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errors resulting in serious harm are the "tip of the iceberg," they represent the small subset of errors that signal major system breakdowns with grave consequences for patients.

Reporting systems that focus on safety improvement are "voluntary reporting systems." The focus of voluntary systems is usually on errors that resulted in no harm (sometimes referred to as "near misses") or very minimal patient harm. Reports are usually submitted in confidence outside of the public arena and no penalties or fines are issued around a specific case. When voluntary systems focus on the analysis of ''near misses," their aim is to identify and remedy vulnerabilities in systems before the occurrence of harm. Voluntary reporting systems are particularly useful for identifying types of errors that occur too infrequently for an individual health care organization to readily detect based on their own data, and patterns of errors that point to systemic issues affecting all health care organizations.

The committee believes that there is a need for both mandatory and voluntary reporting systems and that they should be operated separately. Mandatory reporting systems should focus on detection of errors that result in serious patient harm or death (i.e., preventable adverse events). Adequate attention and resources must be devoted to analyzing reports and taking appropriate follow-up action to hold health care organizations accountable. The results of analyses of individual reports should be made available to the public.

The continued development of voluntary reporting efforts should also be encouraged. As discussed in Chapter 6, reports submitted to voluntary reporting systems should be afforded legal protections from data discoverability. Health care organizations should be encouraged to participate in voluntary reporting systems as an important component of their patient safety programs.

For either type of reporting program, implementation without adequate resources for analysis and follow-up will not be useful. Receiving reports is only the first step in the process of reducing errors. Sufficient attention must be devoted to analyzing and understanding the causes of errors in order to make improvements.


Recommendation 5.1 A nationwide mandatory reporting system should be established that provides for the collection of standardized information by state governments about adverse events that result in death or serious harm. Reporting should initially be required

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