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IN RESPONSE REFER ~ /04. ~
M o UNITED STATES *
- ' r,[' i- NUCLEAR REGULATORY COMMISSION A/Mf5 tc// 75 #705 2B
,i WASHIN GTON, D.C. 20555 ACTIONSjThompsongNMSSy Cys: Stello
%***** . Taylor OFFICE OF THE Rehm SECRETARY August 10, 1987 Jordan, AE0D !
Beckjord,RES i Murray,0GC/B McElroy, NMSS 'j 1
MEMORANDUM FOR: Victor Stello, Jr. , Exec, tive Director for Operations
- 1 FROM: Samuel J. Chilk, Secre a
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SUBJECT:
STAFF REQUIREMENTS - B$II: ING ON MEDICAL USE OF-RADIOISOTOPES AND THE MEDICAL MISADMINISTRATION RULE, 10:00 A.M., >I WEDNESDAY, JULY 29, 1987, COMMISSIONERS' CONFERENCE ROOM, D.C. OFFICE (OPEN TO PUBLIC ATTENDANCE)
The staff briefed the Commission on medical uses of radioisotopes and initiatives to assure that medically prescribed medication / therapy are correctly administered.
Chairman Zech requested his fellow Commissioners to vote on SECY-87-29A, if they-have not already done so.
The staff stated that it would perform an analysis and' recommend to the Commission options relating to the (
regulatory authority of. naturally occurring and D) >
accelerator-produced radioactive materials (NARM).
gMDQ F # #(esn# s#s estfsE s # # #M fDW 81% (NMSS) (ED0 SUSPENSE: 12/21/87) i The staff committed to-brief and update the Commission on j the Medical Misadministration Rule following the staff's analysis of public comments on the proposed rule and the Advanced Notice of Proposed Rulemaking. At this briefing, the staff should arrange for the Commission to hear from representatives of the NRC Advisory Committee on the Medical Uses of Isotopes and industry scientific committees.
(@QQ) (SECY SUSPENSE: 3/15/88)
(NMSS)
Copies:
Chairman Zech Commissioner Roberts Commissioner Bernthal Commissioner Carr Commissioner Rogers I Commission Stafi Offices Rec'd Off. E00 <
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Minutes of a meeting with Robert Shalek, Will Hanson, and Norman McElroy at MDAnderson Hospital on August 18, 1987.
S don't get into 90 page implementation guides. Malpractice is a bigger club than an NRC rule (note that S is an attorney in addition to a medical physicist).
fledical users .have a good attitude--beware of being counterproductive.'
H circuit rider physicists are ok in some cases. we can't have 100% performance.
There -is a risk / cost balance--the patient dies while we're doing QA tests.
Therapy methodologies are fluid and dynamic.
S The RPC (Radiologic Physics Center) investigates dosimetry for clinical trials to assure validity of data. We do measurements plus calculations. The national cancer institute (NCI) supports clinical research in cancer for phases 1, 2, and 3. Phase 1--new prescription drugs, hyperthermic, negative pi mesons for example. Phase 2--safety and efficacy, best dose, tolerance dose. ,
Phase 3--Optimize. .Many such studies, including multi-modality. There are about 20 clinical trial groups each with 6 - 200 hospitals, and about 200 studies at any one time.
The RPC validates dosimetry. It has a grant from NCI, It usually finds only small errors, however, seldom do we have no recommendations for improvements.
Oncology groups get administrative funds plus free drugs, incidental expenses. ]
NCI contracted with hospitals to provide research care. Regarding the use of TLD's in mail-order QA, we have a 5% action level. We estimate we get 3%
accuracy in mailorder studies, and 2% accuracy in laboratory studies.
'In our QA visits, one man does two hospitals per week plus about 6 weeks to turn around a draft report. The RPC is on the legal edge: misses, and recommendations, and timeliness. One man writes, another reviews. H reviews, it gets typed, and then goes through the circuit again.
Don't overdo your rule--remember, someone can get sued if someone misses samething.
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l H There is a strong examination of quality of care' by the ref rr ng physician.
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Remember we are dealing with optimization : response T +- H . n _T tumor dose Hhealthy j Do not disturb referral patterns. Note that some protocols may allow 25%
deviation. We think our inspections are good to about 5%. Your misadministrat'.on definition of 10% for brachytherapy sources in unreasonable; it should be 15% for a simple gynecologic implant and 30% for a single plane interstitial (within 2mm of a isodose line).
Separate billing to third parties may balance the impact of DRG's on physics support.
The RPC seeks systematic error, not human error, which is what you are looking for. Some of the groups have intera ctive outside review for QA of prescription before therapy.
Modifications of therapy are field size, blocking, dose, ,
1 Regarding dose information, beware of scaring patients away from care.
The probability of random error is inversely related to the frequency of the treatmert modality or method.
For your QA inspections, estimate about 16 site visits per man-year including overhead (travel, research, program maintenance). Note the ACR efficiency audits that are available.
Physician fellowships are usually limited to research, not clinical experience.
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'6 RADIATION ONCOLOGY DEPARTMENT MANUAL QUALITY ASSURANCE PRINCIPLES
- 1. Only written radiation prescriptions shall be filled.
- 2. A posted or otherwise well-known departmental policy concerning the maximum dose allowed to various organs shall be observed in conventional treatments.
- 3. Radiation beams shall be calibrated and reviewed by a second person at reasonable !
Intervals, not to exceed one year.
- 4. Checks of beam calibrations staall be performed on-site or by mailed dosimeters by individuals outside of the institution at reasonable intervals.
- 5. At least weekly output checks shall be made on therapy beams; output checks shall be correlated with periodic calibrations. f
- 6. A manual check of dase per fraction shall be made to at least one point in computer-generated treatment plans.
- 7. An independent check of treatment plans shall be made by a second person.
- 8. There shall be a weekly review of the accumulating patient dose in external beam therapy.
- 9. Passive monitoring of time of exposure or monitor units delivered shall be done for external beam treatments by an automatic device or a second person.
- 10. A note concerning the functioning of an external beam machine shall be made for each treatment.
- 11. The validity of the prescription, the identity of the patient, and the strength of brachytherapy sources or 32 P as a radiation therapy pharmaceutical shall be verified by a second person before fulfillment of dose prescription.
- 12. Patients shall be surveyed with a radiation detector after removal of brachytherapy sources.
- 13. If an inconsistency is found in a treatment prescription, measurement, calculation, expected patient response to treatment, or functioning of a machine, that inconsistency shall be understood and resolved before proceeding with patient treatment.
- 14. In the event of a misadministration of radiation treatment the department head or his designee shall be informed promptly.
. 15. Detailed records of radiation machine performance, maintenance arid malfunctions ,
shall be maintained. i
- 16. Mechanical or electrical modifications of radiation machines shall be made only by the manufacturer.
Draf ted by Robert ,1 Shalek 2/19/87
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Title:
Briefing on Medical Use of By-Product -
Materials and the MedicalvAdministratian Rule kiS Location: Washington,.0. C.
Date: Wednesday, July 29, 1987 Pages- 1 - 66 1
i Ann Riley & Associates Court Reporters 1625 i Street, N.W., Suite 921 Washington, D.C. 20006 (202) 203-3950
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O I SC LA I MER 2
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This is an unofficial transcript of a meeting of the 7 Unitad States Nuclear Regulatory Commission held on a 7/29/87 ..
in the Commission's office at 1717 H Street, 9 'N.W., Washington, D.C.
The meeting was open to pubIic 10 attendance and observation. i This transcript has not been 11 reviewed, corrected, or edited, and it may contain f
12 inaccuracies.
13 The transcript is intended solely for general 14 informatlonai purposes. As provided by 10 CFR 9.103, it is 15 not part of the formal or informal record of decisien of the i
16 matters discussed. Expressions of epinion in this transcript '
17 do not necessarily reflect final determination or betiefs. No 18 pleading or other paper may be filed with the Corm i s s i on in 19 any proceeding as the result of or addressed to any statement 20 or argument centained herein, except as the Cemmission may 21 authori=e.
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1 UNITED STATES OF AMERICA 2
NUCLEAR REGULATORY COMMISSION 3 ***
4 i BRIEFING ON MEDICAL USE OF BY-PRODUCT MATERIAIS 5
AND THE MEDICAL MISADMINISTRATION RULE 6 ***
7 PUBLIC MEETING 8 *** '
9 Nuclear Regulatory Commission 10 Room 1130 11 1717 H Street, Northwest 12 Washington, D.C.
13
- 14 Wednesday, July 29, 1987 15 16 The Commission met in open session, pursuant to 17 notice, at 10:00 a.m.,
the Honorable LANDO W. ZECH, Chairman of 18 the Commission, presiding.
19 COMMISSIONERS PRESENT:
20 LANDO W. ZECH, Chairman of the Commission 21 THOMAS M. ROBERTS, Member of the Commission 22 FREDERICK M. BERNTHAL, Member of the Commission 23 KENNETH CARR, Member of the Commission 24 1
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1 STAFF AND PRESENTERS SEATED AT THE TABLE:
2 3
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5 6 S. CHILK 7 W. PARLER 8 B. BERNERO '
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- 5. TAYLOR 1 10 N. McELROY 4 11 R. CUNNINGHAM 12 V. MILLER 13 .
H. THOMPSON 14 V. MILLER 15 16 .
17 18 19 20 21 22 23 24
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1
. PROCEEDINGS 2
CHAIRMAN ZECH: Good morning, ladies and gentlemen.
3 The purpose of the meeting this morning is for the 4
Commission to be briefed on the activities regarding the 5
medical use of by-product material and the medical 6
misadministration rule.
7 The Commission has been interested in this area for (
i 8
quite some time and has a strong commitment to safety in the ' i 9
hospital and industrial uses of nuclear materials.
10 I personally visited several hospitals recently and 11 also a manufacturer of radiopharmaceuticals. I've been 12 impressed by what I have seen. I 13 There are many benefits to be gained from the medical 14 use of nuclear materials for the citizens of our country. j 15 However, I believe there is always room for improvement. The l
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Commission, I believe, should do everything we can to minimize
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17 l the problems and reduce the chances of misadministration. I l 1
18 know that this is not an easy task, because of the many 19 thousands of licensees involved and the many uses of nuclear 20 materials every day throughout our country.
21 On the other hand, misadministration on occasion, l 22 although rare, do occur.
I think it merits our attention. i
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l 23 The staff recently submitted a paper proposing two 1 24 rulemakings on medical administrations which will be discussed 25 at this briefing.
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I would ask at the conclusion of the meeting if my 2
fellow Commissioners would vote on this paper, SECY-87-29(a), i 3
if they haven't alseady done so, or they vote as soon as they 4
possibly can, so that we can move forward on this important 5 issue.
6 Do any of my fellow Commissioners have opening 7 remarks to make this morning?
8 COMMISSIONER BERNTHAL: I would just comment that it '
9 has taken us a while to get here, but I want to congratulate 10 the staff on a considerably improved SECY paper and proposal 11 compared to at least one or two previous trial efforts in this 12 area. I think the latest proposal looks quite good and has 13 many significant improvements.
14 With that, let's proceed.
15 CHAIRMAN ZECH: Thank you very much. Proceed, Mr.
16 Taylor.
17 MR. TAYLOR: Yes, sir. Good morning.
18 As you noted, Mr. Chairman, the staff has submitted 19 the Notice of Proposed Rulemaking and Advanced Notice of 20 Proposed Rulemaking, both of them directed to imposition of 21 quality assurance type criteria in medical administrations of 22 by-product materials under our regulations.
23 As you mentioned, there are about 8,000 licensees 24 involved and each year, the staff estimates that about 10 25 million patients receive either diagnostic or therapeutic doses
i n 5
1 of by-product material in the practice og nuclear medicine. !
