H26

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.