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Revised fact sheets answer your questions about the 2003 Clinical Laboratory Improvement Amendments (CLIA).

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CLIA Facts 2: Test Method Verification

CLIA Facts 3: Seeking Accreditation from a CMS-Approved Program

CLIA Facts 4: CLIA Certificate Types

CLIA Facts 5: What to Expect During Your CLIA Survey

CLIA Facts 6: How to Respond After Your On-Site CLIA Survey

CLIA Facts 7: CLIA Sanctions and Procedures for Appeal

CLIA Facts 8: What to Expect During Subsequent Surveys

CLIA Facts 9: CMS Validation Survey Process

CLIA Facts 10: How to Properly Register Your Shared Laboratory with CMS

CLIA Facts 11: Waived Testing

CLIA Facts 12: Requirements for Provider-Performed Microscopy Procedures

CLIA Facts 13: Facility Administration

CLIA Facts 14: Quality Systems – General Laboratory Practices

CLIA Facts 15: Quality Systems – Pre-Analytic Phase

CLIA Facts 16A: Quality Systems – Analytic Phase – Procedure Manual & Test Systems

CLIA Facts 16B: Quality Systems – Analytic Phase – Performance Specifications & Calibration

CLIA Facts 16C: Quality Systems – Analytic Phase – Maintenance & Function Checks & Test Records

CLIA Facts 16D: Quality Systems – Analytic Phase – Comparison of Test Results & Corrective Actions

CLIA Facts 16E: Quality Systems – Analytic Phase – Control Procedures

CLIA Facts 17: Quality Systems – Post-analytic Phase

CLIA Facts 18: Control Procedures for Chemistry

CLIA Facts 19: Control Procedures for Hematology

CLIA Facts 20: Control Procedures for Microbiology

CLIA Facts 21: Control Procedures for Immunohematology

CLIA Facts 22: Meeting Personnel Standards for Moderate Complexity

CLIA Facts 23: Meeting the Personnel Standards for High Complexity

CLIA Facts 24: Responsibilites of the Laboratory Director

CLIA Facts 25: Additional Pathways to Qualify as General Supervisor/Testing
Personnel For High Complexity Testing

CLIA Facts 26: Proficiency Testing Information

CLIA Facts 27: Enrolling in Proficiency Testing

CLIA Facts 28: Proficiency Testing Providers

CLIA Facts 29: Proficiency Testing Paperwork

CLIA Facts 30: Evaluating Your PT Results

Sets of CLIA Facts