[Federal Register Volume 70, Number 83 (Monday, May 2, 2005)]
[Notices]
[Pages 22722-22728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8173]
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NUCLEAR REGULATORY COMMISSION
Report to Congress on Abnormal Occurrences Fiscal Year 2004
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. 104-66)
requires that AOs be reported to Congress annually. During fiscal year
2004, 17 events that occurred at facilities licensed or otherwise
regulated by the NRC and/or Agreements States were determined to be
AOs. The report describes four events at facilities licensed by the
NRC. One event involved a uranium hexafluoride release at a fuel cycle
facility. Another event, also at a fuel cycle facility, revealed
excessive uranium concentrations found in ash deposits in various
locations in an incinerator. A third event involved a patient
undergoing therapeutic brachytherapy treatment. The fourth event
involved an unintentional excessive dose of sodium iodide (I-131)
administered to a patient. The report also addresses 13 AOs at
facilities licensed by Agreement States. [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 33 Agreement States. During FY 2004, the
NRC received notification of 13 events that occurred at Agreement
State-licensed facilities, including 8 therapeutic medical events, 3
diagnostic medical events, 1 event involving an unintentional dose of
I-131 to an embryo/fetus, and 1 event involving an extremity
overexposure to a radiopharmacy trainee. 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 action taken to
prevent recurrence. Each event is also being described in NUREG-0090,
Vol. 27, ``Report to Congress on Abnormal Occurrences, Fiscal Year
2004.'' This report will be available electronically at the NRC Web
site http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/ staff/.
Nuclear Power Plants
During this period, no events occurred at U.S. nuclear power plants
that were significant enough to be reported as AOs.
Fuel Cycle Facilities
(Other Than Nuclear Power Plants)
During this period, two events occurred at U.S. fuel cycle
facilities that were significant enough to be reported as AOs.
04-01 Uranium Hexafluoride Release at Honeywell Speciality Chemicals,
Inc. in Metropolis, Illinois
Date and Place--December 22, 2003; Honeywell International, Inc.,
Honeywell Specialty Chemicals, Metropolis, Illinois.
Nature and Probable Consequences--On December 22, 2003, a uranium
hexafluoride (UF6) release occurred from one of the plant's
chemical process lines. The release occurred due to improper valve
alignment which caused inadvertent pressurization of the system. The
licensee did not have a written procedure for a process that was
performed infrequently and relied on the operator's memory to perform
the required actions. The release lasted approximately 40 minutes. The
licensee observed a visible cloud crossing the site boundary and
declared a site area emergency, which was terminated approximately 4
hours later. Approximately 25 members of the public were temporarily
evacuated from their homes, and approximately 75 persons remained
sheltered in their homes for a time. Four members of the public went to
the hospital. Three of the four were examined and released, while the
fourth was held for observation and released the next day.
This individual showed skin reddening on portions of his face and
part of one arm, which indicated a hydrogen fluoride (HF) acid burn.
Honeywell's initial estimate of a release of 7 pounds of UF6
was later refined to be approximately 70 pounds. Honeywell shut the
plant down and agreed to discuss corrective actions with the NRC before
restarting operations to determine whether the NRC had any objection to
restarting specific operations.
Cause(s)--An NRC Augmented Inspection Team (AIT) and Honeywell's
Root Cause Investigation Team identified similar root and contributing
causes. The Honeywell Root Cause Investigation Team provided its
findings to the NRC in a meeting on February 11, 2004.
Key causes were as follows:
The licensee failed to have a written procedure for an
infrequent evolution and, thus, relied on the operator's memory to
perform the required actions.
The licensee's corrective action program had not
adequately corrected a previously identified lack of procedures for
certain activities, the licensee had not adequately aligned staff to
the need for procedures for activities.
The licensee did not have an alarm to warn operators that
the system was becoming pressurized. The licensee did not have
procedures or measures to respond to abnormal conditions during
operations. The licensee did not have procedures or processes for
documenting when equipment was not in proper working order.
In addition, the AIT and Honeywell Root Cause Investigation Team
identified problems in implementing the emergency plan once the
licensee identified the release, including problems in communication
with State and local authorities.
[[Page 22723]]
Actions Taken To Prevent Recurrence
Licensee--In addition to the Root Cause Investigation Team,
Honeywell chartered a Plant Engineering Team, a ``Triangle of
Prevention'' Team, and a Corporate ``Deep Dive'' Team to review the
facility and operations. These teams reviewed certain UF6
safety and environmental improvements, management processes, change
management, mechanical integrity, and the emergency plan. As a result
of these reviews, Honeywell developed a list of corrective and
improvement actions to be completed before restarting operations. On
March 4, 2004, Honeywell submitted a list of the actions to be taken
for each phase of the restart. Honeywell has also worked with State and
local authorities to improve emergency response, and the company
conducted an emergency drill with local agencies on March 11, 2004.
That drill identified items that needed to be improved, including use
of the dedicated phone for communicating with off site authorities.
