Il Sistema di Gestione integrato della Sicurezza e della Qualità nelle Università e negli Enti di Ricerca: l’esperienza della Sezione di Immunologia e della Sezione di Anatomia e Istologia Umana dell’Università degli Studi di Verona.

The aim of the thesis is the implementation of a Safety and Quality Integrated Management System in two sections of the University of Verona: the section of Immunology and the section of Anatomy and Human Histology. The Immunology section carries out both research and diagnostic activities, as part of the Azienda Ospedaliera Universitaria Integrata-Verona (AOUI). Under this agreement, the Immunology section is identified as “Clinical Immunology Unit” and it is certified UNI EN ISO 9001: 2008 since 2002; the part of the section that is exclusively committed to research is not covered by any type of certification. The Anatomy and Human Histology section carries out only research activities and is not covered by any type of certification for the Safety and Quality Management System. In the Clinical Immunology Unit we integrated information about safety into the documentation of the Quality Management System. This was the first step aiming to an integration of Quality and Safety Management System. This integrated system will be developed through the following steps:  definition of policy and objectives for the health and safety of workers in the Unit;  identification of specific indicators related to safety;  drafting of specific procedures for safety, such as: o management of accidents o management of emergencies  periodical integrated monitoring of the critical aspects and achievements of the objectives for both Quality and Safety;  management review and replanning of the objectives aiming to a continual improvement of the system. As regards the University component of the Immunology Section the goal was to implement a common Quality and Safety Management System with the Management System of the Clinical Immunology Unit; however, from the analysis of the above mentioned organization, it emerged that it is not possible to identify common liabilities for Safety Management according to D.Lgs. 81/08 and thus it is impossible to build a shared organization chart and univocally define tasks and responsibilities. For this reason, the initial objective was to work out a Safety Management System in the Immunology Section, in order to meet the rules stated in the D.Lgs. 106/09, integrating it later with the specific contents of the Quality Management System and to finally reaching the initial objective of sharing as many as possible integrated documents on Quality and Safety between the two parts of the Section. As regards the Anatomy and Human Histology Section, we tried to raise awareness in the Director and staff of the Section in order to reach, as a first step, the implementation of a Safety Management System and then a Quality and Safety Integrated Management System. The actions carried out during this study were the following:  Collection and update of the Section planimetry  Elaboration of the organization chart for the staff of the section  Elaboration of a database with the description of the elements in the staff, position covered, activities, exposure to toxic/carcinogenic substances, evaluation of the risk in which all processes are carried out. The work carried out in the Anatomy and Human Histology Section was concluded at this stage of data collection; this phase should be followed by the drawing of the procedures. A clear evidence, which emerged from what has been related above, is that the two contexts considered in this study show wide differences in the way the Management systems have been approached and in the way the staff has been involved. The different sensitivity to the issues considered originates from the course taken so far, which showed a scarce interest of the academic world in the certified management systems that, over the last few years, have gained ground in the working environment worldwide. At an operational level, in the Clinical Immunology Unit, further to implementing all the documentation for the Quality Management System which is already partially integrated with Safety guidelines, the staff showed awareness and felt involved in the implementation of the System. As a consequence, the process of integration with the Safety Management System was felt as a natural evolution of the work so far carried out. All the staff of the Section/Unit of Immunology proved more willing to adopt the new integrated procedures for Quality and Safety. Only a small portion of the staff in this Section is only academic, and is thus not yet primed with all the Quality guidelines put in place in the Unit, yet, in a context in which most of the workers are already trained and involved in the process of implementation of the Management System, the goal of extending this knowledge to 100% of the staff seems to be easily attainable. The shared hope is that this will eventually drag the university staff in a stepwise path that, starting from the implementation of a Management System for Safety which grants the fulfilment of all the regulatory requisitions, will allow the final integration with a Quality Management System. Awareness towards the Management Systems is an issue that was more heavily felt within the Anatomy and Human Histology Section, where a good portion of the efforts were spent in activities aimed at involving the staff and explaining the principles standing at the base of the Management Systems. The study could not therefore go beyond the definition of roles, tasks and the identification of all activities being carried out within the Section. The path towards the implementation of a Safety Management System implies not only the definition of a Policy, Objectives, Improvement Plan, Check and Management Review, but also the drafting up of organizational and technical procedures.