[Federal Register Volume 66, Number 84 (Tuesday, May 1, 2001)]
[Notices]
[Pages 21788-21793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10821]


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NUCLEAR REGULATORY COMMISSION


Report to Congress on Abnormal Occurrences Fiscal Year 2000; 
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 U.S. Nuclear Regulatory Commission (NRC) determines 
is 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 annually. During fiscal year 
2000, nine 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. 23, ``Report to Congress on Abnormal Occurrences, Fiscal Year 
2000.'' This report will be available electronically at the NRC Web 
site http://www.nrc.gov/NRC/NUREGS/indexnum.html> at the NRC Homepage.

Nuclear Power Plants

    The following event that occurred at U.S. nuclear power plants 
during fiscal year 2000 was determined to be significant enough to be 
reported as an AO to Congress.
00-1  Steam Generator Tube Failure at Indian Point Unit 2 in Buchanan, 
New York
    Date and Place--February 15, 2000; Indian Point Unit 2, a 
commercial nuclear power plant operated by Consolidated Edison Company, 
located about 24 miles north of New York City.
    Nature and Probable Consequences--On February 15, 2000, at 7:17 
p.m., the Indian Point Unit 2 nuclear plant experienced a steam 
generator tube failure which required the declaration of an ``Alert'' 
(the second lowest of four emergency classifications in the NRC-
required emergency response plan) at 7:29 p.m., and a manual reactor 
trip at 7:30 p.m. The steam generator is a heat exchanger which allows 
heat to pass from the reactor (primary system) to the turbine generator 
(secondary system). It also provides the boundary between the 
radioactive primary system and the non-radioactive secondary system. At 
Indian Point Unit 2 there are four steam generators and each steam 
generator has approximately 3300 tubes. On February 15, the failure of 
one of these tubes allowed reactor water to leak into the secondary 
system. By 8:31 p.m. the operators had taken steps to isolate the steam 
generator which contained the leaking tube. After the steam generator 
was isolated, the operators began to cool down the plant. At 9:02 p.m. 
they were forced to suspend the cooldown process when they realized 
they had inadvertently established an excessive cooldown rate. This 
excessive cooldown rate caused a rapid reduction in reactor coolant 
system (pressurizer) level. To restore the level the licensee pumped 
borated water into the reactor coolant system using the safety 
injection system. After the level was restored the operators resumed 
the cooldown and reached cold shutdown at 4:57 p.m on February 16, 
2000. The licensee exited the ``Alert'' emergency classification at 
6:50 p.m. that day.
    The steam generator tube failure resulted in an initial primary-to-
secondary leak of reactor coolant of approximately 146 gallons per 
minute, and required an ``Alert'' declaration. This event involved some 
procedural and equipment issues that challenged operators, complicated 
the event response, and delayed achieving the cold shutdown condition. 
It caused significant public and media interest, and required increased 
NRC attention. The event resulted in a minor radiological release to 
the environment that was well within regulatory limits. No 
radioactivity was measured offsite above normal background levels, and 
the event did not impact public health and safety.
    Following the event, the NRC performed an inspection and determined 
that Consolidated Edison Company had not performed an adequate 
examination of the steam generator tubes during its 1997 outage.

[[Page 21789]]

As a result, degraded tubes were allowed to remain in service during 
plant operation, which ultimately led to a steam generator tube 
failure.
    Cause or Causes-- The event was caused by primary water stress 
corrosion cracking (PWSCC) flaws in steam generator tubes. There were 
deficiencies in the overall direction and execution of the 1997 steam 
generator in-service examinations at Indian Point Unit 2. Specifically, 
the licensee did not identify the presence of PWSCC flaws in steam 
generator tubes and remove these tubes from service, despite 
opportunities to do so. As a result, tubes with PWSCC were left in 
service following the 1997 steam generator inspection until one of 
these tubes failed on February 15, 2000, when the reactor was at 100 
percent power.

