[Federal Register Volume 62, Number 84 (Thursday, May 1, 1997)]
[Notices]
[Pages 23802-23810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11295]
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NUCLEAR REGULATORY COMMISSION
Report to Congress on Abnormal Occurrences Fiscal-Year 1996;
Dissemination of Information
Section 208 of the Energy Reorganization Act of 1974 (PL 93-438)
identifies an abnormal occurrence (AO) as an unscheduled incident or
event that the 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 (PL 104-66) requires that
AOs be reported to Congress on an annual basis. During fiscal-year
1996, eighteen events which occurred at NRC licensed facilities were
determined to be AOs. These events are discussed below. 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. 19, ``Report to Congress on Abnormal Occurrences,
Fiscal Year 1996.'' This report will be available at NRC's Public
document Room, 2120 L Street NW. (Lower Level), Washington, DC, about
three weeks after the publication date of this Federal Register Notice.
Nuclear Power Plants
96-1 Plant Trip With Multiple Complications at Wolf Creek Nuclear
Generating Station
One of the AO reporting criteria notes that major deficiencies in
design, construction, use of, or management controls for licensed
facilities or material can be considered an AO.
Date and Place
January 30-31, 1996; Wolf Creek Nuclear Generating Station, a
Westinghouse-designed pressurized water reactor nuclear power plant,
operated by the Wolf Creek Nuclear Operating Corporation and located
about 5.63 kilometers (3.5 miles) northeast of Burlington, Kansas.
Nature and Probable Consequences
One train of the essential service water system (ESWS) was
inoperable due to frazil 1 ice blockage of the intake trash
racks, and the second train was degraded. The ESWS removes heat from
plant components which require cooling for safe shutdown of the reactor
or following a design basis accident. The ESWS consists of two
redundant trains, provides emergency makeup to the spent fuel pool and
component cooling water systems, and is the safety related water supply
to the auxiliary feedwater system. Freeze protection for the ESWS is a
design provision, and is provided by a warming line from each ESWS
train which discharges directly in front of the train's trash rack.
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\1\ Minute ice crystals called frazil were formed when wind and
temperature conditions caused water in the ultimate-heat-sink
reservoir to become supercooled (cooled to a few hundredths of a
degree below the freezing point without solidification). The frazil
ice crystals mixed with the supercooled water, and adhered to the
objects (i.e., trash racks) with which they collided.
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At approximately 2:00 a.m. on January 30, 1996, operators at Wolf
Creek received alarms indicating that the traveling screens for the
circulating water (CW) system were becoming blocked. The site watch
reported that the traveling screens for Bays 1 and 3 were frozen and
that water levels in these bays were approximately 2.44 meters (8 feet)
below normal. The ESWS was started with the intent to separate the ESWS
from the service water (SW) system. However, the ESWS was incorrectly
aligned, which reduced warming flow to the ESWS suction bays (the
lineup was corrected approximately 6 hours later). At approximately
3:30 a.m., operators received a service water low pressure alarm (CW
system bays were subsequently determined to be at 3.66 meters (12 feet)
below normal) and an electric fire pump started. The shift supervisor
then directed a manual reactor/turbine trip. Following the scram, five
control rods failed to fully insert (from 12 to 30 steps out). The
event was further complicated because the turbine driven auxiliary
feedwater pump developed a packing leak and was declared inoperable.
The loss of CW system bay level was subsequently determined to be
caused by ice blockage of the traveling screens, which was caused by
freezing water from the spray wash system.
Train ``A'' ESWS pump was tripped and declared inoperable at 7:47
a.m. due to low discharge pressure and high strainer differential
pressure. At about 5:45 p.m. the operators declared Train ``A''
operable based on an engineering evaluation. However, the pump was
[[Page 23803]]
stopped 1\1/2\ hours later at approximately 7:30 p.m. when the pump
exhibited further oscillations in flow and pressure. At approximately
8:00 p.m., operators noted that ESWS Train ``B'' suction bay level was
4.57 meters (15 feet) below normal and decreasing slowly. Operators
placed additional heat loads on Train ``B'' and the suction bay levels
subsequently recovered. At 10:14 p.m., the operators again started
Train ``A'' ESWS, but later secured it, at 10:27 p.m., due to
decreasing flow and pressure. At about 9:00 a.m. on January 31, 1996,
divers inspected the suction bay of Train ``A'' and noted complete
blockage of the trash racks by frazil ice. The condition of the Train
``B'' trash racks was not determined because the pump was running. The
ice blockage was cleared later that day using heating, and air sparging
of the trash racks.
Cause or Causes
The root cause of this event was deficiencies in the ESWS warming
line design. This problem was exacerbated by the initial incorrect
alignment of the ESWS. A 1976 design calculation specified a warming
line flow rate of 15,142 liter/minute (4000 gpm) to prevent frazil ice.
This calculation assumed a warming line temperature of 2 deg.C
(3 deg.F) above freezing. This assumption was never validated: The
warming line temperature during the event was only approximately
0.5 deg.C (1 deg.F) above freezing. Additionally, due to the elevations
and configuration of the warming line, portions of the line operated
with partial pipe flows. Flow through the lines was estimated to have
been 9464 liter/minute (2500 gpm) and, with the initial improper
lineup, warming flow was estimated to be 6435 liter/minute (1700 gpm),
less than half the design specification.
Actions Taken to Prevent Recurrence
Licensee
The hydraulics of the ESWS discharge to the ultimate heat sink, and
the warming line to the ESWS pumphouse, have been changed to establish
and distribute the proper amount of flow to the ESWS warming line. The
licensee has installed back pressure orifices to establish the required
flow rates. This work was completed by October 1, 1996.
NRC
NRC entered a monitoring phase following the Notification of an
Unusual Event at 9:00 a.m. on January 30, 1996. During February 6
through February 15, 1996, NRC conducted an Augmented Inspection Team
inspection at Wolf Creek as a result of this event. NRC issued a civil
penalty of $300,000 because of violations as a result of this event.
96-2 Containment-Bypass Leakage via Disconnected Hydrogen-Monitor
Lines at Braidwood Units 1 and 2
One of the AO reporting criteria notes that a major reduction in
the degree of protection to public health and safety from a major
degradation of essential safety-related equipment can be considered an
AO.
