[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