[Federal Register Volume 72, Number 86 (Friday, May 4, 2007)]
[Notices]
[Pages 25339-25342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8551]
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NUCLEAR REGULATORY COMMISSION
Report to Congress on Abnormal Occurrences Fiscal Year 2006;
Dissemination of Information
Section 208 of the Energy Reorganization Act of 1974 (Public Law
93-438) defines an abnormal occurrence (AO) as an unscheduled incident
or event which the U.S. Nuclear Regulatory Commission (NRC) determines
to be significant from the standpoint of public health or safety. The
Federal Reports Elimination and Sunset Act of 1995 (Public Law 104-66)
requires that AOs be reported to Congress annually. During fiscal year
2006, nine events that occurred at facilities licensed or otherwise
regulated by the NRC and/or Agreements States were determined to be
AOs. The report describes three events at facilities licensed by the
NRC. The three AOs at NRC-licensed facilities included a spill of high-
enriched uranium solution at a fuel fabrication facility, a medical
event, and an unintended dose to an mbryo/fetus. The report also
addresses six AOs at facilities licensed by Agreement States.
[Agreement States are those States that have entered into formal
agreements with the NRC pursuant to Section 274 of the Atomic Energy
Act (AEA) to regulate certain quantities of AEA licensed material at
facilities located within their borders.] Currently, there are 34
Agreement States. During Fiscal Year 2006, Agreement States reported
six events that occurred at Agreement State-licensed facilities,
including four medical events, one unintended dose to an embryo/fetus,
and one industrial event. As required by Section 208, the discussion
for each event includes the date and place, the nature and probable
consequences, the cause or causes, and the action taken to prevent
recurrence. Each event is also being described in NUREG-0090, Vol. 29,
``Report to Congress on Abnormal Occurrences, Fiscal Year 2006.'' This
report is available electronically at the NRC Web site http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/.
Nuclear Power Plants
During this period, no events at U.S. nuclear power plants were
significant enough to be reported as AOs.
* * * * *
Fuel Cycle Facilities
(Other Than Nuclear Power Plants)
During this reporting period, one event at an NRC-licensed fuel
fabrication facility was significant
[[Page 25340]]
enough to be reported as an AO based on the criteria in Appendix A to
this report.
06-01 Spill of High-Enriched Uranium Solution at Nuclear Fuel
Services in Erwin, Tennessee.
Date and Place--March 6, 2006, Erwin, Tennessee.
Nature and Probable Consequences--In a facility authorized to
process high-enriched uranium (HEU), a transfer of HEU solution through
a transfer line resulted in a portion of the HEU solution,
approximately 35 liters, leaking into a glovebox where criticality was
possible and subsequently to the floor where criticality was also
possible because of the presence of an elevator pit.
Immediately before the event, the facility operator decided to move
the unused filter glovebox to another location. Workers opened and
drained the filters so that the filter glovebox could be moved. After
draining the filters, workers failed to reseal the system tightly.
During the next transfer of HEU solution through the line, HEU solution
leaked into the filter glovebox. On several occasions before the event,
workers had reported signs of a yellowish liquid in the filter
glovebox. Supervisors had failed to fully investigate the reports
because they assumed the yellowish liquid was natural uranium solution
which had been used to initially test the process.
Criticality was possible in the filter glovebox because of the size
and shape of the glovebox and because there were no controls in the
filter glovebox to prevent accumulation of solution. The solution
leaked out of the filter glovebox through uncontrolled drains to the
floor. Investigation of the event revealed that the floor contained an
uncontrolled accumulation point, an elevator pit, where criticality was
also possible. In different circumstances, the total volume of the
transfer would have been more than enough for criticality to be
possible in the filter glovebox or the elevator pit. If a criticality
accident had occurred in the filter glovebox or the elevator pit, it is
likely that at least one worker would have received an exposure high
enough to cause acute health effects or death. The NRC conducted a team
inspection to determine the root causes of the event and performed a
series of three readiness reviews before allowing this portion of the
facility to restart. The NRC issued an order to the licensee
delineating specific actions designed to address this and other
performance issues at the facility.
Cause(s)--Failure to maintain configuration control of facility
equipment and failure to comply with procedures.
Actions Taken to Prevent Recurrence--The operator stopped all
processing of HEU in the affected processing area, removed the
enclosure and associated piping, filled in an uncontrolled accumulation
point (the elevator pit) with concrete, and conducted an extensive
review to identify any similar configuration issues.