Date and Place
February 15, 1995; Braidwood Unit 2, a Westinghouse-designed
pressurized water nuclear reactor plant, operated by Commonwealth
Edison Company and located about 38.6 kilometers (24 miles) south
southwest of Joliet, Illinois.
Nature and Probable Consequences
On November 9, 1994, the licensee completed a containment
integrated leak rate test (ILRT). For this test, the 6.35-millimeter
(0.25-inch) containment penetration hydrogen sensing lines for trains
``A'' and ``B'' were disconnected and a balloon placed on the end to
identify any leakage. The procedure did not specify whether to
disconnect the sensing line inside the hydrogen monitor cabinet or
outside. The operators who lined up the test disconnected the lines
inside the cabinet. The licensee's investigation concluded that when
other operators restored the system from the test, they observed the
exterior sensing lines and assumed that the lines were reconnected.
Therefore, the sensing lines remained disconnected inside the cabinet.
On January 31, 1995, the operations department wrote a problem
identification report to identify a growing difference in the hydrogen
readings on the ``A'' and ``B'' trains which are taken during each
shift. On February 15, 1995, during troubleshooting, the ``A'' train
lines were found to be disconnected, approximately 3 months after being
disconnected. Surveillance tests performed on December 11, 1994, and
January 25, 1995, provided opportunities to detect the deficiency with
the ``A'' train but were missed. It could not be conclusively
determined when the ``B'' train was restored. Two maintenance workers
had a recollection of discovering balloons on the sensing lines in a
hydrogen monitoring cabinet in late 1994. Maintenance records indicate
these individuals worked on the ``B'' train on December 20, 1994.
However, computer and operator logs for the ``B'' train appear to have
been accurately reading containment hydrogen following the ILRT.
The hydrogen monitors are normally isolated. However, during a loss
of coolant accident, the Emergency Operating Procedures direct the
operators to put them into service to monitor containment hydrogen
concentration. This would create an unfiltered release path from the
containment to the auxiliary building. The licensee calculated that,
under worst case conditions using guidance from NUREG-1465, ``Accident
Source Terms for Light-Water Nuclear Power Plants,'' regulatory dose
limits could be exceeded within approximately 3 hours. NRC review found
the licensees calculations to be conservative.
There are area radiation monitors near the hydrogen monitors. These
area radiation monitors alarm in the control room and the alarm
response procedures call for notification of Radiation Protection
personnel to survey the area. Additionally, there are radiation
monitors in the auxiliary building exhaust that would assist the
operators in identifying the leak. The containment bypass flow path
could be isolated remotely from the control room and it appears
credible that the leak could be isolated prior to exceeding regulatory
limits.
Cause or Causes
The cause of this event was a procedural deficiency in that the
ILRT procedure did not provide adequate guidance on where the
containment penetration hydrogen sensing lines should be disconnected.
Additionally, the operator tasked with reconnecting the containment
penetration hydrogen sensing lines, after the ILRT was completed, did
not display a questioning attitude when he found that the lines
appeared to be reconnected.
Actions Taken to Prevent Recurrence
Licensee
Corrective actions included revision of ILRT line up and
restoration sheets to provide adequate guidance on where disconnections
and connections are to be performed. Additionally, a General
Information Notice was issued to all site personnel highlighting the
human performance problems identified from this event.
NRC
Escalated enforcement was exercised on this issue and the licensee
was assessed a $100,000 civil penalty. Information Notice 96-13,
``Potential Containment Leak Paths Through
[[Page 23804]]
Hydrogen Analyzers,'' was issued to alert other licensees to this
event.
Other NRC Licensees
(Industrial Radiographers, Medical Institutions, Industrial Users,
etc.)
96-3 Medical Brachytherapy Misadministrations by Jose L. Fernandez,
M.D., in Mayaguez, Puerto Rico
One of the AO reporting criteria notes that administering
therapeutic radiation such that the actual dose is greater than 1.5
times the prescribed dose, or the event (regardless of any health
effects) affects two or more patients at the same facility, should be
considered an AO.
Date and Place
Between January 14, 1994, and October 10, 1995; Jose L. Fernandez,
M.D.; Mayaguez, Puerto Rico.
Nature and Probable Consequences
On January 14, 1994, Dr. Fernandez acquired an eye applicator
device, which contained a strontium-90 (Sr-90) source of approximately
3219 megabecquerel (87 millicurie) activity, from the estate of a
deceased licensee in Mayaguez, Puerto Rico. (Eye applicator devices are
used for the supplemental treatment of non-malignant growths on the eye
after surgery is performed.) NRC knew that Dr. Fernandez acquired the
Sr-90 source because the estate was acting under a Confirmatory Action
Letter (CAL) to maintain control of the Sr-90 source and to either
dispose of it or transfer control of it to an authorized recipient.
Since Dr. Fernandez was already an NRC licensee for another Sr-90
source in San Juan, Puerto Rico, his license was amended so that he was
an authorized recipient when the transfer took place. (After the
transfer took place, Dr. Fernandez was licensed to have two sources.)
NRC did not require Dr. Fernandez to receive additional training in the
use of the Sr-90 source after he acquired it from the estate because he
was already an authorized user for a Sr-90 eye applicator as defined by
10 CFR 35.
When Dr. Fernandez took possession of the eye applicator device, it
was in the manufacturer's carrying case. A label attached to the
carrying case contained the following hand written information: (1) the
dose rate for the device, which was calibrated as 24 centigray (cGy)
per second (24 rad per second); (2) the instrument used to calibrate
the dose rate; (3) the date when the dose rate was calibrated; and (4)
the name of the individual who performed the calibration. Dr. Fernandez
assumed that the hand written information on the label attached to the
manufacturer's carrying case was correct and proceeded to treat
patients.
On October 18, 1995, during a routine inspection, an NRC inspector
questioned the labeled dose rate on the eye applicator device and the
resultant administered doses. Dr. Fernandez was unable to provide
documentation to answer the questions. He then voluntarily ceased the
administration of radiation doses and requested a calibration of the
device by the manufacturer. The actual dose rate was found by the
manufacturer to be 53 cGy per second (53 rad per second); i.e., more
than twice the assumed dose rate.
