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.

Fee Schedule

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.

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, you must comply with all current federal and state disease reporting requirements. Failure to report may result in enforcement action.

Last Updated: April 4, 2024