News | March 24, 2015

FDA Takes Action Against New Jersey Mammography Facility for Adverse Event

Facility was found to have serious problems with mammography image quality

March 24, 2015 — The U.S. Food and Drug Administration (FDA) reports it has revoked the Mammography Quality Standards Act (MQSA) certificate for AP Diagnostic Imaging Inc., a facility at 1692 Oak Tree Road in Edison, New Jersey. The facility has ceased performing mammography.

On Sept. 23, 2014, the American College of Radiology (ACR) initiated an Additional Mammography Review (AMR) of mammograms performed by the facility. The AMR was initiated due to serious image quality problems identified during the review of clinical images submitted for accreditation renewal. On Nov. 10, 2014, the ACR notified the facility that mammograms reviewed during the AMR did not meet the ACR’s criteria for clinical image quality and that the deficiencies posed a serious risk to human health.

The facility was undergoing accreditation renewal at the time that the clinical image quality problems were detected by the ACR. The facility did not complete the ACR’s accreditation renewal process, and the facility’s Mammography Quality Standards ACT (MQSA) certificate expired on Oct. 9. 2014.

Based on the 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 image quality problems at the facility. The facility successfully completed the PPN and was notified of such by the FDA on Feb. 24, 2015.

As part of the 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.

For more information: www.fda.gov

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