[Federal Register Volume 77, Number 120 (Thursday, June 21, 2012)]
[Notices]
[Pages 37446-37456]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15172]


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NUCLEAR REGULATORY COMMISSION

[NRC-2012-0128]


Report to Congress on Abnormal Occurrences; Fiscal Year 2011; 
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

[[Page 37447]]

reported to Congress annually. During Fiscal Year (FY) 2011, 24 events 
that occurred at facilities licensed by the NRC and/or Agreement States 
were determined to be AOs.
    This report describes five events at NRC-licensed facilities. The 
first event involved radiation exposure to an embryo/fetus, and the 
second was an event of high safety significance at a commercial nuclear 
power plant. The other three events occurred at NRC-regulated medical 
institutions and are medical events as defined in Title 10 of the Code 
of Federal Regulations (10 CFR) part 35. The report also describes 19 
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, the second event involved an 
exposure to the extremities of a radiographer, and the third event 
involved a stolen radiography camera. 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 being described in NUREG-0090, 
Vol. 34, ``Report to Congress on Abnormal Occurrences: Fiscal Year 
2011.'' This report is available electronically at the NRC's Web site 
at http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/ 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 does 
not meet the AO criteria but has 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, one event at an NRC-regulated 
facility and three events at Agreement State-licensed facilities were 
significant enough to be reported as AOs. Although two of these events 
occurred at medical facilities, they involved unintended exposures to 
individuals who were not patients. Therefore, these events belong under 
the Criteria I.A, ``For All Licensees,'' category as opposed to the 
Criteria III.C, ``For Medical Licensees,'' category.
NRC11-01 Human Exposure to Radiation at Portsmouth Naval Medical Center 
in Portsmouth, Virginia
    Date and Place--January 12, 2011, Portsmouth, Virginia.
    Nature and Probable Consequences--The U.S. Department of the Navy 
(the licensee) reported that a female patient at the Naval Medical 
Center in Portsmouth, Virginia (NMCP), received 3,630 MBq (98 mCi) of 
iodine-131 for thyroid ablation therapy. On the day of the treatment 
the patient informed NMCP staff that she was not pregnant and NMCP 
staff administered a pregnancy test as a routine precaution. The 
pregnancy test yielded a negative result. Based on the negative 
pregnancy test results and the patient's interview responses, NMCP 
staff administered iodine-131 to the patient.
    On January 27, 2011, the patient became aware that she was pregnant 
and informed the physician who had administered the treatment. An 
obstetrician estimated that conception had occurred somewhere around 
January 7-10, 2011, and that a pregnancy test administered on January 
12, 2011, would not have been sensitive enough to produce a positive 
result. The NMCP estimated the dose to the embryo to be 21.3 cGy (21.3 
rem) and notified the Naval Radiation Safety Committee that the patient 
may have been pregnant before the therapy. The NMCP staff estimated a 
slight increased risk of early pregnancy failure and this was discussed 
with the patient. The NMCP staff subsequently refined the dose estimate 
to 24.7 cGy (24.7 rem). The NRC contracted with a medical consultant 
who estimated a fetal/embryo dose of 27 cGy (27 rem) and stated that 
embryonic tissue capable of concentrating iodine-131 is not formed 
until 10 to 12 weeks of gestation; therefore, the 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 close proximity of 
conception, which resulted in a negative pregnancy test result, to the 
administration of the iodine-131.
Actions Taken To Prevent Recurrence
    Licensee--The NMCP revised the initial consultation procedures for 
the prescribing physician to stress the importance of discussing with 
the patient the need for sexual abstinence at least 10 days before 
therapeutic dose administration.
    NRC--The NRC conducted an inspection on February 2, 2011, through 
June 2, 2011, and there were no violations of the NRC's requirements 
associated with this event.
AS11-01 Human Exposure to Radiation at Montefiore Medical Center in New 
York City, New York
    Date and Place--September 22, 2006 (reported on April 27, 2011), 
New York City, New York.
    Nature and Probable Consequences--Montefiore Medical Center (the 
licensee) reported that a female patient received 3,519 MBq (95 mCi) of 
iodine-131 for thyroid ablation therapy. Before the treatment, the 
licensee interviewed the patient and ascertained that she was not 
pregnant. The licensee's staff administered a pregnancy test as a 
routine precaution. The pregnancy test yielded a negative result. Based 
on the negative pregnancy test results and the patient's interview 
responses, the licensee administered iodine-131 to the patient.
    On December 22, 2006, the patient returned to the licensee for a 
followup visit. Following that visit, the nuclear medicine department 
staff was informed by another section of the medical center that the 
patient was pregnant. The licensee confirmed the pregnancy with the 
patient's obstetrician/gynecologist. The ultrasound performed by the 
patient's obstetrician/gynecologist revealed that the patient was 
approximately 2-3 weeks pregnant at the time of the iodine-131 
treatment. The licensee estimated that the fetus received about 25 cGy 
(25 rem) of radiation exposure 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 fully formed at the time 
of the treatment. The patient was advised to see a genetic specialist 
to discuss the possible consequences to the fetus from this exposure. 
Although the licensee claimed that it had originally reported the event 
to the New York City Office of Radiological Health in 2006, the

[[Page 37448]]

