EA-01-200 - Franklin Hospital Corporation

August 1, 2001

EA-01-200

Franklin Hospital Corporation
d/b/a Southampton Memorial Hospital
ATTN: Ms. Judith A. Garrett
             Chief Clinical Officer
100 Fairview Drive
Franklin, Virginia 23851

SUBJECT:

NRC INSPECTION REPORT NO. 45-18103-01/01-01 AND NOTICE OF VIOLATION

Dear Ms. Garrett:

This refers to the inspection conducted by this office on June 20, 2001, at your facility located in Franklin, Virginia. The enclosed report presents the results of the inspection.

The inspection was an examination of activities as they relate to safety and compliance with the Commission's rules and regulations and with the conditions of your license. Within these areas, the inspection consisted of selected examination of procedures and representative records, and interviews with personnel. A preliminary exit briefing was held with you at the completion of the inspection. A final telephonic exit briefing was held with you on July 26, 2001. During the telephonic exit briefing, you were informed that the NRC was considering escalated enforcement action for an apparent violation involving Franklin Hospital Corporation's failure to maintain security and control of licensed byproduct material that was stored in the hospital's nuclear medicine hot laboratory, as required by 10 CFR 20.1801 and 10 CFR 20.1802. Additionally, you were informed that NRC believed it 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 during a follow-up telephone conversation of July 30, 2001, that Franklin Hospital Corporation did not believe that a predecisional enforcement conference or written response was necessary prior to taking enforcement action.

Therefore, based on the information developed during the inspection, the NRC has determined that a violation of NRC requirements occurred. The violation is described in the enclosed Notice of Violation (Notice) and involves Franklin Hospital Corporation's failure to secure from unauthorized removal and control and maintain constant surveillance of licensed byproduct material. The licensed material involved radiopharmaceuticals that were located in the nuclear medicine hot laboratory, and included approximately 115 microcuries of Barium-133 and 239.5 microcuries of Cesium-137, a generator containing approximately 165.35 millicuries of Technetium-99m/Molybdenum-99, approximately 20 millicuries of Technetium-99m Neotec, and 35 millicuries of Technetium-99m Cardiolite. The violation occurred during the inspection when the NRC inspector observed that the door to the nuclear medicine hot laboratory was open and the area unattended and unsecured by the Nuclear Medicine Technologists. This violation did not result in any actual safety consequences since the licensed material was not lost or stolen during the period that it was not properly controlled, nor were there any radiological exposures to other employees, patients, or members of the public. Nonetheless, the failure to maintain appropriate control of the licensed material created the potential for both loss or misuse of the material or unnecessary radiation exposure. Therefore, this violation has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions - May 1, 2000," NUREG-1600, as amended on December 18, 2000, (Enforcement Policy) at Severity Level III.

In accordance with the Enforcement Policy, a civil penalty with a base value of $6,000 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement action, the NRC considered whether credit was warranted for corrective action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. The corrective actions described by you during the telephonic exit interview of July 26, 2001, included the retraining of staff on the importance and practice of controlling and maintaining surveillance of licensed material, and the installation of a self closing feature and a push combination lock on the door to the nuclear medicine hot laboratory. Based on this, the NRC has determined that credit should be warranted for corrective actions.

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized, after consultation with the Director, Office of Enforcement, to propose that no civil penalty be assessed in this case. However, you are on notice that significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action that may subject you to increased inspection effort.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response, will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library. To the extent possible, your response (if any) should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.

If you have any questions about this inspection, please contact Mr. Douglas Collins, Director, Division of Nuclear Materials Safety, at (404) 562-4700.

		Sincerely,
		/RA/
		Luis A. Reyes Regional Administrator

Docket No. 030-14475
License No. 45-18103-01

Enclosure: Notice of Violation

cc w/ encls:  Commonwealth of Virginia

---

NOTICE OF VIOLATION

Franklin Hospital Corporation Franklin, Virginia

Docket No. 030-14475 License No. 45-18103-01 EA-01-200

During an NRC inspection conducted on June 20, 2001, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions - May 1, 2000," NUREG-1600, as amended on December 18, 2000, (Enforcement Policy), 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, on June 20, 2001, the licensee did not secure from unauthorized removal or limit access to millicurie quantities of licensed materials located in the nuclear medicine hot laboratory, which is a controlled area, nor did the licensee control and maintain constant surveillance of this licensed material. Specifically, the hot laboratory, which contained millicurie quantities of licensed material, was unsecured and uncontrolled by the licensee.

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

Pursuant to the provisions of 10 CFR 2.201, Franklin Hospital Corporation is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrator, Region II, 61 Forsyth Street SW, Suite 23T85, Atlanta, GA 30303, 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 the violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level, (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 previously 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 a 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.

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.

Because your response will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at the Public NRC Library. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

Dated this 1st day of August 2001