EA-03-122 - Northern Michigan Hospital

August 11, 2003

EA-03-122

Sherry Haneckow, Director
Patient Care Operations
Northern Michigan Hospital
416 Connable Avenue
Petoskey, MI 49770

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT NO. 03011715/2003-001(DNMS)

Dear Ms. Haneckow:

This refers to the inspection conducted from May 29 through June 12, 2003, at Northern Michigan Hospital, Petoskey, Michigan. 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. One apparent violation of the NRC requirement involving security and control of licensed materials was identified during the inspection. On June 12, 2003, a telephone exit meeting was conducted with Mr. Dan Dryden to discuss this issue. The enclosed report presents the results of this inspection.

During the telephone exit meeting on June 12, 2003, Messrs. Darrel Wiedeman and Christopher Martin of my staff informed Dan Dryden, Radiation Safety Officer, that the NRC was considering escalated enforcement for the apparent failure to secure licensed material located in the Nuclear Medicine Department. Messrs. Wiedeman and Martin also informed Mr. Dryden 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. Mr. Dryden indicated that Northern Michigan Hospital did not believe that a predecisional enforcement conference was needed and that a written response would be provided.

Based on the information developed during the inspection and the information that you provided in your response, dated July 16, 2003, 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 are described in detail in the subject inspection report. During the inspection, the NRC inspector entered the hot laboratory in the Nuclear Medicine Department without being challenged. At the time the inspector entered the laboratory, licensed materials in an aggregate quantity greater than 1000 times the quantity specified in Appendix C to 10 CFR Part 20⁽¹⁾ were present. However, the members of the nuclear medicine staff were engaged in activities outside of the laboratory and did not provide constant surveillance of the unsecured licensed materials.

Although there were no actual radiation safety consequences associated with the violation, the failure to secure from unauthorized access or maintain constant surveillance over licensed materials is a significant safety issue. 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. Corrective actions included: (1) immediately closing and locking the hot laboratory door; (2) removing the magnetic hardware on the door to the hot laboratory used to hold the door open; (3) counseling and training the technologist responsible for the violation; (4) training other technologists; and (5) performing periodic spot checks of the laboratory.

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

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 your July 16, 2003, letter. Therefore, you are not required to respond to this letter unless the description in your letter 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 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. 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 for
		J. E. Dyer Regional Administrator

Docket No. 030-11715
License No. 21-16732-01

cc: State of Michigan

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NOTICE OF VIOLATION

Northern Michigan Hospital Petoskey, Michigan

Docket No. 030-11715 License No. 21-16732-01 EA-03-122

During an NRC inspection conducted from May 29 through June 12, 2003, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed 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 May 29, 2003, the licensee did not secure from unauthorized removal or limit access to: (1) 351 millicuries of technetium-99m in unit dose form; (2) 1210 millicuries of molybdenum-99 in a Tc-99m/Mo-99 generator; (3) 0.04 millicuries of iodine-131 in capsule form; (4) 22 millicuries of xenon-133 gas; and (5) various check sources of microcurie activity, located in the hot laboratory of the Nuclear Medicine Department, which is a controlled area, nor did the licensee control and maintain constant surveillance of this licensed material. Specifically, a nuclear medicine technologist exited the hot laboratory and failed to close the door leaving the licensed material unsecured, and the remaining technologists were unable to provide constant surveillance of the licensed materials.

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

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 your letter, dated July 16, 2003. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description in your letter 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-03-122" 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, 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 11^th day of August 2003.

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^1. The NRC-licensed materials consisted of: (1) 351 millicuries of technetium-99m (Tc-99m) in unit dose form; (2) 1210 millicuries of molybdenum-99 (Mo-99) in a Tc-99m/Mo-99 generator; (3) 0.04 millicuries of iodine-131 in capsule form; (4) 22 millicuries of xenon-133 gas; and (5) various check sources of microcurie activity.