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NUC. LEAR REGULATORY COMMISSION W ASHIN GTON, D.C. 20555 ellO Z[ l l
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l December 16, 1986 Sniezek f OFFICE OF THE BeckjOrd l SECRETARY IaylOr Denton Murray COMFB-86-8 _g r0{_
COMLZ-86-25 MEMORANDUM FOR: Victor Stello, Jr.
Executive Director for Operations FROM: a el J. Chilk, Secretary
SUBJECT:
MEDICAL MISADMINISTRATION - NEED FOR IMPROVED OVERSIGHT On April 14, 1986, the Commission directed the staff to prepare and submit to the Commissions by April 15, 1987, a rulemaking package that would strengthen NRC oversight of medical licensees.
In the ensuing months, additional serious medical misadministration involving both diagnostic and therapeutic doses of licensed radioisotopes have been brought to the Commission's attention.
In view of the foregoing, the Commission requests that the development of a proposed rule be given priority attention and be accelerated to the greatest extent practicable. To this end, the staff is requested to provide, for Commission review, the Advanced Notice of Proposed Rulemaking (currently in draft) no later than January 31, 1987.
In addition, the Commission requests that you prepare and discuss with the Commission a comprehensive analysis and list of recommendations with options for improvements in administering NRC's regulations under Part 35 and other initiatives that may be effective in reducing medical misadministration. At a minimum, the following elements should be discussed and considered:
- 1. Whether the rulemaking under development in response to the April 14, 1986 SRM goes far enough in strengthing NRC regulations?
- 2. What additional measures are needed, including improvement in the regulations or inspection program? Should there be changes to the content or an increased frequency of NRC inspections of Part 35 licensees?
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Victor.Stello, Jr. 3. Whether the training, guidance, and supervision of technologists is. adequate;
- 4. Development of a mechanism to track practitioners known to have willfully violated NRC regulations so that such information is considered in any subsequent licensing; also an assessment of the adequacy of the feedback of information on individuals who repeatedly violate NRC regulations;
- 5. A requirement that all licensees naintain, and provide to patients upon request, a record of the anticipated and actual radiation doses received by patients as a result of all licensed procedures;
- 6. A mechanism for following up on patients who have been subject to reported misadministration.
- 7. A procedure to verify that referring physicians and patients are indeed notified of misadministration, as currently required by NRC regulations;
- 8. The need for additional feedback mechanisms such i as additional NRC information notices on reported medical misadministration to ensure that all licensees'can benefit from lessons learned;
- 9. Whether, apart from increased NRC oversight, there are any changes in industry practice or standards that could substantially improve the ,
quality of performance and minimize human error, and l
- 10. What interactions do we have with industry organizations and what initiatives do they have in progress which could help?
In regard to item 10, the staff should identify appropriate professional organizations such as the American College of )
Radiology and the American College of Nuclear Physicians i with which the Commission could arrange to meet to discuss the role of industry initiatives which could be effective.
1 in preventing medical misadministration.
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l8 Victor Stello, Jr. l The Commission requests that the paper. discussing the above elements be provided by February 16, 1987. Following review of the draft.ANPR and the requested paper, the Commission will provide additional guidance toward a goal of having a proposed rule prepared and published for comment by July 1, 1987.
The Commission has also agreed that it should take appro-priate actions to strengthen the material licensing / medical programs during the current reorganization initiatives.
Commissioner Carr believes that item 5 above is of secondary.importance and that the emphasio should be on prevention of misadministration.
Copies:
Chairman Zech.
Commissioner Roberts-Commissioner Asselstine Commissioner Bernthal Commissioner Carr OGC (H Street) 1 y
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