ML20216D019

Incomplete Transcript of 1994 All Agreement States Meeting on 941024 in Portland,Me.Pp 223-235

ML20216D019
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Issue date:	10/24/1994
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References
FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-084, AE41-2-84, NUDOCS 9804150149
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Title:

$9QL AGREEMENyMES MEETING Docket Number: (Not Applicable)

Location: Portland, Maine Date: Monday, October 24,1994 Work Order No.: NRC-11 Pages 1-290 NEAL R. GROSS AND CO., INC.

Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.

Washington, D.C. 20005 g41gi49980402 20 62FR4120 PDR

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- 1 223 1 area, hopefully not quite as contentious as the things that we i 2have been talking about heretofore.

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3 There are four things I'm going to try and briefly '

4 cover: what has been nicknamed " wrong patient"; the rule Smaking on patient release; rule making related to pregnancy 6 nursing; and the almost final rule making related to 7 radiopharmacy.

8 You can go ahead to the next slide. This first one, 9which we have nicknamed " wrong patient," we talked to you 10about at the senior managers meeting back in July, coming out l

11of some enforcement actions where there was a question, '

12 basically, with regard to whether it was Part 20 or Part 35 13which was the controlling regulation in the case of an 14 administration which was to an individual who was not to have l 15 received it. i l

16 The dose to the individual was greater than the dose 1711mit to the members of the public in revised Part 20, so it 18was greater than 100 millirem, but it was less than the 19 threshold for reporting as a misadministration under Part 35, 20so it was less than five rem.

21 And the issue of jurisdiction came into play once 22again, as similar sort of issue with the issue of patient 23 release. This is Part 20 or Part 35. We are attempting to 24 move to try and resolve these sets of issues. We are trying 25to do that in a consistent sort of manner.

e 224 1 Go ahead to the next light. Which basically is to 2come down on the side that it's Part 35 when you're dealing 3with medical. It's not Part 20. And when we discussed this 4at the senior management workshop, Aherdam (phonetic), back in 5 July, we had a lot of questions about why are you bothering to 6do this rule; is this really worth doing and getting ourselves 7really wrapped around the axle, if you will, of the whole 8 definition of patient.

9 And we went back, and we thought about that, and we 10 concluded that it was an issue because these things keep 11 coming up with regard to the jurisdiction between Part 20 and 12Part 35.

13 And the more we thought about it, the more we 14 realized that there's always two ways to fix a problem. If 15you have a question with regard to what is the patient, you 16can either spend a lot of time trying to define what a patient 171s or you can find another way around it.

18 And the approach now being looked at by the NRC 19 staff is sort of another way around it, which is to say that 20the whole problem comes down to the fact that the patient, 21 word patient, that term, is used in three places in the 22 revised Part 20.

23 It's used in scope; it's used in the definition of 24 member of the public; and it's used in the dose limits for 25 members of the public, as one of the things that are

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225 1 supposedly excluded from the regulations and three slightly 2different sets of words are used in each of those cases.

3 And so what we are now looking at, what we have 4being reviewed by the officers right now, and there was to be 5another meeting this week on this is to remove that nasty 611ttle word " patient" from Part 20 in those three places and 7instead look at a consistent wording which would, basically, 8say that it is an individual who receives an administration.

9 Now, if it's an individual who receives an 10 administration, you then get around the problem of whether it 11was the right individual or the wrong individual. It was an 12 individual. They received a medical administration.

13 It gets you around soms of the issues of whether it 14was perhaps by-product material or some other material, and we )

15think it gets you around the issue of whether or not we're 16 dealing with someone on the wrong side of the shielding wall 17or whether it was someone who actually was receiving a 18 treatment of some kind because in the third case, as you folks 19 rightly pointed out, you don't want to get yourself in the 20 position of having all of your basic dose limits for members 21of the public and your shielding calculations and those sorts l 22of activities impacted by a decision of trying to get around a l 23 wrong patient. l 24 And an individual who is sitting in an office or a 25 room on the other side of a shielding wall, obviously, isn't i f

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226 1 receiving an administration of material.

