[Federal Register Volume 60, Number 158 (Wednesday, August 16, 1995)]
[Notices]
[Pages 42630-42632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20239]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-00472, License No. 37-02385-01, EA No. 95-021]
Carlisle Hospital, Carlisle, PA; Order Imposing a Civil Monetary
Penalty
I
Carlisle Hospital (Licensee) is the holder of Byproduct Materials
License No. 37-02385-01 (License) issued by the Nuclear Regulatory
Commission (NRC or Commission) on March 12, 1985. The License was most
recently renewed by the Commission on April 7, 1993. The License
authorizes the Licensee to possess and use certain byproduct materials
in accordance with the conditions specified therein at the Licensee's
facility in Carlisle, Pennsylvania.
II
An inspection of the Licensee's activities was conducted on
February 2 and 3, 1994, at the Licensee's facility located in Carlisle,
Pennsylvania. In addition, an investigation was conducted subsequently
by the NRC Office of Investigations. The results of this 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 June 6, 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 one of the violations.
The Licensee responded to the Notice in a letter dated July 5,
1995. In its response, the Licensee admits the violation assessed a
civil penalty (Violation I), and requests abatement or mitigation of
the penalty.
II
After consideration of the Licensee's response and the statements
of fact, explanation, and argument contained therein, the NRC staff has
determined, as set forth in the Appendix to this Order, that an
adequate basis was not provided for abatement or mitigation of the
penalty and that a penalty of $5000 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 $5000 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, Maryland 20852-2738.
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, DC 20555, with a copy to the Commission's 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 I, 475 Allendale Road, King of
Prussia, PA 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 violation admitted by the Licensee as set forth in
[[Page 42631]]
Section I of the Notice referenced in Section II above, this Order
should be sustained.
Dated at Rockville, Maryland this 7th day of August, 1995.
For the Nuclear Regulatory Commission.
James Lieberman,
Director, Office of Enforcement.
Appendix--Evaluations and Conclusion
On June 6, 1995, a Notice of Violation and Proposed Imposition
of Civil Penalty (Notice) was issued for violations identified
during an NRC inspection conducted at the Licensee's facility
located in Carlisle, Pennsylvania. The penalty was issued for one
violation. The Licensee responded to the Notice in a letter, dated
July 5, 1995. In its responses, the Licensee admits the violation
assessed a penalty (Violation I), and requests abatement or
mitigation of the civil penalty. The NRC's evaluation and conclusion
regarding the Licensee's requests are as follows:
Restatement of Violation Assessed a Civil Penalty
10 CFR 35.21(a) requires that the licensee, through the
Radiation Safety Officer, ensure that radiation safety activities
are being performed in accordance with regulatory requirements.
License Condition 11 of Amendment No. 19 of NRC License No. 37-
02385-01, which expired on February 29, 1992, but which remained in
effect (until Amendment No. 20 was issued on April 7, 1993) pursuant
to a timely renewal application made on October 7, 1991, states that
licensed material shall be used by, or under the supervision of,
Charles K. Loh, M.D., or Robert F. Hall, M.D.
10 CFR 35.13(b), in effect at the time the violation occurred,
provided that a licensee shall apply for and must receive a license
amendment before it permits anyone, except a visiting authorized
user described in 10 CFR 35.27, to work as an authorized user under
the license.
10 CFR 35.11(b) provides that an individual may use byproduct
material in accordance with the regulations in this chapter under
the supervision of an authorized user as provided in 10 CFR 35.25,
unless prohibited by license condition.
10 CFR 35.25(a)(3) requires, in part, that a licensee that
permits the use of byproduct material by an individual under the
supervision of an authorized user, shall periodically review the
supervised individual's use of byproduct material and the records to
reflect this use.
Contrary to the above, from December 3, 1992 to April 7, 1993,
the licensee, through its Radiation Safety Officer, failed to ensure
that radiation safety activities were being performed in accordance
with the above requirements. Specifically, during this period,
byproduct material was used by two individuals (other than Dr. Loh
or Dr. Hall) to perform teletherapy; and the two individuals were
not listed as authorized users on the license and did not qualify as
visiting authorized users pursuant to 10 CFR 35.27, and the
individuals' use of byproduct material was not under the supervision
of Dr. Loh or Dr. Hall (in that neither Dr. Loh nor Dr. Hall
reviewed the individuals' use of the byproduct material, and the
related records reflecting such use).
This is a Severity Level III violation (Supplements VI and VII).
Summary of Licensee's Request for Mitigation
The Licensee maintains that it is committed to full regulatory
compliance as illustrated by its past record. The Licensee stated
that it has only been issued one other Notice of Violation and
admitted that it involved a similar matter of concern as addressed
by the present Notice. The Licensee stated that it was of the belief
that this matter had been addressed adequately by having the
authorized users supervise the unauthorized users. The Licensee
further stated that its otherwise stellar record of compliance
evidences its commitment to compliance with regulatory requirements
of the NRC.
The Licensee also stated that, although the previously issued
Notice involved unauthorized use similar to that described in the
present Notice, it should not be the basis for escalation of the
proposed penalty because the Licensee believed that the issue of
unauthorized use had been adequately addressed. The Licensee
contends that the underlying cause of the present violation stems
primarily from poor channels of communication and that these causes
were not apparent and not an issue, at the time of the previous
Notice. The Licensee stated that it did not previously have the
opportunity to address these communication issues.
