[Federal Register Volume 75, Number 136 (Friday, July 16, 2010)]
[Notices]
[Pages 41553-41556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17373]
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NUCLEAR REGULATORY COMMISSION
[NRC-2010-0238]
Report to Congress on Abnormal Occurrences Fiscal Year 2009;
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 which the U.S. Nuclear Regulatory Commission (NRC) determines to
be significant from the standpoint of public health or safety. The
Federal Reports Elimination and Sunset Act of 1995 (Pub. L. 104-68)
requires that AOs be reported to Congress annually. During Fiscal Year
2009, nine events that occurred at facilities licensed or otherwise
regulated by the NRC and/or Agreement States were determined to be AOs.
The report describes three events at NRC-licensed facilities. All three
NRC-licensee events were medical events, as defined in Title 10, Part
35, of the Code of Federal Regulations (10 CFR part 35). The report
also describes six events at Agreement State-licensed facilities.
[Agreement States are those States that have entered into formal
agreements with the NRC pursuant to Section 274 of the Atomic Energy
Act (AEA) to regulate certain quantities of AEA licensed material at
facilities located within their borders.] Currently, there are 37
Agreement States. The first two Agreement State-licensee events
involved radiation exposure to an embryo/fetus. The other four
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,
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. 32, ``Report to Congress on Abnormal Occurrences:
Fiscal Year 2009.'' This report is available electronically at the NRC
Web site http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/.
There are three major categories of events 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, available on the
NRC Web site, provides the specific criteria for determining when an
event is an abnormal occurrence (AO) and discusses ``Other Events of
Interest'' that do not meet the AO criteria but which the Commission
has determined should be included in the report. The event
identification number begins with ``AS'' for Agreement State AO events
and ``NRC'' for NRC AO events.
I. For All Licensees
A. Human Exposure to Radiation From Licensed Material
During this reporting period, two events at Agreement State-
licensed facilities were significant enough to be reported as abnormal
occurrences (AOs). Although both of these events occurred at medical
facilities, they both involved unintended exposures to individuals who
were not the patient. Therefore, these events belong under the criteria
I.A, ``For All Licensees'' category as opposed to the criteria III.C,
``For Medical Licensees'' category.
AS09-01 Human Exposure to Radiation at Chester County Hospital in West
Chester, Pennsylvania
Date and Place--March 30, 2009, West Chester, Pennsylvania.
Nature and Probable Consequences--Chester County Hospital (the
licensee) reported that a therapeutic dose of 2,001.7 MBq (54.1 mCi) of
iodine-131 resulted in a dose to an embryo/fetus of 119 mSv (11.9 rem).
On March 30, 2009, the patient was given a pregnancy test and it
yielded a negative result. Based on the negative pregnancy test, the
licensee administered the iodine-131 to the patient.
On May 13, 2009, the patient informed the authorized user that she
was pregnant. The administration of iodine-131 was given to the patient
approximately 5 days post-conception, a time period at which the
thyroid had not developed. The hospital discovered the pregnancy at 9.5
weeks gestation, at which time the thyroid had developed. Due to
residual iodine-131 in the patient's system, both a whole body and an
organ dose exposure occurred. The hospital calculated a total whole
body dose to the embryo/fetus of 119 mSv (11.9 rem) and a fetal thyroid
dose of 9.7 mSv (0.97 rem). The hospital recommended that the patient
consult with a genetic counselor for any potential health effects to
the embryo/fetus.
Cause(s)--The cause of this event was the close proximity of
conception, which resulted in a negative pregnancy test, to the
administration of iodine-131.
Actions Taken To Prevent Recurrence:
Licensee--The licensee is providing additional instructions to its
staff to strongly emphasize to patients the risks associated with being
pregnant prior to the administration of radioiodine treatments.
State--The State conducted a follow-up inspection and did not take
any enforcement action regarding this event.
* * * * *
AS09-02 Human Exposure to Radiation at Loyola University Medical Center
in Maywood, Illinois
Date and Place--September 21, 2009, Maywood, Illinois.
Nature and Probable Consequences--Loyola University Medical Center
(the licensee) reported that the administration of 925 MBq (25 mCi) of
iodine-131 resulted in a dose to an embryo/fetus of 67 mSv (6.7 rem).
Prior to the administration of iodine-131, a urinary pregnancy test was
conducted by the licensee on September 21, 2009, and it yielded a
negative result. On September 29, 2009, the patient notified the
licensee that she took a home pregnancy test and it was positive. The
patient's pregnancy was confirmed by an independent clinic that
administered a second pregnancy test.
The administration of iodine-131 was given to the patient at 2 to 3
weeks gestation (as determined by a consulting physician), a time
period at which the thyroid had not developed. Shortly thereafter, the
pregnancy ended. The licensee calculated a total whole body dose of 67
mSv (6.7 rem) to the embryo/fetus. There was no dose to the fetal
thyroid since the pregnancy had ended before the thyroid had developed.
