[Federal Register Volume 65, Number 45 (Tuesday, March 7, 2000)]
[Notices]
[Pages 12041-12048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5473]


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NUCLEAR REGULATORY COMMISSION


Report to Congress on Abnormal Occurrences, Fiscal Year 1999; 
Dissemination of Information

    Section 208 of the Energy Reorganization Act of 1974 (Public Law 
93-438) identifies an abnormal occurrence (AO) as an unscheduled 
incident or event that the U.S. Nuclear Regulatory Commission (NRC) 
determines is significant from the standpoint of public health or 
safety.

[[Page 12042]]

The Federal Reports Elimination and Sunset Act of 1995 (Public Law 104-
66) requires that AOs be reported to Congress annually. During fiscal 
year 1999, 13 events that occurred at facilities licensed or otherwise 
regulated by the NRC and/or 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, 
Vol. 22, ``Report to Congress on Abnormal Occurrences, Fiscal Year 
1999.'' This report will be available electronically at the NRC Public 
Electronic Reading Room link http://www.nrc.gov/NRC/ADAMS/index.html> 
at the NRC Homepage.

Nuclear Power Plants

    None of the events that occurred at U.S. nuclear power plants 
during fiscal year 1999 was determined to be significant enough to be 
reported as an abnormal occurrence (AO) to Congress.

Fuel Cycle Facilities (Other Than Nuclear Power Plants)

    The following event that occurred at a fuel cycle facility during 
fiscal year 1999, was determined to be significant enough to be 
reported as an AO to Congress.

99-1  Fire Breaches Containment and Requires Shutdown of a Portion of 
the Cascade at the Portsmouth Gaseous Diffusion Plant in Piketon, Ohio

    Date and Place--December 9, 1998; Portsmouth Gaseous Diffusion 
Plant, a uranium enrichment plant, operated by Lockheed Martin Utility 
Services for the United States Enrichment Corporation, located about 
3.2 kilometers (2 miles) east of Piketon, Ohio.
    Nature and Probable Consequences--On December 9, 1998, the 
certificate holder's operations staff observed a series of abnormal 
conditions associated with the side purge cascade, Cell 25-7-2. The 
staff's immediate response to the abnormal conditions was not 
successful in restoring normal operations and an exothermic reaction 
was either started or propagated within the cascade. The exothermic 
reaction continued until sufficient heat was generated to cause a 
failure of the Cell 25-7-2 cooling system, initiating a second 
exothermic reaction. Subsequent heat and pressure increases within the 
side purge cascade resulted in: (1) The creation of holes within the 
process gas cascade boundary of Cell 25-7-2; (2) an automatic shutdown 
of the side purge cascade caused by the motor load overcurrent 
protection system that provides ``Defense in Depth;'' (3) the 
activation of a portion of the Building X-326 automatic fire 
suppression sprinkler system; (4) an emergency response and 
approximately 2 hours of firefighting activities by the onsite fire 
department; and (5) challenges to the continued operation of the 
remainder of the process gas cascade.
    There were no measurable radiological consequences or chemical 
consequences to the plant staff or the general public from the release 
of radioactivity during this event. The holes created in the side purge 
cascade equipment and piping created a credible pathway for water to 
accumulate in unsafe geometry sections of the cascade. This led to the 
need to revise the criticality safety basis for this portion of the 
side purge cascade.
    Cause or Causes--The extensive fire damage experienced by Cell 25-
7-2 equipment has made it difficult to determine the root cause. Much 
of the equipment has been damaged to such an extent that evidence 
needed to determine the root cause was destroyed. The investigation by 
the certificate holder identified two possible initiating events: a 
physical failure of the compressor impeller or a chemical deposit 
caused by wet air leakage into the equipment. In either event, 
mechanical friction within the process gas cascade equipment generated 
a sufficient amount of sustained heat to begin an exothermic reaction 
between the aluminum compressor components and the process gas (uranium 
hexafluoride). On the basis of a review of some of the Cell 25-7-2 
components removed since the fire, the exothermic reaction was believed 
to have been initiated in the Stage 2 compressor and propagated through 
the cell equipment to the Stage 4 compressor. In the Stage 4 
compressor, the reaction was thought to have been intensified by the 
input gases, received from the remainder of the cascade, resulting in 
increasing internal process gas cascade temperatures until there was a 
failure in the freon coolant system boundary. Elevated pressure, caused 
by the introduction of freon from the coolant system and a second 
exothermic reaction between the hot metal and freon, was thought to be 
the final event that occurred before the holes were burned in the 
process gas cascade boundary.

