[Federal Register Volume 59, Number 160 (Friday, August 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20423]
[[Page Unknown]]
[Federal Register: August 19, 1994]
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NUCLEAR REGULATORY COMMISSION
Abnormal Occurrences for First Quarter CY 1994; 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 first quarter of CY 1994, 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. 17, No. 1, (``Report to Congress on
Abnormal Occurrences: January-March 1994''). 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.
Nuclear Power Plants
94-1 Inoperable Main Steam Line Isolation Valves at Perry Nuclear
Power Plant
One of the AO reporting guidelines notes that a major reduction in
the degree of protection to public health and safety from a major
degradation of essential safety-related equipment can be considered an
AO.
Date and Place--March 1992; Perry Nuclear Power Plant, a General
Electric-designed boiling water reactor (BWR), operated by Cleveland
Electric Illuminating Company and located about 11 kilometers (7 miles)
northeast of Painesville, Ohio.
Nature and Probable Consequences--The main steam isolation, leakage
control and outboard drain valves in three of four main steam lines
penetrating containment failed to meet the Technical Specifications
limiting condition of operation (LCO) for leak tightness.
For many BWRs, the LCO for leakage of each main steam isolation
valve (MSIV) is 0.326 standard cubic meters (11.5 standard cubic feet)
per hour. Because it is difficult to measure the leakage of each valve
individually, a maximum combined allowed leakage is specified for the
inboard and outboard MSIVs, and the associated control and drain
valves. This LCO is 0.71 standard cubic meters (25 standard cubic feet)
per hour. During testing at Perry in 1992, the leakages through the
MSIVs were approximately 12 times allowable. Due to a history of poor
performance and multiple main steam line valve leakage, a detailed
analysis of the 1992 MSIV leakage was performed. The analysis is
required obtaining detailed information from the licensee; a number of
calculations, reviews, and subsequent reanalyses; and multiple meetings
among the staff to determine the impact on safety.
MSIVs are designed to close and limit the release of radioactivity
to the environment in the unlikely event of an accident. When the Perry
facility was issued an operating license, there was reasonable
assurance that the MSIVs would operate as intended, and the potential
off-site doses resulting from postulated accidents, which includes
assumptions regarding fuel damage and fission product release, would be
below the guideline values for release to the general public. Because
of the excessive leakage, the NRS staff, using conservative
assumptions, calculated the potential off-site doses to the general
public that might result from a postulated loss-of-coolant accident.
Using the very conservative licensing basis calculational
methodologies, the calculated dose exceeded the guidelines for release
to the general public. A more realistic calculation using the new
approach presented in draft NUREG-1465, ``Accident Source Terms for
Light-Water Nuclear Power Plants'' (U.S. Nuclear Regulatory Commission,
NUREG-1465, ``Accident Source Terms for Light-Water Nuclear Power
Plants,'' Draft Report for Comment, June 1992) showed that the
potential off-site doses would not exceed the limits for release to the
general public; however, additional measures would be needed to
minimize exposure of control room personnel.
Cause or Causes--The licenses determined the reason for the
excessive MSIV leakage during the 1992 tests to be excessive friction
from oxide buildup, which caused end-of-stroke angular misalignment
resulting in non-360-degree seat contact (Licensee Event Report 50-440/
92-006-01, ``Local Leak Rate Test Results Exceed Allowable Primary
Containment Leakage for Main Steam Lines A, B, and D,'' August 14,
1992). The reason for the difficulty of the Perry MSIVs to meet test
leakage limits is design geometry. The MSIVs are ``Y'' pattern valves
with the valve stem at 45 degrees to the piping axis. To seat properly,
translational motion of the poppet at the moment of impact must change
from the direction of the stem to a direction parallel to the axis of
the pipe. Seating is made more difficult because of the large size of
the valves (66 centimeters [26 inches] diameter) and the weights
involved (4500 kilograms [10,000 pounds]).
