ML20128E824
| ML20128E824 | |
| Person / Time | |
|---|---|
| Issue date: | 01/29/1993 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| REF-10CFR9.7 NUDOCS 9302110093 | |
| Download: ML20128E824 (189) | |
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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMIS SION 4
NO BPIIFING By AGREEMENT STATES ON T11EIR ACTIVITIES IN MEDICAL USE AREA Location ROCKVILLE, MARYLAND baI6*. JANUARY 29, 1993 Pag 6S: 116 PAGES NEALR.GROSSANDCO.,INC.
COURT BEPodTERE AMD TRANSCRIBERS 1323 Rhode Island Avenue, Northwest Washington, D.C. 20005 (202) 234-4433 9
0
____.____________________________.___________________________________._.__._____.____________.____________._______._______.__________________.__________d
1 DISCLAIMER i
l i This is an unofficial transcript of a meeting of 6
the United States Nuclear Regulatory Commission held on January 29, 1993 in the Commission's office at one White Flint North, Rockville, Maryland. The meeting was open to public attendance and observation. This transcript has not been reviewed, corrected or edited, and it may contain inaccuracies.
The transcript is intended solely for general informational purposes. As provided by 10 CFR 9.103, it is not part of the formal or informal record of decision of the matters discussed. Expressions of opinion in this transcript do not necessarily reflect final determination or beliefs. No pleading or other paper may be filed with the Commission in any proceeding as the result of, or addressed to, any statement or argument contained herein, except as the Commission may authorize.
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1 UNITED STATES OF' AMERICA 2 NUCLEAR REGULATORY COMMISSION 3!
i 4 BRIEFING BY AGREEMENT STATES ON THEIR ACTIVITIES
- IN MEDICAL USE AREA 5
6 7 PUBLIC MEETING 8
9 Nuclear Regulatory Commission 10 One White Flint North 11 Rockville, Maryland 12 13 Friday 14 January 29, 1993 15 16 The Commission met in open session, pursuant to 17 notice, at 2:00 p.m., the Honorable IVAN SELIN, Chairman 18 of the Commission, presiding.
. 19 20 COMMISSIONERS PRESENT:
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21 IVAN SELD s Chairman of the Commission 22 KENNETH C.. ROGERS, Member of-the Commission-23 JAMES R. CURTISS, Member of the Commission 24 FORREST J. REMICK, Member of the Commission 25 E. GAIL de-PLANQUE, Member of the Commission NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE LSLAND AVENUE. N W.
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- 1. STAFF AND PRESENTERS SEATED AT THE COMMISSION TABLE:
2 SAMUEL J. CHILK, Secretary 3 WILLIAM C. PARLER, General Counsel 4 HUGH THOMPSON, Assistant Deputy Executive 5 Director for Operations 6 G. WAYNE KERR, Chairman, Organization of 7 Agreement States 8 TOM HILL, Past Chairman, Organization of 9 Agreement States 10 MARY CLARK, Chairman Elect, Organization of 11 Agreement States 12 CARL KAMMERER, Director, Office of State 13 Programs, NRC 14 AUBREY GODWIN, Director, Arizona Regulatory 15 Agency 16 EDGAR BAILEY, Chief, Radiologic Health Branch, 17 State Department of Health Services, California 18 ROLAND FLETCHER, Administrator, Rad Health 19 Program, Department of Environment, Maryland .
20 DAVID LACKER, Chief, Bureau of Radiation 21 Control, Texas Department of Health 22 23 24 25 NEAL R. GROSS COURT AEPORTERS AND TRANSCRIBERS 1323 AHODE tSLAND AVCNUE. N W.
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1 P R O C E_E D IJi_O S (2:03 p.m.)
2; l
3 CHAIRMA11 SEL1ti t Good afternoon, ladies and 1!
The Commission is meeting at this time to 4f gentlemen.
0 l 5 receive a briefing on the activities of the Agreement 6 States in the regulation of the medical uses of byproduct 7 materials within their borders. This in the second in a _
8 series of briefings for the Commission on medical use 9 regulation.
10 Just a week ago, the Commission received a 11 briefing from our own staff on 11RC activities in this ,
12 area. On February 8th, we will receive a briefing on the 13 results of the staff investigation of the therapy 14 misadministration incident that occurred last 11ovember in 15 Indiana, Pennsylvania.
16 On February 9th, the Commission will hear from 17 the NRC staff's Advisory Committee on Medical Uses of 18 Isotopes, and on February 22nd we will be briefed on a 19 proposed rulemaking on the preparation and use of 20 pharmaceuticals. We assume that all these murky issues a
21 will become crystal clear towards the end of February. We tf' 22 hope you will help us in arriving at an understanding of 23 these issues today.
24 The incident in Indiana, Pennsylvania and the 25 subsequent patient death, the recent serica of articles NEAL R. GROSS COURT REPORTERS AND TPANSCRIBERS 1323 RHODE ISLAND AVENUE N W-W ASHINGTON. O C 2000$ (202) 234-4431 (202) 234.4433
4 1 published in the Cleveland Plain Dealer, and a number of 2 other items have heightened the Commission's already keen 3l,, interest in this critical area of our regulatory U
4 , responsibility, i
5 We look forward today to hearing the views of 6 the Agreement States representatives who share many of 4
7i these regulatory responsibilities and, n fact, have the 8 further responsibility of integrating radioactive material 9 regulation with other radiation regulation.
10 We certainly appreciate the ef forts that you've 11 made to be here with us today. I see that we have today-12 representatives of the Organization of Agreement States, 13 including Chairman Kerr, representatives of the States of 14 Arizona, California, Maryland and Texas, carefully chosen 15 in alphabetical order. You are all welcome. Do we have 16 any introductory comments?
17 (No response.)
18 Mr. Thompson, would you care to start the 19 proceedings? .,
20 MR. THOMPSON: Yes, thank you, Mr. Chairman and 21 Commissioners. This is an appropriate opportunity for us 22 to just take a moment to reflect back over since the 23 Commission assigned the responsibility for the oversight 24 of the Agreement State programs about a little over a year 25 ago, to the EDO staff. And during that period of time, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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1 5-1 the emphasis has been to fully integrate the Agreement 2 States programs in our rulemakings as well as. state-3 prograr.- within our own organization. And we made a very 4 ' conscientious ef fort to do that both in the rulemaking as 5 well as the day-to-day activities.
6 One of the in:portant area thu we have had an 7 effort on underway is in the medical area. We've had-two 8 workshops, one in July in Atlanta. We also had as part of 9 the all Agreement States meeting in October, a full day 10 meeting on the medical issues. So, the medical area is 11 one that, as you indicated,' properly _has been receiving a 12 lot of attention by the Commission and by the staff.
13 Today's briefing will be in two parts. First we 14 will hear from the Organization's leadership, and then we 15 will hear, on the second part, with the specific states 16 that were identified with some incidents in the Cleveland 17 Plain Dealer's article.
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18 With that, I will turn it over to Mr. Kerr, and
- 19 then we will_ introduce the second presenters at the_ second l_ 20 phase. Wayne?
l =
Thank you. Mr. Chairman--and members 21 MR. KERR:
22 of the Commission, we.are pleased to be.here today to 23 discuss with- you a matter of- mutual interest, the 24 regulation of nuclear materials. I am accompanied by Tom L- 25 Hill, the Past Chair, on my right, and Dr. Mary. Clark, i NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W (202) 234-4433 WASHINGTON. D C 20005 (2^2) 234-4433
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6 1 Chair Elect, from the State of Florida.
2 I plan to make some general remarks addressing 3 certain regulatory issues and then some remarks related 4 specifically to Illinois. Then I will ask Mr. Hill and 5 Dr. Clark to make their remarks.
6 The words " protection of the public health and 7 safety" are few in number, but carry a lot of 8 responsibility. Words similar to those are found.in the 9 Atomic Energy Act as well as the legislation of each of 10 the Agreement States, and we all take them very seriously.
11 We appreciate the efforts of NRC in assisting us and in 12 trying to keep us coordinated to the extent necessary to 13 carry out that essential responsibility. It is not an 14 easy task for you to deal with 29 sovereign states and, as 15 you know, some of us are very sovereign.
16 There has been considerable effort expended by 17 NRC and the Agreement States in the last few months to 18 address problems associated with materials regulatory 19 programs. Some relate to information gathering, medical -
20 regulation, investigations, and some to enforcement.
21 These problems may be real in some cases and in others may 22 be only perceived. But I urge everyone to focus on the 23 proper target, and that is, are the regulatory programs of 24 both the NRC and the Agreement States adequately 25 protecting the pubic health and safety as required by the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE, N W.
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l 7 1 Atomic Energy Act for you, and by Section 274 of the Act 2 and our own state laws for us? We have stated on previous 3l occasions that we believe it inappropriate to place too l) 4e much emphasis, however, on processes and procedures. The 5 purpose of my general remarks are to highlight some areas 6 where we have different approaches perhaps, but maintain
- 7. the same public health and safety objective.
1 8 I want to focus on four items in particular that 9 have been the subject of some recent discussions. First, 10 is inf ormation gaps. We hear that some -- the public, the 11 Congress, the NRC, maybe others -- may not know everything 12 about each Agreement State program in the detail that is 13 known about NRC programs. However, we don't believe it 14 necessary for such detailed information to be maintained 15 in some centralized fashion. It's not that we have 16 anything to hido, our files are essentially-an open book 17 to the NRC. But knowledge of every detail should not be 18 necessary, and we don't believe that Section 274 of the
. 19 Atomic Energy Act contemplates that kind of oversight.
20 Second is the subject of investigations. There
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21 apparently is some concern that Agreement States don't- do 22 investigations or that we don't do them with the same 23 procedural rigor as the NRC. I'm certain that they all do 24 perform investigations of incidents, but not necessarily 25 following the rigorous procedures that you have. We NEAL R. GROSS COUAT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE. N W.
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8 1 certainly do investigations in Illinois, but we do not 2 have a staff dedicated to investigations. I'm aware of 3 it only one state that does. Texas has had such a unit since il But we get the job done anyway and, it sometimes 4 1981.
5j can be argued, with more vigor than NRC. State programs 6 do have the advantage of being in closer proximity to the
- i 7 regulated facilities, and in the case of facilities that 8 also use x-ray machines, we inspect those facilities for 9 all sources of radiation, with the result being a more 10 frequent presence. As a result of an NRC suggestion, 11 Illinois does have an Incident Review Committee which 12 meets monthly to review events involving either 13 radioactive materials or electronic product machines.
14 Third is enforcement. Enforcement practices no 15 doubt vary among the Agreement States which, in part, is 16 due to our sovereign nature. Some may find methods of 17 enforcement that are effective without civil penalties.
18 Most, like the NRC, do find civil penalties useful. But, 19 in any event, our processes may vary, but the goals are -
20 the same. I'd like to give you three examples.
21 Several years ago in the days of low-level waste 22 crises, Nevada returned a defective shipment of waste to 23 an NRC shipper. Since the shipment came- f rom an NRC 24 licensee, Nevada could have referred it to NRC for 25 enforcement action and waited two or three months for NEAL R. GROSS COURT REDORTERS AND TRANSCR10ERS 1323 F.AODE ISLAf 40 AVENUE. *:W WASHINGTON. O C 20005 (202) 234 4433 (202) 2344433
9 1 possible imposition of a civil penalty, but they found the 2 action they took was both prompt and effective.
3, A major university in California had significant 4 problems in their radiation safety program over a period 5 of years in the 1980s. Administrative actions such as 6 restrictive license conditions and management conferencas 7 did not fully correct the situation. The university was 8 placed on probation, a fine of $25,000 was imposed, and a 9 fellowship in radiation safety was established at $25,000 10 per year fer three years. Subsequently, a $65,000 penalay 11 was imposed for additional violations. California did 12 follow rigorous court proceedings in the latter stages-of 13 that case. Currently, the licensee is operating 14 satisfactorily.
15 On Thanksgiving Eve last year,. Illinois issued 16 an emergency order to a medical institution to cease 17 operations due to lack of authorized users, no approved 18 RSO being available, and no commitment to procedures
. 19 regarding selection of patients, prescribing doses and 20 interpreting results. The elapsed time from when our 21 inspector confirmed these problems to the time of issuance 22 of the order was a matter of hours. And one of our IDNS 23 inspectors personally delivered the order on Thanksgiving 24 Day. Now, these cases may be a little unorthodox, and may 25 be lacking in procedural niceties, but are they ef fective?
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i 10 1 We think so.
2 I might add as an aside that I understand Mr.
3l Ben Hayes, the Director of your Of fice of Investigations, i
4: visited the state of Washington last summer and reviewed e.
5 their enforcement practices, and he found that although 6 they dif fcred from NRC's, they were just as offective. ,
7 And I think it would be nice if that were put in writing 8 to the State of Washington.
9 I've left the most intractable subject for the 10 last. That is the issue of regulation of medical uses of 11 radioactive materials. Although the Agreement States have 12 differed with the NRC on some aspects of the issue, I'm 13 sympathetic to your attempts to resolve it. The issue is 14 greatly complicated by the players involved -- NRC, the 15 FDA, the Agreement State regulators, the medical licensing 16 boards, the state pharmacy boards, and not the least of 17 which are the medical practitioners and the patients. I.
18 think the difficulty partly stems from the differences of 19 opinion as to each of those groups' roles and a lack of '
20 clarity about their respective authority.
21 The medical issues paper was presented at the 22 public meeting on October 29, 1992, in Baltimore, and was, 23 in my opinion, a good initial effort at trying to sort out 24 the issues. I personally believe one of the most 25 important tasks is to establish clearly the respective NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISt.AND AVENUE. N W.
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t 11 1 roles of these various organizations, and I urge you to 2 work toward that goal expeditiously.
3i The quality management and medical 4L misadministration rules are interrelated and do have e
5 significant impact on Agreement States. Our main I
l 6 differences with NRC have been over the level oi detail 7 required and, in sono cases, with specific provisions.
i 8I The Agreement States tend to disagree with the level of 9 compatibility assigned to these rules and in general to 10 medical rules. We feel that a Division 3 category is more 11 appropriate since the issues, by and large, are matters 12 betwean each Agreement State and its licensees. Medical 13 licensees do not generally work across state lines nor 14 make products entering into interstate commerce.
E 15 Tnerefore, there is not a need for the same degree of 16 uniformity u may affeet radiographers or source 17 . distributors, for example.
18 Now, I want to briefly address some aspects of 19 the Illinois regulatory program. We have been an 20 Agreement State since June, 1987, and regulate about 800 21 specific licensees. Of these, we consider 97 to be major 22 licenses. Each review of our program by NRC since 1987 23 has concluded that it is adequate to protect the public 24 health and safety.
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1 professionals and four clerical. Other managerial and 2 technical support is provided by three health physicists and two administrative. Additionally, laboratory' 3f I 4 services, instrument calibration, and assistance in a
5 decommissioning projects are available throingh another 6 office in IDNS. The state operates for our own use and ,
7 for use by other states, a calibration lab accredited by 8 CRCPD. We have a comprehensive fixed lab facility which 9 supports all the functions of the Department, and have a 10 mobile lab for field use.
11 We have a fee schedule' structured differently 12 than NRC's, but it is expected to recover about 35 percent 13 of our costs in FY 1993. A few categories of licensees 14 are on a f 111 cost recovery basis.
15 We took 698 licensing actions in 1991 and 756 in 16 1992. We do pre-licensing visits-for those with complex 17 actions and, when deemed necessary, do obtain clarifying 18 information. We performed 13 in the last two yeers.
19 Our inspection priority system for specific 20 licensees is'similar to NRC's except our maximum interval 21 is four years. Thus, we are nearly identical'on the high 22 priority licensees, but more frequent than NRC on the 23 ' lower priority licensees. We conducted 375 -inspections in 24 1991 and 300-in 1992. We issued three orders in the last 25 two years as follows: First, a physician for unsupervised NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1.123 AHODE (SLANO AVENUE, N W (202) 2344433 WASHINGTON. O C 20005 (202) 2344433
l 13 1 use of radioactive material resulting in a hearing and a 2 civil penalty of $12,500; an industrial firm for multiple 3j repeat violations. A hearing was held and a civil penalty 4 of $4700 imposed; and a suspension order to the hospital 5 that I previously mentioned, for using material with no 6 authorized users, no RSO, and an improper license.
9 7 Our civil penalty procedures are specified 8 specifically in our regulations, and are based on licensee 9 compliance history, sevarity, and negligence. In 10 addition, we held two management conferences in these two !
11 years.
12 Our medical reporting rule -- and that's known 13 as misadministration in the NRC parlance -- is essentially 14 the same as NRC's with only minor differences. In 1991, 15 we had 25 recordable but non-reportable diagnostic events.
16 In 1992, we had six recordable events and one reportable 17 therapeuti:' event.
18 Our x-ray program is large, covering some 24,000
- 19 wachines at 9500 facilities. About half the machines are 20 inspected each year, and they are subject to various fees.
21 and civil penalties. We register accelerators and lasers, 22 and regularly inspect accelerator facilities.
23 Illinois has had a radiologic technologist-24 accreditation program since 1984. We accredit 25 radiographic technologists, chiropractic techs, nuclear NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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14 1- medicine techo, and radiation therapy techs. There are 2 currently ebout 8700 technologists accredited in Illinois.
3[ Of these, about 800 are nuclear medicine techs and about 4 500 are therapy technologists, which includes x-ray, 5 accelerator, teletherapy, and brachytherapy.
6 Civil penalties in the tech accreditation 7 program have been available since 1989. Penalties for ,
8 technologists are $250 for the first violation, $500 for 9 the second, and $1,000 for others. Employers' penalties 10 are $500 for the first, and $1,000 for all subsequent.
11 Since 1989, we have assessed $32,250 in penalties against 12 57 technologists and 36 employers,'most of which have been 13 in the last 12 months. Of these 57 t7chnologists, four 14 have been in nuclear medicine and three in radiation 15 therapy. We have a number of additionc.1 ones pending, but 16 there have'been no suspensions or revocations to-date.
17 There are 27 ' states plus Puerte Rico which have 18 implemented certification programs, although they may vary- I 19 in scope and detailed provisions. Of these, 17 are ,
20 Agreement States.
21 I would like to _ close - by announcing that - the -
22 Organization of Agreement States Executive Committee, we 23 three, have decided to appoint two committees to operate 24 over the next few months, one to address a variety of the 25 medical issues, many of which you've heard about already NEAL R. GROSS COURT REPORTERS AND TRANSCRidERS 13 3 RHOOE ISLAND AVENUE. N W WASHINGTON. D C. 20005 4202iJu 44+t (202) 234 4433
. _ _ _ - _ . _ _ . _ 4 _ .. .. _ _ _ _ . . ,
I 1 last - week -- and are currently; the . subject of ~ lots - of 2' discussion; the other is a data : gathering committee to l
3 review the kind of- data that NRC requests to see :if: we can _
4' avoid any duplication and simplify and see, you know, the-5 merit of that information to the Agreement States.
6 Now, I would like to ask Mr. Hill to make his 7 remarks, if I may.
8 COMMISSIONER de PLANQUE: Before you go,on -- ,
9 MR. KERR Yes?
10 COMMISSIONER de PLANQUE: -- I'd like toJask a 11 question about the accreditation programa. If -you;1ook at_
12 the numbers, about 30 percent of- the Agreement _ States.have -
^
13 credentialing programs through medical -- nuclear medicine 14 technologists, and only about 10 percent; of the . states 15 regulated through the NRC program have such programs.
16 The hypothesis has been made -- that you would 17 expect to see the rate of misi.dministrat' ions to be about- *
< 18 the came - in the AgreementL States as the non-Agreement-19 States. I wonder what you would say about the influence' l 20 of the accreditation programs.on misadministration. - Would-
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21 you think that that would be something. that shou' 'be 22 taken into consideration _if__you look.at that hypothesis? ,
23- MP. KERR: Well,=I-don't know that there is'any. ,
24 - connection. We don ' t know either. The _one therapy i - .
25 misadministration that-we had in 1992, was due to the ->
l~
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16
- 1. technologist not reading the order _ that was changed by the 2- doctor after ha first gave_it. On the-diagnostic, I do 3 not know because we only basically -have_ the therapy 4 reported to'us. But it't. something-that I think various people ought to consider. There are other_ states that-5 6 have possible plans for adopting accreditation programs at 7 this time, but they may not ' all vary. They may be 8 d.tfferent than ours, I'm not sure of the scope of all of ,
9 t h en. , but they all have some - --
cl. e 27 have i
10 accreditation programs.
11 COMMISSIONER de PLANQUE: It _ is a striking 12 difference in the percentages, and one wonders how you 13 could measure the effectiveness of those programs in that 14 regard. ,
15 MR._KERR Well, let me just say'that of those 16 that we issued civil penalties to, all have been_for lack of accreditation, not having_the accreditation when-they D
18 started to-work, or something like that. They were.not-19 penalties on cases that have happened. ,
20 COMMISSIONER de PLANQUE: One_other question.
21 You mentioned the review committee and that.you hnve one_ -
22 in Illinois. Is_this something that you would recommend.
23 that all the states have?
24 MR. KERRt Well, I don't know. We talk about a .
25 lot of trivial stuff. In fact, you know, very few are.
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17 1 really incidents --
we call it the Incident Review 2 Committee -- but a lot of it are things like encountered 3 sources, when the alarms go off at a trash yard, contaminated metal, those kinds of things, wc get a fair 4[
5 number of those -- material has gone f rom the hospital to 6 the local dump and they have a detector, and it ends up 7 with baby diapers and so forth. So, we cover a lot of 8 things and see what we can learn from it, but it's 9 something that certainly others could consider.
10 COMMISSIONER de PIANQUE: .Okay.
11 COMMISSIONER REMICK: Mr. Kerr, before you 12 proceed, I had a question related to something you 13 mentioned in your statement. On the enforcement example 14 in California, you mentioned that there was a fellowship 15 in radiation safety. Do you know to what -- and I infer 16 from that that that state must have the ability to use 17 fines for purposes like that. If that is the case, do you 18 xnow how many states have that provision where they can, 19 through their enforcement action, get something like 20 f allowships or other typa of remedial action, use of those 21 funds?
22 MR. KERR: The two gentlemen from California can 23 probably answer better, but let me just say I think it was 24 part of a negotiated settlement, and I used it to 25 illustrate. ?t was something I thought rather unique and NEAL R. GRCSS COURT REA")RTERS AND TRANSCRIBERS 1323 RN 00C ISLAND AVENUE N W (202) 234
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18 1 kind of interesting to-have them do that.
2 COMM1SSIONER REMICK: I know some states have 3 that ability in other areas, not necessarily in radiation, 4 where they can use enforcement action to negotiate 5 something like a reeearch program related to the area 6 where the fine or the enforcement action was taken. You 7 don't have an idea how many states have that ability?
8 MR. KERR: Certainly, our state doesn't have -
9 anything explicit to say you can go negotiate those kinds 10 of ancillary programs. I don't know whether they would 11 find the authority to do that or not. Frankly, I'd have 12 to ask our counsel whether we could or not.
13 COMMISSIONER REMICK: Thank you.
14 CHAIRMAN SELIN: Mr. Hill? Thank you very much, 15 MI. Kerr.
16 MR. HILL: Thank you, Mr. Chairman and_ members 17 of the Commission. It's a pleasure meeting with y_ou 18 again, continuing our - discussion of issues of mutual-19 concern. Since I met with the Commission on June the -
20 lith, 1991, to discuss compatibility issues, we have -
21 participated in meetings and workshops -with NRC. The 22 Agreement States provided early input into NRC 23 rulemakings, most notably, Parts 34 and 35. Today, I must 24 report to you that the Joint NRC-Agreement State Committee 25 recommended by the Agreement States to develop a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W (202) 2344433 WASHINGTON. D C 20005 (202) 2344433
-s 19 1 compatibility strategy has not yet been established.
2 Next, I want to briefly discuss Georgia's 3; Radioactive Materials Program.
L 4 CHAIRMAN SELIN: You can't just come off that-5 point like that.
6 (Laughter.)
e 7 MR. HILL: I understand that there may be-some 8 meetings or something forthcoming in the future that would 9 work to develop for the Agreement States and_the NRC to 10 jointly work on compatibility, I hope so, whenever.
11 CHAIRMAN SELIN: I really_need to say something 12 at this point, that with all duo' respect, the reason that 13 we're so interested in the Agreement' States program is not.-
14 because of-the sovereignty of the individual states,Eit's 15 because we understand that conditions vary from state-to--
16 state and that, in principle, provided - the states meet 17 certain prerequisites, that- in1many cases they ' are in 18 better position than we are to figure out what's- the best 19 way to carry out agreed objectives for the regulatory 20 programs, -in this case- in the - medical _ programs,_ and';
e .
21 specifically in medicine,- to provide some coordination f or 22 different sources of radiation,-so that people who.~are- -
23 injured through radiation aren't treated differently if 24- the radiation comes from an electromagnetic device versus 25 if-it-comes from a byproduct piece.
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20 1 And the question --
we hope we are, and we 2 certainly intend to be, pretty liberal on the question of compatibility, that it's not to -- we really don't care if 3 p!
4[ there's a uniform set of enforcement procedures from 5 state-to-state. We're not regulating commerce so that 6 physicians will pick a state to practice in based on the 7
4 enforcement procedure, what we're really interested in is 8 effective regulation. And if individual states have a 9 better insight as to how to carry things out in that state 10 than we do, so much the better.
11 What we are interested in, and one of the 12 reasons that Mr. Thompson alluded to, is to integrate th'e 13 Agreement State program with our own program in the sense 14 of learning from each other, that one of the benefits is 15 we have 30 different regulatory programs, 29 Agreement 16 States' plus ours, to learn from, instead of jur.t one.
17 So, we are very interested in pushing the compatibility 18 work and identifying as few issues as possible that need 19 to be strict compatibility, and as many where some. local .
20 flexibility canrot only be allowed and enforced, and the 21 reason we want the data is not to follow up on the 22 individual misadministrations, but to get some idea of how 23 thingu are working, to look at the states as a set-of 24 states, not to review each of the 29 states individually.
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21' I to-be some more work done just to make'sure'that things -
2- are more or. less compatible, is _ in the - question of i
3 informing patients. We do feel that this-is not something-4 that should vary on local customer, or local information.
5 When patients have suffered a misadministration, we feel 6 very _ strongly that their physician and the individual, 7 absent some overwhelming medical-reason, should get this 8 information.
