ML20137C272

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

ML20137C272
Person / Time
Issue date:	12/26/1985
From:	Heltemes C NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:	Cunningham G, Minogue R, Taylor J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE), NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES), NRC OFFICE OF THE EXECUTIVE LEGAL DIRECTOR (OELD)
Shared Package
ML20137C277	List: ML20137C272 ML20137C294 ML20137C307
References
NUDOCS 8601160262
Download: ML20137C272 (2)

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.....* DEC 2 6 1995 MEMORANDUM FOR: James M. Taylor, Director, IE Robert B. Minogue, Director, RES Guy H. Cunningham, Executive Legal Director, ELD Thomas E. Purley, Regional Administrator, Region I James Nelson Grace, Regional Administrator, Region II James G. Keppler, Regional Administrator, Region III Robert D. Martin, Regional Administrator, Region IV John B. Martin, Regional Administrator, Region V FROM: C. J. Heltemes, Jr. , Director Office for Analysis and Evaluation of Operational Data

SUBJECT:

AE0D CASE STUDY REPORT,

" THERAPY MISADMINISTRATIONS REPORTED TO NRC PURSUANT TO 10 CFR 35.42" Enclosed for your information 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 reouirements for radiotherapy facilities licensed by NRC.

Contact appropriate professional organizations to encourage and support the initiation of a voluntary, industry-directed phjsical 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.

8601160262 B61226 PDR NRC 8601160262 PDR

. .  ; i DEC 2 6 1985 James M. Taylor, et al. -

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.

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

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

If you should have any questions regarding the report, please contact Samuel L. Pettijohn of this office on x24496.

Originni nic,ned by:

C. J. Holtemes, Jr.

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

Enclosure:

As Stated Distribution:

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