office had no record of the report. The New York City Office of 
Radiological Health identified the missing report in April 2011, and 
subsequently notified the NRC on June 15, 2011.
    Cause(s)--The cause of this event was the close proximity of 
conception to the iodine-131 treatment and a false negative result on a 
pregnancy test done before the administration of the treatment.
Actions Taken To Prevent Recurrence
    Licensee--The licensee's corrective actions included additions to 
its Safety Precaution Form stressing the necessity of sexual abstinence 
before the treatment and recommending that patients also take 
precautions to avoid getting pregnant for 6 months after the treatment.
    State--The New York City Office of Radiological Health conducted an 
inspection on June 16, 2011, and determined that the licensee had 
followed acceptable protocols before the administration of iodine-131. 
Consequently no civil penalties or enforcement action for this event 
are warranted.
AS11-02 Human Exposure to Radiation at Caribbean Inspection & NDT 
Services, Inc., in Port Lavaca, Texas
    Date and Place--September 12, 2011, Port Lavaca, Texas.
    Nature and Probable Consequences--Caribbean Inspection & NDT 
Services Inc. (the licensee) reported that a radiographer trainee 
received an overexposure to his right hand and was seeking medical 
attention. The radiographer trainee stated that on September 12, 2011, 
while conducting radiography operations in the field, he removed a 
radiography camera guide tube from the Amersham 660 D radiography 
camera. The radiographer trainee stated that he noticed the 2.7 TBq (73 
Ci) iridium-192 source was not fully retracted and protruding from the 
camera about 2 inches. The radiographer trainee stated that he may have 
brushed the source with his hand when he removed the guide tube.
    On September 19, 2011, the radiographer trainee presented himself 
to a Houston, Texas hospital with observable deterministic effects, 
which included blistering of the thumb, index and middle fingers. These 
types of effects correspond to an exposure range of 20-40 Sv (2000 to 
4000 rem) to the extremities. His doctors initially conferred with the 
Radiation Emergency Assistance Center/Training Site in Oak Ridge, TN 
regarding his medical treatment. The trainee is continuing his 
treatment at the Houston, Texas hospital as an out-patient. The 
licensee stated that the results of the trainee's dosimeter indicated 
that he received 14.1 mSv (1.41 rem) whole body exposure based on the 
film badge he was wearing at the time of the event.
    Cause(s)--The State of Texas is currently investigating the cause 
of this event.
Actions Taken To Prevent Recurrence
    Licensee--The licensee is conducting an investigation to determine 
the exact nature and cause of this event. Pending the results of this 
investigation the licensee will determine corrective action and inform 
the State of the circumstances of the event and the corrective actions.
    State--Texas Department of State Health Services, Radiation Control 
Program is currently investigating this incident, which includes 
collecting information from the physicians, the licensee, and the 
individuals involved in the event. Pending the results of this 
investigation and the depositions performed through the General 
Counsel, the Texas Department of State Health Services will determine 
the probable causes of the event and review the licensee's corrective 
actions and consider what, if any, civil penalties and enforcement 
actions to pursue.
AS11-03 Stolen Radiography Camera at Acuren Inspection, Inc., in La 
Porte, Texas
    Date and Place--July 19, 2011, La Porte, Texas.
    Nature and Probable Consequences--Acuren Inspections Inc. (the 
licensee) reported the theft of a radiography camera containing 1.25 
GBq (33.7 Ci) of iridium-192. On July 19, 2011, the licensee discovered 
that their radiography truck had been broken into, and the radiography 
camera, associated equipment, and portable generator had been stolen. 
The alarm system on the truck was then tested and determined to be 
operational; however, the alarm had not been set at the time of the 
theft. Attempts to locate the camera included the use of portable 
radiation detection equipment on vehicles, Austin Police Department/6 
Civil Support Team helicopter flyovers of the area, and a U.S. 
Department of Energy fly-over survey between the cities of Austin and 
San Antonio, using a fixed wing plane.
    It should be noted that at the time this event was reported to the 
NRC, the radioactive material in the camera was at a level considered 
to be risk-significant. However, as of October 1, 2011, the radioactive 
material had decayed to a level considered to not be risk-significant. 
The radioactive source has not been recovered at the time of this 
report.
    Cause(s)--Licensee failure to use the vehicle alarm system.
Actions Taken To Prevent Recurrence
    Licensee--The licensee conducted a company-wide review of the 
incident with all employees, inspected all their trucks to verify the 
alarm systems were operating, and required all employees to view a 
video that showed the proper way to lock and secure radioactive 
material.
    State--The Texas Department of State Health Services conducted an 
inspection on July 21, 2011, and determined that the radiographer had 
failed to activate the alarm system on the truck containing the 
radiography camera. The licensee and the radiographers involved were 
cited for the violation.

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.
NRC11-02 Commercial Nuclear Power Plant Event at Browns Ferry Nuclear 
Plant, Unit 1, in Athens, Alabama
    Date and Place--October 23, 2010, Athens, Alabama.
    Nature and Probable Consequences--The Tennessee Valley Authority 
(TVA) (the licensee) reported a commercial nuclear power plant event at 
Browns Ferry Nuclear Plant, Unit 1, a boiling-water reactor designed by 
General Electric. On October 23, 2010, during a refueling outage, it 
was discovered that a residual heat removal (RHR) low pressure coolant 
injection (LPCI) flow control valve failed while the licensee was 
attempting to establish shutdown cooling. The flow control portion of 
the valve, called the disc, was found stuck in the seat of the valve. 
The disc had become separated from the valve stem and could no longer 
be controlled by the valve motor operator. The RHR system is primarily 
used for LPCI during accident conditions and for cooling while the 
reactor is shut down. As a result of the flow control valve failure, 
Loop II of the RHR system could not have performed its safe shutdown 
functions and was declared inoperable. The licensee promptly placed the 
other loop of the RHR system (Loop I) into service and, as a result, 
the failure of the flow control valve did not involve an actual safety 
consequence or impact the health and safety of the public.

[[Page 37449]]

    However, the NRC reviewed this event under its significance 
determination process and determined that the licensee's history with 
regards to this valve performance issue represented a finding of high 
safety significance (red finding). The basis for this finding was that 
the flow control valve's failure (condition) caused a weakness in the 
licensee's fire mitigation strategy, resulting in a significant 
increase in the core damage frequency. The licensee's fire mitigation 
strategy limits the availability of alternative sources of reactor 
coolant inventory makeup and both loops of LPCI could potentially be 
unavailable in some accident scenarios. Automatic valve function was 
lost, as well as the ability of plant operators to manually use this 
loop of the RHR system.
    The public was never actually endangered because no event requiring 
use of the RHR system occurred. However, the RHR system is counted on 
for core cooling during certain accident scenarios, and the flow 
control valve failure left it inoperable, which could have led to core 
damage had an accident involving a series of unlikely events occurred. 
The NRC determined that this event did not represent an immediate 
safety concern, because the licensee staff had, as part of its 
immediate corrective actions, implemented repairs and modifications in 
accordance with design requirements that returned the flow control 
valve to an operational condition (the red finding was for licensee 
performance deficiencies resulting in a past inoperability).
    Cause(s)--The immediate cause for this condition was separation of 
the valve disc from the stem/skirt, with the disc wedged into the seat 
in the closed position. The licensee determined that part of the root 
cause was a valve manufacturing defect that resulted in undersized disc 
skirt threads at the disc connection to the valve stem. In addition, 
the NRC identified several other performance deficiencies on the part 
of the licensee. Specifically, the NRC determined that the licensee's 
failure to establish adequate programs to ensure that motor-operated 
valves continue to be capable of performing their design-basis safety 
functions was a performance deficiency. The NRC also concluded that TVA 
should have foreseen the results of not including these valves within 
the scope of the program described in Generic Letter 89-10, ``Safety-
Related Motor-Operated Valve Testing and Surveillance,'' dated June 28, 
1989, and should have corrected the problem. This failure to 
effectively maintain and inspect these valves within the program 
contributed to the performance deficiency. The licensee's corrective 
action program and root cause evaluation also did not appear to address 
the broader issues associated with programs to ensure the continued 
capability of motor-operated valves to perform their design-basis 
safety function.
Actions Taken To Prevent Recurrence
    Licensee--The TVA reported this condition under 10 CFR 50.73, 
``Licensee Event Reporting System,'' and under 10 CFR part 21, 
``Reporting of Defects and Noncompliance Process.'' In addition, TVA 
has presented corrective actions related to the flow control valve 
failure and corrective actions that are planned to address long-term 
fire strategies at the Browns Ferry Nuclear Power Station. The flow 
control valve was repaired promptly, and inspections were performed on 
all similar valves for Units 1, 2, and 3 to verify their functional 
capability. The TVA informed the NRC of plans to reduce operator manual 
actions; implement procedural changes related to fire strategy; install 
modifications as a result of its review of National Fire Protection 
Association Standard 805, ``Performance-Based Standard for Fire 
Protection for Light Water Reactor Electric Generating Plants,'' and 
continue to reduce fire risk at the station.
    NRC--The NRC assessed the performance of Browns Ferry Nuclear Power 
Station, Unit 1, to be in the Multiple/Repetitive Degraded Cornerstone 
Column of the NRC's Action Matrix beginning in the fourth quarter of 
Calendar Year 2010. This finding resulted in increased NRC oversight at 
Browns Ferry Nuclear Power Station, including a supplemental inspection 
to evaluate safety, organizational, and programmatic issues at the 
plant. The NRC staff initiated the supplemental inspection at the 
Browns Ferry Nuclear Power Station beginning on September 12, 2011. 
This inspection is being conducted in accordance with inspection 
procedures, and will include extensive reviews of programs and 
processes not inspected as part of the NRC's baseline inspection 
program. The inspection will also include an assessment of the Browns 
Ferry Nuclear Power Station's safety culture. Part 1 of this 
supplemental inspection was completed and an inspection report was 
issued on November 17, 2011 (available at Agencywide Documents Access 
and Management System (ADAMS) Accession No. ML113210602). The results 
of this inspection will be combined with the results from Parts 2 and 3 
of the Browns Ferry Inspection Procedure 95003 (available at ADAMS 
Accession No. ML102020551), and will assist the NRC in determining the 
breadth and depth of safety, organizational, and programmatic issues at 
Browns Ferry Nuclear Power Station. The NRC will report on the final 
supplemental inspection results as part of the FY 2012 AO report to 
Congress.