Actions Taken To Prevent Recurrence

    Licensee--The licensee performed the necessary actions to protect 
the health and safety of the public. Before the event, the licensee was 
in the process of implementing a station improvement program. This 
event demonstrated the need for continuous management attention to 
planned improvements to ensure they are timely and effective. 
Subsequently the licensee made the decision to replace all four steam 
generators prior to returning to power. The industry completed a 
lessons-learned report based on the Indian Point Unit 2 steam generator 
tube failure event and provided it to the NRC on October 26, 2000.
    NRC--The NRC reviewed the causes, safety implications, and licensee 
actions following the event. Information Notice 2000-09, ``Steam 
Generator Tube Failure at Indian Point Unit 2,'' was issued on June 28, 
2000, to alert other licensees to this event. A Notice of Violation was 
issued to Indian Point 2 on November 20, 2000. A lessons-learned report 
on the steam generator tube failure at Indian Point Unit 2 was 
completed on October 23, 2000. In this report, the NRC evaluated the 
staff's technical and regulatory processes related to assuring steam 
generator tube integrity and identified and recommended areas for 
improvement applicable to the NRC and the industry. Subsequently, the 
NRC established a Steam Generator Action Plan detailing activities to 
be addressed by the NRC and the industry to improve management of steam 
generator performance.
    This event is closed for the purpose of the AO report to Congress.

Fuel Cycle Facilities (Other Than Nuclear Power Plants)

    None of the events that occurred at the fuel cycle facilities 
during fiscal year 2000, was determined to be significant enough to be 
reported as an AO to Congress.

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

    The following three events occurred at facilities licensed or 
otherwise regulated by the NRC during fiscal year 2000 and were 
determined to be significant enough to be reported as AOs to Congress.
00-2  Overexposures at Mallinckrodt, Inc., in Maryland Heights, 
Missouri
    Date and Place--From 1995 through 2000; Mallinckrodt, Inc.; 
Maryland Heights, Missouri.
    Nature and Probable Consequences--On March 31, 2000, a contract 
employee who was providing services for Mallinckrodt, Inc., was 
attempting to correct flow problems with a 703,000 megabecquerel (19 
curie) molybdenum-99/technetium-99m generator. The employee performed 
the operation in a glove box. The employee's initial attempts to 
correct the generator problem were not successful. The employee then 
removed the generator column containing the radioactive material from 
its shield and determined that the inlet line was not connected and the 
outlet line was bent at an angle. Holding the unshielded column in his 
right hand, the employee corrected the problems with the inlet and 
outlet lines. This process took between 10 and 20 seconds to complete. 
Dose rates at the location of the column held by the employee were 
calculated to be approximately 510 mSv (51 rem) per second. As a result 
the employee's thumb and index finger of the right hand received a dose 
ranging from 5,100 mSv (510 rem) to 11,200 mSv (1,120 rem) shallow-dose 
equivalent. The NRC annual dose limit to the skin or any extremity is 
500 mSv (50 rem) shallow-dose equivalent. The employee believed that 
the gloves he wore provided him adequate protection from radiation.
    On April 5, 2000, Mallinckrodt determined that the radiation 
monitor worn on the employee's right hand recorded a dose of 57 mSv 
(5.7 rem) shallow-dose equivalent in excess of its administrative 
weekly limit which was 20 mSv (2 rem). Mallinckrodt's investigation of 
the exposure determined that the employee had directly handled the 
generator column and reported the event to the NRC on April 13, 2000. 
The employee was examined by a physician, who identified no immediate 
health effects. Due to the inability of either the NRC or the licensee 
to precisely estimate the likely exposure to the employee's finger and 
thumb, long-term health effects could not be predicted.
    During its investigation of the March 31, 2000, event, Mallinckrodt 
identified other employee overexposures that occurred in the preceding 
5 years during the performance of two routine operations. As a result 
of the first routine operation, 11 employees involved in the hand-
labeling of vials containing millicurie quantities of indium-111 (In-
111) (a State-regulated, non-NRC licensed material) received extremity 
doses ranging from 500 mSv (50 rem) to 3,200 mSv (320 rem) shallow-dose 
equivalent. In addition to these doses from In-111, the 11 employees 
had also received doses from NRC-regulated material, typically less 
than 5 percent of their total extremity doses.
    The second operation involved the handling of unshielded and 
partially shielded vials and syringes containing radioactive material 
(State- and NRC-regulated material) in a sterility testing laboratory. 
As a result of this operation Mallinckrodt identified four employees 
who received extremity doses ranging from 680 mSv (68 rem) to 960 mSv 
(96 rem) shallow-dose equivalent.
    Cause or Causes--The causes of the March 31, 2000, event were 
insufficient training to ensure that the employee understood the 
difference between radioactive contamination and radiation and 
inadequate oversight of the laboratory. The written, approved procedure 
on the employee's assigned duties did not allow the removal of the 
generator column during manufacturing. However, an ad hoc procedure had 
been developed by the staff of the laboratory that was not known to, or 
approved by, the management outside the laboratory. The ad hoc 
procedure allowed the removal of the generator column from the shield 
using remote handling tools. On March 31, 2000, the employee was using 
the ad hoc procedure but the tools that were used to remove the 
generator column from the shield had fallen to the bottom of the glove 
box and were out of the employee's reach. The employee decided on his 
own to remove the column and to perform repairs without using tools.
    Regarding the other operations that resulted in significant doses, 
Mallinckrodt personnel believed, erroneously, that the doses recorded 
by the personnel monitoring devices worn by its employees reflected the 
actual

