Background

As part of the Mammography Quality Standards Act (MQSA), Congress mandated that there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide. In order to provide this information in the timeliest manner, we now post the following information in “real time,” as actions taken against mammography facilities are concluded:

Mammography Facility Against Which There Was An Adverse Action

The State of Florida

Facility Name and Address

Women's Care Florida OB &GYN Specialists
1551 Clay Street
Winter Park, FL 32789

Facility ID Number

243332

Adverse Event:

On May 22, 2019, the FDA notified the facility that it was required to undergo an Additional Mammography Review (AMR) performed by its accreditation body, the American College of Radiology (ACR), based on the facility’s operation of a mammography unit without first obtaining an MQSA certificate extension from the FDA or accreditation from the ACR.

On July 11, 2019, the ACR notified the FDA that the facility had failed the AMR with eighteen (18) out of thirty (30) cases not meeting the ACR’s clinical image quality criteria.

Action Taken

Based on the failed AMR results, on July 26, 2019, the ACR revoked the facility’s mammography accreditation.

After evaluating the reasons for the accreditation revocation, on July 26, 2019, the FDA declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.

Corrective Action

Based on the serious image quality deficiencies noted during the AMR, the FDA declared the mammography performed at this facility to be a serious risk to human health and therefore required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all at-risk patients and their providers of the mammography quality problems at the facility.

The facility successfully completed the PPN and was notified of such by the FDA on January 3, 2020.

Status of the Facility

The facility's accreditation was reinstated, and the facility was issued an MQSA certificate. The facility is currently performing mammography.