Actions Taken to Prevent Recurrence
Licensee--In the early 1980s, Atwood & Morrill, suppliers of the
MSIVs, and the BWR Owners Group recognized the need for better
maintenance and for modification of the MSIVs. Modifications included
improved poppet nose guides to overcome eccentricity during seating and
poppet anti-rotation devices. During the 1992 refueling outage, these
modifications were installed by the licensee on the six (out of eight)
MSIVs which have had leakage problems (Licensee Event Report 50-440/92-
006-01, ``Local Leak Rate Test Results Exceed Allowable Primary
Containment Leakage for Main Steam Lines A, B, and D,'' August 14,
1992). Based on leakage tests performed in 1993 and 1994, the
modifications were successful in significantly reducing MSIV leakage.
NRC--NRC is closely monitoring the licensee's program and progress
in reducing the leak rate through the MSIVs.
* * * * *
Other NRC Licensees (Industrial Radiographers, Medical Institutions,
Industrial Users, etc.)
94-2 Medical Brachytherapy Misadministration at Hospital Metropolitano
in Rio Piedras, Puerto Rico
One of the AO reporting guidelines notes that a therapeutic
exposure to any part of the body not scheduled to receive radiation can
be considered an abnormal occurrence.
Date and Place--December 11, 1993; Hospital Metropolitano; Rio
Piedras, Puerto Rico.
Nature and Probable Consequences--On December 9, 1993, at 5:20
p.m., a patient began a gynecological low-dose-rate brachytherapy
treatment. The patient was prescribed a treatment of 3000 centigray
(cGy) (3000 rad) by a 48-hours exposure to approximately 2.3
gigabecquerel (61.3 millicurie [mCi]) of cesium-137 (Cs-137).
On December 11, 1993, at approximately 7:30 a.m. (about 10 hours
before the end of the prescribed treatment), the patient intervened
with the procedure by removing the implant containing three Cs-137
sources of approximately 730 megabecquerel (20.4 mCi) each, and placed
it next to her thigh. Shortly after removing the implant, the patient
showed the device to the floor nurse. The nurse recognized the implant
and understood the need for concern. She did not take the device from
the patient but reported the situation to her supervisor. The patient
apparently returned the device next to her thigh beneath the bed linen.
At the time of being informed, the nursing supervisor was
experiencing difficulty with another patient, and was involved in shift
turnover. Due to these distractions, the supervisor failed to realize
the urgent nature of the situation and did not make required
notifications.
On several occasions that morning, other licensee personnel entered
the patient's room without realizing that the radioactive source was
exposed because it was covered by bed linen; the patient did not notify
any additional staff members that she had removed the implant.
Approximately 2\1/2\ hours after the estimated time of the source
removal, the attending physician attempted to perform a routine check
of the implant and discovered that it had been removed and placed next
to the patient's thigh.
After properly accounting for and storing the sources, the
physician examined and interviewed the patient. Based on discussions
with the patient and review of the exposure received, the attending
physician terminated the treatment. This decision was based on the
physician's determination that the treatment received was clinically
adequate and his concern that the patient was a threat to herself and
others.
The actual dose delivered to the intended treatment site was
calculated to be 2270 cGy (2270 rad). The written directive was revised
to reflect the lower dose delivered. The licensee's evaluation of the
incident indicated that assuming the implant remained in the same
location for three hours, the maximum dose to the skin of the patient's
thigh (the wrong treatment site) was 572 cGy (572 rad). The licensee
reported that no adverse effects to the patient are expected.
The patient was notified verbally at the time the misadministration
was discovered and then notified in writing on January 13, 1994.
Cause or Causes
The initial cause of the misadministration was the patient's
removal of the implant which was compounded by the failure of the two
nurses to follow emergency procedures. The nurses' failure to respond
to the emergency resulted in approximately 2\1/2\ hours of unnecessary
exposure.
Actions Taken to Prevent Recurrence
Licensee--The licensee determined that the nursing supervisor's
failure to make the required notifications was due to the lack of
familiarity with established radiation safety procedures to which he/
she had been trained. The licensee's investigation of the event
revealed that the lack of familiarity with radiation safety procedures
was caused by the infrequent handling of patients undergoing therapy
with licensed materials (Letter from Hospital Metropolitano, to Hector
Bermudez, Senior Inspector, NMI Section, NRC Region II, Forwarding a
Misadministration Report dated December 29, 1993, and an Addendum to
the Misadministration Report dated January 11, 1994, Docket No. 030-
11155, Licensee No. 52-16033-01). The licensee held a Radiation Safety
Committee meeting in which the incident and corrective actions to
prevent recurrence were discussed.
