Diagnostic Testing & Laboratories

Under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), the Office of Licensure and Certification evaluates laboratories--including physicians offices, hospitals, and nursing homes--that perform diagnostic testing on human specimens. CLIA requirements also apply to laboratories seeking payment under the Medicare and Medicaid programs. There are over 6,850 federally certified CLIA laboratories in Virginia.

CLIA applications must be submitted by postal mail with an original director signature:

Office of Licensure and Certification
Division of Acute Care Services
ATTN: CLIA Program
9960 Mayland Drive, Suite 401
Henrico, VA 23233

CLIA inquiries and questions may be sent to clialab@vdh.virginia.gov.

Frequently Asked Questions

NEW: Does my workplace need a CLIA certificate to test employees for COVID-19?

Yes. In an effort to provide support to workplaces who may be doing COVID-19 testing, the U.S. Centers for Medicare and Medicaid Services (CMS) has prepared materials to outline the simple steps necessary to do this. Generally, a CLIA certificate of waiver is necessary for a workplace to do testing.  For information regarding CLIA requirements and the application process for workplace COVID-19 testing, please see the Quick Start Guide for COVID-19 Testing in the Workplace and the Workplace COVID-19 Testing Fact Sheet.

Please note: CMS is temporarily exercising enforcement discretion and allowing employers to start waived SARS-CoV-2 Point of Care testing after a facility has submitted a CMS-116 application.

NEW: Do I need a CLIA certificate if I am conducting diagnostic testing for COVID-19?

Yes, you are required to obtain a CLIA certificate if you are conducting diagnostic testing for COVID-19. If you are only collecting specimens and not conducting any diagnostic test, a CLIA certificate is not required.

Please be advised that if you are conducting COVID-19 diagnostic testing, the U.S. Centers for Disease Control and Prevention require you to report both the positive and negative results of COVID-19 diagnostic and screening tests. This includes data for all diagnostic and screening testing completed, which includes molecular, antigen, and antibody testing for each individual tested. These data must be reported daily, within 24 hours of test completion. Failure to report may result in enforcement action.