III. Events at Facilities Other Than Nuclear Power Plants and All 
Transportation Events

C. Medical Licensees

    During this reporting period, three events at NRC-licensed or NRC-
regulated facilities and 16 events at Agreement State-licensed 
facilities were significant enough to be reported as AOs.
AS11-04 Medical Event at Western Pennsylvania Hospital in Allegheny, 
Pennsylvania
    Date and Place--February 23, 2009, Allegheny, Pennsylvania.
    Nature and Probable Consequences--The Western Pennsylvania Hospital 
(the licensee) reported that a medical event occurred associated with a 
high-dose-rate (HDR) mammosite treatment for breast cancer; the 
treatment consisted of 184.2 GBq (4.9 Ci) of iridium-192. The patient 
was prescribed to receive 34 Gy (3,400 rad) in 10 fractionated doses, 
but instead, received a dose of 50 Gy (5,000 rad) to the skin tissue 
around the catheter entry point (wrong treatment site). The patient's 
physicist notified the patient and the referring physician of this 
event.
    Before starting the treatment on February 23, 2009, the medical 
staff performed a check to verify the catheter length and treatment 
calculations. In addition, the treatment procedure required daily CT 
scans to verify the treatment site. On February 27, 2009, a different 
therapy physicist identified a potential error in the patient's chart 
and contacted the patient's physicist. On March 3, 2009, the patient's 
physicist checked the other therapy physicist's findings and discovered 
there had been a 3 cm error in the placement of the source during 
treatment. This incorrect distance resulted in the intended site 
receiving only 30 percent of the intended dose and the skin tissue 
receiving the full dose. The patient received followup care for 
erythema of the skin tissue and the licensee concluded that this 
medical event would not have a significant medical effect on the 
patient.

[[Page 37450]]

    Cause(s)--The medical event was caused by human error in the 
placement of the source during treatment.
Actions Taken To Prevent Recurrence
    Licensee--The licensee revised all mammosite policies and 
procedures to strengthen the accuracy of measurement, planning, 
treatment, and quality control. Specifically, the licensee modified the 
mammosite worksheet to add the expected catheter length beside the 
block where the measured catheter length is recorded, and required that 
the catheter measurement wire be kept in place during CT simulation 
following catheter measurement.
    State--The Pennsylvania Department of Environmental Protection 
investigated the incident on March 18, 2009, 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 November 14, 2011.
AS11-05 Medical Event at the University of Pennsylvania in 
Philadelphia, Pennsylvania
    Date and Place--January 21, 2010, Philadelphia, Pennsylvania.
    Nature and Probable Consequences--The University of Pennsylvania 
(the licensee) reported that a medical event occurred associated with a 
brachytherapy seed implant procedure to treat prostate cancer. The 
patient was prescribed to receive a total dose of 145 Gy (14,500 rad) 
to the prostate using 65 iodine-125 seeds. Instead, the seeds were 
inadvertently placed outside the intended treatment site (wrong 
treatment site). The patient received an approximate dose of 161 Gy 
(16,100 rad) to the penile bulb (glans) (wrong treatment site). The 
patient and referring physician were informed of this event.
    On January 21, 2010, the iodine-125 seeds were implanted in the 
patient's prostate using real time dosimetry under ultrasonic guidance. 
The written directive called for a therapeutic radiation dose of 145 Gy 
(14,500 rad) to the prostate volume, plus 5 mm of margin. On February 
23, 2010, the patient returned for a 30 day post implant CT scan, which 
revealed that the implanted seeds were ``in an appropriate pattern,'' 
but outside the intended target volume, which resulted in unintended 
dose to the penile bulb (glans). The licensee concluded that the 
medical event would not have a significant medical effect on the 
patient.
    Cause(s)--The medical event is presumed to have been caused by 
misuse of a new ultrasound unit.
Actions Taken To Prevent Recurrence
    Licensee--The licensee's Radiation Oncology Department suspended 
all prostate brachytherapy treatments pending an additional quality 
assurance review. Upon completion of the quality assurance review, the 
licensee modified its prostate brachytherapy treatment procedures. As 
of January 2012, the licensee has not yet resumed prostate 
brachytherapy treatments after implementation of these modified 
procedures.
    State--The Pennsylvania Department of Environmental Protection 
investigated the incident on April 15, 2010, 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 November 14, 2011.
AS11-06 Medical Event at University Community Hospital in Tampa, 
Florida
    Date and Place--February 14, 2010, Tampa, Florida.
    Nature and Probable Consequences--The University Community Hospital 
(the licensee) reported that two patients were prescribed single-
channel HDR brachytherapy treatments of 34 Gy (3,400 rad). An actual 
average dose of 17 Gy (1,700 rad) to the first patient, and 26 Gy 
(2,600 rad) to the second patient, were delivered to the target area of 
the breast, and some parts of the planned volume received greater than 
700 percent (first patient) and 220 percent (second patient) of the 
prescribed dose. In addition, other areas of the breast not in the 
target region received up to 136 Gy (13,600 rad) in the first patient 
and 75 Gy (7,500 rad) in the second patient. The maximum skin dose was 
calculated to be 42.5 Gy (4,250 rad) to the first patient and 75 Gy 
(7,500 rad) to the second patient. The patients and their referring 
physicians were informed of the events.
    On February 14, 2010, the licensee noted that the source within the 
mammosite catheter was erroneously positioned approximately 2 to 2.5 cm 
away from the tumor. This was the result of the operator entering the 
wrong dwell position into the planning system. The licensee concluded 
that no significant adverse health effects to the patients are 
expected.
    Cause(s)--The cause of the medical events was human error involving 
entering the wrong position of the reference end of the catheter into 
the planning system.
Actions Taken To Prevent Recurrence
    Licensee--Corrective actions included implementing various quality 
assurance steps to ensure that the correct treatment calculations and 
data are used for future treatments. Additional procedural guidance 
will be created with detailed instructions.
    State--The Florida Bureau of Radiation Control initiated an 
inspection on February 18, 2010. The State completed the inspection on 
March 1, 2010, 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 February 1, 2011.
AS11-07 Medical Event at Coral Springs Clinic in Coral Springs, Florida
    Date and Place--March 11, 2010, Coral Springs, Florida.
    Nature and Probable Consequences--The Coral Springs Clinic (the 
licensee) reported that a medical event occurred associated with an HDR 
brachytherapy treatment for basal cell carcinoma of the ear. The 
patient was prescribed 14 fractionated doses of 2.5 Gy (250 rad) to the 
ear, but instead, the patient received 22.5 Gy (2,250 rad) on the 
second fractionated treatment dose. The patient and referring physician 
were informed of this event.
    While starting the treatment the radiation therapist accidentally 
pushed the incorrect button on the HDR device, which was the ``auto 
radiography'' button rather than the ``treatment'' button on the 
machine control console. This resulted in the patient receiving 
approximately 9 times the intended dose for that fraction of the 
treatment. Further treatments were canceled. The patient and doctor 
were notified of the incident. The licensee concluded that no 
significant health effects to the patient are expected as a result of 
this incorrect dose.
    Cause(s)--The medical event was caused by human error in that the 
radiation therapist failed to push the correct button on the HDR 
device.
Actions Taken To Prevent Recurrence
    Licensee--The licensee immediately disabled the autoradiograph 
function on the HDR and other similar devices. The licensee modified 
its procedures to include the use of an independent mechanical timer 
and provided additional training to its entire clinical staff.
    State--The Florida Bureau of Radiation Control initiated an 
inspection on April 27, 2010, 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 October 
10, 2011.

