Example: dental hygienist

EP28-A3c: Defining, Establishing, and Verifying Reference …

October 2010EP28-A3cDefining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline Third EditionThis document contains guidelines for determining Reference values and Reference intervals for quantitative clinical laboratory guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process. SAMPLEC linical and Laboratory Standards InstituteSetting the standard for quality in clinical laboratory testing around 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.

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in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI documents.

Tags:

  Methods, Review, Slic

Information

Domain:

Source:

Link to this page:

Please notify us if you found a problem with this document:

Other abuse

Transcription of EP28-A3c: Defining, Establishing, and Verifying Reference …

1 October 2010EP28-A3cDefining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline Third EditionThis document contains guidelines for determining Reference values and Reference intervals for quantitative clinical laboratory guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process. SAMPLEC linical and Laboratory Standards InstituteSetting the standard for quality in clinical laboratory testing around 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.

2 Consensus ProcessConsensus 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 DocumentsCLSI documents undergo periodic evaluation and modification to keep pace with advancements in technologies, procedures, methods , and protocols affecting the laboratory or health 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.

3 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 ProcessIf it is believed that an objection has not been adequately addressed, the process for appeals is documented in the CLSI Administrative 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.

4 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 further information on committee participation or to submit comments, contact and Laboratory Standards Institute950 West Valley Road, Suite 2500 Wayne, PA 19087 USA P: : EP28-A3c Vol. 28 No. 30 ISBN 1-56238-682-4 Formerly C28-A3c ISSN 0273-3099 Vol.

5 28 No. 30 Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline Third Edition Volume 28 Number 30 Gary L. Horowitz, MD, Chairholder Sousan Altaie, PhD James C. Boyd, MD Ferruccio Ceriotti, MD Uttam Garg, PhD, DABCC Paul Horn, PhD Amadeo Pesce, PhD Harrison E. Sine, PhD Jack Zakowski, PhD, FACB Abstract Clinical and Laboratory Standards Institute document EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline Third Edition is written for users of diagnostic laboratory tests. It offers a protocol for determining Reference intervals that meet the minimum requirements for reliability and usefulness. The guideline focuses on health-associated Reference values as they relate to quantitative clinical laboratory tests.

6 Included are various requirements for studies to determine Reference values for a new analyte or a new analytical method of a previously measured analyte. Also discussed is the transfer of established Reference values from one laboratory to another. Clinical and Laboratory Standards Institute (CLSI). Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline Third Edition. CLSI document EP28-A3c (ISBN 1-56238-682-4). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2008. 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.

7 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 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: ; Fax: ; E-Mail: Website: SAMPLEN umber 30 EP28-A3c ii Copyright 2008 Clinical and Laboratory Standards Institute.

8 Except as stated below, any reproduction of content from a CLSI copyrighted standard, guideline, companion product, or other material requires express written consent from CLSI. All rights reserved. Interested parties may send permission requests to CLSI hereby grants permission to each individual member or purchaser to make a single reproduction of this publication for use in its laboratory procedure manual at a single site. To request permission to use this publication in any other manner, e-mail Suggested Citation CLSI. Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline Third Edition. CLSI document EP28-A3c. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.

9 Proposed Guideline March 1992 Approved Guideline June 1995 Approved Guideline Second Edition June 2000 Proposed Guideline Third Edition March 2008 Approved Guideline Third Edition November 2008 October 2010 (corrected version) ISBN 1-56238-682-4 ISSN 0273-3099 SAMPLEV olume 28 EP28-A3c v Contents Abstract .. i Committee Membership .. iii Foreword .. vii 1 Scope .. 1 2 Introduction .. 1 3 Standard Precautions .. 2 4 Terminology .. 2 A Note on Terminology .. 2 Definitions .. 3 Abbreviations/Acronyms .. 4 Clarifications .. 5 5 Use of Syst me International d Unit s (SI Units) .. 5 6 Protocol Outline for Obtaining Reference Values and Establishing Reference Intervals .. 5 New Analyte or Analytical Method.

10 5 Multicenter Reference Interval Studies .. 7 Previously Measured Analyte .. 7 7 Selection of Reference Individuals .. 8 Introduction .. 8 Exclusion and Partitioning .. 8 Sample Questionnaire .. 9 Selection of Reference Individuals .. 11 8 Preanalytical and Analytical Considerations .. 13 Subject Preparation .. 13 Specimen Type, Collection, Handling, and Storage .. 14 Analytical Method Characteristics .. 15 9 Analysis of Reference Values .. 15 Minimum Number of Reference Values .. 16 Treatment of Outlying Observations .. 17 Partitioning of Reference Values .. 19 Examples .. 20 Confidence Intervals for Reference Limits .. 26 10 Transference .. 28 Transference: Comparability of the Analytical System.