ML20148J980

Transcript of 880322 Briefing on Status of Proposed Rulemaking on Basic QA in Radiation Therapy & Related Activities (Public Meeting) in Washington,Dc.Pp 1-54

ML20148J980
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Issue date:	03/22/1988
From:	NRC COMMISSION (OCM)
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REF-10CFR9.7 NUDOCS 8803300445
Download: ML20148J980 (80)

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ORlGl ! AL l

UNITED STATES OF AMERICA l NUCLEAR REGULATORY COMMISSION '

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Title:

Briefing on Status of Proposed Rulemaking on Basic QA in Radiation Therapy and Related Activities (Public Meeting)

Location: Washington, D. C.

Date: March 22, 1988 i

Pages: 1 - 54 l

l Ann Riley & Associates Court Reporters 1625 l Street, N.W., Suite 921 Washington, D.C. 20006 (202) 293-3950 8803300445 080322

.7 PDR

_ -- _ .- -. - - ____ _ D

l 1 D 1 SC LA I MER I

3 4

l l

5 j i

1 6 This is an unofficial transcript of a meeting Of the l l

7 United States Nuclear Regulatory Commission held on 8 3/22/G8 .. In the Commission's office at 1717 H Street, 9 ' N . tJ . , LJa s h i ng t on , D.C. The meeting was open to public l 1

I 10 attendance and observation. This transcript has not been 11 reviewed, corrected, or edited, and it may contain 12 Inaccurscles.

I 13 The transcript is intended solely for general l 14 informational purposes. As provided by 10 CFR 9.10S, it is I 15 not part of +he formal or informal record of docision of the 16 matters discussed. Expressions of opinion in this transcript 17 do not necessarily reflect final determination or beliefs. No 18 pleading or other paper may be fl!ed with the Commission in l

19 any proceeding as the result of or acdressed to any statement 20 or argument contained herein, except as the Commission may 1

21 authorize. l 22 2S i

24 25 I

. I 1 UllITED STATES OF AMERICA 2 IJUCLEAR REGULATORY COMMISSIOli 3 * *

• 4 BRIEFIldG Oli STATUS OF PROPOSED RUL EM A KI!iO 5 ON BASIC QA Ill RADIATIO!J THERAPY AND RELATED ACTIVITIES 6 * *

• 7 PUBLIC MEETIIIG I l

8 * *

• I 1

9 Nuclear Regulatory Commission 10 Room 1130 l

11 1717 H Street, N.U.

12 Washington, D.C.

13 March 23 1988 14 15 The Commission met in open session, pursuant to 16 notice, at 2:04 p.m., the Honorable LANDO U. ZECH, JR.,

17 Chairman of the Commission, presiding.

18 19 Commissioners Present:

20 21 LAllDO W. CECH, Chairman 22 THO11 A S !! . ROBERTS, Commissioner 23 PREDERICK M. B E Rt!T H A L , Commissioner 24 KEllllETH ROGERS, Commissioner 25 K E!Ill E T H M. CARR, Commissioner

2 1

2 Staff and presenters seated at table:

3 4 S. CHILK - SECY 5 S. PETTIJOHil 6 11 . McELROY 7 J. TAYLOR 8 B. M O P.R I S 9 B. BERNERO 10 W. PARLER -

OGC 11 12 Audience Speakers:

13 14 H. THO!!P S Oli l l

15 l 16 17 18 19 20 21 22 23 24 25

4

'3 0

-1 P RO C EE D I NG S.

2 CHAIRMAN ZECH: Good afternoon, ladies and 3 gentlemen. The purpose of this afternoon's briefing is to 4 discuss the rulemaking initiatives underway'for. quality 5 assurance for medical uses of. isotopes.

6 This is an information briefing and no vote is 7 expected. ,

8 Many of you know that the Nuclear Regulatory 9 Commission is proposing to amend its regulations 10 concerning the medical use of by-product material. -

11 The proposed amendments would require medical 12 licensees to implement quality assurance steps that would 13 reduce the chance of misadministrations.

14 The Commission is also considering a mo"e j i

15 comprehensive program for quality assurance in raedical use  !

1 16 and in the standard of care.

17 To discuss these issues, we have with us today 18 representatives from the Office of Nuclear Materials 19 Safety and Safeguards, the Office of Research, and the 9

20 Office for Analysis / Evaluation of Operational Data.

I 21 Before we begin, do any of my fellow  ;

22 Commissioners have any opening' comments to make? l 23 (No response.)

24 CHAIRMAN ZECH: If not, Mr. Taylor, will you 25 begin, please. l

4 1 MR. TAYLOR: Mr. Chairman, I'll begin by 2 introducing the presenters today. On my immediate left is 3 Mr. Norm McElroy from NMSS, Mr. Sam Pettijohn from AEOD; 4 my immediate right, Mr. Billy Morris from research and Bob l

5 Bernero, the Deputy Director of- N!!SS.

6 The basic introduction and discussion will be led l l

7 by Mr. Bernero. Bob.

8 MR. BERNERO: Thank you. Gentlemen, just to put  ;

I 9 this presentation today in some context, I'd like to point 10 out to you that on !! arch 8th you received a comlai s c ion 11 paper which contained an advanced notice of proposed 12 rulemaking regarding training and experience criteria for 13 the medical use of by-products. That is a separate i

l 14 initiative from what we're talking about today, and that l

15 is a Commission directive to get public comment on such 16 criteria.

17 Secondly on March 14th you received a Commission 18 paper on the medical use program. This is a broad plan 19 which grew out of the strategic planning procesa which you 20 have reviewed, and which is consistent with our FY '88, 21 '89 budget and that covers a five-point program for the 22 overall enhancement of the regulatory oversight of medical 23 uses, the by-product material.

24 Neither of these two papers is the subject today, 25 but today's subject is of course related to them and can

5 1 be related to them.

2 They all fit together'in our broad' plan to 3 improve the regulatory oversight of medical.uses of 4 by-product material.

5 As the Chairman said, we're in the midst of a 6 basic QA rule which goes toward.the quality assurance for 7 procedures in radiation therapy and in diagnostic 8 procedures where there's a potential for high dose.

4 9 We also have an advanced notice for a broader 10 more comprehensive QA program that would cover everything 11 that we regulate. '

]

12 Now we're going to talk now as an interim  ;

13 discussion. We don't have the final rule. You'll hear

• 14 shortly that it is in the final review process and you can 1

15 expect to see it at the end of April'. This is an 16 excellent opportunity for discussion of it before it's 17 submitted, and we're going to have first some context in 18 the trends in misadministration that we're aware of 19 recently; we'll have Sam Pettijohn of AEOD present those.

20 Then Billy Morris of Research is going to cover 21 the QA rule itelf, the public comments on it.

22 Norm !!cElroy of NHSS is going to discuss the 23 recent meeting of the Advisory Committee on the 11e di c a l l

l 24 Uses of Isotopes, and lastly I till address briefly the 25 regulatory alternatives that we face now. So let nie turn d

d

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6 1 it over co Sam right now.

2 CHAIRMAN ZECH: All right. Thank you very much.

3 You may proceed.

4 MR. PETTIJOHN: Viewgraph No. 2, please.

5 (Slide.)

6 MR. PETTIJOHN: Mr. Chairman, the viewgraph by 7 the AEOD of the data on misadrinistration covers therapy 8 misadministrations and diagnostic misadministrations that 9 involve greater than 100 microcuries of iodine.

10 The 100 microcuries of iodine limit was set in 11 order to capture a specific type of diagnostic 12 misadministration. Viewgraph No. 3, pleasu.

13 [ Slide.)

14 MR. PETTIJOHN: That AEOD data covers November 15 1980 through 1987 when the rule -- the effective date of 16 the rule was November 1980. There has been a variation 17 over the years in the number of misadministrations 18 reported, both therapy and diagnostic; however, we're not 19 able to attribute anything specifically or to determine 20 any specific trend.

21 The only milestone in this period was in 1986 ,

l 22 when NRC sent a copy of the therapy misadministration l

23 report that AEOD urote out to the licensees.

l 24 We categorized two types of errors for these 25 misadministrations and they had to do with the lack of l

l l

7 1 redundancy and inadequate communications of instructions 2 to personnel. Viewgraph No. 4, please.

3 [ Slide.]

4 MR. PETTIJOHN: Based on the reported data, we 5 calculated an error rate for both -- this is an error' rate 6 per patient for both therapy and - the diagnostic ones that 7 involve iodine, and the error rates are 10 to minus 4, 10 8 to 5 and based on the number of NRC licensed facitilites.

9 Viewgraph No. 5, please.

10 (Slide.)

11 MR. PETTIJOHN: In addition to looking at the 12 error rate, we also looked at other factors that we 13 considered significant in regard to misadministrations.

4 14 And one is we noted that since 1976, there have been'five 15 events in which -- therapy events that involved multiple

. 16 patients -- the number of patients would range f r ora 8 to '

17 about 400, and we also looked at 1984 through 1937 data in 18 regard to abnormal occurrences.

19 1984 through 1987 was selected because the 20 abnormal occurrence reporting was changed in 198' t o.

21 specifically address misadministrations.

22 COMMISSIONER BERNTHAL: Let's see, you said the 23 numbers ranged from what again? To 400?

24 MR. PETTIJOHN: The number of patients In other 25 words these-were single events that i n v o l v e d 2r.u l t i p l e

8 1 patients, and the first was in 1976 at. Riverside that 2 involved the 400 patients, and so the lowest number of 3 patients involved was 8.

4 CO!! MIS S IONER BERNTHAL: But we have not had a 5 reporting requirement before 1980.so we really don't know 6 what happened between '76 and '80, I would assume,. except 7 for the most egregious cases; isn't.that true?

8 MR. PETTIJOHN: Well, except for the fact that 9 these cases were ones that were reported to NRC and 10 that --

11 COMMISSIONER BERNTHAL: Right. Right.

12 MR. TAYLOR: That became known to us.

13 MR. PETTIJOHN: But we don't have the number --

14 we don't have the total --

15 CO!!MISSIONER B E R !! T H A L : Right, but we don't know j 16 how many weren't reported.

17 MR. PETTIJOHN: That's correct.

18 COMMISSIONER BERNTHAL: Okay.

19  !!R . PETTIJOHN: All right.