Actions Taken To Prevent Recurrence

    Certificate Holder--Initial compensatory and corrective measures 
implemented by the plant staff as a result of the fire included: (1) 
administrative controls to preclude a restart of the side purge cascade 
and some other plant operations pending the completion of a root cause 
evaluation for the fire; (2) immediate manual vibration monitoring of 
other centrifugal compressors to search for other unstable equipment; 
(3) covering of openings created in the process gas piping and 
equipment of Cell 25-7-2 as a result of the fire; (4) development of a 
revised nuclear criticality safety basis for Cell 25-7-2; (5) interim 
training of cascade operators and managers on the lessons learned about 
operations from the event; and (6) interim training of firefighters and 
management on the safety risks of and the proper fire fighting 
techniques for a fire concurrent with holes in process gas cascade 
equipment. The long-term corrective actions include the following 
``Defense in Depth'' features and administrative actions: (1) adding 
process gas temperature monitoring to detect high temperature reactions 
in a timely manner; (2) adding alarm and automatic shutdown systems on 
the side purge compressors for compressor high-process gas temperature 
to protect against the propagation of high-temperature accidents by 
detecting hot spots in a timely manner; (3) improving the process for 
evaluating and responding to cascade component vibrations to improve 
the identification of precursors to a hot metal reaction; and (4) 
completing procedures for improving operator response to other 
precursors to hot metal reactions. These corrective actions will be 
instituted prior to re-introducing process gas into the side purge 
cascade.
    NRC--An augmented inspection team was sent to the site on December 
9, 1998. The team documented its findings in an inspection report 
issued on February 19, 1999. A follow-up inspection was conducted in 
March 1999 to evaluate the effectiveness of the certificate holder's 
corrective actions. Although the follow-up inspection team found the 
certificate holder's corrective actions adequate, several procedural 
and reporting violations were identified during the follow-up 
inspections. One violation was that the event met the criteria for an 
``Alert'' declaration and that the certificate holder failed to 
identify and declare the Alert. Since many credible accidents 
postulated for the Portsmouth Gaseous Diffusion Plant can occur 
suddenly and last a short duration, it is important for the certificate 
holder to make proper and timely emergency declarations that would lead 
to timely notifications to the

[[Page 12043]]

appropriate regulatory agencies. Therefore, even though, in this case, 
there were no significant radiological releases to the environment, the 
NRC staff considered the certificate holder's failure to declare an 
Alert, which is the lowest level emergency category, a serious 
violation (Level III) that carried a $55,000 civil penalty. The 
certificate holder acknowledged the violation and paid the civil 
penalty.
    This event is closed for the purpose of this report.

Other NRC Licensees (Industrial Radiographers, Medical 
Institutions, etc.)

    The following three events that occurred at institutions licensed 
or otherwise regulated by NRC during fiscal year 1999, were determined 
to be significant enough to be reported as abnormal occurrences (AOs) 
to Congress.

99-2  Medical Event Involving the Administration of Iodine-131 to a 
Pregnant Patient at St. Joseph Health Center in Kansas City, Missouri

    Date and Place--October 6, 1998; St. Joseph Health Center; Kansas 
City, Missouri.
    Nature and Probable Consequences--After a patient was administered 
a 5.75 gigabecquerel (155.2 millicurie) dosage of iodine-131 (I-131) 
for ablation of residual thyroid tissue and for the treatment of 
metastatic thyroid cancer, the patient was determined to be pregnant.
    Preceding the administration of the I-131 therapy dosage, the 
licensee's nuclear medicine technologist and the authorized user, 
following internal policies and procedures to determine the pregnancy 
status of a patient, repeatedly questioned the patient regarding the 
possibility of a pregnancy and whether she was breast-feeding. The 
patient stated that she was not breast-feeding and there was no 
possibility of pregnancy. Approximately 3\1/2\\ hours after the I-131 
administration, the licensee received the positive results of a 
pregnancy test previously ordered by the patient's referring physician. 
The licensee had not been aware that the referring physician had 
ordered the pregnancy test.
    Upon notification of the pregnancy, the licensee told the patient 
she was pregnant and attempted to minimize the potential exposure to 
the fetus by having the patient increase fluid intake in order to flush 
the free iodine from her system. The licensee also notified the 
patient's referring physician of the event. Ultrasound performed 
following identification of the pregnancy confirmed that the patient 
had been approximately 13\1/2\\ weeks pregnant with twins at the time 
of the procedure.
    The licensee does not expect the patient to experience any ill 
effects. The dose equivalent to each fetus was estimated to be about 
0.38 sievert (Sv) (38 rem) and the dose equivalent to each fetal 
thyroid was estimated to be in excess of 2,000 Sv (200,000 rem). The 
licensee expected that such a dose would result in the following likely 
effects to the fetuses: (1) Thyroid ablation; (2) a 30 percent increase 
in the likelihood of microcephaly (small head size); (3) a 20 to 50 
percent increase in the probability of childhood cancer; and (4) an 
increased probability for mental retardation. On the basis of this 
information, the patient elected to terminate the pregnancy.
    Cause or Causes--This medical event appears to have been caused by 
the licensee's reliance on the patient's statements preceding the 
administration of I-131 that she was not pregnant. The patient's 
referring physician had ordered a pregnancy test for the patient 
preceding the administration of I-131; however, neither the patient nor 
the referring physician had informed the licensee. The referring 
physician believed that the pregnancy test was standard practice 
preceding all radiopharmaceutical therapy treatments.

Actions Taken To Prevent Recurrence

    Licensee--The licensee modified its internal procedures for the 
administration of therapeutic radiopharmaceuticals, including 
diagnostic quantities of I-131 in excess of 7.4 megabecquerel (MBq) 
(200 microcurie [vvvCi]). All such procedures will include a statement 
that female patients between the ages of 10 and 55 years, without 
exception, prescribed to receive I-131 dosages equal to or greater than 
7.4 MBq (200 vvvCi) shall obtain a ``beta serum pregnancy test'' within 
24 hours preceding administration.
    NRC--The NRC staff reviewed the licensee's revised procedures and 
determined that they were adequate to address the cause of this medical 
event and to preclude similar events. Because the licensee made a 
reasonable effort to obtain a confirmation from the patient that she 
was not pregnant before the I-131 administration, no NRC requirements 
were violated.
    The corrective actions taken by the licensee were voluntary and 
were not required by NRC regulations.
    This event is closed for the purpose of this report.