Honeywell plans to improve this communication method. In addition,
Honeywell is in the process of implementing other corrective and
improvement actions.
NRC--The NRC developed a Restart Readiness Oversight Plan to review
Honeywell's actions, including safety and emergency preparedness
improvements. The NRC has reviewed actions the licensee planned to
prevent recurrence. In addition, the NRC observed an emergency drill of
the revised Emergency Plan and procedures.
The NRC held two public meetings in Metropolis, Illinois (on March
18 and April 21, 2004) during the restart phase to inform the public of
the licensee's plans and progress and to describe the NRC's oversight
activities and results. In addition, the NRC completed inspections of
the licensee's corrective actions before the restart of licensed
operations. On May 10, 2004, the NRC issued a Notice of Violation for
two significant violations identified during the AIT inspection.
Specifically, those violations involved (1) reconfiguration of the
fluorination system without detailed instructions (which allowed a
UF6 leak to occur), and (2) failure to maintain and execute
various response measures in the emergency response plan.
The NRC performed followup inspections specifically focused on
Honeywell's implementation of its corrective actions on June 10 and
August 13, 2004. The areas inspected included plant operations,
chemical safety, emergency preparedness, maintenance and surveillance,
management organization and controls, and operator training. The June
inspection did not identify any violations, but the August inspection
identified two Severity Level IV violations. Those cited violations
concerned the conduct of operations that were not adequately described
in written operating procedures and an inadequate evaluation of the
radiological conditions associated with storage of bed material and
filter fines.
On September 30, 2004, the NRC held a public meeting with Honeywell
to discuss the company's progress in implementing long-term corrective
actions that will ensure sustained performance improvements.
Honeywell's long-term efforts were primarily directed at procedures and
training, plant material conditions, and emergency preparedness. The
NRC also described the additional inspections completed since the
restart of licensed operations at the site and the agency's plan to
continue increased oversight.
The NRC performed an additional inspection in December 2004, and
identified a violation that involved the failure of the licensee's
operations personnel to properly perform pre-fill inspections of
UF6 cylinders. This failure resulted in Honeywell's shipment
of 14 cylinders with prohibited Hunt valves attached. Based upon the
results of this inspection, together with those of the previous
inspections, the NRC has determined that the heightened oversight of
licensed activities performed at the Honeywell facilities will
continue.
This event is open for the purpose of this report.
* * * * *
04-02 Incinerator Event at Westinghouse Columbia Fuel Fabrication
Facility in Columbia, South Carolina
Date and Place--Discovered on March 5, 2004; Westinghouse Columbia
Fuel Fabrication Facility; Columbia, South Carolina.
Nature and Probable Consequences--The licensee uses a standard
industrial incinerator to reduce uranium-contaminated process waste
volume and facilitate uranium recovery from the waste. During a
technical review of a proposed procedure change, the licensee
determined that its incinerator off-gas system was being operated
outside the approved safety basis. Samples of ash deposited at various
locations in the incinerator exceeded the assumed uranium concentration
for incinerator ash. The licensee immediately stopped incinerator
operations and performed a complete incinerator clean-out. The licensee
determined that approximately 271 kilograms of ash at a maximum uranium
concentration of approximately 30 wt% had accumulated in the
incinerator's secondary combustion chamber. The licensee had performed
a criticality analysis that concluded no ash would accumulate in the
secondary combustion chamber, and the maximum uranium concentration of
ash in the incinerator system could not exceed 21.6 wt%. No criticality
safety controls were in place to prevent the accumulation of fly-ash
containing excessive uranium concentrations.
Cause(s)--The licensee's criticality safety staff failed to
recognize that fly-ash could accumulate in the incinerator's secondary
combustion chamber, and ash uranium concentrations could exceed 21.6
wt%. Contributing factors were the failure to control incinerator
operations that allowed the increased uranium concentration in the fly-
ash, and failure to recognize excessive material accumulation or
uranium concentration increases.
Actions Taken To Prevent Recurrence
Licensee--The licensee immediately stopped incinerator operations
and initiated a project to prevent future material accumulations. The
licensee also initiated a program to upgrade criticality safety at the
plant, including assigning additional staff to the nuclear criticality
safety program, improving ownership of criticality safety by production
and engineering staff, improving management and ownership of change,
performing a comprehensive review of existing criticality safety
analyses, using the integrated safety analysis process to prioritize
changes to administrative criticality safety controls, and implementing
a comprehensive program throughout the plant to ensure procedure
compliance.
