A World Health Organization field trial assessing a proposed ICD-11 framework for classifying patient safety events

Objective: To assess the utility of the proposed World Health Organization (WHO)'s International Classification of Disease (ICD) framework for classifying patient safety events. Setting: Independent classification of 45 clinical vignettes using a web-based platform. Study participants: The WHO's multi-disciplinary Quality and Safety Topic Advisory Group. Main outcome measure(s): The framework consists of three concepts: harm, cause and mode. We defined a concept as 'classifiable' if more than half of the raters could assign an ICD-11 code for the case. We evaluated reasons why cases were nonclassifiable using a qualitative approach. Results: Harm was classifiable in 31 of 45 cases (69%). Of these, only 20 could be classified according to cause and mode. Classifiable cases were those in which a clear cause and effect relationship existed (e.g. medication administration error). Nonclassifiable cases were those without clear causal attribution (e.g. pressure ulcer). Of the 14 cases in which harm was not evident (31%), only 5 could be classified according to cause and mode and represented potential adverse events. Overall, nine cases (20%) were nonclassifiable using the three-part patient safety framework and contained significant ambiguity in the relationship between healthcare outcome and putative cause. Conclusions: The proposed framework enabled classification of the majority of patient safety events. Cases in which potentially harmful events did not cause harm were not classifiable; additional code categories within the ICD-11 are one proposal to address this concern. Cases with ambiguity in cause and effect relationship between healthcare processes and outcomes remain difficult to classify.