CLSI GP2-A5 实验室文件：开发与控制批准指南第五版

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Clinical and Laboratory Standards Institute

Advancing Quality in Healthcare Testing

Clinical and Laboratory Standards Institute (CLSI

formerly NCCLS) is an international, interdisciplinary,

nonprofit, standards-developing, and educational

organization that promotes the development and use of

voluntary consensus standards and guidelines within the

healthcare community. It is recognized worldwide for the

application of its unique consensus process in the

development of standards and guidelines for patient

examination and related healthcare issues. Our process is

based on the principle that consensus is an effective and

cost-effective way to improve patient examination and

healthcare services.

In addition to developing and promoting the use of

voluntary consensus standards and guidelines, we

provide an open and unbiased forum to address critical

issues affecting the quality of patient examination and

health care.

PUBLICATIONS

A document is published as a standard, guideline, or

committee report.

Standard A document developed through the consensus

process that clearly identifies specific, essential

requirements for materials, methods, or practices for use

in an unmodified form. A standard may, in addition,

contain discretionary elements, which are clearly

identified.

Guideline A document developed through the

consensus process describing criteria for a general

operating practice, procedure, or material for voluntary

use. A guideline may be used as written or modified by

the user to fit specific needs.

Report A document that has not been subjected to

consensus review and is released by the Board of

Directors.

CONSENSUS PROCESS

The CLSI voluntary consensus process is a protocol

establishing formal criteria for:

• the authorization of a project

• the development and open review of documents

• the revision of documents in response to comments

by users

• the acceptance of a document as a consensus

standard or guideline.

Most documents are subject to two levels of consensus—

“proposed” and “approved.” Depending on the need for

field evaluation or data collection, documents may also be

made available for review at an intermediate consensus

level.

Proposed A consensus document undergoes the first stage

of review by the healthcare community as a proposed

standard or guideline. The document should receive a wide

and thorough technical review, including an overall review

of its scope, approach, and utility, and a line-by-line review

of its technical and editorial content.

Approved An approved standard or guideline has achieved

consensus within the healthcare community. It should be

reviewed to assess the utility of the final document, to

ensure attainment of consensus (i.e., that comments on

earlier versions have been satisfactorily addressed), and to

identify the need for additional consensus documents.

Our standards and guidelines represent a consensus opinion

on good practices and reflect the substantial agreement by

materially affected, competent, and interested parties

obtained by following CLSI’s established consensus

procedures. Provisions in CLSI standards and guidelines

may be more or less stringent than applicable regulations.

Consequently, conformance to this voluntary consensus

document does not relieve the user of responsibility for

compliance with applicable regulations.

COMMENTS

The comments of users are essential to the consensus

process. Anyone may submit a comment, and all comments

are addressed, according to the consensus process, by the

committee that wrote the document. All comments,

including those that result in a change to the document when

published at the next consensus level and those that do not

result in a change, are responded to by the committee in an

appendix to the document. Readers are strongly encouraged

to comment in any form and at any time on any document.

Address comments to Clinical and Laboratory Standards

Institute, 940 West Valley Road, Suite 1400, Wayne, PA

19087, USA.

VOLUNTEER PARTICIPATION

Healthcare professionals in all specialties are urged to

volunteer for participation in CLSI projects. Please contact

us at customerservice@clsi.org or +610.688.0100 for

additional information on committee participation.

Licensed to: Cameron Wannamaker

This document is protected by copyright. CLSI order # 71377, id # 477046, Downloaded on 12/11/2009.

GP2-A5

ISBN 1-56238-600-X

Volume 26 Number 12 ISSN 0273-3099

Laboratory Documents: Development and Control; Approved

Guideline—Fifth Edition

Lucia M. Berte, MA, MT(ASCP), SBB, DLM; CQA(ASQ)CQMgr

Donald R. Callihan, PhD

Joan Carlson, MLT(CSMLA), BSc(MLS), MT(ASCP)

Beverly J. Charlton, CLC(AMT)

Christine D. Flaherty, MHA, MT(ASCP)

Mary H. Hopper, MA, MT(ASCP)

Barb Kirkley, MT(ASCP)

Oliver Ndimbie, MD, FCAP

Jennifer Schiffgens, MBA, MT(ASCP)

Peggy J. Stupca, MS, CLSp(CG)

Nita Sudderth, MT(ASCP), CQMgr(ASQ)

Joyce I. Wilson, MS, MT(ASCP)

Shelia M. Woodcock, MBA, FCSMLS(D)

Abstract

Clinical and Laboratory Standards Institute document GP2-A5—Laboratory Documents: Development and Control; Approved

Guideline—Fifth Edition presents the important components of writing and managing documents for the clinical laboratory. This

guideline describes common and specific sections for inclusion in laboratory documents. Several examples of process and

procedure documents for preexamination, examination, and postexamination laboratory activities are provided in the form of

appendixes; such appendixes are simply illustrative, and not prescriptive.

Clinical and Laboratory Standards Institute (CLSI). Laboratory Documents: Development and Control; Approved Guideline—

Fifth Edition. CLSI document GP2-A5 (ISBN 1-56238-600-X). Clinical and Laboratory Standards Institute, 940 West Valley

Road, Suite 1400, Wayne, Pennsylvania 19087-1898 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 healthcare 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/NCCLS documents. Current editions are

listed in the CLSI catalog, which is distributed to member organizations, and to nonmembers on request. 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

Licensed to: Cameron Wannamaker

This document is protected by copyright. CLSI order # 71377, id # 477046, Downloaded on 12/11/2009.

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标签： #实验室 #CLSI

摘要：

CLSI GP2-A5《实验室文件：开发与控制批准指南第五版》是临床与实验室标准协会（CLSI）发布的一项重要标准，旨在为实验室提供文件开发、管理、审核、批准及控制的全流程指导。该指南适用于医学实验室、检验机构及科研单位，强调文件标准化、版本控制、责任划分与合规性要求，帮助实验室建立高效、可追溯的文件管理体系。第五版在原有基础上更新了电子文档管理、数据完整性及风险控制相关内容，是实验室质量管理者、体系审核员及文件编写人员必备的权威参考工具，有助于提升实验室整体运行效率与认证评审通过率。

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