EA-01-134 - Citizens General Hospital

June 1, 2001

EA 01-134

Kathleen Myers
Controller
Citizens General Hospital
631 Fourth Avenue
New Kensington, PA 15068-5010

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report 030-03111/01-01)

Dear Ms. Myers:

On January 26, 2001, the NRC was informed by your consultant, Radiological Physics Services, Inc., that two gadolinium-153 sealed sources that you possessed under your license were missing from the facility. The sources were being held in storage until they could be transferred to another licensed facility, given your plans to terminate your license. Subsequently, the consultant contacted the NRC on January 29, 2001, to indicate that after an investigation, the sources were located by another contractor who had inadvertently taken the sources during a work activity involving the removal of certain equipment from the Hot Lab. That consultant was not licensed to possess the sources. On February 26, 2001, Radiological Physics Services sent the NRC by facsimile a report of its investigation of the temporary loss of the two sources. During a telephonic inspection conducted by Ms. M. Beardsley, Region I with Andrew Bukovitz, Interim Radiation Safety Officer, on May 21, 2001, the NRC was informed that the sources have since been transferred to an authorized recipient.

Based on the NRC review of your consultant's investigation report, as well as the telephone inspection, the NRC identified a violation of NRC requirements. The violation, which is described in the enclosed Notice of Violation and inspection report, involves the failure to maintain appropriate security and control of the two licensed sources, each of which contained approximately 40 millicuries of gadolinium-153, when the sources were taken by contractors for transfer to another facility. The actual safety significance of the violation in this case was low since both sources, at the time they were recovered approximately two days later, were still in the original containers with tape over the shutter mechanisms that had not been disturbed. In addition, the sources were recovered intact and presumably unused, and there were no known radiological exposures to other workers or members of the public from the handling and transfer of these sources. Nonetheless, the potential existed for loss or misuse of the sources that could have resulted in unplanned exposures. Therefore, given the loss of control of the sources, the violation is categorized as a Severity Level III violation in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In a telephone conversation on May 30, 2001, Ms. M. Beardsley, of my staff, informed you that the NRC was considering escalated enforcement for the apparent violation. Ms. Beardsley also informed you 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 Citizens General Hospital (Citizens) did not believe that a predecisional enforcement conference or written response was needed.

In accordance with the Enforcement Policy in effect at the time of the violation, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Because your facility has not been the subject of an escalated enforcement action within the last two years or two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were considered prompt and comprehensive. These actions included, but are not limited to: (1) locating the sources and having them returned to your facility within two days; (2) subsequent transfer of all sources to another authorized facility; (3) performing close-out radiological surveys at the facility; and (4) requesting the NRC to terminate the facility license. Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case.

The NRC has concluded that information regarding the reason for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence, were already described adequately in this letter and in the attached inspection report. 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 and its enclosures, and your response will be available electronically for public inspection in the NRC Public Document Room or from the Publically Available Records (PARS) component of the NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public Reading Room.

		Sincerely,
		/RA/  James T. Wiggins acting for
		Hubert J. Miller Regional Administrator

Docket No. 030-03111
License No. 37-09016-01

Enclosure:  Notice of Violation

cc w/encl:  Commonwealth of Pennsylvania

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ENCLOSURE 1

NOTICE OF VIOLATION

Citizens General Hospital New Kensington, PA

Docket No. 030-03111 License No. 37-09016-01 EA No. 01-134

During an NRC inspection conducted on May 21, 2001, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violations are 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. 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 January 24, 2001, the licensee did not secure from unauthorized removal, or limit access to, two sources containing approximately 40 millicuries (original activity approximately two years before the incident was 200 millicuries) each of gadolinium-153 located at the Citizens General Hospital, New Kensington, Pennsylvania nor did the licensee control and maintain constant surveillance of this licensed material. Specifically, contractors, who were transferring other equipment to another facility, took unauthorized possession of the sources and removed them from the location listed on the license, until the sources were transferred back to Citizens General Hospital (the location listed on the licensee) on January 26, 2001.

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

The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence are already adequately addressed on the docket in the letter transmitting this Notice, as well as in the NRC Inspection Report 03003111/2001001. 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 I, 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 placed in the NRC Public Document Room (PDR) and on the NRC Web site. To the extent possible, it should, therefore, not include any personal privacy, proprietary, or safeguards information so that it can be made publically available without redaction. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public.

Dated this 1st day of June 2001