Law n° 219 of 21st October 2005 defines the Essential Health Care Levels for transfusion activities (Art. 5) and through specific agreements, sanctioned by the Permanent Conference for Relations between the State, the Regions and the Autonomous Provinces of Trento and Bolzano, ensures the uniform delivery of these levels throughout Italy (Art. 6).
In pursuance of the provisions of the previously mentioned Law, the State-Regions Conference approves the minimum structural, technological and organisational requirements of healthcare activities to which transfusion services and blood and blood component collection units must comply, as well as the relevant verification methods, and approves the guidelines for the institutional accreditation of the aforesaid facilities.
Legislative Decree No. 261 envisages that compliance certification with the requirements applicable to transfusion facilities be achieved through regional authorisation and accreditation processes. These include the obligation to verify the aforementioned facilities at least every two years in all Regions and Autonomous Provinces (PPAA) with the support of the regional verification teams supplemented by at least one inspector qualified by the Italian National Blood Centre (CNS) and registered in the National Directory of Inspectors of the Italian Transfusion System (VSTI).
In support of the Regions and PPAAs, the CNS organises and implements project, coordination, training and supervisory activities aimed at updating quality management systems in blood transfusion facilities to ensure they are compliant with national and European regulations.
In particular, the CNS:
- regularly plans and organises training courses and dissemination campaigns on issues related to the quality of blood transfusion activities, addressed to those involved in the Italian blood transfusion network
- promotes and manages projects aimed at improving the network, e.g. providing support to regions/PAAs as regards institutional authorisation and accreditation procedures
- participates in projects/initiatives at European level aimed at harmonising assessment processes and establishing uniform basic characteristics of the authorities responsible for blood and blood components
- manages and periodically updates the National Directory of Inspectors of the Italian Transfusion System (VSTI)
- develops and ensures that all network actors have access to guidelines/support tools for the correct design and verification of quality management systems used in blood establishments
- carries out supervisory, control and surveillance activities in scenarios envisaged by the regulations in force
In collaboration with the Italian National Centre for Drug Control and Evaluation (CNCF) of the Italian National Institute of Health, the CNS coordinates and organises an External Quality Assessment (EQA) Programme on serological and molecular testing assays,with the aim of providing all participating blood transfusion services with a valid tool for monitoring the quality of their screening activities.