2 Today'u briefing will touch a little later on the 3
rule but is also intended, as we said in the staff paper to 4
you, to cover the general area in an information briefing on I 5 nuclear medicine. I think as,you are briefed by the staff i j
6 hoday, it is important to keep in mind, and the staff i l
7 I emphasized this to me in our previous discussions, how rapidly 8
the field of nuclear medicine is changing. It is a. field in ' )
9 which new developments are being made and the practices are 10 changing.
The staff, I think, in imposing QA criteria, will be 11 trying to do that against what could be changing targets, 12 practices and methods used in by-product administration.
13 I will now ask Mr. Bernero to start with the 14 briefing.
15 MR. BERNERO: Thank you.
16 Members of the Commission, here at the table today, 17 we have on tr e far right, Dick Cunningham, who is our Director 18 of the Division which handles fuel cycle material work. On my 19 left, I have Vandy Miller, who is Chief cf the Medical, 20 Academic and Commercial Use Safety Branch. On Jim Taylor's 21 right is Norm McElroy, who is the leader of the Medical and
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22 Commercial Use Safety Section of that Branch.
23 Norm is not only an NRC staff member of high value to 24 us, but he is also a member of the adjunct faculty at George 25 Washington University in the Department of Radiology. He is
4 s 6
1 qualified.
He will be giving you the briofing. His experience 2
as a radiation safety officer, I think, is a great help in 3 illuminating this subject. Before he s?. arts, I would like to 4 make one personal point.
5 I have appeared before this Commission many times in C
my career here, speaking of reactor core Delts and containment 7 failures and the doses that go with it. Those are theoretical 8
doses, thank goodness, they haven't occurred, at least not in '
9 this country.
When we speak of a severe reactor accident, we 10 start counting people exposure to the millions of person rem.
11 l We are now today a talking about real radiation exposure to 12 people in this country, done with care and for benefit under 13 4 the control of the medical profession and our regulatory !
14 authority, which in any one year gives personnel exposure on 15 the same order of magnitude as the worse kind of reactor 16 accident.
17 It's an important regulatory arena. These are real 18 doses and the people are getting them. That underlies the 19 importance of our attention here as well as the medical 20 profession's attention to this field.
21 COMMISSIONER BERNTHAL: That's a point well taken, 22 Bob. I see Joe Fouchard smiling in the back of the room and I 23 l would also note that the press table is empty today, which I l 24 think places matters in a bit of context here. l 25 MR. BERNERO: Let me turn it over to Norm. i i
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1 CHAIRMAN ZECH:
i Before you do that, I certainly agree 2 with you, Bob. This is a very important matter. The 3
Commission has been concerned about it for some time. I think L
4 l it is timely that we are having this meeting. You are 5 absolutely right.
I These are real doses that are' occurring 6
right now throughout the country and throughout the world.
7 Even though misadministration and mistakes occur, on 8
a rare basis, we are dealing with one of our most professional '
9 groups, people are involved in it.
I think our attention to 10 this matter -- it has been my desire during this year and the 11 next few years to bring more emphasis to this area. That's why 12 I have tried to visit a few hospitals recently myself and also 13 why you are here today. My fellow Commissioners I know agree 14 with me that this is an area that we want to emphasize and your 15 remarks are well taken and we share that concern.
16 Let's proceed.
17 MR. McELROY: As has been pointed out, we are here to 18 examine rules that will reduce the frequency of .
19 misadministration. In the larger scheme of things, we are 20 talking about quality of medical care in this country. What we 21 do as an Agency has the potential for profound impact on the l 22 delivery of medical care. l 23 I Before we take any actions, we think it is important l 24 i to examine the delivery of medical care in this country today.
25 We will look at radiation care and we will also 1cok at some a_______ __.m_ . .
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, CC"Mi$$10N 8aftffkG ufDICAL U$f 0F 9V9e000CT Matt #fAL JULY 29 1987 Current Uses and Trends Radiopharmaceuticals Otagnostic Devices Teletherapy implant Therapy Business Considerations I Industry Initiatives for Cuality NRC Initiatives for Quality Voluntary Efforts Misadministration e lemakings u
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general business considerations driving the delivery of 2
medicine that may impact on the efficiency and efficacy of our 3 rulemaking attempts. l l
4 I'd like to spend a few minutes examining delivery of 5 i radiation medical care in this country today. I think you will 6
see very clearly that the key feature of radiation care is 7 change. i There is change in technology brought about by j 8
scientific breakthroughs and new equipment. There is change in '
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9 the business of medicine brought about by other activities in 10 the Federal Government. There is change in industry, brought 11 about by changes in diseases and new technologies that are 12 available.
13 We are looking at licensing whole new categories of 14 individuals who have never before held an NRC license.
15 We will then move on to examine some of the industry 16 quality assurance initiatives that have been going on for more 17 than 15 years in radiation therapy, particularly. Finally, 18 examine the initiatives that the staff prepared in response to 19 your directive. i 20 If you turn to the first slide, we have an example of 21 conventional nuclear medicine. This is where the 10 million 22 individuals get dosed every year for diagnostic imaging 23 purposes.
Radiation has been used in medicine since Roentgen 24 discovered X-rays in 1895 for diagnostic purposes. Within 25 months after his discovery of radioactivity, Becquerel was 1
i 4 o .:u 4er of Clinice! Cases Nati nwide tach Year
- Diagnostic Imaging 10 Million
- Test Tube 100 Million o Number of Licensees s Agreemest I hRC States' l
- Hospitals I 2000 4600
- Private Practitioners 300 600 s
There are about 8000 hospitals in the United States.
Medical regulations have historically not been a matter cf compatibility; the Commissien's recent directive to require all Agreement States to establish a misadministration reporting program set a precedent. Future quality assurance requirements will likely be a matter of compa tibility, s
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<Today, in this particular. slide, we are looking at a 3 diagnostic examination.
4 CHAIRMAN ZECH: Excuse me. Do we have slides
', 5 available?.
6 MR. McElROY: We submitted photocopies of the 7 briefing.
8 CHAIRMAN ZECH: I think they are going to print up '
9 some more. I don't know if they have been printed up yet or 10 not.- Can anybody tell me?
i 11 !
Will you distribute them to the people in the 12 audience when we get them, please? 1 I think we all have a book. j 13 but not everybody has the book, that's my point. Since you 1 l
14 l don't have slides to show either, we will get copies for the 15 people in the audience as soon as they are available. 1 1
16 1 Sam, would you make sure they get passed out, please, 17 when we get them? 4 18 MR. CHILK: Yes.
- 19 CHAIRMAN ZECH
- You may proceed. 1 20 MR. McELROY: on page one, you have an example of a 21 heart imaging procedure. The patient has been injected with 22 about 30 mil 11 curies of pertechnetate that goes into the blood 23 pool.
By examining the images, the physician can determine the I 24 efficiency with which the heart is working. We will see some 25 different kinds of images a little later on.
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years ago because the computers needed to do the image 3
processing were not available in the community hospitals.
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4 will look a little more at imaging in just a moment. {
l 5 i I want to mention in passing that radioactivity is )
6 also used in test tube work in the hospital setting. You have !
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all sent blood samples down to the lab, somewhere down in the 8 basement. '
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Radioimmuncassay is a technique that was developed by 10 the late Sol Berson and Rossalyn Yallow, who now holds a Nobel 11 Prize for that work. It is a test tube technique in which the 12 radioactivity is not administered to the patient but rather l l
13 used in a test tube process to measure trace chemicals in the 14 blood pool. It may be used to measure the concentration of a l 15 natural hormone such as thyronine. It may be used to trace the 16 concentration of an administered drug, such as digoxin that is 17 used to treat some kinds of heart disease.
18 The test tube process alone in this country results 19 in about 100 million measures requiring 200 million tubes of 20 radioactivity with trace amounts, nanocuries levels of I-125.
21 Following that little tangential note, we will go 22 back into the administration of radioactivity to patients.
23 COMMISSIONER BERNTHAL: May I ask a question? You 24 mentioned I-125. That raises an issue that you may not want to 25 address now but at some point before we leave today, I would 1
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, 11 1 like to get some comment on. Nothing we can do anything about, 2
at least not without congressional action, but as I understand 3
it, we don't have any regu'latery authority over Iodine 125 4
because it is not a by-product material from nuclear reactors.
5 It'is an accelerator produced material. We have this 6
regulatory anomaly, that side by side, you can have Iodine 131, 7
which does happen to be a.by-product material, and Iodine 125.
8 One is regulated by the NRC. The other is regulated, I' don't '
9 know by whom, FDA, I suppose.
I don't even know who regulates 10 this.
> 11 MR. McELROY: The individual states have the 12 NARM authority to regulate the norm material that comes out of a 13 cyclotron or is natural radioactivity. There is no Federal 14 WAA//
organization regulating norm radioactivity.
15 COMMISSIONER BERNTHAL: That's the anomaly. They are 16 absolutely the same in terms of effect and usage in any 17 reasonable respect. I would like to get some comments on that 18 at some point, now or later.
19 MR. McELROY: If you move to slide two, you will see 20 an example of the image that physician actually looks at to 21 make a diagnosis. This is an example of a new drug that came 22 on the market in the last few years, the generic name is 23 disofenin. It is used for imaging liver and gallbladder 24 disease. About 5 millicuries of radioactivity is administered 25 to the patient by injection. It is immediately taken out of
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the blood pool by the liver and then passed into the 2 gallbladder.
3 This can be used to diagnose or stage or determine 4
the extent of liver disease or gallbladder disease.
5 You might note that the illustration here is not as 6 crystal clear as an X-ray. You might wonder, well, should we i 7
reduce the amount of radioactivity administered, reduce the 8 dose.
It certainly couldn't reduce the quality of the image '
9 very much.
To reduce the dosage in an attempt to reduce the 10 radiation dose to the patient, it would likely compromise the 11 study.
It would no longer have any medical utility at all.
12 The physician has to baldnce the optimum amount of 13 radioactivity administered with the imaging equipment, the 14 patient's condition and so on, to get the best image available 15 for that patient.
16 This is an example of what we call a static study, 17 where a single view of an organ is taken- If you turn to page la three, we have an example of a serial study, that provides a i 19 good illustration of the impact of computers.
20 Again, the material was injected into the patient. 1 21 You see a series of pictures taken of the liver. This patient 22 had presented the physician with abdominal pain, non-specific 3
23 origin, and suspecting gallbladder disease, the physician 24 administered the drug at 35 minutes, the first image en the 25 second row, he administered a dosage of sincalide, which is a i
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IMP ACT OF COMPiliE Ps Use LunvE NT 10nAL IMAGE DISPLAY o Image Olsplay
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dump the radioactive compound into the small intesti e to begin 3 fat metabolization.
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administered at 50 minutes, and then the gallbladder starts to 7 release its content.
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on surgery, the patient was found to have a '
l 9 gallbladder disease that was correctable.
I 10 1 The impact of computers in diagnostic radiation care I 11 has been incredible. They were not there when I was in the i
12 field in the early to late 1970s. The best example of all, I 13 think, is with an x-ray machine. You have all heard of CAT 14 scanners or CT scanners.
15 When I did the dosimetry on the first available CT 16 scanner in this country in 1973, it took the machine 5 minutes 17 fcu r~/et' to go through its gyrations and 15 minutes to do a foray 18 transform, and gave two cross sectional images of the brain.
19 It was 20 minutes to get two pictures.
20 Ten years and three generations later, the machine 21 took half a second to go through its gyrations and half a 22 f' ourier second to do a fcat foray transform. One generation later, we 23 have real time CT scans. That is five generations in 15 years.
24 I don't think this Agency is used to dealing with that rapid 25 pace of technological evolution.
l
, 14 1 !
We can't assure quality today with our regulations 2
and then guarantee you that 5 years down the road, we will have 3
the same level of assurance.
