[Federal Register Volume 78, Number 171 (Wednesday, September 4, 2013)]
[Notices]
[Pages 54493-54502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21477]
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NUCLEAR REGULATORY COMMISSION
[NRC-2013-0094]
Report to Congress on Abnormal Occurrences: Fiscal Year 2012,
Revision 1; Dissemination of Information
Section 208 of the Energy Reorganization Act of 1974 (Pub. L. 93-
438) defines an abnormal occurrence (AO) as an unscheduled incident or
event that 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 (Pub. L. 104-68)
requires that AOs be reported to Congress annually. During Fiscal Year
(FY) 2012, 22 events that occurred at facilities licensed by the NRC
and/or Agreement States were determined to be AOs.
This report describes four events at NRC-licensed facilities. The
first event at an NRC-licensed facility was an occurrence at a
commercial nuclear power plant and the other three events occurred at
NRC-licensed medical institutions and are medical events as defined in
part 35 of Title 10 of the Code of Federal Regulations (10 CFR). The
report also describes 18 events at Agreement State-licensed facilities.
Agreement States are the 37 States that currently 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. The first
Agreement State-licensee event involved radiation exposure to an
embryo/fetus, and the second event involved an exposure to a
radiographer. The other 16 Agreement State-licensee events were medical
events as defined in 10 CFR part 35 and occurred at medical
institutions. 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 actions taken to prevent recurrence. Each
event is also described in NUREG-0090, Volume 35, ``Report to Congress
on Abnormal Occurrences: Fiscal Year 2012,'' issued May 2013 (ADAMS
Accession No. ML13149A083). The report was revised to include editorial
corrections and reissued in August 2013 as NUREG-0090, Volume 35,
Revision 1, ``Report to Congress on Abnormal Occurrences: Fiscal Year
2012'' (ADAMS Accession No. ML13225A395). This report is available
electronically at the NRC's Web site at http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/.
Three major categories of events are reported in this document--I.
For All Licensees, II. For Commercial Nuclear Power Plant Licensees,
and III. Events at Facilities Other Than Nuclear Power Plants and All
Transportation Events. The full report, which is available on the NRC's
Web site, provides the specific criteria for determining when an event
is an AO. It also discusses ``Other Events of Interest,'' which do not
meet the AO criteria but have been determined by the Commission to be
included in the report. The event identification number begins with
``AS'' for Agreement State AO events and ``NRC'' for NRC AO events.
I. For All Licensees
A. Human Exposure to Radiation From Licensed Material
During this reporting period, two events involving Agreement State-
licensees were significant enough to be reported as AOs. Although one
of these events occurred at a medical facility, it involved unintended
exposure of an individual who was not the patient. Therefore, this
event belongs under the Criterion I.A, ``For All Licensees'' category,
as opposed to the Criterion III.C, ``Medical Licensees'' category.
AS12-01 Embryo/Fetus Exposure to Radiation at Lankenau Hospital in
Wynnewood, Pennsylvania
Date and Place--October 6, 2011, Wynnewood, PA.
Nature and Probable Consequences--Lankenau Hospital (the licensee)
reported that a patient received 2.7 gigabecquerel (GBq) (73.7
millicuries (mCi)) of iodine-131 for thyroid ablation therapy. Before
the treatment, the patient informed the licensee that she was not
pregnant, and was administered a pregnancy test as a routine
precaution. The pregnancy test yielded a negative result. Therefore,
the licensee administered iodine-131 to the patient.
On October 26, 2011, the patient became aware that she was
pregnant. The licensee contacted the patient's obstetrician/
gynecologist and was informed that an ultrasound confirmed that she was
approximately 10 days pregnant at the time of the iodine-131 treatment.
The NRC contracted a medical consultant, who estimated a fetal or
embryo dose of 174 mSv (17.4 rem) and stated that embryonic tissue
capable of concentrating iodine-131 is not formed until 10 to 12 weeks
of gestation; therefore, this tissue had not yet formed at the time of
the treatment. The medical consultant concluded that there was a low
possibility of carcinogenesis or malformations.
Cause(s)--The cause of this event was the inability of the
pregnancy test to provide a positive determination of pregnancy in
close proximity to conception.
Actions Taken To Prevent Recurrence
Licensee--The licensee assessed the event and determined that it is
following best practices by ordering a pregnancy test and relying on
its results.
State--The Pennsylvania Department of Environmental Protection (PA
DEP) conducted a followup inspection to review this incident and
collect information from the medical consultant and the licensee to
complete this review. PA DEP has no further action planned for this
event.
AS12-02 Human Exposure to Radiation at Non-Destructive Inspection
Corporation, in Pasadena, Texas
Date and Place--March 24, 2012, Pasadena, TX.
Nature and Probable Consequences--The Non-Destructive Inspection
Corporation (the licensee) reported that a radiographer received a
total effective dose equivalent (TEDE) of 293.2 mSv (29.3 rem). The
licensee reported that the drive cable of a radiography camera
containing 2.41 terabecquerels (TBq)
[[Page 54494]]
(65.1 curies (Ci)) of iridium-192 broke, and the source pigtail
disconnected from the drive cable inside the source guide tube. The
radiographer trainer disconnected the source guide tube from the
exposure device and placed it around his neck while he climbed down the
ladder of a scaffold. The source was in the guide tube at that time,
but its location within the guide tube is uncertain. When the
radiographer trainer reached the platform he removed the guide tube
from his neck. He then noted that the other radiographer was having
problems disconnecting the crank assembly from the exposure device and
that the exposure device locking mechanism was still unlocked.
Radiation surveys were performed of the exposure device and source
guide tube. Radiation levels revealed that the source was within the
guide tube. The radiographer trainer picked up the guide tube with long
tongs and the source fell out of the guide tube onto the floor. An
authorized individual responded to the site and performed source
retrieval. The radiographer trainer's film badge was processed and read
0.812 mSv (81.2 mrem). During event reenactment, it was determined that
the source guide tube was around the radiographer trainer's neck for
approximately 35 seconds. The licensee calculated and assigned an
estimated TEDE dose of 293.2 mSv (29.3 rem). The event was reported as
a Level 2 (incident) on the International Atomic Energy Agency's
International Nuclear and Radiological Event Scale (INES).
Cause(s)--The cause of this event was corrosion of the drive cable
and improper maintenance coupled with the failure of the operators to
perform the proper radiation surveys.
Actions Taken To Prevent Recurrence
Licensee--The corrective action taken by the licensee included a
complete cessation of operations and review of the incident with every
radiographer in the company; and an inspection of all of the licensee's
equipment, with replacement as needed. The radiographer trainer was
retrained and re-tested. The licensee stated it will incorporate
routine equipment maintenance and inspections performed by the
manufacturer.