20 COMMISSIO!!ER CARR: Well, even now we don't have 1

21 the agreement states reporting to us yet, do we?

l 22 MR. P E T T I J O H!! : That's correct. l 23 COMt!I S S IO!!E R ROGERS: Well, can you just say l

24 something about that error rate table so that these l 25 numbers fall into --

the error rate for misadministrations I

-- - .-- -- ,- . ...-...-....--a

9 0

1 table. Those are all small numbers. What period of time 2 does this cover? When, was this one year or --

3 MR. PETTIJOHM: Well, it covers a seven year 4 period from November 1980 through 1987, and it really just 5 takes --

6 COMMISSIONER ROGERS: This is for that whole 7 period since 1980 then?

8 MR. PETTIJOHU: That's correct. In fact, very 9 quickly -- back up to Slide No. 1. There is a slide here 10 that shows the calculation in error rate.

11 COMMISSIONER CARR: If you want to title that 12 properly, it should be "Error Rate for Reported 13 Misadministrations", right?

14 MR. PETTIJOHM: That's correct. Essentially it's 15 the number of patients in a seven year period over the 16 number of events that were reported taking into 17 consideration that this is only for NRC licensecs.

18 COMMISSIONER ROGERS: So this one -- or so that 1

19 involves 400 patients, that must have been prior to 1980, I I

20 then? '

21 MR. PETTIJOHM: It was prior to 1980, that is 22 correct.

I 23 COMMISSIONER ROGERS: Was that a telerherapy --  ;

24 MR. PETTIJOHU: It was a teletherapy 25 misadministration.

10

-c i

?

-1 COMMISSIONER ROGERS: Because all the others aro  !

3 a one-to-one relationship between the number of patients l

3 and the number.

.l 4 MR. PETTIJOHN: Except for one. And in the 1980 5 through 1987 data, there was one ~ misadministration that 6 involved 53 patients and that's why in teletherapy we have 7 83 patients and 31 events. ,

8 COMMISSIONER ROGERS: Yes, that's-right. Okay.  ;

9 Thank you.

10 MR. PETTIJOHN: Okay. You're welcome. Viewgraph  !

11 No. 5, please.

i 12 (Slide.]

13 MR. PETTIJOHN: To complete the Viewgraph No. 5, l

l 14 in regard to abnormal occurrences we looked at'thoso for 15 1980 through 1987. There were 50 misadministrati.ns 16 during that period and 29 of those were reported as 17 abnormal occurrences.

18 We also looked at some evaluations by rae di c a l 19 consultants of adverse effects on patients, and roughly 20 out of the group that were abnormal occurrences, 11 of the  !

1 1 l 21 patients could likely, based on consultant reports, have.

I i

! 22 some adverse health effects. l 1 l 4

23 overall, the misadministrations account.ed for 4

' l 24 about 25 percent of abnormal occurrences reportcd for that l l.

25 period. Viewgraph No. 6, please, i

l 1

. . _ _ _ _ . _ , , . _ _ . _ _ . .-,_,_._,..,...._,,-,..._,,-__1

_. . , . ~ . . .

11 e

1 (Slide.)

2 COMMISSIONER DERNTHAL: How did they determine 3 how somebody could likely suffer adverse health effects?

4 MR. PETTIJOHN: Well, in the cases involving ~~

5 these cases involving iodine, there are cases where people

• 6 got several thousand rads dose to the_ thyroid, and thu 7 reporting requirements for misadministrations required '

8 licensees to indicate an estimate of health effects on the 9 patient, and these are based on the fact that there's a 10 probability the patient would be hypothyroid --

the I i 11 patient's thyroid would be ablated and thereforc that 12 being the health effect.

s 13 In other cases where the medical consultant did a ,

14 more in-depth study, they based it mostly'on similar casen '

15 in which patients had received light doses of radiation  :

}

16 and then looked at what the outcome was for those 17 patients, i

18 COMMISSIONER DERNTHAL: Well, I don't know what

]

19 the threshold might be, and somebody here must know, for i

j 20 physical effects to the thyroid which may be a different 21 thing than adverse health effects. I do know that roughly i

22 speaking for whole-body dosee, I believe around 20 R you 23 begin to detect -- it's detectable in the -- the effects l

, on the blood. It's somewhere in that nuichborhood; and 4

j ;5 certainly at 50 R, it's easily detectable and one could hs j

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_m., r . , , , , , _ _ . . . . - - . , . _ _ _ . . , . . , , _ _ . _ . _ - .

9 12 1

well define that then as being an adverse health effect.

2 I don't know that the threshold is so tidy in the

,- 3 case of the thyroid, but I'm wondering how you made the l

4 determination. If-it's detectable, then one could arguo 5

that's an adverse health effect, whether or not they end 6

up with nodules or cancer of the thyroid, it seems to me.

7 MR. PETTIJOHN: That's correct. Except the cases 8

again -- well, the consultant and licensees reports were 9

based on a fairly high likelihood, in other words in the 10 case of thyroid. Doses given to patients to ablate 11 thyroids are roughly these same doses so that per petient, I

12 yet in five millicuries of iodine --

13 COMMISSIONER BERNTHAL: Well, that's a huge dose 14 i

and therefore my point that that's a very high threshold i 15 I to be using to make the determination for adverse health  !

F 16 effects it seems to me --

1 I would tend to choose, and we 11 17 certainly elsewhere in our regulatory actitivities tend to 18 choose, levels at which -- well, let's see. What was 19 the I'm trying to remember the context, this came up a 20 i

long time ago, but we certainly tend to view clear health i 21 effects threshold for whole body dose as being that point I 22 at which it's a detectable effect on the blood without 23 reaching the question over the long term anything truly 24 nasty is going to happen.

i I

• ) $ MD D t? ?? { T A f t " . * -. *

• 13 1 effects versus --

2 COMMISSIONER BERNTHAL: Exactly. So it seems to 3 me you're not using quite, I don't know whether you or who 4 decided, but it seems to me the threshold being used here 5 does not really comport with the threshold that we're 6 using elsewhere to determine adverse health effects.

7 But I just wanted to make that point. Let's go 8 ahead.

9 MR. PETTIJOHN: Okay. In summary, the 10 conclusions, in fact the error rate as we saw was very 11 low; however, we thought that that notwithstanding that 12 misadministrations are potentially injurious to patients, l

13 that there are this potential for -- or there is a l 14 potential for events that involve multiple patients and we l 15 also noted that a substantial number of misadministrations 16 are reported as abnormal occurrences.

17 That concludes the AEOD presentation. l l

18 CHAIRMAN ZECH: All right. Thank you very much. l 19 MR. TAYLOR:  !!r . Morris.

20 COMMISSIONER BERNTHAL: Let me ask one other 21 question before we get off the AEOD tabulations here of 22 data, and I understand that that's essentially what you 23 do.

24 t1R . PETTIJOHN: Correct.

25 C OMl!I S S ION E R BERNTHAL: You also indicate on the

14-5 I

1 last point that misadministration Aos were 25 percent of~

2 ~ the ~ total. Is that really representative of the trend in 3 the last -- in the more recent past? It was my impression 4- that it was pressing on and up during the times --

5 MR. PETTIJOHN: Well, this i s'up' through 1987, in 6 other words 1984 through 1987 data on the 7 '

misadministrations as well as the abnormal occurrence 8 reports for that period.

9 Prior to 1984, the abnormal occurrence reporting l 10 did not specifically address the types of events that >

11 occurred in misadministrations, so you know I'd say if you '

12 look at '85 through '87 it looks about the same.  !

13 COMMISSIONER BERUTHAL: '86 and '87, though, the 14 numbers that I have been given seem to indicate more like 15 45 percent.

16 MR. PETTIJOHN: If you take the --

well, then the i

17 earlier years and numbers are lower than they are in the  !

l 18 latter.

19 COMMISSIONER DERNTHAL: And granted, there has a

20 been more attention focused on this in recent Lines. '86

)

21 and '87, that's a little bit reminiscent of fitness for 22 duty programs, there's no problem until you start looking.

1 i 23 and then you find some.

24 COMMISSIONER CARR: Well, I think it's shaky to 25 draw any conclusions on these numbers if you don't have

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1 all the. reports in, and if we're not getting reports from 2 the agreement states, and we haven't gotten reports since 3 '74 to '80 from anybody, why, I'm not:sure our database is 4 any good. Having said that, let's proceed. i 5 COMMISSIONER.BERNTHAL: Tha t 's _ my- concern . I 6 agree.

7 CHAIRMAN ZECH: Let's proceed.  !

3 MR. TAYLOR: It's built on the NRC database.

9 COMMISSIONER.BERNTHAL: Yes. Yes.  ;

10 CHAIRMAN ZECH: Let's proceed.

11 MR. MORRIS: The purpose of this part of the  ;

12 presentation is to provide you.first the status report on 13 the development of the final rule on basic quality 14 assurance in radiation therapy, and then a much n. ore brief 15 discussion of the advance notice of proposed rulemaking on 16 comprehensive quality assurance.

17 The objective of this rulemaking is to codify the 18 regulations' basic quality assurance requirements that 19 would reduce misadministrations due to human errors, such 20 as those just described in Mr. Pettijohn's presentation.

21 The proposed rule on basic QA was published last 22 October 2nd for a 60 day comment period ending on December 23 the 1st.

24 (Slide.)

25 MR. MORRIS: When the comment period ended, the

16 1 Office of Research assumed the lead responsibility for the 2 rulemaking from NMSS. l 3 Mr. Anthony Tse of our office was assigned the 4 task to be the task leader, and in this process, he  !

5 assumed the efforts --

he had the benefits of the efforts  !

6 of Mr. McElroy, who is over here, from flMSS; Mr. McElroy l

7 has continued to assist Mr. Tse and us in the Office of 8 Research in this project.

9 Mr. Tse also has had the benefit of assistance i

10 from expert consultants in the field of radiation therapy  !

I 11 and has visited a number of hospitals to get a first-hand '

12 impression of how the rule can be put into practice.  !!e x t J

13 slide, please.

14 (Slide.]

15 MR. MORRIS: This time ue have analyzed the 16 public comments and have revised the rule according to the 17 information we gained from those comments, and we have 18 developed a regulatory analysis, and we've sent these 19 documents out for division review both to headquarters and 20 to the regions.

