21788 Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices

MATTERS TO BE CONSIDERED: 

Week of April 30, 2001

There are no meetings scheduled for

the Week of April 30, 2001.

Week of May 7, 2001—Tentative

Thursday, May 10, 2001

10:25 a.m.—Affirmation Session

(Public Meeting) (If needed).

10:30 a.m.—Briefing on Office of

Nuclear Regulatory Research (RES)

Programs and Performance (Public

Meeting) (Contact: James Johnson, 301–

415–6802).

Friday, May 11, 2001

10:30 a.m.—Meeting with Advisory

Committee on Reactor Safeguards

(ACRS) (Public Meeting) (Contact: John

Larkins, 301–415–7360).

Week of May 14, 2001—Tentative

There are no meetings scheduled for

the Week of May 14, 2001.

Week of May 21, 2001—Tentative

There are no meetings scheduled for

the Week of May 21, 2001.

Week of May 28, 2001—Tentative

Wednesday, May 30, 2001

10:25 a.m.—Affirmation Session

(Public Meeting) (If needed).

Week of June 4, 2001—Tentative

Tuesday, June 5, 2001

9:25 a.m.—Affirmation Session

(Public Meeting) (If needed).

2 p.m.—Discussion of Management

issues (Closed-Ex. 2).

Wednesday, June 6, 2001

10:30 a.m.—All Employees Meeting

(Public Meeting).

1:30 p.m.—All Employees Meeting

(Public Meeting).

The schedule for Commission

meetings is subject to change on short

notice. To verify the status of meetings

call (recording)—(301) 415–1292.

Contact person for more information:

David Louis Gamberoni (301) 415–1651.

ADDITIONAL INFORMATION: By a vote of 5–

0 on April 23, the Commission

determined pursuant to U.S.C. 552b(e)

and § 9.107(a) of the Commission’s rules

that ‘‘Affirmation of Final Rule to

Amend 10 CFR Part 2, Subpart J, in

Regard to the Licensing Support

Network’’ be held on April 24, and on

less than one week’s notice to the

public.

The NRC Commission Meeting

Schedule can be found on the Internet

at: http://www.nrc.gov/SECY/smj/

schedule.htm

This notice is distributed by mail to

several hundred subscribers; if you no

longer wish to receive it, or would like

to be added to the distribution, please

contact the office of the Secretary,

Washington, DC 20555 (301–415–1969).

In addition, distribution of this meeting

notice over the Internet system is

available. if you are interested in

receiving this Commission meeting

schedule electronically, please send an

electronic message to dkw@nrc.gov.

Dated: April 26, 2001.

David Louis Gamberoni,

Technical Coordinator, Office of the

Secretary.

[FR Doc. 01–10955 Filed 4–27–01; 12:20 pm]

BILLING CODE 7590–01–M

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 NRCrequired 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 nonradioactive 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-tosecondary 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.

Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices 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 lessonslearned 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 lessonslearned 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) molybdenum99/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) shallowdose 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 NRCregulated 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

21790 Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices

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 airkerma, 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

Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices 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

21792 Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices

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.

Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices 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 Ir192 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 Ir192 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-radiumequivalent 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

NUCLEAR REGULATORY

COMMISSION

Plan for Updating and Consolidating

the Decommissioning Policy and

Guidance of the Nuclear Regulatory

Commission’s Office Nuclear Material

Safety and Safeguards, and Notice of

Public Meeting

AGENCY: Nuclear Regulatory

Commission.

ACTION: Publication of plan and notice

of public meeting.

SUMMARY: The Office of Nuclear

Material Safety and Safeguards (NMSS)

intends to consolidate and update the

policy and guidance for NMSS’s

decommissioning program. This

endeavor is in response to the NMSS

performance goals, in the NRC’s

Strategic Plan, of: (1) Making NRC

activities and decisions more effective,

efficient, and realistic; and (2) reducing

unnecessary regulatory burden on

stakeholders.

DATES: Comments on this plan should

be submitted by June 15, 2001. The

comments will be considered by NRC in

the process of updating and

consolidating the policy and guidance

for NMSS’s decommissioning program.

ADDRESSES: Submit written comments

to: Jack D. Parrott, Project Scientist,

Office of Nuclear Material Safety and

Safeguards, Mail Stop T–7F27, U.S.

Nuclear Regulatory Commission,

Washington, DC 20555–0001. Handdeliver comments to: 11555 Rockville

Pike, Rockville, MD, between 7:30 a.m.

and 4:15 p.m., Federal workdays. Copies

of comments received may be examined

at the NRC Public Document Room,

11555 Rockville Pike, Room O–1F21,

Rockville, MD 20852. The NRC Public

Document Room is open from 7:45 a.m.