Mammography Facility Adverse Event and Action Report – March 5, 2024: Stockdale Radiology
Status of the Facility
Stockdale Radiology has a Mammography Quality Standards Act (MQSA) certificate in effect, is currently accredited and may provide mammography services.
Facility
Stockdale Radiology
4000 Empire Drive
Suite 100
Bakersfield, CA 93309
Facility ID Number
241800
Inspection/Reporting Entity
U.S. Food and Drug Administration (FDA)
Actions Taken by the FDA
On March 7, 2023, the American College of Radiology (ACR), on behalf of the FDA, initiated an Additional Mammography Review (AMR) of a selection of mammograms performed at the facility from February 7, 2022, through September 29, 2022, based on the results of the facility’s annual MQSA inspection that occurred on November 9, 2022.
On April 10, 2023, the ACR notified the facility that it had failed the AMR. Eighteen (18) out of thirty clinical cases submitted did not meet ACR’s clinical image evaluation criteria. Some of the deficiencies were severe. As a result, on April 24, 2023, the ACR revoked the facility’s accreditation.
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and that in order to protect the public health, on April 25, 2023, declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 patients who had mammograms performed at this facility from April 25, 2021, through April 25, 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 August 25, 2023. The facility submitted its corrective action plan documentation to the ACR and applied for accreditation reinstatement. The ACR reinstated the facility’s accreditation on September 8, 2023, and the FDA issued the facility an MQSA certificate to legally perform mammography.
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.