill it. 15 MR. CAMERON: And do any of those questions deal 16 with the public protection aspect? 17 DR. AHLUWALIA: They deal with the public l 18 protection, regulatory aspects also, I forgot to mention.
'19 MR. CAMERON: Okay. All right.
.20 DR. AHLUWALIA: And I think -- that's'why I ;
21 brought the question up, because NRC is looking towards the 22 safety. If I have to take a board exam, which is Part A and 23 Part B, there are only 15 percent questions or 20 percent 24 questions on safety, that may or may not fulfill our l 25 criteria, what you are bringing in front of us. [ ANN RILEY & ASSOCIATES, LTD. , l Court Reporters I 1025 Connecticut Avenue, NW, Suite 1014 1 ! Washington, D.C. 20036 (202) 842-0034
210 1 MR. CAMERON: All right. r~x I s_,) 2 DR. AHLUWALIA: So if the board has to come out
-3 and say.some particular person passed 20 percent, but he 4 didn't pass 20' percent, but he passed -- I think it will be 5 very. complicated.
6 MR' CAMERON: Okay. Thank you, Wally. Jack. 7 DR. BASKIN: The ABIM boards in endocrinology have 8 no questions regarding radiation safety, therefore, we are 9 looking at setting up a Board of Nuclear Endocrinology just 10 in order to' fulfill this examination requirement if it were 11 to go through, its approval was ruled. 12 MR. CAMERON: And let me ask -- let me jump the 13 tracks a little bit. In order for -- if we don't have the s 14 examination and we go the training route, would the 15 endocrinologists have to do something similar along the 16 training? 17 DR. BASKIN: We do 80 hours of radiation safety. 18 MR. CAMERON: But you just don't have an exam in 19 it? 20 DR. BASKIN: But we do not have an exam. 21 MR. CAMERON: Okay. That's interesting. 22 MS. HANEY: You would still continue to come under 23 the 2.B approach, when you were requesting licensure? 24 DR. BASKIN: Right. Yes. 25 MR. CAMERON: So that if they were under the ('~) V ANN RILEY & ASSOCIATES, LTD. Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 ! Washington, D.C. 20036 (202) 842-0034
p; l 1 211 ; 1 Approach 1, they would have to do something new. (_h
\s /
2 MS. HANEY: They would have to do an exam either 3a way. 4 MR. CAMERON: But if they are under Approach 2, 5 they would be at least in the ball park. 6 MS. HANEY: Right. 7 MR. CAMERON: All right. 8 MS. HANEY: Now, have you done any preliminary 9 estimates on the impact financially of this rule? 10 DR. BASKIN: It is -- the expense that was 11 mentioned by Miriam, $120,000, seemed low compared to what 12 we have gotten, our estimates on this, to set up a bank of 13 questions that would be psychometrically -- we have looked 7g 14 at it and it is going to be terribly expensive. U - 15 MS. HANEY: Okay. ! i 16 MR. CAMERON: And I think that is a useful 17 question for the -- or information for the staff either to 18 off in the meeting or outside. I know that Frans gave me an 19 example of, you know, what the cost was of setting up their 20 testing program. Miriam has said some words about that. So 21 that there is data there. 22 MS. MILLER: $120,000 was our starting point, then 23 we started getting into the cost. But that is just the 24 basic starting point. 25 MR. CAMERON: All right. Alan. l b,, ANN RILEY & ASSOCIATES, LTD. i Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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212 1 DR. MAURER: Alan Maurer. The more I listen, the 2 more I am convinced that it is impossible to have one exam l 3 that is going to cover the different levels of training and 4 experience that you are looking for. It seems to me that 5 the best approach would be to leave to each of the 6 professional societies a boards to establish what they 7 believe, at whatever level, for example, in health physics, 8 the level for an RSO or for a nuclear medicine physician, 9 the level of training and experience that the professional 10 societies deem appropriate, incorporate that into their 11 training and examination process and have the NRC look at ! 12 those and approve that board at that level of training. So 13 I would very strongly urge that the boards be allowed to 14 establish the training criteria, under some guidelines from
\- 15 the NRC, as you proposed in the appendix, and let the 16 societies, as a professional society, continue to do that.
17 We have had some recent experience, as I said, we 18 -just changed over in our testing agency and 120 as a minimal ! 19 start. So it is a very expensive thing, even with the 20 transition with an established testing agency, to just 21 switch over. So I would-reiterate, I think you have 22 multiple levels of training and experience criteria that you 23 are going to need to handle. That can't be done with one l 24 examination, and I would leave it to the professional ! 25 societies who have established criteria, and let them set i ! l \ O ANN RILEY & ASSOCIATES, LTD. Court Reporters ; 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
f i 213 1 what.they think their candidates need to know, but have the 2 NRC look at it under some guidelines. 3 MR. CAMERON: Okay. So, certainly, not have the 4 NRC develop the test, but there would be some approval 5 aspect.