The licensee decided to dedicate one floor of the hospital for all
therapies involving NRC-licensed materials. This will provide
additional controls to allow the licensee to better ensure that nurses
assigned to the floor are kept current and familiar with operating and
emergency procedures. The licensee is also evaluating the need to
increase patient awareness regarding non-intervention of procedures.
The licensee is revising its procedures for responding to
radiological emergencies involving patients undergoing
radiopharmaceutical or sealed source therapy. As a minimum, the
procedures will define what is a radiological emergency and will
provide examples of situations which must be considered radiological
emergencies or which could result in misadministrations. The licensee
also committed to developing and implementing a retraining program
based on the revised emergency procedures for all hospital employees
who may be involved in handling patients receiving radiation therapy.
NRC--A special inspection was conducted on December 15 and 17,
1993, to review the circumstances surrounding the misadministration and
the licensee's Quality Management program. A Confirmatory Action Letter
(CAL) was issued to the licensee on December 30, 1993 (Letter from J.
Philip Stohr, Director, Division of Radiation Safety and Safeguards,
NRC Region II, to Hospital Metropolitano, Attn: Mr. Victor Marrero,
Administrator, forwarding a Confirmatory Action Letter, CAL No. 2-93-
14, Docket No. 030-11155, License No. 52-16033-01, dated December 30,
1993). The CAL confirmed that the licensee would revise its emergency
procedures and implement a training program, based on new procedures,
for all licensee employees who may handle patients undergoing radiation
therapy. An NRC medical consultant has been retained to perform a
clinical assessment of this misadministration. The medical consultant's
report is expected to be available in time to discuss his findings in
the second quarter AO Report. As of the issuance of this report, NRC is
pursuing escalated enforcement action against the licensee.
* * * * *
94-3 Teletherapy Misadministration at Triangle Radiation Oncology
Associates in Pittsburgh, Pennsylvania
One of the AO reporting guidelines notes that a therapeutic
misadministration that affects two or more patients at the same
facility, regardless of any health effects, can be considered an
abnormal occurrence.
Date and Place--December 20, 1993; Triangle Radiation Oncology
Associates; Pittsburgh, Pennsylvania.
Nature and Probable Consequences--On December 20, 1993, Triangle
Radiation Oncology Associates in Beaver, Pennsylvania, notified NRC of
two potential teletherapy misadministrations that occurred between
December 13 and 17, 1993, at the licensee's Pittsburgh, Pennsylvania,
facility. The potential misadministrations were identified during a
review of patient records on December 17, 1993, when the licensee
observed calculation errors involving the depth of the dose given to
each of the two patients.
Both cases involved breast treatments where the original treatment
plan prescribed 28 treatments of 180 centigray (cGy) (180 rad) from a
cobalt-60 teletherapy source (using 2 parallel opposed fields) for a
total absorbed dose of 5040 cGy (5040 rad). The primary breast
treatments were concluded on December 10, 1993. The physician wrote
separate written directives for each patient to receive an additional
1000 cGy (1000 rad) to the scar in 5 treatments of 200 cGy (200 rad)
per day. One of the written directives indicated that the absorbed dose
was to be delivered at dmax, the maximum extension of the
teletherapy unit, which, as stated by the physicist, is typically a
depth of 0.5 centimeter (cm) (0.2 inch). The other written directive
did not indicate a depth; however, the physician stated that the
intended depth was dmax.
As described above, such a treatment plan would typically have been
calculated by the teletherapy technologist at the Pittsburgh facility
and communicated by telephone to the teletherapy physicist at the
Beaver facility to be checked. However, this procedure changed when the
computer at the Pittsburgh facility was taken out of service on
December 1, 1993.
