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Marked-up Transcript of Advisory Committee on Medical Uses of Isotopes 850503 Meeting in Bethesda,Md.Pp 1-182
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Issue date:	05/03/1985
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1 ORIGINA'_ l UN11ED STATES NUCLEAR REGULATORY COMMISSION O

IN THE MATTER OF: DOCKET NO: ,

ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES l

O .

LOCATION: BETHESDA, MARYLAND PAGES: 1- 182 DATE: FRIDAY, MAY 3, 1985 ACE-FEDERAL REPORTERS, INC.

Official Pzparters 10 444 North Capitol Street 8

P g 62 % $ NkOkuI Washington, D.C. 20001 PDR (202)347-3700 NACONWIDE COVERAGE

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UNITED STATES OF AMERICA .

I 2

NUCLEAR REGULATORY COMMISSION 3

ADVISORY COMMITTEE ON 4 THE MEDICAL USES OF ISOTOPES S Holiday Inn 8120 Wisconsin Avenue Bethesda, Maryland Friday, May 3, 1985 -

7 I The meeting convened at 9:05 a.m., Richard E. Cunningham, 8 .

chairman, presiding.

9 10 EE MEMBERS:

)

RICHARD E. CUNNINGHAM, Chairman !

II VINCENT P. COLLINS, M.D. i FRANK HOWARD DeLAND, M.D.

l 12 SALLY J. DeNARDO, M.D.

JACK K. GOODRICH, M.D. i 13 MELVIN L. GRIEM, M.D.

NILO E. HERRERA, M.D. ;

y -B. LEONARD HOLMAN, M.D.

, GERALD M. POHOST, M.D. l l EDWARD W. WEBSTER, Ph.D. i 15 DAVID H. WOODBURY, M.D.

JOSEPH B. WORKMAN, M.D.

16 jCONSULTANTS: '

i 17 PETER R. ALMOND, Ph.D.

jg WILLIAM H. BRINER, Capt. USPHS (Ret.) ,

NRC STAFF MEMBERS:

19 PATRICIA VACCA 20 NORMAN L. McELROY GINNY THARPE 21 i

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) !

23 24 l re .i n.oon.n. w. ;

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CONTENTS i 2 I PRESENTATION BY: PAGEl 3 DR. LAWRENCE MUR FF 10 I

g 4 DR. JAMES CHRISTIE 14 y %.

l ROBERT C. SCHLANT 20 l

5 g DR. WILLIAM H. BLAHD 26 6

DR. GEORGE BELLER 7 34!

DR. BARRY A. SIEGEL 38i 8 I DR. K. LANCE GOULD 44 DR. KEITH M. LINDGREN 47 1

10 DR. DANIEL J. GOLDBERG 56 !

II DR. JAMES A. RONAN 61 U

12 DR.-L?.1

.mr FOX 70 i

13 DR. MICHAEL WELCH 83 g DR. ALLAN ROSS 89 IDR. ROBERT GARCIA 96 15 i

'DR. EDMOND E. GRIFFIN 104 16 lDR. PHILfIPC. JOHNSON 105 17 {,

18 I I

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2i 22 23 24 federci Reporters, Inc.

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8210~01 01 3 1 DAVbw 1 PROCEEDINGF 2- MR. CUNNINGHAM: I think we're ready to begin, 3 ladies and gentlemen.

4 Good morning, ladies and centlemen. My name is 5 Richard Cunningham. I am a member of the Nuclear Regulatory 6 Commission Staff. I will chair the meeting today.

7 This meeting of the Advisory Committee on the 8 . Medical Uses of Isotopes is being held in accordance with -

9 the rules and regulations of the General Services

/

10 Administration, Title 41, Part of the Code of Federal

^

11 Regulations,AMthe rules and reculations of the Nuclear 4

in Ti+le~ 10, 12 Regulatory Commission entitirf },gart 7.

13 The meeting was announced in the Federal Recister

() 14 of February 14, 1985.

15 It was called to order at 9:04.

16 Let me first start the meeting by introducing the 17 members of the committee and a few members of the Staff.

18 I have a hard time seeing down the table, so if 19 people will raise their hands, so people will know where 20 they are.

21 Dr. DeLand, Dr. DeNardo, Dr. Goodrich, Dr. Gricm,-

22 Dr. Herrera, Dr. Holman, Dr. Pohost, Dr. Webster, 23 Dr. Woodbury and Dr. Workman.

J

() 24 We did this in alphabetical order.

J 25 With me on my right is Mr. Norm McElroy, who is a l

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8210 01 02' 4 1 DAVbw 1 member.of the NRC Staff, and there are other members of the 2 NRC Staff in the audiencj here, I think. The ones you will W6d5 3 recognize are certainlyjpea-Miller, the Chief of the f( ) 4 Material /LicensinaDranch, and Pat Vacca, whom most of you 5 have worked with, in the back. I'd also introduce Ginny 6 Tharpe, who is at the recistration desk. Ginny, 7 incidentally, has airlines guides, schedules and that sort 8 of thina that can give you some assistance in changes if 9 changes in travel reservations are necessary.

10 One more thinc. We have two important consultants 11 with us today, Dr. Peter Almond, who is our medical physics 12 consultant, and Capt William Briner, radiopharmaceutical 13 consultant.

14 Sorry. That was on a separate list.

15 Pefere we begin to discuss the tcpic at hand, a 1

16 few comments about the function of the committee are in 17 order. The committee advises the'NRC Staff on issues and 18 ouestions that arise from the use of radioactive material 19 for diaonosis. The committee does not direct the Staff, but 20 rather provides counsel. From its inception, the committee 21 has been composed of members from a broad rance of 1

1 22 specialities, in order to deal with complex issues, cutting 23 across several medical specialties. The committee is 24 composed of members whose primary speciality includes MfMMht/

25 internal medicine, masse physics, diaonos(hhradiolocy, and l

l l

R210 01 03 5 1 DAVbw 1 more recently, cardiology. All have experience in the 2 disonostic and therapeutic use of radioisotopes. The members 3 come from various types of medical practices and medical rs

() 4 institutions. This provides for a diverse background of 5 experience on which the NRC can draw. The members of 6- the committee do not individually represent any medical 7 specialty or professional organization, but are assistino 8 NRC as a member of the committee.

9 The primary purpose of this meetina is to discuss 10 traininc and experience criteria for physicians who propose 11 to use by-prcduct materials for diagnostic and medical 12 ,

procedures; however, if time permits, the committee will 13 also ask for comments on medical issues.

14 For several years the NRC has had training and O 15 experience criteria for physicians who propose to use I

16 by-product materials. The criteria are comprised from the 17 training generally believed necessary for the physician to 18 use by-product materials while providing pro.tection for l WM 19 workers, patients and the public from (unam$5Hft, ament or 20 unnecessary radiation exposure in accordance with the NRC 21 rules.

22 Until recently, physicians who wanted use 23 by-product materials could satisfy the training criteria by 24 completing an intecrated three-month program; however, at 25 several committee meetings held over the years, experts from 26 the medical community said that because of the increase in

8210 01 04 6 1 DAVbw I ccmplexity of the diagnostic interpretation of nuclear 2 medicine studies, the training and basic knowledge of 3 radiation protection had increased.

.[) 4 ,

,In response, in December 1982, the NRC published a 5 newdraMl A

.-+-+- y+ and experience criterien-that said that the n

6 necessary training could be obtained by king a formal 7 integrated six-month program. It is important to note that 8 the radiation trainina criteria were not increased, rather 9 this change reflected the time needed mainly to adeauntely 10 deal with increased complexity of diagnostic image 11 intepretat, ion.

12 The notice also said a physician who wishes to be 13 authorized for only one or two specific diagnostic 14 procedures may have his training and experience reviewed O 15 case by case by the NPC with advice frcm the committee. In 16 December 1983, the American Collece of Cardioloay A r" I f ' ?qr_

17 alternative criteria for physicians who wanted to perform-18 cardiovascular radioloalcal procedures. Representatives of dtW 19 JJwe oroanization and several other af fected oraanizations 20 met to discuss several alternative criteria and reported 21 their results of their meetinas.

22 There appears to be ceneral agreement on the 23 topics that should be included in the trainina proaram.

24 They are described in the Federal Register Motice that 25 announced this meeting.

4 8210 01 05 7 1 DAVbw 1 It appears the central issue is the operational 2 wording for the duration of intecrated programs. All 3 the representatives have endorsed the four-month r~

(hj 4 integrated program for physicians whose use of by-product 5 material would be limited to cardiovascular imagina; 6 however, there appears to be a difference of opinion as OP 7 to whether the four-month program ef the six-month procram 8 is necessary for thosq physicians who want to perform 9vicM urts.

9 nuclear medicine 2nd pe^enadingr.jns 10 The duration of intearated programs for 11 cardiovascular imacina, as well as for all other nuclear 12 medicine proceedings is what what we will discuss today.

13 The central guestion is, how much and what duration of 14 training does.a ohysician need to safely use diacnostic i

O 15 radiopharmaceuticals.

16 One~ purpose'of this meeting is to allow the 17 affected individuals and the public to present thhgk 18 thoughts, so they may be taken into consideration by the 19 committee and staff. It thus must be very clear that NRC's e$a. $ hyssenEn &

20 nuthorization r- th: - :it!-- use ejgby-product material for 21 diagnosis and treatment implies that the NIEUE and trainine 22 is sufficient to avoid unwarranted radiation exposure to the 23 physician, workers and the public, includino patients.

con nobL 24 That authorization does not cut qg_ achievement of 25 a particular level of clinical competence. In this sense, 26 the HRC authority is limited to radiological protection,

Y 8210 01 06 8 2 DAVbw I according to its rules rather than the cuality of medical 2 practice. We must also be very clear that the public 3 comment process is not a voting mechanism. Rather it is to

() 4 provide information that should be considered during the 5 regulatory process, that may not be available to the HRC.

6 Although this was stated in the meeting notice, we 1

7 did receive 100 form letters endorsing a particular 8 pro h l. In response to the meeting several 9 persons have asked to make statements. The speakers have 10- been listed on the agenda in the order in which we received 11 the renuests to speak. Speakers are reminded that their 12 comments must pertain to the topic at hand. Because of the I 13 large number of speakers, I must ask that they limit their 14 comments'to five minutes.

15 The full text of the prepared statements will be i

16 included with the record of this meeting. The record will 17 be kept open until itav 17, 1985 for additional written 18 comments. Cuestions may only be asked by the committee 19 members and the NRC Sta f f. This unfortunately, is necessary 20 for the orderly conduct of the meetina in the limited time 21 available.

22 I ask at this time if any of the ecmmittee members 23 wish to make further comments in this introductory nart.

24 (No response.)

25 t:R. CUNNIDGliAM: If not, we will start with our j

s

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8210 01 07 9 1 DAVbw 1 first speaker. Before you begin your comments, please 2 identify yourself. Also please state whether or not you are 3 representing an organization or yourself. It should be

() 4 added that discussions at this meetina are being recorded i 5 and a eecomplete transcript will be placed in the Public 6 Document Room.

7 To give you some idea of the order in which you 8 will appear, I'll just run down the list very, very 9 quickly. The first reauest to speak was from Mr. Linton, 0

10 but Drs. Christie and Murpff are going to use that time, 11 followed by Dr. Schlant, substituting for Dr. Williams, 12 Dr. Blahd, Dr. George Beller, substituting ~for Dr. Dyan, 13 followed by Dr. Siegel, Dr. Gould, Dr. Li cren, s

14 Dr. Goldberg, Dr. Ronan, Dr. Lindsay, Dr. Fox, Dr. Martinez, O 15 Dr. Welch, Dr. Ross, Dr. Watson, Dr. Griffin and 16 Dr. Johnson.

r 17 Again I ask you, so that we can move on with this, 18 to make your statements as concise and brief as possible.

19 Certainly, you can add and supplement your statement as much 20 as you wish for the record in this meeting. Incidentally, I 21 might say that the record of this meeting will be very 22 important, because in reaching a decision, a final decision, 23 we have to have the technical, econcmic and whatever other 24 bases in the record on which we can base any continuation of f i

25 present criteria or any alterations of criteria for the

l l 8210 01 08 10 1 DAVbw 1 future.

2 DR. GARCIA: I didn't hear my name called.

3 Dr. Carcia, American College of Muclear Medicine.

i () 4 MR. CUNNINGHAM: I beg your pardon. You're on the 5 list.

6 We'll start with Drs. Christie and Muraff, who i

7 presumably won't speak together.

8 DR. MUR F: MynameisLawrenceMurfff. I am a 9 practicing radiolocist, specializino in nuclear medicine in 10 Tampa, Florida. I'm here as Chairman of the American 11 College of Radiology's Commission on Nuclear Medicine, l 12 and I am therefore speaking for the more than 17,000 College 13 members. These radi, ologists are responsible for the 14 overwhelming majority of nuclear medicine practiced in the -

0 15 United States.

i 16 I am pleased to have the opportunity to submit 17 these comments on the medical use of isotopes. The issue of 18 revised trainino and experience criteria for physicians who 19 use isotopes for medical purposes has been studied 20 exhaustively since 1979. As the Advisory Committee is 21 aware, the ACR and expert committees have worked for the NRC 22 throughout these discussions to assure that the license 23 requirements for licensure are adecuate to protect the 24 public.

r s 25 The !!RC mandate is to provide for the safe use !

l l

l

p 8210 01.09 of ph 11 1 DAVbw 1 JMP radiation sources and medical applications. In that 2 context, the patient and the general public are served best 3 by physicians who are adequately trained in radiation safety (s) 4 procedures.

5 It is imperative that there be no double standard 6 or short cut in training related to safety.

7 ACR believes that the minimum standards for 8 safety should be equally applicable for all users. The 9 hazards associated with the use of by-product materials do 10 not related to the discipline of the physician who Il administers the isotope. Radiation safety requires equal 12 experience regardless of the isotope application or body 13 system involved.

14 We have pointed out, the residents in radiology 15 and nuclear medicine spend the entirfky of their' training 16 period working with radiation sources. They receive formal 17 instruction, plus hundreds of hours of practical experience 10 in handling isotopes, calculating doses, implementing safety 19 programs and supervising radiological technologists. This 20 extensive training is recessary to tune into the need for

?1 radiation safety as an integral part of every patient 22 procedure. The MRC has appropriately recognized 23 American Poard of Radiology certification, diagnostic or As 24 therapeutic radiology jersufficient to meet safety standards.

25 The ACR is convinced that all physicians who seek l

l l

8210 01110 12 1 DAVbw I full responsibility for the application of radioactive 2 materials should be required to meet minimum standards of at 3 least four months of basic safety training. The fact that a

() 4 physician may elect to limit his use of isotopes to one cart 5 of the body does not detract from the need for a thorough 6 understanding of and competence in comprehensive radiation 7 safety procedures.

8 Safety procedures, in our opinion, do not vary 9 fundamentally from one body system to the other or from one

{ 10 administering physician to the other. The physician who 11 uses isotopes outside of a authorized nuclear medicine or 12 radiology department must accept full responsibility for L

13 radiation safety. This is particular,Ytrue for application 14 outside the hospital or an institution in the formal i

O 15 radiation safety program.

16 The ACR participated in two meetings over the past 17 year in an effort to accommodate the interests of all

[

18 concerned, while recognizing the responsibility of the 19 Nuclear Regulatory Commission. In those meetings the ACR 20 accepted the position that a requirement of four months of 21 radiation safety training, that we feel the requirements for 22 appropriate clinical training are outside this discussion.

23 We feel that Appendix A could be modified, as agreed in i

3 24 those meetings, without threatening the public health and

! 25 safety.

8210 01 11 13 1 DAVbw 1 Last fall the Council of the American College of 2 Radiology adopted a resolution setting forth the College's 3 position on trainino reouirements for isotopic use. That

,() 4 resolution, "The ACR agrees to the concept of a four-month 5 training period as part of an approved residency program in 6 radiology, nuclear medicine or cardiology, which includes a 7 minimum of 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of basic science trainino and 650 hours0.00752 days 0.181 hours 0.00107 weeks 2.47325e-4 months 8 of clinical training in radionuclide handling should be 9 sufficient to meet Nuclear Regulatory Commicsion 10 recuirements. To ensure public health and safety, the 11 licensure should use all approved Groups 1, 2 and 3 12 radionclides and all approved forms.

13 I thank you for the opportunity to make these 14 comments. I will be happy to answer any of your cuestions.

15 MR. CUNtII!!GHAM: Thank you, Dr. Muraff.

16 Do any members of the committee had ouestions of C

17 Dr. Murpff.

10 Dr. Webster.

19 DR. WEPSTER: Doctor, when you say 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months plus 20 650 hours0.00752 days 0.181 hours 0.00107 weeks 2.47325e-4 months , do you mean a total of 850?

21 DR. !!URAFF: We believe these can be accommodated 22 in a concurrent fashion, but within the context of a 23 four-month period.

O 24 MR. CUNNING!!A!!: Thank you, Dr. !!urgf f.

i

('

25 Dr. Christie.

. . .. . _ = . . _-. - - _ . ._ . -.

8210 01 12 14

1 DAVbw 1 DR. CHRISTIE: HMr . Cunningham, ladies and 2 gentlemen of the ecmmittee.

3 I'm Dr. James Christie, Trustee of the American

() 4 Board of Radiology and Chairman of its Examination 5 Committee. I have been asked by the Trustees of the American j

6 Board of Radiology to attend this meeting to present its 7 position concerning the meeting we're having today.

8 The American Board of Radiology was founded in 9 1934 to set minimum standards of competence, especially of 10 radiology, to certify candidates who have demonstrated this 11 competence through examination. In the encuing 51 years, ,

12 the American Board of Radiology has examined more than ,

13 30,000 candidates and certified more than 22,000. At our 14 oral examination in June of this year, the American Board of O 15 Radiology will examine 1650 ca'ndidates for various branches 16 of radiology.

17 over the years, the American Board of Radiology ;

18 through its examination process has undoubtedly dictated to 19 some dearee the educational content of training programs.

20 We have not and we will not dictate to our residency 21 programs how this material will be taucht. I 22 Thir, is not unique to radiology. It is indeed 23 true in all staces of medicine. It is essential that you 24 understand that our residency training procrams vary greatly i

! 25 in those strengths and weaknesses, as do our residents, and '

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8210-01 13 15 1 DAVbw 1 that only program directors and their faculty understand 2 these strengths and weaknesses and can eng,make the necessary 3 adjustments.

() 4 Furthermore, it is essential that you understand 5 that we are teaching in essential five different modalities.

6 And in most instances organ systems and disease processes 7 can be imaged by more than one and occasionally by all of 8 the modalities underlying the resident teaching rotations as 9 a core of learning on the anatomy and pathophysiology of 10 these, which is a critical foundation necessary to use any 11 imaging modality. In order to use this knowledge as a 12 competent radiologist, the resident must learn the specific l 13 strengths, limitations and operational weaknesses of each i

14 modality.

15 Since there is great overlap as to how a disease 16 process can be imaged, it is immaterial that this core is 17 learned in ultrasound and computer tomography or the nuclear '

18 medicine rotation. Therefore, in a program which is I

19 strong on computer tomography, for example, the director may 20 well choose to teach this core knowledge there rather than 21 in ultrasound or nuclear medicine.

J t 22 Since there is also a technical overlap in these 23 differnt modalities, such as computer aralysis and 24 reconstruction, it is necessary that in the individual

! kl 25 modalities, teach only those principles unique to that I

_ . . . _ . = . .

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16 8210 01 14 1 DAVbw 1 modality. i l 2 This training, integrated with our physics and our :

1 I 3 basic science training is usually accomplished in two to l j 4 three month rotations. Thereafte,r, resident skills and

! 5 diaanosis are fine-tuned throuah the intecrated training in :

I 6 the multiple modality simultaneously. !

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8210 02 01 17 !

2 DAVpp 1 We are convinced that the ability to use and 2 understand all modalities is essential to using one and 3 critical in directing a referring physician to the most

() 4 useful technique to solve a particular patient problem.

5 Mr. Cunningham, during the last two years and 6 especially during the last year since your new regulations 7 went into effect, the American Board of Radiology and, I 8 unfortunately I in particular, have literally been bombarded l

9 with letters, phone calls, questions at public meetings from 10 department chairmen, program directors, as to what your new

, 11 requirements entail and how they can be met. These have not ,

f 12 been easy questions for me to answer since I and they cannot t i

13 conceive of how the simple addition of 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of 14 supervised work experience handling radioactive materials 15 . can, in any way, contribute to improved public health and 16 safety.

17 Now, since we were satisfied for more than 30 18 years, that three months training coupled with our separate 19 physics and hasic science training is sufficient to teach ,

20 the fundamentain of nuclear energy and to fulfill your !

21 mandate to provide for safe use of radioactive sources, 22 medicalapplicationhg[tstandstoreasonthatthenoardcan

23 accept the compromise four-month program i

24 If you with to extend your mandate and dictate 25 additional clinical training, we implore you for the sake of

8210 02 02 18 1 DAVpp 1 260 program directors and more than 4500 residents in 2 training for which the deadline is fast approaching, to tell' 3 us and tell us now and soon, exactly what you want us to do.

() 4 The practice of medicine in radiology is changing 5 very rapidly and we must be in a position to meet the 6 challenges imposed by these changes. If your requirements l 7 are reasonable in the total concept of our training l 8 responsibilities we will accept. If they're not reasonable.

l l 9 then the trustees of the American Board of Radiology will be 10 forced to make some very difficult and far-reaching 11 decisions.

12 In considering today, over 80 percent of 13 hosoitals in the United States depend mainly upon !

g- 14 radiolocists with minimum training in nuclear medicine to

(/ 15 supervise and interpret nuclear images on a part-time l

16 basist part-time because the work really is insufficient to I ,

17 permit the economic employment cf a full-time nuclear 10 radiologist or nuclear medicine physician.

l 19 I appreciate the opportunity to express our 20 thoughts and concerns today and I'll be happy to answer any 21 questions.

22 MR. CUNNIt!G! LAM: Thank you very much, i 23 Dr. Christie.

24 Do members of the committee have any questions 25 of Dr. Christie?

l l

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! 8210 02 03 ' 19 l- 1 DAVpp 1 (No respor.se.)

2 MR. CUNNI!!GliAM: I have one question of 3 Cr.. Christie.

t

-O 4 aiewt t two eco vo= aid twat voe o wave to 5 consider large changes in the way nuclear medicine vould be 1 6 e.mployed if the six-month program is in effect. Now,db I l 7 understandthatcorrectlyf a DR. CHRISTIE: It depends whether the six-month 7 9 program is something we can live with. We can't live with 10 the program you designed for us today. If it's a program Il that we can live with, that we can put into our teaching and 12 not interfere with the teaching of other modalties, then we ;

l 13 can accept it. But if it's a six-month program where we're 14 isolated and forced to keep them in the nuclear medicine f

( 15 laboratory for six months, I doubt very much we can. accept t

t 16 this. -

17 MR. CUNNINGl!AM: The idea being that they get at i i

18 least part of this training in other areas.

19 DR. CIIRISTIE: Of course. And we teach all of 20 these things as integrated within a spectrum. We don't '

21 teach nuclear medicine in a vacuum. We don't teach 22 ultrasound in a vacuum. We do for a short period of time in i

23 order to familiarize people with the eauipment and [

24 everything else. ;

25 But thereafter to isolate these people, it i 4

8210 02 04 20 2 DAVpp 1 wouldn't make any difference what imaging modality we'd 2 ask them do to. If we put them in ultrasound and kept them 3 just within ultrasound an additional three months, it would 4 be a terrible waste of their time. They should be f^J')

L 5 integrating this material with all other material.

6 And, as I said, it makes no difference whether we l

7 learn cardiology or the pathophysiology of cardiac disease.

8 Whether we learn that from the angiographics or nuclear l

9 medicine or learn that in ultrasound, the anatomy is the 10 samer the physiology is the samer the diseases are the 1

l 11 same. All we're doing is 1 coking at them differently.

l 12 MR. CUNNINGHAM: Thank you very much.

13 Dr. Schlant?

l 14 DR. SCl!LANT: Mr. Cunningham, Members of the O 15 Advisory Committee, my name is Robert C. Schlant, Professor 16 of Medicine and Director of the Division of Cardiology at l

l 17 Emory University School of Medicine.

18 Since 1902 I've been the chairman of a joint task 19 force of the American College of Cardiolooy and the American 20 Heart Association looking at the matters of nuclear 21 cardiology issues. I'm also testifying today on behalf of 22 this task force and on the American College of Physicians.

23 Our task force has reviewed in detail the 24 questions of the duration of training necessary for Okl L

25 physicians safe /y to use radioisotopes in nucicar 26 cardiology.

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8210 02 05 21 1 DAVpp 1 We've spoken with many specialists in nuclear 2 cardiology and many directors and trainees. We've 3 considered the cost duration and content of training in O 4 c rat 1oev =a nron a tr i i=9 =a verie=ce r 9=tre =t-5 for physicians performing nuclear cardiology.

6 Our conclusions are based upon what we would 7 consider to be appropriate but safe applications of 8 radioisotopes and for the protection of public safety.

9 We have not concerned ourselves with matters 10 that are under jurisdication dispute. Our task force has 11 had regular meetings for the last several years.

12 On June 28th and October 4th, 1984, 13, representatives of our task force met with respresentatives 14 of the American College of Radiology, the Society of Nuclear O 15 Medicine, and the American College of Nuclear Physicians.

16 At these meetings we had frank and open discussions.

17 Although our position has been that a two- or three-month 10 training period for physicians performina procedures limited 19 to the cardiovascular system is adeouato for protection of 20 public safety /cdid, at these meetings, agree to a' 21 compromise reccmmendation for a four-month training 22 program. We will accept this compromise training period 23 which we holieve in more than adequate to insure public 24 safety in the use of hyproduct materials.

25 We're makina this statement on the basis of what

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! 8210 02 06 22 1 DAVpp 1 we feel is appropriate for nuclear cardiology and the 2 applications of radioisotopes in the field of nuclear !

l 3 cardiology. , ,

7he peschen

() 4 Er : -Pc;:icir - of the American College of 5 Cardiology, the American lleart Association, the American >

l 6 College of Chest Physicians and the American College of 7 Physicians, which represent together over 70,000 physicians,5<

8 that the new NRC recuirements of six months of training for 9 physician use of isotopes, especially in those restricted to 10 the practice of nuclear cardiology, is excessive in view of 11 the basic purpose of the NRC activities to ensure safe and r

12 knowledgeable handling of clinically radioactive material.

P 13 We feel that NRC licensure to insure the public 14 health and safety should, in fact, be attainable within a O 15 training program of even.less than four months.

16 Nevertheless, we have agreed to a compromise with 17 our colleagues and organizations representing the nuclear -

18 medicine and the radiology communities. This compromise l 19 conetsts of 650 hours0.00752 days 0.181 hours 0.00107 weeks 2.47325e-4 months of training with experience in at (

20 least 100 documented patients.

