ML22230A183
| ML22230A183 | |
| Person / Time | |
|---|---|
| Issue date: | 03/02/1978 |
| From: | NRC/OCM |
| To: | |
| References | |
| Tran-M780302 | |
| Download: ML22230A183 (1) | |
Text
.ORIG/~
RETURN TO SECRETARIAT RECORDS NUCLEAR REGULATORY COM.MISSION IN THE MATTER OF~
PUBLIC MEETING POLICY SESSION 78-12 Place_ Washington, D. c.
Date - ~Thursd?Y,2 March 1978 Pages l - 84 Telephone:
(202) 3.47-3700 ACE - FEDERAL REPORTERS, INC.
Official Reporten 4.44 North Capitol Street Washington , D.C. 20001 NATIONWIDE COVERAGE* DAILY
DISCLAIMER thi~ is an unofficial transcript of a meeting of the United States Nuclear Regulatory Commission held on March 2, 1978 in the
. Commi~sion 1 s offices at 1717 H Street, N. W., Washington, D. C. The meeting was open to publi~ attendance and observation. This transcript has no't been revi_ewed~ corrected, or edited, and it may contain inaccuracies.
The transc~iJ)t is iri.tended*solelyfor general information~, purposes.*
As prov.idea b_y'.10 CFR .9.103,dt is not part of the formal or informal record of de~*ision of:.the'.matters discussed. Expressions of opinion in this transcript do npt n~c_essarily reflect final determinations or beliefs.
- No plea:dihg or other P!:lpermay be filed \*1ith the Commission*in
- any proceeding as the result of or. addr:-essed to any statement or argument
- (. )* .
contained herein, except as .th.e Commission may authorize.
- t
1
- CR 6587 U.S. NUCLEAR REGULATORY COMMISSION
,:'.I'HORPE/
'.blt All 2 MEETING OF THE COMMISSIONERS
- 3
- 4 5
PUBLIC MEETING POLICY SESSION 78-12 6
7 Commissioners' Conference Room 1117 H Street, N. W.
8 Washington, D. C.
- k. 9 - Thursday*,. 2 March 1978 10 2: 4 5 p .. m.
11 COMMISSIONERS PRESENT:
12 Chairman Joseph M. Hendrie 13 Commissioner Richard T. Kennedy 14 Commissioner Victor Gilinsky 15 Commissioner Peter A. Bradford 16 STAFF MEMBERS PRESENT:
17 Assistant Secretary John Hoyle 18 Thomas Dorian 19 R. M. Bernero 20 R. E. Cunningham 21
- w. Dircks 22
.e 23 A. Kenneke 24
.Ace*Federaf Reporters, Inc.
25
2 1 PROCEED I'N GS 2 CHAIRMAN HENDRIE: Since we have a quorum, why 3 *don't we go ahead?
i--* 4 5
The Commission is meeting this afternoon for a briefing and discussion on.medical uses of isotopes. I 6 believe Dick Cunningham bears the principal responsibility.
7 Bob Bernero apparently put.his finger in the pencil sharpener.
- a He can hardly be trusted with medical, applications.
9 (Laughter.)
10 Let's see, who will have the lead? Dick, will 11 you lead off, or Bill?
12 MR. DIRCKS: Dick has the lead, Mr. Chairman,
- e 13 but we just want to remind you that this is another one of 14 those progr~m comprehensive briefings we've been bringing 15 down to you in recent weeks. We're trying to lay out not 16 only what's going on in the regulatory area of medical 17 isotopes, but at this time we bring forth a proposal, a 18 staff proposal to the Commission, regarding the issuance of 19 a proposed rule.
20 As you noted, Dick Cunningham of NMSS will pre-21 sent the briefing, along with Mr. Bernero, but I think we'd 22 like to stress that this represents the views of all the
.e 23 \
-~rogram and staff offices of the agency. we do have other
\
24 Ace,Federel Reporters, Inc, offices with heavy involvement in this'particular area, 25 including emphasizing the role of Inspe~tion and Enforcement.
3 Whatever they*re saying will represerit the views of the 2 other offices.
3 MR. CUNNINGHAM: May I have the first slide,
- -., 4 5
please?
(Slide.)
6 Mr. Chairman, in November of 1976 we had a 7 meeting with the Commission to discuss some issues dealing 8 with nuclear medicine, some rather di.fficul t policy issues, 9 and at that time the instructi9ns of the *commission were to 10 develop policy guidance which will guide the course we take in subsequently developing regulations for nuclear medicine.
12 What we did was get public involvement in develop-13 ing this policy. We have now done that, Mr. Chairman, and 14 what we have today are some policy statements which we would 15 propose to publish for public comment prior to adoption, 16 in addition to some proposed rules that we would like to 17 have published for public comment.
18 Before we go into the policy statements and the 19 proposed rules, Mr. Chairman, I' think we would like to take 20 this opportunity to give you a background briefing on our 21 medical licensing program. It is a rather large program in 22 that it affects a lot of pe6ple, and it isn't one of those 23 programs that are up before the Commission very often. We 24 Ace-Feder~* Reporters, Inc.
would like to take this opportunity to give you a background 25 briefing.
4 May I hav~ the next slide~ 1please?
2 (Slide.)
3 When we talk about nuclear medicine, of course, 4 . or the medical radioisotope industry, :Lt's necessary to start with the reactor that produces the radioisotopes.
6 From there they're transported to the drug manufacturer, who 7 changes these radioisotopes into a drug of pharmaceutical 8 quality, and from there it goeij to the hospital or nuclear 9 medicine laboratory, where it is administered to the patient 10 in one way or another .
.11 COMMISSIONER BRADFORD: Dick, could you give me 12 *some idea of the numbers that go into each of those boxes, 13 how many people produce radioisot9pes?
14 MR. CUNNINGHAM: Basically there are only two 15 reactors in the United States that were producing radio-
'---~---~---- ---
16 isotopes. Those wer~ the GETR in Balacitos and the Union 17 Carbide reactor in Sterling Forest. When the GETR shut 18 down because of the seismic issues, a great deal of the 19 slack was picked up by the high~flux reactor, HFRr I guess 20 it is, in Oak Ridge, as well as Sterling Forest's reactor 21 increasing their production.
22 In terms of quantity, the quantity of isotopes 23 are a few hundred or thousand. curies a week. It's not a 24 *1ot in terms of the curie to radioisot6pes produced.
~:fi(jeral Reporters, Inc.
25 COMMISSIONER BRADFORD: When Oak Ridge produces
5 1 them, that's at a Government facility?
2 MR. CUNNINGHAM: Yes.
3 COMMISSIONER BRADFORD: Do they then sell them 4 :just the way G.E. would?
5 MR. CUNNINGHAM: To my knowledge, they do. They 6 sell the~ -- it's cost recovery, and I 'think they sell them 7 just the way G.E. would.
8 The University of Missouri had a high-flux reactor 9
that picked up some of the slack.
10 Some of these production procedures require a 11 reactor with relatively high flux, and it does create a bit 12 of a problem when these reactors go down. You can't stockpile
--- 13 14 the radioisotopes that are.used in medicine; you have to keep the system full, so it does create some problems if 15 you don 1 t have the flexibility of shifting from one reactor 16 to another.*
17 COMMISSIONER BRADFORD: And how many manufacturers 18 are there?
19 MR. CUNNINGHAM: There are, I would say, half a 20 dozen major manufacturers that are the major suppliers of 21 radioisotopes of pharmaceutical quality, radiopharmaceuticals.
22 There.aren't very many manufacturers~
- e 23 So far as the medical users go, I do have a 24
- ~-Federal Reporters, Inc.
graph that I'll be getting to; but there are thousands.
25 COMMISSIONER BRADFORD: And they are all supplied
6 1 by those half-dozen manufacturers?
2 MR. CUNNINGHAM: Yes, essentially half a dozen.
3 There are others in the business, but it's essentiilly half
- .. *** 4
- 5
.a dozen.
Incidentally, our reactors produce radioisotopes 6 that are used -- practically all the medical radioisotopes 7 u~ed in Japan are produced in this country, as well as quite 8 a few of the European uses of radiois~topes come from reactors 9 in this country.
'['
10 But for purposes of today's briefing, when I 11 talk about the medical program, the people involved, the
- . 12 13 14 risks, the types of things* that are going on, 'I'm directing my talk to the medical use, _what happens in nuclear medicine laboratories, not any risk.that might be involved in operat-rs ing the reactor or in making radiopharrnaceuticals or in 16 the transportation among these groups. That's covered 17 elsewhere, so really I'm talking about what's happening in 18 the nuclear medicine laboratory.
19 May I have the next* slide, please?
20 (Slide.)
21 Medical uses of radioisotopes can be broken down 22 into two categories: diagnostic applications, where you try 23 to determine what is happening in the body; and therapeutic 24 applications, where you're trying to cure something.
Act-_Federal Reporters, Inc.
25 May I have the next* slide, please?
7 (Slide.)
2 Diagnostic applications are really four categories.
In vivo, as you may recall, means inside the body as opposed 3
,f. '.
' . 4 to in vitro, which means that you take a sample outside the 5 body and manipulate it somehow to get information.
6 In vivo function studies involve things like the 7 rate at which the thyroid will take up iodine when you inject 8 a quantity of radioactive iodine into the body and measure 9 the thyroid. Renal function studies, blood volume studies 10 and that sort of thing.
11 In vivo scanning studies are for the most part 12 looking for tumors inside the body. The radioisotope most
- 13 14 15 commonly used is technetium 9~ metastable.
half-life.
It has a short Depending upon .what chemicals you combine it with, it has selective uptake in various parts of the body 16 and you can look for tumors in places like the brain, thyroid, 17 *1iver, kidney, what-have-you -- almost anywhere you want to, 18 really.
19 In vitro diagnosis, these are mainly radiobioassay 20 studies that really are used to measure concentrations of 21 things like hormones in the blood. They're used quite a 22 bit. As a matter of fact, to show that somebody can still 23 do something in this radioisotope busine.ss, Dr. Yahlo of 24 the Bronx V.A. got a Nobel Prize this year for her work in
- Ace-.Fideral Reporters, Inc.
25 developing radioimmunoassay procedures.
8 You can measure down to nanocuries per gram or 2 picacuries per gram with these procedures, so they're very 3
4 5
sensitive .
And the diagnostic devices:
analyzer is a typical use.
The bone mineral You just measure the density of 6 the bone for various reasons.
7 Next slide, please.
8 (Slide.)
9 Therapeutic applications are basically three 10 types, where you inject a large -- comparatively large 11 quantity of a radiopharmaceutical into the body that goes 12 to a selected organ. It's mainly used for thyroid cancer,
.e 13 14 hyperthyroidism, polycythemia vera, where you have an overpro-duction of red blood cells. You inject P-32. Metastatic 15 bone disease, again P-32, where the phosphorous goes in the 16 bone.
17 Teletherapy. This is using a cobalt 60 source 18 that is used in a shielded container outside the body to 19 trY to irradiate tumors in the body.
20 Brachytherapy. These are interstitial implants 21 that are sewn right into tumors, usually near the surface 22 of the skin.
23 May I have the next slide, please?
24
. Aell-.Fetjeral Reporters, Inc, (Slide.)
25 To give you some idea of the extent to which these
9 are used, there are about 15 million in vivo procedures 2 conducted per year, 20 million in vitro procedures and about 3 7 million teletherapy procedures.
- 4 5
The significance of this is that there are a lot of people that are coming under the umbrella of the 6 licenses we issue in nuclear medicine.
7 May I have the next slide, please?
8 (Slide.)
9 An idea of the size of the .industry from a money 10 standpoint. Of the $118.5 _billion spent on health, about 11 $2.2 billion is spent on nuclear medicine services.
12 May I have the next slide, please?
- 13 14 15 (Slide.)
Looking at the size of the program from the licensing standpoint, we have about 1600 licensees for 16 hospitals to do diagnostic and therapeutic work; about 600 17 to physicians; 450 teletherapy licenses; and a fairly large 18 number of people who register under general licenses to do 19 very limited types of work.
20 I should say these are just NRC medical licenses.
21 If you include the agreement states, you do a little bit 22 better than double those numbers.
I 23 The number of people that are occupationally 24 involved under our licenses we estimate -- and it's only an Aclt°Fideral Reporters, Inc.
25 estimate, but we think it's about 30,000 people under these
10 medical licenses.
2 Now, in developing -- may I have the next slide?
3 (Slide.)
4 That is just by way of background . . When we consider de-5 veloping our policy to guide us in our future regulatory 6 work in medical licensing, there are really two major con-7 siderations: what's the risk to the patient, general public 8 and the workers; and, secondly; what are other people doing 9
that are also involved in regulating or in somehow impacting 10 on the control of nudlear medicine.