~
4 There are some new drugs being developed. One of 5 them is illustrated on page four. There is some research going 6
on in developing new drugs for both brain studies and heart 7 studies. J This is an example of a drug called isopropyl 8 iodoamphetamine, that goes to the brain. We have two rapid '
9 developments illustrated on page four.
10 This is a tomograph using nuclear materials taken at ;
11 the eye level in the brain. I On the left, is a normal patient l 12 I who has been administered the material. On the right, a {
13 (
patient suffering from Alzheimer's diseasa. You can see there I 14 is reduced uptake in the temporoparietal region of the brain, 15 which is indicative of Alzheimer's. {
16 l This kind of drug can also be used to diagnose other l 17 neural diseases, such as Huntington's chorea. Again, it I l
18 involves the administration of about 5 mil 11 curies of 19 radioactivity.
20 The test is so sensitive that this kind of 21 /ess examination has to be done in a quiet, darkened room, er 1;;. 1 22
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the natural metabolism of the brain will contort the results of 23 the test.
24 In addition to the drug, the idea of having a camera 25 that can take these cross sectional pictures is new. It wasn't I
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15 1 available in the clinic 5 years ago. Now, this is available to 2
every community hospital in the country. Again, rapid 3
evolution, new kinds of care that weren't even dreamed of 10 4 yearn ago.
5 COMMISSIONER BERNTHAL: Why does the PET imaging G require an on-site cyclotron? Is that because they are using 7 the short life isotope? '
8 MR. McElROY: The radioactivity has a half life on '
9 the order of 2 minutes to 10 minutes, depending on which 10 species, nitrogen, oxygen and carbon are all available, very, 11 very short half lives.
12 We have tho evolution of a new class of chemicals 13 here and a new piece of equipment, that as I mentioned, were 14 not available just a couple of years ago. The most exciting 15 development, which makes us jump from the 1890s up to the 1990s 16 in one step, is illustrated on page five.
17 A 19th Century German physician by the name of Paul 18 Ehrlich postulated the immuncresponse theory that is the basis 19 for disease in medicine today. He conceived of a thing called 20 a magic bullet, an antibody that would go only to a certain 21 kind of diseased cell, some kind of drug that is specific to 22 the disease at hand.
23 In fact, the illustrations in his first monographs 24 that he published are just like illustrations that are used 25 today.
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This development of new drugs represents genetic 2 engineering, hybridization of cell lines. The example you have 3
here, we have two mice that were injected with the monoclonal 4 antibody that is specific to human colon cancer. These images 5 were taken serially for four days. The mouse on the top has a 6 human colon tumor grafted to his flank. The mouse on the 7
bottom is a normal control.
8 You see the radioactivity concentrates at the tumor '
9 site on the mouse on the top, who has the disease specific for 10 the monoclonal antibody that has been administered. The mouse 11 on the bottom doesn't have the right kind of disease, so all 12 the radioactivity is flushed out of his body and promptly, 13 within.a day or two.
14 COMMISSIONER BERNTHAL: What is the time span here?
15 MR. McE120Y: Days one through four.
16 \
This represents possibly the most exciting l 17 1 development we will have in radiopharmacy. This monoclonal !
18 antibody could be labeled with a low toxicity radioactive 19 compound and used to diagnose and stage disease, determine if 20 it has migrated beyond the original site. If a disease is not {
21 present, the radioactivity is simply flushed out of the body.
22 If the disease is present, perhaps the same compound could be 23 labeled with a highly toxic form of radioactivity, such as 24
( iodine or perhaps even an alpha emitter, and used for therapy.
25 I stress again, disease specific, t
3
, 17 1
The quality assurance that would go along with the 2
development of these drugs, the handling of 3
radiopharmaceuticals that have hundreds of millicuries of I-131 4
attached, is something de will have to consider.
5 COMMISSIONER BERNTHAL: You don't happen to know if 6
this particular sequence was done with an alpha emitter or beta 7 gamma?
\
8 MR. McELROY:
t I believe this was done with I-131. I 9
believe for a mouse, you need about 8 microcuries.
10 So far, we have examined radiopharmacy, where
- 11 radiopharmaceuticals are injected into patients.
\; There are 12 other methods of using radioactivity for diagnosing disease and 13 a very interesting example is on page six.
14 This machine is called a lixiscope. It is a real 1
15 time x-ray imaging device hand held. There are no hidden powe?
16 cords here anywhere. i It is battery operated. It has sealed 17 i
source of 200 millicuries of I-125 in the capsule at the end of 18 the stick, where the yellow sticker is.
19 This provides a physician with a tool that is much 20 less expensive than a conventional x-ray machine. It exhibits 21 a much lower dose rate to the patient. You have probably seen 22 one of these, if you watch professional football on television.
23 Of course, the arm that holds the radioactive source to the 24 image intensifier is much larger, so it can fit around a 25 football player.
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We mentioned the possibility of licensing new 2 categories of individuals. podiatrists have never held NRC 3 licenses before. In emergency medicine, either on the sports 4
field or in a rescue vehicle responding to a traffic accident, 5
this device could play a very important role. We are looking 6
at the potential of having a device like.this on every rescue 7
vehicle in the country that has to respond to an automobile 8 accident, because -
you move a patient with a broken bone, you '
9 risk severing the spinal chord and end up with instead of minor lo injuries, a quadriplegic.
11 I am not suggesting that is what is going to happen.
12 There is a very real potential for that kind of need for this ~
13 dev, ice as it gets out in the marketplace.
14 We are dcaling not only with new technology here, but
- 15 new classes of users.
16 In addition to new devices, we have new diseases in l'
17 this country, as illustrated on page seven.
18 COMMISSIONER GERNTHAL: I would just comment that is j 19 a very impressive device.
It also has a pretty impressive 20 loading of Iodine 125, your point about a new class of users is l
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21 well taken. One hopes they are well trained. I 22 MR. BERNERO: This goes right to your point, Mr.
23 Bernthal, about who regulates it.
24 nR. CUNNINGHAN: Iodine 125 is regulated by us.
L 25 COMMISSIONER BERNTRAL: It is? Hov does that happen?
( . . . _ _ _ _ _ . - _ - - - -
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l BON ( MINTRAI ANALYlfR I
o Osteoporosis affects 251 of post-menopausal women o Falls are freovently fatal within one year a No widely accepted treatment
- Calcium supplement
- Estrogen therapy 1
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It's a daughter product of a reactor produced material?
2 MR. McELROY: I believe it can be produced in either 3
fashion, and unless the user can prove that it came from a 4
cyclotron, he falls under our regulation.
5 COMMISSIONER BERNTHAL: You can't produce it as a 6 primary product in a reactor? It may be a daughter product of 4
7 reactor produced material.
8 MR. McELROY: On page seven -- '
9 MR. CUNNINGHAM: I might add on your ccament of new 10 class of users, this kind of device also presents a lot of .
11 opportunity for abuse.
1 12 i COMMISSIONER BERNTHAL: That is right. !
13 MR. BERNERO: You remember the shoe examiners.
14 COMMISSIONER BERNTHAL: I don't even want to think l 15 about them.
. 16 [ Laughter.)
17 COMMISSIONER BERNTHAL: I remember them too well.
18 t MR. McE120Y: Those were x-ray devices. Of course, 19 we didn't regulate those.
20 COMMISSIONER BERNTHAL: I know!
21 CHAIRMAN ZECH: Let's proceed.
22 MR. McELROY: In addition to new devices, we have new 23 diseases in this country. You have seen printed or television i
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24 press on the disease, osteoporosis. It potentially affects 25 25 percent of the older female population in this country. Being
_ ___ _ w
. 20 ,
1 confined to a wheel chair perhaps might not be all that 2
terrible, but in fact, many of the individuals suffering from 3 this disease fall. You have heard the phrase'"she fell and 4
broke'her hip," #she fell and landed on the pubic bone.d' They 5
have been so demineralized by this. disease process, that it was 6
not able to withstand the impact and shattered when the patient '
7 fell.
8 Alternatively, simply by taking a misstep, putting a l
9 little too much pressure on that bone, it can cause it to i 10 shatter. In either case, the patient is sent to bed with a 11 cast, but' recall, she is suffering from a bone degenerative 12 disease. The break doesn't heal very rapidly. Confinement may_
13 last as long as a year.
14 Something on the order of 30 percent of those falls 15 are' fatal within a year, either because of opportunistic 16 infection or secondary conditions that come on, that accompany 17 extended bed confinement. This is something that potentially 18 costs a lot of money and a lot of human life with this disease.
19 This tool again loaded with the 200 millicuries
/haf del Wally 20 iodine source actively measures bone density. It allows the 21 physician to scan the patient, simply scan the forearm with a 22 pencil beam of radiation on an initial visit and then perhaps 23 avery six months to determine the progress of the disease or if i- 24 it has initiated. As yet, the best method of care has not been I 25 determined by the medical community. Again, a device that is e
I il
21 1
getting out into the market and may be used by a new class of 2
physicians who have not before had an NRC license to use 3 materials.
4 I would point out on page eight that what we see is '
5 the possibility of actually having nuclear medicine serving as 6
the gatekeeper of the hospital in the 21st Century. I confess 7
to having gotten this slide from a nuclear medicine physician 8
who had eyes on the chair of the Chief of Staff, but '
9 nonetheless, it is not outlandish.
10 You have seen a lot of different techniques that .
t 11 nuclear medicine has in its armamentaria t.o diagnose disease.
12 That is a quick survey of diagnostic use of radia' tion.
13 If you turn to page nine, you have an example of 14 radiation therapy. This is a Cobalt treatment unit that has 15 5,000 to 10,000 curies of Cobalt-60. The patient would be i 16 treated usually for cancer using this device. This requires 17 interaction of a variety of medical professionals; a physician 18 who prescribes the amount of radiation to be administered and 19 how large a treatment volume is necessary; a dosimetrist who 20 would calculate how long the unit has to be turned on to 21 deliver the prescribed dese; a technologist who actually 22 administers the radiation dose every day; a physicist who 23 checks the calculations to determine they are correct and also 24 actually measures the output of the radiation therapy unit.
25 Radiation has been used alone. It can also be used
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. Cobalt therapy 100.000 -
o Number of hospitals or Clinics providing teletherapy nationwide f
. Cobalt only 280
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- Cobalt and X-ray Total 1150 o Typical regiment 5000 rads as 200 rads / day for 25 days .
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1 with adjuvant therapies. It can be coupled with the; f
2 administration of certain chemicals that can kill the tumor.
l 3
Some hospitals have facilities in which the primary tumor can 4
be excised in' surgery and while tha patient is still open, have 5
.the patient transported to the radiation therapy clinic and 6
have the tumor bed irradiated to. kill any remaining cells that 7 were not removed during surgery.
8 You have seen examples of monoclonal antibodies that '
9 can be administered in conjunction'with radiation therapy.
10 Tumors are typically deficient in oxygen tension, 11 therefore, they are less sensitive to radiation damage. There 12 i are various mechanisms used to increase the amount of oxygen in
~
13 the tumor bed, whether by having a patient breathe pure oxygen 14 or putting him in a high pressure room for a few minutes before 15 radiation is administered. Heating coupled with radiation also 16 may be beneficial.
17 This raises a very important technical question which 18 the staff will have to deal with. We have a definition of 19 misadministration. Should that definition go out to encompass l 20 the adjuvant therapies that are used. Should we define a 21 misadministration as failure to achieve the correct tumor I 22 temperature when using hyperthermic before administering the
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23 radiation. It is simply a technical question presented to 24 demonstrate the difficulty of the task that the staff will be 25 dealing with.
l
4 4 23 1
on page 10, we have aut actual example of a treatment 2 plan.
Here again, you see the impact of computers in radiation 3
therapy.. A CT scanner was used to determine patient contour, 4
the tumor volume to be treated'and also radio sensitive 5 surrounding healthy tissue. That CT scan can be fed directly 6
into a treatment computer that is used to calculate dose 7 profiles.
