Report: FDA Oversight of State Mammography Accrediting Bodies Adequate

Posted 18 January 2013 | By

A report completed by the US Food and Drug Administration (FDA) in 2012 and just released on 16 January 2013 provides an evaluation of one of the agency's lesser known responsibilities: overseeing quality standards for mammography facilities.

That responsibility was given to it in 1992 under the Mammography Quality Standards Act (MQSA). Amended in 1998 and 2004, the act is intended to make sure that facilities are accredited by approved certifying agencies and organizations. Though FDA rarely exercises this authority directly-though critics have sometimes requested it do so for political purposes-it does oversee approve state certifying and private nonprofit certifying agencies. Unaccredited facilities may not provide mammography services to women.

The authority is perhaps the only instance in which FDA directly oversees the practice of medicine on a regular basis. By statute, FDA is supposed to inspect-either directly or indirectly-the resources, data management, record keeping and reporting capabilities of each facility in addition to spot-checks of images taken at the facilities.

Since at least 2004, FDA has been required to detail the results of these inspections in an annual report to Congress, of which the 2011 report released by FDA is one.

As of that year, there were four entities accredited by FDA ("accrediting bodies," or ABs): the American College of Radiology, and the State ABs of Arkansas, Iowa and Texas. FDA indicated that it was also involved in directly reviewing the phantom images-or radiological images of test objects meant to simulate cancerous breast tissue-of all four accrediting bodies, noting that in only one contested case did Arkansas' accrediting body fail one of its tests. That image managed to divide FDA reviewers on a 3-2 basis, and regulators said it was nevertheless of the opinion that the AB's performance "remains high and has not deviated from past performance."

FDA's review also found that most facilities were fully compliant with FDA regulations. Eighty-three percent of facilities had no violations of the MQSA during 2011, a slight increase relative to 2010 (82%). One-half of one percent of facilities had violations that were characterized as being the "most serious" a facility could commit, and FDA noted that eight facilities had their accreditation applications denied in 2011 by the American College of Radiology. Three of those were revoked outright, according to FDA data.


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