State--The Texas Department of State Health Services (DSHS)
collected information from the licensee, including medical surveillance
information, and completed its review of the event and the licensee's
corrective actions. The DSHS cited both the licensee and radiographer
trainer with several violations associated with this event.
II. Commercial Nuclear Power Plant Licensees
During this reporting period, one event at a commercial nuclear
power plant in the United States was significant enough to be reported
as an AO.
NRC12-01 Commercial Nuclear Power Plant Event at Fort Calhoun Station,
Unit 1, in Fort Calhoun, Nebraska
Date and Place--June 7, 2011, Fort Calhoun, NE.
Nature and Probable Consequences--The Omaha Public Power District
(OPPD) (the licensee) reported a commercial nuclear power plant event
at Fort Calhoun Station (FCS), Unit 1, a single pressurized-water
reactor designed by Combustion Engineering. On June 7, 2011, a fire
started in a recently replaced safety-related electrical breaker in an
electrical switchgear room at the plant. The fire resulted in FCS
declaring an alert because the fire impacted safety-related equipment.
The catastrophic failure of the replacement breaker and subsequent fire
resulted in a large quantity of soot and smoke. The soot and smoke were
sufficiently conductive that arcing occurred and the feeder breaker for
the redundant train of electrical switchgear tripped. Operators took
action to isolate equipment potentially affected by the fire. The event
resulted in the loss of the spent fuel pool cooling function and could
have resulted in the loss of a safety function or multiple failures in
systems used to mitigate an event had the event occurred while the
plant was operating at power. The reactor was shutdown at the time of
the fire.
The NRC determined that the event represented a finding of high
safety significance (red finding). The basis for this determination was
the high fire frequency given the short period of time that the
replacement breaker had been in service, the significant damage caused
by the failure, and the fact that the event affected both trains of
safety equipment. The public was never endangered because the plant was
in cold shutdown for a planned refueling outage at the time of the
fire. Significantly less safety equipment is required in this plant
condition to safely cool the fuel. However, had this event occurred
while the plant was operating at power, the response to the event would
have been much more complex.
Cause(s)--The direct cause of the fire was the high electrical
resistance of the replacement breaker and the lack of proper cleaning
and tightening of the electrical switchgear. Additionally, the area of
the electrical connection was found to be full of hardened grease and
copper oxide because of poor electrical maintenance practices by the
licensee.
Actions Taken To Prevent Recurrence
Licensee--As a result of the event and other factors, OPPD has
maintained FCS in a shutdown condition. Through its root cause analysis
process, the licensee preliminarily determined that a wiring
discrepancy caused the fire to spread to the opposite safety-related
electrical train. The licensee also performed checks to ensure the
wiring discrepancy is no longer present in the plant on the replacement
equipment or other similar equipment.
NRC--The NRC transitioned FCS oversight from that described in
Inspection Manual Chapter (IMC) 0305, ``Operating Reactor Assessment
Program,'' to that described in IMC 0350, ``Oversight of Reactor
Facilities in a Shutdown Condition due to Significant Performance and/
or Operational Concerns.'' The IMC 0350 process for FCS was implemented
to:
Establish a regulatory oversight framework as a result of
significant performance problems and a significant operational event.
Ensure the NRC communicates a unified and consistent
position in a clear and predictable manner.
Establish a record of actions taken and technical issues
resolved.
Verify that corrective actions are sufficient for restart.
Provide assurance that, following restart, the plant will
be operated in a manner that provides for adequate protection of public
health and safety.
On February 26, 2013, the NRC issued a revised Confirmatory Action
Letter (CAL) (EA-13-020) ``Confirmatory Action Letter--Fort Calhoun
Station,'' (available at the NRC's Agencywide Documents Access and
Management System (ADAMS) Accession No. ML13057A287) to confirm those
actions that the NRC determined will need review or inspection before
the restart of the plant. This revision supplemented two previously
issued confirmatory action letters (ADAMS Accession Nos. ML112490164
and ML12163A287) that confirmed actions that were necessary prior to
restart. This revision was issued to incorporate three additional items
to the Restart Checklist, that relate to (1) qualifications for
containment electrical penetrations, (2) containment internal structure
deficiencies, and (3) a number of safety system functional failures
resulting in the associated performance indicator crossing into the
white threshold. Prior to the NRC terminating the CAL and allowing FCS
to restart, the NRC will verify that the licensee's
[[Page 54495]]
corrective actions adequately address all of the items detailed on the
restart checklist.
III. Events At Facilities Other Than Nuclear Power Plants and All
Transportation Events
C. Medical Licensees
During this reporting period, three events at NRC licensees and 16
events at Agreement State-licensees were significant enough to be
reported as AOs.
AS12-03 Medical Event at Greenville Memorial Hospital in Greenville,
South Carolina
Date and Place--September 15, 2009, Greenville, SC.
Nature and Probable Consequences--Greenville Memorial Hospital (the
licensee) reported that a medical event occurred associated with a
radioembolization brachytherapy treatment for liver cancer involving
1.7 GBq (45.9 mCi) of yttrium-90. The patient was prescribed to receive
a total dose of approximately 13 Gy (1,300 rad) to the liver, but
instead received a dose of approximately 26 Gy (2,600 rad) to the
liver. This delivered dosage was approximately 100 percent greater than
the prescribed dosage to the patient. The patient and referring
physician were informed of this event.
On September 17, 2009, the licensee notified the South Carolina
Department of Health and Environmental Control that following an
infusion of radioactive yttrium-90, a postprocedure record review
revealed that the patient was administered 1.7 GBq (45.9 mCi) of
yttrium-90 versus the prescribed dose of 0.94 GBq (25.4 mCi). Upon
investigation, it was discovered by the licensee that errors occurred
both while preparing the treatment and estimating the activity from the
written directive. Upon medical followup, the patient had good tumor
response with no adverse medical effects.
Cause(s)--The cause of the medical event was human error in failing
to administer the correct activity as stated on the written directive.
Actions Taken To Prevent Recurrence
Licensee--The licensee corrective actions included: (1) Mandatory
refresher training for all participants in this event, (2)
implementation of a requirement to confirm the prescribed dose by two
nuclear medicine technologists prior to administration, (3)
implementation of a requirement for the written directive to be typed
or printed with the dose amount highlighted, and (4) discussion of the
event and corrective actions at the next meeting of the Radiation
Safety Committee.
State--The South Carolina Department of Health and Environmental
Control conducted an investigation on September 17, 2009, and
determined that no items of non-compliance were noted. The State
forwarded the final update of this event to the NRC on October 18,
2012.
AS12-04 Medical Event at the Duke University Medical Center in Durham,
North Carolina
Date and Place--October 22, 2010, Durham, NC.
