Advances in Quality Assurance of Laboratory Testing for Transfusion Safety

摘要

Requirements for quality assurance of testing for blood-borne viruses and other laboratory processes are part of most international standards for the quality and safety of transfusions. Under the Code of Good Manufacturing Practice (cGMP) and other regulations or guidelines, all steps of transfusion processes are expected to be quality assured. For the laboratory processes employed to screen for possible infec-tivity of blood, the quality assurance requirements are sometimes defined more thoroughly.The Council of Europe Guidelines [1] has a complete section on laboratory testing and its quality assurance. The importance of quality assurance for the screening of donations for infectious markers is emphasized, and both general and specific approaches are suggested in these guidelines. The cGMP in Australia, Section 837, also requires that testing conducted for screening should be quality assured [2],