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 Virginia

Facility Name and Address:

Valley Health System
Winchester Medical Center – Diagnostic Center
300 Campus Blvd.
Winchester, VA 22601

Facility ID Number:

129379

Adverse Event:

On July 1, 2019, the American College of Radiology (ACR) notified the facility that it was required to participate in an Additional Mammography Review (AMR) based on the facility conducting mammography with an unaccredited digital breast tomosynthesis (DBT) unit.

On August 22, 2019, the ACR notified the Food and Drug Administration (FDA) and the facility that the AMR revealed serious deficiencies with clinical image quality and that the facility failed to meet the ACR’s clinical image evaluation criteria.

Action Taken:

Based on the failed AMR results, on September 4, 2019, the ACR revoked the facility’s accreditation.

After evaluating the reasons for the accreditation revocation, on September 5, 2019, the FDA declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 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 31, 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.