COVID-19: Information for Laboratories

This page provides information about regulatory issues related to SARS-CoV-2 and COVID-19 for clinical and public health laboratories.

COVID-19 Testing Notification: The Department of Public Health requires ALL California licensed laboratories currently testing for COVID-19 to notify us. This includes clinics and sites conducting only waived tests. The Department needs information about California laboratories currently testing for COVID-19. You must fill out this notification form to submit your laboratory’s information.

Introduction

The United States is responding to an outbreak of respiratory disease caused by coronavirus disease that was first detected in China and which has now been detected in more than 190 countries internationally, and all 50 States, the District of Columbia, and the U.S. territories. The virus has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2”) and the disease it causes has been named “coronavirus disease 2019” (“COVID-19”).

California is actively working with the White House, federal Centers for Disease Control and Prevention (CDC), local governments and health jurisdictions, health facilities, and health care providers across the state to protect Californians from COVID-19.

The California Department of Public Health (CDPH) is providing information, guidance documents, and technical support to local health departments, health care facilities, providers, schools, universities, colleges, and childcare facilities across California.

For general information about Coronavirus Disease 2019 (COVID-19), please visit the CDPH Division of Communicable Disease Control's webpage and the California COVID-19 webpage, where you can find daily updates with information about COVID-19, including numbers in California, news releases and updates, and guidelines for the general public.

The California Testing Task Force webpage provides information about testing, including how to locate a testing center and technical information about testing, as well as a dashboard with testing data.

Unfortunately, scammers are operating unauthorized fake COVID-19 testing sites. Visit the California Attorney General’s website and the Federal Trade Commission website for information and tips. Any facility where clinical testing (including COVID testing) is performed is considered under federal and state law to be a clinical laboratory, and is required to have both California state licensure and federal CLIA certification to perform tests in California. To verify a laboratory’s state licensure, check the LFS laboratory facility licensure verification webpage. Federal CLIA certification can be verified on the Centers for Medicare & Medicaid Services (CMS) website under the “demographic look-up” tab. You can also email LFSCOVID@cdph.ca.gov for further questions about licensure.

• CALREDIE - Important Information for Laboratories
  Important information for laboratories about California's mandatory reporting system for COVID-19.

• Division of Communicable Disease Control – Reportable Diseases and Conditions
  Important updates about COVID-19 reporting requirements for laboratories and health care providers.

• CAMLT: California Needs Your Help with COVID-19 Testing
  California labs are in need of qualified personnel to help with testing for SARS-CoV-2. If you meet the federal CLIA requirements for high-complexity testing and would like to help, please visit this page sponsored by the California Association for Medical Laboratory Technology (CAMLT) to find a list of laboratories that need testing personnel.

• State of California COVID-19 Medical Contributions
  Please visit this website if you want to contribute resources, either for donation or purchase, to support California's response to COVID-19

• FDA Fraudulent Coronavirus Disease 2019 (COVID-19) Products
  The U.S. Food and Drug Administration is issuing warning letters to firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure coronavirus disease 2019 (COVID-19).

• FDA Coronavirus (COVID-19) Guidance Update
  On March 16, 2020, the FDA issued an update to its Coronavirus (COVID-19) guidance to provide more regulatory relief and help expedite the availability of diagnostic testing.

• Executive Order N-39-20 regarding COVID-19 (PDF)
  On March 30, 2020,  Governor Newsom signed an executive order allowing the Department of Consumer Affairs to waive some requirements for licensure. This order does not affect clinical laboratory licenses.

• Executive Order N-25-20 regarding COVID-19 (PDF)
  On March 12, 2020, Governor Newsom signed an executive order regarding COVID-19. Please see section 9 regarding a change to licensure requirements for clinical and public health laboratory testing personnel. For the duration of the COVID-1 emergency, people may perform high-complexity SARS-CoV-2 testing if they meet CLIA requirements for high-complexity testing personnel. Please contact LFS at LFScovid@cdph.ca.gov or LFSscientist@cdph.ca.gov if you have questions about this section.

• CDPH DCDC Guidance Documents: Coronavirus Disease 2019 (COVID-19)
  Provides guidance documents with information about specific situations (health care facilities, schools, event organizers, first responders, employers, and health care plans