21 I must emphasize that this represents a i 22 considerable compromise since it has been our position that l

23 a 300-hour trainino period would be adequate to satisfy the 24 NBC's statep :

/as k- 25 It is significant that this four-month compromise I

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8210 02 07 23 1 DAVpp 1 training period for licensure of physicians performing 2 radionuclide diagnostic procedures limited to cardiology, 3 has been approved by the American College of Cardiology, the l-() 4 American Heart Association, the American College of 5 Physicians, the American College of Chest Physicians, the 6 American College of Radiology, the Society of Nuclear 7 Medicine, and I believe, the American College of Nuclear 8 Physicians.

i 9 We've also prepared a detailed description of the ?

10 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of our proposed training in basic radioisotope 11 handling techniques which I would be prepared to give you 12 after my presentation.

13 It is our position that issues relating to the 14 process of insuring the competence in a clinical practice of I O 15 medicine should be left in the hands of professional 16 societies, residency and fellowship review groups, and 17 boards and state and hospital accreditation bodies.

18 In summary, Mr. Cunningham, it is the position of 19 the American Heart Association, the American College of 20 Cardiology, the American College.of Physicians, the American !

! 21 College of Chest Physicians that a four-month training i 22 requirement is a compromise position, but that actually two 23 to three months of training would be more appropriate for l 24 carryinc out the mission of the NRC. !

25 At least for the needs of the practice of nuclear 1

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8210 02 08 24 1 DAVpp 1 cardiology, we believe that a four-month training period is 2 more than sufficient to meet the Nuclear Regulatory 3 Commission's responsibility to insure public health and

() 4 safety and to limit licensure to those who use one, two, 5 three and four isotopes in approved form.

6 Thank you for giving me the opportunity to 7 testify.

8 MR. CUNNINGHAM: Thank you very much, 9 Dr. Schlant.

10 Are there any questions by members of the l 11 committee 7 12 (No response.)

13 MR. CUNNING!!AM: Again, I have a question.

14 You talk about a compromise in training 15 requirements. In other medical organizations, assuming that 16 the people who work on these compromises -- or who 17 participated in these meetinos rather -- are all 18 well-qualified people.

19 Why, in your opinion, do you think there is such 20 a diverse opinion as to what is necessary for training to 21 protect the public health and safety on these isotopes.

22 DR. SCl!LA!!T: Some of these, for example, will 23 depend on whether the trainino was dealing only with safety

,_ 24 or also involved areas of clinical competence. In the past 25 some recommendations have boon modo, for examplo, that i

i l

l t

8210 02 09 25 1 DAVpp 1 involve a total training period that was not just dealing 2 with matters of radiation safety and protection of the 3 public and physicians and everybody and also excessive

()

v 4 duplication.

5 But it also involved other areas of clinical 6 experience and knowledge and selection and tests and 7 interpretation of tests, and the sensitivity as to which 8 test to use. So there's an overlap be. tween areas that we 9 would consider more in clinical competence and experience 10 versus those dealing primarily with radiation safety. They 11 do, obviously, overlap but I think that some of it had to l 12 withthosemattejf.

l 13 DR. !!OLMAN: I just have one question about the l

_ 14 report of the combined group concerning the 650 hour0.00752 days 0.181 hours 0.00107 weeks 2.47325e-4 months l

15 requirement. This is obviously a move from 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of l

16 training in isotope handling plus 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of clinical 17 experience. I wonder exactly what you had in mind in terms 18 of structuring that 650 hours0.00752 days 0.181 hours 0.00107 weeks 2.47325e-4 months so it would meet the needs of l 19 both handlino and training?

20 DR. SCilLANT: The 650 would roughly be broken 21 down into the initial 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of radiation safety l 22 including didactic lectures on radiation physics, l 23 radiopharmaceuticals and other subjects. I have a breakdown 24 of that.

(O

(' 25 There will be approximately 250 hours0.00289 days 0.0694 hours 4.133598e-4 weeks 9.5125e-5 months of handling 1

8210 02 10 26 1 DAVpp 1 of radiation, radionuclide materials. And approximately 200 l 2 more dealing with at least 100 patient studies and more l 3 clinical aspects, in addition, in virtually all programs

(') 4 both in radiology and in cardiology as well as nuclear 5 medicine.

6 The remainder of the program consists of 7 extensive patient contact -- cardiology, certainly, where 8 the trainees are continually exposed to these techniques --

9 interpretation, selection of them, and I think, avoiding 10 excessive duplication both from a cost and a radiation 11 standpoint.

12 But the 650 hours0.00752 days 0.181 hours 0.00107 weeks 2.47325e-4 months is broken down. We have 13 recommended, by the way, this so-called compromise, 650 14 hours1.62037e-4 days 0.00389 hours 2.314815e-5 weeks 5.327e-6 months , not the 700 that finally came out in the federal i 0 15 register. It was four months but we allow them a little .

l 16 vacation there, so it actually came out to 650 rather than f 17 700 hours0.0081 days 0.194 hours 0.00116 weeks 2.6635e-4 months . -

18 MR. CUNNINOllAM: Thank you very much.

19 The next speaker is Dr. Blahd.

20 DR. BLAl!D Mr. Cunningham, members of the 21 committee. I'm William II. Blahd. I'm at the Wadsworth 22 Veterenj3AdministrationllespitalinWestLosAngelesand f

[ 23 Professor of Medicine at the UCLA School of Medicine.

24 I'm former Chairman of the American Doard of 25 tfuelear Mediciner former President of the Society of !!uclear ,

l

8210 02 11 27 1 DAVpp 1 Medicine; and a Regent of the American College of Nuclear 2 Physicians.

3 I'm here today to present the views of the

() 4 American Board of Nuclear Courd oggMedicine concerning the 5 petition of the American College of Cardiology to change the 6 training and experience requir,ements of the Nuclear

@gStud HS 7

Regulatory Commission, for r^ritic ggwho wish to use 8 byproduct materials for the performance of cardiovascular 9 diagnostic procedures.

10 The full statement of the Board has been duly 11 submitted to the Nuclear Regulatory Commission for its 12 consideration. However, the Board wishes to emphasize l

13 certain aspects of its statement for the committee's 14 consideration.

() 15 In 1980 and 1982, the American Board of Nuclear -l i

16 Medicine and other responsible nuclear medicine professional 17 organizations, including the Society of Nuclear Medicine, 18 the American College of Nuclear Physicians, the American 1

19 College of Nuclear Medicine, the College of American !

20 Pathologists, the American College of Radiology, and the 21 American-Medical Association, all provided extensive 22 information to the NRC supporting the concept that the 23 minimal requirements for licensure for specific uses of 24 Sh radioactive materials pould be increased from 3 to 6 months O 25

+ #

trainingandexperience/.

9 1 3

8210 02 12 of 28 1 DAVpp 1 Based on these recommendations ,t6 the nuclear 2 medicine community, the NRC ultimately established six 3 months of training and experience as a minimum requirement

()e s_

4 for licensure and incorporated these recommendations and 5 regulations. That became effective in July, '84.

6 In December, 1983, as I understand it, the NRC 7 received a petition from the American College of Cardiology 8 requesting that the requirements for licensure for 9 physicians who wish to perform cardiovascular nuclear 10 medicine procedures, be reduced. No evidence was presented 11 to indicate that the carefully considered opinions and

)

12 deliberations of 1980 and 1982 upon which the NRCs current a

13 regulations are based, are no longer valid.

14 Cardiovascular nuclear medicine procedures have O 15 become no less complex and, if anything, are more 16 complicated. The safety of medical work errors and patients 17 is even more at risk as a result of the increasing 18 complexity in the use of these procedures. In fact, the l

19 Board believes that this six-months training and experience j

\

20 for licensure is the bare minimum time needed to attain l 21 competency to perform cardiovascular nuclear medicine l 22 procedures.

23 According to the NRC interpretation of

, i 24 professional competency, as expressed in Volume 44 of the i

\

25 Federal Register No,. 8242, "The staff and will continue to 1

1

8210 02 13 29 1 DAVpp 1 interpret this to =ean th;;*; -*

E;;;;;; bthat !!RC approval 2 of a physician to use byproduct =aterials in hu=ans for 3 treat =ent and diagnosis relates to radiation safety; to

() 4 training sufficient to avcid unwarranted radiation exposure 5 to the physician, =edical workers and the public, including 6 patients."

7 Since cardiovascular nuclear =edicine procedures 8 are sc=e of the = cst ec= plex, difficult, and de=anding 9 nuclear =edicine procedures requiring detailed kncvledge, 10 not only of the principles of radiological and health 11 physics, but also equally detailed knowledge of =ethods of 12 radiation detecticn, image for=ation and processing, and 13 cc=puter utilization and image interpretation;

- 14 y[t follcws that the use of these technicues by

k. 15 inadequately trained physicians can result in the 16 perfor=ance of test precedures that are not indicated, not 17 properly perfor=ed, and inec=petently interpreted.

18 Although, the unfortunate consequences of

)

19 physicians inadequate training and experience =ay not result 20 in reportable deaths, they =ay result in unnecessary 'staf f 21 and patient radiation exposure.

22 The concept that these = cst difficult nuclear 23 =edicine procedures can be =astered in less than six months 24 cf intensive training and experience, and that such training p

k- 25 can provide a level of ec=petency that will protect the

8210 02 14 30 1 DAVpp_ 1 public and patients, is patently unrealistic.

2 In view of the extensive body of knowledge that 3 must be acquired to competently practice cardiovascular

() 4 nuclear medicine, the Board has carefully considered the 5 proposal of the American College of Cardiology to reduce 6 training and experience requirements forlicensurqjfto 7 perform cardiovascular nuclear medicine procedures, and has 8 determined that such changes may be inimical to patient 9 safety and therefore are not in the public interest.

10 Accordingly, the Board urges that the NRC not 11 change its six-months training and experience requirement 12 for licensure for physiciens who wish to practice any aspect 13 of nuclear medicine, including cardiovascular nuclear 14 medicine.

O 15 The American Board of Nuclear Medicine expresses 16 its appreciation for this opportunity to express its views.

17 Thank you.

18 MR. CUNNINGHAM: Thank you very much, Dr. Blahd.

19 Any questions by members?

20 DR. POHOST: Dr. Blahd, are you aware of the new Socie.h 21 compromise position that the Sci:n 3 of Nuclear Medicine and 22 the American-College of Radiology and the American College 23 of Cardiology came up with? Is the Board aware of it?

24 DR. BLAHD: Yes, indeed.

O

\- 25 DR. POHOST: In the face of that expert group of

- .- - . -~ . . - - . _. -- . - . . - . . . - . = - . .- ._ _- -

8210 02 15. 31

1 DAVpp 1 individuals, do you still propose retaining six-month? ;

1 2 DR. BLAHD: That's the Board's position.

3- DR. POHOST: I just want to make it-clear. This 4 is not the position shared by your colleagues.

5 DR. BLAHD: Of course it's the Board's position.

6 I understand what you're saying.

I

- 7 a

8 9

i 10 11 12

, 13

!O 15

) 16 17 4

0 18 19 20 i

21 1 22 i

23

! 24 O

25 t

4

, ,- - , . - _ _ . _ , , ,. . . . , . _ . _ _ _ + . , . - . , , , _ . , . . _ , . , _ , , - - . , . , , . ~ , . -,,...-...m. ~ . . . -

8210 03 01 32 1 DAVpp 1 MR. CUNNINGHAM: I think we'll hear from the 2 Society of Nuclear Medicine later on. I'd have a couple of 3 questions for you.

() 4 You're quite firm on the minimum six months 5 training requirement. In fact, you feel it should be 6 higher.

7 DR. BLAHD: The Board has always felt that way.

8 MR. CUNNINGHAM: Given the fact that technicians 9 do much of the radioisotope handling in the nuclear medicine 10 laboratory, and what this training relates to is really 11 health physicsj g[owmuchtrainingdoyouthinkeach 12 technician should have relative to the physician to provide 13 safety in handling of radioisotopes?

14 DR. BLAHD: We feel, I guess, that the 1

15 technicians should be competently trained. Most of them 16 have at least one full year of training. -

17 MR. CUNNINGHAM: In radiation safety?

18 DR. BLAHD: That's part of their training.

19 Our technologists in our school receive, I guess, 20 roughly equivalent to 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of training in radiation 21 safety and related basic sciences anyway.

22 MR. CUNNINGHAM: Am I interpreting your answer 23 correctly? I want to be sure of it. Are you saying that 24 technicians should have as much training in radiation safety O

k/ 25 as the physician and that should be at least six months.

8210 03 02 33 1 DAVpp 1 DR. BLAHD: No, I'm not saying that technicians 2 have to have six months of training in radiation safety.

-3 They have to have six months in the aspects that are

() 4 important. This includes the basic information, the basic 5 sciences, handling, and patient experience. I'm not saying 6 this is all radiation safety.

7 The Board has always considered that 8 interpretation as a very important part of safety in terms 9 of the patient's safety. We consider that to be part of 10 radiation training.

11 MR. CUNNINGHAM: Then the place where the 12 controversy seems to rest -- I gather what you're saying 13 -- is in this gray area where you separate clinical 14 competence from radiation safety training?

O 15 DR. BLAHD: Yes, I think that's true. We, all of -

N 16 us, felt that interpretation is aeg of safety. If the 17 procedure is not interpreted properly, if the test is not 18 recommended when it should be or shouldn't be, these are 19 matters also that certainly are important in terms of 20 safety.

21 MR. CUNNINGHAM: That's an issue the committee 22 has to take up.

23 Any other questions of Dr. Blahd?

24 Dr. Goodrich?

25 DR. GOODRICH: Just to balp clarify for this

8210 03 03 34 1 DAVpp 1 committee, my concept of the American Boards, whether it be 2 radiology or nuclear medicine, is that they are constituted 3 in such a way that they are independent, completely

() 4 autonomous with respect to the peer groups, the other 5 societal agencies that deal with the discipline. And in 6 this fashion they represent, essentially, a Mt. Olympus. It 7 is truly the overseer and the benchmark of standards. Is 8 that correct?

9 DR. BLAHD: I think the Board is as interested in 10 radiation safety as any other organization. I think they 11 have the same concerns for patient safety and public 12 safety.

13 DR. GOODRICH: D,r. Christie, is that a 14 reasonable expression from the Board of Radiology?

O 15 DR. CHRISTIE: What you just said? Yes, it is.

16 DR. GOODRICH: Thank you very much.

17 MR. CUNNINGHAM: Thank you very much, Doctor.

.18 DR. BELLER: Mr. Cunningham, members of the 19 Advisory Committee. My name is Dr. George Beller, 20 representing the American Heart Association. Unfortunately, i 21 Dr. Ryan could not be here.

22 I'm Head of the Division of Cardiology and 23 Professor of Medicine at the University of Virginia Medical 24 Center.

25 Since my arrival there in 1977, I have been

l 8210 03 04 35 1 RDAVpp 1 personally responsible for the training of nuclear 2 cardiology fellows in our residency training program in 3 cardiology. I've also been a member of the American Heart

() 4 Association and the American College of Cardiology combined 5 task force on nuclear cardiology issues.

6 I'm also a member of the Society of Nuclear afdst cd 7 Medicine and have been involved in the genera (-of multiple 8 documents over the years on training guidelines for nuclear s 9 cardiology training.

10 On behalf of the American Heart Association and 11 the American College of Chest P'nysicians, I would like to 12 declare support for the four-month training period for i

13 physicians who only want to perform cardiovascular imaging 14 procedures.

15 There is no doubt that public safety will be 16 assured if this compromise proposal is accepted. We feel 17 that the four-month training program is more than adequate 18 to meet NRC requirements.

19 Now, in most cardiology eed training programs, 20 supervised examination of patients to determine suitability 21 for radioisotope diagnosis and recommendation on dosage to 22 be prescribed as well as collaboration in the interpretation 23 of radionuclE gtest results, often involves significantly 24 more than the 100 pat ionts as described in the minimum 25 re'quirements.

, - - v , r-

8210 03 05 36 1 DAVpp 1 Our Fellows are each involved in nearly 900 to 2 1,000 new nuclear cardiology studies over a two-year 3 period. All case histories are reviewed under the tutelage

() 4 of an attending nuclear cardiologist or physician.

5 I believe that the reason for the sentiment in It 6 1980 to increase training requirements Jrf six months by my 7 colleagues who testified in a similar advisory committee 8 meeting, is really geared towards increasing the competency 9 in clinical training in radionuel kimaginginvolvingmore 10 experience in exercise stress testing techniques, scan 11 interpretation, learning more cardiovascular pathophysiology i nucigar-12 as it related to nur_rry,ardiology testing, hemodynamics and

! 13 the like.

i 14 This was not intended as a recommendation to

)

15 increase the requirements for training and experience in

! 16 basic science or radiation safety. Most accredited, let me i 17 say, cardiology fellowship training programs) trainees 18 undergo an extensive ex?osure to the decision-making process

^

iM4 19 of which radionucleeggtest is appropriate, if any. What are 20 the advantages and disadvantages of a particular nuclear 21 cardiclogy test?

22 They're also trained throughout their period of As i 23 fellowship to the manner in which optimum performance of 24 tests, or optimum quality results, are achieved. They are l s- 25 supervised in scan interpretation on daily reading sessions l l

l l

1 i

0210 03 06 37 2 DAVpp 1 and weekly or biweekly conferences.

2 -

Correlation with other tests such as cardiac 3 catheterization, echo cardiography, is an important part of I) 4 the training, in order to better understand the 5 false-positive or false-negative results that are often 6 acquired or occasionally acouired and follow-up of patients 7 is also part of the standard nuclear cardiology training 8 program.

9 So therefore, although the requirements of the

' 10 four-month training period are sufficient, we believe, for 11 licensure for nuclear cardiology practice, the exposure to 12- nuclear cardiology clinical procedures goes on for the 13 entire program on a patient-by-patient basis.

14 1

Therefore, we believe, clinical competency is a 15 continuum which involves multiple rotations throughout the 16 training program.

17 Thank you.

10 MR. CUNNINGHAM: Thank you very much, Dr. Beller.

, 19 Are there any questions of Dr. Beller?

20 Yes, Dr. Workman?

21 DR. WORKMAN: Perhaps I missed this. I apologize 22 if I did.

23 Did you mention the basic' training? You spent a 24 good bit of time on the clinical training but how many hours O' 25 of basic training do you people at UVa get?

.I i

1

8210 03 07 38 2 DAVpp 1 DR. BELLER: The number is close to, I believe, 2 well over, I think, 600 hours0.00694 days 0.167 hours 9.920635e-4 weeks 2.283e-4 months . This is done where our 3 cardiology trainees go to the nuclear medicine service in

() 4 July at the beginning of a year and undergo this basic 5 training, didactic lectures, radioisotope handling with the ,

6 radiology residents. Then they come back to the cardiology 7 fellowship program and, over the subsequent two years, we 8 believe that it is very important for them to become expert 9 in the clinical interpretation of scans because -- as was 10 mentioned previously by another speaker -- this involves 11 patient safety as well to minimize false-positive 12 interpretations which then may lead to unnecessary invasive

! 13 procedures. I l

j 14 MR. CUNNINGHAM: Thank you very much, Dr. Beller. l O 15 Dr. Siegel?

- I 16 DR. SIEGEL: Mr. Cunningham, members of the 17 Advisory Committee.

18 My name is Barry Siegel, Professor of Radiology ,

j 19 and Medicine and Director of the Division of Nuclear 20 Medicine at Washington University School of Medicine.

I 21 I also am a Fellow of the American College of 22 Cardiology, Fellow and Government Relations Committee member 23 of the American College of Nuclear Physicians, a Fellow of

24 the American College of Radiology, and Vice Chairman of its 25 Commission on Muclear Medicinej y[TrusteeandGovernment a

J

8210 03 08 39 1 DAVpp 1 Relations Committee Member of the Society of Nuclear 2 Medicine and an American Board of Radiology Delegate to the 3 American Board of Nuclear Medicine. And a recently retired

() 4 member of the Residency Review Committee for Nuclear 5 Medicine.

6 I tell you this only as a means of highlighting 7 my multi-organizational perspective on the problem before i

8 this committee because today I am representing none of these l

! 9 organizations but rather I'm here to share my personal 10 observations and opinions with the Advisory Committee.

11 The detailed comments in my letter of March 4 12 have already been made available for your review.

13 Accordingly, I wish only to reiterate a few key points.

14 First, I have been concerned for some time now

()

15 that the lobbying that has led to the augmentation of the 16 minimum training and experience criteria for physician use 17 of byproduct material has been motivated less by a desire to 18 insure radiation safety and more by a desire of certain 19 groups of practitioners to maintain their 20 government-sponsored franchise.

21 In particular, I am puzzled by any professional 22 organization that should wish to increase the int ' usion of 23 the federal government, or any government for that matter, 24 into the practice of medicine, especially since the evidence 25 that nuclear medicine is intrinsically unsafe, is not at all 1

\

l l

l 1

8210 03 09' 40 1 DAVpp 1 clear, and since medicine as a whole and nuclear medicine in 2 particular already are regulated to an excessive degree.

3 Despite what I just said, I also firmly believe

] 4 that more nuclear medicine training is better than less. I

)

5 also personally believe that it is difficult to train a 6 physician to be an excellent practitioner in our specialty 7 in less than one year; two years is even better in this 8 regard. Therefore, I believe it is quite important to 9 distinguish between the minimum training necessary to insure 10 safe radiation practices and the training necessary to 11 insure that nuclear medicine is practiced to the highest 12 standards of excellence.

13 It is my understanding that the NRC has a 14 statutory mandate to insure safe medical use of byprodtet

' O 15 material but does not wish to be responsible for insuring 16 clinical competence.

j 17 I think this is entirely appropriate since no 18 other medical specialty has federal licensing requirements 19 relating to clinical competence including the several 20 specialties whose practitionera use other forms of ionizing 21 radiation in their medical activities.

22 In all of the rest of medicine, the traditional 23 approach for a delineation of privileges is based on 24 recommendation and the guidelines established by O. 25 professional societiest the certification process by l

i i

I +

f

8210 03 10 41 1 DAVpp 1 specialty boards of individuals who are trained in formal 2 programs approved by residency review committees; and 3 through the credentialing process of hospital staff

() 4 accreditation committees.

5 Certainly, poorly trained physicians in other 6 specialties are no less hazardous to the public health and 7 safety than are poorly trained authoriced users of byproduct 8 material and, yet, nuclear physicians are subject to a 9 unique additional level of regulation.

10 My objections to the current training and 11 experience criteria to which the monster we have created, 12 are discussed in my letter in some detail.

13 However, it is clear tc me, just briefly as a 14 training program director, that a full 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of hands-on

( 15 experience working with byproduct material is not optimal 16 use of the precious time alloted to the training of 17 residents.

18 Morover, the 200-hour block of didactic training, 19 albeit time-honored, does not seem to me to be clearly based 20 on any data showinq that it takes precisely this long to 21 achieve the educational objectives of such training.

22 Accordingly, I would argue the following: That 23 the NRC should dis-insert itself from the practice of 24 medicine to the fullest extent it believes consistent with 25 its statutory mandate.

l (

8210 03 11 42 1 DAVpp 1 Whatever training is required should be kept to a i

2 minimum; should be based on carefully thought-out and 3 documented objectives; and should be uniformly applied to

() 4 all applicants for licensure.

5 The process of insuring competence among nuclear 6 medicine practitioners should be left in the hands of those

7 professional bodies that somehow manage to insure competence 8 most of the time in all other medical specialties.

9 To go even one step further, I Qould suggest that l

I

10 specific physician licensure only should be required for 1

i 11 byproduct material use in practice centers where the license 12 is actually granted to a particular physician. In 13 institutional settings where the license is granted to 14 the institution and requires a formal radiation safety

(:) 15 program, I believe that the institution should determine who 16 can a'nd cannot be an authorized user.

i 17 I believe that licensed institutions will be i

18 motivated to select the most clinically competent, '

19 best-trained individuals as the surest way of guaranteeing 20 that the institution fulfills all of the safety requirements i

21 of 10 CFR necessary to gain and maintain licensure.

22 I thank you for the opportunity to address the 23 committee.

i 24 MR. CUNNINGHAM: Thank you very much, indeed, for 25 your comments, Dr. Siegel.

i !

r

_r.._.__,..-~_ , - _ _ -

8210 03 12 43 1 DAVpp 1 Do the committee members have questions of 2 Dr. Siegel? ,

3 (No response.)

I 4 MR. CUNNINGHAM: I'm surprised.

5 (Laughter.)

6 MR. CUNNINGHAM: There are two areas, I guess.

]

l 7 Your introductory comments that perhaps the real issue '

) 8 'behind this question on training is not protection of public q 9 health and safety but may be one of economics.

10 Some people have held that suspicion. Is that 11 what you indicated in the first part? ,

12 DR. SIEGEL: I believe that my involvement in 13 discussions in many different organizations lead me to i

1 14 believe that there may be some truth to that.

l ( 15 MR. CUNNINGHAM: That might be part of the .

i 16 issue. -

j i

! 17 DR. SIEGEL: That might at least be part of it. t i 18 MR. CUNNINGHAM: One other question.

! r 19 You heard Dr. Blahd's testimony previously prior '

1 20 to your testimony. We will continue to have problems with !

21 this gray area where we begin to separate clinical practice 22 from radiation detection. Do you have any thoughts on that?

I

\

23 I recognize your idea of licensing the hospital rather than 24 the physician, but can you help any in making that i 25 separation? i i

i i

)

4 8210 03 13 44 1 DAVpp 1 DR. SIEGEL: I'm not sure that I can really 2 clarify the matter, but I think it really has become the l

3 crux of what is dividing opinions here.

4 But I would only suggest that if we really think

(~}

5 that the NRC should get into the business of going the full 6 step to insure clinical competence, let's all march downtown ,

7 as soon as this meeting is over and go to Capitol Hill and 8 HHS and let's aet a set of regulations up that are 9 equivalent for diagnostic radiology, for surgery, for 10 medicine, because their kinds of individuals, bad 11 radiologists, bad surgeons, bad internists, are just as drL 12 dangerous to the public health and safety as eaggbad nuclear 13 medicine physicians.

14 It's pretty hard to do a lot of damage with O 15 technetium 99 M. It isn't tough to do damage with a scalpel ,

16 that doesn't know where it's going.

17 I think we've just blown all this out of 18 proportion.

19 MR. CUNNINGHAM: Thank you very much.

20 Dr. Gould?

21 DR. GOULD: Thank you.

22 I'm Dr. Lance Gould. I want to thank you for 0

23 being here and compipment the NRC Staff for the 24 professionalism and objectivity and fairness -- their !

25 professionalism, et cetera. I respect that very much.

I

l l 8210 03 14 45 1 DAVpp 1 I'd like to outline my credentials as a basis for i

j 2 my opinion, which would be very brief.

3 I was originally trained in physics and internal ,

() 4 medicine and cardiology. Currently, I'mDirectondFofthe l 5 Division of Cardiology at the University of Texas at Dallas l

6 and also the Positron Diagnostic and Research Center, 7 which in perhaps Texas style, may be one of the world's 8 largest positron programs for clinical imaging right now. [

9 We have an entire building devoted to this, three cameras in rou b uSC '

10 - -rrutr ,_and the entire staff of physicists, electrical 11 engineers, computer scientists, radio chemists, 12 physiologists, clinical people, and radiologists, h 13 neurologists, and psychiatrists, all under one administrative '

I 14 group getting along quite happily.

O 15 occasionally, Indians circle this compound in Texas but we manage to survive without Turkeyshe 4s(?

