Quality assurance and quality control in the laboratory andrology.

Abstract

Quality assurance (QA) and quality control (QC) are fundamental aspects of any laboratory measurement. However, in comparison with other medical disciplines, the need for QA and QC in laboratory andrology has been recognized only recently. Furthermore, there is evidence that the effort required to undertake QA and QC has not been wholly welcomed by some clinicians. Nevertheless, accrediting bodies and regulatory authorities increasingly require evidence that laboratories have effective QA and QC measures in place because both are central to the quality management processes. Following the publication of the 5th edition of the World Health Organization Laboratory Manual, existing QA and QC systems will need to be updated to take into account some of the methodological changes recommended by the manual. Three of these are discussed in this commentary; they relate to: (i) the move to infer semen volume from its weight; (ii) the re-classification of sperm motility grades from four to three; and (iii) the publication of a lower reference limit for morphology of 4% (with a corresponding 95% confidence interval of 3%-4%). The importance of QA and QC in all laboratory tests, including up and coming new tests to assess sperm DNA integrity, is discussed. The need for adequate initial training and continuing professional development programmes to support laboratory scientists performing andrology is also described.