[Federal Register Volume 61, Number 105 (Thursday, May 30, 1996)]
[Notices]
[Pages 27106-27107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13515]
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NUCLEAR REGULATORY COMMISSION
[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
[[Page 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
