of hospitals and eventually be required of other institutional and ambulatory care delivery settings. Congress should
• designate the National Forum for Health Care Quality Measurement and Reporting as the entity responsible for promulgating and maintaining a core set of reporting standards to be used by states, including a nomenclature and taxonomy for reporting;
• require all health care organizations to report standardized information on a defined list of adverse events;
• provide funds and technical expertise for state governments to establish or adapt their current error reporting systems to collect the standardized information, analyze it and conduct follow-up action as needed with health care organizations. Should a state choose not to implement the mandatory reporting system, the Department of Health and Human Services should be designated as the responsible entity; and designate the Center for Patient Safety to:
(1) convene states to share information and expertise, and to evaluate alternative approaches taken for implementing reporting programs, identify best practices for implementation, and assess the impact of state programs; and
(2) receive and analyze aggregate reports from states to identify persistent safety issues that require more intensive analysis and/or a broader-based response (e.g., designing prototype systems or requesting a response by agencies, manufacturers or others).
Mandatory reporting systems should focus on the identification of serious adverse events attributable to error. Adverse events are deaths or serious injuries resulting from a medical intervention.1 Not all, but many, adverse events result from errors. Mandatory reporting systems generally require health care organizations to submit reports on all serious adverse events for two reasons: they are easy to identify and hard to conceal. But it is only after careful analysis that the subset of reports of particular interest, namely those attributable to error, are identified and follow-up action can be taken.
The committee also believes that the focus of mandatory reporting system should be narrowly defined. There are significant costs associated with reporting systems, both costs to health care organizations and the cost of operating the oversight program. Furthermore, reporting is useful only if it includes analysis and follow-up of reported events. A more narrowly defined program has a better chance of being successful.
A standardized reporting format is needed to define what ought to be