8 For this particular patient, the physician is using a '
9 three port regimen in.which the beam will be delivered for one 10 minute from beam location two at about 7:00, and the machine
- 11 will be turned off. The technologist we'Jd go in and rotate 12 the machine over the top of the patient, snine the beam in from h
, 13 12:00 for one minute and shine in from 5:00 for one minute.
14 This is done to spare the healthy overlying tissue 15 while providing maximum treatment dose to the tumor volume.
16 Again, an example of evolution.
17 When I was working in radiation therapy in the early' 18 1970s, the'se computers weren't available. We did this on a few 19 patients using templates taken out of textbooks. This 20 represents a really evolutionary step.
21 You have demonstrated some concern about the quality 22 of the back-up devices used by our licensees. This treatment 23 planning computer is certainly one of the most important. It
'24 might be important to have an independent agent other than the 25 computer manufacturer verify the validity of these programs.
4 C___._______~____._. - - - _ -
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This program is sufficiently complex that 2
verification is outside the capability of most community 3 hospitals.
You will see a little later on in the briefing that l
4 some professional organizations, scientific organizations, have I 5
established committees to examine this kind of problem. The s l 6
industry is taking some steps and we will take a look at those !
7 a little later. }
8 I think you can see now the complexity of the problem' 9 we are dealing with.
10 We have an example of a new development on page 11, 11 which is called a remote afterloader. I mentioned that 12 Becquerel tried using radium plaques to treat skin lesions 13 early on. That was unsuccessful due to the high beta dose rate 14 coming off the plaque. The implant of radioactivity within the 15 tumor volume has been around for a long time. Radium seeds 16 were developed early on that could be used for tumors. For 17 some kinds of tumors, success rates as high as 95 percent have 18 been achieved using implanted radioactive seeds.
19 This is a relatively new device demonstrated here.
20 It is called a remote afterloader. Down at the bottom of page 21 11, you see a physician has pre-implanted nylon catheters in 22 the treatment volume, ,after using an x-ray to determine they 23 are in the correct position.j Ihemachinecanbecoupledtothe 24 implant and then the radioactive seeds can be inserted into the 25 machine, into the implant site.
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1 This higher activity that can be used with this i
2 machine holds promise of great benefit because if a lower I i
3 i activity seed is manually implanted for this kind of treatment, f
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4 the patient is normally confined, conscious and to bed for as i 5 long as three days, completely immobile. A Draconian measure 6 but in many cases, successful. Using this device, 7 !
administering a higher amount of radioactivity allows for
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8 shorter treatment time. '
9 You can see on 12, it is obviously a lot more i 1
10 comfortable for the patient.
11 On page 13, again we have an example of a dose 12 distribution for that patient; 7 catheters were implanted into l
< 13 the breast tissue. The computer has been used to calculate the 14 isodose curves here in rads per hour. i This is a fairly simple 15 implant, yet you see we have a fairly complex set of isodose 16 lines surrounding implant volume.
17 i One of our misadministration definitions requires ;
18 that a hospital report a misadministration if the dose is more 19 than 10 percent different than prescribed. Taking that i 20 definition and this illustration, it led one of the members on i 21 our Advisory Committee on the medical use of isotopes, to 22 characterize that as being similar to trying to define the 23 tcpography of the United States with an integer. i 24 COMMISSIONER BERNTHAL: How long have we had that 10 25 percent criterien?
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26 1 MR. McELROY: That was in the original rule, in 1979.
2 COMMISSIONER BERNTHAL: Close to 8 years. That is 3
when the first rule dealing with that came out? l 4 MR..McELROY: That's correct.
5 COMMISSIONER BERNTHAL: It does seem a bit 6 unreasonable.
7 MR. McELROY:
A bit difficult to make clear to the 8
licensed industry exactly when a report is required or when we '
9 have made a datarmination that a misadministration has in fact 10 occurred.
Again, a technical problem that the staff is going 11 4
to have to deal with, establishing definitions that apply to 1 12 current methods of treatment.
g j . ,.jg 13
' In 1979, when these maps were not available, it was a 14 nol little bit more reasonable, it was given to misinterpretation.
a 15 MR. BERNERO: We have thought for years in terms of a 16 doctor designating a dose of 2,000 rad and the sole question 17
. is, did you get 2,000 or 2,200 or 1,800, a rather simplistic j 18 view, but as the sciences develop, you are really talking about 19 a very complex exposure and a very complex system of other
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20 factors, temperature, pressure, the conditions, there are so i j
21 many peripheral things, that it makes it a far more complex 22 thing to say, how far off the mark was this administration of i
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23 radioactive exposure, how misadministered was it. 4 24 It doesn't lend itself to that very simple plus er I 25 minus something.
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I 5 27 1 i COMMISSIONER BERNTHAL: I don't recall exactly how we 2
dealt with this in the proposed rule, this particular issue, 3
but it seems to me that a fairly straight forward principle 4
suggesta itself, and that is what the prescription is. In 5
other words, that we make a clear distinction between what 6
happens in the patient, if the prescription is followed. Was 7
the prescription by the doctor correctly followed and then of 8
course I suppose there is a separate question of whether it was '
9 accidentally or completely the wrong prescription. That is a
'10 different matter. I 11 MR. BERNERO: As long as the prescription is rather 12 simply stated, but the prescription becomes a plan really.
13 Just recently,we were discussing a case where the prescription 14 was rule'out osteomyelitic. It was a strategy, it was an 15 objective. There is a plan. In this particular case, this 16 patient, the plan is to attack this tumor by a distributed '
17
, dose, by a strategy, that has many numbers, many exposure 18 levels, distributed over a volume of tissue. That is where you 19 start to bog down, the conditions under which they were applied 20 and the distribution of doses. It gets farther and' farther 21 away from anything that lends itself to a simple plus or minus, 22 how close did you hit the mark.
23 MR. TAYLOR:
- l. We really follow the prescription; l- 24 right?
25 MR. McELROY:
t That's correct.
z___ -
i 11
. 28 1 MR. BERNERO: So many percent off the mark. That 2
happened to match the technology of some years ago.
3 MR. McELROY: You have seen the calculated dose 4 distributions. In the past, the physician would simply 5
prescribe 5,000 rads to the tumor volume and say where the 6 tumor volume was. Now, with the availability of the treatment I l
7 planning computers, he can prescribe not only that, but he can 1
8 also prescribe a homogeneity coefficient within the treatment '
k 9 volume.
10 If you don't have an absolutely uniform dose f 11 I throughout the prescribed treatment volume, you go back and you f 12 calculate another treatment plan. It's not just the 5,000 i l? rads.
It is every cell in there gets within the 5,000 rads. I 14 I The prescriptions can become much more complex than in past 15 times.
16 COMMISSIONER BERNTEAL: We certainly don't want to 17 engage in hair splitting or second guessing. At the same time.
18 \
there is a world of difference between that and some of the 19 huge factors of ten.
20 COMMISSIONER CARR: You are also able to administer 21 it with more accuracy than before, too. When you can get a 22 plan like this, the reason you get a plan like this is because 23 you are able to administer it with some degree of accuracy.
24 MR. McELROY: I would suggest that the greater 25
, improvement has been in actually being able to examine what the
_____E___ -
, 29 1 dose distribution is. going to be. The actual accuracy of 2
administration,-setting up the patient and the x-ray machine or 3
the cobalt machine, granted, have improved with new devices but 4
nearly so much a's the description of the radiation dose profile 5
within the' patient.
l' .6 COMMISSIONER CARR: It will land itself to putting i 7
some kind.of a film under the patient and re-figuring what.you 8 gave them after the fact. '
9 MR. McELROY:
. We are examining the feasibility of 10 that.
, 11 One of the
- consultants that we hired to assist in Crada Non ?
12 this project said it'was just too damn measurable.
13 CHAIRMAN ZECH: I hope we are consulting with experts 14 in the medical profession because our views are regulatory, of
^
15 course, and we want to make them as sensible and protective of 16 the public as we should. On the other hand, with all the 17 advances that you are describing, it certainly seems to me that 18 the medical people themselves should be able to advise us as to 19 maybe higher or lower doses or perhaps even more or less of a-20 figure that might be used, more than 10 percent or less than 10 21 parcent in certain cases, that would not harm the patient but i 22 would allow perhaps some disease to be eliminated.
23 With the advances in medicine, we hope we are --
24-certainly, I don't think it is appropriate that we get involved 25 i in the medical decisions but that we confine ourselves to the i
m . ,
1
4 30 r
1 regulatory, and I think we need to keep very close. touch with 2
the experts in the medicine and the various diseases.
3
.As we are making progress, which you-are describing, 4
I think it is wonderful. I hope we are working very-closely 5
with those who are experts in'the medical field, too.
6 MR. McELROY: We certainly are. The rules that you 7
have on the table were reviewed by all of the members of our' 8 Advisory Committee.
We have-retained consultants to work '
9 specifically on this project, both very well known and highly 10 qualified individuals.
The scientific committees of the 11 appropriate organizations are gearing up to assist the staff 12 when the paper is made publicly available. They were just told 13 to get some committees ready to examine this matter.
14 MR. BERNERO: I might add, when we get public 15 comments on this, we will rely on these advisors again to 16 assist in interpreting the comments. We intend to provide an 17 opportunity for the commission to hear directly from those 18 advisors as well.
19 CHAIRMAN ZECH: Excellent. We will look forward to
- 20. that.
21 COMMISSIONER BERNTEAL: Taking the particular case in 22 hand here, looking at number 13, I would assume that is the 23 L product of a therapy procedure that makes use of the 24 instrumentation in number 11; is that correct?
25 MR. McELROY: That's correct.
U__-__-__-__._--_-__ ' '
31 1
COMMISSIONER BERNTHAL: It would seem to me that our {
2 responsibility is not where those catheters happen to be l l
3 inserted, what the pattern that shows up on 13 happens to be f
I 4 particularly, but whether in fact the number of sealed sources i l
5 I that were supposed to be implanted somewhere in the tubes of
{
6 J that device were implanted and removed at the appropriate time. )
7 Any detail beyond that is basically in some sense not a i
{
8 responsibility of the NRC.
9 Number 13, I would say, is not our responsibility, 10 provided the insertions were done as programmed and planned.
11 MR. McEIROY: Your point is exactly the goal of the 12 regulatory text that we have provided. We are trying to assure 13 ,
that whatever the physician has prescribed is in fact 14 administered. We have not gotten into a determination of which 15 is the correct prescription.
16 CEAIRMAN ZECH: Very good. Let's proceed.
17 MR. PARLER: That is none of our business. That is 18 certainly the way the General Counsel understands it. If he is 19 wrong, somebody should correct him.
20 CHAIRMAN ZECH: I think that is the way we all 21 understand it. That was my point, too. I don't think we !
22 should tell the physicians what to prescribe. I think l
23 Commissioner Bcrnthal is making the same point.
1 Our business 24 is regulatory.
We want to make sure that our regulatory 5
25 requirement is sensible and reasonable. That's our business.
i
.s ,
r
32 l 1 Let's proceed.
2 MR. McELROY: On page 14, you have an example of some 3
of these implant sources, the nylon catheters and so on. A 4
very interesting one is at the left of the pencil. That is in 5
fact a platinum plated gold seed that will be used for 6 permanent implant. It has a very short half life, about 2.7 7 days.
It has a very nice energy for radiation therapy. Here 8
is a case where the seed is not removed from the patient after '
9 treatment but is simply inserted within the tumor volume and 10 left there for the duration. Again, a different twist on the 11 science of brachytherapy.
