Adverse Events in Hospitals: Overview of Key Issues
MedSun: Newsletter #36, May 2009

A Report from the Department of Health and Human Services Office of Inspector General, December 2008

The Tax Relief and Health Care Act of 2006 (the Act) mandates that the Office of Inspector General (OIG) report to Congress regarding the incidence of “never events” among Medicare beneficiaries, payment by Medicare or beneficiaries for services furnished in connection with such events, and the processes that the Centers for Medicare & Medicaid Services (CMS) uses to identify events and deny payment. Never events are a specific list of serious events, such as surgery on the wrong patient, that the National Quality Forum deemed “should never occur in a health care setting.” Expanding beyond this specific list, this and subsequent OIG reports use the broader term “adverse event” to provide for a more comprehensive examination of key issues. This report is one in a series to fulfill the requirements in the Act and inform decision-makers.

To facilitate OIG efforts to comply with the mandate, the OIG staff first sought to identify key issues regarding adverse events in hospitals to provide direction and context for their work. This overview report combines evidence, analysis, and opinion from a wide range of sources. These sources, referred to collectively as “stakeholders,” represent diverse entities involved in addressing adverse events in hospitals, including government agencies and other policymakers, professional associations, oversight organizations, patient safety groups, providers, and researchers.

OIG identified the following seven issues as most critical to understanding the landscape of adverse events in hospitals:

Issue 1: Estimates of the incidence of adverse events in hospitals vary widely and measurement is difficult. Research estimates of the frequency of adverse events in hospitals vary from 3 percent to 20 percent of hospital admissions, in part because there is no optimal method for measuring incidence. Research also indicates that elderly patients are particularly vulnerable.

Issue 2: Nonpayment policies for adverse events are gaining in prominence and are viewed as a powerful incentive to reduce incidence but raise potential drawbacks. CMS’s new policy will deny hospitals higher payment for admissions complicated by selected adverse events, and private health care payers are adopting similar policies. Stakeholders generally believe that nonpayment provides an incentive to prevent costly adverse events. Potential drawbacks of nonpayment raised by stakeholders include limited access to care, increased hospital costs, and reduced hospital revenue.

Issue 3: Hospitals rely on staff and managers to report adverse events internally, but barriers can inhibit reporting. Reporting events and suspected causes can help hospitals improve practices to prevent adverse events and ensure accountability for poor care. Hospitals also use reported information to inform affected patients and families, which is thought to boost public trust, and to improve clinical decision-making and compliance in treatment. However, hospital staff may not report events because they do not believe that reports will lead to improvement, do not have time, or fear punitive action.

Issue 4: Hospitals report adverse events to various oversight entities, although stakeholders suspect substantial underreporting. Although there is no comprehensive national reporting system for adverse events, a number of Federal, State, and nongovernmental entities receive adverse event reports from hospitals. Hospitals are believed to underreport adverse events, although it is difficult to know to what extent. However, stakeholders indicated that reporting every adverse event is not necessary to achieve the aim of improving practices to prevent adverse events.

Issue 5: Public disclosure of adverse events can benefit patients but also raises legal concerns for patients and providers. Access to adverse event information provides public scrutiny that may pressure hospitals to improve practices. However, concerns that hospitals, clinicians, and patients can lose legal protections when adverse event information is reported can inhibit full disclosure of adverse events.

Issue 6: Information to help prevent adverse events is widely available, but some hospitals and clinicians may be slow to adopt or routinely apply recommended practices. Hospitals and clinicians are sometimes slow to adopt recommended practices, such as evidence-based clinical practice guidelines, which outline systematically developed procedures to improve care. Literature indicates that hospital staff and clinicians may believe that the guidelines are not relevant to their setting or that they value individual practitioner judgment more than regimented standards of care.

Issue 7: Interviews and literature reveal strategies that may accelerate progress in reducing the incidence of adverse events in hospitals including:
-Assessing the desirability and feasibility of a national body to lead patient safety efforts, which would help to coordinate, but not replace, current efforts by government agencies and private entities;
-Focusing on hospital use of recommended practices and evidence-based guidelines to reduce the incidence of adverse events, including measuring hospital use;
-Establishing methods for measuring the incidence of adverse events, including tools for practical and accurate data collection;
-Expanding the use of electronic health records within and between hospitals, thus improving communication and continuity of care to potentially reduce the incidence of adverse events;
-Monitoring the impact of policies to deny hospitals higher payment for admissions complicated by selected adverse events; and
-Improving the utility of adverse event reporting, including evaluating the comparability of data reported across entities and streamlining reporting mechanisms to reduce burden on hospitals.

Additional Information:

U.S. Department of Health and Human Services. Office of the Inspector General. Adverse Health Care Events. December 2008.

U.S. Department of Health and Human Services. Office of the Inspector General. Adverse Health Care Events. Full Report. December 2008.

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