CLSI C24-2016

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C24

Statistical Quality Control for Quantitative

Measurement Procedures: Principles and

Denitions

This guideline provides denitions, principles, and approaches

to laboratory quality control design, implementation, and

assessment.

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

4th Edition

Clinical and Laboratory Standards Institute

Setting the standard for quality in medical laboratory testing around the world.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-prot membership organization that brings

together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a

common cause: to foster excellence in laboratory medicine by developing and implementing medical laboratory

standards and guidelines that help laboratories fulll their responsibilities with eﬃciency, eﬀectiveness, and global

applicability.

Consensus Process

Consensus—the substantial agreement by materially aﬀected, competent, and interested parties—is core to the

development of all CLSI documents. It does not always connote unanimous agreement, but does mean that the

participants in the development of a consensus document have considered and resolved all relevant objections

and accept the resulting agreement.

Commenting on Documents

CLSI documents undergo periodic evaluation and modication to keep pace with advancements in technologies,

procedures, methods, and protocols aﬀecting the laboratory or health care.

CLSI’s consensus process depends on experts who volunteer to serve as contributing authors and/or as participants

in the reviewing and commenting process. At the end of each comment period, the committee that developed

the document is obligated to review all comments, respond in writing to all substantive comments, and revise the

draft document as appropriate.

Comments on published CLSI documents are equally essential, and may be submitted by anyone, at any time, on

any document. All comments are managed according to the consensus process by a committee of experts.

Appeals Process

When it is believed that an objection has not been adequately considered and responded to, the process for

appeals, documented in the CLSI Standards Development Policies and Processes, is followed.

All comments and responses submitted on draft and published documents are retained on le at CLSI and are

available upon request.

Get Involved—Volunteer!

Do you use CLSI documents in your workplace? Do you see room for improvement? Would you like to get

involved in the revision process? Or maybe you see a need to develop a new document for an emerging

technology? CLSI wants to hear from you. We are always looking for volunteers. By donating your time and talents

to improve the standards that aﬀect your own work, you will play an active role in improving public health across

the globe.

For additional information on committee participation or to submit comments, contact CLSI.

Clinical and Laboratory Standards Institute

950 West Valley Road, Suite 2500

Wayne, PA 19087 USA

P: +1.610.688.0100

F: +1.610.688.0700

www.clsi.org

standard@clsi.org

C24, 4th ed.

September 2016

Replaces C24-A3

Statistical Quality Control for Quantitative Measurement Procedures:

Principles and Definitions

Curtis A. Parvin, PhD

Nils B. Person, PhD, FACB

Nikola Baumann, PhD

Lili Duan, PhD

A. Paul Durham

Valerio M. Genta, MD

Jeremie Gras, MD

Greg Miller, PhD

Megan E. Sawchuk, MT(ASCP)

Abstract

Clinical and Laboratory Standards Institute guideline C24—Statistical Quality Control for Quantitative Measurement

Procedures: Principles and Definitions discusses the principles of statistical QC, with particular attention to the planning of a QC

strategy and the application of statistical QC in a medical laboratory. Although these principles are of interest to manufacturers,

this guideline is intended for use by medical laboratory personnel in order to provide a QC strategy that uses control materials

that are external to a reagent kit, instrument, or measuring system and that are intended to simulate the measurement of a patient

specimen.

Clinical and Laboratory Standards Institute (CLSI). Statistical Quality Control for Quantitative Measurement Procedures:

Principles and Definitions. 4th ed. CLSI guideline C24 (ISBN 1-56238-946-7 [Print]; ISBN 1-56238-947-5 [Electronic]).

Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2016.

The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through

two or more levels of review by the health care community, is an ongoing process. Users should expect revised editions of any

given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or

guideline, users should replace outdated editions with the current editions of CLSI documents. Current editions are listed in

the CLSI catalog and posted on our website at www.clsi.org. If you or your organization is not a member and would like to

become one, and to request a copy of the catalog, contact us at: Telephone: +1.610.688.0100; Fax: +1.610.688.0700; E-Mail:

customerservice@clsi.org; Website: www.clsi.org.

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摘要：

CLSI C24-2016 是由美国临床实验室标准化协会（CLSI）发布的关于临床检验统计质量控制的最新权威指南。该标准规范详细阐述了实验室在进行室内质量控制（IQC）时的统计方法、质控规则选择、质控品管理以及性能验证要求，旨在帮助医学实验室建立科学、有效的质控体系，确保检验结果的准确性和可靠性。对于从事临床检验、实验室管理及质量控制的专业人员而言，掌握 CLSI C24-2016 的核心内容是提升实验室质量水平、满足国内外认证（如 ISO 15189）的重要基础。该文档取代了旧版标准，纳入了最

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CLSI C24-2016

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