NRC--On May 13, 2004, the NRC issued Inspection Report 70-1151/
2004-001, which described the event. On July 19, 2004, the NRC issued
an Information Notice to fuel cycle licensees concerning the use of
less-than-optimal bounding assumptions in criticality safety analyses
at fuel cycle facilities. On July 28, 2004, the NRC issued a Notice of
Violation and Proposed Imposition of Civil Penalty in the amount of
$24,000 to the licensee for failure to establish and maintain double-
contingency protection in the incinerator and failure of management
controls to detect the accumulation of a critical mass of fissile
material in an unsafe geometry vessel. Although the normal civil
penalty assessment process
[[Page 22724]]
would have fully mitigated the civil penalty, the NRC exercised
enforcement discretion in accordance with Section VII.A.1 of the
Enforcement Policy and proposed a base civil penalty to reflect the
safety significance of the issue, which resulted in a substantial
increase in the likelihood of a nuclear criticality event. On October
21, 2004, the NRC conducted a management meeting with the licensee to
discuss the incinerator event and its proposed corrective actions. The
NRC will follow the corrective actions through the agency's inspection
and oversight programs.
This event is closed for the purpose of this report.
* * * * *
Other NRC Licensees (Industrial Radiographers, Medical Institutions,
etc.)
The NRC determined that the following events which occurred at
facilities, licensed or otherwise regulated by the NRC, during this
reporting period were significant enough to be reported as AOs:
04-03 Iodine-125 Brachytherapy Seed Medical Event at Albert Einstein
HealthCare Network in Philadelphia, Pennsylvania
Date and Place--October 16, 2003 (identified on November 20, 2003);
Albert Einstein HealthCare Network in Philadelphia, Pennsylvania.
Nature and Probable Consequences--A patient received a permanent
brachytherapy implant using iodine-125 (I-125) seeds as treatment for
prostate carcinoma on October 16, 2003. The authorized user prescribed
a dose of 145 Gy (14,500 rads) to the prostate gland. The implant was
performed under ultrasound guidance, and 89 sources were implanted as
prescribed in the written directive. On November 17, 2003, the patient
returned for a routine postoperative computerized tomography (CT) scan.
On November 20, 2003, a review of the scan revealed that many of the
seeds were not located in the prostate as intended, but were in
adjacent tissue where they were ineffective during treatment. As a
result, the prostate gland received an inadequate dose of 18.6 Gy
(1,860 rads), while the adjacent tissue received a dose of
approximately 115 Gy (11,500 rads). An NRC medical consultant
determined that the probable consequences to the patient would be
comparable to the effects of external beam radiation treatment for
prostate cancer and would not cause further damage to the patient. The
patient and the patient's referring physician were notified of the
event.
Cause(s)--The licensee determined that this medical event was
caused by human error, the most likely being the misidentification of
the prostate gland on the intra-operative ultrasound. Other possible
causes include shifting of the needle grid in the patient on the
operating room table or the suction of the seeds into the needle tract
after the removal of the individual needles from the patient.
Actions Taken To Prevent Recurrence
Licensee--The licensee's corrective actions for future prostate
brachytherapy treatments include new requirements that an outside
radiation oncologist with expertise in prostate brachytherapy will
monitor authorized users, and an experienced prostate brachytherapist
will observe authorized users as they perform prostate implant
procedures. In addition, the licensee implemented revised procedures,
including performing a pre-operative CT scan; reviewing pre-planned
ultrasound studies prior to, during, and after the procedure; and
reviewing postoperative pelvic x-rays within 1 day of the procedure.
Furthermore, the Radiation Safety Committee will review all forms,
documents, education, and oversight associated with the permanent
prostate implant program, and will make recommendations or amendments,
as necessary, to reflect programmatic changes.
NRC--The NRC staff conducted a special safety inspection on
December 5, 2003, and did not identify any violations associated with
the licensee's actions. The NRC also reviewed the licensee's current
prostate implant program, and concluded that 12 other I-125 prostate
implants had been completed without incident.
This event is closed for the purpose of this report.
* * * * *
04-04 Diagnostic Medical Event at William Beaumont Hospital in Royal
Oak, Michigan
Date and Place--June 8, 2004; William Beaumont Hospital; Royal Oak,
Michigan.
Nature and Probable Consequences--The licensee reported that a
patient was prescribed a dose of 0.37 megabecquerels (MBq) [10
microcuries ([mu]Ci)] of I-131 for a thyroid uptake procedure, but
instead received 33.86 MBq (915 [mu]Ci) of I-131. The pipette used to
prepare I-131 therapy dosages earlier in the day was inadvertently used
to draw the 0.37 MBq (10 [mu]Ci) I-131 uptake dosage. The technician
properly disposed of the I-131 uptake dosage after identifying the
error.
The technician then obtained the ``uptake'' pipette and prepared a
second dosage from the I-131 bulk uptake solution. However, the
``uptake'' pipette had inadvertently been switched with the ``therapy''
pipette used earlier. This may have occurred because both the thyroid
``uptake'' pipette and the ``therapy'' pipette had illegible labels. As
a result, the second dosage contained 0.074 MBq (2 [mu]Ci) of I-131
remaining from the earlier therapy administrations and the newly drawn
I-131 prepared for the thyroid uptake. The total activity for the
second dosage measured 33.86 MBq (915 [mu]Ci). The technician focused
on drawing the calculated volume required to obtain the prescribed
activity, rather than the radioactive activity measured in the dose
calibrator and interpreted the ``0.915 millicuries (mCi)'' displayed on
the dose calibrator as ``9.15 [mu]Ci.'' The technician electronically
transferred the dosage measurement from the dose calibrator to a dosage
label. A second technician administered the dosage to the patient.
