Protecting People and the EnvironmentUNITED STATES NUCLEAR REGULATORY COMMISSION
SSINS No.: 6835
IN 86-85
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF INSPECTION AND ENFORCEMENT
WASHINGTON, D.C. 20555
October 3, 1986
Information Notice No. 86-85: ENFORCEMENT ACTIONS AGAINST MEDICAL
LICENSEES FOR WILLFULL FAILURE TO REPORT
MISADMINISTRATIONS
Addressees:
All NRC medical licensees.
Purpose:
This notice is provided to alert all NRC medical licensees of enforcement
actions taken by NRC against medical licensees who willfully failed to
report misadministrations. It is suggested that addressees review this
notice and disseminate it to their employees. However, suggestions contained
in this information notice do not constitute NRC requirements; therefore, no
specific action or written response is required.
Description of Circumstances:
NRC recently has taken escalated enforcement action against two hospitals as
described below.
In the first case, several violations of NRC requirements were identified
during an NRC inspection at a hospital. An Enforcement Conference was
conducted with the licensee to discuss the violations. Subsequent to that
conference and as a result of an investigation conducted by the NRC's Office
of Investigations, NRC established that four diagnostic misadministrations
had occurred before the NRC's inspection and were not reported to the NRC as
required by 10 CFR 35.43. Two hospital employees stated to NRC investigators
that the Radiation Safety Officer (RSO), who also was the Director of the
Nuclear Medicine Department, instructed them to inform NRC inspectors that
diagnostic misadministrations had not occurred. It also appeared that the
RSO willfully concealed a film of a nuclear medicine misadministration scan
and thus impeded NRC's inspection into whether misadministrations had
occurred. As a result, on April 22, 1986, the NRC issued an Order to the
hospital (1) to remove the RSO from that position and from all involvement
in the performance or supervision of NRC-licensed nuclear medicine
activities, and (2) to suspend all licensed activities at the hospital until
the licensee demonstrates that a qualified individual has been appointed as
the RSO and authorized by the NRC.
8609300125
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IN 86-85
October 3, 1986
Page 2 of 3
In the second case, an alleger stated that the Chief Nuclear Medicine
Technologist (CNMT) of a hospital did not report a misadministration to
either the NRC or the patient's referring physician as required by 10 CFR
35.43. During an interview conducted by the NRC's office of Investigations,
the CNMT admitted performing a diagnostic misadministration and not being
truthful with NRC inspectors. The CNMT explained that the hospital RSO, who
is also the Medical Director of Radiology, instructed her via a hospital
radiologist not to report the misadministration. During an interview with an
NRC investigator, the RSO admitted that although he was aware of the NRC
requirement, he did not report the misadministration because he did not
think the incident was that serious.
As a result, on June 17, 1986 the NRC issued an Order to show cause why the
license should not be modified to prohibit these individuals from any
further involvement in the performance or supervision of licensed
activities. Consideration was given to removing the CNMT from NRC-licensed
activities by an immediately effective Order. However, this was not
considered necessary because the CNMT had already left the hospital. In
addition, although the violations occurred because of the deliberate,
irresponsible actions of the two individuals, the NRC was concerned that
hospital management did not aggressively pursue an investigation of the
alleged misadministration when informed of it during the NRC inspection, but
rather awaited the initiation of the NRC investigation. Thus, the NRC issued
a proposed Imposition of a Civil Penalty in the amount of five thousand
dollars ($5000).
Discussion:
NRC requires the submittal of all misadministrations pursuant to 10 CFR
35.43 since some misadministrations can have health effects on the patient.
For example, Information Notice No. 85-61 describes four diagnostic
misadministrations in which the patient received an unplanned significant
dose of radiation. In one of those misadministrations, the patient received
an estimated dose of 6500 to 9000 rads to the thyroid instead of the 0.7
rads that would have resulted from the planned diagnostic procedure.
Normally, failure to report a medical diagnostic misadministration would be
characterized as a Severity Level IV violation. However, escalated
enforcement actions were taken in these two cases because the failure, to
report the misadministrations was willful and willful material false
statements were made to NRC inspectors regarding the misadministrations. All
licensee personnel should be aware of the importance of being truthful with
NRC inspectors and of complying with NRC regulations. NRC has the authority
to order the immediate removal of personnel (such as RSOs or technologists)
involved in willful material false statements from NRC-licensed activities
if the NRC determines that licensee personnel have misled NRC inspectors
and/or there is no longer reasonable assurance that they can be relied on to
comply with NRC requirements.
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IN 86-85
October 3, 1986
Page 3 of 3
No specific action or written response is required by this information
notice. If you have any questions regarding this matter, please contact the
Regional Administrator of the appropriate NRC regional office or this
office.
James G. Partlow, Director
Division of Inspection Programs
Office of Inspection and Enforcement
Technical Contact: H. Karagiannis, IE
(301) 492-9655
Attachment: List of Recently Issued IE Information Notices