99-3  Medical Event Involving the Administration of Iodine-131 to a 
Pregnant Patient at Camden-Clark Memorial Hospital in Parkersburg, West 
Virginia

    Date and Place--September 1, 1998; Camden-Clark Memorial Hospital; 
Parkersburg, West Virginia. The investigation on this event was 
completed in Fiscal Year 1999.
    Nature and Probable Consequences--A patient was administered 340 
megabecquerel (MBq) (9.2 millicurie [mCi]) of sodium iodide-131 (I-131) 
in accordance with licensee procedures for the treatment of 
hyperthyroidism. However, after the procedure was performed, the 
licensee learned that the patient was pregnant.
    On July 15, 1998, the patient was scheduled for a thyroid uptake 
and scan involving the administration of 7.62 MBq (0.206 mCi) of 
iodine-123 (I-123). Before performing the procedure, the licensee's 
nuclear medicine technologist asked the patient if she was pregnant. 
The patient indicated that she was not pregnant and the technologist 
administered the dosage of I-123. On August 4, 1998, the patient was 
examined by one of the licensee's authorized users. As part of the 
examination, the patient was asked about her pregnancy status and she 
again stated that she was not pregnant. The licensee confirmed with the 
patient's referring physician a negative pregnancy test, performed on 
May 5, 1998. The authorized user determined that the patient was a good 
candidate for I-131 therapy based on the results of the thyroid scan 
and other tests and prepared a written directive for the administration 
of 333 MBq (9 mCi) of I-131. The authorized user informed the patient 
about the effects of I-131 to the fetus if it is administered to a 
pregnant patient. The patient signed a form acknowledging the risks 
associated with the procedure, as explained by the authorized user, and 
stated that she would not become pregnant for 1 year after the I-131 
procedure.
    The patient returned to the licensee's facility on September 1, 
1998, and was administered 340 MBq (9.2 mCi) of I-131 in accordance 
with the written directive and other licensee procedures regarding the 
administration of radiopharmaceuticals. On October 5, 1998, the patient 
informed the licensee about recent information she received indicating 
that she was about 5 months pregnant. Subsequently, it was determined 
that the patient had been 14 weeks pregnant at the time of the 
administration.
    The licensee personnel contacted a pediatric endocrinologist for 
assistance

[[Page 12044]]

in calculating the thyroid and the whole-body doses to the fetus. Using 
the information supplied by the licensee, the dose equivalent to the 
fetus was estimated to be about 0.023 sievert (Sv) (2.3 rem) and the 
dose equivalent to the fetal thyroid to be about 88 Sv (8,800 rem). The 
fetus received intra-amniotic thyroid hormone therapy from high-risk 
pregnancy specialists at a major university hospital.
    On October 8, 1998, the licensee notified the patient's referring 
physician of the event and potential consequences. On October 20, 1998, 
the licensee notified the NRC of the event. The NRC staff engaged a 
medical consultant to evaluate the incident. The consultant concluded 
that: (1) the hypothyroidism developed in the fetal thyroid is expected 
to be permanent; (2) there is no increase in the risk of thyroid 
carcinoma; (3) a radiation-induced severe mental retardation is 
unlikely; and (4) the risk of leukemia and other childhood cancers is 
slightly higher than normal. At the time of the evaluation of this 
event the patient had decided to continue the pregnancy.
    Cause or Causes--The cause of the event was the licensee's 
assumption that the patient was not pregnant at the time the 
radiopharmaceutical was administered based on the verbal and written 
statements made by the patient to the licensee staff.

Actions Taken To Prevent Recurrence

    Licensee--The licensee is considering professional standards such 
as the 1996 American College of Radiology's ``Standard for the 
Performance of Therapy with Unsealed Radioactive Sources,'' which 
specifies acceptable methods for ruling out pregnancy preceding the 
administration of therapeutic doses of radiopharmaceuticals. These 
include a pregnancy test obtained within 48 hours preceding 
administration of the radiopharmaceutical; or documented hysterectomy 
or tubal ligation; or post-menopausal condition.
    NRC--An inspection was conducted to review the circumstances of the 
event. Because the licensee made a reasonable effort to obtain a 
confirmation from the patient that she was not pregnant before the I-
131 administration, no NRC requirements were violated.
    The corrective actions taken by the licensee were voluntary and 
were not required by NRC regulations.
    This event is closed for the purpose of this report.

99-4  Sodium Iodide Radiopharmaceutical Misadministration at Holy 
Redeemer Hospital and Medical Center in Meadowbrook, Pennsylvania

    Date and Place--September 14, 1999; Holy Redeemer Hospital and 
Medical Center; Meadowbrook, Pennsylvania.
    Nature and Probable Consequences--A patient's referring physician 
intended for the patient to receive a thyroid uptake and scan. The 
licensee routinely performed this procedure using iodine-123 (I-123). 
However, because of an error, the patient was administered iodine-131 
(I-131).
    The authorized user intended to administer 11.1 megabecquerel (MBq) 
(0.300 millicurie [mCi]) of I-123 to a patient for the evaluation of 
hyperthyroidism. However, no one prepared a written directive to 
indicate the type of thyroid procedure to administer. The patient was 
mistakenly listed on the licensee's schedule for a whole-body imaging 
as part of an evaluation for thyroid cancer therapy. The licensee 
routinely performs this type of procedure using I-131. Therefore, the 
licensee's technologist administered a 196.1 MBq (5.3 mCi) dosage of I-
131 without obtaining a written directive. As a result of this error, 
the licensee's medical physicist determined that the patient's thyroid 
received an unintended dose of about 41.9 gray (4,190 rad) based on a 
65 percent uptake.
    The NRC's consultant stated that the impact of the 
misadministration on the status of the patient's health should be 
negligible, with no expected long-term disability. The licensee 
believes that no harm was done to the patient because the patient's 
condition required additional thyroid treatment using I-131. The 
patient was notified of the misadministration on September 16, 1999, 
and a written report was prepared. The patient's referring physician 
was also notified.
    Cause or Causes--The technologist performed a thyroid procedure 
using I-131 without a written directive from an authorized user. The 
licensee's authorized user was not involved in the process of 
administration of I-131 to clarify what type of thyroid evaluation was 
needed for the patient.

