ML20059G736
| ML20059G736 | |
| Person / Time | |
|---|---|
| Issue date: | 12/02/1987 |
| From: | NRC OFFICE OF INVESTIGATIONS (OI) |
| To: | |
| Shared Package | |
| ML20058A679 | List:
|
| References | |
| FOIA-93-34 NUDOCS 9401250257 | |
| Download: ML20059G736 (19) | |
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UNutD STATES i
NUCLEAR REGULATORY COMMISSION IN THE MATTER OF
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INVESTIGATIVE INTERVIEW:
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l EUGENE L. SAENGER
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(CLOSED)
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LOCATION:
Cincinnati, Ohio PAGES:
1 through 17 DATE:
December 2, 1987 i
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9401250257 930514 PAGE I OF I 9 PAGE(S)
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DAVIS 93-34 PDR
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UNITED STATES NUCLEAR REGULATORY COMMISSION Sec50T&I OFFICE OF INVESTIGATIONS 2
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In the Matter of:
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INVESTIGATIVE INTERVIEW:
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6 EUGENE L.
SAENGER
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7 (CLOSED)
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9 Conference Room University of Cincinnati Medical Center 10 234 Goodman Street Cincinnati, Ohio 11 Wednesday 12 December 2, 1987 The above-entitled matter came on for hearing, 13 14 pursuant to notice, at 11:03 a.m.
15 16 APPEARANCES:
On behalf of the Nuclear Regulatory Commission:
17 18 HAROLD G. WALKER, Senior Investigator Office of Investigations 19 Chicago Field Office 799 Roosevelt Road 20 Glen Ellyn, Illinois 60137 21 On behalf of the Witness:
22 WILLIAM H. FISCHER, ESQ.
Assistant Senior Vice President 23 University of Cincinnati Medical Center Mail Location 784, Mont Reid Pavilion 24 Cincinnati, Ohio 45267 25 Heritage Reporting Corporation (202) 628-4888 EXHIBIT _
PAGE OF PAGI
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CONTENTS EXAMINATION 2
WITNESS:
3 Eugene L.
Saenger Page 4 4
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9 10 EXHIBITS:
11 None 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Heritage Reporting Corporation (202) 628-4888 EXHIBIT _
PAGE__
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PROCEEDINGS 2
MR. WALER: For the record, this is an interview of 3 Dr. Eugene L. Saenger. 4 Would you_ describe to us your present position? 5 DR. SAENGER: I think that I am Vice Chairman now of 6 the Radiation Safety Committee. At the time of this incident, 7 I was Chairman of the Radiation Safety Committee. ~ 8 MR. WALKER: And what is with the University of 9 Cincinnati? 10 DR. SAENGER: The. University of Cincinnati. l 11 MR. WALKER: Yes, sir. 12 DR. SAENGER: Under the broad license or whatever it 13 is of the NRC. 14 MR. WALKER: And in addition to Dr. Saenger, Mr. i 15 Fischer is here. Would you identify yourself, sir. 16 MR. FISCHER: Yes, I am William Fischer. I am 17 Assistant Senior Vice President of the University of Cincinnati 18 Medical Center and an attorney. I am here on behalf of the ) 19 University and Dr. Saenger in his capacity as a University 1 20 employee. 21 MR. WALKER: And Dr. Saenger, is it your request that 22 Mr. Fischer remain throughout the interview? 23 DR. SAENGER: I do not like to go anywhere without 24 Mr. Fischer. 25 MR. WALKER: I assume that is a yes? Heritage Reporting Corporation (202) 628-4888 EXHIBIT PAGE-OF PA'
i f 4 1 DR. SAENGER: Yes. 2 MR. WALKER: As agreed with Dr. Saenger, this is-3 being transcribed by the Court Reporter,_Andy Emerson. The 4 location of this interview -is at the University of Cincinnati-5 Medical Center, Cincinnati, Ohio. l 6 At this time, I would like to swear Dr.: Saenger in. l J 7 Sir, would you please raise your right hand. 9 Whereupon, 9 EUGENE L. SAENGER 10 having been first duly sworn, was called as a witness herein, 11 and was examined and testified as follows: \\, 12 EXAMINATION 13 BY MR. WALKER: 5 14 Q At this time, sir, would you briefly provide us with e l 15 your professional background prior ~to you becoming the 16 Radiation Safety Committee Chairman? 17 A Well, I am a physician licensed in the State of Ohio.- 18 At that time, I was a professor of radiology at the University 19 of Cincinnati. I became emeritus in September of 1987. 'I 20 relinquished the chairmanship of this committee about_a couple 21 of years before that. At the time of this incident,f I was the. .I 22 Chairman of that committee. 23 I started-to work in nuclear medicine here at the-n 24 University of Cincinnati back in 1950, and have helped over the years with the development of the application of radioactive 25 i l i Heritage Reporting Corporation (202) 628-4888 EXHIBIT I ! PAGE-OF PAG
