EA-00-076 - Glendive Medical Center

June 29, 2000

EA-00-076

Ms. Sandra McGovern
Director of Human Resources
Glendive Medical Center
202 Prospect Drive
Glendive, Montana 59330-1999

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $2,750 (NRC Inspection Report No. 030-12470/00-01)

Dear Ms. McGovern:

This refers to your letters dated May 8, 24, and June 6, 2000, regarding a routine inspection conducted at your Glendive, Montana facility. The inspection identified one apparent violation which was considered for escalated enforcement involving an apparent failure to secure from unauthorized removal or access molybdenum-99/technetium-99m generators. The results of the inspection were discussed with you and your staff on April 11, 2000, and were documented in the subject inspection report dated May 1, 2000.

In the letter transmitting the inspection report, we provided you the opportunity to address the apparent violation identified in the report by either attending a predecisional enforcement conference or by providing a written response before we made our final enforcement decision. By letters dated May 8, 24, and June 6, 2000, you provided a written response to the apparent violation.

Based on the information developed during the inspection and the information that you provided in your May 8 and 24 letters, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it were described in detail in the subject inspection report. During our inspection, we found that on certain weekends molybdenum-99/technetium-99m generators were delivered to the nuclear medicine imaging room and remained unsecured for several hours. We found 19 instances when generators were left unsecured for several hours in a hallway that was accessible to members of the public.

Each of these generators contained approximately 24.6 GBq (661 millicuries) of molybdenum-99/technetium-99m. The potential safety significance of the violation is that the loss of a generator containing millicurie quantities of byproduct material could pose a significant potential for exposure to members of the general public. 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 civil penalty with a base value of $2,750 is considered for a Severity Level III violation. Because your facility has been the subject of escalated enforcement actions within the last two inspections,⁽¹⁾ the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Since the NRC identified the violation, we have determined that credit for Identification is not warranted. However, based on your corrective actions, the NRC has determined that you are deserving of credit for the Corrective Action factor. This results in the assessment of a civil penalty at the base value. Your corrective actions were clarified in your June 6, 2000, letter in which you stated that spent generators will be locked in the hot lab on Friday afternoons, keys to the hot lab will be secured in a touch-pad coded lock key box, and the code for accessing the key safe will be given to authorized delivery personnel (and authorized radiology department employees) only. Authorized delivery personnel will be instructed to access the keys to the hot lab and to lock the hot lab after exchanging the spent generator with the new one. In this manner, the generators would always remain in the locked hot lab when authorized hospital personnel are not available.

Therefore, to emphasize the importance of securing licensed material, and of prompt identification of violations, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the base amount of $2,750. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. You may refer to previously docketed correspondence when responding to this letter. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and its enclosure will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library.

		Sincerely,
		/RA/
		Ellis W. Merschoff Regional Administrator

Docket No. 030-12470
License No. 25-17265-01

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty

cc (w/encl):

Montana Radiation Control Program Director

Chairman, Board of Trustees
Glendive Medical Center
202 Prospect Drive
Glendive, Montana 59330-1999

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NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY
Glendive Medical Center Glendive, Montana		Docket No. 030-12470 License No. 25-17265-01 EA-00-076

During an NRC inspection conducted on March 9 through April 11, 2000, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The violation and associated civil penalty are set forth below:

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. As defined in 10 CFR 20.1003, controlled area means 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 unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, on 19 occasions between March 1, 1999, and March 9, 2000, the licensee did not secure from unauthorized removal or limit access to packages containing approximately 24.6 gigabecquerels (661 millicuries) of molybdenum-99/technetium-99m generators. The generators were delivered to the nuclear medicine department each Sunday morning at approximately 10 a.m., and the courier left the generator in the imaging room, an area that was not restricted at the time of delivery. The licensee also did not control and maintain constant surveillance of the licensed material. (01013)

This is a Severity Level III violation (Supplement IV).
Civil Penalty - $2,750

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in the licensee's letters dated May 8, 24, and June 6, 2000, and this letter. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein 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," 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 IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

The Licensee may pay the civil penalty proposed above in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, a statement indicating when and by what method payment was made, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violation listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.

Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.

The response noted above (statement as to payment of civil penalty or Answer to a Notice of Violation) should be addressed to: Mr. R. W. Borchardt, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011.

Any response you provide will be made available to the Public. 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 29th day of June 2000

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¹ A Severity Level III violation and a $2,500 civil penalty were issued on October 21, 1993, (EA 93-231) for conducting licensed activities for several months without a Radiation Safety Officer and for conducting activities without an authorized user for several months.