9 So, we are very anxious that this work on 10 compatibility proceed. We are pleased that so much of the 11 actual registration is in the-hands-of - I'm sorry --: .
inspection and regulation is in the hands of the Agreement 12 13 States, and we don't want' things arbitrarily to be -
14 considered first category of compatibility, _ if there's no 15 good reason to do that. So, we do need to make sure that 16 w h a t e v e r.. t h e mechanism,- this committee or some other 17 mechanism, goes forward to work on that point.
18 MR. HILL: We agree, and we wish to continue'to work with the Commission . in . moving forward - on- those 19 -
F 20 issues.
21' MR. THOMPSON: -Mr. Chairman, I might add' , in.
22 response to the Commission's approval for us to take 'a new 23 look and-then'to_ generic a process for compatibility, we 24 intend to fully encompass the Agreement- State, 1 the-25 leadership and the Agreement State efforts in that effort.
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I 22 1 So, we clearly intend to do that, and I think that's 2 consistent with the Commission's guidance to do that.
3 CHAIRMAN SELIN: Thank you, Mr. Hill.
U MR. HILL: Thank you. Georgia has been an 4
5 Agreement State for 23 years. As of this past December, 6 we have 519 licenses as compared to 596 in June of 1990.
i 7 Our current staff includes six technical, two 8 administrative support, and one manager. Additional 9 support for laboratory services and emergency response la 10 available within the Department. The Radioactive 11 Materials Program, unlike Radiation Control Programs in 12 other states, does not have responsibility for registering q
13 and inspecting x-ray machines or generatots of nonionizing 14 radiations.
15 During calendar year 1992 we conducted 124 16 inspections and completed 819 licensing actions. A total 17 ' of 539 of those licensing actions administratively amended 18 or added a license fee condition. Twenty-nine percent, or 19 81, of the remaining licensing actions were new or renewal -
20 applications.
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21 Georgia's inspection priority system is 22 essentially the same as NRC's. In November of 1990, af ter 23 several years of effort, the program eliminated- its 24 inspection backlog. To date we have completed all 25 scheduled inspections. I'm not optimistic-that we can NEAL R. GROSS COURT REPORTERS AND TRANSCAIBERS 1323 RHODE ISLAND AVENUE. N W WASHINGTON. O C 20005 (202) 234 4433 I
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l 1 ' keep inspectlons'from becoming backlogged.
A revision of.-
2 our rules and regulations and their adoption by the board, .
3 i: in accordance with our Administrative Procedures _ Act,_ must 4 be completed this year.
5 Fees. In fiscal year '92, _the Radioactive 6 Materials Program received approximately 50 percent of its 7 funding f rom fees, the remainder from the state's general 8 fund. Beginning fiscal year '93, this past July let,.the ;
5 program is 100 percent supported by fees. The -fee 10 schedule adopted by the Board of Commissioners is similar to NRC's fee schedule.
11 The notable exception is that our 12 annual fees are approximately one-third of NRC's-_ fees.
~
13 Our rules and regulations provide: for-14 enforcement, including civil penalties.- All-enforcement-15 activities including- the assessment of civil _ penalties 16 must be conducted in accordance with the Georgia 17 Administrative Procedures-Act.
l 18 And as an aside here, addressing -- the quest' ion
- - 19 about alternate penalties or fees that Commissioner Remick ,
20 mentioned a moment ago, we - will frequently, in _ou'r 21 . procedures,-use a consent: order in which a civil' penalty;
-22 or-a dollar amount can be assigned.and. negotiated, and-those types of things similar to what California' used have
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23 24 not been used, but:I think they could be if management _so-l 25 ' wished to use that approach _in a consent order.-
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24 1 In.1992, licensees and: companies reported 18 2 incidences.. These were investigated, and all but one are-3 closed. Reports of three diagnostic medical 4 misadministrations were received in 1992. -
5 One final comment. In 1985, while attending lan 6 NRC sponsored workshop on large irradiators, I learned <
7 that the NRC Regional Materials staff and the Agreement.
8 States had some of the same problems with NRC's 9 headquarters. I challenge the NRC to review its Regional T
10 Materials Licensing and Inspection Programs using the same 11 criteria that has been developed and used to evaluate 12 Agreement States. Who knows, from such a review NRC may.
13 discover the equivalent of five additional Agreement 14 States. Therefore, the compat'ibility that is worked out 15 between the NRC and the Agreement States may be beneficial 16 within and have application within the-NRC. Thank.you.
17 CHAIRMAN SELIN: For your information, Mr. Hill,-
18 we have finally gotten :around -to notice that-
=19 recommendation, and we have asked the staf f to do at least ,
20 the same type of review of our own. programs that'we.do on.
21 Agreement States. There's no reason that-the workload-22 indicators and the process indicators should be all that-23 different=from one to the other. So, we find mills-of 24 regulation turn slowly,'but I think we've finally gotten 25 around to that recommendation.
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1 MR. IIILL Thank you.-
2 COMMISSIONER de PLANQUEI' On that point,. I think 3-; that it-wasn't'even a new idea-then. A little_ digging in 4 the files indicated that back'in '79 when Mr. Kerr was on S the Agreement States program staff, a- similar l 6 recommendation went forward. Could you enlighten us at-7 all why-nothing happened at that time?
8 (Laughter.) .
-9 MR. KERRt' That's really getting old for a 10 person of my age to remember, but I remember in general 11 that we brought the subject up, and I don't remember any 12 specific words that came back, but I think they were along -
13 the lines, well, we look at similar factors when we go out -
14 and review the regions.
15 The other thing is,-I'm not exactly sure-when 16 regionalization of the-materials program took place. I 17 don't remember the date. So, there could have been some 18 crossover there when things -- certainly, I remember the e 19 pilot program: started in Region III_and:went f or- _.a .f ew -
l 20 years before~it was extended to the other regions.
~
21 COMMISSIONER de PLANQUE: =And-.there were l
L 22 differences in terms:of inspection versus.l! censing, sol 23 that would --
24 MR. KERRt. Well, yes, right, the regions always 25 had the inspection, but the licensing program, too. And,:
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I 26 1 so, I don't remember specifically, but I certainly do know 2 that it did come up.
3 COMMISSIO!1ER de PLANQUE: So, nothing in i
4 particular we should learn today from what happened then?
i 5 MR. KERR I goess, as the Chairman has 6 indicated, it's sometimes useful to review all the past 7 doc'iments to see if we, you, or whoever, has done what we 8 said we would do.
9 CHAIRMAN SELIN: Absolutely. I should point out 10 that our main emphasis is not to try to find patterns 11 among our five regions, but if we have programs that do 12 the same things that the Agreement States programs do, 13 they should be basically subjected to the same type of 14 l measurement. It's more to look for consistencies, .or ,
15 explain inconsistencies, between our programs and the -
16 Agreement States, than dif ferences among our five regions.
17 MR. IIILL: Okay. Dr. Clark?
18 COMMISSIONER REMICK: Excuse me, Mr. Hill, two 19 questions. Is it safe for me to assume the reason that , ,
20 tenere's been a substantial decrease in - the number of 21 licensees is 100 percent fee recovery? <
22 MR. HILL: I think that plays a.very, very large 23 part in it because I.'ve graphed the drop of our licensees 24 over time, you can see a definite drop each time the fee 25 structure has changed, in number of licensees terminating, NEAL R. GROSS CoVRT REPORTERS AND TRANSCRIDERS 1323 RHODE ISLAND AVENUE, N W (202)2344433 WASHINGTON. O C. M10$ (202) 234 4433
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27 [
1 and even those who didn't pay the first time they were l 2 invoiced, when the second invoice went in, the termination l
> r 3l request would come in.
4 COMMISSIONER RELICM The other thing, you t
a ,
5 indicate that you do not have responsibility for x-ray i 6 machines and other generators, and nonionizing radiation.
7 Who does that in the State of Georgia?
8 MR. IIILL: The Department --
I'm in the 9 Department of Natural Resources. That responsibility lies 10 with the Department of lluman Resources, Office of 11 Regulatory Services. .'
12 COMMISSIONER REMICK I see. Any - views on 13 whether ideally that should be combined or not?-
14 (Laughter.)
15 MR. IIILL t Well, two and a half years ago, we 16 were split apart. Legislation went forward that removed 17 the Radioactive materials Program from 11uman Resources, 18 and placed it in Natural Resources. Keep'.in mind that'. ;
19 when-the Department of Natural Resources was formed.in 20 1972, part of the Environmental Radiation. Monitoring 21 Program went to the Department of Natural Resources 22 shortly thereafter, and. a - few years later- emergency 23 response responsibility- went there. And now, several 24 years later, the Materials Licensing Program has been 25 moved to that department.
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28 1 COMMISSIOllER REMICK: I see. A related 2 question, as I'm sure you're aware, there are some who 3!!H feel that the flRC should have the authority over, such 4l things as x-ray machines, linear accelerators, and linear 5 accelerator produced radioactive materials. Do you have 6 any views on that? Is that something that you think might .
7 be a good idea or not? Any views on that matter?
8 MR. KERR Well, I saw the comment in The Plain 9 Dealer article, and I, as Mr. Bernero indicated last week, 10 never heard of such a thing when I was around here, and I 11 don't remember hearing it from anywhere else. Frankly, I 12 don't know where they got that idea. It really had never 13 entered in my thought that that should be done. It's 14 quite a different -- the x-ray program is quite different 15 than the Materials Regulatory Program, it operates a lot 16 dif ferently, and it's very huge, very large program. So, 17 I don't see any particular need to do it that way.
18 COMMISSIO!1ER REMICK: Anybody agree or disagree 19 with that?
20 DR. CLARK: I was going to say I agree with 21 'tayne, the issue is very different. I mean, you turn the 22 machine off and there's no more radiation. And also the 23 nature of the inspection is very different. The surveys of x-ray machines is just a very different sort of 25 investigation than a radioactive materials inspection.
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29 1 COMMISSIO!1ER REMICK: I agree it's different.
2} I'm not sure that that is compelling reason.
3 !I MR. IIILL One comment I'll make though, on that 4: line. We work with the Departinent of Human Resources.
. 1 5f They do register, for instance, accelerators, and we do I license the material that they produce.
, 6; I
7! COMMISSIO!1ER REMICK: I see. Um-hmm. In the 8 area of x-ray machines, I'm just curious, do you have 9 particular trouble with universities using them for 10 research, in which they modify the x-ray machines?
11 MR. KERRt I don't recall that that's been a 12 particular problem in Illinois.
13 COMMISSIO!1ER REMICK: Okay. Thank you.
14 COMMISS1011ER ROGERS: Just before we leave this 15 -- I mean, maybe I'm stepping into something I shouldn't 16 step into, but your reference to the same problems that 17 you have that the regional 11RC people have with 18 headquarters, what kind of problems are these?
19 MR. HILL: In discussions in the meeting, we 20 were talking about licensing and inspection procedures,
~
21 reviewing assistants' approaches to things that when we 22 were being reviewed, it was those types of things. We 23 felt that -- a statement has been made earlier that the 24 states are closer to their licensees, some of the regional 25 folks felt that they were closer to their licenseos, had NEAL R. GROSS COURT REPOnttRS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUC, N W pca ?u 4433 WASHINGTON. O C ?000$ (?ch ? w 44 0
i l
30 1 a better relationship with them, like the states fool that 1
2 they do, compared to what I was hearing irom their >
h 3 comments in our discussions, that they felt that 44 headquarters had, and that they were -- could not operate, 5 I'm assuming because of procedures or something on that 6 line, in a way that they felt cornfortable and they felt 7 would be offective. 11ow, that's the way I recall it from 8 eight years ago.
9 COMMISSIO11ER ROGERS: Well, the relationship is 10 very dif f erent to headquarters, of our regional offices 11 and the Agreement States, and if you have -- and it's a 12 little difficult for me to see exactly what the same 13 problems are there. I mean, maybe that's a smaller list 14 that might -- I'm sure that regional of fices of 11RC have 15 their own particular reasons to be unhappy with 16 headquarters that have nothing to do with the kind of 17 reasons that you might be unhappy with 11RC headquarters.
18 And, so, when you say that they had the same 19 problems, I'm looking at an overlap there between the two -*
20 classes and what that amounts to.
21 MR. HILL: I think maybe I can give you-one 22 specific type example. We in the Agreement States, we in 23 Georgia, and I'm assuming in other Agreement States, use 24 license conditions. Sometimes we do not use one that is 25 a standard condition that is appropriate for that, and as NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS
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F 31 1 some of the regional licensing folks felt that they worn, 2 as I recall, rostrained somewhat irom using nonstandard i 3 licenso conditions or the approval process to got thoso 4 done would have been difficult. That is, I think, one i 5 type of example that I could give that might be a little j 6 more specific.
7 HR. KERRt Lot me just comment, .ommissioner 8 Rogers. Wo have some regions also. We have a region in 9 Glenelyn right across the street from your regional 10 of fico, where we have both x-ray and materials inspectors, I 11 and then wo have two regions that have single x-ray 1 12 inspectors in them, and there's always some tension ,
13 betwoon regions and hondquarters, about un versus them, or 14 we don't got enough guidance, or you're not clear, and,-
15 well, that's headquarters, we'll do our own thing -- you 16 know,'I'm sure you're wall aware that managing regions-17 takes a lot of effort- to -- a lot of them are -
18 administrative type things, but some are interpretations.
- 19 Dut, you know, today in the days of fax machines and so 20 on, we can do a lot, but- there's still always that 21 relationship there that has to be watched.
22 CilAIRMAN SELIN: Dr. Clark. ,
23 MR. KERR Yes, Dr.-Clark.
24 DR. CLARK: Thank you, Wayne. Mr. Chairman and 25 members of the Commission, I would also like to take this NEAL R. GROSS CouMT REPORTERS AND THANLCAIDER$
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32 1 opportunity to explain briefly my state's radiation 2 protection program. Florida became an Agreement State in 3 1964, and we currently have over 1100 specific licenses.
4 Approximately half of those are for medical purposes. In 5 addition, we have over 500 general licenses. We inspect 6 medical licenses with greater frequency than does the !!RC 7 in most categories. Laat year, we inspected over 500 8 licensees.
9 We have ten technical staff dedicated for 10 licensing activities, and ten support staff that is 11 clerical / accounting sort of staff responsible for both 12 inspection and licensing activities. We also have 11 13 full-time equivalent radioactive materials inspectors, and 14 I'll explain in more detail later how our inspection' staf f 15 is organized.
16 Besides regulating radioactive materials, we 17 also register and inspect x-ray machines and accelerators 18 as well as certify all radiologic technologists in the 19 state, of which there are about 30,000 certificate ,
i 20 holders, 15,000 of them are active certificate holders.
21 There are also over 30,000 x-ray tubes, over 22 half of which are medical, and 200 medical accelerators 23 registered in Florida. The medical machines are inspected l
l 24 annually. There are approximately 32 full-time equivalent 25 inspectors statewide for machine inspection.
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1 33 1 When we inspect medical facilities for either l
2 radioactive rnatorials or machine-produced radiation, we !
l 3 also verify that the radiologic technologists are properly ;
4 credentialed. We do register laser devices. And I would 5 mention that our misadministration rule does apply to both 6 machine-produced radiation and radioactive materials.
7 Conducting timely inspections is one of our most 8 important responsibilition. To accomplish this as well as 9 to maintain the ability to respond promptly to reports of 10 radiation accidents or incidencer, we have ten area and 11 satellite offices throughout the state. This means that 12 with the exception of Key West, there is an inspector well ,
13 within 100 miles of any location in the state.
inspectors
~
14 Most of our perform both x-ray 15 surveys and some radioactive materials inspections, 16 although we do have more senior inspectors conducting 17 primarily the materials inspections.
18 Approximately two-thirds of our radioactive
? inspections are unannounced.
19 Pre-license visits are 20 performed for significant license applications and-21 renewals. New licensees who do.not receive pre-license-22 visits are hand-delivered their licenses by an inspector, 23 at which time reviews of the facility and procedures are 24 perfo$med. We want to make sure if there is supposed to 25 be two locks, there are two' locks, for example.- Last NEAL R. GROSS CoVRT ACPOR1[R$ AND 18ANSCH$f RS 1323 RHOOf LSLAND AVENUC. N W
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1 34 1 year, there were 40 pre-license visits and 150 hand-2 delivered licenses.
3l!
Our program is fee-supported with our fee 4 schedule not tied to that of the NRC's. We took about 5 1300 licensing actions in 1991, and about 1400 in 1995 6 We have the authority to administer fines for the 7 radioactive materials, x-ray and radiologic technologist 8 programs, and we do administer fines.
9 Let me conclude my remarks by saying that we 10 believe our state's regulatory -activities and the 11 integration of them provides the necessary expertise and 12 ability to protect the public haalth and safety.
13 CHAIRMAN SELIN: Thank you. Before we -- do 14 you have some questions?
15 MR. KERR No, just go ahead,_any questions for 16 us.
17 CHAIRMAN SELIN: I just wanted to ask you to 18 think about one proposition. You talked about data 19 before. As I tried to explain, we're not so much 20 interested in individual state data in more detail so that 21 we can review, we're interested in trends information and overall patterns, both to learn from and to see if there
~
22 23 are noted discrepancies in the Agreement states as a 'whole 24 versus our own regulating-as a whole. And we've assume 25 that we're going to collect these data from the individual NEAL R. GROSS
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i 35 l 1 states and integrate them in our of fice of State Programs, ;
i 2 but it's possible that the Organization of Agreement 3 States might decide to take a more active role in 4 collecting some of this data across your universe and 5 working with ocr of fice of State Progrt no, and we would be- !
6 open to suggestions as the most efficient b y of getting
= i 7 some of these data together on a regular -- relatively as-8 painless as possible fashion',
9 MR. KERR The committee we intend to establish ,
10 will have f airly broad freedom to explore - any. of these 11 things, and some items - woro - mentioned : upstairs this 12 morning, too.
13 We as the Organization of Agreement - States 14 really don't have much authority. We can sit here and say ;
15 something about- other Agreement States,' but we don't have 16 the authority to tell them to do anything or make them do 17 anything, we are more or less a focal point' for you folks- .
18 and so on, .but certainly we'll consider all those .;
't- 19 comments.
20 CHAIRMAN SELIN . But you're the alternative to 21 the NRC, and that might give you a; certain amount - of l
'22 status.
, a
- 23 (Laughter.)
24 MR.~ KERR Yes'.
25 CHAIRMAN.SELIN: Any other questions?
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) COMMISSIO!1ER de PLAT 1QUE : I have a question.
2 Again, on the data, speaking in general for the Agreement 3 States, are there any problems with the data that the states submit to the 11RC7 Are you getting adequate 4h .
5 feedback, or are there any suggestions you'd like to make 6 in this regard? .
7 MR. KERR Well, one of the things I'm going to 8 ha"o to look at on the feedback is how useful is the 9 inf ormation to us? Are we getting it back, and how useful 10 is it to us? I mean, I realize you have dif ferent reasons 11 for wanting the data perhaps than we do, so they will be 12 asked to look into that. And I don't know for sure about 13 specific problems.
14 One that kind of bothers me a little bit, one of 15 the things is allegation tracking. If we get an 16 allegation, we tell the 11RC and you track it. So, you're 17 tracking the trackers, and I'm not sure, you know, why you 18 really need to track how we do on a day-to-day or month-19 to-month basis about tracking allegations. You know, many 20 of these turn out to be "no, never minds" anyway and, you 21 know, they're just part of our regular program. But 22 they'll look at a broad range of these things, 23 Commissioner.
24 COMMISSIO!1ER de PLA!1QUE: Okay. And one other 25 area, that of voluntary standards produced by the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W WASHINGTON. D C 20005 (202) 234 4433 (202) 234 4433
l 37 1 professional societies. There's always the question of 2 are those voluntary standards applicable instead of given 3 rules or regulations. Ilow do you feel the Agreement 4 States function in this area? Are they taking more or 5 less advantage of voluntary standards that are out there's 6 MR. KERR Well, I think on the material side, 7 it's not so much the national standard. We basically, you 8 know, follow the NRC pattern by and large now. On the x-9 ray vilde and the certification, our certification program 10 accepts national standards of the various certifying 11 organizations. We do not do independent certification per 12 se, you know. If they certify them, then we do that and 13 we have continuing education requirements. But it was a 14 fairly well established system before we ever got in the 15 business. And, so, we decided to proceed to accept that.-
16 COMMISSIONER de PLANQUE: Okay. Thank you'.
17 COMMISSIONER ROGERS: Have you made comparisons 18 of medical misadministrations reported. in each of your
, 19 states, on a per-procedure basis, and made any comparisons 20 with NRC regulated states?
l
~
21 MR. KERR No.. First, Commissioner, in terms of '
22 our own state; I'm not sure what the others have done, I 23 don't think so. Our rule only went in effect in July, 24 1991. Now, we were continuing to get reports from the NRC 25 rule that was in place when we became' an Agreement State.
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38 1 A licensee would call us up and say, " Hey, we got this, do 2 you want to hear about it?" We said, "Well, you're not 3 required, but please go ahead and send it in, we'd like to 4 see it". So, that's why we were able to report some data 5 from the past years in that interim period. Dut, no, we 6 have not done any comparison on procedure-by procedure. .
7 COMMISSiOllER ROCLRS: Do you have any interest 8 in doing it?
9 MR. KERR: Well, I don't know, we haven't coally 10 had -- we've had one therapy misadministration is all 11 we've had, and the rest have been what we call recordable 12 events, which are not required to be reported to us. They 13 have to maintain the records and so on, and they're 14 subject to review and inspection. At this point in time, 15 I'd say we've not considered it. I'm not sure whether wo 16 would or not.
17 COMMISSIONER ROGERS: Well, if you were to look 18 at the percentage of recorded events that you have, and 19 made a comparison with other states or other states under -
20 NRC regulation, and you found a significant difference, 21 would that bother you?
22 MR. KERR Well, I think it would certainly 23 raise questions. I'm not so sure whether it would bother 24 me, you know. You have heard f rom the community about the 25 whole business of misadministration reporting, NEAL R, GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W (202) 2M-4433 w ASHINGTON. D C 20005 (202) 2M4433
39 1 particularly the diagnostic that used to be there, on 2 whether it really serves a useful purpose. And many in 3 the medical community, of course, feel that they're at a-4 l Very low frequency to start with. cersalnly, the serious 5 therapy ones, you know, we investigate the ones that are 6 therapy, and that's where I think we would focus the 7 attention.
8 On the diagnostic ones, I'm not so sure that it 9 would be that much --
t 10 COMMISSIONER ROGERS: Well, if we just talk 11 aoout the therapy.
12 MR. KERR: Well, yeah. Well, see, the situation 13 is with us, we consider a therapy misadministration, we ,
14 would review it like we would some other incident if it-15 was non-medical, and what lessons we might learn f rom that 16 we don't know at-this point since we've only had one, but 17 it certainly deserves more consideration.
18 COMMISSIONER ROGERS: Well, but I'm coming to 19 the point that if there's a question about whether these 20 are really being reported accurately or correctly, you 21 don't-have much of a comfort factor to go by by just 22 simply saying you have the low number or low percentage --
23 compared to what? I mean,'what's the average that one 24 expects, and the fluctuations in that average from state-25 to-state around the country? Unless you-know what that NEAL R, GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENVE, N W.
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40 1 is, I don't know how you can feel very comfortable that 2 it's a low number. I mean, even though it's a small 3 absolute number, I don't know that you really have much 4 comfort that you have an adequate reporting system.
5 MR. KERRt Well, I think time will tell in our 6 state because the reporting system has only been there for ,
7 a year and a half, but --
b COMMISSIONER ROGERS: -Well, I think it's an 9 important question to be able to answer for yourself.
10 MR. KERR Yes.
11 DR. CLARK: I would say that one would first 12 need to look at, when looking at the data, how one 13 uncovers the misadministrations, that I would first look 14 at the categories in which they are found, whether they've 15 been reported, whether it's as a part of the inspection, 16 whether it's anonymous complaint, reported by either the 17 physician, someone else in the hospital, or a technologist 18 there, the physicist. Then I would also categorize the 19 cause -- I_think Wayne alluded to.that -- the causes of -
.i 20 the misadministrations, before I would be able to 21 determine whether the lack of reporting or the lack of 22 numbers of misadministrations was the result- of an 23 inadequate reporting system.
24 COMMISSIONER ROGERS: Well, fine. I mean, l _25- that's certainly the right thing to do, but the question L NEAL R. GROSS CoVRT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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e 41 7
1 is, what are you comparing it to, to give you somo fooling ;
2 that your process of examining thoso things is uncovering.
3 overything? It's an absoluto, you know, it's just a 4 datorministic absoluto approach, and you don't have any 5 kind of referenco point, base point to look at. I would 6 be worried about that.
7 MR. KERR: Well, I don't 1.nvo anything else to- i 8 add at this point.
9 COMMISSIO!1ER ROGERS: Yoah.
10 HR. KERR Apprecinto your com:nont.
11 CilAIRMA14 SELIll Thank you very much. We're e 12 very pleased that you've set up --
13 COMMISSIO!1ER REMICK: Excuse me, Hr. Chairman.
14 CllAIRMAll SELIll: Oh, excuso me, . Commissioner "
15 Romick.
16 COMMISSIO11ER REMICK: A couple of questions to 17 all three of you, as you choose to answer. Do you find 1
18 the fines that you're able to issue for misadministrations
+ 19 or violations, are adequate to assure adherence to'your ,
! 20 regulations, or make corrections, or 'is it more the stigma ,
i '
- l. 21 of the associated publicity, or is it' a combination of the 22 both?
~23 MR. KERR: Well, I--think in all'the cases we-24 have, the two fines in the ono. medical and one industrial ~, ;
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42 1
1 of those. So, you know, so far we'd say, okay, I got 2 their attention and presume it's adequate. Ilow, if we had ,
3 repeats, then that would certainly raise a difforent ;
4 question. '
s -
5 COMMISSIONER REMICK: But do you !.now if it was 6 the amount of fine or the publicity associated with the l 7 issuance?
8 MR. KERR Well, the fines, you know -- let me 9 just mention particularly on the techs, looked rather 10 small. I said $250. Well, those techs make about $23,000 11 or $25,000 a year, and that's 1 percent of their salary. :
12 Now, it's not a lot of dollars to us, but I think for 13 those of us nitting around this table, if we were asked to 14 give 1 percent of our salary as a fine, it would be more 15 than pocket money. So, it's not, you know, terribly big 16 in the absolute terms, but they're operating in . a 17 different salary scheme than we are. I don't think those 18 techs that got those fines will probably repeat going out .
19 and working without their proper accreditation.
- 20 COMMISSIONER REMICKt Yes.