11 There are a number of subsets of questions*you 12 can ask about this. F'or example, in arriving at policy you
- 13 14 15 have to ask yourself what regulations truly benefit the patient and the public and :at what point do regulations
'really inhibit the physician's ability to make decisions on 16
. patient management to the detriment of the patient.
17 If you overregulate a physician, of course, he's 18
.not free to make judgments very quickly.
19 Another set of questions might be how much regu-20 lation is necessary to prevent misuse of nuclear medicine, 21 where it might be used as a fad r~ther than a legitimate 22 tool by qualified physicians,* or the converse of that, at
.e 23 what point do we regulate physicians to the point that they 24
~-Federai Reporters, Inc, avoid using nuclear medicine, again to the detriment of the 25 patient -- make it so difficult for them that they'd rather
11 not get involved with it.
2 Finally, of course, you have the question of 3 what can NRC regulate best and what should better be left 4 to other people to regulate.
5 May I have the next slide, please?
6 (Slide.)
7 on the question of risk in nuclear medicine, 8 in the first place the risk to .the patient, in diagnostic 9 procedures the risk is usually low. A typical scan using 10 technitium 99 is about -- results in about a whole body dose 11 of about 250 milligrams -- *not a very large dose for medical 12 purp9ses.
13 Therapeutic procedures, however, can be another 14 story. There, of course, you're trying to actually kill 15 certain cells in the body. In doing so you irradiate cells 16 you don't necessarily want to irradiate.
17 Typical teletherapy exposures can range as high
- 18. as 2- to 6,000 rem over a course of treatment. Now, when 19 you consider that the LD-50 for radiation is somewhere in 20 the neighborhood of 450 rem, you can see how important 21 . how a little error can produce very adverse results.
22 Patients receiving teletherapy treatment very 23 often suffer the typical radiation, acute radiation syndrome 24 'thing. They vomit, they have erythema, they lose hair Ace-Federal Reporters, Inc, 25 all these sorts of things happen to them. So there is a risk
12 1 in these therapeutic doses.
2 ~ay I have the next slide, please?
3 (Slide.)
4 5
The risk to the public is pretty low. A typical surface dose from a patient for a very short time after he 6 receives a diagnostic quantity of material is about 10 MR
.. *\
7 per hour, and that goes away very quickly. Of course, if 8 you're giving therapentic dose~ you hospitalize the patient 9 if they're given internal therapeutic doses. Teletherapy 10 treatment, of course, doe~n*t involve radiation inside the n patient -- I mean administration of radioactive material 12 inside the patient.
13 Again, when I talk of risk to the public I'm
- 14 not talking about the whole nuclear medicine industry if 15 you consider the risk of o~erating the reattor, making 16 pharmaceuticals and so forth.
17 As for risk to the public who may be in or 18 "
around a nuclear medicine laboratory, you always must remem-19 ber that nuclear medicine laboratories are in hospitals and 20 hospitals have people wandering around the corridors.
21 MR. DIRCKS: And it excludes transportation.
22 MR. CUNNINGHAM: Yes, it excludes transportation
- 23 24 AC!l*Fe.Jeral Reporters, Inc.
and all this sort of thing.
May I have the next slide, pl~ase?
25 (Slide.)
13 The risk to workers. There is some risk if good 2 health physics procedures aren't followed, and there is some 3 risk even if good health physics procedures are followed.
4 Every once in a while, for example, the shutter 5 on a teletherapy unit will jam for some reason or another.
6 Somebody has to go in and pull the patient out of the tele-7 therapy treatment room. That's a risk.
8 Very often you have: quite sick patients. You 9 have emergencies on your hands. You can't follow the best 10 procedure. You have to balance what happens to the patient H against following all the nice procedures you would like to 12 follow, so there's always that tradeoff.
- .- 13 14 In most nuclear medicine laboratories they handle a lot of technetium. When.you generate*or eluate to get 15 the technetium, the vial, right after it's eluted, will be 16 hundreds of R per hour at the surface of that vial. If it's 17 picked up or mistreated it can result in problems.
18 Nevertheless, I think our surveys that we have 19 conducted to try to find out what typical exposures are to 20 medical workers, they're running around .5 rem per year; 21 so it's not too bad on the whole.
22 'l'hat summarizes* the risk to workers. Now I'd
- 23 24 Aee-Federal Reponers, Inc.
25 like to talk -- ~f I may have the next slide (Slide.)
-- a little bit to our interface with other people who
14 regulate nuclear medicine.
2 You can see here that we've drawn a little sche-3 matic of all these groups, whether they're regulatory groups 4 or peer groups, what-have-you, who one way or an.other are 5 involved in the regulation or setting standards of practice 6 for the practice of nuclear medicine.
7 we have to define what we best can do and what 8 can best be left to others.
9 Probably the two most -- well, three most important 10 groups -- if I may have the next slide.
H (Slide.)
12 These are just peer groups:,_ all of which we have
. \
13 14 15 to -work with. We have done quite a bit of work in the past to get the American Board of Nuclear Medicine established.
We heavily supported that work a few years ago so we can 16 get some standards, professional st_andards, of practice and 17 physician qualification, although we're still looking at 18 physician qualifications.
19 All of these are peer groups that in .one way or 20 another impact on the quality of.nuclear medicine practice.
21 May I have the next slide, please?
22 (Slide.)
- - 23 24 Aelt*Federel Repo"ers, Inc, 25 Again, state health organizations.
license physicians to practice medicine'..
States
'l'hey license paramedics, and in some instances they license pharmacies.
15 This is all relating to the quality of medical practice in 2 0 ne way or another.
3 And, of course, we have the agreement states, 4 and I don ' t need to expand on that ..
.5 May I have the next slide, please?
6 (Slide.)
7 I guess our major interface in regulating nuclear 8 mec:iicine comes with the Food and Drug Administration. Food 9 and Drug, FDA, contro_ls good manufacturing practices. This 10 is the control of the radi~pharmaceutical manufacturer to
.H . be sure the drugs are :g~od pha-rmaceuticals. There you' re
_12 worried. about things like steril_ity and that sort of thing 13 drug quality.
14 They assure that' the drug or device is properly 15 1abeled. That mearis that ft has a label that says it's 16 .safe at applications for such a purpose, giving the indicat-17 ions on it, counter indications,. dose range and so forth.
18 And they do control ,investigational use of 19 ctrugs. 'I'his is the controL of .the use of drugs beifore I
20 they're*ready to say it's saf~ and effective.
21 These investigational use laws, or the most_
re@ent ones, flowed.out of the th~lidomide scandal a decade 22
.23 or.so ago.
' , I 24 Until very recently,' within the past two years
.
- Aelt*Federal Reporters, Inc, 25 or so, we\ regulated for :padioph:armaceuticals the investigationa
16 use of drugs and decided when they should be put into routine use until FDA got .staffed up and into a position where they 2
3 could take this function over.
They have new legislation now covering medical devices, and they aren't yet in a position to completely 5
regulate those. I'll get to that a little bit later, but 6
- that's one of the things coming up.
7 Ih developing a policy-~ if I may have the 8
9 next slide, please.
10 (Slide.)
11 As I said before, we were before the Commission
.12 .in November of '76. In May of 1977 we held public meetings 13 on questions of policy and. the direction in which we should 14 be going in policy to guide us. We also held a meeting 15 with our Medical Advisory Committee. We now have a pro-16 posed policy statement.
17 I think in.developing this policy what we want 18 to do, of course we don't want to overregulate physicians 19 and we don't want to underregu.late physicians. If this 20 policy is adopted, specific regulations that come in the 21 future will be reviewed in the context of this policy.
22 May I have the next slide, please?
23 (Slide.)
24 So the three policy ~tatemetits that we have, A~Federal Reporters, Inc.
25 the first one is that we believe the NRC should regulate
,..--~-------------------------:-------------------------~
l7 the medical uses of radioisotopes as necessary to provide 2 for the radiation safety of the workers and the general public.
This is practicing our role in just health
-~-****
3
.. *. *, ,* 4 physics, if you will, as we do in other facilities. This 5 iS one of the things that we knowhow to do, and we can do 6 it, I think, fairly well.
7 May I have the next slide, please?
8 (Slide.)
9 Now, the next policy statement, we start entering 10 into the qualifications of the physician to practice medi-11 cine and to the physician-patient relationship. This gets 12 13 14 a little bit more difficult.
The next policy statement, though, is that NRC will regulate the radiation safety of patients where justi-15 fied by the risk to patients and where voluntary standards, 16 or compliance with these standards, are inadequate.
17 This implies that we will not regulate in areas 18 where there are standards mandated by other agencies and 19 these other agencies have competence to impose, or to en-20 force their regulations.
21 May I have the next stide, ple~se?
22 (Slide.)
23 The third policy statement is that we will mini-24 mize our intrustion into medical judgments affecting patients A~*Federal Reporters, Inc.
25 and into other areas traditionally considered to be a part
18
- 2. I might say here that the AEC, and now the NRC, 3 is the only Federal agency that ever regulated, the quality of the practice of medicine. I don*t know whether that's 5 ****good or bad. Nuclear medicine has grown tremendously over 6 the years, and we haven't had any major scandals. I don't 7 know if they've done that in spite of us or because of us, 8 but we are the only agency'whohas done that sort of thing.
9 Now, the question of how we implement the policy.
10 May I have the next slide, please?
11 (Slide.)
12 Looking at specific items.of interest: physicians' 13 qualifications. We have requirements, minimum requirements, 14 I might add, for physicians' qualifications to practice 15 nuclear medicine. We have repeatedly brought up this ques-16 tion to our Medical Advisory Committee and peer groups as 17 to whether or not we should continue to license physician 18 qualifications.
19 We got int6 licensing physician.qualifications 20
- to practice nuclear medicine when there were no other 21 standards and when nuclear medicine was new. This started 22 long before the time, I guess, *of any of us here in AEC, 23 *back in the late '40s when AEC was first formed.
24 since that time a Board of Nuclear Medicine has Ace-Federal Reporters, Inc.
25 been. established. The Board of Radiology has subgroups
19 1 approving nuclear medical physicians., Nevertheless, the 2 advice of our Medical Advisory Committee is to still con-3 tinue this practice, not turn it over completely to the
- e
. ' 4 peer groups, because there has to be some mechanism for
. . /,".
5 the approval of some physicians for certain things that 6 the peer groups don't approve.
7 We accept with certain limitations board certifi-8 cations as an indication of qualifications, but I have to 9 stress that our criteria *f6r physician qualification are 10 minimal and about the best, probably, that we set for this n is that it keeps people who aren't serious about this busi-12 ness out of the field. It doesn't let people dabble in
- - 13 14 the field.
Selection of patients, that's a medical judgment.
15 Selection of instruments to diagnose patients, 16 that again, we feel, is a medical judgment.
17 Selection of drugs, we limit those to drugs 18 approved by the FDA, approved for investigation by the FDA.
19 And selection of the procedures. That is the 20 purpose for which the drug. is used. We do this to a limited 21 extent, and Bob Bernero will talk to you about that a little 22 bit more.
- 23 24 Ace-Federal Reporters, Inc.
Next $lide, please.
tSlide.)
25 Selection of patient dose. That's a physician
20 judgment call.
2 Measurement of dose. We do require under our
).
3 4
regulations -- we're in the process of doing this for teletherapy licensees -- that the dose be measured, so we are moving in that direction. That's just good practice,
.5 6 and we feel we can impose that.
7 Calibration of diagnostic instruments. We do 8 require dose calibrators to be. calibrated. The scanners 9 and things like that, thatis ah qpenLquestion.
10 There is a question whether or not we should pass 11 on the qualifications of paramedics to assist in nuclear 1.2 medicine laboratories. This is an open question. Lots of 13 14 15 states do license their paramedics. There are paramedic certification programs, but nevertheless this is an open question. There aren't consistent rules, certification 16 procedures, that can be applied.
17 It would be a difficult thing to do. In the 18 first place, there are probably on the order of five to ten 19 paramedics working in a nuclear medicine laboratory for 20 each physician. That gives an increased workload. And 21 the ways in which paramedics are used vary quite markedly 22 from one laboratory to another, and their professional
.e 23 qualifications vary, too. A paramedic may be a technician 0
.. 24 with a high school educati6n, or he may be a Ph.D. physicist .
Act-Federa(Reporters, Inc.
25 It depends just on how they're: used.
21 If we, get into this~-we're exploring it, but
.. 2 we're*not sure where we come out on this question.
3 Misadministrations, the repo:i:::f::ing .. of mis-4 administrations. This is a question that's been up to 5 the Commission once. We've gone back to.the drawing board, 6 and we do have a proposed rule that Bob will discuss.
7 That really ends my presentation on the pol-icy.
8 There is one other thing I would like to bring to your at-9 tenti6n in deliberating about these rules.
10 I might say that o~er the years the direction 11 we have been going on licensing nuclear medicine is to exer-12 '
cise less control over the practice of nuclear medicine.