21 Based on comments from that review, we nave 22 revised the package again and I've just sent the rule out 23 for office comments and concurrence. We expect office 24 comments by April the 1st and it's our objective to 25 revolve those comments, achieve office concurrences, and

, 17 1 have a package that EDO can concure in to send to the 2 Commission by the target date of the end of April. And 3 that was the date that we had been directed to have this 4 prepared, and we're on schedule and expect to meet that 5 schedule. Next slide, please.

6 (Slide.]

7 MR. tiORRIS: We received 69 comment letters on 8 the rule. They came from a variety of sources: 41 from 9 hospitals, 6 from private physicians, 7 from professional 10 associations, 5 from state and regulatory agencies, 2 from 11 an instrumentation manufacturer, and 8 from individuals.

12  !!e x t slide, p: ease.

13 (Slide.)

14 MR. MORRIS: The degree of support for the 15 rulemaking varies: 25 percent of those responding 16 supported the rule. Those included the Commission on 17 Radiation Therapy of the American College of Radiology, 18 and the College of American Pathologists.

19 20 percent opposed the rule, in general terms.

20 Those included the American College of Radiology, and the 21 Society of Nuclear Medicine.

22 C O Mt!I S S I O ll E R ROBERTS: Pardon me. Is the 23 Commission on Radiation Therapy of the American College of 24 Radiology a subset of the American College of T: a d i o l o g y ?

25 MR. 110R R I S : That is correct, yes.

. 1 18.

1 COMMISSIONER ROBERTS: All right.

2 MR. MORRIS: Of the other respondents, 55 percent 3 had specific suggestions for changes to theLrule. Some of 4 the representatives in.that category. included the Americ?.n 5 Association of Physicists in Medicine, the American 6 College of Medical Physics, and the National Council on 7 Radiation Protection. Next slide, please.

8 (Slide.)

9 MR. MORRIS: Just to give_you some perspective of 10 the nature of comments we received --

11 COMMISSIONER BERNTHAL: Dill, excuse me.

12 Commissioner Roberts raises an interesting point that I 13 think needs to be stressed.

14 MR. MORRIS: I'm sorry. I thought we got the 15 answer. Let's go back to the previous slide.

16 (Slide.)

17 COMMISSIONER BERNTHAL: I just wanted to verify 18 that apparently the College of Radiology, I don't know 19 whether it works on a recommendation system or not, but 20 presumably they were well aware of the views and comments 21 of the Commission on Radiation Therapy and yet they chose 22 to take the opposite point of view; is that true?

23 MR. McELROY: These two organizations, the 24 American College of Radiology and its Commission on 25 Radiation Therapy, may be speaking from different 1

I

, 19 1 perspectives in the desire to.further quality assurance.

2 The commission -- its Commission on Radiation Thurapy is 3 likely to support this endeavor. The Board of Directors

-4 of the American College of Radiology may be responding to 5 different concerns of greater magnitude.

6 COMMISSIONER ~ B E R !! T H A L : Well, that seems clear, 7 but can you be a little more specific, perhaps?

8 MR. McELROY: I'd prefer not without reviewing 9 those comment. letters again.

10 MR. MORRIS: I can point out at least one 11 difference between the two. The Commission on Radiation 12 Therapy are essentially oncologists.

13 COMMISSIO!!ER ROBERTS: Is what?

14 MR. MORRIS: Oncologist. Those are physicians 15 who treat cancer. The American College of Radiology 16 includes physicists as well physicians, so they do have a 17 slightly different perspective, but it's very difficult --

18 it would be difficult for us to tell you more than that.

19 That just tells you something different about the make-ups 20 of --

21 CO!!MI S S IOllER BER!! THAL:  !!edical physicists or --

22 MR. MORRIS: I think they're physicists.

23 C O ti M I S S I O!! E R BER!! THAL: Did you say physicists?

24 MR. MORRIS: Medical physicists and physicians.

25 C O Mt!I S S I O !!E R BERNTHAL: Okay. Okay.

'~

'30.

1 MR. MORRIS: Go on-to the next' slide now, Joy.

2 (Slide.]

3 MR. MORRIS: .We've generalized some of those- '

4 comments that we've received just to'give you an idea of 5 the kinds of comments that we are seeing where there is 6 opposition.

7 We have an assertion, for example, that because

, 8 the probability of misadministrations is already very low,

9. the rule is not needed; others said that additional 4

i 10 regulation would not reduce the frequency of human 11 errors, and there was also a concern that additional 1

12 requirements would increase the overall costs of radiation '

13 therapy. l 14 COMMISSIO!!ER ROBERTS: Does the~ Staff take a 15 position on that third one?

16 MR. MORRIS: On the third one, what we have done 17 is taken advantage of the information provided by those  !

I 18 commentors who gave us specific comments, and !!r . Tse's l 19 advice from his consultants and his visits to the  :

20 hospitals, and have found ways where we believe we can 21 reduce the burden from the rule without having significant 22 impact on its effectiveness in reducing the frequency of 20 human error in misadministrations, s

24 So our position is simply that where we have been i 25 able to discover that there are parts of the originally 2

g

21 1 proposed rule which we can eliminate without eliminating 2 the benefit of the rule, we've done so. And we've done i

i 3 also a cost -- we've made some estimates of the costs and 4 I'll go on to some of those here later and show you tvhat t

5 we believe those costs may be like just to give us all of 6 us a chance to judge for ourselves how much the burden l

7 might be, i

, 8 MR. BERNERO: Mr. Roberts, please keep in mind  ;

9 this is still a fluid situation, i

10 COMMISSICNER ROBERTS: I understand.

11 MR. BERNERO: There isn't a final Staff position l

12 yet. 1 13 COMMISSIONER ROBERTS: I understand.

14 COMMISSIONER CARR: What was the substance of ths l

15 argument for Bullet 23 16 MR. MORRIS: Ic was the idea that by providing l

17 simple redundancy checks, we would'not be able to get at i i

l 18 the issue of human error and reduce it significantly. i a

19 In that regard, as I will be showing you i na 3

20 moment, Mr. Pettijohn and Mr. Tse have done an analysis in I I

i 21 which they have analyzed those events that have occurred 22 and have estimated that maybe 80 percent of the reported 23 events, that's all they've had to operate on, might be 24 eliminated by the rule if it were effectively implemented. i 25 That's their judgment at this time, and as Mr. Bernero 4

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i 1

1 said, what I'm telling you today is preliminary. We have 2 judgments by part of the Staff that have not been reviewed

'3 completely, but that's our preliminary estimate. But 4 their concern was it just wouldn't be able to do what we ,

5 wanted to accomplish.

6 COMMISSIONER CARR: The implication is that they 7 wouldn't pay any attention to it anyway?

8 MR. MORRIS: That was part of the comment that we 9 got. If someone were insistent, you know, on doing 10 something wrong, you would do it, and the only question --

11 COMMISSIONER CARR: I would say it's less likely 12 that two would do it wrong than one. I 13 MR. MORRIS: If you're doing a calculation, is it 14 likely that both are going to make the same error, and 15 that would be the basis for the effect of the rule.

16 COMMISSIONER BERNTHAL: Well, without commenting i

17 on the details, and I understand there's concern over the I 18 proposed rule as it sits and there may be elements of it 19 that aren't quite the way they need to be, it just seems 20 to me, while I accept the proposition that you may never 21 reduce the frequency of human errors, that's almost a j

i 22 given. Of course people are going to make mistakes and l 1

j 03 they'll probably continue to make them at roughly the s ain e 24 frequency as they have throughout human history; but the 25 question is, how do you try and minimize the effects of

. . .. .- - - _.. - -- -. a

23 1 those mistakes? And that really is, it seems to me, the 2 purpose of any additional requirements one might place on 3 here, that is really a quality assurance.

4 You aren't going to assure that there aren't 5 mistakes, people will continue to make mistakes; but as 6 somebody here said, if you got two people checking in the 7 simple sense, then the odds are considerably reduced that 8 they'll make the same mistake at the same time.

9 COMMISSIONER ROGERS: We're looking at and 10 analyzing these 69 comments very assiduously, but 69 is a 11 very small number, it seems to me.

12 What's the base of hospitals that might be 13 affected by this that we would expect some response from?

14 41 doesn't look to me like a very large number nationally.

15 MR. McELROY: We have about 250 teletherapy 16 licensees under NRC jurisdiction and there are about. 800 l l

17 nationwide if this were applied as a matter of l

18 compatibilty.

19 I believe we would capture approximately 800 20 hospitals that provide the high level brachy therapy which 21 is implanting a radioactive seed inside the patient, and 22 of course there's overlap in those populations.

23 Moving to nuclear medicine, virtually e.very 24 hospital in the coutry provides iodine therapy for its 25 patient class.

24  !

1 COMMISSIONER ROGERS: 'Well, could you comment on 2 why there seems to be so few responses on this? Is there 3 any feeling about that?

4- 11R . MORRIS: . The only thing I would' comment on, fi 5 if you will remember there were a number of these comments 6 that came from groups and so they --

to some extent they 7 are representing groups of individuals to the extent they 8 can speak for those groups, and'a larger portion of'the f 9 community may be represented and shown by the BEIR number.- '

10 COMMISSIONER ROGERS: Well, are any of these  !

[

11 groups really representing hospital groups? I don't see 12 any that read that way to me particularly.

i 13 MR. !!cELROY: I believe most of the associations f 14 that commented are representing either a particular group

f 15 of physicians or the physicists, and I know two of the

],

16 organizations did form ad hoc comment groups to respond to l l

17 these notices, so the membership perceived that their l 1

18 invidual comments were reflected in those association 19 comments.

20 COMMISSIONER ROGERS: Okay.

l 21 CHAIRMAN ZECH: All right. Let's proceed.

T 22  !!R . !! ORRIS: Next slide, please.

2 23 [ Slide.)

24 MR. 110R RI S

As I mentioned, we are looking at j 25 the rule carefully based on the comments received, and

' 25 1 looking at where we need to modify the rule or think it 2 would be prudent to do so, and we've identified a number 3 of areas where we think some changes are warranted.

4 As I said before, the basis for this is that we 5 think in most of these cases that they would have minimal 6 impact in having diluted the effectiveness of the rulu 7 from the proposed version of our current version, and in 8 one case we would have added the requirement on patient 9 identification and we would have perhaps eliminated one or 10 more of the misadministrations that occurred.

l 11 Let's move to the next slide, please.

