A systemic methodology for risk management in healthcare sector

Abstract

The recent biomedical, technological, and normative changes have led healthcare organizations to the implementation of clinical governance as a way to ensure the best quality of care in an increasingly complex environment. Risk management is one of the most relevant aspects of clinical governance and approaches put forward in literature highlight the necessity to perform comprehensive analyses intended to uncover root causes of adverse events. Contributing to this field, the present paper applies Reason’s theory of failures to work out a systemic methodology to study risks impacting not only directly but also indirectly on patients. Also, the steps of such approach are organized around Human Reliability Assessment phases, in order to take into account the human component of healthcare systems. This framework is able to foster effective decision making about reducing failures and waste and to improve healthcare organizations’ maturity towards risk management. The developed methodology is applied to the pharmacy department of a large Italian hospital. An extensive validation in different healthcare settings is required to fully prove benefits and limitations.