[Federal Register Volume 71, Number 86 (Thursday, May 4, 2006)]
[Notices]
[Pages 26393-26397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6746]
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NUCLEAR REGULATORY COMMISSION
Report to Congress on Abnormal Occurrences; Fiscal Year 2005;
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
2005, 9 events that occurred at facilities licensed or otherwise
regulated by the NRC and/or Agreements States were determined to be
AOs. The report describes three events at facilities licensed by the
NRC. All three events occurred at medical institutions. The first event
involved a patient who received the incorrect dose distribution while
undergoing therapeutic brachytherapy \1\ treatment. The second event
involved an infant who was administered the incorrect diagnostic dosage
of technetium-99m. The third event involved three patients who received
unintended radiation doses to the skin of their thighs while undergoing
therapeutic treatment. The report also addresses 6 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 34 Agreement States. During Fiscal Year 2005,
Agreement States reported six events that occurred at Agreement State-
licensed facilities, including five therapeutic medical events and one
diagnostic medical event. All six events met the criteria for AO
categorization. As required by section 208, the
[[Page 26394]]
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. 28, ``Report to Congress on Abnormal Occurrences, Fiscal Year
2005.'' This report will be available electronically at the NRC Web
site http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/.
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\1\ Brachytherapy means a method of radiation therapy in which
sources are used to deliver a radiation dose at a distance of up to
a few centimeters by placement of sources on the body surface, in
natural body cavities, or by placement directly in tissues.
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Nuclear Power Plants
During this period, no events at U.S. nuclear power plants were
significant enough to be reported as AOs.
Fuel Cycle Facilities (Other Than Nuclear Power Plants)
During this period, no events at U.S. fuel cycle facilities were
significant enough to be reported as AOs.
Other NRC Licensees (Industrial Radiographers, Medical Institutions,
etc.)
During this reporting period, three events at NRC-licensed or
regulated facilities were significant enough to be reported as AOs.
05-01 Medical Event at the University of Minnesota in Minneapolis,
Minnesota
Criterion IV, ``For Medical Licensees,'' of Appendix A to this
report states, in part, that a medical event that results in a dose
that is (1) equal to or greater than 1 Gy (100 rads) to a major portion
of the bone marrow, to the lens of the eye, or to the gonads or (2)
equal to or greater than 10 Gy (1,000 rads) to any other organ; and
represents a prescribed dose or dosage that is delivered to the wrong
treatment site will be considered for reporting as an AO.
Date and Place--January 24, 2005, Minneapolis, Minnesota.
Nature and Probable Consequences--The licensee reported that a
patient being treated for cervical cancer received an incorrect dose
distribution. One area of the cervix received 8.21 Gy (821 rads)
instead of the intended 16.43 Gy (1,643 rads). Another area of the
cervix received 3.72 Gy (372 rads) instead of the intended 4.65 Gy (465
rads). Additionally, other locations received higher than intended
doses. The intended doses to the bladder and the rectum were 11.47 Gy
(1,147 rads) each, but they received 14.48 Gy (1,448 rads) and 20.12 Gy
(2,012 rads), respectively. The treatment involved an applicator with
an insert which contained low-dose radiotherapy sources. The licensee
cut the insert 6 centimeters (cm) too short so that when the applicator
was positioned in the patient's cervix, the three cesium-137 (Cs-137)
sources were not extended the proper distance. The referring physician
and patient were informed of this event. The licensee does not believe
that this event will have any adverse health effects on the patient.
The patient subsequently received a follow-up treatment to deliver the
full intended dose to the treatment sites.
Cause(s)--This event was caused by human error. The incorrect dose
was administered to the incorrect location.
Actions Taken to Prevent Recurrence--Corrective actions taken by
the licensee included stopping all low dose-rate treatments until all
individuals are trained, and modifying their procedures to incorporate
a dual verification system.
This event is closed for the purpose of this report.
05-02 Medical Event at St. Johns Mercy Hospital in St. Louis, Missouri
Criterion I.A.2, ``For All Licensees,'' of Appendix A to this
report states, ``Any unintended radiation exposure to any minor (an
individual less than 18 years of age) resulting in an annual total
effective dose equivalent (TEDE) of 50 millisieverts (mSv) (5 rem) or
more, or to an embryo/fetus resulting in a dose equivalent of 50 mSv (5
rem) or more,'' will be considered for reporting as an AO.
