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Mammography Facility Adverse Event and Action Report - May 25, 2018: Invision Diagnostics

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:
Invision Diagnostics
11220 Elm Lane
Suite 200
Charlotte, NC 28277

Facility ID Number:
242978

Adverse Event:
On December 14, 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 November 03, 2017 MQSA Inspection performed by the State of North Carolina.

On February 19, 2018, 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 March 01, 018, the ACR revoked the facility’s mammography accreditation.

On March 01, 2018, the FDA declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 of such by the FDA on May 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.