[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Pages 38214-38219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16266]
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NUCLEAR REGULATORY COMMISSION
[NRC-2011-0132]
Report to Congress on Abnormal Occurrences; Fiscal Year 2010;
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
2010, fifteen events that occurred at facilities licensed or otherwise
regulated by the NRC and/or Agreement States were determined to be AOs.
This report describes eight events at NRC-licensed facilities. The
first event involved radiation exposure to an embryo/fetus. The other
seven events occurred at NRC-licensed or regulated medical institutions
and are medical events as defined in Title 10, Part 35, of the Code of
Federal Regulations (10 CFR part 35). The report also describes seven
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 two Agreement State-licensee events
involved radiation exposure to an embryo/fetus. The other five
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. 33, ``Report to Congress on Abnormal Occurrences:
Fiscal Year 2010.'' This report is available electronically at the NRC
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
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-licensed or
regulated facility and two events at Agreement State-licensed
facilities were significant enough to be reported as AOs. Although
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.
AS10-01 Human Exposure to Radiation at Mohamed Megahy MD, Ltd in
Maryville, Illinois
Date and Place--May 1, 2007 (reported on June 17, 2010), Maryville,
Illinois.
Nature and Probable Consequences--Mohamed Megahy MD, Ltd (the
licensee) indicated that on May 1, 2007, a patient was given 3,807 MBq
(102.9 mCi) of iodine-131 as a treatment for the recurrence of thyroid
cancer. On June 11, 2007, the licensee was contacted by the patient's
obstetrician/gynecologist (OB/GYN) who advised them that the patient
was 25-27 weeks (6 months) pregnant at the time of the iodine-131
administration. At the time of administration, the patient indicated to
the licensee that she was not pregnant, and the licensee did not
perform an independent test.
In June 2010, the Illinois Emergency Management Agency was
contacted by the licensee and requested to make a dose estimate to a
fetus as a result of administration of iodine-131 to a patient who was
later found to be pregnant. When the Illinois Emergency Management
Agency requested additional information to determine the appropriate
parameters of the event, the licensee advised the Illinois Emergency
Management Agency that the administration had occurred 3 years earlier.
The Illinois Emergency Management Agency calculated an estimated dose
to the fetus of 860 mSv (86 rem) and the fetal thyroid of over
1,000,000 mSv (100,000 rem). A full-term child was subsequently born in
August 2007 without a thyroid. The child was immediately placed on
replacement hormone therapy and continues such treatment.
Cause(s)--The cause of the event was found to be a combination of
miscommunication and failure of the licensee to conduct an independent
confirmatory pregnancy test.
Actions Taken To Prevent Recurrence
Licensee--The licensee has subsequently made procedural changes to
the interview process for screening patients for iodine-131 treatment.
This policy includes a confirmatory negative pregnancy test. In
addition, the licensee identified the significant delay in reporting
the event to the Illinois Emergency Management Agency as not knowing
the reporting requirement for this type of event.
State--The Illinois Emergency Management Agency conducted an
investigation of the event and issued a Notice of Violation (NOV) for
the licensee's failure to report the event. The Illinois Emergency
Management Agency is considering rulemaking to require the performance
of testing to determine pregnancy prior to administration of iodine-
131.
AS10-02 Human Exposure to Radiation at Mercy Medical Center in Durango,
Colorado
Date and Place--March 16, 2010, Durango, Colorado.
Nature and Probable Consequences--Mercy Medical Center (the
licensee) reported that a therapeutic dose of 1,110 MBq (30 mCi) of
iodine-131 for hyperthyroidism resulted in a dose to an embryo of 80
mGy (8 rem) whole body. Prior to the treatment, the patient informed
the licensee's staff that she was not pregnant and 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 April 26, 2010, the patient performed a home pregnancy test that
resulted in a positive test result. The patient's pregnancy was
confirmed with a positive blood serum pregnancy test on April 27, 2010.
