CLIA Regulations & Compliance
CLIA applies to all U.S. and CLIA-certified international laboratories or sites that test specimens from humans (e.g., blood, tissue, and body fluid) to assess health or to diagnose, prevent, or treat disease.
Here you can find key resources and guidance about:
- CLIA regulations, including Federal Register information
- Compliance topics and interpretive guidelines
- Specific quality control, quality assurance, and proficiency testing requirements under CLIA to maintain quality laboratory testing, including:
To understand how laboratories perform, check out the annual Report to Congress (PDF).
Access Important CLIA Laws & Regulations
Is the official daily publication for notices, proposed rules, and final rules published by federal agencies and organizations. It also includes executive orders and other presidential documents.
Codifies general and final rules published in the Federal Register. CLIA regulations (42 CFR 493) outline the conditions and standards that all laboratories must meet to perform human specimen testing under CLIA.
Visit CDC’s website for more information.
Visit the Policy & Memos to State and CMS Locations website for more information.
Access Important CLIA Interpretive Guidelines & Survey Procedures
To help laboratories maintain compliance with federal regulations, refer to the interpretive guidelines and documentation principles.
State Operations Manual (SOM)
Appendix C – Survey Procedures and Interpretive Guidelines
Outlines survey procedures and interpretive guidelines for laboratories and laboratory services.
Appendix Q – Immediate Jeopardy
Includes core guidelines for determining immediate jeopardy. This memo outlines guidance for identifying immediate jeopardy concerns that may occur in clinical laboratories.
Chapter 5 (PDF) – Complaint Procedures
Outlines the procedures and protocols laboratories and other provider types must follow for receiving, triaging, investigating and resolving complaints and incidents to ensure compliance with federal requirements.
Chapter 6 (PDF) – Special Procedures for Laboratories
Focuses on survey and certification processes for laboratories, including procedures to conduct various types of surveys, outlines enforcement actions, surveyor responsibilities, and laboratory conditions of participation.
Principles of Documentation
These documents offer guidance for documenting compliance during laboratory surveys: