Description

CLSI H26-A2 (R2018) – Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard-Second Edition, H26A2

This document covers portions of the life cycle of an automated multichannel hematology system andprovides guidance for validation, verification, calibration, quality assurance (QA), and quality control(QC) through standardized approaches to ensure good laboratory science and clinical relevance. Theintended audience includes manufacturers of such devices, end-user clinical laboratories, accreditingorganizations, 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.