[Federal Register Volume 59, Number 103 (Tuesday, May 31, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13143]


[[Page Unknown]]

[Federal Register: May 31, 1994]


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NUCLEAR REGULATORY COMMISSION
 

Miami Valley Hospital, Dayton, OH; Order Imposing Civil Monetary 
Penalty

[Docket No. 030-02643, License No. 34-00341-06, EA 93-288]

I

    Miami Valley Hospital (licensee) is the holder of Byproduct 
Material License No. 34-00341-06 issued by the Nuclear Regulatory 
Commission (NRC or Commission) on June 24, 1958. The license authorizes 
the licensee to use and possess licensed material for the purposes 
described in 10 CFR 35.100, 10 CFR 35.200, 10 CFR 35.300, 10 CFR 
35.400, 10 CFR 35.500, 10 CFR 31.11, and in accordance with the license 
conditions specified therein.

II

    An inspection of the licensee's activities was conducted from 
October 25 to October 27, 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 March 1, 1994. The Notice stated 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 
Violation I.A.
    The licensee responded to the Notice by letter dated March 28, 
1994. In its response, the licensee admitted the violations but 
requested that the civil penalty assessed for Violation I.A. be 
mitigated.

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 Violation I.A. occurred as stated and that the penalty 
proposed for Violation I.A. 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 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, 
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 III, 801 Warrenville Road, 
Lisle, Illinois 60532-4351.
    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 Violation 
I.A. designated in the Notice, this Order should be sustained.

    Dated at Rockville, Maryland this 23rd day of May 1994.

    For the Nuclear Regulatory Commission.
Hugh L. Thompson, Jr.
Deputy Executive Director for Nuclear Materials Safety Safeguards and 
Operations Support.

APPENDIX--Evaluation and Conclusion

    On March 1, 1994, a Notice of Violation and Proposed Imposition 
of Civil Penalty (Notice) was issued for violations identified 
during an NRC inspection. Miami Valley Hospital (licensee) responded 
to the Notice on March 28, 1994. The licensee admitted the 
violations but requested that the civil monetary penalty proposed 
for Violation I.A. be mitigated. The NRC's evaluation and conclusion 
regarding the licensee's request follows:

Restatement of Violation I.A.

    Condition 24. of License No. 34-00341-06 requires that licensed 
material be possessed and used in accordance with statements, 
representations and procedures contained in an application received 
on September 25, 1988.
    Item 10.4 of the section of the referenced application entitled, 
``Safe Use of Radiopharmaceuticals,'' requires that the licensee 
follow Appendix I to Regulatory Guide 10.8, Revision 2. Item 2 of 
Appendix I requires individuals to wear gloves at all times while 
handling radioactive materials.
    Contrary to the above, on September 10, 1993, an individual 
handled radioactive material, strontium-89, without wearing gloves.

Summary of Licensee's Request for Mitigation

    The licensee admitted the violation and requested that the civil 
penalty be mitigated because, according to the licensee: (1) The 
apparent willful nature of the violation was not deliberate or 
capricious and the authorized user is not a deliberate violator of 
NRC regulations but rather acted out of conflicting needs dictated 
by concern for the safety of the technologist, the patient's 
condition, the authorized user's schedule, and the small risk of a 
spill; (2) the authorized user was completely candid; (3) the 
authorized user was fully cooperative; (4) the authorized user has 
an excellent record of performance with NRC license requirements and 
this is the first violation in which he has been involved; (5) the 
violation is the isolated action of the authorized user and did not 
result from lack of management oversight; and (6) substantial 
corrective action has already been taken and documented, concerning 
this violation.

