Waived and Point-of-Care Laboratory Testing
Waived testing is simple, not unregulated
CLIA categorizes tests by complexity; waived tests are those cleared by the FDA for use by untrained operators, but the laboratory must still follow the manufacturer's instructions exactly, perform quality control, and maintain records. Point-of-care testing includes glucose, urine dipsticks, pregnancy hCG, rapid strep, and INR devices.
Before testing, verify the patient with two identifiers, check the test strip or device expiration and storage, and confirm the meter or analyzer is within calibration and that controls are in range. Run at least two levels of external controls-a normal and an abnormal-at the frequency the package insert and your policy require, including with each new lot and after maintenance. Record lot numbers, control values, operator, and time.
Common pitfalls: glucose results altered by unwashed hands (fruit sugar) or by extreme hematocrit; urine dipstick pads read after the stated time (false positives) or too early (false negatives); pregnancy tests with dilute urine; rapid strep with poor swab technique. When results are unexpected, repeat with a fresh sample and a new device before reporting.
Traps: assuming waived means no QC, using expired reagents, or failing to document competency assessment. Any critical or inconsistent result should be verified and reported per policy, with the nurse or provider notified and the notification documented.