Mammography Facility Adverse Event and Action Report – September 6, 2022: Ste. Genevieve County Memorial Hospital
Status of the Facility
Ste. Genevieve County Memorial Hospital has a Mammography Quality Standards Act (MQSA) certificate in effect, is currently accredited, and may provide mammography services.
Facility
Ste. Genevieve County Memorial Hospital
800 Ste. Genevieve Drive
Ste. Genevieve, MO 63670
Facility ID Number
170068
Inspection/Reporting Entity
The U.S. Food and Drug Administration (FDA)
Additional Mammography Review
On April 14, 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 April 14, 2019, and April 14, 2021, based on the 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 May 27, 2021, the ACR notified the facility it had failed the AMR. Ten (10) 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 May 27, 2021, the ACR notified the facility that it intended to revoke its 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 June 16, 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 June 23, 2021, declared the facility's MQSA certificate to be no longer be in effect 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 April 14, 2019, to June 23, 2021, 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 16, 2021. The facility submitted its corrective action plan documentation to the ACR and was reinstated on May 18, 2022.
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.