This standard (SMI Q 2) describes aspects of quality assurance in the diagnostic virology and serology laboratory. It covers laboratory aspects of quality assurance, specifically the analytical phase. However, laboratories are urged to pay equal attention to ensuring that pre and post examination phases are reviewed and controlled to minimise the risk of errors occurring.
Quality must start with the selection of the appropriate analytical method and equipment. Practice should, where possible be supported by World Health organization (WHO) / National Institute for Biological Standards and Control (NIBSC) reference methods and materials. However, where there are no recommended WHO/NIBSC reference methods/materials/standards for a process, laboratories must carry out their own validation. Standardisation of methods, and thence results is key to the use of pathology data between laboratories and for wider purposes such as surveillance.
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SMI Q 2: Quality assurance in the diagnostic virology and serology laboratory - Publications - GOV.UK