EA-01-133 - Mercy Hospital

June 12, 2001

EA 01-133

Mr. J. Penn Krause
Executive Vice President
Mercy Hospital
1400 Locust Street
Pittsburgh, PA 15219-5166

SUBJECT:

NOTICE OF VIOLATION (NRC Office of Investigation Report No. 1-2000-038)

Dear Mr. Krause:

This refers to the investigation initiated by the NRC Office of Investigations (OI) that reviewed the transfer of licensed material, namely depleted uranium (DU), located in a linear accelerator, to South Pittsburgh Cancer Center (SPCC) from Mercy Hospital. The investigation also involved the unauthorized possession of that DU by SPCC, in that accelerator as well as another accelerator, and attempts to improperly dispose of that DU to avoid disposal costs. The NRC investigation was concluded on May 7, 2001. Although OI found that the inappropriate transfer of DU material from Mercy Hospital to SPCC was not a willful violation of NRC requirements, the NRC has determined that a violation of NRC requirements (non-willful) occurred as a result of actions by the Mercy Hospital staff. Our findings are described in the factual summary of the OI report that is enclosed with this letter. Previously, on October 27, 2000, the NRC sent you a Confirmatory Action Letter (CAL), confirming your commitment to take certain immediate actions to address the apparent violation. In a letter to the NRC, dated December 1, 2000, you detailed those actions.

The violation involves the transfer of licensed byproduct radioactive material to SPCC who was not authorized to receive it. The violation occurred in 1994 when the staff at Mercy Hospital transferred the DU in one Varian Clinac 4 linear accelerator (LINAC) to SPCC. Although the NRC license for Mercy Hospital allowed possession of DU material in a LINAC, SPCC did not have an NRC license for possession of the material. This violation did not result in any actual safety consequences; however, the failure to appropriately transfer the DU material created the potential for loss, misuse, or inappropriate disposal of the radioactive material and potential unplanned radiation exposure. Therefore, the violation is categorized at Severity Level III in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In a telephone conversation on June 07, 2001, you informed Mr. Frank Costello, of my staff, that you did not believe that a predecisional enforcement conference, nor a written response, was needed, prior to the NRC deciding on appropriate enforcement action. The NRC agrees that it has sufficient information to take the action described below.

In accordance with the version of the Enforcement Policy in place at the time the violation occurred, a base civil penalty 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, as described during the inspection, as well as in your response to the NRC Confirmatory Action Letter (CAL), were considered prompt and comprehensive. These actions included, but are not limited to: (1) immediately securing the DU material at SPCC from unauthorized access or removal; (2) eventual proper removal of the DU material from SPCC; (3) revision of the procedures at Mercy Hospital to ensure that all licensed material is removed or transferred in accordance with NRC requirements; and (4) training of the Mercy Hospital staff regarding the procedure revisions.

Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action. In addition, issuance of this Notice constitutes escalated enforcement action that may increase the NRC inspection effort at your facility.

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 the inspection report attached to this letter; in the NRC CAL, dated October 27, 2000; in your reply to the NRC CAL, dated December 1, 2000; or in this letter. 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. 030-02982
License No. 37-01321-02

Enclosure: Notice of Violation

cc w/encl:  Commonwealth of Pennsylvania

---

NOTICE OF VIOLATION

Mercy Hospital Pittsburgh, PANY

Docket No. 03002982 License No. 37-01321-02 EA 01-133

During an NRC investigation concluded on May 7, 2001, one 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 violation is listed below:

10 CFR 40.51(a) and (b)(5) require, in part, that no licensee transfer source material except to a person authorized to receive such source material under the terms of a specific or general license issued by the Commission or Agreement State.

Contrary to the above, in January 1994, the licensee transferred depleted uranium to South Pittsburgh Cancer Center, a person who was not authorized to receive such source material under the terms of a specific or general license issued by the Commission or Agreement State.

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

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 are already adequately addressed on the docket in the letter transmitting this NOV; in the NRC Confirmatory Action Letter (CAL), dated October 27, 2000; or in the Mercy Hospital reply to the NRC CAL, dated December 1, 2000. 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 12th day of June 2001