ML20236U818
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UNITED STATES y y *
.F%j NUCLEAR REGULATORY COMMISSlQN y E WASHINGTON, D.C. 20555 March 14, 1986
\***** a:g:LST ULY BY J' OFFIC E OF THE It w COMMISSIONER Cys: Stello COMFB-86-3
, Roe Rehm MEMORANDUM FOR: Chairman Palladino a Sniezek Commissioner Roberts Commissioner Asselstine [g/'SW[
y Minogue GCunningham-Commissioner Zech tA,'ya Heltemes FROM: Frederick M. Bernthal ED0 R/F-
SUBJECT:
MEDICAL MISADMINISTRATION OF RADIATION THERAPY In recent weeks, there have been,two notifications to the Commission regarding significant medical misadministration of radiation therapy. The first was the Mercy Hospital case, in which the wrong patient.was subjected to such therapy and the radiation safety officer allegedly ordered the matter to be covered up. The second case was the recent Washington Hospital Center incident, in which a radiation therapy physician, apparently without any order from the attending physician, decided to approve therapeutic treatment of 150 rads for a patient.
Two years ago, the Commission corrected significant technical deficiencies I j
and inconsistencies in its regulations governing medical misadministration. These latest incidents now illustrate the serious problems identified by a recent AE0D case study. The report of this study highlighted the need for requirements that therapy licensees independently verify the accuracy of patient doses prior to administration. More significantly, however, the two recent cases reveal a major inconsistency between the broad standards that apply to the Commission's regulatory
.. activity in this area as compared with other areas. Specifically appears that undcr current regulations the mistaken (negligent)application y, it of radiation to the wrong patient does not constitute any violation of NRC requirements, so long as the incident is reported to the Commission within the time period specified in the reporting requirements.
I do not understand why medical licensees of the Commission should be held any less accountable for the negligence of their employees and agents or 1 practitioners then other licensees of the Commission. Indeed, radiation- i related injuries to the public from commercial nuclear powerplant operations thus far pale in comparison to injuries sustained as a result of {
medical misadministration of radiation (especially when machine-produced ;
radiation not regulated by the NRC is taken into account). It defies l reason that the NRC may penalize licensees for negligent acts which result in the release of no radioactivity, but apparently has no authority to levy ~
penalties when medical patients are mistakenly subjected to radiation exposures no member of the public has ever sustained in the operation of
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E 8712030396 87120i PDR PR b
_35 52FR36942 PDR
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'. I believe the Commission should direct the Staff to review the authority currently possessed by the Commission in this area. Staff should prepare and submit to us a rulemaking package (as part of current Part 35 revisions, if appropriate) which would provide whatever authority we need to:
.' 1) require independent verification of theraputic doses, as we do in the case of diagnostic procedures (cf. AE0D report), and -
'2') penalize medical licensees for their negligence or that of their e'mployees, agents or practitioners.
SECY, please track responses.
cc: ' EDO -
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Fred, J
Your points are well taken and I believe deserve attention.
l I share your concern particularly about the two recent misadministration and feel it is worthwhile for staff to review our current authority in this area to assure a proper balance in our regulatory requirements.
NP /
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