EA-04-093 - Missouri Baptist Medical Center

August 20, 2004

EA-04-093
NMED No. 040297

Carn Moceri, President
Missouri Baptist Medical Center
3015 N. Ballas Road
St. Louis, MO 63131

SUBJECT:

NOTICE OF VIOLATION [NRC INSPECTION REPORT NO. 030-08325/2004-001(DNMS)]

Dear Mr. Moceri:

This refers to the special inspection conducted on April 26 and April 27, 2004, at Missouri Baptist Medical Center, St. Louis, Missouri, to review the circumstances related to a medical event that resulted in a radiation exposure of approximately 600 to 2,000 rads to the patient's upper thighs during a fractionated high-dose-rate (HDR) remote afterloader brachytherapy treatment on March 11, 2004. On April 22, 2004, the facility Radiation Safety Officer (RSO) determined that a medical event occurred and notified the U.S. Nuclear Regulatory Commission (NRC). One apparent violation, pertaining to the failure to develop and implement written procedures to ensure each brachytherapy administration was in accordance with the written directive prior to patient treatment, was identified during the inspection. The inspection report was provided to you on June 14, 2004.

In the letter transmitting the inspection report, we provided you the opportunity to address the apparent violation identified in the report by either attending a predecisional enforcement conference or by providing a written response before we made our final enforcement decision. The required written report of the event was provided by you in letters dated May 7 and May 21, 2004, and you provided a response to the apparent violation in a letter dated July 2, 2004.

Based on the information developed during the inspection and the information you provided in letters dated May 7, May 21, and July 2, 2004, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. In summary, Missouri Baptist Medical Center did not develop written procedures to assure the source transfer tube remained secured to the vaginal cylinder during an HDR brachytherapy treatment and thus ensure that NRC-licensed material was administered in accordance with the written directive from an authorized user physician, as required by 10 CFR 35.41, "Procedures for Administrations Requiring a Written Directive." An authorized user physician prepared a written directive prescribing three HDR remote afterloading brachytherapy treatments to a patient after the patient received treatment from external beam radiation. Each HDR treatment was to consist of 700 rads from an Iridium-192 source of approximately 3.5 curies by vaginal cylinder. Erythema was noticed on the inner portion of each of the patient's thighs, subsequent to the third treatment on March 11, 2004, indicating the radiation source did not transverse the entire length of the transfer tube during the HDR treatment. The authorized user physician did not expect any adverse medical effects to the patient as a result of this medical event. The violation involving the failure of Missouri Baptist Medical Center to have written procedures to ensure that each administration of NRC-licensed material was in accordance with the written directive has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 at Severity Level III.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $3,000 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement actions within the last two inspections, 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. Credit was warranted for the Corrective Action factor. Corrective actions included: (1) developing written procedures to determine if the transfer tube is in place before and after treatment; (2) marking the transfer tube as part of a visual check to determine whether the transfer tube moves during treatment; and (3) training the medical physics and nursing staffs on the procedures.

Therefore, to encourage prompt 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, 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 letters from Missouri Baptist Medical Center dated May 7, May 21, and July 2, 2004. 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 2.390 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response (should you choose to respond) will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), which is accessible from the NRC Web site at the Public NRC Library. To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction. The NRC also includes Issued Significant Enforcement Actions on its Web site.

		Sincerely,
		/RA/ Geoffrey E. Grant for
		James L. Caldwell Regional Administrator

Docket No. 030-08325
License No. 24-11128-02

Enclosure: Notice of Violation

cc w/encl:
W. Joseph Privott, Ph.D.
Chairman, Board of Directors

cc: State of Missouri

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NOTICE OF VIOLATION

Missouri Baptist Medical Center St. Louis, Missouri

Docket No. 030-08325 License No. 24-11128-02 EA-04-093

During an NRC inspection conducted on April 26 and April 27, 2004 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 35.41(a) requires, in part, that for any administration requiring a written directive, licensees develop, implement, and maintain written procedures to provide high confidence that: (1) the patient's or human research subject's identity is verified before each administration; and (2) each administration is in accordance with the written directive. Procedures must meet the requirements described in 10 CFR 35.41(b) to verify that the administration is in accordance with the treatment plan and the written directive.

Contrary to the above, as of March 11, 2004, the licensee did not develop, implement, and maintain written procedures to provide high confidence that each administration is in accordance with the written directive. Specifically, the licensee did not develop written procedures to meet the requirements described in 10 CFR 35.41(b) to verify the source transfer tube was securely fastened to the vaginal cylinder during use of its high-dose-rate (HDR) remote afterloader brachytherapy device to ensure that each administration was in accordance with the treatment plan and the written directive.

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 letters from Missouri Baptist Medical Center dated May 7, May 21, and July 2, 2004. 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, EA-04-093," 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 III, 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, D.C. 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 NRC's document system (ADAMS), which is accessible from the NRC Web site at the Public NRC Library. Therefore, 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. 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 2.390(b) to support a request for withholding confidential commercial or financial information).

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

Dated this 20^th day of August 2004.