Dr. Fernandez and NRC reviewed the computer sorted records of all
administrations using the eye applicator device and determined that
between October 24, 1994, and October 10, 1995, 87 patients had
received radiation doses which were approximately twice the prescribed
dose. However, the computer sort was not complete, since Dr. Fernandez
later discovered an additional 17 cases which occurred between January
1994 and October 1995. Dr. Fernandez notified the patients about the
misadministrations. NRC contracted a medical consultant to review the
medical aspects of the misadministrations.
The NRC medical consultant, who reviewed patient records for the 87
patients initially identified, determined that 25 of the patients were
at higher risk for complications. These 25 patients were initially
prescribed treatment doses of 1500 to 2880 cGy (1500 to 2880 rad), but
received doses of 3312 to 6360 cGy (3312 to 6360 rad) instead. Of these
25 patients, 12 were then prescribed second treatment doses of 1000 to
2160 cGy (1000 to 2160 rad), but received doses of 2208 to 4770 cGy
(2208 to 4770 rad) instead. Additionally, two of these 25 patients were
prescribed third treatment doses of 1500 to 3000 cGy (1500 to 3000
rad), but received doses of 3313 to 6625 cGy (3313 to 6625 rad)
instead. The highest total dose received by a patient was 13,603 cGy
(13,603 rad) to the surface of the eye, with an estimated 544 cGy (544
rad) to the lens of the eye.
The NRC medical consultant believes that the long-term consequences
of the misadministrations to the 25 highest dose patients could
include: (1) increased risk of cataracts; and (2) increased risk of
infections, due to severe thinning or ulceration of the sclera, which
could cause blindness if not detected early and aggressively treated.
No adverse health effects were reported during a reexamination of seven
of these 25 patients by Dr. Fernandez. However, the NRC medical
consultant indicated that the possible adverse consequences to these
patients may not appear for a period of up to 10 years after
irradiation.
Cause or Causes
Dr. Fernandez used an incorrect dose rate for the Sr-90 source, as
calibrated by a medical physics consultant employed by the deceased
former licensee, to develop treatment plans.
The incorrect dose rate calibration occurred when the former
licensee had a medical physics consultant calibrate the Sr-90 source,
after the original calibration certificate was lost. The medical
physics consultant used an inappropriate measurement instrument for the
calibration, which gave an erroneous dose rate calibration of 24 cGy
per second (24 rad per second). (The label attached to the carrying
case of the eye applicator device indicated that the medical physics
consultant calibrated the Sr-90 source in September 1990.)
Also, Dr. Fernandez had no Quality Management Program (QMP) as
required by 10 CFR 35.32, which could have helped in detecting the
calibration error. Medical use licensees, as required under 10 CFR
35.32, must establish a QMP to provide high confidence that radiation
will be administered as directed by the authorized user.
Actions Taken to Prevent Recurrence
Licensee
Dr. Fernandez initially ceased operations until the eye applicator
device was properly calibrated; reliable dosimetric data was available
to perform the dose administrations; and a QMP was developed and
submitted to NRC for review. Dr. Fernandez subsequently decided to
cease using the Sr-90 source and to terminate his license. (The QMP was
never implemented.)
NRC
A CAL was issued to confirm that Dr. Fernandez would submit a QMP
for use of the eye applicator device, and that he would cease
operations until approval was received from NRC to resume operations. A
second CAL was issued confirming that Dr. Fernandez would perform an
in-depth review of his records to identify the misadministrations and
to notify the patients.
After Dr. Fernandez requested termination of his license, NRC
issued an order, which required him to maintain the Sr-90 sources in
locked, safe storage until the sources were transferred to an
authorized recipient, to
[[Page 23805]]
transfer the Sr-90 source within 90 days, to identify and notify any
additional patients who may have received misadministrations, to obtain
the services of an independent medical physics consultant with
expertise in therapy dosimetry calculations, and to perform several
other tasks specified in the order. Dr. Fernandez currently has a
possession only license until his sources are properly transferred and
his request for termination has been granted by the NRC. In addition,
NRC is requesting that the Puerto Rico Health Department perform a
long-term follow-up of these patients.
NRC also issued Information Notice 96-66, ``Recent
Misadministrations Caused by Incorrect Calibrations of Strontium-90 Eye
Applicators,'' on December 13, 1996, to alert all medical use licensees
authorized to use Sr-90 eye applicators of misadministrations caused by
incorrect source strength determinations of Sr-90 eye applicators.
Dr. Fernandez purchased the medical practice and the Sr-90 source
from the estate of the deceased former licensee, Dr. Luis A. Vazquez of
Mayaguez, Puerto Rico. Consequently, Dr. Fernandez has the records of
all of the administrations that were made using the Sr-90 source while
it was licensed to Dr. Vazquez. In a letter to Dr. Fernandez dated
October 28, 1996, NRC confirmed with Dr. Fernandez that he would
preserve the patient records of the former licensee and perform a
computer search to identify the patients who were treated with the eye
applicator. NRC is considering options for the review of these records
to determine how many additional misadministrations occurred when the
incorrectly calibrated Sr-90 source was in the possession of the former
licensee.
96-4 Medical Brachytherapy Misadministrations by Phillip J. W. Lee,
M.D., in Honolulu, Hawaii
One of the AO reporting criteria notes that administering a
therapeutic dose from a sealed source such that the errors in source
calibration and time of exposure result in a calculated total treatment
dose differing from the prescribed treatment dose by more than 10
percent, and the event (regardless of any health effects) affects two
or more patients at the same facility, can be considered an AO.
Date and Place
May 6, 1995, through November 16, 1995; Phillip J. W. Lee, M.D.;
Honolulu, Hawaii.
Nature and Probable Consequences
During an NRC inspection, it was determined that the licensee had
incorrectly performed calculations for the decayed activity of a
strontium-90 (Sr-90) source in an eye applicator. Consequently, the
licensee had the Sr-90 eye applicator calibrated by the National
Institute of Standards and Technology (NIST). Based on calibration data
provided by NIST, NRC and the licensee determined that 17
misadministrations involving 16 patients had occurred between May 6 and
November 16, 1995. (Two of the misadministrations involved one patient
who was treated on both eyes.) The delivered doses were from 21.1 to
22.7 percent greater than the prescribed total dose of 4000 centigray
(cGy) (4000 rad). (The total dose was to be delivered in four fractions
of 1000 cGy [1000 rad] each.)