Nature and Probable Consequences--Duke University Medical Center
(the licensee) reported that a medical event occurred associated with a
high dose rate (HDR) endobronchial brachytherapy treatment for small
cell lung cancer. The treatment involved the use of 199.8 GBq (5.4 Ci)
of iridium-192 split between two treatment catheters. The patient was
prescribed to receive two doses of 10 Gy (1,000 rad) for a total dose
of 20 Gy (2,000 rad) to the tumor site. However, the direction of the
catheters was reversed during treatment, resulting in a dose of 20 Gy
(2,000 rad) to the voice box (wrong treatment site). The patient and
referring physician were informed of this event.
On October 22, 2010, the medical staff initially identified the
locations of the two treatment catheters using computed tomography (CT)
images. During the treatment, the direction of the catheters was
mistakenly reversed. This changed the starting position of the HDR
source and resulted in the dose being delivered to the voice box rather
than the targeted treatment site on the left side of the patient's
airway. The patient exhibited minor swelling of the voice box, but no
airway compromise, hoarseness, shortness of breath, or painful
swallowing. The licensee concluded that the medical event would not
have a significant medical effect on the patient. The patient was
subsequently given the correct total dose in a followup treatment.
Cause(s)--The cause of the medical event was human error in that
the oncology staff failed to correctly place and verify the position of
the two treatment catheters. A contributing factor to the cause of the
event is that the oncology staff infrequently uses two catheters to
simultaneously deliver doses during HDR treatments.
Actions Taken To Prevent Recurrence
Licensee--The licensee's corrective actions included: (1) A root-
cause analysis of the event, (2) development of a more detailed
standard operational procedure for this type of treatment, (3) a
revised HDR patient quality assurance form to include extra levels of
verification, and (4) a new verification procedure. The licensee also
provided training on the revised procedures for all radiation oncology
staff approved to conduct HDR therapy.
State--The North Carolina Division of Radiation Protection
conducted an investigation on December 14, 2010, and identified several
procedural weaknesses in the licensee's HDR program. One item of
noncompliance was issued and the State forwarded the final update of
this event to the NRC on November 28, 2012.
AS12-05 Medical Events at Our Lady of Bellefonte Hospital in Ashland,
Kentucky
Date and Place--October 3, 2001 through February 24, 2009 (reported
on December 13, 2010), Ashland, KY.
Nature and Probable Consequences--The Kentucky Department of Public
Health (KDPH) identified a medical event at Our Lady of Bellefonte
Hospital (the licensee) associated with a brachytherapy seed implant
procedure to treat prostate cancer. The patient was prescribed to
receive a total dose of 132.8 Gy (13,280 rad) to the prostate using 105
palladium-103 seeds, but instead the patient received an approximate
dose of 131 Gy (13,100 rad) to the penile bulb (glans) (wrong treatment
site). The patient and referring physician were not informed of this
event because the licensee believed that the treatment was
satisfactory. However, the patient was subsequently informed of this
event during a consultation at another medical treatment facility.
The licensee was unable to perform a dose assessment of the
affected tissue due to the radiation oncologist's inadequate
postprocedure seed implant records. The patient sought a second opinion
from a different radiation oncologist, who performed a CT scan of the
treatment site. Based on the results of this CT scan, the second
radiation oncologist determined that the penile bulb received the
majority of the prescribed dose. On November 30, 2010, KDPH
investigated this event and the licensee's entire prostate
brachytherapy treatment program. The KDPH discovered 34 additional
cases of improper prostate seed implantation performed by the same
radiation oncologist between October 3, 2001, and February 24, 2009.
The KDPH documented procedural violations by the radiation oncologist
including written directives not containing the prescribed or delivered
doses, no
[[Page 54496]]
records of postprocedure implant doses, and the lack of postprocedure
CT scans.
Cause(s)--The cause of the medical events was human error in the
failure of the radiation oncologist to follow the licensee's procedures
and the failure of the licensee to maintain oversight of its
brachytherapy program.
Actions Taken To Prevent Recurrence
Licensee--The corrective actions taken by the licensee included
providing personnel with additional training, permanently suspending
the brachytherapy program, and removing the radiation oncologist who
performed the implant procedures from the license.
State--The KDPH conducted an extensive investigation from November
30, 2010 through November 2, 2012, and cited the licensee for numerous
violations in the oversight of its manual brachytherapy program.
Additionally, the Kentucky Medical Board investigated the radiation
oncologist for infractions that resulted in rescinding the Kentucky
medical license.
AS12-06 Medical Event at Banner Good Samaritan Medical Center in
Phoenix, Arizona.
Date and Place--December 22, 2010, Phoenix, AZ
Nature and Probable Consequences--Banner Good Samaritan Medical
Center (the licensee) reported that a medical event occurred associated
with an HDR mammosite treatment for breast cancer, involving
approximately 139.5 GBq (3.8 Ci) of iridium-192. The patient was
prescribed to receive a total dose of 34 Gy (3,400 rad) in 10
fractionated doses to the left breast; however, on the ninth treatment,
a kink in one of the catheters apparently caused the source to punch
through the catheter and slide along the skin tissue of the left
breast. The patient received a dose of 20 Gy (2,000 rad) to the skin of
the left breast (wrong treatment site). The patient and referring
physician were informed of this event.
In preparation for the seventh treatment, the licensee had
difficulty in attaching the transfer tube to the HDR unit, and one
catheter kinked. During attempts to straighten and re-attach the
transfer tube, the catheter broke off completely. The licensee used a
technique that it developed to repair the catheter and test its
integrity since the manufacturer provides no specific recommendations
on how to deal with damaged catheters. In addition, the licensee
determined that repairing the catheter was the best option, versus
risking the surgical procedure to replace the catheter. During the
ninth treatment, the patient reported a sensation of electricity on her
left breast during the positioning of the source in one of the
catheters. The remaining catheter treatment was completed without
further complaints by the patient and the sources were retracted into
the normal shielded position. On January 3, 2011, the prescribing
physician noted very faint erythema over the lumpectomy site and no
evidence of erythema where the source had been in contact with the
skin. Later ulcerations developed and healed without further
complication. The licensee concluded that there did not appear to be
any skin effects from the ruptured catheter, and the patient gradually
improved over time.
Cause(s)--The cause of the medical event was a material problem
with the repaired catheter and ineffective procedures for handling a
damaged catheter.
Actions Taken To Prevent Recurrence
Licensee--Corrective actions included changes to the licensee's
procedures so that the entrance site and catheters will be visible by
camera and that the treatment will be interrupted upon any abnormal
observation or response from the patient. In addition, the licensee
procedures were revised so that if kinking or damage to a catheter is
observed and the catheter shows any signs of weakening, the device will
be replaced.
State--The Arizona Radiation Regulatory Agency conducted an
investigation and determined that the licensee's corrective actions
were adequate. No enforcement action was taken, and the State forwarded
the final update of the event to the NRC on May 1, 2012.
