January 30, 2013 — A mammography facility in Georgia had its mammography acceditation revoked by the American College of Radiology (ACR) following an investigation that showed major quality issues.
The Mountain Lakes Medical Center in Clayton, Ga., was investigated in April 2013 by the State of Georgia, under contract to the U.S. Food and Drug Administration (FDA). An annual Mammography Quality Standards Act (MQSA) inspection revealed the facility operated for 75 days without performing film processor quality control when clinical images were processed. On May 13, 2013, FDA required the facility submit images to the ACR for an additional mammography review (AMR). On June 20, 2013, the 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.
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. On Jan. 24, 2014, the FDA notified the facility that it successfully completed the PPN process.
The FDA said the facility has ceased performing mammography.