On December 9, 1993, the teletherapy technologist hand wrote a
paraphrased request of the written directive for the two breast-
treatment patients needing scar booster dose calculations. Rather than
writing dmax, the technologist stated the tumor dose at a depth of
5 cm (2 inch) and sent the request, via facsimile transmission, to the
teletherapy physicist at the Beaver facility. Hand calculations were
performed for 200 cGy (200 rad) treatments at a 5 cm (2 inch) depth,
checked by a certified physicist, and sent back to the technologist,
via facsimile transmission, on December 9, 1993.
The patients were treated from December 13 to 17, 1993, and
received doses of 1300 and 1320 cGy (1300 and 1320 rad) respectively,
rather than the 1000 cGy (1000 rad) intended. This resulted in
misadministrations of 30 and 32 percent greater than the intended dose.
The licensee's physician stated that no adverse clinical effects are
expected as a result of the overexposures.
After the initial report, the licensee told NRC in subsequent
telephone conversations that a recalculation of the dose averaged over
the entire tumor volume did not exceed 30 percent and, therefore, the
licensee no longer thought the definition of a misadministration
applied in this case.
NRC performed a special inspection on December 28 and 29, 1993, to
review the potential misadministrations. Information gathered during
this inspection, including the calculations of the administered doses,
was given to an NRC scientific consultant to evaluate. The scientific
consultant, in his report to NRC, stated that ``the dose prescription
was to dmax (i.e., 0.5 cm [0.2 inch] depth on the central axis)
and a misadministration can only be judged by considering the dose
given to this point. * * * clearly in both cases a misadministration
has taken place.'' On March 25, 1994, the licensee was informed that
the doses to both patients were deemed to be misadministrations. The
licensee submitted its report of misadministrations in a letter dated
April 7, 1994.
After receiving the scientific consultant's report, an NRC medical
consultant was retained to perform a clinical evaluation of the
patients. The medical consultant is still reviewing the potential
health effects to the patients. The consultant's report is expected to
be completed in time to update this writeup in the next AO report to
Congress.
The referring physician was notified and determined that, based on
medical judgment, informing the patients of the misadministrations
would be harmful.
Cause or Causes--The technologist incorrectly transposed the
treatment depth on the facsimile used to prepare the treatment plan.
The technologist failed to make reference to dmax and entered the
depth value incorrectly as 5.0 cm (2 inch) instead of the intended 0.5
cm (0.2 inch).
Actions Taken to Prevent Recurrence
Licensee--The licensee implemented a requirement for a stamp to be
placed on all written directives that prompts a clear documentation of
key treatment parameters such as site, method, daily dose, fractions,
total doses, depth of calculation, spinal blocks, other blocks, and
date. Previously, key parameters had been informally handwritten
directives on patients's treatment charts. The licensee also formalized
its requirement to include the written directive for all dosimetry
calculation requests from the Beaver facility, and revised its ``weekly
chart check'' procedure to increase chart reviews from once a week to
twice a week, as was the practice prior to December 1, 1993.
NRC--NRC is reviewing the licensee's April 7, 1994,
misadministration report and the findings of the December 28 to 29,
1993, NRC inspection. Once the NRC medical consultant's report is
received, enforcement action will be considered.
* * * * *
94-4 Lost Reference Sources at Brooks Air Force Base in San Antonio,
Texas
One of the AO reporting guidelines notes that any serious
deficiency in management or procedural controls in a major area can be
considered an abnormal occurrence.
Date and Place--1993; Armstrong Laboratory, Brooks Air Force Base
(AFB); San Antonio, Texas.
Nature and Probable Consequences--As prescribed by the licensees's
Compliance Accountability and Control Procedures, in 1993, the licensee
performed an audit of all licensed sources at Armstrong Laboratory.
During this audit, the licensee identified four missing strontium-90
(Sr-90) reference sources of approximately 14.8 megabecquerel (400
microcurie) each. The licensee conducted an extensive physical search
for the sources and reviewed all radioactive material permits issued to
other organizations at Brooks AFB. When the disposition of the Sr-90
sealed sources could not be determined, the licensee reported the loss
of the four sealed sources to NRC by telephone on September 22, 1993.