16 shoes --)and I 17 want to emphasize that.

18 I represent the AHA and the ACC. I'm also a 19 member of the American Association of Physicians and the 20 American Society for Clinical Investigations sometimes, 21 perhaps, too elitist a group of scientists who have 22 contributed to a variety of medical research.

23 l

24 25 1

i 1 \

l

8210 04 01 .

46 1 DAVpp 1 I would simply like to say that based on my 2 experience and extensive training in developing programs, 3 that I think that the six-month rule is really quite

() 4 excessive and unnecessary. The three months of training is 5 quite adequate for radiation safety matters.

6 I would like to address your question about why 7 there is this difference of opinion.

8 I, too, believe that it relates to the question j 9 of clinical competence and believe that that should be 10 restricted to professional societies and not the 11 responsibilty of the NRC.

I 12 The greatest problems of safety that we have had 13 are che death of a patient who was put on the nuclear study f(

14 15 treadmill because the nuclear physician at the time looked at the EKG and did not recognize'an acute myocardial 16 infarction in evolution.

17 The second case was a near-de-th resulting from 18 neurologic deficit permanently in the patient who had

)

19 complete heart block, also en-route to an EKG. That was not

]

20 recognized. ,

21 Those are the sorts of risks that we face that 22 are major ones which required clinical competence and I 23 believe that should be left to the professional societies.

24 It does require extensive training and that the 25 radiation safety matters can be dealt with very well within l I !

l l

~8210 04 02 47 4 1 DAVpp 1 the three-month period. And I would support that point of 2 view.

3 Thank you very much.

(') 4 MR. CUNNINGilAM: Thank you, Dr. Gould.

5 Questions by members of the committee?

6 -(No response.)

7 MR. CUNNINGHAM: Thank you very much, Dr. Gould.

8 Dr. Lindgren?

9 DR. LINDGREN: Thank you.

10 My name is Dr. Keith M. Lindgren. I'm a 11 practicing, board-certified cardiologist. In this locale, 12 I'm co-Director of Cardiology at the Washington Adventist 13 Hospital, past President of the Montgomery County Heart ,

i 14 Associatjon, Clinical Assistant Professor of Medicine at O 15 Georgetown University Medical Center, and Fellow of the 16 American College of Cardiology.

17 I come to you because I am concerned that nuclear 18 cardiology tests must be available in the community where 19 they are crucial to the detection and treatment of heart 20 disease.

21 In the past five years, I've been actively 22 involved both in a hospital setting and working in 23 conjunction with other nuclear medicine professionals, also hash hhu (D 24 with colleagues who have often faced facilities.

25 With all these nuclear cardiology proarams where

i s

8210 04 03 48 1 DAVpp 1 cardiologists have nuclear medicine training in three months 2 or less, I have never seen or heard of a significant spill j 3 accident or safety violation. l I

() 4 Furthermore, I understand from my colleagues ,

5 across the country, that there has never been such an

6 accident involving a nuclear cardiologist in the entire t i

4 7 country, a record beyond reproach for training programs that L 8 are less than those proposed.

9 secondly, in reviewing the proposal, it is my

! 10 experience that with 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of didactic training, an ;

11 additional 250 hours0.00289 days 0.0694 hours 4.133598e-4 weeks 9.5125e-5 months of handling experience is excessive.

12 This is really part of one's ongoing work in the area.

. 13 Certainly a training program provides habits for l 14 compulsive recordkeeping and meticulous techniques are very

]

15 important, but it really is the development of this as a 16 lifelong habit rather than specifying in a few months or 17 training a number of hours. And that really requires i

18 ' supervision while you are learning those habits and i i i 19 correction of deficiencies in setting a pattern and then 20 carrying it on for years rather than a matter of a few

21 months.

I 22 Lastly, I'm concerned about the availability of 5

t 23 physicians competent to perform nuclear cardiology tests. [

24 As has been pointed out by Dr. Could and ;

( 25 Dr. Beller, the major risk of these tests in cardiology i

i i

l L I

8210 04 04 49 1 DAVpp 1 involves who should be tested safely taking people with 2 heart disease and running them through exercise tests and l 3 similar things. Nuclear cardiology aspects are very crucial l O 4 det vrod div mot td tir **r t #1=e or e 1 vort #t 5 clinical matter.

6 As a board-certified cardiologist with 15 years 7 of experience and knowledge of cardiac pathophysiology --

8 which is really the basis of the way the nuclear medicine 9 test gives us information -- cardiac catheterization 10 techniques with experience in radiation imaging and 11 interpretation, long experience with exercise testing, 12 advanced cardiac life support to be able to take care of 13 problems should they develop in the laboratory. All of this

?

14 is necessary to competently and safely do and'interret 15 nuclear cardio'legy tests.

16 I was able to learn the nuclear medicine theory 17 and practice of safety in an efficient course. If you had 18 to similarly train a current medical school graduate, take 19 him and train him to the level of clinical cardiology l 20 competence necessary to decide who should have the test, 21 conduct the test properly, make sure it's done safely and 22 interpret the test accurately, the nuclear medicine safety 23 aspects of it are really a very minor part. I 24 The major costs and importance of training is 25 really the clinical competence and that has been pointed out

8210 04 05 50 1 DAVpp 1 by many people.

2 I think what past experience has done has shown i

3 that nuclear medicine training programs that include

() 4 radiation safety procedures of less than four months, have 5 done that job. The safety record of nuclear cardiologists 6 demonstrate that nuclear medicine training for cardiologists 7 need not be lengthy.

8 I appreciate your allowing me to express my views 9 before your group.

10 MR. CUNNINGHAM: Thank you very much, 11 Dr. Lindgren.

I 12 Dr. !!olman?

13 DR. !!OLMAN: I'm sorryr I may have missed it.

14 What are you preposing to us that we do?

O 15 DR. LINDGREN: My basic purpose is to say that I 16 think there's no need to lengthen the training program in 17 nuclear medicine as it pertains to nuclear cardiology.

18 I think the past record does not demonstrate any 19 need.

20 DR. !!OLMAN: So you are suggesting the four-month l 21 compromise? ,

22 DR. LINDGREN: It is certainly long enought yes.

! 23 MR. CUNNING!!AM: Mr. McElroy?

l 24 f1R. MC ELROY: Could you characterize for the NRC !

( 25 Staff's benefit the approval mechanism that a hospital uses l

_t

l 8210 04 06 51 t i 1 DAVpp 1 when granting privileges to a doctor in any department? <

i l 2 DR. LINDGREN: Actually, I'm sure that varies ;

i

3 from hospital to hospital. I would speak only of the !

t

() 4 cardiologists in our hospital. They're covered by the 5 license of the hospital nuclear medicine department. Only l 6 two of us have nuclear medicine licensures so that our !

7 cardiologists doing the clinical cardiology part of it, and !

i

) 8 the tests are interpreted jointly by the nuclear medicine 9 people and radiology.

10 So we have worked out a joint combination but :

i

. 11 that varies across the country. l t

t j 12 MR. MC ELROY: No, I mean to ask for other 13 medical specialists such as surgeons? ,

14 DR. LINDGREN: I'm not sure any other group of I l

15 subspecialists in our hospital really does nuclear medicir.e 16 testing.

i 17 MR. MC ELROY: My question, then, isn't clear.

I j 18 Does the hospital have some approval mechanism !

40 19 before it lets a doctor come ig practice,whatever specialty 20 he practicest not just nuclear?

j 21 DR. LINDGREN: Certainly, right.

I 22 MR. MC ELROY: Can you explain that approval 23 mechanism?

i 24 DR. LINDORENs This is a medical staff j 25 procedure. You have to have at least certification or board l

e

._ _. . _ . . . _ . - _ _ . ~ . . _ . _ _ _ . _ _ . _ _ . _ _ _ _ _ . _ . _ _ _ _ .

E 8210 04 07 52 >

l 1 DAVpp 1 qualification or a subspecialty. Your credentials have to ;

! i l 2 be reviewed. All of this has to be documented and approved 3 not only by the credentiald committee of the hospital, but

() 4 also by the department in which that subspecialty falls. So 5 you have to have training documented by board certification 6 and qualification. If not, he must go through a training .

7 program adequate to meet the board qualification.

8 MR. MC ELROY: Does the Joint Commission on 9 Accreditation of Hospitals review this paper path?

10 DR. LINDGREN: Yes. :

hM only board certify *Ith n 11 DP. WOODBURY: You -

12 physicians on your medical staff?

i 13 DR. LINDGREN No. But to achieve certain f

14 privileges, for example, to do cardiac catheterization in !

() 15 our hospital, yes, you have to be board certified.

16 DR. WOODBURY: I was just a little curious about 17 the curious -- the implication of the question is that 18 medical practice is primarily in hospitals. I'd like to j 19 remind the Staff that there is a good deal of medical !

20 practice outside of hospitals with entirely different sets 21 of credentials. [

22 DR. WEDSTER: You seem to have uncovered a l

l 23 Pandora's box that I didn't intend to open but what does the ,

I I 24 Board of Cardioloay have to say about examination of t i 25 cardiologists in the nucient medicine area -- nuclear r

8210 04 08 53 1 DAVpp 1 cardiology -- do they do it?

2 DR. LINDGREN: I think most cardiology training 3 programs that would graduate a subspecialist would certify

() 4 that he is adequately trained in that area. That has to do '

5 with other areas within cardiology such as catheterization l

l 6 and scho cardiography. All those techniques are learned in l

l 7 one's training program and one's training program verifies 8 adequate training.

9 Certainly, in cardiac catheterization probably wo 10 examine more thoroughly than, say, nuclear raedicine 11 training. We have to have documentation from their mentor 12 of the number of cases that they have done and their record l ,

13 so we do look at that as a credentialing body.

14 In other areas, we have not done that.

O 15 DR. WEBSTER: The gist of my question is that the 16 cardiologist would probably tend to rely more on licensure 17 by the NRC than board certification because it would 18 emphasize -- I think is what I'm hearing from you -- the i 19 nuclear medicine component much more stronglyr is that true? i l 20 DR. LINDGREN: I think that if a persor -- a l

21 cardiologist wants to use nuclear medicine, say, outside of 22 a hospital setting where there's a radiation safety officer i

23 and such, certainly, he has to be licensed.

I 24 And once again, that's not a hospital looking at 25 his credentials. Ue, in viewing people who do nuclear I

l

l 8210 04 09 54 1 DAVpp 1 medicine testing within the hospital, rely on the training l 2 program to verify their qualifications to do and interpret 3 nuclear medicine tests.

() 4 MR. CUNNINGHAM: Captain Briner?

5 CAPT. BRINER: Currently, what are those 6 qualifications you look at? I'm not clear on that.

7 DR. LINDGREN: They are the training program --

8 in other words, we'll state that they are qualified to do 9 and interpret, and usually recite the number of kind of 10 tests they can do, thallium exercise tests if they have 11 received adeouate training in both supervising and deciding 12 upon the implications for interpreting these tests.

13 CAPT. BRINER: Who decides whether the training 14 is adequate in that area?

O 15 DR. LINDGREN: Their trajning program.

16 .

DR. WORKMAN: The American College of Cardiology 17 does not examine applicants, then, in radionuclide studies?

18 DR. LINDGREN: I think that is the job of the 19 certifying body. There is board certification in 20 cardiovascular diseases which are certifying bodies.

21 DR. WORKMAN: Do they examine people?

22 DR. LINDGREN: They cover the whole spectrum, 23 yes. I can't quote chapter and verse about how much 24 radiation safety is on that examination.

25 MR. CUNNINGHAM: I want to be real clear on this

8210 04 10 55 1 DAVpp I to be sure I understand it.

2 In board cerkification-in cardiology, they test

', 3 and recognize a certain level of competence in nuclear

! ,4 cardiovascular diagnostic procedures; is that correct?

5 DR. LINDGREN: That is part of the training 6 program and, as I said, I haven't taken the boar 7 recently, but I think that in covering the broad spectrum of f 8 cardiology training, they would cover the application and 9 use of nuclear medicine.'

4 10 MR. CUNNINGHAM: It's part of the determination , .

.g 4 12 DR. LINDGREN: Board certification.

13 ,,

MR. CUNNINGHAM:. Perhaps if you'd be so kind as

<- 14 to supplement the record on that.

15 DR. LINDGREN: Okay. I'll have to be in contact 16 with ye g he American Board of Internal Medicine, which W.

17 is the governing body.

18 MR. CUNNINGHAM: Any other questions?

19 Dr. Goodrich?

20 . , . DR. GOODRICH: Of your own personal knowledge of

/

21 the training programs that you've participated in and

., 22 theEs in your peer group, have you ever known anyone who 2[ Qa's jot approved or who was required to take additional

s 24 training in order to satisfy the basic concerns of this 25 body?

Qg gang s/M/ts k4*dW -Q , ~ %?? & * */ f m y a e oa.uLm sM "'.M A M 6o .p; k a n ,y , y % > M '

. " Wr waag m wy;w.

8210 04 11 56 1 .DAVpp 1 DR. LINDGREN: In nuclear cardiology? No, I 2 don't know of any one individual who was asked to return and 3 get more training; no.

() 4 MR. CUNNINGHAM:

hu Thank you.

5 Dr. "i--?

Pb MOST: qp.

6 DR. f4&bbERg_ How many of your trainees are 7 certified in nuclear cardiology?

8 DR. LINDGREN: Now, we're a group of five 9 hospital-based cardiologists. All five do nuclear medicine 10 testing. Only two of us are licensed.

PodaFr:

11 DR. M!LLrngp,Do you have a training program?

12 DR. LINDGREN: No. We rely entirely on their 13 training programs before they join us.

14 MR. CUNNINGHAM: Thank you very much.

15 Dr. Goldberg?

l 16 DR. GOLDBERG: I'm Daniel J. Goldbero. I'm a .

l 17 board-certified cardiologist in private practice in 18 Bethesda, Maryland. I'm a Fellow of the American College of l

19 Cardiology.

20 !!y practice has a special interest in the area of 21 nuclear cardiology and, as well, I have te obtain a license 22 to practice nuclear cardiology in this s tra t e . After 23 studying the current NRC regulations for licensure, I 24 believe they have a significant shortccming.

25 Primarily, they fail to recognize the expcsure to

8210 04-12 57 1- DAVpp 1 radiation safety that physicians require during the course 2 of their entire training.

3 Physician's training in radiation safety begins 4 as a medical student. Exposure to radiation-related (J~3 5 subjects, including radiation safety, is continued 6 throughout the internal medicine internship and residency.

7 When the physician decides to become a 8 cardiologist, he enters into approved cardiology fellowship 9 training, as we all know. lie must master tremendous skills 10 within two or three years. These include many diagnostic 11 skills, including electrocardiography, electrophysiology, 12 stress testing, cardiac catheterization, expertise in 13 hemodynamics, and obviously, nuclear cardiology.

14 I feel they are all complimentary. They allow Perfsm 15 the cardiologist to 4esg 3 each one of his techniques more 16 expertly. Specifically, training in a cardiac 17 catheterization laboratory includes extensive experience in 18 the concepts of radiation exposure, radiation protection and 19 especially radiation safety.

20 This is supported by the documentation over the 21 past decade of hundreds of thousands of angiographic 22 procedurd[thathavebeenperformedbycardiologistswithout 23 any reports of a radiation-related safety event.

24 Therefore, when this physician moves into the

(- 25 arena'of nuclear cardiology, he brings with him a heightened

f 8210 04 13 58 2 DAVpp 1 awareness or concern for radiation safety that has already 2 been inculcated in him in the cardiac catheterization 3 laboratory.

() 4 Personally, I have worked in six different 5 nuclear laboratories in six years. Four of them were 6 supervised by nuclear cardiologists. These experiences 7 occurred during my fellowship and since I've been in private 8 practice. They occurred in the State of Kentucky and the 9 State of Maryland.

10 During this time I have not seen any adverse 11 patient event due to inadequate safety precautions, 12 especially in the laboratory supervised by the nuclear 4

13 cardiologist. ,

14 During my cardiology training, I experienced the i O 15 kind of training which was presently recommended and

]

16 presently is held by the NRC. I have 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of 17 supervised experience in the handling of radioactive 18 materials, in addition to 250 hours0.00289 days 0.0694 hours 4.133598e-4 weeks 9.5125e-5 months of didactics.

19 My experience -- we were not forced but we were 20 asked to at least be involved in at-least 600 hours0.00694 days 0.167 hours 9.920635e-4 weeks 2.283e-4 months of 1 21 clinical experience, which was totally separate and often 22 run concurrently with the other part of the training.

A 23 Certain questions were asked &c Dr. Lindgren 24 regarding certification in a cardiology fellowship program.

25 Since I finished my fellowship five years ago -- four i

I

8210 04 14 59 1 DAVpp 1 years ago to be exact -- the question was asked was anyone 2 ever not certified to do nuclear cardiology. I can say 3 yes.

(~)'

v 4 In the training program that I was in, there were 5 approximately eight to ten people. Only four of the eight 6 were allowed to apply for their license at that time. This 7 decision was made by a radiation physicist, by the director 8 of the nuclear medicine program, and by the director of 9 cardiology.

10 So there have been people who, in my opinion, 11 have not been accepted to be approved by the program. I l

12 believe that the amount of experience that I received was 13 excessive and overkill. I felt that it was excessive in And 14 terms of handlino the principles of radiation safety.

~^

\

-) . 15 It's for this reason that I feel that the 16 licensure criteria could be easily met over the three to 17 four months.

l 18 I firmly believe that it is necessary for 19 guidelines to be established delineating the amount of 20 training necessary to safely handle the use of radioactive 21 isotopes. This training must include didactics, supervised 22 clinical experience, and expertise in the handling of sealed

. 23 and unsealed radioactive isotopes.

l 24 However, in my opinion, the present NRC ruling is

(~)

\/ 25 excessive in that it does not take into account overall l

. _ _ .- . . _. ~ . - _ . _ . __ -. _ _ - . . _ . _ . . - _ - __ . _ _ _ . _ _ _ . . . _ _ -_. _

4 8210 04 15 60 1 DAVpp- 1 training and experience that the physician in the cardiology ;

2 fellowship receives. ;.

I 3 I, therefore, support the recommendation proposed r

O 4 dr ** ^= ric # c 11 e- e c rai 1 sv #a ** ^= ric # " r*

5 Association. I feel they recognize the total training of ;

6 the cardiologist and the present training. program at this [

7 time. I

8 Thank you for granting me this time. t 9

i

. i i lo

{ 11 .

1

! 12 i 4

13 :

j 14 -

.O .

~15

. 16 l, j 17 j 18 .

19 i-20 21 ,

22 ,

23 24 j 25 1

i

l l

l 8210 05 01 61 1 DAVpp 1 MR. CUNNINGHAM: Thank you very much, 2 Dr. Goldberg.

3 Questions?

( 4 Dr. DeMardo?

5 DR. DE NARDO: Did you do the studies you were 6 talking about in your office?

7 DR. GOLDBERG: No.

8 DR.,DE NARDO: Thank you.

9 MR. CUNNINGHAM: Any other questions?

10 (No response.)

11 MR. CUNNINGHAM: Thank you.

n 12 Dr. Ronan?

13 DR. RONAN: Mr.Cunningham,membefofthe.

14 Advisory Committee, thank you for allowing me to express my

[}

15 opinion $n these matters.

16 My name is James Ronan, a cardiologist in private 17 practice of cardiology in this community.

18 I'm interested in the area of nuclear cardiology 19 and I've been licensed by the NRC to handle radioactive 20 materials in cardiovascular diagnostic procedures. ;

21 I'm also interested in the training of. physicians 22 in cardiology and I previously served for nine years as l

23 full-time faculty in tho Department of Cardiology of 24 Georgetown University School of Medicine.

25 I still teach weekly and hold the rank of

8210 05 02 62 1 DAVpp 1 Clinical Professor of Medicine at that institution.

j 2 I mention this background only to indicate my 3 interest and experience in teaching and learning because I

) 4 believe that the NRC is establishing the required curriculum 5 for education and handling radioactive materials.

6 Radiation safety is the goal of that curriculum 7 and like many scientific courses, has been divided into i

8 sections of lectures and two separate sections of practical 9 application unrelated to basic radionuclide handling 10 techniques and one to clinical training.

11 While the subject matter included in this 10 curriculum is reasonable, it appears that the decisions made 13 as to the time required to accomplish those goals, although 14 possible, are somewhat arbitrary.

15 The background biology and mathematics in .

16 radiation protection cannot be argued. That knowledge is 17 absolutely mandatory.

18 The requirement for 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months worth of didactic 19 work in those fields may seem excessive to some and is 20 really the equivalent of 12 semester college credit hourc.

21 But in my judgment, it's not unreasonable.

22 !!owever, the weakness in the logic of the i

23 training requirements, to me, seems to lie in the second

(

24 part of the program and in our failure to recognize the 25 overlap and the knowledge transfer which exists between i .

1 i

r 8210 05 03 63 1 DAVpp 1 these separate areas.

2 In the section devoted to radionuclide handling 3 which is 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months , that's equivalent to 62 work days, or 4 three months, that's required. That duration seems l

5 particularly excessive when we consider that the subject l 6 material which is to be included in that three-month period 7 and let me list that for you:

8 Number one, ordering, receiving and unpackaging 9 radioactive material safely. Number two, calibration of 10 dose calibrators and operational checks on survey meters.

11 Number three, calculationj preparation and calibration of 12 patient doses. Number four, administration of doses to 13 patients. Number five, appropriate internal control 14 procedures to prevent the misadministration of materials to

}

15 patients. Number six, procedures to handle spilled elufs'en 16 materials safely and, number seven, illution of technetium 17 99 M from generator systems.

18 These tasks are unnuestionably important for '

19 sheer safety but they're really not terribly difficult to 20 learn, particularly considering that there are several 21 overlaps between the original 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months and the 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months , 22 dedicated to handling the material. The foundation for all 23 those tasks will have already been covered in great detail

-24 in the didactic portion and that knowledge is directly 25 transferable.

L_

8210 05 04 64 1 DAVpp 1 Furthermore, many of the tasks in the group are 2 simply bookkeeping and recordkeeping chores having to do 3 with ordering, receiving, and preventing the

() 4 misadministration of materials. It really should not take 5 three months to learn those tasks, particularly when the 6 physician has the basic scientific background and 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months 7 worth of preparation.

8 I recently asked a technician in our nuclear 9 medicine department hew long he thought it would take to 10 teach a technician those tasks, granted that they aircady 11 have their own background,their material. Their estimates 12 ranged from one to two weeks. That is, from 40 to 80 13 hours1.50463e-4 days 0.00361 hours 2.149471e-5 weeks 4.9465e-6 months . Certainly, it should not take most physicians three 14 months.

15 I understand the importance of this experience 16 and I don't mean to minimize it. I just think that the I 17 arbitrery decision to require 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months in this curriculum I 18 is just not reasonable, and it's prolonging the program 19 unnecessarily.

20 Lastly, let me say that the separation of the 21 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months in handling from the 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months required for 22 clinical training, is an artificial separation and is really 23 not realistic. There's considerable overlap in knowledge 24 transfer between those portions of the curriculum and it's O 25 probable that a trainee would and should consider them

l l !

i l 8210 05 05 65 [

2 DAVpp 1 together.

2 Ideally, a trainee should be totally involved in 3 the patient's problem so that during this period of

() 4 training, he could examine the patient and select the 5 appropriate nuclear test, order the radionuclide, calculate, 6 prepare or calibrate, and administer the dose and also i 7 interpret the test. That's a logical way to train a 8 person.

9 separating those tasks into two different 10 categories is an artificial separation. Let me say that I 11 don't know the correct answer to the time required for this j 12 curriculum. My division may be just as arbitrary as others, 13 however, I think we must recognize that there's a great deal 14 of overlap between the subject materials and the tasks O 15 considered in these three separate categories, and that wo 16 shecid not consider them as entirely separate, independent 17 courses needed to graduate.

18 The last two categories have been separated -

19 mainly because we're accustcmed to thinking of them as l 20 separate individual responsibilities. These tasks in the 21 handling category are placed in the hands of the 22 technician traditionally, while those in the clinical area 23 have been the physician's responsibility.

l 24 Well, different tasks have been in practice O 25 before by .tifferent persons. There's no reason why, in that l

l.--_______-_-__--_-_______----_-_---_____-._____-__

I !

8210 05.06 66 DAVpp period of training, they could not be learned 1 1 2 simultaneously, thereby, reducing the required time for 3 learning.

() 4 some comparison could be made to the curriculum 5 in an automobile driving school. A certain number of hours !

l 6 is not devoted exclusively to learning to stop the car while j f

7 another certain number of hours is not devoted exclusively !

i 8 to learning to turn the car. }

9 There's considerable overlap in the process of I i

10 1 earning those skills. It's my estimate that the 200-hour f L

11 didactic material will be retained, but that the remaining j 12 material can be learned in three months.

13 Furthermore, the clinical period of training i 14 would only be the starting time for the cardiologist in that :

O 15 three-month period. That's only the beginning of their l

16

experience . They will necessarily continue to learn j 17 throughout their clinical experience. !

i 10 Thank you very much.

19 MR. CUNNINGHAM: Thank you very much. !

i 20 Questions? !

21 DR. QRIEM: Where is the basic math and physics l l

22 in this program, the concept of tissue absorption and all .

)

23 these things. -

24 DR. RONAN: It's a very extensive program. In l 25 the course I took, we had 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months . It seemed like it was I

t I

__ _ _ . _ . _ . _ . _ _ _ ~ _ . - _ _ _ _ _ _ _ _ . _ _ _ _ _ . . _ _ _

i

I 8210 05 07 67 i i 1 DAVpp 1 eternal for me. It seems like it never ended. It's the i j 2 equivalent of 12 college credit semester hours. A lot of .

1 :

3 time, and I don't think we need to relearn that when we l

() 4 go in the laboratory to write out the procedure for the l 5 radioisotopes. <

^

i

( 6 MR. CUNNINGHAM: Dr. DeNardo? I i

, 7 DR. DE NARDO: Are you doing any single photon

Cth: 5610 0

8 trergic.;? .

3 c f 9 DR. RONAN: Nc. f i

! 10 DR. DE NARDO: Do you intend to? ;

i 11 DR. RONAN: I can't answer that. I i

12 DR. DE NARDO: If you were to do so, how would l

13 you set up the quality control for the instrumentations?

l 5 14 DR. RONAN: I wouldn't want to do it until I went !

i 4

j 15 through training and felt qualified to do that. e 16 DR. DE NARDO: Thank you.

I

] 17 MR. CUNNINGHAM: Thank you very much.

J {

} 18 It's now 10:30. I'd hoped we'd be throuch with l 1

l 19 these presentations but I've had questions as have members ,

t

! 20 of the committee.

i ;

! 21 Perhaps we nhould take no more than a 15-minute i

. 22 break and be back here.

1 .

, 23 (Recess.)

J l 24 O 25

! 6 i

l

1 8210 05 08 68 1 DAVpp 1 MR. CUNNINGilAM: We've got to start again. ;

2 The next person that wants to make a statement is i 3 Dr. Lindsay. l

() 4 DR. LINDSAY: Mr. Chairman and committee members, ;

l 5 I'm Dr. Joe Lindsay. I'm an academic Cardiologist and I've 6 been a faculty member of three medical schools for 19 j 7 years. In my practice I've been interested primarily in 8 patient care -- I've been a clinician -- and the teaching of l 9 patient care. I'm presently a program director of a {

'\

10 fellowship program in cardiology.