[[Page 21790]]

exposures received. However, the actual doses were, in some instances, 
100 times greater than those recorded by the monitors. This was due to 
the distance between the monitors, which are normally worn like a ring 
at the base of the finger, and the fingertips, where the exposures were 
received.

Actions Taken To Prevent Recurrence

    Licensee--The licensee staff was instructed in the proper handling 
of unshielded containers of radioactive material. The licensee 
increased its radiation safety and supervisory oversight in the 
generator manufacturing laboratory. In addition, the licensee initiated 
and implemented managerial changes to its operations and agreed to: (1) 
Retain an independent organization to assess the radiation safety 
program and the radiation safety aspects of its radioactive material 
manufacturing processes; (2) provide assurance that workers have 
received training and understand procedures and practices to maintain 
radiation exposures as low as is reasonably achievable (ALARA); (3) 
develop a plan to review operations for the last five years to 
determine if additional workers have received exposures in excess of 
regulatory limits; and (4) request an amendment to incorporate a 
corrective action program into its license. NRC confirmed the 
licensee's agreement in a Confirmatory Order Modifying license issued 
on June 22, 2000.
    NRC--The NRC conducted an Augmented Inspection Team (AIT) 
inspection on May 4 through May 26, 2000, and a follow up inspection on 
July 17 through August 4, 2000. As a result of the AIT inspection, NRC 
issued the June 22, 2000, Confirmatory Order Modifying License to 
Mallinckrodt. On December 21, 2000, NRC issued a Notice of Violation 
and Proposed Imposition of a $125,000 Civil Penalty.
    This event is closed for the purpose of the AO report to Congress.
* * * * *
00-3  Brachytherapy Misadministration at Sibley Memorial Hospital in 
Washington, District of Columbia
    Date and Place--September 15-20, 2000; Sibley Memorial Hospital; 
Washington, District of Columbia.
    Nature and Probable Consequences--Two patients were prescribed 
doses of 70 Gy (7,000 rad) each for eye treatment. The first patient 
received a dose of 108.7 Gy (10,870 rad) and the second patient 
received a dose of 114.70 Gy (11,470 rad).
    The two patients were prescribed iodine-125 (I-125) eye plaques for 
treatment of ocular melanomas. These treatments were performed in an 
attempt to preserve the patients' eyes, which otherwise would have been 
surgically removed. The licensee's treatment planning system uses air-
kerma, and the supplier of the I-125 seeds uses millicurie units. The 
licensee made an error converting air-kerma to millicurie units. 
Consequently, orders were placed for a higher source strength of I-125 
seeds, which were subsequently administered to the patients, resulting 
in the overdoses.
    The error was identified by the licensee during a review of the 
patients' charts on September 22, 2000, after the physicist noted that 
the dosimetrist was ordering I-125 seeds for an upcoming study with 
higher than expected source strength.
    The patients were informed of the misadministrations. Before the 
start of the treatments, the patients were informed of the substantial 
risk of vision loss, the possibility of cataract formation, and a 10 to 
15 percent possibility that removal of the eye might be required due to 
tumor progression or eye pain.
    Cause or Causes--The principal cause of the misadministrations was 
a human error in converting source strength of the I-125 seeds from 
air-kerma to millicurie units. A secondary cause was the failure of the 
authorized user and medical physicist to recheck the conversion factor 
equations before the treatment was completed (a requirement of the 
licensee's Quality Management Plan).

