Abstract：
This paper is a description of the ICSH guidance for internal quality control (IQC) policy for blood cell counters. It follows from and links to a separate ICSH review for such policies and practices. The ICSH has gathered information regarding the current state of practice through review of published guidance from regulatory bodies, a questionnaire to six major cell counter manufacturers and a survey issued to 191 diagnostic laboratories in four countries (China, the Republic of Ireland, Spain, and the United Kingdom) on their IQC practice and approach to the use of commercial IQC materials. This has revealed diversity both in guidance and in practice around the world. There is diversity in guidance from regulatory organizations in regard to IQC methods each recommends, clinical levels to use and frequency to run commercial controls, and finally recommended sources of commercial control materials. The diversity in practice among clinical laboratories spans the areas of IQC methods used, derivation of target values, and action limits used with commercial control materials, and frequency of running commercial controls materials. These findings and their implications for IQC Practice are addressed in this guidance document, which proposes a harmonized approach to address the issues faced by diagnostic laboratories.
摘要：
本文介绍了ICSH血细胞计数器内部质量控制（IQC）政策指南。它来自并链接到针对此类政策和实践的单独的ICSH审查。ICSH通过审查监管机构发布的指南，收集了有关当前实践状态的信息，对六个主要细胞计数器制造商的问卷和对四个国家191个诊断实验室的调查(中国，爱尔兰共和国,西班牙,和英国）关于他们的IQC实践和使用商业IQC材料的方法。这揭示了世界各地在指导和实践方面的多样性。监管组织在各自建议的IQC方法方面的指导意见多种多样，使用的临床水平和运行商业控制的频率，最后推荐商业控制材料的来源。临床实验室在实践中的多样性跨越了所使用的IQC方法的领域，目标值的推导，以及与商业控制材料一起使用的作用极限，和运行商业控制材料的频率。本指导文件阐述了这些发现及其对IQC实践的影响，它提出了一种统一的方法来解决诊断实验室面临的问题。
