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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 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).

RECOMMENDATION 5.2 The development of voluntary reporting efforts should be encouraged. The Center for Patient Safety should

• describe and disseminate information on external voluntary reporting programs to encourage greater participation in them and track the development of new reporting systems as they form;

• convene sponsors and users of external reporting systems to evaluate what works and what does not work well in the programs, and ways to make them more effective;

• periodically assess whether additional efforts are needed to address gaps in information to improve patient safety and to encourage