EMS Point-of-Care Testing

Questions and Answers

1 What is “point-of-care” testing?

Point-of-care testing (POCT) is medical diagnostic testing done in a setting remote from a centralized laboratory facility. These tests are generally simple and can be performed at the bedside. This is in contrast to centralized laboratory facilities that perform a variety of testing in one location that does not perform patient care.

2 Which POCT has been performed in the prehospital environment?

Blood glucose measurement was one of the first prehospital POCTs available. Some EMS systems have used handheld lactate analyzers, particularly with prehospital sepsis protocols. Other blood analyzer systems may be used for many different labs, such as troponin levels, blood gases, coagulation profiles, and electrolytes. These systems are most commonly seen in use by critical care transport or community paramedicine/mobile integrated healthcare programs rather than by 9-1-1 providers.

3 What are Clinical Laboratory Improvement Amendments (CLIA) regulations?

CLIA regulations include federal standards applicable to all US sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. In general terms, the CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid, and tissue, for the purpose of diagnosis, prevention, or treatment of disease or assessment of health. The CLIA program is administered by the Centers for Medicare & Medicaid Services (CMS) and is implemented through three federal agencies—CMS, the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA).

4 Can CLIA requirements be waived?

All facilities in the US that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under CLIA. There are some waived tests that have been cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. CLIA requires that waived tests must be simple and have a low risk for erroneous results.

5 How are POCT and CLIA-waived testing different?

CLIA waiver is a regulatory term and POCT refers to the location where the testing occurs. In other words, POCT means the testing is not happening in a central laboratory, but rather closer to the patient. Some POCTs are waived, whereas others can be designated as moderately complex or highly complex.

6 Which POCT is useful in the prehospital environment?

Certain POCTs, such as glucometry and 12-lead electrocardiograms (EKGs), have clearly been shown in the literature to impact patient outcomes. However, in areas where patients receive rapid response to emergency calls with subsequent rapid transport, the value of POCT is questionable.

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