I-5: Semen Analysis - Clinical Laboratories; Is Standardization Applied?

Reduced semen quality is commonly claimed to be one of the main signs of male infertility and thus, analysis of semen is recommended as the cornerstone of a male fertility investigation. However, to control possible sources of physiological and methodological variation, and to generate reliable information on semen quality that can be accurately compared across different laboratories, semen analysis should be performed according to generally accepted, international recommendations and standardized procedures. Quality assurance (QA) and quality control (QC) are essential aspects of any laboratory testing process. Both ensure that the data generated by the laboratory are consistent from one day to the next and that the results from one laboratory can be compared with those generated by others. However, whereas QA and QC approaches in many areas of laboratory medicine (e.g., clinical biochemistry and haematology) were relatively well developed in the 1970s and 1980s, their application to the andrology laboratories has been a relatively recent development. 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, 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 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. The World Health Organization (WHO) laboratory manual is recognized worldwide as the gold standard for human semen examination. It provides clear guidelines for this analysis and for the reduction of laboratory errors. The manual was first published in 1980. Since then, it has been regularly revised and updated, and the most recent fifth edition appeared in 2010. Although the WHO manuals have been available for more than 30 years, there are still reports revealing a lack of standardization of the methods used in andrology laboratories and wide variation in the results obtained among laboratory technicians in many countries. The principle of good practice in laboratories is the implementation of standardized, validated methods and equipment for the evaluation of the defined parameters. In consequence, it assures a proper basis for achieving an accurate, reliable and controlled service in the laboratory and its accreditation. For more than 30 years, the WHO has attempted to improve the quality of semen analysis by publishing manuals providing a detailed description of standardized methods and procedures for the evaluation of semen analysis. Unfortunately, adherence to these guidelines is sometimes selective and laboratories adopt not all the recommended methods for their seminological service, which may result in difficulties in interpreting and comparing the results of semen analysis.