[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]


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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