* * * * *
Other NRC Licensees
(Industrial Radiographers, Medical Institutions, etc.)
During this reporting period, two events at NRC-licensed or
regulated facilities were significant enough to be reported as AOs
based on the criteria in Appendix A to this report.
06-02 Medical Event at Bozeman Deaconess Hospital in Bozeman,
Montana.
Date and Place--May 9, 2006, Bozeman, Montana.
Nature and Probable Consequences--The licensee reported that a
patient was prescribed a brachytherapy treatment of 145 Gy (14,500 rad)
to the prostate gland for prostate cancer using 82 iodine-125 seeds,
but instead received a 130 Gy (13,000 rad) dose to an unintended
treatment site. The brachytherapy seeds were implanted under ultrasound
guidance; however, a post-treatment computerized tomography scan
confirmed that only 10 seeds were implanted in the prescribed location
of the prostate, resulting in a dose of 8.6 Gy (860 rad) delivered to
the intended treatment site. Concerning the 72 seeds not in the
intended treatment site, the urologist was able to recover 3 seeds and
determined that 69 seeds were implanted inferior to the prostate in the
wrong treatment site. The referring physician and the patient were
informed of this event and were advised that the patient may experience
discomfort during urination. The NRC staff conducted a reactive onsite
inspection on May 16, 2006. An NRC contracted medical consultant
experienced in radiation oncology reviewed the case and agreed with the
licensee's analysis and conclusions. An NRC inspection report has been
issued.
Cause(s)--This medical event was caused by human error because the
licensee did not verify that the sources were positioned in the proper
location in the prostate. The urologist misidentified the anatomy
viewed under the ultrasound guidance procedure.
Actions Taken to Prevent Recurrence--The licensee revised its
procedures, requiring a fluoroscopic examination early in the implant
procedure to ensure that the seeds are placed in the correct location,
thus resolving any questions concerning ultrasound images prior to
commencing with the implant. The licensee also implemented additional
staff training.
* * * * *
06-03 Dose to an Embryo/Fetus at Munson Medical Center in Traverse
City, Michigan.
Date and Place--May 3, 2006, Traverse City, Michigan.
Nature and Probable Consequences--The licensee reported an
unintended dose to an embryo/fetus. On May 3, 2006, the licensee
administered a therapy dosage of 5.55 GBq (150 mCi) of I-131 to a 26-
year-old female patient who had affirmed in writing that she was not
pregnant. On May 22, 2006, the patient informed the licensee that she
had been approximately 10 to 14 days pregnant at the time of the
administration. Based on this new information, the licensee estimated
that the dose to the embryo/fetus was approximately 400 mSv (40 rem).
The referring physician and patient were informed of this event. The
NRC-contracted medical consultant agreed with the licensee's dose
estimate and concluded that this event should result in no harm to the
embryo because the administration occurred during a stage of
development when the thyroid does not take up iodine. The medical
consultant recommended that a complete thyroid evaluation be performed
after delivery.
Cause(s)--This medical event was caused by the patient's incorrect
written statement that she was not pregnant prior to receiving the
therapy dosage. The licensee did not require an independent pregnancy
test for women of child-bearing age prior to administering the dosage.
Actions Taken to Prevent Recurrence--The licensee implemented a
procedure that requires pregnancy tests for all women of childbearing
age prior to any therapy dosage of radioactive material, a checklist to
ensure that the pregnancy test is ordered, and staff training.
* * * * *
Agreement State Licensees
During this reporting period, six events at Agreement State-
licensed facilities were significant enough to be reported as AOs based
on the criteria in Appendix A to this report.
AS 06-01 Industrial Radiography Occupational Overexposure at Anvil
[[Page 25341]]
International in North Kingston, Rhode Island.
Date and Place--March 3, 2006, North Kingston, Rhode Island.
Nature and Probable Consequences--The licensee reported that a
radiographer and a trainee received unintended radiation exposures in
excess of those specified in the AO criteria. The incident occurred at
a permanent radiography facility and involved an iridium-192 source
with an activity of 3.44 TBq (93 Ci). After performing surveys outside
a dedicated radiography cell, where radiation levels confirmed that
radiography was in process in the cell, the radiographer and the
trainee went to an alternate location and performed equipment
maintenance and training. They were joined by a third radiographer, who
was performing radiography inside the cell. All three radiography
personnel entered the cell to view the radiography setup and examine
the guide tube for training purposes. However, they entered without a
survey meter and were unaware that the source was still exposed. As a
result, the first radiographer and the trainee handled the collimator
and guide tube (which contained the source) for approximately 15-60
seconds. The first radiographer received a dose to the left hand
ranging from 1.4 to 2.8 Sv (140 rem to 280 rem). The trainee received a
dose to the left hand ranging from 11 Sv to 85 Sv (1,100 rem to 8,500
rem). The third radiographer did not receive a dose in excess of
regulatory exposure limits, since he did not handle the equipment.
