Ruggiero Perrino, Nunzia (2013) CLINICAL RISK MANAGEMENT:ENHANCING PATIENT SAFETY. [Tesi di dottorato]

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Risk Management was in the beginning primarily considered a means of controlling and managing litigation, which has been the major worry for clinicians in many countries for a considerable time and a growing problem in the international context. Early risk management strategies were dominated by attempts to reform the legal system and reduce the levels of compensation and the associated costs (Mills, 1995). Gradually the need to address the underlying clinical problem became apparent and the term risk management came to include strategies and projects to reduce the incidence of harm and improve the quality of care, whilst also taking a proactive approach to caring for injured patients. Looking ahead there are, of course many challenges for clinical risk management and patient safety. In one particular area, however, there is still a long way to go and this may ultimately determine the long term impact of risk management. At the moment is still the responsibility of a comparatively few persons in health care organizations. In contrast in aviation or in other complex industrial systems "safety is everyone's responsibility". Patient safety and risk management need to become embedded in the culture of healthcare, not just in the sense of individual high standards, but of a widespread acceptance of a systematic understanding of risk and safety and the need for everyone to actively promote patient safety (Charles Vincent, 1995). The organizational accident model of James Reason (1997) has been particularly influent in providing the foundations for a broader, system view of error and safety. In fact Reason has suggested that: "medical mishaps share many important causal similarities with the breakdown of complex socio - technical systems". Besides in the last few years has been a growing interest in a wider range of safety and reliability techniques used in other industries. Healthcare staff may resist the application of techniques from industry on the grounds that healthcare is "different" in some respect and cannot be treated in the same way as a production line. Aviation, nuclear power, chemical and petroleum industries and healthcare are complex, hazardous activities carried out in large, complex organizations by, for the most part, dedicated and highly trained people. We have to observe that there are also important differences between healthcare context and other industries. However, none of this is to say that HRA techniques should not be applied and utilized in healthcare. If the lessons learnt in one other industry can be transferred to another, the effort and energy required to solve system safety problems will be greatly enhanced. In one of the few review of HRA techniques Jeremy Williams (1985) began by saying: "It must seem quite extraordinary to most scientists engaged in research into other areas of the physical and technological world that there has been little attempt by human reliability experts to validate the human reliability assessment techniques which they so freely propagate, modify and disseminate". There is considerable scope for Human Factors and Reliability techniques to be applied to many aspects of healthcare. There is broad and deep evidence that this relatively new discipline can make a big impact on healthcare error. HF and HRA methodologies will need to be adapted and modified if they are to be of real value to clinicians. A set of proactive approaches needs to be generated to help risk managers and clinicians understand why care is sometimes substandard and to help them devise generic error reduction strategies to limit the potential for adverse occurrences in the future. To attain this objective, one must first of all find a method by means of which practical operational experience can be acquired such that qualitative and quantitative analyses on human errors will become possible. General objectives of the research The focus of my PhD thesis is on using industrial risk management and human factors engineering theories, in order to understand the specific characteristics of healthcare organisations and to design principles and methodologies for the improvement of patient and health care employee safety. The present research aims to: ¾ Explore the Italian state of art in Clinical Risk Management. Which is the Clinical Risk Management organisational configuration in Italian healthcare context? Which specific techniques and methodologies have used in Italian health care systems? ¾ Individuate and verify the factors influencing the growing and sharing of the safety culture. This investigation begins with the consideration that a fundamental part of risk management is about changing behaviour towards safer care. This change comes about through learning, which takes place at the level of individual health professional, at the organizational systems levels, and at point in between. How much and in which way cultural aspects influence the success of Risk management processes? ¾ Understand and describe the possibility to transfer human reliability methodologies and theories to healthcare domain. How to develop useful and applicable clinical risk management tools and solutions, basing on Human Factors discipline? Methodology of research I conducted a qualitative research, adopting the Multiple Case Studies method. I used interviews and focus groups techniques for the data collection and I applied within and cross case analysis. I performed a literature review of Industrial Risk Management and Clinical risk management process and its characteristics. I individuated four theoretical constructs. Then, in order to ascertain the full range of the available HRA techniques and their potential application in healthcare I carried out an extensive literature review of this specific topic. I analysed a number of useful methods and techniques in existing industrial sectors for performing human reliability and error analysis in the healthcare system.

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