11 I came to nuclear cardiology somewhat late in my :

. e 12 career, in 1976, attracted l'y the advantages this technique ;

13 seemed to offer my patierits. And through a very cooperative l 14 team effort with*the Nuclear Medicine Department in our O 15 institution, I have been heavily involved in it now for that 16 seven-year period to the point that I have been a principal 17 autt.or of about five papers in referee journals relating to 18 clinical application of these techniques. -

19 I have been impressed primarily by the very 20 favorable impact of nuclear cardiology on the care of my ;

21 patients. I'll mention only one of the numerous favorable !

l 22 impacts that exist. That is the ability to select more 23 carefully patients to undergo cardiac catheterization, a l l l l 24 procedure which, as you know, carries some small risk to the ;

() 25 patient in addition to a substantial radiation exposure to :

?

i i

8210 05 09 69 1 DAVpp 1 the patient as well as to the pnysician doing the 2 examination.

3 I support the position of the American College of

() 4 Cardiology and the compromise proposal for a four-month 5 training period because, while I believe that the ideal 6 approach to nuclear cardiology is a team effort between a 7 nuclear medicine physicie.n or a radiologist and a 8 cardiologist, this appre.ach is often impossible, 9 particularly in smaller centers and particularly in i 10 outpatient settings.

11 The increased training from three to six months l

1 12 has resulted in a reduced nunber of cardiologists who can be 13 qualified to offer these services to our patients, thus, ;

14 certain patients may be deprived of the opportunity to have i 15 these important dirignostic tools. This should not take i

16 plade, in my view, because of an inappropriately long 1

17 required training period.

18 In addition, as has been pointed out before, 19 to .any period devoted exclusively to nuclear cardiology, 20 cardiology training incorporates a supervised training and 21 integration of nuclear cardiology findings to the care of 22 the patient.

23 I fully understar.d and heartily support the 24 concern of the !!uclear Regulatory Commission in the handling O 25 of isotopes. I would have it no other way. But I would l

t

0210 05 10 70 1 DAVpp 1 urge you to make your decision on the basis of the grounds 2 of safety, taking into account the excellent safety record 3 that has boon produced by nucient cardiologists testing as

() 4 well as the limited number of tests and isotopos to ho 5 employed by cardiologists authorized to use these.

6 Thank you for allowina me to testify.

7 f tR. CUNNINGilAM: Thank you very much, 8 Dr. Lindsay.

9 Any questions by members of the committee?

10 (No response.)

11 MR. CUNNING!!AM: I soo no questions. Thank you 12 very much.

13 Dr. Fox? ,

g-) 14 DR. FOX: Mr. Chairman, ladios and gentlemon.

V k 15 l ' m D r . Lc. }. . g,, Fox .I'm a practicing 16 cardiologist. After spending 21 years in the Navy, when I 17 retired I joined the faculty of Georgetown University. I've 18 hoon practicinq cardiology at Coorgetown since then. For 19 the last five years I've boon doing nucionr cardiology in 20 the Nuclear Medicine Department at Coorgetown.

21 I recently, through my own interest, went and 22 took the five-wook course of didactic training in a program 23 designed to moot the NRC requirementn. I didn't do it

_ 24 because I nooded the cortification becauno I was practicing k- 25 in a nuclear medicino sotting and I found no nood for that.

l <

i l l i

8210 05 11 71 [

1 DAVpp 1 But I did it out of my own interest. j 2 I found it quite interesting and enjoyable. I i I

3 did find that at least half -- or I'll say a significant l' O 4 nortion of the time -- was svent en suh3ects and mod 11 ties 5 that had very little relationship to cardiology.

6 For instance, radioimmunoassay is something that '

r 7 I have no plans to use ersonally, that is, to employ these ;

8 procedures myself g ere is a great deal of time spent 9 on imaging of other organ systems, brain, lung, bones, !

10 kidney, liver, et cetera. Again, very interesting. f r

11 I don't count the time wasted but it had very i 12 little application to my own interest of cardiology so that t

13 at least-in that fairly restricted sense, I'm not even sure [

14 that the 200 didactic hours are truly a requirement or a 15 necessity for someone who's going to confine his practice to j i

16 nuclear cardiology.

l 17 In Georgetown, as perhaps many of the other 18 speakers have indicated, we have a very comfortable working 19 relationship with the Nuclear Medicine Department. t 20 Un have cardiology for those nuclear medicine (

i 21 fellows, radiology residents rotating through, and I'm ;

22 heavily involved in teaching all of these as well, of l 23 course, au performing the cardiac tests. I think this {

24 arrangement is a very comfortable one and one that certainly O 25 is the ideal. I can't pretend to say that this should be a ,

l I

r .

i i

8210 05 12 72 1 DAVpp 1 requirement for everyone who wants to do nuclear 2 cardiology, and it's obviously the NRCs job and your job to !

l l

3 figure out exactly what the requirements should be for this

() 4 and other specialties.

l 5 I think that as much as possible, it would seem l

l 6 to me, that the philosophy in back of your decision should 7 be to confine the Nuclear Regulatory Commission's !

8 regulations to radiation safety as much as possible. This 9 has already been alluded to and I won't go into it further.

10 Dut I think clinical competency, as much as possible, ,

4 11 should be left to the professional organizations.

12 One point that I haven't heard alluded to so far,

( 13 and that is the way in which isotopes are prepared in l

14 different settings. At Georgetown, we use a prepackaged !

O. '

15 service for all of our nuclear medicine needs which, I

(

16 found, is very much more conienient for the physician. We 17 don't have to worry about all these quality control la aspects. - "

i i

19 I wonder whether this should't be something that ,

l 20 should be encouraged more widely. It cartainly maken it 21 easier to practice, focusing on the clinien1 aspects of what 22 you're doing rather than having to worry quite so much about 23 the strictly radiation safety enlibration, et cetern, l 24 aspects of the procedures. ,

( 25 I think that's really all I have to say. Thank I

8210 05 13 73 1 DAVpp 1 you for the opportunity to speak.

2 MR. CUNT 11 ngl!AM: Thank you, Dr. Fox.

l i

I l 3 Dr. Itolman?

O 4 DR. notM^N Does your testimonv mean that you 5 are supporting the position of the American College of 6 Cardiology and the American lleart Association?

t 7 DR. FOX: Yes, I do support their position, 8 although, my own personal feeling is that even a shorter 9 duration of formal training or required training would be 10 quite appropriate. It, perhaps, couldn't go back to what it f 11 used to be, a three-month period, prior to all the changes 7 12 that were introduced.

13 HR. CUNNINGilAM: At the same time, you are ,

I 14 suggesting that it would be better to uso prepackaged dose 0 15 forms rather than generators. Do you couple the length of T

16 the training you subscribe to with the idea that you only

(

17 use prepackaged dose forms? !

10 DR. FOX: I wasn't particularly coupling them, 20 p h shou iv s e hou tt l

21 MR. CUNNINGilAM: What would your position be on 22 that? !

23 DR. FOX: personally, I'm quite ccmfortable using l

l 24 the prepackaged dose forms. I find it a real advantage not O '

25 to have to worry about all the other aspects. Whether that

G210 05 14 74 1 DAVop 1 should be a recuirement for a doctor who's not in the sort 2 of setting I'm in, whether that would be appropriato, I 3 can't say.

4 MR. CUNNINGHAM: Dr. DeNardo?

5 DR. DE NARDO: In your recent general nuclear 6 medicine course, I had several somewhat related questions.

7 Did you find that the bono imaging to be of any use in terms 8 of your use for those types of agents in cardine work?

9 DR. TOX: Thegonoralprincipk g ot imaging woro 10 of some value, I think, but not the details of the more 11 specific aspects.

12 DR. DE NARDO: Did you got a chance to work or 13 see or be involved in either discussions or actual hands-on 14 in indium laholod blood cells?

15 DR. FOX: Durino that course'there wara 16 discussions. There wore lectures, et cetera, but not 17 hands-on experience.

10 DR. Dr. NARDO: Do you think that would be of any 19 usoj or would you be interested in doing one way or the

?)

like indium labeled platelots requir dWo'nar(tery 20 other, 21 thrombosis or indium labeled antibody studies?

22 DR. FOX: Wo have discussed using indium labolod 23 platelots to detect thrombosis and so far have not felt that l

l 24 it was worth the effort.

r~N

! '- 25 All of the difficulty involved in performing l

l

i l I 0210 05 15 75 1 DAVpp 1 those specific tests, as I'm sure you well know, it's a very l l 2 tedious and time-consuming procedure. And we haven't felt- l l

l 3 that it was warranted to try to set that up. ,

O 4 5 .

i 6 l 7 t 0

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10 1 11 12 [

13 ;

I 14 15 j 16 17 10 19 .

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20 1

21 1 22 <

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23 24 25 1 I

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0210 06 01 76 1 DAVpp 1 DR. DC UARDO: Doyouthinkyourbackgroung 2 training in general nucioar medicino has been useful in 3 helping to inske, and in the future to help makoj that nort of lg) 4 decision on cardiac radiopharmaceuticals?

5 DR. TOX: I found the discussions on 6 radiopharmaceuticals in general quito interesting, yes, and 7 I'm sure they will be of nomo help to me.

8 DR. DE NARDO: Thank you.

9 !!R. CUNNINGl!AM: Captain Drinor?

10 CAPT. DRINCR: Dr. Fox, I gather from your 11 statomont that you are not advocating that it be required 12 that physicians practicing cardiovascular nucionr medicine 13 uso propackaged donano forma?

7-) 14 DR. FOX: No. I just throw that in as my own

('~ /

15 experience and that it'n a very neat way to practice. I'm 16 not saying that we ought to make this a recuirement.

17 CAPT. DRINER: That's comforting because it's not 10 widely avnlinble in n lot of the 1cosor populated arons.

19 DR. 00X: I'm nurn that's the caso. In the bio 20 cition, it's economienlly feasible to have companies that do 21 thin for you.

22 CAPT. DRINCRs Dut I hepo you're not inferrino 23 that you should not have any knowledge or interest in 24 ounlity control of the agenta you use?

25 DD. T0X: l'ot at all.

l l l

1 l 8210 06 02 77 l l 1 DAVpp 1 CAPT. DRINER: And you feel you've had adequate j l

2 training to provide that?

i 3 DR. FOX: Yes, sir. l

() 4 MR. CUNNINGHAM: Any other questions?

5 (No response.) l l

6 MR. CUNNINGHAM: Thank you very much.

7 Dr. Martinez. j O DR. MARTINEZ: Mr. Chairman, members of the ;

9 committee. My name is Jose Martines. I'm a physician. I'm {

I 10 an internist with board certification in internal medicine.

11 I practice in Maryland in a 150-bed community hospital. I'm i

12 also the President-Elect of the American College of Nuclear !

13 Physicians and I'm testifying on behalf of the college. [

14 The physicians of the college have had me send in l O 15 a document which has been distributed to you and I will not l

i 16 reiterate it. But the essence of our position is that we 17 are in support of the reduction of the currently required 10 six-month training for physicians -- cardiologists wishing !

19 to engage in cardiac imaging through the use of f 20 radionuclides. He are in opposition to the reduction of the 21 six-month training period for all other physicians wishino l 22 to practice nuclear medicine.

l l 23 He, too, like other professional anscelations, l 24 are very much in support of a single standard for radiation :

l l

C:) 25 safety and the proposals we support are in concert with that i I

L i

(

I

i 8210 06 03 70 1 DAVpp 1 position.

2 The difference between the training requirement 3 of the two groups does not address the basic safety

() 4 requirement, the basic education, the basic body of 5 knowledge which is necessary to insure radiation safety.

6 And I could perhaps add at this point that, indeed, there is 7 an awful lot of transfer of knowledge between didactic 8 instruction and practical hands-on experience. But the role 9 of hands-on experience is not only to confer or transfer 10 knowledge, it is also to insure dexterity.

. 11 It appears to us eminently reasonable when a 12 physician states that his purpose is tp perform only a 13 limited part, a limited number of proceduren available to 14 him in nuclear medicine, that we should require that 15 physician to document for the Nuclear Regulatory Commission, 16 clinical exposure to only those procedures he can support.

17 We concur with the Nuclear Regulatory Cornission 18 that it is not the intent of the Commission to certify 10 competence. We certainly do not believe that this is a 20 certification of competence, but what it does provide is an l

21 assurance that the physician has had the opportunity of 22 translating his basic knowledge into clinical applications 23 and we find it quite reasonable to expect somebody who 24 wishes to engage in the broad field of nuclear medicine to l

O 25 document if he has been exposed to a wider clinical

0210 06 04 79 1 DAVpp 1 experience than somebody who wishes to limit himself to just l

l 2 ene discipline within the broad field of nuclear medicine.

3 The regulations under which we currently are r O 4 tr i i=9 were oontea eter m #v ve r or disces io= e=a 5 have been in effect only since July of 1984. They have 6 created severe problems for directors of training programs 7 in radiology.

8 We would be naive not to expect them to create 9 such problems in a discipline where there has been literally 10 an explosion of knowledge over the past 15 years. Dut they 11 have only been in existence for ten months, and we urge you 12 not to reverse them if enough experience has been available to conclusively demonstrate whether they have beneficihl or i 13 14 detrimental training implications.

O 15 This concludes the position of the college. .

16 If I may digress with your permission very 17 briefly to address my personal feeling about pre-packaged 4

10 doses, they are an extremely convenient way of taking 19 radiopharmaceutients. I do not consider that they relieve 20 me or any other physician from the obligation from 21 personally assuring, at least on a sampling basis, that tho 22 representations of the radiopharmacy are supported.

l

23 Thank you.

l l 24 Mft. cut!!!!!!OllAMI Thank you very much, l

U 25 Dr. Martinez.

I

0210 06 05 00 1 DAVpp 1 I'm sure on your last personal statement you will '

l 2 have strong support. .

3 (Laughter.)

() 4 MR. CUNNINGHAM Are there any questions of 5 Dr. Martinez?

6 If I may, I have a question for you. l 7 You support the four-month training for nuclear 0 cardiologists but six-months training for the broader field 9 of nuclear medicine.

10 Now, as we see more specialty areas coming to 11 these as time passes, there will be other specialized groups 12 that want to use nuclear diagnostic or perhaps even 13 therapeutic techniques. Would you elaborate on nucient 14 cardiology as a subspecialty in performance training.to the

.O 15 other areas where, if they want to use nuclear techniques in 16 a very narrow field -- would you support the idea of 17 four-months training in those instances?

10 DR. MARTINEZ Again, Mr. Cunningham, I'll speak 19 for myself, not for the college.

20 We physicians must remember that what we are 21 granted is a license. It is a permit to perform such 22 functions, not license to perform functions that is absolute 23 freedom to perform functions. This process of licensing 24 reflects essentially societal concerns.

l 25 1 do not look upon nuclear cardiology, really, as

0210 06 06 81 1 1 DAVpp 1 a subspecialty but, rather, as the inclusion in the practice

l l 2 of cardio1'ogy of a skilled procedure which the cardio1cgist 1 3 is able to perform well, and which benefits his patient.

() 4 As the body of knowledge in other subspecialtien 5 grows, we probably will have to address the same question i 6 elsewhere. I only hope that then we will be guided by the 7 same principles we're addressing today, that is, that the 8 training to which a physician is willing to submit himself 9 should assure us, as a society, that the services he will 10 render to the patient will be appropriate, will not result 11 in cost overruns -- a word we in medicine have to borrow 12 from the military today -- and that they will not result in 13 the radundancy of what is extremely expensive resources. ,

I 14 We do spend $1 billion a day on medien1 care for 15 this country today and we have a responsibility for cost -

i 16 containment. It's not vested in any one of us but it's l

17 vested in all of us and we simply have to address it as it -l 10 comes along with the same integrity we address this one.

10 MR. CUN!!!!!OllAtt Thank you very much.

i 20 Dr. Webster? :

1 21 DR. WEDSTER: Following up on the question, could 22 you conceive of a specialist, another kind of specialist 23 requiring loss than four months training? For example, we ;

! 24 do have physicians now who practice some aspect of nuclonr i l

() 25 medicine under a general license.

i l

r

l i -

8210 06 07 82 1 DAVpp 1 DR. MARTINEZ My personal experience and my ,

2 personal practice is under a specific license. Where an 3 institution has a broad license the delegation of the 4 responsibility for credentialing the physician is given to l

5 the institution. Implicit in this is that each institution 6 develops its own criteria in compliance with rules, 7 regulations and laws.

O I am concerned about the fact that an increasing 9 amount of diagnostic medicine is being practiced outside 10 hospitals and will increasingly be practiced outside 11 hospitals where the processes of credentialing, quality j 12 assurance, and physician review do not exist. I 13 Ipso facto the mechanism for regulating this i 14 activity in society's benefit on the patient's falls back on 15 government. -

16 If I may, Mr. Chairman, since I've beo. ;

17 recognized again, may I make a small point? !

10 !!R. Cutilitt10llAM: Certainly. j 19 DR. MARTIlltZ s We are a bit concerned about the 20 fact that in the rederal Register's last notice of February, 21 only cardiology programs are designated as able to provide 22 the training of cardine nuclear medicine. We understand 23 that this is not intended to disenfranchise training ;

24 programs in radiology. Dut, we urge that in the final form 25 that regulations make that clear.

' ' ~

g 8210 06 08 7, 83

, 1 DAVpp 1 ,

MR. CUNNINGHAM: The point is well noted.

2 You bring up a point, though, that diagnostic

- 3 procedures are moving outside the hospital. I think

-( ) 4 Dr. Siegel brought out a good point in extending the broad 5 license certification of physicians to other hospitals. But

+

n G the trend se' ems to be have diagnostic procedures moving 7 autside the hospital to clinics; is that correct?

, 8 DR. MARTINEZ: Yes, sir, they are known as 9 cost-efficiency pressures that are brought to bear in this l

/

10 field. A freestanding diagnostic facility does not have to 11 underwrite the cost of unreimbursed care. It does not have 12' to underwrite the cost of training programs and education li " ' programs

m. 14 By definition the overhead of the freestanding 15 facility is less than a hospital. In today's climate, 16 this /creates unsurmountable pressures to move the diagnostic

( 17 exercises outside the hospital to the freestanding l

18 facilities.

19 MR. CUNNINGHAM: Thank you very much.

l 20 DR. MARTINEZ: Thank you, sir. l 21 MR. CUNNINGHAM: Dr. Welch?

1 22 DR. WELCH: Mr. Cunningham, members of the 4 .

23 Advisory Committee. My name is Michael Welch, Professor of e

. 24 Radiation Chemistry and Radiology at Washington University I

O 25 School of Medicine in St. Louis. I'm President of the x.- < ,

k i,% ' , . . . .

l 8210 06 09 84 1 DAVpp 1 Society of Nuclear Medicine. I'm here to testify on behalf 2 of the Society of Nuclear Medicine.

3 The formal position statement of the Society of

(~T 4 Nuclear Medicine was sent to you prior to the meeting and is

(,/

5 the same as the ACNP statement, that is, to support the 6

Me-OttMk fer--1 training requirement for the practice of

/

7 cardiovascular nuclear medicine 'six months for physicians 8 practicing general nuclear medicine.

9 During my_ time, I'm going to give you some 10 backgrounds to the generation of this statement in the 11 Society of Nuclear Medicine. The Society contains members 12 from all of the groups testifying before you today. In 13 fact, the majority of people testifying on behalf of other 14 organizations -- as we have heard -- are, in fact, also 15 members of the Society of Nuclear Medicine.

16 Not only do members of the Society but members of 17 our Board of Trustees and Executive Committee have very 18 divergent views on this issue. The positions range from the 19- one supported by Dr. Blahd that the. current regulations, in 20 fact, represent a compromise and that any misadministration 21 of radiopharmaceuticals impacts on radiation safety and so 22 that the current regulations should not be changed.

23- The opposite extreme is represented in the 24 testimony of my colleague at Washington University, Darry O, 25 Siegel. Since my installation as President of the Society

8210 06 10. 85 1 DAVpp. 1 of Nuclear Medicine, the issue before you has been the major 2 topic discussed at our Executive Committee, Board of 3 Trustees, and in the many phone calls and letters that I've E 4 received over the past ten months.

5 This issue has, in fact, consumed the major 6 portion of my time since last June and I strongly believe 7 that the joint ACNP-SNM position represents the only 8 possible-change in the current regulations. With the 9 anti-nuclear sentiment in the general public, we believe 10 that altering the regulations affecting general nuclear 11 medicine -- especially regulations that have only been in 12 effect for a few months -- will be perceived as I say.

13 We do acknowledge that the Commission can grant 14 exemptions to the current regulations and that the 15 physicians sole 19 practicing cardiovascular nuclear medicine 16 work /with, and will always work with, less 17 radiopharmaceuticals than the nuclear medicine physician who 18 studies all organs.

19 It seems logical, therefore, that the training 20 necessary to allow the safe handling of a limited number of 21 radiopharmaceuticals and the clinical practice in order to 22 -study them should be less than that required to handle all 23 radiopharmaceuticals for-all organs.

24 This is the Society of Nuclear Medicine's i 25 position. This has been a difficult and time-consuming l

8210-06 11 86 1 DAVpp 1 issue for the Society of Nuclear Medicine to discuss.

2 Even after our compromise position has been 3 reached, I am still receiving phone calls and, in fact, two

() 4 special delivery letters yesterday from members of the 5 society who hold what I will call the extreme positions. I, 6 however, strongly believe that when all the facts are taken 7 into account our position represents the only possible 8 change from the current regulations.

9 Thank you.

10 MR. CUNNINGHAM: Thank you very much, Dr. Welch.

11 Any questions?

12 Dr. Webster?

13 DR. WEBSTER: I road your statement very 14 carefully. I was impressed by the argument that you made.

( 15 You felt that in terms of the clinical limitations of the 16 field, that nuclear cardiology could get by, so to speak, 17 on less training -- four months. But actually, you didn't 2

18 mention four months, you just said less training.

19 But when you get right down to the end of your 20 statement -- almost the very last' paragraph -- you suddenly 21 produce six months out of the air, so to speak, with no 22 logical build-up or lead-up or justification of the six l

^

l 23 months. You could have said four months and three months l

24 but you said six months and four months.

f')

\' 25 The only point you really made in your statement l

l l

I i

I

8210 06 12 87 1 DAVpp 1 was that it should be less for cardiologists but it should 2 be six months for other physicians.

3 DR. WELCH: If you look at the first paragraph of

(} 4 5

my formal testimony, it states, "I'm sure you had an opportunity to carefully review the November 8, 1984 letter 6 to Mr. Cunningham from the various specialty groups." And 7 we felt when making the formal statement that that was part 8 of the record and the arguments that are presented by the 9 Society and by the ACNP for the retention of six months for 10 general nuclear medicine are in that lettter.

11 DR. WEBSTER: I didn't mean that at this time. I 12 had read it in the past.

13 My point is that you are really speaking to one 14 of two issues. One is, should there be a reduction of p

15 time. Secondly, should the six months be maintained. It 16 seems to me that there are arguments for that that have to 1

17 be reiterated at this point in this climate in this 18 meeting.

19 DR. WELCH: I think that our position is the same 20 as.the ACNP that was stated by Dr. Martinez that the six 21 months for general nuclear medicine was a position that was !

22 reached after much discussion,after/Neof r- h ge W ky this group.

l 1

23 That's a position that has only been in effect i

24 for ten months and we feel strongly that ten months isn't a l

) 25 long enough time to change this position.

1 i

1 l

8210 06 13 88 1 DAVpp 1 MR. CUNNINGHAM: Dr. Woodbury?

2 DR. WOODBURY: One question. Whereas today the 3 question is relative to cardiology training, suppose next 7-)s

(_ 4 year the field has progressed, let's say in hematology, so 5 that the hematologists and oncologists want to be licensed 6 to have antibodies and therapy training. Would you then 7 come back to this committee and suggest that we have a 8 separate form of training or period of training for that 9 group?

10 DR. WELCH: I think I mentioned in the statement 11 I just read, that the NRC does grant exemptions and that 12 each subgroup should be considered on its merits.

13 I would feel that, yes, if a group such as you 14 mentioned or even neurologists practicing nuclear medicine 15 should come along, they should be considered on their 16 merits. But I also agree with Dr. Martinez that four months 17 is probably the minimum because one always needs the' core 18 radiation safety training and also some clinical practice.

19 MR. CUNNINGHAM: I would like to make a comment, 20 Dr. Welch, about how difficult it is, as current President 21 of the Society, to deal with opposing views until the 22 Society of Nuclear Medicine comes to a resolution on the 23 issue. I hope you have some sympathy for the NRC Staff.

s 24 (Laughter. )

25 MR. CUNNINGHAM: We understand warring j 1

8210 06 14 89 1 DAVpp 1 professional society and organizations.

2 DR. WELCH: I feel great sympathy for you. You 3 have the same people calling you wearing different hats

() 4 than they call me.

5 MR. CUNNINGHAM: Thank you very much.

6 Dr. Goodrich?

7 DR. GOODRICH: I would just like to recall for 8 everybody's memory, that indeed this Committee -- this 9 Advisory Committee -- heard the many hours of testimony and 10 the many days of efforts that went bnto communications 11 leading to the judgments that placed in the Federal Register 12 this July requirements for the six-month period.

13 I really would not feel that we would be required 3 14 to ask for further reiteration from the Society of Nuclear 15 Medicine or any of those bodies -- the justifications that 16 they presented at that time.

17 MR. CUNNINGHAM: Dr. Ross?

18 DR. ROSS: Thank you.

.19 Good morning.

20 Mr. Chairman and Staff, members of the Advisory 21 Committee.

22 I'm Allan Ross, Director of the Division of 23 Cardiology at George Washington University School of l

24 Medicine. j O' 25 It is my feeling that nuclear cardiac imaging is i

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l i- l 8210 06 15 90 1 DAVpp. ~1 an important and useful diagnostic modality. I believe it l 1

2 is best realized by individual physicians with appropriate i- 3 training in clinical cardiology, exercise testing, other ,

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i 5 angiography, recussitation, et cetera.

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8210 07 01 91 1 DAVpp 1 But your position also requires the safe, ,

2 medically appropriate use of radio tracer materials. This 3 seems to be a universal provision. I believe that the NRC

() 4 Staff should duly issue an NRC licensure for the medical use 5 of isotopes independent of what appears to me to be much 6 medical politics, or as just stated, warring professional 7 societies. These should not be an issue for the NRC.

8 It is obviously advantageous for some individuals 9 to have federal regulationn mandate an apparently excessive 10 training period. I think that's somewhat irrelevant.

11 I wonder why the NRC has not employed its 12 . excellent staff to simply define the requirements necessary 13 to satisfy the NRC charge to protect the public health and 14 safety. It seems that the old regulations accomplished that 15 charter.

16 The clinical training aspects of diagnostic 17 nuclear cardiology procedures should be overseen by those 18 medical societies in residency and training responsible for 19 the overall training cf specialized physicians. The safety 20 issues shculd be left to the NRC Staff.