NRC Evaluation of Licensee's Request for Mitigation

    On September 10, 1993, an authorized user physician administered 
3.5 millicuries of strontium-89 to a bedridden patient at the 
patient's home. The physician was not wearing gloves during this 
palliative treatment, although he had been reminded by the Manager 
of Nuclear Medicine that he needed gloves for the procedure. As the 
physician attempted to expel air from the syringe, a small amount of 
strontium-89 was also expelled from the syringe, which contaminated 
the physician's right index finger, resulting in an overexposure. 
The overexposure would have been avoided had the physician worn 
gloves.
    The NRC agrees that the nature of the violation was not 
deliberate (i.e., the authorized user was not a deliberate violator 
of NRC regulations). If that had been the case, more stringent 
enforcement sanctions would have been considered, including 
enforcement action directly against the authorized user under the 
Deliberate Misconduct Rule (56 FR 40664). NRC did find that the 
violation was willful. 10 CFR part 2, Appendix C, ``Policy and 
Procedure for Enforcement Actions; Policy Statement'' (Enforcement 
Policy) provides in Section IV.C. that the term ``willfulness'' 
embraces a spectrum of violations ranging from deliberate intent to 
violate of falsify to and including careless disregard for 
requirements (emphasis added). In reviewing the incident, the NRC 
concluded that, based on the reminder from the Manager of Nuclear 
Medicine and based on the licensee's contention that the physician 
was not ignorant of NRC license requirements, the physician either 
knew or should have known that he was required to use gloves during 
the procedure. While the physician may have believed that other 
factors, such as convenience or scheduling, outweighed the need to 
wear gloves, this does not excuse his disregard of the requirements 
once the issue of the gloves was specifically brought to his 
attention. If there was any confusion concerning the issue, the 
authorized user clearly should have sought a clarification, for 
example by contacting the RSO. Therefore, the matter of not wearing 
gloves constitutes a willful violation involving careless disregard 
as those terms are used in the Enforcement Policy. The licensee's 
argument that the violation is not deliberate provides no basis for 
mitigation of the civil penalty amount.
    Regarding the licensee's characterization of the authorized user 
(i.e., candid, cooperative, and excellent record of NRC 
performance), the character attributes of a person are not relevant 
to whether a civil penalty will be mitigated. Rather, the NRC 
Enforcement Policy identifies six specific factors to be considered 
for escalation or mitigation of a civil penalty. (See Section 
VI.B.2, Enforcement Policy). Furthermore, the NRC expects and 
requires that licensee personnel be candid and cooperative and 
comply with all NRC requirements.
    The NRC recognizes that this was an isolated event; however, 
that does not change the fact that the violation occurred. The 
violation was willful and was appropriately categorized at Severity 
Level III. Had there been multiple examples of the violation, the 
base civil penalty would have been increased by as much as 100% 
based on the escalating factor in the Enforcement Policy for 
multiple occurrences.
    Regarding the licensee's argument that the violation did not 
result from a lack of management oversight, the NRC acknowledges 
that management above the level of the authorized user was not 
involved in the violation. However, the NRC Enforcement Policy, 
Section IV.C, Footnote 7, defines a ``licensee official'' as 
including an authorized user of licensed material whether or not 
listed on a license. In this case, the authorized user, acting as a 
``licensee official'', did not exercise sufficient oversight over 
his own actions to ensure that NRC requirements were followed.
    Finally, the licensee argues that the civil penalty should be 
mitigated because of the actions taken to correct the violation. The 
NRC recognized the licensee's corrective actions and considered 
whether to allow mitigation for those actions in determining the 
amount of the civil penalty. The staff fully mitigated the base 
civil penalty for corrective actions for the violations in Section 
II, however, the staff exercised discretion as permitted in Section 
VII of the Enforcement Policy and did not mitigate the base civil 
penalty for the willful violation in Section I.A. as stated in the 
NRC's letter of March 1, 1994. NRC did not mitigate the civil 
penalty for Violation I.A. to emphasize that willful violations 
cannot be tolerated by either the Commission or the licensee.

NRC Conclusion

    The NRC has concluded that this violation occurred as stated and 
that neither an adequate basis for a reduction of the severity level 
nor for mitigation of the civil penalty was provided by the 
licensee. Consequently, the proposed civil penalty in the amount of 
$2,500 should be imposed.
[FR Doc. 94-13143 Filed 5-27-94; 8:45 am]
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