Radiation-Emitting Products

Mammography Facility Adverse Event and Action Report - May 13, 2014

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 this action taken against a mammography facility has concluded:

Mammography Facility Against Which There Was An Adverse Action

The State of Florida

Facility Name and Address:
CMS Open MRI and Diagnostic Services
9601 SW 40th Street
Miami, FL 33165

Facility ID Number:
238054

Adverse Event:
On November 8, 2013, this facility was notified by the American College of Radiology (ACR) that it must participate in an Additional Mammography Review (AMR) due to serious image quality problems identified during the review of clinical images submitted for accreditation renewal. The facility voluntarily ceased performing mammography. On January 14, 2014, the ACR notified the facility that the problems found in the mammograms evaluated during its AMR revealed serious deficiencies involving the quality of mammography.

Action Taken:
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 image quality problems at the facility.

Corrective Action:
The facility replaced its mammography equipment and provided training to its technologist and interpreting physician. On March 13, 2014, the facility met the requirements of the ACR for its provisional reinstatement of accreditation. On April 30, 2014, the FDA notified the facility that it successfully completed the PPN process.

Status of the Facility:
Performing mammography under a provisional certificate.

Page Last Updated: 07/02/2014
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