CLIA

The Clinical Laboratory Improvement Amendments regulate all laboratory testing performed on humans in the United States, requiring certification for any facility that performs clinical lab tests.

If your practice performs any kind of laboratory testing, even a simple rapid strep test or a urine dipstick, you need a CLIA certificate. There is no exception for the simplicity of the test or the size of your practice. A solo family medicine doctor who does one rapid flu test per week needs CLIA just like a major reference laboratory. CLIA certificates come in several levels. A Certificate of Waiver covers simple, low-risk tests that are approved for waived testing (like rapid strep, glucose monitoring, urine pregnancy tests, and rapid COVID tests). Most small practices operate under a waiver. A Certificate for Provider-Performed Microscopy covers certain microscopy procedures performed by the provider during a patient visit. Higher-complexity testing requires a Certificate of Registration, Compliance, or Accreditation with much more stringent standards. Your CLIA certificate number appears on credentialing applications and must be included when billing for laboratory services. If you bill for a lab test without a valid CLIA certificate, the claim will be denied and you could face penalties. To get a CLIA certificate, you apply through CMS using form CMS-116. The application asks about the types of tests you perform, your testing volume, and your laboratory director. For a Certificate of Waiver, the process is straightforward and approval typically comes within a few weeks. You will pay a small biennial fee. CLIA certificates must be renewed every two years. Like everything else in credentialing, if you let it lapse, your claims for lab services will be denied and payers may flag it during re-credentialing. Set a reminder six months before expiration. Some states have their own laboratory licensing requirements in addition to federal CLIA. New York, for example, has particularly strict state lab regulations. Check your state requirements before assuming your CLIA certificate is sufficient.