[Federal Register Volume 61, Number 38 (Monday, February 26, 1996)]
[Notices]
[Pages 7123-7124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4227]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
Report to Congress on Abnormal Occurrences July-September 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 third quarter of CY 1995, the following incidents at NRC
licensed facilities were determined to be AOs and are described below,
together with the remedial actions taken. Each event is also being
included in NUREG-0090, Vol. 18, No. 3 (``Report to Congress on
Abnormal Occurrences: July-September 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.)
95-7 Medical Brachytherapy Misadministration at Marshfield Clinic in
Marshfield, Wisconsin
One of the AO reporting guidelines notes that administering a
therapeutic dose from a sealed source such that the calculated total
treatment dose differs from the prescribed total treatment dose by more
than 10 percent and the actual dose is greater than 1.5 times the
prescribed dose can be considered an AO.
Date and Place--June 8, 1995; Marshfield Clinic; Marshfield,
Wisconsin.
Nature and Probable Consequences--A patient was prescribed a dose
of 1640 centigray (cGy) (1640 rad) for a low dose rate brachytherapy
treatment of the cervix using cesium-137 sources.
After the sources were implanted, but prior to completion of the
treatment, the physician entered the wrong date for removal of the
sources into the final treatment plan. Because of this error the
treatment was extended for an additional day. As a result, the
calculated administered dose was 2440 cGy (2440 rad) which was
[[Page 7124]]
approximately 50 percent greater than the prescribed dose.
The physician informed the patient of the misadministration both
verbally and in writing. The licensee evaluated the consequences of the
misadministration and determined that there would be no adverse health
effects.
An NRC medical consultant evaluated the consequences of the
misadministration and agreed with the licensee's conclusion.
Cause or Causes--The licensee failed to notice that the planned
explant time documented in the final treatment plan did not represent
the prescribed treatment time documented in the written directive.
Also, the licensee's written directive/low dose rate brachytherapy log
form, used to record events occurring during low dose rate
brachytherapy treatments, did not contain a location to document the
prescribed time for source removal.
Actions Taken To Prevent Recurrence
Licensee--The licensee revised its written directive/low dose rate
brachytherapy log form to include documentation of the actual
implantation time, and the time for the prescribed and actual removal
of sources. Additionally, the revised form will include verification of
such times by a licensee staff member.
NRC--NRC conducted an inspection and reviewed the circumstances
surrounding the misadministration. NRC also retained a medical
consultant to review the case. A Confirmatory Action Letter was issued
which confirms that the licensee will verify that its authorized users
meet training and experience requirements. A Notice of Violation was
issued with five Severity Level IV violations.
* * * * *
95-8 Medical Brachytherapy Misadministration at Providence Hospital in
Southfield, Michigan
One of the AO reporting guidelines notes that a therapeutic
exposure to any part of the body not scheduled to receive radiation can
be considered an AO.
Date and Place--July 25, 1995; Providence Hospital; Southfield,
Michigan.
Nature and Probable Consequences--A patient was prescribed a dose
of 1230 centigray (cGy) (1230 rad) for a palliative manual
brachytherapy treatment of the brain using an iridium-192 seed.
After implantation, confirmatory x-rays were taken but could not
confirm the location of the seed and the treatment was terminated about
31 hours after implantation. The licensee determined that the seed was
implanted about 4 centimeters (1.57 inches) from the intended treatment
site of the brain. Consequently, the wrong treatment site received an
unintended radiation dose of about 739 cGy (739 rad) and the tumor
received only about 72 cGy (72 rad).
The licensee determined that no adverse health effects would result
from the misadministration. An NRC medical consultant has reviewed the
case but has not yet submitted a report to NRC. The licensee notified
the referring physician and the patient about the misadministration.
Cause or Causes--The licensee said that the seed became detained at
the elbow of the applicator during implantation and changed direction.
The physician consequently encountered resistance while inserting the
source and assumed that it reached the intended treatment site. A
confirmatory x-ray taken at the time of insertion did not show the
location of the source. (The licensee had used a fluoroscope [real time
imaging] during simulation of the treatment, but a fluoroscope was not
used to observe the actual seed implantation.)
Actions Taken To Prevent Recurrence
Licensee--The licensee reported that when using this type of
applicator in the future, fluoroscopy will be used to assure proper
implantation of radioactive material.
NRC--NRC conducted an investigation to review the circumstances
surrounding the misadministration. The NRC staff is currently reviewing
the inspection results for possible violations, and enforcement action
is pending.
* * * * *
95-9 Ingestion of Radioactive Material by Research Workers at the
National Institutes of Health in Bethesda, Maryland
One of the AO reporting guidelines notes that a moderate exposure
to, or release of, radioactive material licensed by or otherwise
regulated by the Commission can be an abnormal occurrence.
Date and Place--June 28, 1995; National Institutes of Health (NIH);
Bethesda, Maryland.
Nature and Probable Consequences--A pregnant research employee
became internally contaminated with phosphorus-32 (P-32) and was sent
to a local hospital for treatment.
NRC formed an Augmented Inspection Team (AIT), which included a
medical consultant, to review the incident. The medical consultant
stated, based on the licensee's initial report, that there would not be
any adverse health consequences to the researcher or the fetus. Also,
an NRC scientific consultant at the Oak Ridge Institute for Science and
Education's Radiation Internal Dose Information Center was consulted.
An independent assessment was also performed by Lawrence Livermore
National Laboratories.
The licensee subsequently found that 26 individuals (in addition to
the pregnant researcher) were also contaminated. The Federal Bureau of
Investigation (FBI), the NRC's Office of Investigations (OI), and the
NIH Police Department are currently investigating the event. The AIT
has concluded its inspection efforts. OI continues to work with the
FBI.
Cause or Causes--Because of the ongoing investigation, NRC has not
reached a final conclusion as to the cause of the event.
Actions Taken to Prevent Recurrence
Licensee--The licensee continues to investigate the incident. The
licensee performed bioassay sampling to identify the isotope, calculate
preliminary estimates of intake, and determine the scope of the
contamination. In addition, the licensee will take actions to enhance
security for handling radioactive materials.
NRC--In addition to forming an AIT, NRC subsequently conducted a
special inspection to determine the effectiveness of NIH security over
radioactive materials.
NRC also issued two Confirmatory Action Letters. The first
confirmed the actions that the licensee would take to reduce the
possibility of further ingestion and to determine the extent of the
contamination. The second confirmed the actions that the licensee would
take in response to the special inspection that reviewed the NIH
security policy for handling radioactive materials.
* * * * *
Dated at Rockville, MD, this 20th day of February 1996.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 96-4227 Filed 2-23-96; 8:45 am]
BILLING CODE 7590-01-P
