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