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Mammography Facility Adverse Event and Action Report - February 11, 2020: Raleigh Radiology - Blue Ridge

Background

As part of the Mammography Quality Standards Act (MQSA), Congress mandated that 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:

Raleigh Radiology – Blue Ridge
3200 Blue Ridge Rd., Suite 100
Raleigh, NC 27612

Facility ID Number:

183087

Adverse Event:

On August 27, 2019, the American College of Radiology (ACR) notified the facility that it was required to participate in an Additional Mammography Review (AMR) based on the facility conducting mammography on an unaccredited unit. 

On October 23, 2019, the ACR notified the Food and Drug Administration (FDA) and the facility that the AMR revealed serious deficiencies with clinical image quality and that the facility failed to meet the ACR’s clinical image evaluation criteria. 

Action Taken:

Based on the failed AMR results, on November 5, 2019, the ACR revoked the facility’s application for accreditation.

After evaluating the reasons for the accreditation revocation, on November 6, 2019, the FDA declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 declared the mammography performed at this facility to be a serious risk to human health, and therefore 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 January 31, 2020.

Status of the Facility:

The facility’s accreditation was reinstated, and the facility was issued an MQSA certificate.  The facility is currently performing mammography.