Is quality assurance in semen analysis still really necessary? A view from the andrology laboratory.

Quality assurance (QA) is a fundamental part of laboratory medicine, of which internal and external QA (proficiency testing) is an important part. In a recent debate article published in Human Reproduction, it was argued that it was no longer necessary for semen analysis to be subject to QA, primarily because it is now being performed robustly and there is little evidence that it has any real clinical value. In response to this argument, it is suggested here that although there may have been some improvements in the training of laboratory scientists, recent studies have shown that the techniques of semen analysis are still poorly implemented at many locations. Moreover, as the impact of the introduction of QA into the andrology laboratory begins to take effect, there are a growing number of studies showing that the results of semen analysis do correlate well with natural conception and some assisted reproductive technologies. However, since the processes of QA are central to the principles of total quality management, which in turn underpins the process of laboratory accreditation, QA needs to remain in the andrology (and embryology) laboratory so that they can achieve the same accredited status as medical laboratories in other disciplines.