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[#)pR )-_ Motif "kg NUCLEAR REGULATORY COMMISSION UNITED STATES
- WASHINGTON, D C. 20555
% ....* December 17, 1986
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SUBJECT:
MISADMINISTRATION RULE b 8d MO84 d ! /2 M E)
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Reference our discussion of 12/16/86 on the misadministration rule.
fhe outcome of the discussion was that we would modify our approach some . .
what to give the Commission options on how they want to process. The revised approach will be:
- l. . A prompt rulemaking on quality assurance that provides a . ,
prompt upgrade to quality program requirements. The Commission will be given the_o.ption of proceeding with an ))# ;!
immediately effective rule or a ihort comment period for a v '
proposed rule. The staff will recommend the "short comment ,
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period" proposed rule.
- 2. An advanced notice of proposed rulemaking for a rule that:
(a) responds to the Staff Requirements Memorandum COMFB-86-3, dated April 14, 1986, as the staff understands the SRM.
This is the ANPR you now have out for concurrence and W deals with (1) quality programs; and, (2) enforcement for negligence.
9L (b) responds to the April 14 SRM for (1) quality programs; and, (2) suggests that the enforcement aspects of mis- .p administration be considered, not by rblemaking, but by ,
modification to enforcement policy, if needed.
It should be noted that the final rule modification will seek to envelop ' gf 7, the whole matter of misadministration and may include some modification ,,.
'# fd to definitions.
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B712020359 871201 PDR PR 35,52g 3694L PDR
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R. E. Cunningham Decenber 17, 1986 You intend to deal with the Regions and other concurrence units by telephone to explain this concept. As drafts are developed they will be promptly provided for their input.
Comments on the ANPR paper are attached.
Enclosure:
As stated ,
cc: D. B. Mausshardt J. D. Evans
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COMMENTS ON 3 CONCURRENCE COPY OF ANPR MISADMINISTRATION
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l COMMISSION PAPER
- l. p.1 Why limit the QA programs to teletherapy and brachytherapy? de[' "
- 2. p. 3 What issues are "outside NRC's jurisdiction?" You may want to do o delete "some outside NRC's jurisdiction."
- 3. p. 4 How could this rulemaking impact on patient care and tort law? ro d S vah;.ukanud ~
ENCLOSURE 1 .g, c4'
- l. p. 3 The use of the term " negligent application" I assume is in lieu ,
.f of the word " misadministration." You may want to continue to M "f use the word misadministration since I believe the purpose of the rulemaking would be to identify the relationship between mis-administration and negligence.
- p. 5 This paragraph can be read to set aside radiopharmaceutical 2.
therapy from the quality program measures of the ANPR because f, current requirements are mfficient. These requirements relate J to measures to assure that the dose to be delivered is correct. #Y chi l If my reading is correct, I'm not certain I agree. As I under- #p )*
stand the quality measures being considered, they go beyond .
assurances of dose measurement to such things *gas patient j.
y GENERAL ,#}
My major concern with the ANPR is what I have read as a difference of quality to be achieved depending on the method of threatment--teletherapy / bra chytherapy or radiopharmacentical. I believe the level of quality should be the same. a The technical means of achieving this may differ but the process means (i.g., p )g..
patient control) should be the same. . ,. p9 ej g
You may want to add questions. For example, you may wa toidentifywhatwehl .M believe to be the major causes of misadministration, a comments for other pa causes and ask how these can best be controlled. / Nfp'g c+ ; y d.
Please assure that the dominate tone of this effort is one of preventing mis- f administration. A ,y
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DEC 121986 , , _ ~-
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1 BRIEFING ON QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE Scheduled: December 16, 1986; 10:30 am Purpose of Briefing: To provide a status report on the subject rulemaking and review plans.
i Background Information: The staff has prepared an Advance Notice of l Proposed Rulemaking that poses certain questions for public comment, and has almost completed an immediately effective Notice of Final Rulemaking l that would require therapy licensees to implement certain basic quality assurance steps. Both notices will be submitted in one Commission Paper.
In informal conversations the Office of General Counsel has indicated that a Notice of Proposed Rulemaking with a short public coment period may be the better course. A final rule could still be issued by late spring of 1987.
List of Attendees: J. Davis, NMSS d ,#///.c4 <v'4/ff gjyf5 D. Iteussh dt,201:S-R. Cunningham, FC g /f fgY C. Seelig, PPAS TQ N. McElroy, FCML / g ,n d offed gcc
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