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r MEMORANDUM FOR: Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety FROM: James L. Montgomery, Chief Nuclear Materials Safety and Safeguards Branch
SUBJECT:
REQUEST FOR CONCURRENCES ON COMMISSION PAPER:
QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE The following information is provided in response to the above request for comment and concurrence which was transmitted by your letter dated December 24, 1986. Additional information in reply to your request for comments and concurrence on the Advance Notice of Proposed Rulemaking: " Radiation Therapy Quality Assurance and Penalties for Negligence" is not included since this was addressed in our previous memorandum to you which was detted December 5, 1986.
In reviewing the " Case Study Report on the Therapy Misadministations Reported to the NRC Pursuant to 10 CFR 35.42", December 1985, which was enclosed with your submittal and request for concurrence, we note that some of the brachytherapy misadministration had been due to a failure by the licensee to independently verify that the correct sources had been loaded in the applicator oc implanted into the patient. However the proposed regulation does not appear to address this type of misadministration. We suggest that rulemaking be considered which would also require that licensee personnel independently verify that the correct sources have been loaded or prepared prior to their use for brachytherapy.
Additional comments which are offered in response to the specific proposed regulatory requirements are as follows:
Section 35.302 Administration of radiopharmaceutical dosages This section should be revised to include the additional requirement to prohibit the administration of any diagnostic or therapeutic radiopharmaceutical dosage (except for prescriptions of less than 10 microcuries) that differs from the prescribed dosage by more than 10 percent. Although this same wording has been incorporated into the proposed Revision 2 to Regulatory Guide 10.8, the basic nature and importance of this administrative procedure in preventing misadministration would appear to justify its inclusion as a separate regulatory requirement rather than its appearance in a document intended as gsidance only.
9712O20104 871201 FDR PR 30 52FR36942 PDR
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R. Cunningham oW, '
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Section 35.454 Check of Calculations The word " treatment field" in sub paragraph (b) shc-uld be changed to the more appropriate term " treatment volume", since no treatment fields are involved in brachytherapy.
Section 35.454 Check of calculations Section 35.654 Checks of dose calculations and measurements or dose Section 35.633 Independent check of full calibration measurements i Although patient charts and calibration records normally cont ain information needed to demonstrate that a licensee has implemented a quality assurance program, this may not always be the case. Unless there is a regulatory requirement for maintaining records to document all quality assurance checks, it may be difficult for the inspector to verify compliance. Similar reasoning 4 applies to Section 35.633 regarding full calibration measurements.
Section 35.654 Checks of dose calculations and measurements of dose.
Paragraph (a) should be revised to make it clear that the manual calculations are to be checked not only for errors in arithmetic but also for other errors including misinterpretation of the prescription, use of incorrect physical constants and parameters, and inappropriate equations or rationale used as a basis in performing the calculations.
i We~ recommend changing paragraph (d) to the more comprehensive statement: "If the field size, source-to-skin distance or other physical parameters which affect the output or dose profile, are dissimilar to those which were utilized during full calibration measurements, the Ideensee shall make a physical measurement of the dose rate to be administered to the patient."
Section 35.432 Source strength measurements If the licensee's measurements are to be meaningful in evaluating the accuracy and to identify gross errors in tbe source strength values as reported by the manufacturer, then the source strength measurements must also be accomplished with a fairly high degree of accuracy. Accordingly, the regulation should also include the requirement to perform the measurement to within a specified range of accuracy.
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James L. Montgomery, Chief l Nuclear Materials Safety and Safeguards Branch '
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cc: T. Martin, DRSS, RI J. Stohr, DRSS, RII J. Hind, DRSS, RIII R. Bangart, DRSS, RIV