《血细胞分析仪室内质量控制策略ICSH指南》解读

doi:10.3877/cma.j.issn.2095-5820.2026.03.001

中华临床实验室管理电子杂志 ›› 2026, Vol. 14 ›› Issue (03) : 183 -189. doi: 10.3877/cma.j.issn.2095-5820.2026.03.001

标准、指南与共识

《血细胞分析仪室内质量控制策略ICSH指南》解读

曲林琳¹, 方蕾², 彭明婷³^,^†(

)

¹　130031　吉林长春，吉林大学第一医院检验科
²　132013　吉林吉林，北华大学医学技术学院
³　100730　北京，北京医院，国家卫生健康委临床检验中心

收稿日期:2026-06-08 出版日期:2026-08-28
通信作者: 彭明婷
基金资助:
吉林省医疗卫生人才专项(JISRCZX2025-009)

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

Linlin Qu¹, Lei Fang², Mingting Peng³^,^†()

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 Published:2026-08-28
Corresponding author: Mingting Peng

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2024年1月，国际血液学标准化委员会（ICSH）发布了《血细胞分析仪室内质量控制策略ICSH指南》。该指南基于不同国家室内质量控制的开展现状和要求，结合医学实验室在实践层面的多样性以及商品化室内质量控制提供者的建议，对质控方法、质控品来源与浓度水平、质控频率、统计分析规则等方面提出了推荐性意见。本文对指南的条款进行解读，并结合国内 WS/T 641-2018《临床检验定量测定室内质量控制》的要求，重点分析血细胞分析仪质控品与浓度选择、质控频率、统计判定等内容，以便于医学实验室和制造商更好地理解和使用该指南。

关键词: 血细胞分析仪, 室内质量控制, ICSH指南, 解读

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

1	MCCAFFERTY R, CEMBROWSKI G, DE LA SALLE B, et al. ICSH guidance for internal quality control policy for blood cell counters[J]. International journal of laboratory hematology, 2024, 46(2): 227-233.
2	MCCAFFERTY R, CEMBROWSKI G, DE LA SALLE B, et al. ICSH review of internal quality control policy for blood cell counters[J]. International journal of laboratory hematology, 2024, 46(2): 216-226.
3	CLINICAL AND LABORATORY STANDARDS INSTITUTE. Statistical quality control for quantitative measurement procedures: Principles and definitions: CLSI C24[S]. 4th ed. Wayne, PA: Clinical and Laboratory Standards Institute, 2016.
4	CLINICAL AND LABORATORY STANDARDS INSTITUTE. Validation, verification, and quality assurance of automated hematology analyzers; approved standard—second edition: CLSI H26-A2[S]. 2nd ed. Wayne, PA: Clinical and Laboratory Standards Institute, 2010.
5	中华人民共和国国家卫生健康委员会. 临床检验定量测定室内质量控制: WS/T 641-2018[S/OL]. (2018-12-11)[2026-06-08].
6	中华人民共和国国家卫生健康委员会. 临床血液检验常用项目分析质量标准: WS/T 406-2024[S/OL]. (2024-05-09)[2026-06-08].
7	中华人民共和国国家卫生健康委员会. 临床血液与体液检验基本技术标准: WS/T 806-2022[S/OL]. (2022-11-02)[2026-06-08].
8	CLINICAL AND LABORATORY STANDARDS INSTITUTE. Reference and selected procedures for the quantitative determination of hemoglobin in blood: Approved standard—third edition: CLSI H15-A3[S]. 3rd ed. Wayne, PA: Clinical and Laboratory Standards Institute, 2000.
9	中华人民共和国卫生部. 红细胞比容测定参考方法: WS/T 342-2011[S]. 北京: 中国标准出版社, 2011.
10	CLINICAL AND LABORATORY STANDARDS INSTITUTE. Procedure for determining packed cell volume by the microhematocrit method: Approved standard—third edition: CLSI H07-A3[S]. 3rd ed. Wayne, PA: Clinical and Laboratory Standards Institute, 2000.
11	中华人民共和国国家卫生健康委员会. 血细胞分析校准指南: WS/T 347-2024[S/OL]. (2024-04-02)[2026-06-08].
12	BULL B S, ELASHOFF R M, HEILBRON D C, et al. A study of various estimators for the derivation of quality control procedures from patient erythrocyte indices[J]. American journal of clinical pathology, 1974, 61(4): 473-481.
13	CEMBROWSKI G S, LUNETZKY E S, PATRICK C C, et al. An optimized quality control procedure for hematology analyzers with the use of retained patient specimens[J]. American journal of clinical pathology, 1988, 89(2): 203-210.
14	NOSANCHUK J S, GOTTMANN A W. CUMS and delta checks. A systematic approach to quality control[J]. American journal of clinical pathology, 1974, 62(5): 707-712.
15	VAN ANDEL E, HENRICKS L M, GILIAMS A P M, et al. Moving average quality control of routine chemistry and hematology parameters-a toolbox for implementation[J]. Clinical chemistry and laboratory medicine, 2022, 60(11): 1719-1728.
16	INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. Medical laboratories — Requirements for quality and competence: ISO 15189:2022[S]. Geneva: International Organization for Standardization, 2022.
17	COLLEGE OF AMERICAN PATHOLOGISTS. Hematology and coagulation checklist[R]. Northfield, IL: College of American Pathologists, 2022.
18	LOH T P, BIETENBECK A, CERVINSKI M A, et al. Recommendation for performance verification of patient-based real-time quality control[J]. Clinical chemistry and laboratory medicine, 2020, 58(8): 1205-1213.
19	温冬梅, 郝晓柯. 基于患者数据的实时质量控制建立原则及研究进展[J]. 中华检验医学杂志, 2022, 45(1): 82-86.
20	段昕岑, 王蓓丽, 潘柏申, 等. 基于患者样本的实时质量控制系统的理论基础和研究展望[J]. 中华检验医学杂志, 2021, 44(10): 956-959.
21	续薇, 郝晓柯, 崔巍, 等. 血液分析自动审核规则建立与验证的多中心研究[J]. 中华检验医学杂志, 2018, 41(8): 601-607.
22	李映潼, 王学军, 续薇, 等. 血液分析自动审核的周期性验证及其应用适宜性评价[J]. 中华检验医学杂志, 2020, 43(10): 1021-1031.
23	WESTGARD J O, BARRY P L, HUNT M R, et al. A multi-rule Shewhart chart for quality control in clinical chemistry[J]. Clinical chemistry, 1981, 27(3): 493-501.
24	WESTGARD J O, WESTGARD S A. Six sigma quality management system and design of risk-based statistical quality control[J]. Clinics in laboratory medicine, 2017, 37(1): 85-96.
25	孙慧珍, 王薇, 赵海建, 等. 临床检验定量测定项目室内统计质量控制程序的研究进展[J]. 中华检验医学杂志, 2019, 42(10): 879-883.
26	CLINICAL AND LABORATORY STANDARDS INSTITUTE. Laboratory quality control based on risk management: CLSI EP23[S]. 2nd ed. Wayne, PA: Clinical and Laboratory Standards Institute, 2023.

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