]
l 6 DR. MAURER: Yeah, I think you would have to look j 7 at it. And I think critical to it is the level of training 8 and experience for different levels of authorized user 9 status, whether it is the radiation safety officer, or just 10 a clinical user.
'11 MR. CAMERON: All right. Thank you. Ken.
12 MS. HANEY: I would just going to say, Alan, you 13 had said that you made some changes in your exam recently. 14 Can you give us an idea of what the percentage is that is 15 radiation safety based now? 16 DR. MAURER: It is -- well, again, it is lumped 17 because there is physics, radiation -- I would say it is 18 about 20 percent of 200-plus questions. I 19 MS. HANEY: Okay. Thanks. 20 MR. CAMERON: All right. Ken. 21 DR. BURMAN: Yes. Thank you. We certainly agrr9 22 with the comments that were just made, and Dr. Baskin spoke 23 for the Endocrine Society as well in terms of the ABIM. 24 There are few, if any, questions that I am aware of directed 25 at specific issues related here. O) ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
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1 ! 214 l 1 MR. CAMERON: Okay. Thank you. (~\
\s / 2 DR. MAURER: Let me backup a second. The last !
3 comment I wanted to make, if you think the examination, the 4 development of an examination and certification of that is a j 1 5 difficult problem, I think looking at the components of a j 6 training program is going to be even more difficult. I just 7 wanted to put that on the table. I think you are going to 8 discuss that tomorrow. 9 The American Board of Nuclear Medicine, I think as 10 Phil said, the ABR, however, do very strongly feel that the 11 clinical component is an essential component of the training { 12 process and learning how to utilize radiation safety. And I 13 think whatever training program approvals are there, we need g-wy 14 to look at some, mechanism, whether it is ACGME or other, to d 15 look very closely at what the structure of the training 16 program is, how those sites are going to be visited, how the l 17 candidates are going to be questioned about the adequacy of < 18 training and that is going to be a very difficult problem. 19 MR. CAMERON: And are you -- I just want to get -- 20 I am going to put this up here for tomorrow. When you talk 21 about resource issues, you are talking about resource issues 22 in terms of the potential NRC review and approval. 23 DR. MAURER: Yes. 24 MR. CAMERON: All right. Because that -- 25 DR. MAURER: Particularly under 2.B, I think that
. ym
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L ! L , 215 ! 1 is going to be very problematic. k-s/ 2 MR. CAMERON: Okay. Now that brings us back to 3 this issue that I thought we had some sort of feeling on 4 before about that, the resource requirements associated with l 5 Approach 1 would be much greater than the resource issues f
- 6. associated with Approach 2. Now, you are questioning that.
7 Okay. I want the~ record to show that,-and let's 8- specifically go'into that tomorrow. Let's try to finish up ; 9 with the exam business today. Peter. 10 DR. MOORTON: The physics portion of the AOBR 11 certification exam is 100 questions, and I am just guessing : 12 that it is 10 to 15 percent on radiation safety. Ours is a 13 lumped question format. You could easily pull those 4 f-~g 14 questions out if it was -- as far as you wanted to get a 15 score on the radiation safety questions. So that wouldn't 16 be a problem, and if that was the way you wanted to go, we 17 could actually.have a separate number of questions, or we 18 could increase the number or decrease the number, I mean it 19 is all flexible. . 20 The question that Ed brought up regarding 21 radiation safety of the public, I think we deal with that 22 every day. I mean we are checking possible future -- or 23 possible pregnancy patients with pregnancy tests before we 24 do'radionuclide-procedures. As far as the radiation safety 25 officer, we are in small hospital, one of my partners is the n ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202)1842-0034
216 7_ 1 radiation safety officer. ~ He also is in charge of checking
\s l- 2 the film badge exposures and all this. We give lectures to 3 the hospital staff about exposure to radiation. And so I .
i 4 think that is -- everybody that is an authorized user isn't i 5 necessarily going to be the radiation safety officer, so if ' 6 -one person is delegated, then there could be a' format or a 7 job _ description that he fulfills. And if you wanted to test i 8 on-that job description,-you could do that. But I think 9 everybody that is an authorized user isn't in that official 10 position of being the radiation safety officer also. 11 MR. CAMERON: Thank you. Rich, you sort of 12 started us off on this. 13 MR. FEJKA: Just for NRC's information and the es 14 rest of the members here, the Board of Pharmaceutical
\ 15 -Specialties and specifically the Nuclear Pharmacy Specialty 16 Council, we don't provide training and turn around and test 17 people. We are an organization that grants board 18 certification to those pharmacists who come to us having 19 completed, as I stated, 4000 hours. That could be divided
;20 up over a couple years, either in a graduate program beyond 21 your having graduated Pharmacy School and then 2000 hours on 22 the job training or else 4000 hours on the job training 23 altogether, so our exam has been put together by 24 individuals, radiopharmacists and psychometrically tested 25: and c.7 through that whole process and I can attest it is an ANN RILEY & ASSOCIATES, LTD.
