EA-00-221 - Columbia/HCA Healthcare Corporation

October 13, 2000

EA-00-221

Edward H. Lamb, CHE
President/Chief Executive Officer
Columbia/HCA Healthcare Corporation
dba Columbia Alaska Regional Hospital
P.O. Box 143889
Anchorage, Alaska 99514-3189

SUBJECT:

NRC INSPECTION REPORT 030-14720/99-01 AND NOTICE OF VIOLATION

Dear Mr. Lamb:

On September 25, 2000, the NRC completed an inspection of licensed activities at the Columbia Alaska Regional Hospital (ARH), Anchorage, Alaska. The enclosed inspection report documents this inspection. The inspection was conducted in response to a telephonic notification of four brachytherapy medical misadministrations that occurred between March 24 and May 4, 1999. The inspection findings were discussed with you and other members of your staff during a preliminary exit briefing on July 2, 1999, and during a final telephonic exit briefing on September 25, 2000.

During the telephonic exit briefing on September 25, 2000, you were informed that the NRC identified one violation that was being considered for escalated enforcement action in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG 1600. The current Enforcement Policy can be found on the NRC's website. The violation involved ARH's failure to implement its quality management program in a manner that provided high confidence that radiation from byproduct material was administered as directed by authorized users. Additionally, you were informed that NRC believed it had sufficient information regarding the 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 ARH did not believe that a predecisional enforcement conference or written response was needed. As such, the NRC is making its enforcement decision.

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 your failure to establish and maintain a quality management program that included written policies and procedures for checking source carriers and ovoids for correct dimensions and proper fit prior to brachytherapy. The failure to verify the correct position of the right source carrier used in a brachytherapy applicator prior to patient treatment, was identified as a root cause of the misadministrations. In considering the significance of the violation, we note that the dosages for the four patients were lower than intended. For three patients, the dosages were still within the range of doses considered acceptable for this type of treatment. The fourth patient received external radiation treatment to boost the dose to the acceptable range. Therefore, this violation has been categorized in accordance with the Enforcement Policy at Severity Level III.

In accordance with the Enforcement Policy, a civil penalty with a base value of $5,500 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement action within the last 2 years, 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. ARH's corrective actions included administrative changes for ordering, storing, maintaining, and conducting quality assurance checking of brachytherapy applicator parts. Based on ARH taking immediate and long-term corrective actions that addressed the causes of the misadministrations and which restored compliance with the NRC quality management program requirements, the NRC has determined that ARH is deserving of corrective action credit.

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 this report and in ARH's letters to NRC dated July 9 and 12, 1999. 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 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.

		Sincerely,
		/Thomas P. Gwynn for/
		Ellis W. Merschoff Regional Administrator

Docket No.: 030-14720
License No.: 50-18244-01

Enclosure:  Notice of Violation

cc w/enclosure:  Alaska Radiation Control Program Director

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NOTICE OF VIOLATION
Columbia Alaska Regional Hospital Anchorage, Alaska		Docket No. 030-14720 License No. 50-18244-01 EA-00-221

During an NRC inspection completed on September 25, 2000, 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 35.32(a) requires, in part, that the licensee establish and maintain a written quality management program to provide high confidence that radiation from byproduct material will be administered as directed by the authorized user. Pursuant to 10 CFR 35.32(a)(3), the quality management program must include written policies and procedures to meet the specific objective that final plans of treatment and related calculations for brachytherapy are in accordance with a written directive.

Contrary to the above, as of June 24, 1999, the licensee's quality management program did not include a written procedure to meet the objective that final plans of treatment and related calculations for brachytherapy are in accordance with a written directive. Specifically, the licensee did not have a procedure to determine or verify the correct position of each radioactive source in Fletcher-Suit-Delclos (FSD) mini-ovoid brachytherapy applicators prior to their placement and use in FSD applicators for patient treatments after replacement parts had been installed. As a result, a wrong dimension FSD replacement part (source carrier) containing cesium-137 sealed sources was displaced from its correct position in a right FSD applicator during patient brachytherapy, resulting in four misadministrations that occurred between March 24 and May 4, 1999.

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

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 this report and letters received from Columbia Alaska Regional Hospital dated July 9 and 12, 1999. 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 to the Public. 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.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 13th day of October 2000