Waived Testing and Point-of-Care Testing
What this domain tests
Waived and point-of-care testing (POCT) questions test whether low-complexity testing is outside CLIA (it is not) and how sites maintain quality when testing moves to the patient's side.
Core rules
- Waived tests are FDA-cleared for home use or simple enough that erroneous results are unlikely to harm the patient. The site still needs a certificate of waiver, must follow the manufacturer's instructions, and must permit inspection.
- Provider-performed microscopy (PPM) is a separate certificate for certain microscopic exams by qualified practitioners.
- POCT sites must use the correct CLIA certificate for the test complexity; adding a moderate-complexity test to a waiver site requires a different certificate.
- Training, storage, expiration dating, QC as required by the manufacturer, and documentation are expected quality practices.
Worked example
A nursing home uses a waived glucose meter. The staff does not check control solutions because 'the meter is waived.' Reasoning: waived status does not eliminate manufacturer QC instructions. If the manufacturer requires control testing, the site must perform and document it; otherwise patient glucose results lack the required quality check. The site also must have a CLIA waiver certificate for the testing.
Traps
Thinking waived means no certificate or no oversight. Ignoring manufacturer instructions. Using an expired reagent. Performing a non-waived test under a waiver. Failing to document POCT training and QC.