Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations and Responsibilities: Ensuring Quality Testing in US Facilities
Summary
- The Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations apply to all U.S. facilities that test human specimens for health assessment or disease diagnosis.
- CDC, in partnership with Centers for Medical and Medicaid Services (CMS) and the Food and Drug Administration (FDA), supports the CLIA program to ensure clinical laboratory quality.
- CLIA Regulations establish federal standards for laboratory testing to ensure the quality and accuracy of results for diagnosis, prevention, or treatment of disease, or assessment of health.
About
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations apply to all U.S. facilities or sites that test human specimens for health or disease assessment. The CDC, in partnership with Centers for Medical and Medicaid Services (CMS) and the Food and Drug Administration (FDA), supports the CLIA program to ensure clinical laboratory quality.
Background
The 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, such as employment-related Drug Testing by SAMSHA certified laboratories, forensic testing for criminal investigations, and research or Surveillance Testing where patient-specific results are not reported.
Responsibilities
The CDC partners with CMS and FDA to support the CLIA program and clinical laboratory quality. CDC’s responsibilities include providing analysis, research, technical assistance, developing standards and guidelines, conducting quality improvement studies, monitoring Proficiency Testing practices, providing professional information and educational resources, and managing the Clinical Laboratory Improvement Advisory Committee (CLIAC).
Laws and Regulations
The Clinical Laboratory Improvement Amendments (42 USC 263a) is an amendment to the Public Health Services Act that revised the federal program for certification and oversight of clinical laboratory testing. CLIA Regulations establish Quality Standards for laboratory testing performed on human specimens and were published in 1992, phased in through 1994, and subsequently amended.
Certificates
Facilities can apply for a CLIA certificate to meet the federal standards for laboratory testing. Information about W-9 forms, certificate status, renewal fees, updating certificate information, Regulations, and state licensure can be obtained from the appropriate state agency.
Training
CDC offers free educational materials for public health and clinical laboratories, including brochures and booklets for waived testing, provider-performed microscopy, individualized Quality Control plans, and training courses available through the Laboratory Training website.
Contacts
For CLIA-related questions, contact LabExcellence@CMS.hhs.gov. For general inquiries, contact CDC-INFO, pay your CLIA laboratory user fee online or by mail, and remember that CDC does not issue CLIA certificates or process fee payments.
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.