Assuming a 55% uptake, the absorbed dose to the patient's thyroid was
26.75 Gy (2,675 rads) with an effective dose equivalent of 0.81 Gy (81
rads). The patient and referring physician were notified of the medical
event on June 9, 2004. The licensee indicated that the additional
dosage administered to the patient would not result in any increased
risk or biological effect to the patient.
Cause(s)--This event was caused by human error. The nuclear
medicine technologist who drew the dose misinterpreted the reading on
the dose calibrator, and the technician who administered the dose did
not verify the dose before administration.
Actions Taken To Prevent Recurrence
Licensee--The licensee implemented a requirement to use a new
pipette each time an I-131 uptake dose is prepared, reprogrammed the
computer to accept uptake dose activity rather than volume and stopped
the computer from printing a dose label when the activity is not within
the established range. The licensee also trained the radiopharmacy
staff not to override the computer's failsafe mechanisms, and retrained
the nuclear medicine technologist in the process for dose verification
prior to administration.
NRC--The NRC staff conducted a special safety inspection on June
10, 2004. Then, on September 14, 2004, the NRC issued a Notice of
Violation for a significant violation involving the administration of a
dosage of liquid I-131 to a patient for a thyroid uptake study that was
approximately 90 times
[[Page 22725]]
larger than the 10-[mu]Ci dosage prescribed by the authorized user
physician.
This event is closed for the purpose of this report.
* * * * *
Agreement State Licensees
The NRC determined that the following events, which occurred at
Agreement State licensed facilities during this reporting period, were
significant enough for reporting as AOs:
AS 04-01 I-125 Brachytherapy Seed Medical Event at Central Arkansas
Radiation Therapy Institute in Conway, Arkansas
Date and Place--December 4, 2003; Central Arkansas Radiation
Therapy Institute; Conway, Arkansas.
Nature and Probable Consequences--The licensee reported that a
patient received a radiation dose to an unintended area during an I-125
prostate-seed implant procedure. The patient was prescribed treatment
with 122 I-125 seeds, with each seed containing an activity of 13.3 MBq
(0.36 mCi). During the patient's post-implant CT scan on December 18,
2003, the licensee discovered that the seeds had been implanted 2
centimeters (cm) too low and missed treating the upper portion of the
prostate gland. As a result, 68 cm\3\ of adjacent tissue received the
prescribed dose of 144 Gy (14,400 rads). The licensee reported that the
adjacent tissue should not be affected adversely by the dose delivered
by the seeds. The licensee administered additional treatment to deliver
the intended dose to the upper 2 cm of the prostate gland. The licensee
notified the patient and the patient's referring physician of the
event.
Cause(s)--This event was attributed to human error in that the
treatment site was not verified.
Actions Taken To Prevent Recurrence
Licensee--The licensee wrote a new procedure to implement the use
of fluoroscopic guidance to ensure the correct placement of seeds.
State Agency--The State has reviewed and accepted the licensee's
corrective actions.
This event is closed for the purpose of this report
* * * * *.
AS 04-02 Dose to Fetus at Hillcrest Hospital of Mayfield Heights, Ohio
Date and Place--November 20, 2003, Hillcrest Hospital; Mayfield
Heights, Ohio.
Nature and Probable Consequences--The Ohio Bureau of Radiation
Protection reported that a 19-year-old female patient was administered
5.18 gigabequerels (GBq) (140 mCi) of I-131 as prescribed for thyroid
carcinoma. At the time, the patient was unaware that she was pregnant
and she completed the required forms indicating that she was not
pregnant. However, on December 5, 8, and 11, 2003, quantitative tests
confirmed that the patient was pregnant. The licensee provided the
results to the patient's endocrinologist, who recommended performing a
fetal dose calculation. The licensee was notified and its consultant
informed the endocrinologist that the fetus would have received a whole
body dose of 0.19 Gy (19.8 rads). The endocrinologist sent the results
to the Center for Human Genetics at the University Hospital in
Cleveland, Ohio, where an assessment determined that the pregnancy
could safely continue.
Cause(s)--This event was caused by human error. At the time of the
administration, the patient was unaware of her pregnancy status and
completed forms indicating that she was not pregnant.
Actions Taken To Prevent Recurrence
Licensee--The licensee has implemented pregnancy testing for
patients of child bearing age, who receive radiation therapy.
State Agency--The Ohio Bureau of Radiation Protection was notified
of this event on January 16, 2004, and performed a special inspection
on January 22, 2004. The State found the licensee's corrective actions
adequate to prevent recurrence.
This event is closed for the purpose of this report.
* * * * *
AS 04-03 High Dose Rate Afterloader Medical Event at New Orleans Cancer
Institute at Memorial Medical Center, Louisiana
Date and Place--March 31, 2004; New Orleans Cancer Institute; New
Orleans, Louisiana.
