Introduction -- Background -- Purpose -- -- Ready? -- Overview -- Prepare for testing -- The Test instructions -- Know how to do the test the right way -- Quality control testing -- -- Set? -- Overview -- Test ordering -- Patient preparation -- Sample collection -- Collection devices -- Sample labeling -- Safety issues -- Biohazardous waste -- Disinfecting work surfaces -- -- Test -- Overview -- Performing the test -- Reading the results -- Resolving problems -- Recording results -- Issuing test reports -- Confirmatory or supplemental testing -- Public health reporting -- Record keeping -- Proficiency testing -- -- Tips, Reminders, and Resources -- Ready? -- Set? -- Test! -- Reminders -- Resources -- Safety links -- -- Appendix A. Temperature Log Instructions -- Appendix B. Common Components of a Manufacturer’s Instructions. -- Appendix C. Quality control log instructions; Instructions for logging or recording results -- Appendix D. Hand hygiene job aid; Blood/body fluid exposure; Glove removal job aid -- Appendix E. Common disinfectants and antiseptics -- Appendix F. Terms and abbreviations.

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