Date and Place--March 9, 2005, St. Louis, Missouri.
Nature and Probable Consequences--The licensee reported that a 5-
month old infant was prescribed 18.5 MBq (0.5 mCi) of technetium-99
metastable (Tc-99m), but instead received 414.4 MBq (11.2 mCi) of Tc-
99m. Hospital personnel did not look at the dosage label to verify the
dose to be administered. The whole body dose to the infant was
calculated to be between 0.052 to 0.10 Sv (5.2 to 10 rem). The
physician informed the infant's parents. The NRC's medical consultant
determined that there were no acute or subacute effects noted in the
patient, but recommended that a pediatric gastroenterologist monitor
the patient for cancer for an extended period of time.
Cause(s)--The event was caused by human error. The hospital staff
member did not look at the dosage label before administering the
radiopharmaceutical.
Actions Taken to Prevent Recurrence--Corrective actions taken by
the licensee involved revision of their procedures to require dual
verification of all dosages to be administered to children and
retraining the staff on the new procedures.
This event is closed for the purpose of this report.
05-03 Medical Event at St. Joseph Regional Medical Center in South
Bend, Indiana
Criterion IV, ``For Medical Licensees,'' of Appendix A to this
report states, in part, that a medical event that results in a dose
that is (1) equal to or greater than 1 Gy (100 rads) to a major portion
of the bone marrow, to the lens of the eye, or to the gonads or (2)
equal to or greater than 10 Gy (1,000 rads) to any other organ; and
represents a prescribed dose or dosage that is delivered to the wrong
treatment site will be considered for reporting as an AO.
Date and Place--Between January 26 and March 22, 2004 (reported
March 25, 2005 due to a misinterpretation of reporting requirements by
the licensee), South Bend, Indiana.
Nature and Probable Consequences--The licensee reported in March
and April 2005, that between January 26 and March 22, 2004, three
patients received unintended radiation doses to the skin of their
thighs from cesium-137 brachytherapy sources. The vaginal applicator
used for the treatments was loaded with incorrectly sized cesium-137
sources, which migrated from the intended treatment position through
the placement spring when the patient moved to a more up-right
position. As a result of the sources moving, the patient's inner thighs
received unintended doses of radiation. Approximately two weeks after
treatment, the patients developed skin lesions on their inner thighs.
The licensee determined that these patients received unintended doses
to a small area of the skin on the upper thigh of approximately 2000,
1500, and 2000 cGy (rad), respectively. Based on clinical observations,
the licensee determined that all patients received the respective
prescribed doses to the intended treatment areas. The referring
physician and patients were notified of the event. The licensee
referred the patients to other institutions and care providers for
specialized followup wound care to treat the recurring skin
ulcerations. The NRC retained a medical consultant during the
inspection associated with the event. The long-term health effects on
the patients, as a result of the unintended doses, is unknown.
Cause(s)--The causes of these events were improper source
selection, inadequate manufacturer instructions, inadequate management
oversight, and inadequate procedures.
Actions Taken to Prevent Recurrence--Corrective actions taken by
the licensee involved modifying the applicator by using different
hardware to hold the sources in place, revising
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their procedures, and retraining the staff on the new procedures.
This event is closed for the purpose of this report.
Agreement State Licensees
During this reporting period, six events at Agreement State-
licensed facilities were significant enough to be reported as AOs.
AS 05-01 Iridium-192 Brachytherapy Seed Medical Event at LDS Hospital
in Salt Lake City, Utah
Criterion IV, ``For Medical Licensees,'' of Appendix A to this
report states, in part, that a medical event that results in a dose
that is (1) equal to or greater than 1 Gy (100 rads) to a major portion
of the bone marrow, to the lens of the eye, or the gonads, or (2) equal
to or greater than 10 Gy (1,000 rads) to any other organ; and
represents a prescribed dose or dosage that is delivered to the wrong
treatment site, will be considered for reporting as an AO.
Date and Place--October 26, 2004; LDS Hospital; Salt Lake City,
Utah.
