U.S. Nuclear Regulatory Commission

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

HPPOS-297 PDR-9306220123

Title: Legal Interpretation of the Misadministration

Reporting Requirements as Applied to the Incident at

Tripler Army Medical Center

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