The licensee and referring physicians did not observe any adverse
consequences to the patients. The licensee noted that the
misadministered doses were within the ranges recommended for this type
of treatment. NRC contracted a medical consultant to review the cases
and make an independent assessment of the potential health effects to
the patients. As of the date of this report, the reviews of the NRC and
its consultant were ongoing.
The licensee notified the patients of the misadministration.
Cause or Causes
The licensee did not know how to calculate the decay of the Sr-90
source, and used a linear function rather than a logarithmic function.
In addition, the licensee used an incorrect half-life for Sr-90;
however, this error was less significant.
Actions Taken to Prevent Recurrence
Licensee
The licensee had the Sr-90 eye applicator calibrated at NIST and
learned how to calculate the decay of the Sr-90 source.
NRC
NRC requested that the licensee have the Sr-90 eye applicator
calibrated at NIST and taught the licensee how to calculate the decay
of the Sr-90 source. NRC is conducting an inspection, which will remain
open until the NRC medical consultant finishes reviewing the cases and
provides an assessment of the potential health effects to the patients.
Enforcement action may be taken in the future if necessary.
96-5 Medical Brachytherapy Misadministration at Harper Hospital in
Detroit, Michigan
One of the AO reporting criteria notes that a therapeutic exposure
to any part of the body not scheduled to receive radiation can be
considered an AO.
Date and Place
November 24, 1995; Harper Hospital; Detroit, Michigan.
Nature and Probable Consequences
A patient was being treated with a strontium-90 eye applicator for
pterygium (a growth over the eye which causes gradual blindness). The
patient was prescribed three 800-centigray (800 rad) treatments lasting
30 seconds each. Each of the treatments was to be administered to the
medial side of the left eye. However, the second treatment was
mistakenly administered to the lateral side of the left eye. The
physician realized the error and immediately treated the correct side
with the prescribed dose.
The patient was notified of the misadministration and given a
written report. The patient's referring physician was notified. An NRC
medical consultant evaluated the effects of the misadministration and
concurred with the licensee that the patient was not expected to suffer
any adverse health effects.
Cause or Causes
The patient's chart was upside down and the treating physician
incorrectly interpreted the sketch of the left eye on the diagram that
specified the treatment site. (The diagram was part of the written
directive for treatment using the strontium-90 eye applicator; however,
it did not show the nose, top of the page, or bottom of the page.)
Also, the second treatment was administered by a different physician
and physicist than the first treatment.
Actions Taken To Prevent Recurrence
Licensee
The licensee revised the diagram so that it shows the nose, thereby
making it obvious which is the left eye and which is the right eye.
NRC
NRC conducted a special safety inspection. A Notice of Violation
was issued for failing to ensure that the administration was in
accordance with the written directive. Since the inspection showed that
actions had been taken to correct the violation and to prevent
recurrence, no reply to the violation was required.
[[Page 23806]]
96-6 Medical Brachytherapy Misadministration at New England Medical
Center in Boston, Massachusetts
One of the AO reporting criteria notes that a therapeutic exposure
to any part of the body not scheduled to receive radiation can be
considered an AO.
Date and Place
November 10, 1993; New England Medical Center; Boston,
Massachusetts.
Nature and Probable Consequences
A patient with carcinoma of the cervix metastatic to the brain was
being treated with an intercavity implant using cesium-137 sources in a
gynecological applicator. During treatment a source became dislodged
and delivered radiation to the patient's thigh, which was an
unprescribed treatment site.
The licensee subsequently calculated that the consequent dose to
the patient's thigh was 71 centigray (cGy) (71 rad), as compared to 65
cGy (65 rad) which would have been delivered to the thigh at 20
centimeters (7.87 inches) distance from the applicator during the total
procedure if performed as prescribed.
During a routine NRC inspection conducted on April 10-12, 1995, the
NRC inspector noted the incident report and brought it to the attention
of NRC management. NRC subsequently determined that the event was a
misadministration and notified the licensee. The licensee consequently
submitted the required notifications to NRC, and notified the patient
in writing of the misadministration.
Cause or Causes
A malfunction of the aging gynecological applicator and a possible
lack of attention to details by the personnel involved in loading the
applicator caused the misadministration.
Actions Taken to Prevent Recurrence
Licensee
The licensee replaced the malfunctioning gynecological applicator.
In addition, the licensee now requires that two persons perform loading
of the gynecological applicator to insure that the sources are in and
that the ovoids are taped to insure that the sources do not come out
inadvertently.
NRC
The NRC again reviewed the information provided by the licensee and
determined that a violation of the licensee's Quality Management Plan
had occurred. An NRC medical consultant reviewed the circumstances of
the misadministration, determined that the licensee had used an
inaccurate source-to-thigh distance in its dose calculation, and
determined that the patient received a dose of 864 cGy (864 rad) to the
thigh instead of 71 cGy (71 rad) as calculated by the licensee. The
medical consultant stated that the patient experienced no ill effects.
96-7 Medical Brachytherapy Misadministration at William Beaumont
Hospital in Royal Oak, Michigan
One of the AO reporting criteria notes that a therapeutic exposure
to any part of the body not scheduled to receive radiation can be
considered an AO.
Date and Place
March 19, 1996; William Beaumont Hospital; Royal Oak, Michigan.
Nature and Probable Consequences
A patient with cancer of the vagina was prescribed treatment with a
high dose rate (HDR) remote afterloader brachytherapy unit having an
iridium-192 source. The treatment plan specified a step size of 2.5
millimeters (mm) (0.098 inches). A wrong step size of 5.0 mm (0.197
inches) was entered into the HDR unit's computer control program.
Therefore, a part of the body not scheduled to receive radiation was
exposed.
