Clinical Laboratory Improvement Amendments (CLIA) | CMS

Clinical Laboratory Improvement Amendments (CLIA) | CMS Clinical Laboratory Improvement Amendments (CLIA) Spotlight CLIA transitioned to a paperless system. We no longer mail CLIA certificates or paper fee coupons. Additionally, all CLIA certification and survey fees must be paid online (payments by paper check are no longer accepted). Laboratories must have a valid email address on file to receive electronic CLIA certificates*, fee coupons*, and other CMS communications. This does not apply to CLIA exempt states or state licensure. Tip : Use a business email address, or one that many staffers can access and use. Need help? Contact your State Agency or Accreditation Organization to update your email. Refer to the FAQs about the Transition to Paperless , which provide key information to support your laboratory following the transition. Online Laboratories must pay their CLIA certification and survey fees online though pay.gov , a secure platform hosted by the U.S. Treasury Department. Get Online Payment Info (PDF) Apply for CLIA Certification Use the Certification Quick Start Guide to help you complete the CMS-116 application About CLIA 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) program. The objective of CLIA is to ensure quality laboratory testing. In 1988, Congress passed CLIA regulations to establish quality standards for all testing laboratories to ensure that all patient test results are: Accurate Reliable Timely CLIA regulations are based on the complexity of the test method. The more complicated the test, the more stringent the requirements. More information about laboratory test categorization and complexity CLIA covers approximately 320,000 laboratory entities. State Survey Agencies are authorized to set and enforce CLIA standards. Although all laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities. Contact your State Agency about: CLIA fees or payment CMS-116 applications Demographic updates Certificate status or upgrades Laboratory Director changes Filing a complaint For other questions about the CLIA program, email us at LabExcellence@cms.hhs.gov Resources for You Apply for a CLIA Certificate Information about the application process and forms you need to submit Get Certified CLIA Brochures Helpful resources to learn about CLIA and laboratory requirements Downloads CLIA Cert Quick Start Guide (PDF) BD BACTEC™ Blood Culture Media Bottle Shortage, Frequently Asked Questions (FAQs) -August 29, 2024 (PDF) CLIA Post-PHE Guidance FAQs Only (PDF) CLIA of 1988 Proficiency Testing Regulations Related to Analytes and Acceptable Performance (CMS-3355-F) FAQ Sheet 7/7/2022 (PDF) LDT and CLIA FAQs 10/22/2013 (PDF) Research Testing and CLIA 12/10/2014 (PDF) Direct Access Testing 03/22/2019 (PDF) Live Blood Cell Analysis Under CLIA 03/17/2017 (PDF) Form W-9 2026 (PDF) Related Links CLIA Fee, Histocompatibility, Personnel, Alternative Sanction, CMS-3326-F, Final Rule, 12/28/2023 How Laboratorians Can Safely Calculate Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening Devices 08/05/2015 CDC PPMP - A Focus on Quality Practices Booklet CDC Division of Laboratory Systems Clinical Laboratory Fee Schedule Page Last Modified: 03/10/2026 11:46 PM Help with File Formats and Plug-Ins