National recommendations of the Working Group for Post-analytics of the Croatian Society of Medical Biochemistry and Laboratory Medicine: implementation of autovalidation procedures.

Abstract

Autovalidation is a computerised postanalytical tool that uses a sequence of procedures to verify laboratory test results without manual intervention. The Working Group for Post-analytics of the Croatian Society for Medical Biochemistry and Laboratory Medicine has prepared procedures for the implementation of autovalidation in routine laboratory work, which complement the existing national recommendations and aim to clarify the procedures of autovalidation. Before implementation, it is necessary to determine the need for the introduction of autovalidation in routine laboratory work, and then appoint the autovalidation team, whose task is to decide in which area of laboratory work autovalidation should be introduced, create the algorithm and supervise the verification of autovalidation. Standard rules included in the algorithm are patient data, messages from the analyzer, values of interference indices, autovalidation range and delta check. All criteria defined in the autovalidation algorithm have to be documented and approved by the laboratory manager. This autovalidation procedure shows the basic rules of autovalidation that can be used by any laboratory in the initial phase. The justification for using autovalidation will depend on the number and complexity of laboratory tests, the size of the laboratory personnel, and the available financial and material resources. Autovalidation avoids the subjective evaluation of laboratory test results as it is based on the same rules and is standardised to a certain extent, which further increases the quality of laboratory test results.