The patient's OB/GYN estimated that conception
[[Page 38215]]
occurred on March 13, 2010 (about 1 week pregnant at the time of
administration). A consulting medical physicist reviewed the case and
estimated the embryonic exposure (whole body) at 53 to 92 mGy (5.3 to
9.2 rem). The possibility of embryonic thyroid exposure was also
investigated and determined to be insignificant due to the early stage
of embryonic development. At this dose and administration time in
relation to the embryonic development (blastogenesis), the licensee
determined that no adverse impact will be likely on subsequent
embryonic or fetal development and that subsequent health risks were
unlikely. The patient was informed of the dose estimates and potential
risks and she elected to continue the pregnancy.
Cause(s)--The cause of this event was the close proximity of
conception, which resulted in a negative pregnancy test, to the
administration of the iodine-131.
Actions Taken To Prevent Recurrence
Licensee--To help prevent recurrence, the licensee added additional
questions to the screening process to help identify patients that might
be pregnant even though all procedures to prevent this occurrence were
followed.
State--The State conducted an investigation and concurs with the
licensee that a reasonable standard of care was met and, consequently,
no enforcement action is warranted.
NRC10-01 Human Exposure to Radiation at Tripler Army Medical Center in
Honolulu, Hawaii
Date and Place--June 7, 2010, Honolulu, Hawaii.
Nature and Probable Consequences--Tripler Army Medical Center
(TAMC) (the licensee) reported that a female patient underwent a
therapeutic administration of iodine-131 for thyroid ablation therapy.
Prior to the treatment, the patient informed the licensee's staff that
she was not pregnant and 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 July 8, 2010, the patient became aware that she was pregnant and
informed the licensee and her physician. On August 3, 2010, an
ultrasound was performed on the patient and a determination was made
that the actual date of conception was June 1, 2010 (about 1 week
pregnant at time of administration). The TAMC radiation safety officer
(RSO) estimated the embryonic dose to be 41.27 cGy (41.27 rad) and
concluded that the exposure of the embryo in the first 2 weeks
following conception is not likely to result in malformation or embryo/
fetal death despite the fact that the central nervous system and the
heart are beginning to develop in the third week. The NRC contracted
with a medical consultant to perform an independent medical evaluation
of this embryo/fetal overexposure event. The consultant's report agreed
with the TAMC conclusions with the exception that the medical
consultant did not want to rule out the chance of embryo/fetal
malformation.
Cause(s)--The cause of this event was the close proximity of
conception, which resulted in a negative pregnancy test, to the
administration of the iodine-131.
Actions Taken To Prevent Recurrence
Licensee--The patient consent form has been updated to reflect that
the pregnancy test may not show a positive result until the embryo has
implanted, which may not occur until 7-10 days after conception. In
future consultations, the clinic plans to ask the patient to refrain
from any action that may lead to pregnancy during the period
immediately prior to therapeutic radioisotope administration.
NRC--The NRC conducted an inspection on October 13-14, 2010, and
concluded there were no violations of NRC requirements associated with
this event.
II. Commercial Nuclear Power Plant Licensees
During this reporting period, no events at commercial nuclear power
plants in the United States were significant enough to be reported as
AOs.
III. Events at Facilities Other Than Nuclear Power Plants and All
Transportation Events
C. Medical Licensees
During this reporting period, seven events at NRC-licensed or
regulated facilities and five events at Agreement State-licensed
facilities were significant enough to be reported as AOs.
AS10-03 Medical Event at Mercy St. Vincent Medical Center in Toledo,
Ohio
Date and Place--November 8, 2005 (reported on March 3, 2010),
Toledo, Ohio.
Nature and Probable Consequences--Mercy St. Vincent 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 160 Gy (16,000 rad)
to the prostate using 67 iodine-125 seeds. Instead, the patient's
sigmoid colon received at least the full prescription dose of 160 Gy
(16,000 rad) and a significant portion of the bladder base including
the region of the urethral orifices received at least 108 Gy (10,800
rad) (wrong treatment sites). The patient and referring physician were
informed of this event.
