[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