21 MR. HILLt We have received a fee as.the result 22 of a consent order, not a civil penalty hearing, a consent..
23 order, and we have not-had a repeat of that violation, but 24 in this case it-was the licensee's failure to-renew-a 25 license and to work toward a renewal of that -- it was an NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS -
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43 1 induettial licenso -- and the penalty, the dollar value --
2 it's kind of hard to call it a penalty -- the dollar value }
3 was low compared to what that industry has paid many timos I 4 before for omission of hazardous material out of stacks. .
5 CilAIRMAll SELIlls Commissioner Romick, aro you 1 6 through? 1 7 COMMISSIONER REMICK Yoo.
8 DR. CLARK: My responso would be very similar to j 9 Wayne's, that when wo administer fines, we do find wnother 10 or not excessive in terms of thousands and-thousands of -;
'i dollars. I think that does work to achlove con.pliance.
12 For example, with the technologists, I think you find that -
13 facility --
you find the facility as. well as the 14 technologist, you do find that that f acility is' much loss 15 likely -- in fact, never --
going to hire again an -
16 improperly credentialed technologist. ,
17 COMMISSIONER REMICK: Okay. Mr. - Kerr, you 10 indicated that y_ou do perform inspections of therapeutic
- 19 misadministrations. I would appreciato the others i 20 responding in that area. And also, each of.you,.do you-l- .
21 follow up with the individual patient? To what extent do 22 you follow up, how far with individual.pscients?
23 MR. KERRt We have not performed a follow-up on 24 the patient.
25 MR. HILL: Wo have not followed up on -- with-i l NEAL R. GROSS CoVRT REPORitR$ AND TRANSCniBE nS 1373 HHODE ISLAND AVE NUE, N W r
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1 1
44 1 ;he patient either.
2 COMMISSIONER REMICK: Dut you do perform an 3 inspection -- .
4 MR. IIILL: We would perform an inspection for a i 5 thotapeutic misadministration. Before the Rad Materials 6' Program and the x-ray program were split up, there was a 7 therapeutic misadministration from an accelerator which 8 was inspected and followed up on.
9 COMMISSIONER REMICK: Okay.
10 DR. CLARK: We also perform inspections, and 11 then we require as part of our investigation, a plan, a 12 follow-up plan, to the --
while we don't follow up_
13 ourselves on the patient, we require there be a-follow-up 14 plan by the facility.
15 COMMISSIONER REMICK: Thank you very much.
16 CHAIRMAN SELIN: Thank you very much, you folks.
17 We're pleased that you've set up this Medical Use 18 Subcommittee, and expect to have a lot of contact. with it.
19 I think that will be very useful for overybody around the 20 table. Thank you very kindly.
21 MR. THOMPSON: Mr. Chairman, the next portion of' 22 the briefing will be by the four' Agreement State program:
23 managers who have their programs or -incidents under their -
24 retiponsibilities identified in The Cleveland Plain Dealer.
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45 -
i l fer Davide I think Dave is right hero -- musical chaira, 2 this in the muelcal chairs. Ed, you're in the middle; i 3 Roland, I think you're on the far end by Carl; and, 1 Aubroy, I think you're right there by -- !
B ). Cli? tRMAtt SELIll Whoever said they don't 6 adainister tha n programa closely? '
7 iLaughter.) ,
8 COMMISS!CNER ROGERS: Micromanagement. !
9 (Whercupon, the panel stopped back from the i 10 table and the next panol came forward.)
11 MR. Til0MPS0!!: The briefing sequence that we !
12 have nelected today will be first by Mr. Aubrey Godwin, 'f 13 from the Arizona Program; then by Mr. Edgar Hailey, who la 14 in the middle hero, who is a certified health physicist 15 f rom the California program; Mr. Roland Fletcher, from the 16 Maryland program; and then Mr.'Davjd Lacker, from Texas.
17 Aubrey? ,
l 18 MR. GODWIll Mr. Chairman, Commissioners, I'm:-
a 19 Aubrey Gcdwin, f rom the Arizona program. I'vo. boon thero !
20 since September, so I'm f airly new,. and I hope they voted.
21 to confirm me today in the Sonato. <
i 22 (Laughter.)
23- MR.'GODWIN: I'm not real sure. .,
24 M R .- T il0 M P S O ft: But he does have'a long history 25 with the program, so he's not that now in the aron.
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46 1 HR. GODW11H Certified in health physics, and 2 worked with Alabama for 30 years, so I'm sort of talking '
3 about two different programs.
4 I thought I would go to commissioner Rogers's :
5 question just a little bit if I could. One of the things ;
6 we did in Alabama as a part of our review, was go into and. ,
7 look at patient records and compare the patients logged in 8 on their record dose versus what was being logged in in-9 the nuclear medicine or in the therapy department, and 10 compare that to the prescription to make sure there was a 11 consistency in that. And on-occasion we did find some 12 even before the misadministration rule went into effect, 13 and this would -- it wasn't a great percent, but-it did 14 give us a little bit of confidence that we had checked and 15 that they knew we would be there locking at it. So, that 16 did help us a little bit and give confidence.there.
17 Going on-to the Arizona program, we really are 10 going to talk about two events. The first event, _ the ,
19 Desert Samaritan llospital, was passed out and you all have.
- 20 a written statement on it, and I also provided some-more 21 information relative to the Good Samaritan llospital,'it's
- 22 actually two dif ferent f acilities, and if it's all right, 23 Mr. Chairman, I'll just sort of-rush through the first one 24 and then try to stay a little bit-of time-on the second 25 one.
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47 1 Looking at the first slido -- make that the 2 second s11do -- we're talking about the Dosort Samaritan 3 Hospital. (Slide) 4 And we're lust briefly going to talk about the 5 situation thero. Third slido. (Slido) Moving quickly on 6 the slides thero. ,
l 7 Describe the event, few things that contributed )
1 8 to it, and what we've done. The problem was to koop up l 9 with the current status until we got to the second one.
10 Next slido, please. (Slido) -j 11 Okay. This particular event involved a call to j 12 the radiopharmaceutical company asking f or a dose. _ . It wan l 13 supplied at 100 mil 11 curies instead of 100 microcuries.
14 The technician didn't check things, and subsequently gave 15 .it to the patient, resulting-in an estimated 200,000 rada i 16 to the thyroid, with roughly 170 rads whole body.. This 17 occurred in November of 1989.
18 The woman had five children -- that was involved 19 -- had five children in the home.- The critical dose was 20 to the four- and five-year-old children,_and-their dose 21 was 3_rada to thyroid, .and wo estimated 2 millirads whole 22- body.-- Next slide. (Slide)-
23 COMMISSIONER REMICK: Excuse ma. What wasitho? i 24 source of the thyroid exposure to --
25 MR. GODWIN - Iodino 131.
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48 )
i 1 COMMISSIO!1ER REMICK: 11 0 , but what was the l 2 transfer mechanism? l l
3 HR. GODWI!1: On, just contamination within the i
4 home.
5 COMMISSIO!1ER REMICK: I see.
6 HR. GODWIll: The patient was home with 100 7 millicuries, and you lose rather quickly. The technician i 8 did not confirm what the dose -- calibrate what the dose 9 was. They looked at .i t . They had some question.
10 Although we subsequently did not leave this as a finding 11 so f ar as compliance was concerned, but still thet question 12 was there, how well the survey was conducted, or did they 13 conduct a survey of the incoming package. A side question ;
14 related to whether the - shielding was- supplied for the 15 incoming package that was normal.for a therapeutic dose, 16 and all indications was there was no shield ' in there, 17 which should have been there for a-millicurie type dose.
18 They did not compare the doses as prescribed, was the root 19 cause of that. Next slide.. (Slide)
- 20 -When we went over to the radiopharmaceutical 21 company and looked there, we couldn't' read his writing 22 either. Also, they had no methodology ~of confirming what ,
23 the prescribed dose would be versus.what<was. ordered, so
~
24 they' didn't check it out either, and they did-not even' 1 25 . identify who'd received the order, who had made the order.
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49 i 1 It was just a little note, here it comes. They also did 2 not put the name on the proucription for this type thing, .
3 which sometimes happens. Next slide. (Slide) !
4 This resulted in a $12,000-civil penalty to the f; 5 facility, and int a short time a reduction to using over t
6 100 microcuries of iodine. That subsequently was lifted e 7 after they demonstrated they were able to . institute 8 necessary safety programs. Next slido. (Slide) ;
9 The radiopharmaceutical company was initially ,
10 issued an order that required them to confirm the. therapy
- 11 dose for lodine 131 if it was over 1 millicurie, must have 12 patient's name, and the name of the individual ordering 13 the dose, so we'd have a little bit clearer understanding 14 of what's happening there. They subsequently adopted that 15 procedure nationwide, I understand, and that's just part j 16 of the lodine condition now.-- Next slide. (Slide) ,
17 Good Samaritan Hospital is a teletherapy I 18 exposure. This particular iacility had one cobalt unit .
- 19 and. two particle accelerators. The event was on the cobalt 20 -unit. Next-slide. (Slide) -
21 In this particular. event, they. lost- their
~
22 medical physicist, and they had a dosimetrist who was 23 doing -- 75 percent of the time was related to dose
- 24. calculation and 25 percent was to ather duties,'and they- ->
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50 ;
1 in using their computer. They entered the wedge factor i 2 effectively twice and, therefore, it lengthened the 3 exposure time, and ended up with up to a 40 percent 4 increase in radiation. I should point out that we list 5 four patients there. Three of the patients would be 6 misadministrations, onc of them died during the treatment, 7 did not complete the treatment, so never became a 8 misadministration in the technical sense.
9 We did request assistance from NRC, and wo 10 requested that, I believe, in September, and we received 11 it in tiovember of, again, '89, so these events are sort of 12 overlapping. The medical physicist did not indicate that 13 it was a radiation cause and effect related to the 14 patient's death, but there was a patient death involved 15 here. '
16 CHAIRMAN SELIN: It wasn't a misadministration 17 because all that was kept track of was the cun.ulative 18 dose?
19 MR. GODWIN: That's correct.
20 CHAIRMAN SELIN: But the actual intensity was 21 much higher than --
22 MR. GODWIN: Was higher, that's correct.
23 CHAIRMAN SELIN: But that may be a-weakness in l
E 24 how we define misadministration.
25 MR. GODWIN: Well, you know, it just didn't get' NEAL R. GROSS l _ COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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51 I to the endpoint. Next slido. (Slide) 2 MR. T110MPSON: Mr. Chairman, I think in the new 3 medical misadministration rule, we have changed that 4 aspect.
a 5 COMMISSIONER ROGERS: It would be each step in 6 the full procedure, would it not? i 4
7 HR. THOMPSON: That's correct.
8 MR. GODWIN: The contributors, you know, they 9 didn't understand. You had several successive userw of 10 this particular computer program who didn't understand how 11 it was plugged into the program. It was a loss of 12 communication, really, is where it fell down.
13 And also some contributors was that the 14 Radiation Safety Committee, for example, wasn't meeting 15 when it was supposed to. They would meet without the 16 radiation safety officer or the administrative folks.
17 They'd meet without anybody from oncology. And even af ter 18 the event, they didn't aggrossively get involved - for a
+ 19 while. So, we had several events that contributed to it.
20 Next slide. (Slide) 21 You all did-provide a medical physicist. That's 22 really not an enforcement action, but it's the only place 23 we could plug it quickly into the slidos here. We 24- initially proposed a $3',000 civil penalty af ter - their
( 25 response to that, and some more factors led us to believe L NEAL R. GROSS COUNT NEPORTER$ AND TRANSCRIBE 45 '
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52 1 that they were not being very aggressive, and the 2 penalties revised upward. Then we made some other 3 discoveries. And it was proposed at S7,000. At that 4 point, they got real aggressive on things.
5 We also discovered a problem where we were ,
6 trying to issue a citation in which we were saying that 7 the intentional exposure under a medical prescription is 8 okay, but anything above that would not be okay. And 9 there were some quirks about how it was set up, and our 10 attorney general did not feel that we had as good as case 11 as the way this particular set of events set up, as wo I
12 should have. So, subsequently, we did not pursue the' 13 civil penalty. However, we have conditioned the' license, 14 and they have been in compliance since then. They've kept 15 a full-time medical physicist on staff. So, we got their ,
16 attention. Did not go through with the civil penalty.
17 And I think I'll wrap it up at this point, 18 unless you all have some questions.- I wanted to just hit 19 these rather quickly.
- 20 CHAIRMAN SELIN: What I'd like to do is go 21 through all the pieces, and then we might have some 22 questions across-the-board. Mr.-Bailey?
23 -MR.. BAILEY Mr. Chairman,, Commissioners, I am 24 Edgar D. Bailey.. I'm Chief of the California Radiologic 25 Health Branch. California has been.'an Agreement State NEAL R. GROSS -
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- 33 l
1 since 1962. We have approximately 2,300 radioactive 2 materials licenses, with an annual budget in the 3 department, or within the Itad llealth Branch, of between S6 4 and $7 million. We collect our operating expenses 100 5 percent on fees, and for about the past three years we've 6 been donating to the general fund about $1 million a year, A
7 to help out the deficit we have.
8 We also register x-ray machines. We probably 9 have 58,000 facilities of that type. We also certify 10 technologists, both x-ray technologists and nuclear 11 medicine technologists, and probably unique, I think, is 12 that we also certify doctors to use x-ray machines. They 13 actually have to come in and get a permit from us in 14 addition to their medical license, before they can take x-15 rays. In that group, we have about 50,000, in the docs 16 and techs.
17 We also have somewhat over 1500 nuclear medicine 18 technologists. We operate out of three regional officen
- 19 and three county offices.
20 The incident I'm here to describe today to you 21 is one that occurred, resulted in a death on August 21st, 22 1988, of Dwight Gregory Goldstein, II, who died at 23 Children's llospital in Oakland, California. According to 24 the death certificato, the death was caused by respiratory 25 failure, and I quote, "due to, or as a consequence of NEAL R. GROSS COURT REPCRTERS AND TRANSCRtBERS 1323 RHODE ISLAND AVENUE t4 W QO2) 234 4433 WASHINGTON. D C 20005 (702) 2R4433
l 54 1 radiation damage".
2 In September,1992, several members of the staf f 3 of the Radiologic Health Branch, including myself, were 4 contacted by a reporter from The Plain Dealer. The 5 reporter asked for our files and information related to 6 this 1987 cobalt-60 teletherapy misadministration at Alta 7 Bates Hospital in Oakland which resulted in the death of 8 a nine-year-old boy.
9 At the time of the reporter's calls to RHB, we 10 had no information regarding the alleged incident. In 11 response to questions from RHB staff regarding the 12 reporter's accusationa, representatives from Alta Bates 13 Hospital assured them that the reporter's claims were 14 erroneous. On September 9, 1992, I personally talked to 15 a representative of the Risk Management Department at hita 16 Bates Hospital. When I was talking to some of the people 17 here, they said I might point out that the Risk Management 18 Department is essentially the department that attempts to 19 limit the liability of the hospital. There may not be any
- 20 safety engineers located in that deparv. ment, so there's a 21 little different connotation to risk.
22 CHAIRMAN SELIN: Different management of risk.
23 MR. BAILEY: It's a question of whose risk it 24 is.
25 (Laughter.)
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55-F 1- MR. BAILEY: At that time, I was_ told that the .
2 incident involved treatment with a linear accelerator, not 3 a teletherapy unit. I was also told that. the dose 1 i
4 prescribed was the dose delivered. I was also told that.
C 5 the dose vas delivered to the correct location.- In l
l -
6 addition, I was told that the dose was a palliative 7 treatment of a terminal patient with neuroblastoma, and 8 led to believe that in general the whole thing was simply ->
9 a malpractice suit.
10 This information was provided to me even though-11 we discussed the fact that the medical misadministration 12 reporting regulation had become effective in california on 13 October 5, 1989, nearly two years af ter. the incident 14 occurred.
15 on December the 13th,:as you're'all aware, the~ i 16 first in the series of'The Plain Dealer articles 'was 17 published. The lead story was about the incident at Alta' 18 Bates Hospital. Somewhat to our surprise, there was no l
4 19 pick-up by the local Bay Area newspapers or television 20 stations. And I'm not saying that that -- at first,. tended:
21 to lend some credibility to the -information we'd received 22 from the hospital because, you know, we didn't go to the -
23 mass, " Hey, do you believe this-story _or not". However, 24 on January 6 of-this year, due to increasing' concern that 25 we didn't have all the facts, the manager:of our regional NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N.W.
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56 1_ office in Berkeley went to Alta Bates Hospital and found 2 that we had not been - told the truth in the earlier 3 contacts with the hospital. He found that in essence the newspaper article was correct in what it had reported as '
4 5 having occurred. Contact two days later with the West 6 Coast Cancer Foundation, which was the consulting medical 7 physics group which developed the treatment plan for the-8 patient, collaborated the new information.
9 The following is the sequence.of events as we 10 now believe they occurred. The child was referred to Alta -
11 Bates Hospital by Children's Hospital of ' Oakland for 12 treatment for -- and if there are any phyoicians here, 13 please forgive my pronunciation --
of rhabdomyosarcoma 14 because Children's Hospital did not the appropriate 15 radiation therapy equipment.
16 A treatment plan-for the child was developed by 17 West. Coast Cancer. This medical physics group worked 18 under contract to Alta- Bates because the hospital did not 19 employ staff medical physicists. The - treatment plan-
- 20 involved a series of complex treatments covering a part of 21- the face and upper neck. That is to say, the treatment' 22 was to occur over several days with multiple beams and a 23 number of fields.
24 Treatment of the patient-began on December 4 25 1987, and continued on a ' daily - basis, except; for - the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 2344433 WASHINGTON D C. 20005 (202) 234 4433
57 I weekends, for 15 treatmento ending on December 24. The 1
2 patient developed what has been described as "a sore" in 3 his mouth, and with the holidays approaching were told 4 that they decided to halt the treatment to allow the 5 patient to improve. When the patient returned in January, 6 the face and neck contours had changed so much that a new 7 treatment plan was ordered. _
8 As it turns out, the same physicist at West 9 Coast Cancer Foundation was drawing up the treatment plan.
10 When he drew it up, he noticed that there was a 11 significant difference in the numbers from what he had 12 done in December. lie looked at them and found that 13 basically what had happened in December was that the time 14 of treatment was twice as long as it should have been, 15 which resulted in the prescribed dose of 180 rods per day, 16 when in fact about 360 had been delivered each day.
17 On January 28th, the West Coast Cancer 18 Foundation notified the staff oncologist at Alta Bates o 19 Ilospital of the mistake, and the radiation oncologist 20 filed a written hospital incident report with the 21 hospital's Risk Management Department on February 5th.
22 No additional radiation therapy treatments were 23 given. The child died seven months later. An autopsy was 24 perf ormed, but at this time we do not have a copy of that.
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58 1 been conducted at West Coast Cancer. The radioactive 2 materials license issued to the group is for the 3 possession and use of three small calibration or check.
4 sources. The actual activity of preparing treatment plans 5 or doing the calculations is not a licensed activity per 6 se, but is included in the authorization to-the hospital 7 for the teletherapy treatment of ' humans. Medical 8 physicists are not licensed in California at this' time, 9 although there is an effort underway this year by the 10 medical physicists to get state licensure similar .o what' 11 they were able to get in Texas a couple of years ago.
12 During the inspection at West Coast Cancer-13 Foundation --
there's a question we ask on-all of-our 14 inspections basically, and that is, are there any usual 15 occurrences or incidents that have occurred that haven't 16 been reported to us or haven't been mentioned. The RSO at 17 that time, the Radiation Safety Officer, responded-that-18 there had been none. When' asked about this. response in 19 January of this year, he said that he had not mentioned it- -
20 because the case..was in litigation. And that'certainly 21 raises a little bit of' concern with us about how 'many
- 22. other cases 1 we weren't told about because they possibly-23 .were in litigation.
24 On June 20th and21st, 1990, we did.a routine-25 inspection at Alta - Bates. A review of the Radiation NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE, N W.
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l 59 1 Safety Committee's minutes show no reference to this 2 misadministration. And this year in January, when we 3 questioned the RSO, she said that she and the chairman of 4 the Radiation Safety Co.. nittee only became aware of the 1 misadministration when we called them to get information 5
6 in 1992. Although the head of the radiation oncology unit 7 must have known about the incident when it occurred, it 8 appears that he did not inform the RSO or the committee 9 oven though he was a committee member. lie has since left 10 the staff of the hospital.
11 It should be noted that the West Coast Cancer 12 Foundation is no longer the consulting medical physics 13 group to the hospital.
14 It is reported that West Coa r.t Cancer 15 Foundation, or the radiation oncologist, and the hospital 16 have settled lawsuits with the patient's family.. The 17 doctor and/or West Coast Foundation has reportedly settled -
18 for half a million dollars and the hospital reportedly o 19 settled for $30,000. I think in our looking at both.of 20 those numbers, they are extremely small and then therefor 21 somewhat questionable to the accura y of those settlement 22 numbers.
23 Following discussions with Mr. Kammerer of the 24 Office of State Programs, I fax'd him a letter on January 25 14th requesting assistance from NRC of an investigator NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 7344433 WASHINGTON; O C 2000S (202) 234 4433
60 1 from the Office of Investigations to help us thoroughly 2 investigate what appears on the surf ace to be a deliberate 3 attempt to cover up the occurrence of this apparent 4 misadministration. On January 22nd, Mr. Ben Hayes, your I
5 Director of Of fice of Investigations, instructed his staf f 6 in Region V to assist California in its investigations.
7 We held our first meeting with the assigned investigator, 8 Mr. Eugene Power, in Sacramento last Monday.
9 In addition to Mr. Power, RHB is seeking the 10 assistance of our Licensing and Certification unit. They 11 are the organization within the Department of Health 12 Service that are responsible for the licensing and 13 regulation, the overall licensing and regulation, of 14 hospitals. And it appears at this time that there-may be 15 some violation of their reporting requirements because 16 they were not notified of this incident when it occurred.
17 Our Office of Legal Services has already 18 assigned an attorney to work on this, and he has contacted 19 the Attorney General. It is the intent of RHB that a -'
20 thorough and complete investigation of his entire incident 21 will be conducted, and that if violations of California 22 laws and regulationc are identified, the case will be 23 referred to the AG or the district attorney as 24- appropriate, for their action. At the present time, the 25 investigation is ongoing.
l- NEAL R. GROSS l COURT REPORTERS ANO TRANSCRIBERS I 1323 RHODE ISt.AND AVENUE, N W (202) 234 4433 WASHINGTON. O C. 20005 (202) 2344433
61 1 It is clear to me that there are difficulties 2 that exist in investigating and taking m'en n i n g f u '.
3 enforcement action in incidents like the one I've 4 described. There are a few recommendations or suggestions i
5 that I believe would be helpful.
6 The first is that misadministrations should be 7 violations. At the present time only the failure to 8 report them is a violation. One has to cite failures to 9 follow procedures such as does assay, patient 10 identification, and so forth.
11 We have, in our law on nuclear medicine 12 technologists, we have words to the effect that the 13 license or certificate may be revoked, denied, suspended 14 by the state for among other things,- incompetence or 15 negligence in performing nuclear medicine- technology 16 functions. I think it would be appropriate if that were 17 a reason to suspend a nuclear medicine license or an 18 authorized user from a license. If you have a series of
' 19 misadministrations, and we have at least < >ne hospital 20 where that's occurred, we've had a series cr them, it may
^
21 be time to say, okay, we're going to suspend them and get 22 the program in line.
23 Secondly, consideration should be given to 24 requiring medical licensees to report the filing of 25 malpractice suits against the licensee or named users on NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE tSLAND AVENUE, N W (202) 2344433 WASHINGTON. O C 20005 (2021 234 4433
62 1 the license. This would follow the precedent already set 2 of requiring licensees to report the filing of bankruptcy 3 actions.
4 Third, consideration should be given to 5 requiring that each Agreement State have inspectors or 6 investigators who are p3 ace officers. The Food and Drug 7 Administration already requires such of certain state food 8 and drug personnel. These state investigators should be 9 required to have training similar to that provided to NRC 10 investigators.
11 And, fourth, ont that's not on here is , _ we 12 really need to develop a common database and implement 13 that database system in Agreement States and in NRC. This 14 go-around certainly illustrated the lack of uniform data 15 and consistency in what it means.
16 That concludes my remarks. Mr. Donald Bunn, our 17 Chief of Enforcement and Compliance, is with me today. He 18 and I would be happy to answer any questions you might 19 have.
- 20 CHAIRMAN SELIN: Before we go on, Mr. Bailey, 21 I'll tell jou one thing -- there are many things that are 22 troubling about your report, of course, but the one thing 23 that's particularly troubling, we've sort of assumed that 24 the records are available if you only take the trouble to 25 find them and that therefor the probability of gross NEAL R. GROSS COURT REPORTERS AND TRANSCA1BERS 1323 PHODE ISLAND AVENUR il W (202) 234M33 WASHINGTON, D C 20005 (202) 234M33
63 1 underreporting of misadministrations or something like 2 that ir 'quite low. But you've really described a 3 oituation where the records just weren't there. And 1 l l
4 wonder if you'd care to comment on that. l l
4 5 MR. BAILEY: Well, I guess, two things. First 6 of all, we did not have a misadministration reporting rule 7 at the time.
8 CllAIRMAtl SELIll I'm talking about within the 9 institutions, even if they don't report them to the 10 agency, that if one goes in and looks at their recorda, 11 one should have a very high probability of finding them.
12 That doesn't neem to be the cane in the situation that 13 you're describing.
14 MR. BAILEY: Yeah. I think what we may have l
15 more often than we'd like to admit is that within a 16 hospital, you have a contract radiation oncology group 17 that in semi-independent of the nuclear medicine program 18 and, therefore, the information may not be fed in. We may 19 have a very special case here where one individual, for i 20 whatever reason, chose not to inform the . rest of the 21 committee. From the information we have, it was clearly -
22 - it seems like it's clear that he would have reported 23 that to the committee t,f which he was a member, but 24 according to what we know at this point, he did not. So, 25 that's one of the things that certainly is disturbing to NEAL R. GROSS count f1EPORTERS AND TRANSCAlHEf1S 1323 (D40DE ISLAND AVENUE, N W (202; 234 4433 WASHINGTON, D C 20005 (702) 234 4413
64 1 us, too, when we start looking at what goes on in 2 hospitals. I think we've got other examples where 3 contract therapy groups come in and they are independent 4 from the nuclear medicine group, and they pretty much run 5 their own show, unfortunately.
6 CHAIRMAN SELIN: Mr. Godwin? '
7 MR. GODWIN: Mr. Chairman, in Alabama, we found 8 that you really had to dig to get always to the bottom of 9 the record. We had at least one incident in which a 10 hospital threatened to use risk management as a way to 11 hide records, but they decided not to after some 12 discussions.