~ i i t 5 1 materials to diagnosis, therapy and research in the College of l 2 Medicine and also throughout the University. I have offered-a l 3 considerable number of scientific reports. I developed the 4 radiation safety program here. 6 5 I pioneered in the handling of radiation accidents. ~ 6 And I also have served both with the AEC, and ERDA,. and the NRC 7 as a consultant to the Division of. Inspection and Enforcement, b 8 which I continue to do. 9 0 Thank you, sir. The subject of this interview will 10 be the August 1984 iodine-125 leakage which I believe you are. 11 familiar with. And to begin with, I would like to ask you to 12 place yourself back in that time frame as best possible'. 13 And would you tell me in your position when did you 14 first become aware of any contamination in the radiation 15 department? 16 A Well, Mr. Walker, all of the information which I-have 17 about this incident has been reflected in several documents, 18 which I presume that you have copies of, because they all went-19 to Region 3. And everything that I know about it:is set forth 20 in here. 21 Q What I have done here is that I have-provided Dr. 22 Saenger with a copy of the report ofLcontamination which was 23 provided to the NRC through'his office at the time of the 24 inspection conducted by Region 3. I will refer to this as a 25 chronology, Dr. Saenger, for lack of better words for this, the Heritage Reporting Corporation (202) 628-4888 EXHIBIT PAGE OF PAGE -m ,w me e t ie-- m e+ f ..nem
6 1 report of the contamination. 2 Was this, report gathered at your request?. 3 A I think that it was part of our routine in handling a 4 situation where we find a leakage of a radioactive material. 5 This is set forth under our broad license, and we have a 6 standard form. This is not my own pro.cedure, or something that 7 I would have instituted. It was something that was instituted 8 as part of the procedure of the institution. 9 Q This report which I am referring to would have been 10 implemented for any other unusual occurrence for lack of better ) 11 words? 12 A That is correct. 13 O And was not a specific implement due to this ) 14 particular event? ) 15 A I do not understand your question. 16 Q This was not something that was originated, this 17 report was not originated specifically as a result of this ) 18 event of August 19847 19 A It was originated because the event took place. 20 Q Certainly. But you just told me that this kind of reporting would have been done on any other sort of unusual 21 22 event. 23 A I have not been over the records of our whole ] 24 committee over the years. But certainly, Region 3 has been 25 through us frequently. And I think that any time that we have Heritage Reporting Corporation (202) 628-4888 EXHIBIT PAGE OF PAGEF
1 1 had events such as this that we have made very careful reports, 2 and notifications, and descriptions, et cetera, et cetera, of 3 which this is just one. 4 Q Do you recall which physician or Ph.D who compiled 5 this chronology. I 6 A I do not recall who made up this specific list. It 7 was very carefully reviewed by people in our radiation safety 8 office and people in radiation therapy, and so on. I do not s 9 know. 10 Q Where you first notified at the time of the event, 11 Dr. Saenger, or was it after the -- let's go to the time frame. 12 August 27th through Labor Day of September 1984. 13 Do you recall if you were made aware of this 14 contamination during the event or afterwards? 15 A I do not have a specific recollection of that. I 16 just do not recall it. 17 0 Okay. 18 A I might add, Mr. Walker, that one of the reasons that 19 I do not recall it is our handling of events like this are not 20 predicated on a single individual being available. Because at 21 one point I note here that sometimes some months later that I 22 was away from Cincinnati, and another one of our members of the 23 committee was asked to respond to a request from you. And I do 24 not think that there is enough redundancy in our program so 25 that there is no single individual who has to be there, or Heritage Reporting Corporation (202) 628-4888