12 CHAIRMAN ZECH: Go ahead.

13 (Slide.)

14 MR. MORRIS: Again, I mention that these are i

15 preliminary numbers. We've tried to get some estimates of 16 the benefits and the costs where we could quantify them to 17 the extent the database allows us to do that, and we have l 18 also looked at some of the potential impacts that are l

19 difficult to quantify.

20 Based on that analysis that I spoke of that has 21 been done of the potential impact or effectiveneus of the 22 quality assurance measures, we believe that of the 75 23 misadministrations reported to the URC over the last seven 24 years, about 80 percent of those could have be a averted 25 to effective implementation of the revised ruie, that's a

26 4

1 preliminary estimate. It's subject to some change.

2 If one scales that up to count for all licensees 3 including the NRC licensees and the agreement state 4 licensees, it comes out about to be about 20 5 misadministrations per year that would have been averted.

6 Remember, that's a scaled effect and doesn't 7 account for real misadministrations that have been 8 reported.  ;

9 We evaluated the costs of the rule based on.

10 primarily the cost of the redundant checks of calculations 11 by separate individuals. That's the major contribution of l 12 costs, and another large contribution is the requirement 13 that if parameters in the radiation therapy fall outside 14 the range of the calibration issue, we should recheck 15 that.

16 And when we sum these up, we come a about S1.7 17 million per year as a total estimated cost. What one 18 has --

what we hear from the comments is, that a large 19 number of the commenters believe that most hospitals 20 already f ollow many of' these quality assurance measures.

21 So we believe that the incremental costs from the rule 22 would be to something less than the 1.7 million per year:

23 we've just taken it as an assumption, and that's all it is 24 now, it's an assumption that about 80 percent et the 25 hospitals already are implementing such measurcs so that

c

, 27

, 1 the incremental costs might be $400,000 a' year.

2 COMMISSIO!!ER BERUTHAL:  !!ow again your analysis  ;

i i

3 is based on those incidents reported, and we have 4

I i 4 established that we do not have the agreement status i n H i

l 5 that database; is that correct?-

4 i 6 MR. MORRIS: Yes.

7 MR. PETTIJOHN: That's correct.

l 8 COMMISSIOt!ER BERNTHAL: That's a pretty-big l

)

9 chunk, it seems to me.

10 MR. MORRIS: But, remember, we scaled .:p. the 11 reported number based on the ratio of the number of 12 agreement states and non-agreement states to the number of 13 non-agreement states, a

j 14 -COMMISSIONER B ER!!TH AL : Number of states or i

15 number of hospitals and institutions in each?

16 MR. MORRIS: It.would be the reports from l

{ 17 hospitals and institutions and states of different sorts:

1 l

j 18 First, the non-agreement states, and the a g r e e:ae n t states. )

< 19 COMMISSIONER BERNTHAL: Okay. So the scaling was 1

f; 20 based on the --

l l 21 MR. MORRIS:

It's just a ratio.

a 3

22 COMMISSIONER BERNTHAL: Okay. l 1 23 MR. MORRIS: We were looking for some figure of i

24 merit, and it's a qualified figure, as you understand, and I

j t

25 we found that if we assume that S400,000 costs to all n

- - - . , , - -,. , r,- - . _ ,m n.,-.

3 28 1 licensees and that 20 misadministrations were averted, it 2 would be about $20,000 per misadministration averted.

3 That would be a figure of merit that one could use to look 4 at the effactiveness of the --

the cost effectiveness of 5 the rule.

6 One thing that we have also learned from the 7 comments and from the comments of the advisory group to 8 NMSS, is that there may be other impacts that flou from 9 this burden of effort, and those would be things like the 10 following: Less flexibility in medical practice, 11 difficulty in ensuring timely availability of quality 12 personnel, that is to do the second checks If you're a 13 small hospital, it might be difficult to find someone to 14 make that overcheck.

15 Because hospitals are not able to simply pass on 16 their expenses to their patients becaure of the neu 17 federal guidelines, the cost increment from this kind of 1 1

18 regulation may result in a re-allocation of rescurces in 19 quality assurance in radiation therapy which may not 20 optimize the effectiveness of overall medical care. l l

21 tiow when you look at the total cost of the I i

22 industry and think of the total number of licensees )

I 23 involved, the cost per licensee doesn't come to very large l

)

24 numbers; it's i i. the order of a few thousands pt c year, 25 say. So that's another perspective that we will -- one l l

1

4 29 1 needs to keep in mind to evaluate all of this. lie're 2 trying to factor all of this together in looking at our 3 regulatory analysis in giving you our analysis.

4 CHAIRMAll ZECH: All right. Fine. Let's go on.

5 MR. MORRIS: I think I just will spend a brief 6 moment to mention to you -- next slide, please --

that we 7 do have an advanced notice of proposed rulemaking on 8 comprehensive quality accurance, and this was issued at 9 the same time as the basic quality assurance rule, but the 10 comment period ended a month later to give more time for 11 commenters to think about this much more broad set of 12 questions, questions related to the adoption of existing 13 industry standards, training, and certification, and 14 accreditation of Staff involvmont in administration of 15 radiation therapy, the need for limitations on case load i

16 of the Staff members, verification of computer software 17 and so forth.

l 18 (Slide.]

19 MR. MORRIS: For that particular rulemaking, we 20 got 20 letters of comment, and 15 percent stated that i

21 certain actions might be needed, others answered questicas 22 raised in the notice, others opposed any additienal rules 23 that !!R C might consider promulgating.

24 According to the original schedule given t. o us 1y 25 the Commission, our schedule would be to e v a l u n t .: those 1

6 30 l l

1 comments and draft the proposed rule for Commission revieu 2 in September. The final slide, Joy.

3 (Slide.)

4 MR. MORRIS: Just to give you an impression of 5 the kinds of comments we received here, not greatly 6 different from the ones that we received on the basic QA 7 rule. The current QA training and certification are 8 adequate, additional NRC regulations will not further 9 improve the situation, and hospital QA programs are 10 reviewed and evaluated by the Joint Commission on 11 Accreditation of Health Care Organizations, are some of 12 the kinds of comments that we've received.

13 MR. TAYLOR: Norm McElroy.

14 CHAIRMAN ZECH: You may proceed. Thank you.

15 MR. McELROY: In accordance with your original 16 Staff requirements memorandum, the Staff convened a 17 meeting' of the Advisory Committee on the Medical Use of 18 Isotopes in January to discuss this topic.

19 We remind you that the committee members 20 collectively represent a wide-range of experience in the 21 medical use of all kinds of radiation and not just l

22 by-product material.

{

23 And the committee members are reminded that they I

24 are not there to represent a particular faction when they l

1 25 provide counsel to the NRC. l

i 31 i

1 The committee members discussed the subject 2 rulemaking. :They also' heard presentations from the 3 Society of Nuclear Medicine, the American College of 4 Radiology, and some physicians working at a variety of i

5 hospitals throughout the country.

6 There were four general comments made by the 7 Committee: First, they believe that there's already good  ;

8 support for quality assurance, and they believe this is 9 best demonstrated by the very low misadministration rate 10 of by-product material particularly when compared to a 11 misadministration rate of non-radioactive drugs of about 12 15 percent.  ;

1 13 COMMISSIOUER ROBERTS: How much?  ;

14 MR. McELROY: 15 percent. If you go into a j i

15 hospital, there is about one chance in six that you will 16 be given an incorrect pill.

17 COMMISSIONER BERNTHAL: I think we ought to move 18 us out of this room to another agency in town.

19 i COMMISSIONER CARR: I believe one doctor says i 1

20 about one in three in her testimony. '

21 MR. McELROY: It depends on whose study you read, 22 the values ranges from about 3 percent to 20 percent.

23 MR. BERMERO: A word of caution about t h .9 24 standards of adverse health effects or simply 25 misadministration, you know the wrong pill; the wronc pill

t .

in

-~

1 might not hurt you.

2 COMMISSIONER CARR: But it's still wrong.

3 MR. TAYLOR: If you're lucky.

4 MR. McELROY: If you're lucky. It was pointed 5 out that quality assurance' procedures must vary throughout 6 hospitals simply because they serve different patient 7 loads. There are military hospitals under our 8 jurisdiction, Veterans hospitals, there are hospitals in 9 affluent suburban communities, university research 10 hospitals, and county or city general hospitals, all 11 potentially subject to this regulation.

12 COMMISSIONER BERNTHAL: Let me turn this around 13 just a moment. Why would one believe that if the error 14 rate and misadministrations rate is 30 percent, pick your 15 number, in general administration of drugs, that it really 16 is as low, and we understand that there is some problems 17 with the numbers we're getting, but are the procedures o 18 that much better for us or for things involving nuclear 19 materials, or does it lead one to worry a bit more about 20 the numbers?

l 21 MR. McELROY: Part of that much lower rate stems l I

i 22 from the nature of the business, when you're doing a j i

l 23 diagnostic nuclear medicine study or radiation therapy l 24 process, it's a very labor and capital equipment intensive

]

1 25 process and you don't want to do it for the wrong patient

4 j 33 1 or provide the wrong process.

2 MR. !!ORRI S : And of course we take enforcement 3 when we don't -- we find out that they haven't. reported, 4 that's --

5 MR. McELROY: Secondly, already for the 6 diagnostic. dosages of radiopharmaceuticals, we already 7 apply safety measures virtually equivalent to those that 8 are applied to narcotics and dangerous drugs that are 9 occasionally used in hospitals.

10 The Committee felt that the QA' program that we 11 impose should be compatible with the overall hospital 12 quality assurance program. There are lots of quality 13 assurance programs in hospitals, and there was some ,

14 feeling that this was not developed in close coordina* ion i 15 with those other programs.

l 16 There's the Joint Commission on Accreditation of 17 Health Care organizations that you've heard of, there is 18 also an organization called Peer Review Organizations that 19 examines quality of care for cases that are being 20 reimbursed by the Federal Government under Medicare.

1 21 And there is also an organization called 22 Radiologic Physics Center that does quality assurance for 23 hospitals that are participating in 17IH clinical trials.

