Full Text Reports…

Hospital incident reporting systems captured only an estimated 14 percent of the patient harm events experienced by Medicare beneficiaries. Hospitals investigated those reported events that they considered most likely to lead to quality and safety improvements and made few policy or practice changes as a result of reported events. Hospital administrators classified the remaining events (86 percent) as either events that staff did not perceive as reportable (61 percent) or as events that staff commonly report but did not report in this case (25 percent).

As a condition of participation in the Medicare program, Federal regulations require that hospitals develop and maintain a Quality Assessment and Performance Improvement (QAPI) program. To satisfy QAPI requirements, hospitals must “track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital.” To standardize hospital event reporting, AHRQ developed a set of event definitions and incident reporting tools known as the Common Formats. We requested and reviewed incident reports from hospitals regarding patient harm events. We had previously identified these events from a nationally representative sample of Medicare beneficiaries discharged in October 2008.

All of the hospitals we reviewed had incident reporting systems designed to capture events; hospital administrators we interviewed indicated that they rely heavily on the systems to identify problems. Hospital accreditors reported that they do not investigate event collection methods, such as incident reporting systems, unless evidence of a problem emerges through the survey process.

Because hospitals rely on incident reporting systems to track and analyze events, improving the usefulness of these systems is critical to hospitals’ efforts to improve patient safety.

Therefore, we recommend that AHRQ and CMS collaborate to create and promote a list of potentially reportable events for hospitals to use. We further recommend that CMS provide guidance to accreditors regarding their assessments of hospital efforts to track and analyze events. CMS should also suggest that surveyors evaluate the information collected by hospitals using AHRQ’s Common Formats. Additionally, CMS should scrutinize survey standards for assessing hospital compliance with the requirement to track and analyze events and reinforce assessment of incident reporting systems as a key tool to improve event tracking.

We received comments on the draft report from AHRQ and CMS. AHRQ concurred with our recommendation, stating that it will collaborate with CMS to create a list of potentially reportable events and provide technical assistance to hospitals in using the list. CMS also concurred with our recommendations, stating that strengthening hospital reporting systems and practices is an essential component of efforts to prevent patient harm. CMS stated that a voluntary list of adverse events used for informational purposes could be highly beneficial for improving incident reporting practices. CMS also stated that it is developing draft guidance for surveyors regarding assessment of patient safety improvement efforts within hospitals.

Adverse Events in Hospitals: Medicare’s Responses to Alleged Serious Events (PDF)
Source: U.S. Department of Health and Human Services, Office of Inspector General

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.