27106 Federal Register / Vol. 61, No. 105 / Thursday, May 30, 1996 / Notices

(3150–0011), NEOB–10202, Office of

Management and Budget, Washington,

DC 20503.

Comments can also be submitted by

telephone at (202) 395–3084.

The NRC Clearance Officer is Brenda

Jo. Shelton, (301) 415–7233.

Dated at Rockville, Maryland, this 8th day

of May, 1996.

For the Nuclear Regulatory Commission.

Gerald F. Cranford,

Designated Senior Official for Information

Resources Management.

[FR Doc. 96–13514 Filed 5–29–96; 8:45 am]

BILLING CODE 7590–01–P

[Docket Nos. 50–325 and 50–324]

Carolina Power & Light Company;

Notice of Withdrawal of Application for

Amendment to Facility Operating

License

The U.S. Nuclear Regulatory

Commission (the Commission) has

granted the request of Carolina Power &

Light Company (the licensee) to

withdraw its December 29, 1992,

application for proposed amendment to

Facility Operating License Nos. DPR–71

and DPR–62 for the Brunswick Steam

Electric Plant, Units 1 and 2, located in

Brunswick County, North Carolina.

The proposed amendment would

have revised the Type A test acceptance

criterion for the as found containment

integration leakage rate from 0.75 La to

1.0 La (and 0.75 Lt to 1.0 Lt) that

represents the maximum allowable

containment leakage rate.

The Commission had previously

issued a Notice of Consideration of

Issuance of Amendment published in

the Federal Register on June 23, 1993,

(58 FR 34070). However, by letter dated

January 30, 1995, the licensee withdrew

the proposed change.

For further details with respect to this

action, see the application for

amendment dated December 29, 1992,

and the licensee’s letter dated January

30, 1995, which withdrew the

application for license amendment. The

above documents are available for

public inspection at the Commission’s

Public Document Room, the Gelman

Building, 2120 L Street, NW.,

Washington, DC, and at the local public

document room located at the

University of North Carolina at

Wilmington, William Madison Randall

Library, 601 S. College Road,

Wilmington, North Carolina 28403–

3297.

Dated at Rockville, Maryland, this 16th day

of May 1996.

For the Nuclear Regulatory Commission.

Brenda L. Mozafari,

Project Manager, Project Directorate II–1,

Division of Reactor Projects—I/II, Office of

Nuclear Reactor Regulation.

[FR Doc. 96–13516 Filed 5–29–96; 8:45 am]

BILLING CODE 7590–01–P

[Docket No. 030–03368; License No. 46–

02645–03; EA 96–004]

Department of the Army, Madigan

Army Medical Center, Tacoma,

Washington; Order Imposing Civil

Monetary Penalty

I

Madigan Army Medical Center

(MAMC, Licensee) is the holder of NRC

Materials License No. 46–02645–03,

first issued by the Atomic Energy

Commission on May 12, 1960. The

Nuclear Regulatory Commission (NRC

or Commission) issued its first license

amendment to MAMC on May 26, 1977.

The license authorizes the Licensee to

possess byproduct material of various

types and to use such material in

implementing a nuclear medicine

program in accordance with the

conditions specified therein.

II

An inspection and investigation of the

Licensee’s activities were conducted

June 6 through December 21, 1995,

following the Licensee’s report of

medical misadministrations that were

discovered in June 1995. The results of

the inspection and investigation,

documented in a report issued on

January 5, 1996, NRC Inspection Report

No. 030–03368/95–01 and Investigation

Report 4–95–027, indicated that the

Licensee had not conducted its

activities in full compliance with NRC

requirements. A predecisional

enforcement conference was conducted

on January 18, 1996, at the Licensee’s

facility. A written Notice of Violation

and Proposed Imposition of Civil

Penalty (Notice) in the amount of $8,000

was served upon the Licensee by letter

dated February 22, 1996. The Notice

described the nature of the violations,

the provisions of the NRC’s

requirements that the Licensee had

violated, and the amount of the civil

penalty proposed for the violations.

The Licensee responded to the Notice

in two letters both dated March 21, 1996

(Reply to a Notice of Violation and

Answer to a Notice of Violation). In its

responses, the Licensee admitted the

violations but requested mitigation of

the proposed civil penalty based on

actions taken by the Madigan Army

Medical Center (MAMC) to identify and

correct the violations.

III

After consideration of the Licensee’s

response and the statements of fact,

explanation, and argument for

mitigation contained therein, the NRC

staff has determined, as set forth in the

Appendix to this Order, that the

violations occurred as described in the

Notice, and that the penalty proposed

for the violations should be imposed.

