[Federal Register Volume 59, Number 3 (Wednesday, January 5, 1994)]
[Notices]
[Pages 608-610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-126]
[[Page Unknown]]
[Federal Register: January 5, 1994]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-20111, License No. 25-21258-01, EA 93-202]
Physicians' Laboratory Service, Inc. (Former Licensee) Bozeman,
MT; Order Imposing Civil Monetary Penalty
I
Physicians' Laboratory Service, Inc. (Licensee or PLS) was the
holder of NRC License No. 25-21258-01 (License) issued by the Nuclear
Regulatory Commission (NRC or Commission). The License, which was
transferred to Bozeman Deaconess Hospital on July 2, 1993, authorized
the Licensee to possess and use byproduct material to conduct nuclear
medicine activities in accordance with the conditions of the License.
II
An inspection of the Licensee's activities was conducted July 14-
16, 1993. The results of this inspection indicated that the Licensee
had not conducted its activities in full compliance with NRC
requirements. A written Notice of Violation and Proposed Imposition of
Civil Penalty (Notice) was served upon the Licensee by letter dated
October 18, 1993. The Notice described the circumstances surrounding
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 a letter dated November 17,
1993. In its letter, the Licensee admitted the violations which
resulted in the proposed civil penalty, but requested that the NRC
reconsider the circumstances surrounding the violations and mitigate
the proposed civil penalty for reasons that are summarized in the
Appendix to this order.
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 stated and that the penalty
proposed for the violations designated in the Notice 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 the civil penalty in the amount of $2,500
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 the Director, Office of Enforcement,
U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk,
Washington, DC 20555.
V
The Licensee may request a hearing within 30 days of the date of
this Order. 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,
ATTN: Document Control Desk, Washington, DC 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, the
provisions of this Order shall be effective without further
proceedings. If payment has not been made by that 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 22nd day of December 1993.
For the Nuclear Regulatory Commission.
Hugh L. Thompson, Jr.,
Deputy Executive Director for Nuclear Materials Safety, Safeguards and
Operations Support.
Appendix--Evaluation and Conclusions
On October 18, 1993, a Notice of Violation and Proposed
Imposition of Civil Penalty (Notice) was issued for violations
identified during an NRC inspection on July 14-16, 1993. Physicians'
Laboratory Service, Inc. responded to the Notice on November 17,
1993. The Licensee admitted the violations that resulted in the
proposed civil penalty, but requested that the NRC reconsider the
circumstances surrounding the violations and mitigate the proposed
civil penalty. A restatement of the violation, and the NRC's
evaluation and conclusions regarding the Licensee's request follow:
Restatement of Violations Assessed a Civil Penalty
10 CFR 35.32 (a) and (e), require, in part, that by January 27,
1992, each licensee establish and maintain a written quality
management program to provide high confidence that byproduct
material or radiation from byproduct material will be administered
as directed by the authorized user. The quality management program
must include written policies and procedures to meet specific
objectives, including that prior to administration, a written
directive is prepared for any administration of quantities greater
than 30 microcuries of sodium iodide I-125 or I-131.
10 CFR 35.2, ``Definitions,'' defines a written directive, in
part, as an order in writing for a specific patient, dated and
signed by an authorized user prior to administration of a
radiopharmaceutical and specifies, in part, that for the
administration of quantities greater than 30 microcuries of either
sodium iodide I-125 or I-131 or any therapeutic administration of a
radiopharmaceutical other than sodium iodide I-125 or I-131, the
written directive must include the dosage.
1. Contrary to the above, between January 27, 1992, and July 27,
1992, the licensee did not establish a written quality management
program (01013).
2. Contrary to the above, on numerous occasions after January
27, 1992, including March 8 and 22, May 13, June 3, and July 1,
1993, the licensee administered sodium iodide I-131 for diagnostic
purposes in quantities greater than 30 microcuries without a written
directive signed by an authorized user (01023).
These violations represent a Severity Level III problem
(Supplement VI).