12 We have talked about evolution of technology. We can 13 examine evolution of medicine or a particular disease, for l 14 example. l 15 CHAIRMAN ZECH: Are we on page 15 now?
le MR. McELRCY: Page 15. We talk about quality of i 17 care. The delivery of medical care is evolutionary. There are 18 well documented regional variations in practice. A disease is 19 quite likely treated differently in Massachusetts than it is in 1 l
20 California. It is not uncommon to go to a scientific meeting 21 and have a dais of five nationally known medical experts be 22 given a real case history with the patient interview, the x-ray 23 pictures, the lab results, the biopsy slides and so on, have 24 the same case given to five physicians and have five different 25 prescriptions given for that patient's care.
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- 33 1
It is not always clear what is best for the disease.
2 We have covered this.in our discussion in the last couple of 3 minutes.
M 4
Taking that one step further, it may'not always be 5
. - absolutely clear what' quality assurance methods are absolutely 6 necessary or in fact, available. In some cases,.there is.a 7
severe shortage of the technologists available to do the kinds 8- of quality assurance work that we envision. We particularly '
9.
,, requested comments from the public on that in'the Register 10 notices.
'll I think you are beginning to see a high manpower 12 intensive industry.- It is not 150 men running a 1300 megawatt 13 power plant.
You have four individuals that have to work 14 together to take care of an individual patient. It is a much 15 different situation there. You have to deal with the 16 interactions and the availabilities of the various trades.
17 So much for medicine as a technology. I mentioned 18 there were some business factors.
19 COMMISSIONER CARR: The same four individuals can s
20 work with a lot of people.
21 MR. McELROY: That's correct. They will typically 22 work with as many as 40 or 50 patients a day who would be 23 receiving treatment off a single unit.
24
., Turning to 16, we mentioned there were come business 25 considerations. We are not the only Federal agency that
-s; '
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BUSINES$ TRENDS IN MEDICAL CARE o DRG's (Diagnostic Related Groups) ,,
o RAP DRG',s (R, radiologists, A, anesthesiologists. ,
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34 1 regulates medical care.
When Medicare and Medicaid were 2
designed by Congress a few years ago, the staffers who were 3
assigned to do a cost /benafit analysis of that regulation 4
underestimated the need for medical care in this country by l-K 5 about a factor of ten. The Federal Government was going broke i- 6 covering medical bills for 30 million patients a year.
7 A couple of years ago, the Department of Health and
\
8 e Human Services instituted an alternative method of '
9 reimbursement called diagnostic related groups, in-which the 10 hospital is reimbursed up front based on the admission's 11 diagnosis. For example, if a entered the hospital emergency
, 12 room with'a simple forearm fracture, the hospital would get a
'13 flat fee to take care of you.- It wouldn't get additional money 14 depending en how many splints or how much gauze or how many 15 aspirin were administered. i 16 This turned the business of medical care literally 17 upside down.
Instead of making more money by providing more 18 care, i the hospitg1 was now cutting into its lump sum payment by
, 19 providing more care.
20 The participation of some professionals in the 1 21 medical care process, specifically radiologists,
{
22 l anesthesiologists and pathologists, was not properly, some have '
23 said, taken into account. They don't provide care directly to 24 the patient. They provide a consultative service to the 25 primary care physician.
. . . . d
. , 35 1
In radiation therapy, I think you see that having a 2
medical physicist on hand becomes very important, because he is 3
measuring amounts of radiation coming.from sources and he is 4 measuring or auditing the calculations. Yet, his participation 5
as a professional service was not recognized. He was lumped 6
.. down there with the technologist after having completed as much 7
formal schooling and as much on 44MP site training as the 8 physician had completed. '
9 There are some business things, business matters, 10 driving delivery of medical care.
11 I hesitate to get involved in the matter of 12 insurance. It is granted a normal business expense for a 13 physician, but not too many of us as individuals are used to 14 dealing with $130,000 a year liability premium, which is what 15 physicians have to face. A back of the envelope calculation 16 this morning indicated that every time you go to the physician, 17 the first $20 of your bill goes toward his liability insurance.
- 18 It is that much of an operating expense. It has gotten so 19 great that some physicians have chosen to care for indigent by going nalso!,
20 I
patients or going without liability insurance, because the 21 patients can't afford their portion of the physician's 22 liability insurance.
( 23 A business matter that should not drive our 24 deliberations but should be taken into account. It should 25 appear as a parameter in our deliberations.
u.
f-l . .
1 i !
36 1
COMMISSIONER BERNTRAL: Maybe we need a,Prico-2 Anderson plan for the medical profession.
1 3 MR. PARLIR: Somebody is already working on that, j 4 [ Laughter.]
5 MR. PARLIR: They have gotten the word and are making 6 progress.
I don't know whether it would be sound public policy 7
or not but that is for somebody else to say.
8 MR. McELROY: On 17, there is concern for the quality '
9 of medical care and the quality of prescriptions. In fact, the j 10 American College of Radiology got started on this about 15 11 years ago with a thing called patterns of care study, in which 12 they developed not a survey, but a census list of every -
13 radiation therapy center in the United States, about 1,150 of 14 them, if I remember correctly, and actually examined what kind 15 'of prescription is given for this kind of disease at this 16 stage. They are still, 15 years lator, in the process of 17 examining that data. Reports on the mean dosc distribution for 18 the 12 most common kinds of cancer have been published in the 19 literature for guidance to the medical community.
20 The American Association of Physicists in Medicine 21 comprised primeu/ily of physicists who either participate in 22 radiation therapy or the diagnostic use of radiation, has 23 established over 30 scientific committees, examining single ad 24 hoc quality ascurance topics.
25 I mentioned, for example, the validity of ccmputer
'____m----
= ,
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INDUSTitV INITIATIVES
-l o American Colleg.e of Radiology ( ACR; 20,000 physician members) -
. - ' Patterns of Care Study -
i o American Ass,ociation of Physicists in Medicine (AAPM: 5,000 ,
physi 51st p' embers) i .
- iThirty scientific committees on quality assurance topics . ,
s , .
o Society of Nuclear Medicine ($hM; 8,000 physician and 4,000 ,
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37 1 programs. They are examining the best way to measure the 2
radiation coming off one of the implant sources. They just 3
completed a ten year project that redefined the way radiation 4
dose coming from a cobalt unit or a high energy x-ray machine 5
should be measured,_what tools are needed, and what measurement 6
processes should be used, to calculate the dose coming from 7 that machine.
8 The Society of Nuclear Medicine, another key '
9 organization, has five general oversight quality assurance 10 committees and establishes ad hoc committees as necessary.
11 We are prepared to deal with all of these 12 organizations and in fact the groundwork has been laid, so that 13 our endeavors don't reduce the quality of medical care in this 14 country.
15 That is dealing with medical matters or clinical 16 matters.
In addition to that, there are physical quality s/;de /d 17 assurance matters.
For example,,the AAPM project on measuring-18 radiation dose from treatment units, measuring the 19 radioactivity in treatment seeds, and here are some examples of 20 initiatives that have taken placa recently.
21 An intercomparison workshop at a regional meeting in 22 which each ph7sicist takes his measuring instrument s.o a single 23 site and cgapares it with everyone else's instrument, to ensure l; 24 that all the instruments respond the same, t$ the same dose of
[- 25 radiation.
L _ _ - _ _
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' 38 t
1 The M.D. Anderson Hospital and Tumor Institute in 2
Houstoit, one of the two meccas for radiation therapy in this 3
country, has recently begun a mail order thermoluminescent 4
, dosimetry service, in which a client hospital can be mailed TLD 5
chips, irradiate them, and calculate how much dose was given to 6 the chips. The chips are read out back in Houston and the 7
amount of dose actually administered can be compared with the 8
calculated dose 7 ghat verifies that the correct arithmetic was '
9 being done for individual treatment plans.
10 COMMISSIONER CARR: Before you leave that one, I 11 noticed at the bottom, it talks about simulator use at CT 12 facilities. Is that for training?
13 MR. McELROY: The CT facility would be the marriage 14 i of the CT Unit with the treatment computar to determine dose 15 distributions inside the patient. A simulater is a nodified 16
.i conventional x-ray machine that has all of tha degrees of 17 freedom of a therapy machine. If you want to take a radiograph 18 of the patient, you can do that with a Cobalt unAt or high 19 energy x-ray machine, but the picture would be of incredibly
[
20 poor quality, because of the physics of interaction of high 21 energy radiation with matter.
22 A simulator can be developed and there are several on
) 23 the market now, that looks similar to the high energy x-ray 4
24 machine or Cobalt machine, but instead of a high energy target 25 or Cobalt source, it has a conventional x-ray tube in there, so ,
k 39 1
you can mimic the manipulations that you will be using on the 2 l treatment unit, but then get a nice high quality radiograph of 3
the patient and the surrounding tissue, which is just not
'4 obtainable with the treatment unit. That is what a simulator 5 is.
6 CHAIRMAN ZECH: I presume that is using computers to 7 give you that picture in the simulator?
8 MR. McELROY: No.
The simulator is a conventional 9
fluoroscopic x-ray machine but it has different ways of moving 10 than a conventional x-ray machine like you have seen in a 11 diagnostic radiology clinic.
12 CEAIRMAN ZECH: It doesn't use computers to give you 13 a simulated picture?
14 MR. McELROY: No. It is a real fluoroscopic picture 15 or a film picture.
I 16 CHAIRMAN 2ECH: Why do you call it a simulator? j
\
17 MR. McELROY: Because it simulates the configuration l l
\
18 of the treatment machine.
19 CHAIRMAN ZECH: So it's a configuration?
l 20 MR. McELROY: Of the patient and how far the patient i
21 is from the treatment machine and how large the fields are and {
22 so on. rob \
1 These are things that conventional x-ray machines can 23 do.
24 MR. TAYLOR: That would be used preparatory to the l 25 actual therapy.
1 1
__ .' ._ _:__ _ - Q
< t 40 1 MR. McELROY: That's correct. That's used to plan 2 the treatment.
3 CHAIRMAN ZECH: Fine.
4- MR. McELROY: We have on page 19 taken some staff 5 initiatives on this matter. I think the most important thing 6
here is developing good relations with newsletter editors. The 7
NRC can send out bulletins and reminders to its licensees, and 8
all too often it may be interpreted as: Here comes the Federal '
9 Government again telling us how to practice medicine, but they 10 aren't paying for our malpractice insurance.
11 !
By working with the newsletter editors over the last 12 few years, we are essentially working hand in hand with the 13 scientific organizations, and having our information appear in 14 their newsletters, I think, lands a scientific or technological 15 credence that is not available with an NRC logo on medical 16 matters.
17 We intend to continue working with the editors in the 18 future, and they have demonstrated interest in running our l
19 articles on an occasional basis.
20 COMMISSIONER BERNTHAL: I am not sure I'm getting the 21 point here.
You are suggesting that one of these articles was 22 reported inaccurately or that it was giving the wrong --
23 MR. McEIROY: No, my point is that all of these 24 articles have gotten into the associations newsletter. These l
25 were not NRC reports that were mailed out with an NRC i
. .- + .
I ' '
l -
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ARC INFORMAff0N INit!ATIVE$ UNDER WAY o Four' articles in nationally. distributed newsletters since July 1986 .' ,
o AE00 case study report on therapy misadeinistrations distributed to.
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. ' 41 l' letterhead.
We are getting the word out to the community 2
through the-newsletter that they read every month, but it is 3 the newsletter _of their own organization. We are working hand
~
A in hand with the scientific organizations, and when the Society 5
of Nuclear Medicine goes hand in' hand with the Nuclear 6
Regulatory Commission, a physician or a technologist would be 7 very hard pressed to question the statements made.
8 COMMISSIONER CARR: I think he is saying if Joe 9
Fouchard releases it, it'snotbel16vable,butifit'spnside 1C NRC, it's okay.
- 11. (Laughtcr.)
9 12 MR. TAYLOR: I don't think we are. intending that we ,
t 13 would no longer issue information notices. We would continue.