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1 l l 217 l 1 expensive process. t% d 2 We pnrticularly, the Nuclear Pharmacy Group, is 3 the smallest of the boards that are recognized for specialty 4; practice, although we probably might look at the possibility 5 of assisting NRC if they choose to go down the pathway of 6 examining' individuals through the 2.B method, to possibly 1 7 work in conjunction to maybe take some of our questions from 8 the bank and then offer it.to those individuals who just 9 want to meet the requirement for authorized nuclear pharmacy 10 -with the 700 hours. 11 But I question again whether or not if an 12 individual comes to you to become an authorized nuclear 13 pharmacist by taking the board examination, whether or not l i' 14 that break-out, although we can do it because they can tell 15 which questions deal with radiation safety whether or not 16 again we open ourselves up to being a means or a mechanism l 17 by which the NRC could possibly control or slightly control 18 the examination process of granting board certification to 19 radiopharmacists who test overall and not within individual i 20 particular competencies. i 21 MR. CAMERON: So you would have some fear that-22 somehow the integrity of your overall examining process 23- might be weakened in some way if you had to have a separate 24- section that was labelled Radiation Safety, and I don't know 25 if that is something that the working group has -- that's l f^s ! . ANN RILEY & ASSOCIATES, LTD. l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
[- 1 218 ! 1 been broached with the working group or in the working group n k) 2 at all. 3' DR. SIEGEL: I don't think it's come up but one 4 actually could argue based on the arguments we have heard I 5 from Mark and Miriam that almost your entire exam qualifies 6' as radiation safety, because of the implications of problems 7 with drugs for patient radiation safety and so -- 8 MR. FEJKA: Yes, if you want to look at it in that 9 sense, look at our whole exam as being a radiation safety 10 issue but our working areas that we put together -- you l 11 know, how a radiopharmacist spends his day -- and divide it { 12 up and look at specific questions that are asked along that { 13 route, specifically there's only 15 percent, but yes, if you < 14 look at what if you mix up a kit wrong, what if you do the 15 QC wrong, what if you didn't know that you've got to do your 16 daily surveys with an exposure meter versus an ion l 17 chamber -- in that broad sense we are okay. In the narrow 18 -sense, what you say that you didn't pass the 15 percent that 19 was specifically radiation safety, I think that_that might 20 be a problem and then again I can't see a radiopharmacist 21 who is going to say, gee, I am going to sit to become board 22 certified and I have to take a separate NRC required H23 radiation safety test versus the overall Board of 24 Pharmaceutical Specialty Nuclear Pharmacy test. 25 MR. CAMERON: All right. Well, there's some more !
- (q)
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219 l . 1 food for thought for the examination aspects on that. 2 Frans? 3: DR. WACKERS: In our exam it is a four and a half 4 hour exam on 75 questions and the majority of questions 5 actually are with images. Initially we start out with 6 questions and we add more and more images and it takes more 7 time. Of those questions we have 10 percent -- so 17.5 I B guess -- so it's 10 percent of the questions deal with 9 physics and radiation safety. 10 They are mixed into the whole exam, and why we do 11 that I don't know -- whether that is to make people, if you 12 are bad at physics you don't have a whole run of bad 13 questions and bad answers so it is mixed in the exam, but 14 they are graded separately and actually all our candidates 15 whether they pass or fail get a report that shows for 16 every -- whether it is 10 sections I believe, how they did 17 every single section, so they look and see whether they are ; 18 weak in radiation safety or not, i 19 MR. CAMERON: Going back to the rationale that l
'20 Cathy offered for the separate portion of the exam, is it !
=21 likely that someone could flunk every question on radiation 22 safety on the exam and still pass the exam?