13 Two things are happening, of course. The field 14 is maturing. We.know what :the problems are now much better 15 than we did years ago. And there are other peer groups set-16 ting standards for practice, so the industry in a w.ay can 17 be self-regulated.
18 In addition to that, there are other agencies 19 who can regulate some areas better than we can. For example, 20 FDA in the quality of drugs.
21-I will show you one last slide before I turn this 22 over to Bob, and that is the manpower we're expending on 23 medical licensing. It's not very much when you consider 24 Aol*Federel Report11rs, Inc.
the population of licensees we .have, the population of people 25 we are regulating and the population of ~eople that are
~ - - - - ---------
22 receiving radioisotopes.
2 (Slide.)
3 Six people in our organization responsible for
.:e*
4 evaluating and issuing licenses; I&E has ten inspectors; 5 and Standards is putting. three manyears into regulatory 6 effort.
I suspect that ~ight everi be a little bit high, 7
8 but for the size of the population and the things that are 9 going.on in nuclear medicine laboratories, we feel that 10 this is indeed a modest program.
n If we were to do things like evaluate the quali-
- 12 fications of paramedics and do some other things, of course,
,e 13 the number of people that would have to be involved in this 14 would have to expand.
15 If there are no*questions on this, I'll defer 16 to Bob at this point.
17 MR. BERNERO: What you've just heard is the*
18 policy question, the overall medical policy. That's one 19 separate action that's put to you today.
20 And there are two other distinct actions. They 21 are proposed rules which are developed consistent with that 22 proposed policy, walking that line between underregulation
.e 23 and overregulation.
24 Now, the two parallel and separate actions that Ace-Federal Reporters, Inc.
25 I will cbver here relate to clinical procedures and
23 misadministration.
2 May I have the next chart, please?
3 (Slide.)
.'i.
4 5
The clinical procedures, we'll cover that first.
Our regulations, Part 35, are set up so that radiopharma-6 eutical licenses can be handled in groups where the activi-7 ties involved are put into categories of increasing com-1 8 plexity, increasing demands in.skills, in training, in 9 procedures and in equipment.
10 Those licensing groups are listed here. Groups 11 I to I I I are for diagnostic radiopharmaceutical uses and 12 generators and kits. We're getting up to that level of
- e 13 14 complexity where the radioisotope.is actually contained in a device, and the procedure is to get the material out for 15 actual administration to the patient.
16 May I have the next slide, please?
17 (Slide.)
18 GI"Q~ps , 'IV through VI are for therc3.py and devices 0
19 which are more complex, involve higher doses, more com-20 plexity, more difficulty to -- more demands of the skill 21 of the user of the radiopharmaceu.tical' material.
22 So *what we are looking to here is a way to 23 simplify our regulation on the diagnostic or lower risk 24 -~ide.of these licensing groups.
ACQ*Federal Reporters, Inc.
25 May I have the next slide, please?
24 (Slide.)
2 The proposed rule we have here is to go into 3
4 5
Croups I, II and III -- again, the diagnostic padio-
_pharmaceuticals -- and to delete the clinical procedures fiom the regulations.
6 Let me have the next slide, 'please.
7 (Slide.)
8 What this really means, if we go into an example, 9 in our current rule, currently Part 35 .. 100, it would list, 10 as you see here, for any given isotope at least several, l1 a number of variations of the use of iodine 131. It would 12 list for that one isotope a list of chemical forms , ... and
- e 13 14 associated with each chemical form is a procedure, a clinical procedure -- the measurement of thyroid uptake or a liver 15 function study, or whatever.
16 The physician operating under that license is 17 constrained to use that isotope in that chemical form for 18 that clinical procedure, and he is constrained by the 19 labeling on the radiopharmaceutical to the path of admini-20 stration and the dose involved.
21 Now, the simplification we propose -- may I 22 have the next slide, please?.
23 (Slide.)
24 is to take out**the clinical ~roceduies and just have Ace*Federel Reporters, Inc.
25 the rule cover the radioisotope in question and list the
25 chemical forms, the forms of this isotope, which can be 2 used by the physician operating under this license.
3 Now, we would by that -- may I have the next 4 slide, please?
5 (Slide.)
6 We would by that means leave the physician the 7 option of using it for some procedure, some clinical pro-
' I
~----------
8 c.edure, which is not the direct approved~ FDA-approved 9 procedure. He would still' be constrc;1.ined to the same '
10 chemical and physical form, the same 'route of administration, 11 *and the dosage range. These are all covered by the labeling.
12 But he has the freedom to practice medicine to the extent 13 of his skill and to move out for a different clinical pro-14 cedure within these constraints we hold him to.
15 Now, the reason* for allowing this i~, first of 16 al'.J., we' re dealing with diagnostics, where the risk is 17 fairly low; and by using an approved isotope in approved 18 chemical form and route of administration we have already 19 seen that th~ patient is provided with sufficient eVidence 20 of ~afety, ~nd one is left with only a ' question perhaps of 21 efficacy: Is the procedure he's:using it for as effective 22 as the approved.one?
. 23 If we were to wait for approved clinical pro-24 6edures only, as our regulations are p~~sently constructed, Ace-Federal Reporters, Inc.
25 then the physician would be constrained from an additional
26 use of this radiopharmaceutical until the FDA approval has 2 been obtained. This could be very many years, and in the*
3 case of some radiopharmaceuticals, having obtained one
- 4 5
FDA approval, the manufacturer may not be as inclined to invest the large amount of money and time to get or a third.
a second 6
So by holding off the use of this radiopharma-7 8 ceutical for another clinical procedure, we could be denying 9 the patient a valid use of'.that radiopharmaceutical.
10 COMMISSIONER GILINSKY: Right now they are l1 denied that?
12 MR. BERNERO: Yes, in effect right now Part 35.100
~- 13 14 says you may use that isotope in that form for that pur-pose that liver scan or.whatever it might be.
If that same liver scan would provide that 15 16 physician what is to him an important and valuable insight 17 into another organ, the regulation does not permit him to rn use it for that other purpose.
19 COMMISSIONER GILINSKY: So you're proposing to 20 open up the use of these isotopes?
21 MR. BERNERO: Modestly. He still is constrained 22 to use that isotope in that form, administered in that
- 23 24 Aol*Federal Reporters, Inc.
25 path 7- some vein or whatever -- and in that dosage range.
Those are not changed.
COMMISSIONER GILINSKY: And this is at the request
27 of doctors to make this kind of change?
2 MR. BERNERO: No. I believe this was staff-3 inspirSd originally.
- 4 5
MR. CUNNINGHAM: It 1 s a combination of things.
I think some physicians did suggest it. The FDA has supported 6 this position, and the staff supports it simply because it 7
certainly cuts down on the.administrative burden of the work.
8 What you' re really doing -- and the FDA h_as a 9 policy position on that where they support this kind of 10 thing -- but you're making a tradeoff.
11 On the one hand you're allowing the physician 12 more flexibility to practice medicine as he sees fit within
--- 13 14 certain constraints.
going to be.
You know what the radiation dose is 15 what you're losing is the question of whether 16 or not a drug used for a purpose other than for which 17 '*
the safety and efficacy has been established,:you're losing "18 something in knowing whether or not you would get a false 19 positive or a false negative reading. We're not worrying 20 about radiation risk~ but if he tries to diagnose something 21 other than what the label says to use it for he runs a higher 22 risk of making a false negative or a false positive reading.
- 23 24 ACfl*Feoeral Reporters, Inc, This could be important to the patien~- if you miss a tumor or think something's there and opk;rate on him and 25 it isn't there.
28 MR. BERNERO: That's indeed been the medical 2 ju4gment part. This change would be consistent with the 3 FDA policy with respect to the drugs.
- 4 5
COMMISSIONER GILINSKY: What is the significance of FDA approval if you can go beyond it? Why is the FDA suggesting that we not pay attention to their approv~ls?
6 7 MR. CUNNINGHAM: The FDA has its own position 8 on this. They did not suggest to us that we should do it.
9 And the FDA has done it for some time.
TO MR. DIRCKS: But they're not opposed to it.
11 MR.CUNNINGHAM: Oh, no, not at all.
12 COMMISSIONER KENNEDY: .They're not opposed, you
- 13 14 15 say?
MR. DIRCKS:
MR. CUNNINGHAM:
They're not opposed.
They're not opposed to it, not 16 at all.
17 That 1 s a little bit hard for me to explain in "18 FDA's case, more than it is in NRC's case, because what 19 it really gets to is the sa.fety and efficacy of drugs, which 20 we think is an FDA question, not an NRC question.
21 rt certainly does, to my way of thinking, circum-22 vent some.of the investigational drug rules, but the inves-23 tigational drug rule~, as I understand it, are for fairly 24 large-scale investigations.
Aw-Federal Reporters, Inc, 25 COMMISSIONER GILINSKY: But these proposed
29 procedures would circumvent those rules. Is that what 2 you're saying?
3 MR. CUNNINGHAM: Well, FDA's policy circumvents
- 4 5
their own investigational drug rules to some extent.
COMMISSIONER GILINSKY: The policy on what?
6 MR. CUNNINGHAM: That.you can use a drug for 7 a purpose other than that which is on the label.
8 MR. BERNERO: In effect the FDA, when it makes 9 a finding on a drug, is saying that this drug is safe and 10 efficacious for some purpose, administered in some way, l1 concentrations and what-have-you.
12 They do not fhen say that under no circumstances
- 13 14 15 can the same drug administered in the same way be used for some other purpose.
phYSician.
They leave that available to the 16 Of course, in that case the physician is going 17 beyond the clear labeled and call it certified u~e of
'l8 the drug, and he takes it upon himself or herself a much 19 greater level of responsibility in the practice of medicine.
20 But FDA in their statements does not forbid 21 that. It is not their policy.
22 COMMISSIONER GILINSKY: Do we have the views
- 23 24 Aee-Feoeraf Reporters, Inc.
of some medical group on this?
MR. CUNNINGHAM: Yes, this was brought up before 25 ur Medical Advisory Committee and in the public meeting, 0
30 and I think all groups supported* this. * 'l'here was some dis-2 cussion,* but so long as we control the route of administra-3 tion and the dose the only other remaining question would
- 4 5
be the efficacy of the drug. They feel that for these diagriostic procedur~s the freedom given outweights any dis-advantages that might acc:r;.ue.
6 7 What we're really dealing with.here, what we're 8 really controlling in that case, is drug safety and efficacy,
. 9 which we believe we agree with FDA that it's an FDA 10 problem, and FDA is treating these drugs the same as they 11 do any other drug.
12 I can read the statement h.ere. We have it in
-* 14 13 15 the staff paper. There is a statement of the FDA position on this in which they say that there are reasons to do this and it would not be in violation of the Food, Drug and 16 cosmetic Act. It'* s on page 16, Enc;::losure 1, of the staff 17 paper that was sent to you.
'18 MR. BERNERO: In essence FDA is recognizing that 19 the approved use of the drug may not be as up-to-date as 20 it could be to be fully useful to the practicing physician, 21 5 o the practicing physician can take the responsibility to 22 be up-to-date and* use this radiopharmaceutical in what is
- 23 24 A~*Federel Reporters, Inc.
already an approved method. It's a question of the pro-cedure and the purpose ::of*_ the use.
25 COMMISSIONER GILINSKY: This: is strictly in r
r 31 2 MR. BERNERO: Strictly in diagnostic. There is 3
no attempt here to go into the more grave actions or quanti-4 ties involyed with therapeutic.doses. It's strictly in 5 diagnostic, so it 1 s in Classes I, II and III.
6 COMMISSIONER KENNEDY: Whe~e the quantities are 7 very small.
8 MR. BERNERO: Yes, we're speaking of small 9 quantities. What one is really weighing are the relative 10 merits of what may be a superfluous or an unnecessary ex-11 pQsure to some small degree against what may be a medically 12 useful thing for the doctor working with the patient.
13 COMMISSIONER GILINSKY: What sort of doses do 14 you end up getting?
15 MR. CUNNINGHAM: Typically technetium is the 16 most commonly used diagnostic isotope -- 20 millicuries on 17 a diagnostic procedure results in about 250 millirem total
'l8 dose.
19 COMMISSIONER GILINSKY: Millirem?
20 MR. CUNNINGHAM: Yes, millirem.
21 MR. BERNERO: Millirem quantities, not rem --
22 orders of magnitude difference.with therapeutic.
23 COMMISSIONER GILINSKY: Say that again.
24 A~*Federel Reporters, Inc.
MR. CUNNINGHAM: About 250 millirem total dose 25 for a diagnostic procedure. That's typical. It varies,
32 of course.