Actions Taken To Prevent Recurrence

    Licensee--The licensee suspended all procedures involving the eye 
plaques until corrective actions were developed and the staff was 
trained in the corrective actions. Written procedures were established 
to ensure the accuracy of the treatment calculations. The licensee has 
submitted to the NRC its planned corrective actions to prevent 
potential errors in the future.
    NRC--An inspection was conducted by the NRC's Region I office on 
September 28 and 29, 2000, to examine the circumstances of the 
misadministration and the licensee's corrective and preventive actions. 
In accordance with the NRC's Medical Event Assessment Program, the NRC 
has retained a medical consultant to assess the misadministrations and 
their potential consequences. Enforcement action is pending.
    This event is closed for the purpose of the AO report to Congress.

Agreement State Licensees

    The following six events occurred at facilities of Agreement State 
licensees during fiscal year 2000 and were determined to be significant 
enough to be reported as AOs to Congress.
AS 00-1  Gamma Stereotactic Radiosurgery Misadministration at 
Healthsouth Medical Center in Birmingham, Alabama
    Date and Place--April 12, 2000; Healthsouth Medical Center; 
Birmingham, Alabama.
    Nature and Probable Consequences--Patient A was prescribed a dose 
of 80 Gy (8,000 rad) to the left trigeminal nerve using a gamma 
stereotactic radiosurgery (GSR) device. However, because of an error, a 
dose of about 0.2 Gy (20 rad) was delivered to the intended treatment 
site and a dose of 80 Gy (8,000 rad) was delivered to a wrong treatment 
site.
    On the same day that patient A was scheduled for a GSR treatment, 
patient B was also admitted for a similar treatment using the same 
device. During the approval process of the treatment plan, the dose 
delivery sheet of patient B was inadvertently switched with that of 
patient A. As a result, patient A was treated with the radiosurgery 
parameters intended for patient B, and a dose of 80 Gy (8,000 rad) was 
delivered at the wrong treatment site within the patient's skull. The 
misadministration was discovered immediately following the delivery of 
the dose by the patient's radiation oncologist. The identification of 
this misadministration prevented a related misadministration for 
patient B. The licensee notified the State agency of this 
misadministration on April 12, 2000. The patient returned to the 
Medical Center on April 20, 2000, and was treated as prescribed.
    The licensee stated that the misadministration resulted in no 
observable acute effects to the patient. The patient was notified 
verbally within 24 hours by the referring physician and the 
neurosurgeon and will be closely monitored by the neurosurgeon.
    Cause or Causes--This misadministration was caused by mixing 
patient treatment protocol documentation during approval of the 
treatment plans for the two different patients that were prescribed 
similar treatments.

Actions Taken To Prevent Recurrence

    Licensee--The licensee took immediate action to prevent the mixing 
of patient treatment protocol documentation. As a result, each page of 
the treatment protocol contains a unique

[[Page 21791]]

