In addition, in all the Regions and Autonomous Provinces, an inspection has to be performed at least every two years in the above-mentioned facilities by the regional audit/inspection teams integrated by at least one inspector qualified by the Italian National Blood Centre (CNS) and enrolled in theNational Directory of Inspectors of the Italian Transfusion System (VSTI).
The Ministerial Decree of 26th May 2011, entitled “The establishment of a national directory of inspectors of the transfusion system for performing inspections at blood transfusion services and blood and blood-component collection units”, in reiterating the contents of Annex B of the above-mentioned Agreement, entrusts the Italian National Blood Centre with the following duties:
- establishing the National Directory of Inspectors of the Italian Transfusion System for the purpose of carrying out the tasks provided for in Article 5 of Legislative Decree 261
- ensuring the training and continuous updating of the inspectors (VSTIs)
- verifying periodically the inspectors’ competence and proficiency to ascertain their eligibility to remain in the directory
- managing the directory
The directory is updated by Decree of the Director of the CNS periodically and/or following the introduction of new transfusion service inspectors appointed by the Regions and Autonomous Provinces and qualified by the CNS through targeted training.
The Forum is a tool to support the nationwide implementation of regional verification pathways aimed at authorization/accreditation of transfusion facilities. Discussion on the common set of applicable requirements represents an opportunity for cultural growth of the system and a guarantee of homogeneous application of the requirements; at the same time, the Forum provides the CNS with a valuable point of observation on the overall evolution of the process and feedback for outlining future training and verification strategies for VSTIs’ maintenance of competencies.