2 COMMISSIONER GILINSKY: That's a whole body dose?
3 MR. CUNNINGHAM: Whole body dose, yes.
- 4 5
MR. BERNERO: I'd like to go on to the next related paper, which I think may lend further insight to 6 the judgments being*made here.
7 This is on misadministration.
8 May I have the next slide, please?
9 (Slide.)
10 We're defining a misadministration here as is 11 1isted on the slide. It's the wrong act to the wrong 12 patient through the wrong path. And we're inserting here
- 13 14 15 a quantitative judgment to define sharply the difference in diagnostic uses and therapeutic uses on a percentage basis. It's a matter of judgment for us to define it to 16 say a misadministration is more than a 20 percent error 17 in diagnostic use and a 10 percent error in therapeutic rn use.
19 These numbers have been drawn based on the capa-20 bility of measuring and administering these things, and 21 they do reflect with the tighter constr~int of 10 percent 22 that therapeutic, of course, involves greater quantities,
- 23 24 A~-Feoeral Reporters, Inc.
greater exposures.
May I have the next slide, piease?
25 (Slide.)
33 The misadministration goes back a number of years.
2 There was an original rule back in 1973. GAO did a study 3 and recommended that AEC regulatory take action on that,
- 4 5
and in implementing this GAO regulation there was a mis-administration rule proposed then which would specify the 6 activities that a licensee could delegate to others, the 7 sort of training required for technicians, and it did bring 8 up the subject of reporting misadministrations.
9 That proposed rule back in 1973 had in it a 10 proposed requirement to report misadministrations to the 11 patient or family of the patient. That was a staff-inspired 12 change, not a GAO recommendation.
- 13 14 15 NOW, that proposed rule got a lot of comment.
May I have the next slide, please?
(Slide.)
16 There was a lot of comment at that time, and, of 17 course, the medical policy was in a state of evolution since rn the Government regulatory policy was in some state of 19 evolufi6ri- a-f- fiie- same time.
20 The principal comments, of course~-many of them 21 you could* expect to see--misadministration *reporting, :.:,espeeial y 22 inv6lvifi~ patient notification,-brings up the !d~a gf self-
- 23 24 A~*Federal Reporters, Inc.
incrimination.
COMMISSIONER GILINSKY: Is this on the part of 25 the doctors?
34 MR. BERNERO: Yes, inviting the increase of mal-2 practice suits.
3 Our legal advice is that it's really not self-4 incrimination. The question here is not one of Fifth 5 Amendment*or anything like that. We're not dealing with 6 a .felony here.
7 COMMISSIONER KENNEDY: But we're dealing with 8 malpractice suits, though.
9 MR. BERNERO: Yes, but that question is certainly 10 a substantial one, challenges on -- interfering ot~fueddling n in medical ethics and pointing out that where are comparable 12 requirements on other drugs -- why should radiopharmaceuticals 13 have this unique requirement.
14 So this was the general thrust of all the comments 15 on that.
16 Well, with this new policy, ~.:this presently pro-17 posed policy we have here -- may I have the next slide?
rn (Slide.)
19 We have a new NRC proposal on misadministration 20 by which we would withdraw the 1973 proposal and require 21 that the licensee keep records of misadministrations as de-22 fined on that earl:ier slide -- wrong act, wrong place and 23 so forth, and using those quantitative limits -- and we would 24 further require by this rule that the licensee report to NRC Ace-Federal Reporters, Inc.
25 all the therapy misadministrations -- all therapy, because
35 it's a grave matter. There are high doses, large quantities.
2 And all serious diagnostic misadministrations -- serious 3 being where one is dealing with clinically detectable
- 4 5
adverse effects.
It's an almost undefiriable thing to say a serious 6 diagnosti6 misadministration is exactly this or exactly 7 that. There is a great deal of medical judgment involved
- 8 in judging. or reading what is serious.
9 COMMISSIONER GILINS~Y: Well, let me ask you.
10 Suppose the wrong patient got one of these diagnostic n doses we were just referring to. Would that fall in this 12 category?
- 13 14 15 MR. BERNERO: Not unless there was a serious effect, a clinically detectable adverse effect.
COMMISSIONER GILINSKY: You mean after-the-fact?
16 MR. BERNERO: After-the-fact. But if it were 17 merely the wr~ng patient, it would be a recordable mis-rn administration. I'm speaking of a diagnostic act, not a 19 therapeutic act.
20 A diagnostic administration that went to the 21 wrong patient -- you know, two people named Brown sort of 22 thing -- that would be a recordable misadministration, not 23 a reportable one, unless it had an after-the~f~ct adverse 24 effect.
Ace-Federal Reporters, Inc.
25 COMMISSIONER GILINSKY: You really have to get
36 up into many, many rems before you got an observable effect.
CHAIRMAN HENDRIE: I think the clinically 2
observable is more likely to be a chemical pharmaceutical 3
- 4 5
effect.
MR. BERNERO:
something like that.
Yes, an allergic reaction or 6
By their nature the diagnostic procedures are 7
relatively mild and are not likely fo induce any seri6us 8
effect, but if the wrong patient got it and there were some 9
10 gllergic reaction to the drug, some purely chemical thing, 11 it would at least bring that-out as an immediately report-12 able misadministration.
13 COMMISSIONER GILINSKY: Well, let's take this 14 cas*e here. I don't know what form the material comes, 15 but suppose he got a dose which was too large by a factor 16 of 100. Would that fall in this category?
17 MR. CUNNINGHAM: By a factor of 100?
'l8 MR. BERNERO: Oh, yes.
19 COMMISSIONER GILINSKY: Would there be an observ-20 able clinical effect?
21 MR. BERNERO: Excuse me. You don't need both.
22 If--let's take one patient. It's not the wrong person.
- 23 24 A!=8-Federal Reporters, Inc.
We're dealing with the right person, and that patient is supposed to get a diagnostic procedure of some number of millicuries that would give him a dose of 250 millirem. And 25
37 the technician, 9r whoever caused the.mistake, doubled the 2 dose, 100 percent increase -- that would be a --
3 COMMISSIONER GILINSKY: I asked about a factor
- 4 5
of 100, but you go ahead.
MR. BERNERO: That would be a recordable mis-6 administration, but it would only be reportable if the 7 patient reacted to it.
8 COMMISSIONER GILINSKY: That's what I'm asking.
9 what would require a report to the NRC?
10 MR- BERNERO: If the mistake was made on a 11 therapeutic, a defined mistake made on a therapeutic, or 12 0 n a diagnostic where there is a clinically detectable 13 adverse effect, and only there; all of them are recorded 14 for NRC scrutiny.
15 You see, the distinction really is how quickly 16 will we learn of the event. The recordable one waits for 17 the inspector to show up to read it; the reportable one by-rn passes the inspection process and time by notifying us 19 promptly.
20 COMMISSIONER GILINSKY: Then what do we do with 21 it when we get it?
22 MR. BERNERO: Well, I'll get to that. There are 23 a variety of things we can do with this.
24 Ace-Federal Reporters, Inc; May I have the next slide?
25 (Slide.)
38 MR. DIRCKS: I think an issue that should be 2 brought out is now we're not getting any reports, reportable 3 or recordable.
4 COMMISSIONER GILINSKY: Right now?
5 MR. BERNERO: Yes. The West Virginia and all
- 6 of those things are by guess and by gosh picked up. There 7 is no regulation that says those have to come in.
8 COMMISSIONER KENNEDY: An interesting point 9 that you didn't cover on the other slide, which I gather 10 is also new -- or is it? -- ~s that you'd be requiring the n licensee in those reportable cases to at the same time 12 report the fact to the attending physician.
- 14 13 15 MR. BERNERO: Yes, indeed.
COMMISSIONER KENNEDY: Who may not be the same individual who was supervi:sing the procedure.
16 MR. BERNERO: 'I'ypically isn't. The licensee is 17 typically a licensed radiologi:st or someone like that, and
'18 ~e would be required in reporting to us to report to the 19 physician, the real d6ctor for the patient.
20 And then the referring phy:sician is the one in 21 the position to determine :should the patient be told, would 22 it be unnecessarily alarming, or how should the patient
- 23 24 Ace-Federal Reporters, Inc.
be told: should the wife or the husband or whatever.
COMMISSIONER KENNEDY: Is that physician in a 25 position to make that kind of a judgment? I know he i:s
39 vis-a-vis the patient himself, but does he know the level 2 of seriousness? Is h~~able to assess that?
3 MR. BERNERO: Well, he',s in a position to know
- 4 5
the patient and to consult with the radiologist and any other authorities he deems necessary to make a judgment of 6 whether some sufficiently grave consequences are involved 7 that he should inform the patient.
8 Now, the choice there, of course, is a broad one.
9 We could.go to the one extreme and leave it to the doctors.
10 ~urrent medical practice is that the licensee would be re-11 porting to the referring physician; that would be the 12 typical medical practice, and we could just not require
- 13 14 15 anything. Or we might go even further.
COMMISSIONER KENNEDY: If that is regular prac-tice, ~hy would we require it by regulation?
16 MR. BERNE.RO: Perhaps as a matter of clarification, 17 to show what we feel is an appropriate requirement on our rn part with respect to this misadministration.
19 The question logically comes up: Should we not 20 require the licensee to report to the patient? That's 21 one alternative that was discu~sed at great length: Ju~t 22 be adamant about the thing; go down there and report that
- 23 24 Ace-Federal Reporters, Inc.
25 to the patient.
The obvious challenge can be raised. You could take a person who's already ill and unnecessarily alarm them
40 I
I I
1 with a relatively minor thing .. I I
2 Another alternative is to insist!that the I
'3 licensee. report to the patient subject to the veto of the I
I 4 referring physician. That gets sort of com:rplicated. And I
5 how much different is that from just givinglit to the re-:-
I 1
6 ferring physician? I I
7 As a matter of clarity, the rule I would say report I
8 to NRC these defined misadministrations andjreport them to I
9 the referring physician, and leave it at th~t; leave it I
10 I for the referring physician to determine. 1
\
11 COMMISSIONER GILINSKY: Do physi¢ians typically 12 report this to a patient? I I
13 MR. CUNNINGHAM: 'l'hey' re suppo se4 to. I think I
14 I that it hasn't been followed in all cases. 1 I
15 I COMMISSIONER KENNEDY: Isn't that a matter of 16 patient-doctor relationship?
17 MR. CUNNINGHAM: Yes.
I
'l8 COMMISSIONER KENNEDY: Isn't thatr a matter of I
19 the medical judgment of the doc:tor*himself? i
- I 20 MR. CUNNINGHAM: That's right. I I
21 _MR. BERNERO:
- I Yes. And the issues that people I
I 22 raise are, "Well, won't.he protect his colle!ague from a I
23 malprac~ice suit?" I
- 24 Ace-Feder.al Reporters, Inc.
COMMISSIONER GILINSKY: Well, i t s more than a I
25 I colleague here. I mean, it's somebody to whom he referred I
r 41 the patient.
2 MR. BERNERO: Oh, yes. He referred the patient 3 to that radiologist, whatever the licensee is.
4 MR. CUNNINGHAM: Are you talking.about. liability 5 *of the referring physician for something another physician 6 does or fails to do?
7 COMMISSIONER GILINSKY: Well, he's involved in 8 the matter.
9 MR. CUNNINGHAM: Yes, I think so.
10 MR. BERNERO: Yes, there's a level of involve-11 ment.
12 MR. CUNNINGHAM: The fact is that the referring 13 physician is the one that's managing the patient and should 14 be the one to make the medical judgments ne:cessary.
15 Now, if he doesn't follow medical ethtcs, that's 16 a problem we can't do a whole lot about; but he's the one 17 in the best position to make those kinds o~ judgments of rn what's best for the patient.
19 MR. BERNERO: You know, in a way it's like filter-20 ing out the selfish acts. We can look at the licensee and 21 saY we expect him to report it if he makes ,such a mistake, 22 but in order to filter out those who won't to protect them-
- 23 24 Ace-Federal Reporters, Inc.
selves we will apply the filter of requiring, having a 1icense requirement that they be reported.
I 25 we could apply a second level of filtration and
r 42 1 go to the referring physicians and say let's make sure that 2 they're not charlatans either, and so we get a fraction of 3 a fraction thereby removed. There is a matter of degree,
- 4 5
how far we can go.
COMMISSIONER GILINSKY: Well, it's not a matter 6 of charlatans, I think, here. It's a question of whether 7 there's some obligation to the patient that he be informed.
8 MR. BERNERO: Yes, and whether that responsibility 9 for deciding pn that reportin~ should be held by us, 10 delegated to the licensee as far as we're concerned, or n delegated to the referring physician.
12 And our recommended choice is in effect to dele-
- 13 14 15 gate the decision to the referring physician, the one closest to the patient and well removed fro~ the fault, from the misadministration responsibility, removed by one 16 step.