Civil Penalty--$2,500
Summary of Licensee's Request for Mitigation
In response to the violation involving the failure to establish
a written Quality Management Program, the Licensee admitted that it
did not establish a Quality Management Program by the January 27,
1992 effective date of the rule. The Licensee states that it first
learned of the requirement to establish a Quality Management Program
following receipt of the June 1992 NMSS Newsletter and that it
immediately devised a plan and submitted it to the NRC by July 27,
1992. Because corrective action was taken without NRC intervention,
the Licensee requested that the violation be dismissed or mitigated
to a reprimand without penalty.
In response to the violation concerning the administration of
sodium iodide without a written directive signed by an authorized
user, the Licensee admitted that a ``minimal number'' of patients
received dosages of greater than 30 microcuries without written
directives having been prepared. The Licensee stated that it took
immediate corrective action and requested that the violation and the
civil penalty be mitigated. In addition, the Licensee requested that
the NRC take into account the fact that during the past 23 years,
approximately 20,000 to 23,000 diagnostic administrations had
occurred with no known misadministrations.
NRC Evaluation of Licensee's Request for Mitigation
The violations were not considered separately in this case. The
proposed penalty was based on the aggregate of the two violations
(i.e., a Severity Level III problem). Thus, the severity level of
the violations was based on their collective significance--that is
the combination of not establishing a Quality Management Program
until six months after the effective date of the rule and not
implementing the requirements of the Quality Management Program even
after a written program was established by the Licensee.
The NRC places a great deal of importance on its Quality
Management regulation. Thus, its Enforcement Policy was revised at
the same time the rule was adopted to place an emphasis on
noncompliance with the rule. Example C.6 was added to Supplement VI,
such that violations involving ``A substantial failure to implement
the quality management program as required by Sec. 35.32 * * *'' was
to be classified at Severity Level III (Note: This was later amended
to state ``Substantial failure to implement the quality management
program as required by Sec. 35.32 that does not result in a
misadministration * * *'').
The term ``substantial'' has consistently been applied to
failures of a programmatic, as opposed to an isolated, nature. In
this case, the Licensee's failure was deemed programmatic because
the Licensee repeatedly failed to use written directives for
diagnostic administrations of sodium iodide I-131 on quantities that
exceeded 30 microcuries because of weaknesses in the program. Thus,
the violations were appropriately classified in the aggregate as a
Severity Level III problem.
With regard to the magnitude of the proposed civil penalty, the
Licensee's argument are related to the civil penalty adjustment
factors of Identification, Corrective Action and Licensee
Performance. The use of these factors is described in Section VI.B.2
of the Enforcement Policy. No adjustment was made to the proposed
base penalty with respect to any of these factors.
Although the Licensee identified its failure to establish a
Quality Management Program and corrected it by submitting a plan to
the NRC, the plan it submitted lacked specificity, contributing in
part to the second violation, the failure to use written directives
for diagnostic administrations of I-131 in excess of 30 microcuries.
The second violation was identified by the NRC, continued for nearly
a year after the Licensee became aware of the regulation, and was
occurring at the time of the license transfer. The Licensee's
arguments do not provide a basis for mitigation under the
identification factor.
No adjustment was made under the corrective action factor
because these violations were discovered after the license had been
transferred to another entity. Thus, this factor did not, and still
does not, appear to be applicable to the circumstances of this case.
In addition, although the Licensee corrected its failure to
establish a Quality Management Program, its corrective action was
weak, i.e., the Licensee did not implement the use of written
directives for diagnostic procedures, as discussed above. Thus, the
Licensee has not provided a basis for mitigation under the
corrective action factor.
No adjustment was made under the licensee performance factor.
The Licensee's performance was considered relatively poor in the two
inspections that preceded the July 14-16, 1993 inspection. Several
Severity Level IV and V violations were issued following each of the
two prior inspections, one occurring in September 1991 and the other
occurring in March 1990. This was balanced, however, against the
fact that the July 1993 inspection found only the violations related
to the Quality Management rule. Thus, notwithstanding the Licensee's
statements about an absence of misadministration, the Licensee has
not provided a basis for mitigation under the prior performance
factor.
NRC Conclusion
The Licensee has not provided any information that provides a
basis for reclassifying the violations or mitigating the proposed
civil penalty. The proposed civil penalty in the amount of $2,500
should be imposed by order.
[FR Doc. 94-126 Filed 1-4-94; 8:45 am]
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