Actions Taken to Prevent Recurrence

    Licensee--The licensee counseled the technologist on the importance 
of implementing the NRC regulations.
    NRC--The NRC staff conducted a special safety inspection on 
September 17, 1999, and is evaluating enforcement options.
    This event is closed for the purpose of this report.

Agreement State Licensees

    The following nine events, which occurred at Agreement State 
licensees during fiscal year 1999, were determined to be significant 
enough for reporting as AOs to Congress.

AS 99-1  Medical Event Involving the Administration of Iodine-131 to a 
Pregnant Patient at Via Christi Regional Medical Center in Wichita, 
Kansas

    Date and Place--May 7, 1999; Via Christi Regional Medical Center; 
Wichita, Kansas.
    Nature and Possible Consequences--A pregnant patient was 
administered a 436.6 megabecquerel (MBq) (11.8 millicurie [mCi]) dosage 
of I-131 for a thyroid treatment.
    Before the treatment, the technologist and the authorized user 
interviewed the patient regarding her pregnancy status and the patient 
certified that she was not pregnant and signed a consent form for the 
treatment. The patient then was administered the dosage of 436.6 MBq 
(11.8 mCi) of I-131. Approximately one week after the I-131 
administration during a routine gynecological exam the patient learned 
that she was between 18 and 20 weeks pregnant.
    A telephone report was made to the State of Kansas Radiation 
Control Program on May 12, 1999, and the State staff conducted an on-
site investigation on May 13, 1999. They contacted the Department of 
Energy's Radiation Emergency Assistance Center/Training Site (REACTS) 
in Oak Ridge, Tennessee for assistance. REACTS provided initial medical 
guidance and dosimetry calculations and agreed to act as consultant to 
the attending physician.
    The dose equivalent to the fetus was estimated to be about 0.03 
sievert (Sv) (3 rem) and the dose equivalent to the fetal thyroid was 
about 253 Sv (25,300 rem). The fetal thyroid dose was considered to be 
ablative. The authorized user notified the patient and her husband 
about the fetal exposure and the possible consequences. The patient 
continued her pregnancy to full term.
    Causes or Causes--The cause of the event was the licensee's 
assumption that the patient was not pregnant at the time the 
radiopharmaceutical was administered based on the verbal and written 
statements made by the patient to the licensee staff.

Actions Taken To Prevent Recurrence

    Licensee--The licensee's radiation safety officer conducted an 
investigation and determined that the licensee's procedures and 
policies had been followed and that a reasonable effort

[[Page 12045]]

had been made to determine the pregnancy status of the patient 
preceding the administration of I-131. The licensee indicated a 
revision of its policy to require that all females of child-bearing age 
be tested for pregnancy preceding administration of therapeutic doses 
of radioactive material.
    State Agency--The State staff conducted an investigation and agreed 
with the licensee's findings and believes that the licensee's proposal 
is adequate to prevent recurrence.
    The corrective actions taken by the licensee were voluntary and 
were not required by the State Agency.
    This event is closed for the purpose of this report.

AS 99-2  Industrial Radiography Occupational Overexposure at Global X-
ray and Testing Corporation in Aransas Pass, Texas

    Date and Place--December 31, 1998; Global X-ray and Testing 
Corporation; Aransas Pass, Texas.
    Nature and Probable Consequences--A radiography trainee failed to 
retract a 4.6 terabecquerel (123 curie) source of iridium-192 into the 
shielded position after taking a radiograph (exposure). As a result, 
the trainee received an estimated TEDE of about 100 mSv (10 rem) and an 
extremity annual shallow-dose equivalent of about 30,000 to 50,000 mSv 
(3,000 to 5,000 rem).
    On December 31, 1998, a radiographer and a radiography trainee were 
working at a job site. At about 6 p.m., the radiography trainee thought 
that the radiography work was completed and removed a tool belt with a 
dosimeter and an alarming ratemeter and placed it in the truck. 
However, the radiographer asked the trainee for assistance to obtain 
additional radiographs. The trainee tried to take an additional 
radiograph but the source would not crank and the trainee realized that 
the source was not retracted into the shielded position after the 
previous exposure. During this process, the trainee stood at the end of 
the guide tube for approximately 4 minutes at a distance of about 61 
centimeters (2 feet) and touched the end of the guide tube where the 
source was located three or four times for about 2 or 3 seconds each 
time.
    On January 10, 1999, signs of a radiation injury, including 
redness, dry skin, and slight swelling accompanied by aching pain, 
appeared in the index finger of the trainee's right hand. On January 
27, 1999, the finger developed a callous. On follow-up of the symptoms, 
it was indicated that the trainee received an extremity annual shallow-
dose equivalent of about 30,000 to 50,000 mSv (3,000 rem to 5,000 rem).
    Cause or Causes--The company's president told the office manager 
that the radiographer could act as a trainer because the paperwork 
requesting to name the individual radiographer as a trainer had been 
mailed to the State's Bureau of Radiation Control. Therefore, the 
radiographer was sent with the trainee to the job site. However, the 
radiation safety officer later told the office manager and the 
president of the company that Global X-ray and Testing Corporation had 
not yet received a license amendment naming the radiographer as a 
trainer.
    The radiographer had been a trainer for several other radiography 
companies and was familiar with the requirements for a trainer working 
with a trainee. However, the radiographer was new with the company, was 
not familiar with this trainee, and was not aware that the trainee was 
not a radiographer. Therefore, the trainee was not appropriately 
supervised.
    The trainee thought that the work for the day was completed and 
took the belt off and put it in the truck. The dosimeter and alarming 
rate meter were on the tool belt and were not used during the 
additional exposures. An operating survey meter was available, but the 
trainee did not use it during the radiographs.

