[Federal Register Volume 64, Number 109 (Tuesday, June 8, 1999)]
[Notices]
[Pages 30551-30554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14468]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
Report to Congress on Abnormal Occurrences, Fiscal Year 1998,
Dissemination of Information
Section 208 of the Energy Reorganization Act of 1974 (Pub. L. 93-
438) identifies an abnormal occurrence (AO) as an unscheduled incident
or event that the 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 on an annual basis. During fiscal-year
1998, six events that occurred at facilities licensed or otherwise
regulated by the NRC and the Agreement States were determined to be
AOs. These events are discussed below. As required by Section 208, the
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,
Volume 21, ``Report to Congress on Abnormal Occurrences, Fiscal Year
1998.'' This report will be available at NRC's Public Document Room,
2120 L Street N.W. (Lower Level), Washington, D.C., about three weeks
after the publication date of this Federal Register Notice.
Fuel Cycle Facilities (Other Than Nuclear Power Plants)
98-1 Seismic Risk From Liquid Uranium Hexafluoride at the Withdrawal
Facilities at the Paducah Gaseous Diffusion Plant, Paducah, KY
One of the AO criteria notes that a major condition or significant
event not considered in the license/certificate that requires immediate
remedial action will be considered for reporting as an AO.
Date and Place--February 18, 1998; Paducah Gaseous Diffusion Plant,
a uranium enrichment plant, operated by Lockheed Martin Utility
Services for the United States Enrichment Corporation (USEC) and
located about 16 kilometers (10 miles) west of Paducah, Kentucky.
Nature and Probable Consequences--On October 31, 1997, USEC
submitted a certificate amendment request that provided an updated
Safety Analysis Report, containing a new accident analysis, for
Paducah. The seismic accident analysis stated that equipment (piping,
condensers, and accumulators) in the withdrawal facilities containing
liquid uranium hexafluoride (UF6) could fail at a 70-year
return earthquake (0.05 gravitational acceleration (g) peak ground
acceleration (pga)) rather than at the 250-year return design basis
earthquake (0.15 g pga). However, the consequences of the accident
analysis were noted as minimal because of the assumptions made in the
accident analysis. The NRC's request for additional information (RAI)
dated February 5, 1998, raised concerns about the conservative nature
of assumptions for the seismic accident analysis. In response to the
RAI, USEC confirmed that the seismic accident analysis assumption of no
liquid UF6 in the withdrawal facilities' accumulators
underestimated the potential source term for the seismic accident
analysis.
The accumulators are normally empty and serve only as a reservoir
for liquid UF6 when cylinders are changed after being
filled, or during periods of equipment problems or surveillances.
However, with no operational restrictions on the amount of liquid
UF6 in the accumulators, a seismic event could occur with
the accumulators full. Consequences from a 0.05 g pga earthquake with
full accumulators in the withdrawal facilities could involve onsite
fatalities and significant offsite injuries from exposure to the
released UF6 and reaction products.
Cause or Causes--The cause of this event was an inadequate seismic
design for the facility and an inadequate accident analysis that failed
to consider the full range of allowable operations of the withdrawal
facilities.
Actions Taken To Prevent Recurrence
Licensee/Certificate Holder--Immediate corrective actions included
restricting operations in the withdrawal facilities to limit the amount
of liquid UF6 available for release. Long-term corrective
actions were to install seismic modifications that will allow the
withdrawal facilities' equipment to withstand a design-basis
earthquake. The modifications have been completed as directed by the
NRC.
NRC--An immediately effective ``confirmatory order modifying
certificate'' to incorporate the immediate and long-term corrective
actions was issued on April 22, 1998.
* * * * *
[[Page 30552]]
Other NRC Licensees (Industrial Radiographers, Medical
Institutions, Industrial Users, etc.)
98-2 Multiple Medical Brachytherapy Misadministrations by Jose N. De
Leon, M.D., in Rio Piedras, PR
One of the AO criteria notes that a medical misadministration that
results in a dose that is: (1) Equal to or greater than 1 gray (Gy)
(100 rad) 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 (1000 rad) to
any other organ and that represents a dose or dosage that is at least
50 percent greater than that prescribed in a written directive will be
considered for reporting as an AO.