17 COMMISSIONER BRADFORD: Why is it ever going to rn harm the patient to be told that there was a misadministra-19 tion? Why would that information ever be withheld?
20 COMMISSIONER KENNEDY: Because do,ctors typically 21 withhold a great deal of information on the simple assumption 22 that to provide it to the patient would do him more harm than
- 23 24 Ace-Federal Reporters, Inc.
good, from a psychological if no other poiht of.view.
a rather typical thing,:: to make a judgment about whether It's 25 informing the patient is going to help him in his recovery or
43 r
hinder him or make it impossible,.which is also possible.
I 2 MR. CUNNINGHAM: I think it's fairly easy to 3 construct some instances where you don't want to tell a
- 4 5
patient this. If you have a patient that has a bad cardiac a pulmonary embolism or a cardiac patient or somebody who 6 has just had surgery and you tell them, "Well, we made a I
7 mistake and your thyroid' s been burned out,*:, this may add some 8 shock that really doesn't do the patient ve~y much good at 9 that time.
10 COMMISSIONER BRJ\DFORD: Well, nobody has said n anything about the timing of when you tell him, but what's 12 the other side of that coin? Is it possible for a patient
- - 13 14 15 who has been in some way overexposed and doesn't know it to be traveling or move to another part of the:country and to expose himself or herself far more than they would if they 16 knew that they'd been overexposed before?
17 MR. CUNNINGHAM: It)s hard to imagine that rn being very much of a problem.
19 COMMISSIONER GILINSKY: Let me ask a related 20 question. Suppose you went from one doctor,to another doctor 21 and started a new radiation therapy. Would ,they, .pe required 22 to inform the new doctor of the maladministration?
23 MR. BERNERO: Well, let's reconstruct that a 24 1ittle. The original referring physician h~s a procedure Ace-Federal Reporters, Inc.
25 done or asks for a procedure to be done. A misadministration
I I
I 44 -45 I
1 occurs. The original referring physician k:nows about it I*
2 . I and perhaps chooses not to tel 1 t h e patien~.
3 I The patient now goes to another 1physician al-l 4* together, and the new referring physician ils in charge of I
5 the case. Typical medical practice is he i mmediately con-1 1
6 I sults with the original referring physician~.
I 7 our regulation wouldn't speak td that issue, I
8 but the choice is clearly left with the ori:ginal referring 9 I physician to advise him of the.medical hist,ory "as I knew 10 !
it and saw it, and this is where I left thei patient."
I l1 I (Simultaneous discussion.)
12 I COMMISSIONER BRADFORD: Why shou]ld that be a
- - 13 14 15 choice at all?
. . I. .
Whatever there is to be sai d for not telling 1
I the patient, surely there's nothing to be s:aid for not tell-i ing the second physician? :
I 16 MR. BERNERO: Oh, no. It's justl that our regula-j 17 tions don't speak to that sort of thing. That's typical I
18 medical_practice to do so, the full explanahion.
19 I For instance., the second physician might be told I
20 bY the first physician that "I've been givihg this a patient 21 a lot of placebos to keep her from worrying:, " and he won't 22 I tell the patient that because it would defeat the whole pur-1 23 I pose of what he's prescribing. That's medical practice.
I 24 Ace-Federal Reporters, Inc. Our regulation doesn't speak to ~hat issue. It I
25 I I
gets too complicated to set up these hypothetical situations.
I I
i I
I
46 1 But we do speak to this questioq of informing 2 the patient or family, and we stop short of that in the 3 recommendation.
.e 4 COMMISSIONER GILINSKY: Why not 'have some formula-5 tion whereby the patient would be informed ,unless the 6 doctor would say -- you know, unless he would certify to 7 NRC that it would be harmful to the patienf to be informed?
8 MR. BERNERO: Well, this is the bne option that 9 was ventilated in the paper and we consider'ed, and that was 10 that we would require the licensee to report to the referring 11 physician and with some tag lag, some conditional character, 12 report to the patient and/or family subject to a veto.
- - 13 14 15 handled.
Wellr this raises some complicated questions.
one is timing and administration so that the thing is properly A timely report and yet a timely bpportunity for 16 the referring physician to make a judgment.;
17 secondly, what would be the level of veto? How rn would one go about doing this without really getting. awfully 19 deep in the doctor-patient relationship?
20 Would we judge the referring phy~ician criteria, 21 motives or logic for saying yea or nay?
22 COMMISSIONER GILINSKY: Well, th~s is off the
- 23 24 Ace-Federal Reporters, Inc.
25 top of my head. You might not j~dge it at all. In other words, you might leave it up to the doctor, 'but he would at 1east have to certify that was the case. If it came up I
47 sometime later there would be a record of it.
2 MR. BERNERO: There would be a bias on the act 3 . in the sense that there would be a pressure to inform
- 4 5
where his action would be to stop it as against no pressure and his action to pass it on.
6 COMMISSIONER GILINSKY: That's right.
7 MR- BERNERO: And, of course, I agree there would 8 be a record later on that he formally said,. "No, don't tell 9 him."
10 COMMISSIONER KENNEDY: What would that record do 11 £or whom*, other than being interesting?
12 MR. BERNERO: In a malpractice suit.
- - 13 14 15 in some way.
COMMISSIONER GILINSKY:
CHAIRMAN HENDRIE:
Well, if it were abused Well, you have a record in 16 the other case.
17 MR. BERNERO: Yes, there's a record of the mis-18 administration.
19 COMMISSIONER GILINSKY: Except the patient 20 doesn't get informed.
21 CHAIRMAN HENDRIE: If the patient is not informed, 22 you know the information went from A to Band didn't go to
- 23 24 Ace-Federal Reporters, Inc.
C. So that's a matter of record.
MR. BERNERO: The record is there with the re-25 quirement to inform the referring physician.
48 COMMISSIONER BRADFORD: First of :all, *by whom are 2 these kinds of issues handled with regard to 6ther, non-3 radioactive drugs? Is this a Federally handled matter, or
- 4 5
is it normally handled at the state level-~ or not handled at all?
6 MR. CUNNINGHAM: They aren't.
7 MR. DIRCKS: It 1 s a regulation of medicine which 8 no one really has approached.
9 MR. CUNNINGHAM: As far as we can tell, there 10 are ethical practices that physicians are supposed to meet~
n .rrhis is one of the issues, of course: Why is NRC getting 12 into this business when no other field of medicine requires
- 13 14 15 such reporting?
MR. BERNERO:
doctor-patient relationship already.
We're uniquely deep into the 16 COMMISSIONER GILINSKY: Well, no~ yet.
17 MR. KENNEKE: In this respect.
18 MR. CUNNINGHAM:* In the way we regulate nuclear 19 medicine, we are. As I said earlier, we're .the only Federal 20 agency that gets involved in the physician-patient relation-21 ship.
22 COMMISSIONER BRADFORD: What does the FDA do?
- 23 24 Ace-Federal Reporters, Inc.
25 DO they approve a drug for use and once it's approved it's fair game?
MR. CUNNINGHAM: Actually, FDA is tied to ICC
49 rules. What they do is approve -- their approval says the 2 drug is labeled in accordance with the way it's going to 3
perform; it's safe and efficacious if used in this dose 4 range, for this purpose, with these indications, with 5 these*counterindications. It's allowed to be introduced 6 into interstate commerce.
7 They have no direct regulatory control over the 8 physician except in the case of investigatibnal drugs, 9 and there a physician is required to file an investigational 10 plan.
l1 MR. BERNERO: When we look to requiring mis-12 administration recording and reporting, what we see that
- 13 14 15 we would do with the information is look for some generic implications, misadministrations that may be a serious problem in many institutions and might call for some sort 16 of publicity or advice campaign.
17 COMMISSIONER KENNEDY: Or an institution which rn seems typically to be involved in the misadministration 19 syndrome.
20 MR. BERNERO: Then one can look to the licensee:
21 Are the corrective actions appropriate? Is this licensee 22 responding in a proper way? Do we see a trend here of 23 perhaps sloppy practice, of too many misadministrations at 24 Ace-Feder;tl Reporters, Inc. 0 ne licenseei 25 These are valuable tools for the inspector, for
50 the licensing body to have this information for an individual licensee.
2 But we're not using the misadministration report-3
- 4 5
ing or recording for a direct action with respect to par-ticular patients. The focus is more on individual licensees or licensees as a class. Th~ focus is not on the single 6
patient.
7 COMMISSIONER GILINSKY: Do we have any idea of 8
what the rate of misadministration is?
9 MR. CUNNINGHAM: I'll try to answer that. When 10 this issue first c*ame up, we looked at some studies that 11 had been done in medicine._ The misadministration rate, as 12
- 13 14 15 I recall, was something like about 5 percent.
CHAIRMAN HENDRIE:
MR. CUNNINGHAM:
This is generally.
Generally. Now this can in-16 clude such minor things as the nurse giving a pill to the 17 p~tient before dinner instead of after dinner, giving the 18 wrong pill to the patient, or very serious things, like 19 giving the wrong blood type to a patient, which could kill 20 you pretty quickly.
It covers a vast range of things, but it's 21 22 somewhere around -- some estimate 5 percent and some esti-
- 23 24 Ace-Feoer;~I Reporters, Inc.
mate it as high as 12 percent.
we think nuclear medicine, because we have in fact been involved in this because of its special nature, 25
51 that probably the misadministration rate is much lower than 2 that.
3 There have been some fatalities from misadministra-4 tion of radiopharmaceuticals, however.
5 COMMISSIONER KENNEDY: Radiopharmaceuticals?
6 MR. CUNNINGHAM: Yes, sir. It has happened.
7 CHAIRMAN HENDRIE: Pharmaceutical overdose sort 8 of thing?
9 MR. CUNNINGHAM: No. I could give you an example.
10 Most of these are just human errors that are hard to explain.
11 One patient I recall a few years ago. One treat-12 ment for cancer patients is to give a colloidal phosphate.
13 CHAIRMAN HENDRIE: Oh, this is a therapeutic?
14 MR. CUNNINGHAM: Yes. And they gave the wrong 15 they gave a soluble phosphate. So things like that happen.
16 Actually, mspitals aren't all that safe places 17 to be. Avoid them if you can.
18 (Laughter.)
19 But we think that the misadministration for 20 radiopharmaceuticals is low.
21 CHAIRMAN HENDRIE: If you feel ill, gentlemen, 22 ask to be taken to your nearest nuclear power plant.
23 (Laughter.)
24 COMMISSIONER KENNEDY: We'd be safer than coal-Ace-Feger11I Reporters, Inc.
25
. or oil-fired plants, because the President of the United States
52 1 just said so.
.2 CHAIRMAN HENDRIE: At least safer than hospitals .
3 MR. CUNNINGHAM: Well, things do happen, but we 4 think the misadministration rate of radiopharmaceuticals is 5 lower than the_ general average; but we can't prove it. We 6 have no reporting requirement.
7 CHAIRMAN HENDRIE: Let's see, should we perhaps 8 proceed onward with this briefing, which I suspect has not 9 nearly run its full course?
10 MR. BERNERO: I would like to terminate the por-11 tion I've been covering and turn it back to Dick Cunningham 12 to give you the broader perspective of how this relates 13 to all the other medical policy things and things you're 14 going to see in the near-future.
15 MR. CUNNINGHAM: May I have the next slide, 16 please?
17 (Slide.)
18 We can just wind this up in about 2 minutes 19 probably.
20 There are some additional rule changes coming 21 up. The teletherapy calibration rule was published as a 22 proposed rule and will now be up to the Commission as a
- 23 24 Ace-Federal Reporters, Inc.
25 final rule.
Measurement of doses, there's a minor rule change.
53 Plutonium powered cardiac pacemakers -- again, 2 this was a proposed rule and +/-s coming to you as a final 3 rule.
- 4 5
FDA recently -- well, within the last couple of years, I guess -- got new legislation over medical devices,*
6 which covers everything from sutures to heartpumps, to 7 regulate medical devices in the same manner they do drugs.
8 They*' re trying to get geared up to do this. It's a tre-9 mendous undertaking. When they do, we will develop some 10 Memorandum of Understanding with them so that we don't over-11 lap in our work. I would assume that they would be taking 12 0 ver some of the things that we are currently doing when
- 13 14 15 they're properly staffed to do it.
And the qualifications of paramedical personnel is one that requires some more staff work to find out where 16 we are on that.
17 CHAIRMAN HENDRIE: That comes up what? In 18 terms of training, for instance, for nurses or laboratory 19 technicians --
20 MR. CUNNINGHAM: Yes, sir.
21 CHAIRMAN HENDRIE: -- who may be preparing for 22 administering these things?
- 23 24 Ace-Federal Reporters, Inc.
MR. CUNNINGHAM: That is correct. Paramedics maY be the technicians that run the scanners, the technicians 25 and nurses that administer the drugs, people that do the
54 calibration work, or it may be a physicist who does the 2 calibration on a teletherapy unit -- a whole raft of things.
