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UNITED STATES Stello
's NUCLEAR REGULATORY COMMISSION Roe j E WASHINGTON, D.C. 20655
' Rehm Sn k November 26. 1986_ ,
OFFICE OF THE f2M3I RE.E.7 8Y Ir[MWnn buMEy"
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COM'FB M 4 PV34 l
MEMORANDUM FOR: Chairman Zech Commissioner Roberts g ['0R/F Commissioner Asselstine CC: f Commissioner Carr g FROM: Frederick M. Bernthal< WM
SUBJECT:
MEDICAL. MISADMINISTRATION: Need for Improved Oversight On April 14, the Commission unanimously approved action on the above-captioned subject (COMFB-86-3) and directed staff to prepare and submit to the Comission by April 15, 1987 a rulemaking package that would strengthen NRC oversight of medical licensees.
In the ensuing weeks, additional serious medical misadministration involving both diagnostic and therapeutic doses of licensed radioisotopes have been brought to the Comission's attention. The clustering and severity of these cases suggests the need for greater NRC attention to this area of regulatory responsibility, in view of the manifest risks to public health and safety.
I therefore suggest that staff now be further directed to prepare for Comission review within 60 days a comprehensive discussion and list of recommendations for improvements in administering NRC's regulations under Part 35. The following elements (at least) should be considered:
(1) Increased frequency of NRC inspection of Part 35 Ifcensees; (2) As sugger f by the thainnan, development of a mechanism to track practitioners known to have willfully violated hRC regulations so that such information is considered in any subsequent licensing; (3) A requirement that all licensees maintain, 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; (4) A mechanism for following up on patients who have been subject to
. reported misadministration; (5) A procedure to verify that referring physicians and patients are indeed notified of misadministration, as currently required by NRC regulations.
I would further propose that staff be directed to expedite preparation of ,
the 4/14/86 required rulemaking package, to reach the Comission no later than January 31, 1987, so that the Comission may consider the proposed l rulemaking issues in a timely manner in connection with the administrative initiatives outlined above. ;
SECY, please track. l
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