Jacob Thommesen

Validating the Danish adaptation of the World Health Organization's International Classification for Patient Safety classification of patient safety incident types

Objectives Validation of a Danish patient safety incident classification adapted from the World Health Organizatons International Classification for Patient Safety (ICPS-WHO). Design Thirty-three hospital safety management experts classified 58 safety incident cases selected to represent all types and subtypes of the Danish adaptation of the ICPS (ICPS-DK). Outcome Measures Two measures of inter-rater agreement: kappa and intra-class correlation (ICC). Results An average number of incident types used per case per rater was 2.5. The mean ICC was 0.521 (range: 0.199–0.809) and the mean kappa was 0.513 (range: 0.193–0.804). Kappa and ICC showed high correlation (r = 0.99). An inverse correlation was found between the prevalence of type and inter-rater reliability. Results are discussed according to four factors known to determine the inter-rater agreement: skill and motivation of raters; clarity of case descriptions; clarity of the operational definitions of the types and the instructions guiding the coding process; adequacy of the underlying classification scheme. Conclusions The incident types of the ICPS-DK are adequate, exhaustive and well suited for classifying and structuring incident reports. With a mean kappa a little above 0.5 the inter-rater agreement of the classification system is considered ‘fair’ to ‘good’. The wide variation in the inter-rater reliability and low reliability and poor discrimination among the highly prevalent incident types suggest that for these types, precisely defined incident sub-types may be preferred. This evaluation of the reliability and usability of WHOs ICPS should be useful for healthcare administrations that consider or are in the process of adapting the ICPS.

Modelling of Safety Barriers Including Human and Organisational Factors to Improve Process Safety

It is believed that traditional safety management needs to be improved on the aspect of preparedness for coping with expected and unexpected deviations, avoiding an overly optimistic reliance on safety systems. Remembering recent major accidents, such as the Deep Water Horizon, the Texas City explosion, and the Mont Blanc Tunnel Fire, such an approach may have helped to maintain the integrity of the designed provisions against major deviations resulting in these disasters. In order to make this paradigm operational, safety management and in particular risk assessment tools need to be refined. A valuable approach is the inclusion of human and organisational factors into the simulation of the reliability of the technical system using event trees and fault trees and the concept of safety barriers. This has been demonstrated e.g. in the former European research project ARAMIS (Accidental Risk Assessment Methodology for IndustrieS, see Salvi et al 2006). ARAMIS employs the bow-tie approach to modelling hazardous scenarios, and it suggests the outcome of auditing safety management to be connected to a semi-quantitative assessment of the quality of safety barriers. ARAMIS discriminates a number of different management issues such as competence management, dealing with conflicts, management of maintenance and inspection, and management of procedures. Shortcomings in these management processes effectuate increased probabilities of failure-on-demand (PFD) of the safety barriers, depending on the type of safety barrier (passive, automated, or involving human action). Such models are valuable for many purposes, but are difficult to apply to more complex situations, as the influences are to be set individually for each barrier. The approach described in this paper is trying to improve the state-of-the–art, and it is based on the understanding that certain human and organisational factors may be seen as a kind of common cause failures that influence the performance of several barriers. Therefore, the model links the performance of a barrier with the necessary set of specific activities to maintain and/or to control that barrier. These specific activities are executed within one of the aforementioned management processes, and the efficiency of the activity will depend on the quality of this management process.