To test or not to test? Considerations for waived testing [Spanish]

Health 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). Waived tests include test systems cleared by the Food and Drug Administration (FDA) for home use and those tests approved for waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) criteria. The FDA list of waived tests is continuously being revised as new tests are waived. The most current information on FDA cleared waived tests can be found at the following website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm CLIA requires that waived tests must be simple and have a low risk for an incorrect result. However, this does not mean waived tests are completely error-proof. To decrease the likelihood of incorrect results, waived testing needs to be performed correctly, by trained personnel and in an environment where good testing practices are followed. This booklet describes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a CLIA Certificate of Waiver. CS255581-A 15_255581-A_Stang_RST_Booklet_508Final.pdf

Stephen B. Thacker CDC Library collection