24 Finally the Committe felt there are less l l

25 prescriptive ways such as. participating in standards '

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

I i 34 1 development or assisting in the development of training 2 programs.

3 CHAIR!!AN ZECH: Who are the members of the 4 Advisory Committee?

S' MR. McELROY: We have HMSS -- back up one. As 6 you can see here, there are a variety of physicians 7 representing several specialties, they are in different 8 clinical environments and they come from all over the 9 country.

10 CHAIRMAN ZECH: These are the advisors to the 11 NRC?

12 MR. McELROY: This is our Advisory Committee that 13 has assisted us on policy and technical matters for 14 several years.

15 CHAIRMAli ZECH: All right. Thank you.

16 1f R . McELROY: Okay. Returning-to Page 17, 17 specifically commenting on the rules that were circulated 18 for their review, the Committee was unanimous in stating 19 that they do not feel the rulemaking would significantly 20 or measurably reduce the misadministration rate.

21 C H A I Rt!A li ZECH: Well, uhat would?- Did they hav._

22 any other alternatives?

23 11R . McELROY: They perceived that mistakes that 24 are made to cause misadministrations are' human crror 25 mistakes and --

. __=

4 35 1 CHAIRMAN ZECH: No way to improve, is that what 2 they're saying?

3 MR. McELROY: They were able to offer no 4 alternative for improvement.

5 CHAIRMAN ZECH: Okay. Not very helpful, it 6 sounds to me.

7 MR. McELROY: The mistakes that are made are not 8 peculiar to the medical setting, they're the human 9 mistakes that all of us'make.

10 CHAIRMAN ~ZECH: Well, they make them too, and 11 ordinarily people who make mistakes try to improve, try to 12 make fewer mistakes. It's kind of surprising to me that 13 this group doesn't think -- that they don't like the rule, 14 Then I would hope that they would think of some 15 alternative. How can they improve?

16 What they're saying, I think, if I hear you 17 right, is that they're doing about as good as they can do 18 and can't do any better.

19 MR. McELROY: They would like to improve, I 20 assure you, because it costs them money and-loss of base 21 when they --

22 CHAIRMAN ZECH: Well, what -- they don't have any 23 alternatives, though.

24 MR. McELROY: They have not posed alternatives.

25 CHAIRMAN ZECH: All right. Let's go on.

6 36 1 MR. THOMPSON: Mr. Chairman, I do think it would 2 be -- this is'Hugh Thompson from HMSS --

I think it would 3 be fair to say at least in my memory of the meeting there 4 that they supported the industry's effort to improve 5 quality assurance activities as opposed to necessarily NRC

. 6 activity.

7 I do think that they certainly supported the 8 quality assurance activities and thought that most of the 9 current industry approaches were aimed at that direction.

10 I think we've all had experience, it's the bottom 1 11 percent of the 2 percent often that our regulations have 12 addressed as opposed to the activities the industry will 13 do voluntarily.

14 CHAIRMAN ZECH: Well, does industry have an 15 active program to improve?

16 MR. THOMPSON: The association, I guess --

what 17 is it, the Society of Nuclear Medicine and I think this 18 Joint Committee on Accreditation have recently established 19 some efforts and activities to improve the quality 20 assurances in the area even related to the nuclear 21 programs also.

22 So I think that's one of the areas that we're 23 evaluating as we consider the various alternatives now 24 before the Staff.

25 CHAIRMAN ZECH: Okay. Thank you.

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

i - 37 1 COMMISSIONER BERNTHAL: I guess the thing that 2 surprises me a little bit is that you're telling us that 3 the public comment, which included a number of very 4 distinguished groups and individuals, I suppose,-that in 5 the public comment on the proposed rule, 25 percent 6 supported it, 55 percent suggested changes which means I 1

7 gather that they did not oppose issuing a rule, and only l 8 20 percent opposed.

9 Now I would think that our Advisory group would 10 have taken this under advisement, so to speak, and yet 11 you're saying that even with this public comment, they 12 side with the 20 percent which feel that there should be 13 no rule. Is that what you're saying?

14 MR. McELROY: I would recharacterize that simply 15 to state that the 55 percent that just recommended 16 changes, may have seen it coming and may not have ,

I 17 perceived the possibility that there would be no 18 rulemaking, so they wanted it to be as technically valid 1

19 as possible. l l

l 20 I'm not certain that you can read into that, that 21 they supported this effort from this organization.

22 MR. TAYLOR: Norm, don't you get on to the 23 recommendations on the subsequent slide that comes -- some 24 of these questions may be answered.

25 CHAIRMAN ZECH: Okay. Let's go on.

l

s 38 1 MR. McELROY: We have some Advisory C om:ai t t e e 2 recommendations --

3 MR. BERNERO: Excuse me. Just to clarify one 4 point, Norm. I don't think the analysis of comments was 5 fully developed and available for the January meeting, and 6 I think that was part of your question, Mr. Bernthal.

7 COMMISSIONER BERNTHAL: I see. Okay. Thank you.

8 MR. McELROY: Still on-Page 17, there was concern 9 expressed that in fact this rulemaking could precipitate a 10 decline in the quality of patient care available '

11 throughout the hospital simply because it might divert 12 resources from other areas that present greater risk to 13 the patient; for example, in anesthesia, surgery, or the 14 problem of what is referred to as nosocomial infections; 15 an infection that a patient gets that he didn't have when 16 he was admitted to the hospital.

17 There is about a 3 percent chance that he'll pick 18 up a disease in the hospital that he didn't have when he 1 l

19 walked in the front door.

20 COMMISSIONER BERNTHAL: Don't you think that that 21 80 percent, though, if they believe that this could result 22 in a decline in patient care would have. opposed the rule?

23 I guess I find it incredible that the Advisory 24 Group thinks that there could be a reduction in~the 25 quality of patient care and yet those distinguished panele l

l

. i

, 39 1 that reported, or rather commented on the proposed rule 2 certainly did not reach such a conclusion apparently, 3 because I would have thought their medical principles 4 would have required-them to oppose it under those 5 circumstances.if they thought there was a significant 6 probability of that occurring.

7 MR. McELROY: The organizations that commented, I 8 think are very sensitive to the role that NRC'has played 9 in this field in the last few years. I think they i 10 probably perceived that there was going to be a rulemaking 11 and they simply wanted to be sure it was as good as i

12 possible.

13 MR. TAYLOR: Commissioner, we're going to 14 recommend that you meet with this Advisory Group, and then i

l 15 some of these questions may be able to be answered 16 directly by the participants, but we're acting as the 17 messenger in this sense.

18 MR. BERNERO: You can tell he's enthusiastic, 19 too.

I 20 MR. McELROY: There of course,was concern l 21 regarding the cost of the rulemaking, and finally on Page 22 17, there are not the individuals in.the pipeline who are 23 needed to perform these quality assurance checks. There

]

24 is a shortage of health care personnel in this field.

25 (Slide.]

i

40 1 MR. McELROY: Turning to Page 18, the Advisory 2 Committee did make some general recommendations. i 3 First of all, concerning regulations, if the 4 Commission believes it necessary to proceed with 5 rulemaking, the Advisory Committee felt that perhaps 6 rather than issuing a prescriptive rulemaking as we have ,

1 7 currently on our table, that we develop a performance I i

8 based regulation that would provide for more flexibility l 9 and allow each quality assurance program to be site 10 specific; we could inspect against that custom OA program 1

11 as well as against strong regulations.

12 There should be more adoption of voluntary 13 standards because they are on-hand and they have peer 14 reviewed; and finally, any rulemaking should be tested ,

15 with a pilot study to examine its workability in the 16 clinic setting, but --

17 COMMISSIONER CARR: I think that's a very l t

i 18 important point. I was impressed with Dr. Marcus' try at i

19 implementing the rule and she said .the only thing she l 20 could come out with was signing her name to the 21 prescription that didn't interfare with what she was 22 trying to do.

I 23 So I would say that's a very important part of l 24 whatever we decide to do is to do pilot project.

25 MR. McELROY: The Committee did caution that such l

.. 41 1 a-pilot project-would not likely demonstrate the 2 effectiveness of a rulemaking because of the already low f

3 misadministration rate.

4 COMMISSIONER CARR: But you could -- it.would 5 determine the effectiveness of what you tried to get-6 people to do. It might not proves that we have less 7 misadministrations, but it prove whether the rule was 8 workable or unworkable. That's what I would like to see 9 in the pilot project.

10 MR. McELROY: It would certainly examine the 11 workability of the rulemaking. The Advisory Committee 12 recommended that we continue our interactions with the i

13 professional organizations, and that we provide additional 14 training and educational support to licensees and 15 organizations, and that we expand methods of communicating <

16 with licensees.  ;

i 17 All three of these functions arefaiready in placo l 1

18 and will be expanded in the future by the llM S S Graff.

19 That brings us to a variety of regulatory alternatives on 20 Page 19 that Mr. Bernero will address.

21 MR. BERNERO: Let me wrap this up .ather briefly.

22 Would you put up that Page 19.

1 23 (Slide.) l 24 MR. BERNERO: We, the NRC, we're moving to l 25 improvement in quality assurance, and really there are l

E 42 1

1 three alternatives on the table'before us: The first is 2 the revision of the basic QA rule as Billy Morris spoke of 3 it, you know, modified, intelligently changed, 4 promulgating that as a final rule.

5 The second alternative would recognize or give 6 recognition to the possibility that impact on other 7 medicine or lack of resources, competition of resources, 8 is a difficulty and one would want greater flexibility; an )

l 9 alternative, too, basically is to shift gears a bit and 10 make a performance oriented rule putting the prescriptive l i

11 character of it into something like a reg guide, and 12 thereby have the flexibility -- the majority of 13 institutions would be expected to adopt the full scale  ;

I 14 thing, but the lesser institutions, the ones under some 15 constraint or other, could adapt and have a program 16 appropriate to their situation.

17 The third alternative is to step back altogether 18 and suspend rulemaking and rely instead on the supporting 19 and even the promoting of the industry efforts that Hugh 20 Thompson spoke of; the quality assurance initiatives that 21 the participants have generated themselves.

