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).

2025年1月7日 · Brochures to help explain the Clinical Laboratory Improvement Amendments (CLIA) regulation requirements are listed below in the Downloads Section.

2024年9月10日 · 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.

2024年9月11日 · 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.

2024年9月11日 · Clinical laboratory test systems are assigned a moderate or high complexity category on the basis of seven criteria given in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations.

Through the Clinical Laboratory Improvement Amendments (CLIA) Program, CMS regulates all lab testing (with some specific exceptions and state exemptions) done on humans in the U.S. to ensure accurate, reliable, and timely patient test results.

This part sets forth the conditions that all laboratories must meet to be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

2025年1月9日 · The final rule increased CLIA’s fees, changed provisions concerning alternative sanctions, amended histocompatibility requirements, and (most importantly) adopted new laboratory testing personnel requirements.

2017年6月16日 · The final rule is issued jointly by three agencies within HHS: the Centers for Medicare & Medicaid Services (CMS), which is generally responsible for laboratory regulation under CLIA, the Centers for Disease Control and Prevention (CDC), which provides scientific and technical advice to CMS related to CLIA, and the Office for Civil Rights (OCR ...

Complete the Application for Certification Form (CMS-116) (PDF), unless you're: A New York state non-physician office laboratory applicant. Email or call the New York State Department of Health at (518) 485-5378 for guidance. A Washington state applicant. Email or call the Washington State Agency at 253-395-6746 for guidance.