23 DR. WACKERS: We can easily go back and actually I 24 am planning to do that. I cannot tell you whether that at L 25 all happened, that people really were bad in one area. f3 (_) ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l Washington, D.C. 20036 (202) 842-0034
i 220 1 Usually you see that people are usually sort of when they p ( 2 are bad they are bad all across. 3 [ Laughter.] 4 DR. SIEGEL: Right, but it is possible -- 5 DR. WACKERS: It is possible -- 6 DR. SIEGEL: I mean if only 10 percent of the 7 questions, your passing score is surely not 90. It's some 8' number lower than that in terms of raw score. 9 MR. CAMERON: All right. Thank you, Frans. Phil? 10 DR. ALDERSON: The examination of the American 11 Board of Radiology is given in two parts. They are nine 12 months apart. There is a written examination which is the 13 sort of thing we were all talking about before, which really f_ 14 amounts to essentially a qualifying exam, and nine months ( 15 later they take a rigorous film-based exam that takes a half 16 a day and you are not interested in that. That is strictly 17 a clinical competence exam, that part. 18 The part that is analogous to the exam everyone 19 else here is talking about is the written exam of the ABR,
~
20 and the written exam has somewhere in the -- totally like 21 .250 to 300 items on it, but the medical instrumentation 22 physics part is a portion of that and it is graded 23 separately, but radiation safety specifically is not popped 24 up out of that section, so there are things about medical c25 physics and instrumentation and things in that section, and r~y () - ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I 221 r~T 1 those aren't separated from the radiation safety, radiation ; l (_) 2 biology, things of that type but the total physics exam is 3 graded separately and each candidate gets a separate score 4 that says you did or did not pass physics, you did or did 5- not pass diagnostics, and within that context it is about 10 6 percent. Again I would say it's probably directly parallel to what you have been talking about. 7 It may be a little ; I 8 more than that. 9 With regard to one of the questions asked earlier 10 about public safety, transportation, I don't know about this 11 year's exam but I know that those items, I know personally 12 of the fact that those items have been tested in the past 13 and I think they probably are tested periodically. It
-s 14 depends what questions are on what test what year, and the \' / 15 only teaching experience is my own and I do teach'it. I do !
16 teach it on a regular basis, so it's there. 17 If we were to have to change and further block out 18 this part of the exam, I think there would be a cost 19 associated. There would be an expense. 20 MR. CAMERON: Okay. Cathy, if that is 21 something -- it sounds like there is at least several of the 22 ' organizations who if they were forced to separate out, 23 there's the integrity of the exam question that Rich brought 24 ty) but there is also the fact that the. number of groups 2d .might incur some costs in doing this, and I don't know if
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l 222 1 that was included on our regulatory analysis.
/ T (s ,/ 2 MS. HANEY: We did include some dollar amounts for 3 having to make changes to current examining processes.
4 MR. CAMERON: Okay, thank you. Chuck? ! 5 MR. ROSE: Well, we are in a bit of a different ; 6 situation because we are not doing a board examination but 1 7 we are the ones who have been giving an examination, j 8 We have been training people in the bar.ics of l 9 radioisotope handling for over two decades. We started l 10 giving a written examination in the 1989-1990 academic year. 11 Prior to that we didn't give a written examination. We 12 actually gave a written examination but it was an open book 13 and I have a question whether you would really want to call s 14 it an examination. It was how quickly you could look things ( )
\' 15 up and how well you had taken notes.
16 So since the 1989-1990 academic year we have given 17 examinations to approximately 1300 physicians who had become 18 authorized users and we give the examination in four parts. 19 There is a minimum of 240 questions total in those 20 four parts -- in other words, 60 or more questions in each 21 part. We have six and a half hours to complete it during 22 the four segments of the exam. That's not six and a half 23 times four, right? 24 We have a pool of questions of way over 1000 25 questions that we have tried that have been narrowed down to 4 n 1 ( ,/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
223 1 1000 of questions.which seem to have validity, that have ; ( 2 been tested to see how well people do, and we draw from 3 those questions, so we have approximately four times the ! 4 number of questions as we actually use, and we do choose ' 5 dif.ferent questions at different times for the obvious 6 . reason that thele people do talk, even though they are not 7 allowed ;o take a copy of the exam out or anything like 8 that -- but did you remember there was a question on i 9 such-and-such? -- so we do change it, just like the American ~ i 10 Doards of Radiology does. l 11 The test that we give is 100 percent in the basics 12 of radioisotope handling and that is what the NRC p? posed 13 criteria is in, the basics of radioisotope handling. We l 7-s 14 somehow got on just radiation safety or pure radiation l
-- 15 safety and the criteria here includes instrumentation, it 16 includes physics, it includes radiation biology and it 1
17 includes radiopharmaceutical chemistry. That is what the 18 NRC has in their criteria for the basics of radioisotope 19 handling. i i 20 Now that does not mean that that is the practical 21 handling experience. I want to make sure that there is a l 22 difference there, so as we talk about radiation safety I 23 think some of you, some of your boards, if you look at it in 24 that way you probably have more questions than you thought 25 in the basics of radioisotope handling, because if you are
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224 1 talking about just pure radiation safety questions that are l O) ( 2 easily identified as being only radiation safety questions, 3 then yes, it may be 10 percent, 7 percent or whatever it is, 4 but if you include those instrumentation questions and those 5 other questions related to radiopharmaceutical chemistry 6 that are part of the basics or radioisotope handling that is 7 required by the NRC, then you may find that you have more 1 8 questions, all right? -- or you may be in better shape than 9 you think you are. 10 Our experience has been that on the exam that we 11 have been giving or the series of the four examinations that 1 12 we found that overall, even though it varies a great deal 13 between groups, overall we have had about a 92 percent 14 successful completion rate on our examination and I agree i
\-- 15 with the comment that was made here -- I think it was Frans 16 that made it to Mark -- people who tend to do poorly tend to 17 do poorly all the way across.