13 In Arizona, apparently the situation is 14 essentially similar there. There've been some cases where 15 they're saying it's in litigation and they don't want to 16 discuss it until it gets through litigation. So, you can 3 17 have these situations occur.
18 COMMISSIONER CURTISS: Let me just ansk one 19 question here. I don't want to go into the details of -
20 this. Do you have the capability within the staf f of your
~
21 state to conduct investigations generally of events like 22 this?
23 MR. BAILEY: Yes, in general, we do. What may.
24 be another unique feature of the California regulation, 25 the law enacting, the Radiation Control Act, makes it a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 74HOOE ISLAND AVENUE. N W (202) 234-4433 WASHINGTON. D.C 20005 (202) 2344433
65 1 misdemeanor to violate the law or any regulations 2 promulgated thereunder. So, in theory at least, every 3 single violation can be a criminal violation as well as a 4 civil cause of action. So, from that standpoint, yes, we d
5 do go in quite often.
6 What we have here, though -- and those we pretty-7 much handle and get the information that we need. What we 8 don't have are really trained legal investigators, people 9 who are used to taking depositions and that sort of thing.
10 We felt that this was a serious enough thing, and it was 11 outside the normal regulatory reg violation because we 12 felt that we'd been misled, that we asked for assistance 13 from you all to help is with --
to make sure that we 14 didn't mess it up, essentially.
15 COMMISSIONER CURTISS: Okay.
16 CHAIRMAN SELIN: Thank you. Mr. Fletcher? You 17 guys aren't sitting in alphabetical order, very confusing.
18 MR. FLETCHER: Mr. Chairman, good aftornoon, r 19 members of the Commission. My name is Roland Fletcher.
20 I'm the Administrator of the Radiological Health Program 21 in Maryland. Maryland became an' Agreement State in 1971.
22 We currently have 521 licenses in effect. We also-23 regulate x-ray machines. We have 4400 x-ray facilities.
24 It comes to about 13,000 x-ray tubes.
25 We also do other things with a staff of just a NEAL R. GROSS l
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66 1 little under -- just a little over 30. But the reason 2 that I'm here this afternoon is to go over the incident 3 that occurred at Sacred Heart Hospital back in 1978 --
4 actually, it happened over the period September, 1987, to
, t 5 October, 1988. During thct period, 33 of 39 patients 6 being treated for intercranial lesions -- and let me note ,
7 here that all of these patients, all 39, had been 8 diagnosed as terminally ill -- they received fractional 9 radiation doses that were 75 percent excessive to the 10 doses prescribed. Now, why did this happen? ,
11 The cause has been found to have been the fact 12 that in March,1987, a cobalt-60 source exchange occurred 13 at the hospital. The new source was 7645 curies. That 14 was what it was recorded assayed on March 29th. And all 15 of the computer files for the use of this new source were 16 updated save one, and that was the file regarding the use 17 of tremors. And the reason that file was not updated was 18 because the radiotherapist insisted that the health 19 physicist who was installing the new program did not have 20 to update that file, it was never used, and as a result 21 that file was not updated to reflect the new source, the 22 new concentration. So, the file retained information that 23 was pertinent to the old source rather than the new.
24 Upon the request of therapy technicians of 25 Sacred Heart Hospital to their consultant, Mid Atlantic NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE, N W (202) 234 4433 WASHINGTON, D.C. 20005 (202) 234 4433
C7 1 Radiation Services, and their concern for the 33 patients, 2 a complete review was conducted by the consultant, which 3 uncovered the patient overexposures. Confirmation was 4 made on October the 26th, 1988. It was at that time that t
5 we were notified by Sacred lleart's vice president the next 6 day, of the 33 patient overexposures, lie added that all 7 M the cobalt-60 schedule treatments had been suspended 8 pending a r. ongoing investigation. Notification of all 9 attending physicians and families were being carried out 10 according to the vice president's information.
11 Now, let me point out here, as is the case in 12 almost every misadmjnistration s!.cuation, what we had to 13 respond to was the fact of the rcport of the 14 misadministration, not the misadministration itself, the 15 time period of the reporting. The reporting was not done 16 in accordance with the regulations, and that is a 17 limitation, but we did respond promptly with investigation 18 of the entire situation, and found that the physician, the a 19 radiotherapist, had actually been using the program using l
20 tremor bars that had not been updated, and that's why the 21 actual dose being given was excessive.
22 Of course, we recognized that this was a very 23 serious incident and notified, you know, all of those on 24 our staff, and conducted a very thorough investigation j 25 which lasted quite a bit of time. We wanted to make sure NEAL R. GROSS COURT AEPORTERS AND TRANSCR!BERS 1323 RHODE ISLAND AVENUE, N W.
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68 1 that the hospital followed through. We did not . feel 2 qualified to follow through in medical diagnosis, or 3 medical prognosis, medical treatment, but we wanted to 4 make sure that the hospital, and the hospital did assure 5 us repeated.ly that the attending physicians were notified, 6 and the attending physicians were to therefor notify 7 families. But that was the level of follow through that 8 we followed. Our concern was to ensure that the hospital 9 itself corrected the situation and put rules in place to 10 ensure that it didn't happen again.
11 CHAIRMAN SELIN: But did, in fact, this 12 information get transmitted to the attending physicians 13 and to the patients?
14 MR. FLETCHER: That's what we were told. We did 15 not personally check to make sure it happened, but the 16 hospital administrator said that it did.
17 CHAIRMAN SELIN: Do you know today whether this 18 happened or not? There was something in the paperwork 19 that suggested that this information wasn't transmitted 20 for confidentiality purposes, or some other reason.
21 MR. FLETCHER: No. The information that was 22 reported in the paper -- the information we have is that 23 the attending physicians did tell- the families,.but we 24 didn't personally check to find out.if that happened.
25 CHAIRMAN SELIN: Do your rules require that the NEAL R. GROSS COURT REPORTERS AtlO TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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69 1 patients or the families be told?
2 MR. FLETCHER: No, not by'us.
CHAIRMAN SELIN: Are your rules silent on '
3 4 whether the patient has to be informed, or do they require 5 that the patient be informed by the-hospital? What's the-6 status of your rule on informing the patient?
7 MR. FLETCHER: I think our-rules are silent on.
8 whether or not the actual families have to be informed. '
9 COMMISSIONER CURTISS: If, and when, you come 10 into compatibility with Part 35, your rules will have to 11 do that.
12 MR. FLETCHER: Yes.
13 COMMISSIONER CURTISS: So, if you're not 14 compatible now, Part 35 requires you to do that. .Whether 15 they did before, I don't know.
16 MR. FLETCHER: Right. We're in the process.of -
17 -
c 18 MR. TRUMP This is Carl Trump,.of.the State of a 19 Maryland. Our regulations do require that-families of 20 those suffering or recurring misadministrations are 21 notified. That question was repeatedly asked of the 22 administration, and we had the ~ assurance of 'the 23' ' administration -on. all occasions. that the attending 24 physicians of those patients being treated.for those type 25 of brain tumors were notified, even to the point where two NEAL R.-GROSS COURT REPORTERS AND TRANSCR10ERS 1J23 RHOOE ISLAND AVENUE. N W (202) 234-4433 ' WASHtNGTON. O C; 20005 (202) 234 4433
70-1 attending physicians were out of town at one point._ They 2 pressured the physicians upon return to the hospital, to 3 notify those families. So, yes, they were, but we do not 4 exactly go to those families themselves and ask the next 5 of kin or the families or friends per se, if they had been -
6 notified by the attending physician.
7 (Whereupon, Chairman Selin left the Commission 8 meeting room.)
9 COMMISSIONER ROGERS: Just continue.
10 MR. FLETCHER: Okay. We continued the 11 investigation. It was initiated on October 28th. In 12 order to ensure that we had a complete evaluation of the 13 patients, we brought in a medical oncologist as a 14 consultant, to review the patient records. We also 15 brought in a medical physicist to examine the program that 16 had been put on the treatment program, to verify that that 17 was actually the cause of the'misadministrations.
18 We went through the hospital procedure as f ar as 19 the Radiation Safety Committee programs were concerned. -
20 The hospital was very willing and cooperative to do
^
21 everything they needed to do to currect the situation. As 22 I said, we worked on this investigation for almost a year.
23 The hospital's action, they terminated the radiotherapist 24 responsible for the misadministrations. They hired a new L 25 oncologist. And they hired the Mid Atlantic Radiation l NEAL R. GROSS COURT REPORTERS AND TGANSCRIBERS 1323 RHODE ISLAND AVENUE, N W.
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71 1 Services as a weekly consultant.
2 As a result of this event, we produced a letter 3 on September 8th,1988, to Sacred lleart llospital, seeking 4 corrective actions and pursuit of a $15,000 civil penalty, s.
5 and recovery of $2,000 paid to the consultants.
6 On a request from the hospital and in 7' consultation and advice with the Attorney General's Of fice 8 and the HD staff at that time, we reached a consent 9 agreement with the hospital in November of 1989. The 10 settlement -- we accepted a settlement of $7500 against 11 the penalty and, of course, the $2,000 recovery that we -
12 had previously sought. In the consent agreement, we had ,
13 stated, or we had agreed that . we would not --
would 14 actively seek to release the information regarding this 15 event, in protection of the families that had been 16 involved.
17 In late spring of this year, late May, we were 18 contacted by the Cleveland Plain Dealer .regarding the
- 19 situation that had occurred at Sacred !! cart in-1988. In 20 consultation at that time, we provided them with a summary 21 of the events, but we also provided them with a copy of 22 the consent agreement which, at that time, we were still i
23 recognizing.
l 24 We examined the request. We-examined the file.
25 We looked to see how we could meet the request.from the NEAL R. GROSS COURT REPORTEHS AND TRANSCRWERS 1323 AHODE ISLAND AVENUE, H W-1202; 234 4433 WASHINGTON. D C 20005 (202) 234 4433-
l l
l 72 1 Cleveland Plain Dealer and, at the same time, protect 2 those families, and we came to the conclusion that that 3 could be done. We would just protect the families named, 4 and that was the decision that we made in late-1992, and-5 we released that information.
6 COMMISSIONER ROGERS: All right. Shall we move 7 on to Mr. Lacker, please?
8 MR. LACKER: Thank you. Mr. Chairman and 9 members of the Committee, my name is David Lacker. I have 10 with me Richard Ratlitt, who is the Director of our 11 Division of Compliance and Inspection.
12 It's interesting, January the 10th of this year 13 was the 30th anniversary of our signing an agreement with 14 the Commission, and March the 1st of this year will be-the 15 30th anniversary of the effective date of that agreement, 16 and I've been there all that time -- (laughter) -- which 17 may be indicative of something, I'm not sure.
18 (Laughter.)
19 But we do appreciate the opportunity to meet 20 with you and discuss these issues.
21 I would like to just make one brief comment to 22 some discussions earlier when the three organization.of
, 23 Agreement States people were up here and talking about how l
24 penalties could be adjusted.
25 While our administrative penalties rules don't l NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS l
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l c7 3 1- say that we can direct that th'ey put money.into a certain' '
2 aspect, we propose a penalty _ for _ v' dations, then our ,
- )
3 office of General counsel can negotiate what those-- J l'
4 penalties will be. And on one occasion, we hadEin-an 5 industrial setting required that in lieu of money given to j 6 the state, they spend cortain money. on their radiation i o
7 safety program. So, that's the flexibility we.have, just-8 as an item of interest.
9 I was asked to briefly . talk about 'two ,
1 10 misadministrations that occurred in Texas, . West flouston - ,
11 Medical Center. The Plain Dealer article-is essentially 12 correct in everything it says about that.- Tne event was-13 a patient was given a 30 millicurie instead' of 30.
14 microcurie Iodine 131 dose. The technologist who normally 15 worked in the-nuclear medicine department wasn't:there, 16 and a bac k up technologiste had received appropriate training-in nuclear medicine,-and was presumed capable of
~
17 18 doing:her job.
4 19 When the doctor order the thyroid scan, the 20 technologist ordered 30 millicuries -from- a nuclear ,
21 pharmacy rather than 30.microcuries, and did not recognize -
.22 the . error, - n1though there was a~ delay in getting the : dose 23 to the hospital' when the pharmacy explained that it had to 24 be postponed because they_couldn't change the delivery on-25 the day it had originally been requested.
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 2344433 WASHINGTON. D C 20005 (202) 234-4433
74 1 -When the dose arrived, the-technologist placed 2 it on a dose calibrator, was perplexed by the high rate -
3 count, and commented to the physician, and he didn't '
1 4 really recognize the problem, and they went ahead and did 5 it, did the examination. The patient was given the 6 capsule, to go home, take the 30 mil 11 curie dose, which .
7 should have been 30 microcuries, and then return the next--
8 day for the scan. -
9 Actually, after the dose was- given, the 10 technW ogist later on in the day called to order for the 11 next day, and ordered 30 microcuries as appropriate for 12 the scan, the next scan, and was told that it would'be~
13 there the next --
be delivered right away, and she 14 wondered why. The pharmacist said, well, because the 15 other order- was for 30 millicuries, not --
this is 30 16 microcuries. The technologist did recognize she had made 17 a mistake. She notified another physician on the' hospital 18 staff, and that physician consulted with the - patient's 19 physician and called her back to the hospital and .
20 administered a blocking agent, but it was 12-hours after 21 and it was a little bit late to-do much good = -
22 Estimates were that the thyroid received--
23 approximately 30,000 rads. That was estimated by the 24 hospital. Our calculations estimated approximately 34,000 25 rada, which is well within normal range-or difference for-NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE, N W (202) 234-4433 WASHINGTON, D.C 20005 (202) 2344433
75 -l 1 that- kind of a dose. The liospital-is performing follow-up 2 .on the patient. We have not heard recently on'the status- -)
3 of that patient. We will be checking as a result of this,1 4 to find out what the hospital has done.
a 5 We did not issue any penalties to the hospital I 6 because of this particular incident. They had had.a good 1 7 compliance history. They had not had any significant 8 noncompliance --
I think two or three minor items of l l
9 noncompliance over a four-year period. They : agreed to . l 4
10 change their procedures to prevent this kind of thing f rom 11= happening in the future, and that's the status-of that.
i 12 I was also asked to talk about one that doesn't 13 deal with byproduct material, but deals with an- l 14 accelerator incident at East Texas Cancer Center ~~-
15 COMMISSIONER de PLANQUE: Before you-go on to-16 the next one, Texas- has n' credentialing program for:
17 technologists, is that correct?
18 MR. LACKER: Yes, it's.not=run by our' bureau,
- 19 though.
20- COMMISSIONER de PLANQUE: lOkay.
21 MR. LACKER: It's run in a separate _---
22- COMMISSIONER de PLANQUC: ' Was this technol6 gist
-23 : credentialed?
24 MR. LACKER: At the time, this- -- I don't 25 believe the technology credentialing law was in place.
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76 1 COMMISSIONER de PLANQUE: At that time.
2 MR. LACKER: I think it was put in in '87.
3 COMMISSIONER de PLANQUE: And was there any 4 action taken at all with regard to the technologist?
5 MR. LACKER: She is no longer ut, the hospital.
6 I don't know whether she resigned or was discharged, but 7 we didn't take any action as an agency. The East Texas 8 Cancer Center at Tyler operated a Thayerac 25 accelerator, 9 and it is computer operated, and we received a report of 10 this overexposure, or misadministration, on April the 8th 11 of 1986, and we did not have a reporting rule in place.
12 The licensee voluntarily reported it. And we felt like we 13 had pretty good reporting even before the rule was-in 14 place, on these kinds of things.
15 A patient was being treated on the right side of 16 his face with the accelerator. The operator pressed the 17 treatment button, the machine shut down and indicated 18 malfunction 54 on the screen. . The operator went into the 19 room, and the patient was struggling to get up. He -
20 complained of a sharp pain in his ear and a warm 21 sensation. He - said he saw a flash of-light. Later he 22 suffered from nausea and vomiting. The physicist went on 23 to report that another incident'had occurred on March the 24 21st to another patient who was receiving a treatment in 25 the scapular area. The machine had shut off automatically NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHOOE ISLAND AVENUE, N.W.
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77 1 before the treatment was complete, displaying malfunction-2 24.- Again,.the patient reported that he felt a burning:
3 sensation and was trying to get off the table. The.
)
4 patient actually got of f the table and was in the entrance - l e
5 to the treatment room when the operator reset and tried to l 6 init. late another treatment.
7 During our-investigation, we discovered that'at )
8 the time of the first incident, the intercom to the 9 treatment room wasn't working and the television monitor 10 was not plugged in. There were two technolog'ists working- j 11 with the machine at the time of treatment, and through 12 some miscommunication neither of them had hooked up the TV 13 monitor.
14 The physicist reported that after the first 15 incident, he requested that the manufacturer look into the--
16 problem. The _ manuf acturer's representative could not 17 recreate the malfunction 54, and found no. problem with the 18 accelerator. An electrical engineering firm was called-to 19 look into the _ possibility of an electrical shock, but-20 found no electrical problems.
^
21 After the second incident, th'e physicist was 22 successful in recreating the incident. Both patients.had 23 -been scheduled ' for . electron therapy. The -operator 24 incorrectly entered-proton therapy,-which automatically-25 set the-energy at 25 MEV. Af ter the prescription was-NEAL R. GROSS COUni HEPORTERS AND TRANSCRm(R$
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- ~ . . . . . . , - -
78 1 entered, the computer verified the treatment parameters.
2 The operator, in making the corrections, did so before 3 verification was complete, resulting in the machine being 4 partially set for x-ray therapy and partially set.for 5 electron therapy.
6 Both patients received an unmodified eleceron 7 beam with an energy of 25 MEV. Both developed skin 8 lesions to the treated areas. The first patient 9 complained of partial paralysis of the left arm and leg, 10 and currently -- this is at the time of this r^ port --
11 exhibited signs of Horner Syndrome. Both patients have 12 subsequently died. The second patient died of a grand 13 mall seizure. An autopsy was performed, but the report we 14 didn't have, and I have not seen that report yet.
15 We immediately reported the incident to the Food 16 and Drug Administration, since this was a medical device, 17 and they regulate medical devices. And the one thing I 18 want to comment about was that there was an indication in 19 The Plain Dealer article that there was some time before -
20 FDA made corrections, but that wasn't exactly true. While 21 the new procedures were finalized and the corrections were-22 made to software sometime later, all of the people who 23 owned these types of machines in this country were 24 notified of these' incidents --
there was also one in 25 Washington, I believe -- and were given some procedures to NEAL R. GROSS COURT REPORTERS AND THANSCRIBERS 1323 RHODE ISLAND AVENUE, N.W.
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79 1 follow to be sure that it didn't happen, at least orally.- j l
2 -So,-they were working on getting the issue corrected alli
.I 3 that time. j l
4 Again, we issued-a notice of' violation citing e ;
5 the f acility for not maintaining visual contact which was !
6 a requirement of their license, during the treatments,_
7 again, based on their compliance history, and this..wac 8 basically a software problem with the computer. We di'd-9 not issue any civil penalties or administrative penalties.
10 That concludes my report.
11 COMMISSIONER CURTISS: Do you have civil penalty 12- authority?
13 MR. LACKER: We have what we call administrative 14 penalty authority, which is $10,000 per day per violation',
15 max. That is graduated down under the terms of the law --
16 -it's a complex-procedure--- where you give-credits and-17 faults. You can increase or decrease-based on certain-18 factors --
bad compliance history or good - ~ compliance a
- 19 history and those sorts of things.
20 We have civil penalties through the courts, 21 which is the way it's stated in Texas statute. That 10 up-22 to $25,000 per day per violation, and then we have-23 cri.minal penalties also.
24 COMMISSIONER CURTISS: Can you tell me just.off 25 the-top of your head, let's say over the past five criten NEAL R. GROSS COURT REPORT 3HS AND TRANGCR10ERJ 13'3 RHODE ISLAND AVENUE N W.
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11 80 1 years, how many administrative penalties you have issued?
2 MR. LACKER: Just happen to -- (laughter) -- 2 9 3 administrative penalties, two criminal penalties, and 32 4 civil actions.
5 COMMISSIONER CURTISS: And the time frame for 6 that is?
7 MR. LACKER: That's -- what is it, Richard?
8 MR. RATLIFF This is Richard Ratliff. That's 9 going to be.from about 1987 through current time period.
10 COMMISSIONER CURTISS: Okay. Do you have_ a 11 dollar amount on the administrative penalties?
12 MR. LACKER: No. I think it ---I don't have 13 that data with me, unleus Richard just recalls it.
14 MR. RATLIFF: I can address that if you'd like.
15 COMMISSIONER CURTISS: Would you, please?
16 MR. RATLIFF: On the-administrat.ieo penalties,=
17 they go from a low of $500 to a high of - -let me get the-18 right number here -- $625,000. The large one was for a 19 waste processor who was-not following procedures andLwe
- 20 had multiple problems. This is a variety of industrial, a
21 _ primarily the radiographers, waste licensees, and then the 22 medical that we have are primarily x-ray _ registrants---
23 dentists, chiropractors, veterinarians. On the 24 administrative penalties, the low is from S500.and the 25 high is up to $83,000. The ~ S83,000 was a radiography NEAL R. GROSS i CoVHT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W.
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1
81 l
1 penalty, but we mitigated a $16,500 cash penalty, and then 2 required the company each year f or three following years, 3 to put money into additional safety beyond what was 4 reg' ired by the regulations.
5 What's not noted in here, though, we had four 6 what we called " death" penalties in that we revoked 7 licenses, which we f elt was the ultimate because then they _
B went out of business.
9 COMMISSIOt3ER CURTISS: I have some other 10 questions.
11 COMMISS1011ER ROGERS: Please go right ahead.
12 COMMISSIOt1ER CURTISS: Actually, the questions 13 that I have are fairly limited, but I'd like to address 14 them to the group as a whole, and ask each of you if you s 15 could address these questions.
16 First, could you tell me what your authorized 17 staffing level currently is, and whether you are up to 18 your authorized staffing level with your programs?
< 19 Secondly, if you know what your attrition rate currently 20 is, I'd be interested in knowing that. And then, third, 21 with respect to each of these incidents that you've talked 22 about, I guess I'd be interested in knowing for a period 23 of time leading up to the incident, whether the scheduled 24 inspections that you had under your program - had been 25 conducted in accordance with the schedule called for, and NEAL R. GROSS COURT REPORTER $ AND TRANSCRmERS l 1373 RHODE ISLAND AVENUE. N W (202) 234-4433 WAfiHINGTON. D C. 70005 (202) 234-4433
82 1 we can go in whatever order you'd like.
2 MR. IACKER: Since I was last first, I'll be 3 first last.
4 (Laughter.)
S Staffing in Texas, we have 141 authorized 6 positions. We have about six or seven vacancies, I don't ,
7 know the exact number. We've been pretty fortunato in 8 being able to keep most c,f our positions filled 'til now.
9 With regard to -- would you repeat the second --
10 COMMISSIONER CURTISS: Attrition race.
Il MR. IACKER: Attrition rate is not very high, as 12 you can see. We've had -- (laughter) -- we're fortunate 13 in that people like --
14 COMMISSIO!1ER CURTISS: Pres = nt company excluded.
15 MR. IACKER: Well, yeah. We have had turnover, 16 obviously, but it's probably around 7 percent par year 17 average, over the last -- since 1981 when we grew f ror.: a 18 baby to an adult program. The second question.
19 COMMISSIONER CURTISS: The third quection was, 20 for the two events that you talked about, were the 21 inspections that were scheduled under your program to 22 normally be conducted, done, undertaken?
23 MR. LACKEFt They were current at the time, 24 yeah.
25 COMMISSIONER CURTISS: They were current. Okay.
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1 HR. BAILEY: Calif ornia has something in the 2 neighborhood of 100 authorized positions through both my 3 branch and the counties we contract with for staff. We, 4 at the present time, have approximately 25 vacancios, and i S have had for the -- essentially all of this year. :
6 COMMISSIOllER CURTISS: One-fourth of your ,
a 7 positions are currently unfil Led? 'I 8 HR. BAl'EY: Actually, I think that the number i 9 within our department is 11ko 30 percent of the ones 10 within Department of floalth Services. The countion havo l 11 boon a little more fortunato. The California budget 12 situation has been devastating to overyone. As of July of '
13 this year, we will go in a special fund where our foes ,
14 actually pay for our program, where we actually take in 15 the money and spend the money directly on our program'.
16 The attrition rato really hasn't boon very high 17 except in two areas. One is other programs Ianded by 18 federal dollars that people go into because those programs e 19 can hire people and we can't, .under hiring froozos because 20 we are presently in the general fund. The other area is i 21 in the area of clerical support and, _because of the 22 projocted layoffa and stuii within the- Stato - of 23 California, it has boon very difficult- within the 24 Department of Health Services, which is one of t ho --
25 agenclos slated for the largest cuts percentagowise,-for NEAL R. GROSS COURT REPORTERS AND TRANSCRIDERS l 1323 FIHODE ISLAND AVENUf., N WJ
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1 84 I anyone to come to work there because of the union 2 situation where the last one in is the first one out if 3 there's e cut in hiring. So, those two things have really 4 impacted us.
t 5 Both of the licensees that we talked about in 6 our situation had been inspected proper interval and were 7 current. I would like to mention one thing about the 8 university that was mentioned earlier. The fellowships 9 were actually administered by the university.
10 COMMISSIONER REMICK: Was it part of a consent 11 agreement?
12 MR. BAILEY: It was part of a consent agrooment.
13 That one was one that almost got out of control. There 14 was --
I don't know -- it was a 180-something count 15 indictment, criminal indictment, which named professors 16 and so forth. And then later on after there was a 17 settlement, there was a truck driver who was stopped, and 18 the DA in the county wanted to make sure that that truck 19 driver went to jail, he wanted somebody in jail. And, so,
- 20 that got real nasty before it got all settled.
4 21 One of the ones which I think we've just gotten 22 this pst month, which is sort of unique, is a technologist 23 who committed what we call a misadministration but you all 24 wouldn't, that he used a dirty needle, and ilIV needle on 25 a non-HIV patient, got a suspension of their certification NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE N W 9 02) 2344433 WASHINGTON. D.C 20005 poi, D44433
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- 85 1 for one year, with a three-year probation, 45 days actual 2 suupension, required to attend inf octious dinonne control 3 coursen, and refresher nuclear medicine cournen, and 4 required to report to un quarterly.
5 One advantage we have being in the health 6 department is when we get into thone medical issuen, we 7 have doctors in our hierarchy who can act as witnessen, au _
8 we had in thin particular case. We also are seeing a 9 great deal of support in pursuing the Alta Bates thing 10 irom the medical community itnelf.