The licensee calculated that the skin of the patient's thighs,
which was the wrong treatment site, received a maximum unintended dose
of 500 centigray (500 rad) because of the misadministration. An NRC
medical consultant determined that the patient should have no side
effects as a consequence of the misadministration. The patient and the
referring physician were notified of the misadministration.
Cause or Causes
The wrong step size was entered into the HDR remote afterloader
brachytherapy unit's computer control program.
Actions Taken To Prevent Recurrence
Licensee
The licensee revised its ``physics worksheet'' to include the step
length as an additional entry; developed a checklist for the physicist/
dosimetrist to verify the treatment plan parameters, and posted it on
the treatment console; and instituted a policy that all treatment plan
parameters must be verified, and the verification recorded, prior to
each treatment.
NRC
NRC conducted a special safety inspection, where one apparent
violation was noted. This was the failure of the licensee's Quality
Management Program to provide assurance of correct administration of
the prescribed dose in compliance with the physician's written
directive.
96-8 Medical Brachytherapy Misadministration at Community Hospitals of
Indiana in Indianapolis, Indiana
One of the AO reporting criteria notes that a therapeutic exposure
to any part of the body not scheduled to receive radiation can be
considered an AO.
Date and Place
August 16, 1996; Community Hospitals of Indiana; Indianapolis,
Indiana.
Nature and Probable Consequences
A patient was prescribed a 500 centigray (cGy) (500 rad) treatment
for an esophageal tumor using a high dose rate remote afterloader unit
having an iridium-192 source. Because of a treatment planning error, a
non-prescribed treatment area approximately 27 millimeters (mm) (1.06
inches [in]) below the tumor volume received a maximum dose of 465 cGy
(465 rad) instead of the estimated dose of 50 to 100 cGy (50 to 100
rad).
The patient was notified of the misadministration. The licensee
expects no adverse health effects to the patient. A NRC medical
consultant was retained to review the case.
Cause or Causes
Because of a treatment planning error, the source was placed
approximately 27 mm (1.05 in) below the tumor volume.
Actions Taken To Prevent Recurrence
Licensee
A table of offset distances for the various sources and catheter
lengths used by the licensee was placed in the licensee's quality
control manual.
NRC
NRC conducted a special safety inspection.
96-9 Medical Brachytherapy Misadministrations at EquiMed, Inc., in
Lehighton, Pennsylvania
One of the AO reporting criteria notes that a therapeutic exposure
to any part of the body not scheduled to receive radiation can be
considered an AO.
[[Page 23807]]
Date and Place
December 31, 1995; EquiMed, Inc.; Lehighton, Pennsylvania.
Nature and Probable Consequences
Two patients were prescribed vaginal treatment with a high dose
rate (HDR) remote afterloader brachytherapy unit having an iridium-192
source. The prescribed total dose for each patient was between 2000 and
2200 centigray (cGy) (2000 and 2200 rad), and was to be delivered in
five fractional doses over a period of several weeks. Each fractional
dose was to be between 400 and 500 cGy (400 and 500 rad).
For one of the treatment fractions, 500 cGy (500 rad) was to be
delivered to each patient over a treatment length of 5 centimeters (cm)
(1.97 inches [in]) using a step size of 5 millimeters (mm) (0.197 in).
However, a wrong step size of 10 mm (0.394 in) was entered into the HDR
unit's control console, and a length of 10 cm (3.94 in) was treated
instead of the prescribed length of 5 cm (1.97 in). Therefore,
radiation was delivered to the wrong treatment site for each patient.
The licensee concluded that each patient received 312 cGy (312 rad)
instead of the prescribed dose of 500 cGy (500 rad) (an underdose of
37.6 percent), and an additional length of 5 cm (1.97 in) received an
unintended dose of 312 cGy (312 rad).
The licensee did inform the patients of the misadministrations, and
does not expect the patients to have any adverse effects from the
misadministrations.
Cause or Causes
A wrong step size was entered into the HDR unit's control console
because the licensee did not follow its Quality Management Procedures
(QMP). The QMP requires that treatment planning information be checked
by the person entering the data in the control console, and then
verified by the authorized user.
Actions Taken to Prevent Recurrence
Licensee
The licensee's authorized user and the HDR physicist will extract
the pre-treatment printout of the input parameters from the HDR
treatment console, review the input data for accuracy, and compare it
with the written directive. Both the authorized user and the HDR
physicist will then initial the printout before the HDR treatment is
initiated.
NRC
NRC determined that the incidents occurred because the licensee did
not follow its QMP. NRC contracted a medical consultant to evaluate the
health effects on the patients from the misadministrations.
Subsequently, the consultant determined no probable deterministic
effects of the radiation exposure to the unintended site were expected.
96-10 Medical Brachytherapy Misadministration at the University of
Wisconsin in Madison, Wisconsin
One of the AO reporting criteria notes that a therapeutic exposure
to any part of the body not scheduled to receive radiation can be
considered an AO.
Date and Place
October 19, 1995; University of Wisconsin; Madison, Wisconsin.
Nature and Probable Consequences
A patient had two separate lung tumors, one in the lower section of
the right lung and one in the middle section of the left lung. The
patient was prescribed a total treatment dose of 1600 centigray (cGy)
(1600 rad), with each tumor to receive a total dose of 800 cGy (800
rad). The total treatment dose was to be administered in four fractions
of 400 cGy (400 rad) each over 2 days using a high dose rate (HDR)
remote afterloader unit having an iridium-192 source. Each fraction was
to be administered in two parts; a 200 cGy (200 rad) dose to the lower
section of the right lung followed by a 200 cGy (200 rad) dose to the
middle section of the left lung. Catheters of appropriate length were
inserted into each lung to guide the source during treatment; i.e., a
long catheter was inserted into the right lung and a short catheter was
inserted into the left lung.
While the HDR controller was inserting the source into the left
lung during the first treatment fraction, the source stopped moving
when it touched the bottom of the short catheter in the left lung even
though the HDR controller was attempting to move it further into the
left lung. Because the intended treatment sites had been reversed
during treatment planning and were subsequently programmed into the HDR
controller, the controller had positioned the source in the middle of
the right lung during the first part of the first treatment fraction
and was attempting to position the source in the lower part of the left
lung during the second part of the first treatment fraction.
