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 Subject of an Adverse Action

The State of Arizona

Facility Name and Address:
Lake Havasu Imaging Center
1944 Mesquite Avenue
Lake Havasu City, AZ 86403

Facility ID Number:
223612

Adverse Event:
On November 2, 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 a review of clinical images submitted for accreditation renewal. On January 6, 2016, the ACR notified the facility and the Food and Drug Administration (FDA) that mammograms reviewed during the AMR did not meet the ACR’s criteria for clinical image quality and that the ACR believed the deficiencies posed a serious risk to human health.

Action Taken:
The ACR revoked the facility’s accreditation effective January 19, 2016. After evaluating the information leading up to the ACR’s revocation decision, on January 21, 2016, the FDA determined that the facility’s MQSA certificate should be placed in a "No longer in effect status" until such time as the facility's accreditation was reinstated and the facility complied with all requirements under the MQSA.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:
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 March 31, 2016.

Status of the Facility:
The facility is currently not performing mammography.