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Mammography Facility Adverse Event and Action Report - May 08, 2018: SonoCare, LLC

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 North Carolina

Facility Name and Address:
SonoCare, LLC
125 Wamsutta Mill Road
Suite B
Morganton, NC 28655

Facility ID Number:
241750

Adverse Event:
On October 24, 2017, the Food and Drug Administration (FDA) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility due to deficiencies noted during the August 22, 2017 MQSA Inspection performed jointly by the State of North Carolina and the FDA.

On December 13, 2017, the ACR notified the 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:
Based on the failed AMR results, on December 21, 2017, the ACR revoked the facility’s mammography accreditation.

On December 21, 2017, the FDA declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 of such by the FDA on April 12, 2018.

Status of the Facility:

The facility is currently not performing mammography.