ML20236U637
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m o UNITED STATES 90/2
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8 o NUCLEAR REGULATORY COMMISSION /j 7; y WASHINGTON, D. C. 20555 i
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NDV 191986 TO ALL MEDICAL LICENSEES The Nuclear Regulatory Commission (NRC) requires all radiation therapy misadministration to be reported to NRC. This reporting requirement was precipitated, in part, by a 1976 teletherapy misadministration event in which about four hundred patients received radiation doses that were substantially different than prescribed. The NRC carefully examines each misadministration report to determine the cause of the avent, mitigating factors, and measures that might reduce the chance of recurrence.
The enclosed report, which was prepared by the NRC's Office for Analysis and Evaluation of Operational Data, analyzes the radiation therapy misadministration events reported to the NRC from November 1980 through July 1984. The report shows that each year about one percent of the Nuclear Regulatory Commisssion's therapy licensees report a misadministration. These events generally result from inadequate training, inattention to detail, and lack of redundancy. Many of the misadministration could have been detected by timely chart reviews.
This report is being distributed to all medical licensees for their information. Although it includes recommendations, it does not irpose requirements on licensees, and it does not represent the NRC final position on therapy misadministration. Various alternatives for regulatory action with regard to misadministration are under review by the NRC staff. If the NRC decides that new requirements may be needed, there will be ample opportunity for public comment.
ndy iller, def ateri Licensing Branch Division of Fuel Cycle and Material Safety
Enclosure:
As stated Q20y226B71201 35 52FR36942 PDR
PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE--PNO-III-86-137 Date November 19, 1986
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This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received without /$}UH
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verification or evaluation, and is basically all that is known by the Region III staff on this date. '
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Facility: Toledo Hospital Licensee Emergency Classification: U/W Toledo, OH Notification of an Unusual Event
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Alert License No. 34-01710-05 Site Area Emergency General Emergency X Not Applicable
Subject:
DIAGNOSTIC MISADMINISTRATION RESULTING IN A THERAPEUTIC DOSE On November 19, 1986, the licensee reported that a patient had been administered the wrong radiopharmaceutical for a diagnostic bone scan. The diagnostic procedure had been prescribed verbally on cbout November 12, 1986, but was not clearly described on the diagnostic center's calendar. The intended procedure was for a bone scan using 20 millicuries of technetium-99m MDP, but on November 18, 1996, the patient was administered 20 millicuries of iodine-131 for a thyroid scan, which was the technologist's interpretation of the ambiguous test description.
The error was discovered when the patient returned to the hospital on November 19, 1986, for the diagnostic procedure. The principal organ exposure from the incorrect radiopharmaceutical would be to the thyroid. The patient had previously experienced hypothyroidism, and the radiation dose would be expected to further reduce thyroid activity.
The patient's attending physician is monitoring her condition. Region III (Chicago) will have the case reviewed by an NRC medical consultant. An inspection is scheduled for early next week to review the circumstances of the misadministration.
The State of Ohio will be notified.
Region III was notified of this incident by the licensee at 11:30 a.m. , November 19, 1986.
This information is current as of 3 p.m. , November 19, 1986.
Information Routing Only CONTACT: J. L. Lynch D. G. Weideman b.b -
FTS 388-5669 FTS 388-5616 9. L.388-5612 FTS AxelsorMaus@ardt CC: Q.LD \
1h DISTRIBUTION:
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Comm. Asselstine AE00 NRC Ops Ctr )
Comm. Bernthal Comm. Carr SP Regional Offices ACRS I SECY INPO NSAC CA RIII Resident Office PDR Licensee: (Corp. Of fice - Reactor Lic. Only)
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ELIMINARY' NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE--PNO-III-86-135 Date November 17, 1986
'his preliminary notification constitutes EARLY notice of events of POSSIBLE safety
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>r.public interest significance. The information is as initially received without 7 verification or evaluation, and is basically all that is known by the Region III j
'3 itaff on this date.
facility: ' Cleveland Clinic Foundation Licensee Emergency Classification:
9500 Euclid Avenue Notification of an Unbsual Event Cleveland, OH Alert Site Area Emergency License No. 34-00466-02 General Emergency X Not Applicable iubject: THERAPEUTIC HISA0 MINISTRATION ,
'he licensee reported that an elderly, terminally ill patient was exposed to 2000 rads of
>adiation rather than the prescribed 1200 rads while undergoing cobalt-60 teletherapy
,reatment for a blood disease, he treatment, which covered the patient's urcer torso, began October 6, 1986, and ended stober 8, 1986. The error was discovered on November 11, 1986, but was not reported to the
)RC until November 17, 1986. The delay was apparently due to the licensee's failure to realize
- hat a misadministration of this' type requires _immediate notification.
