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

Mammography Facility Adverse Event and Action Report – December 8, 2022: Radiology Consultants

Status of the Facility

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

Facility

Radiology Consultants
210 South Federal Hwy, Ste 200 - 2nd FL
Hollywood, FL 33020

Facility ID Number

132688

Inspection/Reporting Entity

The U.S. Food and Drug Administration (FDA)

Actions Taken by the FDA 

On March 23, 2022, the facility’s accreditation body, the American College of Radiology (ACR), on behalf of the FDA, initiated an Additional Mammography Review (AMR) of mammograms performed at the facility between March 22, 2021, and January 27, 2022, based on the results of the facility’s annual MQSA inspection that occurred on January 27, 2022.

On April 21, 2022, the ACR notified the facility that the AMR was deficient. Ten (10) out of thirty (30) clinical cases submitted did not meet the ACR’s clinical image evaluation criteria. The ACR required the facility to submit a Corrective Action Plan (CAP) to address the deficiencies noted in the AMR report. On June 10, 2022, the ACR notified the facility that their CAP was incomplete and that failure to submit a complete CAP by June 20, 2022, would result in revocation of mammography accreditation due to non-compliance. On June 21, 2022, the ACR revoked the facility’s accreditation due to non-compliance, effective immediately.

Based on the information obtained from the ACR concerning the reasons for the revocation of the facility’s accreditation, on June 22, 2022, the FDA declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.

Corrective Action

The facility submitted CAP documentation to the ACR and applied for accreditation reinstatement. The ACR has reinstated the facility’s accreditation, and on September 16, 2022, the FDA issued the facility an MQSA certificate to legally perform mammography. 

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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