3 CHAIRMAN HENDRIE: Isn't that establishment of 4 qualifications much better placed in the professional groups 5 in the field rather than fall under Government regulation?
6 MR. CUNNINGHAM: Certainly this is the opinion 7 of very many medical groups. There are certification organi-8 zations. This is one of the issues we're looking at.
9 The question was originally raised by GAO in 10 ne of their reports. We think that a lot has happened with 0
11 certification of paramedical people since that GAO report 12 came out.
- 13 14 15 If 0ur work finds that professional organizations are doing a job that appears to be.adequate, we certainly don't want to get into it. Among other things, it will be 16 costly for us.
17 CHAIRMAN HENDRIE: I was going to say, with the 18 greatest affection and respect for our good friends in GAO, 19, theY do have a tendency to swing.first, saying, "Boy, you 20 ought to get in and really fix this up," and then five years 21 later they come along and say, "What? You've got a thousand 22 people working on this on the Government*payroll? That's 23 outrageous~ How dare that happen!"
24 Ace-Federul Reporters, Inc.
I think what we've seen is the first swing. And, 25 sort of in line with some of the general thrusts of our
55 standards-setting activity, I would think we would be better 2 off, ;_,if we' re not al together plea*sed with the professional 3 group certifications, to encourage them to do a little better.
4 If we are going to write anything into our rules that covered 5 it, it would probably much better be to put some mild re-6 quirement that administerers of these things be certified 7 by the professional group, but then on the other hand you 8 would encourage the professional group to upgrade the 9 standards rather than going into NRC licensing and testing 10 and so forth.
11 MR. BERNERO: We don't want to add it to Part 55.
12 MR. CUNNINGHAM: Certainly, Mr. Chairman, this 13 iS the direction we're going. I hope to see within the 14 next few years that we can get out of looking at physician 15 requirements to practice medicine, also. We're moving in 16 that direction. We have made progress, although our advisors 17 say, "Don't do it yet."
18 MR. DIRCKS: I think we might want to mention 19 some of the related issues.
20 MR. CUNNINGHAM: Oh, yes, there's one more slide, 21 Mr. Chairman.
22 (Slide.)
23 There are some related issues, of course. There's 24 the fertile women question.
Ace-Federal Reporters, Inc.
25 COMMISSIONER KENNEDY: We discuss that once each
56 1 year at about this time.
2 MR. KENNEKE: In the spring.
3 MR. CUNNINGHAM: It's important here, because
- 4 5
of that 30,000 population of workers under the medical licenses, a large percentage -- I suspect over 50 percent 6 are women, which isn't typical of the other industries.
7 Transportation question -- very important. Medical 8 pharmaceuticals, or radiopharmaceuticalis must be transported 9 on passenger-carrying aircraft. The half-lives of these 10 materials are short. Cargo services in the United States l1 just won't get them to the hospit~~~ in time.
12 This is an issue that has been raised now and
- 13 14 15 again. It is covered ~n the GEIS on medical transportation.
MR. BERNERO: Yes, NUREG 0170 identifies this.
MR. CUNNINGHAM: But it has been subject to a 16 lot of question.
17 Then we have NARM, which stands for Naturally rn occurring Radioactive Materials. There is a question whether 19 or not we should --
20 CHAIRMAN HENDRIE: Let's see, it's Naturally 21 Occurring and Accelerator Produced Radioactive Materials.
22 MR. CUNNINGHAM: Yes. Some ho~pitals are going
- 23 24 Ace-Federol Reporters, Inc.
to greater and greater use of accelerators.
more of it, I guess, as time goes on.
We will see The agreement states 25 have raised this q~e~tion, and it will be something we will
57 be coming up to rou with, with some recommendations.
2 And, of course, we have the occupational exposure.
3 I left that for last even though it's first .. We are trying 4 to apply the Principle to medical uses of radio-5 isotopes.
6 I think that covers what we had, Mr. Chairman.
7 we have the proposed policy for publication for public com-8 ment, and we have these two rules that Bob has gone over 9
with you for publication for public comment.
10 CHAIRMAN HENDRIE: Al, I had a note that you want 11 to make a comment on 68.
12 MR. KENNEKE: Across the board, Mr. Chairman, we 13 think the policy statement is moving the Commission in the 14 right direction. The staff job is well reasoned and fully 15 sound, and, as Dick and Bob have pointed out, it's a con-16 tinuation of a trend of thinking that's been going on for 17 some time.
18 We would, however, point out that it seems that 19 the reluctance to go beyond the diagnostic, changes with 20 the diagnostic list, seems somewhat inconsistent with the 21 pol-icy statement. you' re about to -~~-~l!.§, which is to say that 22 you are going to minimize intrusion into the physician-23 I patient relationship.
24 Ace-Federal Reporters, Inc.
AS Dick and Bob have both indicated, the residual 25
58 rules that would exist even after your approval of the 2 changes to Part 35 will maintain a strong degree of NRC in-3 volvement in the physician-patient relationship by going 4 beyond what FDA itself requires with regard to the use of 5 these materials.
6 So you might wish to consider what more might 7 be done or what further steps you might take to examine 8 moving still further in the direction of being fully con-9 sistent with the policy you're about to issue.
10 The other point that we wish to make was on 11 CHAIRMAN HENDRIE: I didn't understand that last 12 0 ne.
13 MR. KENNEKE: Assuming that you approved this 14 policy, then the change that's being made to Part 35 --
15 CHAIRMAN HENDRIE: Perhaps doesn't go as far as 16 you might want to go?
17 MR. KENNEKE: As far as the policy seems to 18 indicate it would go.
19 CHAIRMAN HENDRIE: I see.
20 MR. KENNEKE: The other point that we would 21 suggest might be looked at a little bit in terms of a few 22 word changes in the policy statement is), to improve the 23 \ response for the 90 or so commenters about the rule on mis-24 administration, to better describe, as has been done here Ace-Feoerul Reporters, Inc.
25 today and is done in Paper No. 70, the reasons why these
59 changes in fact don't intrude into the' physician-patient 2 relationsh.ip. We think in that ca5e a somewhat better 3 description could be provided to foreclose that. Much of
- 4.
5 the discussion that has gone on here is indication of that.
MR. CUNNINGHAM: If I may make a point, Mr.
6 Chairman, as I indicated earlier, we do have a Medical 7 Advisory Committee that is quite active in giving us advice.
8 rt assists us on applications and has guided us through a 9 lot of these policy issues over the years.
10 In our consultations with not only that committee 11 but with various peer groups that I have li~ted, one senses "12 well, they state quite emphatically that they don't want
- 13 14 15 NRC to completely withdraw from physician qualification, physician-patient relationship entirely, because that opens up the field of nuclear medicine to people who aren't 16 serious about it.
17 Nuclear medicine has developed with tight control 18 without these major scandals, and I think people recognize 19 that. We are phasing out, but I don't think anybody that 20 I've talked to wants it to be precipitous.
21 This policy will point us in the right direction, 22 but it recognizes we aren't completely out of it yet.
- 23 24 Ace-Feder;,1 Reporters, Inc.
25 CHAIRMAN HENDRIE: So you think in fact that, although indeed Al's comment is correct, that the Part 35 changes proposed do not back all fhe way out, but at this time
60 it's a little premature to do that.
2 MR. BERNERO: We're not ready to justify getting 3 out of Classes IV through VI there.
- 4 5
CHAIRMAN HENDRIE: And with regard to improved 1anguage in response to comments, I take it you're always 6 glad to receive suggestions for improved language.
7 COMMISSIONER GILINSKY: Let's see, the 98 comments 8 were on what?
9 MR. BERNERO: The 98 comments were back on that 10 1 73 rule, which was misadministration and delegation of 11 authority and qualifications of technicians.
12 COMMISSIONER GILINSKY: They're rather old com-13 ments?
14 MR. BERNERO: Yes, they're dated, and now it's 15 a fresh ~late. That history is available, but it is better 16 now to have this singular rule on misadministration.
17 MR. DIRCKS: And we're going out for comment.
18 MR. BERNERO: All of this is proposed to go out 1.9 for comments, and in a sense it's in light of this new 20 proposed policy: Here's the correlary proposed rule for 21 misadministration and the. correlary proposed change to 22 part 35.100. So we would go out for comment on all three.
- 23 24 Ace-Fl!(Jer;al Reporters, Inc.
25 COMMISSIONER GILINSKY:
medical advisory group?
Who sits on your Are they all doctors?
MR. CUNNINGHAM: Weli, we have four physicians.
61 We're right in the process of rotating some members.
2 COMMISSIONER GILINSKY: No patient~?
3 MR. CUNNINGHAM: No patient5. These are cho5en 4 strictly for their medical credentials.
5 COMMISSIONER KENNEDY: Hopefully you'd have to 6 rotate those pretty rapidly.
7 (Laughter.)
8 MR. CUNNINGHAM: The Advisory Committee has, I 9 I think it s six physicians re*ally, one medical physicist, 10 and we also have a radiopharmaceutical consultant plus 11 another medical physicist consultant.
12 Incidentally, I think we spent $11 thousand in 13 fees, services, travels to the meeting and everything last 14 year for this committee, and I think it's one of the best 15 bargains NRC gets.
16 CHAIRMAN HENDRIE: How much?
17 MR. CUNNINGHAM: Eleven thousand dollars.
18 CHAIRMAN HENDRIE: How much does it cost us to 19 run the ACRS?
20 MR. BERNERO: No invidious comparisons intended.
21 CHAIRMAN HENDRIE: Let's see, we have your 22
- 23 24 Ace-Feger;~( Reporters, Inc.
recommendation on the policy question and the publication of the proposed policy statement in the Federal Register in-viting public comment and so on. This matter, I guess, is 25 before the Commission at the moment.
62 MR. DIRCKS: Yes, sir.
2 MR. BERNERO: All three. There are three separate 3 actions in effect.
4 CHAIRMAN HENDRIE: I'm prepared to have limited 5 objective right at the moment.
6 Let me first ask about the 6~, which is the 7 policy statement that the Commission is concerned and does 8 propose to regulate the radiation safety of patients where 9 justified by the risk and where voluntary standards or 10 compliance with these standards is inadequate, and to publish 11 in the Federal Register the policy statement, statement 12 of considerations, for public comment.
13 I wonder if it's at a stage where you might be 14 able to vote it up or down or would like to consider further?
15 COMMISSIONER GILINSKY: I'd like to consider it 16 further~ just to get a better feel for what it implies for 17 the other items.
18 CHAIRMAN HENDRIE: Okay.
19 illMMISSIONER BRADFORD: I was going to say some-20 thing more limited in the same way, which is you can't 21 separate it from Number 70 because Item 10 in here overlaps 22 with the it contains a commitment to publish the mis-23
, administration standard concurrently. Or, if yoti published 24 Ace-Federal Reporters, Inc. a different misadministration standard, you'd have to change 25
63 Item 10 in 68.
2 CHAIRMAN HENDRIE: Okay.
3 COMMISSIONER GILINSKY: On the misadministration
- 4 5
paper --
CHAIRMAN HENDRIE: Well, I'm going to hold on 6 a vote for that and ask for discussion on the other items.
7 COMMISSIONER GILINSKY: I notice that there are 8 some offices that favor informing the patient, and I wonder 9 if we could hear from those.
- 10 MR. DORIAN:* There is one office that favors 11 the veto procedure. It's the Legal Director's Office.
12 COMMISSIONER GILINSKY: Well, let's hear about
- 13 14 15 that.
MR. DORIAN: We think that there will be more of an inclination for the doctors to tell the patients if 16 something goes wrong if the NRC stands in the middle of 17 that, that is, if we say please inform the patient unless 18 the doctor thinks there is something wrong with that. If 19 there is a veto relationship, the doctor would be more in-20 clined to inform the patient.
21 COMMISSIONER KENNEDY: Why? That would imply 22 his medical judgment would be affected somewhat?
- 23 24 Ace-Federal Reporters, Inc.
MR. DORIAN: It might imply that we think COMMISSIONER KENNEDY: Isn't he going to tell 25 the patient what he thinks is wise from the point of view
64 of patient care? Isn't that what his obligation is?
2 MR. DORIAN: He might think twice as opposed to 3 simply dismissing it.in a cursory way. He might be more 4 inclined to think of it knowing that someone may be peering 5 0 ver h~s shoulder.
6 COMMISSIONER KENNEDY: I hope you guys don't 7 come around when I have another case of heart surgery. I*,
a could die waiting for them to get around to deciding.
9 CHAIRMAN HENDRIE: Unless you propose that in
- 10 making the veto you're going to ask physicians in general 11 to sit down and develop elaborate briefs as to why they 12 chose not to pass the information on. I presume that's 13 not the intention -- or is it?
