In Italy, the Blood System is part of the National Health Service. Healthcare services, including blood and blood component collection, processing, testing, storage and distribution as well as all transfusion medicine activities, are delivered by the Regional Health Services within a federalist legislative framework, which defines the functions of the Ministry of Health (legislation, coordination, supervision).
National Blood Centre (Centro Nazionale Sangue – CNS): the CNS is the national competent authority for blood and blood components on behalf of the Ministry of Health. It is located at the National Institute of Health and it operates independently, under the aegis of the Ministry of Health. It is responsible for coordination as well as scientific and technical control of the national Blood System. It also provides blood inspectors training and qualification and it manages a national register of qualified blood inspectors as well as the periodic assessment of their activities and skills. The CNS coordinates also the Italian Cord Blood Network (ITCBN) with the support of the National Transplant Centre and it collaborates with the National Medicines Agency as concerns the evaluation of plasma for fractionation and plasma-derived medicinal products.
Regional Health Authorities: they inspect, authorize and accredit both Blood Establishments and Blood Collection Units, according to regional, national and European legislation. Each regional inspection team must include at least one nationally qualified blood inspector from the CNS register.
Regional Blood Centres: in each of the 21 regions, a Regional Blood Centre is established by law. The regional Blood Centres coordinate the related local networks of Blood Establishments and Blood Collection Units, complying with national regulation and self-sufficiency, quality and safety plans.
Blood Establishments: in addition to performing blood and blood component collection, processing, testing, storage and distribution, most Blood Establishments also work as hospital blood banks. At the end of 2007, the implementation of the structural, technological and organizational requirements foreseen within the qualification process of the Italian Blood System begun in compliance with both national and European legislation related to blood and blood components. The process got its completion on June 30th, 2015 and it determined the organizational re-adjustment of the national blood system with a set of activities to be carried out to ensure the quality and safety of the national blood transfusion chain.
Blood Donors Associations: there are four main blood donors organizations (AVIS, FIDAS, FRATRES, CRI) that are highly involved in the blood donor management. By law, they can run Blood Collection Units upon the release of specific regional authorisation and accreditation, under the technical control of both Blood Establishments and Regional Blood Centres.