Mammography Facility Adverse Event and Action Report – August 5, 2022: Watson Imaging Center
Status of the Facility
Watson Imaging Center is currently unaccredited and does not have a Mammography Quality Standards Act (MQSA) certificate in effect and may not provide mammography services.
Watson Imaging Center
3915 Watson Road
St. Louis, MO 63109
Facility ID Number
The U.S. Food and Drug Administration (FDA)
Additional Mammography Review
On May 5, 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 May 5, 2019, and May 5, 2021, based on clinical image quality deficiencies noted during a routine Validation Image Check (VIC) process. A VIC is a periodic review of images from the facility by its accreditation body to determine if a minimum level of image quality is maintained during the facility’s 3-year accreditation cycle.
On June 22, 2021, the ACR notified the facility it had failed the AMR. Fourteen (14) 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 June 22, 2021, the ACR notified the facility that it intended to revoke the facility’s accreditation. The facility appealed the adverse accreditation decision to the ACR, which was subsequently denied, and the ACR revoked the facility’s accreditation, effective on July 8, 2021.
Actions Taken by the FDA
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health, and that in order to protect the public health, on July 9, 2021, placed the facility's MQSA certificate in “no longer in effect” status, until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 all patients who had mammograms performed at this facility from May 5, 2019, to July 9, 2021, and their referring health care providers, of the mammography quality problems at the facility.
The facility successfully completed the PPN and was notified of such by the FDA on October 8, 2021. The facility has not reapplied for accreditation and does not currently have a 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.
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.