ML20137C294

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Forwards,For info,AEOD/C505, Case Study Rept on Therapy Misadministrations Reported to NRC Per 10CFR35.42. Recommendations Include Having NMSS Communicate Info to Affected Licensees & Amending 10CFR35.21
ML20137C294
Person / Time
Issue date: 12/26/1985
From: Heltemes C
NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To: Kerr G
NRC OFFICE OF STATE PROGRAMS (OSP)
Shared Package
ML20137C277 List:
References
NUDOCS 8601160269
Download: ML20137C294 (2)


Text

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WASHINGTON, D. C. 20555 DEC 2 61985 MEMORANDUM FOR:

G. Wayne Kerr, Director Office of State Programs FROM:

C. J. Heltemes, Jr., virector Office for Analysis and Evaluation of Operational Data

SUBJECT:

AE00 CASE STUDY REPORT,

" THERAPY MISADMINISTRATIONS REPORTED TO NRC PURSUANT TO 10 CFR 35.42" Enclosed for your information and action is the AE00 Case Study Report,

" Therapy Misadministrations Reported to NRC Pursuant to 10 CFR 35.42."

This report was issued June 18, 1985 and June 28, 1985 for peer review and has been revised based on the comments received during the peer review.

Our study, together with peer review comments, have led us to make the following recommendations:

1.

That the Office of Nuclear Material Safety and Safeguards (NMSS) communicate the information contained in this report to the affected licensees.

2.

That the Office of Nuclear Material Safety and Safeguards (NMSS) consider the following actions in regard to establishing quality assurance requirements for radiotherapy facilities licensed by NRC.

Contact appropriate professional organizations to encourage and support the initiation of a voluntary, industry-directed physical quality assurance program for radiotherapy facilities.

We believe that the commitment of the professional organizations in this regard should be assessed by the NRC and a conclusion reached as to the effectiveness of the voluntary program within two years.

If substantial progress toward completion of the voluntary program, including a final completion date, has not been demonstrated at the end of two years, we recommend that NMSS initiate the necessary studies to determine whether a rulemaking is justified to require that radiotherapy facilities licensed by NRC have quality assurance programs to insure the accuracy of patient doses.

The program should include such things as:

independent verification of patient dose calculations and independent verification of the activity of brachytherapy sources before the sources are implanted.

8601160269 851226 PDR MISC 0601160262 PDR

DEC 2 61988; G. Wayne Kerr 1 3.

That 10 CFR Part 35.21 should be amended to include the calibration of beam modiffers such as wedge filters, shaping filters, trays, etc.

4.

That to the extent that the NRC implements recomendation 3, the action should be made an item of compatibility for Agreement States.

Recomendations 1,- 2, and 3 are directed to NMSS.

Recommendation 4 is directed to SP.

We request that prompt consideration be given to implementing Recommendation 4.

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 x24496.

Original signed by:

C. J.11eltemes, Jr.

i Heltemes, Jr., Director 0

e for Analysis and Evaluation of Operational Data l

Enclosure:

As Stated i

Distribution:

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.K. M. Black S. Pettijohn iOFC

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OFFIClAL RECORD COPY 1.