name and time stamp, which the radiation oncologist or medical 
physicist will in the future check before delivering the radiosurgery 
treatment.
    State Agency--The Alabama Department of Public Health, Office of 
Radiation Control was satisfied with the licensee's corrective actions. 
The licensee's corrective measures will be reviewed during the agency's 
next routine inspection of the licensee's activities.
    This event is closed for the purpose of the AO report to Congress.
* * * * *
AS 00-2  Gamma Stereotactic Radiosurgery Misadministration at 
University of California in San Francisco, California
    Date and Place--September 11, 1998; University of California; San 
Francisco, California. The California Department of Health Services, 
Radiologic Health Branch was notified of the misadministration on 
September 17, 1998. The NRC staff was informed of this event in July 
2000. The State of California indicated that the delay in reporting 
this event to the NRC resulted from a computer error.
    Nature and Probable Consequences--A patient was prescribed a 
radiation therapy treatment of two metastatic lesions of the brain 
using a gamma stereotactic radiosurgery (GSR) device. One of the brain 
lesions was prescribed a dose of 16 Gy (1,600 rad). However, because of 
an error, the wrong site of the brain received more than 10 Gy (1,000 
rad).
    The patient was treated for two metastatic brain lesions, one in 
the left thalamus and the other in the right parietal regions of the 
brain. A treatment plan was developed for the lesion in the left 
thalamus to deliver a single dose of 16 Gy (1600 rad), at the 60% 
isodose line. However, one of the seven parameter settings of the GSR, 
the ``left Y'' coordinate, was erroneously set at 111 mm (4.37 in.) 
instead of 101 mm (3.98 in.) resulting in a 5 mm (0.20 in.) 
translocation of the treatment volume. This error resulted in an under-
dose of a portion of the intended treatment volume and an unintended 
dose of more than 10 Gy (1,000 rad) to brain tissue outside of the 
prescribed treatment volume. The misadministration was discovered when 
the licensee performed a quality control verification of the GSR 
parameters after the radiation treatment.
    The licensee reported that the patient experienced no acute side 
effects from this misadministration. The physician who was involved in 
this treatment notified the patient of this misadministration. The 
physician explained the necessity of another treatment because of the 
under-dose to a portion of the tumor site. An additional treatment was 
added to the treatment plan to complete the prescribed dose to the 
intended treatment volume of the left thalamus, and the treatment was 
completed. The patient died as a direct result of the metastatic 
condition on March 3, 1999.
    Cause or Causes--The misadministration was caused by a human error. 
One member of the treatment team set a wrong coordinate and another 
member of the treatment team failed to independently verify the 
coordinate setting.

Actions Taken To Prevent Recurrence

    Licensee--The initial corrective actions by the licensee included 
decreasing distractions to the treatment team by limiting telephone 
calls in the treatment control area and restricting conversations in 
the treatment room to conversations required for the treatment of the 
patient.The licensee was requested by the State to contact other GSR 
facilities to review their methods of operation. The licensee found 
that another GSR facility had performed a study comparing the frequency 
of incorrect coordinate settings by licensees who did one independent 
verification and licensees who did two. The licensee used this study as 
a guide and has adopted the procedure of performing two independent 
checks of the coordinate settings before each treatment and retaining 
the follow-up check of the coordinate settings after each treatment to 
determine if an error was made.
    State Agency--The findings of the onsite investigation by the State 
staff agreed with the findings of the licensee's quality assurance 
review. The State also shared the finding of the study performed by the 
licensee with other Agreement States and with the NRC because of the 
study's generic implications. The State was satisfied with the 
licensee's corrective actions and believes they should be adequate to 
prevent recurrence. No enforcement actions were taken by the State for 
this misadministration.
    This event is closed for the purpose of the AO report to Congress.
* * * * *
AS 00-3  Gamma Stereotactic Radiosurgery Misadministration at 
Healthsouth Doctor's Hospital in Coral Gables, Florida
    Date and Place--January 25, 2000; Healthsouth Doctor's Hospital; 
Coral Gables, Florida.
    Nature and Probable Consequences--A patient was prescribed a gamma 
stereotactic radiosurgery (GSR) treatment for 80 brain lesions. Each 
brain lesion site was prescribed 12 Gy (1,200 rad). However, a lesion 
site was treated twice because of an error.
    The patient's treatments were based on computer-generated magnetic 
resonance imaging (MRI) slices taken in the Z direction. Prior to each 
treatment, the lesion site coordinates were printed out as part of the 
written directive and they were checked manually and initialed by the 
authorized user and the medical physicist. For the fourth treatment, 
the licensee intended to deliver 12 Gy (1,200 rad) to lesion site 47. 
However, prior to the treatment the wrong MRI slice was displayed in 
the computer showing lesion site 16 (Z=70.7 mm [2.78 in.]) instead of 
lesion site 47 (Z= 65.0 mm [2.56 in.]). Thus, the treatment plan was 
calculated at lesion site 16, which had already been treated. The 
written directive was prepared and signed by the authorized user and 
the radiation safety officer (RSO) indicating a dose of 12 Gy (1,200 
rad) to Z=70.7 mm (2.78 in.). The treatment was administered as 
indicated in the directive. As a result, lesion site 16 was treated 
twice. The RSO discovered the error on January 28, 2000, during a 
routine quality assurance review of the treatment plan. The licensee 
indicated that the retreatment of site 16 did not result in harmful 
effects for the patient. The patient was rescheduled for treatment of 
lesion site 47 and treatment of additional untreated sites.
    The misadministration was reported to the Florida Bureau of 
Radiation Control, the authorized user, and the patient on January 28, 
2000.
    Cause or Causes--The licensee determined that this 
misadministration was caused by human error.

