FDANews
The QMN Weekly Bulletin

FDA Yanks MQSA Certificate From California Radiology Facility

June 3, 2016

In a rare move, the FDA has revoked the mammography quality standards act certificate from a California radiology facility.

The agency revoked the MQSA certificate for California-based Huntington Radiology March 4, marking only the second time the agency has made such a move.

The company has a history of violations dating back to 2010, and has been the subject of several actions taken by the FDA, the American College of Radiology and the State of California Department of Public Health.

The FDA worked with ACR as it performed a review of a sample of mammograms performed by Huntington Radiology that included images taken between September 2008 and September 2010. Results from that review included poor quality mammograms with possibly unreliable results.

The FDA suspended the facility’s MQSA certificate in March 2015, and the following month the agency required the facility to notify all patients who received mammograms since Sept. 8, 2014, and their referring healthcare providers, about its problems with mammography quality.

The only other time the FDA revoked the certificate involved Bay Imaging, a group of mammography facilities in Brooklyn, N.Y., says CDRH spokeswoman Angela Stark.

“This is the first time the FDA has published the names of the individuals prohibited from owning or operating a mammography facility for two years,” Stark said.

Huntington Radiology was acquired by Radnet Management in May 2015. Since then, Radnet has been engaged in the process of having the facility recertified by the American College of Radiology, FDA and the State of California, company spokeswoman Laura Foster said.

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