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Mammography Facility Adverse Event and Action Report - February 16, 2016: Boston Diagnostic Imaging

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 Subject of an Adverse Action

The State of Florida

Facility Name and Address:
Boston Diagnostic Imaging
1751 S. Orange Ave.
Orlando, FL 32806

Facility ID Number:

Adverse Event:
On June 12, 2015, the American College of Radiology (ACR) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility due to serious image quality problems identified during the review of clinical images submitted for accreditation renewal. On July 21, 2015, the ACR notified the facility that mammograms reviewed during the AMR did not meet the ACR’s criteria for clinical image quality and that the deficiencies posed a serious risk to human health.

Action Taken:
The ACR revoked the facility’s accreditation effective July 29, 2015. After evaluating the reasons of the revocation, on August 13, 2015, the Food and Drug Administration (FDA) suspended the MQSA certificate until such time as the facility's accreditation is reinstated and the facility has complied with all requirements under the MQSA.

Corrective Action:
Based on the serious image quality deficiencies noted during the AMR, the FDA 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 November 30, 2015.

Status of the Facility:
The facility’s accreditation has been reinstated and the facility is currently performing mammography.

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