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 Minnesota

Facility Name and Address:

North Memorial Clinic - Silver Lake Clinic, Blaine
1420 109th Avenue NE
Suite 100
Blaine, MN 55449

Facility ID Number:

241796

Adverse Event:

On December 20, 2016, the American College of Radiology (ACR), the facility's accrediting body, initiated an Additional Mammography Review (AMR) of mammograms performed by this facility due to serious image quality problems identified during a review of clinical images submitted for accreditation renewal.

On February 8, 2017, the ACR notified the facility that it failed the AMR because the mammograms reviewed did not meet the ACR's criteria for clinical image quality.

Action Taken:

The ACR revoked the facility's accreditation effective February 20, 2017. After evaluating the information leading up to the ACR's revocation decision, on February 21, 2017, the FDA determined that the facility's MQSA certificate should be placed in a "No longer in effect status" until such time as the facility's accreditation was reinstated and the facility complied with all requirements under the MQSA.

Corrective Action:

On February 27, 2017, 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 June 27, 2017.

Status of the Facility:

The facility is no longer performing mammography.