CLSI C46-A2 (R2018)

This guideline is a consolidation of six CLSI documents and projects. The Area Committee on Clinical Chemistry and Toxicology concluded that CLSI’s constituencies (professions, government, and industry) would be better served with the production of a single document that retains the essential information from the six original documents, while making it even more relevant and useful. It addresses blood gas, pH, and related measurements (eg, hemoglobin and hemoglobin fractions, oxygen content, hemoglobin-oxygen saturation, electrolytes, and selected metabolites) as measured in blood. It defines terminology and discusses performance characteristics as well as preanalytical variables and analytical considerations. It also addresses quality control issues.

This guideline consolidates and updates previously published CLSI/NCCLS documents C12-A–Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved Standard; C21-A–Performance Characteristics for Devices Measuring pO2 and pCO2 in Blood Samples; Approved Standard; C25-A–Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood: Terminology, Measurement, and Reporting; Approved Guideline; C27-A–Blood Gas Preanalytical Considerations: Specimen Collection and Controls; Approved Guideline; and C32-P–Considerations in the Simultaneous Measurement of Blood Gases, Electrolytes, and Related Analytes in Whole Blood; Proposed Guideline; and unpublished CLSI document C33–Practical Blood Gas and pH Quality Control. Sections of another CLSI/NCCLS document H11 also are included; however, H11 will remain a separate document, because its content is of interest to a broader audience.