CLSI AUTO10-A-2006

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October 2006

AUTO10-A

Autoveriﬁcation of Clinical Laboratory Test

Results; Approved Guideline

This document provides a general framework that will allow

each laboratory to easily design, implement, validate, and

customize rules for autoveriﬁcation (automated veriﬁcation)

based on the needs of its own patient population.

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

Clinical and Laboratory Standards Institute

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

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-proﬁt 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 clinical laboratory

standards and guidelines that help laboratories fulﬁll 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 modiﬁcation 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 addressed according to the consensus process by a committee of experts.

Appeals Process

If it is believed that an objection has not been adequately addressed, the process for appeals is documented in

the CLSI Standards Development Policies and Process document.

All comments and responses submitted on draft and published documents are retained on ﬁle 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 further 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: 610.688.0100

F: 610.688.0700

www.clsi.org

standard@clsi.org

AUTO10-A

Vol. 26 No. 32

ISBN 1-56238-620-4 Replaces AUTO10-P

ISSN 0273-3099 Vol. 26 No. 4

Autoverification of Clinical Laboratory Test Results;

Approved Guideline

Volume 26 Number 32

illiam Neeley, MD, FACP, DABCC

Gerald Davis, MT(ASCP), MPH

andy R. Davis

ill Marquardt, C(ASCP), MBA

aren L. Nickel, PhD, DABCC, FACB

Curtis A. Parvin, PhD

William L. Roberts, MD, PhD

Richard S. Seaberg, MT(ASCP)

David R. Velasquez, MT(ASCP)

Abstract

Clinical and Laboratory Standards Institute document AUTO10-A—Autoverification of Clinical Laboratory Test Results;

Approved Guideline provides a general framework that will allow each laboratory to easily design, implement, validate, and

customize rules for autoverification (automated verification) based on the needs of its own patient population. The goal is to

provide a new set of guidelines that will take us beyond traditional autoverification to the next generation that allows the use of

more sophisticated algorithms to meet laboratory needs, as well as accurately reflect the medical philosophy of the laboratory.

In addition, important supporting sections are provided that deal with the different aspects of regulatory compliance and

validation of algorithms that are essential to establishing and maintaining a modern autoverification program. Through utilization

of this structured approach, the end users will be able to ensure compliance with regulatory agencies (where acceptable by law),

yet effectively develop and establish monitors to ensure that all aspects related to quality are maintained. Guidelines are provided

for the automated delivery of high priority results that can be customized to meet a provider’s specific needs, along with a

confirmation process that results have been received.

Clinical and Laboratory Standards Institute (CLSI). Autoverification of Clinical Laboratory Test Results; Approved Guideline.

CLSI document AUTO10-A (ISBN 1-56238-620-4). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite

2500, Wayne, Pennsylvania 19087 USA, 2006.

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 your organization is not a member and would like to become

one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail:

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

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摘要：

CLSI AUTO10-A-2006 是美国临床实验室标准化协会（CLSI）发布的标准文档，全称为“实验室自动化：基础概念、定义与系统分类指南”。该标准为临床实验室自动化系统的设计与实施提供了统一的术语定义、分类方法以及关键性能指标，旨在帮助医疗机构、检验科及设备制造商理解自动化集成中的关键概念，包括模块化工作流、数据接口规范及质控要求。作为行业参考文件，它对于优化实验室效率、减少人为误差以及确保结果可追溯性具有重要指导意义。

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