ML20244E510
Text
- _ _ _ _ _ _
2nr jx' Lww ,
, % , (.,
December 5,1986 v/ fl MEMORANDUM FOR: John G. Davis, Director Office of Nuclear Materials Safety and Safeguards FROM: James M. Taylor, Director Office of Inspection and Enforcement
SUBJECT:
COMMISSION PAPER CONCERNING MISADMINISTRATION OF RADIATION THERAPY (ADVANCE NOTICE OF PROPOSED RULEMAKING)
We have reviewed the proposed Commission paper and have the following comments to offer.
It appears that the approach in the paper is heavily directed towards the regulatory or enforcement aspects of therapeutic misadministration. We believe i that a successful rulemaking will be possible if it is done in a way which does j not antagonize the medical community. Furthermore, the use of the term
" negligence" associated with this rulemaking will diminish the chances of its success. Such rulemaking should be on the positive aspects of quality assurance
~
(QA) and quality control (QC) for the administration of radioisotopes in therapy.
To stress the enforcement aspects at this time constitutes a negative approach and will not get the cooperation of the medical community. Also, the language in the Staff Requirements Memorandum regarding negligence could be accomplished by acknowledging that negligence and similar acts of wrongdoing are included in the current Enforcement Policy. Many medical institutions already have QA-QC l programs. The purpose of the paper should be to solicit views from licensees l and other professional organizations on what they believe QA-QC programs should consist of.
The language in the proposed Federal Register notice concerning QA program elements is essentially good, but it is expressed in question form. As such, responses to these questions could be simply yes or no and the NRC may therefore get only a limited amount of factual information useful to regulatory decisionmaking. It is suggested that the request for comments be put in the form of statements in which commenters would be asked for more definitive information about what constitutes reliable quality assurance programs for different types of licensees.
IE does not agree with the statement on the bottom of page 5 of the proposed Federal Register notice that simply measuring the radioactivity of dosages satisfies the need for a quality assurance program. Many licensees already have a more extensive program in this area and the NRC would thereby be condoning a reduction of effort in this important aspect. We believe that the use of a dose -
calibrator alone for radiopharmaceutical therapy does not satisfy the need for a quality assurance program for such therapy. For example, in addition to the requirements of measurement of radiopharmaceutical dosages described in
[1 f @
.. Ct . ;
s I
- u.
- l
' John G. Davis .
l 10 CFR Part 35, quality assurance items should include (1) calculations of therapeutic dosages prior to calibration of dosages, (2) screening and approval by the nuclear medicine physician of all procedures that require administration ;
. of I-131, I-123, P-32, and (3) written prescription of dosages by the nuclear '
l medicine physician on an individual basis for therapeutic procedures. )
In summary, the areas concerning " negligence" and the questions concerning enforcement actions should be omitted from the paper. These considerations l should come after the fact, that is, following rulemaking regarding regulations '
of therapeutic administrations. We suggest a " positive" approach to first establish the regulations in a way which will enhance the cooperation of industry.
Original Signed by R. W. StatesteeM -
James M. Taylor, Director Office of Inspection and Enforcement Distribution DCS SMPB reading DI reading -
JMetzger, IE GSjoblom,IE RSpessard, IE JPartlow, IE RStarostecki, IE JTaylor, IE NMcElroy, HMSS BBeach, IE ,
%.49 o
(* see previous concurrence)
I / / /1 //
...lf.![f......[b[f![f....[S[.![f.....[b[ .b....((b k .[. b; ......l . ......
NAME :JMetzger :GSjoblom :BBeach :RSp ssard :JPar low :RSt ro' ecki:JTa p c -
DATE 2hh86sr 2 hh6 :$2 f8h 2 f h6 2)6 h6 $2 6
- - - - - - - - - - - - - - - --