18 It's not a gray area usually -- when you plot an 19 array here, it's those that know and those that don't have a 20 clue. Not that all 8 percent didn't have a clue, but'it is 21 not easy to differentiate, so we are a little bit different 1 22 in that we are not a board but we have roughly a decade of 23 experience giving.a test in the basics of radioisotope 24 handling. 25 MR. CAMERON: Okay. I guess that raises a f-)
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l 225 I 1 ' terminology issue. Whatever terminology we would use in the i 2 rule, we would want to be pretty clear about what was l 3 included within tnat universe -- radiation safety, 4 radioisotope handling'--
- 5. MR. ROSE: And it's there.
6 MR. CAMERON: -- whatever, okay. 7 Let's go to the audience who we haven't heard from B except for one time today. Let's start with Rob. Rob, go 9 ahead. 10 MR. FORREST: Rob Forrest, University of 11 Pennsylvania. 12 I would like to offer the flip-side of the split 13 exam, and that is the fact that a person fails the clinical
- 14 uspect but passes the radiation safety aspect, and therefore L~/. s) 15 do they become an authorized user and if that is the case l
i 16 then I could probably become an authorized user that I doubt i 17 anyone would want me treating them. l l 18 MR. CAMERON: Okay. Thank you. 19 DR. SIEGEL: If you're not a physician you can't 20 be an authorized user -- it's defined in the rule -- and you 21 can't write a prescription. I 22 MR. CAMERON: Okay. Anybody e e out there in the 23 audience who wants to offer anything? 24 [No response.) 25 MR. CAMERON: Okay. I know we are a little bit i k ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue. NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l l 226 A-1 over time. I don't know how much more we have to say about (,,) 2 the issue of number of exams and who develops them. 3 I think Alan, when he spoke, talked about -- I 4 mean your recommendation was pretty much that there is a 5 need for tailored exams and leave that to the boards to 6 figure out how to do that. 7 I know the last time we got together we talked 8 about a common exam and as I mentioned befole Ed and Phil 9 had comments on that. 10 We haven't taken a straw poll yet but is this -- 11 how do people feel about the idea of a common exam or exams 12 as opposed to leaving it to each board? What are the 13- benefits of coming up with a so-called common exam? Is that
~.s 14 worth pursuing? Do people in the societies and the boards 's- 15 feel that that would be useful to them either from a 16 standpoint of their own certification process or from the 17 standpoint of satisfying the NRC, I suppose? Alan?
18 DR. MAURER: I was going to say I think there is 19 some value to the concept of a common exam, but that would 20 be at a very minimal level and again I think you would have 21 to establish some guidelines for a tiered level of l 22 certification. 23 As you get more and more in depth with 24 radiopharmacy or therapy or health physics in radiation 25 safety I think things change, so at a minimum level there ANN RILEY & ASSOCIATES, LTD. Court Reporters i 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
1 227 l t-1 could be a common exam, and that certainly could be ( ,T) 2
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established or that material could be distributed among the 3 boards that are going to examine, but beyond that I think 4 there's too much diversity in the levels of experience. 5 MR. CAMERON: Yes, but even to the extent that 6 there might be some commonality, would there be benefits to 7 the -- I mean you could always do it, but would there be a 8 benefit-to the boards from doing it, even to the limited 9 extent that it could be done? 10 DR. MAURER: It may be of benefit to some of the 11 newer boards who don't have criteria established for setting 12 those minimum requirements. I think some of the more 13 established boards probably have the minimum material in 14 there but they might have to look at it themselves again to ( 15 make sure. 16 MR. CAMERON: So there could be some sort of 17 assistance function to that? Ed? 18 DR. MAHER: I would say that there's -- from the 19 outsider's standpoint the boards are using radiation safety 20 or testing radiation safety as it pertains to their 21 specialty and they ought to have that purview. I mean they 22 know best, and there's other forces out there, lawsuits, 23 whatever the case is, malpractice, that they ought to do 24 that. 25 There is one area that is different, and that is i , ey j' \, . ANN RILEY & ASSOCIATES, LTD. l Court Reporters 1025 Connecticut Avenue, NW, Suite c'. Washington, D.C. 20036 (202) 842-0034
i 1 228 j 1 the RSO. That is the only one I think you ought to have-a ' 2 common exam in. I think the rest of the board ought to have , 3- .:their own examination and include radiation safety from the ;
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4' specialty standpoint, and the NRC shouldn't have that ' 5 purview. 6 MR. CAMERON: All right. 7 DR. MAHER: RSO is different. . 8 MR. CAMERON: And I would also invite comments 9 about the value of the RSO exam also -- let's go to Rich. 10 MR. FEJKA: I think with Alan's comment maybe at a 11 fundamentally basic level there could be a commonality for 12 an exam -- the part dealing with uptake, dilution, and 13 excretion, or imaging -- you have to have a dose calibrator,
-s 14 what type of tests do you do on it, how could you calculate ' ' \- 15 the exposure from a certain amount of technetium if you know 16 its specific gamma ray constant. >
17 Maybe some of those are the fundamental radiation 18 safety questions that could be asked, based on what Dr. 19 Siegel seemed to agree, and our exam may be overall what we 20 do as radiopharmacists in a broad sense deals with radiation 21 safety as a whole, same thing that Charlie brought up. 22 For RSO, although I under the rules can be an RSO 23- because I have passed the board certification exam. I work 24 down at NIH but sure as heck I am not going to volunteer for 25 the RSO job down there.