21 I would urge the NRC to move in this direction so 22 medical politics are not the driving force behind any 23 government regulatory activity.

24 It's clear to me at this time that a training

^

25 period arbitrarily of six months to satisfy an URC mandate, I

.- - .. o

8210'07 02 92 1 DAVpp 1 at least in cardiovascular nuclear energy, is excessive.

2 And a two- or three-month training period should be more 3 than adequate, at least for that particular practice.

() 4 Thank you for affording me the opportunity to 5 offer my opinions.

6 MR. CUNNINGilAM: Thank you very much, Dr. Ross.

7 Questions by members of the panel?

8 (No response.)

9 MR. CUNNINGHAM: I have one.

10 In your hospital, Dr. Ross, what arrangements do 11 you have with other physicians, vis-a-vis who provides 12 imaging service and who interprets the image. How do you

. 13 work that out?

14 DR. ROSS: Well, at George Washington University 15 we have physicians licensed in the use of radioisotopes in 16 three departments, the Division of Cardiology, the

17 Department of Medicine in Nuclear Medicine, and in 18 Radiology.

19 For the majority of imaging modalities such as 20 those we're discussing this morning, the tests are all 21 performed under the direct supervision of cardiology faculty 22 members licensed to handle the material. The 23 interpretation is performed invariably in.the large teaching 24 environment. Actually, the working _ interpretation is done

(~' :

25 in a conference room with members of the Nuclear Medicine 1

1 1

)

8210 07 03 93 1 DAVpp 1 Department, members of'the Cardiology Division and trainees 2 from both disciplines, and it has been done that way since 3 the first image was made at our hospital.

4 MR. CUNNINGHAM: Dr. Holman?

5 DR. HOLMAN: Isn't it possible that your opinion 6 that two- to three-months training is sufficient, falls 7 directly from that wonderful cooperative venture you have 8 between radiology and cardiology?

9 DR. ROSS: My position that two- to three-month 10 would be perfectly adequate does not, in fect, at all relate 11 to our environment.

12 Where I think a logical approach at our 13 institution would probably be mandatory physics and safety w 14 courses of, perhaps, 100 hours0.00116 days 0.0278 hours 1.653439e-4 weeks 3.805e-5 months or 200. And that all 15 subsequent training requirements -- and that's what I mean 16 by I believe that is the role of the NRC to determine -- how 17 much time it takes a post-graduate physician to refresh on 18 physics and learn safety. And from that moment forward I 19 think it is a clinical issue; indications for tests, use of 20 the tests, interpretations. And I don't believe that there 21 will ever be a way to put a bracket or a number of months 22 around this increasing array of tests and subspecialists.

23 I think that the only logical way to do it is to l

,,, 24 separate them entirely. I think it is probably best left to j b 25 training directors in immunology to decide how much clinical 1

i

8210 07 04 94 1 DAVpp 1 training an immunologist might need, with hands-on 2 experience, to use these tests than for me or you or 3 anyone.

() 4 I think the issue before us today is the basic 5 safety of the training period in physics and safety. I, for 6 one, would think that it is my obligation to determine how 7 long a trainee of mine has got to work in my laboratory 8 before I feel that he is ready to go forward, having had the 9 safety instruction and the physics knowledge. Now I have 10 given him the clinical piece. I think I have to decide when 11 he can now perform those tests well and appropriately 12 without my supervision. And I dare say I would not want to 13 impose that limit, which for me migh,t be two months, on the 14 immunologist or on an endocrinologist.

15 DR. GRIEM: Do you feel that operation of the 16 imaging equipment is part of radiation safety?

17 DR. ROSS: Yes. I think there is an element of 1

18 radiation safety involved in the operation of the 19 instrumentation just in calibration and in understanding 20 doses.

21 DR. GRIEM: I mean the actual thing that ,

22 generates the information that you interpret. ,

23 DR. ROSS: Would you mind restating your l l

24 question? l 25 DR. GRIEM: Do you feel that the imaging

8210 07 05 95 1 DAVpp 1 equipment is part of the process of radiation safety? In 2 other words, that this plays a role in radiation safety or 3 not? In other words, the imaging equipment is used.

() 4 DR. ROSS: Are we talking about the camera, the 5 computer?

6 DR. GRIEM: Yes.

7- DR. ROSS: Yes, I think they're involved in 8 safety.

9 MR. MC ELROY: How many labs do you have in the 4haf use 10 hospital +c rci;gg,the various materials?

11 DR. ROSS: I can't even answer that. There are 12 numerous labs around the institution. Many of them, of 13 course, are research laboratories. There is a satellite and 14 separate lab for the nuclear cardiac imaging since it's all 15 done in my laboratory and is somewhat remote from the main 16 nuclear medicine department.

17 DR. WEBSTER: Following up on the instrument 18 question,who is responsible or who does, should I say, the 19 quality assurance on the imaging systems?

20 DR. ROSS: That is functionally a joint 21 enterprise.

22 DR. WEBSTER: Between who andTdro?

23 DR. ROSS: The Nuclear Medicine Department and 24 Cardiology.

- 25 DR. WEBSTER: I'm thinking about the

8210 07'06 96 2 DAVpp 1 complimentary responsibility. What about personal ,

2 responsibility; who does it?

3 DR. ROSS: Three technicians who spend most of

() 4 their time -- and e$h,arenuclearmedicineemployeeswho 5 spend most of their time with us -- one nuclear medicine 6 physician and one cardiologist.

7 DR. WEBSTER: They are overseen by the clinical

8 ,

staff in some way? Is there are somb assurance?

9 DR. ROSS: They are the overseers.

4 10 MR. CUNNINGHAM: Thank you very much, Dr. Ross.

j 11 Dr. Garcia? ,

12 DR. GARCIA: My name is Robert Garcia. I'm a 13 pra'cticing Nuclear Physician in the Northern Virginia area.

14 I have been in the practi'ce of nuclear medicine for almost

( .

15 25 years and have practiced nuclear cardiology for over ten 16 years. I have done this in conjunction with board 17 certified cardiologists and we have 'a very good working 18 relationship with the cardiologists whom I admire and -

19 respect.

20 I would like to now read a prepared statement 21 from the American College of Nuclear Medicine, wNich 22 organization I'm representing today.

23 "The safety of patients subjected to. diagnostic 24 and therapeutic procedures utilizing radioactive materials 25 'and the reduction of radiation fron such precedures to both

i .

1 8210 07 07 97 1 DAVpp 1 patients and medical personnel is of great importance to the 2 American College of Nuclear Medicine, to American physicians 3 and to all United States citizens. The optimum safe use of

() 4 radioactive materials in medical practice depends upon the 5 knowledge, competence, and experience of physicians who 6 receive formal training in radiation safety, radiation 7 protection, and quality control procedures prior to 8 licensure by the Nuclear Regulatory Commission.

9 "During the period of 1980 through 1982, many 10 organizations including the American Board of Nuclear 11 Medicine, the American College of Nuclear Physicians, the 12 American College of Radiology, the College of American i 13 Pathologists, the Society of Nuclear Medicine, and the

~

14 American College of Nuclear Medicine, gave testimony or 15 statements to the NRC regarding minimal training standards 16 in radiation safety and protection. This was done by each 17 organization after a long and careful deliberative process.

18 "In 1982, the NRC established regulations which i

'19 became effective on July 1, 1984 which require a minimum of 20 six-months training and experience in the use of 21 radioisotopes for licensure.

22 "During the period of this regulation, there has 23 been a visible increase in the development of outpatient 24 40-hour-a-week, self-referral laboratories-providing a wide. l I) 25 spectrum of nuclear medicine services: This has had a l

l i

l

8210 07 08 98 1 DAVpp 1 considerable impact upon the full-service hospital-based 2 laboratory which must offer 168-hour service each week and :

3 satisfy the strict requirements of the hospital

() 4 radioisotope committee for quality control and radiation 5 safety as well as those of the Joint Commission on 6 Accreditation of Hospitals.

7 "In many hospitals the use of technetium 8 generators in in-house radiopharmaceutical preparation had 9 to be returned to rather than use the more costly unit doses 10 supplied by local radiopharmacies at some increase in 11 personal radiation to the personnel in the hospital.

12 "It is the stated contention of the American 13 College of Nuclear Medicine that any further reduction in 14 training standards will have a widespread increase in the 15 use of radiopharmaceuticals in a less well-regu'la'ted 16 environment than the full-service hospital laboratory, and 17 yet this may be undesirable from the standpoint of 18 protection of the public from unnecessary medical radiation 19 exposure.

20 "The American College of Nuclear Medicine 21 continues the training standards set forth by the American 22 Board of Nuclear Medicine as the optimum for radiation 23 safety, radiobiological knowledge, radiation protection, and 24 would consider any.further reduction in the training O 25 standards from the six-month level as totally unjustified,

, - . , -- v -e ~ ~e-, ~

8210 07 09 99 1 DAVpp 1 ao no new scientific information to support that move has 2 been made apparent."

3 Parenthetically I would just like to add, the j

() 4 American Board of Nuclear Medicine was established to l 5 address the multi-disciplinary aspects of nuclear medicine i

! 6 and was established as a conjoint board of the American 7 1 hoards of $[nternal dhdicine, 'athology and adiology, and l

l 8 sponsored by the Society of Nuclear Medicine. And it is a 9 member of the American Board of Medical Specialties.

10 This conjoint board provides for a minimum of two 11 years -- 2,000 hours0 days 0 hours 0 weeks 0 months of training in nuclear medicine -- to

{ 12 include no less than 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months devoted to radiation, i 13 biology, _ nuclear physics, and radiation safety; to insure w 14 the adequate protection of the health and safety of the

+

15 public from radiation hazards as mandated by the 66th 16 Congress and the Atomic Energy Act of 1954 as amended.

17 I stand ready to answer questions.

18 MR. CUNNINGHAM: Thank you very much, 19 Dr. Garcia. I'd like to ask a question first. I 20 As I understood the first part of your testimony, 21 at least part of the basis on which you suggest a six-months 22 training program is to try to limit the number of people who 23 will engage in nuclear diagnostic techniques so that the 24 hospitals will have enough patient load to provide a full l

( 25 range of services, rather'than turning itself into private i

l l

__ . _ ._~ __ _ _. _ . _ _ -_ _

I I

8210 07 10 100 ,

1 DAVpp 1 clinics. '

2 DR. GARCIA: That's absolutely correct, sir.

3 MR. CUNNINGHAM: Is this an economic question?

() 4 Is that correct?

5 DR. GARCIA: This is not just economic, sir. If 6 you have more patients being observed in outpatient 7 facilities, you're broadening the base of population 8 exposure.

9 MR. CUNNINGHAM: That's an interesting 10 observation.

11 DR. GARCIA: Not only that, but you will not have 12 the radiation protection committee, the radiation safety 13 committee, or the "cir

'$st+-k4 d.ontfwidiget on AetrehMor) c_ 2rrrefiteti^n type of No and M 14 inspection,of

, facilities3 supervising,these facilities.

15 MR. CUNNINGHAM: I think those are arguable 16 issues but let me be sure I understood.

17 For the sake of argument, let's say that we agree 18 on that. I don't necessarily say we do but let's say we 19 agree on that. Would it still be your position that at 20 least in part these training requirements are useful to 21 limit the number of people engaging in these activities 22 outside the hospital environment; is that correct?

23 DR. GARCIA: No, sir. You're misconstruing what 24 I said.

25 MR. CUNNINGHAM: I don't understand what you

8210 07 11 101 1 DAVpp 1 said.

2 DR. GARCIA: I said in order to protect the 3 health and safety of the individuals, we believe that an

() 4 optimum radiation safety standard needs to be established.

5 That seems to be optimally operating right now with the 6 community hospital.

7 Right now the con.munity hospital is supplying the 8 bulk of the radioisotope examinations, however, in one of my <

9 own hospitals -- due to the fact that outpatient facilities 10 have increased -- there has been approximately 60 percent

11 reduction in workload. These patients are being examined i

12 now in an outpatient environment totally separate.

j 13 I, of course, have no control over the radiation 14 safety. I do know that because of that, I have had to Lo 15 reinstitute quality control and cost-effective measures 16 which require the establishment of technetium generators and S Lsitk ' f 17 so forth, "iin from unit-doses. In order to compete 4

18 effectively, they have to operate 168 hours0.00194 days 0.0467 hours 2.777778e-4 weeks 6.3924e-5 months a week in our 19 hospital. We have to do the emergency lung scans, the 20 emergency GI bleeders in the middle of the night, as well as 21 the routine things.

22 I might parenthetically add that this statement 23 has very little to do with nuclear cardiology, as it was 24 nuclear oncology that was established and which diluted the 25 workload of the particular hospital I'm talking about.

i k

(

8210'07 12 .

102 l 'DAVpp 1 So I think there are greater principles involved 2 and greater principles that you need to address than 3 looking at nuclear cardiology issues. These are the

() 4 viability of the community hospitals supplying a good

~

}

5 quality control program on a full 24-hour a day, 6 7-day-a-week basis so that all participants, all patients,

! 7 can be serviced with radiation safety and effectiveness. ,

8 MR. CUNNINGHAM: You believe this is something 9 that should involve the NRC7 i 10 DR. GARCIA: I absolutely do believe it should 11 involve the NRC.

12 ' MR. CUNNINGHAM: Any other questions of 1

j 13 Dr. Garcia?

I Yes?

14-1 J fbHOST:

15 DR . +E6bOR : Dr. Garcia, can you tell me what the 16 American College of Nuclear Medicine is.and how many members 17 it has?

18 DR. GARCIA: This is a college that was

! 19 established in 1971. 'It was the first college established 4 20 for nuclear medicine. I happen to be a member of two 21 colleges of nuclear medicine, the American Society of.

22 Nuclear Medicine and the American College of Radiology and l 23 _the American Board of Radiology.

24 This is one of the organizations that I belong

(:t 25 to. It has about 800 members. It had, at one' time, 1200 i

I L

8210 07 13 103 1 nAVpp 1 members. It is primarily composed of grass-roots physicians 2 who work in small community hospitals, as I perceive it at 3 this time, and who have been involved in direct patient care

() 4 of patients, as opposed to much of the testimony today, I 5 believe, came from university physicians who are not aware 6 of some of these changes that we've perceived at the smaller

, 7 community hospital level.

8 I'm sympathetic to the American College of 9 Cardiology in its position for this. I have nothing but the 10 utmost respect for the cardiologists and their involvement 11 in nuclear medicine. I think they've helped us move it 12 a long way and I would not perform nuclear medicine cardiac 13 studies without the assistance of a cardiologist.

14 We have an open staff arrangement with respect to 15 the cardiologists interfacing with us in that institution.

16 MR. CUNNINGHAM: Any other questions?

17 (No response.)

18 MR. CUNNINGHAM: Thank you very much, Dr. Garcia.

19 The next is Dr. Watson.

20 DR. GARCIA: I spoke for Watson. I combined 21 Watson and Allen.

22 MR. CUNNINGHAM: Dr. Griffin?

23 24 -

O i,_/

25 i

. _ . _ ~ . _ _ _ __

8210 08 01 104 1 DAVbur 1 DR. GRIFFIN: Mr. Chairman, members of the 2 committee and colleagues, my name is Edmond Griffin. By 3 training, I am a research radiation biologist. By

() 4 profession, I am a radiation safety officer at the 5 University of Texas Science Center in Dallas, an institution 6 in which we have approximately 400 biomedical research labs 7 using radionuclides, and we have two hospitals in which 8 there are two separate nuclear medicine programs, and 9 combined, they perform more than 12,000 nuclear medicine 10 studies a year.

11 I appreciate the opportunity to make' a comment 12 here, and rather than belabor some of the points of the 13 origin of the debate we have been in for a long time, I will 14 try to summarize mine as succinctly as possible.

15 In 1981 and '82, before the training requirements 16 were increased from three to six months, I commented on this i

17 issue that radiological health and safety would be better 18 served through regulatory agency enforcement ofj and training 19 programs' compliance,with the three months training 20 requirement than it would by increasing the requirement to 21 six months, especially if there was no.added assurance of 22 improved compliance, and I really haven't changed my 23 position since then.

24 While I accept the presently proposed requirement O 25 of a four-month training program in radiation safety as ,

1

8210 08 02 105 2 DAVbur 1 being more than adequate to minimize unnecessary radiation 2 exposure, I remind all parties that my acceptance comes from 3 the expectation of full compliance with the letter and l'i 4 intent of this requirement; that is, those physicians L/

5 requesting approval for the independent use of by-product 6 materials in medicine must perform and shcw documentation 7 that they have actually completed all aspects of the 8 training as described in the proposal.

9 In conclusion, I accept the establishment of and 10 compliance with the four-month training requirement as being 11 adequate and more than adequate for all physicians licensed 12 to use by-product mater $al in medicine.

13 Thank you very much.

14 MR. CUNNINGHAM: Thank you very much.

\

I

\> 15 Questions for Dr. Griffin?

16 (No response.)

17 MR. CUNNINGHAM: Thank you very much.

18 Finally, we have Dr. Johnson.

19 DR. JOHNSON: I am Dr. Philip Johnson. I practice 20 and have boards in internal medicine, endocrinology, and 21 nuclear medicine.

22- Cardiac problems make up a significant portion of 23 my internal medicino practice. On occasion I interpret 24 cardiovascular ag results for a nearby hospital. I do

,n

) 25 research, and I am in private practice.

8210 08 03 106 2 DAVbur 1 For 20 years -- and the reason I am here -- I have 2 been a member of the Texas Radiation Advisory Board. Its 3 Medical Committee functions similar to this committee that I

() 4 am addressing now. Our committee's major problem is 5 verifying the quality of training, not the number of 6 months.

7 First, I will point out that I have no objection

) 8 to shortening the number of training months needed by a 9 cardiologist provided that this training is part of board 10 requirements. For a license to practice without the 11 umbrella of an institutional broad license, you must certify 12 that your training in nonclinical, defined oy the NRC as i 13 basic classroom training and supervised handling experience 14 and supervised clinical nuclear medicine, meet current NRC 15 requirements.

16 Generally, with board qualification in specified 17 specialties there is no problem, since required NRC training 18 is included in these American board director training 19 programs. These boards ensure institutional compliance by 20 rigid inspections. The regulatory authorities know that the 21 applicant has completed the required courses. Although a 22 passing grade is not required, it can be assumed that'the 23 applicant will run a safe lab, and if not, it would be found 24 during an agency inspection. The preceptor, and in this

, gg

'd 25 case the residency program director, would have no qualms J

8210 08 04 107 1 DAVbur 1 signing an appropriate certification because the residency 2 is American board approved and NRC necepted without 3 reservation.

)

4 When an applicant has not completed an NRC v

5 specified residency, the task before the NHC, and in Texas' 6 case our Medical Committee, is to assure that the 7 applicant's knowledge is adequate so that the nuclear 8 medicine tests will be performed in a manner that is safe 9 for the general public, the radiation workers performing the 10 tests, and the patients.

11 The guiding role is obviously ALARA, mandating 12 minimal exposure to everyone, and an extension of the ALARA 13 philosophy requiring that the information justifies the 14 radiation exposure. Each applicant brings a signed document 15 indicating a tral..ing period at least equal to that listed 16 in the requirements.

17 Nhile I would like to think otherwise, without a 18 board-backed training program, the preceptor signing the 19 license application has no easy way of knowing whether the 20 training was adequate, what the NRC means by basic 21 classroom training, whether the NRC requirements have 22 recently changed, and that the applicant's knowledge would 23 be enough to ensure a safe lab.

24 With only a vague idea of the regulations, as (j 25 noted by Dr. Beller, the preceptor does have a good

l 8210 08 05 108 1 DAVbur 1 knowledge of the applicant's supervised clinical experience,

[ , 2 since the preceptor sees this firsthand.

l 3 Lacking a board-mandated and prescribed curriculum 4 in the basic nonclinical training and experience, the 5 teaching is conventionally left to someone else, maybe in 6 the nuclear cardiology or nuclear medicine laboratories.

7 Since we know the application is often handed to 8 the preceptor as the applicant impatiently waits, any doubts 9 about competence are submerged or rationalized by the 10 signing. We wonder exactly what he is thinking when he 11 signs these papers. Without a board requiring basic 12 classroom training and supervised handling experience, it is 13 difficult to evaluate competence for licensure.

, 14 In Texas we have found there is no way out of this 15 verification dilemma., certainly, we would not question the 16 professor of cardiology or radiology.

17 Therefore, I would suggest a departure from the 18 present licensure requirements. To me, it would seem wiser 19 not to force a specified number of training months, but have 20 the regulations require any application without board 21 credentials use outside experts with certain and acceptable 22 credentials. I would thus change the regulations to state 23 that in the absence of nonclinical training in the specified 24 specialty, the applicant must add to the application a named 25 responsible individual trained to and responsible for the l

l

8210 08 06 109 l 1 DAVbur 1 nonclinical operation of the proposed cardiovascular imaging 2 laboratory.

. 3 This responsible individual might be a health ,

(} 4 physicist, a radiologist it might be a nuclear medicine 5 person and would not have to know how to interpret the 6 cardiovascular imaging tests. This would be done by the 7 cardiologist.

8 The responsible individual would know the 9 regulations and how to run a safe lab. NRC inspection would

10 be of the responsible individual rather than of the '

11 applicant cardiologist because inspections will continue to 12 be on laboratory practice and health aspects while ignoring 13 medical competence.

14 In large teaching institutions with broad -

15 licenses, the nonclinic'al aspects of cardiovascular imaging 16 are generally not controlled by the cardiologists.

17 Therefore, my proposal is similar to the situation 18 encountered by a cardiology' resident while he is in I

< 19 training.

20 TheNRCar.dMhreementhkatescanbereasonably 21 assured that anyone who is trained to practice cardiology 22 will interpret the nuclear studies in an intelligent way..

23 This is what is already being taught to the resident. l 24 Somewhat like Dr. Siegel, we feel that adopting !

l () ,

25 this kind of a program will be in the interest of the t .

s I

i

8210 00 07 110 1 DAVbur 1 public,willbeofhelpto$greementhtateswhomaywishto 2 issue licenses to board qualified cardiologists, will 3 encourage cardiology, the field, specifically to include

) 4 nonclinical training in their residency program and will 5 help the regulatory agencies and other specialties who come 6 forth to request licensure of their own particular nuclear 7 imaging tests and dedicated laboratories.

8 Thank you.

9 MR. CUNNING!!AM: Thank you very much, 10 Dr. Johnson.

11 Are there any questions?

12 (No response.)

13 DR. CUNNINGilAM: Thank you so much.

7, 14 We are very close to the lunch hour. I had hoped i

'J 15 we could begin discuccions before that.

16 I would like to say, is there anyone who wants to 17 make about a two-minute statement who hasn't been heard 18 from?

19 (tio response.)

20 MR. CUNNINGilAM: Good.

21 (Laughter.)

22 MR. CUNNINGilAM: The opportunity is lost.

23 At this point, I would propose that we break fer 24 lunch now. We might get ahead of the crowd a little bit.

'u/ 25 When we return, the committee will begin its deliberations.

l l

8210 08 08 111 1 DAVbur 1 What we will try to do in the course of these 2 deliberations is to establish a good record of the technical 3 or other bases for the various training schemes and also L

" f'N 4 rely heavily on the opinions of the various members of this

' (_) r" '

[5 committee.

i 6 From this, the staff will subsequently try to 7 extract defensible positions which will be subsequently u 8 promptly reviewed by the committee. I would anticipate it

, 9 would be reviewed by the Commission if there are changes 10 proposed and published for public comment prior to 11 adoption.

12 So recognizing that this is just the beginning of

+

'~%

J- 13 a longer process, what we will try to do here is not make 14 decisions. That isn't the function of this committee, to 15 make final decisions on behalf of the Nuclear Regulatory 16 Commission, but rather it is to establish the scientific, 17 technical, economic, or other bases for making those 18 decisions.

19 We might think a bit about that at lunchtime

.20 before we begin developing the basis for subsequent 21 decisions.

22 It is now five minutes till 12:00. I propose 23 there are a number of places to eat in this area. I think a 24 large number of them are fairly close.

() 25 I think everybody is going to want to get out of

.1,r*

(- . .

W w

'82'10 08-09 112 1 .DAVbur 1 here as early as possible this afternoon. Perhaps we can 2 reconvene at 1:15. That should allow adequate time, should 3 it not?

O 4 we ~111 reco#ve=e et 1=1s.

5 (Whereupon, at 11:55 a.m., the meeting was 6 recessed, to reconvene at 1:15 p.m., this same day.)

7 8

9 10

. 11 12 I 13 O -

15 16 17 18

'19 20 21 22 23 24 l-

.O 25 I

8210 08 10 113 1 DAVbur 1 AFTERNOON SESSION (1:15 p.m.)

2 MR. CUNNINGHAM: Ladies and gentlemen, if you will 3 take your places, please, we should get started.

() 4 We have now heard from those who asked to make 5 statements before the committee, and I thank all those that 6 did participate. I think it was very helpful, certainly to 7 me and the staff and also to the members.

8 Now, we begin committee deliberations. I would 9 like to make these as informal as possible. I don't want to 10 exclude members of the audience from participation in these 11 discussions to the extent I can. We do want to move on 12 because we do want to stop at'a reasonable time this 13 afternoon.

14 I know many of you -- in fact, most of you -- have O 15 to travel from the city to get home, which is difficult on 16 the weekend.

17 As I see it, there are three decisions that the 18 NRC must eventually make with the advice of the committee.

19 The first of these is the length of training 20 requirements for the specialty of nuclear cardiology. That 21 has been specified broadly as four months duration, as 22 stated in the Federal Register.

23 Coupled with that, the question is raised of 24 - whether or not it is appropriate to require only four months n

25 for the more broad practice of nuclear medicine diagnostics,

8210 08 11 114 l

1. DAVbur 1 since the radiological safety issues alone are very similar l

'2 for most types of diagnostic precedures as they are in 3 nuclear cardiology, even though there may be more

() 4 procedures, larger quantities of radioisotopes, and larger 5 patient doses.

6 The-next question is whether or not other 7 specialized areas of nuclear medicine practice, diagnostic 8 practice should also be subject to four months training 9 requirements rather than six months if such criteria were 10 indeed adopted for nuclear cardiology diagnostic Procedarts ,

11 er^---Ainna.

=A 12 Those are the three issues, I think, that the

13 staff must be prepared to address in any further alteration 4

14 of its criteria.

15 Now, there are two more things that we need to 16 bear in mind as these deliberations are to be made. The 17 first is that there are developments right now in nuclear

, 18 medicine that will probably become more widespread.in the 19 early investigation stage or perhaps later in the 20 investigation stage in some instances relating to diagnostic 21 procedures related to some types of cancer and therapy for 22 certain types of cancers.

23 In a decade, probably we will see much more broad 24 use of these diagnostic and therapeutic procedures. We are 25 not simply planning for what the situation is now. Federal

i 8210 08 12 115 1 _DAVbur 1 agencies, as you well know, can be rather slow, so we must 2 think about the future.

3 The other trend that we should be very much aware

4 of, that is probably being caused by the economics of medical

(>T 5 practice and how patients' bills are paid, is the 6 relationship of hospitals to private clinics.