Nature and Probable Consequences--A patient received 27.56 Gy
(2,756 rads) instead of the prescribed 5 Gy (500 rads) during a high
dose-rate (HDR) treatment for larynx cancer. The event involved an
iridium-192 (Ir-192) source with an activity of 244.2 GBq (6.6 Ci). The
error was caused by the use of the diameter instead of the radius of a
circular tool to mark the treatment site in a computer software
program. As a result, the area treated was 2 centimeters (cm) away from
the intended treatment site. The error was discovered before the third
fraction. The prescribing physician stopped the treatment until
dosimetry information was completed. The licensee notified the patient
and the patient's referring physician of the event. The licensee
determined that the impact of the additional dose is probable acute
radiation effects and possible late or chronic toxicities.
Cause(s)--This event was caused by human error. The incorrect size
button corresponding to the circle tool was used, which caused the
diameter instead of the radius to be used in the dosing plan. This
caused the incorrect dose to be administered to the incorrect location.
Actions Taken To Prevent Recurrence
Licensee--The licensee suggested that the software manufacturer
print the word ``RADIUS'' on the ``size'' button located adjacent to
the circle tool. To date, the manufacturer has not responded to this
issue. The licensee will measure the distance on the brachytherapy
device's hard copy output with a ruler to confirm that the distance is
entered correctly. The licensee also modified the HDR dose check
program so that, in addition to confirming the doses to coordinates
entered into the device's input, user specified point coordinates may
be manually entered into the check program and compared to what is
calculated.
State Agency--The Utah Division of Radiation Control investigated
the event on November 3, 2004 and approved the corrective actions that
the licensee implemented to prevent the recurrence.
This event is closed for the purpose of this report.
AS 05-02 Diagnostic Medical Event at Baystate Health Systems in
Springfield, Massachusetts
Criterion IV, ``For Medical Licensees,'' of Appendix A to this
report states, in part, that a medical event that results in a dose
that is (1) equal to or greater than 1 Gy (100 rads) to a major portion
of the bone marrow, to the lens of the eye, or the gonads, or (2) equal
to or greater than 10 Gy (1,000 rads) to any other organ; and
represents a prescribed dose or dosage that is delivered by the wrong
treatment mode, will be considered for reporting as an AO.
Date and Place--January 7, 2005; Baystate Health Systems;
Springfield, Massachusetts.
Nature and Probable Consequences--The licensee reported that a
patient should have received 0.63 MBq (0.017 mCi) of iodine-131 (I-131)
for a thyroid uptake study but instead received 133.2 MBq (3.6 mCi) of
I-131 for a total body scan. A nuclear medicine technologist
incorrectly placed the order for a total body scan instead of a thyroid
uptake study without looking at the diagnosis. The I-131 was
administered and it was later discovered that the wrong procedure was
administered. The administration resulted in a thyroid dose of 131 Gy
(13,100 rads). The patient and referring physician were notified of the
error. The licensee indicated there would be no negative health effects
from this administration because the patient had hyperthyroidism, thus,
the unintended thyroid dose will be taken into account when additional
I-131 is given to the patient.
Cause(s)--Human error in that the procedure was erroneously posted
as a total body scan when it was actually a thyroid uptake study. This
caused the wrong quantity of I-131 to be administered.
Actions Taken To Prevent Recurrence
Licensee--Corrective actions taken by the licensee involved
modifying procedures to include removing Central Booking from
radioisotope ordering (the referring physician will fax the order
directly to Nuclear Medicine), switching from I-131 to I-123 for
thyroid uptake studies, and revising the nuclear medicine request form
for thyroid procedures.
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 05-03 High Dose-Rate Afterloader Medical Event at Saddleback
Memorial Medical Center in Laguna Hills, California
Criterion IV, ``For Medical Licensees,'' of Appendix A to this
report states, in part, that a medical event that results in a dose
that is (1) equal to or greater than 1 Gy (100 rads) to a major portion
of the bone marrow, to the lens of the eye, or the gonads, or (2) equal
to or greater than 10 Gy (1,000 rads) to any other organ; and
represents a prescribed dose or dosage that is delivered to the wrong
treatment site will be considered for reporting as an AO.
Date and Place--January 24-28, 2005; Saddleback Memorial Medical
Center; Laguna Hills, California.
