Quality standards and internal quality control practices in medical laboratories: an IFCC global survey of member societies

Abstract Objectives The trueness and precision of clinical laboratory results are ensured through total quality management systems (TQM), which primarily include internal quality control (IQC) practices. However, quality practices vary globally. To understand the current global state of IQC practice and IQC management in relation to TQM the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a survey of IFCC member countries on IQC practices and management. Methods The survey included 16 questions regarding IQC and laboratory TQM practices and was distributed to IFCC full and affiliate member countries (n=110). A total of 46 (41.8 %) responses were received from all regions except North America. Results Of the responding countries, 78.3 % (n=36) had legislative regulations or accreditation requirements governing medical laboratory quality standards. However, implementation was not mandatory in 46.7 % (n=21) of responding countries. IQC practices varied considerably with 57.1 % (n=28) of respondents indicating that they run 2 levels of IQC, 66.7 % (n=24) indicating they run IQC every 24 h and 66.7 % (n=28) using assay manufacturer IQC material sources. Only 29.3 % (n=12) of respondents indicated that every medical laboratory in their country has written IQC policies and procedures. By contrast, 97.6 % (n=40) of responding countries indicated they take corrective action and result remediation in the event of IQC failure. Conclusions The variability in TQM and IQC practices highlights the need for more formal programs and education to standardize and improve TQM in medical laboratories.

摘要 目的 临床实验室结果的准确性和精确性通过全面质量管理体系（TQM）得以保证，该体系主要包括内部质量控制（IQC）措施。然而，质量措施在全球范围内存在差异。为了解与TQM相关的IQC措施和IQC管理的当前全球状况，国际临床化学和检验医学联合会（IFCC）全球实验室质量工作组（TF - GLQ）就IQC措施和管理对IFCC成员国进行了一项调查。 方法 该调查包含16个关于IQC和实验室TQM措施的问题，并分发给IFCC正式成员国和附属成员国（n = 110）。除北美外，所有地区共收到46份（41.8%）回复。 结果 在回复的国家中，78.3%（n = 36）有管理医学实验室质量标准的法律法规或认证要求。然而，在46.7%（n = 21）的回复国家中，实施并非强制性的。IQC措施差异很大，57.1%（n = 28）的受访者表示他们进行2个水平的IQC，66.7%（n = 24）表示他们每24小时进行一次IQC，66.7%（n = 28）使用检测试剂制造商的IQC材料来源。只有29.3%（n = 12）的受访者表示他们国家的每个医学实验室都有书面的IQC政策和程序。相比之下，97.6%（n = 40）的回复国家表示在IQC失败的情况下他们会采取纠正措施并对结果进行补救。 结论 TQM和IQC措施的差异凸显了需要更正式的项目和教育来规范和改善医学实验室的TQM。