Consequently, the middle of the right lung had received an unintended
dose of 200 cGy (200 rad) during the first part of the first treatment
fraction.
After the error was discovered, the correct treatments were
delivered. The patient was notified of the misadministration both
verbally and in writing. The referring physician was also notified.
An NRC medical consultant evaluated the misadministration and
concluded that the patient would not have organ damage or long term
biological effects.
Cause or Causes
When planning the treatment, the treating physicist deviated from
standard protocol and used different dummy sources to obtain clearer
opaque x-ray markers for source location. Upon recording the data, the
planned source locations for each treatment fraction were reversed. An
independent verification of the treatment plan by a second physicist
did not include a review of the x-rays for proper source location, so
the error was not immediately discovered.
Actions Taken To Prevent Recurrence
Licensee
The licensee revised its Quality Management Program to include an
independent review of the x-rays for source location by a second
physicist. Also, when there is a deviation from the protocol, the
results must be documented and reviewed by a second physicist.
NRC
NRC conducted a special safety inspection in conjunction with a
routine inspection. A Notice of Violation was issued for failing to
establish adequate procedures to ensure that final treatment plans were
in accordance with the written directive. The licensee responded in
writing and no additional actions were required.
96-11 Medical Brachytherapy Misadministration at Thomas Jefferson
University Hospital in Philadelphia, Pennsylvania
One of the AO reporting criteria notes that a therapeutic exposure
to any part of the body not scheduled to receive radiation can be
considered an AO.
Date and Place
August 14, 1995; Thomas Jefferson University Hospital;
Philadelphia, Pennsylvania.
Nature and Probable Consequences
A patient was undergoing brachytherapy treatment of the palate;
i.e., the roof of the mouth. A total of 64 iridium-192 seeds, having a
total activity of 1102.6 megabecquerel (29.8 millicurie), were inserted
into six
[[Page 23808]]
catheters. Four of the catheters were sutured inside the mouth, and two
were placed in the nostrils.
While making a routine visit to the patient, the prescribing
physician noticed that two catheters were outside of the patient's
mouth and had been taped to the patient's right cheek. Also, one of the
two catheters remaining in the mouth was loose and its sutures were
removed. Because the catheters were not properly positioned, the
physician terminated the treatment.
The radioactive seeds were subsequently removed. The patient was
informed both verbally and in writing that the sources had become
dislodged and had consequently delivered radiation to the wrong
treatment site. It was determined that the patient's cheek received a
dose of 70 centigray (70 rad).
Cause or Causes
While responding to a call from the patient, a nurse noticed that
two of the catheters were loose and subsequently taped them to the
patient's cheek. The nurse had not been trained to recognize that the
radioactive seeds were moved from their intended positions.
Actions Taken to Prevent Recurrence
Licensee
Refresher in-service training was given to the nurses who care for
brachytherapy patients. Emphasis was placed on identifying radioactive
sources and handling them properly under normal and emergency
conditions. Also, the nurses will be briefed on the details of a
planned treatment at the time the sources are implanted with emphasis
on radiation safety issues. Finally, physicians will visit implant
patients at least twice daily during treatment.
NRC
After conducting an investigation, NRC determined that the event
was a misadministration. An NRC medical consultant concluded that no
significant injury would be expected. A Notice of Violation was issued
with one Severity Level IV violation.
96-12 Medical Brachytherapy Misadministration at Macombe Hospital
Center in Warren, Michigan
One of the AO reporting criteria notes that a therapeutic exposure
to any part of the body not scheduled to receive radiation can be
considered an AO.
Date and Place
March 11, 1996; Macombe Hospital Center; Warren, Michigan.
Nature and Probable Consequences
A patient was undergoing a cervical boost brachytherapy treatment
with a manually afterloaded standard gynecological applicator using
cesium-137 sources. Approximately 100 minutes after the treatment was
started, a nurse found one of the sources from the applicator lying on
the sheet between the patient's legs. The dislodged source contained
1.29 gigabecquerel (34.8 millicurie) of cesium-137 and was intended for
the right ovoid of the applicator. The nurse placed the source into the
portable shielding that was available in the room and notified the
radiation safety officer. The radiation safety officer immediately
returned to the patient's room with the physician, who inserted the
source into the right ovoid for the remainder of the prescribed 48
hours of treatment.
The licensee calculated that the unintended skin dose to the
patient's upper inner thighs was 5 centigray (cGy) (5 rad). NRC
concurred with the licensee's calculation and did not obtain a medical
consultant. The dose of 5 cGy (5 rad) is within the occupational
exposure limit and is not expected to result in deleterious effects to
the patient. The patient and physician were notified of the
misadministration.
Cause or Causes
When the radiation oncologist manually afterloaded the sources from
the right and left carriers into the ovoids, difficulty was encountered
in identifying the correct carrier for the right ovoid. Also, the hinge
on the correct carrier for the right ovoid was tight. The radiation
oncologist believed that the sealed source dislodged from the carrier
bucket when the problem with the hinge was encountered.
Actions Taken To Prevent Recurrence
Licensee
To prevent recurrence, the licensee will: (1) ensure that the
carrier bucket hinges are working properly prior to loading the source
into the bucket; (2) inscribe the handles of the ovoid carriers, with
``R'' for right ovoid and ``L'' for left ovoid, so that they can be
readily identified without difficulty; (3) require the physicist to
observe the radiation oncologist during the afterloading procedure in
order to detect a dislodged source; and (4) require that the radiation
oncologist complete a visual check of the bed sheets and immediate area
before leaving the room.
NRC
NRC conducted a special safety inspection. NRC issued a Notice of
Violation for failing to meet the objective that each administration is
in accordance with a written directive. The inspection showed that
actions had been taken to correct the violation and to prevent
recurrence.
96-13 Medical Brachytherapy Misadministration at Unity Hospital in
Fridley, Minnesota
One of the AO reporting criteria notes that administering a
therapeutic dose such that the actual dose is less than 0.5 times the
prescribed dose should be considered an AO.
Date and Place
August 19-20, 1996; Unity Hospital; Fridley, Minnesota.
