Introduction and Aims Whether ill or well, young, or old, we trust in the healthcare system to protect our health and prolong our life rather than harm or end it. Yet healthcare, in comparison to other safety critical industries, has a high degree of preventable harm. Many scholars believe a different or new risk assessment tool may improve patient safety.

This dissertation examines the role of risk assessment tools in healthcare, exploring why these tools are not benefiting healthcare to the same extent as they benefit other safety critical industries. Four main questions guide this investigation.

Methods and Research Questions Using Design Research Methodology, a mixed method approach is used to answer the four research sub-questions. Question 1, what is the nature ofpatient-safety risk in healthcare, is answered through a literature review and observational study of risk in three clinical procedures. Question 2, which tools are commonly used for safety assessment, is explored through literature review. Question 3, how is patient safety currently assessed in healthcare, is answered by a survey and interview study of US and UK based risk managers. Finally, Question 4, what are the requirements for quality risk assessment in healthcare, is determined by synthesizing the findings from the previous three research questions.

Results and Conclusion This dissertation finds that risk in clinical care is primarily driven by human factors, with skill- based errors and routine violations generating a particularly high degree of preventable risk. The tools currently used to assess risk in healthcare may not be ideal for capturing the nature of risk. Regardless, there appears to be insufficient resources available at most healthcare institutions to support the proper use of any but the most basic risk assessment tool. A poor organisational safety culture appears to be at the root of these and other issues with risk assessment tools. This dissertation concludes that while many risk assessment tools may provide benefit to healthcare, including those currently used, severe problems in safety culture prevent such benefit from being realized.