' 'Qf\
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l l 229 1 [ Laughter.] 2 MR. FEJKA: But I think that I am appropriate if I 3 were to operate a nuclear pharmacy for one of the 4 centralized pharmacies to be an RSO in that particular area, 1 5 so maybe in the sense that my particular board questions me I 6 in a broad sense then I think that I would -- RSOs are 7 appropriate to the. type of area that you work. You know, 8 small hospital where there is one tech, where a physician 9 has the license, maybe that tech could serve as an RSO : 10 because they are not going to be doing idenations where you 11 need to know what the effluents could be or how much stuff 12 .you could throw down the sewer -- stuff like that. 1 13 I guess, in a general comment, maybe at the basic i
,s 14 fundamental level there could be some questions. But that
)
s' 15 is where we would need to get direction from the NRC as to 16 what they consider -- what they want to be asked on this j 17 type of exam. 18 MR. CAMERON: Okay. And that is the million { 19 dollar question. I guess that -- I suppose that if there 20 was some value to a set of basic quertions to help ; 21 up-and-coming boards, although that is sort of a strange 22 phrase to use, I guess, I don't know if a group such as the l 23 Advisory Committee on the Medical Use of Radioisotopes could 24 .have a subcommittee to develop something like that. I mean ; 25~ I suppose that the Advisory Committee could, and perhaps ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 : (202) 842-0034
l 230 1 does do things that are not just reactive to what NRC puts
/~~
(_)T 2 on its plate, but can actually undertake. projects like that.
- 3. Frans.
4 DR. WACKERS: Well,.I would not be in favor of a 5 common exam for a number of reasons already mentioned, and 6 one other reason is that, as a cardiologist, the nuclear 7 cardiologists take already all of the board's exams, it is 8- one more. I think I would not be in favor of it. 9 MR. CAMERON: Okay. Thank you. And Phil. 10 DR. ALDERSON: The only thing that I can see that 11 would be in favor of a common exam would be the fact that 12 you would be protected against the disgruntled candidate who 13 failed the exam and then was unable to practice whatever 14 profession he or she was aimed at, and then made the claim 15 that, if it were not a common exam, could say, well, I, you 16 know, had to take, you know, a much harder exam in the 17 radiopharmacy test to qualify for this than that radiologist 18 did, because I know him and he doesn't know anything, and 19 yet I -- he passed and I failed. So I am -- you know, I 20 have been obstructed in my right to earn a living and I am 21 going to sue somebody, probably the NRC. 22 [ Laughter.] 23 DR. ALDERSON: And so if you had a common pool of 24 questions, you know, you could avoid -- because then 25 everybody would say, well, we have sort of the same pool of l (Q
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Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l l 231 _ 1 questions that are all -- but the problem with that then, tO ( _,) 2 the reverse side of that, is that we aren't all one 3 organization, and we give our exams at different times. And 4 if you don't believe that a black market won't get started. 5 And, you know, hey, I am having trouble, I know that the 6 NMTCB exam in July and my exam isn't until September, so I 7 am going to, you know, cultivate a few friends over on that 8 side. And, of course, they are going to come out and 9 remember the questions they were asked and they are going to 10 tell me, and then I am going to tell them. And this gets 11 really complicated. 12 And so the answer to the straw poll is don't do 13 it. You know, I mean it is just another one of the thousand f 14 reasons not to do it. 1
\~ 15 MR. CAMERON: Okay.
