Point-of-Care and CLIA-Waived Tests: QC and Expected Values
Waived tests are simple and low risk, but you still follow the maker's instructions exactly, run controls when required, and report critical values at once.
CLIA waiver basics
- A waived test meets at least one criterion: cleared by FDA for home use; so simple and accurate that errors are unlikely; or no reasonable risk of harm if done wrong (42 CFR 493.15(b)).
- Named in the regulation: dipstick or tablet urinalysis (bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen), fecal occult blood, visual ovulation and urine pregnancy tests, non-automated ESR, copper sulfate hemoglobin, blood glucose by FDA home-use meters, spun microhematocrit, hemoglobin by single-analyte instruments (493.15(c)).
- Other devices (many rapid strep and some PT/INR meters) are waived by FDA categorization; check the FDA CLIA database for the exact device.
- A Certificate of Waiver lab must follow the manufacturer's instructions (493.15(e)); the certificate is valid for no more than 2 years (493.37).
- Any off-label change, such as an unlisted specimen type, turns the test into high-complexity testing not covered by the waiver (CDC).
Preview only. The full sheet also covers: Quality control for waived tests (CDC Ready? Set? Test!); Common POC tests: expected values; Critical values: examples only.
Sources
- 42 CFR 493.15 Laboratories performing waived tests · Electronic Code of Federal Regulations (eCFR), National Archives and U.S. Government Publishing Office
- 42 CFR 493.37 Requirements for a certificate of waiver · Electronic Code of Federal Regulations (eCFR), National Archives and U.S. Government Publishing Office
- CLIA Categorizations · U.S. Food and Drug Administration
- Ready? Set? Test! Patient Testing is Important. Get the Right Results. (2025 edition, with appendices: pretesting checklist, temperature log instructions) · Centers for Disease Control and Prevention
- 6. Glycemic Goals, Hypoglycemia, and Hyperglycemic Crises: Standards of Care in Diabetes-2026. Diabetes Care 2026;49(Suppl 1):S132-S149 (PMC12690178); full text not reachable on 2026-10-26; level 1 (<70 mg/dL) and level 2 (<54 mg/dL) confirmed through the 2026 ADA quotation in Osher and Kost 2026 (PMC13115040) · American Diabetes Association via PubMed Central
- 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2026. Diabetes Care 2026;49(Suppl 1):S27-S49 (PMC12690183); fasting cut point cross-checked 2026-10-26 against the Merck Manual table citing the ADA Standards · American Diabetes Association via PubMed Central
- Hemoglobin A1C (HbA1c) Test (Medical Test) · MedlinePlus, U.S. National Library of Medicine
- Hemoglobin (Medical Encyclopedia) · MedlinePlus, U.S. National Library of Medicine
- Hematocrit (Medical Encyclopedia) · MedlinePlus, U.S. National Library of Medicine
- Urinalysis (Medical Encyclopedia) · MedlinePlus, U.S. National Library of Medicine
- Urine specific gravity test (Medical Encyclopedia) · MedlinePlus, U.S. National Library of Medicine
- Urine pH test (Medical Encyclopedia) · MedlinePlus, U.S. National Library of Medicine
- Prothrombin time (PT) (Medical Encyclopedia) · MedlinePlus, U.S. National Library of Medicine
- Strep A Test (Medical Tests) · MedlinePlus, U.S. National Library of Medicine
- Pregnancy Test (Medical Test) · U.S. National Library of Medicine (MedlinePlus)
- Osher K, Kost GJ. Critical Decision Thresholds for Urgent Physician Notification of Point-of-Care Testing Results. Diagnostics (Basel) 2026;16(8):1139 (PMC13115040): 417 U.S. hospital notification lists · PubMed Central (NIH National Library of Medicine)
- Table: Diagnostic Criteria for Diabetes Mellitus and Prediabetes (FPG normal <100 mg/dL; cites ADA) · Merck & Co., Inc. (Merck Manual Professional Edition)
- Low blood sugar (Medical Encyclopedia; fact-checking only) · MedlinePlus, U.S. National Library of Medicine
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