国际生殖健康/计划生育杂志

国际生殖健康/计划生育 ›› 2010, Vol. 29 ›› Issue (3): 145-148.

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男科实验室质量保证和质量控制

Pacey AA   

  1. School of Medicine and Biomedical Sciences，Academic Unit of Reproductive and Developmental Medicine，the University of Sheffield，the Jessop Wing，Tree Root Walk，Sheffield S10 2SF，UK
  • 收稿日期:1900-01-01 修回日期:1900-01-01 出版日期:2010-05-15 发布日期:2010-05-15

Quality Assurance and Quality Control in the Laboratory Andrology

Pacey AA   

  1. School of Medicine and Biomedical Sciences，Academic Unit of Reproductive and Developmental Medicine，the University of Sheffield，the Jessop Wing，Tree Root Walk，Sheffield S10 2SF，UK
  • Received:1900-01-01 Revised:1900-01-01 Published:2010-05-15 Online:2010-05-15

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摘要： 质量保证（QA）和质量控制（QC）是所有实验室进行检测分析的基础。与其他医学学科相比，研究者最近才认识到男科实验室需要有QA 和QC。此外，有证据表明，一些医生并不完全赞成尚需进行QA 和QC 的努力。然而，由于QA 和QC 是质量管理实施过程的中心环节，评审机构和监管部门越来越需要实验室制定有效的QA 和QC措施。随着《世界卫生组织人类精液分析实验室技术手册》第5 版的出版，该手册推荐的实验方法学已有相应的修改，现行的QA 和QC 体系也需作出一定程度的更新，以适应新的变化和要求。主要讨论该手册在3方面的变化，即：①建议根据精液质量推测体积。②精子活力等级由原来的4 级改为3 级。③将精子形态的参考值下限定为4%（95%CI 为3%~4%）。还讨论了QC 及QA 在所有男科实验室检测中的重要性，包括即将开展的评估精子DNA 完整性的实验。同时，阐述对从事男科学检验工作人员开展充分的初级培训与专业继续教育的必要性。

关键词: 男科学, 卫生保健, 质量保证, 质量控制, 精液分析

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.

Key words: Andrology, Health care, Quality assurance, Quality control, Semen analysis