7 So the nuclear medicine practice -- there may be a 8 shift in nuclear medicine practice, which is largely 9 conducted at present in hospitals, toward private clinics, 10 and I don't think that the training requirements as such 11 will have a significant influence on that. It isn't .

12 apparent to me, but certainly the economics of medical 13 practice itself will influence that change, and it appears 14- to be heading in that direction.

15 So we have to think about how patient care 16 delivery is going to shift over the coming decades as we 17 reach these various types of decisions.

18 Having said that and with the committee bearing in 19 mind these points, one thing that we might discuss some is 20 this gray area between requirements for radiation safety and 21 the quality of medical practice. That gray area is what, I 22 think, Dr. Blahd referred to as the idea that if you perform 1

23 a diagnostic procedure on a patient that isn't needed or if )

24 you misinterpret the diagnostic procedure, that patient has 25 received some radiation dose that provided no benefit to the

8210 08 13 116 1 DAVbur 1 patient at best.

2 -The question is: is that part of radiation 3 safety, or is that part of the quality of medical practice?

() 4 Perhaps this might be an area where we can start 5 discussion of ideas from members of the committee. Does 6- somebody want to start this?

7 Dr. Griem?

8 DR. GRIEM: Yes. The question that I put to 9 Dr. Ross, which we discussed this morning, is related to the 10 imaging equipment, which is part of the whole process of 11 information gathering for which an isotope is given to the 12 patient. He said it was part of the use of isotopes.

13 Is the sensitivity -- if such equipment were f- 14 operatedateg-foldlesssensitivethanit should be

(~/ 15 operating at, then the dose to achieve an image would go up 16 by a factor of 2. As a matter of fact, the dose across the 17 board to the operator, the public, and everything would go 18 up by a factor of 2.

19 And what I am really getting to is the question of 20 quality assurance of the operation of.such imaging 21 equipment, which also, I believe, is involved in radiation

'22 safety, not necessarily image interpretation, and I wonder, 23 as we Icok at our requirements in basic science, if that is 4

24 emphasized enough.

("3 k/ 25 Maybe Dr. Webster might want to expand on that.

t

8210 08 14 117 1 DAVbur 1 DR. WEBSTER: I thought about that since we 2 discussed it a few minutes ago, and I don't think we are 3 right, putting it bluntly. If you have equipment which is off calibration, then you would just register a different

_() 4 5 number of counts from the activity that you used.

6 Therefore, you would either get a higher count rate or a 7 lower count rate, but you won't change the dosage into the 8 patient. That has already been done. It is either 9 microcuries or millicuries. You will just get a different 10 image.

11 So I don't think it is a patient dosage problem.

12 I think it is an image quality problem.

13 In radiotherapy, if you have a machine which is 14 off calibration and you give twice as much dose as you think O 15 you are giving, then _ the patient indeed gets more dose.

16 There have been a number of notable cases of malpractice 17 based on that.

18 But I don't think it applies to nuclear medicine 19 detection equipment. I am sorry I had to say that.

20 DR. HERRERA: Excuse me. In one sense, if you do 21 not control it, your machine is working suboptimally. If 22 you do a test and the result is poor, the likelihood it will 23 be repeated is much greater.

24 DR. WEBSTER: That is a question of what is a 25 satisfactory image and when is it so had that you have to do

8210 08 15 118 1 DAVbur 1 it over?

2 3

O 4 5

6 7

8 9

10 11 12

(

13 14 O 15 16 17 18 19 20 21 22 23 0

24 i

O 25 l

y-

+

l 8210 09.01 119 lf DAVbw- 1- DR. WORKMAN: In that sense, it is a problem of 2 radiation detection, don't you think?

3 DR. WEBSTER: It could be, if the image is

() 4 specifically unsatisfactory; right. And then it could be 6

5, very serious, because you might have to do a whole day's 6 work over again.

, 7 DR. HERRERA: May.I address an issue that was i

j 8 raised by Jim Christie this. morning? You cannot talkj yft 9 is not realistic to think in terms of blocks of time. In

10 reality, the most prominent training on the integrating 11~ basis over tho length of the program. I think Jim _ Christie 12 is carrect when he says it is not realistic to-think of, i

13 these blocks of times, as if.they were by themselves. An 14 indication, the likelihood is.that.the program in radiology,

- k- 15 ~ a lot of the' basic sciences'are covered, not necessarily at 16 the time of exposure to nuclear medicine or radiation.

i 17' physics, radiation biology. They must-be covered somewhere l 18 along the line.

19 So that confuses the issue of how long a period of

{ 20 time.

21 .The other issue, I agree alsc,.is.that clinical 22 competence is something that cannot be achieved in three 23 . months, four months.- For most of us, clinical competence 24 is a lifelong process, continuing and continuing.. If we are 1

'O_.

25 going to' maintain some level of' clinical competence. I l

1 e;

I 4

h 1-

.___. . . . . _ ., _. - . . _ . . _ . _ . _ - . ,_ _ .-. . . _ _ , _ . _ , _ _ . . _ . - _ ~ -

8230 09 02 120 1 DAVbw 1 MR. CUNNINGHAM: Dr. Holman.

2 DR. HOLMAN: Could I begin to address some of the 3 issues you raised as the primary questions? I want to see (O

_/ 4 how far we can get without addressing directly the stickiest 5 point.

6 I'd like to begin by addressing one of the 7 suggestions that was brought to us, and that was the most 8 minimalistic approach with the least involvement of Nuclear 9 Regulatory Commission. I personally feel that the 10 involvement of the Nuclear Regulatory Commission has been 11 very important in medical practice and its importance is 12 going to increase with time. While it is true that in 13 hospital practice there are now a number of safeguards 14 provided by the medical community, these same safeguards are 15 much less effective in office practice, as we see ourselves 16 moving in the directidn of diagnostic image centers and 17 office imaging procedures. The ability at least of the 5

18 :::i:21 '4== ^#

thg medical community to handle credential 47-19 in this environment is minimal.

20 We can see that to some extent in radiology, other 21 types of imaging procedures, but there is less involvement 22 of the Nuclear Regulatory Commission and where, indeed, it 23 has been shown that poorly trained individuals provide 24 substantially higher radiation dose to the patient. And at 1

25 least the potential is present for increasing patient j 1

1

8210 09 03 121 1 DAVbw 1 throughput by poorly trained individuals, increasing both 2 cost and radiation dose.

3 As far as the second issue, that of cardiology

() 4 training requirements, first of all, I'm very happy to see 5 so many of the important groups involved in this coming to 6 agreement on the issue. This is pe haps the first time e Ag.19ff AtfMUT rttechg ?]

7 there has been such agreement since 1982_ when the American e spose A CT) 8 College of Cardiology first pEoposed six months of 9 training.

10 I think that all the groups involved, both the 11 Society of Nuclear Medicine, the American College of 12 Cardiology and the ACNP had much to lose by coming to this 13 rather unpopular compromise position, since, as we heard 14 today, there are many in each of the groups with rather O 15 diverse opinions extending across the spectrum. So I think 16 that we and certainly the Staff at the NRC should think very 17 carefully about the recommendation of the Ad Hoc Committee 18 to go to four months of training as a compromise position 19 but one that has been addressed by individuals with a great 20 deal of experience, both from the cardiologic, radiologic 21 and nuclear medicine aspects of the problem.

22 I would think that therefore not to accept the 23 recommendation of the committee of four months would require ,

\

24- overwhelming quantitative information to the contrary, and I j 25 don't believe that we've heard that in the testimony this i

2 8210 09 04 122 1 DAVbw 1 morning.

2 Finally, we're left with what I think is the third 3 issue. That is the length of training for involving in

()

4 general nuclear medicine applications. And here we've heard 5 much more diverse testimony, ranging from four months to six 6 months. If you heard carefully, probably testimony on each 7 side of those numbers, as well.

I 8 Perhaps we can dissect this problem into two 9 competing principles, two principles at war with each 4

10 other. One is, what is the proper length of training that

11 is required, and the second principle is, given the four 12 months of training for nuclear cardiology, do we wish to

13. institutionalize, more than it is already institutionalized, 14 the concept of a limited licensure. And I feel here that 15 since, as we've heard, it is most difficult to agree on the 16 preciselengthoftimeatwhichpointan/ individual is 17 adequately trained, particularly as we do now, by limiting 18 our ability to quantify that training, I think the second 19 principle, that of limited licensure, becomes the prominent 20 one.

21 I am most concerned about the idea of 22 institutionalizing one group with four months of training in

h 23 a limited aspect and radio [) racer application, simply 24 opening up the way for other groups to come in, asking in 25 their own subspeciality or limited areas of practice for

8210 09 05 123 1 DAVbw I less hours than are provided in the training for general 2 application of the tracer.

3 So I think whatever we do, it should be the same r -,

4 number of hours for each, whether it is in the limited area 5 of nuclear cardiology or the general application of the 6 technique to all of nuclear medicine. How this should be 7 structured, I think is something that would be a little bit 8 difficult to generate at this time.

9 I might suggest that if we look at four months, 8%5 10 that comes out, as the report es shown to 650 hours0.00752 days 0.181 hours 0.00107 weeks 2.47325e-4 months , I i

11 certainly agree with the report that all the previous work 12 of this committee in coming up of 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of didactics 13 should be maintained. The area that would most reasonably es 14 be modified is the one of isotope handling, where 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months 0 15 certainly appears excessive and the number should be reduced 16 by some amount, and the rest of the training should beoen as 17 it is now in clinical experience with radiotracer 18 applications.

19 MR. CUNNINGHAM: Thank you very much, indeed, 20 Dr. Holman. I think that's very helpful.

21 Did somebody want to comment on Dr. Holman's 22 comment, because I think it was very articulate.

23 DR. WEBSTER: Dr. Holman did say at the beginning, 24 with the patient in the private office, we tend to give more

' 25 dose. I think that is arguable.

4

8210 09 06 124 1 DAVbw 1 DR. HOLMAN: I didn't say that. I said the 2 untrained user of radiotracers would be likely to give the a 3 low dose and that the untrained person might more easily be

() 4 able to practice using radiotracers in the private office, 5 if the NRC were to puli out completely and not provide a 6 measure of certification.

^

7 DR. WEBSTER: That is different. What I was going e

8 to say is that every package of isogypes has a package 9 insert which lists rather carefully the particular dose 10 indications, which I guess even an untrained person could 11 read. So that was the point I was going to make, but it 12 isn't quite so bad as I thought it was.

, 13 (Laughter.) ,

14 MR. CUNNINGHAM: Dr. Holman, I want to be sure I O 15 understand.

16 You said toward the end of your statement that you 17 believe that no distinction should be made in hours of 18 training between a limited speciality, nuclear cardiology, 19 and general training requirements for nuclear medicine, that 20 is, radiation safety training. That's your position.

21 DR. HOLMAN: Yes.

22 MR. CUNNINGHAM: Frank? Dr. DeLand?

23 DR. DE LAND: I'm wondering. There is something 24 that's been bothering me for a long time. As you know, I've 25 been on this committee since it was formed in 1898.

-8210 09 07 125 1 DAVbw 1 (Laughter.)

2 DR. DE LAND: We get these applications. One of 3 the things that bothers me is that I don't have the numbers

() 4 in front of me, but everyone of them got their 30 hours3.472222e-4 days 0.00833 hours 4.960317e-5 weeks 1.1415e-5 months of ev<< haunt Q) 5 this and 10 hours1.157407e-4 days 0.00278 hours 1.653439e-5 weeks 3.805e-6 months . Did this every hurt you? Nobody ever 6 got 42 hours4.861111e-4 days 0.0117 hours 6.944444e-5 weeks 1.5981e-5 months of training. They got 40 hours4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months . Nobody ever 7 got 98 hours0.00113 days 0.0272 hours 1.62037e-4 weeks 3.7289e-5 months of training. Nobody ever did 101 brain scans.

8 They all did 100 or 80 or 110. So this has bothered me for .

9 a long time, the philosophy, and I think this was brought up 10 this morning, this philosophy'that, okay, we're going to say

!, 11 you're going to do two months, four months, six months, I 12 don't care what it is.

13 I wonder if that is really correct? I wonder if 14 the philosophy of the Board is not better, and that is, we i 15 will look at a minimum time we think it is going to take you 16 to do something, but at the same time, you've got to 17 demonstrate your proficiency.

, 18 Now we have no problems with the American Board of

, 19 Radiology or the American ' Board of Nuclear Medicine. As 20 pointed out by Jim Christie and Barry Siegel, throughout the 21 Board it's not broken up into little tiny segments, except 22 perhaps for some of the didactic lecture series that you 23 get. It's all integrated in. You pick up a tremendous i 24 amount of knowledge over two, three or four years, however.

O 25 long you're at it. And you really can't differentiate that a

i i

I

8210 09 00 126 1 DAVbw 1 at the time, but at the end of that time, then, what you 2 supposedly have gotten by direct contact, osmosis, or 3 what have you, you're going to find out by examination.

() 4 As I say, it bothers me a great deal. I'm sure 5 that a lot of these applications that are signed off are 6 not, shall we say, necessarily inaccurate. Whoever signs-7 them off doesn't pay any attention to them. I'm still 8 wondering that;rather than having a big battle over whether 9 we do three months, four months or six months, perhaps we 10 should look at just a min bum time and then no matter who it 11 is, they've got to show their proficiency. I think the 12 NRC has accepted the fact that if you have your ABRs and 3

13 your AgM, that that is evidence, and that you have received 14 and utilized sufficient information throughout the area of O 15 the basic science, which may also include knowing how to run 16 an instrument. And I just threw that fo/rth.

17 To me, the way we've been doing this is 18 artificial.

19 MR. CUNNINGHAM: Of course, a regulatory agency 20 can only go so far. Certainly, board certification is an 21 indication of competence, but the NRC cannot exclude people, 22 physicians, who are not board certified from applying to use 0

23 these radioisot/ pes. Unless we could show thatj a strong 24 basis hasn't yet been demonstrated, that only g > i L/ 25 board certified certification is acceptable, I think we i

l l

8210 09 09 127 2 DAVbw I would have to be prepared to consider this. Indeed, that's 2 why we have the qualification criteria. I've been around 3 this even longer than you, Frank, 1897, something like that,- ,

() 4 but I recall working years ago with Merrill Bender in the l 5 initial stages of getting Board certification in nuclear 6 medicine, and the objective at that time, my personal 7 objective and the objective of the organization, which was 8 the Atomic Energy Commission, was to enable us to withdraw 9 from regulating physicians at all, but it never worked.

10 One of the reasons it never worked was because the 11 physicians who were licensed to use nuclear medicine wanted 12 the AEC, now the NRC, to continue in this role.

13 -

So I would agree with the objective, but it hasn't 14 worked out that way.

O~ 15 DR. DE LAND: I wasn't promoting it or proposing, da+

16 it, only the Board certified people to be licensed. What 17 I'm saying is, I think this method of just having a form 18 filled out -- you don't mind if I say all these things?

19 MR. CUNNINGHAM: No.

20 DR. DE LAND: This idea of just having a form 21 filled out and signed by somebody, you know, we got one the 22 other day.

23 MR. CUNNINGHAM: Don't name names.

24 DR. DE LAND: No names. We got one the other O

\/ 25 day. You may remember it. The training was 15 years

-8210 09 10 128 1 DAVbw 1 earlier. Are you going to tell me that you remember 15 2 years ago that you gave him 40 hours4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months of radiopharmaceuticals 3 and 20 hours2.314815e-4 days 0.00556 hours 3.306878e-5 weeks 7.61e-6 months , and 20 hours2.314815e-4 days 0.00556 hours 3.306878e-5 weeks 7.61e-6 months of this, and so forth?

() 4 So I'm thinking maybe the philosophy should be 5 changed, and we should have a better way to evaluate and not 6 just say, "Well, you've got to do this, this and that." If 7 it's written on that application form that he did this, this 8 and this, then we've got to sign off on this as acceptable.

9 MR. CUNNINGHAM: What are you proposing, Frank?

10 DR. DE LAND: What I'm proposing is, that the NRC lasnt 11 .mggup with some method, that the'NRC come up with some 12 method that they can evaluate the actual training.

13 ttR. CUNNINGHAM: Are you proposing that the NRC 14 administer tests?

l 15 DR. DE LAND: If necessary, yes.

16 (Laughter.)

17 DR. DE LAND: Now wait a minute. Our cardiology 18 -- to get down to the nitty-gritty, in cardiology, we 19 have said throughout this whole session, we will have to 20 admit there are certain, shall we say, training programs 21 where cardiologists go through it and are really not very 22 well trained. I am seeing them, and.I'll have to disagree 23 with what somebody said there, that there ain't never been 24 no accident by a cardiologist. I had to tape up a whole O'- 25 damn hallway, because of a board cardiologist who shot

i 8210 09 11 129 2 DAVbw 1 technetium up and down the hallway.

2 MR. CUNNINGHAM: It happens to nuclear physicists 3 too, who are not cardiologists also.

() 4 MR. DE LAND: I only want-to make the point on 5 cardiologists, we have so many cardiologist here, and that 6 is, as far as board certification is concerned, on the

~

7 Cardiology Boards, they should have the necessary basic 8 science examination, if they are going to qualify their 9 people in nuclear cardiololgy. If they do have, then why 10 would that not be acceptable?

11 MR. CUNNINGHAM: Dr. Webster.

12 DR. WEBSTER: I don't want to speak too much, but 13 an issue did arise this morning along this table about the f3 14 NRC inspection and the thoroughness of it. Inspections

. V 15 right now are in strictly the radiation safety aspect. The 16 inspector comes around and looks at the people who have 17 gotfenmoreorlessexposure,moretypically,howmany 18 spills there have been and what have you done wrong in the 19 waste disposal area, et cetera, et cetera.

20 But they do not look into training programs, in 21 my experience, and this might be one handle to grapple with 22 this problem. The inspectors, when they come around, should 23 actually try to document the amount of training that a given 24 institution which offers the training procram is giving.

O 25 That would perhaps lead to great honesty.

8210 09 12 130 1 DAVbw 1 We heard just now that these forms are signed as a 2 matter of rote without too much respect for the truth. That 3 would be my suggestion, that the inspectors take care of

() 4 that.

5 MR. CUNNINGHAM: Somebody from our inspection 6 office, I know Len Cobb was here earlier. Yes. Do you want 7 to come up to the microphone and let the reporter and 8 the committee know who you are.

Z en 9 MS. KARAGIANN/S: Ees I&E has to go des licensing 10 condition or written regulations. So unless the licensee's 11 license conditions says that we're going to have so many Caft 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months pf training for our physicians, I&E cannot osegg on 13 that. So it has to be a regulation or a license condition.

14 MR. CUNNINGHAM: That is the problem. You can't O 15 inspect the training program, unless it is part of the ef tat 16 by-product material license, institution.

D 17 WHR. WEBSTER: I was thinking that there could be a 18 regulation introduced to cope with that. I agree that it is 19 one step away, but it's there, and it involves the sort of 20 things that people are licensed for.

21 So it is an important consideration, obviously.

22 MR. CUNNINGHAM: I think that this is dependent on 23 how this comes out. This is one of the things that we have 24 to look at . There may be some opportunity to do something 25 in that area.

- + , , - - - , v-

8210 09 13 131 1 DAVbw 1 I'd like to -- in order to fully understand the 2 nature of the problem associated with training, I'd like 3 to ask the committee one or two questions.

(~j) 4 Let's look at exposure of physicians, technicians

, s 5 and members of the public, exclusive of the patient.

6 Our experience has been that occupational exposure 7 in nuclear medicine is,,on the averace somethina less than

[4 % elves perewsNed, an i6 Ot'd Na f.20).

8 10 percent. Also, in my recollection, there have been very 9 few, and I can't even recall the specific incident, although 10 I am sure there are some, where a technician or physician or 11 a member of the public, other thanfatients, received a A

12 substantial overexposure due to accidents of one sort of 13 another.

14 Given this, how critical is the four-month O 15 compared to the six-month tr.aining? I guess it is the other 16 . way around. How much more protection are we going to 17 provide to this category of person, these categories of 18 people, by having six-month training as opposed to 19 four-month training in radiation protection?

20 Is this going to make a significant difference?

21 I am trying to break this in pieces now.

22 Does it make any significant difference?

23 24 m

(_) 25 l

l

t i

8210 10 01 132 1 DAVpp 1 .DR. WORKMAN: I don't think we know, Dick. There 2 were comments this morning about hcw there had been no

! 3 spills, no problems and so forth, with nuclear cardiology.

() 4 particularly. But if that's so, that's based on six-months So if it's not broke, why fix it.

5 training.

6 MR. CUNNINGHAM: I think it's the other way 7 around, Joe, as a matter of fact. We receive today in 8 nuclear medicine -- as a whole, I don't know about the 9 cardiology speciality -- fairly low occupational doses.

10 Essentially no dose to members of the public.

11 This has resulted from the lower training 12 requirements we had previous to adoption of the six-months. .

13 We haven't had a six-months training period that long so 14 that's what we're seeing. -

15 The question is, for these categories of people 16 is that additional training appropriate. I don't see any 17 indication that it is. If members of the committee see some 18 indicationy then I'd like to know'about it.

19 Dr. Goodrich?

YdecA_

~

20 DR. GOODRICH: I asked Ms. Okker this morning dmd 21 about their experience in licensing inspectd$$' facilities 22 other than the universities or the major medical centers, 23 1. e . , the mobile units in the private practice sectors.

4 24 From her thoughtful reply, I gather that the vast majority G

k/ 25 of activities that are defined as nuclear medicine that are !

l l

1 l

4

8210 10 02 133 1 DAVpp- 1 subject to inspection and licensure, are resting to date in 2 we)1-identified medical facilities, not small outlying 3 imaging centers, et cetera.

4 The thrust of my comment, therefore, is based on

((])

5 the observation that in the setting of the university or the 6 300 to 700-bed private medical facility, there is an 7 environment of safety that is superimposed through the 8 health safety officers or the office of radioisotope 9 committees, et cetera, that supplements the knowledge -- or 10 I would say the trained awareness -- of the new physician in 11 training that he. gleans from this very minimal health 7h4 nose) 12 physics training. The proceeds from his program; he's

^

trWre n ntrtf 4- ;P/:r r+ of safety that is maintained 13 operating in an

. T 14 through the offices of a rather large group of both 15 practitioners and physicists and technologists who are 16 trained. .

17 That will not obtain in the imaging center or in 1!heer~

18 the private practice sector because, you know, one of those 19 successes is their lack of administrative expenses, their 20 lack of need and the extensive support personnel that 21 fulfill the requirements at the hospital.

22 So I think that we need to have training 23 suf ficient go to beyond the awareness of the need for those 24 support services. We need to go to the level of training 25 that will provide the implementation by the individual of L

8210 10 03 134 1 DAVpp 1 those safe practices rather than his being dependent and 2 accepting a very healthful environment.

3 MR. CUNNINGHAM: But that doesn't answer my 4 question. I'm trying to pin down whether or not the

(~s) s 5 additional training is going to make a substantial 6 difference in the amount of exposure these categories of 7 individuals receive. I'm going to get to the patient in a 8 little bit.

9 What we're dealing with --

10 DR. GOODRICH: I respectfully submit that that 11 did answer your question. To be more explicit, yes, I think 12 the additional training is necessary for the reasons I've 13 given because I see the future of medicine and the future 14 seat of the activities of medicine that we're discussino

( 15 moving significantly out into the private sector or the 16 small unit facility. And I' think that the need for training 17 is sufficient to be able to implement on a personal basis, 18 is necessary. I don't see that as being achieved in the t

19 pricr three-month wonder programs.

20 DR. WEBSTER: I'd like to give a slightly 21 different answer to that.

22 This morning we heard several people say -- and I 4

23 think this is true -- that the additional time from three 24'- months to six months which came into effect over a year ago,

(~T x l ., 25 I

was devoted to further clinical training not to further

8210 10 04 135 l 1 DAVpp 1 training in radiation safety. That the 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months hadn't l-l 2 been increased and the hands-on ' experience hadn't been 3 increased, but the clinical component had.

l() 4 Therefore, I would submit that the increased 5 clinical training would have a rather small impact, if any 6 at all, on the exposures and the radiation safety issues, 7 the exposures people are getting. That would be my 8 impression.

9 MR. CUNNINGHAM: Dr. DeNardo?

ff69 10 DR. DE NARDO: Just to comment briefly Ju> my 11 perspective of what you asked in terms of exposure to 12 physicians, technicians, and the public relating to, in 13 particular, nuclear cardiology training requirements being 14 less than that for nuclear medicine physicians in general.

O 15 And I guess the other question being are the radiological 16 residents training in nuclear medicine?

17 The changes that I perceive when it was addressed i

'18 by Dr. Goodrich and the fact that the diagnostic center is 19 becoming a very important economic institution and is being 20 pushed by big business, it is happening all over and we're 21 getting there. ,

l '22 What I see in'our area, at least, is the fact l 23 that in the diagnostic center when someone frequently who f

i

.24 has less than maximum training, who has minimum i ,

25 requirements, is sent there to set up particular types of r

l I

I 8210 10 05 136 l 1 DAVpp 1 nuclear medicine studies and from his perspective awareness 2 of the things that he's setting up for now and for the 3 future, leaves much to be desired.

l () 4 I bring that about in my thinking by looking at 5 what I expect to see, for instance, in nuclear cardiology.

6 There, we look at where are we now. Why do you see such a ;

7 low dose in the physicians, technicians, and any one of the 8 public who happens to be monitored. Like the secretary ;

9 sitting with a badge on her desk, I guess, because that's 10 the only way I know to get a reading on the public.

11 But technetium is what is being used at the 12 moment in most nuclear cardiology -- thallium by a few 13 people -- but most of the studies are technetium studies.

14 We've been lucky. Like'with penicillin. With

() 15 technetium you can't do too much and get a high reading l

l 16 unless you really do something terrible.

I 17 On the other hand if we look at the near future, i

18 you certainly have heard a lot about antibody studies in 19 myocardial disease. I think we are looking at a lot of 20 possible indium studies of antibodies, platelets, various 21 types of receptor studies. We're looking at pharmacological l

l 22 studies that I think are going to be a real thing, if not in 23 five years, within-this decade. And we're looking at !

24 physiologic studies with a lot of, I'think, exceedingly 25 exciting but new and different isotopes.

l

8210 10 06 137 1 DAVpp 1 And in standing on the threshhold of all this 2 coming about clinically, we are talking about traininq 3 people to use technetium isotopes and calling that adequate 4 and I think that's having blinders on.

l f^)-

s_

5 !!R. CUNNINGilAM: Thank you very much, I think 6 that's very helpful.

7 Dr. Pohost?

8 DR. PO!!OST: I'd like to just make a few 9 comments.

10 First of all, I fully agree with Dr. Webster.

11 That is that the additional time is really devoted to 12 clinical activities which really doesn't change radiation 13 safety and hazards to the surrounding group of individuals.

14 Second, I think that nuclear cardiology, if I can O 15 speak to that -- the experience of most of us is that 16 thallium is used very widely as well as technetium, and that 17 there are some new isotopes on the horizon. But I haven't 18 heard any of them mentioned -- that antibody studies are 19 not something that we anticipate ever using in nuclear 20 cardiology, that they're an interesting research and passing 21 fancy and perhaps they'll be useful for other organ systems 22 for cancer detection, but they're certainly not useful for

! 23 cardiac diagnosic methc4s.