On March 3, 2010, the Ohio Department of Health (ODH) performed an
inspection of the licensee and noted that the licensee had not reported
this medical event to the State and the NRC. The licensee had not
identified the medical event as a reportable event and did not
investigate it to determine a cause. Subsequently, the licensee
reported the medical event to the NRC. The licensee confirmed that 13
of the permanent iodine-125 seeds were improperly positioned in the
bladder and subsequently removed from the patient's bladder immediately
after the procedure. A post-implant dose calculation showed that the
prostate received a dose of 15.43 Gy (1,543 rad), or 9.6 percent of the
prescribed dose. The patient chose to then receive an external beam
treatment with a linear accelerator to treat the tumor. About 13 months
after the brachytherapy procedure, the patient developed rectosigmoid
bleeding that required hospitalization and argon laser coagulopathy. In
August 2010, ODH ordered an independent medical expert evaluation of
the event. The independent medical expert concluded that the subsequent
delivery of external beam radiotherapy may have contributed to the
rectosigmoid damage, but the high dose from the brachytherapy procedure
almost certainly was the primary cause of the damage.
Cause(s)--The cause of the medical event was the failure of the
licensee to adequately visualize the prostate prior to the implant
procedure.
Actions Taken To Prevent Recurrence
Licensee--Corrective actions taken by the licensee included
training of the RSO, medical physicist, clinical director, and
radiation oncologists on ODH regulations concerning medical events. New
procedures were also developed for brachytherapy seed implant
procedures.
State--In March 2010, ODH conducted a special inspection of the
licensee and issued an NOV. The NOV required the licensee to perform a
self
[[Page 38216]]
audit of all brachytherapy cases performed since November 2004, which
revealed seven additional medical events that were not reported. In
June 2010, an Adjudication Order and administrative penalty of $25,000
were issued to the licensee.
NRC10-02 Medical Event at Chippenham & Johnston-Willis Medical Center
in Richmond, Virginia
Date and Place--December 16, 2008, Richmond, Virginia.
Nature and Probable Consequences--Chippenham & Johnston-Willis
(CJW) Medical Center (the licensee) reported a medical event with its
gamma stereotactic radiosurgery (GSR) unit. A patient being treated for
trigeminal neuralgia (inflammation of the nerve) was prescribed a
treatment of 40 Gy (4,000 rad) to the right trigeminal nerve but
received the treatment dose to the left trigeminal nerve (wrong
treatment site). The patient and referring physician were informed of
this event.
The licensee noted that on the day of the treatment, the top
portion of the written directive correctly documented the prescribed
treatment site; however, while the staff was preparing the daily
patient treatment log, it was inadvertently annotated that the dose was
to be delivered to the left trigeminal nerve. This error was carried
through by the medical physicist during preparation of the patient's
treatment plan and completion of the bottom part of the written
directive. Upon completion of the procedure and after reviewing the
patient's file, the treatment team identified the inadvertent treatment
of the left trigeminal nerve. The NRC contracted medical consultant
concluded that although no actual consequences resulted, an unlikely
injury to the brain stem was possible due to high radiation dose to a
tiny volume of the brain stem tissue and an increased risk of cataract
formation.
Cause(s)--The cause of the medical event was the licensee's failure
to have adequate procedures that verify the location of treatment sites
and ensure that any inconsistencies in the written directives are
resolved prior to administration.
Actions Taken To Prevent Recurrence
Licensee--The licensee revised their GSR treatment procedures to
affirm that (1) a ``Physician Order'' will be the primary source of
documentation of the treatment site and will accompany the patient
through the entire course of the treatment, (2) the radiation
oncologist and the neurosurgeon will independently verify and document
the treatment site, (3) the nurse and the medical physicist will
confirm that the treatment site identified by the radiation oncologist
in the written directive and the neurosurgeon's ``physician order''
both match, (4) the neurosurgeon will mark the treatment site with ink
in the presence of a nurse, and (5) a ``Time-Out'' process involving
independent verification of the final treatment plan by each of the
four members of the clinical team (who are required to sign-off their
presence and acceptance of time-out in the presence of the patient
before moving ahead with the treatment) will be used with the patient
or the patient's authorized representative to confirm the treatment
site.
NRC--The NRC initiated an inspection on December 18, 2008. The NRC
completed the inspection on November 30, 2009, and issued one Severity
Level III violation to the licensee on January 21, 2010.
