EA-97-360 - Berwick Hospital
Ms. Diane Krolikowski, Vice President
Patient Care Services
701 East 16th Street
Berwick, Pennsylvania 18603
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-12854/97-001)
Dear Ms. Krolikowski:
This refers to the NRC inspection conducted on July 9, 1997, at the above address in Berwick, Pennsylvania, the findings of which were discussed with you during an exit meeting on July 9, 1997. During the inspection, one violation of NRC requirements was identified, as described in the NRC inspection report transmitted with our letter dated August 19, 1997. In the August 19, 1997 letter, the NRC provided you an opportunity to either respond in writing to the apparent violations addressed in the inspection report or request a predecisional enforcement conference. You responded to the apparent violation in an August 27, 1997 letter to the NRC and admitted the apparent violation.
Based on the information developed during the inspection and the information you provided in your August 27, 1997 response, the NRC has determined that one 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. The violation involves failure to secure licensed materials in your Hot Lab, an unrestricted area. The violation represents a significant regulatory concern because the failure to maintain appropriate security of the material could result in it being lost or stolen, and also has the potential to cause exposure to members of your staff, as well as members of the public. Therefore, the violation is classified at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600. The violation demonstrates the importance of adequate oversight of management in general, and your radiation safety staff in particular to ensure this requirement is met.
In accordance with the Enforcement Policy, 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, 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, which were described in your August 27, 1997 letter, included, but not limited to, (1) installation of a self-closing device and a push button combination lock on the door of the hot lab; and (2) plans to have your consultant, in addition to your Radiation Safety Officer, periodically audit security of materials.
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.
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 August 27, 1997. 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 will be placed in the NRC Public Document Room (PDR).
Sincerely, ORIGINAL SIGNED BY WILLIAM L. AXELSON for Hubert J. Miller Regional Administrator
Docket No. 030-12854
License No. 37-17502-01
Enclosure: Notice of Violation
Commonwealth of Pennsylvania
Berwick Hospital Docket No. 030-12854 Berwick, Pennsylvania License No. 37-17502-01 EA 97-360
During an NRC inspection conducted on July 9, 1997, 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 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, for approximately 10 minutes on July 9, 1997, the licensee did not secure from unauthorized removal or limit access to licensed material (including a 1.5 curie technetium-99m generator and 370 millicuries of technetium-99m eluate) located in the Nuclear Medicine hot lab, which was an unrestricted area, nor did the licensee control and maintain constant surveillance of this licensed material. (01013)
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 letter from Licensee dated August 27, 1997. 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, D.C. 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).
Dated at King of Prussia, Pennsylvania
this 25th day of September 1997