Nature and Probable Consequences
A patient was prescribed a dose of 2500 centigray (cGy) (2500 rad)
for a gynecological brachytherapy procedure, using a gynecological
applicator containing cesium-137 sources in two ovoids. Because 3-
centimeter (cm) diameter caps had been used on the ovoids of the
gynecological applicator, instead of the intended 2-cm diameter caps,
the patient received a dose of 1186 cGy (1186 rad) to the vaginal
surface.
With the addition of the external beam therapy that the patient had
received prior to this treatment, the total administered dose was 5680
cGy (5680 rad). The treating physician determined that the total
administered dose was within the medically accepted range of treatment,
and that no negative effects to the patient were expected. The treating
physician did not plan to administer any further radiation treatments
to the patient to compensate for the underdose.
The patient was notified of the misadministration both verbally and
in writing. The referring physician was also notified.
Cause or Causes
There was poor communication between the treating physician and the
dosimetrist who prepared the treatment plan regarding the size of the
ovoid caps to be used for the treatment. (The treating physician may
select 2-cm diameter caps, 3-cm diameter caps, or no caps at all from
an applicator kit, depending on the anatomy of the patient.) In
addition, licensee personnel may have become desensitized to the
possibility that an ovoid cap size different than 2-cm in diameter
could be used; the treating physician failed to follow-up on earlier
instructions to the dosimetrist to verify the correct cap size used;
and the applicator kit was not returned immediately to the radiation
[[Page 23809]]
oncology department following the implant of the applicator device.
Actions Taken To Prevent Recurrence
Licensee
The licensee revised its written-directive form to require the
treating physician to enter the cap size when ovoids are used, and for
a second person to verify that the information was entered. If the
entry on the form is not made, the person confirming the information
must independently verify which size ovoid caps were used.
NRC
NRC conducted a special safety inspection on September 9, 1996. No
violations of NRC requirements were identified during the course of
this inspection.
96-14 Radiopharmaceutical Misadministration at Universal Imaging in
Taylor, Michigan
One of the AO reporting criteria notes that administering a
radiopharmaceutical other than the one intended, where the actual dose
is greater than five times the prescribed dose, can be considered an
AO.
Date and Place
March 18, 1996; Universal Imaging, Inc.; Taylor, Michigan.
Nature and Probable Consequences
A patient was prescribed a 7.4 megabecquerel (MBq) (200 microcurie
[Ci]) dosage of iodide-123 (I-123) for a thyroid scan, but was
administered 7.4 MBq (200 Ci) of iodide-131 (I-131) instead.
The referring physician's directive stated that I-123 was to be
used. (This is the only isotope of iodine used at the facility.) A
technologist then accidently ordered the I-131 from the nuclear
pharmacy. A second technologist recognized that the I-131 was different
from the I-123 routinely used, but assumed that it was prescribed and
administered it anyway.
The licensee estimated that the dose to the patient's thyroid was
104 centigray (104 rad).
The referring physician was notified of the misadministration. The
referring physician decided not to notify the patient because the
information would be harmful to the patient.
An NRC medical consultant reviewed the event and determined that
the impact of the misadministration on the status of the patient's
health was very low, and that no specific medical follow-up care was
necessary.
Cause or Causes
The misadministration was apparently caused by a lack of sufficient
oversight of licensed activities, inadequate training, and failure to
establish a written protocol for ordering and verifying
radiopharmaceuticals.
Actions Taken To Prevent Recurrence
Licensee
The licensee implemented the following corrective actions: (1) All
technologists were informed not to use any radiopharmaceutical that was
not listed in the licensee's ``Prescribed Dosage List''; (2) orders
must be sent to the nuclear pharmacy via facsimile, rather than over
the telephone; (3) the nuclear pharmacy was instructed not to deliver
I-131, I-125, or any other therapeutic radiopharmaceutical to the
licensee; (4) all technologists were informed in writing not to proceed
if they were unsure of any procedure; and (5) copies of
radiopharmaceutical orders and their activities were to be checked
against receipts.
The licensee is not required to have written directives to follow.
This is because it does not perform therapy of any kind, does not use
I-125 or I-131 in quantities greater than 1.11 MBq (30 Ci),
and has no Quality Management Program.
NRC
NRC conducted an inspection. Based on the results of the
inspection, eight apparent violations were identified and are being
considered for escalated enforcement action. A predecisional
enforcement conference was held to discuss the apparent violations and
any potential enforcement action is pending.
96-15 Radiopharmaceutical Misadministration at Miami Valley Hospital
in Dayton, Ohio
One of the AO reporting criteria notes that if an actual diagnostic
dose of a radiopharmaceutical is greater than five times the prescribed
dose it can be considered an AO.
Date and Place
September 21, 1995; Miami Valley Hospital; Dayton, Ohio.
Nature and Probable Consequences
A patient was administered a 2.8 megabecquerel (MBq) (77 microcurie
[Ci]) dosage of iodine-131 (I-131) for a thyroid uptake study,
rather than the prescribed dosage range of 0.19 to 0.37 MBq (5 to 10
Ci) of I-131. The licensee determined that the dose to the
patient's thyroid was 80.85 centigray (80.85 rad).
The patient was informed of the misadministration in writing. The
patient's referring physician was also notified.
An NRC medical consultant determined that no adverse health effects
are expected from the additional dosage.
Cause or Causes
A nuclear medicine technologist inadvertently picked-up the wrong
capsule, and in accordance with the licensee's practice did not
calibrate the dosage in the dose calibrator prior to administration.
The licensee's staff did not believe there was a requirement to assay
dosages below 1.11 MBq (30 Ci).
Actions Taken To Prevent Recurrence
Licensee
The licensee implemented procedures to require that all dosages
must be assayed regardless of their activity, and to review the assay
of dosages on a quarterly basis.
NRC
NRC conducted a special safety inspection. NRC issued a Notice of
Violation for failing to measure dosages containing less than 1.11 MBq
(30 Ci) before they were administered to patients for medical
use. The licensee responded in writing and no additional actions are
required.
96-16 Radiopharmaceutical Misadministration at St. Joseph Mercy
Hospital in Ann Arbor, Michigan
One of the AO reporting criteria notes that if an actual diagnostic
dose of a radiopharmaceutical is greater than five times the prescribed
dose it can be considered an AO.