NRC10-03 Medical Event at Virtua Health System in Marlton, New Jersey
Date and Place--January 19, 2009, Marlton, New Jersey.
Nature and Probable Consequences--Virtua Health System (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 93 iodine-125 seeds. Instead, the patient
received an approximate dose of 12.2 Gy (1,220 rad) to the rectum
(wrong treatment site). The patient and referring physician were
informed of this event.
On January 19, 2009, the urologist inserted needles in the
patient's prostate gland under transrectal ultrasound guidance while
the radiation oncologist left the operating room to obtain the
radioactive seeds. The licensee's staff (including the authorized
medical physicist [AMP]) questioned the accuracy of prostate
visualization prior to implantation of the seeds but took no action to
resolve the question. On February 23, 2009, following a post-implant
computed tomography (CT) scan, it was noted that some mispositioning of
the sources occurred and the patient was notified that additional
treatment may be necessary. On March 19, 2009, the AMP reviewed the
case and determined that 100 percent of the seeds were implanted
outside of the prostate, which received about 10 Gy (1,000 rad). The
NRC contracted with a medical consultant who concluded that although
the probability of long-lasting negative health effects to the patient
is low, an increased risk of impotency and fibrosis was possible due to
the high radiation dose.
Cause(s)--The cause of the medical event was failure of the medical
implant team to adequately visualize and identify the prostate prior to
the implant.
Actions Taken To Prevent Recurrence
Licensee--The licensee revised its policy and procedures to require
that (1) all members of the implant team be present before the patient
is brought to the operating room and placed under anesthesia, (2) the
AMP be included in the pre-implantation ultrasound, (3) the authorized
user consult with the urologist before needle insertion, (4) both the
radiation oncologist and the urologist agree on the positioning and the
visualizing of the target anatomy, (5) any objection or question by an
implant team member is cause for stopping the implant and performing a
review, and 6) the implant be stopped if there are any ultrasound image
questions. The licensee's staff was also trained on the revised
procedures, the definition and reporting requirements of a medical
event, and the communication of any CT scan abnormalities or seed
misplacement to the RSO.
NRC--The NRC initiated an inspection on March 20, 2009. The NRC
completed the inspection on August 26, 2009, and issued one Severity
Level III violation to the licensee on October 21, 2009.
NRC10-04 Medical Event at Nanticoke Memorial Hospital, Seaford,
Delaware
Date and Place--March 5, 2009 (reported on July 15, 2009), Seaford,
Delaware.
Nature and Probable Consequences--Nanticoke Memorial Hospital (the
licensee) reported that a medical event occurred involving a
brachytherapy seed implant procedure to treat prostate cancer. The
patient was prescribed a total dose of 145 Gy (14,500 rad) to the
prostate using 61 iodine-125 seeds. Instead, the patient received an
approximate prostate dose of 26 Gy (2,600 rad) (18 percent of the
prescribed dose) and a dose of 139 Gy (13,900 rad) to unintended tissue
(wrong treatment site). The patient and referring physician were
informed of this event.
The seeds were implanted under ultrasound guidance using an axial
view; however, following the implant, the urologist performed a
cystoscopy to remove 22 of the seeds from the bladder. When the patient
returned to the hospital for a post-implant CT scan, the images
revealed that 32 seeds were displaced superiorly to the prostate and 7
seeds were implanted in the prostate.
[[Page 38217]]
The NRC contracted with a medical consultant who concluded that no
significant adverse health effects to the patient were expected.
Cause(s)--The cause of the medical event was due to a
miscalculation of the prostate depth in relation to the skin surface
due to possible patient movement during the procedure.
Actions Taken To Prevent Recurrence
Licensee--The licensee revised its prostate implant procedure to
include the use of both the axial and sagittal views of an ultrasound
probe to determine prostate depth. In addition, the licensee revised
its medical event policy to ensure timely reporting of medical events
and to clearly state the parameters under which a medical event must be
reported. The licensee provided training on the revised policies and
procedures to its staff.
