EA-02-056 - Wilcox Memorial Hospital

April 25, 2002

EA-02-056

Dave Patton, PhD
President & CEO
Wilcox Memorial Hospital
3420 Kuhio Highway
Lihue, Hawaii 96766

SUBJECT:

NRC INSPECTION REPORT 030-09666/02-01 AND NOTICE OF VIOLATION

Dear Dr. Patton:

This refers to the inspection conducted on March 1, 2002, at your facility in Lihue, Hawaii. This inspection was an examination of activities conducted under your license as they relate to safety and compliance with the Commission's rules and regulations and with the conditions of the license. Within these areas, the inspection consisted of selective examination of procedures and representative records and interviews with personnel. The preliminary inspection findings were discussed with you and members of your staff on March 1, 2002. A final telephonic exit meeting was conducted with you and other members of your staff on April 1, 2002.

During the telephonic exit briefing on April 1, 2002, you were informed that the NRC was considering escalated enforcement action for an apparent violation involving a failure to control and maintain constant surveillance of licensed material that was in a controlled or unrestricted area and that was not in storage. 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 that Wilcox Memorial Hospital agreed that a predecisional enforcement conference or written response was not needed.

Therefore, based on the information developed during the inspection, and the information you provided in your March 5, 2002, letter, the NRC has determined that a violation of NRC requirements occurred. The violation is described in the enclosed Notice of Violation (Notice), and involves your failure to control and maintain constant surveillance of licensed material that was in a controlled or unrestricted area and that was not in storage. Although this violation resulted in no actual safety consequences, securing licensed material and/or maintaining constant surveillance of the material is an important deterrent in preventing theft or unauthorized removal and possible radiological hazards to members of the public. Therefore, this violation has been categorized in accordance with the General Statement of Policy and Procedure for NRC Enforcement Actions (Enforcement Policy), NUREG-1600, dated May 1, 2000, at Severity Level III.

In accordance with the Enforcement Policy, a civil penalty with a base value of $3000 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. In your March 5^th letter, you described several corrective actions taken immediately following the inspection. These included: 1) replacing the lock cylinder and installing a padlock on the door to secure the hot lab prior to the inspector's departure; 2) working with the manufacturer to re-enable the lock's function; 3) deleting all the old codes from the lock's memory and creating a new limited set of codes for entry; 4) manually checking the door as part of the daily survey procedure to ensure the lock is functioning correctly; and, 5) implementing random, unannounced checks of the hot lab by hospital security officers to ensure security of the door. Thus, credit for corrective action is warranted.

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, not to propose a civil penalty 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.

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 Inspection Report 030-09666/02-01 and your letter dated March 5, 2002. 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 enclosure 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). ADAMS is accessible from the NRC Web site at the Public NRC Library.

		Sincerely,
		/RA/
		Ellis W. Merschoff Regional Administrator

Docket No.: 030-09666
License No.: 53-15737-01

Enclosure: Notice of Violation

cc w/enclosures: Hawaii Radiation Control Program Director

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ENCLOSURE 1

NOTICE OF VIOLATION

Wilcox Memorial Hospital	Docket No.: 030-09666
Lihue, Hawaii	License No.: 53-15737-01
	EA-02-056

During an NRC inspection completed on April 1, 2002, one 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 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 March 1, 2002, the licensee failed to control and maintain constant surveillance of licensed material in a controlled or unrestricted area and not in storage. Specifically, on March 1, 2002, the licensee's hot lab facility controlled area, containing curie quantities of molybdenum-99 contained in molybdenum-99/technetium-99m generators and other radiopharmaceuticals, was left unsecured and unattended. The door to the hot lab was shut and had an electronic keypad-type locking mechanism installed, however, it was determined that the lock did not function as designed, resulting in the door being unlocked.

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 in Inspection Report 030-09666/02-01 and your March 5, 2002, letter. 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 IV, 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 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). ADAMS is accessible from the NRC Web site at the Public NRC Library. Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.

Dated this 25^th day of April 2002