CLIA Waiver Certificate Information
Skilled nursing facilities/nursing facilities (SNFs/NFs) must have a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver to perform COVID-19 testing to be used in point-of-care or waived settings. This applies to the test models (Quidel Sophia2 and BD) being sent to all nursing homes to test residents and staff. VHCA-VCAL sent an email to each facility that we were advised did not have a certificate on record. For all other nursing facilities, we encourage you to locate the record of your CLIA certificate or request a copy from VDH Office of Licensure and Certification (OLC).
Currently, 92 percent of SNFs have a CLIA certificate. To request a copy of your CLIA certificate from OLC, use the following contact information:
Virginia Department of Health
Office of Licensure and Certification
9960 Mayland Drive, Suite 401
Richmond, VA 23233
(804) 367-2107
FAX: (804) 527-4504
Email: CLIAlab@vdh.virginia.gov
Under CLIA, facilities are prohibited from testing any human specimens for the purpose of diagnosis, prevention, treatment, or health assessment without a valid CLIA certificate. To become CLIA-certified, laboratories must comply with the accuracy, quality, and reliability requirements as dictated by the statute. The purpose of these requirements is to ensure the information that patients or their health care providers receive from a clinical laboratory is accurate and reliable. Laboratories that wish to become CLIA-certified must apply for a CLIA Certificate.
Please review the following FAQ about CLIA waivers provided by the CMS CLIA team:
- Q: Do I need to amend my CLIA certificate/waiver to add COVID?
A: No, you do not need to amend your CLIA Certificate of Waiver to add COVID-19 testing to your test menu. If your facility already holds a CLIA Certificate of Waiver it can begin performing COVID-19 testing that has been authorized by the FDA for use in Point of Care or waived settings.
- Q: The FDA waiver list does not list POS AG test for Quidel or BD; are they waived tests?
A: Yes, they are authorized to be performed in CLIA Certificate of Waiver laboratories. Here are the links for the Quidel and BD assays. The FDA letter of authorization states, “This test is authorized for use at the Point of Care, i.e., in patient care settings operating under a CLIA Certificate of Waiver.”
- Q: If I have a CMS CLIA certificate/waiver can I use these COVID tests per manufacturer recommendations?
A: If your facility is CLIA-certified and already holds a CLIA Certificate of Waiver it can begin performing COVID-19 testing that has been authorized by the FDA for use in Point of Care or waived settings. Virginia does not have any additional requirements for CLIA waiver status.