24 Receptors and pharmacologic studies all sound l

l C} 25 interesting but, really, from a clinical perspective, therc l

t I

l

l r ,

l 8210 10 07 138 l

1 DAVpp, 1 is no evidence that any of these things will have a role in j

2 nuclear cardiology.

3 So I think for a long time past and for long time

() 4 from now on, the technetium and thallium will remain as the ;

5 principal agents of the nuclear cardiologists in {

6 cardiovascular nuclear medicine. j 7 I don't see anything on the horizon that has 8 stuck around for a long enough period of time to have any i

9 hope that we're going to be changing those isotopes in the 10 future. There may be a technetium myocardial imaging agent l 11 in the future but that's technetium.

! i 12 I think if I could comment on a few other things ;

13 along with this, the indium and the indium labeled platelets 14 are also fascinating but not clinically relevant. Nobody to I

( 15 date has shown any convincing evidence that they're very 16 important.

17 In addition to that, tomography -- that is, r phefwl 18 singlert;gemissioncomputertomography--remainsa l

19 research tool. Although there's some data that suggests it 20 may be marginally better for thallium studies, there's.no 21 convincing evidence. It may, of course, be true that F

22 positron emission tomography is far superior but that's not ,

l 23 the purpose of this discussion. ,

24 With regard to the boards, just one comment 25 here. I'm in the unique positie.n of having taken both the l

I

yw t 8210 10 08 139 q l 'DAVpp 1 cardiology and the nuclear medicine boards. There were 2 questions on the cardiology boards about nuclear "1 3 cardiology -- even when I took them in the 1800s -- and the

() "

1 4 in the nuclear medicine boards, at least when I took them in 5 the late 70s.I wouldn't rely on them to help us understand 6 someone's competence from a safety perspective. I think s .

7 "they're inadequate mechanisms for documenting that someone

8 is safe versus someone who is not safe on the basis of pass 9 or fail of that particular board.

s a 10 I passed it on the first time around, s ~ .

P~' 'S ' 11 , fortunately, so I have a great objection to boards as being 1, 1 12 the principal means for which you should decide if someone r i

<m -

s, 13 is competent and safe in the handling of radionuclides.

3 i 14 On a different note, I'd like to point out that

.. N?

15 the task force -- and I don't mean to 'swltch gears. The 16 task force that you organized -- and I would like to 17 compliment you for having the ability to bring together the

,, s f

r 13 people that seem to function well representing all l

i, , 19 disciplines, cardiology, nuclear medicine, nuclear

/ *' f*- 20 radiology, radiology. This group functioned very well and I o' 21 within a very short period of time, to all of our surprise, W

i .

22' came up with a very nice c'ompromise position which seemed 23 very logical from each perspective.

V l 5 24 But I would like to remind everyone that the l (~\

k /#

i, F

, 25 perspective that I came from was that the training

+

g1 k

3 er

l 8210 10 09 140 l 1 DAVpp 1 requirements just for the safe use of radiolabeled tracers, 1 2 were excessive at six months. And I still firmly believe 3 it's excessive at four months, and four months really

() 4 r'epresents actually a compromise position.

5 I'd like to remind everyone that our original 6 position was we felt that it would be appropriate and safe 7 for individuals that didn't use generators, that used only 8 prepackaged agents to have, perhaps, two months of 9 training. And those who required the use of the generators 10 on the basis of experience of many years before, that the 11 three-months training period was, in fact, adequate. That 12 was our proposal.

13 I don't mean to open up a can of worms, but I 14 just wonder what the feeling is of the people in this 15 committee toward even lesser amounts of training for L

16 competence in the area of radiation safety, particular,y 17 with regard to dividing up the clinical issues which I 18 think we've heard today, and I believe strongly, should be 19 judged _on the basis of training programs on an. individual 20 basis versus the radiation safety issue,-which the NRC is 21 interested in. And I'd like to really find out what the 22 opinion of the physics people on this committee is with 23 regard-to that issue.

24 I think I've said enough.

( )"'

25 (Laughter.)

i

8210 10 10 141 1 DAVpp- 1 MR. CUNNINGHAM: You said it.

2 (Laughter.)

3 MR. CUNNINGHAM: That's the end point.

(} 4 I wanted to discuss some of these issues that 5 will lead us to that point in some logical manner but I'll 6 give Dr. Webster -- and Dr. Almond, perhaps may want to 7 respond since you asked the question of medical physicists 8 who are with us today.

9 Dr. Almond?

10 DR. ALMOND: This has been an interesting sort of 11 experience for me because it's somewhat outside of my field 12 of interest. But I think there are a number of points that 13 can be made. I'm impressed by the number of people who said 14 today that they really don't want to operate without the NRC O 15 sort-of input. And you just pointed out a moment ago, this 16 goes back to the old AEC days.

17 We just don't have the baseline for any 18 information of using these materials when there weren't 19 regulations in force so it's very hard to say, have we 20 improved the situation or not? No one, I think, would want 21 to go without any kind of criteria for-training and 22 experience to use these, so there has to be some minimum.

23 With regard to the sort of basic training and the 24 sciences, after 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months , it's a well sort-of established t)

(_/ 25 sort-of time period that we have. By the way, talking about

8210 10 11 142 1 DAVpp 1 the forms and Frank did this -- you didn't see the one that 2 came around the other day because it was in therapy. The 3 applicant had put 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months down for physics, 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months down

() 4 for mathematics, 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months down for biology, and 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months 5 down -- I happen to know the physicist who taught the 6 program and I said, maybe he had these guys in class all day 7 long. Obviously, I think people misread or just put down 8 what they feel the committee wants to see. It's very hard 9 to know when those forms are filled out, really, what the 10 training is.

11 The other thing about that is, though, you don't 12 know the quality of the training that these people are 13 getting. Some people can learn that stuff in 50 hours5.787037e-4 days 0.0139 hours 8.267196e-5 weeks 1.9025e-5 months and 14 some it's going to take 250 hours0.00289 days 0.0694 hours 4.133598e-4 weeks 9.5125e-5 months , or 300 hours0.00347 days 0.0833 hours 4.960317e-4 weeks 1.1415e-4 months and it seems O 15 to me there has to be a compromise on those hours.

16 I think for the physics and radiation protection 17 that 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months is, I think, a good compromise. Some people 18 get it in a shorter time; some people it takes a little 19 longer. I think it would be cutting it to reduce that 20 although in some instances I suspect you do get less.

21 But this is good training.

22 MR. CUNNINGHAM: Dr. Webster?

23 DR. WEBSTER: I'd like to talk to some other 24 aspects of that same problem of training, more in terms of A

k-) 25 -how the training is divided; how much do you spend on what I

8210 10 12 143 1 DAVpp 1 area.

2 Several people this morning, Dr. Siegel and 3 Dr. Ronan in particular, aimed rather sharply at the second

(} 4 phase, 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of hands-on training. I feel kind of 5 strongly about that, too. I think they're absolutely right 6 in what they said. It doesn' t take 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months to do those 7 eix or seven things, which Dr. Ronan spelled out.

8 For example, ordering and receiving and 9 unpackaging. You can learn how to do that in three hours 10 comfortably. Calibration of a dose calibrator and of a 11 survey meter, generously, a couple of days to learn that, 12 16 hours1.851852e-4 days 0.00444 hours 2.645503e-5 weeks 6.088e-6 months . I'll run down the list.

13 For the first six items, I think 60 to 70 hours8.101852e-4 days 0.0194 hours 1.157407e-4 weeks 2.6635e-5 months 14 would be quite adequate. I mean, how long does it take to 15 learn how to administer doses to patients with shields and a 16 syrin'ge. I was generous; I And the last GI tih,said on four hours.

17 one. There's one about illutie,g, assay, breakthrough 18 testing, and preparation of radiopharmaceutical kits.

19 There's a fair amount of meat on that one.

20 I believe that one probably by itself is more 21 important than-all the others put together in terms of the 22 time demands. But I would allow two weeks for that. That's 23 80 hours9.259259e-4 days 0.0222 hours 1.322751e-4 weeks 3.044e-5 months .

24 My sum total for_that whole program for the (D

%) 25 second phase comes to 66 plus 80, which is 146 hours0.00169 days 0.0406 hours 2.414021e-4 weeks 5.5553e-5 months , ,

l l

.8210 10 13 144 1 DAVpp . I approximately one-third of what is being asked.

2 While the balance of the time could be used in 3 doing this clinical training, the balance of the four-month 4 or whatever is going to be decided in increasing the 5 clinical training component, because you've got a lot of 6 time left if you've only got 146 hours0.00169 days 0.0406 hours 2.414021e-4 weeks 5.5553e-5 months in that second i

7 phase.

j 8 So that would be my attitude as a trainer, so to 9 speak, to the entire program. ;

, 10 11 .

12 1 13 14

. O 15 .

16 .

17 18 19 20 1 21 22

23 24 1 25 t

r -. , 1 ., . . - . , , ,. , - . , .-. p

8210 11 01 145 1 DAVpp 1 MR. CUNNINGHAM: That's very helpful and I'd like 2 to come back to this, Dr. Webster.

3 But before I do that, I see several people who

() 4 have got to leave. I think Dr. Siegel had his hand up a 5 moment ago.

6 One last shot, Dr. Siegel?

7 DR. SIEGE 5: Actually, I might stick around for 8 little while longer.

9 Just a comment relative to your question about 10 the radiation safety to the general public and occupation 11 workers and physicians related to some of the things I 12 heard the committery saying. It bothers me a little bit and 13 I think we see the tail wagging the dog a little bit here.

14 We're talking about Appendix A of Regulatory 15 dkuide 10.8 which is not the entire federal structure 16 for regulation of radiation safety. The remainder of Title 10 17 Af of the Code of Federal Regulations has a fair amount of

~ 18 teeth in it and a fair number of very specific rules, some 19 of which we hope will be very clearly codified soon so that 20 everybody will have the same set of rules that they have to 21 follow. So physician training criteria alone are not the 22 primary basis for protecting the safety of the general 23 public.

24 One other point is,.yes, nuclear medicine is O 25 going to get more complex in the near future. .All of

~ , .

8210 11 02- 146 1 DAVpp 1 medicine is getting more complex on a daily basis.

2 Some of the things that Dr. DeNardo suggested are 3 going to happen and become part of practice may indeed

() 4 happen. A fair number of them, however, are not relevant to 5 this discussion because they're going to happen with 6 non-byproduct material and you all have no jurisdiction to 7 really be discussing this.

8 MR. CUNNINGHAM: I think, Dr. Siegal, that I Grt$

9 would agree with you that for protection of workers sa-the 10 public, there are a body of rules that must be complied 11 with. I think what Dr. DeNardo is indicating that without 12 sufficient training we will have physicians who don't know J 13 how.to comply with those rules and some other developments.

14 DR. SIEGEL: If I can just retort,'I hope in my 15 statement this' morning I was not misunderstood to be 16 suggesting that there be no physician training requirements 17 at'all because certainly in the office setting where the 18 license is issued to the physician and where there is.no 19 generalized institutional program of checks and balances, 20 then you have to have some starting place.

21 So, I absolutely say, I think my letter clearly 22 says that in the office setting, physician qualification to

.23 insure. safe radiation practice must be maintained.

'24 I would-just throw out.the concept that in the !

! )- 25 provider setting and institutional setting, it's conceivable l

~

8210 11 03 147 1 DAVpp 1 that they could be done away with.

2 MR. CUNNINGHAM: By having institution --

3 DR. SIEGEL: Having the institution take that as

( /,

r 4 part of its licensed responsibility and suffering the 5 consequences if they screv it up.

6 MR. CUNNINGHAM: I think your position has been 7 quite clear. We very much appreciate it.

8 The purpose I brought up, the occupational and 9 public exposure, what I'm trying to do is try to eliminate 10 those things from the controversy if we possibly can. I 11 think what Dr. Webster said is very helpful.

12 We also -- some of the things that Dr. De Nardo 13 said --

14 Dr. Woodbury?

15 DR. WOODBURY: I gues's the reason most of us have 16 been reluctant to jump in and try to answer the question or elesure (?)

17 with any definitiveness of exposure is because so much is 18 speculation. Early on when the Atomic Energy Commission 19 came out with a set of guidelines, it was in realization 20 that if not handled correctly, if the source was not handled 21 by persons trained, then it could inure to the deficit of 22 the population at large.

23 I think out of those rules and regulations we 24 have a reasonably good record of exposure but you-really 25 need one untoward event to set the whole thing on its head.

8210 11 04 148 1 DAVpp 1 For instance, in almost 15 years of practice I 2 never had a patient who asked about the effects of 3 radioactivity until the Three Mile Island accident. Then

() 4 the population became aware of exposure and so on and wanted 5 to know, did they glow in the dark and that type of thing.

en Une 3 6 In trying to answer your question er to exposg 7 ye$p it would all be speculation so we don't have hard 7

8 feelin'gs to predict what would happen in the future.

9 We do know the one thing that is certain is that 10 medicine, the practice of medicine, the practice of nuclear 11 medicine is changing; it's not as it was. We also know that 12 even at the time when the AEC began the regulations that 13 most of nuclear medicine was practiced in research centers,,

fs

14 the large centers. Now we know it's going to be U 15 dispersed.

16 We also know that nuclear medicine regardless of 17 what form, whether it's cardiology or nuclear medicine in 18 general, is not going to be any safer and so to regress in.

19 training would seem to me to be foolhardy.

20 I can't answer in terms of what we might expect 21 in terms of exposure. I can speculate as could anyone 22 else. It would seem to me to reduce the training that has 23 at least brought us the good marks we have so far. It would 24 be foolish to cut back.

A k/ 25 MR. CUNNINGHAM: I should point out that let's

~8210 11 05 149 1 DAVpp 1 not lose sight of the fact that the six-month training o- 2 program has not been in effect that long. We are not seeing 3 the benefits of that additional training time at the l 4 present.

(~2 m

5 The record of nuclear medicine and it's, I think,a.

A 6 good record with regard to protection of worker exposure, 7 exposure to the public, is based on training requirements 8 over the years that have been much less than the four months 9 that are being proposed now.

10 We simply aren't seeing what the six months will 11 do;.what the Akita is. I, myself, cannot see very much 12 difference, see much expectation of very much difference in 13 the quality of radiation eYposure to workers and members 14 of the public added by that six months training program.

O 15 That's just one part of the picture. I'd like to 16 go to the other part.

17 Dr. Holman?

18 DR. HOLMAN: I think that we're. spending a lot of 19 time talking about a given. The problem is so minimal as 20 you point out, with the three months of training that goan9 10 21 ineq-six was not the reason that somebody suggested you go 22 to it. So I-prefer that we go onto the reasons.

2 23 MR. CUNNINGHAM: Let's deal with the tough 24 question and that is the patient.

25 I would like to hear from members of the i

v -

t w-

8210 11 06 150 1 - DAVpp 1 committee what they would expect to get in patient radiation 2 protection by six months training as opposed to four months 3 training; what they would expect to get or what they don't j} 4 expect to get.

5 Does anybody want to volunteer?

6 DR. HOLMAN: I have a question for you.

7 (Laughter. )

8 MR. CUNNINGHAM: You're not allowed to ask the 9 Chairman questions.

10 DR. HOLMAN: You have a baseline here because you 11 did that very nice misadmistration of dose study in 12 association with ALARA to find out what the incidents of 13 misadministration is with three months of training but would 14 provide, perhaps, a basis for the rest of us to speculate.

( 15 MR. CUNNINGHAM: There are two things, of course,

-i 16 I would point out, the ALARA requirements. That was made on 17 agqcccupational exposure. There was a misadministration 18 study following that.

19 For diagnostic misadministration involving 20 diagnostic procedures, I will make the generalization that 21 came out_in a report just recently but in general the

-22 misadministrations are associated with random human error.

23 We have not been able to pick a pattern which is subject to 24 correction by regulation or license requirements.

k_w) 25 Typically, somebody gets a patient's charts mixed )

)

1 i

i

8210 11 07 151 l s 1 DAVpp 1 up. They just simply misread a label. They pick the wrong l 2 syringe out of the shield; they don't read it properly. And 3 it's random in most instances. There might be some 4 institutions that do that but these mistakes appear to be

(

5 random, human errors for unexplained reasons.

6 I don't know that an increase in training will 7 correct that. I'm not qualified to answer whether increased 8 training could change that.

9 In some cases, the technician misreads the 10 physician's handwriting which should induce physicians to 11 better penmanship, perhaps. That's happened in more than 12 one instance. But I don't see the relationship.

13 We haven't been able to draw a relationship of 14 these errors to training. As a matter of fact,.we've gone O 15 back through our license requirements and physician 16 training. In most' cases, the physicians have what would be 17 considered very good training and many of them have been 18 conforming for years.

19 Bill, did you want to make a comment on this?

20 CAPT. BRINER: I've b'een waiting so long I've 21 forgotten what I was going to say.

22 (Laughter.)

23. CAPT. BRINER: But I would like to comment on 24 that misadministration Pandora's box that you just opened

=

25 .and relate a part of that study,.unless my memory's P

(

c 8210 11 08 152 1 DAVpp 1 completelyfailingme,[hemost significant number of 2 misadministrations in that original study were caused by the 3 output of a nuclear pharmacy and a physician accepting these

()

?:.'

4 things without question and using them.

5- I pose the qu,estion: Would additional training G onthepartofthat{htJ58ti4M

, ^eitiq3,or those physicians have 7 prevented those misadministrations[ Am I correct in that o

8 statement about the nuclear pharmacy issue?

9 MR. CUNNINGHAM: I guess I have to answer that or 10 try to_ answer it.

11 Certainly, the first part of the problem is 12 dealing with the nuclear pharmacy that puts out nuclear drug 13 forms. And following this, we've taken some rather severe 14 enforcement action, or plan to do so, to the extent that AMd 15 misadministration is also involved, the physician is the 16 NRC.' It also raises the question whether NRC requirements 17 for checking these doses should be changed. But I don't 18 know t's really a training issue so much as a license 19 requirement issue.

20 I suppose one could argue that a more trained 21 physician would have suspected these things and checked them 22 independent of NRC requirements to check them.

23 I just don't know how to answer that part of the 24 question.

25 CAPT. BRINER: That was the point of my

l l

1 l

8210 11 09 153 !

1 DAVpp 1 question. l 2 MR. CUNNINGHAM: And I don't know the answer to 3 that, Bill. Does anybody want to attempt to answer it?

(_s) 4 Dr. Webster? ,

5 DR. WEBSTER: There's one anecdote from an 6 institution with which I'm very familiar. We had a rush of 7 three misadministrations last fall, that institution did. I 8 don't want to be cornered on that.

9 (Laughter.)

10 DR. WEBSTER: It was found that these were done, 11 these errors were made by probably the best nuclear medicine 12 technologists we have who blame human errors, in this case, 13 on the pressure of work.

14 Obviously, the training for this particular 15 person isn't going to have an impact. It probably wouldn't 16 have much impact on physicians. In this particular 17 institution, the physicians do not make the injections in 18 general.

19 Let me stop there.

20 That bears out, I think, the earlier comment.

21 MR. CUNNINGHAM: Before we leave this 22 misadministration, I might point out something to-the 23 committee. There does seem to be an area where we will 24 'probably come to_ misadministration. It has to_do with O 25 quality control of-therapeutic doses. I don't want to 1

l

8210:11 10 154 1 DAVpp 1 mislead the committee into saying that these 2 misadministrations have indicated nothing. I think there is 3 an area we need to explore further. We will probably be 4 coming back to the committee on that.

5 Okay, let's get back to the patients and 6 train'ing.

7 As I understand it from some of the things I've 8 heard today, one of the issues that is perceived as 9 important in training is to prevent unnecessary exposure of 10 the patient either through prescribing procedures that are Aaf a

11 necessary or interpreting procedures-incorrectly.

12 While that is very closely associated with the 13 quality of clinical practice, it can be argued that a 14 misinterpretation of the results of the procedure is, in (3] 15 fact, giving some radiation dose to the patient ~without any 16 benefit.

17 Is this an important thing from a radiation 18 safety standpoint as opposed to the quality of clinical 19 practice, is a question for the members of the committee.

20 Dr. Pohost?

21 DR. POHOST: I think the issue is really one of 22 quality of practice and not one of radiation safety. That 23 is to say, knowing when a test is indicated and knowing how 24 to interpret it properly in the context of clinical

') 25 practice.

L

8210 11 11 155 2 DAVpp 1 MR. CUNNINGHAM: Dr. Holman?

2 DR. HOLMAN: Performance of a unnecessary test 3 utilizing radiotracers obviously increases the radiation 4 exposure to that patient who had the unnecessary test, f~)

u.

5 Therefore, it's a radiation safety issue.

6 (Laughter.)

7 MR. CUNNINGHAM: This gives me just the answers I 8 need.

9 DR. POHOST: Let me say one other thing. It 10 becomes a radiation safety issue after the clinical mistake 11 is made but it's original.ly a clinical problem and if people 12 are not educated clinically, then they could make a 13 radiation safety mistake. But I think it's the problem, you 14 know, which is first the chicken or the egg and we're 15 talking about now the fact that the. clinical. problem is 16 driving the safety issue.

17 So, I think that the clinical issue is paramount 18 and the safety issue is secondary.

19 MR. CUNNINGHAM: So I understand your answer is 20 that, yes, it becomes a safety issue but the cause of the 21 safety issue is the quality of the clinical training as 22 opposed to the radiation safety training.

23 Let me ask Dr. Webster or Dr. Almond a question.

24 All these. radiation doses we're talking about.are evolved 25 stochastically; am I right, doses.that are below the O

8210 11 12 156 1 DAVpp 1 non-stochastic'threshhold.

2 DR. WEBSTER: There would be no acute medical 3 effect. We'll be thinking about long-term.

(p 4 MR. CUNNINGHAM: With a certain probability 5 associated with them.

6 DR. WEBSTER: Absolutely.

7 MR. CUNNINGHAM: Dr. DeNardo?

8 DR. DE NARDO: Just-commenting on the issue we rel 9 had on the floor "=aG.3"q,to medical training being

='

10 necessary for the safe use of radioisotopes in patients.

't 11 The one area is that of retesting. In a sense if 12 a bad judgment call is made, in terms of how a study is 13 performed, either because the instrumentation is not 14 functioning right or because.the patient is given the wrong 7-)g 15 pharmaceutical because the judgment call was-to do an indium 16 white cell study, but it should have been gallium.

17 We need to bring the patient back the next week 18 and do a gallium study, particularly a problem in children.

19 And vice versa, whether the gallium was used and it should 20 have been an indium white cell study or whether basically 21 good technique was not done and it was not caught by the 22 physician and the patient has to be returned for any of the 23 studies involved means that the patient is getting twice, 24 and sometimes more than_twice, the injected dose of 25 radioactivity. And I think that's a radiation problem.

h

821'O 11 13 157 1 DAVpp 1 Yes, it was driven by the clinical problem but 2 that's why we're here, to practice nuclear medicine and 3 because patients have problems.

() ~4 MR. CUNNINGHAM: Dr. Gould?

5 DR. GOULD: I want to just add an additional 6 answer to your question. Cardiologists face the decision of 7 cath, which involves a great deal of radiation exposure, in 8 many cases, more than in nuclear cardiology. We face that do 9 as $zfradiologists, the same sorts of decisions.

10 I agree completely that radiation safety may be 11 related to the clinical problem. However, the ultimate

-12 decision as to whether to go back for a repeat is a clinical

. 13 ,

one. In my own experience, the specialists in the clinical 14 area making that decision, ultimately are responsible for

, 15 that second study or not, and certainly in cardiology almost 16 invariably the nuclear group will offer three or four more 17 tests which we have to make a clinical decision about, 18 because we ' re the ones that understand the physiology, 19 et cetera, that's necessary to make it.-

20 So I agree that the radiation safety problem is 21 germane, that the solution is clinical competence which 22 really is not the area that you're addressing and that the

-23 pure radiation safety part that has to do with doses, the 24 extra exposures if one drops the wrong syringe, that kind of G.

J 25 training is adequate for-the shorter period of time.

l l

l 8210 12 01 158 l 1 DAV/bc 1 MR. CUNNINGHAM: This is what we would like to do, l 2 Dr. Gould. Separate clinical training from radiation safety 3 training. But, then, when I hear arguments that the lack of

~

() 4 good clinical training results in radiation safety problems, 5 that obscures that. And that's the difficult part.

6 I'd like to separate them. But, these kinds of 7 arguments lead us back into the quality of clinical 8 training.

9 DR. GOULD: I agree very much, if the NRC wants to 10 address the issue of clinical training, I would be happy to 11 participate in that discussion, if it has that jurisdiction.

12 I can say that the aspect of the decision of going 13 back for repeated studies, certainly, in cardiology, as I 14 understand radiologic training, that's a fundamental process 7s

\] 15 of training that we teach and. learn every single. day, for 16 now, in most programs, a three-year period of training. And 17 that the clinical training for the value of the given study 18 very much impacts that with our current program.

L.

19 For example, many cardiologists don't use thagium 20 very much because they don't think the value is worth the 21 exposure and hassle to the patient, so they go on to another 22 study. And one can argue the technical merits of that. But 23 I'm saying that they_are trained and fully exercising ,

i i 24' expertise in making those decisions now, for which there is )

) 25 an enormous record. )

8210 12 02 159 1 DAV/bc 1 If you look at the AHA presentations and the 2 abstracts of the ACC, these are the verp issues that these 3 trained people are addressing. So there are technical

() 4 differences but their exposure is really quite thorough, 5 very thorough.

6 MR. CUNNINGHAM: Dr. DeNardo.

7 DR. DENARDO: I'd like to clarify a point there.

8 If you decide you want your patient to have a study, do you 9 need the information provided by that study? You have made 10 a physician's judgment decision. If I do that study and 11 either let my technical staff, radiopharmaceutical staff, or 12 myself... excuse me, botch the job because of either the way 13 it's done, what's injected, or the.way the informaticn is 14 recorded, and I cannot give you the information, if you 15 needed that information in the first place, most likely you 16 will turn around, unless something has changed, and say, "I 17 still need the information." I have then caused the patient 18 to get a second dose of radioactivity.

19 And that's a little-different from saying, "I've 20 done the study, and I have given you the information. .Now, 21 do you want to get another study to give you different or 22 complementary information?"

23 That's another physician judgment call. I'm 1

24 speaking, however, in a repeat.of the study, talking about '

] 25 the studies and the many that are repeated, because of the i l

l i

l l

8210 12 03 160 1 DAV/bc 1 first study being done inappropriately, inadequately because 2 of basic problems in getting the appropriate data -- not 3 because it wasn't the right study to do.

()

4 And on the question I raised regarding the effect 5 of the disease process, that's another one. That's a little 6 more of a judgment call. But there are some basic things in 7 training that yield definite information tbt._ isn't followed 8 by people who haven't had both the clinical and the pre-9 clinical training to make those decisions.

10 And that one gets repeated when such things happen 11 as a patient with a low white count gets her blood drawn, 12 sent outside to lab X, who doesn't know that there's no 13- white cells, sends back indium on.gcod gracious knows what, 14 and it gets injected; instead of getting a white cell scan,

.O 15 you get a gmish.

