[Federal Register Volume 59, Number 81 (Thursday, April 28, 1994)]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-10123]
[Federal Register: April 28, 1994]
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NUCLEAR REGULATORY COMMISSION
Abnormal Occurrences for Fourth Quarter CY 1993 Dissemination of
Information
Section 208 of the Energy Reorganization Act of 1974, as amended,
requires NRC to disseminate information on abnormal occurrences (i.e.,
unscheduled incidents or events that the Commission determines are
significant from the standpoint of public health and safety). During
the fourth quarter of CY 1993, the following incidents at NRC licensees
were determined to be abnormal occurrences (AOs) and are described
below, together with the remedial actions taken. The events are also
being included in NUREG-0090, Vol. 16, No. 4, (``Report to Congress on
Abnormal Occurrences: October-December 1993''). This report will be
available at NRC's Public Document Room, 2120 L Street NW. (Lower
Level), Washington, DC 20555 about three weeks after the publication
date of this Federal Register notice.
Other NRC Licensees (Industrial Radiographers, Medical Institutions,
Industrial Users, etc.)
93-11 Medical Branchytherapy Misadministration at Washington
University Medical School in St. Louis, Missouri
One of the AO reporting guidelines notes that a therapeutic dose
that results in any part of the body receiving unscheduled radiation
can be considered an abnormal occurrence.
Date and Place--January 7, 1993 and February 26, 1993; Washington
University Medical School; St. Louis, Missouri.
Nature and Probable Consequences--On January 7, 1993, a Nucletron
Micro-Selectron low-dose-rate (LDR) remote afterloader unit ejected a
radioactive source without being programmed to do so and without a
guide tube and applicator attached to the channel. The unguided source
lay at an approximate distance of 3 centimeters (cm) (1.2 inches [in]
from the nearest skin surface for approximately 5 minutes. The licensee
estimated that less than 0.1 centigray (cGy) (0.1 rad) of additional
dose was delivered to the skin surface.
On February 26, 1993, a very similar incident occurred at the same
facility. The incident involved a different patient and the same remote
afterloader unit. The device again ejected the same strength and type
of radioactive source without being programmed to do so. However, in
this case, the source lay near the patient's leg for approximately 60
to 75 minutes, at an approximate distance of 5 cm (2 in) from the
nearest skin surface. The licensee estimated the additional dose to the
patient's leg to be approximately 3.5 cGy (3.5 rad).
In both cases, the treatment of each patient was completed on
another LDR remote afterloader unit in another room of the medical
center.
Cause or Causes--After the first incident on January 7, 1993, a
manufacturer service engineer, who studied the device malfunction, was
unable to identify the cause of the failure during his repair visit.
The licensee's staff subsequently tested the device for 20 hours
without discovering the cause of the failure, and concluded that the
device was acceptable for use. This decision was based on the fact that
they could not reproduce the malfunction. The remote afterloader was
put back into service. On February 26, 1993, the device failed again
when a second unprogrammed source was ejected by the afterloader. After
this incident, which resulted in the second misadministration, the
manufacturer provided a different field engineer who correctly
diagnosed the problem as a failure in an operational amplifier.
A previous recommendation made by the manufacturer to store unused
sources in the auxiliary storage safe, instead of the remote
afterloader's mobile storage container, may have contributed to the
incident. The second field engineer indicated that some of the safety
features which prevent sources from being erroneously ejected were not
in effect or were not monitored by the device for the unprogrammed
channels containing the unused sources.
Actions Taken To Prevent a Recurrence
Licensee--The licensee informed the NRC that use of the two Micro-
Selectron-LDR remote afterloader units will be discontinued and a new
model LDR afterloader will be installed. NRC has also asked the
licensee to address the manufacturer's recommendation for storing the
sources and the removal of some of the safety features, and any
resulting corrective actions.
NRC--The vendor has now revised the device's operating software to
monitor and generate error messages and audible alarms for unprogrammed
(unused) channels. The NRC has sent a letter to the licensee
identifying the two events as misadministrations and requesting that
the licensee ensure the required notifications to the referring
physicians and patients have been made. (Letter from Roy J. Caniano,
Chief, Nuclear Materials Safety Branch, NRC Region III, to Robert J.
Hickok, Assistant Vice President for Medical Affairs, Washington
University Medical School, forwarding inspection reports No. 030-02271/
93001, 030-31205/93001, 030-15101/93001, Docket No. 030/02271, 030-
31205 and 030/15101, License No. 24-00167-11, dated January 12, 1994.)