The licensee informed NRC that the United States Air Force (USAF)
Inspector General would review this incident. The licensee suspected
that the sources had been inadvertently discarded and transported to a
sanitary landfill.
The licensee evaluated possible radiation exposure to members of
the general public and concluded that unless the sources were removed
from the container, the radiation levels from the sources would be near
background level. Furthermore, unless a deliberate effort was made to
open the source capsules, an individual handling the sources would
receive less exposure than allowed by regulatory limits for the general
public.
Cause or Causes--During 1991, the timeframe during which the
sources were apparently lost, a number of individuals were responsible
for the radiation safety program at Brooks AFB. These individuals were
temporary or part-time Radiation Safety Officers (RSOs), and had
extensive, temporary duties at other sites.
The results of the USAF Inspector General's investigation
determined that ``programmatic issues started to plague radiation
safety at Brooks AFB after the dismantling of the base/clinic program
and the inception of additional duty RSOs.'' The report explained that
in 1986, the radiation safety function and responsibility was
transferred to the base clinic at Brooks AFB. Almost simultaneously, a
Joint Military Medical Command (JMMC) was established and the base
clinic became a part of JMMC. JMMC was a medical command established to
service all branches of the Armed Forces in the San Antonio, Texas,
area. With this action, the radiation safety program was managed by an
organization that was not responsible to any management level at Brooks
AFB. Furthermore, the report stated that JMMC dismantled the clinic's
radiation safety program, and ``requested that all organizations
previously under the clinic's program establish and run their own
radiation safety program.'' Exacerbating the problem was the
appointment of the additional duty RSOs, who had ``limited to general
knowledge of radiation safety,'' and no directives or other guidance to
assist them. Additionally, ``the additional duty RSOs received little
management oversight after they had been appointed to the RSO
position.''
The investigation concluded that from 1986 through 1991, there had
been a lack of commitment to management oversight, and a serious
disregard for radiation safety issues.
Actions Taken to Prevent Recurrence
Licensee--In 1991, Armstrong Laboratory was placed under a new Air
Force Command. The Command committed to increased management oversight
of the radiation safety programs. Additionally, physical inventory
procedures were revised.
NRC--NRC conducted an inspection (Letter from Dwight D.
Chamberlain, Acting Director, Division of Radiation Safety and
Safeguards, NRC Region IV, to Lt. Colonel Joseph J. Donnelly, chief of
USAF Radioisotope Committee Secretariat, forwarding Inspection Report
No. 030-28641/93-10, Docket No. 030-28641, License No. 42-23539-01AF,
dated January 19, 1994) at Brooks AFB on December 21, 1993, to review
the circumstances associated with the loss of licensed material, after
receiving a written report from the licensee on December 10, 1993. NRC
also held an Enforcement Conference with the licensee on February 3,
1994, to review the findings of the inspection and to determine
enforcement action.
On February 11, 1994, NRC issued a Notice of Violation (Letter from
L.J. Callan, Regional Administrator, NRC Region IV, to Department of
the Air Force, USAF Radioisotope Committee, forwarding Notice of
Violation, Docket No. 030-28641, License No. 42-23539-01AF, dated
February 11, 1994) for violations involving (1) a failure to secure
licensed material and (2) failure to include in one USAF permit a
requirement to conduct a periodic physical inventory of all licensed
materials.
These violations were categorized as a Severity Level III and a
Severity Level IV, respectively (Severity Level I through V range from
the most significant to the least significant, respectively). No civil
penalty was assessed because of the Air Force's discovery of this
violation and the promptness and comprehensiveness of the corrective
actions. The licensee has responded in writing to the Notice of
Violation and no additional actions are required.
* * * * *
94-5 Medical Brachytherapy Misadministration at the University of
Cincinnati in Cincinnati, Ohio
One of the AO reporting guidelines notes that a therapeutic
exposure to a part of the body not scheduled to receive radiation can
be considered an abnormal occurrence.
Date and Place--January 7, 1994; University of Cincinnati;
Cincinnati, Ohio.
