ML20207P682
| ML20207P682 | |
| Person / Time | |
|---|---|
| Issue date: | 01/14/1987 |
| From: | Heltemes C NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD) |
| To: | Jennifer Davis, Taylor J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20207P683 | List: |
| References | |
| FRN-52FR36942, RULE-PR-35 AC65-1-031, AC65-1-31, AC65-31, AEOD-N701, NUDOCS 8701200047 | |
| Download: ML20207P682 (4) | |
Text
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UNITED STATES NUCLEAR REGULATORY COMMISSION
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,I WASHINGTON, D. C. 20586
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,/ January 14, 1987 AE0D/N701 MEMORANDUM FOR: John G. Davis, Director Office of Nuclear Material Safety and Safeguards James M. Taylor, Director Office of Inspection and Enforcement
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FROM: C. J. Heltemes, Jr., Director Office for Analysis and Evaluation of Operational Data
SUBJECT:
AE0D ENGINEERING EVALUATION REPORT: DIAGNOSTIC MISADMINISTRATIONS INVOLVING THE ADMINISTRATION OF MILLICURIE AMOUNTS OF 10 DINE-131 4
Attached is the AEOD Engineering Evaluation Report on Diagnostic Misadminis-trations Involving the Administration of Millicurie Amounts of Iodine-131 (Attachment 1). This report documents our review and evaluation of 14
- - diagnostic misadministrations, each of which involved the administration of a 1-10 millicurie dosage of iodine-131 to a patient, whereas the prescribed radiopharmaceutical was either iodine-131 (6-300 microcuries), iodine-123 i
(150-400 microcuries), technetium-99m (0.1-10 millicuries), or technetium-99m methylenediphosphonate (20 millicuries). These misadministrations were f reported to NRC between January 1982 and June 1986.
From our evaluation of these events we found, among other. things, that while
- ten of the 14 misadministrations occurred as a result of either the referring physician's orders being misinterpreted by or miscomunicated to the tech-nologist or the technologist not knowing the correct dosage to administer for the prescribed thyroid scan, the underlying cause of 11 of the 14 (79%)
misadministrations was that licensees did not exercise adequate control over the ' administration of millicurie amounts of iodine-131 to patients. That is,
! most of the misadministrations could have been prevented, despite the errt,rs of misinterpretation or miscomunication if the prescription for the iodine-131
- dosage had been verified before the iodine-131 was administered to the patient.
We believe that the overall data highlight the need for better quality l assurance practices to ensure the accuracy of radiophamaceutical dosages of
, iodine-131 that, although administered for diagnostic purposes, fall in the dosage range nomally used for therapy.
AE0D issued a case study report in December 1985, AE0D/C505, " Therapy Misadministrations Reported to the NRC Pursuant to 10 CFR 35.42," that docu-ments an analysis of 16 teletherapy and two brachytherapy misadministrations. .
A significant finding of the case study was that: Although professional medical groups involved with radiotherapy and related government agencies -
encourage quality assurance programs in radiotherapy facilities, no government 8701200047 870114 PDR ORO NEXD PDR
Multiple Addressus 2 agency or nongovernmental accrediting body requires that radiotherapy facili-ties have quality assurance programs that conform to the programs recommended by professional medical groups. Thus, many facilities may not have quality assurance programs that are consistent with recommendations of medical profes-sional groups involved with radiation therapy.
We believe that this finding likely applies equally to NRC licensed facilities '
which may administer millicurie amounts of iodine-131 for diagnostic and therapeutic purposes.
Since undertaking the engineering evaluation study, we have received three additional reports of diagnostic misadministrations involving the adminis-tration of millicurie amounts of iodine-131 to patients (a summary of each report is given in Attachment 2). The cause of these misadministrations was the misinterpretation by or miscommunication to the technologist of the referring physician's order. These events further support the findings, conclusions, and suggestions contained in this report.
We have suggested in our engineering evaluation report that:
(1) The Office of Inspection and Enforcement send an update to Information Notice IN-85-61 (Misadministrations to Patients Undergoing Thyroid Scans) to the affected licensees informing them of the more recent misadministration events involving iodine-131.
(2) NMSS assess the proposed regulatory changes to 10 CFR 35 to determine whether the requirements for quality assurance procedures for radiotherapy facilities should be expanded to include a requirement for ouality assurance procedures for the administration of radiopharmaceuticals for therapy or for diagnosis in which the dosage of the radiopharmaceutical administered is in the therapy dosage range for the radio-pharmaceutical.
We understand that an ANPRM is being developed in regard to amendments to Part 35 involving misadministrations. We suggest that consideration be given to incorporating item 2 into this ANPRM.
If we can be of further assistance in this regard or if you have questions on other matters regarding the report, please contact Samuel L. Pettijohn of this office on X28348.
k~a h C. Hel'tEneRJr., Director Off for Analysis and Evaluation af Operational Data
Attachment:
As Stated cc: See next page
Multiplo Address:es 3 cc: D. Ross, RES
-G. Wayne Kerr, SP T. Murley, R-I J. Nelson Grace, R-II J. Keppler, R-III R. Martin, R-IV J. Martin, R-V D. Humenansky, OCM V. Stello, ED0 T. Rehm, A0/ED0 J. Sniezek, DEDR0GR M. Beaumont, Westinghouse Electric Corporation C. Brinkman, Combustion Engineering Company.
R. Borsum, Babcock & Wijcox L. Gifford, General Electric Company f
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Multiple Addressees 3 cc: D. Ross, RES G. Wayne Kerr, SP T. Murley, R.I J. Nelson Grace, R-II J. Keppler, R-III R. Martin, R-IV J. Martin, R-V D. Humenansky, OCM V. Stello, EDO T. Rehm, A0/ED0 J. Sniezek, DEDR0GR M. Beaumont, Westinghouse Electric Corporation C. Brinkman, Combustion Engineering Company.
R. Borsum, Babcock & Wilcox L. Gifford, General Electric Company Distribution:
C. J. Heltemer F. J. Hebdon S. Rubin M. Williams W. Lanning K. M. Black S. L. Pettijohn
/ PDR OFC :NAS :C/NAS :DD/AEOD :D/AEOD : : :
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NAME :SPettijohn:eh:KBlack :F bdon :CJ temes : : :
DATE :01As /87 :01h3 /87 :01/4/87 :01/1487 : : :
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