عوامل انسانی و روش قابل اطمینان به مدیریت ریسک بالینی : مدارک و شواهد از موارد ایتالیایی

Similarly to the industrial sector in the late 1980s, nowadays leading organizations in the healthcare sector acknowledge the fact that human errors, adverse events and system failures must be managed and controlled. Whilst Human Reliability Analysis (HRA) has been well-accepted and integrated into safety management processes in other industries, the application of such error techniques to the problem of managing the associated risks in healthcare is rare. The main purpose of this research is to analyse clinical risk management (CRM) and patient safety improvement in Italian healthcare organizations, through human factors and human reliability theories. In particular, the specific objectives are to explore the Italian state-of-the-art in CRM, with regard to organizational and managerial issues; to identify and verify the factors influencing the growth and sharing of the safety culture and to understand and describe the possibility of transferring human reliability methodologies and theories to the domain of healthcare. Six case studies belonging to the Italian scenario have been performed, in order to describe the Italian healthcare system and to identify the key influencing factors of CRM policies. Results obtained from within and cross-case analysis give an empirical contribution to the recent introduction of CRM in the Italian context and a theoretical contribution referring to the framework used to analyse CRM in healthcare organizations, and to the indications which emerged on the key factors influencing CRM.

Currently the theme of clinical error and risk is an issue of great interest for various healthcare sectors and it has a strong social impact. The healthcare system is a complex system in various respects, on a par with other contexts such as nuclear centres, aviation and military defence (Ministero della Salute, 2004). Since in every complex organization error and the possibility of accidents cannot be eliminated, all possible interventions must be used so that these are, at least, controllable. Risk management in healthcare represents the group of various complex actions, implemented to improve the quality of the healthcare services and guarantee the safety of the patient (Walshe and Dineen, 1998), safety based therefore primarily on learning from error (learning organization). It is necessary to consider the error as an ineliminable component of the human reality. For this reason, if human error and the risk associated with it cannot be entirely eliminated, it is essential to encourage ideal working conditions: it is a question of implementing a group of actions that make it difficult for man to make a mistake and, secondly, implementing defences able to stem the consequences of any error which may occur. It is in this context that fundamental importance is given to the human factors theory and the human reliability theory, originating in the industrial context, and fruitfully applicable to complex socio-technical systems, such as healthcare systems (Stanhope et al., 1997). Promoting the “learning from error” culture, and not hiding it, is a successful and rewarding strategy, as experiences matured in other contexts demonstrate (Spencer, 2000). Clinical risk can be contained through risk management initiatives implemented at the level of the individual healthcare organization, at corporate and regional level. These initiatives, to be effective, must concern all the areas in which the risk can emerge during the patient’s clinical care process. Considering the social and scientific importance held by the knowledge of the risk in the healthcare field and its management methods, the purpose of this work is to understand its state-of-the-art in some of the best Italian healthcare organizations. In particular, the function of clinical risk management (CRM) will be analysed together with the process of risk management and management of patient safety in Italian healthcare organizations, through the theory of human reliability and human factors methods. For this reason, a qualitative research, adopting the multiple case studies method (Yin, 2003) has been performed. This article is organized as follows: Section 2 provides the main characteristics of the Italian healthcare system; Section 3 reports the theoretical framework resulting from the literature review; Section 4 defines the research questions and describes the data collection and analysis method used; Section 5 presents the results of the study; and Section 6 discusses the results and draws conclusions.

The objective of this work is to analyse and develop the function and the process of risk management in Italian healthcare organizations, through the theory of human reliability and the human factors methods. The analysis of the literature on the issue led to the identification of four macro dimensions (constructs) that characterize the management of clinical risk in the healthcare sector. These are: clinical risk management, patient safety culture, quality management and human factors, and reliability systems. The four constructs, duly identified with the aid of the relevant literature, have constituted the framework for the analysis of the six case studies of Italian healthcare organizations, following a structured methodology of multiple case studies. Under the organizational profile different configurations and different levels of formalization have emerged in the firms examined, but what seems to unite the various experiences is the gradual tendency towards the integration of different and complementary competences and culture for risk management. In the analysis of the RM process a delay was recorded in the adoption of adequate CRM instruments, which concern almost exclusively the risk identification phase and are very often adopted experimentally; this delay is inferable from comparison with other European and international experiences (Vincent et al., 2001 and Wilson et al., 1995). As far as the safety culture is concerned a good use of training has been found a propulsive lever. A fundamental strategic support to the interventions for the control of clinical risk is the training of operators, which must not limit itself to identifying and discussing the answers to the question “why” manage the safety of healthcare interventions, but it must also satisfy the question of “how” to manage. “Primum non nocere” is the ethical imperative according to which the nursing professional must act by activating ethically responsible behaviour, that ensures levels of essential, secure, effective and efficient assistance and is centred on the patient. One notices, however, a scarce diffusion of the safety culture within the organizations under examination; in particular communication appears particularly limited both within and outside of the healthcare firms. In order to obtain a more reliable measure of the diffusion of the safety culture it would be appropriate to extend this data gathering to the “front-line” operators. On the other hand, it appears to be confirmed that the cultural level is a decisive factor in creating an organization centred on the human factors, in accordance with the high-reliability organization theory, and firms with a limited attention towards the human factors indicate a purely reactive approach to risk management. Nevertheless, an element of synergy for the development of a learning organization, even though it is not sufficient for the diffusion of the safety culture, is the quality certification present, at different levels, in many of the firms under consideration. Lastly, in all the cases analysed one observes a deficiency in the activities, methodologies and managerial policies specifically oriented towards the human factors. Techniques which are potentially transferrable to the Italian healthcare situation are therefore the most simple, as described in Section 5.4. In short, given the recent introduction of CRM in our country, though one registers a plurality of initiatives and the gradual insertion of the RM function in the organizational structure of healthcare firms, at the moment one observes a limited safety culture and a scarce attention towards the human factors. These are the elements on which attention must be directed in order to promote the future development of this management area which is so important in the healthcare sector. To conclude, the contributions provided by this study to the scientific and academic world, as well as the healthcare firms, are: – the definition of a framework made up of the key constructs and the respective dimensions that interact and characterise risk management in healthcare firms; – the first individuation of links/relations between the dimensions examined, which would nevertheless be studied more in-depth in subsequent analyses; and – the extension of the knowledge of the Italian healthcare sector provided by the examination of empirical cases of “first mover” healthcare firms in the introduction of CRM.