Nature and Probable Consequences--A cancer patient undergoing
therapeutic radiation treatment for prostate cancer received 18 Gy
(1,800 rads) to the wrong treatment site. This error occurred using a
high dose rate (HDR) afterloader device with a radioactive source
containing 270.7 GBq (7.32 Ci) of Ir-192. The event occurred after the
dosimetrist made an error while inputting data into the afterloader's
dosimetry software program. Although the dosimetrist appropriately
clicked the ``catheter tip'' selection, the dosimetrist did not
highlight and choose ``catheter tip.'' Therefore, the computer cursor
stayed on the ``connector end'' selection. This resulted in a 2-cm
positioning error, which caused the source to stop short of the target
so that the total prescribed dose was not delivered. The patient was
informed of the event, and the remaining dose was delivered by external
beam therapy. According to the Radiation Oncologist, no detrimental
effects are expected. The patient was self-referred for the therapeutic
treatment.
Cause(s)--This event was attributed to operator error.
Actions Taken To Prevent Recurrence
Actions taken to prevent recurrence include implementing procedures
to add a visual check and documentation that the treatment plan was
administered with the source position calculated from the tip end of
the catheter or needle. This procedure will be added to the pre-
treatment checklist, which is performed and signed by the radiation
oncologist, physicist, and dosimetrist. The checklist will be performed
prior to initial treatment and at treatment plan changes, and will be
part of the patients' permanent records. Also, the licensee contacted
the device's manufacturer regarding the confusion associated with the
default orientation in the software program, and requested an
adjustment to the program. The manufacturer stated that this could not
be done at this time, but is discussing the issue. The manufacturer
offered additional training to the licensee's employees, and the
licensee is sending its employees to the training.
State Agency--The State accepted the licensee's implementation of
new procedures and its corrective actions as appropriate.
This event is closed for the purpose of this report.
* * * * *
AS 04-04 Diagnostic Medical Event at Northeast Alabama Regional Medical
Center, Alabama
Date and Place--August 10, 2004; Northeast Alabama Regional Medical
Center; Montgomery, Alabama.
Nature and Probable Consequences--A patient received 111 MBq (3,000
[mu]Ci) of I-131 instead of the prescribed dose of 0.93 MBq (25
[mu]Ci). The licensee discovered the event on August 12, 2004, when the
patient returned for the whole body scan 48 hours later. The referring
physician had requested a diagnostic I-131 scan to assess a thyroid
nodule, which requires 0.93 MBq (25 [mu]Ci). The technologist
misunderstood the order by assuming that the referring physician wanted
a whole body scan to assess thyroid cancer, and administered 111 MBq
(3,000 [mu]Ci) of I-131 without
[[Page 22726]]
requesting clarification or approval from the authorized users.
Two authorized users determined that the patient could become
hypothyroid. Therefore, patient followup assessments included thyroid
profiles and thyroid uptakes to determine thyroid function. The patient
and the referring physician were informed of the event.
Cause(s)--This event was attributed to human error. The
technologist misunderstood the treatment ordered by the referring
physician and failed to verify the written directive.
Actions Taken To Prevent Recurrence
Licensee--The licensee implemented corrective measures to ensure
that authorized users approve all procedures involving the
administration of radiopharmaceuticals and re-instructed nuclear
medicine personnel.
State Agency--The State conducted an inspection.
This event is closed for the purpose of this report.
* * * * *
AS 04-05 Occupational Exposure at Palmetto Health and Baptist Hospital
in Columbia, South Carolina
Date and Place--March 17, 2004; Palmetto Health and Baptist
Hospital; Columbia, South Carolina.
Nature and Probable Consequences--The licensee reported that a
pharmacist trainee received an extremity exposure resulting in a
shallow dose equivalent to the hand of 7,420 mSv (742 rem), a deep dose
equivalent to the hand of 70 mSv (7.02 rem), and a thyroid dose of 0.9
mSv (0.09 rem). The exposures occurred when a spill took place while
compounding I-131 from a vial. The pharmacist trainee cleaned up the
area, decontaminated his skin, and reported the spill to the imaging
manager the following day. The imaging manager conducted a second
survey of the area, which showed that no contamination remained from
the spill. The pharmacist trainee completed a spill report but did not
reveal his contamination in the report. The pharmacist trainee left for
vacation and 11 days later, after his return, informed the Radiation
Safety Officer (RSO) that his forearm had been contaminated during the
I-131 spill. Immediate actions were taken to determine whether any
contamination still remained on his arm. Elevated levels were
discovered on his right forearm and left fingertips. The appropriate
hospital/nuclear medicine personnel were notified. The pharmacist
trainee was suspended from any and all duties involving radioactive
material.
Cause(s)--This event occurred as a result of human error and
failure to follow established procedures. An initial crimp failure on
the vial may also have contributed to the spill.
