Implementation of a comprehensive clinical risk management system in a university hospital.

Background: Adverse events during hospital treatment are common and can lead to serious harm. This study reports the implementation of a comprehensive clinical risk management system in a university hospital and assesses the impact of clinical risk management on patient harms.

Methods: The clinical risk management system was rolled out over a period of eight years and consisted of a training of interdisciplinary risk management teams, external and internal risk audits, and the implementation of a critical incident reporting system (CIRS). The risks identified during the audits were analyzed according to the type, severity, and implementation of preventive measures. Other key figures of the risk management system were obtained from the annual risk reports. The number of liability cases was used as primary outcome measurement.

Results: Of the 1,104 risks identified during the risk audits, 56.2% were related to organization, 21.3% to documentation, 15.3% to treatment, and 7.2% to patient information and consent. The highest proportion of serious risks was found in the category organization (22.7%), the lowest in the category documentation (13.6%). Critical incident reporting identified between 241 and 370 critical incidents per year, for which in 79.5% to 83% preventive measures were implemented within twelve months. The frequency of incident reports per department correlated with the number of active risk managers and risk team meetings. Compared with the years prior to the introduction of the clinical risk management system, an average annual reduction of harms by 60.1% (95% CI: 57.1; 63.1) was observed two years after the implementation was completed. On average, the rate of harms dropped by 5% per year for each 10% increase in roll-out of the clinical risk management system (incidence rate ratio: 0.95; 95% CI: 0.93; 0.97) .

Conclusion: The results of this project demonstrate the effectiveness of clinical risk management in detecting treatment-related risks and in reducing harm to patients.