11 MR. GODWIN: Well, we have a small program in 12 Arizona. We have 20 authorized positions. We are 13 currently negotiating with the legislature to up to 1.4 14 FTE because -- well, the governor's office does not 15 believe they can appropriste FTEs and they want to, and 16 they've taken our vacancy rate, is what they are baalcally 17 doing.
18 We have a 26 percent attrition rate.
= 19 COMMISSIONER CURTISS: You are up at your 20 authorized 1cvel?
21 MR. GODWIh I believe I have one slot lef t, but 22 I'm not funded for it yet.
23 COMMISSIONER CURTISS: Okay.
24 MR. GODWIN: Okay? We have a 36 percent 25 attrition rate --
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86 1 COMMISSIONER ROGERS: Per year?
2 MR. GODWIN: This year. That's because we had 3 a 24 percent reduction in staff ovor the last two years.
4 And that's the latest figures out of the personnel group.
s 5 It's actually changed a little bit in the last two or ,
6 three months since I've been there, but up until, say, ,
7 through September, that's what it was. The state has a 8 budget problem. The materials programs does not pay all 9 of their way in Arizona, nor is it appropriated into a 10 separate fund. It's part of the general fund 11 appropriation. So, we must go through the legislature and 12 to the governor's office, budget office, as does every 13 executive agency, and make our case. And in all-honesty, 14 being candid across the country -- and I'm going to sort 15 of switch hats and talk about as a Conference of Radiation 16 Control Program Directors, chairmen, across the country, 17 state radiation control agencies have a probicm in that-18 they are just not very visible. If you do your job, you 19 don't get any problems, you don't get any money.
- 20 There are several states -- I: say several --
21 some states, the governor's of fice or the health of fice or 22 whichever, has elected to do away with the radiation 23 programs, and that's ' occurring in states --
there's 24 consideration being made today. Montana is one state ,
25 where that's being considered. So, you know, we just have NEAL R. GROSS-COURT REPORTERS AND TRANSCRIBERS 1323 AMODE ISLAND AVENUE, N W.
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s 87 1 to face things are real thin, so when you go in as a part 2 of your review, you're going to have to overcomo a s e t. l 3 philosophy that says we're going to reduco the nize of i 4 at.ato government, we're going to reduce eponding, wo don't 5 have the money, and show that this particular program is 6 meaningful and cost-offoetive for the state to be a part 7 of it. And you'vo got to_go to the top officials, I mean 8 to tho governor himself. You've got to go - to the 9 logislaturo, the chairmen of the various committees, the 10 Speaker of the llouse, President of the Sonate, those kind 11 of things. It's a very tough soll thing.
12 At the time of those events, we woro up-to-dato 13 on our inspection schedulo, .and they were approximately. on 14 timo. I believe at that time there was a two-year 15 interval for those inspections. I think the telethorapy.
16 has switched to one year since then. I may be wrong on 17 that, but they were up-to-date the best wo know.
18 hR. FLETCllER In Maryland, authorized staf fing,
-o' 19 as best I can calculato, we have 19 professional staf f and 20 four clerical staff. Now, I say-it that way because.as
-21 you -- you know, being here in Maryland, we are also under 22 some very tight funding constraints, and what happens is >
23 if any of-our positions becomo vacant, at least-thus far,-
24' ~they are not. filled. So, even though our authorized'- - j 25 what we' havo-onboard right now is 19, however, a.few -- .
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80 1 you know, 12 or 12 months ago, that number would have been 2 21. So, our authorized levet adjusts as the needs of the 3 budget. dictate.
4 COMMISSIONER CURTISS: As your actual employees 5 attrit, I guess, your authorized level goes down.
6 MR. FLETCl!ER: Right. Yes. Currently, that's ,
7 the way it happens. We have added to that what we call 8 our contractual employees. We have three technical and 9 one clerical there. As far as attrition is concerned, 10 we've lost three people over the last 12 months, and the 11 problem is that the pool isn't very deep. Even if we were 12 permitted to go out and replace some of these people, they 13 are just not out there. And the salarios that most of us, 14 most states can offer, just aren't attracting a lot of 15 people to go into the ficid. So, as far as our scheduled 16 inspections at the time of this event, I'm going to have 17 to ask Carl to address that.
10 MR. TRUMPS The particular hospital, Sacred 19 Ileart, was inspected by myself only less than two years
- 20 before, and at that time our inspection frequency for
+
21 hospital programs was about four years. So, that really 22 wasn't due to be inspected again for perhaps a_ year or-23 year and a half later.
24 COMMISSIONER CURTISS: Okay. Thank you. That's 25 all I have.
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89 1 MR. GODWIN: If I could add just one more 2 comment. Regarding enlaries, the typical way that state 3 personnel groups work both in Alabama and it noemn to be 4 the same thing in Arizona and talking to the states in the 5 southeant, virtually every one of them operated this way, 6 they compare salaries state-to-state and, in Alabama's 7 case, they specifically stated, they would not try to 8 match federal salaries. I mean, you could bring in all 9 the federal salaries you want, but they absolutely would 10 not consider in doing the averaging to try to figure 11 things out. As a result, your states are co nparing their 12 salaries, but we aren't losing people f rom state-to-st. ate 13 for the most part. There are a few that shift like I did, 14 irom Alabama to Arizona, but in most cases, people are 15 going either to federal government, DOE, in some cases 16 yourselves, or to private industry. So, if you don't do 17 your salary comparison with the private industry where 18 people are going, you never have an opportunity to do 19 anything other than serve as a great training course. And 20 you all train a lot of folks for various things.
~
21 COMMISSIOllER CURTISS: Yes.
22 MR. GODWIN: And it's very dif ficult to convince 23 the legislature that it takes a year to train a good 24 health phy51cist, and that that's money that you've just 25 lost.
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j 90 1 COMMISSIONER REMICK: I'd like to take advantage 2 of the fact that you represent agencies in feur states 3 plus experience in a fifth state, and ask a couple of 4 questions, and I'll try to be brief by telling what my 5
5 assumption is and you tell me if I'm wrong.
6 My first assumption is that in all five cases, ,
7 you have follow-up inspections or investigations of 8 therapeutic misadministrations. Is that a correct 9 assumption?
10 MR. GODWIN: Yes.
11 MR. BAILEY: Yes.
12 MR. FLETCHER: Yes.
13 COMMISSIONER REMICK: I will assume that you do 14 not, as an agency, follow up on individual patients from 15 a medical standpoint, from an egency standpoint, am I 16 correct in that assumption?
17 MR. GODWIN: Yes.
18 MR. BAILEY: Sort of. In one of our recent 19 therapy misadministrations -- we've had eight since the 20 rule went into offect ~~ we did require that a follow-up n
21 plan be developed for the patient.
22 COMMISSIONER REMICK: But you did not, as an 23 agency, you required the licensee --
24 MR. BAILEY: We did not develop that plan. We 25 required that a consultant physician be hired to do that.
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91 1 COMMISSIONER RTHICK: Okay. !t l
2 MR. GODWIN: In the case where it's not a 3 misadministration but where you have someone, if you ;
4 would, injured on the job like an industrial radiography
= I 5 where they may need to have some medical follow-up, we may i
6 follow it long enough to assure that our licensee or 7 registrant -- this is certainly true in Alabama -- would 8 carry through and get the individual offered care that 9 they needed. To me, -it would seem like we -have an 10 obligation to use our medical consultant's capabilities, 11 whateser you say, to identify the ones who are injured and 12 make sure there is a care opportunity for- them. It's 13 long-term information, so it's everybody's ballgame right-14 now.
15 (Whereupon, Chairman - Selin returned to the 16 Commission meeting room.)
17 HR. _ FLETCHER Please, -if I may, = sometimes 18 incidents-that we'are '.alking about here serve as lessons learned in some cases, and more recently we have followed
~
19 20 up on -- once again it was not a patient, but it was an-21 individual who was overexposed to an accelerator, and we 22 have f ollowed up . on that individual. We've gotten l
23 cooperation of the doctor to _ keep us informed of how that 24 has'gone. But, once again, this is ---
25- COMMISSIONER -- REMICK: You're not paying' the NEAL R. GROSS COURT HEPOR1ERS AND TRANSCH10ERS 1323 RHODE ISLAND AVENUL N W -
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92 1 doctor, though.
2 MR. F1ETCilER: No, wo're not paying the doctor.
3 We're just following up to see how his condition 4 progresses.
5 COMMISSIONER REMICK: One final question, The 6 Plain Dealer, if I recall, there's an allegation that the ,
7 Agreement States and the NRC do not share information. - To 8 what extent do you believe that is true and, if it is 9 true, do you have any suggestions on how that situation 10 might be improved?
11 MR. GODWIN: Overall, I feel that the NRC staff 12 does a better job of sharing information than some other j 13 agencies, frankly. I think that the thing that confuses 14 the public is the fact that there are several different 15 iederal agencies involved in the'overall radiation mix.
16 FDA does a great job of working with the state 17 in which an incident is. reported, and they get the 18 information and they work pretty well getting it out 19 through the profession, working through the manufacturers 20 and things like that, but sometimes just due to their-
- 21. system - -and I don't_want to try to throw'any stones at' 22 them -- the other states may not hear' about it until
! '23 several months after the event,.which is sometimes a bit -
24 .of a problem. But for most things, NRC is pretty good on.
25 I mean, we all have our_ problems from time to time, but-I NEAL R. GROSS COURT REPORTERS AND TRANSCR$ERS 1323 RHODE (SLAND AVENUE N W.
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93 '
I think most often they do pretty good. In some cases, too 2 much, frankly.
3 (Laughter.) )
l 4 MR. FLETCilER: I was about to say, you know, we i o )
5 sometimes get stacks and stacks and thick documents from 6 the 11RC on certain things. And we understand-that you t 7 don't know what part of it might be to our use, so you- ;
8 give us the whole thing and let us sort through it, and we _
9 understand that.
10 There was at one time concern that some of the 11 more high priority press releases and announcements that 12 come from the NRC, sometimes the states weren' t ' given 13 enough notice to be prepared for the fallout from those. ,
14 That situation also has improved, and I just encourage the 15 11RC to keep on giving us'the notice, because ofttimes our 16 phone starts ringing before our fax starts working.
17 COMMISSIONER REMICK: Any differences or an 18 agreement?
'19 MR. BAILEY: I think the only comment that I --
20 or the thing that I notice that there was some complaint 21 about really was in specific names, and I think we don't'.
22 generally put an individual's name in-something, and that 23 may be a shortcoming particularly where you have - an.
24 incident that-you decide someone caused. And .I understand 25 the sensitivity of putting the name in. And, no, in a lot NEAL R. GROSS COURT REPORTERS AND TFMNSCRIBERS
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94 1 of casen, unless you actually issue an order, that name 2 never appears, and so we don't know who it is, and I think 3 that was one of the things --
4 HR. LACKER: Yeah. This is one of the real 1
5 problems we see, is that identifying individuals. You are 6 obviously going to be in a tort situation once that ,
7 individual knows what's happened. You require that person 8 to be notified, or his f anily, his or her f amily. It gets 9 a little sticky when you make those names available in the 10 public domain, under those circumstances, or potentially.
11 Our legal counsel generally says be very careful what you 12 do and let go.
13 COMMISSIONER REMICK: Thank you very much. It's 14 been a very, very help presentation.
10 MR. LACKER: Thank you all very much. We 16 appreciate your time.
17 CHAIRMAN SELIN: We're not done yet.
18 COMMISSIONER de PLANQUEt We're not done yet.
19 Well done.
- 20 (Laughter.)
21 CHAIRMAN SELIN: I'm sure you'll still 22 appreciate the time.
23 COMMISSIONER de PLANQUE: We just touched on the 24 subject of having taultiple regulatory bodies and boards 25 all contiected in some way or another in the medical field.
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95 1 In this posing a problem for you and, if it is, do you 2 have any recommendations as to what should be done with 3 the problem of dealing with multiple bodies?
4 MR. LACKER: I think this goes to a subject that 5 was mentioned about the nonbyproduct -- reactor byproduct l
6 materials regulation. I think the Conference of Radiation j 7 Control Directors and the Agreement States in general have.
8 sort of pestored the NRC for years, to get involved in !
9 those things -- not the electronic radiation devices, but i 10 the radioactive materials type ~~ NORM and .NARM and 11 whatever else acronyms there are.
12 We do have a problem in some areas between the !
13 relationships with EFA and NRC. We have some problems in
- 14 the relationships between perhaps FDA and NRC and EPA, and 15 then on down the alphabet soup. There are some, but :)
16 generally those are not, in my opinion, insurmountable i 17 situations.
18 I think what we-really need, though, is one' lead 19 agency at the federal level, who can set standards across-20 the-board for radioactivity, and then we can all trail 21 along and be on the same wavelength,on'those kinds of 22 things. Obviously, I don't think it would be appropriate 23 for the NRC to:be in the electronic x-ray end of the-24- thing, but-I certainly think that it would be appropriate. .
I 25 for you to look at whether or not your should regulate NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W (202) 2344433 WASHINGTON, D C. 20005 (202) 234 4433 -
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96 1 these high energy accelerators.
2 COMMISSIONER de PLANQUE: Yes.
3 MR. GODWIN: On the high energy accelerators, 4 you have a semi-entre because a lot of them have depicted 1
5 uranium as shielding. Now, whether our f riend the General 6 Counsel down there would be happy with you eatending the ,
radiation f rom the electronic part as being the overall --
7
. k 8 radiation from the use of the product would be, I guess, 9 a dif ferent issue -- but there is a difference between the 10 high energy accelerators and how you need to approach 11 their evaluation, and-x-rny equipment.
12 COMMISSIONER de PLANQUEt Yes.
13 MR. GODWIN: In Alabama, we handledd it as a 14 part of our materials program because we really saw the 15 need to have it in that high energy range, but even then 16 there was a lot of little quirks to it, but that would be 17 one area that could be of some interest.
18 Now, FDA does have some general manufacturing 19 requirements, but they do not look any at all at the user
- 20 end of it. And it's just very short on ' training. out 21 there.
22 If I'might just-digress a second, I understand 23 that 36 percent now was the overall - program -- -- the 24 attrition rate that I mentior.ed ~~-it was probably on the 25 order of 5 to 8 percent in the materials program-because NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W_
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I we kept feeding people over into thn materials program to l
2 keep it up. What vu got behind was the regulations, and 3 that's where we used to rent out people to do the 4 regulation work up.
5 HR. DAILEY: I make a comment about the 6 accelerators, if I may. I don't remember -- I've got it t 7 written in pencil here. When we went through, we found [
8 that there are about ten times as snany therapy 9 accelerators as there are teletherapy units in California, 10 and I think that is a fairly good ratio when you look at-11 the number of facilities with materials licensen versus !
12 the number of facilities with x-ray equipment. Over the 13 years, in my experience, it's been about 10-to-1 the 14 number of facilities.
15 I was really quite surprised that there wasn't 16 a smaller number of-taletherapy units, quite frankly. I'
]
17 understand -- I talked to your Region. V, and.you all only 10 have one teletherapy licensee left in Region V. So,.I -
- 19 think mout of the people that you have in teletherapy.will :
P 20 be going to accelerators.
21 COMMISSIONER de PLANQUE Okay.
22 CHAIRMAN SELIN: Just' about that, could - you 23 follow up a little, why do they go to accelerators?- Are 24 the'y .better devices, or are they more generously
-25 regulated?
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98 1 (Laughter.)
2 MR. BAILEY: Well, let me start, nuinber one, 3 there's no fee associated with accelerator, to speak of.
4 Number two, there's no regulation to speak of in many --
4 5 certainly, not in federal f acilities, or very little. And 6 number three, I think there are some definite advantages ,
7 in using accelerators for therapy. They are a more 8 versatile instrument.
9 MR. GODWIN: Higher dose output is a big one.
10 MR. BAILEY: Yeah, higher dose output, varying 11 energies, varying modalities of treatment, electrons or x- l 12 ray beams. So, there are definitely some real reasons to 13 go to accelerators.
14 COMMISSIONER de PIANQUE: I'd also like to ask 15 you the same question I asked the earlier panel, and that 16 is on credentialing. In your state, you have a mixed bag 17 of credential programs. Do you see any connection between 18 that and potential for misadministrations? Can you prove 19 a connection that would give some value to these - i 20 crcdentialing programs?
~
21 MR. DAILEY: I would say that in our case we may 22 never be able to separate them out because- cur 23 credentialing program went in about the same: time the 24 nuclear medicine reporting went in. I think intuitively we 25 all feel the better someone is trained, the more likely ;
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99 1 thny are to make a stupid -- or --
2 COMMISSIOll!'R do PIA 11QUE The lous likely they 3 aro.
4 (Laughter.)
5 MR. BAILEY Yeah.
6 COMMISSIOllER do PIAt10llE t It's getting lato.
7 MR. BAILEY: One of the prominos io, if you know 0 how to do it right, you're more apt to do it right than if 9 you don't know how to do it right and just luck into doing 10 it right.
11 MR. FLETCllER: Our experience, of courso, in 12 thin particular situation was with the physician, the 13 radiotherapist. The physicist. in this instance, did not 14 fool enough -- that they had enough authority to correct 15 the rsdiotherapist. So, I don't think, at least in thin 16 instance, it was a problem with the nucionr medicine 17 person. We do have credentialing, but the crodontialing 18 in Maryland is under the lloalth Department rather than 19 under the Department of Environment, and there in still, 20 in many casos, some debate about grandfathering a:1d et
. 21 cotera that have not totally been resolved. I think it 22 will at. least give us a higher level of reassuranco, if 23 you will, that the persono who are working in those 24 programs are better qualified.
25 MR. GODWIN: Well, I'm going to start with NEAL R. GROSS l COUNT REPORitR$ AND 1hANSCHIBtnS 1373 HHODE ISLAND AVENUE, N W (20?)?)44433 WASHINGTON O C 2000$ (?O?)2344433
100 1 Alabama experience. Alabema did not have credentialing.
2 I don't know that our misadministration rate was 3 particularly any different, so I'm not sure that [
4 credentialing is the key. However, while I was there we 4
5 often thought about and seriously considered listing as ,
6 part of tha people named on the license, the technicians, ,
7 because we kept seeing a lot of operation, particularly in 8 the diagnostic area, and although the individual doses are 9 f airly low, if you get a lot of them, you spread that same 10 effect out some -- it shows up oomo.
11 These people are -- a lot of times are working .
12 fairly alone. We had a lot of circult-riding radiologists 13 in nuclear medicine, people in Alabama, and your 14 university types don't understand the problems they run 15 into. They will talk to and get the information they need 16 to select a patient and prescribe the dose and then come 17 around and interpret it later, but they don't -- they're 18 not right there. They are doing these thinga by phone.
19 They are talking to the referring physicians by phone. -
20 They are looking at the records today and they are doing
^
21 the injections tomorrow. The technician represents a- .
22 rather important piece of the picture in nuclear medicine, 23 and'even in your teletherapy work, most oncology groups in 24 Alabama, the radiologist would come in and, for the first 25 treatment or two', set things up, make sure everything was.
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101 I 1 going right, but there may bo poveral treatments where 2 it's strictly up to the therapy technician, 00, you do 3 have uomo need, I think, to have that individual clopoly 4 involved, particularly 11 you're going to depend upon the 5 recordo, that you're later going to nuo nome 6 miundminintration. If you have that licensod 1:!dividual 7 comewhere where you can taku away their bonofit or eomo o material thing irom them, they'll have bottor interont in 9 keeping those records right.
10 So, I think there in uomo connidoration can bo 11 given to that. I'm not euro we ought to make a push on 12 it, but it certainly ought to be nomething to think about.
13 In Arizona now, awitching hatn again, we do havn 14 a credentialing program, and the technicians do havo 15 licennes, and we do have nome way to cono back. Wo 16 haven't acon any need to go back, and the numbora are ao 17 omall that you'd be looking at only a small number of 18 nituations that I don't think you can draw any conclusions
- 19 out of yet.
20 HR. LACKER: In our cano, the radiologic
.' 21 technology certification, I don't know that there's a 22 correlation that we could make there. The medical 23 radiation physicist liconsing law junt. actually became 24 offective the first of this year, no we don't have 25 anything. I think the potential in much better that we'll NEAL R. GROSS Count HEPontins AND TRANstfilotRS O 23 5940 00 ISLAND AVINUL N W.
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i 102 I have better qualifled people making thene decisions in the 2 hospitals than we have in the past, with the cortification 3 program. It's not run by our bureau, but it's within the 4 Department of !!ealth.
4 5 COMMISSIollER de PLA!1QUE: I have just one last 6 question, I'd appreciate your comments. With all the l 7 attention being paid to some of those casou in the past, 8 are there any particular lessons learned that you'd liko :.
9 to share with us, or any comments that you'd like to make, i 10 having gone through this exercise?
11 HR. FLETCllER: Well, you're looking in my 12 direction, so I'm going to start. The answer to your-13 question is yes, we still feel that protection of patient 14 records and patient names, et cetera,_ should _ be i 15 maintained, and our law, I think, supports us_in that.
16 But we were under a different advisory position then.__ In 17 f act, we were under, for the majority, dif ferent staf f all 18 the way through the department. .And the conclusion that 19 was come to in 1988, I'm relatively-sure would not be the =.
,j 20 conclusion that we'd come to in 1993, even though the 21- process of coming to the conclusion would be the same.- 1 22 So, there.-is a lesson learned there, and we do learn well. -
23 MR. GODWINt Well, I think . that the same
'24 conclusion can be drawn from any incidence that you 25- investigate. You-always end up looking back and saying, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE 10 LAND AVENUE, N W, (202) 2344433 WASHINGTON. O C. 20005 ~(202) 234 4433
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103 l 1 " Gee, I wish I'd documented better. I wish I'd taken a 2 little more time to assess that". You always run into 3 that kind of second-guessing.
4 I think the use of your medical connultant, when 4
5 to call them in, is a very critical thing. You really 6 need to clearly define what you're going to use them f or, 7 and I sort of outlined what I would look at.
8 In Alabama, we did on occasion use some of our 9 inedical advisory committee as our medical consultant, and 10 what we would try to do is scope out the injuries and then 11 make sure that there was a care opportunity for anyone who 12 was injured.
13 We did not go into the epidemiological or long-14 term follow-up. I'm not sure where that should be other 15 than maybe CDC or something like that. That may be a 16 better place for it because -- I'd want to ba very careful 17 we didn't end up like the syphilis study where they ended 18 up doing a long-term study and some portions of it were 19 denied treatment so they could just see the effects. And 20 I would certainly hesitate to have anything like that 21 created.
22 Of course, we all know that there are cancer 23 registries and there are other registries. I believe DOE 24 has some registries that are established, but they are all 25 related to occupational workers, so I'm not sure hcw this NEAL R. GROSS CCURT REPORT [R$ AND 1RANSCRIBERS f 1323 RHODE ISLAND AVENUE, N W l 4 02) 2344433 WASHINGTON. D C 2000$ (202) 234-4433
104 1 would work in the general public.
2 MR. LACKER: From my point of view, I think the 3 key lesson we've learned from this most recent exercise is 4 that we need to do what we're doing with the working
, 5 groups that are established, and that is get our data-6 gathering uniform so that we can make sense out of the 7 data we gather, and not have all this different 8 information floating around that when you try to put it 9 together it's apples and oranges.
10 HR. BAILEY: I think one thing that's come out 11 of this and some recent inc! dents that we've investigated 12 is really the need for, from my standpoint, trained 13 investigators in some of these, who are trained maybe not 14 even in health physics, but are trained in dting 15 investigations and taking statements.
16 The technician that I mentioned, ir. retrospect, 17 if we'd dono a real thorough investigation there, there 18 would have probably been some rather severe penalties 19 against the hospital. But the hearings officer said, you -
20 know, it was an accident waiting to happen, the way the
~
21 hospital was running their program. So, I think that's 22 the main thing that's como out of the series with us, that 23 we do need trained investigative skills.
24 COMMISSIONER de PLANQUE: Okay. That's all I 25 have. Thank you very-much.
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105 1 CllAIllMAll SELIll Commissioner Rogers?
2 COMMISSIOllER HOGEllS t Yes. I was a little 3 concerned about, I think it was the comment you made, Mr.
4 Ila11ey, about the independence of the oncology departments 1
5 in some honpitals from their nuclear medicine groups.
6 They are both urder the same radiation saf ety of ficer, 7 aren't they, in the hospitals? They really have -- they 8 are obligated, and should be obligated, to follow the same 9 procedures and guidelines and reporting rules. Ilow common 10 do you think that is?
11 MR. 11AILEY : I don't know. It may be that wo 12 just had a couple of them occur very recently, you know, 13 and when we looked at the oncology group, they basically 14 came in and practiced oncology, and they had their sources 15 and, yes, the RSO may lead test them and that sort of 16 thing. The RSO might provide the film badges, but 17 basically they do their own thing.
18 An example is that the oncologist would end up
+ 19 ordering the iridium seeds, f or instance, and the oncology 20 group essentially handles the shipping back of those to 21 the supplier. And then when they turn up missing, the RSO 22 says, "Well, hey, nobody told me about it". So, I think 23 we may find, if we look -- it's one of those things, 24 you're almost afraid to look for fear of what you would 25 find. That's my f eeling right now, that we really need to NEAL R. GROSS CoVRT REPORif RS AND TRANSCRIDLRS 1323 RHODE ISLAND MENUE, N W l
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106 1 look and see who theso groups report to. If they are 2 separate companies coming in, separato medical groups, 3 then I see a real potential for miscommunication, And I 4 think Aubrey here mentioned in some of the hospitals he 5 was familiar with, they actually had separate licenses.
6 MR. GODWIN: There have been occasions. I think .
7 that's by f ar the minority, where there would be separate 8 licenses, to the extent where you might even have a 9 different RSO. But I think that all regulatory programs 10 are discouraging that arrangement. I know of no one that 11 would really -- that would be toward the exception side.
12 If you look at the case at the Good Samaritan, 13 there was a problem in that the radiation safety committee 14 was meeting without the oncology group. Well, it was 15 meeting without the radiation safety officer, too, as far 16 as that goes. So, you do have situations where the 17 hospital group gets very bureaucratic and 18 compartmentalized --
19 COMMISSIONER ROGERS: Oh, I know that very well.
- 20 MR. GODWIN: Universities are tough on that, 21 too, so you have to --
22 COMMISSIONER ROGERS: I was associated with a 23 hospital at one time as a trustee, and I know very well 24 about those things. I'm just wondering to what extent 25 some of these difficulties get called to the attention of NEAL R. GROSS l CoVRT REPORTERS AND TRANSCRlPERS !
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1 nither the board of truntoon or board of directors if they 2 are a for-profit organization.
3 It's buon my experience that onco the truetons i
4 of a heepital know about some of those dif ficultion, they c r 5 got very, very upset, and the rink management group which
..~. !
6 may be under the oxocutivo director of the hospital, have 7 to worry about some other risks at. that point, and I would 8 nay that I personally fool that it's very important to got ,
9 thoso dif ficultica called to the very highout attention in j 10 the organization, and then that's going to do -- hopef ully ;
11 it will do a lot of goou. I think in the instancen I've 12 scon, you know, the directors of a hospital, the trusteen 13 of a hospital, are-public spirited citizens, and they are 14 very concerned about the image of that organization, and _
15 its quality. And when they hear about some of theso 16 things, they get very upset. And nomo_of the things that 17 your mentioning of the disconnect betwoon the oncology 18 department and the nuclear medicino department, the turf 19 battle over this kind of thing, I think that a' board would 20 get very, very upact about that kind of thing. And to-21 what extent they can really atop it is another matter, but-22 I would call attention to the highout levola of the 23 organization when one snif f a out some kind of a diaconnect 24 of that sort because it certainly is intolerable.
25 MR. BAILEY:- Well, I-think --
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1 MR. GODWIN: It's public spirit --
2 MR. BAILEY: Excuse me, Aubrey. I think that --
3 we asked the hospital administration to acknowledge that 4 the radiation safety of ficer has the authority to stop any f
5 procadure, you know, ant that's acknowledged in the t
6 application, and that sort of thing. Ilowever, politically ,
7 within the realm of the hospital, he may have some 8 limitations. But one thing that I think we could do 9 possibly is lay out more specifically the requirements, 10 training requirements for the radiation safety of ficer in 11 medical facilities. We have it for industrial 12 radiographers and all these other pretty well laid out, 13 the training they have to meet and all this sort of thing, 14 but we don't really -- we havn for the users, the medical 15 training that's necessary, but we really don't have 16 anywhere spelled out clearly what the radiation safety 17 officer training should be. And maybe we need to go even-18 higher than just the administrator with the authority of <
19 the radiation safety officer.
20 MR. GODWIN: It was the routine practice in both 21 Alabama and Arizona that we dealt with the administrator, 22 certainly on the exit interview. HeLwas available, and 23 ~a ll correspondence related to compliance went to the 24 administrator. Further, if there was . any management 25 oriented problems, we had to have that management level, NEAL R. GROSS COURT REPORTER $ AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE N W.
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109 1 it wan not just, you know, maybe, or farm it off or 2 something, we had to go into that.
3 Univornition, like I said --
I don't want to 4 harp on them particularly -- but they do have a lot. of the 4
5 inotitutional restrictions to communicationo, and they 5 quite of ten try to cut the radiation saf ety of ficer out of 7 certain operationn, and we routinely went to the president 8 . of the univernity and told him, "If you want the 11conne, I
91 you will stop it". And I can recall two or three 10 conversations with prenidents of universitico, with their 11 lawyers there, and usually the other party there nald, 12 "What's thio ntate aguncy telling another state agency 13 what to do", but never once did we get legally challenged 14 by the lawyern relative to what we were doing.
15 MR. DAILEY: One other thing I might mention, wo 16 did a study following the llIV cano miandministration that 17 we had. I think it was at 20 or 21 hospitals where we la went in with the infectious diceano control people, and 19 what we f ound in the majority of those hospitals was a 20 lack of routine infectioun disense control .in the nuclear 21 medicino departments. It was the nuclear medicine 22 department was nort of aside, the infectious diseane 23 control people didn't come in there, and no there were 24 many cases where -- just a simple example where they were 25 recapping the needles instead of putting them in sharps NEAL R. GROSS cwnt nreOnnns ANoinwsenans 1323 nHODt. ISLAND AVE NUE, N W.
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I 110 1 containers, and risking being punctured - with an HIV 4 2 needle. And a lot of nuclear medicine ri it new is 3 related to HIV-positive patients.
4 MR. GODWIN: I would also say you could do a 1
5 similar operation relative to the boards of pharmacy. In 6 Alabama, we conducted joint investigations with our board ,
7 of pharmacy nn nuclear pharmacy, and both groups ended up _
8 finding the pharmacist made a few mistakes. The total fine 9 was about $20,000.
10 COMMISSIONER ROGERS And I think also a point 11 that Mr. Bailey made that's come out here from the lessons 12 learned question of Commissioner de Planque, of the 13 necessity for establishing common databases. I personally 14 would really like to urge that the organization, the 15 Agreement State Organization, look very seriously at how 16 it can 1r. ,at. Yes, you don't have absolute authority -
17 over anybody, but I think the point the Chairman made very 18 early on, it's a good way to avoid attention from the NRC, 19 -to do things yourself. And I think that I would certainly 20 encourage you to think about ways of developing common 21 databases among all of your members, and to be willing and 22 happy to share those with NRC. I think there are some 23 serious questions as to the credibility of son e of the 24 numbers that we have been kicking around, a n c. u n l e s s 25 there's some systematic way of developing databases, they NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE. N W (202) 234 4433 WASHINGTON, D C 20005 (202) 234 4433
l 111 1 are always going to be challenged. So, I think that -- I 2 know cost is always a f actor in these matters, but I think 3 that by thinking of ways to do it that are not necessarily 4 costly but do represent - - scious nttention to trying to 9
5 do things on a common casis, that we will devetop 6 nationally a much better ser se of where we stand here that 7 I don't think we have todaf at all. But I thank you very 8 much, I think it was a very informative meeting.
9 CHAIRMAN SELIN: Yes. First of all, we all wc 10 to thank you for coming forward. This can't have been too 11 pleasant to come down on a public meeting and lay out the 12 anatomy of a series of serious misadministrations, but I 1 think we've all learned a lot from this. I hope you also 14 have learned something from this. We thank you for coming 7 15 forward on this.
16 I /.o have a few remarks to make before we cut 17 off. Number one, that it is true that these 18 misadministrations are a very low incident rate, and d 19 usually they are in doing therapy, you are dealing with 20 very sick people. So, the question about whether one 21 should undergo the medical procedure or not is really not 22 a relevant question for the patients. Of course they 23 should undergo the procedure. But it doesn't f ollow that 24 we should then look the other way and say these are 25 tolerably low rates and considering that this is dangerous NEAL R. GROSS COURT REPOP.TERS AND TRANSCRIBERS 1323 RHODE ISLANt, AVENUE, N W (202) 234 4433 WASHINGTON. D C 20005 (202) 234 4433
112 1 medicine and dangerous diseases, that this is a small cost 2 to pay because we are talking about misadministrations, we 3 are talking about mistakes. We are not talking about 4 sometimes you do a treatment and, on a statistical basis, 5 occasionally it will cause more harm than good, that's 6 understood, but this is not the subject of these meetings. ,
7 There is clearly room for improvement in the 8 practice of the practitioners, in the practice of the 9 regulators. We all have something to learn.
10 The second, the number of areas that have come 11 out are bothersome, and I hope Mr. Bernero is taking notes 12 as I go through thiu list. First, my confidence in the 13 report itself has been shaken somewhat. I had assumed, 14 obviously naively, that all this misadministration data 15 are clearly in the records if you just go to look for it 16 and, therefore, the numbers that we have are probably 17 pretty accurate. And you 've had a couple of powerful 18 examples where that's not the case. In Mr. Bailey's case, 19 he had specific questions to ask and he got f alse answers,
- 20 and he couldn't go through the records and just say, "Ah, 21 here's some difference". So, just the basic data that 22 we're working with, even if you get down to the roots and 23 not to derive statistics leave one nervous.
24 The second is the responsibility of the 25 organization question that you've gone through cases over NEAL R. GROSS COURT PcPORTERS AND TRANSCRIDERS 1323 RHODE ISLAND AVENUE, N W.
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113 1 and over again where nobody is clearly responsible, where i
2 the responsibility is shif ted between the physicians, the !
3 p e plo doing the calculations,-the people delivering the M
4 medicine. j 5 The third is this whole question of chronic 6 offenders. It seems to come up over and over again that 7 there are chronic offenders, and our mechanism really_ l 8 doesn't catch them and follow them, that we are oriented-9 towards the licensees and not towards the offenders. But j 10 if we are going to do the root cause analysis and wc-find -l 11 not just lack of training, but specific people who are 12 cavalier or otherwise ill-trained, there has to be-a way 13 to follow up on them and do something.about that. '
14 The fourth are the organizational problems in I 15 the facilities that you've talked about, the role of the 16 RSO or, in particular, the lack of a role of an RSO. We i 17 found in the Indiana incident that the RSO really didn't'- -- I 18 do his job, and nobody checked on it. At other places,
- 19 the RSO was cut out.-
20 The fifth is this issue L of --identifying . and ,
^
21 informing patients of the situation, what's;been done to 22 them. Mr. Godwin's point in a very good point. It's not 23 just enough to tell them what _ the dose is and what's:
24 happened, in many_ cases it's to make sure that this is 25 translated into good medical advice. We can't just assume NEAL R. GROSS COURT REPORTERS AND TRANSCRIBER $
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-114 1 that the attending physician knows exactly what to do with 2 this and walk away from the nituation.
3 Another thing is n conflict between what are 4 perceived as legal risks and good regulation, with the w
5 tendency of the regulators to step back when a tort case 6 may be involved, or a question of privacy. Ilealth and ,
7 safety is the first issue, and we need some clear 8 guidelines to not be scared off by the thought that, oh, 9 my, you're going to play into the hands of the tort 10 lawyers. Tort lawyers have plenty of tools, you don't 11 have to worry about giving them an extra tool, they'll do 12 fine with or without us. We need to protect the-patients 13 and not worry.about the tort impact.
14 Another is the lack of clear definition of the 15 role of the medical consultants. It's come-up-in our own 16 investigations. It.'s come up in your discussions. - You've 17 given us some good advice on:this point.-
18 A third ~ major area is that we see . room for 19 management improvement's in.how"we and-how the Agreement.
- 20 States run their programs, not just how the practitioners- .
21 and the related facilities are run, and that's clearly the .
22 main emphasis that we have to put on.-
23- And then the fourth area is to look for 24 comparability.- I didn't say compatibility, I said
-25 comparability between what the Agreement States do and NEAL R. GROSS COURT AEPOCTERS AND TRANSCHIBERS 1323 AH00E ISLAND AVENUE. N W -
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-115 1 what' the NRC does in the programs that we regulate, that' 2 there are a lot of different organizations, a lot of-3 dif ferent local f actors but, in f act, the.niedicino and the 4 physics are the same throughout. And, so,-if one group 5 finds that some of these innovations make e lot of sense, 6 we should all learn from these. And if- there .are N
7 differences, they should be because there are real 8 distinctions and not just because the history- is 9 different.
10 And, finally, I have to tell you that I've been 11 -on a number of boards of directors, and the boards of 12 directors, they may have high objectives, but they don't 13 want to be embarrassed and they don't want-to be sued, and 14 going to a board of directors when there is a serious 15 problem is a very effective mechanism. Somehow that- gets 16 reflected very quickly into action. So, all inall, this 17 has been an illuminating session.
i
- 18. We have felt, as you know, for quite a while,
= 19 that there's something awry here. Each event, as we find:
20 events ourselves, as we get the newspaper' articles, as we 21 talk to our colleagues, puts-a little more concrete-push 22 on this.- -It's not-that we're trying to scare. patients.
23 I mean, people keep saying we should somehow put a gags 24- rule on this operation because we're scaring - patients.
25 That's not the objective, and that's not the outcome. . We NEAL R. GROSS COURT REPORTERS AND THANSCHlBERS 1323 RHODE ISLAND AVENUE. N W.
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I 116 1 live in a society where we believe that putting-2 information on the table will lead to improvements and not 3 just to sensationalism, and I think it's our obligation to l 4 follow up on that approach. l 3 1 5 So, thank you very 2nuch for coming in. -I found 1
6 it illuminating, and I'm sure the rest'of the Commission s 7 has as well.
8 MR. GODWIN: Thank you.
9 MR. BAILEY: Thank you.
10 (Whereupon, at 4:40 p.m., the meeting was 11 adjourned.)
12 13 1
14 15 16 17~
18 19 20 21 23 24 25 NEAL R. GROSS COURT AEPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVENUE, N W. -
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,l
CERTIFICATE OF TPANSCRIBER This is to certify that the attached events of a meeting of the United States Nuclear Regulatory Commission entitled:
TITLE OF MEETING: BRIEFING BY AGREEMENT STATES ON TilEIR
, ACTIVITIES IN MEDICAL USE AREA PLACE OF MEETING: ROCKVILLE, MARYLAND DATE OF MEETING: JANUARY 29, 1993 were transcribed by me. I further certify that said transcription _
is accurate and complete, to the best of my ability, and that the transcript is a true and accurate record of the foregoing events.
(PIL 12 w %
C 0 0 Reporter's name: PHYLLIS YOUNG a
e NEAL R. GROSS COURT RtPORTits AND TRANSCRIBik$
1323 RHODE 15 LAND AVIHUI. H.W.
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- $12,000 civil PENALTY
- POSSESSION LIMIT FOR IODINE 131 REDUCED TO 100 MICROCURIES FROM 500 MILLICURIES j
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CONTINUES SPECIAL REQUIREMENTS FOR IODINE 1311 THERAPY DOSES :
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Remarks by G. Wayne Kerr, Chairperson Organization of Agreement States before U.S. Nuclear Regulatory Commission January 29, 1993 Mr. Chairman and members of the Commission. We are pleased to be here today to discuss with you a matter of mutual interest - the regulation of nuclear materials. I am accompanied by Mr. Tom Hill of Georgia, Past Chair of the Organization of Agreement States (OAS) and Dr. Mary Clark of florida, Chair-Elect of the OAS.
I plan to make some general remarks addressing certain regulatory issues and then some remarks related specifically to Illinois. Then I will ask Mr.
Hill and Dr. Clark to make their remarks.
The Organization of Agreement States is a loose affiliation of the 29 Agreement States whose main purpose is to address issues of common concern and to serve as a centralized point of contact for NRC on generic issues.
The words " protection of the public health and safety" are few in number, but carry a lot of responsibility. Words similar to those are found in the Atomic Energy Act and in the legislation of each Agreement State. We all take them seriously. We appreciate the efforts of NRC in assisting us and ,
in trying to keep us coordinated to the extent necessary to carry out that essential responsibility. It is not an easy task for you to deal with 29 sovereign States and, as you know, some of us are very sova 7ign.
e.
There has been considerable effort expended by NRC and the Agreement
$tates in the last couple of months to address problems associated with materials regulatory programs. Some relate to information gathering, some to medical regulation in particular, some to investigations, and some to enforcement. These problems may be real in some cases and in others, only perceived. I urge everyone to focus on the proper target. Are the regulatory prog, is of both the NRC and the Agreement States adequately protecting se public health and safety as required by the Atomic Energy Act (AEA) for you and by Section 274 of the AEA and our own $ tate laws for us? As we have stated on previous occasions, we believe it inapplopriate to plate too much emphasis on processes and procedures, lhe purpose of my general remarks are to highlight some areas where we may have different approaches, but maintain the 5- public health and safety objective.
I want to focus on four items in particular that have been talked about recently. first, information gaps. We hear that some - the public, the Congress, the NRC - may not know qverythina about each Agreement State program in the detail that is known about NRC programs. However, we don't believe it necessary for such detailed information to be maintained in some centralized 1
fashion. It's not that we have anything to hide - our files are almost an open book to NRC. But knowledge of every detail should not be necessary. We don't believe Section 274 of the Atomic Energy Act contemplates that kind of oversight.
Second is the subject of investigations. There apparently is-some concern that Agreement States don't do investigations or that we don't do them with the same procedural rigor as the NRC, I am certain all Agreement States do perform investigations of incidents. Some may not follow the s ne rigorous 2-I
4 procedures as NRC. We certainly do investigations in Illinois, but we do not have a staff solely dedicated to investigations. I am aware of only one State that does. lexas has had such a unit since 1981. But we get the job donc anyway, and it can be argued with more vigor than NRC. State programs have the advantage of being in closer proximity to the regulated fscilities, and in the case of facilities that also use x-ray machines, we inspect these facilitios for all sources of radiation with the result being a more frequent presence. As a result of an NRC suggestion, Illinois does have an incident Review Committee which meets monthly to revhw
- events" involving either radioactive materials or electronic product machines.
Third, I want to briefly address enforcement. [nforcement practices no doubt vary among the Agreement States, which in part is due to the sovereign nature of States. Some may find methods of enforcement that are effective without civil penalties. Most, like NRC, find civil penalties useful, in any event, c';r processes may vary from those of NRC, but the goals are the same.
Let me give some examples. Several years ago in the days of low-level waste crises, Nevada returned a defective shipment of waste to an NRC shipper.
Since the shipment came from an NRC licensee, Nevada could have referred it to NRC for enforcement action - and waited two or three months.for possible issuance of a civil penalty. But they found the action they took was both prompf and effective.
A major university in California had significant problems in their radiation safety program over a period of years in the 1980's. Administrative actions such as restrictive' license 'conditior.s and management conferences did not fully correct the situation. The university was placed on probation, a fine of $25,000 was imposed, and a fellowship in radiation safety was 1
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-d established-at $?5,000 per year for three years. Subsequently, a $65,000 I penalty was imposed for additional violations. California followed rigorous !
court proceedings in the latter stages of this case. Currently, the licensee is operating satisfactorily.
I On Thanksgiving Eve last year, Illinois issued an emergency order to a medical institution to cease operations due to lack of authorized users, no approved Radiation Safety Officer being available, and no commitment to procedures regarding selection of patients, prescribing doses and interpreting results. The elapsed time from when our inspector confirmed these problems to the time of issuance of the order was a matter of hours. One of our IDNS- ,
inspectors personally delivered the order on ihanksgiving Day. These cases
- may be a little unorthodox, and sometimes lacking in procedural niceties. Are they effective? We think so.
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1 have left the most intractable subject for last.- That is-the ($ sue of regulation of medical uses of radioactive materials. Although the Agreement ,
States have differed with the NRC on some aspectsLof this issue, I am sympathetic to your attempts to resolve it. The' issue is greatly complicated ;
by the number of players involved - NRC, FDA, Agreement State regulators, medical licensing Boards, State Pharmacy Boards, and not least of. which are ,
the medical practitioners and the patients. I think the difficulty partly stems from differences of opinion asito each of- those groups' roles, and 'a
. lack of clarity about their respective authority. The Medical issues paper presented at the public meeting on October 29, 1992 in Baltimore was, in my opinion,La good initial effort at trying to sort out the issues. I personally believe one of the most important tasks is to establish clearly the respective-4 a
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roles of T0A, NRC, and the licensing Boards, and I urge you to work toward that goal expeditiously.
The quality management and medical misadministration rules are interrelated, and do have significant impact on Agreement States. Our main dif ferences with NRC have been over the level of detail required by the NRC rule, and in some cases with specific provisions. 1he Agreement States tend to disagree with the level of compatibility assigned to these rules and in general to medical rules. We feel that a Division 3 category is more appropriate, since the issues by and large are matters between each Agreement State and its licensees. Medical licensees do not generally work across State lines, nor make products entering into interstate commerce. Therefore, there is not a need for the same degree of uniformity as may affect radiographers or source distributors, for example.
Now, I war.t to briefly address some aspects of the Illinois program, Illinois has been an Agreement State since June 1987, and we regulate about 800 specific licensees. Of these, we consider 97 to be major licenses (e.g.,
broad licenses, laundrias, l.LW, manufacturing and distribution, teletherapy, nuclear pharmacies, Category IV irradiators). Each review of our program by NRC since 1987 has concluded that it is adequate to protect the public health and safety.
The program is administered by sixteen health physics professionals and four clerical. Other managerial and technical support is provided by three health physicists and two administrative. Additionally, laboratory services, instrument calibration services, and assistance in decommissioning projects are available through another office in IONS. The State operates for our own 5-
9 8 !
use and for use by other States a calibration laboratory accredited by CRCPD. l Ve have a comprehensive fixed laboratory facility which supports all the functions of the Department. We also have a mobile lab for field use. !
We have a fee schedule structured differently than NRC's, but it is expected to recover about 35% of our costs in FY 1993. A-few categories of licensees are on a full cost recovery basis.
We took 698 licensing actions in 1991 and 756 in_1992. Pre-licensing ,
visits are conducted for complex actions and when deemed necessary to obtain .
t clarifying information. We performed thirteen such visits in the'last two years.
I Our inspection priority system for Specific licensees is similar to i NRC's except that our maximum interval is four years. Thus- we are nearly identical on the high priority licensees but more frequent than NRC on-the lower priority licensees. We conducted 375 inspections in 1991:and 300 in a
1992. We issued three Orders in the last two years as follows:
- 1. A physician for unsupervised use of radioactive material resulting in a hearing and.a civil penalty of $12,500;
- 2. An industrial firm for multiple repeat violations. A hearing was held and a civil penalty of $4,700 imposed; and
- 3. A suspension order to a hospital. for using licensed material =with no authorized users, no R50, or valid license (transfer of ownership without IONS approval).
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-L Our civil penalty procedures are specified in our regulations, and are f based on licensee compliance history, severity, and negligence, in addition, !
we hcid two management conferences in these two years. ,
t Our medical reporting rule (misadministration in NRC's parlance) is l essentially the same as NRC's with only minor differences, in 1991, we. had 25 q T.tCordable but non-repAtidig ditynsti: events. in 1992, we had six recordable events and one report wpJ- ti.W apeutic event, t
Our x ray regulatory program is large, covering some 24,000 machines at 9,500 facilities. About one-half of the machines are inspected each year.
They are also subject to various fees and civil penalties. We register- -
accelerators and lasers, and regularly inspect the ACcelerat0r facilities.
Illinois has had a radiologic technologist accreditation program since ;
1984. We accredit radiographic technologists, chiropractic technologists, nucicar medicine technologists and radiation therapy technologists. 'There are currently about 8,700 technologists accredited in Illinois. Of these, about 800 are Jclear medlCine technologists and-aboutL500 are therapy technologists
_(inc1', des x-ray, accelerator, teletherapy, and brachytherapy). They are subject to renewal every two years, and 24-hours of continuing education credits are required every two years.
Civil penaltie; in the tech accreditation program have been available since 1989. Penalties may be applied-to both the technologist and his or her-employer. Penalties for technologists are- $250 for first violation, 5500 for second, and $1,000 for others. Employers' _ penalties are $500- for .first
. violation, $1,000 for'second and subse4Jent violations. Since 1989, we have .
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assessed $32,250 in penalties against 57 technologists and 36 employers, most of which have been in the last twelve months. Of these 57 technologists, four have been in nuclear medicine and three in radiation therapy. We have a number of additional ones pending. There have been no suspensions or revocations to date.
Thsre are 27 states plus Puerto Rico which have implemented certification programs, although they may vary'in scope and detailed j provisions. Of these, seventeen are Agreement States.
! will next ask Mr. Hill and Dr. Clark to present their remarks. .l l
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t-Remarks by Thomas E. Hill, Manager [
Radioactive Materials Program l Georgia' Department of Natural Hesources !
before U.S. Nuclear negulatory Commission ;
January 29,1992 {
INTRODUQILON :
Good afterncon, Mr. Chairman and memborn of the Commission. It is a
- i pleasure meeting with you again, continuing our discussion of issues of. mutual concern. Sinco I mot with the Commission on-June 11, 1991 to discuss.
compatibility issues, we have participated in many meetings and workshops with j NRC. The Agreement States _ provided early input into NRC rulo makings _. Most '
a notably, Parts 34 and 35 rule makings. Today, I must report to you that the joint : .
NRC/Agrooment Stato Committoo recommended by the Agrooment States to ,
develop a compatibility strategy has not yet been established.- -
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, .i I will briefly discuss Georgia's Radioactivo Materials Regulatory Program.,
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Georgia has been an Agrooment State for twenty three (23) years. As of December 31,1992 we havo S19 licenses compared to 596 in June of 1990. Our current staff includes six (6) technical, two (2) administrative support and one i
manager. Additional support for laboratory services and emergency response is available within the Department. The Radioactive Materials Program, unliko the-Radiation Control Programs of other states does not have responsibility for registering and inspecting x ray machinos or generators of nonionizing radiations.
WDEK_L_OAD & PRIOBlTY SYSTEM During CY 1992 we conducted 124 license inspections and completed 819 -
licencing actions. A total of 539 of those licensing actions administratively -
amended or added a license fee condition. Twenty nine percent (29%) or (81) of the rernaining licensing actions were new and renewal applications.
L Georgia's inspection priority schedulo is essentially the same as NRC's. -In p
November of 1990, after several years of effort, the Program eliminated-its inspection back log. To date we have completed all scheduled inspections, I am not optimistic that we can keep inspections from becoming back logged. A 2
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revision of our Rulos and Regulations and their adoption by the Daard, in l
accordance with our Administrative Procedures Act, must be completed thic year. !
EEE In FY 92 the Radioactive Materials Program roccived approximately 50% of its funding from foes, the remainder from the state's general fund. Beginning FY 93, which began this past July.1", the Ptogmm is 100% supported by fees. The -
fee schedule adopted by the Board of Commissioners is similar to the NRC Foo Schedule. The notable exception is that our annual fees are approximately one-third (%) of yours.
ENFORCFMhlT AND civil PENALTIES Our Rules and Regulations provide for enforcement, including civil penalties. All enforcement activities including asessment of civil penalties must be conducted according to the Georgia Administrative Procedures Act.
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1 gyVEN[S/COMPLAjNES#d!S60MINISTRATIONR In 1992 licensees and companies reported eighteen (18) incidents.
investigations wero conducted. All but ono have been closed. Reports of three (3) diagnostic medical misadministrations were received in 1992. ~
One final comment. In 1985, while attending a NRC sponsored workshop l on largo irradiators,I learnod that the Regional Materials staff and the A0reernent States had the same problems with NRC headquarters. I challonDe the NRC to roview (inspect) it's Regional Materials Licensing and Inspection Programs using the same criteria developed and used to ovaluato Agreement States. Who knows, from such a review NRC rnay discover the egg dient of five (5) additional agreement states. Therefore, the compatability strategy developed by the yet to be established joint NRC/ Agreement Stato Committoo may bo applicable within NRC.
Thank you.
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STATEMENT TO THE UNITED STATES NUCLEAR REGUIATORY COMMISSION by Edgar D. Bailey, C.H.P.
Chief California Radiologic Health Branch January 29, 1993 Mr. Chairman and Commissioners, I am Edgar D. Dailey, ChAef of the California Radiologic Health Branch.