Nature and Probable Consequences--On January 14, 1994, NRC was
notified by telephone of a misadministration involving a leaking
iodine-125 (I-125) brachytherapy implant seed. On January 7, 1994, 16
I-125 seeds, each ranging from 370 to 1110 megabecquerel (MBq) (10 to
30 millicurie [mCi]) activity, were implanted in the brain of a 30-
year-old male patient. Following the explant procedure on January 14,
1994, the licensee identified radioactive contamination in the surgical
room and bathroom used by the patient. Personnel from the licensee's
radiation safety office identified the contamination to be I-125 and
confirmed that at least one seed was leaking. Further analysis by the
licensee determined that one seed was damaged during the implant
procedure by a surgical staple. The seed originally contained 758 MBq
(20.5 mCi) of I-125 and, based on an assay of the explanted source, the
licensee estimated that the loss was approximately 74 MBq (2.0 mCi).
Thyroid monitoring of the patient's visitors and hospital employees
involved in the care of the patient was performed by the licensee. One
of the licensee's employees was determined to have received a committed
dose equivalent to the thyroid of 50 microsievert (Sv) (5
millirem [mrem]). In addition, a visitor was determined to have
received a committed dose equivalent to the thyroid of 540 Sv
(54 mrem), or a total effective dose equivalent of 160 Sv (1.6
mrem), which is less than the annual limit for members of the general
public of 1000 Sv (100 mrem).
Through patient monitoring, the licensee estimates that
approximately 5 percent of the free I-125 was taken up in the patient's
thyroid. (In a normally functioning, unblocked thyroid, approximately
25 percent of the free iodine would be taken up in an individual's
thyroid.) The licensee estimates that the uptake would result in a
radiation dose to the thyroid of approximately 300 centigray (300 rad).
The licensee does not expect any adverse medical effects to the patient
as a result of the misadministration. An NRC medical consultant
concluded that the non-radioactive iodinated contrast agent used during
an imaging procedure performed on the patient prior to the implant
blocked the absorption of the I-125. He also concluded that exposure to
the radiation levels described has resulted in an increased probability
of developing thyroid tumor(s) in the future.
The licensee notified the referring physician, the patient, and the
patient's family of the misadministration.
Cause or Causes--The seed leaked after being inadvertently crushed
by a surgical staple used to secure the catheters during the implant
procedure.
Actions Taken to Prevent Recurrence
Licensee--For future procedures, the licensee plans to ensure that
the implanted seeds are located further down the catheter in order to
reduce the likelihood of seed damage from surgical staples. The
licensee also plans to examine each I-125 seed for leakage following
each explant procedure.
NRC--NRC dispatched two inspectors on January 16, 1994, to monitor
the licensee's decontamination efforts and to obtain more details on
the misadministration. NRC also obtained the services of a medical
consultant to review the medical implications of the incident. A
followup NRC inspection (Letter from W.L. Axelson, Director, Division
of Radiation Safety and Safeguards, to Donald Harrison, M.D., Senior
Vice President and Provost for Health Affairs, University of
Cincinnati, forwarded Inspection Report No. 030-02764/94001, Docket No.
030-02764, License No. 34-06903-05, dated March 10, 1994) was conducted
from February 7 to 11, 1994. On March 16, 1994, NRC held a telephone
Enforcement Conference with the licensee to discuss the safety
inspections conducted in January and February 1994, at the University
of Cincinnati.
A Notice of Violation was issued by NRC on March 25, 1994, which
imposed a fine of $5000 for a violation not associated with this
misadministration. In the Notice of Violation, NRC determined that the
inadvertent opening of the I-125 sealed source did not constitute a
violation of the University of Cincinnati's license.
* * * * *
94-6 Medical Brachytherapy Misadministration at Keesler Medical Center
at Keesler Air Force Base in Biloxi, Mississippi
One of the AO reporting guidelines notes that a therapeutic
exposure to a part of the body scheduled to receive radiation such that
the actual dose received is greater than 1.5 5imes the prescribed dose
can be considered an abnormal occurrence.
