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Ready Set Test Booklet

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).

a test system in a way other than that described in the intended use, precautions, limitations, or other sections of the manufacturer’s instructions (See Appendix B for an explanation of the common components found in a manufacturer’s instructions). The modified use of a test system

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