[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]



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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]
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