Mammography Update: Huntington Radiology of California: Revocation of Mammography Certificate

On March 4, 2016 the FDA revoked the certificate of J. Bruce Jacobs M.D. Inc. doing business as Huntington Radiology in Huntington Park, California. The facility may not perform mammography until it is certified under the MQSA and implementing regulations. Additionally, the individuals named in the revocation notice may not own and/or operate a facility that requires an MQSA certificate during the two years following revocation of the facility's certificate.

The certificate was revoked after a series of FDA and American College of Radiology actions to get the facility to come into compliance with the MQSA and implementing regulations after it was found to be performing low-quality mammograms in violation of MQSA quality standards. This is the second time in MQSA history that the FDA has revoked a facility’s certificate and the first time the names of the individuals barred from owning and/or operating a mammography facility that requires an MQSA certificate have been posted publicly.

Under the Mammography Quality Standards Act (MQSA) of 1992, the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States¹. If facilities do not meet standards for mammography quality under the Act and implementing regulations, the FDA will take appropriate action and may require the facility to issue notifications to patients and referring providers of the quality issues and recommending actions they can take to mitigate risks to health and ensure patient safety.

More information about this action is available on the FDA’s MQSA Reports webpage.

U.S. Food and Drug Administration

¹ Note that 900.2(q) exempts Veteran’s Administration facilities from the MQSA.