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Filetype[PDF-2.43 MB]

  • English

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      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:

      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. Although not routinely done, the Centers for Medicare & Medicaid Services (CMS) will inspect waived testing sites under certain circumstances such as: if a complaint is made, to determine if the testing site is performing tests not permitted with a certificate of waiver, if there is risk of harm to a patient due to inaccurate testing, and to collect information about waived tests.

      This booklet describes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a CLIA Certificate of Waiver.


      CDC-INFO Pub ID 221451

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