Date and Place--Between April 27, 1995, and June 26, 1996; private
medical office of Jose N. De Leon, M.D., Rio Piedras, Puerto Rico.
Nature and Probable Consequences--Nine patients were treated after
surgery for non-malignant eye growths with a strontium-90 (Sr-90) eye
applicator, at Dr. De Leon's private medical office. Each of the nine
patients received a dose of 4000 centigray (cGy) (4000 rad) instead of
the intended dose of 2000 cGy (2000 rad). The NRC staff identified this
event during Fiscal Year 1998.
On June 1, 1994, Dr. De Leon submitted to NRC a Quality Management
Program (QMP) indicating that his 4.625 gigabecquerel (125 millicurie)
Sr-90 eye applicator device would deliver to a patient a dose of 2000
cGy (2000 rad) in 26 seconds. In April 1995, Dr. De Leon hired a health
physics consultant to calculate a decay correction for the surface dose
rate of the Sr-90 eye applicator. In April 1995, Dr. De Leon submitted
a revised QMP to the NRC, incorporating the surface dose rate
corrections performed by the consultant, stating that the Sr-90 eye
applicator device would deliver a 2000 cGy (2000 rad) dose in 60
seconds.
On December 11, 1997, the NRC conducted a special inspection of Dr.
De Leon's licensed activities. During this inspection, the NRC
determined that in April 1995, Dr. De Leon's consultant had made a
calculation error. Without verifying the consultant's calculations, Dr.
De Leon had adjusted the treatment time from 26 seconds to 60 seconds.
When Dr. De Leon became aware of this error, he indicated that: (1)
All patients or next of kin were notified, (2) a free examination was
offered to all patients, which was declined, and (3) there were no
problems or complications reported by patients associated with the
misadministrations. Dr. De Leon also indicated that it is unlikely for
patients to develop any harmful effects as a result of the
misadministration.
The NRC hired a medical consultant to review the medical aspects of
the misadministration. The NRC's medical consultant reviewed the
information obtained from the NRC, Dr. De Leon, and Ryder Memorial
Hospital, and concluded that: (1) The range for a single fraction for
eye radiation treatments, recommended by the medical community using a
Sr-90 applicator, is about 1800-3000 cGy (1800-3000 rad), (2) the
highest single dose, using a Sr-90 applicator, recommended in published
medical reports is 3000 cGy (3000 rad), and (3) the patients treated by
Dr. De Leon are at a higher risk for harmful effects because of the
high doses given in single fractions.
Cause or Causes--Dr. De Leon's consultant made a calculation error
in correcting the surface dose rate of the Sr-90 applicator for
radioactive decay and Dr. De Leon failed to verify or question the
consultant's calculation before using the revised surface dose rate in
patient treatments.
Actions Taken To Prevent Recurrence
Licensee--Dr. De Leon has retired; he has properly transferred the
Sr-90 eye applicator to a foreign user and he has obtained from NRC a
termination of his license.
NRC--The NRC's Advisory Committee on the Medical Use of Isotopes
will be recommending courses of action to the NRC. NRC will perform
additional inspections of NRC licensees authorized to possess and use
Sr-90 eye applicators to confirm the use of proper decay corrections
and source calibrations. In addition, the NRC staff will review this
case with the Secretary of Health of the Commonwealth of Puerto Rico
for possible action.
* * * * *
98-3 Multiple Medical Brachytherapy Misadministrations at Ryder
Memorial Hospital, in Humacao, PR
One of the AO criteria notes that a medical misadministration that
results in a dose that is: (1) Equal to or greater than 1 gray (Gy)
(100 rad) 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 (1000 rad) to
any other organ and that represents a dose or dosage that is at least
50 percent greater than that prescribed in a written directive will be
considered for reporting as an AO.
Date and Place--Between April 22, 1995, and February 21, 1996; at
Ryder Memorial Hospital; Humacao, Puerto Rico.
