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Mammography Facility Adverse Event and Action Report – May 30, 2019: East Palestine Family Medical Clinic Inc.

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 Ohio

Facility Name and Address:

East Palestine Family Medical Clinic Inc.
50410 State Rt. 14
East Palestine, OH 44413

Facility ID Number:

111310

Adverse Event:

On November 20, 2018, the Food and Drug Administration (FDA) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility, conducted by the facility’s accreditation body, the American College of Radiology (ACR), due to deficiencies noted during the October 30, 2018 MQSA Inspection performed by the State of Ohio.

On March 19, 2019, 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 April 01, 2019, the ACR revoked the facility’s mammography accreditation.

Furthermore, on April 02, 2019, the FDA declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.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 required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all at-risk patients of the mammography quality problems at the facility.

On April 26, 2019, the FDA posted a Public Safety Notice. To date, the facility has not complied with the FDA’s PPN order.

Status of the Facility:

The facility is currently not performing mammography.