EA-02-236 - Community Health Center of Branch County

December 11, 2002

EA-02-236

John Howrey, Chief Financial Officer
Community Health Center of Branch County
274 East Chicago Street
Coldwater, MI 49836

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT NO. 03011390/2002-001DNMS)

Dear Mr. Howrey:

This refers to the inspection conducted on October 11, 2002, at Community Health Center of Branch County, Coldwater, Michigan. The purpose of this inspection was to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. The inspection report was transmitted to Community Health Center on November 1, 2002, and identified two apparent violations of NRC requirements involving the failure to secure licensed material from unauthorized access and the failure to place radioactive waste in designated, labeled, and properly shielded receptacles.

In the letter transmitting the inspection report, we provided Community Health Center the opportunity to address the apparent violations identified in the report by either attending a predecisional enforcement conference or by providing a written response before we made our final enforcement decision. In a letter, dated November 22, 2002, Community Health Center provided a response to the apparent violations.

Based on the information developed during the inspection and the information provided in Community Health Center's response to the inspection report, the NRC has determined that two violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report.

Violation A of the Notice involves the failure to secure from unauthorized access or maintain constant surveillance over licensed material in a controlled area. During the inspection on October 11, 2002, the NRC identified two separate occasions where the same individual left licensed material in the hot lab unattended and the door to the hot lab was not locked. Upon identification of the first example, the inspector informed your management staff and discussed the importance of securing licensed material from unauthorized access. Approximately two hours later, the inspector identified the second example of the apparent violation. When informed of a violation of NRC requirements, licensees are expected to take prompt and effective corrective action to achieve and sustain compliance.

The failure to adequately secure and limit access to licensed material is a significant safety concern. Implementing adequate security requirements for licensed material is intended to prevent members of the public from being unknowingly and unnecessarily exposed to radiation, and to prevent the loss or theft of licensed material. 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 $3,000 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. Credit is warranted for corrective actions that included: (1) ensuring that the hot lab was locked or under surveillance by authorized persons; (2) installing an automatic hot lab door closer mechanism; (3) posting the hot lab door with a sign warning staff that propping the hot lab door open may result in termination; (4) retraining the involved technician on the proper security of licensed material; (5) revising the safety procedure to include a discussion of security at the beginning of the procedure and adding random checks for compliance with security of licensed material; and (6) annual retraining and competency evaluation of nuclear medicine staff and relief technologists.

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.

Violation B of the Notice involves the failure to properly dispose of radioactive material in accordance with your procedure titled, "Rules for the Safe Use of Radiopharmaceuticals." Failure to place radioactive waste in designated, labeled, and properly shielded receptacles has resulted in unauthorized disposal of radioactive waste to non-radioactive waste disposal sites. Unauthorized disposal of radioactive waste can result in radiation exposure to members of the public and the need for licensees to recover the radioactive material from non-radioactive waste disposal sites. In this case however, the apparent violation did not result in unauthorized disposal of radioactive material because the inspector identified it, and your staff took appropriate actions to prevent unauthorized disposal. Therefore, 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 on the docket in Inspection Report No. 03011390/2002-001(DNMS) and Community Health Center's letter, dated November 22, 2002. Therefore, you are not required to respond to this letter unless the description therein 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 enclosure, 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, if you choose to provide one, 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/
		J. E. Dyer Regional Administrator

Docket No. 030-11390
License No. 21-16642-01

Enclosure: Notice of Violation

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NOTICE OF VIOLATION

Community Health Center of Branch County Coldwater, Michigan

Docket No. 030-11390 License No. 21-16642-01 EA-02-236

During an NRC inspection conducted on October 11, 2002, 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. 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 two occasions on October 11, 2002, the licensee did not secure from unauthorized removal or limit access to at least: 343 millicuries of molybdenum-99, 465 millicuries of technetium-99m, and 59 microcuries of cesium-137 stored in the hot lab, nor did the licensee control and maintain constant surveillance of this licensed material. This is a Severity Level III violation (Supplement IV).

B.

Condition 13 of NRC License No. 21-16642-01 requires that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the letter, dated January 26, 2001. Item 10.4, of the January 26, 2001 letter, titled, "Rules for the Safe Use of Radiopharmaceuticals" requires that radioactive waste be disposed only in designated, labeled, and properly shielded receptacles. Contrary to the above, on October 11, 2002, the licensee failed to dispose of radioactive waste in designated, labeled, and properly shielded receptacles. Specifically, the licensee disposed of radioactive waste in two non-radioactive waste receptacles in the nuclear medicine department. This is a Severity Level IV violation (Supplement VI).

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 on the docket in Inspection Report No. 03011390/2002-001(DNMS) and Community Health Center's letter, dated November 22, 2002. 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, EA-02-236," 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, 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 December 2002.