Nature and Probable Consequences--Twelve patients treated with a
strontium-90 (Sr-90) eye applicator at the Ryder Memorial Hospital
received a dose of 4000 cGy (4000 rad) instead of the intended dose of
2000 cGy (2000 rad). Two patients received a second treatment dose of
4000 cGy (4000 rad) to the same eye. These treatments were performed by
Dr. Jose De Leon, who, in addition to his private practice in Rio
Piedras in Puerto Rico, was authorized by NRC to practice at the Ryder
Memorial Hospital in Humacao, Puerto Rico. The NRC staff identified
this event during Fiscal Year 1998.
On June 28, 1994, Ryder Memorial Hospital notified the NRC that it
had canceled the authorization given to the ophthalmologists named on
their license to use Sr-90 at its facility, and a Quality Management
Program was not needed for this activity. However, during a routine
inspection of Ryder Memorial Hospital, conducted between November 17
and December 11, 1997, the NRC staff learned that Dr. De Leon had used
his Sr-90 eye applicator at the Ryder Memorial Hospital without
authorization from the hospital. NRC was unable to determine whether
Dr. De Leon had been told by Ryder Memorial Hospital that his authority
was canceled for the use of Sr-90 eye applicator.
On December 11, 1997, the NRC conducted a special inspection of Dr.
De Leon's licensed activities. During this inspection, the NRC
determined that in April 1995, Dr. De Leon's consultant had made a
calculation error. Without verifying the consultant's calculations, Dr.
De Leon adjusted the treatment time from 26 seconds to 60 seconds.
Ryder Memorial Hospital representatives and Dr. De Leon, notified
the patients or next of kin of the misadministrations. The information
presented by Ryder Memorial Hospital describing the effects on patients
from misadministrations was based on the information submitted by Dr.
De Leon. Specifically, Dr. De Leon indicated that the delivered dose of
4000 cGy (4000 rad) falls within the dose range used by the medical
community to prescribe these treatments and no adverse effects were
expected.
The NRC medical consultant reviewed the information obtained from
the NRC, Dr. De Leon, and Ryder Memorial Hospital, and concluded that:
(1) The range for a single fraction for eye radiation treatments,
recommended by the medical community using a Sr-90 applicator, is about
1800-3000 cGy (1800-3000 rad), (2) the highest single dose, using a Sr-
90 applicator,
[[Page 30553]]
recommended in published medical reports is 3000 cGy (3000 rad), and
(3) the patients treated by Dr. De Leon are at a higher risk for
harmful effects because of the high doses given in single fractions.
Cause or Causes--Dr. De Leon's consultant made an error in
calculating the surface dose rate of the Sr-90 applicator, and Dr. De
Leon failed to verify the consultant's calculation before incorporating
the revised surface dose rate in patient treatments. In addition, Dr.
De Leon performed ophthalmic brachytherapy using his Sr-90 eye
applicator device at Ryder Memorial Hospital under Ryder Memorial
Hospital's NRC license, without the hospital's authorization.
Actions Taken To Prevent Recurrence
Licensee--Ryder Memorial Hospital reiterated its withdrawal of Dr.
De Leon's authority to use the Sr-90 eye applicator device at Ryder
Memorial Hospital and does not intend to authorize future use of the
Sr-90 eye applicator for ophthalmic brachytherapy. In addition, Dr. De
Leon has retired; he has properly transferred the Sr-90 eye applicator
to a foreign user and he has obtained from NRC a termination of his
license.
NRC--The NRC's Advisory Committee on the Medical Use of Isotopes
will be recommending courses of action to the NRC. NRC will perform
additional inspections of NRC licensees authorized to possess and use
Sr-90 eye applicators to confirm the use of proper decay corrections
and source calibrations. In addition, the NRC staff will review this
case with the Secretary of Health of the Commonwealth of Puerto Rico
for possible action.