[[Page 37451]]

AS11-08 Medical Event at Rhode Island Hospital in Providence, Rhode 
Island
    Date and Place--April 23, 2010, Providence, Rhode Island.
    Nature and Probable Consequences--The Rhode Island Hospital (the 
licensee) reported that a medical event occurred during a thyroid 
diagnostic uptake scan. The patient was prescribed to receive 7.4 MBq 
(200 [micro]Ci) of iodine-123, but was administered 148 MBq (4 mCi) of 
iodine-131. The administration resulted in a dose of approximately 
3,108 cGy (3,108 rad) to the patient's thyroid, rather than the 
estimated 7 cGy (7 rad) that would have resulted from the iodine-123 
administration. The patient and referring physician were informed of 
this event.
    The patient's physician handed the patient a written prescription 
for the iodine-123 scan, but the physician's office faxed an incorrect 
order to the hospital for an iodine-131 scan. On April 23, 2010, the 
patient presented the correct written prescription slip, for the 
iodine-123, to the licensee's admitting receptionist. The receptionist 
refused the written prescription, because she thought the hospital 
already had the correct prescription in its records. The patient was 
administered the iodine-131, and the whole body scan was performed. The 
nuclear medicine technologist noticed something was wrong based on the 
scan results. The impact of this event on the patient was not reported 
by the licensee.
    Cause(s)--The cause of this medical event was human error and 
failure of the licensee staff to follow existing written procedures and 
protocols.
Actions Taken To Prevent Recurrence
    Licensee--The licensee reviewed existing written protocols and 
training procedures used for the nuclear medicine technologists. The 
licensee's corrective actions included modifying the procedures and 
conducting refresher training for the nuclear medicine technologists. 
In addition, the licensee developed a thyroid interview and patient 
assessment history sheet and now requires a pathology report for all 
thyroid cancer patients before iodine-131 doses are administered.
    State--The Rhode Island Department of Health, Radiation Control 
Program, conducted an investigation of this medical event on April 30 
through May 20, 2010, and issued a Notice of Violation (NOV) to the 
licensee. The Rhode Island Department of Health also issued a 
regulatory citation regarding the licensee's failure to follow 
established procedures and forwarded the final update of the event to 
the NRC in September 2011.
AS11-09 Medical Event at Lovelace Medical Clinic in Albuquerque, New 
Mexico
    Date and Place--May 4, 2010, Albuquerque, New Mexico.
    Nature and Probable Consequences--The Lovelace Medical Clinic (the 
licensee) reported that a medical event occurred associated with an HDR 
brachytherapy treatment for endometrial carcinoma; the treatment 
consisted of 129.7 GBq (3.5 Ci) of iridium-192. The patient was 
prescribed to receive a total dose of 21 Gy (2,100 rad) in three 
fractionated doses to the vaginal cuff, but instead, the skin tissue on 
the patient's thigh received 30.6 Gy (3,060 rad). The patient and 
referring physician were informed of this event.
    On May 4, 2010, the patient received the third fractionated dose of 
7 Gy (700 rad) and, 1 week later, noticed the appearance of two 
somewhat painful dark spots on the skin of her thigh. On May 18, 2010, 
the patient notified the licensee of the appearance of the spots on her 
skin and was examined by the prescribing physician the next day. The 
prescribing physician did not diagnose the spots as radiation erythema 
at this time, but asked the patient to return for a followup 
examination approximately a week later. On May 26, 2010, the physician 
identified two circular areas with a diameter of approximately 1 cm, 
which were determined to be radiation erythema. The average skin dose 
to the patient's thigh was calculated to be 30.6 Gy (3,060 rad) and the 
thigh dose at a depth of 2.5 cm was calculated to be 4.08 Gy (408 rad). 
The licensee concluded that no long-term medical effects are expected 
for the patient.
    Cause(s)--The medical event was caused by either improper placement 
or workers inadvertently moving the catheter while adjusting the 
patient for better alignment with the treatment device.
Actions Taken To Prevent Recurrence
    Licensee--The licensee revised its procedures to ensure that the 
catheter is correctly positioned before the start of the treatment. In 
addition, the licensee required staff training to address the procedure 
updates.
    State--The New Mexico Radiation Control Bureau is conducting a 
long-term investigation of the event and the licensee's corrective 
actions and is still considering what, if any, enforcement actions to 
pursue.
AS11-10 Medical Event at Lancaster General Hospital in Lancaster, 
Pennsylvania
    Date and Place--June 3, 2010, Lancaster, Pennsylvania.
    Nature and Probable Consequences--The Lancaster General Hospital 
(the licensee) reported that a medical event occurred associated with 
an HDR brachytherapy treatment for ovarian cancer; the treatment 
consisted of 310.8 GBq (8.4 Ci) iridium-192. The patient was prescribed 
to receive 7.2 Gy (720 rad) in five fractionated doses, but instead 
during one of the fractionated treatments received a dose of 19 Gy 
(1,900 rad) to the small bowel (wrong treatment site). The patient and 
referring physician were informed of this event.
    On June 15, 2010, before starting the second treatment, the medical 
staff noted that an incorrect target area had been previously entered 
into the HDR device for the first treatment on June 3, 2010. The 
medical staff noted that the intended treatment area in the written 
directive differed from the actual area treated by approximately 3 cm. 
This error in treatment area resulted in a dose of 19 Gy (1,900 rad) to 
the small bowel. The licensee concluded that the medical event would 
not have a significant medical effect on the patient.
    Cause(s)--The medical event was caused by human error in that the 
licensee entered the incorrect target area into the HDR device.
Actions Taken To Prevent Recurrence
    Licensee--The licensee implemented corrective measures including 
procedure modifications to discontinue using the part of the HDR 
software that allows for treatment offsets to occur.
    State--The Pennsylvania Department of Environmental Protection 
investigated the incident on June 21, 2010, 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 November 14, 2011.
AS11-11 Medical Event at the Greater Baltimore Medical Center in 
Baltimore, Maryland
    Date and Place--July 9, 2010, Baltimore, Maryland.
    Nature and Probable Consequences--The Greater Baltimore Medical 
Center (the licensee) reported that a medical event occurred associated 
with a manual brachytherapy treatment for cervical cancer. The patient 
was prescribed to receive 35 Gy (3,500 rad) to the cervix over the 
course of 73 hours using 1.635 GBq (44.2 mCi) of cesium-137. While the 
sources were being

