CLIA Facts
Fact sheets that answer your questions about the Clinical Laboratory Improvement Amendments (CLIA).
This highly popular item has recently been revised to make it current with the final CLIA regulations published in January 2003.
The new series of CLIA Facts stress the systems approach to laboratory testing, and include topics under the following categories:
- Updated Regulations
- Registering for CLIA
- The CLIA Inspection Process
- Waived & PPMP Testing
- Facility Administration for Non-waived Testing
- Quality Systems for Non-waived Testing
- Specialty-Specific Control Procedures
- Personnel, and Proficiency Testing
You are welcome to download them for free from this page.
Number/Title:
1 What’s New in the Final Regulations
3 Seeking Accreditation from a CMS-Approved Program
5 What to Expect During Your CLIA Survey
6 How to Respond After Your On-site CLIA Survey
7 CLIA Sanctions and Procedures for Appeal
8 What to Expect During Subsequent CLIA Surveys
9 CMS Validation Survey Process
10 How to Properly Register Your Shared Laboratory with CMS
14 Quality Systems: General Laboratory Practices
15 Quality Systems: Pre-analytic Phase
16A Quality Systems: Analytic Phase–Procedure Manual and Test Systems
16B Quality Systems: Analytic Phase–Performance Specifications and Calibration
16C Quality Systems: Analytic Phase–Maintenance and Function Checks and Test Records
16D Quality Systems: Analytic Phase–Comparison of Test Results and Corrective Actions
16E Quality Systems: Analytic Phase–Control Procedures
17 Quality Systems: Post-analytic Phase
18 Control Procedures for Chemistry
19 Control Procedures for Hematology
20 Control Procedures for Microbiology
21 Control Procedures for Immunohematology
22 Meeting Personnel Standards for Moderate Complexity
23 Meeting Personnel Standards for High Complexity
24 Responsibilities of the Laboratory Director
26 Proficiency Testing Information
27 Enrolling in Proficiency Testing
28 Proficiency Testing Providers