[Federal Register Volume 60, Number 142 (Tuesday, July 25, 1995)]
[Notices]
[Page 38059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18196]



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NUCLEAR REGULATORY COMMISSION


Report to Congress on Abnormal Occurrences January-March, 1995 
Dissemination of Information

    Section 208 of the Energy Reorganization Act of 1974, as amended, 
requires NRC to disseminate information on abnormal occurrences (AOs) 
(i.e., unscheduled incidents or events that the Commission determines 
are significant from the standpoint of public health and safety). 
During the first quarter of CY 1995, the following incident at an NRC 
licensed facility was determined to be an AO and is described below, 
together with the remedial actions taken. The event is also being 
included in NUREG-0090, Vol. 18, No. 1, (``Report to Congress on 
Abnormal Occurrences: January-March 1995''). This report will be 
available at NRC's Public Document Room, 2120 L Street NW. (Lower 
Level), Washington, DC, about three weeks after the publication date of 
this Federal Register Notice.

Other NRC Licensees (Industrial Radiographers, Medical 
Institutions, Industrial Users, etc.)

95-1  Medical Brachytherapy Misadministration at Welborn Memorial 
Baptist Hospital in Evansville, Indiana

    One of the AO reporting guidelines notes that a therapeutic dose 
that is greater than 1.5 times the prescribed dose can be considered an 
abnormal occurrence.
    Date and Place--November 18, 1994; Welborn Memorial Baptist 
Hospital, Inc.; Evansville, Indiana.
    Nature and Probable Consequences--On November 18, 1994, a 73-year-
old patient was prescribed to receive a brachytherapy treatment dose of 
600 centigray (cGy) (600 rad) at the vaginal cavity using a GammaMed 
IIi high dose rate afterloading unit. However, because of a treatment 
error the patient received a 1250 cGy (1250 rad) dose instead of the 
prescribed dose.
    The licensee identified the misadministration during a quality 
management review on November 21, 1994. The licensee reported the event 
to the NRC on November 22, 1994, and followed up with a written report 
on December 6, 1994. The referring physician was notified. The patient 
was notified on November 23, 1994, by the licensee's Radiation Safety 
Officer and was provided with a written report of the incident.
    An NRC medical consultant was retained to evaluate the medical 
consequences of the misadministration. The medical consultant expressed 
concern that long term effects such as fibrosis or loss of blood supply 
may occur as a result of the 1250 cGy (1250 rad) treatment. The medical 
consultant also suggested that this case be considered for the U.S. 
Department of Energy (DOE), Office of Epidemiology and Health 
Surveillance long term medical study program. Information regarding the 
DOE program and a copy of the NRC medical consultant's report were 
provided to the referring physician.
    Cause or Causes--NRC concluded that the cause of the 
misadministration was twofold: (1) The technologist failed to activate 
a button that automatically corrects for treatment time based on source 
decay, failed to notice a display indicating the treatment time 
correction that would have been entered automatically, reentered the 
treatment time instead, and failed to notice the error; and (2) the 
treatment software did not stop the technologist from proceeding after 
the initial error was made as it was supposed to because an integrated 
circuit containing the software code failed to operate.

Action Taken To Prevent Recurrence

    Licensee--In order to prevent recurrence of the incident as of 
November 25, 1994, the licensee revised its internal ``Policy and 
Procedure for all HDRs'' to require both individuals operating the unit 
to verify the displayed time factor and compare it to the factor 
supplied by the manufacturer. Prior to this misadministration, the 
device operators were required to verify only operator entered data. 
Also, the unit was evaluated by the licensee's medical physicist and a 
GammaMed service representative. As a result of the evaluation, the 
printed circuit board (card) with the read-only-memory integrated 
circuits containing the defective software program was replaced with a 
card having the correct software program.
    NRC--NRC conducted a safety inspection on November 30 and December 
1, 1994. An interoffice review of the event was conducted through 
December 8, 1994, to review the circumstances of the misadministration. 
No violations of NRC requirements were identified. As a result of the 
incident, NRC contacted the manufacturer of the GammaMed IIi and sent a 
letter to all GammaMed IIi users to inform them of this potential 
problem and tell them how to test their software to prevent similar 
events.
* * * * *
    Dated at Rockville, MD, this 19th day of July, 1995.

    For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 95-18196 Filed 7-24-95; 8:45 am]
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