All right. Thank you. And 16 Chuck. l l 17 MR. ROSE: I think you could do it -- I agree 18 almost every comment at the table, but I think that you can 19 do it very simply if you -- to have a commonality, so there 20 is a base level that everybody ought to know. You could 21 either do it through this is a base level of questions, or i 22 this is a base level of knowledge, and tell the people that l 23 they have to test on this -- this lowest level perhaps of 1 1 24 Fafety information, a curriculum, and then you can leave it 25 up to them. It is going to be under your review anyway in ! rO ( ,) ANN RILEY & ASSOCIATES, LTD. ; Court Reporters . 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I L i ! 232 ) i i 1 A, and under B -- or number 1, and under number 2, you are (% J (m,) 2 going to be approving their training program, and part of } the training program can be -- did they teach this? All l 3 4 right. l 5 So either way, you can develop a commonality l 6 without having, let's say, a list of 50 questions that 7 everybody has to ask and everybody has to answer. You can 8 have, instead, perhaps 50 topics. And I don't mean huge ! 9 topics, but 50 topics or concepts that everybody has to 10 know. Then they can develop their own ways of asking those 11 questions, their own way of teaching it, but dog-gone it, 12 you have got to know it in order to be either an approved 13 examination or an approved training program, fg 14 And the NRC becomes the common denominator here f ) k/ 15 because you are going to looking at all of these, right. 16 And it doesn't have to be something which everyone has a { 17 piece of paper and it gets sold or blackmailed or whatever 18 it happens to me. Right. So I think it can be done very 19 simply. i 20 And, by the way, the bottom line is .I think it 21 should be done. I think there should be commonality at the 22 lowest possible level probably, right, that everybody ought 23 to know before they could be an authorized user, or, 24 basically, an authorized handler of radioactive material. j 25 MR. CAMERON: Okay. Thank you. I think maybe we l ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 i (202) 842-0034
1 233 1 should take'a straw poll and probably go home for the night. ' () 2 And if we need to come back to the one remaining examination 3- : question, NRC's role in all of this, we can start tomorrow 4 on that, and then go down to the questions that deal with 5 the staff working draft approach. And I think p.'ople -- we 6 have a lot of comments about the exam approach versus the -- 7 what we are calling the training approach. But I think the l 8 staff would be sort of interested in a straw poll which i 9 certainly doesn't mean that that is going to seal things off l 10 one way or the oar. And, certainly, you don't, you know, 11 have to sign up to be either yes or no, it can be not proven l l 12 or, you know. 13 MS. HANEY: Do I get a vote? __ 14 MR. CAMERON: You don't get a vote, you are here \/ 15 listening to this. 16 MS. HANEY: Oh. Well, I wanted to ask. 17 MR. CAMERON: You have the ultimate vote. 18 MS. HANEY: I wish. 19 MR. CAMERON: But, Ed , what do you feel? 20 DR. MAHLER: I can live under the second rule, if 21 there is a prescribed RSO training program that is -- by the 22 NRC. I don't necessarily have to see the exam. 23 MR, CAMERON: So the key is the training for RSO,
;24 in your opinion.
l 25 DR. MAHLER: Right. I think that is the key for R k) 1001 RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
234 1 me. And I guess I am going to abstain because I don't want
,-s , ,(_) 2 to vote on either one.
3 MR. CAMERON: Yeah, I guess, you know, you don't
\
4 need to vote, but just give ycur opinion, like Ed did on
)
5 that. Miriam. ! l 6 MS. MILLER: I don't chink the NRC thould be in 7 the business of-examining. I think there is too many of the l 8 certification board, and we know what we have been through. 9 If you want to approve training programs, that is another 10 area. 11 MR. CAMERON: So, okay, we will get to that 12 tomorrow then. Mark. l 13 MR. RAYMOND: I would like to learn more about the _ 14 resource requirements for 2.B before voting for Approach B. k~- 15 I would lean in that direction, but would be concerned that 16 the resource requirements, at this point in time, might have l 17 been underestimated. Actually, I don't think we have 18 articulated fully what they are, things out there. 19 MR. CAMERON: Okay. Good. And that ties in with l 20 Alan's comment, and I think we should spend some time 21 investigating what at least the categories -- what the 22 resource implications are. We can do that tomorrow. Wally. 23 DR. AHLUWALIA: Two is a good concept, 24- particularly 2.B is lacking a few aspects. When you say the ! 25 training program, what segment is radiation safety again? (O ,/ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