The Licensee further stated that upon being apprised of the
violations, it took effective and comprehensive actions to correct
the violations and brought the Licensee into immediate compliance.
The Licensee further stated that the violation upon which the civil
penalty is based did not cause injury to patients, employees, or
staff nor did it create a substantial risk. The Licensee also stated
that the unauthorized physicians were well qualified, albeit
unauthorized, and subsequently were listed on the license by the
NRC, upon approval of the Licensee's amendment.
In addition, the Licensee contends that the violation would not
have occurred if the license amendment was timely processed. The
Licensee stated that it filed a license amendment with the NRC on
October 7, 1991. The Licensee further stated that the two
unauthorized physicians were to be added as authorized users. The
Licensee notes that while it did not request that the amendment be
expedited, the need to make such a request was not foreseen, because
it believed that proper supervision was being provided.
For these reasons, the Licensee requests that the proposed civil
penalty be wholly abated or, in the alternative, mitigated so as to
preclude the 100% escalation of the proposed civil penalty.
NRC Evaluation of Licensee's Request for Mitigation
The NRC letter, dated June 6, 1995, transmitting the proposed
civil penalty, notes that the base civil penalty amount of $2500 in
this case was increased by 50% because the violation was identified
by the NRC; increased by 100% because the Licensee had prior
opportunity to prevent the violation from recurring given the
issuance of the Notice of Violation on December 23, 1992, as well as
the telephone inquiry by NRC in February 1993; and decreased 50%
based on the Licensee's prompt and comprehensive corrective actions.
As a result, a penalty of $5000 was proposed.
The Licensee's enforcement history includes one violation
identified during an NRC inspection conducted in 1991, and one
violation identified during an NRC inspection conducted in 1992 that
involved the failure to apply for an amendment before permitting
physicians to work as authorized users. The latter violation was
identified again during the most recent inspection conducted in
February 1994.
The Licensee was given prior notice regarding this violation
based on the Notice of Violation dated December 23, 1992. It is the
Licensee's responsibility to assure that the violation does not
recur. The underlying cause of the violation identified during the
1994 inspection may in fact be different from the cause of the
similar violation in 1992; however, under the NRC Enforcement
Policy, the Licensee is expected to implement lasting corrective
action that will not only prevent recurrence of the violation at
issue but will be appropriately comprehensive to prevent the
occurrence of similar violations in the future. The Licensee
committed to providing supervision of the unauthorized users, and it
is the Licensee's responsibility to assure that the supervision was
provided. The supervision did not occur, even though a Licensee Vice
President informed the NRC during a February 1993 telephone
conversation that it was occurring.
The Licensee requests that credit be given for its prompt and
comprehensive corrective action for the violations identified during
the 1994 inspection. The NRC notes that the base civil penalty
amount was mitigated 50% based on the Licensee's prompt and
comprehensive corrective actions, as provided by the NRC Enforcement
Policy. Therefore, no further adjustment of the base civil penalty
is warranted based on this factor.
While the Licensee also contends that the violation did not
cause injury, the NRC notes that classification of a violation at
Severity Level III is based on its safety and regulatory
significance, and is not premised on an injury to an individual. If
a violation were to contribute directly to an injury to an
individual, a higher Severity Level could be assigned and a higher
civil penalty could be issued.
The NRC recognizes that the Licensee filed a request for renewal
of its NRC license on October 7, 1991, and the processing of that
renewal by the NRC was not completed until April 7, 1993. However,
during the exit interview following the 1992 inspection, the
Licensee informed the NRC inspector that the unauthorized users
would be supervised by physicians named on the NRC license. Then,
during a February 1993 telephone call to the Licensee's Vice
President, General Services, the Licensee again informed the NRC
that such supervision was being provided. Had
[[Page 42632]]
the Licensee provided accurate information to the NRC as required by 10
CFR 30.9, the NRC staff could have focused its review on the
qualifications of the unauthorized physicians and issued a separate
license amendment on an expedited basis to ensure that regulatory
compliance was maintained while patient teletherapy services
continued. Under these circumstances, the NRC staff believes that
the timeliness of the processing of the license renewal should not
be a mitigating factor in assessing the civil penalty amount.
Accordingly, based on the Enforcement Policy in effect at the
time, a $5,000 civil penalty was appropriate.
The NRC notes that its Enforcement Policy was revised on June
30, 1995 (60 FR 34381). In applying the revised NRC Enforcement
Policy, the same civil penalty of $5,000 would be warranted given
the willful nature of the violation; the fact that it was identified
by the NRC; consideration of the Licensee's good corrective actions;
and the exercise of discretion as warranted under the circumstances,
including the facts that the violation represents a recurrence
(i.e., directly repetitive) of an earlier violation and the Licensee
missed a number of opportunities to correct it. Therefore,
application of the new policy results in the same civil penalty
being assessed.
NRC Conclusion
The NRC has concluded that the Licensee did not provide an
adequate basis for abatement or mitigation of the civil penalty.
Accordingly, the proposed civil penalty in the amount of $5000
should be imposed.
[FR Doc. 95-20239 Filed 8-15-95; 8:45 am]
BILLING CODE 7590-01-P
