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Chinese Journal of Clinical Laboratory Management(Electronic Edition) ›› 2026, Vol. 14 ›› Issue (03): 183-189. doi: 10.3877/cma.j.issn.2095-5820.2026.03.001

• Standards, Guidelines and Consensus •    

Interpretation of "ICSH guidance for internal quality control policy for hematology analyzers"

Linlin Qu1, Lei Fang2, Mingting Peng3,()   

  1. 1 Department of Clinical Laboratory, the First Hospital of Jilin University, Changchun Jilin 130031, China
    2 School of Medical Technology, Beihua University, Jilin Jilin 132013, China
    3 Beijing Hospital, National Center for Clinical Laboratories, Beijing 100730, China
  • Received:2026-06-08 Online:2026-08-28 Published:2026-08-28
  • Contact: Mingting Peng

Abstract:

In January 2024, the International Council for Standardization in Hematology (ICSH) released the "ICSH guidance for internal quality control policy for hematology analyzers". Based on current practices and requirements for internal quality control in different countries, as well as the diversity of laboratory practice and recommendations from commercial internal quality control providers, the guidance provides recommendations on quality control methods, sources and concentration levels of control materials, quality control frequency, and statistical decision rules. This article interprets the guidance and in line with the requirements of China's industry standard WS/T 641-2018, focuses on the selection of control materials and concentration levels, quality control frequency, and statistical interpretation rules for hematology analyzers, aiming to help medical laboratories and manufacturers better understand and apply the guidance.

Key words: hematology analyzers, internal quality control, ICSH guidance, interpretation

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