235 1 That should be highlighted. Number 2, I would be very happy s,) 2 to endorse it if you have subsegment of the training program ' 3 and the evaluation'on a routine basis. Any training program 4 is incomplete unless we have a routine evaluation, as Dr. 5 Alderson suggested. Thank you. ! 6 MR. CAMERON: All right. Jack. 7 DR. BASKIN: We would certainly favor the training . 8 program aspect of it, so we would vote for number 2. 9 MR. CAMERON: Okay. Thank you. And Alan. 10 DR. MAURER: I keep looking at this and I am still
'll not sure I understand the difference between l'and 2. I 12 think it means 1 is the NRC does an exam, 2 means it 13 doesn't, with all the trappings that come with it, in which ,g , 14 case,.I think I would favor 2, but we have got to.look at
('/ 15 those trappings. 16 MR. CAMERON: All right. 17 DR. BURMAN: We are not in favor of an exam, but 18 would support further discussion regarding NRC guidelines 19 for the specific board exams themselves to include 20 information. 21 MR. CAMERON: Okay. Thank you. Peter. 22 DR. MOORTON: I would be in favor of continuing 23 the way we are'with the board exams, and with possible 24 . changes in the exam content if it was required by the NRC. 25 MR. CAMERON: Okay. Rich. l ./- l k_ ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
me: 236 1 MR. FEJKA: I think to answer for BPS, Board of (m,/ .2 Pharmaceutical Specialty probably would go with the second , 3 part because that way the integrity of our exam is i 4 maintained. We don't have NRC in there telling us what to 5 do for approval of individuals who take the exam overall. I l 6 But it also gives us an opportunity, if you -- to offer 7 radiation safety -- I have'got to back up on that. No. Two 8 would probably be the way to go to maintain the integrity of 9 our certification. 10 MR. CAMERON: Okay. Thank you. And thanks for 11 raising that integriLy issue, too. Frans. 12 DR. WACKERS: I am in favor of 2. i 13 MR. CAMERON: Okay. Phil. w, 14 DR. ALDERSON: As I have said on several occasions
\'-,) 15 today, I would favor 2. <
! l 16 MR. CAMERON: Okay. 17 DR. ALDERSON: NRC should not examine. 18 MR. CAMERON: All right. And Chuck. 19 MR. ROSE: I don't like either of the straws. If 20 I hav. to choose between the two, I would choose 2, but I 21 thin the components of A -- of 2 and 1 can be combined, all 22 righc, because when you look at a training program, you have 23 to look at the evaluation of a training program. When you 24 look at an exam, you have to look at what you are examining 25 of. I mean what is it you are trying to accomplish. And I ( ANN RILEY & ASSOCIATES, LTD. Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
237 1 see that for both A and B of 1 and 2, all right. But if I i
/ .
(_)T 2 had to choose between these two, yeah, I would hate tc 3 choose 2, right. But I want change the straw around. 4 MR. CAMERON: Okay. 5 MR. ROSE: Is that clear? 6 MR. CAMERON: I think you are saying that, you 7 know, maybe the point you are making is that --- 1 8 MR. ROSE: Looking at a training program -- i 1 9 MR. CAMERON: You really have to look at the same i 10 thing. 11: MR. ROSE: Looking at a training program ! 12 requirements for a board without looking at evaluation of 1 13 it, all right, is not good education. All right. Just like 14 looking at an exam without looking at what you have to do to 15 get the exam is not go'od education. Looking at and 16 examining organization, right, is not good without looking ! 17 at -- and this is 1.B -- without looking at what an 1 18 examining organization does or requires for the education.
,19 I mean you can't separate education from evaluation.
i l l 20 DR. SIEGEL: That requirement was in 1.B and it is 21 in tre proposed rule. l t 22 MR. ROSE: Yeah, I understand. Right. ! 23 MR. CAMERON: Okay. And there may be some -- I 24 still some misunderstanding'about what is involved in all of ! 25 those things, too. (Y (_,/ ANN RILEY & ASSOCIATES, LTD. , Court Reporters l 1025-Connecticut Avenue, NW, Suite 1014 ) Washington, D.C. 20036 (202) 842-0034 i i t
l 238 1 MR. ROSE: Okay.
./
( ,\ / ' 2 MR. CAMERON: With that, I guess we are -- unless 3 Cathy or Barry has anything final to say, we can, you know, l 4- adjourn and come back tomorrow at 9:00 for three hours. 5 [Whereupon, at 5:00 p.m., the meeting was , 6 recessed, to reconvene at 9:00 a.m., Thursday, February 18, s 7 1999.] 8 i
'9 l 10 '
11
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12 13-14 { O, 15 16 17 18 19 20 21 22 23 24 l 25 l
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Court Reporters l 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
p REPORTER'S CERTIFICATE i This is to certify that the attached proceedings- *
-( ) before the United States Nuclear Regulatory Commission in the matter of: :
NAME OF PROCEEDING: PART 35 PUBLIC MEETING WITH REPRESENTATIVES OF THE MEDICAL BOARDS
' CASE NUMBER:
PLACE OF PROCEEDING: Rockville, MD were held as herein appears, and that this is the original transcript thereof for the file of the United-States Nuclear Regulatory Commission taken by me and thereafter reduced to typewriting by me or under the direction of the court reporting company, and that the transcript is a true and accurate record of the foregoing proceedings. , p e M\ J Hundley Official Reporter Ann Riley & Associates, Ltd.
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