During an NRC safety inspection conducted from November 15 to 18,
1993, the inspectors focused on these two incidents in addition to
other inspection areas. The results of this inspection are still under
review.
93-12 Medical Brachytherapy Misadministration at Mercy Hospital in
Scranton, Pennsylvania
One of the AO reporting guidelines notes that a therapeutic dose
that results in any part of the body receiving unscheduled radiation
can be considered an abnormal occurrence.
Date and Place--October 15, 1993; Mercy Hospital; Scranton,
Pennsylvania.
Nature and Probable Consequences--On October 15, 1993, Mercy
Hospital in Scranton, Pennsylvania, notified NRC Region I of a
therapeutic misadministration involving a Nucletron Micro-Selectron
high dose rate (HDR) remote afterloader which occurred at the facility
on April 23, 1993. The licensee identified this misadministration
during a review of the past treatment records.
A patient was scheduled to receive brachytherapy treatment to the
apex of her vagina in three fractions using a Nucletron Micro Selectron
HDR remote afterloader. The prescribed dose was 500 centigray (cGy)
(500 rad) for each fraction and the use of a ring applicator was
specified. On April 13, 1993, the patient was administered the first
fractional treatment. After an examination of the patient following the
first treatment, the physician revised the written directive and
prescribed a change from the ring applicator to a standard vaginal
cylindrical applicator for the remaining two treatments. On April 23,
1993, during the administration of the second treatment, the therapist
erroneously entered the catheter length of 920 millimeter (mm) (36.2
inch) into the treatment computer instead of the intended 992 mm (39.1
inch). The physician failed to identify this error during his review of
the treatment parameters prior to the initiation of the treatment.
As a result of this erroneous entry, a majority of the treatment
dose was administered to an unintended region near the opening of the
vagina, and the intended site received an underdose differing from the
prescribed dose by more than 20 percent. The physician stated that no
adverse clinical effects are expected as a result of the underdose to
the target site because this treatment was intended to administer a
booster radiation dose. The oncologist also stated that the patient is
not expected to experience any adverse effects as a result of the 500
cGy (500 rad) overexposure to the wrong treatment site
misadministration. The NRC medical consultant, in his report to Region
I, also stated a similar opinion (that it is unlikely the patient will
suffer any adverse effects from the misadministration).
The third fraction of the treatment was administered to the patient
on April 29, 1993, as prescribed.
The referring physician and the patient have been notified. The
licensee submitted a written report of the misadministration to NRC
Region I on October 29, 1993.
Cause or Causes--The therapist did not enter the correct catheter
length during initial setup for the second treatment. The licensee
followed established procedures; however, the procedure did not require
verification of all parameters at the time of the second check prior to
each treatment.
Actions Taken to Prevent Occurrence
Licensee--The licensee has instituted a requirement that a medical
physicist also review the final treatment plan prior to initiating the
treatment. The treatment parameters for all brachytherapy (HDR)
treatments will be transferred electronically to the magnetic card
directly from the simulator. The output of this card will be reviewed
by the medical physicist and the oncologist before the initiation of
the treatment.
NRC--Region I conducted a special inspection at Mercy Hospital on
October 19, 1993. Inspection Report No. 030-02983/93-001, issued
November 5, 1993, identified two apparent violations:
(1) Failure to require supervised individual to follow written
quality management procedures (QMP) 10 CFR 35.25(a)(2);
(2) Failure to include policies and procedures in the QMP to meet
the objective that each administration is in accordance with the
written directive 10 CFR 35.32(a) After receipt and review of the
medical consultant's report, Region I issued a Notice of Violation to
the licensee on February 9, 1994, classifying the two violations at
Severity Level IV in accordance with the NRC Enforcement Policy.
An NRC medical consultant has been retained to review this
misadministration. The medical consultant's report was received by
Region I on February 3, 1994. (The medical consultant's report is filed
in Docket No. 030-02983 in the Region I Materials License Docket Room.
Inspection Report No. 030-02983/93-001 issued November 5, 1993, and the
February 9, 1994, Notice of Violation are in the PDR.) The medical
consultant questioned the licensee concerning its identification of a
radiation oncologist as the referring physician. After discussion with
the NRC's medical consultant, the licensee identified the patient's
physician as the primary referring physician and then agreed to notify
the physician. Following a review of the medical consultant's report,
Region I confirmed in a telephone conversation that the licensee had
contacted the patient's physician regarding the misadministration. The
licensee stated that both referring physicians have been notified of
this misadministration. The radiation oncologist had discussed the
misadministration with the patient on October 21, 1993.
