The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. Exceptions to the CLIA regulations exist for certain testing, including employment-related drug testing by SAMSHA certified laboratories, testing performed for forensic purposes (criminal investigations), and research or surveillance testing performed on human specimens in which patient-specific results are not reported (if the results are not used for diagnosis or treatment decisions). For more information, please refer to CLIA at 42 CFR 493.3.
CDC, in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality. CDC’s responsibilities for the national CLIA program include:
- Providing analysis, research, and technical assistance
- Developing technical standards and laboratory practice guidelines, including standards and guidelines for cytology
- Conducting laboratory quality improvement studies
- Monitoring proficiency testing practices
- Developing and distributing professional information and educational resources
- Managing the Clinical Laboratory Improvement Advisory Committee (CLIAC)