On August 21, 1988, Dwight Gregory Golstein II died at Children's Hospital in Oakland, California. Death was caused by respiratory failure "due to, or as a consequence of radiation damage".
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In September 1992, several members of the staff of the California Radiologic Health Branch (RHB) including myself were contacted by a reporter from The Plain Dealer, a Cleveland, Ohio, newspaper.
The reporter asked for the RHB files or information related to a 1987 cobalt-60 teletherapy misadministration at Alta Bates Hospital in Oakland which resulted in the death of a nine-year-old boy.
At the time of the reporter's calls RHB had no information regarding the alleged incident. In response to questions from RHB staff regarding the reporter's accusation, representatives of Alta Bates Hospital assured them that the . reporters claims were erroneous. On September 9, 1992, I- personally talked to a representative of the Risk Management Department at Alta Bates Hospital who told me that:
- 1. the incident involved-treatment with a linear accelerator and not a teletherapy unitt
- 2. the dose prescribed was'the dose delivered and therefore-no misadministration occurred;
- 3. the dose was delivered to the correct location;
- 4. the dose was a palliative treatment of a-patient with terminal neuroblastomar and 5.- the case was simply a malpractice _ suit.
This information was provided to me even though we discussed the fact that the medical misadministration reporting regulation had become effective in California on October 5,- 1989, nearly two years-
0 after the incident occurred.
On December 13, 1992, the first in the series of The Plain Dealer articles was published, and the lead story was about the misadministration at Alta Bates Hospital. Somewhat to our surprise the story about Alta Bates Hospital was not picked up by the local Bay Area newspapers or television stations.
On January 6,1993, due to increasing concern that RHB did not have all the facts concerning this incident, the Manager of the RHB Regional Office in Berkeley went to Alta Bates Hospital and found that RHB had not been told the truth in its earlier contacts with the hospital. De found that in essence the newspaper article was correct in what it reported as having occurred. Contact on January 8, 1993, with the West Coast Cancer Foundation (WCCF), the consulting medical physics group which developed the treatment plan for the patient collaborated the new information.
The following is the sequence of events as we now believe they occurred.
The child was referred to Alta Bates Hospital by Children's Hospital of Oakland for treatment of rhabdomyosarcoma because Children's Hospital did not have the appropriate radiation therapy equipment.
A treatment plan for the -hild was developed by WCCF. This medical '
physics group worked under contract to Alta Bates Hospital since the hospital did not employ staff medica?, physicists. The treatment plan involved a series of complex treatments covering a part of the face and upper neck. That is to say, the treatment was to occur over several days with multiple beams and a number of fields.
Treatment of the patient began on December 4, 1987, and continued on a daily basis (except for weekends) for 15 treatments ending on December 24, 1987. The patient developed what has been described as "a core" in his mouth, and with the holidays approaching the treatment was halted to. allow the patient to improve. When the patient returned for treatment in January 1988, there was enough change in the face and neck contours that a new treatment plan was ordered.
The medical physicist at WCCF who did the treatment plan nappened to be the same one who had done the earlier treatment plan calculations. After the new calculations were completed, he compared them to the previous ones and noted a large discrepancy between the two sets of data. Upon further checking he discovered that the earlier set prepared in December 1987 was the one-in error. The error was in the treatment time calculation. At this time it is believed that the prescribed dose was 180 rads per day but that in fact a dose of 360 rads per day was delivered on each of the fifteen treatment days.
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1 On January 28, 1988, the WCCF notified the staff radiation oncologist at Alta Bates Hospital of the mistake. The radiation oncologist filed a written Hospital Incident Report with the hospital's Risk Management Department on February 5, 1988.
No sdditional radiation therapy treatments were given. The child died seven months later on August 21, 1988. An autopsy was performed, but RHB does not have a copy of it at this time.
On March 1, 1988, a routine inspection was conducted of WCCF. The radioactive materials license issued by RHB to WCCF is for the possession and use of three small calibration or check sources.
The actual activity of preparing treatment plans or doing the calculations is not a licensed activity per so, but is included in the authorization to use a teletherapy unit for the treatment of humans. Medical physicists are not licensed by California as a profession at this time; however, unrelated to this incident is an effort by the medical physicists themselves to get a state law passed that would require state testing and licensing of the profession similar to the law passed in Texas a few years ago.
Durinc) the ins pection of WCCF in response to the inspector's question regardang whether there had been any unreported incidents or unusual occurrences since the last inspection, the radiation efety officer (RSO) responded that there had been none. When asked ebout this response on January 8, 1993, he said that he had not mentioned it because it was in litigation. This leads RHB to wonder if there are other incidents or misadministrations that were not or have not been mentioned since they are "in litigation".
On June 20 and 21,1990, a routine inspection was conducted at Alta Bates Hospital. A review of the Radiation Safety Committee minutes revealed no record of the incident. In response to the question regarding unreported incidents or unusual occurrences, the hospital's RSO reported none. On January 7, 1993, the RSO said that she and the chairman of the Radiation Safety Committee only became aware of the misadministration when RHB called to try to get information about the incident in 1992. Although the head of the radiation oncology unit must have known about the incident when it occurred, it appears that he did not inform the RSO and the Radiation Safety Committee even though he was a member of the committee. He has since left the staff of the hospital.
It should be noted that the WCCF is no longer under contract to Alta Bates Hospital.
It is reported that the WCCF, the radiation oncologist, and the hospital have all settled lawsuits with the patient's family. The doctor and/or WCCF reportedly settled for $500,000 and the hospital reportedly settled for $30,000.
Following discussions with Mr. Carlton C. Kammerer of the Of fice of State Programs, I faxed him a letter on January 14, 1993, requesting the assistance of an investigator from the Office of
o i
Investigations to help the California RHB thoroughly investigate l what appears on the surface to be a deliberate attempt to cover up the occurrence of this apparent gross misadministration. On January 2?, 1993, Mr. Ben B. Hayes, Director of the Office of investigations, instructed his staff in Region V to assist California in its investigations. We held our first meeting with the assigned investigator, Mr. Eugene Power, in Sacramento on Monday (January 25, 1993) of this week.
In addition to Mr. Power, RHB is seeking the assistance of the Licensing and certification Branch (L&C) of the California Department of Health Services (DHi). L&C is the organization within DHS that has the responsibility for the hospital licensing and the regulation of hospitals within California. As such, it has regulations that require the reporting of " unusual events". At this time it appears that there is a possibility that there were L&C violations associated with this incident.
The DHS Office of Legal Services has already assigned an attorney to assist on this case and contact has been made with the California Attorney General. It is the intent of RHB that a thorough and complete investigation of this entire incident be conducted and that if violations of California laws and regulations are identified, these will be prosecuted to maximun. extent permitted under California law.
At the present the investigation is ongoing.
It is clear that there are difficulties that exist in investigating and taking meaningful enforcement actions in incidents like the one I have described. There are a few recommendations or suggestions that I believe would be helpful.
- 1. Misadministrations should be violations. At the present time only the failure to report them is a violation. One has to cite failures to follow procedures such as dose assay, patient identification, etc.
- 2. Consideration should be given to requiring medical licensees to report the filing of malpractice suits against the licensee or named users on the license. This would follow the precedent already set'of requiring licensees to report the filing of bankruptcy actions.
- 3. Consideration should be given to requiring that each Agreement State han inspectors or investigators who.are peace officers. The Food ar[ Drug Administration already requires such of certrin state food and drug personnel.
These state " investigators" should be required to have training similar to tlat provided to NRC investigators.
That concludes my. remarks. Mr. Donald Dunn, Chief of Enforcement and Compliance, is with me today. He and I would be happy to answer any questions you may have.
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The attached paper was provided by 11 MSS at the all Agreement States meeting in October 1992.
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i HEDICAL ISSUES PAPER The following paper on
- Medical Issues" raises a variety of issues in the NRC's medical use program. The purpose of this, paper is to stimulate disct'ssion on these and possibly other issues as part of the development of a proposed medical use management plan to be presented to the Commission. The i discussion of issues within this paper does not necessarily represent official !
NRC policy. l The staff appreciates that there may not be an ultimate resolution'of some.of -
these issues but recognizes a need to address them. Specific items that are beyond the scope of the staff's management plan for the medical use area have been excluded.
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. HEDICAL ISSUES Introduction Several recent rulemakings by the Puclear Regulatory Comission in the area of the medical use of byproduct material have prompted criticism and opposition by certain elements within the medical comunity. These include: 1)the
' Interim final Rule" (effective Au ust 23 1990) which amended regulations, in responsetoapetitionforrulemakng,relatedtothe)reparationof radiopharmaceuticals and
- therapeutic use of radioplarmaceuticals; and 2) the
- Quality Management (~" /rogram and Hisadministration" rule (effective January 27,1992) which ri ,dires, in part, that lic.ensees submit a written certification that a QM program had been implemented. The Commission has been working to effectively resolve these safety issues and to alleviate the associated concerns of the medical comunity while maintaining comunication with the involved parties (meetings with ACMUI, professional organizations, and Agreement States). Despite these efforts, certain tegments of the regulated medical community perceive the Commission as arbitrary and pursuing unnecessary rulemaking that they believe could needlessly interfere with the practices of medicine and~ radiopharmacy.
In order to resolve current anticipated issues, NRC staff has begun a reassessment of the overall medical use program and initiated a number of actions to address the more )ressing problems. Coment and advice is being solicited in meetings with t1e ACHUI and representatives from the Agreement States, to be held in October 1992, on issues relevant to the regulation of the medical use of byproduct material. This document highlights certain program areas which should be reviewed at these public meetings to determine if any changes are necessary to improve the medical use program. There may be othar programatic issues and alternative approaches to regulation not yet identified by the staff which may need to be discussed and evaluated at these meetings.
The outcome of these discussions with the ACHV1 and the Agreement States representatives will culminate in a paper to the Comission outlining the staff's proposed ' medical use management plan" for Comission consideration and direction. It may include the following:
- 1. A formulation of long term objectives and an umbrella plicy under which those objectives are to be achieved. This will include any proposed revision of the current Medical Policy Statement.
- 2. A strategy for achieving the objectives which consists of:
l a. Completion or redirection of ongoing activities intended to address regulatory changes petitioned by the medical comunity as well as L those recently identified by the staff,
- b. Assessments based on periodic meetings with the ACHUI, Agreement States, NRC regional management, the medical comunity (to include physicians, physicists, nurses, and technologists), and the general public. These assessments will consider-the status, direction, and improvement of the program as well as staff assessment of performance under recently adopted programatic changes.
- c. Identifying, evaluating, and, if appropriate, undertaking new ,
initiatives resulting from these periodic assessments. '
- d. Provision for an annual update and modification of the plan, a report to the Commission, and adjustment based on Commission direction.
The staff plans to complete the initial phases of this program review in 1992 l and to forward the management plan to the Comission in January 1993. Once l Comission direction has been provided, the staff will establish periodic meetings with the above mentioned groups (2b) to gather information and consider their input in any further modifications to the medical use program.
Issues within the Medical Use Prooram To facilitate review of the issues we have four fundamental areas, with each area containing multiple subissues. Several of these subissues cannot be l compartmentalized into specific program areas and therefere there may be some j overlap amongst the four major areas. This paper raises questions for open-ended discussions at the public meetings. j l
The text of this paper outlines the fundamental areas, and specific _ topics are !
referred to appendices for more detailed analysis. The paper also includes a discussion of efforts currently underway which are related to issue resolution. l l
- 1. NRC's Role in the Regulation of the Use of Byproduct Material in Medicine NRC's statutory authorit*, to regulate the domestic medical uses of byproduct material is found in the Atomic Energy Act of 1954, as amended. Section 81 of that Act authorizes the NRC "to issue general or specific licenses to ap)11 cants seeking to use byproduct material ... for medical therapy ... or ot1er such useful applications as may be develo)ed". Furthermore, Section 81 directs that "The Comission shall not permit tie distribution of any byproduct material to any licensee, and shall recall or order the recall of any distributed material from any licensee, who is not equisped to observe or who fails to observe such safety standards to protect healti as may be.
established by the Comission or who uses such material in violation of law or regulation of the Comission or in a manner other than as disclosed in the application therefore or op) roved by the Comission". Section 161b generally authorizes NRC to issue suc1 regulations and orders regarding the use of byproduct material "as the Comission may deem necessary or desirable ... to protect health or to minimize danger to life or property". Whereas NRC't statutory authority is clear, the degree of regulation-in exercising that authority may vary in accordance with the administrative prerogative of the Comission.
The NRC issued a policy statement in 1979 to guide its regulation of the medical uses of radioisotopes (Appendix A). This policy addresses the central question as to the level of regulation the NRC considers necessary to exercise its authority in this area. The Comission applies this policy to development 2
, of regulations governing the program (Appendix B), licensing, and to the development of related inspection and enforcement policies (Appendix C),
although the final regulations take precedence over the policy statement.
There are many issues related to the medical policy statement that are discussed in the appendices.
- 2. Operational Flexibility An effective regulatory scheme needs to establish a balance between clear, understandable regulations and a level of operational flexibility for both the licensees and regulatory organizations (e.g., NRC, Agreement States). While meeting the NRC's concerns with protecting the public health and safety, which includes occupational workers, patients, and the general publit;, the medical community is concerned with providing competent, timely. and cost-effective care to their patients. A p1ysician may need to modify a treatment for a specific patient and therefore an effort needs to be made to ensure that the regulations do not needlessly restrict a physician from p m eribing the best treatment without a time consuming review process. However. ere are many safety practices that are routine and should be formalized to ensure uniform standards of radiation protection which allow personnel to handle radioactive material in a way that limits exposure to themselves and members of the public as low as reasonably achievable (ALARA) and helps prevent misadministrations.
10 CFR Part 35 (Medical Use of Byproduct Material) contains both prescriptive and performance based regulations (Appendix B). The regulations will be reviewed to determine if they need to be modified to allow greater flexibility while providing sufficient clarity and specificity to adequately protect public health and safety. A related aspect that may need to be revisited and possibly clarified is the responsibility for supervision of individuals in the safe use of byproduct material and the training and experience criteria for individuals using byproduct material (Appendix D). NRC's broad authority also extends beyond the immediate medical community and patient to the general public. Therefore, it is important that the NRC communicate with workers, patients, and members of the general public as well as directly with licensees regarding the effectiveness of its regulatory program (Appendix E).
- 3. Regulatory Relationships There are multiple regulatory agencies and organizations involved with the regulation of nuclear medicine and radiation oncology. _These include, in part: the Agreement States, the U.S. Food and Drug Administration, and various state Boards. In non-Agreement States, there may be two different sets of regulations for medical use of byproduct material and all other radioactive material. The need for uniformity of practice by co-regulators and an avoidance of duplication may apply not only to safety practices but to national standards for calibrations and equipment such as medical devices.
Communication between co-regulators and delineation of responsibilities would assist the efforts to attain uniformity. Specifically, there may be means other than current regulations to achieve effective and efficient requirements and/or regulations. This will encompass various aspects of the regulatory program including 10 CFR Part 35 (Appendix B), inspertion and enforcement 3
. . _ _ _ _ _ - _ _ _ _ _ . . ~ . _ _ . . - . . . _ _ _ _ _ _ . _ _ _ _ _ _ _ _
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, procedures (Appendix C), and training and supervision issues (Appendix D).
- 4. Professional Relationship.
The NRC seeks good comunication and interaction with different professional groups and associations. The ACMul provides advice on the practicality and :
impact of standards and guidelines related to protection of the public health and safety. The ACHUI also provides advice and recomendations on NRC proposals for the development and/or amendment of standards and criteria for regulating and licensing uses of radionuclides in human subjects including <
medical research, diagnosis and therapy. The Commission has expanded the representation on the ACMV1 and scheduled it to meet more frequently as a group.
In addition to the ACHUI, other professional organizations, such as the American College of Nuclear Physicians (ACNP) and the American Society of Therapeutic Radiology and Oncology (ASTRO), are a resource that contribute during rulemakings. Some of these organizations have developed voluntary standards and audit programs that may be endorsed to some extent in the future in NRC regulatory guides (Appendix C). By maintaining open comunication with different organizations, the NRC staff hopes to be able to react promptly as new technologies emerge so that regulations can be modified to accomodate ,
them.
The Medical Visiting fellows Program is a recent effort initiated by the Commission to improve comunications with the professional comunity. Myron pollycove, M.D. joined NRC in late October 1991, and Mark Rotman, PharmD. in early December 1991 as the first two fellows. The staff anticipates that NRC's knowledge of the medical comunity and its relationship with its members will continue to improve by utilizing the fellows in their role as liaison (Appendix E).
Onooina Efforts There are several ongoing efforts which are intended to address regulatory changes petitioned by the medical comunity as well as those identified by the str.ff, t1at will continue subject to possible redirection in the reassessment process. The Comission has previously been briefed on all these issues and has provided direction to the staff. The direction and status of these ongoing efforts are sumarized as follows:
I 1. Radiopharmacy Rulemaking i
In June 1989, the ACNP/SNM filed a petition for rulemaking to amend
, 10 CFR Part 35 to " correct regulatory incompatibility and permit the traditional practice of nuclear medicine and nuclear pharmacy."
- Elements of the petition involving strict adherence to the package l insert were addressed in the interim final rule, effective August 23, l 1990. Remaining issues which must be resolved are: the practice of l nuclear pharmacy including compounding; the use of radiolabelled biologics; and the use of byproduct material for human research.
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rule language has been discussed with both the ACHUI and the Agreement States representatives and the working draft has undergone substantial change as a result. The staff plans to submit a proposed rule to the Comission for review in November 1992 and anticipates that the proposed rule may be published for coment in early 1993.
- 2. Preparation of Inspection / Enforcement Guidance for QM rule Regional personnel have been instructed to conduct performance-based inspections on QM programs. Formal guidance for the regions is being prepared as a temporary instruction. In addition, the enforcement policy for the QM rule is being modified on an interim basis in order to place the primary focus on programatic failures of QM programs rather than on individual, isolated mistakes leading to misadministrations.
This interim policy will be submitted to the Comission for review and approval. This inspection and enforcement >olicy also will be discussed during a public meeting scheduled for Novem)er 9. 1992 with the ACNP/SNM and other organizations involved with the use of byproduct material affected by the QM rule.
- 3. Contract to review submitted QM programs A statement of work for a contract to review all the submitted QM programs has been prepared and provided to three national laboratories for their submission of proposals. The contract is ex)ected to be awarded in January 1993 and have a duration of 24 montis. The contractor will review the QM programs in accordance with a Standard Review Plan arepared by NRC staff. Following each review, a letter will be sent to tae licensee submitting a QM program identifying weaknesses or omissions or a satisfactory submittal.
- 4. Completion of Broad Scope Guidance including Standard Review Plan On June 4, 1992, a Policy and Guidance Directive was issued providing guidance on licensing medical facilities with broad scope programs in order to eliminate certain confusion that had existed since 10 CFR Part 35 was revised in 1987. A Standard Review Plan for applications for Type A licenses of broad scope has also been drafted and includes medical broad scope facilitics. This should be issued to the regions in the near future. Concurrently, a draft Regulatory Guide (revision to Reg. Guide 10,5) is being prepared and will be published for review and comments.
- 5. Public meeting with ACNP/SNH to explain QM rule and ACNP audit program As part of the override of OMB's disapproval of the information collection requirements for the QM rule, the Comission approved the staff's proposal to hold a public meeting with the ACNP/SNM to describe the recordkeeping and reporting requirements associated with the rule.
The staff will hold this meeting on November 9, 1992 and will invite other professional associations such as American Association of Physicists in Medicine (AAPM), American College of Radiology (ACR), and 5
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ASTRO. This meeting will address the requirements of the rule and the
' related inspection and enforcement guidance being developed. In addition,theACNPpracticeauditprogramwillberevieuedanddiscussed as to the extent NRC can use industry s self-auditing guidelines.
- 6. Elimination of Recordkeeping Raquirements for the Interim Final Rule NRC issued the Interim Final Rule, ef fettive imediately, on August 23, 1990, to amend its regulations related to the preparation of radiopharmaceuticals and therapeutic uses of radiopharmaceuticals. The rule provides latitude under NRC regulations for: 1) certain physician-directed departures from the FDA-approved package insert instructions for preparation of radiopharmaceuticals; and 2) in the case of radiopharmaceuticals for therapeutic use, departures from the package insert instructions regarding indications and methods of administration if certain requirements are met, including a recordkeeping requirement for the departures. The NRC staff has reviewed the documentation collected to date and after consulting with FDA has concluded that the major trends in departures are clear and collectionConsequently, of additionaladata would not reveal any significant new information.
proposed rule eliminating the recordkeeping requirements was published on June 11, 1992. Public coments have been analyzed and a final rule was approved by the Executive Director for Operations and published in the Federal Reaister on October 2, 1992.
- 7. Review and Modification of Abnormal Occurrence (AO) Reporting Criteria The staff has undertaken an effort to review and revise the current reporting criteria for A0s. A presentation was made to the ACHUI by a contractor representing Oak Ridge Associated Universities in May 1992 at which time the ACMUI recommended a number of changes to the contractor's proposal. These recommendations have been reviewed and a proposed major revision will be presented to the Commission in 1993. A status report will be given to the ACMUI during the October 1992 meeting.
- 8. Rulemaking on the Administration of Byproduct Material to Pregnant and Breastfeeding Women This rulemaking was reviewed with the ACHUI at the May 1992 meeting.
The ACMUI recomended certain changes in the rule language and associated guidance. The staff proposed to the Comission in May 1952 that this be a performance-based rule, modifying the QH rule and adding to the definition of misadministration. More recently, the staff met with the Agreement States to review the issue. The staff is planning to submit the proposed rule and corresponding guidante to the Commission in December 1992,
- 9. Rulemaking for Release Criteria for Radioactive Patients Three petitions have been filed with the NRC requesting revision of the release criteria in 10 CFR 35.75 for patients receiving radiopharmaceutical therapy or permanent implants in. The staff is 6
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currently addressing this issue. .The primary issue is to resolve'the 3
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inconsistency between 10 CFR Parts 20 and 35 in terms of the dose limits for individual members of the general public. Furthermore, the release criteria will be clarified taking into consideration the guidelines set- i forth in NCRP Publication No. 37. The proposed rule will allow medical !
use licensees some additional flexibility on releasing patients. The !
staff plans to present the approach to resolving these petitions and 'l draft rule language to the ACHUI in October 1992. l+
t Items to be Excluded from Consideration T The following issues raised by certain members of the medical community extend - ,
beyond the scope of the staff's review of the medical use program and aro therefore to be excluded from consideration during the development of a.
management plant
- 1. Amending the Atomic Energy Act ("the Act") to either exempt the (
regulation of the medical use of byproduc". material, source material, or special nuclear material, or expand NRC's authority to include naturally or accelerator-produced radioactive material (NARM). ,
- 2. Compliance with, compatibility of, or repeal of.The Clean Air and Water Acts' levels of effluent releases. 1
- 3. Low level radioactive waste and mixed medical waste issues.
- 4. Changing or eliminating NRC annual fees.
- 5. Commission's position regarding compatibility with Agreement State and NRC regulation of the medical use of byproduct material.
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APPENDIX A MEDICAL POLICY STATEMENT Backaround On February 9,1979 (44 FR 8242), the NRC issued a statement of general policy to guide its regulation of the medical uses of radioisotopes (Medical Pclicy Statement). The Comission stated:
- 1. The NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public;
- 2. The NRC will regulate the radiation safety of patients where justific, by the risk to patients and where voluntary standards, or compliance with these stendards, are inadequate; and
- 3. The NRC will minimize intrusion into medical judgements affecting patients and into other areas traditionally considered to be a part of the practice of medicine.
The rationale behind these three statements is discussed in the enclosed final policy statement.
Discussign Since this policy statement was published, there have been a number of key NRC regulatory initiatives that have been opposed by members of the medical community. In the developmpnt of these rulemakings, the Medical Policy Statement has been reviewed . However, different interpretations of the policy statement have led to conflicting opinions between members of the NRC staff, the Commission, and the medical comunity. Fo11cwing the Annual Briefing on the Medical Use Program on June 1,1992, the Comission requested, in an SRM dated June 23, 1992, an analysis of whether the evolution of NRC's medical use program has been consistent with the 1979 statement of Comission policy, and whether any changes to the medical policy statement are warranted.
The staff's analysis will be addressed in the medical use management 31an.
Concurrently, the Comission requested that the ACHUI assess whether 1RC's regulatory program for the medical use of byproduct material was consistent with the three principles in the medical policy statement.
The staff believes that a review of the medical policy statement should focus on whether the prevailing rationale is 'different today, and whether there is a proper emphasis on safety and health, while allowing sufficient flexibility to deal with the dynamics of medical technology and the practice of medicine.
Are the three principles in the medical policy statement appropriate? If not, what parts of the medical policy statement should be revised? Since the policy statement is subject to reinterpretation as the Comission changes, is it sufficiently specific to keep the medical use program on track while allowing accomodation of technological development?
The Medical Policy Statement is reviewed during each rulemaking initiative.
Should a line item be included in the statements of consideration of any new rule to discuss its relationship with the medical policy statement?
' It should be noted that regulations take precedence over statements of policy.
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, APPENDIX B 10 CFR PART 35 Backaround in 1983, the staff )roposed a revision to 10 CFR Part 35, which was much more performance-based tian previous requirements. After publication of the proposed rule in 1983, the Comission directed the staff to redraft the rule wit 1 more prescriptive requirements. NRC published the final rule on October 16, 1986 and the current 10 CFR Part 35 became effective on April 1, 1987.
The purpose for the revision was to bring all the cadical use licensing requirements together in one place. Previously, these requirements were found '
in license conditions, regulatory guides, and the former 10 CFR Part 35. The new Part 35 contains both prescriptive and performance-based requirements.
The terms " performance-based" and ' prescriptive" are both relative. One performance-based part of the rule, which is a recent addition, is the Quality Management (QM) Program which lists five general objectives. The licensee may use discretion in determining how to meet these objectives, in general, licensees can improve parts of their programs, meeting the performance-based parts of the regulation, without having their licenses amended. This can be done either through ministerial changes or QH program improvements. Other parts of Part 35 are also performance-based to varying degrees. The ALARA program sets out minimum standards but does not give exact words. The 1::ensee may choose to adopt the more >rescriptive approach set out in Regulatory Guide 10.8. In contrast, tie leak testing criteria specified in 10 CFR 35.59 is very prescriptive with no flexibility.
