A Review of Regulations, Terminology, and Practical Approaches to Reportable Range Verification

Background In the United States, federal regulations under CLIA '88 require reportable range verification of quantitative assays used for clinical purposes. Some accreditation agencies and other standards development organizations have their own additional requirements, recommendations, and/or terminologies relating to reportable range verification, leading to varying practices among clinical laboratories. Content Requirements and recommendations related to reportable range or analytical measurement range verification from different organizations are reviewed and compared. Optimal approaches to materials selection, data analysis, and troubleshooting are collated. This review clarifies key concepts and outlines various practical approaches to reportable range verification.