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 West Virginia

Facility Name and Address:

Summers County Appalachian Regional Healthcare
1500 Terrace Street
Hinton, WV 25951

Facility ID Number:

199257

Adverse Event:

On September 28, 2016, The American College of Radiology (ACR) initiated a Full Additional Mammography Review (AMR) of mammograms performed by this facility based on deficiencies noted with the clinical images submitted by the facility for a Random Image Check.

The ACR notified the facility on March 2, 2017, that the results of the AMR revealed that twenty-seven (27) out of thirty (30) clinical cases reviewed failed to meet the ACR's clinical image evaluation criteria.

Action Taken:

Based on the failed AMR results, on March 13, 2017, the ACR revoked the facility's accreditation.

After evaluating the reasons for the accreditation revocation, on March 14, 2017, the Food and Drug Administration (FDA) declared the facility's MQSA certificate to be no longer in effect until such time as the facility's accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 May 25, 2017.

Status of the Facility:

The facility has had its accreditation reinstated, has a valid MQSA certificate, and is currently performing mammography.