Date and Place--January 13, 1994; Keesler Medical Center, Keesler
Air Force Base; Biloxi, Mississippi.
Nature and Probable Consequences--A patient was prescribed a lung
brachytherapy treatment delivered by an Omnitron 2000 high-dose-rate
(HDR) remote afterloader system. The prescribed tumor treatment plan
included 1000 centigray (cGy) (1000 rad) absorbed doses at 5 treatment
positions using a 144.3 gigabecquerel (3.9 curie) iridium-192 source
within a special needle. At the end of fifth and last treatment, the
source wire retracted 0.5 centimeter (cm) (0.2 inch) and stopped.
Alarms immediately alerted Keesler staff that the source remained
inside the patient's body. Licensee personnel followed emergency
procedures, entered the therapy room and removed the needle from the
patient. Once outside the patient's body, the radioactive source
retracted to the stored position.
The licensee determined that the source remained stuck at 0.5 cm
(0.2 inches) above the fifth position for approximately 2\1/2\ minutes.
The treatment plan called for the delivery of 1000 centigray (cGy)
(1000 rad) at 1cm from each of the 5 treatment positions. As a result
of the additional 2\1/2\ minutes exposure, the last treatment position
received 1732 cGy (1732 rad) absorbed dose, or 73.2 percent over the
prescribed dose. The treatment plan also predicted an 800 cGy (800 rad)
absorbed dose at 0.5cm (0.2 inch) from each of the 5 treatment
positions. The point 0.5 cm (0.2 inch) above the last treatment
position, where the movement of the source stopped, received
approximately 1400 cGy (1400 rad), or 75 percent greater than the
absorbed dose stipulated in the prescribed treatment plan. The failure
of the source to retract resulted in a single overexposure, causing an
overall absorbed dose of 75 percent greater than that prescribed, for
all the tissue surrounding the position 0.5cm (0.2 inch) above the last
treatment site.
The licensee reported that no adverse health effects to the patient
are expected. The patient was immediately notified of the
misadministration.
Cause or Causes
The patient had made a sudden move near the end of the treatment
causing the special needle to bend at the point where it extended
beyond the biopsy needle. The bend prevented the radioactive source
from retracting to the stored position, causing the misadministration.
Actions Taken to Prevent Recurrence
Licensee--The licensee immediately stopped the use of the HDR
device pending a complete check of the system by the manufacturer
(Letter from Omnitron International, Inc. to NRC Document control Desk,
forwarding a Report of HDR misadministration, Part 21- Reporting of
Defects and Noncompliance, Omnitron Report No. 102, dated January 19,
1994, Docket No. 030-26841, License No. 42-23539-01AF; and Letter from
Omnitron International, Inc. to John W. Lubinski, Mechanical Engineer,
Nuclear Material Safety and Safeguards, NRC Washington, D.C.,
forwarding a report of Inspection of Source Wire, dated April 6, 1994,
Docket No. 030-26841, License No. 42-23539-01AF). The licensee also
evaluated the practice of extending special needles beyond biopsy
needles and the probability of patient movement causing damage, and
decided to discontinue this practice (Letter from Department of the
Army, HQ AFMOA/SGPR, Brooks AFB, TX to NRC Region IV, forwarding the
15-Day Report of Misadministration at Keesler AFB, MS, dated February
1, 1994, Docket 030-26841, License No. 42-23539-01AF; and Letter from
Department of the Army, HQ AFMOA/SGPR, Brooks AFB, TX to NRC Region IV,
responding to a NRC Confirmatory Action Letter (dated January 18,
1994), dated March 8, 1994, Docket 030-26841, License No. 42-23539-
01AF).
NRC--A special inspection was conducted from January 19 to 21,
1994, to review the circumstances surrounding the misadministration and
the licensee's Quality Management program. A representative of the U.S.