7 i 4 s 8 9 1 otherwise the thing does not fly. 2 O Following the event itself and the production of the 1 report that I have been referring to as a chronology, did you 3 participate in the exit interview with the inspector at the 4 5 time? 6 A Does it say that I participated? 7 Q Yes, sir. 8 A Whatever the notes say. 9 Q Do you have any recall of the discussions? Why do you not show me what you have in mind, then I 10 A 11 will tell you what I recall. 12 Q Well, you will have to tell me, because I have very 13 little. This is just your name and an asterisk indicating that J l 14 you were. 1 i 15 A I guess that I was there. h 16 Q Do you have any recall of that? 17 A I have been in a number of exit interviews in my J 18 life, so I do not recall. 19 0 The one theme, I want to ask you, the one theme that l 20 runs through these findings appears to be that the leakage of ] the iodine seeds which was determined as of September 5th after. 21 22 the seeds had been explanted and that the physicist had had an l 23 opportunity to calculate their findings was that even if the leakage of the seeds in the patient's tumor had been known.that 24 25 the treatment would not have changed. Heritage Reporting Corporation (202) 628-4888
9 1 Do you recall that? 2 A That would be my understanding, yes. E i 3 0 Okay. 4 A And the reason for it was that considering the nature 5 of the patient's disease, the fact that she had a far advanced 6 tumor, that this was an effort to shrink the tumor. That the r 7 amount of radiciodine that would get to her thyroid gland and s 8 other parts of her body would have really been trivial with 9 regard to producing any serious effects or really any 10 detectable effects given her medical circumstances. And I. Il think that in retrospect that that was a very good judgment. 12 Q Okay. 13 A I think that our dose calculated was that she got 14 some 554 microcuries in the thyroid gland, and that this was an 15 amount of radioiodine that we formerly -- yes, about 2000. 16 This dose was used by some people in early days to do 17 diagnostic studies of the thyroid. 18 Q Okay. 19 A So it really was not of significance in terms of her 20 situation. 21 Q When you say in terms of significance, we are talking 22 about the uptake in the thyroid? 23 A Well, its effect. 24 0 Its effect. Another question that I have and that I 25 have been thinking about, and you can tell me whether -- Heritage Reporting Corporation (202) 628-4888
t 10 1 (Pause.) 2 0 Another thing that I have asked, but I am going to 3 ask you also. The indication that there was a medical decision, not an indication, I am told that there was a medical 4 decision that was made during the treatment period that to 5 leave the seeds in the patient so that the dosage which was 6 prescribed, and I have read 8000 rads, would be placed in the 7 8 correct position, et cetera. At that time, would it have been feasible, and you 9 10 tell me, if-a thyroid blocker had been administered to the patient to prevent the amount of 2087' rads as has been 11 12 calculated? And maybe I am way off base asking that, but it is 13 a curiosity to me. I do not think that in this situation, my personal 14 A 15 opinion having dealt with the thyroid for these many years, i 16 considering the situation of the patient, it really I do not 17 think would have made any difference at all for her. 18 Q Okay. 19 A And this is an experience that I have had in a number of instances elsewhere where I have investigated cases for.the 20 21 NRC. Because in situations where these people with far. 22 advanced neoplasms are so desperately ill, we try to give palliative, or the physicians doing the therapy give palliative 23 24 relief, the amount of radiation elsewhere or to other organs l nearby is really not sufficient to change the effort to get at 25 Heritage Reporting Corporation (202) 628-4888