Actions Taken To Prevent Recurrence

    Licensee--No action was taken by the licensee. The licensee has not 
identified any quality management procedures that need to be changed to 
prevent this type of human error. In addition, the licensee believes 
that this type of error was detected because of its aggressive quality 
assurance program.
    State Agency--The Bureau of Radiation Control performed an onsite 
investigation on February 2, 2000. The investigation found no apparent 
violations of the licensee's license or the regulations. During the 
investigation the licensee indicated that it has performed in excess of 
2,000 GSR procedures and a quality assurance review of each procedure. 
Of the 2,000 procedures the

[[Page 21792]]

licensee has estimated that over 600 procedures involved the treatment 
of 20 or more lesion sites and that this was the only time a lesion 
site was treated twice.
    This event is closed for the purpose of the AO report to Congress.
* * * * *
AS 00-4  Gamma Stereotactic Radiosurgery Misadministration at 
University of Maryland Medical Systems in Baltimore, Maryland
    Date and Place--April 20, 2000; University of Maryland Medical 
Systems (UMMS); Baltimore, Maryland.
    Nature and Probable Consequences--A patient was prescribed a 
radiation therapy treatment for pituitary adenoma using a gamma 
stereotactic radiosurgery (GSR) device. The licensee's therapy 
treatment team planned to deliver a maximum dose of 18 Gy (1,800 rad) 
to the 50% isodose line given in six administrations. However, because 
of the incorrect settings of the Y and Z coordinates, a dose of 12.5 Gy 
(1,250 rad) was administered to the wrong treatment site.
    The licensee's therapy treatment team consisted of a neurosurgeon, 
an oncologist, and a medical physicist. The treatment plan was 
developed, reviewed, and signed by each member of the treatment team 
prior to the administration of the first dose. When the medical 
physicist briefly left the GSR facility, the neurosurgeon and the 
oncologist inadvertently reversed the Y and the Z coordinates while 
adjusting the position of the patient's stereotactic frame (moving the 
patient's head to the incorrect position). When the medical physicist 
returned, each member of the treatment team incorrectly verified the 
position of the patient's frame assembly. All team members signed the 
quality assurance checklist to indicate that they conducted this check 
and that the patient's frame was positioned in accordance with the 
written directive. As a result, the patient's base of the frontal lobe 
received the unintended dose. The medical physicist identified the 
incorrect settings of the Y and Z coordinates while preparing to adjust 
the frame assembly for the second administration. Upon discovery of the 
misadministration, the treatment team revised the treatment plan to 
accommodate for the error and to complete the therapy procedure. The 
State agency was notified of this misadministration on April 21, 2000, 
and performed an onsite investigation on April 26-28, 2000.
    The neurosurgeon notified the patient, provided an estimate of the 
unintended dose delivered, and explained that no adverse health effects 
were expected to result from this event.
    Cause or Causes--This misadministration was determined to be a 
sequence of human errors made by the neurosurgeon, oncologist, and 
medical physicist during patient positioning. However, while the root 
cause of the event appears to be human errors during the setting of the 
patient positioning parameters, other factors may have contributed to 
the event. For example, to position the patient, the treatment team 
used an internal procedure which was not documented in writing. This 
procedure was not sent to the licensee's Radiation Safety Committee or 
the State Agency for approval. The radiation safety officer (RSO) was a 
contract employee of the UMMS. Furthermore, he had not received any 
specialized training, e.g., equivalent to the authorized user training. 
Interaction between the RSO and the authorized users was rare. Finally, 
the RSO failed to complete and document the annual reviews of the GSR 
radiation protection program content and implementation for the 
previous 3 years (1997 through 2000).