IV

In view of the foregoing and pursuant

to Section 234 of the Atomic Energy Act

of 1954, as amended (Act), 42 U.S.C.

2282, and 10 CFR 2.205, it is hereby

ordered that:

The Licensee pay a civil penalty in

the amount of $8,000 within 30 days of

the date of this Order, by check, draft,

money order, or electronic transfer,

payable to the Treasurer of the United

States and mailed to James Lieberman,

Director, Office of Enforcement, U.S.

Nuclear Regulatory Commission, One

White Flint North, 11555 Rockville

Pike, Rockville, MD 20852–2738.

V

The Licensee may request a hearing

within 30 days of the date of this Order.

Where good cause is shown,

consideration will be given to extending

the time to request a hearing. A request

for extension of time must be made in

writing to the Director, Office of

Enforcement, U.S. Nuclear Regulatory

Commission, Washington, D.C. 20555,

and include a statement of good cause

for the extension. A request for a

hearing should be clearly marked as a

‘‘Request for an Enforcement Hearing’’

and shall be addressed to the Director,

Office of Enforcement, U.S. Nuclear

Regulatory Commission, Washington,

D.C. 20555, with a copy to the

Commission’s Document Control Desk,

Washington, D.C. 20555. Copies also

shall be sent to the Assistant General

Counsel for Hearings and Enforcement

at the same address and to the Regional

Administrator, NRC Region IV, 611

Ryan Plaza Drive, Suite 400, Arlington,

Texas 76011.

If a hearing is requested, the

Commission will issue an Order

designating the time and place of the

hearing. If the Licensee fails to request

a hearing within 30 days of the date of

this Order (or if written approval of an

extension of time in which to request a

hearing has not been granted), the

provisions of this Order shall be

effective without further proceedings. If

payment has not been made by that
Federal Register / Vol. 61, No. 105 / Thursday, May 30, 1996 / Notices 27107

time, the matter may be referred to the

Attorney General for collection.

In the event the Licensee requests a

hearing as provided above, the issue to

be considered at such hearing shall be:

whether, on the basis of the violations

admitted by the Licensee, this Order

should be sustained.

Dated at Rockville, Maryland, this 20th day

of May 1996.

For the Nuclear Regulatory Commission.

James Lieberman,

Director, Office of Enforcement.

Appendix—Evaluation and Conclusions

On February 22, 1996, a Notice of Violation

and Proposed Imposition of Civil Penalty

(Notice) in the amount of $8,000 was issued

to Madigan Army Medical Center (MAMC or

Licensee) for violations identified during an

NRC inspection and investigation. The

Licensee responded to the Notice in two

letters both dated March 21, 1996. The

Licensee admitted the violations but

requested mitigation of the proposed civil

penalty based on actions taken by MAMC to

identify and correct the violations.

Restatement of Violations Assessed a Civil

Penalty

I. Violations Assessed a Civil Penalty

A. 10 CFR 35.25(a) (1) and (2) require, in

part, that a licensee that permits the receipt,

possession, use, or transfer of byproduct

material by an individual under the

supervision of an authorized user shall: (1)

instruct the supervised individual in the

licensee’s written quality management

program (QMP); and (2) require the

supervised individual to follow the written

QMP procedures established by the licensee.

Item 4 of the licensee’s QMP specified, in

part, that when computer calculations are

performed, an individual who did not make

the original calculations will check the dose

calculation parameters.

Contrary to the above, the licensee did not

meet the above requirements as specified in

the following examples:

1. As of June 6, 1995, the licensee had not

assured that individuals working under the

supervision of an authorized user, i.e., the

medical physicist and dosimetrist, were

adequately instructed in the licensee’s

written QMP. Specifically, although the

medical physicist and dosimetrist had signed

a record indicating that they had reviewed

department procedures, including the QMP,

they had neither received specific instruction

in the procedures incorporated in the QMP

nor read each of the procedures.

2. Between February 1994 and May 1995,

the licensee took no action to require or

assure that individuals working under the

supervision of an authorized user, i.e., the

medical physicist and dosimetrist, were

aware of, or were following, the licensee

written QMP procedures established by the

licensee. Specifically, computer calculations

performed were not checked by an individual

who did not make the original calculations.

(01012)

B. 10 CFR 35.32(a) requires, in part, that

the licensee establish and maintain a written

QMP to provide high confidence that

byproduct material or radiation from

byproduct material will be administered as

directed by the authorized user.