93-13 Medical Brachytherapy Misadministration at Mountainside Hospital
in Montclair, New Jersey
One of the AO reporting guidelines notes that a therapeutic dose
that results in any part of the body receiving unscheduled radiation
can be considered an abnormal occurrence.
Date and Place--July 1, 1993; Mountainside Hospital; Montclair, New
Jersey.
Nature and Probable Consequences--On December 1, 1993, during a
routine inspection, NRC identified a therapeutic misadministration
involving a high-dose-rate (HDR) remote afterloader, which occurred at
Mountainside Hospital in Montclair, New Jersey, on July 1, 1993. NRC
identified the misadministration while reviewing the licensee's
Radiation Safety Committee (RSC) meeting minutes for 1993.
On July 1, 1993, a patient was scheduled to receive the last of
three brachytherapy treatments to the right mainstem bronchus. Each
fraction was to deliver 750 centigray (cGy) (750 rad) to the target
using a Nucletron Mitro-Selectron HDR remote afterloader and an
intrabronchial catheter. During the July 1, 1993 treatment, the
radiation oncologist mistakenly connected the catheter to the HDR
afterloader with a 750 mm (29.5 inch) transfer tube instead of a short
connector. This prevented the source from entering the intrabronchial
catheter, and while delivering a negligible dose to the tumor, the
face, the lenses of the eyes, the thyroid, and the whole body of the
patient received unscheduled exposure.
The source strength at the time of the incident was 161,000
megabecquerel (4.35 curie) of iridium-192 and the exposure time was
445.5 seconds. Following the reconstruction of the incident by the
licensee, the surface does to the lens of the left eye was determined
by the licensee to be 1.97 cGy (1.97 rad), the does to the chin (the
closest surface of the body) was 4.56 cGy (4.56 rad), and the dose to
the thyroid was 3.07 cGy (3.07 rad). The physician identified the error
upon termination of the treatment and wrote a memorandum about the
incident to the hospital's physicist and radiation safety officer
(RSO).
The physician mistakenly determined that the incident was not a
misadministration, and so advised the RSO. The RSO, relying on the
physician's judgment, did not notify NRC and filed the report in the
RSC minutes folder. The radiation oncologist decided against making up
the missed third fraction of therapy.
On December 3, 1993, NRC notified the licensee by telephone that
the event constituted a misadministration and the licensee notified the
NRC Operations Center the same day. The licensee's written report of
the misadministration, dated December 13, 1993, was received in the NRC
Region I office on December 17, 1993.
After review of the report, Region I called the licensee to
determine if the referring physician and the patient were notified of
the misadministration. The licensee forwarded a copy of a letter dated
December 20, 1993, from the radiation oncologist to the referring
physician confirming a December 6, 1993, telephone conversation in
which the referring physician was informed of the misadministration.
The letter indicated that the referring physician did not feel it would
be in the patient's best interest to be notified of the
misadministration.
NRC contracted a medical consultant to determine the significance
of the misadministration to the patient. The medical consultant's
report was received by Region I on February 3, 1994. The consultant's
calculations of doses to the lens of the left eye, the chin, and the
thyroid of the patient agreed with the licensee's estimates, based on
the strength of the source, the time of exposure and the distances of
the source from the patient. The consultant concluded that the patient
would not suffer any adverse effects from the misadministration. The
medical consultant also determined that the oncologist failed to notify
the patient of the misadministration because he did not fully
understand the requirements of 10 CFR 35.33(a)(3). After discussions
with the consultant, the referring physician agreed to inform the
patient of the misadministration.
Cause or Causes--An error by the attending physician in connecting
the catheter to the HDR remote afterloader, and the failure of the
console operator to recognize the faulty connection were the direct
causes of the event. Both individuals relied on the treatment computer
to indicate any problems with the therapy setup. The computer on a
Nucletron HDR is not designed to alert the user to an incorrect
connection of a longer transfer tube.
In addition, the medical consultant's report indicates that the
second individual observing the transfer tube connection during each
treatment setup was a different console operator. Since the console
operator in attendance during the third treatment had not been present
during the prior treatments, he/she was unaware of the intended setup.
Actions Taken to Prevent Occurrence
Licensee--The licensee arranged for additional training by
Nucletron on July 30, 1993. The training was attended by both HDR
remote afterloader units authorized users and by three technologist-
console operators.
