Update on The Women’s Breast Care Clinic at Jeff Anderson Regional Medical Center (JARMC)

• CEO Message
• Notification Letter
• Frequently Asked Questions

Background
During a 2006 annual inspection of mammography services at The Women's Breast Care Clinic, the Food & Drug Administration (FDA) identified concerns regarding quality control measures at the Clinic.

The investigation focused on documentation and equipment calibration issues. As the review progressed, concerns surfaced that these discrepancies may have impacted the integrity of some of the mammography films. A further technical review of a random sampling of films by the American College of Radiology (ACR) found that some exams failed to meet the minimum standards for diagnostic quality as well as concerns related to positioning.

This does not necessarily mean that the results of the examinations were inaccurate. However enough questions surfaced regarding mammograms taken between October 2, 2004 and October 2, 2006 to raise concern. JARMC determined the prudent and responsible action would be to encourage patients from that time period to repeat their mammogram.

On October 2, 2006, JARMC announced it would voluntarily suspended mammography services on a temporary basis. JARMC has continued to work with the FDA to follow the correct process to notify physicians and patients of the FDA’s findings. JARMC is voluntarily assuming financial responsibility for the cost of repeat mammograms and is working with physicians to provide them with information to assist in the rescheduling of mammograms.

Current status
Patients who received mammograms at JARMC between October 2, 2004 and October 2, 2006 are encouraged to have repeat mammograms.

Physicians who requested tests for their patients were notified beginning Thursday, October 12, 2006 with delivery of an official letter.

Patients who received mammograms at The Women’s Breast Care Clinic between October 2, 2004 and October 2, 2006 began to be notified of the situation via certified mail beginning October 17, 2006.

Patients affected by this issue are encouraged to have a repeat mammogram – which will be paid for by JARMC. If you are one of these patients, you will receive more information by certified mail. A list of certified facilities is being provided to physicians and is available on this Web site under the Frequently Asked Questions' tab. For more information, contact The Women's Breast Care Clinic at 601-553-6250.

Looking forward
Jeff Anderson Regional Medical Center’s focus is on notifying and encouraging affected patients to be retested. We will then work with appropriate regulatory agencies to resume mammography services once re-certification compliance steps are approved.