Pragmatic Approach of Verification of Examination Procedures in Clinical Laboratory for Imprecision,Trueness and Diagnostic Accuracy / 现代检验医学杂志

ABSTRACT

Objective To propose a practice model for implementing procedures employed for the verification of validated ex-amination procedures already used for at least 2 years in their laboratory,in agreement with the ISO 15189 requirement at the Section 5.5.1.2.Methods In order to identify the operative procedure to be used,approved documents were identified, together with the definition of performance characteristics to be evaluated for the different methods;the examination proce-dures used in laboratory were analyzed and checked for performance specifications reported by manufacturers.Then,opera-tive flow charts were identified to compare the laboratory performance characteristics with those declared by manufacturers. Results The choice of performance characteristics for verification was based on approved documents used as guidance,and the specific purpose tests undertaken,a consideration being made ofimprecision and trueness for quantitative methods;diag-nostic accuracy for qualitative methods;imprecision together with diagnostic accuracy for semi-quantitative methods.Conclu-sion The described approach,balancing technological possibilities,risks and costs and assuring the compliance of the funda-mental component of result accuracy,appears promising as an easily applicable and flexible procedure helping laboratories to comply with the ISO 15189 requirements.