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H26-A2
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard-Second Edition
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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.
Analytical measuring interval, automated hematology, carryover, clinically reportable interval, comparability, correlation, imprecision, limit of blank, lower limit of detection, lower limit of quantitation, quality control, reference intervals, repeatability, validation study design, verification study design
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