NRC--The NRC initiated an inspection on July 19, 2009. The NRC
completed the inspection on January 6, 2010, and issued one Severity
Level III violation to the licensee on February 2, 2010.
AS10-04 Medical Event at Hoag Memorial Hospital Presbyterian in Newport
Beach, California
Date and Place--March 20, 2009, Newport Beach, California.
Nature and Probable Consequences--Hoag Memorial Hospital
Presbyterian (the licensee) reported that a medical event occurred
associated with its GSR unit. A patient being treated for an acoustic
neuroma was scheduled to receive between 11 and 18 Gy (1,100 and 1,800
rads) to an intended neuroma volume of 0.08 cm\3\ but, due to an
unintended shift in the treatment volume of about 2 mm, only about one-
half of the neuroma received the treatment dose and an adjacent
temporal bone volume of 0.04 cm\3\ received the treatment dose (wrong
treatment site). The other half of the neuroma received between 3 and
11 Gy (300 and 1,100 rads). The patient and physician were informed of
this event.
The unintended shift in treatment volume occurred due to a
misaligned fiduciary marker (indicator) box during a CT scan used in
the treatment planning process. The misalignment occurred because one
alignment pin of four on the indicator box was not fully seated in the
stereotactic frame attached to the patient's head, resulting in the
indicator box not being correctly aligned. The alignment pin error was
not detected until the conclusion of the treatment. The additional dose
to the temporal bone because of the alignment error is not expected to
result in any significant adverse health effect to the patient.
Cause(s)--The medical event is believed to have been caused by
human error in not ensuring the CT indicator box was properly installed
at the time of the CT scan. It is not known if the improper
installation occurred when the technologist positioned the indicator
box in the stereotactic frame or whether the indicator box became
misaligned during patient positioning in preparation for the CT scan.
Actions Taken To Prevent Recurrence
Licensee--The licensee has retrained all CT technologists
concerning the proper placement of the CT indicator box. Also, because
use of CT imaging for GSR treatment is infrequent (normally MRI is
used), the licensee now requires that a GSR qualified medical physicist
verify the placement of the CT indicator box immediately prior to all
CT imaging that will be used for GSR treatment planning.
State--On June 22, 2009, the California Department of Public Health
(CDPH) issued an NOV related to this event. Subsequently, CDPH received
dosimetry information which they used to interpret the event as not
meeting the AO criteria; however, CDPH was not certain of this
determination and asked the NRC for a final determination. On July 1,
2010, after the NRC Medical Radiation Safety Team (MSRT) had performed
a careful analysis of the event along with the dosimetry data, the NRC
determined that the event met the AO criteria.
AS10-05 Medical Event at Marshfield Clinic in Marshfield, Wisconsin
Date and Place--June 2005 to May 2007, (reported on July 8, 2010)
Marshfield, Wisconsin.
Nature and Probable Consequences--In July 2010, the Marshfield
Clinic (the licensee) reviewed all prostate brachytherapy cases
performed under its license in the past 7 years. The review resulted in
the identification of nine medical events involving permanent implants
of iodine-125 for prostate brachytherapy where the total dose delivered
differed from the prescribed dose by 20 percent or more, or another
organ received at least 50 percent more dose than intended. The three
medical events involved planned doses to the prostate of 120 Gy (12,000
rad), 160 Gy (16,000 rad), and 160 Gy (16,000 rad). The licensee
assumes an identical planned dose to the urethra. However, these
treatments resulted in actual doses to the urethra of 191.6 Gy (19,160
rad), 258.1 Gy (25,810 rad), and 242.6 Gy (24,260 rad), which were
overdoses of 59.7, 61.3, and 51.6 percent, respectively. The licensee
notified the affected patients and referring physicians.
The authorized user physicians had previously determined that
patients would not suffer significant health effects for urethral doses
below 400 Gy (40,000 rad). Because the urethra penetrates through the
center of the prostate and the prostate itself is a small gland, a
balance exists between reducing the dose to the urethra and delivering
the prescribed dose to the prostate. The doses delivered to the
patients in question were well within the 400 Gy (40,000 rad) urethral
tolerance dose, and the licensee considered the treatments to be
clinically acceptable.
Cause(s)--The licensee suspects that the implants deviated from
their intended tracks after insertion into the prostate, causing the
seeds to be deposited closer to the urethra.
Actions Taken To Prevent Recurrence
Licensee--Corrective actions included developing a procedure for
ensuring that treatments were delivered in accordance with the written
directive, planning treatments to D90 (minimum dose received by 90
percent of CT-defined prostate volume) values of 100-110 percent, using
the same written directive form at each site that performs
brachytherapy, increasing ultrasound and fluoroscopy visualization
during prostate implants and providing additional training to
personnel.
State--The Wisconsin Department of Health Services determined that
Marshfield Clinic did not have a procedure for evaluating whether the
dose delivered in a prostate brachytherapy treatment was in accordance
with the written directive. In addition, the licensee did not have
criteria for identifying a medical event for prostate brachytherapy.
The licensee has been cited for several items of noncompliance.
NRC10-05 Medical Event at Yale New-Haven Hospital, New Haven,
Connecticut
Date and Place--August 5, 2009, New Haven, Connecticut.
Nature and Probable Consequences--Yale New-Haven Hospital (the
licensee) reported that a medical event occurred associated with its
GSR unit. A patient being treated for brain metastases was prescribed
18 Gy (1,800 rad). However, while treating a patient earlier in the
day, an equipment malfunction occurred with the GSR unit that resulted
in a positioning shift of the x-axis by 4.5 mm. The positioning shift
in the x-axis
[[Page 38218]]
resulted in an underdose to the treatment site and an overdose to a
wrong treatment site. The patient and physician were informed of this
event.
The malfunction occurred following the treatment of the first
patient on August 5, 2009. The automatic positioning system (APS)
malfunctioned and, after discussion with the GSR manufacturer, the
position error codes were cleared by the AMP. A second patient was
treated for multiple brain metastases later that day. The GSR service
personnel noted on August 5, 2009, that the APS positioning was off by
about 5 mm. After further evaluation, the manufacturer determined that
a position shift (offset) occurred when licensee personnel accepted an
error message concerning position deviation. The NRC contracted with a
medical consultant who concluded that no clinically significant side
effects from radiation damage to the wrong treatment sites would be
expected.
Cause(s)--The cause of the medical event was failure of licensee
personnel to verify that the APS coordinates were in accordance with
the written directive.
Actions Taken To Prevent Recurrence
Licensee--The licensee issued a memorandum to all personnel
involved in GSR treatments to require visual verification of the
physical coordinates against the electronic coordinates before the
start and at the end of each treatment run. The licensee also retrained
all GSR personnel on the importance of fully understanding error
conditions and reviewing unexpected errors with other staff involved in
the treatment (e.g., radiation oncologist, AMP, etc.) prior to clearing
any unexpected error.
NRC--The NRC initiated an inspection on August 13, 2009. The NRC
completed the inspection on April 7, 2010, and issued one Severity
Level III violation to the licensee on May 21, 2010.
NRC10-06 Medical Event at Valley Hospital in Paramus, New Jersey
Date and Place--July 29, 2009, Paramus, New Jersey.
Nature and Probable Consequences--Valley Hospital (the licensee)
reported that a medical event occurred associated with a brachytherapy
seed implant procedure to treat prostate cancer. The patient was
prescribed a total dose of 65 Gy (6,500 rad) to the prostate using 46
cesium-131 seeds. Instead, the licensee determined that an unintended
volume (30.1 ml) of soft tissue received 100 percent of the prescribed
prostate dose. The patient and referring physician were informed of
this event.
On August 6, 2009, the patient returned to the hospital for a post-
implant CT scan. The images revealed that the seeds were implanted in
soft tissue 4 to 5 cm from the prostate. Post-implant dosimetry
calculations indicated that none of the prostate received the
prescribed dose of 6,500 cGy (6,500 rad). The NRC contracted with a
medical consultant who concluded that the additional dose can increase
the risk of soft tissue fibrosis or increase the risk of impotency.
Cause(s)--The cause of the medical event was the licensee's failure
to identify the position of the prostate due to the patient's unusual
anatomy and obesity.
Actions Taken To Prevent Recurrence
Licensee--The licensee revised their prostate implant procedures to
include steps to ensure that the prostate and surrounding anatomy is
adequately visualized prior to implant.
NRC--The NRC initiated an inspection on August 13, 2009. The NRC
completed the inspection on October 29, 2009, and determined that no
violations of NRC requirements occurred.
NRC10-07 Medical Event at Christiana Care Health Center in Wilmington,
Delaware
Date and Place--January 18, 2010, Wilmington, Delaware.
Nature and Probable Consequences--Christiana Care Heath Center (the
licensee) reported that a patient was prescribed a high dose-rate (HDR)
mammosite (brachytherapy) multi-lumen catheter treatment of 34 Gy
(3,400 rad) over a 5-day period to the left breast. The patient
received an average dose of 17 Gy (1,700 rad) to 100 cm\3\ of
unintended breast tissue; 68 Gy (6,800 rad) to 7.5 cm\3\ of unintended
skin and underlying tissue; and 3.4 Gy (340 rad) to 35 cm\3\ of
intended breast tissue. The patient and referring physician were
informed of this event.
On February 22, 2010, during a follow-up examination, the patient
complained about skin reddening on the external breast. In reviewing
the treatment plan, it was discovered that the AMP performed
measurements using a source position simulator (SPS) measurement tool
following a CT scan to determine the treatment distance for each
catheter. The catheter distances were recorded and confirmed with two
manufacturer representatives that were present at the time of the
treatment. However, it was noted that an incorrect measurement caused
the placement of the radioactive source 10 cm proximal to the intended
position. The NRC contracted medical consultant concluded that the dose
that was administered to the unintended left breast tissue is unlikely
to result in any significant or unusual adverse effect. However, a
significant risk exists that local tumor recurrence could occur if
additional intervention is not performed.
Cause(s)--The cause of the medical event was human error in the
failure to identify that the measurement tool was functioning
improperly and to identify an incorrect measurement distance.
Actions Taken To Prevent Recurrence
Licensee--The licensee revised its procedures for HDR brachytherapy
to require a double-check of all patient measurements, a daily and
monthly quality assurance requirement to confirm that the SPS tool is
functioning properly, and a process to ensure that all members of the
treatment team agree on the specifics of the treatment. In addition,
the licensee acquired a new SPS tool, developed and posted a reference
table at the HDR control console, provided training on revised
procedures to staff involved in the HDR program (to be repeated
annually), and implemented a ``New Product'' committee to review all
new product plans.
NRC--The NRC conducted an inspection on July 12, 2010, and issued
one Severity Level III violation to the licensee on August 24, 2010.
AS10-06 Medical Event at Mary Bird Perkins Cancer Center in Baton
Rouge, Louisiana
Date and Place--March 15, 2010, Baton Rouge, Louisiana.
Nature and Probable Consequences--Mary Bird Perkins Cancer Center
(the licensee) reported that a medical event occurred associated with a
brachytherapy seed implant procedure to treat prostate cancer. The
patient was prescribed a total dose of 145 Gy (14,500 rad) to the
prostate using iodine-125 seeds. Instead, the patient received a dose
of 39.55 Gy (3,955 rad) to the rectum, 40.94 Gy (4,094 rad) to the
urethra, and 6 Gy (600 rad) to the bladder (wrong treatment sites). The
patient and referring physician were informed of this event.
During the review of this event, the licensee determined that a
positioning error occurred and the dose was delivered about 3.0 cm away
from the targeted prostate gland. The estimated dose to the prostate
gland was 12.88 Gy (1,288 rad). The licensee concluded that
[[Page 38219]]
no significant adverse health effect to the patient is expected.
Actions Taken To Prevent Recurrence
Licensee--The licensee modified its procedure to insert the needles
that hold the prostate in place prior to obtaining the ultrasound
images instead of immediately before the seed needles are inserted. In
addition, the sagittal image will be captured at the time of planning
image acquisition and confirmed periodically throughout the case, and
the radiation oncologist will personally confirm the location of the
reference base prior to dispensing the first seed.
State--The Louisiana Department of Environmental Quality conducted
an investigation, reviewed the licensee's corrective actions, and found
the corrective actions to be adequate.
AS10-07 Medical Event at Mayo Clinic in Rochester, Minnesota
Date and Place--March 23, 2010, Rochester, Minnesota.
Nature and Probable Consequences--The Mayo Clinic (the licensee)
reported a medical event associated with an HDR biliary treatment for
liver carcinoma containing 329 GBq (8.9 Ci) of iridium-192. A patient
was prescribed to receive four fractionated doses totaling 16 Gy (1,600
rad) to the liver. The treatment to the liver should have produced an
estimated dose to the duodenum (wrong treatment site) of 1.2 Gy (120
rad) but as a result of the event it received a dose of about 10 Gy
(1,000 rad). The patient and referring physician were informed of this
event.
During the second fractioned treatment, the measurement cable was
inserted into the catheter and it was noted that it extended about 17
cm beyond the programmed treatment distance used during the first
fractioned treatment. It was concluded that the measurement wire on the
first treatment had met with some resistance at a tight bend and that
it was not at the end of the catheter. This resulted in overdosing the
duodenum (wrong treatment site). Upon discovery of the treatment
distance error and overdose, the licensee changed the written directive
to add a fifth fractioned treatment to correct for the underdose of the
liver. A lesser total dose to the liver was given because of concerns
regarding the dose already received by the duodenum. The authorized
user concluded that no chronic health effect to the patient is
expected.
Cause(s)--The medical event was caused by human error in failing to
verify that the correct catheter length was entered into the HDR unit.
Actions Taken To Prevent Recurrence
Licensee--The licensee committed to taking several corrective
actions including the imaging of inserted catheters prior to treatments
and performing catheter length checks prior to HDR treatments.
State--On April 6, 2010, the Minnesota Department of Health (MDH)
staff performed a reactive inspection of the licensee's HDR program.
The MDH approved the licensee's corrective actions and did not take
enforcement action.
NRC10-08 Medical Event at Providence Hospital in Novi, Michigan
Date and Place--August 30, 2010, Novi, Michigan.
Nature and Probable Consequences--Providence Hospital (the
licensee) reported that a medical event occurred associated with an
anal brachytherapy treatment using 32 seeds containing iodine-125. The
intended dose was 90 Gy (9,000 rad) to the tumor. Instead, the
patient's seminal vesicle received 19.79 Gy (1,979 rad) more than
intended and the bladder received 3.68 Gy (368 rad) more than intended.
The patient and referring physician were informed of this event.
On September 1, 2010, a follow-up CT scan showed that the permanent
implants had been inserted about 4 cm from the intended location. The
licensee reported that the tumor near the anus and rectum received a
maximum dose of 8 Gy (800 rad). The licensee calculated the dose
difference to the surrounding tissue as a result of the improper
permanent implant placement. The licensee concluded that no significant
adverse health effect to the patient is expected.
Cause(s)--The licensee determined that the cause of the event was
that they did not use tissue markers to confirm source placement and
the insertion needle did not have a visible mark to ensure proper depth
placement.
Actions Taken To Prevent Recurrence
Licensee--Procedures were modified to administer sources as
prescribed in the written directive as follows: (1) Any interstitial
procedure that requires the use of fluoroscopy alone will be done with
the use of tissue markers to confirm source placement, and (2)
interstitial procedures that use fluoroscopy alone will have needle
depth verified. The licensee completed training of licensee staff on
the event and the corrective actions by October 1, 2010.
NRC--The NRC's Region III staff reviewed and concurred on the
licensee's corrective actions. The NRC has retained the services of an
independent medical consultant to determine if any significant health
effects to the patient are expected.
Dated at Rockville, Maryland, this 23rd day of June, 2011.
For the Nuclear Regulatory Commission.
Andrew L. Bates,
Acting Secretary of the Commission.
[FR Doc. 2011-16266 Filed 6-28-11; 8:45 am]
BILLING CODE 7590-01-P