Cause(s)--This event was caused by the failure of radiography
personnel to follow safety procedures and use survey meters inside the
cell.
Actions Taken to Prevent Recurrence.
Licensee--The licensee provided additional training to the
personnel. The licensee also solicited the assistance of a medical
physicist and the source manufacturer in determining the dose to the
radiographers. The licensee also committed to keep the State updated on
the medical conditions of the radiographer and trainee until they are
released from medical oversight.
State Agency--On March 7, 2006, the State issued a suspension
letter to the licensee. On March 8 and March 16, 2006, the State,
accompanied by NRC Region I staff, conducted an investigation of the
event. On April 13, 2006, the State issued a Notice of Violation and on
November 3, 2006, terminated the license after an onsite inspection to
confirm decommissioning actions.
AS 06-02 Medical Event at 21st Oncology, Inc., in Coral Springs,
Florida.
Date and Place--March 31 through April 7, 2006, Coral Springs,
Florida.
Nature and Probable Consequences--The licensee reported that an 80-
year-old female patient received 100 Gy (10,000 rad) to an unintended
area of approximately 2 cm (0.8 in) that was three times the prescribed
dose for the mammosite brachytherapy procedure, using a high dose rate
(HDR) afterloader containing an iridium-192 source with an activity of
240.5 GBq (6.5 Ci). The patient received less than 30 percent of the
prescribed dose to the prescribed treatment site. The source stopped 6
cm (2.4 in) short of the intended position. The patient visited the
attending physician for followup on May 2, 2006. The physician
discovered that the patient's skin was abnormally red. The referring
physician, patient, and patient's family were notified of the incident.
The patient was treated for erythema (skin reddening) and moist
desquamation (skin thinning and weeping).
Cause(s)--This medical event was caused by human error. The
authorized user entered an incorrect distance into the computer entry
data.
Actions Taken to Prevent Recurrence.
Licensee--The licensee developed new procedures requiring the
authorized user to verify the source wire distances during HDR
treatments and provided additional training in these procedures.
State Agency--The State reviewed and accepted the licensee's
corrective actions.
* * * * *
AS 06-03 Medical Event at the McKay Dee Hospital, Inc., in Ogden,
Utah.
Date and Place--June 19, 2006, Ogden, Utah.
Nature and Probable Consequences--The licensee reported that a
patient undergoing treatment for hyperthyroidism received 1.08 GBq
(29.3 mCi) of I-131 instead of the prescribed dosage of 0.56 GBq (15
mCi). On June 19, 2006, two patients were scheduled to receive I-131
treatments at the same time. However, the first patient was
administered the second patient's prescribed dosage resulting in the
patient receiving a higher than intended dose. The error was identified
by the licensee prior to the administration of I-131 to the second
patient. The administration resulted in a thyroid dose of 1,066 Gy
(106,600 rad). The patient and referring physician were notified of the
error. No negative health effects from this administration are
expected. On July 17, 2006, the licensee sent a letter to the State
confirming that a medical event had occurred.
Cause(s)--This medical event was caused by human error. The
licensee failed to verify the prescribed dosage for a specific patient.
Actions Taken to Prevent Recurrence.
Licensee--Corrective actions taken by the licensee included
revising procedures to improve patient identification techniques and
not scheduling patients with similar treatments at concurrent times.
State Agency--The State reviewed and accepted the licensee's
corrective actions.
* * * * *
AS 06-04 Medical Event at Central Arkansas Radiation Therapy
Institute in Little Rock, Arkansas.
Date and Place--March 28, 2006, Little Rock, Arkansas.
Nature and Probable Consequences--The licensee reported that a
patient undergoing implant brachytherapy for prostate cancer received a
radiation dose to an unintended area during an I-125 prostate-seed
implant procedure. The patient was prescribed 108 Gy (10,800 rad) to
the base of the prostate gland with 84 I-125 seeds but it was delivered
4 cm (1.6 in) inferior to the intended treatment site. The post-implant
dose calculation confirmed that the dose was delivered to the wrong
treatment site. The patient will require further brachytherapy
treatment. The patient did not incur adverse health effects as a result
of the medical event. The patient and referring physician were notified
of the medical event.
