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Mammography Facility Adverse Event and Action Report - May 2, 2012

Thu, 05/03/2012 - 5:30am
U.S. Food & Drug Administration

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:

Dorminy Medical Center

200 Perry House Rd.

P.O. Box 1447

Fitzgerald, GA 31750

Facility ID Number:

110452

Adverse Event:

On 9/30/2011, this facility was notified by the American College of Radiology (ACR) that it must participate in an Additional Mammography Review (AMR) due to serious problems found during a clinical image review for accreditation renewal. The facility voluntarily ceased performing mammography. The ACR notified the facility that the deficiencies found in the mammograms evaluated during the AMR revealed serious problems involving the quality of mammography.

Action Taken:

This facility was notified by the FDA that based on the significant risk to individual or public health found during the AMR, it was required to perform a Patient and Referring Healthcare Provider Notification (PPN), which involved notifying all at-risk patients about possible problems with their examinations.

Corrective Action:

The facility met the requirements of the ACR for provisional reinstatement of accreditation, and on 5/2/2012 the facility was notified by the FDA that it successfully completed the PPN process.

Status of the Facility:

Performing mammography under a provisional reinstatement and provisional certification.

HOW TO FIND AN 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.

Internet

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.

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