Legal Interpretation of the Misadministration Reporting Requirements as Applied to the Incident at Tripler Army Medical Center

HPPOS-297 PDR-9306220123

See the memorandum from J. E. Glenn to R. R. Bellamy (and others) dated November 1, 1990.

This NMSS memo was written in response to a request from Region V concerning the reporting requirements applicable to an misadministration incident at Tripler Army Medical Center ("Tripler"). It is OGC opinion (enclosure) that 10 CFR 35.2 is susceptible to varying interpretations on the issue whether the Tripler incident constitutes a diagnostic administration under the present definition and thus reportable as such. However, it should be noted that the proposed enforcement actions based on 10 CFR 35.25 (a) (2) does not require a finding that this incident constitutes a misadministration. Further, this incident could be tracked for regulatory purposes if determined to be an "abnormal occurrence".

The basic facts surrounding this incident are as follows:

On June 19, 1990, iodine-131 (I-131) was administered by personnel at Tripler to a woman patient as part of her medical treatment there. The Tripler medical technologist was not aware that the patient was a nursing mother because she did not volunteer that information and the technologist failed to require, prior to the administration of the I-131, that she complete a questionnaire as to whether she was pregnant or nursing, as required by Tripler internal procedures. Adherence to such procedures is required by 10 CFR 35.25 (a) (2), which provides in part that a licensee that permits the use of byproduct material by an individual under the supervision of an authorized user shall require the supervised individual to follow the instructions of the authorized user.

When the patient returned for a scan on June 21, 1990, Tripler learned that she had nursed her newborn infant during part of the two day interval. This resulted in a large radiation dose to the infant which destroyed the infant's thyroid function. The infant will apparently require synthetic thyroid supplement to grow and develop normally. On June 27, 1990, the Tripler RSO notified the NRC of the incident by telephone and inquired if a written report was required, and on July 20, 1990, Tripler filed a written report on the incident pursuant to 10 CFR 20.405, "Reports of overexposures and excessive levels and concentrations." However, Tripler has asserted that a written report was not required, prompting the request for OCG guidance as to the applicable reporting requirements in NRC regulations.

It is OGC opinion (enclosure) that the written report the licensee submitted was not required by 10 CFR 20.405 [or, at present, 10 CFR 20.2203]. OGC also believes that the language in 10 CFR 35.2 is susceptible to varying interpretations on the issue whether the Tripler incident constitutes a diagnostic misadministration as defined in 10 CFR 35.2; thus making applicable the reporting requirements in 35.33 (c). Good arguments can be made on both sides of the question. In view of the ambiguities in both the present and proposed definitions of the term misadministration, OGC is advising the staff (enclosure) that any revised definition of that term should explicitly cover an incident such as that at Tripler. However, it should be noted that the proposed enforcement actions based on 10 CFR 35.25 (a) (2) does not require a finding that this incident constitutes a misadministration.

In view of the fact that the staff has proposed that this incident be considered as an "abnormal occurrence", it may be tracked for regulatory purposes as such, regardless whether it constitutes a "misadministration" (SECY-90-330, "Section 208 Report to Congress on Abnormal Occurrences for April-June 1990," September 20, 1990).

Regulatory references: 10 CFR 20.405, 10 CFR 20.2203, 10 CFR 35.2, 10 CFR 35.25, 10 CFR 35.33

Subject codes: 12.11

Applicability: Byproduct Material