Corporate Compliance

Adverse event/action report reveals fraud, QA issues

Mammography Regulation and Reimbursement Report, May 1, 2008

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On March 21, the FDA released its 2007 Adverse Event and Action Report, which details actions regulators took against mammography facilities in the past year. The annual report is mandated by Congress and includes information from federal, state, and territorial agencies, as well as the ACR. This report lists fewer facilities than in past years, says Dan Oakey, mammography coordinator for the state of Florida and a certified MQSA inspector.

The 2007 violations mirror those cited in the past. In almost all cases, problems occurred because of a breakdown in communication at the organization, he says.

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