Q. I am a physician who performs urine dip sticks and finger sticks for blood glucose in my office as part of the patient’s visit. Am I considered to have a laboratory, and do I need a CLIA certificate?
A. Yes, the testing you perform qualifies as waived laboratory testing, and you need a CLIA Certificate of Waiver. This testing requires a CLIA certificate regardless of how many tests you perform and even if you do not charge the patient or bill Medicare or other insurances. The Food and Drug Administration (FDA) determines which tests are waived tests (i.e., simple with a low risk of error) and thus fall under the purview of the certificate. You can view the list of waived tests:
More information is available here:
Revised Oct. 28, 2013
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