10/01/2020: Lab Advisory: CMS Releases New Laboratory Quick Start Guide for CMS CLIA Certification
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 Certificationpdf iconexternal icon. This resource outlines the necessary steps laboratories and testing sites must take in order to receive federal government certificationexternal icon 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-116pdf iconexternal icon
- Finding the appropriate State Agencypdf iconexternal icon 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.
- Clinical Laboratory Improvement Amendments (CLIA)
- Frequently Asked Questions about Coronavirus for Laboratories
- COVID-19 Information for Laboratories
- CDC COVID-19 website
- Clinical Laboratory COVID-19 Response Calls
- CDC Laboratory Outreach Communication System (LOCS)
- Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign up
If you have any questions, please contact us at LOCS@cdc.gov.
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)