16 That is again a technical education problem. I 17 don't think that is a clinical judgment call, it's just 18 basically not knowing the things and not, not thinking about 19 the things to look for.

20 DR. GOULD: I think we're in complete agreement in 21 terms of if the job is done by really good technical pecple 22 there's no question. The reason that I run the entire 23 nuclear cardiology is because there is only botched cases by 24 the nuclear people that did not understand fundamental-

\ 25 clinical problems; similarly, just interpretaticns, or

8210.12 04 161 1 DAV/bc 1 whatever, but were off the wall. There was not the 2 fundamental clinical competence to bring it off.

3 So I think if one is competent, I've got no f>J'i 4 problem. But, to define that by a set of rules other than 5 the requirements of good clinical training, I think, is tempdsdce (?)

6 beyond the comprehension of the NRC.

7 MR. CUNNINGHAM: Mr. Dorian is a member of our 8 ,

legal counsel at the NRC and I would just like...

9 MR. DORIAN: I'd just like to bring a little bit 10 of perspective from the nuclear reactor area into this area 11 as well, and then to make another point.

12 As to the perspective we found in connection with 13 operators who run nuclear power plants, that it's very, very 14 important to have quality control and quality assurance in

( . - 15 their training programs; so that the quality of training, as 16 the point has I think been made before, is very important, 17 as are, of course, the number of hours perhaps more 18 important.

19 The other point from the nuclear. power plant area 20 that's important to remember is that recertification is very 21 important. Once someone has had training, just because 22 they've had training, 20 years later, they may forget it.

23 The area advances, things change. I would like to add 24 another perspective, that recertification is important.

O

\l 25 Finally, the pragmatic point. NRC is in a

8210'12 05 162 1 DAV/bc 1 difficult position with respect to the public and with 2 respect to' Congress. I think the doctors realize that.

3 And the pragmatic point is very, very simple.

c'

( 4 Once the NRC has gone so far as to raise the threshold of n

5 training from four to six months, it would be very, very 6 difficult, I would say, wel, hr impossible to lower it 7 again.

8 MR. CUNNINGHAM: What Mr. Dorian said was public 9 concern about nuclear activities in general, once you set a 10 high standard for training, it is very difficult if not.

11 . impossible to go to what appears to the public to be a lower 12 standard. Whether it is or not doesn't matter. We all have 13 had experience. Those of us on the NRC staff have had that 14 experience of this kind of thing in recent years.

15 It isn't nearly so difficult to put on. additional 16 requirements in regulating nuclear energy as it is to remove 17 such requirements.

18 DR. UEBSTER: There's an issue on the other hand 19 which can be made with the opposite point, namely, that a 20 couple of years ago the waste disposal of low level carbon-21 14 and tritium were deregulated so they could be treated as 22 nonradioactive. That might be considered a step backwards.

23 Certainly, it was unraveling some regulations s

24 which already existed. So it isn't impossible. And that's

\/ 25 not the only example of a reversal.

8210 12 06 163 1 DAV/bc 1 MR. DORIAN: As Mr. Cunningham said, my point was 2 that wasn't a public perception.

3 DR. WEBSTER: There was public concern, but it

C,,s) 4 didn't win the day.

5 MR. CUNNINGHAM: That is one time when this was 6 successful. As a general principle, I think Tom correctly 7 points out that it's -'ery difficult to'go to a different 8 standard. I think the point he's making, and you have to 9 consider this, Dr. DeLand has indicated that it isn't the 10 hours, it's the gravity of the practice and the quality of 11 the training.

12 A number of people have said...I think Dr. Collins 13 has said in the past, that, really, it is what the person 14 learns rather than how many hours of training that he's had

< 15 that is'the important thing. The issue we al'Qays confront 16 is how does a regulatory agency measure or regulate this 17 kind of thing?

18 Now perhaps the hours or length of training don't 19 even need to be prescribed if we had to define the types of 20 training. The broad subjects of the training, if we could 21 devise-some method to put quality assurance in the training

22. programs and some way of determining that a person who goes 23 through this training program has indeed learned what he's J

_ ,_ 24 supposed to know.

25 Dr. Holman.

8210 12 07 164 l' DAV/bc 1 DR. HOLMAN: I think this is really the critical 2 issue of trying to put quality in the package. It would 3 certainly make a lot of us more comfortable one way or the (em) 4 other. What you're suggesting, by eliminating the hours 5 altogether, makes it almost necessary to have some kind of 6 competency, which I don't think you want to get into.

7 I was wondering, part of the recommendation of the 8 task force was simply to limit separate training within 9 structuresofapprovedresidenkNEprograms. Maybe that in

~

10 itself might be one way to do it, by disfranchising the 11 unapproved programs, if that sort of thing could be done.

12 MR. CUNNINGHAM: Do other committee members have a 13 comment on what Dr. Holman just said? Where I'm leading is 14 that if we are to move from the six month, training, do we 15 have a basis for doing so by bettert'nsurses irrrin),- quality in the 16 training program?

17 DR. HERRERA: May I address that issue?

18 There are other specialties-in medicine, and I'm 19 not suggesting that the government should do it. I think l 20 it's my own bias that this can be better done by ,

l 21 professional societies. But the fact remains that, j 22 specifically, there are the so-called laboratory medicine or 1

23 clinical medicine where, in addition to what they were '

24 trained, unless you have in place quality control programs 25 both internal and external, no matter what your background,

t 48210 12 08 165 1 DAV/bc 1 experience and training is, the number of errors in your 2 case would be translated into additional radiation dr1bic pa r+ 4 rpk/

3 p-tien, a l l ,O Hnecessary application of radiation, if,

_ (- 4 in addition to the initial training of the individuals 5 involved, there is,. in 4 place a program of quality assurance 6 and quality control.

7 In the case of the technologies, we go as far as

8 having. created a program on a voluntary basis where we are 9 constantly surveying proficiency in performance of variouc 10 laboratories in the country.

l 11 I know that by saying that, half of my friends in 12 this room may never speak to me again. And I'm not 1

t 13 suggesting at all that the Nuclear Regulatory Commission 14 should undertake this task, because I believe that Nuclear 15 Medicine professional societies can develop appropriate 16 programs to provide quality assurance and quality control.

17 Without that, there will always be mistakes, no matter what

{

18 the training is; because people, like the universe, follow 19 the second law of Thermodynamics. No matter where you 20 start, you end up in the sack unless there is some prodding 21- that keeps on. -

22 DR. DELAND: I'd like to reinforce.>what the 23 ' attorney said. Yes, they did relax the carbon-14 tritium 24 problem. But, at home, at any rate, just as soon as it came O

25 out, it was turned down by the public, even though federally l

8210 12 09 166 1 DAV/bc 1 it is actually preforable.

2 The other thing is I appreciate the fact, the

, 3 conversation, as far as I can see, is going toward perhaps a gq)

( 4 less fixed idea in either time, hours or value. I can 5 appreciate the fact that the NRC does not want to get into, 6 or perhaps it is not permissible for them to get into any 7 type of objective evaluation that's in written form.

8 Perhaps something that might he investigated is if 9 the group that came through this compromise, perhaps they 10 could come up with their own program that is applicable.

11 After all, it is applicable to cardiologists, in nuclear 12 medicine people, radiologists and so on. I would think they 13 would come up with their own program that is initiated 14 within all the training programs.

15 And for the. young men and women that are under.

16 training, that, in anticipation of their getting NRC 17 approval, that they are examined through the good auspices r

18 of the ACC, the ACR, the SNM, and so on. And unless they 19 stand or die, then the NRC can accept it and say, Well, 20 whether they have the boards or not, they have passed an 21 exam that all of us have agreed to, that it is objective and 22 shows that they've got the training.

23 By the way, I think training is not so great. But 24 the NRC is not involved in this other than the fact that 1

25 they have a recommendation from people who know what the t

/.

8210 12 10 ' 167 1 .DAV/bc ~1 program should be and what the people should know before j? 2, 'they let them loose.

3 MR. CUNNINGHAM: Thank you very much, Dr. DeLand.

s

' .(-8/ .a 4 .Does anybody else want to comment on this?

%T. 5

f' Dr. Gould.

us.

L 6- DR. GOULD: You asked for a suggestion as to how g 7 one would in a sense defend the six-month as opposed to

+

8 'four. I would suggest one alternative would be that the

. g-9 original extension of three months was concerned with IO further clinical experience at that time.

11 But, now, with larger input-from the American 12 College of Radiology, which I've already gone through, as

"#~

13 Dr. DeLand suggested, and all these other groups, with 14 further input from them, you /now I have the judgment from a 15 larger sample that_would indicate that-the more limited l

- ;, 16 period of time is certainly adequate for safety if one 17 restricts its point;of view to those aspects.

18 In that way, one-really isn't reducing the 19 requirement for safety but is detailing an evolutionary 20 sequence of ideas by the NRC.

21 DR. WEBSTER: On the question.of assuring the

). D 22' quality of training programs, of course, the various boards

[ 23 have an arm, so to speak,-to do that. They have the 24 residency' review committees. They presumably, and I don't

) 25 know just how. deeply these reviews go, but I know they look l l

4-

,y

( .

l . ..k . . - . _., i ' '

8210 12 11 1G8 1 DAV/bc 1 at the quality of equipment, the space and the personnel, 2 and the amount of time put into different areas -- whether 3 or not that should be communicated with the preceptor's r

(%) 4 report to the NRC is something else.

l 5 You might not want that kind of information to go 6 to a government agency. Nevertheless, it would be one 7 hallmark, so to speak, of a good training program, that they 8 have passed the review of the Residency Board.

9 DR. HOLMAN: The Residency Review Committees are 10 not set up by the boards. They have various sponsorships.

11 In many cases, the boarde are one of the sponsors, but, .in l

12 any case, that was my original suggestion. What the 13 residency review committees do is simply determine the

)

14 ' adequacy and quality of residency training programs.

15 Once approved by the residency review committee, 16 it is then essentially an approved program, approved 17 ultimately by the ACGMEj g[heAccreditationCouncilfor 18 Graduate Medical Education, that was precisely my point.

4 19 Such accreditation at least ensures that there is a critical l i

20 mass there to provide the kind of training we're talking l 21 l about, the kind of training in radiation protection, j 1

22 radiation biology, physics instrumentation, the basic 23 sciences, as well as the clinical training.

24 And it would at least provide a semblance of

(

25 assurance that there is the staffing there to provide the.

. .. ~. . - - , _ _ . __. .. . . . -

8210 12 12 169 1 .DAV/bc 1 minimum requirements.-

2 At the present_ time, it is my understanding that 3 the training, at least for those individuals who do not come '

4 to'us-under the aegis of the American Board of Radiology or 5 the American Board of Nuclear Medicine would have their 6 training under any preceptor-that is licensed by the NRC.

7 And-I think that to gain some semblance of-quality 4

8 control, limiting the training to at least a facility which 1

i 9 has an approved training program would be a useful step.

L 10 11 12 13 O.

15 1

16 17 18 19 20 t

21 E 22 23

+

, 24 0 25 s

1 1:

n - - - - - - -

8210'13 01 170 1 DAVbw 1 MR. CUNNINGHAM: We're drawing close to 3:00 2 o' clock. I would like to draw this meeting to a conclusion 3 fairly soon, because I know people have planes to get.

() 4 Do you have a comment?

5 DR. MITCHELL: name is Thomas Mitchell.. I have My$ PM)SCOens 6 been involved in~ training on4> nuclear medical periticrg,,

7 since 1956, across the street in Bethesda with Dick King and 8 since 1969, I have been at Johns Hopkins Medical 9 Institutions. I am currently the director of academic 10 training in the Division of Radiation Health Sciences.

11 I think there are a few things I would like to

12 comment on. Number one, concerning the physicians. We have 13 all been ta,1 king about training. I think there is a certain 14 amount of training involved with physicians in nuclear g-)g

(~

15 medicine and the radiation health sciences in general, but 16 by and large, when a physician is in a residency program, it 17 is really a educational program.

18 I see education has broader than training. I see ,

19 education as a means of approaching problems through a 20 particular discipline. A lot of time has been spent here i

21 with respect to training. I think about training, I think l 22 about dogs, I think about horses and lions, and I think 23 .about technologists. I think about people who are being 24 trained to do a particular task. When I think about O- 25 educating someone, I don't think he has to get.100 percent I

l

8210 13 02 171 1 DAVbw 1 of all material I give to him. On the other hand, when I've 2 training someone, I want him to get 100 percent of the 3 need-to-know material and limit the nice-to-know material.

( )- 4 I think part of the problempf here with respect to 5 filling hours has to do with giving out a lot of information 6 which is nice to know but not need to know. I certainly 7 don't think nuclear cardiologists need, for instance, 20 8 hours9.259259e-5 days 0.00222 hours 1.322751e-5 weeks 3.044e-6 months of training in radiation biology. Under other 9 circumstances, say, in terms of passive defense, in terms of 10 potential weapons attacks, there may be some need for that, 11 but the training requirements are set up on the basis of 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months that I think are completely wrong. What I would 13 rather see are some performance criteria, particularly with 14 respect to safety.

O-15 I am talking about safety with respect to patient, 16 physician, the worker and the general public. .Some of this 17 could be solved very, very easily by some slight changes in 18 the agency's 313-Mj g/he AEC 313-M/ and we had a fair number 19 of formal graduate-level course,s which are for radiologists ghtf5tcSn 20 and for our nuclear medical ^^ i+4^si&

=

to take.

21 I have a little form for them, which says, if you 22 took 18-A 68, thenyouhaveXhoursofradiq[,biologyandY 23 hours2.662037e-4 days 0.00639 hours 3.80291e-5 weeks 8.7515e-6 months of physics and three hours of mathematics and so on.

24 Now, that form is of some limited value, but just

'- 25 as for a recommendation, when a physician or a graduate A

8210 13 03 172 1 DAVbw 1 student is leaving and coing out, you can't use a standard 2 form to tell what that person is capable of doing and not 3 doing. I would like to see some things added to 313-M,

) 4 particularly for those physicians who are going out into 5 private practice, where they are not going to be under a 6 -license, where they are not going to have benefits of radio 7' pharmacists nor radiation physicists. And I would like to 8 fill that out knowing what technical help is going-to be 9 available for them.

10 The Nuclear Regulatory Commission has also 11 realized the value of Board certified physicists in doing a 12 very simple procedure, that is the calibration of 13 teletherapy apparatus. Shouldn't the therapeutic A 14 radiologist be able to do his own calibration? Why does he se' 15 need a board certified radiologist to do a very, very simple 16 thing. Well, the point of this is, you will already 17 recognize that there are specialists who are going to 18 provide certain facilities, I think in the area of 19 radiopharmacy. Those of you who are physicians don't 20 compound your own drugs anymore. There are any number of 21 pharmacists who can be trained very,.very easily. to do 22 radiopharmacy. I am surprised.that there are not more 23 pharmacists who have been trained in' radiopharmacy.

24 Why should the physician have to be responsible 25 for his own~ radiopharmacy? !

l l

8210 13 04 173 1 DAVbw 1 The other major problem, and this is the one I am 2 goingtostfpon, is the area of self-referral. This is one 3 of our biggest problem that I would worry about, if I looked

( ) 4 at people who are licensed out in 'he t community. That is, 5 are they referring them to themselves or are they 6 referring to patients from other physicians.

7 If patients are being referred to them from other 8 physicians, then the marketplace is going to determine if 9 they are incompetent, they are going to go out of business.

10 That is all I want to say. Thank you.

11 MR. CUNNINGHAM: Thank you very much.

12 I would like to attempt to summarize or poll the 13 committee on a couple of points, in order to wind this thing 14 up, but prior to do so, I would_like to know if there are 15 any further comments.

16 Dr. DeNardo?

17 DR. DE NARDO: I think there is one thing that I 18 wanted to just bring forward for the record today, which we 19 have not touched on. That is, the potential and at least 20 the growing obvious area of therapeutic nuclear medicine.

21 One can first point out that a lot of licenses l

22 will exclude the use of therapeutic materials and others l 23 will not. On the other hand, the influx of therapeutic

,, 24 methodology in nuclear medicine above and beyond the 25 techniques that were developed 20 years ago has already

8210 13 05 174 1 DAVbw I started and has started in other countries even more than it 2 has done here.

3 Part of that developmental technology has led them (j 4 to diagnostic tests with small amounts of these therapeutic 5 isotypes, and I think that will also add another dimension 6 to the problems that we see today, in terms of radiation 7 assays.

8 MR. CUNNINGHAM: Thank you, Dr. DeNardo.

9 Dr. Schlant. I think these comments should be 10 held fairly briefly now, because we do need to close the 11 meeting.

12 DR. SCHLANT: The question is, a program can be 13 inspected and deemed competent. That doesn't necessarily fs 14 mean the neople going through it are competent. A test of i >) .

15 competency, if you had'a'few questions on a large one-day 16 examination, where you may have three or five questions on 17 radiation safety, a person could easily miss every one of 18 those questions and still pass the examination and be " Board 19 certified."

20 If you want to give an exam on safety, you'd have 21 tc design a whole separate examination on that, not part of 22 a nuclear medicine e.:aminatiion or cardiology, but a whole 23 separate one, which is a very difficult thing. I don't 24 really think any of the current ones are really th 't proper 25 testingtechniaue[,reallyevaluatingcompetencyin

8210 13 06 175 1 DAVbw 1 radiation safety. So these are some of the dilemmas that 2 even approval of the program or passing a Board exam doesn't 3

lL necessary approve that individual. You still need a letter

] ). ~4 of personal recommendation from the director and some faith 5 in his qualities.

6 MR. CUNNINGHAM: Thank you. Dr. Griem?

7 DR. GRIEM: Concerning therapy. The American 8 Board of Radiology has a written exam which also deals with 9 sealed sources, in particular, brachytherapy. That is part f

i 10 of the written exam. There is also a huge written exam in i

11 radiation effects, including carcinogenesis and genetics.

12 It is a multiple choice exam that lasts about six hours.

~

13 That is in place for Group people, and we look at that.

gs 14 DR. COLLINS: I have only one comment this 7 15 afternoon on the public perception of our action here. If 16 it should go to reduce.our six to four months, we have had a 17 great deal of discussions, but we're talking solely about 18 safety. There is a nasty word I haven't heard mentioned 19 today -- rem, rad, millirem, millirad. That is the danger.

20 If we are so concerned, and we are, it would be well if we 21 gave a little more attention to the magnitude of the 22 problem, because the public perception of about 100 folks 23 gathered from around the country today to discuss their i 24 safety, I think they.can go home and say, well, I really

^

I k-/ 25 don't know what the answer is.

8210 13 07 176 j 1 DAVbw 1 What is the hazard that we are speaking about, the 2 magnitude of it with regard to our nuclear cardiology, for 3 instance? Through my own experience j/or observation, there fj 4 seems to be more hazard in menticning the fluoroscopy that 5 goes on, then it mentioned the nuclear aspect of 6 cardiology.

7 MR. CUNNINGHAM: I think a lot of people would 8 agree with you on that.

9 I would like, before I try to summarize some 10 things, to just start with the members of the committee and 11 to ask if they want to say anything more about the proposal 12 put forth by the Task Force on four months training for 13 nuclear cardiology and the split -- the divided opinions e, 14 between those who worked on this task force between the four

('" l 15 months and six months training for the remainder of nuclear 16 medicine.

17 Does anyone have any more comments on that? That 18 is one of the issues we will have to act on.

19 (No response.)

20 MR. CUNNINGHAM: No more comments on that.

21 Dr. Woodbury?

22 DR. UOODBURY: I think I have already commented.

23 In an effort to have a separation of oualifications, this 24 opens a Pandora's box.

4 25 MR. CUNNINGHAM: Let me try to summrize.

8210 13 08 177 1 DAVbw- 1 What I have been able'to. glean out of this 2 meeting, the first is that there indeed still remain divided 3 opinions about the amount of training necessary to provide L -

4 adequate radiation protection in the practice of nuclear

["/) -

~.

5 . medicine, whether it is one specialty in nuclear medicine or 6 nuclear medicine in'a more broad context.

i 7 ~The second thing is that the point at issue seems 8 to center on the patient rather.than the radiation 9 protection provided to workers and the public.

10 Granted there are some areas where they can be l

l 11 affected, but the key issue seems to center on the patient, L 12 and it has to do with the dividing point between what is 13 clinical practice and what is radiation safety.

14 The example was used here: . bad clinical judgment l . 15 can lead to poor radiation safety.

16 The third point is that many ecmmenters indicated, l 17 and much of the committee indicated, that really the 18 number of hours are not the critical issue. The number of l 19 hours is a mechanism for a regulatory agency to come to l

l 20 grips with. The critical issue is the_ quality of the

! 21 training and the cuality of students. that come out of these

22 training programs. ;

l '23 And ideally, if NRC were to be able to come up l l \

,_ 24 with a quality control program, that is, control of the f

bl y 25 quality assessment program -- I quess I do mean cuality l

l l

l

8210 13'09 178 1- DAVbw 1 control,. control of the quality of training provided to 2 physicians, coupled with some assessment of the physicians' 3 qualifications after they come out of this training program, 4 then, indeed, the number of hours eeegsof training would become a

}

5 moot issue.

6 I also come away from this with the opinion that 7 any long-term effects that NRC might try to provide on the 8 quality of medical practice should recognize, or the quality 9 of radiation protection, should recognize that the patterns 10 of medical practice are changing, a shift away from 11- hospitals to private practitioners and that the types of 12 diagnostic and therapeutic procedures that dominate today's 13 medical practice are not necessarily those froced.(A.ft5 y rc:::Si-~= that A

14 dominate future practice. Therefore, as we change these, L' 15 and we consider these,.we must certainly take the shifting 16 patterns into account.

17 Given these understandings, this is basically what 18 I derive from all that I have heard today.

19 Does somebody want to add to this before I try to 20 say where we r$.ould go?

21 (No response.)

22 MR. CUNNINGHAM: All right.

23 The Staff will review the record and try to come 24 up with some proposal that accommodates. The proposal will t'

l )%

s 25 go to the Commission. We will attempt, under the idea that

8210 13 10 179

1. DAVbw 1 we.might try to accommodate at least in the short term some 2 of these problems various people have brought forth:

3 however, coupled with that, a relook at how NRC determines 4 I want to see, and we

. w[)) _ qualifications for radiation safety.

5 may call on the members of our Advisory Committee, or it

, 6 might be necessary to get some special consultants to see if 7 there is a way to change how we do these evaluations, to 8 bring in the idea of quality control in clinical practice, 9 so we won't be so bound by the number of hours that I 10 believe will continue to be controversial, in part, at 11 least, because it really doesn't, address the fundamental 12 problem with which we're dealing.

13 Now the Staff will try to develop something, I 14 just don't know the time yet, but to discuss it with the be 15 j

Staff, something for you to look at on the. direction we 16 should be going on training, based on what we have been able 17 to learn and understand today.

18 Does anybody want to add to this? ,

19 I propose to leave it at this point, unless !

l 20 somebody wants to add something. Dr. Pohost. I 21 DR. POHOST: Just one brief comment. I wouldn't I

22 count on medicine continuously from then on moving out of 23 the hospital into the outpatient clinic, because similar 24 controls on outpatient clinics can be anticipated in the 4 25 future. So whatever plans you come up with, I think have I

I i

1 4

8210 13 11 180 2 DAVbw I to be tempered with the thought that even the outpatient 2 clinic is in line for DRG-type activities.

'3 MR. CUNNINGHAM: I can't respond to that.

_ ( j 4 DR. POHOST: You mentioned this is one of the v

5 thinas we learned today.

6 MR. CUNNINGHAM: It's not just today. A number of 7^ people have mentioned this. It does seem that there is 8 definitely a shift, whether it continues, I don't know, but 9 there does seem to be a shift that I have heard and that 10 I've read, and I think will continue in the future.

11 Dr. Webster?

12 DR. WEBSTER: When you communicate with the 13 Commission, will you advocate some particular format for the es 14 training of these various groups we,'ve been discussing

'O, 15 today, when you~come to a conclusion, in other words, based 16 on your.own examination of the record?

17 MR. CUNNINGHAM: I'd like to examine the record 18 and discuss that with the Staf f, before I answer that. I 19 just don't know at this point. Certainly, I must say I am 20 really not expecting that we_would all collectively here 21 come to a unanimous opinion about what training should be, 22 but I think we did develop in the course of these 23 deliberations,.some things for the Staff -- to provide a 24 basis for the Staff to proceed, when we look a little bi

.O si 25 closer at the record that's been developed.

9

8210 13 12 181 1 DAVbw 1 I think we can draw this meeting to a close.

2 Before we close, I want to make a couple of more 3 comments, but does anyone have any other subject that they 1 4 want to bring up, briefly?

m 5 (No response.)

6 MR. CUNNINGHAM: I would like, in closing this 7 meeting, something I should have done at the beginning of 8 the meeting, is note that Dr. Pohost and Dr. Herrara are new 9 members of the Advisory Committee. We do have a practice of 10 rotating committee members periodically. Some members have 11 served a long time. Members are not rotated nearly as often 12 as they should be, but I think it is very appropriate that 13 Dr. Pohost and Dr. Herrara, who has had to leave, are

,s 14 du serving on the Committee at ahe same time. Two committee c l v

15 members who are attending these meetings this week are 16 attending for the last time. They are the physician members 17 who have served longest on the Committee, and I want to say 18 that over the years, both these physician members, 19 Dr. Workman and Dr. DeLand, who have been here since 1897 --

20 oh, Dr. DeLand's gone too -- over these years, both 21 Dr. Ucrkman and Dr. DeLand have certainly been very generous i 22 with their time, staff and hhfpeoplegthatwe'vealways been 23 been able to count on and be able to call on with very 24 strange questions, have been very patient with us and 25 certainly very helpful.

T 8210 13 13 182 l~ DAVbw 1 And to me personally, I think that they have been 2 very good friends and very helpful to me in some difficult 3 things I have had to do,to come to grips withjin my tenure

('j 4 at the NRC.

5 So on behalf of the NRC, the Commissioners and 6 certainly members of the Materials Staff, and most 7 gratefully from me, I wish-to thank you, Joe, and I wish 8 Dr. DeLand were here to thank also. Thank you very much.

9 DR. WORKMAN: It's been our pleasure, I'm sure.

10 Thank you very much.

11 MR. CUNNINGHAM: On that note, unless there are 12 other comments, I would close the meeting.

13 Thank you very much.

14 (Whereupon, at 3:20 p.m., the meeting of the b,s= '

15 Advisory Committee was adjourned.)

16 17 18 19 20 21 22 23 24 25

(

CERTIFICATE OF OFFICIAL REPORTER

~

This is to certify that the attached proceedings before f+ the UNITED STATES NUCLEAR REGULATORY COMMISSION in the Is ). matter of:

NAME OF PROCEEDING: ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES DOCKET WO.:

PLACE: BETHESDA, MARYLAND ts DATE: FRIDAY, MAY 3, 1985 J

were held as herein appears, and that this is the original transcript thereof for the file of the United States Nuclear Regulatory Com:rd ssion.

l l

l

' ' '~

(siet)' '

(T1rBD) -

DAVID L. HOFFMAN Official Reporter Recorter s A.F: ACE-fEDE

. AL,lationREPORTERS, INC.

~

9

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