All EMS agencies (i.e. BLS, IALS, ALS, etc.) doing diagnostic testing of human samples, including blood glucose testing, must have a CLIA Waiver. This document provides information on CLIA and explains the process to obtain a CLIA waiver.
As with any FAQ, it is provided as informational materials only and EMS agency legal counsel should be consulted about specific legal requirements. For instance, if your EMS agency is hospital-based, you most likely do not need to obtain a CLIA Waiver, as your hospital will already have a CLIA Certificate, but it may need to be updated to include mobile testing sets (or in other words, ambulances). Any questions, please feel free to contact our office.