United States Nuclear Regulatory Commission - Protecting People and the Environment

EA-04-087 - St. Vincent Hospital & Health Care Center

August 2, 2004

EA-04-087
NMED No. 040229

Jean Meyer, Senior Vice-President
St. Vincent Hospital & Health Care Center
2001 West 86th Street
Indianapolis, IN 46240

SUBJECT: NOTICE OF VIOLATION
[NRC INSPECTION REPORT NO. 030-01579/2004-001(DNMS)]

Dear Ms. Meyer:

This refers to the special inspection conducted from April 7 through April 20, 2004, at St. Vincent Hospital & Health Care Center, Indianapolis, IN, to review the circumstances related to a medical event that was reported to the U.S. Nuclear Regulatory Commission (NRC) on April 5, 2004. The medical event was related to three fractionated high-dose-rate (HDR) remote afterloader brachytherapy treatments on March 15, 22, and 29, 2004, that exceeded the dose prescribed in the physician authorized user's written directive. Specifically, the medical staff planned to deliver 5 fractions of 500 rads each to a patient; however, a radiation dose of 818 rads per fraction was administered to the patient during each of the first three fractionated treatments. One apparent violation, pertaining to the licensee's failure to develop written procedures to ensure each administration is in accordance with the written directive prior to patient treatment, was identified during the inspection. The inspection report was provided to you on May 11, 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 in a letter dated April 15, 2004, and a response to the apparent violation was provided in a letter dated May 17, 2004.

Based on the information developed during the inspection and the information you provided in letters dated April 15 and May 17, 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, St. Vincent Hospital & Health Care Center failed to develop written procedures to ensure that each administration of NRC-licensed material was in accordance with the written directive from an authorized physician user, as required by 10 CFR 35.41, "Procedures for Administrations Requiring a Written Directive." An authorized user physician prepared a written directive prescribing five planned HDR remote afterloading brachytherapy treatments to a patient. Each treatment was to consist of 500 rads at the surface of a 25 millimeter (mm) vaginal cylinder for a total dose of 2500 rads, according to the directive prepared by the physician. A medical physicist, not realizing the physician's written directive specified the intended dose of 500 rads per fraction was to be delivered at the surface of the cylinder, used the standard treatment parameter of 5 mm beyond the surface of the cylinder in developing the treatment plan. The patient was then treated on March 15, 22, and 29, 2004, according to the treatment plan prepared by the medical physicist. Prior to the fourth treatment, a second medical physicist independently reviewed the previously approved treatment plan and discovered the 5 mm error in that plan. As a result of the 5 mm error, an additional dose of 318 rads was delivered at the cylinder surface during each fractionated treatment for a total of 818 rads administered to the patient per treatment instead of the prescribed 500 rads. The authorized user physician subsequently amended the written directive and treatment plan to conclude, upon completion of the fourth fraction, with a total revised prescribed dose of 2954 rads having been administered, as opposed to the originally prescribed total dose of 2500 rads. The authorized user physician did not expect any adverse medical effects to the patient as a result of this medical event. The failure of St. Vincent Hospital & Health Care 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) requiring your staff to independently check treatment plans prior to each treatment; (2) requiring a second medical physicist to review the treatment plan and verify the treatment parameters are correct; (3) requiring the medical physicist to manually calculate the treatment dose and compare it to the dose developed in the treatment plan and written directive prior to administering the treatment to the patient; and (4) disseminating the results of the investigation, including root cause and corrective actions, to all members of the medical physics staff and authorized user physicians involved in HDR treatments.

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 St. Vincent Hospital & Health Care Center dated April 15 and May 17, 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), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. 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 significant enforcement actions on its Web site at www.nrc.gov; select What We Do, Enforcement, then Significant Enforcement Actions.

Sincerely,

/RA/ Geoffrey E. Grant for

James L. Caldwell
Regional Administrator

Docket No. 030-01579
License No. 13-00133-02

Enclosure: Notice of Violation

cc w/encl:
Sister Mary Frances Loftin
Chairperson, Board of Directors
St. Vincent Hospital & Health Care Center
2001 West 86th Street
Indianapolis, IN 46240



NOTICE OF VIOLATION

St. Vincent Hospital & Health Care Center
Indianapolis, IN
Docket No. 030-01579
License No.13-00133-02
EA-04-087

During an NRC inspection conducted from April 7 through April 20, 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) including the requirement to check both manual and computer-generated dose calculations.
Contrary to the above, as of April 7, 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) for the use of its high-dose-rate remote afterloader brachytherapy treatment system to: (1) verify that the administration is in accordance with the treatment plan and the written directive; and (2) check both manual and computer-generated dose calculations.
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 St. Vincent Hospital & Health Care Center (Licensee) dated April 15 and May 17, 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-04-087," 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 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, 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 NRC's document system (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. 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 2nd day of August 2004.

 

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