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EA-03-205 - Rice Memorial Hospital

December 15, 2003

EA-03-205

Lawrence Massa
Chief Operating Officer
Rice Memorial Hospital
301 Becker Avenue, S.W.
Willmar, MN 56201

SUBJECT: RICE MEMORIAL HOSPITAL - NRC INSPECTION REPORT
(IR 030-02239/2003-001(DNMS)) AND NOTICE OF VIOLATION

Dear Mr. Massa:

This refers to a routine inspection conducted on October 30, 2003, at Rice Memorial Hospital, Willmar, Minnesota, with continued in-office review through November 17, 2003. The inspection also included observations of a mobile service operation at the Montevideo Hospital in Montevideo, Minnesota. The inspection was an examination of activities conducted under your license and consisted of a selected examination of procedures and representative records, observations of activities, and interviews with personnel. The enclosed report presents the results of this inspection.

In a telephone conversation on November 17, 2003, Ken O'Brien and Tony Go of my staff informed your representatives: Ms. Margaret Sietsema, Assistant Chief Executive Officer; Dr. Michael Garity, Radiation Safety Officer; and Mr. Tony Rime, Director of Radiology, of the results of the inspection, and that the NRC was considering escalated enforcement for a violation involving the failure to secure from unauthorized access or maintain constant surveillance over radioactive materials. Messrs. O'Brien and Go also informed your representatives that we had sufficient information regarding the apparent violation and your corrective actions to make an enforcement decision without the need for a predecisional enforcement conference or a written response from you. You indicated that you did not desire a predecisional enforcement conference and did not plan on providing a written response.

Based on the information developed during the inspection, the NRC has determined that two violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the enclosed inspection report.

Violation A of the Notice involves the failure to secure from unauthorized removal, limit access to, or maintain constant surveillance over licensed materials in an unrestricted area. During the inspection on October 30, 2003, the NRC identified that a technologist left the doors to the mobile nuclear van unlocked and unsecured when the technologist was in the client hospital and did not maintain constant surveillance of the licensed material located in the van. In addition, your staff indicated that the technologists did not normally lock or secure the doors to a second mobile nuclear van when the technologists were away from the van.

Although there were no actual radiation safety consequences associated with this violation, the failure to secure from unauthorized removal, limit access to or to maintain constant surveillance over licensed materials is a significant safety issue. The implementation of adequate security measures is intended to prevent the loss or theft of licensed materials and to prevent members of the public from being unknowingly and unnecessarily exposed to radiation. Therefore, this violation has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level III.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $3000 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement actions within the last two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. We determined that credit was warranted for your corrective actions which included: (1) directing all staff to lock the mobile nuclear van doors when the vans were not occupied; (2) installing self-closing and locking mechanisms on the doors to your two mobile nuclear vans, and; (3) retraining all staff responsible for performing licensed activities on the importance of security controls for licensed material.

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement actions, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case. However, significant and similar violations in the future could result in a civil penalty. In addition, issuance of this Severity Level III violation constitutes an escalated enforcement action, that may subject you to increased inspection effort.

Violation B of the Notice involves a failure to brace the transport containers such that the containers could not change position during conditions normally incident to transportation. Specifically, the cases were blocked by a one-inch railing, but were not braced to prevent movement during conditions normally incident to transportation. Your corrective action for this violation included adding straps to brace the transport containers to prevent movement. This violation has been categorized in accordance with the Enforcement Policy at Severity Level IV.

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance was achieved, is already adequately addressed in the enclosed inspection report. Therefore, you are not required to respond to this letter unless the description in the inspection report does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response, if any, will be made available electronically for public inspection in ADAMS, which is accessible from the NRC Web site at the Public NRC Library. To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction. The NRC also includes Issued Significant Enforcement Actions on its Web site.

    Sincerely,
    /RA/
    James L. Caldwell
Regional Administrator

Docket No. 030-02239
License No. 22-09562-01

Enclosures:
1. Notice of Violation
2. Inspection Report

cc w/encls:
State of Minnesota
Chairman, Board of Trustees

NOTICE OF VIOLATION

Rice Memorial Hospital
Willmar, Minnesota		   Docket No. 030-02239
License No. 22-09562-01
EA-03-205

During an NRC inspection conducted between October 30 and November 17, 2003, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violations are listed below:

A.

10 CFR 20.1801, requires that the licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802, requires that the licensee control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage. 10 CFR 20.1003 defines a controlled area to mean an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason; and an unrestricted area to mean an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, as of October 30, 2003, the licensee did not secure, from unauthorized removal or limit access to licensed materials, consisting of approximately 145 mCi of technetium-99m and an approximate aggregate activity, contained in sealed sources, of 192 mCi of gadolinium-153 in mobile nuclear vans, which are controlled areas, and the licensee did not control and maintain constant surveillance of the licensed material. Specifically, the licensee routinely left the doors to the mobile nuclear vans unlocked when performing activities in the client's facilities.

This is a Severity Level III violation (Supplement IV).
B.

10 CFR 71.5(a) requires that a licensee who transports licensed material outside of the site of usage, as specified in the NRC license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, comply with the applicable requirements of the regulations appropriate to the mode of transport of the Department of Transportation (DOT) in 49 CFR Parts 170 through 189.

49 CFR 177.842 requires, in part, that packages of radioactive materials be so blocked and braced that the packages cannot change position during conditions normally incident to transportation.

Contrary to the above, on October 30, 2003, the licensee transported unit doses of radioactive materials, outside the confines of its facility in transport cases (ammunition boxes), and the cases were not braced such that the cases could not change position during conditions normally incident to transportation. Specifically, the cases were blocked by a one-inch railing, but were not braced to prevent movement inside the mobile nuclear van during conditions normally incident to transportation.

This is a Severity Level IV violation (Supplement V).

The NRC has concluded that information regarding the reasons for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance was achieved, is already adequately addressed in Inspection Report No. 030-02239/2003-001(DNMS). However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description in the inspection report does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation; EA-03-205," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region III, 801 Warrenville Road, Suite 255, Lisle, IL 60532-4351, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

If you choose to respond, your response will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), which is accessible from the NRC Web site at the Public NRC Library. Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 15th day of December 2003.

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