Radiation-Emitting Products

Mammography Facility Adverse Event and Action Report - October 25, 2012

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 most timely 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:
Georgia Clinic at Peachtree Corners
6330 Primrose Hill Court, Suite 104
Norcross, GA 30092

Facility ID Number:
209981

Adverse Event:
On December 28, 2011, the American College of Radiology (ACR) initiated an Additional Mammography Review (AMR) for this facility due to the poor quality of clinical images reviewed during a targeted film check performed as a result of a consumer complaint. On April 12, 2012, the ACR notified this facility that the deficiencies found in the mammograms evaluated during its AMR revealed serious problems involving the quality of mammography. As a result, the ACR revoked the facility’s accreditation on April 23, 2012. The facility voluntarily ceased performing mammography.

Action Taken:
Based on the significant risk to individual or human health found during the AMR, the FDA required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN), which involved notifying all at-risk patients (and their providers) of the possible problems with their examinations.

Corrective Action:
On September 12, 2012, the FDA notified the facility that it successfully completed the PPN process.

Status of the Facility:
After revocation of accreditation, the certification is no longer in effect, and the facility has ceased performing mammography.

How to Find a FDA-Certified Facility

Cancer Information Service

To operate legally, a mammography facility must have and prominently display an FDA MQSA facility certificate or a similar certificate from an FDA-approved State certifying agency. This certificate shows that the mammography facility is certified as meeting baseline quality standards for equipment, personnel, and practices under the MQSA. Consumers and health professionals can locate MQSA-certified facilities in their geographic area by calling the National Cancer Institute’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). Information specialists at this number are trained to answer questions about mammography and breast cancer. Written documentation on mammography and breast cancer is also available on request.

The FDA Mammography Web Site provides a listing of all MQSA-certified facilities by selected State or U.S. territory and zip code.

National Technical Information Service
A list of all MQSA-certified mammography facilities is available on a computer diskette and sold as either a single issue (the most recent diskette) or a subscription (the diskette is updated quarterly) from:
National Technical Information Service (NTIS)
5301 Shawnee Road
Alexandria, VA 22312
http://www.ntis.gov/

To order a single disk, call 1-800-553-6847. The NTIS order number is SUB-5386/Code D01.