[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]
BILLING CODE 7590-01-P