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READY? SET? TEST!

Get the right TESTINGIS TESTINGIS TESTINGIS ! TEST! TEST! READY? READY? ready ? Division of Laboratory SystemsCenter for Surveillance, Epidemiology, and Laboratory Services CS255581-AIntroduction iiiIntroductionBackgroundHealth care providers use test results to diagnose disease, determine prognosis, and monitor a patient s treatment or health status. Current practice shows an increased trend for medical decisions based on simple tests performed at the point of care. Many of these tests are called waived tests and can be performed without routine regulatory oversight under a Certificate of Waiver from the Centers for Medicare & Medicaid Services (CMS).

Using a waived blood glucose monitoring system to test a patient whose hematocrit or oxygenation level is above or below the range indicated in the manufacturer’s instructions would be an “off-label use” of this system. Results of blood glucose testing in this situation may lead to clinical interventions that could cause patient harm.

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