ML20151U039
| ML20151U039 | |
| Person / Time | |
|---|---|
| Issue date: | 04/22/1988 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| FRN-55FR1439, REF-10CFR9.7 AC65-1-123, M880407, NUDOCS 8804290236 | |
| Download: ML20151U039 (2) | |
Text
, _ _ _.
IN. RESPONSE, PLEASE
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'o UNITED STATES
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NUCLEAR REGULATORY COMMISSION o
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W ASHINGT ON, D.C. 20555 e
April 22, 1988 OFFICE OF THC SECRETARY MEMORANDUM FOR:
Victor Stello, Jr.
6 Executive Director for Ope ptions FROM:
Samuel J. Chilk, Secretar
SUBJECT:
STAFF REQUIREMENTS - BRIEPINp ON PROPOSED BASIC QA RULE WITH REPRES ENTATIVES OF NRC ADVISORY COMMITTEE ON THE6 MEDICAL USES OF ISOTOPES AND INDUSTRY SCIENTIFIC COMMITTEES, 2:00 P.M.,
THURSDAY, APRIL 7, 1988, COMMIS-SIONERS' CONFERENCE ROOM, D.C. OFFICE (OPEN TO PUBLIC ATTENDANCE)
The Commission
- met with the NRC Advisory Committee on the Medical Uses of Isotopes, representatives of the industry's scientific communities and the staff to discuss rulemaking initiativea for quality assurance in medical uses of radioactive isotopes.
Presentations by representatives of the medical profession and the Advisory Committee on the Medical Uses of Nuclear Isotopes were made by the folicwing:
Carol S. Marcus, Ph.D,, M.D.
Los Angeles County Harbor-UCLA Medical Center Glenn L. Tonnesen, M.D.
Fairfax Hospital Otha Linton American College of Radiology Ameri ksoc$tionofPhysicistsinMedicine i
Richard E. Gross Center for Devices and Radiologic Health of the FDA Vincent P. Collins, M.D.
l Private Practitioner, Houston, Texas
- Melvin L. Griem, M.D.
University of Chicago l
l
- Commissioner R6gers was not present.
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- David H. Woodbury, M.D.
Westland Medical Center, Westland, Michigan
- Peter R. Almond, Ph.D.
University of Louisville The Commission made the following requests of the staff:
Consistent with the directives outlined at the March 22, 1988, Commission briefing on the same subject matter, submit for Commission consideration an options paper providing alternatives for rulemaking on quality assurance requirements for medical application of radioactive isotopes.
These alternatives should include (but need not be limited to):
1) the positive elements from the previously published NPR, incorporating suggestions and comments received from the public, where appropriate; 2) a non-prescriptive approach, Requirements should be performance based and should allow licensees to either develop or adopt QA programs tailored to specific clinical environments; and 3) some combination (s) of 1) and 2), above.
As part of the options paper, the staff should outline a pilot program to be conducted during the public comment period for a performance based rule.
The results of the pilot program along with the analysis of public comments should be addressed in recommending a final rule for Commission consideration.
In light of the discussion during the meeting, the staff should also review whether the term "misadministration" itself, as well as its definition should be revised as part of the rulemaking.
(EDO)
(SECY Suspense:
5/31/88)
Insure that the appropriate medical and scientific commu-nities are kept currently informed of medical misadminis-tration events.
(EDO)
(SECY Suspense:
5/31/88)
Explore alternatives to establish better communication channels between NRC and the medical and industry scientific communities.
(EDO)
(SECY Suspense:
5/31/88) cc:
Chairman Zech Commissioner Roberts l
Commissioner Bernthal Commissioner Carr l
Commissioner Rogers OGC GPA PDR - Advance DCS - 016 Phillips