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  1. Mammography Quality Standards Act and Program

Mammography Facility Adverse Event and Action Report – December 12 2017 (Updated December 26, 2017): EVDI Desert Breast Ctr - Country Club

Mammography Facility Adverse Event and Action Report – December 12 2017 (Updated December 26, 2017): EVDI Desert Breast Ctr - Country Club

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 Arizona

Facility Name and Address:
EVDI Desert Breast Ctr – Country Club
1940 S. Country Club Drive
Mesa, AZ 85210

Facility ID Number:
243094

Adverse Event:
On June 02, 2017, the Food and Drug Administration (FDA) initiated a Limited Additional Mammography Review (AMR) of mammograms performed by this facility due to the facility performing mammography without an MQSA certificate and without accreditation from the ACR.

On July 07, 2017, the ACR notified the FDA that the Limited AMR revealed serious deficiencies. Due to the poor quality of the images submitted, the facility was required to participate in a Full AMR.

The ACR notified the facility on September 07, 2017 that the Full AMR failed to meet the ACR’s clinical image evaluation criteria.

Action Taken:
Based on the failed AMR results, on September 18, 2017, the ACR revoked the facility’s application for mammography accreditation.

On September 19, 2017, the FDA issued a Certificate Withdrawal Letter to the facility which declared the facility no longer certified.

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 28, 2017.

Status of the Facility:
The facility’s accreditation was reinstated and the facility was issued an MQSA certificate. The facility is currently performing mammography.