Nature and Probable Consequences--A patient undergoing therapeutic
radiation treatment following a breast lumpectomy was treated with a
high dose-rate (HDR) device using an iridium-192 (Ir-192) source with
an activity of 277.5 GBq (7.5 Ci). The prescribed dose was 35 Gy (3,500
rads) to the inside of the breast at the site of the excised tumor, but
instead the patient received 70 Gy (7,000 rads) to other portions of
the breast during treatment. The unintended irradiation occurred when
the HDR device was mispositioned. Re-evaluation of the treatment plan
revealed that the wrong source wire travel distance was used during the
treatment. The Ir-192 source was positioned 8 centimeters (cm) short of
the planned location. The licensee believes the error occurred when the
source wire travel distance was input to the HDR device; however, since
no record was maintained of the source wire travel distance measured by
the therapy technologist, this could not be verified. It is known that
the incorrect distance was input to the HDR planning system. The
patient and the referring physician were notified of the event. No
long-term health effects are expected due to the unplanned tissue dose.
Cause(s)--This event was attributed to human error and an
inadequate procedure.
Actions Taken to Prevent Recurrence
[[Page 26396]]
Licensee--A procedure was developed specifying the need to verify
and document the verification of source wire travel distance
determination and training on the correct input to the treatment
planning system was performed. In addition, nominal source wire travel
distances for expected types of HDR usage were added to the form
utilized for recording the HDR treatment quality assurance checklist,
thus providing a check on the determination of this parameter.
State Agency--State inspectors investigated the medical event and
issued written violations for failure to follow a license condition
that required independent verification of HDR treatment data input, and
for failure to report the medical event to the state within 24 hours of
its discovery. The State reviewed the licensee's corrective actions and
found them adequate to prevent recurrence.
This event is closed for the purpose of this report.
AS 05-04 Yttrium-90 Therapeutic Medical Event at University of
Wisconsin in Madison, Wisconsin
Criterion IV, ``For Medical Licensees,'' of Appendix A to this
report states, in part, that a medical event that results in a dose
that is (1) equal to or greater than 1 Gy (100 rads) to a major portion
of the bone marrow, to the lens of the eye, or the gonads, or (2) equal
to or greater than 10 Gy (1,000 rads) to any other organ; and
represents a prescribed dose or dosage that is delivered to the wrong
treatment site will be considered for reporting as an AO.
Date and Place--April 5, 2005; University of Wisconsin in Madison;
Madison, Wisconsin.
Nature and Probable Consequences--A patient was administered a 1.78
GBq (48 mCi) dose of yttrium-90 (Y-90), instead of the intended 1.04
GBq (28 mCi) Y-90 dose. As a result of the medical event, the patient
received a dose of 1.07 to 3.20 Gy (107 to 320 rads) to the red bone
marrow, with a median exposure of 2.31 Gy (231 rads) from Y-90. The
error was discovered on April 7, 2005, during a licensee review of
records. The patient and referring physician were notified of the
event. The licensee indicated there will be no negative health effects
from this administration.
Cause(s)--Lack of management oversight which attributed to failure
to prepare a written directive prior to the administration, a poor
training program, and human error.
Actions Taken to Prevent Recurrence
Licensee--The licensee suspended the use of Y-90 and conducted a
root cause investigation of the event. The licensee's corrective
actions included writing new policies and procedures, implementing new
training programs, and hiring new personnel.
State Agency--The State of Wisconsin investigated the event on
April 11, 2005 and determined that the licensee (1) failed to prepare a
written directive prior to administering the Y-90, (2) failed to
prevent usage of a dose that differed from the intended dosage by more
than 20 percent, (3) failed to establish appropriate administrative
procedures, (4) failed to ensure radiation safety activities were
performed under approved procedures, and (5) failed to instruct
individuals working under the supervision of an authorized user of the
licensee's written directive procedures. A medical consultant
contracted by the State of Wisconsin determined that no adverse medical
effects occurred as a result of this medical event. As a result of the
State's investigation, the licensee implemented the corrective actions
detailed above. The State reviewed the licensee's corrective actions
and found them adequate to prevent recurrence.
This event is closed for the purpose of this report.
