The objectives of this study were: "1. To assess the responses of State survey and certification agencies and the Centers for Medicare & Medicaid Services (CMS) to complaints that allege serious adverse events. 2. To describe hospital responses to complaints that allege serious adverse events. […] The term 'adverse event' describes harm to a patient as a result of medical care. In response to the Tax Relief and Health Care Act of 2006, the Office of Inspector General (OIG) released a series of reports regarding adverse events. In that work, OIG estimated that over one-quarter of hospitalized Medicare beneficiaries were harmed during their hospital stays in October 2008. This report examines Medicare's responses to alleged serious adverse events. These responses represent important patient safety opportunities, yet little attention has been paid to their role in improving patient safety. Hospitals must meet the Medicare Conditions of Participation (CoP) to participate in Medicare. On behalf of Medicare, State survey and certification agencies (State agencies) investigate complaints alleging hospital noncompliance with CoPs. Immediate jeopardy (IJ) complaints are the most serious and may allege adverse events. Also, hospitals often conduct their own investigations of adverse events independently of State agencies. Because no national database of adverse events exists, this report uses a random sample of IJ complaints to identify alleged serious adverse events to which Medicare responded. To review the complaints, we used data from CMS, State agencies, hospital accreditors, and the hospitals associated with the sample."
Department of Health and Human Services, Office of Inspector General, Report No. OEI-01-08-00590
United States. Dept. of Health and Human Services. Office of Inspector General: http://oig.hhs.gov/