FDA issues new document outlining Ohio facility's failure to meet mammography standards

The FDA has released a document outlining actions taken against East Palestine Family Medical Clinic Inc. in Ohio over problems with mammography image quality at the institution and its failure to meet certain imaging criteria.

According to the May 30 “Mammography Facility Adverse Event and Action Report,” the FDA commissioned an Additional Mammography Review (AMR) of all mammograms performed at East Palestine after an October 30, 2018 Mammography Quality Standards Act (MQSA) inspection revealed “deficiencies” with the facility’s practices.

The MQSA mandates annual reporting of adverse actions taken against facilities performing mammograms.

The review, conducted by the American College of Radiology, found “serious deficiencies with clinical image quality and failed to meet the ACR’s clinical image evaluation criteria,” according to the FDA document. Based on that information, on April 1 of this year, the ACR revoked East Palestine’s mammography accreditation.

Additionally, the FDA found the facility’s MQSA certificate invalid until its accreditation is reinstated and it has performed a Patient and Referring Healthcare Provider Notification (PPN) to alert all patients who received mammograms at East Palestine Family Medical Clinic on or after March 28, 2017.

Currently, the FDA document noted, the site has not complied with the PPN order and is not performing mammograms.