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To test or not to test? Considerations for waived testing
  • Published Date:
    January 2012
  • Language:
Filetype[PDF-2.21 MB]

  • Corporate Authors:
    Centers for Disease Control and Prevention (U.S.). Office of Surveillance, Epidemiology, and Laboratory Services. Division of Laboratory Science and Standards. Laboratory Science, Policy, and Practice Program Office.
  • Description:
    Introduction -- Overall considerations -- Oversight of testing -- Regulatory requirements -- Location for testing -- Selecting tests -- Testing personnel -- Starting to test -- Quality assurance -- Tips -- Resources -- Appendix A. Example: Safety plan -- Appendix A1. Safety training checklist instructions -- Appendix A2. Incident report instructions -- Appendix B. Security and confidentiality agreement instructions -- Appendix C. Training checklist instructions -- Appendix D. Training evaluation instructions -- Appendix E. Competency and performance assessment instructions -- Appendix F. Procedure contents and tips -- Appendix G. Terms and abbreviations.

    Health care providers use laboratory 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 test systems are waived under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and can be performed without routine regulatory oversight under a Certificate of Waiver from the Centers for Medicare & Medicaid Services (CMS). This booklet describes considerations and preparations needed prior to performing waived testing and may assist those who want to implement and oversee waived testing or offer a new test under a CLIA Certificate of Waiver.

    CDC-INFO Pub ID 221452

  • Supporting Files:
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