Reports (MQSA) > Mammography Facility Adverse Event and Action Report - March 19, 2015

Reports (MQSA) > Mammography Facility Adverse Event and Action Report - March 19, 2015



A Mammography Facility Adverse Event and Action Report has been posted regarding AP Diagnostic Imaging, Inc. of Edison, NJ.  To read about the adverse event, action taken, corrective action, and status of the facility, please see: http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Reports/ucm439052.htm

Mammography Facility Adverse Event and Action Report - March 19, 2015

BackgroundAs 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 New Jersey

Facility Name and Address: AP Diagnostic Imaging, Inc., New Jersey 
1692 Oak Tree Road, Suite 25
Edison, New Jersey 08820

Facility ID Number: 227775

Adverse Event: On September 23, 2014, the American College of Radiology (ACR) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility due to serious image quality problems identified during the review of clinical images submitted for accreditation renewal. On November 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.

Action Taken: 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 MQSA certificate expired on October 9, 2014.

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 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 February 24, 2015.

Status of the Facility: The facility ceased performing mammography.