EA-97-358 - Soldiers and Sailors Memorial Hospital
Ms. Jackie Werts
Assistant Executive Director
Soldiers and Sailors Memorial Hospital
32-36 Central Avenue
Wellsboro, Pennsylvania 16901
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-11497/97-001)
Dear Ms. Werts:
This refers to the NRC inspection conducted on July 7, 1997, at the above address in Wellsboro, Pennsylvania, the findings of which were discussed with you during an exit meeting on July 7, 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 violation addressed in the inspection report or request a predecisional enforcement conference. You responded to the apparent violation in letters to the NRC dated September 3, 1997, and September 11, 1997.
Based on the information developed during the inspection and the information you provided in your September 3 and September 11, 1997 responses, 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 Nuclear Materials prep room/hot lab, an unrestricted area. In your September 3 and September 11, 1997 letters, you indicated that the nuclear medicine technologist left the hot lab door closed, but unlocked while working in the adjacent stress area because she was frequently transferring radioactive material between the two areas, and she was concerned that reaching for a key and setting radioactive material down could spread contamination while she was transferring material.
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 September 3, and September 11, 1997 responses included: (1) adding a keypad combination lock with a self-closing, self-locking door to the hot lab to ensure locking of the door, while at the same time not requiring the technologist to reach for the key; and (2) instituting a policy that the door be locked and never blocked unless authorized personnel are physically present.
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 letters dated September 3 and September 11, 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. 030-11497
License No. 37-16602-01
Enclosure: Notice of Violation
Commonwealth of Pennsylvania
Soldiers and Sailors Memorial Hospital Docket No. 030-11497 Wellsboro, Pennsylvania License No. 37-16602-01 EA No. 97-358
During an NRC inspection conducted on July 7, 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 7, 1997, the licensee did not secure from unauthorized removal or limit access to licensed material (including a vial containing 200 millicuries of bulk technetium-99m, as well as several unit doses of technetium-99m) located in the Nuclear Medicine prep room/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 achieved is already adequately addressed on the docket in the letters from the Licensee dated September 3 and 11, 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