-14 This is another vehicle to get the word around in a very largs 15 community, and when we have issued these information notices, 16 the mailings are very extensive', so it is a little easier to 17 issue them to power reactor licensees. It's a much smaller 18 community. This is a big community. I think Norm is 19 emphasizing that here is a method of getting some of the i 20 1 f regulatory information out to the broader populatien.
21 Is that right, Norm? I 22 MR. McELROY: That is correct. I also would mention 23 i that we only license about one-third of the hospitals in the {
24 country. The other two-thirds are under agreement states.
25 This gets the words out to everybody at the same time, so we i
'I 1
+ m .. -__
a
- l. .
l 42 1
have complete national coverage with this information method.
2 COMMISSIONER CARR: I assume we send those to the
. 3 agreement states, too.
4 MR. McELROY: They are, but I'm not certain how 5 promptly they distribute.
6 MR. TAYLOR: Yes, we do send then.
7 MR. McELROY:
We did come down to discusskm9 8 rulemakings. We have laid on the table two Federal Register '
[sRde 202 9
notices for your consideration.3 There is an advanced notice of 10 proposed rulemaking that asks the public to comment on certain 11 questions, that asks about current standards of quality, should 12 the NRC get involved in quality assurance, how should it go 13 about getting involved, and so on.
14 In addition, we have on the table a notice of 15 proposed rulemaking for basic quality assurance. The regulatory 16 text for that proposal was developed after an examination of 17 the mis-administration events reported to us. We estimate, and 18 it is speculative, but we estimate that had the notice of 19 proposed rulemaking been in effect and implemented, it would 20 have eliminated approximately three-fourths of the mis-21 administration events reported to us.
J 22 We developed that by examining the events and by 23 examining in a theoretical cense the radiation therapy process, 24 the diagnosis of disease, the staging of disease, the 25 administration of radiation and follow-up. That is how we
- _ _ _ _ - L
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NRC RUlfMAKING INITIAffYE5 UNDER-WAY o ANPR for Comprehensive Quality Assurance
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, - Currect standards
- Areas in need of improvement ,
j - Methods of implementation 1
o Topics in Basic Quality Assurance MPP l
- Written prescriptions f or therapy
- Resolution of discrepancies
- Physical measurement of brachytherapy sources
- Espanded teletherapy calibration
- ' Independent check of teletherapy output j e Independent check of dose calculations
- Special requirements for iodine use 20
- _ a
1 l
I 43 l 1 arrived at the --
l 2
l CHAIRMAN ZECH: I presume you are telling us that is I 3 good. Tell us why that is good.
4 MR. McELROY: The staff had a hard time figuring out l 5
how to improve on a process that goes wrong once every 10,000 6
times. That's the frequency of reported mis-administrations.
7 Every event that wG have a report on is different frcm every 8 other.
They exhibit perhaps the same color here and there, but '
9 they are different events, and to try and draft a proposed rule .
10 that would eliminate all therapy mis-administrations without 11 negatively impacting the delivery of medical care in this 12 country is a very difficult procesa.
13 LAs a medical consumer, I wish I could do that, but we I 14 have not had the insight and the resources to go any further 15 than this, especially with the schedule that you have requested I i
16 we follow- l l
1 17 COMMISSIONER CARR: But eliminating 75 percent is &
18 big step ahead. i I
19 CHAIRMAN ZECH: i But I presume the 75 percent you are 20 eliminating you are telling us the mis-administrations in those 1 21 cases are not significant; is that right?
22 MR. McELROY: I don't believe that's what I said.
23 CHAIRMAN ZECH: Tell us what you said, then.
24 MR. McELROY: We are doing the best we can given the 25 schedule we had and the resources we had. It is also very I'
44 1 1
difficult in this kind of process to make it 100 percent fail 2 safe.
3 CHAIRMAN ZECH: No, I understand that.
4 MR. McELROY: I'm just giving you human error. l 5
CHAIRMAN ZECH: I understand that, but therefore you 6
are saying that the 75 percent that you are eliminating, what i 7
kind of assurance do you have that we are taking a conservative 8
and proper approach to our regulatory responsibilities? '
9 MR. TAYLOR: I think Horm is saying that what we did !
10 was to consider after looking at these events what were the 11 causative features. Then we said, gee, if there had been the 12 extra check, if there had been the extra steps taken, we could 13 have stopped about three-quarters or 75 percent of those i 14 occurrences.
15 CHAIRMAN ZECH: Do you mean they would not have l 16 occurred in the f,irst place, or they wouldn't have been 17 reported to us?
18 MR. TAYLOR: They would not have occurred in the 19 first place.
20 MR. Mc3LROY: They would not have occurred.
21 CHAIRMAN ZECH: Tnat is the important thing I was 22 wanting you to emphasize to me.
23 MR. TAYLOR: Right, sir.
i The idea, of course, is to f 24 I
use measures that don't totally constrict the medical process I
25 but to put in place steps, quality control type steps that we l
l l
. 45 1: think are reasonably straightforward and'can be delivered at a
-2 reasoaable zwt.
3 CHAIRMAN.ZECH: !
6..m. If we by rsgulatory rules can _,
, 4 ' _ help prevent the occurrences of mal-administration in the first 5
place,- the n that is a very positive thing for us to do.
1 4-6 MR. TAYLOR: That is the objective.
a 7 CHAIRMAN ZECH:
. I presume that's what you are telling-
, 8 me. Is that correct? '
9 MR. McELROY: That is what I'm telling you. l 10
, CHAIRMAN ZECH: That's very11mportant for us to know.
11 MR. TAYLOR: But I think it is strictly an estimate, _
12 4
but that was.from all the features we could put in, roughly 13 three-quarters of them that had occurred, had been reported.
i 14 CIIAIRMAN ZECH: The main thing I wantod you to !
15 i emphasize, and I think you have now, is that the three-quarters 16 that you are talking about that we might have prevented i
17 happening in the first place -- that's important -- but it's 18 I not that you just didn't want three-quarters of the reports to 19 come in.
20 MR. McEIROY: Oh, no, no.
21 CHAIRMAN ZECH: I just want to make sure that that is 22 clear.
23 MR, McELROY: We are trying to -- we think we have I 24 proposed rules that will eliminate three-fourths of the future t
} 25 events.
t
( .'
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)
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46 I
,, 1 CHAIRMAN ZECH: From, happening in the first place.
2 I MR. TAYLOR: Based on the reported events. f 3 CHAIRMAN ZECH: That is important, you see, to be 4 understood.
5 MR. CUNNINGHAM: And I also want to emphasize, Mr.
6 Chairman, that these are the obvious, relatively easy steps to 7 take now. We are pursuing it further.
8 CHAIRMAN ZECH: I understand it is very complicated, '
9 but if we can improve or we can eliminate even a few, 10 contribute to eliminating a few of the mis-administrations,
. .. 11 then we are taking a very responsible action. I think that is 12 what you are telling me. I just wanted to make sure that that ,
13 'was emphasized and understood.
.14 MR. McELROY: That is the point that was being made.
15 CHAIRMAN ZECH: Fine.
16 COMMISSIONER BERNTHAL: I think your concern is well 17 taken, Lando. . If one gets side-tracked by looking at the la statistics of small numbers, there are so many of these things, 19 so many administrations, and after all, it's only 10 to the u 20 minus 4 or whatever the number is. It sort of begs the 21 question. In the first place, the principle is as low as 22 reasenably achievable in some sense, and secondly, it may well {
23 be that only one person in 10,000 that goes through Central 24 park gets assaulted, but that doesn't change the fact that --
3 25 that may not quite be an accurate statistic -- doesn't change 4
x_ ,_- - -
47 1
the fact that you would like to do something about that one 2 person that cets assaulted. So I think the principle is the 3 same here. s 4
CHAIRMAN ZECH: Right.
5 MR. McELROY: Gentlemen, that concludes the technical 6 portion.
We have one last slide that Mr. Bernero will speak 7 to. i i
(s//d'< 21]
8 MR. BERNERO: We just appended a budget slide. You 9
are separately reviewing the budget. I just wanted to 10 emphasize that this program, as perhaps all of you recognize, 11 has not enjoyed a surfeit of resources in the past. We have 12 only a modest amount of our resources in this area. We 13 recognize the importance of it and we are preparing, in fact 14 seeking effective, innovatiye ways not merely to increase how
{
15 l frequently we inspect things -- you know, doing it the way we 16 did before, only twice as fast -- we are looking for better l 17 ways, perhaps through quality assurance, perhaps through other i l
18 initiatives, to more effectively regulate nuclear medicine 19 without hindering its proper application to the proper health.
20 Remember here the medical profession is trying to use 21 radiation technology to benefit the public health, and it is 22 the optimal use of that radiation exposure that. is tna common 23 goal. i So we are increasing resources, we are seeking further '
24 increase of resources, and we welcome your attention to this 25 field because we think it is a very important one. 1 i
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- i Insoection ! Regions) ., 12.5 !?.? 12.2 12.2 12.2 over teilin9 , 1000 2000 2000 J
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= _ _ _ _ _ _ _ _ - _ . _
48 1 CRAIRMAN ZECH: All right, fine.
2 Any questions from my fellow commissioners? Mr.
, 3 Bernthal.
4 COMMISSIONER BERNTHAL: I want to ask a question or 5
two here that focuses really more on the proposed rule, if I i 6 may.
Before I get to that, though,'I don't think we spent much 7 i time on the last page here that has to do with money and the 8 budget.
I know the chairman is'always very interested in that. ' I J
9 I also noticed that one of the things that you are proposing 10 i'
, for the implementation of the proposed rule would be that the 11 fiscal year 1989 budget provide for the increase of, I guess 'i 12 almost doubling the number of inspections that we do in i i
13 hospitals or medically-related facilities.
14 MR. BERNERO: Something equivalent to that. We don't 15 simply intend to turn the rheestat up by a factor of 2, but 16 essentially equivalent to that.
17 COMMISSIONER BERNTHAL: Do we have any good sense yet 18 where the money is going to come from for that? How much more 19 money is it?
20 MR. BERNERO: It's stated there, the $1 million and 21
$2 million going out, you know, the contractor dollars. Due to 22 the pressure on FTEs, the decision there was to seek the 23 initial cut at implementing the rule through the use of support 24 contract.
l h l 25 MR. TAYLOR:
- l. That noney would be to assist the staff l
l l
l m >
. ,. ' C
' 49 1
in going out and making sure once the rule is out'that they do 2
- t. have.the quality assurance steps prescribed by the rule, that 3
they put them in their procedures, that people have been 4 trained, that they are ready to use them. It is that type of 5
big,.first wave review which the money would help the staff to j 6 accomplish. i l
7 <
CHAIRMAN ZECH: The chosen enphasis on this program,.
8 increased' inspections and increased emprasis. '
9 MR. TAYLOR: i
.Yes, sir, and we would like to get 10 around to the population over a period -- after the basic 11 quality assurance rule goes into effect -- we woul'd like to get 12 to that population within two or three years. That is the 13 plan.
14 MR. BERNERO: Keep in mind the average frequency of 15 inspection now is perhaps once every three years for a 16 licensee. It is a rather rare event. What we are trying to do 17 is be quite a bit more timely than that.
18 COMMISSIONER BERNTHAL: I certainly support that. I 19 . guess I am still a little confused here. Where were you 20 reading that $1 million?
21 MR. BERNERO: On page 21, down at the bottom, for 22 fiscal year '89.
i
. 23 COMMISSIONER BERNTHAL: Oh, I see. Okay. Very good.
