Clinical Laboratory Certification

CLIA Certification

This program operates under the authority of the Centers for Medicare and Medicaid Services enforcing clinical laboratory regulations. The Utah Department of Health contracts with the federal government inspecting clinical laboratories within the state. Facilities performing any testing of human samples for the purpose of assessing a condition or diagnosing an illness are considered a laboratory and are subject to these regulations.

www.cms.gov/clia

CLIA Application

• CLIA Application (CMS 116 Form)
• CLIA Ownership & Controlling Interest Disclosure Forms

Rules

• CLIA Regulations 42 CFR Part 493
• Survey Procedures and Interpretive Guidelines

Quality Assurance

• QA for Moderate/High Complexity Labs (including PPM)
• QA for Waived Labs
• IQCP Workbook

Additional Information

• CLIA Approved Laboratories
• CLIA Laboratory Registry
• CLIA Approved Proficiency Testing Programs
• CLIA Certificate Types
• CLIA Provider Performed Microscopy (PPM) Test List
• CLIA Waived Test List
• CLIA Test Complexity (Categorization)

Resources

• Ready? Set? Test! – Guidance for Waived Tests
• Provider-Performed Microscopy Procedures

Contact us at (801) 965-2588 for more information

Jan Case – Program Manager

Dianne Whitlock – Certification Officer

Cathy Mitchell – Office Specialist