title: General strategies to set quality specifications for reliability performance characteristics.
abstract: Many strategies have been promulgated for the setting of quality specifications in laboratory medicine. Based on the analysis of the effect of error on clinical decision making, general quality specifications for precision, bias, the allowable difference between two analytical methods, drugs, fixed limits for use in external quality assessment and reference methods seem best derived from components of biological variation.
authors.affiliation: Directorate of Biochemical Medicine, Ninewells Hospital and Medical School, Dundee, Scotland.
authors.forename: C G
authors.initials: CG
authors.lastname: Fraser
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D006801:Humans; D011786:Quality Control