[[Page 37452]]

inserted into the patient, one of the cesium-137 sources fell out of 
the Fletcher-Suit applicator and into the patient's hospital gown. 
Consequently, the skin tissue on the patient's buttocks received a dose 
of 10.5 Gy (1,050 rad) from the errant source. The patient and 
referring physician were informed of this event.
    Sometime after the sources had been inserted into the patient, the 
patient removed the hospital gown, folded it, placed it with the trash, 
and donned a clean gown. On July 9, 2010, the oncologist and medical 
physicist removed the sources from the patient and discovered that one 
of the six sources was missing. The oncologist and radiation safety 
officer subsequently located the source wrapped in the soiled hospital 
gown in a bag designated for radioactive waste. The source was 
retrieved and transported back to the Radiation Oncology Department's 
source storage room. The licensee noticed no erythema of the patient's 
skin and concluded that no clinically significant side effects would be 
expected from the radiation exposure to the skin.
    Cause(s)--The cause of the medical event was the failure of the 
source attachment to the applicator, coupled with failure of the 
licensee to establish appropriate procedures to prevent the occurrence 
of the medical event.
Actions Taken To Prevent Recurrence
    Licensee--The licensee plans to discontinue the use of the 
Fletcher-Suit applicator used during this treatment and exclusively use 
the Fletcher-Suit-Delclos applicator. The licensee also plans to revise 
procedures for brachytherapy applicators and provide improved training 
to the staff.
    State--The Maryland Department of the Environment, Radiological 
Health Program conducted an investigation on July 27, 2010, and August 
18, 2010. On October 18, 2010, the Department issued a letter and NOV 
to the licensee and forwarded the final update of the event to the NRC 
in July 2011.
NRC11-03 Medical Event at the G.V. (Sonny) Montgomery VA Medical Center 
in Jackson, Mississippi
    Date and Place--August 4, 2008 (reported on September 8, 2010), 
Jackson, Mississippi.
    Nature and Probable Consequences--The U.S. Department of Veterans 
Affairs (the licensee) reported that a medical event involving prostate 
cancer brachytherapy seed implants occurred at the G.V. (Sonny) 
Montgomery VA Medical Center in Jackson, Mississippi. The patient was 
prescribed to receive a total dose of 145 Gy (14,500 rad) to the 
prostate using 104 iodine-125 seeds. However, the seed placement 
resulted in an approximate dose of 233 Gy (23,300 rad) to the patient's 
rectum (wrong treatment site). The patient and referring physician were 
informed of this event.
    In September 2010, the medical center staff completed a followup 
comprehensive external review and reanalysis of posttreatment dose 
parameters for all prostate seed implants performed at the G.V. (Sonny) 
Montgomery VA Medical Center for the period between February 2005 and 
August 2008. Upon an evaluation of the updated dose information 
generated by external review, medical center staff, working with the 
National Health Physics Program, discovered this event. No adverse 
effect to the patient is expected from the implant procedure, and the 
licensee continues to monitor the progress of the patient.
    Cause(s)--The cause of the medical event was an anatomical anomaly 
of the patient. The patient had an unusually thin tissue layer between 
the prostate gland and rectum, which resulted in a small area of the 
rectum receiving a higher than expected dose.
Actions Taken To Prevent Recurrence
    Licensee--The U.S. Department of Veterans Affairs, working with the 
National Health Physics Program and the medical center's staff, 
performed an initial review of all prostate brachytherapy seed implant 
procedures for the period between February 2005 and August 2008. The 
initial review of this program resulted in the suspension of and 
eventual termination of the medical center's prostate brachytherapy 
implant program in August 2009. The followup comprehensive external 
review and reanalysis of the program identified this event, which the 
medical center reported to the licensee and the NRC.
    NRC--In August 2010, the NRC issued an NOV and Proposed Imposition 
of Civil Penalties to the licensee, based on the results of the initial 
evaluation and analysis of several events associated with the 
licensee's prostate brachytherapy implant program. The licensee was 
cited for failure to have adequate written procedures and failure to 
verify that the administered doses were in accordance with written 
directives. The NRC has not taken any additional actions based on the 
identification of this event.
NRC11-04 Medical Event at Community Hospitals of Indiana in 
Indianapolis, Indiana
    Date and Place--October 6, 2010, Indianapolis, Indiana.
    Nature and Probable Consequences--The Community Hospitals of 
Indiana (the licensee) reported that a medical event occurred 
associated with an HDR brachytherapy treatment for breast cancer; the 
treatment consisted of 340.4 GBq (9.2 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 postsurgical cavity in the left breast 
following excision of a cancerous tumor (treatment site). It was 
determined that the first eight treatment fractions resulted in a 
portion of the treatment site receiving a dose of 266 Gy (26,600 rad). 
In addition, a portion of the patient's skin on the left breast and the 
chest muscle tissue (tissue other than the treatment site) received 
doses of 105 Gy (10,500 rad) and 1,002 Gy (100,200 rad), respectively. 
The patient and referring physician were informed of this event.
    On October 6, 2010, following the eighth fractionated treatment 
dose, an error was discovered in the treatment plan by the medical 
physicist who remembered that he had not changed a default entry in the 
treatment planning system. This error caused the source placement to be 
flipped 180 degrees along the applicator's long axis which resulted in 
a portion of the treatment site at the tip end of the applicator 
receiving less than the prescribed dose, and a portion of the treatment 
site at the connector end of the applicator receiving more than the 
prescribed dose. The licensee concluded that no long-term medical 
effects are expected for the patient. The NRC contracted with a medical 
consultant who determined that the overall impact to the patient is 
minimal.
    Cause(s)--The medical event was caused by human error in that the 
medical physicist failed to change a default entry in the treatment 
planning system as required by the licensee's procedure.
Actions Taken To Prevent Recurrence
    Licensee--The licensee revised its written directive form to remind 
staff to change the default entry in the treatment planning system as 
applicable, added a step to its procedure for multicatheter HDR breast 
treatments to verify that the default was changed as applicable, and 
trained its staff on the revised written directive form. In addition, 
the licensee evaluated all of the other HDR breast treatments that