24 I was also curious about the point that you make, 25 which is true in a sense, I guess, it seems like, about
_ -_-___.----a ' ' ' '
' - ~ -
., . c u e
50 1 technology advancing very rapidly. It seems like perhaps the 2
industrial sactor has something to learn about technology 3
transfer because it does seem to occur fairly quickly in 4 medicine, by and large. But it does raise the question of how 5
an organization like ours, which too typically takes a couple 6
of years to get anywhere on a rulemaking, somet:imes five years, 7
where we have from time to time been accused of inhibiting the 8
transfer of needed technology to nuclear power plants, for 9
example, and I think there is probably not much question that 10 that has been true in some cases. j 11 How do you deal with that'as a regulatory matter? Do 12 you respond by -- I hope you are not advocating this. Do you 13 respond by simply writing very loose regulations that can deal
- 14 with almost any possible eventuality? Do we have a philosophy 15 in how we approach that sort of problem in this particular 16 area?
17 MR. MILLER: I would like to speak to that subject, 18 Mr. Bernthal. Let's take for an example the Lixiscope that we 19 talked about earlier today. For example, we would write down 20 some standards that we would consider this policy for the 21 branch, and once that becomes policy, until such time as we can I 22 regulate it more formally, that will be it. We would not let {
23 something that would cause a health and safety problem out 24 there to be used, whether the regulation is there or not. We l 25 would write Branch positions.
l i
1 il
.. ~
7 ,
51 d
l' COMMISSIONER BERNTHAL: So we don't necessarily back 2
off from whatever proscription you might -- a different use of
-3
. the word " proscription" -- whatever proscription you might feel 4
is necessary and warrantcd in our regulations, but you are' '
5 Lr saying that to be fast on our. feet, we rely, then, on staff 6 policy positions, essentially?
7 MR. MILLER: Yes. I used the Lixiscope as an
, '8 example.- We have a very good document on that device. '
b -
9 COMMISSIONER BERNTHAL: How often does that sort of 10 issue arise where staff has to announce to the world, to the 11 medical nuclear medicine industry and profession that something 12 that doesn't quite fit in to our regulations has popped up and 13 7 this is going to be our policy from this time forward?l Is that 14 a common occurrence?
15 MR. MILLER: It happens occasionally. We were. pushed 16 to come up with a position because of a licensing problem with 17 the. licensees. Every time I give you something, you said that 18 is not correct, so we had to get some document in a policy-type b
19 position that they would be able to follow.
20 MR. TAYLOR: The license becomes the vehicle by which 21 the technical imposition, like in the Lixiscope, what are the 22 basic criteria for safety and protection of the radioactive 23 material so it doesn't get out loose or a patient get over-24 exposed? So the staff takes its positions and then tries to 25 incorporate them in licensing that type of device.
__ *&1,_
52 1
Am I correctly characterizing it? So as these 2
devices are developed and the requests come in, the staff 3
examines those types of features and tries to'make that a 4
condition of the license. Of course, the person or company 5
manufacturing them desires to get a license, so they indicate '
6 the type of precautions that are necessary to use it.
7 Is that not a characterization, Vandy, quickly?
8 MR. MILLER: That's correct. '
9 MR. TAYLOR: And that way we keep up with the 10 technology of development.
11 COMMISSIONER BERNTHAL: I guess what I am trying to 12 get at is is this a problem or not?
It doesn't sound like it's l 13' a big problem, and yet it sounded like it could be a big 14 problem.
If it's not a problem, then let's quit talking about i j
15 it. l I
\
16 MR. CUNNINGHAM:
l We go through several generations, 17 and we have tried to keep the regulations up with some )
18 generations of new medical uses. i For example, a few years ago, 19 five or six years ago, we revised our medical regulations when 20 U we had this whole new program using technesiam compounds. We 21 changed those regulations so that by simple amendments, as FDA 22 approved certain drugs that fall in very specific categories 23 that had scme similarities, that my simple regulation change 24 allowed physicians to use those drugs. That is one kind of
}
25 thing.
1' L ._ _ _ -_ =__ J K
53
- 1. '
As new. things come on the market, we try to stay 2 ahead of them. Right now, though, we see on the' horizon some-3 new and unique uses that will require us to rethink what we are 4 doing.
For example, the use of the monoclonal antibodies for 5 therapy.
- i We are going to run into use of alpha emitters in the 6
. laboratories, nuclear medicine laboratories, never done before.
7 'Something brand new. Some of these things are going up 8 exponentially.
s We have been able to keep up with that.in the '
+
9 past through regulation changes roughly compatible with what 10 has happened, but the pace is more rapid now.
11 i
If you look at the FTEs for program development in 12-1987, what you are looking at is Norm part-time. We are 13 increasing that in fiscal year 1988-89 to keep up with these 14 very things that wa are concerned about ' chat we see on the 15 horizon and are going to demand constant attention.
., 16 COMMISSIONER BERNTHAL: 'Okay, but basically your 17 answer is that we are dealing with this, in your judgment, 18 fairly well.
19 MR. McELROY:
i I would just liks to offer the minority 20 opinion on that.
21 COMMISSIONER BERNTEAL: Well, it sounded like you 22 were offering a different opinion earlier.
23 MR. CUNNINGHAM: We are dealing with it the best we 24 can, but the point here is we have dealt with it in the past as i i
25 best we can, there was an ideal, but now we are seeing more l
I
~
., 3
. 54 i
. things, and one of the purposes of this. briefing is to point i
-2 out and I think you can appreciate how dynamic nuclear medicine 3
is, and it is.just going to take a lot more attention, l 4
introducing better quality control procedures, which is great, 5
and it is going to take even more attention because of new 4
6 emphasis on this.
7 I might also add that'what we do in' quality control, f 8
I think, offers great benefits that go beyond the things we '
9 regulate.
For example, our guides in use of teletherapy are 10 used for linear accelerators for the same type of therapy. I 11 think what we will see here are some side b*enefits for medicine -
12-as a whole because they will start using theca things in other 13 areas also, but we have got to keep up with this and we have ;
14 got to be ahead of it.
15 MR. McELROY: Commissioner, if I may, I would like to 16- address your comment.
- We sort of do keep up by addressing new ,
17 1 safety' issues in the licensing process, but in the nine years j 18 that I was working in the field, but for my presence here today 19
.I would have characterized that as a victim of the licensing 20 process.
The two difficulties with dealing with new issues by {
21 license condition are, first of all, the staff does not get the 22 benefit of wide public comment on technical decisions, and in 23 this package that we have before you and the revision of Part 24 35 that we presented to you last year, important changes were 25 made due to technical comments submitted by the public. When I
,. d -
i o-.
- 95. !
1 .k
[ the staff develops a lic~ensing policy, you lose that '
2 opportunity.
t
'3 Secondly, for the licensee who is not familiar with-4
' licensing policy'and doesn't know to write-and get a copy of ;
5-licensing policy,-he may have submitted an application that has 6
a portion of his radiation safety program that he thought was i
7 sufficient. The, staff, playing the conservative role, might i j
8 add some license conditions onto the license that is finally '
9 supplied. So the licensee has requirements now in his.
lo I application and he has requirements that he never heard about {
11 in his license.
12 L This can lead to confusion and it leads to difficulty l 13 in managing a radiation safety program. So although it covers 14 all of the bases and it covers the theoretical responsibility, 15 it is a difficult thing for the radiation safety officer on i 16 t . site to administer when we do it that way, and I speak from 17 experience.
f 18 1 COMMISSIONER BERNTHAL: Maybe that is enough said on {
19 the subject.
I would hope if there is some regulatory 20 innovation that would allow us to respond in a non-confusing j 21 way mors rapidly and in a more timely manner, that the staff I 22 would suggest that to the Commission.
23 MR. TAYLOR: That is part of Norm's job now; isn't 24 it?
o i
25 MR. McELROY: Yes, sir. I'll have everything fixed i
,, . . ~ -
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$6 1 by the and of the year.
2
[ Laughter.]
3 Mn..BERNERO: Bite your tongue! '
4
. COMMISSIONER BERNTHAL: A quick. question on the 5
Advanced Notice of Proposed Rulemaking and the proposed. rule.
6 I noticed that you have made an isotope specific designation 7
for diagnostic applications for radiciodine. If one wanted to: !
8 be flexible in one's regulations,.wouldn't you want not to '
i 7 9 limit yourself to a single isotope for which we are going to l l
10 specify diagnostic misadministration, but rather recognize i 11' there may be others in the future? -I l
l 12 MR. McELROY:
- i. That is correct. We examined what'is 13 currently available in diagnostic radiopharmacy. I-131 is the s
14 sole nuclide commonly used that is capable of giving a large 15 radiation dose if improperly handled. That is why it was
'16 singled out.
There are no other radiopharmaceuticals in the 17 community hospitals' radiopharmacy that are nearly as 18 radiotoxic. It does stand alone.
- 19 We do not perceive the quick introduction of other 20 I similarly toxic diagnostic pharmaceuticals. They would have to 21 go through a lengthy Food and Drug Administration review before 22 they got out into the community hospitals, thus, the 23 differentiation.
i p 24 COMMISSIONER BERNTHAL: What are we doing to try to i
25 get a handle on the kind of problem that we had recently, where
_us a_ u - -
y
, w t
57 1
- a. computer or the program of a computer or a misunderstanding 2
of a. program of a computer, whatever it was, led to a rather 3' serious event?
4 MR. BERNERO: This is the x-ray machine? The 5 software was bad.
.6 6
COMMISSIONER BERNTRAL: I think so.
"7 _ MR.'BERNERO:
Gave serious deses for the number of 8' uses. '
9 COMMISSIONER'BERNTHAL: What is the follow-up on 10 that?
What are we doing to pravent that sort of thing?
11 MR. McELROY: I think I just heard two different 12
.f cases laid out on the table. Are you referring to the high
] 13 energy x-ray machine that is managed by'a computer and it gave 14 a very, very high radiation dose to the patient?
-15 MR. BERNERO: It was on 60 Minutes about a month ago..
16 MR. McELROY:
~20/20.
17 COMMISSIONER BERNTHAL: There was another case where 18 I think the technician assumed an element was not in the
, 19 software of the program when in fact it was.
20 MR. McELROY: That is correct. The proposed rule 21 requires that an independent 'second individual working in the 22 L
hospital examine the complete computer print-out for the 23 patient, to assure that all of the correct numbers have been 24 entered into the computer program.
u 1
'25 Secondly,[thetreatmentconfigurationisoutofthe l
g, 4
I
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. e 58 1 normal range, which that particular case was,(the patient was 2
being treated at a much greater distance from the source than 3
normal.J 4
ydhep.oposedregulationwouldrequirethephysicist 5
to make a physical measurement of the dose rate in that unusual 6
configuration before treating the patient.
7 COMMISSIONER BERNTHAL: There is some quality control 8
now being imposed at the front end on software, I would hopc, '
9 up stream and in training to make sure people understand what 10 the software does.
11 MR. McELROY: The requirement to have a second 12 individual examine the data entry for the computer program is 13 done as I mentioned. The computer programs are sufficient 1 14 [wou le way complex, to examine the validity of the program itself.4 elt.]
15 COMMISSIONER BERNTHAL: Not in every hospital.
16 MR. McELROY: It simply can't be done. We would 17 expect that any hospital be knowledgeable in the use of 18 equipment before it is provided for patient use.
19 COMMISSIONER BERNTHAL: I think I will stop for now. I 20 I would like, however, maybe when Commissioner Carr is finished 21 with any questions he might have, I would still like to hear l 22 your comments on this strange anomaly that is not our fault,
{
23 but it is an anomaly nevertheless in the regulatory world of l 24 isctopes side by side that are NRC regulated and some that l j
kho d 25 ;
aren't, and I don't,wnether any of that makes sense.
! l l
l l
. o 99 1
COMMISSIONER C?.2R: .I would compliment you on the 2 briefing.
I think it has been a very good briefing. I think 3
we are long overdue in this area, taking care of public health 4 and safety. Since I have been here, the odds of any particular 6
person in the country being radiated are much higher in this l 6 area than any other area we look at.. I thihk we are long 7
overdue in taking those steps which we can take to make sure it 8 is administarad safely and done better. '
9 If that means putting you on full time --
.+
10 (Laughter.)
