10/01/2020: Lab Advisory: CMS Releases New Laboratory Quick Start Guide for CMS CLIA Certification

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

The Centers for Medicare & Medicaid Services (CMS) has released a new Laboratory Quick Start Guide for CMS CLIA Certification. This resource outlines the necessary steps laboratories and testing sites must take in order to receive federal government certification to perform testing on human specimens. Any entity that performs tests for the purpose of providing information about the assessment or impairment of the health of human beings or the  diagnosis, prevention or treatment of any disease is considered to be a laboratory under the Clinical Laboratory Improvement Amendments (CLIA) and must be certified by the CLIA program.

The Quick Start Guide provides direction for these processes:

  • Completing the CLIA application form, CMS-116
  • Finding the appropriate State Agency to submit the form
  • Receiving the fee coupon
  • Paying applicable fees
  • Receiving laboratory certificate and beginning testing
  • Maintaining the certificate

The guide also includes specific information regarding the CLIA Program’s decision to expedite the review process for applications, which helps laboratories and testing sites to begin COVID-19 testing as soon as they meet the applicable CLIA requirements.

For questions, contact LabExcellence@cms.hhs.gov.

Online resources:

If you have any questions, please contact us at LOCS@cdc.gov.

Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)