Mammography Facility Adverse Event and Action Report – April 25, 2023: University Park OBGYN, LLC
Status of the Facility
University Park OBGYN, LLC has a Mammography Quality Standards Act (MQSA) certificate in effect, is currently accredited and may provide mammography services.
Facility
University Park OBGYN, LLC
2401 University Parkway, Suite 201
Sarasota, FL 34243
Facility ID Number
248181
Inspection/Reporting Entity
U.S. Food and Drug Administration (FDA)
Actions Taken by the FDA
On July 19, 2022, the facility’s accreditation body, the American College of Radiology (ACR), initiated an Additional Mammography Review (AMR) of mammograms performed at the facility from April 29, 2022, through July 19, 2022, based on the clinical image quality deficiencies noted during the facility’s initial accreditation process.
On August 24, 2022, the ACR notified the facility that it failed the AMR. Six (6) out of the thirty (30) clinical cases submitted did not meet the ACR’s clinical image evaluation criteria; some of the deficiencies were severe. Additionally, the ACR notified the facility that it intended to revoke its accreditation. The facility did not appeal the adverse accreditation decision and the ACR revoked the facility’s accreditation, effective on September 8, 2022.
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and that in order to protect the public health, on September 9, 2022, declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 29, 2022, through September 9, 2022, 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 November 23, 2022. The facility successfully completed an ACR corrective action plan. The ACR reinstated the facility’s accreditation, and on April 11, 2023, the FDA issued an MQSA certificate to the facility so that it could 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.
Additional Resources
For more information, please refer to the MQSA Program http://www.fda.gov/mammography webpage. Annual and semi-annual reports issued prior to October 2010 can be found on the Document Archives (MQSA) webpage.