Information Notice No. 86-85: Enforcement Actions Against Medical Licensees for Willfull Failure to Report Misadministrations

                                                            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. 

.

                                                       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