Table 1.

Advantages of traceability of results in the clinical laboratory.

Universal agreement on nomenclature, definitions, and assay performance goals Ability of different assays for the same analyte to produce comparable results (i.e. quantitative results that are similar, although not necessarily identical) Standard reference intervals as opposed to method- specific intervals Application of consistent standards of medical care, best practice guidelines, Evidence Based Medicine (EBM), and Laboratory Medicine Practice Guidelines (LMPG) Reduction of laboratory analytical errors and enhanced patient safety Method comparisons to internationally accepted reference measurement procedures instead of“predicate devices” (i.e. device performance is compared to “scientific truth” as determined by best available method as opposed to performance of a pre-existing device that may not represent the state of the art) Objective comparison of assays through Proficiency Testing/External Quality Assurance (PT/EQA) surveys as opposed to relative performance determined by peer groups