AS 05-05 Therapeutic Medical Event at University of Utah in Salt Lake
City, Utah
Criterion IV, ``For Medical Licensees,'' of Appendix A to this
report states, in part, that a medical event that results in a dose
that is (1) equal to or greater than 1 Gy (100 rads) to a major portion
of the bone marrow, to the lens of the eye, or the gonads, or (2) equal
to or greater than 10 Gy (1,000 rads) to any other organ; and
represents a prescribed dose or dosage that is delivered to the wrong
treatment site, will be considered for reporting as an AO.
Date and Place--August 4, 2005; University of Utah; Salt Lake City,
Utah.
Nature and Probable Consequences--A patient received radiation
therapy to the left bronchus using a high dose-rate (HDR) device. The
HDR contained a 252 GBq (6.81 Ci) iridium-192 (Ir-192) source. The
prescribed radiation therapy treatment plan called for three treatments
to the left bronchus, each fraction to deliver a dose of 7 Gy (700
rads). The medical event, which occurred during the second treatment,
was due to a 3-centimeter (cm) error in the source wire travel
distance. The source wire distance was entered incorrectly by a medical
physicist. As a result, a 3 cm length of the left bronchus received
approximately 6.40 to 18.60 Gy (640 to 1,860 rads) at a 0.5 cm depth
and 2.54 to 6.62 Gy (254 to 662 rads) at a 1 cm depth. A 3-cm region
next to the intended treatment site received up to 6 Gy (600 rads) less
than the prescribed dose. The licensee notified the patient and the
patient's referring physician of the event. The patient received no
adverse health effects from the medical 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 implemented a new procedure adding a
question to verify the treatment distances during HDR treatments.
State Agency--The State has reviewed and accepted the licensee's
corrective actions. This event is closed for the purpose of this
report.
AS 05-06 Dose to Fetus at Riverside Methodist Hospital in Columbus,
Ohio
Criterion I.A.2, ``For All Licensees,'' of Appendix A to this
report states, ``Any unintended radiation exposure to any minor (an
individual less than 18 years of age) resulting in an annual total
effective dose equivalent (TEDE) of 50 millisieverts (mSv) (5 rem) or
more, or to an embryo/fetus resulting in a dose equivalent of 50 mSv (5
rem) or more,'' will be considered for reporting as an AO.
Date and Place--November 2 and November 16, 2004; Riverside
Methodist Hospital; Columbus, Ohio.
Nature and Probable Consequences--On November 2, 2004, a patient
was administered 7.59 MBq (0.205 mCi) of iodine-123 (I-123) as part of
a diagnostic procedure for hyperthyroidism. On November 16, 2004, the
patient returned for a therapeutic treatment and was administered 469.9
MBq (12.7 mCi) of iodine-131 (I-131) as treatment. Prior to this
administration, the patient was counseled regarding pregnancy and
acknowledged, in writing, that she was not and could not be pregnant at
that time. A pregnancy test was not performed to confirm this
declaration. Later, the patient saw her physician because of abdominal
pain. A radiograph of the abdomen revealed the pregnancy. A prenatal
specialist determined that the fetus was 17 weeks old at the time of
the I-131 administration. The dose estimate for the fetus was 0.024 Gy
(2.04 rads) to the whole body and 224 Gy (22,400 rads) to the fetal
thyroid from both I-123 and I-131 administrations. The perinatal
specialist performed a blood test on the fetus and confirmed that the
fetus had hyperthyroidism. An ultrasound test on the fetus showed no
abnormalities in fetal development. The perinatal specialist will
perform treatments in-
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utero to mitigate the effects of hyperthyroidism. The referring
physician and patient were notified of the medical event.
Cause(s)--The cause of the event was 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 a policy performing a serum
pregnancy test and receiving the results within 80 hours of
administration of therapeutic amounts of I-131. This test will be
performed on all women 13 to 50 years of age, unless the women have
been surgically sterilized.
State Agency--The Ohio Department of Health performed an on-site
investigation on January 28, 2005 and determined that the licensee
followed all required procedures. The State agency will conduct
periodic inspections to ensure that the licensee's actions taken to
prevent recurrence were implemented.
This event is closed for the purpose of this report.
Dated at Rockville, Maryland this 28th day of April, 2006.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. E6-6746 Filed 5-3-06; 8:45 am]
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