Cause(s)--The cause of this event was the close proximity of
conception, which resulted in a negative pregnancy test, to the
administration of iodine-131.
Actions Taken To Prevent Recurrence:
Licensee--The licensee reviewed its established patient selection
criteria, screening methods, and testing protocols for any procedural
changes. A more sensitive pregnancy test for women capable of bearing
children will now be conducted no more than a few days prior to the
dose administration.
State--After consulting an expert, the State determined that the
administration occurred before the development of the thyroid. The
State also performed independent calculations that verified the
estimate of the fetal dose by the
[[Page 41554]]
licensee. The State reviewed and accepted the licensee's formal report
on October 14, 2009.
* * * * *
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, three events at NRC-licensed or
regulated facilities and four events at Agreement State-licensed
facilities were significant enough to be reported as AOs.
AS09-03 Medical Event at St. Vincent's Medical Center Inc., in
Jacksonville, Florida
Date and Place--September 10-17, 2008, Jacksonville, Florida.
Nature and Probable Consequences--St. Vincent's Medical Center
Inc., (the licensee) reported that a medical event occurred associated
with a high dose-rate (HDR) mammosite treatment for breast cancer
containing 199.8 GBq (5.4 Ci) of iridium-192. A patient was prescribed
to receive 34 Gy (3,400 rad) to the right breast but received 34 Gy
(3,400 rad) to the skin of the left breast.
On October 16, 2008, the patient notified her physician of
erytherma on her left breast. During a records review, the medical
physicist determined that an error in programming the catheter length
in the HDR device caused the source to stop 10 cm short of the intended
tumor site in the right breast. Due to this programming error, the dose
intended for the right breast was delivered to the skin of the left
breast. 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 treatment
planning system.
Actions Taken To Prevent Recurrence:
Licensee--The licensee committed to taking several corrective
actions as a result of the medical event that include (1) utilizing a
catheter length worksheet to determine and verify the mammosite
catheter length, (2) documenting the mammosite catheter length by two
individuals--one physicist and either a dosimetrist, physicist, or
radiation therapist--during simulation treatment set-up, (3) providing
procedures for the medical physicist and authorized user on documenting
the catheter length on the catheter worksheet during the review of the
treatment control unit and treatment plan, and (4) conducting a second
measurement of the catheter length to verify that the length agrees
with the data in the treatment control unit.
State--The Florida Bureau of Radiation Control conducted an
investigation and reviewed the licensee's corrective actions and found
the corrective actions to be adequate.
* * * * *
NRC09-01 Medical Event at Saint Mary's Medical Center in Huntington,
West Virginia
Date and Place--October 15, 2008, Huntington, West Virginia.
Nature and Probable Consequences--Saint Mary's Medical Center (the
licensee) reported that a medical event occurred associated with the
administration of a 5.55 GBq (150 mCi) iodine-131 capsule for thyroid
cancer. A patient was prescribed to receive 10.12 Gy (1,012 rad) to the
esophagus but received 18 Gy (1,800 rad) to the esophagus. The patient
and the referring physician were informed of this event.
During the administration, the patient attempted to swallow the
capsule, but it became lodged in an obstruction in the upper portion of
the esophagus. Licensee staff provided the patient with soda and
applesauce to help dissolve the capsule, and after 2.5 hours the
capsule passed the obstruction. Since the capsule was lodged in the
patient's upper portion of the esophagus for longer than expected, an
estimated dose of 18 Gy (1,800 rad) was received to a small area of
esophageal tissue. If the capsule had not become lodged in the upper
portion of the patient's esophagus, the esophagus would have received
the intended dose of 10.12 Gy (1,012 rad) instead of 18 Gy (1,800 rad).
The dose to the esophagus exceeded the intended dose by 78 percent.
On October 22, 2008, the event was discussed with the patient
during a follow-up visit with the prescribing physician. The
prescribing physician indicated that potential health effects from this
administration could include esophagitis and radiation fibrosis.
Cause(s)--The cause of the medical event was human error in failing
to recognize that the esophageal obstruction might interfere with the
patient's ability to swallow the iodine-131 capsule.
Actions Taken To Prevent Recurrence:
Licensee--The licensee modified its procedure to include a pre-
therapy esophageal dilation for patients known to have difficulty
swallowing. In addition, patients known to have this difficulty may be
administered liquid iodine-131 for treatment.
NRC--NRC contracted a medical consultant to review this event, its
effect on the patient, and the licensee's corrective actions taken to
prevent recurrence of similar events. The medical consultant concluded
that no significant adverse health effect to the patient is expected.
The NRC concluded an inspection on February 6, 2009, and one non-cited
violation was issued to the licensee on February 10, 2009.
