Institutional Reporting Systems

Many health care organizations have an internal incident reporting program, frequently managed by a patient safety officer or equivalent, who carries out analyses of the errors and determines the external programs to which the incident reports should be sent. Often, reports are made directly to one or more of the external programs by the patient or provider, bypassing the patient safety office.

Rates of reporting of events have been quite low (Leape, 2002). Providers’ fear of discoverability during litigation and professional disciplinary action has been a major factor affecting their willingness to report (IOM, 2004c). This particular concern should be alleviated with the recent passage of the Patient Safety and Quality Improvement Act of 2005 (P.L. 109-41). The act promotes the establishment and use of voluntary patient safety reporting systems, peer review protection from report disclosure during legal proceedings, and protection of providers who report from professional retaliation. However, the legislation failed to set measurable goals and criteria for evaluating the reporting program’s success or failure.

Evidence on the effectiveness of reporting programs is limited. There is anecdotal evidence that the Joint Commission on Accreditation of Health Care Organizations’ Sentinel Event Reporting System and the U.S. Pharmacopeia–Institute for Safe Medication Practice Medication Errors Reporting Program have led to important safety improvements (Leape, 2002). The only reporting program whose effect on safety has been demonstrated by a controlled trial is the National Nosocomial Infection Survey (Haley et al., 1985). Many reporting programs distribute newsletters or advisories to alert providers of hazardous situations and possible preventive measures. The impact of these materials is not known (Leape, 2002). However, performance measurement is an important component of quality improvement programs, which include activities directly related to patient safety (IOM, 2001). The new legislation mentioned above is expected to increase physician participation in adverse event reporting systems, and subsequently the translation of findings into learning and improvement. This will facilitate assessment of the positive, neutral, or negative impact of reporting systems in the near term.

State Reporting Systems

About half of all states have passed legislation or regulations related to hospital reporting of adverse events; almost all of these reporting systems are mandatory. The development of state reporting systems is tracked by the National Academy for State Health Policy (NASHP, 2006). Each state reporting system takes a different approach as to what events must be

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