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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Mammography Facility Adverse Event and Action Report - December 12, 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 Kentucky

Facility Name and Address:

Downtown Radiology, Inc.
123 N. 19th Street
Middlesboro, KY 40965
Facility ID Number:
110536

Adverse Event:

On August 1, 2012, the American College of Radiology (ACR) initiated an Additional Mammography Review (AMR) for this facility due to serious problems found during clinical image review for accreditation renewal. On September 14, 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 September 21, 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 December 10, 2012, the FDA notified the facility that it successfully completed the PPN process.

Status of the Facility:

After revocation of accreditation, the certificate was declared no longer in effect, and the facility has ceased performing mammography.