Pacey A A
Academic Unit of Reproductive and Developmental Medicine, The University of Sheffield, Royal Hallamshire Hospital, Sheffield, UK.
Hum Reprod. 2006 May;21(5):1105-9. doi: 10.1093/humrep/dei460. Epub 2006 Jan 5.
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.
质量保证（QA）是检验医学的一个基本组成部分，其中内部和外部质量保证（能力验证）是重要的一部分。在最近发表于《人类生殖》的一篇辩论文章中，有人认为精液分析不再需要进行质量保证，主要是因为目前精液分析执行得很严格，而且几乎没有证据表明其具有任何实际临床价值。针对这一观点，本文认为，尽管实验室科学家的培训可能有了一些改进，但最近的研究表明，精液分析技术在许多地方仍然实施得很差。此外，随着将质量保证引入男科学实验室的影响开始显现，越来越多的研究表明，精液分析结果与自然受孕和一些辅助生殖技术确实有很好的相关性。然而，由于质量保证流程是全面质量管理原则的核心，而全面质量管理又支撑着实验室认可过程，因此质量保证需要保留在男科学（和胚胎学）实验室中，以便它们能够获得与其他学科医学实验室相同的认可地位。
