ML20128N053
| ML20128N053 | |
| Person / Time | |
|---|---|
| Issue date: | 02/12/1993 |
| From: | Parler W NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| To: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| NUDOCS 9302220462 | |
| Download: ML20128N053 (3) | |
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- RELEASED TO THE PDR O o UNITED STATES j g
,E NUCLEAR REGULATORY COMMISSIO,N WASHINGTON. D.C. 2355 ggg3 g o$, p 3 . dat0 i .
,,,,, gjpg o . . . . . . . . . . . . . . .f.ials MEMORANDUM FOR: James M. Taylor Executive Director for Operations FROM: William C. Parler General Counsel
SUBJECT:
NRC RESPONSIBILITIED TOWARD PATIENTS INVOLVED IN MEDICAL MISADMINICTRATIONS We are responding to your February 5, 1993 memorandum which requested our specific recommendations for changes to regulations, guidance or implementation of current regulations or guidance on this subject. Areas identified by OGC as warranting consideration for changes are listed below. In addition, we stand ready to assist the staff in analyzing problems and developing regulatory solutionL and, in particular, to help with language to implement the items that follow.
- 1. Implementing guidance for licensees on the licensee's rerponsibilities in the event of a misadministration including the licensee's duty to inform the patient, who was the subject of the misadministration, about the event and the probable consequences unless the patient's referring physician states it would be harmful to do so.
a comprehensive guidance document pulling together in one place NRC guidance for licensees in the event of a misadninistration, including the licensee's responsibilities on reporting to NRC, patient notification and investigation of the event, and which would therefore replace individual guidance documents on each separate topic (e.g. , NRC Information Notice No. 93-04 which was directed to the responsibilities of Radiation Safety Officers and was not intended to address or change the licensee's duty under NRC rules to provide information to the patient).
reflect in the guidance what information about the misadministration needs to be provided orally and in writing, and insure that patients who received oral reports received written follow-up reports required by section 35.33(a) (4) .
- 2. Evaluate the need for a specific requirement, together with implementing guidance, imposing a duty on licensees to inform 19:127 ju"MP*ISEh*og f d2'l
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2 other persons -who were irradiated- as a result of a misadministration, about the event and the probable consequences, j I
review 10 CFR 20.409(b) and determine whether it needs to be clarified.
- 3. Develop criteria for the following:
- identifying the circumstances .that would make a misadministration appropriate for convening an Incident i Investigation Team or an Augmented Inspection Team. '
for any misadministration that is an " abnormal occurrence" (whether or not it is the subject of an IIT l or AIT) , identifying what efforts NRC will use (e.g.,
obtaining a consultant; doing independent fact-finding on the event) to collect information sufficient to fulfill !
its reporting obligation under Section 208 of the Energy Reorganization Act, including the cause(s) of the occurrence and any corrective measure (s)- to prevent ;
reoccurrence, Ansi the nature and erobable consecuences. of the occurrence for the patient. l following up with respect to patients (or other individuals) suffering acute, present injury or the possibility of radiation-caused illnesses occurring-shortly after the misadministration.
- 4. Review of licensing guidance, regulatory guides and I inspection procedures with respect to the following:'
draft and final guidance (e.g., " Draft Temporary Instruction 2800: Quality Management Program and 1 Misadministration Rule," interim field notes (see Memorandum for Ronald R. Bellamy et al. from - John E.
Glenn, dated December 31, 1992)) to insure NRC inspectors properly emphasize the licensee's duty to report ,
misadministraticas to patients and referring physicians.
- 5. Review existing policies / requirements / guidance on the .
proper role of medical consultants in assisting NRC in carrying out its regulatory responsibilities in the event of a misadministration.
- 6. Review existing policies / requirements on retention of-records including what records must be retained and for how long, and consider specifically whether to reinstate the previous requirement to retain records for an indefinite period (in light of the questionable legality of eliminating indefinite retention in 1986) and whether to require retention of supporting records (other than summary reports) regarding the misadministration (in light of the likelihood that retention of only summary records leaves open
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3 thelpossibility that crucial: facts will be irretrievably lost if--
-supporting records are discarded).
. With respect tofa_ review and evaluation of-the-adequacy of patient notification,'the staff may wish to consider reviewing for.
- each misadministration classified as an abnormal occurrence within'.
the last ? five years, licensees' written reports ~ to patienta -
required by 10 "CFR 35.33 (a) (4) and compare-those reports to the_
written reports submitted to NRC pursuant to 10 CFR 35.33(a) (2) .
l Our suggestions-in this paper are-preliminary recommendations based on our understanding of_the situation today,-and ve.will-be' following this-area closely to better assist the at
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-W lliam C. Parler
-General Counsel cc: The '. Chair. nan
. Commissioner Rogers ,
Commissioner Curtiss
-Commissioner.'.Remick Commissioner'de'Planque SECY t
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