U.S. flag An official website of the United States government
  1. Home
  2. Radiation-Emitting Products
  3. Mammography Quality Standards Act and Program
  4. MQSA Reports and Safety Notifications
  5. Mammography Facility Adverse Event and Action Report – September 6, 2022: Memorial MRI & Diagnostic, LLC
  1. MQSA Reports and Safety Notifications

Mammography Facility Adverse Event and Action Report – September 6, 2022: Memorial MRI & Diagnostic, LLC

Status of the Facility

Memorial MRI & Diagnostic, LLC has a Mammography Quality Standards Act (MQSA) certificate in effect, is currently accredited, and may provide mammography services.

Facility

Memorial MRI & Diagnostic, LLC
3400 Interstate Hwy 30
Ste 100
Mesquite, TX 75150

Facility ID Number

245486

Inspection/Reporting Entity

The State of Texas Certifying Agency (STX CA)

Actions Taken by the State of Texas Certifying Agency

On May 21, 2021, the facility’s accreditation body, the State of Texas accreditation body (STX AB), initiated an Additional Mammography Review (AMR) of mammograms performed at the facility between December 9, 2019, and April 15, 2021, based on the results of the facility’s annual MQSA inspection that occurred on February 8, 2021, as well as the mammography accreditation review process.

On June 29, 2021, the STX CA notified the facility that it failed the AMR. Twenty-two (22) out of the thirty (30) clinical cases submitted did not meet the STX AB clinical image evaluation criteria. Based on the information obtained from the AMR, the STX CA determined that the facility’s practice posed a serious risk to human health, and in order to protect the public health, the STX CA required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert patients who had mammograms performed at this facility from December 9, 2019, through April 15, 2021, and their referring health care providers of the mammography quality problems at the facility.

On March 3, 2022, the STX AB performed a follow-up AMR of mammograms performed at the facility between November 1, 2021, and February 15, 2022. The purpose of the AMR was to determine if corrective actions had improved the quality of mammography at the facility.

On May 17, 2022, the STX CA notified the facility that it failed the follow-up AMR. Fourteen (14) out of thirty (30) clinical cases submitted did not meet the STX AB clinical image evaluation criteria. Based on the issues noted with the mammograms reviewed during the AMR, the STX AB requested that the facility voluntarily suspend providing mammography services until corrective actions have been completed.

The facility paid an administrative penalty of $2,625.00 to the State of Texas for the inspection violations.

Corrective Action

The facility successfully completed the PPN and was notified of such by the STX CA on October 4, 2021.

On May 20, 2022, the facility complied with the STX AB’s request to voluntarily suspend mammography services.

The facility submitted documentation showing that required corrective actions have been completed. On July 26, 2022, the STX AB reinstated the facility’s accreditation.

A follow-up AMR will be conducted in December 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 issed prior to October 2010 can be found on the Document Archives (MQSA) webpage.

 

 
Back to Top