14 MR. DORIAN: The intention is that we don't want 15 to make more work for ':lawyers on this one.
16 (Laughter.)
17 COMMISSIONER KENNEDY: You could have fooled me.
18 I can't see who else it's going to help.
19 CHAIRMAN HENDRIE: If the referring physician 20 simply decides on the one hand that "Yes, I'll pass it on, 21 because the patient can know and it's not harmful to him,"
22 that's orie way of doing it. On the other hand, if he simply
.e 23 says, "I decide to veto," unless you're going to require 24 some elaborate -- let me take the word "elaborate" out --
Ace-Fedeml Reporters, Inc.
25 some procedural step of substance on the veto side, I find
65 them indistingui~hable and I find the*former procedurally 2 easier.
3 MR. DORIAN: Well, the idea was that -- to make
. . : 4 the doctor think twice as opposed to simply thinking once.
5 COMMISSIONER GILINSKY: Wel_l, let Is see' isn It 6 there a difference --
7 CHAIRMAN HENDRIE: I .find it splendid that 8 1awyers think doctors ought to +think _twice.
9 COMMISSIONER KENNEDY: I think doctors ought 10 to think that about lawyers.
11 COMMISSIONER BRADFORD: I'm sure they do.
12 COMMISSIONER KENNEDY: More often, I would addf
- e 13 14 and with good cause.
COMMISSIONER GILINSKY: Well, suppose a doctor 15 did not tell the patient and there really wasn't any good 16 reason for not having done so.
17 COMMISSIONER KENNEDY: But is that our business?
18 COMMISSIONER GILINSKY: Well, it's a question 19 of what the obligations are to a patient.
20 COMMISSIONER KENNEDY: Well, that's his business.
21 CHAIRMAN HENDRIE: I don't find in_.,the Atomic 22 Energy Act a requirement that we regulate physicians' 23 obligations to patients.
24 Ace-Fe{Jer1ii Reporters, Inc.
COMMISSIONER BRADFORD: It's just in the public 25 health and safety, I think.
66 COMMISSIONER GILINSKY: I-mean, you're licensing that stuff, and *it seems to me that belling people when the 2
3 stuff is abused is a r~quirement.
4 Now, the only reason, it seems to me, for not doing it is in the- peculiar circumstances when you're deal-5 6
ing with sick people and it may be in some circumstances more 7
harmful to tell them. You could imagine circumstances like 8
that. If it were not for that, it seems to me the obligation 9 would be to tell them. That's the only factor here which 10 would hold you back from insisting that the patient be told.
1i ,And the question is how one deals with that situation.
12 MR. BERNERO: Perhaps I should have emphasized
- e 13 14 it more when I was talking on the subject. The distinction of our focus of attention in regulating nuclear medicine 15 is on the prospective safety of the patient, to see to it 16 that the patient is being treated by qualified people with 17 appropriately sel~rit~d procedures. When we look at mis-18 administration reporting/recording and what-have-you, our 19 attention is focused on prospective uses of it, to protect 20 the next patient and the next one aftet that, and not on 21 the carrying out of due process and justice for the patient 22 who may have suffered a misadministration.
,**- 23 24 Ace-Fe(ler11i Reporters, Inc, COMMISSIONER GILINSKY:
1eases from-reactors.
Let's say there are re-You could apply the same logic there.
25 .You could say, "There's a release; let's focus on preventing
67 the next release. and making* sure that people around another 2 reactor are not going to be subjected to the- release that 3 people were around this reactor .
4 The fact is that some of these people are going 5 to have heart conditions or whatever, and it may not do them 6
much good to know that the reactor in their neighborhood 7 had a release; yet we insist on telling*them. I don't think 8 the situation here is all that much different.
9 Now, it may be.* useful_ to put in some safeguards 10 for special circumstances. But it seems to me the first n obligation is to the party.
12 MR. KERR: Mr. Chairman, our office was one of
- 13 14 those, also, who commented on this ,state program.
the patient should be informed in those cases where a We feel 15 report is to be made to NRC.
16 We feel the person that's most affected is the 17 patient. He should know if the regulator is going to be told.
18 COMMISSIONER KENNEDY: That would argue equally 19 for not telling the regulator.
20 MR. KERR: Perhaps. Now we also suggested in 21.
there-that if the patient is not able to absorb the shock, 22 in those cases where it might be injurious to his health, 23 that a responsible relative be informed.
24 Ace-Fecjenlli Reporters, Inc, COMMISSIONER KENNEDY: There is a matter of 25 patient relationship there, isn't there? If I understand
68 medical ethics, -and maybe even t,he law -- and I certainly 2 would not suggest that I understand the law -- I think the 3 patient himself, if he's able to do so, would have to 4 authorize a doctor to tell a relative.
5 MR. KERR: I think doctors do tell relatives a 6 number of things.
7 COMMISSIONER KENNEDY: Some things. But there 8 are well understood relationships which have to be carefully 9 guarded there*.
10 MR. KERR: I think our point is that the patient 11 is the one that is the most directly affected.
12 COMMISSIONER KENNEDY: Someone has to decide 13 which of- those relatives is the responsible one.
14 MR. CUNNINGHAM: If I might go back just a 15 little bit, we've come full circle on this issue before us.
16 We have no reporting requirement now. We do have a 17 limited objective with our reporting requirement, as Bob 18 said, and that is to correct something before the next 19 patient.
20 It is also true that something might be done for 21 a patient after exposure. The way we developed this rule, 22 it was not intended to specifically address that problem.
23 It has been discussed many times with our Advisory 24
- Ace-Feqer:11 Reporters, Inc.
Committee, with all these peer groups, with the public in 25 public meetings, and we get about as many ideas on how this
69 should be handled as people you talk' t6 about it.
2 I COMMISSIONER KENNEDY: What did the public say 3 in public meetings on this point?
- 4 5
MR. CUNNINGHAM:
~eally two sets of people:
Well, -the public meeting was the various medical practitioner 6 groups was one segment of the public, and then strong state, 7 agreement state mainly, representation. And I think it 8 would be fair to say that the medical people aren't overly 9 enamored with this rule, because it does put an obligation 10 on them that they don't like particularly. They can point 11
-to things such as hospital ethics committees and what-have-you 12 that address this very problem of what the physician should
- 13 14 15 tell the patient and so forth.
The state, agreement state, people, I think Wayne Kerr just reflected the sentiment of the agreement state 16 groups, who probably tend to -- would like to assert a little 17 bit more control over the physician and the physician-patient 18 relationship than we do.
19 COMMISSIONER GILINSKY: Are their comments in-20 eluded anywhere in your paper?
21 MR~ CUNNINGHAM: They are. They're summarized in 22 60-68.
23 MR. DI'RCKS: They're*in Enclosure Number 3.
24
!
- Ace-Federi1I Reporters, Inc, MR. CUNNINGHAM: Yes, Enclosure Number 3 has 25 comments of various groups summarized-~ page 4.
70 MR. BERNERO: And then Enclosure 3 of paper Number 70 has a summary of comments on the old rule.
2 MR. CUNNINGHAM: I think the point is that this 3
- 4 5
rule as it is intended is to solve-.generic problems that may have resulted in these overexposures. It isn't intended 6
to take care of the one patient that got overexposed spe-7 cifically.
8 And, as I say, there are other-~
9 COMMISSIONER KENNEDY: May I ask a question?
10 The individual has been overexposed.
li MR. CUNNINGHAM: Yes.
12 COMMISSIONER KENNEDY: What is necessary then is
- 13 14 15 there are at least two things that I can think of. One is that he doesn't get further exposure, at least until some measurable period of time~
16 The second is, if circumstances suggest, he 17 ought to get some sort of medical treatment.
18 MR. CUNNINGHAM: That 1 s correct.
19 COMMISSIONER KENNEDY: Now, what does telling 20 him do about either of those? The doctor would be the 21 one who would give him the medical treatment, prescribe it 22 anyway, wouldn 1 t he?
23 COMMISSIONER GILINSKY: He might want another 24 doctor.
Ace-Feder1,1. Reporters, Inc, 25 MR. BERNERO: Yes, _that I s the point. The patient
71
,;,;; 0 uld say, "You guys are but~b.e:ting me. I'd better go some-1 V' (,
- where, else. It's that option that exists.
2 3 When we say report to the referring physician,
- e. 4 the misadministration was an act of a therapist.
5 COMMISSIONER KENNEDY: Somebody else, that's right.
6 MR. BERNERO: When we say report to the referring 7
physician, we take it away from the one who committed the 8
fault and put it in the hands of the medical judge in the 9 matter.
10 There is a secondary quest~on of, "Well, you're 11 the one who referred me to him for this treatment. Aren't 12 you in some way responsible?" That's a rather derivative
.e 13 14 responsibility.
grade.
We just don't consider it that type or 15 MR. CUNNINGHAM: I might also add, for the 16 medical management of the patient, whatever is done in most 17 cases has to be done pretty quickly for the patient's bene-18 fit in the case of a misadministration, and all this re-19 porting business to,**the referring physician catch up.
20 I think there was a case not too long ago where 21 they gave a therapeutic thyroid dose to the wrong patient, 22 and it did destroy or could have destroyed part of his
- 23 24
' A(:e.Feqere1I Reporters, Inc, 25 thyroid. They had to give an injection of some blocking solution pretty quickly.
immediately.
Things would have to be done
72 COMMISSIONER GILINSKY: Well, presumably.if you.
2 have to ieport to a p~tient, you're going to be more careful 3 about administering these doses.
- 4 5
MR. CUNNINGHAM:
Commissioner.
I don't agree with that, I think that these hospitals do exercise 6 controls. Again, if you look at how misadministrations 7 occur, they are hard to explain. They just seem to be 8 human errors. The things are difficult to explain.
9 we don't think that would improve the misadmini-10 stration rate. It might improve subsequent care of the l1 patient. I don't know about that. But I really can't 12 believe, from what I understand of how these misadministra-
- 13 14 15 tions occur, it would lower that rate.
CHAIRMAIN HENDRIE:
would be as recommended?
Let's see, the inclination 16 COMMISSIONER GILINSKY: I would go with the 17 proposal concerning the reporting ~equirements.
18 CHAIRMAN HENDRIE: The veto option.
19 Peter?
20 COMMISSIONER BRADFORD: I'm inclined in that 21 direction as well. Is there a way to publish 68 in a way 22 that leaves -- the only thing standing in the way of publish-23 ing 68 is that Item 10.
24 MR. CUNNINGHAM: I'm sure we could split it out.
Ace-Fl!(jeral. Reporters, Inc.
25 COMMISSIONER BRADFORD: There's probably some way
73 1 to --
2 COMMISSIONER HENDRIE: I think 69 is not contra-3 versial.
4 COMMISSIONER BRADFORD: No, 69 is no problem at 5 all.
6 COMMISSIONER HENDRIE: That I know of.
7 COMMISSIONER KENNEDY: Why can't we publish both 8 as alternatives and let the public comment on them?
,9 COMMISSIONER BRADFORD: You mean on 70?
10 COMMISSIONER KENNEDY:* No, 68, on Section 10, 11 or whatever it is.
12 MR. BERNERO: We're requesting comments on the
- 13 14 15 issue, and we could make it sufficiently conditional if it isn't already.
COMMISSIONER KENNEDY: What I'm saying is you 16 have clearly inferred here, and in the staff indeed, there 17 are two rather different views of this. Why not put them 18 out to the public? What we want is public comment, so why 19 don't we ask for public comment on those particular questions?
20 MR. BERNERO: In fact, as presently constructed
- 21. it's not conclusive in Item 10. Item 10 is reporting to 22 NRC, ':the patient, and/or the patient's physician. It's a
.e 23 string of options. It's sufficiently indefinite, I think, 24 as to be inconclusive.
Ac:e-FB(Jernl Reporters, Inc, 25 COMMISSIONER KENNEDY: Make sure the statement
74 of considerations -- that point is brought up. Why not 2 do that?
MR. BERNERO: It doesn't foreclose anything.
3
- 4 5
COMMISSIONER BRADFORD: That's the language on page. 2 of -- look at page 22, the last paragraph.
6 (Pause.)
MR. BERNERO: The last paragraph of the page?
7 8
COMMISSIONER BRADFORD: Yes.
9 COMMISSIONER KENNEDY: That's the statement of 10 what they were proposing.
11 MR. BERNERO: It's a factual reference to what 12 is there. We could emphatically alt~r this statement, this
- 13 14 15 public statement, to make very clear our emphatic request for comments.
COMMISSIONER KENNEDY: That's what I'm suggest-16 ing.
17 CHAIRMAN HENDRIE: Depending on what one wanted 18 to do -- let's see, one could rewrite that last paragraph 19 on page 22 and not say_that there is a new proposed rule 20 for this reporting requirement elsewhere in the Register.
