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  1. Mammography Quality Standards Act and Program

Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc.

Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc.

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 Florida

Facility Name and Address:
Lakes Radiology II, Inc.
7880 W. Oakland Park Blvd.
Sunrise, FL 33351

Facility ID Number:
237908

Adverse Event:
On February 20, 2018, the American College of Radiology (ACR) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility due to deficiencies noted during the initial accreditation process for a second mammography unit.

On April 09, 2018, the ACR notified the Food and Drug Administration (FDA) and the facility that the AMR revealed serious deficiencies with clinical image quality and failed to meet the ACR’s clinical image evaluation criteria.

Action Taken:
On April 19, 2018, the ACR revoked the facility’s mammography accreditation.

On April 19, 2018, the FDA declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 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 as such on August 16, 2018.

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