* * * * *
98-4 Iodine-131 Medical Misadministration at Virginia Beach General
Hospital, in Virginia Beach, VA
One of the AO criteria notes that a medical misadministration that
results in a dose that is: (1) Equal to or greater than 1 gray (Gy)
(100 rad) 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 (1000 rad) to
any other organ and represents a dose or dosage that is at least 50
percent greater than that prescribed in a written directive will be
considered for reporting as an AO.
Date and Place--November 21, 1997; Virginia Beach General Hospital;
Virginia Beach, Virginia.
Nature and Probable Consequences--A patient was administered a
dosage of 199.8 megabecquerel (MBq) (5.4 millicurie (mCi)) of iodine-
131 (I-131) for a thyroid procedure instead of an 11.1 MBq (0.300 mCi)
dosage of iodine-123 (I-123). As a result, the patient's thyroid
received a dose of 4000 centigray (cGy) (4000 rad), instead of the
intended dose of 2.0 cGy (2.0 rad).
On November 20, 1997, the referring physician prescribed a thyroid
function procedure, which, at Virginia Beach General Hospital, required
the administration of about 11.1 MBq (0.300 mCi) of I-123. Due to poor
communication between the referring physician and her staff (a staff
nurse), the patient was scheduled for a whole-body thyroid scan, which
required the administration of approximately 185 MBq (5 mCi) of I-131.
On November 21, 1997, the technologist who was to perform the procedure
attempted to contact the referring physician to ask questions about the
requested procedure. However, the referring physician was not
available, and the staff nurse who had originally taken the request
from the referring physician and scheduled the procedure confirmed that
the physician wanted an I-131 scan. The technologist, without a written
directive, decided to proceed with the procedure and administered the
dosage of 199.8 MBq (5.4 mCi) of I-131 to the patient. The
misadministration was identified on November 24, 1997, when the patient
returned for a 72-hour whole-body scan.
The licensee stated that no adverse health effects are expected
from the misadministration. The NRC's medical consultant determined
that the impact of the misadministration on the patient's health should
be negligible, with no expected long-term disability.
Cause or Causes--This event was caused by the licensee's failure to
prepare a written directive before the administration of the I-131
dosage and inadequate follow-up by the technologist involved in the I-
131 procedure.
Actions Taken To Prevent Recurrence
Licensee--New procedures were initiated that required all I-131
procedures to be scheduled through the Nuclear Medicine Department, and
additional quality management measures were implemented. The licensee
also initiated changes to the computerized scheduling system and
provided retraining of the staff.
NRC--An inspection was conducted to review the circumstances of the
misadministration. A Notice of Violation was issued for failure of the
licensee to prepare a written directive before the administration of I-
131.
* * * * *
98-5 Exposure to a Minor from a Radiopharmaceutical Therapy Event at
Western Pennsylvania Hospital in Pittsburgh, PA.
One of the AO criteria notes that 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 mSv (5 rem) or more
will be considered for reporting as an AO.
Date and Place--July 28, 1998; Western Pennsylvania Hospital;
Pittsburgh, Pennsylvania.
Nature and Probable Consequences--A female patient was prescribed a
whole-body iodine-131 (I-131) thyroid scan following a thyroidectomy.
The technologist asked the patient if she was breast-feeding but she
did not reply and was administered a dosage of 111 megabecquerel (3
millicurie) of I-131. Two days later, while the thyroid scan was being
performed, the patient said that she had breast-fed her 4-year-old son
during the past few evenings. The licensee performed a bioassay on the
child on August 3, 1998, and determined that the TEDE for the child
based on the International Commission on Radiological Protection
calculations was 89.5 millisievert (8.95 rem), and the dose to the
thyroid was about 184 centigray (cGy) (184 rad).
The NRC medical consultant evaluated the event and estimated that
the dose to the child's thyroid using the Medical Internal Radiation
Dose calculations was about 128 to 152 cGy (128 to 152 rad) and
presented a discussion of potential clinical consequences.
The hospital was notified of the consultant's findings and was
given a copy of the consultant's report. The child has been examined by
a pediatric endocrinologist and the hospital continues to monitor the
patient and her child.
