[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]
BILLING CODE 7590-01-M
