Here’s a pop quiz for you: If you or your practice performs urine dip sticks and finger sticks for blood glucose as part of a patient visit, are you considered to have a laboratory?
If you answered yes, give yourself a gold star because you are correct.
But did you know that because the testing you perform qualifies as waived laboratory testing (i.e., simple with a low risk of error), you need to obtain a Clinical Laboratory Improvement Amendment (CLIA) certificate?
That’s correct. The Food and Drug Administration (FDA) determines which tests are waived tests for this type of certificate, and the Centers for Medicare & Medicaid Services (CMS), the enforcing agency for CLIA, issues five types of certificates, depending on the complexity and range of testing a lab performs.
To find out where a test falls on the complexity scale, see the FDA database of tests, categorized by the Centers for Disease Control and Prevention. You can find the certificate application form on the CMS CLIA page.
But which type of certificate does your practice need and how can you obtain one?
To help answer that question and more, the Texas Medical Association has published a Practice Well podcast on obtaining a the correct CLIA certificate.
In this free quick-tip episode, TMA practice management and reimbursement manager Carra Benson also discusses the consequences of noncompliance and provides billing and documentation tips.
Find more Practice Well podcasts online. And check out other Practice Management courses – many of which are free for TMA members and are accredited for CME – in the TMA Education Center.
Last Updated On
October 07, 2022
Originally Published On
October 17, 2012