[[Page 37453]]

were conducted in 2010 to verify that the applicators were accurately 
reconstructed in the treatment planning computer.
    NRC--The NRC conducted a reactive inspection on October 18-20, 
2010, with continued in-office review through January 18, 2011, and 
issued two NOVs to the licensee on March 1, 2011, and April 20, 2011, 
respectively.
AS11-12 Medical Event at Cleveland Clinic Foundation in Cleveland, Ohio
    Date and Place--October 26, 2010, Cleveland, Ohio.
    Nature and Probable Consequences--The Cleveland Clinic Foundation 
(the licensee) reported, to the Ohio Department of Health (ODH) that a 
medical event occurred associated with a radioembolization 
brachytherapy treatment for liver cancer; the treatment consisted of 
3.96 GBq (107 mCi) of yttrium-90. A postprocedure scan of the patient 
identified significant undesired activity in the duodenum (wrong 
treatment site). The licensee estimated that approximately 0.37 GBq (10 
mCi) of activity was present in the duodenum, with a dose to the 
duodenum of approximately 90 Gy (9,000 rad). The patient and physician 
were informed of this event.
    Approximately 3 weeks before the therapy, the patient was scanned 
for extra hepatic shunting by injecting technetium-99m into the hepatic 
artery. No shunting to the duodenum was identified during this 
procedure. On October 26, 2010, the interventional radiologist 
correctly inserted the catheter into the patient and its placement was 
confirmed by a second interventional radiologist. During the 
radioembolization treatment, the patient complained of pain, which 
resulted in the medical staff performing a postprocedure SPECT/CT scan 
of the patient. The SPECT/CT scan identified undesired yttrium-90 
activity in the duodenum. The patient was hospitalized for observation 
and possible intervention as a result of the dose to the duodenum. Some 
ulceration of the duodenum bulb was observed, but no evidence of 
perforation or bleeding was detected. The licensee is continuing to 
monitor the patient for health effects from the radiation exposure.
    Cause(s)--The licensee reported that the cause of the medical event 
was that some collateral blood vessels became dominant and blood was 
shunted through them to the duodenum, allowing movement of the yttrium-
90 microspheres. Although the licensee has not seen this relatively 
uncommon occurrence in the past 3 years, it has been noted in other 
treatment cases.
Actions Taken To Prevent Recurrence
    Licensee--The licensee modified its radioembolization therapy 
procedure to include posttreatment imaging of yttrium-90 distribution. 
This will allow the licensee to respond appropriately in the event of a 
recurrence. The licensee's rate of occurrence is approximately 10 times 
less than is reported in medical literature; therefore, no specific 
action to prevent a reoccurrence is proposed.
    State--On November 3, 2010, The ODH performed an onsite 
investigation of the event. The ODH reviewed and approved the 
licensee's corrective actions and took no enforcement action.
AS11-13 Medical Event at Rush University Medical Center in Chicago, 
Illinois
    Date and Place--November 23, 2010, Chicago, Illinois.
    Nature and Probable Consequences--The Rush University Medical 
Center (the licensee) reported that a medical event occurred associated 
with a brachytherapy seed implant procedure to treat prostate cancer. 
The patient was prescribed to receive a total dose of 145 Gy (14,500 
rad) to the prostate using 102 iodine-125 seeds. Instead, the seeds 
were placed 4-5 cm inferior of the treatment plan (wrong treatment 
site). The patient received an approximate dose of 273.5 Gy (27,350 
rad), 112 Gy (11, 200 rad), and 183 Gy (18,300 rad) to the urethra, 
perineum, and penile bulb (glans), respectively. The patient and 
referring physician were informed of this event.
    During the treatment, the iodine-125 seeds were manually inserted 
into the prostate needle template via ultrasound imaging. Visualization 
of the seed placement in the postimplantation scan was problematic for 
the licensee's staff; however, the staff's initial estimate of seed 
placement was that the seeds may have been inferior to the ideal 
placement, but still in an acceptable location. An additional 
posttreatment scan at the 4-week posttreatment mark indicated that the 
seeds were placed 4-5 cm inferior to the planned treatment site. The 
licensee surmised that the geometry of the template against the 
patient's perineum shifted during the procedure, and pulled away from 
the patient, perhaps due to leg movement or coughing. This placement 
resulted in an elevated dose to the patient's urethra, perineum, and 
penile bulb (glans). The licensee concluded that there were no observed 
medical effects to the patient, and no long-term significant 
complications are expected.
    Cause(s)--The cause of the medical event was the engorgement of the 
prostate gland and surrounding tissue, which made the visualization and 
placement of the seeds difficult during the implantation procedure.
Actions Taken To Prevent Recurrence
    Licensee--The licensee has indicated that these procedures will now 
be conducted only where fluoroscopic imaging can be performed to 
provide better ``real time'' imaging of seed placement, in addition to 
transrectal ultrasound. Needle unloading procedures have been modified, 
and ultrasound equipment quality assurance tests have been added before 
each procedure.
    State--The Illinois Emergency Management Agency (IEMA) conducted an 
onsite investigation. The IEMA reviewed the event and other similar 
treatment procedures at the facility and determined that this event was 
an isolated incident. The IEMA approved the licensee's corrective 
actions, and issued no citations or enforcement actions at the 
conclusion of the investigation.
AS11-14 Medical Event at the University of Texas Southwestern Medical 
Center in Dallas, Texas
    Date and Place--July 30, 2010, and September 16, 2010 (reported on 
February 15, 2011), Dallas, Texas.
    Nature and Probable Consequences--The University of Texas 
Southwestern Medical Center (the licensee) reported the occurrence of a 
medical event to two young adult patients prescribed colloidal 
phosphorus-32 (ranging from 7.4 MBq (0.2 mCi) to 92.5 MBq (2.5 mCi) of 
activity) for treatment of cranial cysts. The patients were prescribed 
to receive a total dose of 300 Gy (30,000 rad) and 200 Gy (20,000 rad) 
respectively, but instead the patients received an approximate dose of 
565 Gy (56,500 rad) and 506 Gy (50,600 rad) to the cysts. These dosages 
were 88 and 153 percent greater than the prescribed dosages. The 
patients and referring physicians were informed of these events.
    On February 15, 2011, the licensee discovered that two young adult 
patients were administered doses of phosphorus-32 greater than 50 
percent of the prescribed doses. The incidents were discovered when the 
authorized user noticed an area of inflammation surrounding the cysts 
and along the track of the drainage catheter. The authorized user 
discussed these findings with the staff medical physicist who reviewed 
the colloidal phosphorus-32 doses supplied by the nuclear pharmacy. The 
licensee determined that