Cause(s)--This medical event was caused by human error. The
urologist was not able to clearly identify the base of the prostate
gland during the ultrasound used to view the target organ during the
treatment.
Actions Taken to Prevent Recurrence.
Licensee--The licensee implemented a new policy to ensure that the
urologist clearly defines the base of the prostate and urethra.
State Agency--The State reviewed and accepted the licensee's
corrective actions.
* * * * *
AS 06-05 Medical Event at Children's Memorial Medical Center in
Chicago, Illinois.
Date and Place--July 24, 2006, Chicago, Illinois.
Nature and Probable Consequences--The licensee reported that a
patient received a higher than intended dosage of 74 MBq (2 mCi) of I-
131 instead of the prescribed dosage of 0.19 MBq
[[Page 25342]]
(0.005 mCi). The physician did not prepare a written directive. The
authorized user noted the error on July 25, 2006. The licensee
estimated a whole body dose of 0.0189 Sv (1.89 rem) and a dose to the
thyroid of 41.4 Sv (4,140 rem), based on a 59.2-percent uptake. Using
the same assumptions, the intended dosage of 0.19 MBq (0.005 mCi) would
have given the patient a thyroid dose of 0.104 Sv (10.4 rem). The
patient and referring physician were notified of the medical event. The
patient incurred no adverse health effects from the medical event.
Cause(s)--This medical event was caused by inadequate verbal
communications between the nuclear medicine technologist (NMT) and the
physician and the lack of a written directive.
Actions Taken to Prevent Recurrence.
Licensee--The licensee reviewed previous administrations of
radioiodine to confirm that this event was an isolated occurrence. The
licensee added additional procedures to ensure proper oversight by a
physician during all future radioidodine administrations.
State Agency--The State investigated the event and concurred with
the licensee's dose estimates. The State issued a Notice of Violation
to the licensee.
* * * * *
06-06 Dose to an Embryo/Fetus at McLeod Regional Medical Center in
Florence, South Carolina.
Date and Place--May 26, 2006, Florence, South Carolina.
Nature and Probable Consequences--The licensee reported an
unintended dose to an embryo/fetus. The licensee administered 555 MBq
(15 mCi) of technetium-99m on May 24, 2006, and 518 KBq (0.014 mCi) of
I-131 on May 25 as a prelude to a thyroid ablation to a patient. Prior
to the administrations and following a detailed explanation provided by
the physician, the patient signed an informed consent indicating that
she was not pregnant. The licensee's radioactive materials license
requires that a pregnancy test be done on any female of child-bearing
age undergoing radiation therapy. However, the patient convinced the
attending NMT that she could not possibly be pregnant. The NMT did not
perform the pregnancy test and on May 26, 2006, administered 0.548 GBq
(14.8 mCi) of I-131 to the patient for a thyroid ablation. At
approximately 32--34 weeks of pregnancy, the patient visited an
obstetrician and mentioned that she had undergone a thyroid ablation
procedure when she was approximately 17 weeks pregnant. The
obstetrician notified the licensee on October 3, 2006. The licensee
estimated that the fetus received a whole body dose of 0.0517 Gy (5.17
rad) and a thyroid dose of 139.2 Gy (13,920 rad). The child was born in
November 2006. The newborn appears to have no apparent problems
resulting from the radiation exposure with the exception of an
underactive thyroid gland (hypothyrodism). The child is currently
receiving a small amount of thyroid supplement. The referring physician
and patient were notified of the event.
Cause(s)--This event was caused by human error. At the time of the
administration, the patient indicated that she was not pregnant, and
the licensee failed to perform the required pregnancy test.
Actions Taken To Prevent Recurrence.
Licensee--The licensee provided instructions to staff emphasizing
its policy to administer a pregnancy test to female patients of child-
bearing age prior to undergoing radiation therapy.
State Agency--The State reviewed and approved the corrective
actions taken by the licensee and will followup at the next inspection.
The State is in the process of issuing a Notice of Violation.
Dated at Rockville, Maryland this 20th day of April 2007.
For the Nuclear Regulatory Commission.
Andrew L. Bates,
Acting Secretary of the Commission.
[FR Doc. E7-8551 Filed 5-3-07; 8:45 am]
BILLING CODE 7590-01-P