Radiation-Emitting Products

Mammography Facility Adverse Event and Action Report - July 9, 2013

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 U.S. Territory of Puerto Rico

Facility Name and Address:
San Sebastian X-Ray
Avenida Emerito Estrada #1486
San Sebastian, Puerto Rico 00685

Facility ID Number:

Adverse Event:
On February 27, 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. On May 31, 2013, the ACR notified the facility that the problems found in the mammograms evaluated during its AMR revealed serious deficiencies involving the quality of mammography. As a result, the ACR denied the facility renewal of its ACR accreditation. The MQSA certificate for the facility expired on March 15, 2013.

Action Taken:
Based on the serious image quality deficiencies noted during the AMR, the FDA required the facility 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. However, in a written statement to FDA, the facility owner stated she filed for Chapter 11 bankruptcy and could not afford the cost of certified mail or other accountable mail methods required under the PPN.

Corrective Action:
Because the owner of the facility was unable to perform the PPN, on June 27, 2013, FDA posted an MQSA Safety Notification in English and Spanish on the FDA website alerting patients who had mammograms at the facility any time after February 27, 2011 of the mammography quality issues at San Sebastian X-Ray. The MQSA Safety Notification has been distributed to the public in Puerto Rico and the U.S. Virgin Islands via print, television, radio and social media, governmental offices, and the Cancer Coalition and its partners to alert the public about the image quality problems at San Sebastian X-Ray.

Status of the Facility:
No longer accredited and certification has expired. The facility has ceased performing mammography.

Page Last Updated: 11/03/2014
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