[[Page 37454]]

for both cases, the labels had the correct total activity, but the 
incorrect volume and activity per unit volume. Therefore, the doses 
were incorrectly labeled, and the concentration was approximately 60 
percent higher than indicated on the labels. The licensee subsequently 
calculated the doses to the target and surrounding tissues and does not 
expect any patient impact or unfavorable outcomes as a result of these 
events.
    Cause(s)--The cause of the medical event was that the two colloidal 
phosphorus-32 prescriptions provided by the vendor's nuclear pharmacy 
were incorrectly diluted and labeled. In addition, the licensee did not 
perform a verification assay of the doses before their administration.
Actions Taken To Prevent Recurrence
    Licensee--To prevent recurrence, the licensee will obtain future 
doses that have been calibrated to a National Institute of Standards 
and Technology traceable standard. The licensee also will perform a 
verification assay at its facility and will assess the dose volume for 
calculating the specific activity.
    State--On March 1, 2011, the Texas Department of State Health 
Services conducted an inspection and reviewed the causes and the 
licensee's corrective actions. The licensee was cited for a violation 
for failing to perform a direct measurement of the dosage taken from a 
bulk quantity for medical purposes.
NRC11-05 Medical Event at the University of Michigan Hospital in Ann 
Arbor, Michigan
    Date and Place--March 9, 2011, Ann Arbor, Michigan.
    Nature and Probable Consequences--The University of Michigan 
Hospital (the licensee) reported that a medical event occurred 
associated with a radioembolization brachytherapy treatment of liver 
cancer; the treatment consisted of 2.24 GBq (60.5 mCi) of yttrium-90. 
The patient was prescribed to receive a total dose of 74.4 Gy (7,440 
rad) to the left lobe of the liver, but instead, the patient received 
an approximate dose of 159.4 Gy (15,940 rad). This dosage was in excess 
of 100 percent of the prescribed dosage to the patient. The patient and 
referring physician were informed of this event.
    On March 9, 2011, before the treatment, the licensee's medical 
physicist calculated the activity needed for the dose to the left lobe 
of the liver. The medical physicist's calculations used the liver 
segment volumes for the right lobe and medial segment combined, instead 
of the much smaller left lobe. As a result of the volume calculation 
error, the dose to the left lobe of the liver was 159.4 Gy (15,940 
rad), which was in excess of 100 percent of the prescribed dose. The 
licensee concluded that the elevated radiation dose to the patient's 
liver will not result in permanent medical damage or loss of function. 
The NRC contracted with a medical consultant who concluded that the 
administered dose is unlikely to result in any significant adverse 
effects.
    Cause(s)--The NRC determined that the root cause of the medical 
event was a lack of communication between licensee personnel which 
resulted in an inaccurate written directive and subsequent medical 
event.
Actions Taken To Prevent Recurrence
    Licensee--The licensee modified procedures by adding reviews of 
treatment plans to ensure that written directives properly reflect the 
treatment plan.
    NRC--The NRC conducted an inspection on March 15 and 16, 2011, and 
reviewed the licensee's corrective actions. On January 6, 2012, NRC 
issued an NOV for failure to possess adequate procedures resulting in 
the medical event.
AS11-15 Medical Event at Abbott Northwestern Hospital in Minneapolis, 
Minnesota
    Date and Place--March 17, 2011, Minneapolis, Minnesota.
    Nature and Probable Consequences--The Abbott Northwestern Hospital 
(the licensee) reported that a medical event occurred associated with a 
radioembolization brachytherapy treatment of liver cancer; the 
treatment consisted of 1.11 GBq (29.97 mCi) of yttrium-90. The patient 
was prescribed to receive a total dose of 30.8 Gy (3,080 rad) to the 
liver, but instead, the patient received an approximate dose of 46.1 Gy 
(4,610 rad). This delivered dosage was about 150 percent of the 
prescribed dosage to the patient. The patient and referring physician 
were informed of this event.
    On March 18, 2011, after reviewing the treatment procedure from the 
previous day, the licensee's radiation oncologist discovered that the 
dose delivered to the patient's liver was actually 150 percent of the 
prescribed dose. For further clarification, the radiation oncologist 
brought this error to the attention of the lead medical physicist 
responsible for the patient's treatment delivery. Upon investigation, 
it was deduced that the medical physicist had not read the patient's 
therapy written directive prescription correctly, resulting in a higher 
than intended dosage being administered to the patient's liver. The 
licensee's radiation oncologist and interventional radiologist 
concluded that this elevated dose would slightly increase the patient's 
risk of radiation-induced liver disease.
    Cause(s)--The medical event is believed to have been caused by 
human error in failing to correctly read the therapy written directive 
prescription.
Actions Taken To Prevent Recurrence
    Licensee--The licensee implemented corrective measures, including 
increasing the font and highlighting in a different color the final 
dose on the written directive. In addition, the final dose is now 
transferred automatically rather than manually to the spreadsheet 
workbook used to draw up the dose. Also, procedures now require a 
second individual to verify that the correct prescribed activity has 
been transferred to the worksheet used for drawing up the dose.
    State--The Minnesota Department of Health (MDH) conducted an 
investigation on April 5, 2011. During the investigation, MDH met with 
the radiation safety officer, the medical physicist and both radiation 
oncologists involved with the incident, and several members of the 
licensee administrative team. In addition, MDH reviewed the corrective 
actions implemented by the licensee. The MDH did not issue any 
violations or penalties associated with the event; however, MDH will 
evaluate the licensee's corrective actions at its next inspection.
AS11-16 Medical Event at the University of California, Los Angeles in 
Los Angeles, California
    Date and Place--April 4, 2011, Los Angeles, California.
    Nature and Probable Consequences--The University of California, Los 
Angeles (UCLA) (the licensee) reported the occurrence of a medical 
event associated with a brachytherapy seed implant procedure to treat 
prostate cancer. The patient was prescribed a dose of 144 Gy (14,400 
rad) to the prostate using 101 iodine-125 seeds. Instead, the iodine-
125 seeds were implanted inferior to the target volume (wrong treatment 
site), resulting in a dose to this tissue of 144 Gy (14,400 rad). The 
patient and referring physician were informed of this event.
    On May 3, 2011, the patient returned to the UCLA Department of 
Radiation Oncology for a routine postimplant CT scan to verify seed 
placement and final dosimetry endpoints. The routine postimplant CT 
scan indicated that of the 101 total seeds implanted, approximately 72 
seeds had been placed inferior to the target volume. As a result

