ML20236P173
| ML20236P173 | |
| Person / Time | |
|---|---|
| Issue date: | 11/13/1987 |
| From: | Black K NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD) |
| To: | Miller V NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20236P175 | List: |
| References | |
| FRN-52FR36942, RULE-PR-35 AC65-1-028, AC65-1-28, NUDOCS 8711170183 | |
| Download: ML20236P173 (2) | |
Text
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. UNITED STATES.
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NUCLEAR REGULATORY COMMISSION J
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NOV:.13 1987
' MEMORANDUM FOR:
'Vandy Miller, Chief Medical', Academic & Commercial Use Branch, NMSS i
FROM:-
.Kathleen Black, Chief Nonreactor Assessment Staff, AE0D
SUBJECT:
'AE00 TECHNICAL REVIEW REPORT: REVIEW 0F. DATA ON THE-
' TELETHERAPY MISADMINISTRATION REPORTED TO THE STATE' f
0F NEW YORK.
Enclosed is the subject Technical Review (TR) report that ' documents our review
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-of the dat6 on the misadministration that were reported to the State of New York-and that were the subject of PN0 I-87-74. The' review was perfonned in-response to the memorandum dated August: 26,1987 from V. Miller to K. Black, requesting AE0D to review the above data.
Based on our review of the available data we found that:
1..
'The misadministration essentialy resulted from random errors in dose calculations made by a consulting dosimetrist, and that alltof the errors-were made on patient treatment plans'where data was generated by computer
- 3 (computer treatment plans).
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i 2.
In relating the causes of the misaministrations to requirements in the.
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- proposed rule, " Basic Quality Assurance in Radiation Therapy " the require-1 ment-for a check of dose calculations by an individual who did not perform j
thel calculations and the? requirement for weekly accuracy checks of daily
-j arithmetic calculations contained in'the_ proposed rule appear to address the primary causes identified for the misadministration. Therefore, we do not believe that any changes to the proposed rule are occasioned as a i
result of our findings regarding the causes-of the misadministration.
3.
The conclusion in item 2 notwithstanding, the facts of the misadministration highlight several general issues that we will address in a future TR:
a.
Training requirements for personnel ' involved in radiotherapy.
]
b.
Definition of the relationship between radiotherapy consultants, licensees and NRC in regard to training and other regulatory requirements.
c.
Definitive requirements for periodic patient chart reviews to i
detect errors in the patient treatment plan.
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8711.170183 871113 PDR ORG NEXD 4
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7 Vandy Miller
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- d. Requirement for an annual audit of patient! treatment records.
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- e. Standardization of computer treatment plans.
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'f. Expanded definition of a misadministration,
- g. Quality assurance for linear accelerators.
i The above findings are primarily based on our review of data provided by the State of New York Department of-Health.. The data'was compiled by a consulting physicist retained by the hospitals subsequent to the discovery of the misadministration.
The New York Department of Health advised us that the Radiological Health Advisory Committee to the State has been requested to review tha w ta on the misadmini.
strations;:and that a radiological physics consultant um.e contract to NRC has been. retained-to review the data.
Findings from tiie above reviews were not available for inclusion in our report.-
Our TR that addresses the general issues listed above will allow the findings of the TR to be~ considered in the development of the proposed rule for comprehensive quality' assurance.
s Sould you have any questio'ns on the above, please contact Sam Pettijohn on l
extension 28348.
8/
i Kathleen M. Black, Chief Nonreactor' Assessment Staff I
Division of Safety Programs l
Office for Analysis and Evaluation of Operational Data j
Enclosure:
As stated l
DISTRIBUTION DC5/PuM.:g i
NAS'R/F EJordan CJHeltemes TNovak JJohnson, OEDO OSP KBlack
'SPettijohn l
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NAME :SPe DATE :11//.7/87
- 11/0/87 OFFICIAL RECORD COPY
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