AS12-07 Medical Event at Highlands Regional Medical Center in
Prestonsburg, Kentucky
Date and Place--March 17, 2009 (reported on January 14, 2011),
Prestonsburg, KY.
Nature and Probable Consequences--The KDPH performed an inspection
of Highlands Regional Medical Center (the licensee) manual
brachytherapy program on January 14, 2011. The KDPH identified one of
the licensee's authorized users, a radiation oncologist, who the KDPH
investigated in prostate brachytherapy seed implant AO medical events
at Our Lady of Bellefonte Hospital in Ashland, Kentucky (AS12-05). The
KDPH discovered that on March 17, 2009, a patient prescribed to receive
100 Gy (10,000 rad) to the prostate instead received a dose of 160.8 Gy
(16,080 rad). This delivered dosage was approximately 60 percent
greater than the prescribed dosage to the patient. The KDPH documented
procedural violations by the radiation oncologist including written
directives not containing the prescribed or delivered doses, no records
of postprocedure implant doses, and the lack of postprocedure CT scans.
The patient and referring physician were not informed of this event
because the licensee believed that the treatment was satisfactory.
The KDPH uncovered two additional improper prostate seed
implantation events at the licensee's facility performed by the same
radiation oncologist. These two additional events occurred between
February 28, 2008, and April 3, 2008, and in both events the patients
received less than the dose prescribed for the treatment. However,
because of the radiation oncologist's inadequate postprocedure
implantation records, final dose assessments of these events cannot be
performed. The licensee's lack of oversight of the manual brachytherapy
program caused these events to be undetected until the KDPH inspection.
Cause(s)--The cause of the medical event was human error in the
failure of the radiation oncologist to follow the licensee's procedures
and the failure of the licensee to maintain oversight of their
brachytherapy program.
Actions Taken To Prevent Recurrence
Licensee--The licensee's corrective actions included providing
personnel with additional training and removing the radiation
oncologist who performed the implant procedures from the license.
Additionally, the licensee's manual brachytherapy program has been
suspended until the licensee can demonstrate complete regulatory
oversight and compliance with Kentucky regulations.
State--The KDPH conducted an extensive investigation from January
14, 2011 through November 28, 2012, and cited the licensee for numerous
violations in the oversight of its manual brachytherapy program.
Additionally, the Kentucky Medical Board investigated the radiation
oncologist for infractions that resulted in rescinding the Kentucky
medical license.
AS12-08 Medical Event at Eastern Regional Medical Center in
Philadelphia, Pennsylvania
Date and Place--January 19, 2011, Philadelphia, PA
Nature and Probable Consequences--Eastern Regional Medical Center
(the licensee) reported that a medical event occurred associated with a
radioembolization brachytherapy treatment for liver cancer involving
1.42
[[Page 54497]]
GBq (38.3 mCi) of yttrium-90. The patient was prescribed to receive a
total dose of 117 Gy (11,700 rad) to the left lobe of the liver, but
instead received an approximate dose of 257 Gy (25,700 rad). This
delivered dosage was about 120 percent greater than the prescribed
dosage. The patient and referring physician were informed of this
event.
On January 19, 2011, during a formal review, the licensee noted
that the activity delivered to the left lobe of the liver was different
than the activity that was prescribed by the doctor. Upon
investigation, it was determined that a transcription error occurred
while preparing the order form. The error was not recognized upon
receipt of the yttrium-90, because the received amount of yttrium-90
was compared to the amount listed on the order form rather than the
amount prescribed on the written directive. The licensee concluded that
this elevated dose may result in an increased risk of atrophy to the
left lobe of the liver.
Cause(s)--The cause of the medical event was human error in failing
to correctly transcribe the activity from the written directive to the
order form.
Actions Taken To Prevent Recurrence
Licensee--The licensee's corrective actions included the generation
of a computer spreadsheet that populates fields based on initial
calculations, written directives and the order form. In addition,
several procedure modifications were implemented to ensure the correct
dosage is ordered and received.
State--The PA DEP conducted a reactive investigation on January 25,
2011, and identified one violation. The PA DEP inspectors determined
that the licensee failed to implement the procedures developed to
provide high confidence that each yttrium-90 microspheres treatment was
in accordance with the written directive. Specifically, the licensee's
staff did not verify that the activity determined with a dose
calibrator was within 10 percent of the prescribed activity on the
written directive, nor were the decay calculations used to check that
the activity at the time of treatment was as prescribed on the written
directive.
AS12-09 Medical Event at the University of Colorado Hospital in Aurora,
Colorado
Date and Place--July 8, 2011, Aurora, CO
Nature and Probable Consequences--University of Colorado Hospital
(the licensee) reported that a medical event occurred associated with a
patient receiving treatment for Graves Disease. The patient was
prescribed to receive a total dose of approximately 340 Gy (34,000 rad)
to the thyroid gland using 740 MBq (20 mCi) of iodine-131, instead the
patient received 3,748 MBq (101.3 mCi) of iodine-131 resulting in a
dose of approximately 1,722 Gy (172,200 rad). This dosage was in excess
of 400 percent greater than the prescribed dosage to the patient. The
patient and referring physician were informed of this event.
On July 8, 2011, the licensee reported to the Colorado Department
of Health that a patient received the wrong dose of iodine-131. The
licensee stated that the authorized user (AU) reviewed the procedure
with the patient and then left the written directive and all associated
paperwork with the technologists. The technologist who was
administering the iodine-131 to the patient incorrectly assumed that
the patient was receiving treatment for cancer and did not review the
written directive. The technologist then decided to use a therapeutic
dosage of iodine-131, which was intended and labeled for another
patient. The AU discovered this error later that day, when they
attempted to administer the therapeutic dosage of iodine-131 to the
intended patient. On November 10, 2011, and February 8, 2012, the
licensee reported that the patient's thyroid function tests indicated a
normal thyroid function with a small interval change suggesting the
patient is becoming hypothyroid. The difference in the incorrectly
administered iodine-131 dosage is expected to cause hypothyroidism in
the patient and result in the patient needing replacement thyroid
hormone therapy. A less likely possibility is that patient's
hyperthyroidism will reoccur and will need an additional dose of
iodine-131.
Cause(s)--The cause of the medical event was human error in that
the technologist did not properly review the written directive and
label on the iodine-131 dose.
Actions Taken To Prevent Recurrence
Licensee--The licensee's corrective actions included the immediate
suspension of the technician from active duty and an investigation,
followed by procedure additions--including corroboration by two
individuals for therapy doses. The technician was eventually allowed to
return to work, but under the direct supervision of the lead
technologist or supervisor.
State--The Colorado Department of Public Health and Environment
(CDPHE) conducted interviews of the licensee's staff and reviewed the
licensee's written report in July 2011. The CDPHE issued a notice of
violation (NOV) on August 17, 2011, and a followup Compliance Order on
Consent on June 29, 2012.
