ISS - CNT
The National Institute of Health (ISS) is a public technical and scientific body of the Italian National Health System (NHS), under the control of the Ministry of Health (MoH). ISS major activities include the management and coordination of research activities and it acts as consultant for the MoH, for the government and regions.
The Italian National Transplant Centre (CNT) and the Italian National Blood Centre (NBC) are both located at ISS premises.
CNT is a technical body of the MoH, it was set up under the Law n. 91 of 1999 and it is located at the ISS where it performs its activities as a department of the same body. It coordinates activities related to organ and tissue donation and transplantation as well as hematopoietic stem cells (HSC) transplantation and ART. In this field CNT also performs vigilance activities through inspection programme and with detection and management of severe adverse events and reactions. It also manages the Transplant Information System that collects data regarding donation, allocation and transplantation of organs and tissues, ensuring traceability.
As far as HSC transplantation is concerned CNT role was first defined in the State-Regions Agreement n.1770 of 2003 and with the Legislative Decree n. 191 of 2007 and n. 16 of 2010 as transposition of the European Directives 2004/23/CE, 2006/17/EC and 2006/86/EC. As far as the clinical part is concerned, coordination activities are carried out by CNT in close cooperation with GITMO (Italian Group for Bone Marrow Transplantation), whereas for the donation of HSC as well as for the part related to unrelated donors, CNT cooperates with the Italian Registry of Bone Marrow (IBMDR).
The NBC, is an expert technical arm of the Ministry of Health. It has been operating since 1st August 2007 with the priority of implementing the national governance of the blood system, developing the necessary co-operation with the competent European bodies and supporting the Ministry for the legislative and technical work aimed at the completion of the application of the 21st October 2005, “New discipline for blood transfusion activities and national production of blood derivatives”, the latter implying the issue of more than 20 derived legislative/regulatory provisions.
The NCB actually represents the hub of the national blood network, being responsible for co-ordinating the 21 regional spokes; furthermore, it is entrusted with the technical and scientific control on all Transfusion Medicine (TM) issues ruled by national laws and European directives and recommendations, including cord blood banks and hematopoietic stem cell collection.
The NBC has an executive board composed of 3 regional blood co-ordinators, 3 representatives of blood donors’ associations and the president of INIH; the board is chaired by the director of the Centre, who must be a MD experienced in transfusion medicine and healthcare management. In the national co-ordination of the Italian blood network the NBC cooperates with the “National blood technical board” (NTB), instituted by law and composed of the directors of the 21 regional blood co-ordinating centres and of national representatives of blood donors’ associations, TM scientific societies and patients’ associations. The NTB is chaired by the Minister of Health and represents the institutional body entitled to examine technical provisions and regulatory acts pertinent to the blood system, in order to adequately address and share them among the system’s stakeholders before issue.