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  5. Mammography Facility Adverse Event and Action Report – December 8, 2022: South Central Health
  1. MQSA Reports and Safety Notifications

Mammography Facility Adverse Event and Action Report – December 8, 2022: South Central Health

Status of the Facility

South Central Health has a Mammography Quality Standards Act (MQSA) certificate in effect, is currently accredited, and may provide mammography services.

Facility

South Central Health
1007 4th Ave. S
Wishek, ND 58495 

Facility ID Number

185173 

Inspection/Reporting Entity

U.S. Food and Drug Administration (FDA)

Actions Taken by the FDA 

On July 28, 2021, the facility’s accreditation body, the American College of Radiology (ACR) notified the FDA that the facility failed a post-revocation Clinical Image Review (CIR) required for accreditation reinstatement following an accreditation revocation action taken by the ACR on January 27, 2015.  The FDA had also placed the facility’s MQSA certificate into ‘No Longer in Effect’ status on February 10, 2015. The ACR required the facility to complete a Corrective Action Plan (CAP) prior to resuming mammography services. The facility completed the CAP and was provisionally reinstated to resume mammography services on December 8, 2020, however a follow-up CIR revealed ongoing deficiencies in clinical image quality. The ACR required the facility to complete a second CAP which was more extensive than the first CAP. The facility completed the second CAP, however the second post-revocation CIR from July 28, 2021, revealed clinical images that failed to meet the ACR’s clinical image evaluation criteria. Nine (9) of thirty (30) cases did not meet ACR’s clinical image evaluation criteria; some of the deficiencies were severe. On July 28, 2021, the ACR notified the facility that it intended to revoke the facility’s application for accreditation, effective August 11, 2021.  The facility did not appeal the adverse accreditation decision to the ACR, and on August 11, 2021, the ACR revoked the facility’s application for accreditation. 

Based on the information obtained from the ACR regarding the reasons for the revocation of the facility’s accreditation, on August 12, 2021, the FDA notified the facility that it was no longer certified and had to cease performing mammography because the facility was not accredited by an FDA-approved accreditation body. The FDA also notified the facility that it was required to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all patients who had mammograms performed at the facility from December 8, 2020, up to and including the date that the facility ceased performing mammography, and their referring healthcare providers, of the mammography quality problems at the facility. 

Corrective Action

On October 6, 2021, the FDA notified the facility it had successfully completed the PPN. 

The facility submitted documentation to the ACR that it had completed its CAP and was reinstated by the ACR on November 22, 2021. On January 19, 2022, the ACR notified the facility that it passed the post-revocation repeat CIR. Additionally, on August 25, 2022, the facility was notified that it passed a Targeted Image Check (TIC) performed by the ACR to determine if the facility had continued to maintain image quality.  

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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