Actions Taken To Prevent Recurrence
Licensee--The licensee retrained all staff in spill procedures,
emphasizing proper notification of supervisors. Additionally, at the
prompting of the licensee, the vial supplier reevaluated the process of
ensuring that each crimp is acceptable for shipment, although the
supplier believed it was more likely an isolated incident.
State Agency--The State agency conducted inspections and cited the
licensee for violations of regulations for controlling radiation.
* * * * *
AS 04-06 Gamma Stereotactic Radiosurgery (Gamma Knife) Medical Event at
Radiosurgical Center of Memphis in Memphis, Tennessee
Date and Place--January 24, 2003; Radiosurgical Center of Memphis;
Memphis, Tennessee. This event was not determined to be an AO until the
preparation of the FY2004 report.
Nature and Probable Consequences--The licensee reported that a
patient received 27 Gy (2,700 rads) to a brain metastasis instead of
the intended 18 Gy (1,800 rads) during gamma knife treatment. The
physicist did not determine that an error had occurred until the
treatment was complete. The RSO determined that one of the four brain
metastases received greater than the prescribed dose. The other three
brain metastases received the prescribed dose. The tumor that received
the incorrect dose was at the periphery of the brain next to the skull
in a non-critical area so that much of the extra dose was delivered to
the space between the brain and the skull. The cause of the incident
was that a 14-millimeter (mm) (.55-inch) collimator helmet was used
instead of the prescribed 8-mm (.31 inch) collimator helmet. The
personnel setting up the treatment neglected to change the helmet. The
tumor that received the unintended dose was located at the periphery of
the brain, adjacent to the skull. Because most of the unintended dose
was delivered to a non-critical space, between the brain and skull, the
additional radiation exposure should have no significant effect on the
patient.
The referring physician was notified of the event and informed the
patient's family of the unintended dose.
Cause(s)--The cause was human error, in that the event resulted
from use of the wrong collimator helmet.
Actions Taken To Prevent Recurrence
Licensee--The licensee established a new procedure to require the
physician, physicist, and nurse to sign off on the treatment time,
helmet size, and position before each shot. Also, new labels
identifying the size of the helmet were attached to each of the four
helmets. These labels can be seen by personnel via the TV monitor
located at the control panel outside the treatment room. The physician
will verify the correct size before the control panel button is pushed
to start the treatment.
State Agency--The State reviewed and approved the licensee's new
procedures.
* * * * *
AS 04-07 Strontium-90 Eye Applicator Brachytherapy Medical Event at St.
Francis Hospital in Memphis, Tennessee
Date and Place--March 25, 2004; St. Francis Hospital; Memphis,
Tennessee.
Nature and Probable Consequences--A 79-year-old patient was
prescribed radiation treatment for pterygium (an eye abnormality). The
patient was to receive 20 Gy (2,000 rads), but instead received 70 Gy
(7,059 rads). The prescribed dose was to be administered via a Sr-90
radioactive source with an activity of 3.7 GBq (100 mCi) for a duration
of 42.5 seconds. However, the manual timer was incapable of being set
for fractions of a second and interpreted the entry to be 4 minutes and
25 seconds. During the treatment, the physician questioned the
treatment time and terminated the treatment after 2 minutes and 30
seconds. The Radiation Oncologist concluded that the maximum possible
dose delivered to the sclera was well below the sclera tolerance dose
and that the optic nerve and retina did not receive any meaningful
dose. The patient and the referring physician were notified of the
event.
Cause(s)--The wrong treatment time was programmed for the patient's
eye treatment.
Actions Taken To Prevent Recurrence
Licensee--The licensee updated its procedures, which require use of
an additional person to operate a second timer during brachytherapy eye
treatment.
State Agency--The Tennessee Department of Radiological Health
conducted an onsite inspection on March 29, 2004. The State
investigated, reviewed, and approved the licensee's new procedures.
This event is considered closed for the purpose of this report.
* * * * *
[[Page 22727]]
AS 04-08 Therapeutic Medical Event at Southern Regional Medical Center
in Riverdale, Georgia
Date and Place--July 1, 2004; Southern Regional Medical Center;
Riverdale, Georgia.
Nature and Probable Consequences--The licensee informed the Georgia
Department of Natural Resources (GDNR) that a patient received 3.7 GBq
(100 mCi) of I-131 instead of the prescribed dose of 0.64 GBq (17.3
mCi). Three patients were scheduled for I-131 treatments on the same
day. An inpatient was scheduled to receive 3.7 GBq (100 mCi), and two
outpatients were scheduled to receive less than 1.2 GBq (33 mCi). One
of the outpatients was mistakenly injected with the 3.7 GBq (100 mCi)
dose intended for the inpatient and was also allowed to leave the
facility without receiving proper instructions. The licensee did not
discover the error until after the patient had left the facility with
her children. The authorized user who signed the written directive was
at the facility when the dose was administered. The temporary RSO was
at South Fulton Hospital, but was notified of the event. The patient
and referring physician were immediately notified of the event by the
licensee. The GDNR received a report from the licensee's medical
physicist consultant estimating the dose to the patient's children was
0.5 mSv (0.05 rem), with a maximum possible dose of 1.0 mSv (0.1 rem).
