Report to Congress on Abnormal Occurrences; Fiscal Year 2005; Dissemination Of Information, 26393-26397 [E6-6746]
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Federal Register / Vol. 71, No. 86 / Thursday, May 4, 2006 / Notices
unnecessary regulatory burden related
to SSCs of low safety significance by
removing such SSCs from the scope of
special treatment requirements. The
Commission subsequently approved the
NRC staff’s rulemaking plan and
issuance of an Advanced Notice of
Proposed Rulemaking (ANPR) as
outlined in SECY–99–256, ‘‘Rulemaking
Plan for Risk-Informing Special
Treatment Requirements,’’ dated
October 29, 1999.
The Commission published the ANPR
in the Federal Register (65 FR 11488) on
March 3, 2000, and subsequently
published a proposed rule for public
comment (68 FR 26511) on May 16,
2003. Then, on November 22, 2004, the
Commission adopted a new section,
referred to as § 50.69, within Title 10,
part 50, of the Code of Federal
Regulations, on risk-informed
categorization and treatment of SSCs for
nuclear power plants (69 FR 68008).
The NRC issued a draft of this guide,
Draft Regulatory Guide DG–1121, for
public review and comment as part of
the § 50.69 rulemaking package in May
2003. The staff subsequently received
and addressed public comments in
developing the previous revision of this
guide, which the agency published in
January 2006, and has since
incorporated additional stakeholder
comments in preparing the current
revision. However, since this is a new
regulatory approach to categorizing
SSCs, and to ensure that the final
guidance adequately addresses lessons
learned from the initial applications, the
NRC decided to issue this guide for trial
use. Therefore, this trial regulatory
guide does not establish any final staff
positions for purposes of the Backfit
Rule, 10 CFR 50.109, and may continue
to be revised in response to experience
with its use. As such, any changes to
this trial guide prior to staff adoption in
final form will not be considered to be
backfits as defined in 10 CFR
50.109(a)(1). This will ensure that the
final regulatory guide adequately
addresses lessons learned from
regulatory review of pilot and follow-on
applications, and that the guidance is
sufficient to enhance regulatory stability
in the review, approval, and
implementation of probabilistic risk
assessments (PRAs) and their results in
the risk-informed categorization process
required by § 50.69.
The NRC staff encourages and
welcomes comments and suggestions in
connection with improvements to
published regulatory guides, as well as
items for inclusion in regulatory guides
that are currently being developed. You
may submit comments by any of the
following methods.
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Mail comments to: Rules and
Directives Branch, Office of
Administration, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001.
Hand-deliver comments to: Rules and
Directives Branch, Office of
Administration, U.S. Nuclear Regulatory
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workdays.
Fax comments to: Rules and
Directives Branch, Office of
Administration, U.S. Nuclear Regulatory
Commission, at (301) 415–5144.
Requests for technical information
about Revision 1 of Regulatory Guide
1.201 may be directed to Donald G.
Harrison at (301) 415–3587 or via e-mail
to DGH@nrc.gov.
Regulatory guides are available for
inspection or downloading through the
NRC’s public Web site in the Regulatory
Guides document collection of the
NRC’s Electronic Reading Room at
https://www.nrc.gov/reading-rm/doccollections. Electronic copies of
Revision 1 of Regulatory Guide 1.201
are also available in the NRC’s
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Management System (ADAMS) at https://
www.nrc.gov/reading-rm/adams.html,
under Accession #ML061090627.
In addition, regulatory guides are
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Dated at Rockville, Maryland, this 1st day
of May, 2006.
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26393
For the U.S. Nuclear Regulatory
Commission.
Brian W. Sheron,
Director, Office of Nuclear Regulatory
Research.
[FR Doc. E6–6747 Filed 5–3–06; 8:45 am]
BILLING CODE 7590–01–P
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 Statelicensed 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
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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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 https://www.nrc.gov/reading-rm/doccollections/nuregs/staff/.
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.
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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
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(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 (Tc99m), 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.
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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 cesium137 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.
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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
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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
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26395
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
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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 Y90. 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
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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
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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 I131 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-
E:\FR\FM\04MYN1.SGM
04MYN1
Federal Register / Vol. 71, No. 86 / Thursday, May 4, 2006 / Notices
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
DEPARTMENT OF STATE
[Public Notice 5383]
mstockstill on PROD1PC68 with NOTICES
Notice of Proposal To Extend the
Memorandum of Understanding
Between the Government of the United
States of America and the Government
of the Republic of Bolivia Concerning
the Imposition of Import Restrictions
on Archaeological Material From the
Pre-Columbian Cultures and Certain
Ethnological Material From the
Colonial and Republican Periods of
Bolivia
The Government of the Republic of
Bolivia has informed the Government of
the United States of its interest in an
extension of the Memorandum of
Understanding Between the
Government of the United States of
America and the Government of the
Republic of Bolivia Concerning the
Imposition of Import Restrictions on
Archaeological Material from the PreColumbian Cultures and Certain
Ethnological Material from the Colonial
and Republican Periods of Bolivia,
VerDate Aug<31>2005
15:45 May 03, 2006
Jkt 208001
which entered into force on December 7,
2001.