11 the part of the body where the tumor is. 1 In other words, to take that whole thing down for 2 2000 rads to the thyroid I think would not have been 3 4 appropriate. I mean she already had had the insertion and the 5 trauma to the brain and so on. And given your knowledge at 6 that particular time, if I had been in charge of the patient's 7 treatment which I was not, I would have done nothing different 8 than what was done. 9 0 So why I am asking you this is that I know that a thyroid blocker was given to some of the technicians. 10 11 A Right. And I did not find evidence of any thyroid blocker 12 0 13 having been given to the patient. So that was the basis of my 14 question. i 15 A Right. 16 Q I want to approach another point with you, Doctor. ] I want to show 17 Since you have so much experience in this field, you the definitions in the Code of Federal Regulations, l 18 ) 19 10 CFR 35.2. Now this is a 1987 edition, but I believe that i i 20 the definitions remain. 'I think that the only thing that was i 21 changed was the reporting requirements. Anyway take a look at 22 this. And on the definitions, if you would identify the one 23 that I have circled there. It is number three. 24 A Three, "A radiopharmaceuticals or a radiation by route of administration other than.that intended by the -25 Heritage Reporting Corporation (202) 628-4888
[ 12 1 prescribing physician." 2 0 Would you tell me what that means to you, Doctor? i 3 A Well, let me start out in the first place by saying t 4 that the whole area of misadministration has been a very_ 5 grievous one as far as the medical profession is concerned. 6 Because we think that the fine-tuning by the NRC of this 7 definition constitutes practice of medicine by the Nuclear B Regulatory Commission, whereas we believe that the practice of 1 9 medicine should be carried out by the licensed physicians 10 within the state in which practice is carried out irrespective 11 of whether the NRC licenses the safe handling of radioactive 12 materials throughout the country. 13 So that this paragraph three I think could be l i 14 construed in a variety of ways. I think that people like 15 yourself may construe it in one way, and people like myself may 16 construe it in a totally different way. 17 Q Which is why I asked you the question. 18 A I understand that. And what I am trying to say to 19 you is that if an inadvertent situation occurs such as the 20 incision is too long or the incision is too short, or that in 21 the removal of a certain organ the vessel or a nerve was 22 inadvertently tied or cut, these are the things that happen in 23 the practice of medicine which are not guaranteed, because we 24 do not deal in guaranteed products. We deal in professional and we are not guarantors of results. 25
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.i 13 1 So when tnings go awry such as they did in this case 2 very obviously, this was not -- you see, you used the word'here-3 intended by the prescribing physician. Obviously, we do not 4 intend to rupture sealed sources. But the fact that they get 5 ruptured in the course of preparation or administration to a patient is something which may be described as human frailty or 6 7 it can be described as an error. Is it intentional, no. 8 And this is the reason that the whole area of 9 misaaministration is really one that is very much under attack 10 by the medical profession. And I happen to be one of them that 11 is very critical of this. I'have been very critical of it in 12 sessions of some your colleagues on the Nuclear Regulatory f 13 Commission in public meetings. And there has been nothing that 14 has happened since them that has changed my opinion. 15 0 Okay. I guess that you are not going to tell me 16 whether or not this particular event would constitute a 17 misadministration by definition. 18 A By definition, it was not intended, and the word 19 there says that it is intended. 20 0 "A radiopharmaceutical'or a radiation by route of 21 administration other than that intended by the prescribing 22 physician." And I have heard people identify this route as the-r 23 method of giving the medication to.che patient, and I have also 24 heard the route identified as a particular organ. 25 What does the route mean, can you tell me, because I l Heritage Reporting Corporation i (202) 628-4888
14 1 am asking you, you are the expert? 2 A It is your document. 3 Q I know, but you are the physician. 4 A If you want to practice medicine, then you have to go 5 with what I say. 6 Q All right. Would you do me a favor then and look at 7 the number four. 8 A I think that it is number five. 9 O Let me see what I have got here. Number five, "A 10 therapy dosage of a radiopharmaceutical differing from the 11 prescribed dosage by more than ten percent." 12 Would the uptake exhibited in the thyroid constitute r 13 a therapy dosage differing from the prescribed dosage by more 14 than ten percent? r 15 A' Well, it is obvious that it would differ by more then 16 ten percent, because we did not intend to give any dose to the 17 thyroid. But again that is the definition of the NRC. And the 18 circumstances are that the NRC -- this is where we are very l 19 critical of this particular document, because it constitutes i 20 the practice of medicine by the NRC. And I have written an 21 editorial which discusses this. I think that it was in either 22 Radiology or the American Journal of Roentgenology and Radio 23 Therapy. 24 Q Thank you, Doctor. 25 A Okay? Heritage Reporting Corporation (202) 628-4888 )
