Return to Search Guidance for Medicare clinical laboratories regarding the Clinical Laboratory Improvement Amendments (CLIA) establishing quality standards for all laboratories testing to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the test was performed. Final Issued
by: Centers for Medicare & Medicaid Services (CMS) Issue Date: March 05, 2012 Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratories testing to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the test was performed. The CLIA regulations are based on the complexity of the test method; thus, the more complicated the
test, the more stringent the requirements. State Survey Agencies, under agreements between the State and the Secretary, carry out the Medicare certification process. The State Survey Agency is also authorized to set and enforce standards for CLIA and Medicaid. (The State Survey Agency may partially re-delegate the functions to local agencies.) HHS is committed to making its websites and documents accessible to the widest possible audience,
including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the . DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.
. 1992 Feb 28;41(RR-2):1-17.
Free article Regulations for implementing the Clinical Laboratory Improvement Amendments of 1988: a summaryNo authors listed. MMWR Recomm Rep. 1992. Free article Erratum in
AbstractIn 1988, Congress passed the Clinical Laboratory Improvement Amendments (CLIA), which set standards to improve the quality of clinical laboratory testing in all laboratories in the nation that conduct testing on human specimens for health assessment or for the diagnosis, prevention, or treatment of disease. This report summarizes the final regulations for implementing CLIA and provides an overview of each section, specifying laboratory standards and requirements. Similar articles
Cited by
MeSH termsLinkOut - more resources
What is the purpose of CLIA?The Clinical Laboratory Improvement Amendments (CLIA) Program regulates labs testing human specimens and ensures they provide accurate, reliable, and timely patient test results no matter where the test is done. CMS oversees all lab testing (except some research) done on humans in the U.S. through CLIA.
In what year was the Clinical Laboratory Improvement Amendments passed?The Clinical Laboratory Improvement Amendments of 1988 statute is an amendment to the Public Health Services Act in which Congress revised the federal program for certification and oversight of clinical laboratory testing. Two subsequent amendments were made after 1988.
Which is a CLIA test?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.
What are the three categories of testing under CLIA?The FDA categorizes diagnostic tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests.
|