Summary in English

This report has been made by The Norwegian Board of Health Supervision at the request of the Ministry of Health and Care Services. In the report, we systematize information from the reporting system for serious adverse events. The goal is to identify areas with increased risk and to suggest measures to ensure learning from adverse events across health and care services. The report is based on data from the reporting system for the period 2020−2024, as well as knowledge and experiences from supervisory activities and from relevant research.

Recommendations in the report

The findings in this report show that serious adverse events where patients are severely harmed or die in connection to medical treatment and health care is a persistent challenge, and some of the areas of risk are partly well-known. Based on our supervisory experiences and supported by international literature, we believe it is possible to further develop methods to reduce the occurrence of patient harm. We need a collective national effort in several areas, where everyone involved in strengthening patient safety works together, not separately. The report provides four main recommendations:

• to strengthen management and leadership of quality improvement and patient safety work
• to use a broader approach to understand the causes of patient harm
• to improve the involvement of patients and next of kin in the work with quality improvement and patient safety
• to use the potential of analyzing large datasets to gain better insight into areas of risk.

Background

Even though we have modern, well-developed medical and healthcare services with professional and skilled healthcare workers, there will always be a risk of patient harm occurring. Both international research and reports from Norway show that many patient harm can be prevented, and there is a significant potential for learning and improvement in healthcare services. Patient safety incidents are common both in hospitals and in primary healthcare, and there is a need for continuous focus on patient safety in all parts of the services to reduce the occurrence of patient harm.

In Norway, patient safety has been a prioritized area, both through the introduction of different national strategies, legislative changes, and incident and alert systems. Yet there has still been a persistent challenge with patient harm related to certain known problem areas over time.

The reporting system provides information on the most serious incidents

All health care services have a duty to report serious adverse events to the Norwegian Board of Health Supervision. The reporting system was made statutory for the specialist health service in 2012. The duty to report was extended to all health care providers from 2019. At the same time patients, users, and their closest next of kin received a right to report serious adverse events.

The content of the reports received by the Norwegian Board of Health supervision vary. Some provide detailed descriptions of the event being reported, while others are more concise. There are limitations to the type of information and data that can be extracted for analytical purposes from the reporting system. There are several reasons for this, but collectively it means that quantitative analyses of data from the reporting system provide limited insight into risk areas and causal relationships. We have therefore supplemented the data with our supervisory experiences and relevant national and international research.

What does the data from the reporting system say about where and when things go wrong?

We have reviewed data from a total of 5688 reported incidents from the period 2020-2024. Based on these, we review risk areas related to the following topics: surgery, medical examination and treatment, pre-hospital emergency care services, transitions between specialist health services and municipal health and care services, medication errors, fall incidents, maternity care, incidents involving children, mental health care and interdisciplinary specialized addiction treatment, as well as incidents in our material categorized as "other." This last category constitutes a relatively large portion of our total material. Finally, we describe risk areas related to patient and user involvement in the work with serious adverse events and challenges in relation to management and leadership. In the report, we summarize the main findings within each thematic area and use examples from the reporting system.

A recurring finding from our assessments of reported incidents, and from our other supervisory activities outside the reporting system, is deficiencies in the management and leadership of services. There are particularly two overarching issues that recur:

• Management does not have the necessary overview of quality and safety challenges in the services.
• Known quality and safety challenges are not followed up in a way that leads to lasting improvement.

How can we learn from patient safety incidents?

The areas of risk in our review do not answer the question of why patient safety incidents occur or what we can do to reduce the risk of patients being harmed when receiving healthcare.

The reporting system is intended to contribute to necessary learning and improvement so that the extent of patient harm is reduced. In the report, we describe how we can understand learning and what is needed for organizations to learn from patient safety incidents, as well as some factors that can make it difficult for healthcare services to learn and improve. Based on our supervisory experience and supported by the literature, we describe different ways to understand patient safety incidents. Patient safety incidents can be understood as individual or systemic errors. Regardless of whether we start our investigations from the individual or the system, we also must consider whether we think of patient injury as a consequence of some events preceding the injury (linear cause-effect explanation) or as a result of a series of interacting factors (a complex causal explanation). The choice of approach and causal explanation has a significant impact on how we analyze the incident, the conclusions we reach, and the risk-reducing measures recommended. To succeed in reducing the extent of patient harm, we need a holistic approach and to use the strengths of the different ways of understanding patient safety incidents.