Radiation-Emitting Products

Mammography Facility Adverse Event and Action Report - June 24, 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 Montana

Facility Name and Address:
Big Sky Diagnostic Imaging, LLC
401 S. Alabama St, Ste 7
Butte, MT 59701

Facility ID Number:
237691

Adverse Event:
On August 27, 2013 the American College of Radiology (ACR) conducted a random on-site survey at Big Sky Diagnostic Imaging, LLC. Clinical images reviewed during the on-site survey did not meet the ACR requirements for clinical image quality. On November 20, 2013, the facility was notified by the ACR that it must participate in an Additional Mammography Review (AMR) due to the poor quality of the images reviewed during the on-site survey. On January 24, 2014, the ACR notified the facility that the problems found in the mammograms reviewed during the AMR posed a “serious risk to human health”. On February 6, 2014, the ACR revoked the facility’s accreditation.

Action Taken:
On February 7, 2014, the FDA notified the facility that their MQSA certificate was no longer in effect, and that the facility should cease performing mammography immediately. Based on the serious image quality deficiencies noted during the AMR, the FDA also required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all at-risk patients (and their healthcare providers) of the mammography image quality problems at this facility. At- risk patients are those patients who received mammograms at this facility any time after November 19, 2011.

Corrective Action:
Because the facility has not demonstrated to FDA that affected patients and their healthcare providers have been successfully notified, FDA posted a safety notification on its website on June 23, 2014, notifying patients who had mammograms performed at the facility any time after November 19, 2011, of the mammography quality issues at Big Sky Diagnostic Imaging, LLC. and the steps they should take.

Status of the Facility:
No longer accredited. MQSA certification is no longer in effect. The facility has ceased performing mammography.

Page Last Updated: 06/25/2014
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