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EA-01-020 - District Hospital Partners

March 22, 2001

EA 01-020

Mr. Tom Moser
Chief Operating Officer
District Hospital Partners
c/o The George Washington University Hospital
901 23^rd Street, Suite 2500 N
Washington, DC 20037

Dear Mr. Moser:

This refers to the NRC inspection conducted on July 10, 2000, at your facility in Washington, DC to review the circumstances associated with the misadministration of cesium-137 to a patient at your facility on June 14 - 15, 2000. The misadministration was reported to the NRC by your staff on June 22, 2000. The inspection was continued in the Region I office through January 30, 2001, to review other information including the results of a report from the NRC medical consultant. The consultant reviewed the circumstances and significance associated with the misadministration. During the inspection, one apparent violation of NRC requirements was identified. The apparent violation was described in our inspection report sent to you on February 13, 2001. On March 12, 2001, a predecisional enforcement conference was held with you and other members of your staff to discuss the apparent violation, its causes, and your corrective actions. A copy of the enforcement conference report is attached.

Based on the information developed during the inspection and the information obtained during the predecisional enforcement conference, a violation of NRC requirements is being cited. The violation is described in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The violation involved the failure of your Quality Management Program (QMP) to include a procedure to ensure that brachytherapy applicators were adequately secured during treatment so that the intended site receives the prescribed exposure. As a result, a cesium-137 brachytherapy source was displaced during treatment, resulting in a misadministration since there was a 50% increase in exposure to an unintended site. Although this event also initially resulted in a 30% decrease in dose to the intended site, your staff subsequently administered additional dose to the intended site, via a second fraction of the treatment. As a result, the actual total dose given to the intended site was the appropriately prescribed dose.

You stated at the conference that the patient's subsequent complications were of the type typically observed as side effects with this type of treatment. However, the NRC, based on its consultant's review, has concluded that the misadministration was a probable cause of the complications experienced by the patient. Due to the inadequacy in your facility's procedure for securing the brachytherapy applicator, as well as the failure of your staff to recognize that the applicator had moved until approximately 6.5 hours later, this finding represents a programmatic weakness in the implementation of your QMP which resulted in the misadministration. Under circumstances where the problem is programmatic, the violation is categorized as a Severity Level III problem in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 (May 1, 2000 (65 FRN 25368)). The Enforcement Policy is available at the Office of Enforcement website at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation or problem. Because your facility has not been the subject of an escalated enforcement action within the last two years, 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. Credit for corrective actions is warranted because your corrective actions, at the time of the predecisional enforcement conference, were considered prompt and comprehensive. These actions included, but are not limited to: (1) revisions to your Quality Management Program to require double sutures to secure the applicator; and (2) providing more specific guidance in your department procedures for brachytherapy to include securing the applicator, verification that the applicator is secure, visual checks of the patient on a more frequent basis, marking the location of the lower end of the applicator on the patient's leg(s), and recording required information on the patient's chart.

Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence, were already described adequately during the enforcement conference, are adequately addressed on the docket from previous correspondence, or are included in this letter. Therefore, you are not required to respond to this letter unless the description herein 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 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 http://www.nrc.gov/reading-rm/adams.html (the Public Electronic Reading Room).

Docket No. 030-35424
License No. 08-30607-01

Enclosure:  Notice of Violation

cc w/encls:  District of Columbia

ENCLOSURE

NOTICE OF VIOLATION

During an NRC inspection conducted on July 10, 2000, at the licensee's facility in Washington, DC, and continued in the Region I office through January 30, 2001 to review the NRC's medical consultants report received on that date, one violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), 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 byproduct material or radiation from byproduct material will be administered as directed by the authorized user.

Pursuant to 10 CFR 35.32(a)(4), the quality management program must include written policies and procedures to meet the specific objective that each administration is in accordance with a written directive, which is defined in 10 CFR 35.2.

Contrary to the above, as of July 10, 2000, the licensee's quality management program did not include a written procedure to ensure that each administration is in accordance with a written directive. Specifically, the licensee's QMP did not include a procedure to ensure that the brachytherapy applicators were adequately secured during treatment so the intended treatment site receives the prescribed treatment and other sites receive the the planned dose. As a result, the applicator moved during the treatment of a patient on June 14 through 15, 2000. This unintentional movement of the source applicator resulted in a misadministration because the patient received a dose of 1120 cGy, instead of the planned dose of 648 cGy, to an unintended site.

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 previous correspondence from the licensee, or in the letter transmitting this Notice which summarizes the information provided during the enforcement conference. 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, DC 20555 with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

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 http://www.nrc.gov/reading-rm/adams.html (the Public Electronic Reading Room). 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 22nd day of March 2001