11 COMMISSIONER CARR: I woul'd support that.
12 CHAIRMAN ZECH:
u Why den 5t you respond to Commissioner 13 Bernthal's question, please.
14 MR. BERNERO: This is a problem, this mixed j 15 jurisdiction, and in a way, one of the things we are studying i 16 is look at what happened in uranium mills. The whole purpose 17 of the regulation for uranium was as a source of fissile 18 material and yet, our regulation is focused, as is EPA's, on 19 )
the naturally occurring radioactivity and how the radon comes I
+, 20 out after the pile is there.
s 21 In this particular case, the mixture of jurisdiction, t
.- 22 whether it is a Cobalt-60 machine or an x-ray machine, I think 23 since our general approach is one of assuring that the medical 24 plan was followed, that the intended madical procedure was 25 s
properly applied, I think there is a very good sharing for a !
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benefit, that if'you have quality assurance for procedures 2
involving by-product material that we license, those quality 3
assurance procedures are very likely to cover the NARM that is 4
used in the same hospital by the same people in essentially the 5 same circumstances, different procedures.
6 It is my perception that the nightmare that would be 7
attendant.with let's get NRC out and get authority to regulate 6
NARM and all of the attendant things, and I deliberately '
9 brought up uranium milling and other things, where we would be !
10 in a field far broader than we are now.
'll I don't see that the medical uses of NARM are so 12 distinctly different and contrary to the medical uses of by-13 product isotopes, that there would be a substantial need for 14 the NRC to go after authority of some sort.
f 15 COMMISSIONER BERNTHAL: You are saying that in effect i j
16
- the jurisdiction on by-product materials rubs off' on the other \
]
1 17 materials? I 18 MR. BERNERO: Yes; I think it does.
i 19 COMMISSIONER BERNTHAL: I want to make a distinction.
20 I certainly don't consider the distinction that is made between 21 machines and radiopharmaceuticals and radioactivity to be one - l 22 - I think that is one that is easily maintained. I think we 23 can live with that very easily. It still seems to me that the I
l 24 crazy situation, in the same cabinet, side by side, you have 25 radiopharmaceuticals, some of which we are responsible for, I l
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61 1
others which I suppose in principle, if they were 2
misadministered -- w'ould we have any authority at all in terms 3 of enforcement?
4 MR. McELROY: We have no authority there.
5 COMMISSIONER BERNTHAL:
That is just bizarre.
6 MR. BERNERO: Yet, it will come up that you are 7
looking at a program and misadministration or mishandling of L'
8 NARM material can be a contributing piece of information. Our 9
regulation is on the application of by-products.
10 MR. PARLER: Certainly if there is a mixture in the 11 program and they are intertwined, we have jurisdiction there.
12 What you are talking about, as I understaan it, if you have 13 NARM stuff sitting out, isolated, et cetera, do we have l 14 anything to do with that. The answer is no, we don't have the 15 authority.
16 COMMISSIONER CARR: You could if you wanted. It 17 sounds like that is a place looking for a home.
18 (Laughter.]
19 MR. CUNNINGHAM: I'd like to make a few comments on 20 this, certainly from a technical standpoint, there isn't a 21 logical division between NARM and the isotopes we regulate. !
22 The reason we regulate some and not the others stems from what 23 is behind the Atomic Energy Act, which we all know.
24 Having said that, I think there are two things. One, 25 we ought to be Ic u;ing at other ways to achieve the same goal
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. 62 4 1
-with respect to NARM other than regulating it, working with the 2
agreement states, the agreement states taking control of NARM. . 'I 3
I would.also point out that this of course is 4
strictly, whether we regulate it or not, is an important policy 5 decision. The dimensions of the problem, I think, have been 6 understated in'many. instances.
~
7 I heard a paper given at the'NCRP annual meeting 8
about three years ago, in which it was stated there are 50,000 '
9 radium sources used in this country today. I don't know what 10 the division is in medicine or industry but I know a lot of 11 them are used in medicine.
These sources are not manufactured 12 now.
They were manufactured in the 1930s, 1940s and perhaps 13' the 1950s. We don't know who the users are.
We don't know how 14 the sources were constructed. We know that radium is very 15 radiotoxic. It gives off raden. W( don't know anything about 16 the quality of the sources.
17 Assuming that we were to ragt. late NARM, these 18 sources, to the same extent we ragulat'a other things, we have a 19 problem of defining criteria for radium sources, identifying 20 the users of radium sources, and then determining whether those 21 radium sources meet the criteria 'thich we establish. That is a 22 big job.
23 One more example. Use of cyclotrons to produce NARM.
24 some cyclotrons are used in the laboratory to make a short !
25 lived radioisotope, as Norm mentioned. You irradiate your
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63 1
target, you do soms quick chenistry on it and you go to the 2 patient.
It is very difficult, if you are going to regulate 3
that, to separate out the cyclotron from the radioisotope. You 4
are dealing with the same people who are going to operate the 5
cyclotron and do the hot chemistry and go to the patient.
6 There are other questions that come up. Years ago, 7
not tco many years ago, we looked at drug safety and efficacy 8
until such time that FDA was able to take that over. FDA's '
9 rules, as you know, are tied to the Interstate Commerce Act.
10 There are questions as to whether or not we, under our 11 statutes, should then have to look at drug safety and efficacy 12 for the short lived radioisotopes.
13 Again, it is a very resource intensive problem.
14 COMMISSIONER BERNTHAL: I don't think we ought to 15 look the other way because we don't have the resources to 16 handle it. We look the other way right now because we don't 17 have the authority to deal with it.
18 My question is, who does pay attention to these 19 radium sources and to the isotopes that are produced by 20 accelerators and other naturally occurring materials? Does
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21 anybody?
MR. CUNNINGHAM: The agreement states do.
23 COMMISSIONER BERNTHAL: Who else?
l 24 MR. THOMPSON: I think it is an important issue, 25 Commissioner, and it is one that has fairly significant policy
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. r 64 implications.
I think we recognize it is an issue with the 2 agreement states.
I think we owe the commission a better 3 detailed analysis of this issue. If I may, I'd like to commit 4
to make that type of analysis and recommend some options that 5 the Commission might went to consider.
6 CHAIRMAN ZECH: I'm glad you volunteered. I was 7
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about to say it seems like this is a subject that we ought to 8
hear from the staff on, with recommendations. .I agree that we 9 shouldn't just let it hang out there. In any case, it seems to 10 me it would be important enough for the staff to give us a 11 paper on with some recommenda'tions. We will take it up as a 12 separate issue.
13 MR. PARLER:
. It would be an updating of work they 14 have done in years past. It has been looked at before.
15 CHAIRMAN ZECH: Yes, I'm sure it has. It is an open 16 question.
I think this Commission vould like to review it. If 17 the staff would do that, we would all appreciate it.
18 COMMISSIONER CARR: It is fair to say it is an issue 19 that has been looked at a lot and set aside every time.
20 COMMISSIONER BERNTHAL: I agree, Mr. Chairman. I 21 don't want to rush in and suggest we want to seek new 22 regulatory turf here.
I do remember in the 59quoyah event and 23 in Oklahoma, we were speaking about regulatory vacuums and 24 things dropping through the cracks. Just saying that we don't 25 have the responsibility and forgetting about it is probably not i
___ _ - _ _ ~ - - - - ~ - - - -
i 65 1- the responsible thing to do.
2 MR. PARLER: That area, we did look at.
That is a 3 difforent type of problem.
4 COMMISSIONER BERNTHAL: Let's have a look at it. I 5 agree.
6 CHAIRMAN ZECH: Anything else from my fellow 7 Commissioners?
8 (No response.] '
9 CHAIRMAN ZECH: Let me thank all of the staff for a 10 fine. presentation this morning. I beliove the presentation was 11 very helpful.' I certainly agree with the other comments my
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12 colleagues have made.
. You know my personal interest in this 13 matter, which I-have emphasized to you before.' We should be 14 emphasizing this area of our responsibilities and bringing it 15 to light more often than we do.
16 I hope we can give implementation to those desires of 17 my collaagues and my desire to move out in this area, do more 18 than we have in the past. We expect you to follow through on 19 that and make sure that we do.
20 h'
I would urge my fellow Commissioners to vote on SECY-21 87-29(a), if they haven't done so. I do think we need to move 22 forward on that,_to publish the rulemakings in the Federal 23 Register and move ahead, c 24 I think from what we have heard today, I guess the 25 staff still supports those two proposals. Is that correct?
a *
- t , a 66 1 MR. TAYLOR: Yes, sir.
2 CHAIRMAN ZECH: We will hopefully move out on that 3 soon. If there are no other questions or comments from my 4
fellow Commissioners, we will stand adjourned. Thank you very 5 much.
6 (Whereupon, at 11:45 a.m., the meeting was 7 adjourned.]
8 '
9 10 11 12 13 14 15 16 17 18 19 20 21 22 l 23 24 25
e w 1
2 REPORTER'S CERTIFICATE 3
4 This is to certify that the attached events of a 5
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meeting of the U.S. Nuclear Regulatory Commission entitled:
i 7 TITLE OF MIETING: Briefing on Medical Use of By-Product Materials 8
and the Medical Misadministration Rule PLACE OF MEETING: Washington, D.C. -
9 DATE OF MEETING: Wednesday, July 29, 1987 10 11 were held as herein appears, and that this is the original 12 transcript thereof for the file of the Commission taken 13 f stenographically by me, thereafter reduced to typeniting by 14 me or under the direction of the court reporting company, and 15
~
that the transcript is a true and accurate record of the 16 foregoing events.
17
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22 Ann Riley & Associates, Ltd. I
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- M DCS No: 999999870806 Date. August 6, 1987 j} g gj7 G> A % rn.
PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE--PNO-I-87-74 g
This preliminary or pualic interestnotification significance.constitutes EARLY notice of events of POS$IBl.E safety f)gg" verification staff on this date.
or evaluation, and is basically all that is known by the Region ITh Facility: Licensee Emergency Classification:
Northern Westchester Medical Center Notification of Unusual Event New York Agreement State Licensee Alert Site Area Emergency General Emergescy X Not Applicabie
Subject:
TELETHERAPY MISADMINISTRATION On August 6, 198}, Region I received a call from the New York State Department of Health indicating that they had received a report from a licensee, Northern Westchester Medical Center, of a dosimetry problem in their teletherapy program. Because of incorrect calculations in the computerized dosimetry plan the licensee believes that they could be und(rtreating and overtreating patients by as much as 50% and in some cases possibly much more. The exact nature of the calculational error is unknown at this t'me. The number of patients involved and the time frame involved is also unknown The licensee noted that some patients have exhibited " physical symptoms" due to overexposure to radiation. The exact nature of these symptoms are not known at this time. In one example of the problem the licensee indicated that a patient currently undergoing a 5000 rad treatment prograsa should have received 1200 rads at this point in the treatment program but had actually received 2600 rads.
The licensee has voluntarily closed down the teletherapy program. The State has
~
dispatched an inspector. No media interest has occurred yet. The consultant group providing the dosimetry service consults with a number of other hospitals in New York, New Jersey and Connecticut.
The above information is corrent as of 11:00 a.m. , August 6,1987.
CONTACT: J. McGrath 488-1216 DISTRIBUTION:
H. St. MNBB Phillips E/W Willste hhil: ADM:DMB Chairman zech EDO NRR NMSS DOT:Trans only Comm. Bernthal PA OIA RES Comm. Roberts OGC AE00 NRC Ops Crt Comm. Carr ACRS Air Rights INP0----
SECY SP NSAC----
CA PDR Regional Offices TMI Resident Section RI Resident Office Licensee:
(Reactor Licensees)
Region I Form 83 (Rev. July 1987)
$ Q7LL&-65 A P.
L __ _