Clinical Chemistry

  1. Quality Assurance and Quality Control
    1. Pre-analytical Phase
      1. Sources of Error
        1. Patient Preparation
          1. Specimen Collection
            1. Specimen Transport
              1. Specimen Storage
              2. Strategies for Error Reduction
                1. Standardized Procedures
                  1. Training Programs
                    1. Error Tracking
                  2. Analytical Phase
                    1. Sources of Error
                      1. Instrument Malfunction
                        1. Reagent Problems
                          1. Calibration Issues
                            1. Environmental Factors
                            2. Strategies for Error Reduction
                              1. Preventive Maintenance
                                1. Quality Control
                                  1. Method Validation
                                2. Post-analytical Phase
                                  1. Sources of Error
                                    1. Result Reporting
                                      1. Reference Ranges
                                        1. Critical Values
                                          1. Turnaround Time
                                          2. Strategies for Error Reduction
                                            1. Result Review
                                              1. Delta Checks
                                                1. Autoverification
                                              2. Quality Control (QC)
                                                1. Control Materials
                                                  1. Types of Controls
                                                    1. Assayed Controls
                                                      1. Unassayed Controls
                                                        1. Patient-Based Controls
                                                        2. Preparation and Storage
                                                          1. Reconstitution
                                                            1. Stability
                                                              1. Matrix Effects
                                                            2. Statistical Concepts
                                                              1. Mean
                                                                1. Calculation
                                                                  1. Clinical Significance
                                                                  2. Standard Deviation (SD)
                                                                    1. Calculation
                                                                      1. Clinical Significance
                                                                      2. Coefficient of Variation (CV)
                                                                        1. Calculation
                                                                          1. Acceptable Limits
                                                                          2. Application in QC
                                                                            1. Control Limits
                                                                              1. Trend Analysis
                                                                            2. Control Charts
                                                                              1. Levey-Jennings Charts
                                                                                1. Construction and Interpretation
                                                                                  1. Control Limits
                                                                                    1. Trend Recognition
                                                                                    2. Cumulative Sum (CUSUM) Charts
                                                                                      1. Moving Average Charts
                                                                                      2. Westgard Rules
                                                                                        1. Rule Definitions
                                                                                          1. 1-2s Warning
                                                                                            1. 1-3s Rejection
                                                                                              1. 2-2s Rejection
                                                                                                1. R-4s Rejection
                                                                                                  1. 4-1s Rejection
                                                                                                    1. 10x Rejection
                                                                                                    2. Application in QC
                                                                                                      1. Error Detection
                                                                                                        1. False Rejection Rates
                                                                                                        2. Multi-Rule Systems
                                                                                                      2. Quality Assurance (QA)
                                                                                                        1. External Quality Assessment
                                                                                                          1. Proficiency Testing
                                                                                                            1. Participation Requirements
                                                                                                              1. Performance Evaluation
                                                                                                                1. Corrective Actions
                                                                                                                2. Interlaboratory Comparisons
                                                                                                                3. Method Validation and Verification
                                                                                                                  1. Accuracy
                                                                                                                    1. Bias Assessment
                                                                                                                      1. Recovery Studies
                                                                                                                      2. Precision
                                                                                                                        1. Repeatability
                                                                                                                          1. Reproducibility
                                                                                                                            1. Intermediate Precision
                                                                                                                            2. Analytical Measurement Range
                                                                                                                              1. Linearity
                                                                                                                                1. Reportable Range
                                                                                                                                2. Sensitivity
                                                                                                                                  1. Limit of Detection
                                                                                                                                    1. Limit of Quantitation
                                                                                                                                    2. Specificity
                                                                                                                                      1. Interference Studies
                                                                                                                                        1. Cross-Reactivity
                                                                                                                                      2. Reference Intervals
                                                                                                                                        1. Establishment
                                                                                                                                          1. Reference Population
                                                                                                                                            1. Statistical Methods
                                                                                                                                              1. Sample Size
                                                                                                                                              2. Verification
                                                                                                                                                1. Transference Studies
                                                                                                                                                  1. Clinical Validation
                                                                                                                                                  2. Partitioning
                                                                                                                                                    1. Age
                                                                                                                                                      1. Gender
                                                                                                                                                        1. Ethnicity
                                                                                                                                                      2. Critical Values
                                                                                                                                                        1. Definition and Criteria
                                                                                                                                                          1. Life-Threatening Results
                                                                                                                                                            1. Immediate Action Required
                                                                                                                                                            2. Reporting Procedures
                                                                                                                                                              1. Notification Requirements
                                                                                                                                                                1. Documentation
                                                                                                                                                                2. Clinical Communication
                                                                                                                                                                  1. Physician Notification
                                                                                                                                                                    1. Read-Back Verification
                                                                                                                                                                  2. Laboratory Information Systems
                                                                                                                                                                    1. Data Management
                                                                                                                                                                      1. Result Reporting
                                                                                                                                                                        1. Quality Monitoring
                                                                                                                                                                        2. Regulatory Compliance
                                                                                                                                                                          1. CLIA Requirements
                                                                                                                                                                            1. CAP Standards
                                                                                                                                                                              1. ISO 15189
                                                                                                                                                                                1. Accreditation Processes

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                                                                                                                                                                            1. Introduction to Clinical Chemistry