Protecting People and the EnvironmentUNITED STATES NUCLEAR REGULATORY COMMISSION
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555
January 7, 1993
Information Notice No. 93-04: INVESTIGATION AND REPORTING OF
MISADMINISTRATIONS BY THE RADIATION
SAFETY OFFICER
Addressees
All U.S. Nuclear Regulatory Commission medical licensees.
Purpose
The NRC is issuing this information notice to provide guidance to licensees on
the investigation of events surrounding a misadministration. On January 27,
1992, the "Quality Management Program and Misadministrations" rule became
effective. The current (1992) 10 CFR 35.33(a)(2) requires that a report of a
misadministration must be submitted to NRC and must include, in part, why the
event occurred. This superseded the previous requirement in 10 CFR 35.33(c)
that the Radiation Safety Officer (RSO) should promptly investigate the cause
of a diagnostic misadministration and make a record for NRC review.
Furthermore, in 10 CFR 35.21(b)(1), the RSO is required, in part, to
investigate overexposures and misadministrations, and implement corrective
action, as necessary. Information contained in this notice does not
constitute a new requirement, and no written response is required.
Description of Circumstances
The following case of a diagnostic misadministration reported to the NRC
involved inaccurate information provided by the licensee and a failure of the
RSO to adequately investigate the incident.
A diagnostic misadministration report (DMR), submitted by the licensee, stated
that a nuclear medicine technologist, called in from vacation to administer a
dose of I-131 sodium iodide for a thyroid uptake study, inadvertently
administered 112 microcuries instead of the intended dose of 10 microcuries.
The DMR indicated that the error occurred because the technologist incorrectly
read the dose calibrator as 11.2 microcuries instead of 112 microcuries.
This implies that the technologist assayed a single iodine capsule, which she
subsequently administered to the patient. The DMR also stated that, instead
of five capsules for a total of 100 microcuries, an order was placed for five
capsules of 100 microcuries each. No explanation was provided for the order
of five 20 microcurie capsules for a diagnostic procedure utilizing
10 microcuries. During the inspection, the technologist indicated that she
had assayed five capsules at the same time and then mathematically determined
the activity of a single capsule. Thus the measured activity expressed on the
dose calibrator would have read 560 microcuries instead of 112 microcuries as
reported in the licensee's report. This inaccuracy of the DMR obscured a
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January 7, 1992
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violation of 10 CFR 35.53 involving a failure to assay each dosage before
administration, which very likely contributed to the misadministration. The
RSO was also on vacation at the time of the incident and was not made aware of
it until his return. There were inconsistencies between the DMR and verbal
explanations of the misadministration event given by the licensee's
technologists during an NRC inspection. The RSO indicated that he performed
an investigation, but he did not personally make a report or maintain any
records of the investigation, and his efforts did not uncover the fact that
the DMR, which was prepared by the Chief Technologist, was inaccurate and
inconsistent. Thus, the violation of 10 CFR 35.53 remained uncorrected, and
could have resulted in future misadministrations.
Discussion:
Although this event occurred before January 27, 1992, and therefore was
defined as a misadministration under the old rule, it would continue to meet
the definition of a misadministration under the "Quality Management Program
and Misadministrations" rule. Of greater importance, however, is the lack of
complete and accurate information in the misadministration report and the
failure of the RSO to identify and investigate the cause of the
misadministration and implement the necessary corrective action.
10 CFR 30.9(a) requires, in part, that information provided to the Commission
by a licensee or information required by the Commission's regulations to be
maintained by the licensee must be complete and accurate in all material
respects.
Currently, 10 CFR 35.33(a)(2) requires, in part, that the licensee submit a
written report within 15 days after the discovery of a misadministration to
include a brief description of the event, why the event occurred, effect on
the patient, necessary improvements to prevent recurrence, and actions taken
to prevent recurrence as well as other information. 10 CFR 35.21(a) states,
in part, that the licensee, through the RSO, shall ensure that radiation
safety activities are being performed in accordance with approved procedures
and regulatory requirements in the daily operation of the licensee's byproduct
material program. Furthermore, 10 CFR 35.21(b)(1) requires, in part, that the
RSO shall investigate misadministrations, and implement corrective action, as
necessary. An investigation may include: 1) talking to all persons involved
in the misadministration, to include the technologists, authorized user, and
patient (if acceptable to the referring physician and necessary to the
investigation), in order to determine the correct details and sequence of
events; 2) reviewing the records associated with the procedure including the
requesting physician's order(s) and/or the written directive; 3) performing an
independent assessment of the dose delivered to the patient; and 4) reviewing
any other circumstances associated with the incident. This information would
be used to identify the best course of corrective action. If there appear to
be any discrepancies, the RSO should reexamine all the available information
to resolve these discrepancies and make the best determination of the root
cause of the misadministration.
Licensees should ensure that the RSO at their facility is aware of and
understands the requirements to: 1) conduct a thorough investigation .
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January 7, 1992
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following a misadministration; 2) determine improvements needed to prevent
recurrence; 3) implement any necessary corrective action; 4) submit a written
report of the investigation as stated above; and 5) retain a record for five
years of the written report and any other records required by 10 CFR 35.33.
Furthermore, it is essential that the RSO provide sufficient time and
attention to fulfill properly his/her radiation safety program
responsibilities, including all of the requirements in 10 CFR 35.21.
This information notice requires no specific action or written response. If
you have any questions about the information in this notice, please contact
the technical contact listed below, or the appropriate NRC regional office.
ORIGINAL SIGNED BY
Richard E. Cunningham, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical contact: Patricia K. Holahan, NMSS
(301) 504-2694
Attachments:
1. List of Recently Issued NMSS Information Notices
2. List of Recently Issued NRC Information Notices
.
