I-4: External Quality Assessment - A Necessity in The Andrology Laboratory

Andrology laboratories need to produce reliable results for appropriate diagnostic and health care decisions. Since semen analysis is highly complex and procedurally difficult to standardize, quality control (QC) is essential to detect and correct systematic errors and high variability of results. The large discrepancies between assessments of sperm concentration and morphology in different laboratories underline the need for improved QC and standardization, with the goal of improving the quality and standardization of semen analysis and enhancing the comparability of results from different laboratories. Until there are universally accepted standard methods and definitions of motility and morphology, it will not be possible to compare results from different laboratories. Whatever its size, each laboratory should implement a quality assurance (QA) programme, based on standardized methods and procedures, to ensure that results are both accurate and precise. In some countries, QA programmes are required by law, in others, by accreditation bodies or health insurance systems. QC activities performed within one laboratory are referred to as internal quality control (IQC). External quality assessment (EQA) is the evaluation of results for the same samples in several laboratories. Quality assurance is a wider concept including optimization of the services provided. External quality control (EQC) is an integral part of the complete QC process that monitors assay results, while external quality assurance (EQA) monitors all laboratory procedures relating to collecting and reporting data to ensure that laboratory processes are under control. EQC allows a laboratory to compare its results with those of others. It permits different methods to be evaluated and compared on a scale not possible in a single laboratory. EQC encompasses peer comparison and proficiency testing programmes, in which specimens presumed to be identical are sent to all participating laboratories for analysis. Laboratories submit their results to a central facility, where the data are examined for outliers, and means and standard deviations are calculated to characterize the performance of the participating laboratories.