PNO-III-86-135B, on 861006-08,radiation Therapy Misadministration Occurred.Caused by Miscalculation of Exposure Time for Each of Six Planned Treatment.Special NRC Medical Advisory Board Formed to Evaluate Case
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P ELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE--PNO-III-86-1358 Date November 21, 1986 This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest' significance. The information is as initially recefied without verification or evaluation, ar.d is basically all that is known by the Region III staff on this date.
. Facility: Cleveland Clinic Foundation Licensee Emergency Classification:
9500 Euclid Avenue Notification of an Unusual Event Cleveland, OH Alert Site Area Emergency License No. 34-00466-02 General Emergency ggg X Not Applicable
Subject:
THERAPEUTIC MISADMINISTRATION -- (SECOND UPDATE)
The Region III (Chicago) special inspection is continuing at the Cleveland Clinic, reviewing the circumstances surrounding the radiation therapy misadministration which occurred October 6-8, 1986. The patient died November 18.
A special NRC medical advisory board has been formed to evaluate the case. The board, which includes three physicians and a medical physicist, is headed by Dr. Clarence Lusnbaugh of
.0ah, Ridge Associated Universities.
An. autopsy was conducted November 20, 1986, at the Cleveland Metropolitan General Hospital under the authority of the Cuyahoga County Coroner. The pathologist has discussed the case with Dr. Lushbaugh and has agreed to make all medical data and findings available to the NRC advisory board. The cause of death has not yet been determined, and it is expected that it will be two to four weeks before all postmortem evaluations and testing are completed.
I The NRC board intends to convene when the postmortem findings are completed. The review will include. interviews of licensee personnel, a review of licensee procedures and practices, and an evaluation of the medical effects of the misadministration.
The preliminary determination by the licensee and the NRC inspectors is that the misadministration occurred because of a miscalculation of the exposure time for each of the six planned treatment. The error occurred becaut,e the licensee'f. physicist included the distance from the source to the outside of the teletherapy machine in his calculations when that distance was also automatically included in the computer program. As a result, increased source-to patient distance resulted in a longer calculated exposure period.
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PDR Licensee: (Corp. Office - Reactor Lic. Only) 8712030237 871201 a'2 DR PR 35 52FR36942 PDR Region III
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, IMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE--PNO-III-86-135B Date Novemb:r 21 I ,
Th2 treatment plan called for six treatments of 200 rads to the upper torso. The correct er.pssure time would have been 5.31 minutes, but the calculational error resulted in an exposure time of 8.72 minutes. The longer exposure resulted in a dosage of 328 rads or approximately 1968 rads over the six treatments instead of the intended 1200 rads.
A runactment of the treatnient procedures was requested by Region III and is planned for November 22-23; it will be observed by the NRC inspectors. A complete calibration check is also to be performed on the radiation therapy device.
Tha licensee has a large radiation therapy program, treating approximately 100 patients a day. On November 20, Region III issued a Confirmatory Action Letter to the licensee, documenting its agreement to perform a reverification of all treatment calculations prior to the initial treatment of a patient. Licensee technologists are also to check to assure that th double verification was completed before beginning a patient's treatment. (The double ch;ck was part of existing licensee procedures, but the recheck was apparently not made in this case.) The licensee has also agreed to submit, for NRC review and approval, a comprehensive quality assurance / quality control program for its radiation therapy activities.
The State of Ohio will be informed of this updated information.
This information is current as of 12 noon, November 21, 1986.
CONTACT: D. G. Wiedeman W. L. Axelson J. A. Hind FTS 388-5616 FTS 388-5612 FTS 388-5510 I
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