Ready? Set? Test! : Patient Testing is Important. Get the Right Results.

Details

• Description:
  Healthcare providers use test results to diagnose disease, determine prognosis, and monitor a patient’s treatment or health status.
  
  In current practice, medical decisions are increasingly made based on the results of simple tests conducted close to the site of patient care where treatment is provided. Many of these point-of-care tests are “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 approved for waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) criteria. The FDA list of waived tests is continually revised as new tests are waived. The most current information on FDA-cleared waived tests can be found here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm
  
  This booklet describes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a CLIA Certificate of Waiver.
  
  CLIA requires waived tests to be simple and have a low risk of an incorrect result. While no test is completely error-proof, you can greatly reduce the likelihood of incorrect waived test results by cultivating an environment where trained personnel follow good testing practices.
  
  ReadySetTest_2024_Final.pdf
  
  
• Subjects:
  Clinical Laboratory Techniques/standards Laboratories/standards Medical Laboratory Science/standards United States. Clinical Laboratory Improvement Amendments Of 1988
• Document Type:
  Book
• Pages in Document:
  58 numbered pages
• Collection(s):
  Stephen B. Thacker CDC Library
• Main Document Checksum:
  urn:sha256:e04d3314dd99aa7ce62143c231cd418b7aae76e9c7bf6b3652af5c899b2a8237
• Download URL:
  https://stacks.cdc.gov/view/cdc/157843/cdc_157843_DS1.pdf
• File Type:
  [PDF - 7.69 MB ]