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  5. Mammography Facility Adverse Event and Action Report – December 8, 2022: Pickens County Primary Care
  1. MQSA Reports and Safety Notifications

Mammography Facility Adverse Event and Action Report – December 8, 2022: Pickens County Primary Care

Status of the Facility

Pickens County Primary Care, PC is currently unaccredited, does not have a Mammography Quality Standards Act (MQSA) certificate in effect, and may not provide mammography services.

Facility

Pickens County Primary Care, PC
108 4th Ave SW
Reform, AL 35481

Facility ID Number

 246852

Inspection/Reporting Entity

U.S. Food and Drug Administration (FDA)

Actions Taken by the FDA 

On June 17, 2021, the facility’s accreditation body, the American College of Radiology (ACR), initiated an Additional Mammography Review (AMR) of mammograms performed at the facility between June 17, 2019, and June 17, 2021, based on the clinical image quality deficiencies noted during the initial accreditation process. The AMR was performed to determine if the overall mammography quality at the facility had been compromised. 

On July 23, 2021, the ACR notified the facility that it had failed the AMR. Eleven (11) out of thirty (30) clinical cases submitted did not meet ACR’s clinical image evaluation criteria; some of the deficiencies were severe. As a result, on July 23, 2021, the ACR notified the facility that it intended to revoke the facility’s application for mammography accreditation. The facility appealed the adverse accreditation decision to the ACR, and the appeal was subsequently denied based on insufficient justification for overturning the decision. The ACR then revoked the facility’s accreditation, effective August 5, 2021.

Based on the information obtained from the ACR concerning the reasons for the revocation of the facility's accreditation, on August 6, 2021, the FDA notified the facility that it was no longer certified and must cease performing mammography because the facility was not accredited by an FDA-approved accreditation body.  The FDA required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all patients who had mammograms performed at this facility from March 11, 2021   (the date that the facility became provisionally certified) or the date of the first mammogram performed at the facility, whichever date was earlier, up to and including the date that the facility ceased performing mammography,  and their referring health care providers, of the mammography quality problems at the facility.  

Corrective Action

On October 22, 2021, the FDA notified the facility it had successfully completed the PPN. 

Background - MQSA Program

The FDA compiles and makes available to physicians and the general public information that is useful in evaluating the performance of mammography facilities. As of October 2010, the FDA posts individual notices following completion of the adverse actions taken against facilities. This information is useful in evaluating the performance of mammography facilities nationwide and assists providers and patients in making informed decisions.  For additional information, please see the Reports (MQSA) webpage.  

Additional Resources

For more information, please refer to the MQSA Program webpage. Annual and semi-annual reports issued prior to October 2010 can be found on the Document Archives (MQSA) webpage.

 
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