[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

[[Page 26395]]

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-

[[Page 26397]]

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]
BILLING CODE 7590-01-P