Actions Taken To Prevent Recurrence

    Licensee--The licensee held a management conference with key 
members of management, radiation safety, radiation oncology, 
neurosurgery, patient care services, and clinical effectiveness. As a 
result of this meeting, the licensee implemented a written protocol 
regarding patient positioning.
    State Agency--The onsite investigation by the State determined that 
the licensee failed to implement approved written procedures regarding 
treatment planning, patient positioning, and administration of doses. 
Furthermore, the licensee failed to complete and document the annual 
reviews of the GSR radiation protection program content and 
implementation for the previous 3 years. A Department Letter/Notice of 
Violation was issued on June 21, 2000. An enforcement action is 
pending.
    This event is closed for the purpose of the AO report to Congress.
* * * * *
AS 00-5  Teletherapy Misadministration at Western Baptist Hospital in 
Paducah, Kentucky
    Date and Place--October 16, 1996, to November 1, 1996; Western 
Baptist Hospital; Paducah, Kentucky. This misadministration was 
discovered by the hospital on January 8, 1997. The State was informed 
of the misadministration on January 8, 1997 and was reported to NRC on 
March 5, 1997. However, it was identified as an AO during discussions 
of the event at an Integrated Materials Performance Evaluation Program 
review of the State of Kentucky in July 2000.
    Nature and Probable Consequences--A patient was prescribed a 
radiation therapy treatment using cobalt-60 teletherapy equipment. The 
patient was prescribed a dose of 39 Gy (3900 rad). However, the dose 
was administered to the wrong treatment site because of an error.
    The patient was treated for bone pain associated with renal cell 
carcinoma with metastases to the right iliac bone. The prescribed 
treatment was 5 treatments per week for a total of 13 treatments. The 
prescribed dose to the right iliac bone was 39 Gy (3900 rad). When the 
patient returned for evaluation of the right iliac bone pain, the 
physician determined that the dose of 39 Gy (3900 rad) was administered 
to the left iliac bone.
    The licensee stated that the misadministration had no effect on the 
patient's life-span and did not result in any permanent impairment or 
dysfunction.
    Cause or Causes--The causes of this misadministration were that (1) 
markers were not used on the patient's x-ray film to distinguish the 
supine/prone positions; (2) a second x-ray film was incorrectly labeled 
as to left/right; (3) the physician did not perform a visual inspection 
to determine that the correct area had been marked on the patient; and 
(4) the prescribing physician and simulator therapists failed to 
correctly orient left/right on fluoroscopy.

Actions Taken To Prevent Recurrence

    Licensee--The licensee established a requirement to label the x-ray 
films to distinguish left/right and supine/prone positions. One of the 
radiation physicists will review the treatment plans of patients that 
are not responding clinically as expected. The physicists have been 
retrained to check all information in the patient's chart regarding 
calculations and setup. The physicians and therapists have been 
reminded of the importance of accurately determining patient 
orientation.
    State Agency--The State agency reviewed the written directive and 
no problems were noted. A telephone conference was held with the 
radiation safety officer, the attending physician, and the Director of 
Safety Management. The inspection frequency for the facility was 
increased. An inspection in March 1998 found no violations.

[[Page 21793]]

