Analysis and management of the risks related to the collection, processing and distribution of peripheral blood haematopoietic stem cells

Introduction The procedure for improving the quality and safety of any product or service, both directly related to the characteristics of the process through which the product or service is generated, involves a series of common, preliminary steps: 1. a description of the processes related to the life-cycle of the product, 2. identification of all the elements involved in the processes (informatics systems, procedures, human resources, infrastructures) with the creation of a detailed inventory of the materials and equipment, 3. the definition of measurable points of control for every element; the controls must be based on requisites identified a priori and on a mechanism in which the controller and the controlled person are not the same. The information collected by quality management systems and risk analysis techniques is combined in order to determine the priorities for interventions aimed at making improvements. Risk analysis techniques The management of risks in complex processes, such as those present in most health care activities, must be conducted in a multidisciplinary manner. The main aim is to provide an efficacious service for patients, recognising and managing both human errors and system errors with the same level of detail as "good healthcare practices"