2 So, the staff is, at this point, moving forward with 3a proposal that we hope to take to the Executive Director and 4the Commission sometime in the next month. /

5 And go ahead and put the last little slide up which 6 simply says, draft proposed rule to the Commission in )

7 November. Rule would change Part 20 in three places to remove 8the word " patient" go to an individual who received an 9 administration and, at this point, not even touch Part 35 and, 10thereby, we are in hopes to solidify the position that if 11you're dealing with medical administrations or materials, you 12are always dealing in Part 35 space.

13 Why don't we stop and see if we've got any questions 14there, and then I'll go on to the next rule making. Aubrey?

15 MR. GODWIN: I'm sorry, but I don't see how you've 16 changed anything. If an individual goes to get an 17X-Ray and ends up getting a nuclear medicine procedure, you're 18saying he will no longer be considered under Part 20, but 19would be under Part 35 even though he had no prescription to 20 administer a nuclear medicine procedure?

21 MR. COOL: He received a medical administration, and 22under your regs, they would be under whatever part you had, 23whatever set of regulations, and in the case of our rule 24 making for an NRC licensee, then that's right. The medical 25 facility is still dealing with administrations of materials, t

4 227 land we would not, from the standpoint of our rule, get into 2that.

3 MR. GODWIN: You misunderstood, I believe.

4 MR. CCOL: Okay.

5 MR. GODWIN: He went down to get an X-Ray procedure.

6Instead, he got technician brain scan or, let's say, he got, 7well, let's make it technician after all. You would not 8 consider him anything but still a patient; is that correct--

9 MR. COOL: That's correct--

10 MR. GODWIN: --under your proposed rule?

11 MR. COOL: That's correct. He received technetium.

12That would be a misadministration which didn't quality for the 13 threshold of reporting.

14 MR. GODWIN: I think you all are making a mistake, 15and I would urge you to reconsider that. I think they should 16be considered a Part 20 event. You have no limits of exposure 17 contained in Part 35 other than related to misadministration.

18I think that's a mistake.

19 MR. COOL: Okay.

20 MR. KERR: I would like to ask a question then. How 21many here issue notices of violation for violations of Part 20 22for that t"pe of a misadministration of a radiopharmaceutical?

23 MR. WAGNER: Ken Wagner from North Dakota. I know 24we just had that situation where it was a technetium 25 administration to a wrong patient, and I think the total dose I

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4 228 Iwas 135 millirem, and we did not issue a notice of violation.

2 3 Dick Lantern was just up, in fact, and looked at 4that case. It was considered, but we felt he was regulated funder the equivalent of Part 35.

6 MR. KERR: The reason I raised this is the 7 individual I have working for me, Dennis Serig, who's been 8 accumulating misadministration data now for quite a few years, 91s telling me that the situation in which a patient gets a 10 nuclear medicine diagnostic procedure when they are not to get llany procedure like that at all amounts to several hundred a

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12 year distributed among NRC regulated, as well as agreement 13 states.

14 I don't know all the bases of this data. I'm just 15 telling you. So, it seems to me this is a relatively common 16 occurrence, and I am not aware of large rashes of violations 17being issued for these things.

18 And your problem is, in the old days, when we were i

19 tied to roughly 500 millirem a year, or something like that, 20most diagnostic procedures didn't trip it.  !

l 21 Now, when you drop down to 100, most diagnostic j l

22 procedures come in somewhat, all your tech procedures hover 23between, I'd hate to have to do the dose calculation between 24100 TEDE and somewhere between 75 and 150, so it's just that 25there's some real practical issues involved in the whole I

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229 I lthing.

2 MR. SCHELL: Bob Schell from Maine. A quick check j 3with Jay Highland said we've had some misadministrations that 4We have not reported under Part 20 or looked to a similar, our SPart D, I'm sorry, not Part 20, but, you know, this really 6 disturbs me because it seems as though we're getting 7 schizophrenic.

