[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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