Standard Document
Fifth Edition
Hematology

CLSI H02

Procedures for the Erythrocyte Sedimentation Rate Test

Discover the essential principles, materials, and procedures for a standardized erthrocyte sedimentation rate (ESR) test in this comprehensive document. It includes a selected routine method, a procedure for evaluating routine methods, and detailed quality control programs to ensure accurate and reliable resutls.

This document is available exclusively in an electronic format for your convenience and accessibility.

May 31, 2011
Dorothy M. Adcock, MD

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Abstract

Clinical and Laboratory Standards Institute document H02-A5—Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition is a revision of the fourth edition approved standard (H02-A4) published in December 2000. The document outlines the necessary details for the performance of a standardized (Westergren) method on diluted (1:4) blood specimens for the determination of the erythrocyte sedimentation rate (ESR). Quality assurance and evaluation of other methods to measure the ESR are also described, including procedures for the preparation of a fresh blood reference material for use in the laboratory or manufacturing of ESR devices. This standard provides guidance for the validation, verification, quality assurance, and quality control of ESR measurement devices or related controls. The intended audience includes manufacturers of such devices, end-user clinical laboratories, accrediting organizations, and regulatory bodies.

Scope
This document addresses the methodology and devices for the measurement of the erythrocyte sedimentation rate (ESR) phenomenon. It also provides guidance for validation, verification, quality assurance (QA), and quality control (QC) through standardized approaches to ensure good laboratory science and clinical relevance. The intended audience includes manufacturers of such devices, end-user clinical laboratories, accrediting organizations, and regulatory bodies. End-user clinical laboratories will also find guidance for establishment of working methods for ESR test validation and for QA of their ESR testing method(s).
Product Details
H02A5E
1-56238-753-7
36
Additional Details

This document is available in electronic format only.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

Authors
Josep M. Jou, MD, PhD
Francesco Cocola
Bruce H. Davis, MD
Chiara Derioni
John Dorman, MT(ASCP)
John A. Koepke, MD
S. Mitchell Lewis
Renzo Montanari
Monisha Parikh
Mario Plebani, MD
Susan S. Smith
Abstract

Clinical and Laboratory Standards Institute document H02-A5—Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard—Fifth Edition is a revision of the fourth edition approved standard (H02-A4) published in December 2000. The document outlines the necessary details for the performance of a standardized (Westergren) method on diluted (1:4) blood specimens for the determination of the erythrocyte sedimentation rate (ESR). Quality assurance and evaluation of other methods to measure the ESR are also described, including procedures for the preparation of a fresh blood reference material for use in the laboratory or manufacturing of ESR devices. This standard provides guidance for the validation, verification, quality assurance, and quality control of ESR measurement devices or related controls. The intended audience includes manufacturers of such devices, end-user clinical laboratories, accrediting organizations, and regulatory bodies.

Scope
This document addresses the methodology and devices for the measurement of the erythrocyte sedimentation rate (ESR) phenomenon. It also provides guidance for validation, verification, quality assurance (QA), and quality control (QC) through standardized approaches to ensure good laboratory science and clinical relevance. The intended audience includes manufacturers of such devices, end-user clinical laboratories, accrediting organizations, and regulatory bodies. End-user clinical laboratories will also find guidance for establishment of working methods for ESR test validation and for QA of their ESR testing method(s).
Additional Details

This document is available in electronic format only.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

Authors
Josep M. Jou, MD, PhD
Francesco Cocola
Bruce H. Davis, MD
Chiara Derioni
John Dorman, MT(ASCP)
John A. Koepke, MD
S. Mitchell Lewis
Renzo Montanari
Monisha Parikh
Mario Plebani, MD
Susan S. Smith