Standard Document
Second Edition
Hematology

CLSI H26

Validation, Verification, and Quality Assurance of Automated Hematology Analyzers

This document provides essential guidance on validating, verifying, calibrating, and ensuring quality assurance for automated hematology analyzers. It supports manufacturers, clinical laboratories, and regulatory bodies in achieving accurate performance, reliable results, and industry compliance.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as ofSeptember 2016.

 

June 25, 2010
Dorothy M. Adcock, MD

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Abstract

Clinical and Laboratory Standards Institute document H26-A2—Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard—Second Edition provides guidance for the validation, verification, calibration, quality assurance (QA), and quality control (QC) of automated multichannel hematology analyzers. The intended audience includes manufacturers of such devices, end-user clinical laboratories, accrediting organizations, and regulatory bodies.

Overview of Changes

This document replaces and expands on two CLSI hematology documents (H26-A and H38-P) that are no longer in the consensus process. Those documents addressed only calibration and QC of automated analyzers. The present new document adds comprehensive sections for system validation and verification, as well as consideration of preexamination topics. Its approach is more practical than the previous documents, and is focused on specific technical details, with greatly expanded literature references.

Scope

This document covers portions of the life cycle of an automated multichannel hematology system and provides guidance for validation, verification, calibration, 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 clinically reportable intervals (CRIs) and for QA for preexamination and examination aspects of their systems. 

Because current blood cell counters also provide results beyond particle counting and differential separation of cell types, such as expanded platelet and reticulocyte measurements, extended leukocyte differential subtyping, and most recently, proteomic measurements through antigenic identification (ID) using fluorescence measurements, consult the potentially relevant CLSI documents H42, H43,2 H44, H52, and I/LA24.

Product Details
H26A2E
1-56238-728-6
104
Additional Details

This document is available in electronic format only.

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

Authors
Albert Rabinovitch, MD, PhD
Patrick Barnes
Krista M. Curcio, MT(ASCP)
John Dorman, MT(ASCP)
Albert Huisman, PhD
Lan Nguyen
Patrick O’Neil, BS, MLT
Abstract

Clinical and Laboratory Standards Institute document H26-A2—Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard—Second Edition provides guidance for the validation, verification, calibration, quality assurance (QA), and quality control (QC) of automated multichannel hematology analyzers. The intended audience includes manufacturers of such devices, end-user clinical laboratories, accrediting organizations, and regulatory bodies.

Overview of Changes

This document replaces and expands on two CLSI hematology documents (H26-A and H38-P) that are no longer in the consensus process. Those documents addressed only calibration and QC of automated analyzers. The present new document adds comprehensive sections for system validation and verification, as well as consideration of preexamination topics. Its approach is more practical than the previous documents, and is focused on specific technical details, with greatly expanded literature references.

Scope

This document covers portions of the life cycle of an automated multichannel hematology system and provides guidance for validation, verification, calibration, 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 clinically reportable intervals (CRIs) and for QA for preexamination and examination aspects of their systems. 

Because current blood cell counters also provide results beyond particle counting and differential separation of cell types, such as expanded platelet and reticulocyte measurements, extended leukocyte differential subtyping, and most recently, proteomic measurements through antigenic identification (ID) using fluorescence measurements, consult the potentially relevant CLSI documents H42, H43,2 H44, H52, and I/LA24.

Additional Details

This document is available in electronic format only.

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

Authors
Albert Rabinovitch, MD, PhD
Patrick Barnes
Krista M. Curcio, MT(ASCP)
John Dorman, MT(ASCP)
Albert Huisman, PhD
Lan Nguyen
Patrick O’Neil, BS, MLT