In line with the provisions of Law no. 219 of 21st October 2005 and under the Agreement of 16th December 2010, the State-Regions Conference approved the Minimum Structural, Technological and Organisational Requirements for the Healthcare Activities of Blood Transfusion Services (TSs) and Blood and Blood-Component Collection Units (BCUs) (Annex. A), as well as the inspection procedures for TSs and BCUs (Annex B),pursuant to Article 5 of Legislative Decree no. 261 of 20th December 2007, which implemented EU Directive 2002/98/EC.

With the implementation of Law No. 219, under the Agreement of 25th July 2012, the State-Regions Conference subsequently approved the guidelines for the accreditation of blood transfusion services and blood and blood-component collection units. These guidelines provide the Regions with indications for the qualification of personnel assigned to the collection of blood and blood components and for the organisation of networks to ensure the same levels of quality and safety in the production and biological qualification of blood components.

The enactment of European Directive 2016/1214 introduced the obligation for Member States to make the Good Practice Guidelines (GPGs) binding for transfusion facilities. These specific GPGs are set out in a specific appendix of the guide to the preparation, use and quality assurance of blood components,a document of the EDQM (Council of Europe’s Directorate for the Quality of Medicines), now in its 20th edition. This revised version of the GPGs made it necessary to update the minimum requirements of the Agreement of 16th December 2010. The new requirements were approved under the State-Regions Agreement of 25th March 2021 and resulted in the specific training for blood professionals and inspectors.

The Decree of the Minister of Health Nov. 5, 2021, “Establishment and Mode of Operation of the National System of Verification, Control and Certification of Compliance of the Activities and Products of Transfusion Services,” emphasized the need, through the update of ASR Dec. 16, 2010 – All. B, to redefine the modalities for the management of activities related to authorization and accreditation and the organization of verification visits. The revision of All. B was approved by the State-Regions Agreement of September 6, 2023.

Within the framework of the roadmap for the sector’s qualification processes, the Italian National Blood Centre (CNS) has developed a series of support tools for the correct design and verification of Quality Management Systems in blood establishments. These include the two guides to interpreting specific requirements and conducting quality audits in TSs and BCUs, intended for blood professionals and inspectors, and the guide to validation activities of transfusion processes in TSs and BCUs,updated in 2021.