Actions Taken To Prevent Recurrence

    Licensee--The licensee met with all the radiography personnel to 
discuss the incident and make a presentation on radiation safety. 
Trainees were told to verify they were assigned to work with a trainer 
before leaving for a job site and radiographers were told to verify 
whether or not they were assigned to work with trainees. A memorandum 
stating these requirements was added to the licensee's safety training 
program. The office manager was given a written reprimand, which stated 
that another violation of any radiation regulation or safety policy 
would result in immediate termination of employment. The radiographer 
and the radiographer trainee had their employment terminated.
    State Agency--The licensee was cited for violations of the 
radiation safety program and an escalated enforcement conference was 
conducted. As a result, inspection of the licensee's program and the 
radiographers' audit frequency was increased. A ``Preliminary Report 
for Assessment of Administrative Penalties'' was compiled and the 
licensee requested a settlement conference with the State agency.
    This event is closed for the purpose of this report.

AS 99-3  Industrial Radiography Overexposure to a Member of the Public 
at Professional Service Industries, Inc. in Seattle, Washington

    Date and Place--December 16, 1998; Professional Service Industries, 
Inc.; Seattle, Washington.
    Nature and Probable Consequences--The Washington State Department 
of Health was notified by Professional Service Industries, Inc. (PSI), 
that on December 16, 1998, a contractor's employee (member of the 
public) had accidentally handled a source guide tube containing a 2.22 
terabecquerel (60 curie) iridium-192 radiography source at a temporary 
job site in Seattle, Washington.
    A radiographer and a radiographer's assistant working for PSI were 
performing radiography at a large parking garage of an office building. 
The building entrances and the place where radiographs (exposures) were 
taken were properly posted. Two of the contractor's employees were 
allowed inside the parking garage along with the radiographer in order 
to mark locations for future radiographs. The radiographer was talking 
with the contractor's employees while a radiograph was in process. One 
of the contractor's employees needed a ladder and approached the ladder 
in the garage that was being used to support the radiography source 
collimator. The radiography source collimator was positioned on the top 
of the ladder. The contract employee's actions dislodged the collimator 
from the source guide tube. The radiographer's assistant, who was 
monitoring the floor above the parking garage, came back to the garage 
and saw the contractor's employee trying to reassemble the collimator 
and the guide tube. The radiographer's assistant immediately shouted a 
warning and the radiographer, being alerted, ran to crank in the source 
to a safe position.
    PSI's radiation safety officer (RSO) at the Seattle office and the 
corporate RSO were notified and PSI began an immediate investigation, 
including a re-enactment. Preliminary shallow-dose equivalent estimates 
for the extremities ranged from 6 to 17 sievert (Sv) (600 to 1700 rem). 
The Washington State Department of Health's Radiation Control Program 
was notified approximately 4 hours after the incident occurred and an 
investigation team was dispatched the next morning. The Washington 
Radiation Control Program estimated that the individual received a 
shallow-dose equivalent of: (1) 6.8 Sv (680 rem) to the right thumb; 
(2) 1 Sv

[[Page 12046]]

(100 rem) to the right index finger; and (3) 1.7 Sv (170 rem) to the 
palm of the left hand. The TEDE was estimated to be less than 0.05 Sv 
(5 rem). A cytogenetic study by the Department of Energy's Radiation 
Emergency Assistance Center/Training Site in Oak Ridge, Tennessee, 
determined that the TEDE was in the range of 0.01 to 0.15 Sv (1 to 15 
rem).
    No physical signs of radiation damage to the contract employee's 
hands were observed by the primary physician during the weeks following 
the incident. The exposed individual and his physician were kept 
informed of the findings of the investigation.
    Cause or Causes--The cause of the incident was attributed primarily 
to the radiographer's failure to: (1) maintain direct surveillance of a 
radiography operation; and (2) warn individuals in the area that an 
exposure was underway.

Actions Taken To Prevent Recurrence

    Licensee--PSI has complied with the corrective actions recommended 
by the State by: (1) completing a 2-day training for the Seattle PSI 
radiography personnel based on the incident; (2) accelerating the 
schedule of field audits of the PSI Seattle radiography personnel; and 
(3) performing a cytogenetic study for the contractor's employee.
    State Agency--PSI was cited for violations that resulted in the 
overexposure of a member of the public and for failure to maintain 
direct surveillance of the radiography operation by allowing a member 
of the public to enter a high-radiation area.
    This event is closed for the purpose of this report.