10 CFR Part 35 3rescribes requirements and provisions that provide for the protection of tie public health and safety, to include workers, patients, and the general public. Sections of the rule that protect the worker from devices, beams, and radiation sources include: syringe shields (35.60); ALARA program (35.20); surveys (35.50, 35.70, 35.641); leak tests (35.59); and teletherapy interlock checks (35.615). Protection of the patient scheduled for radiation associated procedures is provided by requiring: Quality Management procedures (35.32); measurement of each dose prior to administration (35.53); survey of patient after removal of temporary implants (35.406); and safety checks of teletherapy machines and rooms (35.615).
Finally, there are sections that pertain to protection of the general public and patients not scheduled for radiation procedures such as: surveys to release radiation areas to unrestricted use (35.315, 35.415); release criteria for patients receiving doses of radioactivity (35.75); QM procedures for redundant means of verifying patient identity (35.32); and surveys of waste areas and temporary implants (35.70).
Discussion The use of 10 CFR Part 35 and specific license conditions provides a flexible licensing system that can be used to address new technologies and rare or unique situations. Are there new issues that should be incorporated or added into the current rule?
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The prescrip (ve parts of 10 CFR Part 35 are very task specific, allow little flexibility or room for interpretation, but also make it easier for both licensees and NRC inspectors to determine regulatory compliance. The performance based ) arts provide the-licensee with a great deal of flexibility and results in lac c of uniformity, is the rule, or are parts of the rule, too prescriptive or not detailed enough? Should the rule be entirely performance-based? What techniques should NRC use to identify potential new rulemaking endeavors? What level of research and analysis should be used to make the decision to go forward with rulemaking?
Are there any other provisions of 10 CFR Part 35 that interfere with effective '
regulation of the medical licensees? for example, the information collection requirements required in the QM rule are considered by some members of the medical community to impose an undue burden on licensees. Is there evidence that either the submittal of QM programs or the subsequent recordkeeping ;
requirements have posed such a burden? The QM Rule also contains definitions i for misadministrations and recordable events. The term ' misadministration" l was used to convey that a mistake in the administration of byproduct material i or radiation has occurred. Other less significant events are termed l
" recordable events". . Is there evidence that the use of the term
" misadministration" has had a negative impact on the practice of medicine or directly resulted in medical malpractice suits? In view of the fact that the ,
QM rule addresses quality assurance issues, some members of the medical !
connunity argue that this is an encroachment on the practice of medicine. Are l there any examples that this is the case?
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APPENDIX C INSPECTION AND ENFORCEMENT k karound Section 161 of the Atomic Energy Act authorizes NRC to conduct inspections and investigations and to issue orders as may be necessary or desirable to promote the common defense and security or to protect health or to minimize danger to life or property.
Jnspection Inspection rocedures are detailed in NRC Hanual Chapter 2000. The objectives of inspections are to determine if licensed programs are conducted in accordance with NRC requirements, and to determine if licensed activities are conducted in a manner that will ensure the health and safety of workers and the general public.
Inspectors are instructed to ascertain whether a licensee is in compliance with specific provisions of the license and the regulations by direct observation of work activities, interviews with workers, and demonstration of work practices by a worker in performing tasks regulated by the NRC.
Additionally, information in licensee records is reviewed to determine compliance with recordkeeping requirements. The focus of the inspection is on the observation of the performance of licensed activities.
InforcemeD1 The Commission published the general statement of policy and procedure for NRC enforcement actions on March 9, 1982 (57 FR 9987). Since that time, the enforcement policy has been revised several times, most recently in february 1992. The purpose of the enforcement policy for medical use of byprejuct material is to promote and protect the radiological health and safety of the public, including that of patients and employees, and the environment. This is accomplished by the following mechanisms:
- 1. Ensuring compliance with NRC regulations and license conditions
- 2. Obtaining prompt corrective action of violations and adverse conditions affecting safety
- 3. Deterring future violations and occurrences of conditions adverse to safety
- 4. Encouraging improvement of licensee performance, to include prompt identification and reportia.1 of potential safety problems The basic sanctions available to NRC are notices of violation, civil penalties, and orders of various types. A notice of violation (NOV) is a written notice outlining the violations and usually requires a written response from the licensee. The nature and extent of the enforcement action is intended to reflect the seriousness or severity leve' (SL) of the violation involved. There are five severity levels of violations which reflect safety and regulatory concern, a SL 1 violation being the most significant (e.g.
substantial failure to implement the QM program resulting in patient death) and a SL V violation being minor (e.g. isolated failurt to maintain records).
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Because the NRC wants to encourt.ge and support licensee initiatives for self-identification and correction of problems, NRC may exercise discretion and L
strain from issuing an NOV and/or civil penalty under certain circumstances.
Discussion The purpose of the NRC inspection and tnforcement program is to identify and correct significant radiation safety problems within a program. NRC inspectors may not necessarily review and sample all aspects of a medical use program during an inspection. They con review, in part or in whole,: 1) organizational structure and program administration by the lict.nsee; 2) the QM program and licensee audits; 3) training of employees in the use of radioactive materials, which includes me.surement of doses, contamination and radiation control, proper storage, receipt and shipping, and waste handling;
- 4) reports and notifications of misadministrations and worker exposures; and
- 5) records of surveys, instrument checks and material control. The depth of the review is based on identification of problem areas, safety significance and indication of a programatic breakdown in the area under review. Do NRC inspections focus on those aspects c' a program which are most important to radiation safety? Does the NRC policy of unannounced inspections achieve its purpost of reviewing radiation safety practices as they are normally performed?
There are various incentives to licensees for violations that have less safety significance including self-identification and prompt corrective action.
Under certain circumstances, non-cited violations (NCVs) can be docuranted in field notes, an inspection report, or a Form 591. Additionally, NRC inspectors may exercise discretion to issue an NOV using a form 591 at the inspection site under certain circumstances. In contrast, if there are multiple SL IV and SL V violations, they may-be aggregated as a larger problem to emphasize to the licensee the importance of effective management of licensed activities and operation of its overall radiation safety program. Is NRC placing the appropriate emphasis on the use of NCVs and Form 591s?
Violations that are classified as SL 111 or higher typically result in an enforcement conference, and possibly a ::f vil penalty and press release. These mechanisms are used to obt *n corrective action and act as a deterrent against future violations. If a civil penalty is assessed, varicus mitigation and escalation adjustment factors are applied which <nclude: identification (licensee or NRC), corrective action to prevent recurrence, phst performance, prior opportunity to identify, multiple occurrences, and duration. There are also other mechanisms available to rapidly handle a potentially safety significant situation such as the use of confimatory action letters or orders. is the current inspection and enforcement program effective in identifying and correcting radiation safety concerns? Which aspects of the inspection and enforcement program are cost effective? Are civil penalties and press releases an adequate deterrent? Do existing requirements allow sufficient flexibility to deal with emerging problems or unforeseen circumstances without resulting in violations?
In the medical use ared, there has been a question of whether voluntary accreditation and audit programs coulo be substituted for NRC inspections of performance based programs. The NRC is aware of six voluntary audit programs C-2
- in the ll.S. that have developed quality assurance audit programs. These include the following:
- 1. College of American Pathologists (CAP) - CAP offers a volunta accreditation service involving a complete audit of Nuclear O scine Programs.
- 2. Radiological Physics Center (RPC) - RPC's charter is to reviu patient ~
treatment records, internal consistency of institutions, dosimetry systems, and screening programs with output measurements using TLO's,
- 3. American College of Radiology (ACR) - ACR has been involved-in the development of QA requirements through their voluntary Accreditation of hadiation Oncology Programs, The ACR accreditation involves a site visit where inspectors review charts of patients treated within the past years for certain diseases, review patient treatment (modality,' method -
of treatment, recalculations), and issue a report of their findings.
ACR also offers accreditation of Nrlear Medicine Departments.
- 4. Joint Commission on the Accreditatin of Healthcare Organizations (JCAHO) - The QA program that JCAH] recommends is a generalized quality improvement (Ql) program. JCAHO ccnNets surveys of healthcare organizations which involve reviews of each organization's-quality assurance program (s). Data collected by JCAHO is made available to both federal and state agencies.
- 5. Health Care Financing Administration (HCFA) - HCFA is responsible for accreditation for purposes of Medicare / Medicaid reimbursement. A major factor in HCFA's process is prior accreditation or removal of such by JCAHO.
- 6. American College of Nuclear Physicians (ACNP) - The_ ACNP uses a
")ractice audit program" that is available to any nuclear medicine p1ysician or department-to provide an assessment of the quality of l
nuclear medicine practice.
These programs would need to be reviewed to determine if they are equivalent to the needs of NRC's regulatory program. Some of these may have to undergo significant modifications to be compatible with NRC regulations and inspection and enforcement programs. Should the NRC recognize these voluntary- programs, in full or in part, and waive o~ reduce the frequency of inspections if the licensee participates in an independent audit program? Should NRC take enforcement action on the basis of the findings of these audits?
l In conclusion, the following questions are of primary concern: What inspection methods and enforcement options provide the greatest incentive for maintaining and improving effective safety programs? Is there an appropriate balance between regulatory compliance and program safety? If not, what steps / actions could be taken to achieve an appropriate balance?-
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- APPENDIX D MEDICAL SUPERVISION INCLUDING RELATED TRAINING AND EXPERIENCE ISSUES i Backaround l Medical use licenses are unique in the sense that justification for the use of l radioactive material in the practice of medicine requires that all use be at 1 the direction of a physician. Historically, supervision of the use of j licensed material for medical purposes has been restricted to physicians. 1 Consequently, NRC's training and experience criteria has focussed primarily l upon physician authorized users. In the earliest' days of medical uses of radioactive materials, the physician was frequently the only individual who provided the training to and oversight of any other personnel. Current practice frequently differs from this model. Training and certification programs now exist for other specialties in medical use of radioisotopes.
These include: nuclear medicine technology, radiation therapy technology, medical physics, nuclear pharmacy and therapy dosimetry, in many licensed programs, the actual involvement of the physician authorized user has in practice become more narrowly focused on the selection of patients, medical-procedure and prescribed dose.
The day-to-day supervision of radiation safety is more frequently assigned to one of these other saecialists than to the physician authorized user. The NRC staff, recognizing t1at the physical presence of the physician authorized user is not necessarily required for safe use of material, has accepted a varying range of involvement by physicians. This creates compliance and enforcement problems when the physician user has so little involvement that the claim of-adequate supervision appears to a reasonable person to be insupportable.
However, adequate supervision is often being exercised by a non-physician who has substantial training in radiation safety. In practice, NRC inspectors have had difficulty documenting truly unsupervised radiation safety programs as opposed to adcquate programs with small involvement by the named authorized user.
Training and experience has been and will continue to be an on-going issue for the NRC particularly in light of the supervision issue. An Advance Notice of-Proposed Rulemaking regarding training.and experience for all individuals involved with the medical use of byproduct material was published in the Federal Reaister in May 1988. The Commission received 94 comment letters in response. Using this information and the results of a contractor study'on training and experience criteria for personnel involved in the medical use of byproduct material, the staff prepared an analysis and proposed course of action which was presented at the July 10, 1990 meeting of the Advisory Committee on Medical Uses of Isotopes (ACHUI). At that meeting, the ACMUI voted against modifying NRC requirements for abysicians who perform only .
limited nuclear procedures,-and recommended t1at NRC do nothing about required training and experience criteria for technologists and other non-physician workers-unless additional data indicated that specific required training of these groups could minimize reported events.
NRC policy currently requires that every authorized physician user receive training adequate to supervise a radiation safety program, with the result D-1
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that primary and secondary care physicians must invest considerable )ost-residency time toward radiation safety training to qualify ss an autiorized user who can directly order and interpret scans. However, the techniques of nuclear imaging have matured to the point that other physician specialists wish to request and perform nuclear medicine procedures and interpret the results of nuclear images in the course of the practice of their specialty.
Thus, the NRC is in the path of access to and control of these procedures.
The NRC involvement in authorizing physicians is expected to play an ever increasing role in the reimbursement of physicians and therefore NRC could be increasingly the focus of a professional turf battle. An exampic of this is the controversy between nuclear medicine physicians and cardiologists specializing in nuclear cardiology as to what they believe NRC considers to be the necessary qualifications to interpret nuclear scans. In an effort to address this, the Board of Internal Medicine examiners is currently developing a board certification in imaging cardiology which includes training in radiation safety and protection.
Discussion The NRC and its predecessor, the Atomic Energy Comission, have required physicians to have didactic, practical and clinical training and experience before authorization to use byproduct material for medical purposes.
Currently, 10 CFR Part 35, Subpart J outlines ssecific criteria for training and experience for Radiation Safety Officers, nysician authorized users and teletherapy physicists. These include either aoard certification or specific time in three areas: classroom and laboratory, supervis6d work experience, and clinical experience. Should training and experience requirements be general and basic radiation sciences and radiation safety or should they remain more specific to the users' intended use of material? Are the current criteria necessary if the physician does not bear the primary responsibility for radiation safety? If needed, could the training and experience requirements for a physician user not seeking authorization to supervise radiation safety be less than the current six month program? Is the training and experience of an authorized user physician sufficient to qualify him/her as an RS07 NRC has a " preceptor" process in place for documentation of training received by physician applicants who are not certified by one of the professional boards currently recognized in Part 35, Subpart J. There is some concern that this process requires no commitment by the preceptc, ring individual regr.rding the quality of the documented training. The staff has embarked on tw endeavors to evaluate the current preceptor process for physician authorized users: 1) Myron Pollycove, M.D., Medical Visiting Fellow, is discussing with the medical community such issues as the type and quality of training needed by physician applicants, the feasibility of task-oriented training requirements, and the mechanism for defining the qualifications needed by the trainer; and 2) revising Supplements A and B to NRC Form 313 " Application for Materials License", to solicit a more detailed description of the training received by the applicant and to require certification by the preceptor that the training occurred as documented and was successfully completed by the phy.,ician to be designated as an authorized user. Should NRC become involved in monitoring the adequacy of consultant radiation safety courses, residency programs, and board certification courses as they relate to radiation safety?
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Current NRC training requirements for an authorized user of a radiopharmaceutical, generator, or re:. gent kits for imaging and localization studies include either: 1) board certification; or 2) 200 hr classroom and laboratory, 500 hr supervised work experience, and 500 hr of clinical experience not to be completed in less than six months. With each new development in the medical use of isotopes, practitioners from affected medical specialties want to take advantage of the new technologies. Are the criteria listed in 10 CFR 35.920, " Imaging and localization studies" in need of revision or clarification? Similarly, the development of new therapeutic radiopharmaceuticals has focused attention on NRC's current training and experience requirements for the use of radiophamaceuticals in therapy (board certification or 80 hr classroom and laboratory and supervised clinical experience) and the need to assess the adequacy of those requirements, Are the criteria listed in 10 CFR Part 35.930 sufficient for physicians who wish to be authorized to use radiopharmaceuticals for therapy?
Training and experience of personnel who handle byproduct material, other than the physician, Radiation Safety Officer, and teletherapy physicist, is not addressed in 10 CFR Part 35. NRC recognizes that other individuals involved in the use of byproduct material in the practice of medicine (e.g.
technologists, physicists, nurses, dosimetrists, etc.) may have certification or registration credentialling requirements. However, as in the case of physician authorized users, there must be an alternative to these credentials.
Should there be some minimum level of training and experience described in Part 35 for y!y of the personnel involved in the medical use of byproduct material? Since technologists perform the majority of isotope handling, should there be a minimum training and experience requirement for technologists who use byproduct material for diagnostic and/or therapeutic procedures? Should some radiation training and experience be required of other individuals who handle byproduct material and patients treated with byproduct material (e.g., nurses, volunteers)?
Separation of physician supervision from radiation supervision would permit consideration of changes to the regulatory program. Approval of remote sites where it is difficult to retain specialized' physician services could be accommodated more easily if a qualified technologist were available to supervise day-to-day handling of byproduct material. Should the NRC require the physical presence of a qualified radiation supervisor (physician, physicist, pharmacist or technician) at all times when byproduct material is being used? Should there be some minimal level of training for authorized supervisors who are responsible for the day-to-day safety issues associated with the administration of byproduct material? What level of training would be necessary for authorized supervisors under circumstances when a-single physician may supervise several f acilities, or even remote facilities using modern communications equipment? Should NRC issue licenses where the only physician authorized user is available only by phone if a qualified technologist is on site?
At a recent workshop on medical issues with Agreement State representatives in Atlanta, several participants suggested elimination of any requirements for medical authorized users to be physicians only and to have authorization of use based solely on an individual's radiation safety training and/or responsibility. If the NRC should elect to authorize non-physician radiation supervisors on medical licenses, is a separate category of authorized user D-3
. abysician needed? If the NRC allows a non-physician authorized supervisor to year the primary responsibility for radiation safety, does NRC need to continue to evaluate physician training and experience?
These types of considerations would involve re-examination of the duties and responsibilities of the radiation safety officer (R50) and perhaps the development of training and experience criteria for individuals other than physicians who might be classified as authorized supervisors. What should NRC do to further define the duties and responsibilities of the RSO and should there be a testing process specific to serving in this capacity?
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, APPENDIX F >
OTHER ISSUES Are there any other programatic issues and alternative approaches to regulation not'yet identified by the staff which should be discussed and evaluated?
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APPENDIX E COMMUNICATION hekaround NRC has various means available to communicate with the regulated medical comunity. Workshops, bulletins, licensing actions, inspections, and enforcement actions provide interactive communication between the NRC and the licensees. The NMSS newsletter is a quarterly publication that is mailed to j all materials licensees, Agreement States, and interested parties. The newsletter contains articles on subjects of regulatory interest, describes significant enforcement actions, and lists recent Regulatory Guides, Information Notices, and Federal Reaister notices. In addition, the staff prepares and mails Information Notices to medical licensees to inform them of specific events, safety issues, and NRC actions that have safety significance.
Generic letters are used as a means to address specific topics of importance te all licensees.
l NRC licensees and the general public have the opportunity to provide input on l new regulations under consideration through a public comment period for l Advance Notices of Proposed Rulemakings and Notices of Proposed Rulemakings l that are published in the Federal Reaister.
Discussion l l
The NRC has means to provide information to and communicate with the regulated community, however, the communication is directed to the licensee rather than the individuals directly involved with the use and handling of byproduct material. There is a perception among some in the regulated community that the communication does not always get down to the individual user level in language that is readily understood. Should- NRC-be responsible for communicating directly with the individual user or should the licensee be responsible for communicating to the user what the NRC has sent to licensees?
Is there a mechanism by which NRC can improve two-way communication between NRC and all groups of the medical community (including those users in Agreement States) and the general public?
The staff regularly conducts and participates in licensee workshops that stress safety and compliance issues. Are the number and scope of NRC workshops adequate to meet licensees' needs?
In addition, the staff provides presentations to seminars and meetings sponsored by professional organizations as well as publishing articles in professional publications. Attendance at professional meetings allows the staff to meet with licensees in a neutral environment. Should NRC incree.se its participation and/or attendance in professional seminars and meetings? Is there value in NRC staff meeting with licensees in a neutral environment?
l The communications listed above are mailed to all of the Agreement States.
Many of these documents are not passed on to individual licensees. Is there a way to improve communication with Agreement State licensees?
The ACMUI provides insight into the medical communities' views regarding E-1
l 1
1 I
rulemakings and some )olicy decisions. Recently, the Commission has directed-the staff to expand tie representation on the ACHUI to include groups other than the medical community (e.g. patient rights advocate). Is the ACHUl~
membership now broad enough to represent the varied interests in the regulation of the medical use of byproduct material?
NRC implemented a Medical Visiting Fellows program in 1991. The Fellows ~have been instrumental in improving communications with members of the medical community through ongoing interactions at professional and ACMUI meetings, as well as other opportunities, and providing feedback to NRC staff on key medical use issues. The staff anticipates that NRC's knowledge of the medical community and its relationship with its members will continue to improve by utilizing the Fellows in their role as liaison. Has this program been viewed positively by the medical community?
At this point in time, the only communication NRC has with the general aublic on medical issues (those who are receiving the radiation exposure)_is tirough Federal Reaister notices. Should public meetings be noticed in a publication more readily available to the medical comunity (e.g., professional journal, newsletters) and the general public (e.g., major newspaper) than is the Federal Reaister?
NRC is currently conducting a materials licensees regulatory impact survey.
This study requires looking at the 9 largest material licensees in each of_ the fuel cycle, commercial, and medical areas to assess the impact of regulations on their operations. What other surveys or measures could NRC use to assess the impact of its rules in maintaining or increasing safety in the use of byproduct material?
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APPENDIX F-OTHER ISSUES Are there any otner programatic issues and alternative approaches to regulation not yet identified by the staff which should be discussed and evaluated?
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- APPENDIX A MEDICAL POLICY STATEMENT Are the three principles in the medical policy statement appropriate?
If not, what parts of the medical policy statement should be revised?
Since the policy statement is subject to reinterpretation as the Commission changes, is it sufficiently specific to keep the medical use program on track while allowing accomodation of technological development?
Should a line item be included in the statements of consideration of any new rule to discuss its relationship with the medical policy statement?
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'~ APPENDIX B
- 10 CFR PART 35 ,
Are there new issues that should be incorporated or added into the current rule?
Is the rule, or are parts of the rule, too prescriptive or not detailed-enough?
Should the rule be entirely performance-based?
What techniques should NRC use to identify potential new rulemaking endeavors?
What level of research and analysis should be used tc eake the decision to forward with rulemaking?
c Are there any other provisions of 10 CFR Part 35-that interfere with-effective regulat.on of the medical licensees?
r-
1 j Is there evidence that either the submittal of QM programs or the subsequent recordkeeping requirements have posed an undue burden on medical licensees?
Is there evidence that the use of the term " misadministration" has had a negative impact on the practice of medicine or directly resulted in medical malpractice suits?
Are there any examples that the QM rule is an encroachment on the practice of '
medicine?
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l I APPENDIX C INSPECTION AND ENFORCEMENT Do NRC inspections focus on those aspects of a program which are most important to radiation safety?
Does the NRC policy of unannounced inspections achieve its purpose of reviewing radiation safety practices as they are normally performed?
Is NRC placing the appropriate emphasis on the use of NCVs and Form 591s?
Is the current correcting inspection radiation safety concerns? and enforcement program effective in identifying and Which aspects of the inspection and enforcement program are most effective?
Are civil penalties and press releases an adequate deterrent?
1 f
.- Do existing requirements allow sufficient flexibility to deal with emerging l problems or unforeseen circumstances without resulting in violations?
Should the NRC recognize voluntary accreditation and audit programs, in full or in part, and waive or reduce the frequency of inspections 'if the licensee participates in an independent audit program?
Should audits? NRC take enforcement action on the basis of the findings of these What enforcement options provide the greatest incentive-for uaintaining and improving effective safety programs?
-i is there an appropriate balance between regulatory compliance and program balance? -If not, what steps / actions could be taken to achieve an appropriate safety?
I 1
Do existing requirements allow sufficient flexibility to deal with emerging problems or unforeseen circumsthnces without resulting in violations?
Should the NRC recognize voluntary accreditation and audit programs, in full or in part, and waive or reduce the frequency of inspections if the licensee participates in an independent audit program?
Should NRC take enforcement action on the basis of the findings of these audits?
What enforcement options provide the greatest incentive for maintaining and improving effective safety programs?
Is there an appropriate balance between regulatory compliance and progr safety?
balance?
If not, what steps / actions could be taken to achieve an appropi ate i
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' APPENDIX D- i o
MEDICALLSUPERVISION INCLUDING RELATED' -
. TRAINING AND- EXPERIENCE: ISSUES-Should _ training-and experience requirements be general; and basic radiatien -l sciences'and radiation safety or-should they remain more spec.ific to the users' intendtd use of material? ,
i e
Are the current criteria necessary'if the physician does not' bear the primary responsibility for radiation safety? If needed, could the training and experience requirements for a physician user not seeking authorization ~to. .
super ise radiation safety be less than the current-six month program?!
F Is-the training and experience of an authorized user physician-sufficient to-qualify him/her as an-RS0?
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i Should NRC become involved in-monitoring the adequacyiof consultant 1 radiation-safety courses, residency-programs,1and' board certification courses-as.they relate to radiation safety?;
1 Are the criteria listed in 10 CFR 35.920, " Imaging and localizationLstudies" in need of revision or clarification?
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-W e v e - u w - a ** b * *
< Are the criteria listed in 10 CFR Part 35.930 sufficient for physicians who wish to be authorized to use radiopharmaceuticals for therapy?
Should there be some minimum level of training and experience described in Part 35 for any of the personnel involved in the medical use of byproduct material?
Since technologists perform the majority of isotope handling, should there be a minimum training and experience requirement for technologists who use byproduct material for diagnostic and/or therapeutic procedures?
i l-Should some radiation training and experience be required of.other individuals who handle byproduct material and patients treated with byproduct-material (e.g., nurses, volunteers)?
l Should the NRC require the physical presence of a qualified radiation supervisor (physician, physicist, pharmar.ist or technician) at all times when byproduct material is being used?
l
Should there be some minimal level of training for authorized supervisors who are responsible for the day-to-day safety is.ues associated with the administration of byproduct material?
What level of training would be necessary for authorized supervisors under circumstances when a single physician may supervise several facilities, or even remote facilities using modern communications equipment?
Should NRC issue licenses where the only physician authorized user is available only by phone if a qualified technologist is on site?
If the NRC should elect to authorize non-physician radiation supervisors on medical licenses, is a separate category of authorized user physician needed?
If the NRC allows a non-physician authorized supervisor to bear the primary responsibility for radiation safety, does NRC need to continue to evaluate physician training and experience?
What should NRC de to further define the duties and responsibilities of the RSO and should there be a testing process specific to serving in this capacity?
l APPENDIX E COMMUNICATION Should NRC be responsible for communicating directly with the individual user or should the licensee be responsible for communicating to the user what the NRC has sent to licensees?
Is there a mechanism by which NRC can improve two-way communication between NRC and all groups of the medical community (including those users in Agreement States) and the general public?
Are the number and scope of NRC workshops adequate to meet licensees' needs?
Should NRC increase its participation and/or attendance in professional seminars and meetings?
Is there valte in NRC staff meeting with licensees in a neutral environment?
Is there a way to improve communication with Agreement State licensees?
Is the ACHUI membership now broad enough to represent the varied-interests in the regulation of the medical use of byproduct material?
Has the Medical Visiting Fellows program been viewed positively by the medical community?
Should public meetings be noticed in a publication more readily available to ,
the medical community (e.g., professional journal, newsletters) and the general public (e g., major newspaper) than is the Federal Reaister?
What other surveys or measures could NRC use to assess the impact of its rules in maintaining or increasing safety in the use of byproduct material?
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