Background

As part of the Mammography Quality Standards Act (MQSA), Congress mandated 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 Michigan

Facility Name and Address

Comprehensive Breast Centers of Ann Arbor
4012 Clark Rd.
Ann Arbor, MI 48105

Facility ID Number

107839

Adverse Event

On March 19, 2019, the American College of Radiology (ACR) notified the facility that it was required to participate in an extensive Clinical Image Review (CIR) of mammograms performed in order to determine if the corrective actions taken by the facility following the July 5, 2018, revocation of the facility's accreditation for failing to complete a Food and Drug Administration (FDA)-required Additional Mammography Review (AMR), had led to improvements in mammography image quality.

On August 15, 2019, the ACR notified the FDA that the facility had failed the CIR with sixteen (16) out of thirty (30) cases not meeting the ACR's criteria for clinical image quality.

Action Taken

Based on the failed CIR results, on September 4, 2019, the ACR revoked the facility's application for accreditation.

After evaluating the reasons for the accreditation application revocation, on September 5, 2019, the FDA declared the facility's MQSA certificate to be no longer in effect until such time as the facility's accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 CIR, 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 December 23, 2019.

Status of the Facility

The facility is currently not performing mammography.