22 Right now, the Office of Research has just this 23 week circulated a draft final paper -- Commission paper 24 for Staff review and consensus development. And it covers 25 Alternative One and discusses Alternative Two.

s e 43 6 5 1 You can expect'_that at the end of April, we'll 2 come down here giving you the opportunity and the 3 arguments to consider fairly at least the first 4 alternative, the revised rule for promulgation finally, 5 and some variation of one or both of the other 6 alternatives, you can expect that.

7 We would recommend that you arrange to meet with 8 the Advisory Committee and other experts as well, either 9 in advance of or concurrently with the submission of'that 10 paper.

11 As we said, we expect in our schedule to submit 12 it by the end of April, and we would happily cooperate 13 with scheduling such a meeting.

14 CHAIRMAN ZECH: All right.

15 MR. TAYLOR: That concludes our presentation, 16 sir.

17 CHAIRMAN ZECH: All right. Thank you very m t. c h .

18 Any questions, my fellow Commissioners? Commissioner 19 Roberts?

20 COMMISSIONER ROBERTS: No.

21 CHAIRMAN ZECH: Commissioner Bernthal?

22 COMMISSIONER BERNTHAL: Well, I what you're 23 saying, Bob, and I'm certainly receptive to a somewhat 24 less prescriptive type of rule. I guess the question that 25 follows that, however, and we've been been down this path i

l

, 44

-1 once or twice before, most notably, I guess, and most  !

i l

2 recently with the fitness for duty policy statement and 3 ultimately it appears we're moving toward rulemaking 4 there.

5 But the question.then that comes to mind, I have-l 6 to address toward the end of the table there and ask the 7 general counsel, if we did promulgate the kind of broad l

8 performance based quality assurance rule that Mr. Bernero 9 has suggested, could that or would that in your judgment 10 potentially offer all of the enforcement capability and j l

11 authority that the Commission would be likely to find even l 12 under a more prescriptive rulemaking?

1 13 MR. PARLER: Well, I think the answer to that is l 1

14 fairly obvious, if I may say so. With respect, if you 15 have a prescriptive rule that offers more immediate 16 enforcement opportunities than a less prescriptive rule --

17 I'm kind of like surprised to find that we're tal. king 18 about a prescriptive rule here because I thought that the 19 policy that the Commission or at least prior Commissions 20 generally adopted, was to stay away from prescriptive 21 rules if not absolutely needed.

22 However, in response to your question, I can tell i

23 you that a performance standard based rule would be better 24 for enforcement purposes than no rule at all bect.ase under l l

25 a policy statement, you first have to find something that I l

l l

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

-s 45 1 is bad and issue the order. You don't have anything to 2 cite, such as a violation of a regulation.

3 And, of course, only one agency.that I know of is 4 responsible for assuring that actions that are needed to 5 protect the public health and safety in this area are.  ;

6 taken, and that's this Agency and the Agreement. States who 1

7 have been given the authority in this area, and not any of I l

8 these other organizations, whose views I'm sure are very )

9 important and whose views should be respected.

l 1

10 But only this Agency has the regulatory authority 11 that serves well as a trustee for the American people that

'l 12 undergo these treatments.

13 COMMISSIO!!ER B E RllT H A L : Well, clearly a policy I 14 statement does not give us the authority, but I gather 15 then there would be a difference between a prescriptive 16 rule and a qualitative rule.

17 Let me ask this question: If you had a l

18 performance based rule and there is a misadministration, 19 some sort of clear breach of the procedures -- if i 20 something happens, whether or not there is a clear breach 21 of procedures, there's a serious misadministration, is 22 that in and of itself evidence sufficient to indicate then 23 that they have violated a performance based broadly worded 24 rule?

25 11R . PARLER: Probably, but we'd have to look at

o s 46 1 the specifics. Presumably if there's a performance based 2 rule --

and Mr. Taylor, of course, is the expert here --

3 that would be a program that we would look at.and would 4 approve that would flesh out the performance based ' rule.

5 The performance based rule would give us the 6 entree for the enforcement action. It would'not be just a 7 performance based rule standing alone, I wouldn't think.

8 MR. TAYLOR: Sir, I might say, as a an example, 9 verifications and signatures of verification -- if you had 10 are performance based rule and it drew up procedure's that 11 would impose that within their own hospital, and they had 12 a misadministration, and we went in and found that they 3 13 hadn't followed their own rules --

14 COMMISSIONER BERNTHAL: Right.

15 MR. TAYLOR: -- then we'd have a sufficient 16 bridge to take enforcement. He didn't even follow the u

j 17 rules that you thought were necessary. l 18 COMMISSIONER BERNTHAL: Right. l 19 MR. PARLER: And I agree with that, sir.

20 MR. TAYLOR: We do that.

21 COMMISSIONER BERNTHAL: Okay. Thank you.

22 CHAIRMAN ZECH: Commissioner Carr?

23 COMMISSIONER CARR: Should we go with Alternative 24 Two instead of Alternative One in your fleshed-out piece 25 of paper, what's the time delay in getting Two out in lieu I

,- 47 1 of One?

2 MR. BERNERO: I really don't think it would be a 3 very significant time delay. In fact we've discussed that 4 with the Office of Research a little bit because 5 essentially the material is at hand, it's basically 6 shifting it, converting it. I don't think anyone has 7 identified a specific time.

8 COMMISSIONER CARR: We wouldn't have to have 9 another comment period?

10 MR. BERNERO: We did mention the possibility that '

11 General Counsel might call for a republication for 12 comment, at lest for a short time.

13 MR. PARLER: It all depends on whatever is put I

14 out, but the interested members of the public are on fair l

15 orders so that they could get comments, j 16 If Alternative Two goes beyond that, there is 17 case law which suggests that you have to go out for 18 another round of comments, but that's another thing that 19 we would have to take a look at, at the Alternative Two 20 and how close it is to the alternative that went out.

l 21 COMMISSIONER CARR: Well, personally I'd l 22 certainly lean to the performance based rule concept, but I 23 I hesitate to take another two or three years to get 24 anything on the street.  !

25 COMMISSIOUER BERNTHAL: Oh, no.

j 48 1 CHAIRMAN ZECH: Commissioner Rogers?

2 COMMISSIONER ROGERS: Well, just that I would 3 hope that in presenting something on a performance based 4 rule, which is the approach I tend to favor, that 5 considerable thought be given to the teeth that would be 6 put into enforcement.

7 It seems to-me that you have to balance that 8 flexibility that comes with performance based rule with 9 some clear enforceability thoughts that really make it 10 meaningful.

11 MR. BERNERO: Well, I'd like to remind Staff that i

12 there are two kinds of performance based rule: One is be '

l 13 kind to your mother, and the other is be kind to your 14 mother in these seven respects following or satisfying the 15 following list of criteria;.and some specificity to it, 16 you know. We would think in terms of the latter.

17 We have the material, there's no question of 18 that, we --

19 COMMISSIONER ROGERS: I'm in favor of specifying 20 regular meals and things like that.

21 (Laughter.]

22 CHAIRMAN ZECH: Let me just say too, I think that 23 as regards the prescriptive performance based rule, we're 24 just ieally trying to address our responsibilities, and 25 the performance based rule will satisfy them. I think i

. l 6-49 j i

l 1 that would certainly be something the Commission could 2 entertain.

3 But I think, as the General Counsel has pointed 4 out, this Agency has the responsibility for public health 5 and safety in these areas of medical isotopes, and we'take 6 this vary seriously.

7 We have great respect for the medical 8 communities, medical associations, and individual 9 physicians in our country, and we will certainly listen to 10 their comments, but we ultimately have the responsibility 11 for public health and safety and that is our 12 responsibility that we can't ignore.

13 So what we're doing is asking for their 14 assistance and their good professional assistance as we 15 move into this area of trying to meet our responsibilities 16 to the American people and carry those responsibilities 17 out.in a better manner.

18 We want to do what we can to protect the public, 19 we don't want to intrude in the practice of medicine. And l

20 certainly we don't want to do anything that would have a l 21 negative impact on the health care of our country.

22 My view, though, is that there is always room for 23 improvement. As good as these associations are and these 24 people are, as good as these physicians are, I think there 25 is room for-improvement. I think they should recognize 1

)

s 50 1 that, I think they do. And I believe a rule for quality 2 assurance is what we're talking about has merit in some 3 form or another, but we're not putting out a rule just for 4 rule's sake. We're trying to improve public health and 5 safety and our responsibility in carrying that out.

6 So even if the rule would only heighten 7 consciousness of those who use medical isotopes, I think 8 perhaps that would have merit.

9 But in any case, I would hope that the Staff 10 would continue to work with the health care community of 11 our country with those professionals involved in nuclear 12 medicine.

13 There is a lot of talent out there that I think 14 we could be perhaps a little more innovative than we've 15 been, and try to see how we can better carry out our 16 responsibilities in public health and safety as regards 17 by-product material and medical use of isotopes.

18 So I just think -- it's kind of frustrating to 19 think we've been at this so long. I know there's not man'/

20 misadministrations, but we don't have a good handle on the 21 numbers, even, it looks like, and that's certainly not as 22 good as we'd like.

23 But we have responsibility in this area and as 24 far as I'm concerned we are going to do something about 25 it, and we're asking for help from those communities that

51 1

1 certainly should be able to help us. 3 2 You know, it's one of those things if they don't 3 -help us, they might wish they would or migbr wish they 4 did. We're liable to do something that's,.you know, not 5 as smart as we'd like to do, but we're ask%ng for their 6 help.

7 I think we feel obligated to try go improve, 8 that's all we're trying to do, trying to. improve and I 9 hope they would help us do that. -

10 I do think there is room for improyement-and I 11 would hope that the Staff will continue t o , tf o r k in this 12 area with those professionals who also havel 13 responsibilities for public health and safety in their i

14 chosen professions.  !

15 Are there any other comments, my ,fpilow 16 Commissioners?

17 COMMISSIOllER ROGERS: Yes. . p.

18 COMMISSIOllER BERNTHAL: I want:to - excuse me.

19 COMMISSIO!!ER ROGERS: Well, just,that -- I wonder

. 20 if thought shouldn't be given here in relationship with 21 the states and how -- after all, we're talking about 22 radiation therapy of some sort and part of that is not 23 under our regulation, namely that that's created by X ray 24 machines and devices of that sort, and yet the patient 25 effects are the same.