NRC--NRC is reviewing the licensee's December 17, 1993
misadministration report and the findings of the December 1, 1993 NRC
inspection. An NRC medical consultant was retained to review the
misadministration.
The medical consultant's report dated February 1, 1994, was
received by the NRC Region I office on February 3, 1994. (The medical
consultant's report will be placed in the file for Docket No. 03-02470
located in the Region I Materials License Docket Room. An inspection
report will be issued to the licensee by February 18, 1994, and will be
available in the PDR.) In addition to the comment made in the above
sections, the consultant indicated that if the licensee had required a
medical physicist to be present during every setup and treatment as
recommended in NRC Bulletin 93-01, it is likely that this
misadministration would not have occurred. In the consultant's opinion,
a medical physicist would have been more likely to have noticed the
human error in the setup of the third HDR treatment. An enforcement
conference has been scheduled.
94-14 Exposure to a Nursing Infant at Queen's Hospital in Honolulu,
Hawaii
One of the AO reporting guidelines notes that a moderate exposure
to, or release of, radioactive material licensed by or otherwise
regulated by the Commission can be considered an abnormal occurrence.
Date and Place--December 2, 1991; Queen's Medical Center; Honolulu,
Hawaii.
Nature and Probable Consequences--On October 25, 1993, during a
routine safety inspection, a Region V inspector discovered an
unreported unscheduled exposure to the thyroid of a 9-month-old nursing
infant. On December 2, 1991, a patient was administered 0.56
megabecquerel (15 microcuries) of iodine-131 for a diagnostic scan.
Although the patient noted on a hospital form that she was
breastfeeding, the technologist failed to notice this notation until
the patient returned for a scan the following day. The patient was
informed of the oversight by the licensee and was instructed to stop
breastfeeding. The authorized user and the referring physician were
also notified on December 3, 1991.
The licensee's Radiation Safety Officer calculated the infant's
absorbed thyroid dose to be approximately 250 millisievert (mSv) (25
rem) based on information obtained during the uptake scan of the mother
6 hours after the administration.
The NRC retained a medical consultant to evaluate the circumstances
of this misadministration. The consultant estimated the dose to the
infant's thyroid to be between 160 to 650 mSv (16 to 65 rem). The
medical consultant concluded that the infant is not likely to
experience any adverse effects as a result of this misadministration.
Cause or Causes--Failure of a supervised technologist to adequately
review the hospital form used to inform the hospital staff that a
patient is pregnant or breastfeeding as he/she was instructed by the
authorized user.
Actions Taken to Prevent Recurrence
Licensee--The screening procedure used to inform the hospital staff
that a patient is pregnant or breastfeeding was incorporated into the
clinical procedure manual. It was reviewed by each of the
technologists, and it will be reviewed by all new technologists upon
being hired. It will also be reviewed annually during a radiation
safety training course.
NRC--NRC conducted inspections on September 28 and October 25-27,
1993. The December 2, 1991 misadministration was noted and reviewed
during these inspections. A number of violations were identified as a
result of these inspections and escalated enforcement actions are being
considered. An NRC medical consultant was also retained to review the
case.
93-15 Medical Brachytherapy Misadministration at Good Samaritan
Medical Center in Zanesville, Ohio
One of the AO reporting guidelines notes that a therapeutic dose
that results in any part of the body receiving unscheduled radiation
can be considered an abnormal occurrence.
Date and Place--November 10, 1993; Good Samaritan Hospital;
Zanesville, Ohio.
Nature and Probable Consequences--A patient was being treated for
lung cancer. The treatment included performing an iridium-192
therapeutic implant. The prescribed treatment dose was 6000 rad to the
patient's lung. On November 10, 1993, a catheter was surgically
implanted in the patient. Iridium-192 seeds, contained in a ribbon,
were inserted into the catheter.
Following normal licensee procedure, the physicist requested that
the attending nurse order a ``stat'' chest x-ray in order to verify
source position. The ``stat'' radiograph was completed and two hours
later upon review of the film, the seed positions could not be
visualized. Two additional radiographs using different techniques were
done. In the second radiograph, completed one hour later, the seeds
were located in the patient's throat. The ribbon was removed and the
physician successfully reinserted the ribbon to the proper location.
Another radiograph was done to verify the source location. The
treatment time was recalculated to deliver the total original intended
dose and the treatment was completed without further difficulty.