AS12-10 Medical Event at the Medical Center at Bowling Green in Bowling
Green, Kentucky
Date and Place--November 16, 2011, Bowling Green, KY.
Nature and Probable Consequences--The Medical Center at Bowling
Green (the licensee) reported a medical event associated with a
brachytherapy seed implant procedure to treat prostate cancer. The
licensee scheduled back-to-back seed implant procedures, on consecutive
days, for two patients who were prescribed a dose of 145 Gy (14,500
rad) to the prostate using 79 iodine-125 seeds. The licensee planned
separate seed implant procedures for each patient and used the first
patient's plan to correctly implant the seeds in the first patient.
However, the licensee inadvertently reused the placement procedure for
the first patient while placing the seeds in the second patient. This
resulted in the incorrect placement of the seeds in the second patient
and a dose to the urethra (wrong treatment site) of 310 Gy (31,000
rad). The second patient and referring physician were informed of this
event.
On November 17, 2011, the licensee notified the KDPH that the wrong
permanent prostate brachytherapy implant treatment plan was used on a
patient. The radiation oncologist identified the discrepancy
immediately upon completion of the seed implants on the second patient.
A postprocedure CT and magnetic resonance imaging of the patient's
prostate performed one month later revealed the patient received an
approximate dose of 105.9 Gy (10,590 rad) to the prostate, which was 73
percent of the prescribed dose. The radiation oncologist placed
additional seeds into the patient's prostate to improve coverage and
comply with the treatment plan. The licensee concluded that the medical
event would not have an adverse effect on the second patient.
Cause(s)--The cause of the medical event was human error in that
the radiation oncologist deviated from standard operating procedures
and did not verify the information on the prostate implantation plan.
Actions Taken To Prevent Recurrence
Licensee--The licensee's corrective actions included providing
personnel with additional training on the modified process to ensure
patients are treated using the correct prostate implant plan.
Specifically, an individual will be assigned for printing the prostate
[[Page 54498]]
implant plan, verifying the patient's identity, and signing the
document. Subsequently, a second assigned individual will then verify
the information and sign the document for confirmation.
State--The KDPH conducted a reactive inspection on December 7,
2011, approved the licensee's corrective actions, and did not issue any
violations or penalties for this event.
AS12-11 Medical Event at the University of Toledo in Toledo, Ohio
Date and Place--December 19, 2011, Toledo, OH.
Nature and Probable Consequences--The University of Toledo (the
licensee) reported that a medical event occurred associated with an HDR
brachytherapy treatment for cervical cancer; involving 148.4 GBq (4 Ci)
iridium-192. The patient was prescribed to receive a total dose of 16
Gy (1,600 rad) in four fractionated doses to the cervix (treatment
site). It was later determined that the skin of the patient's right and
left thigh (wrong treatment sites) received doses of 12.51 Gy (1,251
rad) and 12.74 Gy (1,274 rad), respectively. The patient and referring
physician were informed of this event.
During a followup patient visit in January 2012, the attending
physician noticed a reddening of the skin (erythema) on both the right
and left upper thighs of the patient. Upon investigation, the licensee
did not identify any errors with the treatment plan, but discovered a
problem with the hardware used during the procedure. During the
treatment, a tandem is inserted into the patient, and a catheter for
the sealed source is inserted in the tandem. The vendor had recently
switched to a new catheter model that was slightly larger in diameter
and thicker than the original. During the procedure, the catheter got
caught on a minor blockage in the tandem and was not fully inserted,
and the source was approximately 9 centimeter (cm) away from the
treatment site. The misplaced source resulted in a total dose of 13.94
Gy (1,394 rad) to the treatment site and excessive doses to the
patient's thighs. As of March 21, 2012, the attending physician
reported that the patient had fully recovered from the medical event.
The patient reported no bowel or bladder problems, and the damaged skin
areas had totally healed. The physician does not anticipate significant
acute or long-term complications because of this medical event.
Cause(s)--The cause of the medical event was human error in that
the licensee failed to recognize that the catheter was not fully
inserted into the tandem during at least one of the fractionated doses.
A contributing factor was the change in catheter construction, which
allowed it to get caught on the blockage in the tandem.
Actions Taken To Prevent Recurrence
Licensee--The corrective action taken by the licensee includes
marking the new catheters to provide a visual indication of full
insertion into the tandem and inservice training for all staff involved
in HDR treatments.
State--The Ohio Department of Health (ODH) conducted an onsite
investigation and reviewed the incident causes and corrective actions.
In February 2012, the ODH issued a notice to all Ohio licensees
advising them to verify procedures to preclude a recurrence of this
event.
NRC12-02 Medical Event at Benefis Hospital in Great Falls, Montana
Date and Place--January 5, 2012, Great Falls, MT.
Nature and Probable Consequences--Benefis Hospital (the licensee)
reported that a medical event occurred associated with an HDR
brachytherapy treatment for esophageal cancer. The treatment involved
the use of 233.1 GBq (6.3 Ci) of iridium-192 and the patient was
prescribed to receive a total dose of 7 Gy (700 rad) to the esophageal
region (treatment site). However, it was determined that a 4 cm length
of tissue in the nasal and nasopharyngeal sinus area (wrong treatment
site) received a dose of 10 Gy (1,000 rad). The patient and referring
physician were informed of this event.
On January 5, 2012, while planning the treatment, the authorized
medical physicist (AMP) determined the placement of the source using a
radio-opaque marker wire to simulate the source with imaging software.
During the treatment, a nasogastric (NG) tube is inserted into the
patient through the nostril, allowing for positioning of the HDR
catheter and source at the treatment site. The NG tubes also have
radio-opaque markers to aid in their placement in the patient, which
the AMP mistook for the radio-opaque markers on the simulation wire.
This error by the AMP was compounded by the lack of CT images of the
patient's anatomy where the simulation wire was positioned. When the
medical staff removed the HDR catheter and NG tube at the end of the
procedure, they discovered that the HDR catheter had not been fully
inserted into the NG tube. The licensee performed an investigation and
determined that the dose was actually delivered to a location 29 cm
away from the treatment site. The licensee concluded that the medical
event would not have an adverse effect on the patient.
Cause(s)--The cause of the medical event was human error in that
the AMP failed to recognize the source's correct placement relative to
the treatment site.
Actions Taken To Prevent Recurrence
Licensee--The corrective action taken by the licensee included
procedure modification such that catheter length measurements are
performed before treatment and the NG tube and HDR catheter are
introduced to the patient as a unit, rather than separately.
Additionally, CT scans will be taken to cover the entire length of the
HDR catheter during all HDR procedures.
NRC--The NRC conducted a special inspection on January 18, 2012,
and contracted with a medical consultant to review the event. The NRC's
medical consultant agreed with the hospital's analysis of this event,
and the NRC issued a NOV to the licensee.
