EA-96-525 - Maui Memorial Hospital

March 5, 1997

EA 96-525

Mr. Alan G. Lee, Administrator
Maui Memorial Hospital
Radioisotope Service
221 Mahalani Street
Wailuku, Maui, Hawaii 96793

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-03561/96-01)

Dear Mr. Lee:

This refers to the February 5, 1997, letter Maui Memorial Hospital submitted in response to the apparent violation identified in NRC Inspection Report 030-03561/96-01, issued on January 13, 1997.

The NRC inspection was completed on December 11, 1996. As indicated in the NRC letter transmitting the inspection report, one apparent violation was identified involving the security of licensed radioactive material, i.e., an imaging room and nuclear medicine hot lab containing radioactive materials were left unsecured. Maui Memorial Hospital was given a choice of requesting a predecisional enforcement conference or submitting a written response to the apparent violation. Maui Memorial Hospital chose to submit a written response.

In its written response, Maui Memorial Hospital did not dispute the apparent violation, and described specific actions taken to correct the violation. These actions included instructions to technologists to store all licensed material only in designated restricted storage areas, the installation of an automatic door closure and keypad type lock on the nuclear medicine hot lab door, and instructions to technologists to keep this door closed at all times to prevent security breaches.

Based on the information developed during the inspection, and the information that you provided in your response to the inspection report, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and involved a failure in November 1996 to meet NRC requirements regarding the security of radioactive materials.

Although the violation did not result in the theft or loss of radioactive material, the purpose of securing materials is to prevent the unauthorized removal of materials that could pose a health and safety hazard. The NRC considers such violations a matter of significant regulatory concern; thus, this violation has been classified at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600.

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 escalated enforcement action within the last 2 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. Given that the corrective actions described above were both prompt and comprehensive, credit is due for your corrective actions, resulting in no civil penalty being assessed in this case.

Accordingly, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized not to propose a civil penalty in this case. However, significant violations in the future, particularly violations of a similar nature, could result in a civil penalty. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action which may subject you to more frequent inspection by NRC.

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 No. 030-03561/96-01 and letter from Maui Memorial Hospital dated February 5, 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 if you choose to submit one, will be placed in the NRC Public Document Room (PDR).

Sincerely,

org signed by Thomas Gwynn for J. E. Dyer Acting Regional Administrator

Docket No. 030-03561
License No. 53-13519-01

Enclosure: Notice of Violation

cc w/Enclosure:
State of Hawaii
Ms. Diane Plotts
Chairman, Board of Trustees
Hawaii Health Systems Corporation
688 Kinoole Street, Suite 121
Hilo, Hawaii 96720

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NOTICE OF VIOLATION

Maui Memorial Hospital Wailuku, Maui, Hawaii

Docket No. 030-03561 License No. 53-13519-01 EA 96-525

During an NRC inspection conducted November 22 through December 11, 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 20.1801 requires that a licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802 requires that a 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, to which access can be limited by the licensee for any reason. An unrestricted area means an area in which access is neither limited nor controlled by the licensee.

Contrary to the above, on November 22 and 25, 1996, the licensee did not secure from unauthorized removal or access licensed material stored in a controlled area. Specifically, on November 22, waste materials contaminated with iodine-131 were temporarily stored in the nuclear medicine imaging room, and the room was not secured or under surveillance by the licensee, and an individual other than a licensee employee was in the imaging room. On November 25, an eye applicator containing 91.2 millicuries of strontium-90 and a 3 curie molybdenum-99/technetium-99m generator were stored in the hot lab, which is located within the nuclear medicine imaging room, and the hot lab and imaging room were not secured from unauthorized access. (01013)

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

The NRC has concluded that information regarding the reason for the violations, 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 No. 030-03561/96-01 and a letter from Maui Memorial Hospital dated February 5, 1997. Therefore, no response to this Notice is required. 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 IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011.

Dated at Arlington, Texas
this 5th day of March 1997