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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? December :12,19865 %a9 !
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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.
t j James.G. Keppler .
Regional . Administrator t y
Enclosure:
As~ stated ,
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- 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. 4 1
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'n d therefore,' the radiation
.from the . leaking iodine would be concentrated there.) , N ~
., 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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v iodine-125 contamination was detected in the brachytherapy' source storage room. j 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
.' patient' on September 1, a radiation survey of the patient's: neck revealed a
- h 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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4 ,. 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; '
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 t testing lof ~
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both individuals were normal. .
Contamine. tion surveys of the storage room used for the handling of the; fodine-125' seeds showed evidence 'of surface; contamination' ' : Theiroom was: < ' o
. 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:
':[o found to have some resHual contamination and.they were covered iri plastic.l j
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 9 s .. C-
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a technicians-were involved in removing the seeds, and reported thatLafter thei
'u tubes were. removed from the previous patient, they wereidiscolored and the seeds Ri '
' ; 9 were difficult to see. One' technician stated that he~ believed thefdamage mostF , , . ,
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likeik occurred when th'e endslof th'e catheter tubes were' cut;off withiscissors? ' l
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Cause or causes' -- The!cause of the misadministration was found.to be an? s u
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l inadequate procedure used 41n removing; the iodine-125 seeds <from the' catheter . s ,
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' tubes; forf reuse. Further, there1werelinadequate radiationi surveys.perfonned m 1 in the work'areatwhere the! source preparation)was' ~ performed. ' Had adequate l
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.surveysoccurred,theleahing" seed.'might'have/beendiscoveredpriorJtosits L..
c , 3 being: implanted in'the patient.
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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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NRC -- Region III (Chicago) conducted a specialiinsp'ection at'the hospitalf on; 'l c,
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m 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. f f
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-licensee's corrective actions. -
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