AS12-12 Medical Event at Presbyterian Hospital in Charlotte, North
Carolina
Date and Place--January 5 and 12, 2012, Charlotte, NC.
Nature and Probable Consequences--Presbyterian Hospital (the
licensee) reported that a medical event occurred associated with an HDR
brachytherapy treatment for gastric cancer; the treatment involved
185.4 GBq (5 Ci) of iridium-192. The patient was prescribed to receive
three fractionated doses of 7 Gy (700 rad) to the common bile duct
(treatment site). However, it was determined that a 4 cm length of
tissue in the common bile duct and liver (wrong treatment sites)
received a dose of 14 Gy (1,400 rad). The patient and referring
physician were informed of this event.
On January 18, 2012, while conducting the third fractionated HDR
brachytherapy treatment for gastric cancer, the dosimetrist noticed
that incorrect dwell location was used on the previous two fractioned
treatments. On the previous fractionated treatment dates, January 5,
2012, and January 12, 2012, the dwell position on the HDR was
mistakenly adjusted outward rather than inward. This resulted in
treating only 1 cm of the desired treatment site of the common bile
duct and delivered a dose of 14 Gy (1,400 rad) to 4 cm of the proximal
portion of the bile duct and surrounding liver tissue. The licensee
concluded that the medical event would not have an adverse effect on
the patient.
Cause(s)--The cause of the medical event was human error in that
the
[[Page 54499]]
oncology staff presumed that the source position had been properly
adjusted by the medical physics staff and did not notice this error
until the third fractionated treatment.
Actions Taken To Prevent Recurrence
Licensee--The corrective action taken by the licensee included a
procedure modification such that any catheter dwell position
adjustments of greater than 5 millimeters (mm) mandate a replanning of
the treatment protocol.
State--The North Carolina Division of Radiation Protection
conducted a full inspection of the brachytherapy program (to include
HDR) on February 16, 2012. There were no items of noncompliance, and
the State reviewed and approved corrective actions. The State did not
issue any violations or penalties for this event.
NRC12-03 Medical Event at Avera McKennan Hospital in Sioux Falls, South
Dakota
Date and Place--January 16 and 17, 2012, Sioux Falls, SD.
Nature and Probable Consequences--Avera McKennan Hospital (the
licensee) reported that a medical event occurred associated with an HDR
brachytherapy treatment for breast cancer. The patient was prescribed
to receive 10 fractionated doses of 3.4 Gy (340 rad) for a total dose
of 34 Gy (3,400 rad) to the tumor site (treatment site). However, it
was determined that the skin tissue over the rib cage (wrong treatment
site) received a dose of 27.2 Gy (2,720 rad). The patient and referring
physician were informed of this event.
On January 16, 2012, while conducting the fractionated HDR
brachytherapy treatment for breast cancer, the medical staff identified
that an incorrect treatment parameter length had been entered into the
HDR. The programmed length was 10 cm too short and resulted in the
source traveling to a location 10 cm short of the intended treatment
site (inside the breast). This caused an unintended dose to the skin
over the rib cage. This error was corrected and saved as a secondary
treatment plan in the HDR console, which the staff used to correctly
administer the second fractionated treatment. However, after the staff
delivered the third fraction the following day (January 17, 2012), it
was discovered that the original incorrect treatment plan had been
inadvertently selected by the console operator, resulting in a second
instance where the skin over the rib cage received an unintended dose.
The licensee performed an investigation and the NRC contracted with a
medical consultant, who determined that the patient received
approximately 27.2 Gy (2,720 rad) of unintended skin dose and concluded
that the event would not have an adverse effect on the patient. The
patient experienced skin erythema, or reddening, as was expected from
this level of skin exposure.
Cause(s)--The cause of the medical event was that the licensee
failed to develop and implement effective procedures to ensure that
patient treatment was in accordance with the written directive.
Actions Taken To Prevent Recurrence
Licensee--The corrective actions taken by the licensee included
extensive revisions to the HDR procedures, including the development of
requirements for independent verification of treatment parameter
lengths, and staff training on these changes. The hospital also made
organizational and personnel changes to improve the facility's safety
culture.
NRC--The NRC conducted a special inspection from January 30 through
February 2, 2012, and identified several procedural weaknesses in the
licensee's HDR program. On October 3, 2012, the NRC issued a NOV and
civil penalty to the licensee.
AS12-13 Medical Event at Thomas Jefferson University Hospital in
Philadelphia, Pennsylvania
Date and Place--January 19, 2012, Philadelphia, PA.
Nature and Probable Consequences--Thomas Jefferson University
Hospital (the licensee) reported that a medical event occurred
associated with a radioembolization brachytherapy treatment of liver
cancer for two patients. The first patient received a dose of 0.33 GBq
(8.9 mCi) of yttrium-90 to the liver, but this was the dose prescribed
for a second patient, which was 36 percent less than prescribed. The
second patient received the dosage for the first patient, which was
0.514 GBq (13.9 mCi) or approximately 80 Gy (8,000 rad) and 64 percent
greater than prescribed. The patients and referring physicians were
informed of this event.
On January 20, 2012, the licensee reported that on the previous day
the licensee administered the incorrect prescribed dosage of yttrium-90
to two patients. The licensee stated that the two patients were
scheduled to be treated on the same day, in close time proximity, and
that the worksheets were switched and each patient received the other
patient's dose. The licensee concluded that the medical event would not
have an effect on the two patients. However, the first patient received
a higher dose than planned during the next scheduled treatment to
compensate for the previous lower dosage described in this event. No
adverse medical conditions are expected. The clinical judgment with
respect to the second patient is that even though the dosage was 35
percent above that prescribed in the written directive, the activity
was within levels acceptable for this particular patient and tumor
size.
Cause(s)--The cause of the medical event was human error in that
the medical staff did not verify the written directive before
commencing the treatment, coupled with the erroneous transposition of
the written directives in each patient's file.
Actions Taken To Prevent Recurrence
Licensee--The corrective actions taken by the licensee include
developing and implementing written procedures to both minimize the
chance of errors occurring in the microsphere dose preparation process
and to identify and correct any such errors before administration.
Independent checks by multiple individuals will be made to verify
patient identity, treatment site, and prescribed dosage relative to the
prepared dosage.
State--The PA DEP conducted a reactive investigation on January 26,
2012, and identified inadequacies in the administration procedure to
provide assurances that each treatment is in accordance with the
written directive. A NOV was issued by PA DEP; however, no order or
final action was imposed because a revised dosage administration
procedure was subsequently sent to PA DEP for review.
AS12-14 Medical Event at the Intermountain Medical Center in Murray,
Utah
Date and Place--February 2, 2012, Murray, UT.