The sources were in the improper location for about three hours,
delivering an estimated dose to the larynx area of about 282 centigray
(282 rad). An NRC medical consultant evaluated the medical aspects of
the brachytherapy misadministration and concluded that the dose to the
larynx and surrounding area is not clinically significant.
The physician verbally notified the patient of the
misadministration following the successful reinsertion of the source
ribbon. A written report was provided to the patient on November 15
1993.
Cause or Causes--The immediate cause of the misadministration was
an apparent crimp in the catheter which resulted in the seeds not being
placed correctly. The seeds were blocked by the crimp at the level of
the patient's larynx.
An inexperienced radiation therapy technician implanted the source.
During interviews, the physician stated that it would be difficult for
an inexperienced person to know the difference between a properly
seated ribbon and when ribbon insertion was impeded by a crimp in the
catheter.
Actions Taken To Prevent Recurrence
Licensee--The licensee's plan for preventing recurrence of the
misadministration included:
(1) Formalizing the dosimetrist's ``rule of practice'' regarding
comparison of the ribbon and catheter lengths prior to source
implantation in order to ensure that the ribbon is properly seated;
(2) Providing training to all radiation therapy technologists and
each medical physicist in the new procedure;
(3) Requiring that the authorized user physically implant source
ribbons;
(4) Requiring that each radiation therapy technologist receive
hands on training and instruction in source implantation; and
(5) Requiring that the ``stat'' post-insertion radiograph be hand
carried to the prescribing physician for evaluation as soon as possible
to determine proper source placement.
NRC--A special safety inspection was conducted by NRC Region III on
January 19, 1994 to review the circumstances surrounding this
misadministration. An NRC medical consultant was also retained to
review this case. Based on the results of the special inspection, NRC
identified an apparent violation that is being considered for escalated
enforcement action. (Letter from W.L. Axelson, Director, Division of
Radiation Safety and Safeguards, NRC Region III, to Dan Sylvester, Vice
President for Professional Services, Good Samaritan Hospital, forwarded
inspection report No. 030-30954/94001, Docket No. 030-30954, License
No. 34-16725-02, dated February 11, 1994.)
93-16 Medical Brachytherapy Misadministration at Marquette General
Hospital in Marquette, Michigan
One of the AO reporting guidelines notes that a therapeutic dose
that results in any part of the body receiving unscheduled radiation
can be considered an abnormal occurrence.
Date and Place--November 17-19, 1993; Marquette General Hospital,
Marquette, Michigan.
Nature and Probable Consequences--On November 17, 1993, a patient
was undergoing a brachytherapy procedure using cesium-137 sealed
sources placed in a treatment device (catheter) inserted into the
patient's uterus. When the catheter was removed on November 19, it was
observed that it was too short to have been fully inserted into the
uterine cavity. The three sources in the catheter had actually been in
the patient's vagina instead of the uterus.
The case was evaluated by an NRC medical consultant who concluded
that the lower vagina received a radiation dose of 2,700 centigray
(2,700 rad) when it would not have received a significant dose if the
treatment had been performed as planned. The medical consultant
concluded that the radiation doses to the vagina would not be expected
to cause any acute or long term effects because the vaginal tissue is
extraordinarily tolerant of radiation. This placement error did not
result in additional exposure to other organs.
The intended treatment area received about 50 percent of the
intended dose. Subsequently, the patient received an additional dose to
the uterus to complete the prescribed treatment. The licensee informed
the patient of the treatment error.
Cause or Causes--The hospital routinely uses two lengths of
catheters for brachytherapy treatments, a shorter catheter for vaginal
procedures and a longer one for uterine procedures. The medical
physicist inadvertently placed the cesium-137 sources in the shorter
(vaginal) catheter instead of the required long catheter for the uterin
procedure prescribed.
Actions Taken To Prevent a Recurrence
Licensee--The hospital has revised its procedures to include added
precautions for assuring the correct length catheter is used in each
brachytherapy procedure.
NRC--The NRC conducted a special inspection beginning November 29,
1993, to review the circumstances surrounding the misadministration. No
violations of NRC regulations were identified, but the licensee was
directed to review its Quality Management Program to determine what
modifications were needed to prevent similar misadministrations in the
future. The NRC also retained a medical consultant to evaluate this
case.
Dated at Rockville, MD, this 21st day of April 1994.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Assistant Secretary of the Commission.
[FR Doc. 94-10123 Filed 4-26-94; 8:45 am]
BILLING CODE 7590-01-M