21 They could say that the Commission is contemplating one of 22 two general pathways';' One of them as described here, and
,e 23 the other one in which the radiographer, whatever, report 24 ,5erious, reportable ones to the NRC and the patient unless
~ce-Fe(Jerul Reporters, Inc, 25 the referring physician recommended against that.
75 COMMISSIONER KENNEDY: There you will have to put 2 a statement in that Commissioner Kennedy disagrees. I don't 3 think the radiographer ought to report to the patient at all.
- 4 5
If the matter is going to be reported to the patient, it seems to me it's got to be reported to the patient by the patient's doctor.
6 7 CHAIRMAN HENDRIE: We can't do it. We can't 8 regulate down a whole tier of people.
9 COMMISSIONER KENNEDY: We can't have radiographers, 10 who see a patient for 20 minutes on one day --
11 CHAIRMAN HENDRIE: They're the licensee.
12 COMMISSIONER KENNEDY: I know, but he has no
- 13 14 15 relationship with the patient. He's a technician essentially as far as the patient is concerned.
even know this guy.
The patient doesn't 16 If the patient is going to be told that something
\
17 has happened to him that may affect his health, it is his 18 doctor who's got to tell him that.
19 CHAIRMAN HENDRIE: Well, that's a view when 20 you're* going out for public comment.
21 COMMISSIONER KENNEDY:. That's right. If you 1:
I 22 want to say no, it must be the radiographer who's got to do Ace-Fe;Jer,al Reporters, 23 24 Inc, it, all I'm saying is I insist that a statement be put in saying Commissioner Kennedy prefers the' following, or 25 suggest it as another option. That's all. I'm perfectly
76 prepared to get public comment on it.
2 CHAIRMAN HENDRIE: The Proposa l is to_*_*.put it 3 out as two options.
- 4 5
COMMISSIONER KENNEDY: No, you dropped an option, which is the option that was recommended in the first place.
6 CHAIRMAN HENDRIE: To the contrary. That was 7 option Number 1.
8 COMMISSIONER KENNEDY: But that doesn't get to 9 their option.
10 CHAIRMAN HENDRIE: Of course not. That's why 11 I've got option Number 2. And we can comment and wrangle 12 about this
-- 13 14 15 COMMISSIONER KENNEDY:
CHAIRMAN HENDRIE:
We need option Number 3.
and later on you can say you agree with this one or not, or with that one or whatever.
16 COMMISSIONER KENNEDY: I want three options, 17 Mr. Chairman. I respectfully suggest. One is th~ option 18 which they put forward in the first place, in which the 19 decision to convey this information to the patient is entirely 20 with the doctor, the patient's doctor, refe~ring doctor.
21 The second option is the one that our colleagues 22 are suggesting, a perfectly reasonable point of view, which Acit-Feder,al 23.
24 Reporters, Inc.
is no, that referring doctor, having been told this, must provide the information to the patient ~nless --
25 CHAIRMAN HENDRIE: I'm sorry, that's not -- I don't I
71 regard that within the proposition.
2 COMMISSIONER KENNEDY: That's what I thought 3 their option was.
.e 4 CHAIRMAN HENDRIE: Please hear me out. I would 5 ~~nt ELD's opinion on that, and the General Counsel's, whether 6 in fact this Commission through the Atomic Energy Act can 7 regulate the general practice of medicine in that fashion.
8 The referring physic~an is not. a licensee.
9 MR. BERNERO: Excuse me, Chairman Hendrie, if I 10 could interject.
n What we're bogging down on here is more of a pro-12 cedural question. We do indeed license the radiographer,
- e 13 14
- whoever he is. That's the licensee.
put a condition on:
He is the one we can "You will do this and you will do that."
15 We would be having a requirement that he would 16 report to the referring physician, and it is a procedural 17 matter 1that, if we required him to report to the patient, 18 it would be done in conjunction with the referring physician 19 in some way.
20 It is clearly not sending this guy down into the 21 room saying, "Guess what? I zapped you." It's a procedural 22 matter.
- 23.
24 Ace-Federal Reporters, Inc.
25 we can't lay a liGense condition on the referring physician because we don't license him.
COMMISSIONER KENNEDY: We are now really in the
78 practice of medicine.
2 MR. KENNEKE: We're already there with the dose.
3 4
rate.
COMMISSIONER KENNEDY: This is going to put us 5 there in a way we've never been.
6 MR. DIRCKS: It's a different cup of tea when 7 you regulate dose limits than when you regulate the behavior 8 of the physician to the patient. It's much different.
9 COMMISSIONER KENNEDY: A physician who is not 10 the patient's physician.
11 MR. KENNEKE: You' re already restrictd:ng::the 12 physician's ability to treat the patient.
-*- 13 14 MR* CUNNINGHAM:
thing clear.
Wait a minute. Let's make one We don't regulate doses to the patient.
15 MR. KENNEKE: You restrict them to the label.
16 CHAIRMAN HENDRIE: And we do license the nuclear
-17 medicine specialist, but we don't license referring physicians, I. l8 who may be the general run of medical practitioners. You I
19 can't go out and lay requirements on people who aren't*
20 licensees.
21 COMMISSIONER KENNEDY: We can't interfere with 22 their patients, either.
- 23 24 Ace-Federal Reporters, Inc.
25 COMMISSIONER BRADFORD: 'l'o the extent that that was what I had in mind, I think you're probably right.
COMMISSIONER KENNEDY: I thought that's what you
79 did have in mind.
2 COMMISSIONER BRADFORD: I thought that's what I
. :.*** 3 4
had* in mind, too, but I hadn't thought:. of that wrinkle .
'COMMISSIONER KENNEDY: The other wrinkle is 5 a very serious one. That one I can understand. It's the 6 other one I can't.
7 CHAIRMAN HENDRIE: It's an administrative problem 8 in terms of how do you handle the regulation with the people,*
9 .and I just don't see how to do *it.
10 COMMISSIONER BRADFORD: I see the point, unless 11 OELD or the General Counsel feels differently.
12 CHAIRMAN HENDRIE: You can lay a condition on 13
- the radiographer which say 9 , "Radiographer, if there is 14 a reportable incident, send a notice to the patient; however, 15 before you do that, you send a letter to the referring 16 physician. If you don't get. one ba.ck that says, 'God, don't 17 do that,' send it to the patient."
18 That's all a set of conditions you lay on the 19 licensee, and you can do things through that.
20 COMMISSIONER KENNEDY: Can we see that, all 21 :that procedural matter written up so we'll know what we're 22 :talking about, please?
23 CHAIRMAN HENDRIE: I don't want to be ingenious 24
'and then find out we're now in; some fa~hion licensing a Ace-FederE1I Reporters, Inc, 25 :quarter of a million general practitioners with regard to
80 their referring ~atients to~~
2 COMMISSIONER KENNEDY: We're not doing that,* but 3 what we're doing is/stepping irito their practice.
4 CHAIRMAN HENDRIE: I think there's a problem 5 just with the practical regulatory aspects of that.
6 COMMISSIONER GILINSKY: I'd like to have OELD 7 .take a look and see what they come up with.
8 CHAIRMAN HENDRIE: Well, with regard to being 9 *, able to* gotifiorward here, we could either rewrite this para-10 _' graph to say the Commission will soon publish and not indi-1 11
- cate what it is. That's Option 1.
12 or the following statement, policy statement,
- ____ 13 *could be published in the Register which would include both 14 'of these options, provided* some reasonable procedl~.ral ar-15 ' '
,rangement for the veto option could be worked out.
16 I ' I don't have any objection to going either way, 17 1but having come this far and spending two hours on the brief-18 'ing, and having raised our understanding sort of above some I
j 19 I
- minimal threshold so we're beginning to grasp the elements, 20 *I hate to lose that. If we could indeed act to get these 21 ;published here, that would be desirable.
22 MR. BERNERO: The§e:c.*are all proposed policy I ,
I ,
23
- statements and amendments.
I ,
24 If we could commit to a clarification of that Ac:e*Federul Reporters, Inc.
25 paragraph on page 22 of the following paper so as not to be I ,
81 so definitive and that's all it is 2 CHAIRMAN HENDRIE: Well, I think we could in fact decide which of the two ways that would leave the option 3
4 open would be desirable. One way, as Bob says, would be not 5 to in effect state the thrust of the proposed rule here but 6 .* just to say that there will be soon published for comment 7 a rule. That would be one way to handle it, and that would 8 allow this thing to go.
9 I assume we could also do the 69 paper, too, 10 since* I think everybody agrees on that.
11 Now, the other way to fix this would be to say, 12 "Look, *we're*considering two paths, and we'd be interested
- e 13 14
- in comment." One of them is as written out here, and the other one is the one with _the veto arrangement; however, 15 that will require some language that ought to circulate 16 back to us so we can agree it's a practical regulatory 17 scheme. I 18 COMMISSIONER KENNEDY: Who is it who has to 19 render this veto in your scheme?
20 CHAIRMAN HENDRIE: The referring physician.
21 COMMISSIONER KENNEDY: The referring physician.
I ,
22 COMMISSIONER GILINSKY: Well, either one is
- 23 24 I
1 I
acceptable to me.
CHAIRMAN HENDRIE: Any preference? Let me Ace*Federaf Reporters, Inc.
25 recommend leaving this in a form which says the rule will
82 1 be published, without -- and keep it general enough so that 2 both these things fall under the umbrella.
3 I think the sort of thing that you could possifuly
--- 4.
5 note there, since it would be true in either case, would be that the referring physician would 6 MR. BERNERO: Addressing the issue. You know, 7 the policy paper is not the forum wherein we ever intend 8 to make the decision. It's addressing the specific issue,
.9 andd:;.his paragraph on page :22 associated with the policy 10 should be speaking and a rule will be published addressing 11 that issue, considering the range of options, words to 12 that effect, without attempting to tip to a final balance.
- l3 14 15 It's the wrong forum.
paragraph?
CHAIRMAN HENDRIE: Would you like to see that 16 COMMISSIONER KENNEDY: The way Bob's talking 17 about it right now, I'd sign off now without seeing it 18 again.
19 MR. BERNERO: The paragraph would be altered so 20 as to state that a rule will be published which addresses 21 misadministration and attendant recording and reporting 22 requirements, considering issues such as whether to report
- 23 24 Ace-Feden,1 Reporters, Inc.
at all, whether to report to referring physicians and whether to report to the patients, but not by any stretch 25 attempting to set up in this forum the decisionmaking.
83 1 COMMISSIONER KENNEDY: As* far as I'm concerned, 2 I don't need to see it again.
3 CHAIRMAN HENDRIE: .Does it sound all right to
- 9 4 you, Peter?
5 COMMISSIONER BRADFORD: Yes.
6 CHAIRMAN HENDRIE: In that case, with the 7 understanding that page 22 will be thus perfected, and any
(
8 other language in the proposed Federal Register statement 9 will be also perfected to go with it, that that be done, 10 maY I ask for a vote of the Commission?
11 (Chorus of ayes.)
12 So ordered.
- 13 14 15 Before you go, and while you're in a voting mood, I recommend that we accept the staff recommendation in the 69 paper on that 16 MR. BERNERO: Clinical procedure.
17 CHAIRMAN HENDRIE: -- clinical procedure.
18 (Chorus of ayes.)
19 So ordered.
20 MR. BERNERO: And you want 70 ba~k with the --
21 CHAIRMAN HENDRIE: You'd better, then, circulate 22 back 70 with this alternate language. I think you see the
- t 23 ,problem: Who can you tell what things to do? And let's 24 1 try to keep in mind reporting requiremei-its and so on and
. Ace-Fedentl Reporters, Inc.
- 25 trY to arrange these however we come out so that it's a
84 1 minimal procedural burden.both on them a nd on us.
COMMISSIONER KENNEDY: Let us not forget that 2
3 the purpose of this exercise is medicine, not reporting.
Can we possibly do that?
4 5
CHAIRMAN HENDRIE: Look, if you're going to
. raise whole new issues at the last minute . .
. 6 (Laughter.)
7 8 Okay, I must say that I found the briefing on 9
a subject that I'm not very familiar .with, and it has a 10 good many twists and turns in it, to be an exceptionally 11 clear-cut one, a very admirable piece of work for which I 12 congratulate all the staff .concerned. It put the issues, 13 r thought, fairly forcefully out in an understandable and 14 simple way. I very much appreciate the quality of your 15 work.
16 MR. CUNNINGHAM: Thank you, Mr. Chairman.
17 CHAIRMAN HENDRIE: Everybody else, I guess, can 18 wander out and have a fine Thursday afternoon, but the 19 Commission has to stay right he.re and carry on its labors 20 through an affirmation session.
21 (Whereupon, at 4:40 p.m., the meeting was 22 adjourned.)
23 24 Ace-Federal Reporters, Inc, 25
__J