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  5. Mammography Facility Adverse Event and Action Report – March 5, 2024: Farmbrook Radiology
  1. MQSA Reports and Safety Notifications

Mammography Facility Adverse Event and Action Report – March 5, 2024: Farmbrook Radiology

Status of the Facility

Farmbrook Radiology is currently unaccredited and uncertified to perform mammography and cannot legally provide mammography services. The FDA recommends patients contact Farmbrook Radiology to obtain their medical records.

Facility

Farmbrook Radiology
29829 Telegraph Rd., Ste. L-105
Southfield, MI 48034

Facility ID Number

147462

Inspection/Reporting Entity

U.S. Food and Drug Administration (FDA)

Actions Taken by the FDA 

On April 26, 2023, the FDA initiated an Additional Mammography Review (AMR), performed by the facility’s accreditation body, the American College of Radiology (ACR). The AMR included a selection of mammograms performed at the facility from April 25, 2022, through November 23, 2022. During this time period, the facility did not perform the mammography equipment manufacturer’s required quality control tests at the frequency specified by the manufacturer.

On June 13, 2023, the ACR notified the facility that it failed the AMR. Thirteen (13) out of the 30 clinical cases submitted did not meet the ACR’s clinical image evaluation criteria; some of the deficiencies were severe. Additionally, the ACR notified the facility that it intended to revoke its accreditation. The facility did not appeal the adverse accreditation decision, and the ACR revoked the facility’s accreditation, effective on June 18, 2023.

Based on the information obtained from the ACR concerning the reasons for the revocation of the facility’s accreditation, the FDA determined that the facility’s practice posed a serious risk to human health, and that in order to protect the public health, on June 29, 2023, declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation was reinstated and the facility had complied with all the requirements of the FDA. The FDA required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert patients who had mammograms performed at this facility from June 29, 2021, through June 29, 2023, and their referring health care providers of the mammography quality problems at the facility.

Corrective Action

The facility successfully completed the PPN and was notified of such by the FDA on September 19, 2023.

Background - MQSA Program

The FDA compiles and makes available to physicians and the 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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