'he excess exposure resulted from an error in the treatment calculations, and was discovered ten the patient was admitted to the clinic with skin complications.
a NRC medical consultant has been notified and will promptly review the misadministration.
he hospital is required to submit a written report on the incident, including a description
'f correction actions, within 15 days of the initial report. Region III (Chicago) has cheduled an onsite insp'ection to review the incident.
he State of Ohio will be notified, his information is current as of 12:30 p.m. (CST), November 17, 1986.
l DNTACT: D. G. Weideman W. L. Axelson FTS 388-5616 FTS 388-5612 I
' DISTRIBUTION:
'hairman Zech PA IE NMSS DOT:Trans only omm. Roberts ELO OIA RES
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& RIII Resident Office i DR Licensee: (Corp. Office - Reactor Lic. Only)
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{PRELIMUARYNOTIFICATIONOFEVENTORUNUSUALOCCURRENCE--PNO-III-86-135ADateNovember 18, 1986.
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- h. 8 This preliminary notification constitutes EARLY notice of events of POSSIBLE safety l othpublic interest significance. The information is as initially received.without '
v(rification 'or evaluation, and 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 X Not Applicable
Subject:
THERAPEUTIC MISADMINISTRATION (UPDATE) )
1 Rsgion III (Chicago) was notified that the 57 year-old female patient who received 2000 rads I of radiation rather then the prescribed 1200 rads at the Cleveland Clinic October 6-8, died at 1: 04 a.m. , November 18, 1986 in the Cleveland Metropolitan Hospital Burn Clinic.
'Tha patient was admitted to the Burn Clinic on about November 11 with second degree burns ,.
.over 60 percent of her body. She subsequently developed bilateral pneumonia, kidney failure, j and toxic dermatitis (skin poisoning).
The official cause'of her death is unknown at this time. She originally had been treated at the Cleveland Clinic for a blood disease that was considered terminal (Waldstroms macroglobulinanemia). (See PNO-III-86-135)
The cobalt-60 teletherapy treatment, according to the consultant, was prescribed as a final effort to effect a remission of her disease.
The prescribed treatment was 400 rads per day (200 in the morning and 200 in the evening) to her upper torso over a three-day period, for a total of 1200 rads.
The NRC medical consultant and Region III radiation inspectors will be at the Cleveland Cliriic and Burn Clinic to review the misadministration and the corrective actions. Region III also is requesting that patient records, postmortem examinations, and tho de+" stif 6c be forwarded )
to the consultant.
Inf0rmation R0uting Only 39 +
Mausshardt cc: T_Cl DISTRIBUTION:
H. St. EDO NRR E/W '"ll tc h/v no i i :
ADM:DMB Chairman Zech PA IE NMSS DOT:Trans only Comm. Roberts ELD OIA RES Comm. Asselstine AE00 Comm. Bernthal Comm. Carr SP Regional Offices ACRS SECY INP0 NSAC .
CA RIII Resident Office PDR Licensec: (Corp. Of fice - Reactor Lic. Only) j J Region III e, , , ,- a - --
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[ PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE--PNO-III-86-135A Dato November 18, 1986
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Region III will issue a Confirmatory Action Letter November 18 documenting the licensee's agreement to condu' c t an interim Quality Assurance / Quality Controi program.
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This program, at a minimum, requires a double verification of prescribed doses, and management audits.
The State of Ohio will be notified. The NRC commissioners' assistants have been briefed.
The patient's relatives and the referring physician have been notified of the.
misadministration.
This information is current as of 1 p.m. (CST), November 18, 1986.
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CONTACT: D. G. Wiedeman W. L. Axelson FTS 388-5616 FTS 383-5612 e
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