Nature and Probable Consequences--The Intermountain Medical Center
(the licensee) reported that a medical event occurred associated with a
radioembolization brachytherapy treatment of liver cancer. The
treatment plan prescribed 5.32 GBq (143.6 mCi) of yttrium-90 to deliver
a total dose of 120 Gy (12,000 rad) to the right lobe of the liver;
however, the patient received the dosage for a different patient. The
dosage administered to the patient was 1.77 GBq (47.8 mCi) of yttrium-
90, which was approximately 33 percent of the prescribed activity or 67
percent lower than the prescribed dose. The resulting dose to the
patient's liver was 39.6 Gy (3,960 rads). The patient and referring
physician were informed of this event.
[[Page 54500]]
On February 2, 2012, two patients were at the licensee's facility
to receive treatment for liver cancer using yttrium-90 microspheres.
The nuclear medicine technologist inadvertently selected the wrong
yttrium-90 microsphere vial and subsequently, administered to the first
patient the dosage that was intended for the second patient. As a
consequence, the first patient received an under dose of approximately
67 percent and because the licensee identified the error prior to
administering any dose to the second patient, the licensee was able to
treat the second patient with the correct dose. The licensee determined
that the medical event would not have an effect on the first patient.
Cause(s)--The cause of the medical event was human error, which
resulted in the licensee administering the wrong radiopharmaceutical
treatment dose to the patient.
Actions Taken To Prevent Recurrence
Licensee--The corrective actions taken by the licensee include a
requirement for two individuals to sign off on the dosage vial, with
the written directive present, before administering the dosage to the
patient. In addition, the licensee committed to following protocol
verification just before treatment to verify the patient's
identification, site being treated, dose to be administered, and the
correct identification on the dose vial.
State--The Utah Department of Environmental Quality, Division of
Radiation Control conducted an investigation on February 6, 2012, and
concluded its investigation on April 19, 2012. The State approved the
licensee's corrective actions and did not issue any violations or
penalties for this event.
AS12-15 Medical Event at Abbott Northwestern Hospital in Minneapolis,
Minnesota
Date and Place--February 2, 2012, Minneapolis, MN.
Nature and Probable Consequences--Abbott Northwestern Hospital (the
licensee) reported to the Minnesota Department of Health (MDH) that a
medical event occurred associated with a SIR-Spheres (microspheres)
treatment of liver cancer involving 1.55 GBq (41.9 mCi) of yttrium-90.
A postprocedure scan of the patient identified a significant undesired
amount of activity in the upper stomach (gastric fundus), spleen and
small intestine (duodenum) (wrong treatment sites). The licensee
estimated doses to these tissues of 44 Gy (4,400 rad), 35 Gy (3,500
rad), and 35 Gy (3,500 rad), respectively. The patient and referring
physician were informed of this event.
On February 3, 2012, the licensee notified MDH that following an
infusion of radioactive yttrium-90, a postprocedure CT scan of the
patient revealed that some of the yttrium-90 was not in the liver as
intended. The scan indicated that 10 to 15 percent of the yttrium-90
appeared in vessels involving the spleen and digestive track. The
patient received followup diagnostic scans to determine a baseline for
future treatment and the long-term prognosis. On February 6, 2012,
after consultation with international and domestic experts, the patient
was administered the radio-protective agent amifostine. The licensee
concluded that the event may result in unintended, permanent functional
damage and some form of future medical intervention was likely needed.
A special review group including surgeons, radiation oncologists, and
interventional radiologists are managing the care of the patient on an
ongoing basis.
Cause(s)--The licensee stated that they had not anticipated any
adverse reactions to this treatment, and that the treatment was
correctly planned and administered. However, the licensee hypothesized
that the cause may have been the result of temporary blood vessel
contractions in the patient due to the passage of the microspheres.
Actions Taken To Prevent Recurrence
Licensee--Corrective actions were not indicated as the licensee
followed appropriate therapy procedures and the treatment had no
unusual implications. Additionally, based upon the large number of this
type of treatment that the licensee has performed, it appears that this
medical event is a rare occurrence.
State--On February 6, 2012, MDH performed an onsite investigation
of the medical event. The MDH concluded that licensee procedures were
appropriately followed and no violations were issued.
AS12-16 Medical Event at Carolina East Medical Center in New Bern,
North Carolina
Date and Place--May 29, 2012, New Bern, NC.
Nature and Probable Consequences--Carolina East Medical Center (the
licensee) reported that a medical event occurred associated with a
manual brachytherapy treatment for prostate cancer. The treatment
consisted of 27 needles containing 65 pre-stranded seeds of iodine-125
with each seed containing 12.6 MBq (0.34 mCi). The physician prescribed
a total dose of 145 Gy (14,500 rad) to the prostate; however, it was
determined during the post implant seed count that all of the seeds
were implanted in the penile bulb (glans) (wrong treatment site). The
resulting dose to the penile bulb was 145 Gy (14,500 rad). The patient
and referring physician were informed of this event.
On May 29, 2012, after completion of the implantation procedure,
the licensee performed a CT scan of the patient to verify the placement
of the implanted seeds. The licensee confirmed that all of the seeds
were improperly implanted in the penile bulb. The patient was informed
the following day, since he had been under the effects of general
anesthesia during and after the procedure. The patient and his family
were counseled at length by the AU within a week of the occurrence of
the medical event. The AU reported that the patient tolerated the
brachytherapy procedure well, without acute toxicity. The AU reported
that anticipated side effects from this event will be similar to the
anticipated side effects from a typical permanent prostate
brachytherapy implant. The licensee concluded that the medical event
would not have a significant medical effect on the patient.
Cause(s)--The cause of the medical event was the incorrect
identification of the prostate during ultrasound imaging resulting in
the improper placement of the brachytherapy seeds.
Actions Taken To Prevent Recurrence
Licensee--The AU compiled a report and discussed corrective actions
with the urologist and the authorized medical physicist. The licensee
revised the procedures to include a mandatory ``time out'' period
during implant procedures, and a quality assurance procedure for pre-
plan ultrasounds. Additional licensee corrective actions include using
single shot fluoroscopy, in addition to ultrasound, to verify placement
of the brachytherapy seed needle at the base of the prostate. Contrast
and other additional enhancements may be used in conjunction with the
fluoroscopy to ensure more accurate imaging results.
State--The North Carolina Division of Radiation Protection
conducted an investigation on June 12, 2012. Two items of noncompliance
were noted: (1) The licensee failed to have documented procedures to
ensure that a therapy is administered in accordance with the written
directive, and (2) the licensee failed to have a program commensurate
with licensed activities. Enforcement actions are pending the
licensee's responses to the State.
[[Page 54501]]
AS12-17 Medical Events at Wheaton Franciscan Healthcare-All Saints in
Racine, Wisconsin
Date and Place--July 15, 2005 through May 20, 2010 (reported on
July 19, 2012), Racine, WI.
