In 2000, the Institute of Medicine (IOM) publishedTo Err Is Human: Building a Safer Health System, which brought the problem of medical errors to the attention of the healthcare community, as well as the general public, by showing that preventable adverse medical events resulting from human error pose a significant threat to patient safety and cost the healthcare industry over ten billion dollars annually. The issue has remained high on the nation’s healthcare agenda. On July 29, 2005, after being passed by overwhelming majorities in both houses of Congress, thePatient Safety and Quality Improvement Act of 2005(Public...

In our investigation, we contacted state agencies that regulate hospitals to obtain information regarding their systems, if any, for collecting and storing data regarding adverse medical events. We requested copies of reporting forms, codebooks, and other documentation from these systems. Based on this information, we categorized states’ reportable-event definitions and lists, risk assessment indices, and reports of causal analyses using a coding scheme that we developed. We recorded this information in a set of worksheets developed for this purpose.

Between October and December 2004, we surveyed the agencies and departments responsible for hospital licensing and regulation in each of the...

In this chapter, we summarize the number and general characteristics of the voluntary and mandatory adverse medical event reporting systems that we identified in our survey. We also compare, at a broad level, the results of this survey with the results of two previous surveys.

Of all 50 states, the RAND 2004 survey done for this study identified 23 that have at least one formal adverse medical event reporting system. As shown in Table 3.1, of the 23 states that have such systems, 20 states have a single mandatory system and one state has a single voluntary system. Georgia reported...

In this chapter, we provide an overview of definitions of adverse events used by the 24 hospital-based adverse medical event reporting systems surveyed by RAND for this project (See Table 3.1). We compare the definitions of reportable events to the NQF definitions of Serious Reportable Events and to the JCAHO definitions of sentinel events. We begin this chapter with a brief description of NQF and JCAHO event definitions.

InTo Err is Human(IOM, 2000), Congress was urged to designate NQF as the entity responsible for establishing and maintaining a core set of reporting standards to be used by the...

To determine how states record information about adverse medical events, we analyzed the information collected by states about reportable events in terms of the data elements recommended in the IOM (2004) report on patient safety reporting standards. In this report, IOM recommended that health information systems be able to capture common data elements for the generation of multiple reports without redundant data entry. The data elements, shown in Table 2.1 in Chapter 2, represent the classes of information about patient safety events that IOM believes to be most important to the establishment of event reporting standards.

This analysis of data...

Adverse event reports contain information that can be used by safety experts to detect trends in the types of adverse medical events that occur and the causes of these events. But to use data regarding adverse medical events most effectively, the information in the reports from the different states and accreditation agencies must be available to safety experts in a standard form. Without a standard for the form of the data to be reported by the different sources, it will be difficult to assemble those data into a central repository for analysis.

As noted in the previous chapter, we found...

To understand current patterns of adverse medical events and reduce their frequency, researchers, healthcare administrators, and policymakers need data that permit comparisons over time and across healthcare institutions—both within and across the 50 states. To collect ideas about how systems that permit such comparisons might be structured and implemented, RAND assembled a panel of the nation’s foremost experts on patient safety assurance systems to begin to identify and define the essential features of an ideal adverse medical event reporting system and to consider how such a system might be administered to ensure that data regarding adverse medical events are...

This report summarizes three analytic efforts:

A survey of state adverse medical event reporting systems

An examination of the feasibility of using existing standards for reporting health information to characterize adverse medical events when they are recorded in formal event reporting systems

A panel discussion focused on identifying properties of adverse event reporting systems that would permit comparative analyses by healthcare organizations, regulatory and accrediting organizations, and healthcare researchers and would embody characteristics to facilitate implementation and promote compliance.

Below we summarize our findings with regard to each of these topics.

Our survey examined both the administrative aspects of adverse...