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  5. Mammography Facility Adverse Event and Action Report – August 5, 2022: Elliott Breast Clinic
  1. MQSA Reports and Safety Notifications

Mammography Facility Adverse Event and Action Report – August 5, 2022: Elliott Breast Clinic

Status of the Facility

Elliott Breast Clinic has a Mammography Quality Standards Act (MQSA) certificate in effect, is accredited, and may provide mammography services.

Facility

Elliott Breast Clinic
541 Shadows Lane
Suite C
Baton Rouge, LA 70806

Facility ID Number

142240

Inspection/Reporting Entity

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

Actions Taken by the FDA

The facility’s annual MQSA inspection on March 17, 2021, revealed that an interpreting physician failed to meet the initial training and experience requirements prior to independently interpreting mammograms. Specifically, the facility failed to produce documentation of the interpreting physician as, 1) being certified in the appropriate specialty by an FDA-approved board or having at least 3 months of initial training in the interpretation of mammograms and in topics related to mammography, 2) having interpreted or multi-read at least 240 mammograms under the direct supervision of an MQSA-qualified interpreting physician within the 6 months immediately prior to qualifying as an interpreting physician, and 3) having 60 hours of documented, formal category I medical education training in mammography.

As a result, the FDA determined that mammograms interpreted by the facility, and the facility’s ability to ensure the safety, reliability, clarity, and accuracy of mammography services, posed a significant risk to individual and public health. The facility was required to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all patients who had mammograms performed at this facility from December 28, 2020, to March 19, 2021, and their referring health care providers of the mammography problems at the facility.

Corrective Action

The facility completed corrective action to enable the facility to resume providing mammography services. The facility successfully completed the PPN and was notified of such by the FDA on October 6, 2021.

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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