News | September 10, 2014

FDA Takes Action Against Mammography Facility for Adverse Event

September 10, 2014 — The U.S. Food and Drug Administration (FDA) reports it has revoked the Mammography Quality Standards Act (MQSA) certificate for Advanced Diagnostic Inc., a facility at 2300 W. Peterson Ave. in Chicago. The facility has ceased performing mammography.

On Jan. 31, 2014, the MQSA Hotline received a complaint stating that Advanced Diagnostics Inc. was not providing patients with the results of their mammograms. Upon further investigation by the facility’s certifying agency, the State of Illinois Emergency Management Agency, the complaint was substantiated. As a result, the agency issued an emergency order against the facility for failing to notify patients of their mammography results within the required timeframe as required by the agency and MQSA regulations.

On July 9, 2014, the State of Illinois Emergency Management Agency notified the facility that it must cease performing mammography immediately and that its MQSA certificate was revoked for a period of two years. In addition, the agency assessed a fine of $91,540, which consisted of civil money penalties and fees.

The State of Illinois Emergency Management Agency issued an emergency order that required the facility to conduct mandatory notification of results to the patients. The facility complied with the emergency order.

As part of the MQSA, Congress mandated 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 useful in evaluating the performance of mammography facilities nationwide.

For more information: www.fda.gov

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