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Adverse Events in Hospitals: Medicare's Responses to Alleged Serious Events

We found that Medicare's system of hospital oversight missed opportunities to address patient safety in its response to alleged serious adverse events, such as medication and surgical errors, physical abuse by hospital staff, and patient suicide.

In response to the Tax Relief and Health Care Act of 2006, OIG released a series of reports regarding adverse events. In those reports, 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 the CoP on behalf of Medicare. 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 investigations by State agencies. Because no national database of adverse events exists, this report uses a random sample of IJ complaints as a proxy for 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 complaints.

State agency responses to complaints alleging serious adverse events were generally timely and often found problems. However, State agencies and CMS often failed to review hospitals' compliance with the CoP on quality assessment and performance improvement (QAPI) and the CoP on the hospital's governing body; performed little longer term monitoring to verify that hospitals' corrective actions resulted in sustained improvements; and sometimes failed to disclose the nature of the complaints to the hospitals, thereby limiting hospitals' ability to learn from alleged events. Furthermore, contrary to its policy, CMS informed the Joint Commission of few complaints, impeding the Joint Commission's oversight of its accredited hospitals. We also found that hospitals investigated most alleged adverse events in our sample and that they found State agency responses valuable but disruptive. Hospital corrective actions resulted largely in training coupled with policy and process changes.

We recommend that CMS (1) require that all IJ complaint surveys evaluate compliance with the QAPI CoP, (2) ensure that State agencies monitor hospitals' corrective actions for sustained improvements, (3) amend guidance on disclosure to explain the nature of complaints to hospitals, and (4) improve communication with accreditors. CMS concurred with our recommendations.