Biomedical Laboratory techniques

What is disease and what is health status. The parameters and processes to study. The fundamentals of medical diagnosis: the role of the laboratory. Biological variability, analytical variability. Laboratory error. Classification of measurement errors. Fundamental concepts of metrology and terminology. Analytical methods: control of analysis methods, comparison between various methods. Classification and characteristics of methods: reference methods, definitive methods. Validation of analytical methods. Quality assurance. Statistics in laboratory medicine. Requirements for analytical quality. Internal quality control. Measurement uncertainty and intra- laboratory reproducibility. Requirements for analytical quality. Principles of control chart construction. Types of control charts. Types of control samples. Definition of control limits. Setting up internal quality control. Daily interpretation of internal quality control data. Long-term evaluation of internal quality control data. Quality management system. External quality assessment.