Food and Drug Administration (FDA) also participated in this
inspection. No violations of regulatory requirements were identified
during the inspection, but NRC initiated the following actions: (1) A
Confirmatory Action Letter (Letter from James L. Milhoan, Regional
Administrator, Region IV, to Department of the Army, USAF Radioisotope
Committee, HQ AFMOA/SGPR, Brooks AFB, TX, forwarding a Confirmatory
Action Letter, CAL No. 4-94-01, Docket No. 030-28641, License No. 42-
23539-01AF, dated January 18, 1994) was issued to the licensee on
January 18, 1994, which prohibited the use of the HDR unit until
serviced by the manufacturer; (2) a medical consultant was contracted
to evaluate the clinical effects and to assess the events that led to
this misadministration; (3) the manufacturer was asked to analyze the
source wire involved in the misadministration for damage as a result of
the stresses experienced during this event; (4) Southwest Research
Institute was contracted to analyze the special needle for mechanical
failure; (5) a generic communication is being developed to notify other
HDR users of the results of the inspection and related research; and
(6) NRC is coordinating with FDA an evaluation of the generic
implications surrounding this event.
* * * * *
94-7 Medical Brachytherapy Misadministration at Alexandria Hospital in
Alexandria, Virginia
One of the AO reporting guidelines notes that a therapeutic
exposure to a part of the body not scheduled to receive radiation can
be considered an abnormal occurrence.
Date and Place--January 27, 1994; Alexandria Hospital; Alexandria,
Virginia.
Nature and Probable Consequences--On January 27, 1994, a patient
was scheduled to receive a 500 centigray (cGy) (500 rad) brachytherapy
treatment to the trachea using a Nucletron high-dose-rate (HDR) remote
afterloader system. A single catheter was used for this endobronchial
treatment and the licensee performed a routine simulated treatment.
During this simulation, the oncologist established a 3 centimeter (cm)
(1.2 inch) tumor treatment site and added a 1 cm (0.4 inch) margin on
both ends of the tumor site.
Normally, at this time the medial physicist and the dosimetrist
plot distances, measured in centimeters along the length of the
catheter shown in the simulation film, in order to program the HDR for
precise treatment at the prescribed treatment site. This step was not
performed and the procedure was initiated without the HDR being
properly programmed. The unprogrammed source was allowed to travel
beyond the treatment site into the left lung area where the catheter
ended. The treatment resulted in the prescribed 500 cGy (500 rad)
effective dose equivalent being delivered to the left lung instead of
the trachea target site. Prior to administering the dose, the treatment
plan and treatment console printout were reviewed by the dosimetrist,
the medical physicist, and the oncologist. All three individuals failed
to identify the failure to plot the treatment site. Immediately
following the treatment, the licensee's medical physicist realized that
the plotting and programming of the treatment site were not performed.
After discovery of the treatment error, the oncologist determined that
the patient should be treated again using the correct treatment
parameters.
The licensee has advised NRC that no adverse effects to the patient
are anticipated as a result of this misadministration. The licensee has
informed the patient of the misadministration.
Cause or Causes--The licensee's radiation therapy staff failed to
follow the licensee's normal protocol for treatment with the HDR remote
afterloader. The failure to administer the treatment as prescribed
resulted from performing the treatment planning and independent
verification in the vicinity of the HDR console, where there were a
number of distractions.
Actions Taken to Prevent Recurrence
Licensee--The licensee's corrective actions included immediate
retraining of all personnel involved in brachytherapy treatments and
the addition of a checklist for each step in the treatment process. The
licensee also added steps to its Quality Management program for HDR
brachytherapy. These steps now require the use of the treatment
planning computer with manual verification of the input parameter and
the use of the treatment parameter card generated by the planning
computer to program the HDR rather than programming the HDR treatment
parameters manually.
NRC--NRC conducted a special inspection from February 2 to 4, 1994,
to review the circumstances associated with the misadministration, the
licensee's Quality Management program, and the licensee's immediate
corrective actions. In addition, on February 25, 1994, NRC employed a
medical consultant to provide an assessment of the potential clinical
effects of this misadministration and the events that led to it.
The inspection report, medical consultant's assessment, and
enforcement actions for the misadministration are being completed.
Dated at Rockville, MD this 15th day of August, 1994.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Acting Secretary of the Commission.
[FR Doc. 94-20423 Filed 8-18-94; 8:45 am]
BILLING CODE 7590-01-M