    This event is closed for the purpose of the AO report to Congress.
* * * * *
AS 00-6  Brachytherapy Misadministration at Aultman Hospital in Canton, 
Ohio
    Date and Place--August 22, 2000 through October 30, 2000; Aultman 
Hospital; Canton, Ohio.
    Nature and Probable Consequences--As a result of a common error, 
four patients that were prescribed manual brachytherapy gynecological 
procedures were administered doses higher than those prescribed.
    The first patient was prescribed a total dose of 92.9 Gy (9,290 
rad). This dose included brachytherapy treatments of 20 Gy (2,000 rad) 
and 22.5 Gy (2,250 rad) using Ir-192 sources and a dose of 50.4 Gy 
(5,040 rad) from an external beam linear accelerator. On September 18, 
2000, the patient was administered a brachytherapy dose of 33.3 Gy 
(3,330 rad) Ir-192 instead of the prescribed dose of 20 Gy (2,000 rad). 
On October 9, 2000, the same patient was administered a brachytherapy 
dose of 35 Gy (3,500 rad) Ir-192 instead of the prescribed dose of 22.5 
Gy (2,250 rad) Ir-192. The patient was also administered the prescribed 
dose of 50.4 Gy (5,040 rad) from an external beam linear accelerator.
    The second patient was prescribed a total dose of 90.7 Gy (9,070 
rad). This dose included brachytherapy treatments of 19.8 Gy (1,980 
rad) using Ir-192 sources and of 20.5 Gy (2,050 rad) using a 
combination of Ir-192 and radium-226 (Ra-226) sources and a dose of 
50.4 Gy (5,040 rad) from an external beam linear accelerator. On August 
22, 2000, the patient was administered a brachytherapy dose of 35.2 Gy 
(3,520 rad) Ir-192 instead of the prescribed dose of 19.8 Gy (1,980 
rad) Ir-192. On September 5, 2000, the same patient was administered 
the prescribed dose of 20.5 Gy (2,050 rad) using a combination of Ir-
192 and Ra-226 implant sources. The patient was also administered the 
prescribed dose of 50.4 Gy (5,040 rad) from an external beam linear 
accelerator.
    The third patient was prescribed a total dose of 63.9 Gy (6,390 
rad). This dose included a brachytherapy treatment of 18.9 Gy (1,890 
rad) using Ir-192 sources and a dose of 45 Gy (4,500 rad) from an 
external beam linear accelerator. On October 30, 2000, the patient was 
administered a brachytherapy dose of 32.4 Gy (3,240 rad) Ir-192 instead 
of the prescribed dose of 18.9 Gy (1,890 rad) Ir-192. The patient was 
also administered the prescribed dose of 45 Gy (4,500 rad) from an 
external beam linear accelerator.
    The fourth patient was prescribed a total dose of 79.3 Gy (7,925 
rad). This dose included brachytherapy treatments of 20.3 Gy (2,025 
rad) and 14 Gy (1,400 rad) using Ir-192 sources and a dose of 45 Gy 
(4,500 rad) from an external beam linear accelerator. On October 23, 
2000, the patient was administered a brachytherapy dose of 31.5 Gy 
(3,150 rad) Ir-192 instead of the prescribed dose of 20.3 Gy (2,025 
rad) Ir-192. On November 6, 2000, the same patient was administered the 
prescribed brachytherapy dose of 14 Gy (1,400 rad) Ir-192. The patient 
was also administered the prescribed dose of 45 Gy (4,500 rad) from an 
external beam linear accelerator.
    The misadministrations were discovered on November 3, 2000, and 
November 13, 2000, during an internal audit of the licensee's Quality 
Management Program (QMP) by the Radiation Safety Officer (RSO) and the 
Radiation Protection Staff. A telephone report by the licensee's RSO 
was made to the Ohio Department of Health, Bureau of Radiation 
Protection, on November 4, 2000, and November 13, 2000.
    The first, second, and fourth patients were notified of the 
misadministrations. The notification of the third patient is pending 
because the patient was hospitalized for an unrelated infection. The 
licensee stated that the clinical treatment of these patients has not 
been affected by the misadministrations.
    Cause or Causes--The licensee indicated that this event was 
primarily caused by an operator error in the data entry of the source 
strength in the treatment planning computer. The facility obtained a 
new computer in August 2000, and the operator made a mistake and 
entered the source strengths in milligram-radium-equivalent instead of 
millicurie. Also, the quality assurance of the treatment planning was 
inadequate, and the second checks of treatment plans, to which the 
licensee committed in its QMP were inadequate.

Actions Taken To Prevent Recurrence

    Licensee--As soon as the licensee's management determined that a 
reportable event had occurred, the licensee took action to provide 
additional training to the staff involved in brachytherapy procedures. 
The licensee submitted a written report to the Ohio Department of 
Health, Bureau of Radiation Protection, within 15 days of discovering 
the misadministrations.
    State Agency--The Ohio Department of Health, Bureau of Radiation 
Protection, performed an onsite investigation on November 21 and 22, 
2000, to review the procedures and the findings of the licensee's 
quality management review and to confirm that the licensee's corrective 
action proposal is adequate to prevent recurrence. Enforcement actions 
or penalties, if any, will be determined at a later date.
    This event is closed for the purpose of the AO report to Congress.
* * * * *

    Dated at Rockville, Maryland this 25th day of April, 2001.
    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 01-10821 Filed 4-30-01; 8:45 am]
BILLING CODE 7590-01-P