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New Tests Waived Under CLIA

New Tests Waived Under CLIA

New Tests Waived Under CLIA

The latest waived tests under CLIA, the Clinical Laboratory Improvement Amendments of 1988

Courtesy of the National Association for Home Care & Hospice

Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA (Clinical Laboratory Improvement Amendments of 1988). 

  • 80305QW, August 25, 2020, Verify Diagnostics Inc. VeriCheck Drug Test Cup; 
  • 80305QW, August 25, 2020, Verify Diagnostics Inc. VeriCheck Drug Test Dip; 
  • 80305QW, September 23, 2020, Axium BioResearchInc.DrugExam Multi-Drug Screen Test;
  • 80305QW, October 9, 2020, American Screening LLC Discover Panel Dip Card Tests MOR 300; 
  • 80305QW, October 9, 2020, American Screening LLC Discover Quick Cup Tests MOR 300;
  • 80305QW, October 9, 2020, American Screening LLC Discover Quick Cup Tests MOR 2000; 
  • 80305QW, October 9, 2020, American Screening LLC Discover Plus Panel Dip Card Tests MOR 300; 
  • 80305QW, October 9, 2020, American Screening LLC Discover Plus Panel Dip Card Tests MOR 2000; 
  • 80305QW, October 9, 2020, American Screening LLC Discover Plus Quick Cup Tests MOR 300; 
  • 80305QW, October 9, 2020, American Screening LLC Discover Plus Quick Cup Tests MOR 2000; 
  • 80305QW, October 9, 2020, American Screening LLC OneScreen Plus Quick Cup Tests MOR300 
  • 80305QW, October 9, 2020, American Screening LLC OneScreen Plus Quick Cup Tests MOR2000;
  • 80305QW, October 9, 2020, American Screening LLC Reveal Panel Dip Card Tests MOR2000; 
  • 80305QW, October 9, 2020, American Screening LLC Reveal Quick Cup Tests MOR300; and 
  • 80305QW, October 9, 2020, American Screening LLC Reveal Quick Cup Tests MOR2000.

Some home health agencies perform tests that are considered waived under the CLIA, which requires the home health agency or hospice to have a CLIA Certificate of Waiver. Waived tests a home health agency may perform include, but are not limited to:

  • Blood glucose by glucose monitoring devices cleared by the FDA for home use;
  • Prothrombin time home tests (PT/INR);
  • Dipstick or tablet reagent urinalysis; and
  • Flu test.

Performing these types of tests, and any included in the Tests Granted Waived Status Under CLIA table, requires the agency to have a current CLIA certificate of waiver. An agency that obtains a sample and takes it to a laboratory for testing is not required to hold a CLIA certificate of waiver for that particular test (i.e., PT/INR) where the agency’s personnel obtain a blood sample from the patient and take that sample to a laboratory for testing.

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