* * * * *
AS09-04 Medical Event at Presbyterian Hospital of Dallas in Dallas,
Texas
Date and Place--December 2, 2008, Dallas, Texas.
Nature and Probable Consequences--Presbyterian Hospital of Dallas
(the licensee) reported that a medical event occurred associated with
its gamma stereotactic radiosurgery unit (gamma knife) containing 125.8
TBq (3,400 Ci) of cobalt-60. A patient being treated for trigeminal
neuralgia was prescribed to receive 80 Gy (8,000 rad) to the fifth
intracranial nerve but received 14.95 Gy (1,495 rad) to the seventh
intracranial nerve. The patient and the referring physician were
informed of this event.
An error in entry of information into the treatment planning system
caused the wrong nerve to receive treatment. The error was identified
by the neurosurgeon 9 minutes into the 45-minute treatment. The
licensee concluded that no significant adverse health effect to the
patient is expected.
Cause(s)--The medical event was caused by the misidentification of
the anatomical target site listed on the written directive.
Actions Taken To Prevent Recurrence:
Licensee--The licensee modified its written procedure to include
verification of the target site, by the neuroradiologist, for each
treatment. In addition, an updated written directive will document the
new procedure to ensure that the correct treatment site is targeted and
treated in each procedure.
State--The State will conduct a review of at least 20 percent of
the past treatment cases to ensure that this error had not previously
occurred.
* * * * *
[[Page 41555]]
AS09-05 Medical Event at Cancer Care Northwest PET Center in Spokane,
Washington
Date and Place--April 14, 2009, Spokane, Washington.
Nature and Probable Consequences--Cancer Care Northwest PET Center
(the licensee) reported that a medical event occurred associated with a
HDR brachytherapy treatment for prostate cancer containing 185 GBq (5
Ci) of iridium-192. During patient treatment, the aluminum connector to
needle 13 became detached from the plastic guide tube and a dose of
12.5 Gy (1,250 rad) was delivered to a small area of the patient's
inner thigh (wrong treatment site). The patient and the referring
physician were informed of this event.
The source wire for needle 13 hung about 6 inches past the
disconnected guide tube, which resulted in the skin dose. The licensee
conducted several follow-up examinations of the patient's inner thigh
and noted that no skin reddening or injury has occurred and the patient
is not experiencing any pain in this area. Therefore, the licensee
concluded that no significant adverse health effect to the patient is
expected.
Cause(s)--The cause of the medical event was the source wire, for
needle 13, snagged on the seam between the aluminum connector and the
plastic guide tube during retraction.
Actions Taken To Prevent Recurrence:
Licensee--The licensee committed to taking several actions as a
result of the medical event that include (1) requiring the staff to
sign the patient quality assurance list when they check the
applicators, transfer guide tubes, and aluminum connectors; (2)
inspecting the guide tube catheters daily and examining the aluminum
connectors prior to patient use; and (3) revising the refresher
training to include new procedures for staff prior to patient
treatment.
State--The State conducted follow-up inspection activities from
April-May 2009, and reviewed the licensee's corrective actions. The
State found the licensee's corrective actions adequate and did not take
any enforcement action regarding this event.
* * * * *
AS09-06 Medical Event at The Urology Center in Cincinnati, Ohio
Date and Place--May 11, 2009, Cincinnati, Ohio.
Nature and Probable Consequences--The Urology 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 144 Gy (14,400 rad) to the
prostate using 64 iodine-125 seeds as permanent implants. Instead, the
patient received an approximate dose of 76 Gy (7,600 rad) to the
urethra and bulb of the penis (unintended sites). The patient and the
referring physician were informed of this event.
According to the licensee, an interpretation of the ultrasound
image of the patient's prostate resulted in 30 of the 64 seeds
delivered to the prostate while the other 34 seeds were delivered
outside the prostate. Due to the patient's prostate being smaller than
normal, the prostate received 68 Gy (6,800 rad) of the prescribed dose
and the urethra and bulb of the penis (unintended sites) received
approximately 76 Gy (7,600 rad). Prior to the seeds being implanted,
the urologist and radiation oncologist should have consulted on the
ultrasound image of the patient's prostate to determine the correct
seed placement. The licensee concluded that no significant adverse
health effect on the patient is expected. On May 19, 2009, the patient
returned for a second treatment to compensate for the original
underdosing to the prostate.
Cause(s)--The cause of the medical event was the misinterpretation
of the correct size of the patient's small prostate gland by
ultrasound.
Actions Taken To Prevent Recurrence:
Licensee--Corrective actions taken by the licensee included
instituting a new policy requiring agreement by both the urologist and
radiation oncologist on seed placement for all prostate glands
measuring 20 cubic centimeters or less. On May 26, 2009, the licensee
submitted a written report of this event to the Ohio Department of
Health, Bureau of Radiation Protection (ODH BRP).
State--On June 12, 2009, ODH BRP conducted an inspection of this
event and determined that the licensee had followed the correct
procedures for administrations requiring a written directive. ODH BRP
reviewed the licensee's corrective actions for this event and found the
corrective actions to be adequate.
* * * * *
NRC09-02 Medical Event at Gamma Knife Center of the Pacific in
Honolulu, Hawaii
Date and Place--July 2, 2009, Honolulu, Hawaii.
Nature and Probable Consequences--Gamma Knife Center of the Pacific
(the licensee) reported that a medical event occurred associated with
its gamma stereotactic radiosurgery unit (gamma knife) containing
104.86 TBq (2,834 Ci) of cobalt-60. A patient being treated for
multiple brain metastatic sites was prescribed to receive 24 Gy (2,400
rad) to seven discrete brain sites using an 8 mm collimator. However,
an 18 mm collimator was used to treat two of the discrete brain sites,
resulting in a dose of 24 Gy (2,400 rad) to additional brain tissue.
The patient and the referring physician were informed of this event.
The patient received treatment to the first and second discrete
brain sites and after receiving treatment to the second discrete site,
it was discovered that an 18 mm collimator was used to deliver
treatment instead of the prescribed 8 mm collimator. The larger
collimator caused the volume of each of the two discrete sites to
increase by 2.45 cubic meters, resulting in a dose of 24 Gy (2,400 rad)
to additional brain tissue. After the 18 mm collimator was discovered,
it was replaced with the 8 mm collimator and the patient received
treatment to the five remaining discrete sites as prescribed. The
licensee concluded that no significant adverse health effect to the
patient is expected.
Cause(s)--The cause of the medical event was human error in failing
to check the collimator size prior to patient treatment.
Actions Taken To Prevent Recurrence:
Licensee--Corrective actions taken by the licensee included (1)
sending a notice to all authorized users, neurosurgeons, and medical
physicists reiterating that they should each independently check the
collimator size prior to patient treatment and (2) revising procedures
to have a second independent verification of all treatment parameters,
including the collimator size, by a treatment team member.
NRC--NRC conducted an onsite inspection and hired a medical
consultant to review the event. The conclusions from the onsite
inspection and medical consultant's review are ongoing.
* * * * *
NRC09-03 Medical Event at the Veterans Affairs San Diego Health Care
System in San Diego, California
Date and Place--September 21, 2009, San Diego, California.
Nature and Probable Consequences--The Department of Veterans
Affairs (the licensee), National Health Physics Program (NHPP) reported
that a medical event occurred at the Veterans Affairs (VA) San Diego
Health Care System associated with a therapeutic dosage of iodine-131
for the treatment of metastatic thyroid cancer. A patient was
prescribed to receive 6.9 GBq (187 mCi) of iodine-131 to the metastatic
sites around the body but received 6.1 GBq (166 mCi) to the stomach
(wrong
[[Page 41556]]
treatment site). The patient and the referring physician were informed
of this event.
On September 21, 2009, a dosage of 6.9 GBq (187 mCi) of iodine-131
was administered to the patient through an existing feeding tube. Daily
radiation measurements indicated small decreases in radiation readings
that were consistent with the physical decay of iodine-131, but not
consistent with the biological elimination of iodine-131. On September
25, 2009, the feeding tube was replaced and a subsequent investigation
revealed that the majority of the dosage, 6.1 GBq (166 mCi), was
administered to the wrong orifice of the feeding tube. As a result, the
dosage remained in the balloon of the feeding tube and irradiated the
patient's stomach, resulting in an approximate dose of 16 Gy to 19 Gy
(1,600 rad to 1,900 rad) to the stomach.
Cause(s)--Three root causes were identified for this medical event:
(1) Inadequate training of staff, (2) inadequate procedures, and (3) an
inadequate procedure on the verification that administrations involving
feeding tubes were being administered in accordance with a written
directive.
Actions Taken To Prevent Recurrence:
Licensee--Corrective actions taken by the licensee included (1)
immediate suspension of any further gastric tube administrations until
the direct cause of the medical event was identified, (2) suspension of
one individual's participation in administrations requiring a written
directive, (3) informal training of the nuclear medicine technologists
by the Radiation Safety Officer, and (4) development of draft written
policies and procedures on the administration of iodine-131 through a
gastric tube.
NRC--The NRC Region III Office conducted a reactive inspection on
November 3, 2009, and also contracted a medical consultant to review
this event. Based on the results of the inspection, five apparent
violations of NRC's regulations were identified. Enforcement action is
pending and the medical consultant's review is on-going.
Dated at Rockville, Maryland, this 12th day of July 2010.
For the U.S. Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2010-17373 Filed 7-15-10; 8:45 am]
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