Part I: Regulatory Oversight and Laboratory Accreditation
1) Clinical Laboratory Improvement Amendments (CLIA) and Regulatory Oversight
2) CLIA Certificates
3) Waived Testing
4) Laboratory Accreditation
Part II: Verification and Validation of Test Systems
1) Verification and Validation
2) Performance characteristic: Precision
3) Performance characteristic: Accuracy
4) Performance characteristic: Reportable Range
5) Performance characteristic: Reference Interval
6) Performance characteristic: Analytic Sensitivity
7) Performance characteristic: Analytic Specificity
8) Additional Performance Characteristics
9) Unacceptable Results and Resolution
10) Documentation for Verification and Validation Studies
Part III: Quality Management Systems
1) Quality Management Systems (QMS)
2) Essential 1: Organizational Structure
3) Essential 2: Personnel
4) Essential 3: Customer Service
5) Essential 4: Facilities
6) Essential 5: Purchasing and Inventory
7) Essential 6: Equipment
8) Essential 7: Process Control
9) Essential 8: Document Control
10) Essential 9: Information Management
11) Essential 10: Occurrence Management
12) Essential 11: Assessment
13) Essential 12: Process Improvement