EA-96-186 - Abington Memorial Hospital

July 12, 1996

EA 96-186

Gary Candia, Ph.D.
Vice President of Professional Services
and Quality Assurance
Abington Memorial Hospital
1200 Old York Road
Abington, Pennsylvania 19001

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-02948/96-001)

Dear Dr. Candia:

This letter refers to the NRC inspection conducted on May 15-16, 1996, at your facility in Abington, Pennsylvania. The purpose of this inspection was to determine whether activities authorized by your license were conducted safely and in accordance with NRC requirements, and to review the circumstances surrounding an incident in which a brachytherapy sealed source was found by your staff lying on the floor of your radiation waste storage area (a restricted area) on May 13, 1996. At the conclusion of the inspection, the findings were discussed with you and other members of your staff. During the inspection, two apparent violations of NRC requirements were identified, as described in the NRC inspection report, a copy of which was sent to you on June 18, 1996. On July 10, 1996, a predecisional enforcement conference was conducted with you and other members of your staff to discuss the apparent violations, their causes, and your corrective actions. A copy of the Enforcement Conference Report is enclosed.

Based on the information developed during the inspection, information provided in a letter dated June 13, 1996, from your Radiation Safety Officer (RSO), and information provided during the conference, one violation of NRC requirements is being cited in the enclosed Notice of Violation (Notice), and the circumstances surrounding it are described in detail in the subject inspection report. The violation described in the enclosed Notice involves the failure to conduct, for a period of time (possibly up to 20 years), a quarterly physical inventory of a particular brachytherapy source in your possession. NRC regulations require that a licensee in possession of brachytherapy sources conduct a quarterly physical inventory of all such sources in its possession.

The NRC is concerned that your inventory procedure did not account for a brachytherapy source which contained 16.75 millicuries of cesium-137. The source had been purchased in 1976 according to records obtained after discovery of the source on the floor of your waste storage area. Your records of quarterly inventories performed from the date of purchase of the source until May 13, 1996, when the source was discovered, did not include this particular source. In addition, the exact location of the source from 1976 until 1996 was not known with certainty. The NRC also is concerned because this event had the potential to cause exposure to patients, staff and the public. As such, given the number of years that the source was excluded from your inventories, this violation constitutes a significant regulatory concern and is categorized at Severity Level III in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," (Enforcement Policy) NUREG-1600. The violation demonstrates the importance of increased attention to this aspect of your radiation safety program to ensure that regulatory requirements are understood and followed, and your activities are conducted safely and in accordance with those requirements.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for this Severity Level III violation. Because your facility has not been the subject of escalated enforcement in the past 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 was warranted because your corrective actions were considered both prompt and comprehensive in response to the discovery of the source in the waste storage area, as well as in response to the inspection findings. Your corrective actions, which were described in your presentation during the conference, included, but were not limited to: (1) performing a complete inventory of all brachytherapy sources in your possession; (2) color coding all brachytherapy sources in your possession; (3) obtaining source certificates for all brachytherapy sources in your possession; and (4) creating a "Code of Ethics" for the RSO and physicist which requires the RSO and physicist, upon terminating their employment with Abington Memorial Hospital, to turn over all required documentation to the hospital in order to assure that required documentation such as source certificates and inventories are retained by the hospital.

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action at your facility, I have been authorized not to propose a civil penalty in this case. However, any similar violations in the future could result in more significant escalated enforcement action, including issuance of a civil penalty.

The apparent violation concerning the failure to secure the source, is not being cited because the facts do not support a violation of a regulatory requirement. At the conference, you indicated that the waste disposal room, where the source was located, was secured by two doors that were locked and under your control.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and any additional response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information, so that it can be placed in the PDR without redaction. If redactions are required, a proprietary version containing brackets placed around the proprietary, privacy, and/or safeguards information should be submitted. In addition, a non-proprietary version with the information in the brackets redacted should be submitted to be placed in the PDR.

The responses directed by this letter and the enclosed Notice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, Pub. L. No. 96-511.

Sincerely,

Thomas T. Martin Regional Administrator

Docket No. 030-02948
License No. 37-00432-02

Enclosures:

1. Notice of Violation
2. Enforcement Conference Report

cc w/encls:
Ramanik Patel, Radiation Safety Officer
Commonwealth of Pennsylvania

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NOTICE OF VIOLATION

Abington Memorial Hospital Abington, Pennsylvania

Docket No. 030-02948 License No. 37-00432-02 EA 96-186

During an NRC inspection conducted on May 15-16, 1996, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

10 CFR 35.59(g) requires, in part, that a licensee in possession of a sealed source or brachytherapy source shall conduct a quarterly physical inventory of all such sources in its possession.

Contrary to the above, from 1976 until May 13, 1996, the licensee did not conduct a quarterly physical inventory of a specific brachytherapy source in its possession. Specifically, the licensee did not account for a 16.75 millicurie cesium-137 brachytherapy source, 3M Serial No. 10-135, in its quarterly physical inventories. (01013)

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

Pursuant to the provisions of 10 CFR 2.201, Abington Memorial Hospital is hereby required to submit a written statement or explanation 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). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. If an adequate reply is not received within the time specified in this Notice, an Order or Demand for Information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.

Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR 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 at King of Prussia, Pennsylvania
this 12th day of July 1996