The radiation should not have any effects on the patient's children or
other individuals. The medical significance to the patient is the
possibility of developing hypothyroidism which would require thyroid
medication.
Cause(s)--This event was attributed to human error. The wrong
patient was administered a therapeutic dose of I-131 that was
prescribed for someone else.
Actions Taken To Prevent Recurrence
Licensee--The licensee discussed the incident with all technicians
who prepare and administer I-131, revised nuclear medicine protocols
pertaining to the therapeutic use of I-131 and patient instructions,
and revised procedures to incorporate better practices to prevent this
type of error from recurring.
State Agency--The State agency reviewed and approved the corrective
actions that the licensee implemented to prevent recurrence.
This event is considered closed for the purpose of this report.
* * * * *
AS 04-09 Intravascular Brachytherapy Medical Event at Ireland Cancer
Center in Middleburg Heights, Ohio.
Date and Place--December 22, 2003; Ireland Cancer Center;
Middleburg Heights, Ohio.
Nature and Probable Consequences--The licensee reported that a
patient received a radiation dose to an unintended site 3 cm proximal
to the prescribed treatment site during an intravascular brachytherapy
(IVB) treatment procedure. The dose delivered to the unintended site
was approximately 18.40 Gy (1,840 rads). The event involved an IVB
device that used a 3.5-mm catheter and a source train that contained
Sr-90 with an activity of 2.0 GBq (53.8 mCi). The source train traveled
to a location approximately 3 cm proximal to the intended treatment
site. It was determined that there was a kink in the delivery catheter,
which kept the source train from traveling to the correct site. The
kink was not substantial enough to affect the flow of sterile water
used to send and retrieve the source train. The kink was discovered the
following day during medical physics quality checks. The referring
physician and patient were notified of the event. According to the
licensee, no adverse effects are expected.
Cause(s)--The cause of the event was determined to be a kink in the
delivery catheter, which kept the source train from traveling to the
correct site.
Actions Taken To Prevent Recurrence
Licensee--Corrective actions incorporated by the licensee included
additional films taken during procedures to verify the placement of the
catheter. When there is any doubt of the placement of the catheter, the
treatment will be aborted. The treatment team will then evaluate
whether to attempt treatment with a different catheter.
State Agency--The Ohio Department of Health conducted an
investigation, reviewed the licensee's corrective actions, and found
them adequate to prevent recurrence.
This event is considered closed for the purpose of this report.
* * * * *
AS 04-10 Intravascular Brachytherapy Medical Event at Swedish Medical
Center in Seattle, Washington
Date and Place--November 18, 2003; Swedish Medical Center; Seattle,
Washington.
Nature and Probable Consequences--A patient undergoing an
intravascular brachytherapy (IVB) treatment for coronary restenosis
received 13.78 Gy (1,378 rads) to an unintended site (healthy tissue).
The licensee reported that the source train was partially inserted into
a small artery, and the routing did not follow a direct path. When the
difficulty occurred, the source train had been partially inserted 65 mm
proximal to the intended site. The source train contained a total
activity of 2.91 GBq (78.56 mCi). A 143-second exposure time elapsed
before the cardiologist withdrew the source train, even though the
licensee's procedure requires sources to be immediately withdrawn once
a problem occurs. The delay occurred as the cardiologist first worked
to fully insert the source train and then discussed correcting the
problem with the oncologist. The catheter was examined, and there were
no kinks or bends. It was determined that there were no failures of the
IVB device. It was suspected that the pressure from the artery and the
tortuous route to the site caused a contraction of a portion of the
catheter and resulted in the seeds becoming stuck at a particular
location. The cardiologist was suspended from licensed activities until
the details of the event were fully understood. According to the
licensee, no adverse health effects are expected. The patient and the
patient's referring physician were notified of the event.
Cause or Causes--It is suspected that the pressure from the small
artery and the tortuous route to the site caused a contraction of a
portion of the source train and resulted in the seeds becoming stuck at
a particular location.
Actions Taken To Prevent Recurrence
Licensee--Corrective actions included reemphasizing the importance
of adhering to established procedures and protocols before
administering radiopharmaceuticals, and ensuring that all staff
completed refresher training.
State Agency--The State reviewed and approved the corrective
actions taken by the licensee and will follow-up at the next
inspection.
This event is closed for the purpose of this report.
* * * * *
AS 04-11 Diagnostic Medical Event at Swedish Medical Center in
Seattle, Washington
Date and Place--September, 24, 2004; Swedish Medical Center;
Seattle, Washington.
Nature and Probable Consequences--The licensee reported that a
patient received 190.9 MBq (5.16 mCi) of I-131, instead of the
prescribed 74 MBq (2 mCi) for a post thyroid treatment follow-up scan.
