Mammography Facility Adverse Event and Action Report – December 8, 2022: Missouri Delta Medical Center
Status of the Facility
Missouri Delta Medical Center has a Mammography Quality Standards Act (MQSA) certificate in effect, is currently accredited, and may provide mammography services.
Facility
Missouri Delta Medical Center
1008 N Main St.
Sikeston, MO 63801
Facility ID Number
125948
Inspection/Reporting Entity
U.S. Food and Drug Administration (FDA)
Actions Taken by the FDA
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 the clinical image quality deficiencies noted during the Validation Image Check (VIC) process. The VIC is a periodic review by the facility’s accreditation body of mammographic images performed at a facility to determine if image quality is maintained during the facility’s 3-year accreditation cycle.
On June 25, 2021, the ACR notified the facility that 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 25, 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 July 13, 2021.
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 14, 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 May 5, 2019, to July 14, 2021, and their referring health care providers, of the mammography quality problems at the facility.
Corrective Action
On October 20, 2021, the FDA notified the facility it had successfully completed the PPN. The facility submitted its corrective action plan documentation to the ACR and was reinstated on October 27, 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.