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,,,# November 28, 1986 l
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MEMORANDUM FOR: Chairman Zech FROM: Victor Stello, Jr.
Executive Director for Operations
SUBJECT:
STAFF REQUIREMENTS "AEOD CASE STUDY REPORT ON THE RUPTURE OF AN IODINE-125 BRACHYTHERAPY SOURCE AT THE UNIVERSITY OF CINCINNATI MEDICAL CENTER" This replies to your September 26, 1986 memo (COMFB-86-7), in which you asked three questions about the subject requirements:
Question 1:
Explain whether requirements in 10Region III correctly CFR 35.42(a) and b).(applied thedoes If it did, misadministration the General Counsel reporting agree with that application of the regulation?
Answer: ,
Review by OGC has indicated.that the event should have been reported as a misadministration. While the staff agrees that the event was reportable as a 3 misadministration, Pegion III's action, which was based in part on discussion ,
among regional and headquarters staff, in not classifying it as such at the j time is understandable, as described below. l l
This was an unusual case where one of eight sealed sources containing radioactive i iodine (iodine-125) had been inadvertently and unknowingly punctured while being )
prepared for implantation into a patient's brain tumor. Althougn the sources i were left in the tumor to deliver the critical treatment dose as prescribed by i the physicians, the one leaking source caused a concurrent dose to the pa-tient's thyroid via redistribution of unsealed iodine-125. This entire problem i might have been prevented if the licensee had been more careful in handling the sealed sources and had conducted adequate radiation surveys in the area where the sources were prepared for implantation.
The University of Cincinnati Medical Center adopted the use of a procedure in 1984 which involved cutting open containers used to implant iodine-125 sources in a patient so that the sources could be recovered for reuse. During the time period August 10 through August 27, 1984, Medical Center staff performed this protocol two times prior to placing eight iodine-125 sources in the brain tunor of a terminal patient on August 27, 1984 Enclosure 1 provides a brief account of the incident that followed and actions taken by Medical Center staff.
CS 04 +63& 3 5pp. X
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,4 Chairman Zech Licensees are reouired to report misadministration involving therapy proce-dures within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery. All leaking sources are required to be reported within 5 days regardless of whether a misadministration is involved.
As indicated in Enclosure 1, the Medical Center first determined on September 1,1984 substantial, though not quantified, thyroid uptake had oc-curred. Based on a November 2,198a letter from and a November P4,1986 telephone conversation with the Director, Division of Radiation Oncology, the doctors involved suspected leaking iodine-125 sources on August 28 or P9,1984.
In spite of the suspected leaking sources they "... felt that because of the significant medical problem, recurrent malignant brain tumor, that the pa-tient's implant should be continued to achieve full dose. This was felt medi-cally to be of primary importance, far overshadowing the effects of iodine-125 irradiation of the thyroid gland." The staff believes that the Pedical' Center should have reported this to the t'PC within F4 hours after September 1,1984, l when the leaking sources were confirmed. The Medical Center discharged the i patient temporarily on September 1 and upon return on September 4, confirmation of the radiciodine uptake was made through urine sample bioassay. The NRC was first notified on September 4, 1984, when the Medical Center thoroughly de-
' scribed the incident and chronology.
Members of 'he technical staff who deal with uisadministrations on a regular basis had, et the time and currently, mixed opinions as to whether the incident was technically a misadministration. The Region III decision was made after l
careful review of the infomation understood at the time and interpretation of i
! NRC documentation on the subject. The decision was made after discussions among regional and headquarters staff and recognizing that the licensee made a decision to continue the treatment of the tumor believing that.the leaking '
source (s) would result in an exposure of the patient's thyroid.
After further staff and OGC review, we now believe this event would be more appropriately classified as a misadministration. We think that the definitions l
of misadministration are clear enough and that the one in paragraph (c) of l 10 CFR 35.41 covers the incident in question: the radiation's route of administration'n was unintended and, therefore, a misadministration should have been reported. The prescribing physicians intended to irradiate the patient's brain tumor but did not originally intend to also irradiate the thyroid; a leaking source irradiated both. The idea behind paragraph (c) is that a misadministration occurs if radiation is intended to go from one point to another and somehow (for whatever reasor.) does rot reach the intended point or reaches it in some way that was not intended. In this case, the radiation reached the intended point and an originally, unintended point.
i Region III should have used 10 CFR 35.41(c) to classify the incident as a misadministration. It did not, accepting the licensee's decision'on the issue as a reasonable one. In retrospect, the decision should have gone the other ;
way. The case was unusual, however. Though the licensee mishandled a source, it does not appear that the licensee was "trying to pull a fast one" on the ;
staff. The licensee did report the incident. The staff was aware of the >
situation and it did take enforceme.it and other actions.
Chairman Zech Question 2:
Address whether IE, flMSS, and other Regions are applying this regulation and 10 CFR 35.43 (pertaining to reporting diagnostic misadministration) consistently with the appropriate legal interpretation of " misadministration" under the regulations.
Answer:
We believe that for the most part, the misadministration reporting regulations are fairly straightforward and are beino applied consistently. The staff has used this case as an instructional opportunity during a recent meeting among regions and headquarters, to discuss the issues in the misadministration area.
The discussion should help it.make better decisions in the future.
Questions 3:
Address whether the enforcement action by the Region was appropriate with respect to other license requirements implicated in the incident in view of the existing evidence and the Commission's enforcement policy.
Answer:
IE has reviewed the enforcement action by Region III with respect to the incident. The Region's action was taken with regional management review following normal regional practice including the holding of en enforcement i board which is done for the more significant cases in the Region. Based on the Region's determination that there was not a therapeutic misadministration, the Severity Level IV categorization of the two violations identified by the Region, i.e., unauthorized opening of a sealed source containing licensed material and failure to perfonn an edequate survey to detect low level con-tamination, was not unreasonable under Supplements IV and V of the Enforcement Policy. Recognizing that the categorizing of a violation requires the exerci.e I of judgement, it would also not have been unreasonable to conclude that these violations amounted to a significant regulatory concern because the exposures to the number of individuals which occurred, though small in magnitude, were clearly unnecessary and preventable if the Commission's survey regulations were followed. Under that view, the violations could have been categorized at a Severity Level III and a civil penalty considered. The small magnitude of dose to hospital personnel was one basis for the Region's Severity Level TV I assignments.
In retrospect, this matter involved a therapeutic misadministration and, therefore, the violations associated with the misadministration under Supplement VI could have been categorized as a Severity Level III' violation and a civil penalty considered. However, the staff is satisfied that given the time that has passed, the enforcement action taken, the licensee's corrective action, followup inspections, and the publicity given to this event, further enforcement action et this time for the failure to make a more timely report to the flRC or the issuance of a civil penalty is neither necessary nor appropriate.
As to the issue of an investigation, the staff does not believe one is neces-sary or appropriate under the Commission's threshold for investigations.
While the staff does not rule out the possibility that there might have been wrongdoing, given the Region's understanding of the incident, there is neither a reasonable basis to believe that there was wrongdoing in not notifying the Pegion on September 2 instead of September 5,1984, nor is there an identified regulatory need for an investigation. Likewise, based on the facts of this case, neither I nor the staff see any basis for an OIA investigation into the manner in which the staff handled this incident. Given the interest in this matter, the staff will 'oe pleased to brie # the Commission on this incident if the Commission so desires.
OrlEinal Cisned by Victor Stello ,,
Victor Stello, Jr.
Executive Director for Operations
Enclosure:
Summary of Incident cc w/pnclosures:
Commissioner Roberts
. Commissioner Asselstine Commissioner Eernthal Commissioner Carr SECY OGC Distribution:
DCS JDavis SMPB Reading CHeltemes, AEOC DI Reading MBridgers (EDO-2167)
GSjoblom, IE MPeardon, IE RSpessard, IE/JPartlow, IE DDTS # 86-562 R. Cunningham, NMSS RStarostecki, IE/JTaylor, IE BBeach IE JLieberman, OGC VStello, EDO JRoe, ED0/TRehm, EDO JSniezek, DEDROGR WParler, OGC Jreppler, RIII
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Enclosure 1 Summary of Incident August 28, 1984 - Iodine-125 contamination discovered and determined to have originated from the area where implanted sources were prepared. ,
r, August 29, 1984 - It was suspected that the implanted seeds were the source i of the Iodine-1?5 contamination. A medical decision was made to continue the implant. Vipe tests performed on shielding and bandages covering the patient's head and implant did not detect contamination.
August 30 thru - Performed thyroid counting on all personnel who may have August 31, 1984 been exposed to sources.
August 31, 1984 , Urine and blood samples were obtained from the patient and technicians who prepared sources. l l
September 1,1984 - The Medical Center removed the sources from the patient and measured direct radiation level of about 1.5 mrem /hr outside the patient's neck near the thyroid. This showed that a substantial, though not quantified, amount of radioactivity was deposited in the thyroid. The patient .
was discharged but instructed to return to the hospital :
for further bioassays via whole body counting. I September 4, 1984 - Results of the patient's urine bioassay revealed iodine-175 activity in the urine. Tha Pedical Center notified the NRC via telephone.
September 5,1984 - Performed additional whole body thyroid counting of the patient and quantified tM iodine-125 activity present at 557 microcuries, corresponding to 7087 rads to the thyroid.
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