CLSI Publishes Standard for Validation, Verification, and Quality Assurance of Automated Hematology Analyzers

WAYNE, PA–(Marketwire – July 14, 2010) – Clinical and Laboratory Standards Institute (CLSI) recently published “Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard–Second Edition” (H26-A2). This document covers portions of the life cycle of an automated multichannel hematology system and provides guidance for manufacturers’ validation, end-user laboratory verification, calibration, quality assurance (QA), and quality control (QC) through standardized approaches to ensure good science and clinical relevance.

Albert Rabinovitch, MD, PhD, NovoMetrics, Inc., and chairholder of the subcommittee that developed the document, says, “This new document applies the most current scientific and medically relevant approaches to assessment of automated hematology systems, replacing the shortfalls created by disparate individual sources. Beyond scientific presentation of theory, H26-A2 provides very detailed practical information (including appendices) on method evaluation that all readers will find useful. It serves as a model for clinical laboratory test systems in general, not just hematology.”

Historically, each complete blood count (CBC) instrument/reagent manufacturer developed its unique approaches to system validation and performance claims. This standard will help create better standardization among manufacturers, as well as assist practicing laboratories in developing consistent testing.

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.

CLSI is a volunteer-driven, membership-supported, nonprofit organization dedicated to developing standards and guidelines for the health care and medical testing community through a consensus process that balances the perspectives of industry, government, and the health care professions. For additional information on CLSI, visit the CLSI website at www.clsi.org or call 610.688.0100.

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