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

j 52 1 I would hope.that some thought is given in 2 working with the professional community on this, that 3 somehow both aspects of therapy are somehow or another.at 4 least discussed together. Even though we may not have 5 full responsibility with all of that, that somehow there's 6 a linking together, because I think that there's a 7 difference in perception of things like probabilitics and 8 how low is low.

9 What we're doing here in some way, some of these i 10 numbers don't look so low to us in terms of event 11 probabilities that we're trying to drive for with respect 12 to nuclear power plants. They look very low compared to 13 the 5 to 15 percent of misadministrations of medicine, and i

14 the X ray people are probably some place in the middle 15 there between these.

16 I would think that in the national interest, it 17 would make a lot of sense to try to work'together with 18 those groups that are responsible at the state level for 19 the licensing and control of radiation from X ray devices 20 in connection with our own developement of a rule here for j

{

21 other sources.

22 C H AIR!! A!! ZECH: Good point. Commissioner 23 Bernthal, do you have one comment?

24 COMMISSIOllER BER!iTHAL: I just wanted to r egtte s t.

25 that the Staff make a best effort here to get out the best

l 53 1 possible numbers whether it's through the Agreement States 2 or --

we discussed the number of areas in which those 3 statistics might be improved and I understand that AEOD 4 doesn't necessarily even have the data at its disposal, 5 but perhaps you, working with someone else -- for example 6 in other areas, this question of threshold, _how do you 1

decide likely health effects? I would like something a l 7  !

8 little bit better nailed down so that we can make a better j 1

9 judgment on the seriousness of the problem, although there  !

10 seems to be a consensus developing here on how to proceed.

11 Other than that, I would just comment, going back 12 to the case of fitness for duty where the Commission put 13 out a policy statement, one which went a little beyond be 14 kind to y3ur mother, and of course it was only a policy 15 statement, but there did turn out to be a littic bit of a i

l 16 list of particulars there; I always felt that it probably 1

17 could have been stated in about one sentence: Muclear l

18 power plant sites shall be free of drugs and alcohol, and i

19 you've got to be able to demonstrate it, a sort of period.

20 And that kind of a statement, 4t seems to me, 21 translated into the proper scenario here for the subject 22 that we're discussing.today might very well be the kind of 23 rule that we would be looking at here.

24 In other words, I'm a little concerned about a l

25 terribly long bill of particulars following thht "be kind I

j 54 l

l 1 to your mother" and I'm not sure we need that. If you say l

2 that you must have a quality assurance program that's 3 effective, that's part of it, but being'able to 4 demonstrate that it should be effective at least when 5 somebody walks in and looks at it is another part of it, 6 or "please don't take my top-of-the-head words" here as 7 guidance.

8 If you understand what I'm saying, somewhere 9 between a broad qualitative ill-defined statement that may 10 be unenforceable, and dotting all the i's and crossing the 11 t's, there ought to be something that makes sense, it 12 seems to me, and I would hope that we would work toward 13 that.

14 CHAIRMAN ZECH: Are there any other comments?

15 Com.nis sioner Ca rr .

16 COMMISSIONER CARR: What you ought to write-is 17 don't do anything to harm your mother, then we could do 18 something.

19 CHAIRMAN ZECH: Is that it?

20 COMMISSIONER CARR: That's it.

21 CHAIRMAN ZECH: And adjourned.

22 [Whareupon, at 3:20 p.m., the. meeting was 23 adjourned.]

24 l 25

4 1

2 REPORTER'S CERTIFICATE 3

This is to certify that the attached events of a 4

5 meeting of the U.S. Nuclear Regulatory Commicsion entitled:

6 7

TITLE OF MEETING: Briefing on Status of Proposed Rulemaking on Basic QA in Radiation Therapy and Related Activit 8 PLACE OF MEETING: Washington, D.C.

9 DATE OF MEETING: March 22, 1988 10 ,

11 were held as herein appears, and that this is the original 12 transcript thereof for the file of the Commission taken

/' 13 stenographically by me, therea'fter reduced to typewriting by 14 me or under the direction of the court reporting company, and 15 that the transcript is a true and accurate record of the 16 foregoing events.

A O\/

4 ll~;/ -

18

---

(-----;;~ -

19 Mario A. Rodrigudz 20 21

• 22 Ann Riley & Associates, Ltd.

23 24 25

):  :. .

PREPARED ON MARCH 14, 1988 -

c I Co MISSION BRIEFING

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PROPOSED RULEMAKING

! - ON .

. BASICChALITYASSURANCEINRADIATIONTHERAPY 1

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' BY

.1 AEOD, RES, AND NMSS i

i MARCH 27, 1988 i

1 1

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1 . . ,

I l

~:

. t l

I t TOPICS .

l  !

1 l

1. INTRODUCTION (WISS)

\

, 2. REPORT ON RECENT TaENDS IN MISALMINISTRATIONS (AE00)

~

i l 3. BASIC OA RULE (RES)

4. OVERVIEW OF COMPREHENSIVE GA (RES)

I,

5. THE AnvlS0av Co mITTEE !WI THE MEDICAL USES 0F ISOTOPES (NMSS)

6. RE6ULATORY ALTERNATIVES (MISS) en 6O 8, * , "*N*

e * * ~ * *

~

i ANALYSIS OF MISADMINISTRATION DATA FOR

' THERAPY MISADMINISTRATIONS l

AND DIAGNOSTIC MISADMINISTRATIONS INVOLVING GREATER THAN 100 MICR0 CURIES OF IDDINE - 131 G

• O e

- 2 ,

a

• i MISADMINISTRATIONS REPORTED TO NRC THERAPY

• DIAGNOSTIC (I-131)**

YEAR MISADMINISTRATIONS MISADMINISTRATIONS NOVEMBER 1980 - DEC 1981 10 2 1982 4 3

.1983 4 2 1984 14 3

,1985 4 3 1986 7 5 1987 _1 _.E l TOTAL 52 23 ANNUAL AVERAGE 7 3

• THE PRIMARY CONTRIBUTING FACTORS FOR THESE MISADMINISTRATIONS WERE:

- LACK OF REDUNDANCY IN VERIFYING THE ACCURACY OF IMPORTANT MEASUREMENTS AND CALCULATIONS ,

- INADEQllATE COMMilNICATION OF INSTRUCTIONS TO PERSONNEL

" THE PRIMARY CONTRIBUTING FACTOR FOR THESE MISADMINISTRATIONS WAS INADEQtlATE COMMUNICATION

0F INSTRUCTIONS TO PERSONNEL ii 3

• I L

ERROR RATE FOR MISADMINISTRATIONS NUMBER OF NilMBER OF NUMBER OF PATIENT

.IyPE THERAPY / STUDIES

• EVENTS PATIENTS ERROR RATE THERAPY:

TELETHERAPY 308,000 31 83 3E-4 BRACHYTs- :PY 154,000 12 12 8E-5 RADI0 PHARMACEUTICAL 92,400 9 9 IE-4 THE,RAPY DIAGNOSTIC 1,540,000 23 23 2E-5 (MISADMINISTRATIONS INVOLVING 100 MICRO-CURIES OF 10 DINE-131)

• NRC LICENSED FACILITIES ONLY

~

! 4

4 t

SIGNIFICANCE OF MISADMINISTRATIONS SINCE 1976 FIVE THERAPY MISADMINISTRATION EVENTS KNOWN TO NRC HAVE INVOLVED MULTIPLE PATIENTS. THE NUMBER OF PATIENTS INVOLVED RANGED FROM 8 TO 400, FOR'MISADMINISTRATIONS REPORTED FOR 1984 - 1987:

29 0F THE 50 MISADMINISTRATIONS THAT WERE REPORTED FOR THAT PERIOD WERE ABNORMAL OCCURRENCES EVALUATIONS BY NRC MEDICAL CONSULTANTS AND/0R IICENSEES INDICATE THAT 11 0F THE 29 PATIENTS COULD LIKELY SUFFERsADVERSE HEALTH EFFECTS i

MISADMINISTRATION A0s WERE 25% OF THE TOTAL A0s e

5

________m___m___________ _ _ _ _ _ _ _ _ . - -_ _ _ _ _ + _ _ _ _ _ - _ - - _ _ _ _ _ _ _ _ _ _ _ _ _ _ -_ _ _

~

3 CONCLUSIONS ERROR RATE FOR MISADMINISTRATIONS IS LOW THE LOW ERROR RATE FOR MISADMINISTRATIONS N0TWITHSTANDING, MISADMINISTRATIONS ARE:

POTENTIALLY INJURIOUS TO PATIENTS P0TENTIALLY INVOLVE MULTIPLE PATIENTS A SUBSTANTIAL FRACTION ARE ABNORMAL OCCURRENCES l

l h

9 i

6 i.

. BASIC QA RULE THE PROPOSED RULE

' O OBJECTIVE: TO REDUCE MISADMINISYRATIONS DUE TO 4 .

HUMAN ERRORS.

1 O PUBLISHED ON 10/2/87, o COMMENT PERIOD ENDED ON 12/1/87, i

i i

t

.. I

?.. .

7

.-.=.

BASIC QA RULE

! CURRENT STATUS 1, -

O PUBLIC COMMENTS ANALYZED AND RULE REV! SED.

0 DIVISION REVIEW COMPLETE.

0 REGULATORY ANALYSIS REFINED.

t 0 DRAFT RULE SENT FOR OFFICE CONCURRENCE /CCMMENT.

o 0FFICE CONCURRENCE / COMMENTS DUE 4/1/88.

0 SUBMIT DRAFT FINAL RULE TO COMMISSION BY 4/29/88.

i l-t

.]

8

O *=

BASIC 04 RULE

. PUBLIC COMMENTS ON THE PROPOSED RULE ,

I

' . O TOTAL NUMBER OF COMMENT LETTERS RECEIVED - 69 O SOURCES OF THE COMMENT LETTERS

- fil FROM HOSPITALS, I

- 6 FROM PRIVATE PHYSICIANS

- 7 FROM PROFESSIONAL ASSOCIATIONS: '

i 5 FROM STATE REGULATORY AGENCIES

- 2 FROM AN INSTRUMtNTATION MANUFACTURER 9

- 8 FROM INDIVIDUALS (DID NOT INDICATE PROFESSION) f e

!!*5 i1

) il l 9

<_____--.; _. _. ___ _ _. . -=-

BASIC QA RULE i

SUPPORT OF THE PROPOSED RULE I

O 25% SUPPORTED, INCLUDING

- COMMISSION ON RADIATION THERAPY OF THE AMERICAN COLLEGE 0F RADIOLOGY COLLEGE OF AMERICAN PATHOLOGISTS 0 '20% OPPOSED, INCLUDING:,

AMERICAN COLLEGE OF RADIOLOGY ~

- $0CIETY OF NUCLEAR MEDICINE 0 55% SUGGESTED CHANGES, INCLUDING!

! - AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE l

- - AMERI'CAN COLLEGE OF MEDICAL PHYSICS

- NATIONAi. COUNCIL ON RADlATION PROTECTION AND MEASUREMENTS

.10 .

c BASIC QA RtiLE PUBLIC COPPIENTS ON THE PROPOSED RULE MOST SIGNIFICANT OPPOSING COMMENTS O BECAUSE THE PROBABILITY OF MISADMINISTRATION IS ALREADY VERY .

LOW, THE RULE IS NOT NEEDED.

O ADDITIONAL REGULATION WOULD NOT REDUCE THE FREQUENCY OF HUMAN ERRORS.

h

' O PATIENT CARE COST WOULD BE SIGNIFICANTLY INCREASED.

11

-- - w _ _ -_ ____ t _

n . -. ._ _ _

BASIC OA RULE

(.-

MDiFICATIONS BEING CONSIDERED BASED ON SPECIFIC PUBLIC COMENTS

) .

)

0 0 ELIMINATE SHALL DetAGES OF S0DIUM 10DIDE AND DIAGNOSTIC DOSAGES OF OTHER IODINE COMPOUNDS FROM THE GA REQUIREMENTS.

ELIMINATE REQUIREMENT THAT LICENSEE MAY NOT ORDER

~

0 RAD 10 PHARMACEUTICALS HITHOUT APPROVAL OF AUTHORIZED USER.

I O ELIMINATE THE REQUIREMENTS FOR MEASURING BRACHYTHERAPY SOURCES BY LICENSEES.

O ELIMINATE INDEPENDENT CHECK OF OUTPUT OF ANMHAL FULL CALIBRATIONS FOR TELETHERAPY MACHINES, BUT MAlWTAIN INDEPENDENT CHECK FOR FULL CAllBRATinM RESULTING FROM SOURCE CHANGE OR O PROBLEMS HITH THE SOUNCF.. MT DE USE OF 11.D.

. j,

! O ADD REQUIREMENT ON PATIENT IDENTIFICAT.I.ON.

I i

i n

4 . .

BASIC 04 RULE BENEFIT-lMPACT ANALYSIS BENEFITS '

O PRELIMINARY ANALYSIS INDICATES THAT 60 (80%) 0F.THE 75 MISADM.

REPORTED TO NRC BETWEEN 11/80 AND 12/87 COULD HAVE BEEN AVERTED THROUGH EFFECTIVE IMPLEMENTATION OF REVISED RULE.

O FOR ALL LICENSEES, ABOUT 20 MISADM./YR. COULD HAVE BEEN AVERTED.

i

'. IMPACTS 0 ESTIMATED COSTS l

- TO ALL LICENSEES FOR basic OA -------------------- $1.7M/YR

- INCREMENTAL ASSUMING MOST LICENSEES (80%) ALREADY FOLLOW MOST 8ASIC QA MEASURES -------------------- 20.4M/YR

- INCREMENTAL COST PER MISADMINISTRATION AVERTED --- $20,000 0 'OTHER POTENTIAL IMPACTS (FOR THOSE NOT ALREADY PRACTICI

- LESS FLEXIBILITY IN MEDICAL PRACTICE

- - DIFFICULTY IN ASSURING TIMELY AVAILABILITY OF 00AllFIED PERSONNE

- REALLOCATION OF RESOURCES TG QA IN RADIATION THERAPY

! MAY NOT OPTIMlZE FFFECTIVENESS OF DVERALL MEDICAL CARE.

4 I

B

, _ ... . .. ;,7 ; .

- _ _ . . . . _ . . _ . . . _ . . , . . . _ . , . _ , _ :,7..

• ADVANCE NOTICE ON COMPREHENSIVE QA .

i

1. PURPOSE O To SEEK PUBLIC COMMENTS ON COMPREHENSIVE QA PR

2. THE ADVANCE NOTICE OF PROPOSED RULEMAKING 0 PUBLISHED ON 10/2/87.

l O COMMENT PERIOD ENDED ON 12/31/87.

3. PUsLIC COMMENTS 0 20 LETTERS WERE RECEIV.%

0 3 (150.STATEC CCRTAIN ACTIGNS MIGHT BE NEEDED.

0 12 f'DM ANSVEREP GUEST 10N3 RAISED IN THE NOTICE.

0 5 (250 OPPOSE? ANY MTiiTICNAL ROLESt i

18 , F6TURE 4GIOCS O DRAFT PP0'03Eb ROLE DUE Cov4 MISSION ON 9/30/88, 1 11

e ADVANCE NOTICE ON COMPREHENSIVE DA

{

MOST SIGNIFICANT OPPOSING COMMENTS s .

O CURRENT QA, TRAINING, AND CERTIFICATION ARE ADEQUATE.

O ADDITIONAL NRC REGULATIONS MAY NOT FURTHER IMPROVE QA.

0 H9 SPITAL QA PROGRAMS ARE REVIEWED AND EVALUATED BY JCAHO.*

I

'JCAHO - JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS

}. -s-I e

l 15

i THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES

GENERAL COMMENT

S FROM THE MEETING i.

j 0 THERE IS GOOD GENERAL SUPPORT FOR QA IN NUCLEAR MEDICINE i DIAGNOSIS AND THERAPY.

0 QA PROCEDURES VARY BECAUSE OF DIFFERENCES IN PATIENT COMMUNITIES BEING SERVED AND PATIENT LOADS.

l .

, O NRC QA REQUIREMENTS SHOULD BE COMPATIBLE WITH OVERALL HOSPITAL WIDE QA PROGRAMS.

O THERE ARE LESS PRESCRIPTIVE WAYS, WHICH WOULD ULTIMATELY BETTER SERVE PATIENT CARE, FOR NRC TO ENHANCE AND ENFORCE QA THAN THE PROPOSED RULE.

O 1

4 j

~3

' 16

n.

O t THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES COMMENTS ON BASIC QUALITY ASSURANCE RULES o THE PROPOSED RULES ARE UNLIKELY To SIGNIFICANTLY CHANGE ,

i MISADMINISTRATION RATE.

o THE RULES COULD CAUSE A Reu9CTION IN THE QUALITY OF PATIENT CARE DIVERSION OF RESOURCES FROM DTHER HIGHER RISK PROGRAMS DELAYED PATIENT CARE IN CERTAIN SITUATIONS.

O THE PROPOSED RULES ARE COSTLY.

O SUFFICIENTLY TRAINED PERSONNEL NEEDED FOR IMPLEMENTATIGN ARE NOT AVAILABLE.

6 i

,i i

.i

' 17

7 _-

, es

• THE ADVISORY COMITTEE ON THE MEDICAL USES OF ISOTOPES l! REC 0 mENDATIONS ON BASIC QUALITY ASSURANCE RULES o

REGULATORY RECOMMENDATIONS 0 OBTAIN QA PROGRAM COMMITMENT & DESCRIPTION IN llCENSE APPLICATION.

1 0 INSPECT AND ENFORCE LICENSEE'S QA PROGPAM.

~o ADOPT APPROPRIATE VOLUNTARY STANDARDS.

.0 TEST PROPOSED RULES WITH PILOT STUDIES.

i.

NON-REGULATORY RECOMENDATIONS I O SEEK COOPERATIVE INTERACTION WITH PROFESSIONAL ORGANIZATIONS.

0 PROVIDE ADDITIONAL TRAINING AND EDUCATIONAL SUPPORT TO LICENSEES.

j 0 EXPAND METHODS OF COMMUNICATING INFORMATION T0- LICENSEES.

1

,l 1

)I iI

}

- 18

. v .

NRC REGULATORY ALTERNATIVES ALTERNATIVE 1:

PROMULGATE PRESCRIPTIVE basic QA RULE.

ALTERNATIVE 2:

- DEVELOP PERFORMANCE-BASED RULE AND

- DEVELOP REGULATORY GUIDE.

ADOPT VOLUNTARY STANDARDS.

I ALTERNATIVE 3:

DO NOT ISSUE RULE,-INSTEAD EMPHASIZE TRAINING AND ASSISTANCE.

INDUSTRY STANDARDS DEVELOPMENT.

}

I -

19 l

ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES RICliARD E. CUtirlINGilAM, CHAIRMAN VINCENT P. COLLINS, M.D., HOUSTON, TX -- RADIATION ONCOLOGY SALLY J. DENARD0, M.D., SACRAMENTO, CA -- NUCLEAR MEDICINE JACK K. GOODRICil, M.D., ERIE, PA -- NUCLEAR MEDICINE MELVIN L. GRIEM, M.D., OGDEN DUNES, IN -- RADIATION ONCOLOGY NILO E. HERRERA, M.D., DA!! BURY, CT -- NUCLEAR MEDICINE B. LE0llARD HOLMAN, M.D. BOSTON, MA -- CARDIOLOGY AND NUCLEAR MEDICINE GERALD M. PcHOST, M.D., BIRMINGHAM, AL -- CARDIOLOGY AND NUCLEAR MEDICINE EDWARD W. WEBSTER, PH.D., BOSTON, MA -- RADIOLOGICAL PHYSICS DAVID H. WOODBURY, M.D., WESTLAND, MI -- NUCLEAR MEDICINE CONSUI.TANTS TO THE COMMITTEE PETER R. ALMGND, PH.D. LOUISVILLE, KY -- RADIOLOGICAL PHYSICS WILLIAM H. BRINER, CAPT, USPHS (RET), DURHAM, NC -- NUCLEAR PHARMACY

cal.C11LATION OF ERROR RATE TOTAL NUMBER OF PATIENTS INVOLVED IN MISAD (7 YR PERIOD)

PATIENT ERROR RATE =

(THERAPIES /STl1 DIES)/ YEAR)*(22 NRC ST/50 AGREEMENT ST) *7 .

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