ML20058C824
| ML20058C824 | |
| Person / Time | |
|---|---|
| Issue date: | 10/12/1990 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| REF-10CFR9.7 NUDOCS 9011050135 | |
| Download: ML20058C824 (4) | |
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RELEASED TO THE POR nucennEEEEIR d#dY*
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October 12, 1990 e
OFFICE 06 THf SECRtTARY MEMORANDUM FOR:
James M. Taylor Executive Director for O ations
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FROMt Samuel J. Chilk, Secreta
SUBJECT:
SECY-90-330 - SECTION 2 8 REPORT TO THE CONGRESS ON ABNORMAL OC URhENCES FOR APRIL-JUND 1990 This is to advise you that the Commission has not objected to the proposed Second Quarter 1990 Abnormal Occurrences Report.
The staff should incorporate the changes noted below and on the attached pages and provide forwarding letters to the Speaker of the House and the President of the Senate for the Chairman's signature.
The staff should proceed with the publication of Federal Recister notices as described in the subject paper.
1.
The Abnormal Occurrences Report should be updated to
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include information pertaining to the Notice of violation and proposed civil penalty against Barnett Industrial X-Ray in the discussion of NRC Actions Taken to Prever-t Recurrence on page 5.
Attachment:
As stated cc:
Chairman Carr Commissioner Rogers Commissioner Curtiss Commissioner Remick-OGC-SECY NOTE:
THIS SRM AND SECY-90-330 WILL BE MADE PUBLICLY AVAILABLE 10 WORKING DAYS FROM THE DATE OF THIS SRM
,e 9011050135 o0101,
o radiation oncologist (a physician experienced in examining patients who have been treated with large doses of radiation) and blood samples were obtained for cytogenetic studies.
The cytogenetic studies revealed equivalent whole body doses of 17 rem for the radiographer and 24 rem for the assistant. The assistant developed an area of erythema on the left side of his neck, which later showed signs of more significant damage to skin tissue in an area apprcximately 10 centimeters in diameter.
The oncologist determined that the observed effect corresponded to a local skin dose of 5000-7000 rem.
As of June 1990, the skin tissue in this area had regenerated and the physician did not predict any long term effects as a result of this exposure. The assistant remains under the physician's
.:are, and the NC continues to receive reports on his progress.
There were no medical effects observed for the radiographer.
Cause or Causes - The radiographer and assistant failed to conduct a radiation survey of the exposure device after either of the exposures was completed to ensure that the source had been retracted to its shielded position.
The radiographer was exposed to the unshielded source as he changed films between the two exposures, and the assista !
Jceived a large exposure as he carried the source tube containing the sorr.e draped around his neck. Without a radiation survey, neither individual was aware that the source had not been connected to the drive cable and remained in the guide tube.
Actions Taken to Prevent Recurrence Licensee - The licensee's proposed corrective actions include retraining the radiographer in radiation safety procedures and continued observation of his erformance. The assistant radiographer is no longer employed by the kt k $e. \\ke. Met.'s Its@tW%hn cN U)Mtcht-ocSoM.
!E Duri g the investigat'on of this event, on April 12, 1990, an Order modifyin the license u s issued, prohibiting the radiographer and assistant from par icipating in licensed activities (Ref. 3).
This Order has since been relaxed NRC Region IV conducted an enforcement conference with the licensee l
3 on May 25, 1990, to discuss-the event (Ref. 4). The decision to take further enforcement action is currently under review.
Future reports will be made as appropriate.
L 90-13 Medical Diaanostic Misadministration The following information pertaining to this event is also being reported concurrently in the federal Register. Appendix A (see the general criterion) of this report notes that an event involving a moderate or more severe impact on public health or safety can be considered an abnormal occurrence.
Date and Place - June 5,1990; Mercy Memorial Medical Center;-St. Joseph; Michigan 5
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of this report notes that an event involving a moderate or more severe impact on public health or safety can be considered an abnormal occurrence.
Date and Place - June 22, 1990; St. Luke's Hospital; Cleveland, Ohio.
Nature and Probable Consecuences - A 57 year old woman, being treated for lung cancer, was erroneously given a 178 rem radiation dose to the left side of the head on June 22, 1990, using the licensee's cobalt-60 teletherapy unit.
The 1
patient was scheduled to receive a 200 rem radiation dose to the chest area at the time of the misadministration.
The treatment was the ninth of a total of ten treatments in the series for a total of 2,000 rem to the chest.
The i
treatment began June 11, 1990.
A technologlet set the patient up for brain irradiation without looking at the treatment documents.
After the left side of the head was treated, the patient asked if her chest would also be treated.
At this time, the trcatment stsff discovered the error.
Because the misadministration involved & single treatment and because of the l
dosage involved, no adverse medical effects are expected.
Subsequent to the misadministration, the patient received the intended 200 rem radiation dose to the chest area..The tenth treatment was administered, and the patient began a second phase of 25 radiation treatments of 150 rem each to the chest area.
l Cause or causes - This misadministration was caused by the failure of the l
technologist to examine the treatment documentation (the setup sheet and a i
treatment field picture).
Although the technologist had previously treated the patient, the technolo treated. -Th; 'k=;; r; gist erroneously assumed the brain was the area to be pried thei.Ny 5piglidic in edAt ah.iien is r. ttCgetr$ d iibrf l
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%nttstrai i ceses ef thi: typ:? ( k 4
de3tt%ined eu h (n his typ. chen do tAthMh5ile io ik brdn, M IerAMohn d N rdn 4his we Actions Taken to Prevent Recurrence mg g gg g g g44 )
Licensee - The licensee has revised its procedures to require the verification, when circumstances permit, of the treatment setup by a second technologist using the setup documentation. All technologists have been l
trained in the procedure.
The NRC is requesting'the licensee to amend its l
quality assurance procedures to include dual verification of treatment. setups l
prior to any treatment.
E The NRC conducted;a special inspection on June 27 29, 1990, to review the circumstances of the misadministration and to evaluate the licensee's radiation safety and management control programs (Ref. 6).
The inspection also covered an earlier therapy misadministration in which a patient received less than the intended dose.
In this misadministration, a patient received a l~
dose that was 12 per cent less than that intended during a treatment series February 15 through April 3, 1990.. A Notice of Violation was issued for two instances of failure to report the misadministrations within the required time period.
The inspection also identified a concern about staff shortages that may adversely affect the licensee's radiation therapy program.
The NRC requested the hospital's response to this concern.
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'short term, the licensee provided remedial training to a sufficient number of reconstituted operating crews to support restart of both units.
Operational Evaluations were conducted on June 9 10, 1990, by the NRC prior to restart.
The result provided the licensee with sufficient licensed operators to safely start up and resume power operation of both units.
Both units were returned to power operation as of June ll,1990.
The NRC conducted additional Operational Evaluations on July 25 26, 1990, to ensure that a sufficient s
number of qualified operators were available for continued power operation of both units.
The licensee completed a root cause analysis to identify the major weaknesses and contributors that led to the unsuccessful operator performance on the NRC administered requalification examination.
The scheduled corrective actions will result in the licensed operator requalification training program being ready for NRC -^^^ "
- by April 1991.
Prior to conducting this reassessment, the s tus of the licensee's corrective actions and training program will be rev ewed during an NRC training inspection.
4 On August 28, 1990, the NRC issued Information Notice No. 90 54, " Summary of Requalification Program Deficiencies" (Ref. C 1) to all holders of operating licenses or construction permits to alert licensees to problems identified during administration of the NRC's licensed operator requalification examination program.
This notice addressed technical and program weaknesses.
generic to the 10 facilities listed in Table C 1.
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