Breath Analyzer Testing

Our facility performs breath analyzer tests for our occupational medicine program.  Would this test be considered waived testing and if so, would all the inherent documentation, competency, etc., associated with waived testing, also be required?


On February 28, 1992, regulations were published to implement CLIA. In the regulations, waived tests were defined as simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.
The specified tests that are listed in the regulation are:

  1. Dipstick or Tablet reagent urinalysis (non automated) for the following:
    • Bilirubin
    • Glucose
    • Hemoglobin
    • Ketones
    • Leukocytes
    • Nitrite
    • pH
    • Protein
    • Specific gravity
    • Urobilinogen
  2. Fecal occult blood
  3. Ovulation tests – visual color comparison tests for luteinizing hormone
  4. Urine pregnancy tests – visual color comparison tests
  5. Erythrocyte sedimentation rate-non-automated
  6. Hemoglobin-copper sulfate – non-automated
  7. Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use
  8. Spun microhematocrit
  9. Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout

A list of Tests Granted Waived Status under CLIA can be found at  http://www.cms.hhs.gov/CLIA/downloads/waivetbl.pdf

Best practice dictates that staff conducting theses tests should be trained and competency assessed.  This would also fall under Joint Commission standard HR.01.06.01; Staff are competent to perform their responsibilities.

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