[[Page 37455]]

of the seed misplacements, approximately 31 cm\3\ of normal tissue 
inferior to the prostate received at least 144 Gy (14,400 rad) instead 
of the prostate tissue receiving that dose. Rectal and bladder doses 
were not significantly impacted by the seed misplacements and remained 
within typical doses for prostate implants. The licensee concluded that 
there was no harm to the patient from doses to the nontargeted tissue.
    Cause(s)--The licensee reported that the cause of the medical event 
was movement of the prostate gland during the implantation procedure, 
coupled with insufficient ultrasound images needed to identify the 
movement of the prostate gland during the procedure.
Actions Taken To Prevent Recurrence
    Licensee--The licensee temporarily placed the permanent prostate 
seed implantation program on hold pending a review of the procedures. 
Upon completion of the review the licensee changed the implant 
procedure to require the verification of the base prostate plane and 
needle placement using both axial and sagittal plane ultrasound views. 
The licensee also did an internal investigation to determine if any 
similar incidents of seed misplacements had occurred in the past and 
reported that postimplant CT had been performed for at least the 
previous 5 to 6 years without the detection of any significant seed 
misplacement events.
    State--The California Radiation Control Program investigated the 
event and issued violations for failing to have adequate prostate seed 
implantation procedures, failing to report the medical event within 24 
hours of discovery, failing to provide a written report with all of the 
required information for the medical event within 15 days, and failing 
to have procedures and to adequately train staff and authorized users 
for reporting of medical events.
AS11-17 Medical Event at St. Vincent Hospital in Green Bay, Wisconsin
    Date and Place--May 15, 2011, Green Bay, Wisconsin.
    Nature and Probable Consequences--The St. Vincent Hospital (the 
licensee) reported that a medical event occurred associated with HDR 
brachytherapy treatment for breast cancer; the treatment consisted of 
318.2 GBq (8.6 Ci) of iridium-192. The patient was prescribed to 
receive a total dose of 34 Gy (3,400 rad) over 10 fractionated 
treatments. Instead, the patient received 8.84 Gy (884 rad) to the 
tumor site and a dose of 67.5 Gy (6,750 rad) to unintended skin tissue. 
The patient and referring physician were informed of this event.
    On June 6, 2011, the licensee determined that the applicator 
catheter lengths measured using the check ruler were incorrect during 
the breast cancer treatment. The licensee ascertained that the 
incorrect measurement was the result of the wire being caught at the 
apex of the curved catheter, approximately 4.5 cm from of the end of 
the catheter. Members of the licensee's staff assumed that this 
measured length was accurate because they were not aware of the nominal 
catheter length. The Wisconsin Department of Health Services verified 
that the nominal catheter length was not provided in the manufacturer's 
written procedure, and the manufacturer determined that the check wire 
used by the licensee met all design specifications. The licensee 
concluded that there were no observed significant adverse effects to 
the patient, and no long-term significant complications are expected.
    Cause(s)--The cause of the medical event was human error in the 
failure to identify that the check wire was not inserted to the end of 
the catheter's lumen and failure to identify an incorrect measurement 
length.
Actions Taken To Prevent Recurrence
    Licensee--Corrective actions include obtaining a new measurement 
wire that has the same flexible tip as the HDR dummy wire. The 
treatment protocol was changed to incorporate the manufacturer's 
expected applicator treatment distances. In addition, the licensee 
developed a new policy and procedure, which emphasizes the due 
diligence required by the staff before the first clinical use of new 
HDR treatment applicators and guide tubes.
    State--Based on its investigation conducted on June 14, 2011, the 
Wisconsin Department of Health Services cited the licensee for failure 
to develop, implement, and maintain written procedures to ensure that 
each administration is performed according to the provisions of the 
written directive.
AS11-18 Medical Event at the University of Wisconsin--Madison in 
Madison, Wisconsin
    Date and Place--July 7, 2011, Madison, Wisconsin.
    Nature and Probable Consequences--The University of Wisconsin--
Madison (the licensee) reported that a medical event occurred 
associated with radioembolization brachytherapy treatment for liver 
cancer; the treatment consisted of 1.05 GBq (28.4 mCi) of yttrium-90. 
The patient was prescribed to receive a total dose of 120 Gy (12,000 
rad) to the left lobe of the liver, but instead, the patient received 
an approximate dose of 41.8 Gy (4,180 rad) to the right lobe of the 
liver (wrong treatment site). The patient and referring physician were 
informed of this event.
    On July 7, 2011, the patient was scheduled for treatment for 
multinodular hepatocellular carcinoma to the left lobe of the liver. 
The dosimetry for yttrium-90 radioembolization brachytherapy treatment 
was based on the volume (mass) of the left lobe. The written directive 
specified the treatment of the left lobe of the liver; however, the 
right lobe of the liver was treated in error. The licensee concluded 
that the dose received was not medically significant to the patient.
    Cause(s)--The cause of the medical event was human error in not 
correctly following the treatment plan as documented on the written 
directive. The interventional radiologist forgot that he had changed 
the initial target of the procedure after the dose had been ordered and 
did not communicate that change to the rest of the staff.
Actions Taken To Prevent Recurrence
    Licensee--Corrective actions include a series of checks developed 
to occur in the interventional radiology room before an administration. 
Checks include a verbal confirmation between the interventional 
radiologist and the medical physicist and confirmation of the patient 
name, target area, dose, and route of administration. This checklist is 
also compared to the written directive.
    State--The Wisconsin Department of Health Services conducted a 
reactive inspection on August 12, 2011, and did not issue any 
violations to the licensee.
AS11-19 Medical Event at the Swedish American Hospital in Rockford, 
Illinois
    Date and Place--September 13, 2011, Rockford, Illinois.
    Nature and Probable Consequences--The Swedish American Hospital 
(the licensee) reported a medical event involving brachytherapy seed 
implant treatment for prostate cancer. The patient was prescribed a 
dose of 145 Gy (14,500 rad) to the prostate using 71 iodine-125 seeds. 
Instead, 68 of the iodine-125 seeds were implanted in the large bowel, 
the small bowel, and the bladder. The licensee calculated that the dose 
to the prostate was less than 1 Gy (100 rad), but the unintended dose 
to the large bowel was 10.2 Gy (1,020 rad). The patient and referring 
physician were informed of this event.

[[Page 37456]]

    On September 15, 2011, postimplant imaging of the patient revealed 
that only three seeds were properly located in the prostate (target 
site), indicating a dose significantly less than the prescribed amount 
in the written directive. Postimplant imaging also revealed that seven 
seeds were in the bladder; these seeds were immediately removed. 
Additional postoperative imaging indicated that a number of seeds had 
been placed in the bowel wall, bladder wall, and the lumen of the 
bowel. On October 3, 2011, surgery was performed to remove misplaced 
seeds. All but four seeds were removed from the patient. With the 
removal of the seeds that the licensee was able to remove, the licensee 
concluded that the medical event would not have a significant effect on 
the patient.
    Cause(s)--The cause of the medical event was a deviation from 
protocol by not having a medical physicist present during the procedure 
and not using fluoroscopy during needle placement.
Actions Taken To Prevent Recurrence
    Licensee--Corrective actions include emphasizing strict adherence 
to prostate brachytherapy protocols.
    State--The IEMA conducted an investigation on September 26, 2011, 
and verified the root cause of the event as reported by the licensee. 
The IEMA issued an NOV to the licensee regarding this failure to 
implement appropriate procedures.

    Dated at Rockville, Maryland, this 15th day of June, 2012.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2012-15172 Filed 6-20-12; 8:45 am]
BILLING CODE 7590-01-P