8 We're saying it doesn't matter if a person picks up 9a dose simply because they're in a hospital, you know, 10regardless of whether they were intended to or not, and we limust remind ourselves the dose limits dropped from 500 to 100 12 millirem because of a growing body of knowledge about the 13hasards of radiation, and it seems to me rather callous to 14just dismiss a whole group of people as being inconsequential 15with that. You know, that's my opinion.

16 MR. COLLINS: Steve Collins from Illinois. Perhaps 17the reason the states haven't had any trouble is because the 18 Division 1 compatibility definition of public dose, in part, 19says: 'It does not include occupational dose or doses 20 received from background radiation as a patient for medical 21 procedures or from voluntary participation in medical research 22 programs.' And it doesn't say voluntary patient or intended 23 patient or anything. It just says you're a patient.

24 Even if you weren't a patient when you went and some {

25 grabbed you and you don't say no, and you let them expose you,

230 lyou become a patient.

2 MR. COOL: You sound amazingly like our medical 3 visiting fellow, Myram Polycove, and it's that exact logic, 4but getting around our general counsel's and some other folks' Sconcern about the word " patient" that leads us to change that 6one word from " patient" to " individual" to make sure that 7we've always got those included, and then we're basically in 8the mode of operation I think you referred to.

9 To get back to the comment right before there, we 10 thought seriously about the very issue that you raised. You 11have, if you're under one control regime, one standard for 12when we're going to take some actions in a dose limit.

13 You have a very different set of levels when you 141ook at thresholds for reporting and recording and 15misadministrations which was done by rule making for a set of 16 justifications which were all documented in the context of 17 medicine and in the context of trying to trade of burdens in 18 reporting versus what was in the medical community the 19 perceived risk for those.

20 The Commission is attempting at this point simply to 21be consistent in its application of where those decisions were 22made, the medical decision made with regard to the threshold 23for reporting and recording, and what you've brought to light 241s that there is some schizophrenia.

25 I agree with you, there's some schizophrenia, and

3 YQf( 2 231 lone of the things that we may well have to look at down the 211ne revision of Part 35 is whether that balancing and that 3 schizophrenia is correct or not.

4 The infamous Mr. Cameron.

5 MR. CAMERON: Don, would you quit picking on us?

6 MR. COOL: But of course, Mr. Cameron. Why don't we 7go on to patient release? I know we're running over. I'll 8try to talk like the Federal Express guy.

9 Why don't you go ahead and go to the next slide.

10We're going to do this really fast. That rule was out for 11 comment, closed at the end of August, received a fair number 12of comments, the vast majority of them from medical groups, 13 smaller number of comments on the reg guide and the associated 14new reg.

15 Go ahead to the next slide. In fact, go ahead to 16the slide which has got Page 34 on the bottom. Flip down two 1

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17more. There you go.

18 We had four areas where we received a fair amount of 19 comments. First was the issue that we had asked as to whether I '

20there should be activity or dose base. Here, everybody was 21 fairly happy with the proposal that you go to a dose base, and 22everybody was pretty much happy with the half rem sort of .

2311mit.

24 Next question was with regard to release quantities, 25and there, we got sort of a mixed bag of comments, some folks

232 Inot liking the fact that the 30 mil 11 curies disappeared from 2the rule, although it was still present, if you will, in the 3 regulatory guide for ease of application.

4 We had some, we really wanted it to be the rule so 5they could just point to the rule without having to point to 6anything further. We also had some commenting on the other 7 side that you ought to go ahead and not worry about that.

8 We had some people who, very interestingly, were 9 commenting that if 30 mil 11 curies was safe and effective, why 10would you allow anything other than that. I think perhaps 11they missed what we were attempting to do, which was actually 12to provide some flexibility with regard to treatment 13 protocols.

14 Go ahead to the next slide. We get on to the two 15that we received a lot of very negative comment on, as you 16might suspect.

