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 H42,¹ H43,2 H44,³ H52,⁴ and I/LA24.⁵