Pursuant to the authority vested in the
Assistant Secretary for Educational and
Cultural Affairs, and pursuant to the
requirement under 19 U.S.C. 2602(f)(1),
an extension of this Memorandum of
Understanding is hereby proposed.
Pursuant to 19 U.S.C. 2602(f)(2), the
views and recommendations of the
Cultural Property Advisory Committee
regarding this proposal will be
requested.
A copy of this Memorandum of
Understanding, the designated list of
restricted categories of material, and
related information can be found at the
following Web site: https://
exchanges.state.gov/culprop.
Dated: April 21, 2006.
C. Miller Crouch,
Acting Assistant Secretary for Educational
and Cultural Affairs, Department of State.
[FR Doc. E6–6773 Filed 5–3–06; 8:45 am]
BILLING CODE 4710–05–P
DEPARTMENT OF STATE
[Public Notice 5384]
Notice of Meeting of the Cultural
Property Advisory Committee
There will be a meeting of the
Cultural Property Advisory Committee
on Thursday, June 8, 2006, from
approximately 9 a.m. to 5 p.m., and on
Friday, June 9, from approximately 9
a.m. to 2 p.m., at the Department of
State, Annex 44, Room 840, 301 4th St.,
SW., Washington, DC. During its
meeting the Committee will review a
proposal to extend the Memorandum of
Understanding Between the
Government of the United States of
America and the Government of the
Republic of Bolivia Concerning the
Imposition of Import Restrictions on
Archaeological Material from the PreColumbian Cultures and Certain
Ethnological Material from the Colonial
and Republican Periods of Bolivia. The
Government of the Republic of Bolivia
has notified the Government of the
United States of America of its interest
in such an extension.
The Committee’s responsibilities are
carried out in accordance with
provisions of the Convention on
Cultural Property Implementation Act
(19 U.S.C. 2601 et seq.). The text of the
Act and subject Memorandum of
Understanding, as well as related
information may be found at https://
exchanges.state.gov/culprop. Portions of
the meeting on June 8 and 9 will be
closed pursuant to 5 U.S.C.
552b(c)(9)(B) and 19 U.S.C. 2605(h).
PO 00000
Frm 00079
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26397
However, on June 8, the Committee will
hold an open session from
approximately 10 a.m. to 11:30 a.m., to
receive oral public comment on the
proposal to extend. Persons wishing to
attend this open session should notify
the Cultural Heritage Center of the
Department of State at (202) 453–8800
by Thursday, June 1, 2006, 3 p.m. (EDT)
to arrange for admission. Seating is
limited.
Those who wish to make oral
presentations at the public session
should request to be scheduled and
must submit a written text of the oral
comments by May 24 to allow time for
distribution to Committee members
prior to the meeting. Oral comments
will be limited to allow time for
questions from members of the
Committee and must specifically
address the determinations under
section 303(a)(1) of the Convention on
Cultural Property Implementation Act,
19 U.S.C. 2602, pursuant to which the
Committee must make findings. This
citation for the determinations can be
found at the Web site noted above.
The Committee also invites written
comments and asks that they be
submitted no later than May 24 to allow
time for distribution to Committee
members prior to the meeting. All
written materials, including the written
texts of oral statements, may be faxed to
(202) 435–8803. If five pages or more, 20
duplicates of written materials must be
sent by express mail to: Cultural
Heritage Center, Department of State,
Annex 44, 301 4th Street, SW.,
Washington, DC 20547; tel: (202) 453–
8800.
Dated: April 21, 2006.
C. Miller Crouch,
Acting Assistant Secretary for Educational
and Cultural Affairs, Department of State.
[FR Doc. E6–6756 Filed 5–3–06; 8:45 am]
BILLING CODE 4710–05–P
DEPARTMENT OF STATE
[Public Notice 5387]
Notice of Meeting United States
International Telecommunication
Advisory Committee
The Department of State announces a
meeting of the ITAC. The purpose of the
Committee is to advise the Department
on matters related to telecommunication
and information policy matters in
preparation for international meetings
pertaining to telecommunication and
information issues.
The ITAC will meet to discuss the
matters related to the meeting of the ITU
Radiocommunication Sector’s Special
E:\FR\FM\04MYN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 86 (Thursday, May 4, 2006)]
[Notices]
[Pages 26393-26397]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6746]
-----------------------------------------------------------------------
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 https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