17 First, with regard to the record keeping, we got all 18 sorts of nasty evil comments about the costs associated with 19the time and effort to prepare those records, some people 20te111ng us that we had grossly underestimated the cost of 21 record generation and a mixed bag of comments with regard to 22whether or not instructions were needed and whether simply 23having oral instructions or the requirement which was in the 24 proposed rule that they be in writing should be implemented.

l 25 Let's go ahead and go to the last slide. We are in i l

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233 lthe process of evaluating the comments and trying to see what 2we can do about them. Obviously, we have some significant 3 concerns about the record keeping and reporting requirements.

4 One of the things that the staff has toyed with, and SI'm going to throw this out not because we've come to any 6 strong conclusions, because we certainly haven't, but as a 7 possibility, is to back away from the somewhat prescriptive Blisting that was in there on the basis of the fact that 9perhaps we can take advantage of what Part 35 in the medical 10 management plan and similar things already require.

11 Someone pointed out to me, we were standing in a 12 metro platform, that, gee, we already require a written 13 directive, so that means you're already generating a record 14every time you administer one of these things.

15 Would it be possible to simply piggyback onto the 16 fact that those records exist for the purposes of documenting 17how long they have to hold it and when you could release it 18and, thereby, reduce the record keeping burden?

19 We're toying with that idea. I throw that out there 20for you to think about, maybe not necessarily in the public 21 meeting at this point, but to get back to me.

22 We're on a fairly long term schedule. We have a  ;

23 meeting with our Advisory Committee, the ACMUI, in about three l 24 weeks where we'll be bouncing some ideas and getting their l 251nput. We're actually not scheduled to be back to the i i

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• A' 234 1 Commission until the summer of 1995.

2 Let's go ahead and go to the next slide. Keep going 3right now. A rule making on pregnancy nursing which you have 4been talked to several times.

5 Go ahead and go to the next slide. This one has 6been on hold for a number of months due to-the need to apply.

7 additional resources to the radiopharmacy rule.

8. Once the Commission has that rule, and we'll talk 9about the status of that in just a moment, we'll put that rule 10 making back into the hopper trying to continue to develop our

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11 analysis and approach to providing protection for the embryo 12 fetus and protection for nursing infant.  !

13 of course, there have been some incidents where 14there have been some rather significant doses particularly to 15 nursing infants as a result of medical procedures.

16 Staff is looking.at the possibility of using the 17 patient release rule as a mechanism of defining the levels 18that you would look at in terms of a nursing infant and 19 focusing.this rule making strictly then upon protection for l 20the embryo fetus. That has not been completely nailed down 21yet, and we would expect to talk to you further over the next 22few months.

23 As we were able to get that rule making back on l 24 track, that rule making has come over to my group because it 25 deals closely with the same protection issues that we've been l l

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235 Idealing with in wrong patient and patient release and some of 2the Part 20 issues. I'd also be interested in hearing your 3 ideas on those at some point.

4 The last ruling making -- I don't have a slide for 5this, so you can just turn that off -- status of the 6 radiopharmacy rule, that rule, final rule making, very similar 7to the proposed rules in terms of the things that the state 8saw and commented on, is with our Executive Director for 90perations.

10 I anticipate that it will be sent to the Commission 11 shortly. You'll remember perhaps that the interim rule cuts 12out at the end of this year, and so we are still in the 13 process of trying to get the Commission to approve that so 14that it can be effective in January.

15 I know Larry can answer some questions, if you have 16some details, about exactly what things shifted in there, so 17we'll open it up for any brief questions before you go to 18 break.

19 MR. KULIKOWSKI: I think they all need coffee.

20 MR. CAMPER: Let me make a comment.

21 MR. COOL: Okay. Hearing no questions, we'll break-22-23 MR. CAMPER: One comment quickly.

24 MR. COOL: Oh. Sure, Larry.

25 MR. CAMPER: No questions on the radiopharmacy rule.

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