Legislative Decree No. 261 of December 20, 2007 stipulates that the attestation of compliance with the requirements applicable to transfusion facilities is achieved through the regional authorization and accreditation processes, with the obligation to periodically verify these facilities using the Regional verification teams supplemented by at least one evaluator qualified and registered in the “ National List of Evaluators for the Italian Transfusion System ” (VSTI), established and updated periodically by Decree of the Director of CNS. To enter this List, each VSTI must compulsorily participate in the “VSTI Basic Training Program” defined by the current regulations, organized by the CNS, and successfully pass the final qualification examination provided by it.
The desirability of establishing a Certification Body for VSTIs, 10 years after the inception of the National Directory, stems from the need, underscored by the November 5, 2021 DMS, on “Establishment and Operation of the National System of Verification, Control and Certification of Compliance of the Activities and Products of Transfusion Services,” to harmonize regional procedures for verification and certification of compliance and to strengthen the level of effectiveness and tertiary level of verification activities, also in line with the recommendations of the European Guidelines applicable to the sector on inspection activities.
CNS Certification aims to:
- certify VSTIs’ expertise and experience in transfusion audits over time based on objective evidence assessed in an impartial, rigorous and transparent manner against a specific Certification Scheme;
- boost The level of tertiary level of verification activities., for the benefit of the safety of the process delivered by Blood Transfusion Facilities and the successful outcome of the activities that Regions and Autonomous Provinces carry out to pursue self-sufficiency of blood and its products and the quality of transfusion care delivered to the patient.
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