CLM - 595 Method Comparison and Process Validation

This course is designed to prepare laboratory professionals to protect the public health by learning the techniques of validating laboratory methods and processes. Federal government CLIA regulations (Clinical Laboratory Improvement Act) and CAP (College of American Pathologists) will be covered. Quality Assurance (QA) rules and ways of managing QA will be discussed. The course will focus on Methodology Validation: Determination of Accuracy in terms of verification of accuracy, reportable range and evaluation of linearity. Determination of Precision and Reference Range in terms of establishing or verifying a reference interval will be presented. Determination of Analytic Sensitivity, Method Comparison and Medical Decision Points will be explained. Credit Hours: (4)