For the biological qualification of blood and blood components, current transfusion regulations require serological screening tests (anti-HCV, anti-HIV1/2 combined with HIV antigen p24, HBsAg and anti-TP) and molecular screening tests, using gene amplification techniques (NAT) to search for HCV, HIV and HBV viral genomes, for each blood donation1.1Following the risk assessment of transfusion transmission of West Nile Virus (WNV) carried out for previous years, the Italian National Blood Centre (CNS) defines the measures to be applied in the summer-autumn season for the active surveillance and prevention of WNV transmission through the transfusion of labile blood components. The measures also include the NAT test for WNV RNA as an additional surveillance tool for the blood and blood-component donor population in some Italian provinces, and the decision to extend the same test in areas where the circulation of WNV through insects or humans is reported.

The commercialised kits used for molecular testing are validated by the manufacturers after demonstrating their analytical performance in terms of sensitivity and specificity, following European and national guidelines3-4. In addition, the reference laboratories of the transfusion services perform the verification/qualification of the analytical methods used according to the CNS Guideline5.

This has contributed towards the harmonisation of results between laboratories, thus enabling the achievement of a uniform level of quality and safety of diagnostic services. However, in accordance with Presidential Decree of 14th January 1997 and Legislative Decree no. 208 of 9th November 2007 (Annex. I Art. 6.3 paragraph 5)6-7, laboratories must verify the quality of their diagnostic techniques through periodic participation in an External Quality Assessment (EQA) programme. This participation is considered an important tool for the Quality Assurance of a laboratory, as specified in the European Directive 2002/98/EC8. In addition to being an essential requirement for the accreditation and certification of laboratories, the EQA, which is implemented by external qualified institutions operating in compliance with ISO 170439, is undoubtedly the most suitable tool for measuring the correctness of analytical results through self-assessment based on comparison with other laboratories. Through self-assessment, each single laboratory can review its analytical operating procedures and, if necessary, put in place appropriate corrective measures.

In collaboration with the Italian National Centre for Drug Control and Assessment (CNCF)of the Italian National Institute of Health (ISS) the Italian National Blood Centre (CNS) co-ordinates and organises an annual External Quality Assessment (EQA) Programme on serological and molecular screening assays with the aim of providing all participating transfusion services with a valid tool for monitoring the quality of their analytical performance.

The platform for EQA audits, developed within the framework of the Transfusion Services Information System (SISTRA), is a support tool for the activities of the Italian National Centres and participating laboratories, providing various functions for the:

  • Publication/consultation of EQA Programmes
  • Participation in EQA Programmes
  • Submission and consultation of results
  • Evaluation of performance
  • Publication/consultation of working protocols and technical reports.

References

  1. Decree November 2, 2015 Provisions on quality and safety requirements for blood and blood components. G.U. Serie Generale n. 300 del 28/12/2015.
  2. Direttiva CEE/CEEA/CE n. 79 del 27/10/1998. 98/79/CE: Direttiva del Parlamento Europeo e del Consiglio del 27 ottobre 1998 relativa ai dispositivi medico-diagnostici in vitro CNS/CNCS VEQ NAT WNV RNA 2018.
  3. Decreto legislativo 8 settembre 2000, n. 332 (pubbl. in S.O. n. 189/L alla G.U. 17 novembre 2000, n. 269) recante “Attuazione della direttiva 98/79/CE relativa ai dispositivi medico diagnostici in vitro”.
  4. CNS Guideline. Guide to process validation activities in Blood Transfusion Services and Blood and Blood Products Collection Units. 2° edizione, 2021.
  5. Presidential Decree January 14, 1997. Approval of the act of guidance and coordination to the regions and autonomous provinces of Trento and Bolzano on minimum structural, technological and organizational requirements for the exercise of health care activities by public and private facilities. Official Gazette February 20, 1997 (Ordinary Suppl. No. 42).
  6. Legislative Decree Nov. 9, 2007, no. 208. Implementation of Directive 2005/62/EC implementing Directive 2002/98/EC as regards Community standards and specifications for a quality system for blood services. Official Gazette Nov. 9, 2007, no. 261 (Suppl. Ordinario n. 228).
  7. European Directive 2002/98/EC Setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components.
  8. International Standard ISO/IEC 17043:2011: Conformity assessment – General requirements for proficiency testing.