[Federal Register Volume 60, Number 233 (Tuesday, December 5, 1995)]
[Notices]
[Pages 62269-62270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29539]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-30947; License No. 37-28331-01 EA 94-089]
Advacare Management Services, Inc., Bala Cynwyd, Pennsylvania;
Order Imposing Civil Monetary Penalty
I
Advacare Management Services, Inc. (Licensee) is the holder of
Materials License No. 37-28331-01 issued by the Nuclear Regulatory
Commission (NRC or Commission), issued April 4, 1989, renewed most
recently on May 9, 1994. The license authorizes the Licensee to possess
and use byproduct material for diagnostic nuclear medicine studies in
accordance with the conditions specified therein.
II
An inspection of the Licensee's activities was conducted on April
26-28, 1994. Subsequently, an investigation was conducted by the NRC
Office of Investigations. The results of the inspection and
investigation 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 August 30, 1995. The Notice
states 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, dated
September 21, 1995. In its responses, the Licensee admits the
violations as stated in the Notice, but requests mitigation of the
civil penalty.
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 a 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 Mr. James Lieberman, Director, Office of Enforcement, U.S.
Nuclear Regulatory Commission, Washington, D.C. 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,
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 I, 475 Allendale
Road, King of Prussia, Pennsylvania 19406.
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
issues 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 28th day of November 1995.
For the Nuclear Regulatory Commission.
James Lieberman,
Director, Office of Enforcement.
Appendix--Evaluations and Conclusion
On August 30, 1995 a Notice of Violation and Proposed Imposition
of Civil Penalty (Notice) was issued for violations identified
during an NRC inspection and subsequent investigation by the NRC
Office of Investigations. Advacare Management Services, Inc.
(Licensee) responded to the Notice on September 21, 1995. The
Licensee admitted the Violations, but requested mitigation of the
civil penalty. The NRC's evaluation and conclusion regarding the
licensee's requests are as follows:
1. Summary of Licensee's Request for Mitigation
In its responses, the Licensee contends that mitigating
circumstances were not fully considered by the NRC. In support of
its contention, the Licensee noted the following:
a. A prior inspection at the Bala Cynwyd facility identified few
items of non-compliance and thus provided a level of managerial
assurance that the radiation protection/compliance program was
acceptable.
b. The term ``promptly'', as used on page 3 of Mr. Martin's
letter dated August 30, 1995, is clearly a subjective word. The
Licensee stated that its audit reports were received in January 1994
and the NRC inspection was on April 26-28, 1994. The Licensee stated
that it was in the process of correcting the multiple minor areas of
non-compliance identified in the audits and although some of the
corrections were not completed by April 1, 1994, the majority were
corrected by the enforcement conference and by subsequent spot check
inspections by Region I inspectors between the June 1994 enforcement
conference and the time of the Licensee's responses. The Licensee
contends that its response was, in fact, reasonably prompt.
Therefore, the licensee requests that the combination of these
factors should result in a modification of the proposed civil
penalty from $2,500 to $1,250.
The Licensee further noted that it recognized and self-
identified material weaknesses in its radiation safety program and
contracted a consultant medical radiation physicist to assist the
RSO in correcting those weaknesses and that the correction process
was in place at the time of the inspection.
2. NRC Evaluation of Licensee's Request for Mitigation
The fact that an inspection was conducted at the Bala Cynwyd
facility, one of several Licensee facilities, and in which only a
few items of noncompliance were noted, three years prior to the
inspection conducted on April 26-28, 1994, does not alleviate the
need for aggressive managerial oversight of the radiation safety
program. In order to assure continued acceptable performance in the
area of radiation safety, the Licensee is required to not only
perform periodic audits of its radiation safety program in
accordance with its commitments under the ALARA program, but in
accordance with 10 CFR 35.23, through its Radiation Safety Officer
(RSO) identify radiation safety problems, as well as initiate
corrective actions and verify the implementation of those corrective
actions.
Although the Licensee had corrected some of the individual
violations identified by the NRC, it had not corrected the majority
of
[[Page 62270]]
them by the Enforcement Conference. The day prior to that Conference,
the Licensee submitted a lengthy letter addressing the violations
and the status of corrective actions. The information in this letter
was not completely accurate and at the Conference several
corrections were requested. These corrections were later submitted
by the Licensee. In addition, the NRC staff had questioned the RSO's
ability to meet his responsibilities for the numerous facilities and
Licensee management had indicated that it intended to request a
separate license for a New Jersey facility in order to relieve the
RSO of some responsibilities, but it had not yet done so. In
addition, the Licensee did not consider the need to apply similar
corrective actions at the other facilities covered by the license.
Although the Licensee had recognized that it had weaknesses in
its program and had engaged a consultant to assist the RSO, and
these actions led to eventual good comprehensive corrective action,
they were not sufficiently prompt and comprehensive as of the time
of the Enforcement Conference to provide a basis for mitigating the
civil penalty.
3. NRC Conclusion
The NRC has concluded that the violations occurred as stated and
an adequate basis for mitigation of the civil penalty was not
provided by the licensee. Consequently, the proposed civil penalty
in the amount of $2,500 should be imposed.
[FR Doc. 95-29539 Filed 12-4-95; 8:45 am]
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