10 CFR 35.32(a) (3) and (4) require, in part,

that the QMP include written policies and

procedures to meet the objectives that: (1)

final plans of treatment and related

calculations for brachytherapy are in

accordance with the applicable written

directives and (2) that each administration of

radiation from brachytherapy is in

accordance with the applicable written

directive.

Contrary to the above, between February

1994 and May 1995, the licensee’s QMP did

not include written procedures that met the

above stated objectives. Consequently, in five

cases involving patients undergoing

brachytherapy treatment during this time

period, incorrect data values were entered in

a computerized treatment planning system

used to develop final treatment plans. The

entry of incorrect data resulted in errors in

the calculated dose rates identified in final

treatment plans, thus causing the

administered doses to deviate substantially

from the prescribed doses specified in the

authorized users’ written directives. (01022)

These violations represent a Severity Level

II problem (Supplement VI). Civil Penalty—

$8,000

Summary of the Licensee’s Request for

Mitigation

MAMC responded to the Notice on March

21, 1996, admitting the violations but

requesting mitigation of the proposed $8,000

civil penalty based on its actions to identify

and correct the violations. MAMC noted in

its response that ‘‘NRC enforcement actions

are intended to act as a deterrent against

future violations and to encourage prompt

identification and comprehensive correction

of violations.’’ MAMC then noted that it had

identified the violations and made immediate

extensive modifications to the radiation

safety program and Quality Management

Program (QMP) to ensure that the violations

would not recur. MAMC described each of

the corrective actions and stated that

‘‘processes have been implemented to ensure

compliance with the QMP as well as a broad

range of internal controls developed to

prevent reoccurrence.’’ MAMC stated that a

standard civil penalty for a Severity Level II

violation ($4,000) should be sufficient, noting

that this would more appropriately match the

intent of NRC’s Enforcement Policy and more

accurately reflect MAMC’s efforts in

identifying and correcting the program

deficiencies.

NRC Evaluation of Licensee’s Request for

Mitigation

The Licensee is correct that among the

stated purposes of the NRC Enforcement

Policy (NUREG–1600) is to encourage prompt

identification and comprehensive correction

of violations. In this case, normal application

of the enforcement policy guidance in

Sections VI.B.2.b and c did in fact result in

credit for MAMC’s identification of the

violations and corrective actions. However,

Section VII.A. of the Enforcement Policy

provides that civil penalties may be escalated

to ensure that the proposed civil penalty

reflects the significance of the circumstances

and conveys the appropriate regulatory

message to the licensee. The violations which

led to the misadministrations are of very

significant regulatory concern to the NRC.

There were at least five cases involving

patients undergoing brachytherapy treatment

where MAMC administered radiation in

excess of what was intended before MAMC

discovered an error in its computerized

treatment planning program. At least one of

these patient misadministrations was later

determined by medical consultants of the

Licensee and the NRC to have had potential

adverse health effects for the patient

involved.

It was determined by NRC inspection and

investigation that the misadministrations

were caused, at least in part, by the

Licensee’s failure to assure that the MAMC

staff was implementing the facility’s Quality

Management Program (QMP) as required and

failure to adequately oversee the QMP.

Additional training of the Licensee’s

personnel and increased management

oversight could have prevented the

misadministrations. These

misadministrations were preventable.

The violations in this case were classified

as a Severity Level II problem in recognition

of this fundamental breakdown in the very

program that is intended to prevent such

misadministrations from occurring. The

Enforcement Policy provides at Section

VII.A.1(a) that discretion should be

considered to escalate civil penalties in cases

where problems are categorized at Severity

Level I or II. As noted in Section I of the

Enforcement Policy, enforcement action

should be used not only to encourage

identification and prompt, comprehensive

correction of violations, but also as a

deterrent to emphasize the importance of

compliance with NRC requirements. While

no violation is acceptable, the fact that these

violations were preventable cannot be

tolerated. In this case, discretion was clearly

warranted to assess a civil penalty to MAMC,

notwithstanding application of the

identification and corrective action factors, to

emphasize the importance of preventing

significant misadministrations through

supervision, training and management

oversight. Considering the significance of the

actual effects of the violations and their root

causes, it was appropriate and wholly

consistent with the Enforcement Policy

guidance to deny mitigation, exercise

discretion and assess a civil penalty of

$8,000.

NRC Conclusion

The NRC concludes that an adequate basis

for mitigation of the civil penalty is not

provided by the Licensee. The NRC also

concludes that the proposed civil penalty of

$8,000 is appropriate and should be imposed

by order.

[FR Doc. 96–13515 Filed 5–29–96; 8:45 am]

BILLING CODE 7590–01–P