Mammography Facility Adverse Event and Action Report - January 24, 2014

Background

As part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide.

In order to provide this information in the timeliest manner, we now post the following information in “real time,” as this action taken against a mammography facility has concluded:

Mammography Facility Against Which There Was An Adverse Action

The State of Georgia

Facility Name and Address:
Mountain Lakes Medical Center
196 Ridgecrest Circle
Clayton, GA 30525-4111

Facility ID Number:
198960

Adverse Event:
On April 17, 2013, the State of Georgia, under contract to the FDA, conducted an annual MQSA inspection at this facility. The inspection revealed the facility operated for seventy-seven days without performing film processor quality control when clinical images were processed. On May 13, 2013, FDA required the facility submit images to the American College of Radiology (ACR) for an Additional Mammography Review (AMR). On June 20, 2013, the American College of Radiology (ACR) notified the facility that the deficiencies found in the evaluated mammograms posed a serious risk to human health. As a result, the ACR revoked the facility’s accreditation effective June 28, 2013.

Action Taken:
Based on the serious image quality deficiencies noted during the AMR, the FDA required the facility perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all at-risk patients (and their providers) of the mammography image quality problems at the facility.

Corrective Action:On January 24, 2014, the FDA notified the facility that it successfully completed the PPN process.

Status of the Facility:
The facility has ceased performing mammography.