Background: Mandatory and voluntary reporting of adverse events is common in health care organizations but a more accurate understanding of the extent of patient injury may be obtained if additional sources are used. Patients in Sweden may file a claim for economic compensation from the national insurance system if they believe they have sustained an injury. The extent and pattern of reporting of serious adverse events in a mandatory national reporting system was compared with the reporting of adverse events on the basis of patient claims.
Methods: Regional sentinel event reports were compared with malpractice claims data between 1996 and 2003. A sample consisting of 113 patients with deaths or serious injuries was selected from the malpractice claims data source. The medical records of these patients were reviewed by three chief medical officers.
Results: Of the deaths or injuries associated with the 113 patients-25 deaths, 37 with more than 30% disability, and 51 with 16/o-30% disability-23 (20%) had been reported by chief medical officers to the National Board of Health and Welfare as sentinel events. Most adverse events were found in orthopedic surgery, and orthopedic injuries had more serious consequences. None of the patient injuries caused by infections were reported as sentinel events. Individual errors were more frequent in cases reported as sentinel events.
Conclusions: Adverse events causing severe harm are underreported to a great extent in Sweden despite the existence of a mandatory reporting system; physicians often consider them to be complications. Health care organizations should consider using a portfolio of tools-including incident reporting, medical record review, and analysis of patient claims-to gain a comprehensive picture of adverse events.