[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]
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