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).
The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are as follows:
- 81003QW, September 23, 2021. Teco Diagnostics Inc. Uritek TC-201 Urine Chemistry Test System;
- October 7. 2021, Cardinal Health Strep A Dipstick – Rapid Test;
- 80048QW, October 20, 2021, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Basic Metabolic Panel Reagent Disc} (Whole Blood);
- 80053QW, October 20, 2021, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Comprehensive Metabolic Panel Reagent Disc} (Whole Blood);
- 80051QW, October 20, 2021, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Electrolyte Panel Reagent Disc} (Whole Blood);
- 82374QW, 82435QW, 82550QW, 82565QW, 82947QW, 84132QW, 84295QW and 84520QW, October 20, 2021, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood);
- 80069QW, October 20, 2021, Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel Reagent Disc} (Whole Blood);
- 80048QW, October 20, 2021, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Basic Metabolic Panel Reagent Disc} (Whole Blood);
- 80053QW, October 20, 2021, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Comprehensive Metabolic Panel Reagent Disc} (Whole Blood);
- 80051QW, October 20, 2021, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Electrolyte Panel Reagent Disc} (Whole Blood);
- 82374QW, 82435QW, 82550QW, 82565QW, 82947QW, 84132QW, 84295QW and 84520QW, October 20, 2021, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood);
- 80069QW, October 20, 2021, Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel Reagent Disc} (Whole Blood); and
- 87880QW, November 10, 2021, Cardinal Health H. Pylori Rapid Test – Whole Blood/Serum Cassette (Whole Blood).
Some home health and hospice 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 or hospice 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
- Flu test
- Drug 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.