c 15 1 Q Yes, sir. 2 During your discussions, Dr. Aron prepared a letter 3 dated November 2nd in which you had a preface cover letter to. 4 Let me provide that for you for a moment. Your letter is dated 5 8 November 1984, and I will ask you to identify that. 6 A That is my signature. 7 Q The letter by Dr. Aron, was this a request by the 8 NRC, or was this something that was provided to the NRC without 9 it having been requested? 10 A It was requested by Mr. Axelson. 11 Q Do you recall the discussion revolving around the 12 request for this letter? 13 A Well, I do not recall the exact discussion, but I 14 know that Mr. Axelson was concerned about understanding what i 15 took place in this case. And I think that Dr. Aron gave him 16 his opinion as to what it was. I cannot remember. Mr. Axelson l 17 and I have talked about so many things over the years, that I 18 really do not remember this particular conversation. j 19 MR. WALKER: Then with that, I have no further-l 4 20 questions. 21 Mr. Fischer, do you have anything that you would like 22 to add? 23 MR. FISCHER: No questions. 24 MR. WALKER: Dr. Saenger, have I or any other NRC 25 representative threatened you in any manner or offered you any Heritage Reporting Corporation ] (202) 628-4888 I i
) i 1 (. 16 l I rewards in return for this statement? 2 THE WITNESS: Well, I would like to consider my 3 answer to that question and I may reply for the record later. 4 But up until now, I would hold you harmless. 5 MR. WALKER: I do not know if that is flattery or l l 6 not. l 7 Have you given the statement freely and voluntarily? ( 8 THE WITNESS: Absolutely. 9 MR. WALKER: Is there anything further that you would 10 care to add for the record, Doctor? l 11 THE WITNESS: I think that a's long as you are clear 12 that this situatlov was very carefully investigated and very 13 carefully reported at arm's length, and that the decision as to 14 the handling of this particular patient was very carefully 15 thought out by a number of physicians and physicists within our 36 radiation safety program and within our radiation therapy l 17 program. 18 That I as the Chairman of the committee felt that l 19 this was very well handled considering that we inadvertently 20 liberated a very small amount of radioactive lodine which we 21 obviously did not recognize. 22 That the University made significant alterations in 23 our hot room so that this would not recur. And that we also 1 stopped using these high activity seeds, because we felt that 24 25 we were not fully in control of a situation that fortunately Heritage Reporting Corporation j (202) 628-4888 l
17 1 did not harm this particular patient. 2 As long as you are clear on those points, I think 3 that I have said everything that I need to say. 4 MR. WALKER _: Well, I thank you for your appearance. 5 Thank you, sir. 6 THE WITNESS: It has been a great pleasure to talk to 7 you about it, Mr. Walker. 8 MR. WALKER: Thank you, sir. 9 (whereupon, at 11:28 a.m., the interview was 10 concluded.) 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Heritage Reporting Corporation (202) 628-4888
1 CERTIFICATE 2 3 This is to certify that the attached proceedings before the 4 United States Nuclear Regulatory Commission in the matter of: 5 Names Investigative Interview: Eugene L. Saenger 6 7 Docket Number: (Closed) 8 Place: Cincinnati, Ohio 9 Date: December 2, 1987 10 were held as herein appears, and that this is the original 11 transcript thereof for the file of the United States Nuclear 12 Regulatory Commission taken stenographically by me and, 13 thereafter reduced to typewriting by me or under the direction 14 of the court reporting company, and that the transcript is a 15 true and accurate record of the foregoing proceedings. 16 /S/[e /N(P ,b k 17 (Signature typed): Andrew M. Emerson 18 Official Reporter 19 Heritage Reporting Corporation 20 21 t 22 23 24 ~ 25 Heritage Reporting Corporation (202) 628-4888 .}}