Nature and Probable Consequences--Wheaton Franciscan Healthcare-All
Saints (the licensee) reported 15 medical events associated with
prostate brachytherapy seed implant procedures, which occurred between
July 2005 and May 2010. The medical events involved permanent implant
seeds of iodine-125 where the total dose delivered differed from the
prescribed dose by 20 percent or more. The 15 medical events involved
13 patients, including seven patients who received a rectal (wrong
treatment site) dose that exceeded the prescribed prostate dose by more
than 10 Gy (1,000 rads). The patients and physicians were informed of
these events.
The Wisconsin Department of Health Services (WDHS) identified the
medical events during a routine inspection and followed up with a
reactive inspection on July 18, 2012. The WDHS inspectors determined
that the licensee was not reviewing prostate brachytherapy cases
against the medical event criteria. Instead, the licensee was using
established dose-based criteria based upon the postoperative CT scans
of the events. The events involved prostate procedures where the doses
were less than 80 percent or greater than 130 percent of the prescribed
dose, or procedures where the doses to 2 cubic centimeters (cm\3\) of
the rectum or bladder were greater than the prescribed prostate dose.
The AU's review of each of the medical events concluded that the
posterior rows of seeds were placed too close to the rectal mucosa. The
licensee has evaluated all prostate implants performed since 2001. The
licensee concluded that the medical events would not have any adverse
effects on the patients and is monitoring their medical progress.
Cause(s)--The cause of the medical events was human error in that
the licensee was not providing adequate oversight of the permanent
implant prostate brachytherapy program.
Actions Taken To Prevent Recurrence
Licensee--The licensee's corrective actions include: (1) Revising
the prostate implant procedures to include the use of stranded seeds,
(2) allowing only the AU to insert the needles into the prostate, and
(3) a secondary check of the needle position prior to deploying the
seeds. Additionally, the AU is now the only individual who contours the
images on the postoperative CT scan, which is reviewed by the medical
physicist to improve accuracy.
State--The WDHS conducted a reactive inspection on July 18, 2012,
and did not cite the licensee because of the licensee's self-identified
and implemented process improvements prior to the inspection. No
additional cases have met the medical event reporting criteria.
NRC12-04 Medical Event at Deaconess Hospital in Evansville, Indiana
Date and Place--August 15, 2012, Evansville, IN.
Nature and Probable Consequences--Deaconess Hospital (the licensee)
reported that a medical event occurred associated with an HDR mammosite
brachytherapy treatment for breast cancer. The patient was prescribed
to receive 10 fractionated doses for a total dose of 34 Gy (3,400 rad)
to the breast tumor site. However, it was determined that a 4.2-cm
length of skin and fatty breast tissue (wrong treatment sites) received
a dose of 34 Gy (3,400 rad). The patient and referring physician were
informed of this event.
Between March 5 and 9, 2012, the patient received two HDR mammosite
treatments per day to the right breast for a total prescribed dose of
34 Gy (3,400 rad). During a followup appointment on June 11, 2012, it
was noted that the catheter insertion site had not healed. A plastic
surgeon performed surgical removal of the entire skin and breast tissue
area affected by the treatment. The surgical pathology report revealed
a final diagnosis of fat necrosis with granulation tissue radiation
effect. Upon reviewing the pathology report, the prescribing physician
requested complete review of the treatment plan by a qualified
consultant. The consultant discovered that the unintended dose to the
skin and fatty breast tissue was the result of the incorrect
positioning of the HDR source. The possibility of long-term effects are
low, but nonetheless additional skin ulceration and breast tissue
necrosis could occur.
Cause(s)--The cause of the medical event was human error in that
the medical physicist was not familiar with the treatment planning
system for the HDR mammosite device. A contributing factor to the cause
of the event was the licensee's ineffective independent check of the
treatment plan prior to commencing the procedure.
Actions Taken To Prevent Recurrence
Licensee--The corrective actions taken by the licensee include the
independent review, by a qualified third party, of HDR treatment plans
prior to delivery for the first five plans provided by each physician
or physicist. Additionally, the licensee requires the performance of an
additional independent check that verifies the physical orientation of
any channel (catheter) used in an HDR procedure. Finally, the licensee
implemented appropriate training and continuing medical education
programs for all staff participating in HDR procedures.
NRC--The NRC conducted a special inspection on August 22, 2012, and
contracted with a medical consultant to review the event. The NRC's
medical consultant agreed with the hospital's analysis of this event.
On January 31, 2013, the NRC issued a NOV to the licensee.
AS12-18 Medical Event at the Anderson Regional Medical Center in
Meridian, Mississippi
Date and Place--September 10, 2012, Meridian, MS.
Nature and Probable Consequences--Anderson Regional Medical Center
(the licensee) reported that a medical event occurred associated with
an iodine-131 treatment for thyroid carcinoma. The patient was
prescribed to receive a total dose of 25 Gy (2,500 rad) to the thyroid
using 3.7 GBq (100 mCi) of iodine-131. Instead, the patient received
6.03 GBq (162.8 mCi) of iodine-131 for an approximate dose of 40 Gy
(4,000 rad) to the thyroid, which was about 160 percent of the
prescribed dosage to the patient. The patient and referring physician
were informed of this event.
On September 10, 2012, the licensee reported that a patient was
administered 6.03 GBq (162.8 mCi) of iodine-131, instead of the
prescribed 3.7 GBq (100 mCi). An investigation performed by the
licensee revealed that the nuclear medicine technologist misinterpreted
the patient's admission order as a written directive. Specifically, the
nuclear medicine technologist incorrectly interpreted the AU's name and
5.55 GBq (149.9 mCi) of iodine-131 activity on the patient's admission
order as the written directive for the patient's treatment. The written
directive for the patient's treatment was never received by the Nuclear
Medicine Department. The doctor indicated that the patient was
previously treated using a prescribed dose of 100 mCi, and that the
thyroid would be fully saturated with iodine-131. Additionally, the
doctor believes that the thyroid would not have significant uptake of
the excess iodine-131 and this excess would be quickly excreted from
the patient. Therefore, the licensee concluded that this elevated
[[Page 54502]]
dose would not result in any adverse health effects to the patient.
Cause(s)--The medical event was caused by human error coupled with
a new communication process, in which written directives were not
directly communicated to the Nuclear Medicine Department.
Actions Taken To Prevent Recurrence
Licensee--The licensee restored its previous written directive
communication policy, which required the communication of written
directives directly from the AU to the Nuclear Medicine Department and
required written directives for iodine-131 on a specific therapy form.
State--The Mississippi Division of Radiological Health conducted an
investigation on September 19, 2012, and cited the licensee with a
violation for its failure to follow written directive procedures. The
investigation revealed this violation was an isolated incident during a
two-month period where the change in written directive communication
policy took place.
Dated at Rockville, Maryland, this 28th day of August, 2013.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2013-21477 Filed 9-3-13; 8:45 am]
BILLING CODE 7590-01-P