AS 99-4  Gamma Stereotactic Radiosurgery (Gamma Knife) 
Misadministration at University of Maryland Medical Systems in 
Baltimore, Maryland

    Date and Place--December 16, 1997; University of Maryland Medical 
Systems; Baltimore, Maryland. The State agency was notified of this 
misadministration on December 17, 1997, and performed an investigation 
of the event. The investigation was completed on October 23, 1998.
    Nature and Probable Consequences--A patient was prescribed a 
radiation therapy treatment using a gamma knife device for a brain 
metastasis involving three lesions. The patient was prescribed 1,600 
centigray (cGy) (1,600 rad) to the first lesion. However, because of an 
error in the treatment plan, the first lesion received 2,600 cGy (2,600 
rad).
    The neurosurgeon prepared the treatment plan for the first lesion. 
While treating the first lesion, the neurosurgeon prepared the 
treatment plans for the second and third lesions. However, the 
treatment plan for the second lesion unintentionally included the 
settings for a treatment of a focal point of the first lesion. The 
neurosurgeon and the oncologist reviewed the treatment plans but failed 
to identify any deviation from the prescribed dose. After the three 
lesions had been treated, the medical physicist who reviewed the dose 
calculations determined that an error occurred that resulted in an 
overdose to the first lesion. The licensee's oncologist determined that 
the administered overdose was within the range of acceptable prescribed 
dose for intra-cranial lesions. It was not anticipated that any 
complications would occur in addition to those normally seen with this 
type of therapy treatment.
    The neurosurgeon notified the patient and the referring physician 
of the event on December 17, 1997. A letter confirming the discussion 
of the event was also sent to the patient on January 8, 1998. The 
patient died on January 20, 1998, of lung cancer.
    Cause or Causes--This misadministration was caused by human error 
in preparing the treatment plans. The neurosurgeon and the oncologist 
did not follow procedures describing the team approach in treatment 
planning. Furthermore, the treatment planning procedure did not 
accurately reflect the role and responsibilities of each type of 
authorized user. Finally, the neurosurgeon and the oncologist reviewed 
and signed the treatment plan without identifying the unintended dose.

Actions Taken To Prevent Recurrence

    Licensee--The licensee immediately implemented measures to ensure 
that treatment will only be carried out after planning for all 
treatment sites is completed. The medical physicist will participate in 
the entire treatment planning process and will review the treatment 
plan before the plan is executed. The neurosurgeon and the oncologist 
will collaborate at critical points in the process, such as dose 
selection, approval of the written plan, and initiation of treatment.
    State Agency--The licensee was cited for violations that included 
training deficiencies, failure of the radiation safety committee and 
the radiation safety officer to assume their duties and 
responsibilities, failure to apply for and receive license amendments 
before changing procedures, and failure to comply with notification 
requirements. Enforcement action is pending.
    This event is closed for the purpose of this report.

AS 99-5  Gamma Stereotactic Radiosurgery (Gamma Knife) 
Misadministration at Good Samaritan Hospital in Los Angeles, California

    Date and Place--October 15, 1998; Good Samaritan Hospital; Los 
Angeles, California.
    Nature and Probable Consequences--A patient was prescribed 
treatment of 9,000 centigray (cGy) (9,000 rad) to the left trigeminal 
nerve. However, the treatment was administered to the patient's right 
trigeminal nerve.
    The licensee's medical physicist prepared a treatment plan for the 
wrong treatment site (right trigeminal nerve). The radiation 
oncologist, who was an authorized user on the license, signed the 
treatment plan without verifying the neurosurgeon's request, which 
listed the correct treatment site (left trigeminal nerve). Because the 
head restraint was positioned correctly on the patient, the medical 
physicist experienced difficulty positioning the patient in the gamma 
knife for the incorrect treatment site. In response to questions from 
the medical physicist, both the patient and the nurse informed him that 
the correct treatment site was the left trigeminal nerve. Inexplicably, 
this did not lead the medical physicist to recognize that he was about 
to treat the wrong trigeminal nerve. The error was discovered after the 
procedure was completed. As a result, the patient received a dose of 
9000 cGy (9000 rad) to the wrong treatment site. During this procedure, 
the medical physicist was training another medical physicist on how to 
use the facility's gamma knife equipment. The patient's neurosurgeon 
was not present during this procedure because of a scheduling conflict, 
even though it was the licensee's standard practice for the 
neurosurgeon to be present.
    Treatment of the intended left trigeminal nerve was postponed 
pending evaluation of the medical outcome of the treatment of the wrong 
trigeminal nerve. The patient's physician stated that the patient might 
experience increasing numbness on the affected area of the face within 
1 to 18 months. If the numbness occurs, it may affect the plan for 
treating the prescribed left site.
    Cause or Causes--The misadministration occurred because: (1) the 
medical physicist prepared a treatment plan for the wrong treatment 
site; (2) the radiation oncologist signed the treatment plan without 
properly

[[Page 12047]]

verifying it; and (3) the neurosurgeon was not present during the 
procedure, which differed from standard licensee practice. The 
radiation oncologist had not conferred with the patient before the 
treatment, which may have contributed to the incorrect site treatment. 
Although it is possible that his training of the other medical 
physicist distracted the medical physicist, this could not be 
determined as a contributing cause.