Date and Place
April 9, 1996; St. Joseph Mercy Hospital; Ann Arbor, Michigan.
Nature and Probable Consequences
A patient was administered a 596 megabecquerel (MBq) (16.1
millicurie [mCi]) dosage of iodine-131 rather than the prescribed 122
MBq (3.3 mCi) dosage of I-131 for a diagnostic study of the neck and
chest.
The misadministration was discovered after a vial, intended for
another patient, was assayed and found to contain 122 MBq (3.3 mCi)
instead of the expected 633 MBq (17.1 mCi). The patient was notified of
the misadministration. The patient's referring physician was also
notified.
The patient's thyroid gland had been removed previously and
therefore the licensee anticipated minimal medical consequences. NRC
contracted with the Oak Ridge Institute for Science and Education to
conduct an assessment of
[[Page 23810]]
the I-131 dose to the patient. The assessment concluded that since the
patient had no thyroid, the maximum dose was misadministered to the
patient's bladder wall and was equal to 48.3 centigray (48.3 rad).
Cause or Causes
The technologist, when administering the dosage, mistakenly picked
up a wrong radiopharmaceutical vial.
Actions Taken To Prevent Recurrence
Licensee
Licensee personnel failed to completely follow the written Quality
Management Program.
NRC
NRC conducted a special safety inspection. NRC issued a Notice of
Violation for failure of the supervised user (technologist) to follow
instructions in accordance with the written directive.
96-17 Radiopharmaceutical Misadministration at the Veteran Affairs
Medical Center in Charleston, South Carolina
One of the AO reporting criteria notes that administering a
therapeutic dose such that the actual dose is less than 0.5 times the
prescribed dose should be considered an AO.
Date and Place
January 9, 1996; Veteran Affairs Medical Center; Charleston, South
Carolina.
Nature and Probable Consequences
An outpatient was administered 277.5 megabecquerel (MBq) (7.5
millicurie [mCi]) of a prescribed 573.5 MBq (15.5 mCi) dosage of
iodine-131 (I-131) in liquid form. The error was discovered when the
licensee rechecked the prescription vial with a dose calibrator after
the administration to verify that the patient had received all of the
prescribed dose. The licensee discovered that approximately 296 MBq (8
mCi) of the prescribed dosage had been retained in the vial cap, and
consequently was not administered to the patient. The patient was
informed of the event and was subsequently administered an additional
296 MBq (8 mCi) to make up for the underdosage. The licensee also
notified the referring physician of the misadministration. The licensee
expects no adverse effects to the patient from the misadministration.
Cause or Causes
The root cause for the misadministration was a pronounced reaction
of the I-131 with the vial cap, thereby allowing a significant portion
of the radioactive material to bind itself to the cap.
Actions Taken to Prevent Recurrence
Licensee
The licensee's Radiation Safety Officer investigated the incident.
Bioassays were conducted on the individuals who handled and
administered the I-131 dose, and all were found to be negative. The
licensee also revised its policy and procedures to require that only I-
131 in capsule form be used in the future.
NRC
NRC conducted a special inspection to review the circumstances
surrounding the misadministration, and identified no violations of NRC
requirements.
The State Agency is working with the nuclear pharmacy that filled
the prescription and the intermediate processor of the I-131, both
South Carolina state licensees, to determine the cause of event. The
nuclear pharmacy informed its customers of the event.
96-18 Radiopharmaceutical Misadministration at Queen's Medical Center
in Honolulu, Hawaii
One of the AO reporting criteria notes that administering a
therapeutic dose of a radiopharmaceutical differing from the prescribed
dose by more than 10 percent, and the actual dose is less than 0.5
times the prescribed dose, can be considered an AO.
Date and Place
December 8, 1995; Queen's Medical Center; Honolulu, Hawaii.
Nature and Probable Consequences
A patient was prescribed a dosage of 18.5 megabecquerel (MBq) (0.5
millicurie [mCi]) of phosphorus-32 (P-32) to be administered to the
wrist for treatment of symptoms related to rheumatoid arthritis, but
was administered 6.179 MBq (0.167 mCi) instead. The dosage was
administered via a saline solution.
Prior to treatment, the volume of the patient's wrist-joint space
was to be determined using fluoroscopy so that the proper volume of
liquid would be injected. Also, two syringes were to be prepared. One
was to contain 18.5 MBq (0.5 mCi) of P-32 in a 0.25 milliliter (ml)
volume, and the other was to contain 18.5 MBq (0.5 mCi) of P-32 in a
0.5 ml volume. The appropriate syringe was to be chosen based upon the
results of the fluoroscopy.
Because of poor communication, a technologist erroneously prepared
one syringe containing 6.179 MBq (0.167 mCi) in a 0.25 ml volume and
another syringe containing 12.32 MBq (0.333 mCi) in a 0.5 ml volume.
The syringes were not labeled.
Based upon the results of the fluoroscopy, the administering
physician chose the syringe with the 0.25 ml volume, believing that it
contained 18.5 MBq (0.5 mCi) of P-32. However, the 0.25 ml volume
contained only 6.179 MBq (0.167 mCi), which was one-third of the
intended dosage. After the administration, the technologist who
prepared the dosages asked why both syringes had not been used and
explained how they were prepared.
The patient was notified of the misadministration in writing.
The two physicians involved with the misadministration have not
observed any adverse health effects to the patient, and do not expect
any. NRC determined that a medical consultant would not be required to
review the case.
Cause or Causes
The details of the prescribed dosages were not properly
communicated to the technologist who prepared the two syringes, the
details were not independently confirmed by other licensee personnel,
and the written procedure for preparing the dosages did not specify
multiple syringe volumes.
Actions Taken to Prevent Recurrence
Licensee
The licensee now requires the prescribing physician to establish a
standard activity and volume for each treatment site, and the injecting
physician to verbally repeat this information and ask the technologist
to verbally confirm it prior to the administration.
NRC
NRC conducted a special inspection and issued a Notice of Violation
for deficiencies in the Quality Management Program.
Dated at Rockville, Maryland, this 25th day of April, 1997.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 97-11295 Filed 4-30-97; 8:45 am]
BILLING CODE 7590-01-P
