A national reporting system for adverse events
It is often reported in the media that it is about time that Norway had a national reporting system for adverse events that occur in hospitals. For example, we can read in Health Review 1 that: “there are national reporting systems in both Denmark and Sweden, but in Norway there are only local systems”. Norway does in fact have a national reporting system for adverse events that occur in hospitals.
Norway has been a pioneer country with regard to such systems. A reporting system was established in the Directorate of Health as early as 1993 (the Directorate of Health became the Norwegian Board of Health Supervision in 1994). In combination with the requirement to have an internal control system, this provides the conditions for dealing systematically with nonconformities (breaches of, or departures from, laws or regulations) and for working with quality improvement.
In other words:
- Norway has MedEvent – the Reporting System for Adverse Events in Specialized Health Services 2
- Denmark has DPSD – the Danish Patient Safety Database 3
- Sweden has Lex Maria 4
The supervision authorities’ jargon
- We talk about “Section 3-3-reports”, and believe that everyone understands what we are talking about
- We talk about IK-2448, and believe that everyone understands that this is the form that is used for reports
But these need to be explained:
Section 3-3 is a section in the Specialized Health Services Act 5:
Health institutions covered by this act shall as soon as possible report in writing to the Norwegian Board of Health Supervision in the County about serious injury caused to a patient as a result of provision of health services or as a result of one patient injuring another. Events that could have led to serious injury shall also be reported.
The form IK-2448 is the form that is:
- filled out by staff in hospitals and other health institutions that provide health services
- sent to the Norwegian Board of Health Supervision in the Counties
- registered in the database – MedEvent.
A revised form was available from September 2007. The form was revised to take account of changes in the legislation, and to ensure better quality of the data. The form and the guidelines for filling out the form can be found on our website. We also have a project underway to introduce an electronic reporting system.
The main aim of the reporting system is to clarify the background for the event and to prevent similar events happening again, so that patients do not risk being injured. The reporting system is meant to aid the work of the health institution with their internal control system and with improving the quality of services.
The Norwegian Board of Health Supervision in the Counties assess the reports and register them in the national database (MedEvent). They give advice and carry out supervision of the way the health institutions deal with adverse events, and the way their internal control systems function. Recurring events and other serious conditions that put the safety of patients at risk, or that can cause serious problems for patients, are followed up.
The Norwegian Board of Health Supervision uses data from MedEvent to develop a systematic overview of adverse events that occur in specialized health services and in deficiencies in the quality of services 6 . The annual reports for MedEvent provide feedback to the services, and the data are used in the process of deciding which themes and areas to give priority to for carrying out supervision.
The reporting system cannot be used to determine the prevalence of adverse events, deaths or injuries. The 2000 reports that are registered each year provide health institutions and the supervision authorities with useful information about what happens, but not about how often things happen. Even though we encourage health institutions to send in reports more often, we know that not all adverse events are reported.
The reporting system is also not meant to be used to punish health personnel who report events, but to identify errors in the system, so that they can be corrected.
Public statistics published by, among others, Statistics Norway (SSB) 7, the Norwegian Patient Register (NPR) 8 and the National Bureau of Crime Investigation (KRIPOS) 9 provide useful information. In addition, statistics published by the Norwegian System of Compensation for Injuries to Patients (NPE) 10 provide detailed information about risks in specialized health services.
“A man who makes a mistake and does not correct it, makes another mistake.”
5. Act 1999-07-02 No. 61 relating to specialized health services
6. MedEvent - the Reporting System for Adverse Events in Specialized Health Services. Annual reports 1994 - 2006