Cause or Causes--The patient failed to answer the technologist's
question regarding breast feeding and the hospital failed to receive an
answer to the question before dose administration.
Action Taken To Prevent Recurrence
Licensee--The licensee developed a new response form for women aged
between 10 and 50 years for: (1) Asking them if they are nursing, (2)
informing them of the harm to a child if they are breast-feeding after
I-131 administration, and (3) obtaining a signed statement before
administering them radioactive material.
NRC--NRC sent a letter to the licensee requiring it to prepare a
plan describing how to prevent similar
[[Page 30554]]
events. The licensee responded on October 8 and 12, 1998, listing
adequate actions to prevent recurrence of similar events.
* * * * *
Agreement State Licensees
AS 98-1 Medical Brachytherapy Misadministration at Tuomey Regional
Medical Center in Sumter, SC
One of the AO criteria notes that any unintended radiation exposure
to an adult (any individual 18 years of age or older) resulting in an
annual total effective dose equivalent (TEDE) of 250 millisievert (mSv)
(25 rem) or more; or an annual sum of the deep dose equivalent and
committed dose equivalent to any individual organ or tissue other than
the lens of the eye, bone marrow, and the gonads of 2500 mSv (250 rem)
or more will be considered for reporting as an AO.
Date and Place--September 23, 1997; Tuomey Regional Medical Center;
Sumter, South Carolina.
Nature and Probable Consequences--On September 23, 1997, a patient
was scheduled by a referring physician (urologist) for a palladium-103
(Pd-103) permanent prostate seed implant via transrectal ultrasound
guidance. However, the referring physician had two patients with
identical names and the wrong individual got the orders for the Pd-103
treatment. The patient was identified at the Medical Center by verbal
means (asking the patient's name) and by checking the name on the
patient's wristband. In addition, the patient had signed a consent in
the chart stating he was at the hospital for seed implant for treatment
of prostate cancer. The patient received 67 seeds of Pd-103 at 37
megabecquerel (MBq) (1 millicurie (mCi)) per seed, thus a total implant
activity of 2479 MBq (67 mCi). On the basis of pre-implant dosimetry,
the periphery of the prostate was to receive a maximum dose of 9000
centigray (cGy) (9000 rad). The posterior wall of the bladder and
anterior wall of the rectum would receive approximately 4000 cGy (4000
rad) and the whole-body dose would be less than 1 cGy (1 rad). The
procedure was performed without complication.
On September 25, 1997, the referring physician notified Tuomey
Regional Medical Center that he had two patients with identical names
and that the wrong individual had received the implant. On September
29, 1997, the authorized user met with the individual who had received
the Pd-103 treatment and discussed the potential early and late side
effects, and all necessary precautions.
The licensee stated that the early consequences from this type of
implant usually are dysuria and possible hematuria, which, if they
occur, resolve in several days. Late consequences could be an
approximately 25 percent chance of impotence. Damage to the bladder and
rectum occurs in fewer than 1 percent of patients.
Cause or Causes--The referring physician had two patients with
identical names. The wrong individual arrived at Tuomey Regional
Medical Center with orders from the referring physician for the Pd-103
seed implant. The patient who should have had these orders had been to
Tuomey Regional Medical Center for a pre-operative interview. When the
wrong individual presented for treatment at Tuomey Regional Medical
Center with orders for the Pd-103 seed implant, the registration
process failed to note that he was not the same individual who had
undergone the pre-operative interview.
Actions Taken To Prevent Recurrence
Licensee--The licensee performed a comprehensive review of the
patient identification process once the incident occurred. As a result,
the patient identification system was revised on a hospital-wide basis
in order to prevent recurrence of this type of event.
State Agency--The State agency investigated the event and a Notice
of Violation and Enforcement Conference was held on February 10, 1998.
A Notice of Noncompliance was issued for failure to meet the objective
that each administration is done in accordance with a written
directive. The licensee responded in writing and no additional actions
were required.
* * * * *
Dated at Rockville, Maryland this 2nd day of June, 1999.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 99-14468 Filed 6-7-99; 8:45 am]
BILLING CODE 7590-01-P