Clinical Laboratory Improvement Amendments (CLIA) Section
This process involves compliance with the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988, which requires that all laboratories testing human specimens be certified by the federal government. The Los Angeles LFS Office manages the CLIA program.
The mission of the Clinical Laboratory Improvement Amendments (CLIA) section of Laboratory Field Services is to ensure compliance with State and federal clinical laboratory laws and regulations by performing biannual onsite inspections to ensure accuracy and reliability of laboratory test results and conducting review of laboratory performed proficiency testing results.
The CLIA program performs routine inspections of over 800 laboratories and validations of 36 accredited facilities each year. The program is also responsible for inspection of over 200 laboratories with a CLIA certificate of waiver annually.
To contact the Los Angeles LFS Office please call (213) 620-6160.
CLIA Certificate Application Process:
Clinical laboratories and facilities performing clinical laboratory testing must apply for and receive both a state registration or license and a federal CLIA certificate. For exceptions and exemptions to this requirement, please refer to the Regulations and Statutes Enforced by LFS webpage.
Instructions on how to apply for a clinical laboratory registration or license and federal CLIA certificate for waived, provider performed microscopy procedures, moderate or high complexity testing are found on the Laboratory Field Services (LFS) Clinical Laboratory Facilities webpage.
CLIA Federal & State Regulation
CLIA Regulation and Guidance
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).
Regulations and Statutes Enforced by LFS
Regulations and statutes that pertain to LFS regulatory responsibility.