Action Taken To Prevent Recurrence

    Licensee--The licensee revised the gamma knife treatment procedure 
to require that: (1) the treatment plan be verified before each 
procedure by the neurosurgeon, the radiation oncologist, and the 
medical physicist; (2) two of the three individuals (the neurosurgeon, 
the radiation oncologist, and the medical physicist) verify that the 
treatment program coordinates are correctly set; (3) either the 
neurosurgeon or the radiation oncologist verify the prescribed 
treatment site after the patient is positioned; and (4) the 
neurosurgeon and either the radiation physicist or the radiation 
oncologist be physically present during the treatment. Also, the 
radiation oncologist shall examine the patient before the treatment and 
verify the treatment site.
    State Agency--The State cited the licensee for failure to report 
the therapeutic misadministration within 24 hours as required. The 
licensee was also cited for failure of the authorized user to verify 
the dosimetry plan and treatment programming.
    This event is closed for the purpose of this report.

AS 99-6  Therapeutic Radiopharmaceutical Misadministration of Iodine-
131 to the Wrong Individual at Hermann Hospital in Houston, Texas

    Date and Place--August 4, 1999; Hermann Hospital; Houston, Texas.
    Nature and Possible Consequences--A patient was scheduled to 
receive a 1010 megabecquerel (MBq) (27.3 millicurie [mCi]) dosage of 
iodine-131 (I-131) for a thyroid treatment. However, because of an 
identification error, the wrong individual was administered the I-131.
    Two middle-aged female Asian patients were at the licensee's 
nuclear medicine department for different procedures. The patient who 
was scheduled to receive the I-131 dosage left the waiting room. The 
licensee's technologist approached the other patient to verify her name 
and date of birth by stating the name and date of birth of the patient 
who was to receive the I-131 treatment. The patient responded with 
``yes,'' although she did not understand the questions. She also 
indicated she understood the instructions previously given to her about 
the I-131 treatment. Therefore, she was administered the dosage of I-
131. Later it was found that the I-131 was administered to the wrong 
individual. The licensee ordered another dosage of I-131, which was 
administered to the correct patient as prescribed.
    The licensee estimated that: (1) The dose to the patient's thyroid 
as a result of the misadministration was about 220 gray (22,000 rad); 
(2) the patient has about an 85 percent chance of losing thyroid 
function; and (3) replacement thyroid hormone will be required 
indefinitely. The patient's attending physician was contacted and 
remedial action was taken.
    Causes or Causes--The patient who received the misadministration 
spoke English as a second language. She was asked identification 
questions that could be answered ``yes'' or ``no'' without her actually 
understanding the meaning of the questions. No further verification of 
the patient's identification was performed.

Actions Taken To Prevent Recurrence

    Licensee--The licensee has changed procedures for all outpatient 
therapy treatments that involve radioactive materials. The format of 
questions for patient identification will be revised to read ``What is 
your name?'' and ``What is your date of birth?'' instead of ``Is your 
name * * *?'' or ``Is your date of birth * * *?'' Outpatients will also 
be asked to show a picture form of identification. In the case of 
pediatric patients, the child's parent or guardian must confirm the 
patient's identification.
    State Agency--The licensee was cited for administering a 
therapeutic dosage of I-131 to the wrong individual, who had a normally 
functioning thyroid, and for the authorizing physician user not being 
physically present when therapy procedures were being performed. 
Enforcement action is pending.
    This event is closed for the purpose of this report.

AS 99-7  Therapeutic Radiopharmaceutical Misadministration of Iodine-
131 to the Wrong Individual at Milton Hospital in Milton, Massachusetts

    Date and Place--July 31, 1998; Milton Hospital; Milton, 
Massachusetts. The information on this event was sent to the NRC staff 
in March 1999.
    Nature and Possible Consequences--A patient was prescribed a 
diagnostic dosage of 270.1 megabecquerel (MBq) (7.3 millicurie [mCi]) 
of technetium-99m (Tc-99m) for a thyroid scan. However, the patient was 
erroneously administered a therapeutic dosage of 318.2 MBq (8.6 mCi) of 
iodine-131.
    The licensee's technologist administered the patient the diagnostic 
dosage of 270.1 MBq (7.3 mCi) of Tc-99m. After this procedure was 
finished, the patient was asked to remain in the waiting room while the 
thyroid scan was processed. Because of an identification error, the 
patient was taken again into the treatment area by the authorized user 
and was administered the therapeutic dosage of I-131. This dosage was 
intended for another patient who was still in the waiting room. The 
patient was informed of the error.
    The licensee believes that no harm was done because the patient's 
condition required additional thyroid treatment using I-131.
    Causes or Causes--The authorized user, who also was the primary 
care physician for both patients, was aware that both patients were to 
have I-131 treatment. However, on the day of the incident, the patient 
should have received only the Tc-99m dosage. Since the authorized user 
failed to follow the established Quality Management Program (QMP) 
procedures requiring verification of the patient's identity by more 
than one method before administering radioactive material, the wrong 
individual was administered the I-131.

Actions Taken To Prevent Recurrence

    Licensee--The licensee modified its procedures as follows: (1) The 
authorized user will review the chart for each therapy patient; (2) 
each chart will contain a photograph of the patient; (3) each patient 
will be identified by checking the photograph in the chart; (4) 
preceding the administration of radiopharmaceuticals, a band will be 
placed on the wrist of the identified therapy patient; and (5) the 
authorized user and the technologist will be present during the 
radiopharmaceutical administration. The written directive form for 
iodine therapy dosages was modified to include the changes made in the 
procedures.
    State Agency--The State investigated this event on September 10 and 
11, 1998, and the licensee was issued a Notice of Violation on 
September 14, 1998, for not following its submitted procedures for 
radiopharmaceutical therapy as outlined in the QMP. The State 
acknowledged the action taken by the licensee to prevent recurrence of 
this incident.

[[Page 12048]]

    This event is closed for the purpose of this report.

AS 99-8  Therapeutic Radiopharmaceutical Misadministration of Samarium-
153 at Merle West Medical Center in Klamath Falls, Oregon

    Date and Place--March 10, 1999; Merle West Medical Center; Klamath 
Falls, Oregon.

    Nature and Probable Consequences--A patient with metastatic 
prostate cancer was prescribed a dosage of 2,294 megabecquerel (MBq) 
(62 millicurie [mCi]) of samarium-153 (Sm-153) to palliate bone pain. 
However, because of an error, the patient was administered a dosage of 
3,589 MBq (97 mCi) of Sm-153. The recommended dosage for the Sm-153 
procedure is ``1 mCi per kg of body weight'' (37 MBq per kilogram [kg]) 
(1 mCi per 2.2 pounds [lb]).
    The misadministration resulted in an additional dose of 200 
centigray (cGy) (200 rad) to the bone marrow. The patient's other 
organs received additional doses that were below 1,000 cGy (1,000 rad). 
The hospital checked with the manufacturer, DuPont Merck Pharmaceutical 
Company, concerning possible side effects of the misadministration. The 
pharmaceutical company indicated that other studies have been done 
using 74 to 92.5 MBq per kg (2.0 to 2.5 mCi per 2.2 lb) of Sm-153 with 
no significant side effects.
    Both the attending physician and the patient's family were notified 
of the misadministration.
    Cause or Causes--This event was caused by a human error. The 
licensee indicated that the dosage was calculated using the patient's 
weight in pounds instead of kilograms.

Actions Taken To Prevent Recurrence

    Licensee--The incident was discussed with the Radiation Safety 
Committee (RSC). The licensee revised its Quality Management Program 
(QMP) for the use of Sm-153 and strontium-89 therapy to require the 
prescribing physician to calculate and personally order the dosage. The 
RSC approved the changes to the QMP. The technologist involved in the 
procedure was counseled concerning therapy procedures, dosage 
administrations, and the importance of rechecking calculations.
    State Agency--The State cited the licensee for failure to report 
the misadministration within the required time.
    This event is closed for the purpose of this report.

AS 99-9  Sodium Iodide Radiopharmaceutical Misadministration at St. 
Edward Mercy Medical Center in Fort Smith, Arkansas

    Date and Place--December 7, 1998; St. Edward Mercy Medical Center; 
Fort Smith, Arkansas.
    Nature and Probable Consequences--A patient was prescribed a 
thyroid scan using 222 megabecquerel (MBq) (6 millicurie [mCi]) dosage 
of technetium-99m (Tc-99m) pertechnetate. However, the patient was 
administered about a 148 MBq (4 mCi) dosage of iodine-131 (I-131).
    The medical center routinely received unit dosages from a nuclear 
pharmacy packaged in appropriately sized syringes ready for injection 
to patients. However, in this case, instead of being in a syringe, the 
dosage was in a glass vial within a large lead container. The shipping 
package also contained two dispensing straws. The shipping container, 
the lead ``pig,'' and the vial were labeled by the nuclear pharmacy as 
222 MBq (6 mCi) of Tc-99m. The licensee's staff surveyed the incoming 
package but saw nothing unusual. The licensee's staff attributed the 
change in the appearance of the package (a glass vial instead of a 
syringe and the presence of the dispensing straws) to a mistake made by 
the nuclear pharmacy. Therefore, the oral solution of the I-131 dosage, 
mislabeled as Tc-99m, was drawn into a syringe and was injected into 
the patient.
    The licensee's medical physicist determined that the dose to the 
patient's thyroid based on the radiopharmaceutical manufacturer's 
package insert was about 48 gray (4,800 rad). The patient was notified 
of the misadministration by the licensee's radiation safety officer 
(RSO). The patient's attending physician was also notified of the 
circumstances and possible complications. The RSO advised the patient 
to continue long-term follow-up with the primary care physician.
    Cause or Causes--This event was caused by the nuclear pharmacy 
mislabeling a radiopharmaceutical dosage. Also, it appears that the 
medical center's nuclear medicine staff did not question or address the 
unusual package upon receipt.

Actions Taken To Prevent Recurrence

    Licensee--The licensee reported this event to the Arkansas 
Department of Health on December 7, 1998, and submitted a written 
report on December 8, 1998. The center's management revised the policy 
and procedure for the receipt of radiopharmaceuticals from the nuclear 
pharmacy. The revision states that only I-131 radioactive dosages will 
be accepted in glass vials. Any suspect or other labeled isotope 
received in glass vials will be questioned or returned to the pharmacy 
for isotope verification. The nuclear pharmacy indicated that policies 
and procedures for dispensing radiopharmaceutical therapy products have 
been revised to prevent recurrence of similar incidents.
    State Agency--The State staff performed an on-site investigation at 
the medical center and the nuclear pharmacy on December 8, 1998.
    The investigation discovered violations associated with license 
conditions and regulations for activities conducted at the nuclear 
pharmacy.
    This event is closed for the purpose of this report.

    Dated at Rockville, Maryland, this 1st day of March, 2000.

    For the Nuclear Regulatory Commission.
Andrew L. Bates,
Secretary of the Commission.
[FR Doc. 00-5473 Filed 3-6-00; 8:45 am]
BILLING CODE 7590-01-P