The prescribing physician
[[Page 22728]]
realized that the error occurred on September 27, 2004, when the
patient underwent the scan. A viable follow-up scan was performed even
though the error occurred. The referring physician notified the patient
of the error on September 27, 2004. The nuclear medicine physician
indicated there would be no negative health effects from this
administration.
Cause or Causes--The licensee stated that human error led to
procedural checks not being performed prior to the administration.
Actions Taken To Prevent Recurrence
Licensee--Corrective actions included re-emphasis on the importance
of adhering to established procedures and protocols prior to the
administration of radiopharmaceuticals and the completion of staff
refresher training.
State Agency--The State reviewed and approved the corrective
actions taken by the licensee and will follow-up at the next
inspection.
This event is considered closed for the purpose of this report.
* * * * *
AS 04-12 Therapeutic Medical Event at University of California at Los
Angeles Harbor Medical Center in Torrance, California
Date and Place--June 7, 2002; Los Angeles County Harbor University
of California at Los Angeles (UCLA) Medical Center; Torrance,
California. This event was not identified as an AO until the
preparation of the FY 2004 report.
Nature and Probable Consequences--A patient receiving treatment for
thyroid ablation was administered a dose of 4.74 GBq (128 mCi) of I-131
instead of the prescribed dose of 1.18 GBq (32 mCi) of I-131.
On June 7, 2002, five patients were scheduled to be treated with I-
131. Five vials containing I-131 arrived from the radiopharmacy and
were properly labeled with the patients' names. The nuclear medicine
technologist incorrectly thought that the name on the 4.74 GBq (128mCi)
vial did not match any of the patient's names scheduled for treatment
that day. Assuming that this vial was incorrectly labeled, the 4.74 GBq
(128 mCi) dosage was administered to the patient for whom the
technologist thought the dose was intended. However, the technologist
failed to verify whether any of the remaining four dosages were labeled
for that patient. In fact, a vial was correctly labeled as prepared for
that patient.
The authorized user was present during the administration to
supervise the administration of the radiopharmaceutical, and to verify
that the correct radiopharmaceutical and dosage were administered. The
authorized user did not perform an independent verification, but
instead assumed that the nuclear medicine technologist had verified
that the dosage was correct. The error was discovered about 5 hours
later, when the patient scheduled to receive the 4.74 GBq (128 mCi)
dosage arrived at the medical center for treatment. The patient and the
referring physician were notified. The authorized user went to the home
of the patient who received the inadvertent administration and verified
that appropriate radiation safety precautions were in place. The
patient's treatment plans were modified to accommodate the larger
dosage. The authorized user stated that the dosage was intended to
ablate the thyroid and render the patient hypothyroid, and that was
accomplished with the larger dose. He further stated the patient is
doing well, with no complications.
Cause(s)--This medical event was caused by human error which
resulted in the licensee's failure to follow proper policies and
procedures and verify the prescribed dosage for a specific patient.
Actions Taken To Prevent Recurrence
Licensee--The licensee re-instructed all nuclear medicine personnel
on the importance of following the division's policies and procedures
and the use of a third party to check the prescription dose and patient
identification before administration. Additionally, the RSO will review
all I-131 therapy documents and administrations.
State Agency--The State cited the licensee for failure to provide
written notification to the referring physician and the patient within
15 days after the occurrence of the medical event. The State has
reviewed and approved the licensee's corrective actions.
* * * * *
AS 04-13 Diagnostic Medical Event at University Hospital in Cincinnati,
Ohio
Date and Place--March 10, 2004; University Hospital; Cincinnati,
Ohio.
Nature and Probable Consequences--The licensee reported that a
patient was given 74 MBq (2,000-Ci) of I-131 for a thyroid cancer work-
up instead of the prescribed dose of 7.4 MBq (200-Ci) of I-123 for a
thyroid uptake scan. The patient scheduled to receive the I-123 dose
responded affirmatively to being the patient that was to receive the I-
131 dose. The technologist did not follow procedures regarding proper
identification of the patient, which requires two separate methods for
verifying patient identification. A follow-up scan revealed the patient
does have hypothyroidism, and as a result, the 74 MBq (2,000-Ci) of I-
131 would have been prescribed based on the scan results. The referring
physician and patient were notified. No adverse health effects are
expected.
Cause or Causes--The technologist failed to follow established
procedures.
Actions Taken to Prevent Recurrence
Licensee--The licensee disciplined the technologist in accordance
with hospital policy and reiterated to all technologists the need to
thoroughly check patient identification using two approved methods.
Additionally, the Radiation Safety Committee modified the Quality
Management Program to require a photo as one method of verifying
patient identification.
State Agency--The Ohio Department of Health conducted an
investigation of the event on May 11, 2004, and reviewed the licensee's
corrective actions. The State found the licensee's corrective actions
adequate to prevent a recurrence of the event.
This event is closed for the purpose of this report.
Dated at Rockville, Maryland this 18th day of April 2005.
For the Nuclear Regulatory Commission
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 05-8173 Filed 4-29-05; 8:45 am]
BILLING CODE 7590-01-P