Ensuring Compliance with CLIA Regulations for Clinical Laboratories and Facilities
Summary
- The Clinical Laboratory Improvement Amendments (CLIA) section of Laboratory Field Services ensures compliance with State and federal clinical laboratory laws and Regulations by conducting inspections and reviewing Proficiency Testing results.
- The CLIA program performs routine inspections of over 800 laboratories and validations of 36 accredited facilities each year, as well as inspections of over 200 laboratories with a CLIA certificate of waiver annually.
- Clinical laboratories and facilities performing clinical laboratory testing must apply for and receive both a state registration or license and a federal CLIA certificate. Instructions for the application process can be found on the Laboratory Field Services website.
CLIA Certificate Application Process
Clinical laboratories and facilities that perform clinical laboratory testing on human specimens are required to be certified by the federal government under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The Los Angeles LFS Office manages the CLIA program and ensures compliance with State and federal laws and Regulations.
The CLIA program conducts biannual onsite inspections of laboratories to ensure the accuracy and reliability of Test Results. They also review Proficiency Testing results to maintain Quality Standards in laboratory testing.
- The CLIA program performs routine inspections of over 800 laboratories and validations of 36 accredited facilities each year.
- The program is responsible for inspecting over 200 laboratories with a CLIA certificate of waiver annually.
To contact the Los Angeles LFS Office for inquiries related to CLIA certification, you can call (213) 620-6160.
Resources
Clinical laboratories and facilities performing clinical laboratory testing must apply for and receive both a state registration or license and a federal CLIA certificate. Exceptions and exemptions to this requirement can be found on 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 available on the Laboratory Field Services (LFS) Clinical Laboratory Facilities webpage.
CLIA Federal & State Regulation
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 that pertain to LFS regulatory responsibility can be found on the LFS website, providing guidance on compliance with State and federal clinical laboratory laws and Regulations.
Disclaimer: The content provided on this blog is for informational purposes only, reflecting the personal opinions and insights of the author(s) on the topics. The information provided should not be used for diagnosing or treating a health problem or disease, and those seeking personal medical advice should consult with a licensed physician. Always seek the advice of your doctor or other qualified health provider regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. If you think you may have a medical emergency, call 911 or go to the nearest emergency room immediately. No physician-patient relationship is created by this web site or its use. No contributors to this web site make any representations, express or implied, with respect to the information provided herein or to its use. While we strive to share accurate and up-to-date information, we cannot guarantee the completeness, reliability, or accuracy of the content. The blog may also include links to external websites and resources for the convenience of our readers. Please note that linking to other sites does not imply endorsement of their content, practices, or services by us. Readers should use their discretion and judgment while exploring any external links and resources mentioned on this blog.
