ML20236F266
| ML20236F266 | |
| Person / Time | |
|---|---|
| Issue date: | 12/12/1986 |
| From: | James Keppler NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Heltemes C NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD) |
| Shared Package | |
| ML20236F196 | List: |
| References | |
| FOIA-87-377 NUDOCS 8711020071 | |
| Download: ML20236F266 (4) | |
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NUCLEAR REGULATORY COMMISSION 4 if l.
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? December :12,19865
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. MEMORANDUM FOR:'
C. ' J. ' Heltemes, Jr. ' Director, Office of Analysis lan'd :
- 1 Evaluation of Operational Data!
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'FROM:
iJames G.LKappler, Regional Administrator, Region'III
SUBJECT:
PROPOSED ~ ABNORMAL -0CCURRENCE REPORT - UNIVERSITY OF CINCINNATI; As requested by Paul Bobe of your staff, Lwe ha've'p'repared the' enclosed W ;
draft Abnomal Occurrence Report on 'a misadministration whichl occurred in,1984-
-at the University of. Cincinnati.
If you have any questions, please feel free to contact Mr' Jan Strasma at FTS 388-5674.
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James.G. Keppler Regional. Administrator t
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Enclosure:
As~ stated x
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J. G. Davis.-NMSS-H. R. Denton, NRR<
s J. J. Fouchard, PA-~
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R. B. Minogue', RES J.iM; Taylor, IE A G..H. Cunningham, ELD.
I-Regional, Administrators
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PROPOSED A'BN0'RMAL OCCURRENCE REPORT -- UNIVERSITY'0F CINCINNATI s
2-Date and place -- On September 4,1984,' NRC RegionflII (Chicago) was notified by the. University of Cincinnati that an.' iodine-125 radiation source. which had?
.beenimplanted.ina: patient,;had. leaked,causinganunintendedradiat{on exposure to the patient's.thyrold. The leaking radioactive source was on'e of:
eightl implanted in a. patient August 27,.1984, for treatment' of a brain' tumor.-
The eight sources were removed onL September 1.1984.-
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At the time of the incident, it was'not clas'sified as a misadministration.
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However, a reevaluation by the NRC staff in 1986. determined-that'it was; a' 1
misadministration.because the treatment was intended to irradiate: the bra'in tumor, but because of the leaking source, also irradiated the' thyroid.
(In the body, iodine is' deposited in the 'thyroidi a' d therefore,' the radiation n
.from the. leaking iodine would be concentrated there.),
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b On August 27.a total.of eight seeds were placed in' thin p1Astic catheter-tubes and were temporarily implanted in a tennally 111L patient. iThe next day, '
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iodine-125 contamination was detected in the brachytherapy' source storage room.
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4 Ma Bioassay results showed that the. technicians 'who'had worked with the' iodine-125',
seeds had measurable uptakes of iodine.,When.the seeds were removed from the
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.' patient' on September 1, a radiation survey of the patient's: neck revealed a radiation level of.1.5 millirem per hour..at' two inches from the. thyroid,'which.
confirmed the seeds were leaking inside the patient.
The patient _was. then
'l discharged from.the hospital-with instruction to return for further bioassay ;
analyses ~.
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g Suinequent bioassay testin] of the patientIs thyroid deteminetthat(there-hin!.
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.been a deposition of 557. microcuries of iodine-125/in the thyroid. iThisflevel; a
of. deposition would. result in:a, radiation : dose to!the thyroid of 2,087: rad (A rad;isi a standard measure,of> radiationjexposure.)? Such an exposure would be expected to: result in some. diminished thyroid l function.> Drugs 'are available}
m to compensate.for 'the feduced thyroid funct'fon?
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Urine' bioassay testing of> the twuLtechnicihns' involved in prepa'ringjthe>
iodine-125 seeds showed a thyroid. deposition of 29 nanocuries' for one:an'd!.
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57.6 nanocuries for the other. The results of thyroid-func' ion testing lof ~
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both individuals were normal.
a Contamine. tion surveys of the storage room used for the handling of the; fodine-125' seeds showed evidence 'of surface; contamination' ' : Theiroom was: < '
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. decontaminated and then painted to fix any remaining; contamination in placen Subsequent air samples in the room and in. adjoining areas showed no^ detectable' radioactivity. Some -equipment:-
a' sink,' shelving, and storagelsafe -- were:
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o found to have some resHual contamination and.they were covered iri plastic.
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to allow for' radioactive decay prior to use.
c The. licensee's investigation of.the contamination incident deterwined that one^
of the iodine-125 seeds was cut, apparently. when it was being removed!from a.
catheter. tube from a previous patient implanted on' August 13-17.11984. -Twol q
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9 technicians-were involved in removing the seeds, and reported thatLafter thei
'u Ri tubes were. removed from the previous patient, they wereidiscolored and the seeds were difficult to see. One' technician stated that he~ believed thefdamage mostF,,.,
9 likeik occurred when th'e endslof th'e catheter tubes were' cut;off withiscissors? '
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Cause or causes' -- The!cause of the misadministration was found.to be an?
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' tubes; forf reuse. Further, there1werelinadequate radiationi surveys.perfonned m
.I in the work'areatwhere the! source preparation)was' ~ performed. ' Had adequate l
.surveysoccurred,theleahing" seed.'might'have/beendiscoveredpriorJtosits L..
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being: implanted in'the patient.
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Steps taken to prevent recurrence -
o Licensee ~ -- Thellicens'ee's Radioisotope Committee recomended 'thatithelusefo'f[
thehigh-intensity.fodine-125seedsbediscontinued.forthistypeofLrad15 tion 1 1
o therapy, pending a thorough review of, the he.alth physics' aspect'sfof dieir use?
I The hospital also constructed a new radiation source: storage' room with 'al greater? '
1 distance'between the storage ' area and the source, preparation area. /A fume hood!
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was also installed in'the room.
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q NRC -- Region III (Chicago) conducted a specialiinsp'ection at'the hospitalf on;
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October 10-12, 1984, to evaluate the circumstances of thefsourcelleakage tand n
patient use. ' A Notice of Violation'was issued for)two viol'ations?--fopening al y
sealed source and failure to make an, adequate' survey for the-sou'rce storage?
area following the preparation'.of.the' iodine-125 seeds for. patient:use.c
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Followup inspections have been conducted to' determine the. adequacy of the.
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-licensee's corrective actions.
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