United States Nuclear Regulatory Commission - Protecting People and the Environment

U.S. Nuclear Regulatory Commission

Technical Assistance Request, Misadministration at Hutzel Hospital, Detroit, MI

HPPOS-304 PDR-9306230254

Title: Technical Assistance Request, Misadministration at

Hutzel Hospital, Detroit, MI

See the memorandum from J. E. Glenn to J. A. Grobe dated

September 23, 1991. This NMSS memo responds to a technical

assistance from Region III, dated March 14, 1991, regarding

the misadministration that occurred at Hutzel Hospital on

January 17, 1991. Two apparent violations were associated

with the misadministration: (1) the failure of the licensee

to provide instruction to the technologist involved with

the misadministration; and (2) use of materials by

unauthorized individuals. The patient's administered dose

of 5 millicuries was decided upon and administered by

individuals other than any of the authorized physician

users. NMSS requested guidance from the Office of General

Counsel (OGC) in determining whether violations of 10 CFR

35.25 had occurred. HPPOS-304 contains a related topic.

NMSS and OGC concur that a citation against 10 CFR 35.25

(a) (1) for failure of the licensee to provide the

supervised individual with adequate instruction should be

issued. Adequate instruction includes a caution that the

prescribed procedure may not be disregarded or changed

without permission from an appropriate individual such as

an authorized user or the referring physician.

With respect to the use of materials by unauthorized

individuals, the answer is not as clear. OGC provided its

comments in a note dated June 5, 1991, and discusses

additional possible violations of License Condition 12; 10

CFR 35.11 (b); and 10 CFR 35.25 (a) (2). These citations

are discussed below.

License Condition No. 12 and 10 CFR 35.11 (b): OGC

concluded that if the technologist used licensed material

and was not under the supervision of an authorized user as

identified in License Condition 12 and allowed by 10 CFR

35.11 (b) when he performed a nuclear medicine procedure

not approved by an authorized user, then there was a

violation of 10 CFR 35.11 (b) and License Condition 12.

NMSS concluded the following. In this case, the

technologist was working under the supervision of the

authorized user while performing tasks associated with the

administration of a patient dosage of iodine-131. The

individuals were not provided adequate instruction as

discussed previously, and clearly the Physician Assistant

and technologist demonstrated an error in good judgement.

If the technologist had been provided instruction that

precluded changing or recommending changes to the

prescribed procedure or dose and then changed the

prescription without the confirmation of an authorized

user, the technologist would be acting as an authorized

user.

10 CFR 35.25 (a) (2): OGC Enforcement stated that a case

could be made that the licensee violated 10 CFR 35.25 (a)

(2) because of failure to require, by written or verbal

instruction, that the technologist to perform procedures as

ordered absent permission to do otherwise from an

authorized user.

NMSS concluded that the appropriate citation is against 10

CFR 35.25 (a) (1) for failure of the licensee to provide

the supervised individual with adequate instruction.

Therefore, in the absence of adequate instruction, it is

inappropriate to cite against 10 CFR 35.25 (a) (2) for

failure of the licensee to require the supervised

individual to follow instructions not given.

In summary, NMSS concluded that the fundamental problem was

inadequate instruction and only one citation against 10 CFR

35.25 (a) (1) is appropriate. Regulatory references: 10

CFR 33.11, 10 CFR 35.25, License Conditions

Subject codes: 1.3, 12.11

Applicability: Byproduct Material

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