CLSI H26

Validation, Verification, and Quality Assurance of Automated Hematology Analyzers, 2nd Edition

This document provides guidance for the validation, verification, calibration, quality assurance (QA), and quality control (QC) of automated multichannel hematology analyzers for manufacturers, end-user clinical laboratories, accrediting organizations, and regulatory bodies. In addition, end-user clinical laboratories will find guidance for establishment of clinically reportable intervals and for QA for preexamination and examination aspects of their systems.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2016. The document’s next scheduled review is generally five years after the reaffirmation date.

This document is available in electronic format only.

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Chairholder: Dorothy M. Adcock, MD

Date of Publication: June 25, 2010

Order Code PDF: CLSI H26A2E
ISBN Number: 1-56238-728-6

Order Code Print: print not available

Edition: Second

Pages: 104

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CLSI H26 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.