It is important to first differentiate between the terms point-of-care testing (POCT) and waived testing, which is instrumental for the proper application of regulations to ensure compliance with state and federal requirements and accreditation regulations.
Point-of-care testing (POCT)
POCT is an analysis or test that employs an analytical method and is used in a diagnostic setting that is remote from a centralized laboratory facility. Centralized laboratory facilities perform a compilation of laboratory testing methods in one location that does not perform patient care. Examples include core or central laboratories in clinics or hospitals or any other laboratory testing facility, such as a research laboratory, that does not perform patient care.
Locations for POCT include, but are not limited to, the patient bedside, a remote clinic, in a satellite laboratory versus the central laboratory, imaging department, or emergency department.
POCT is designed for decreased turnaround time and increased efficiency in achieving direct reporting to the treating healthcare provider and the patient's medical record. Examples of POCT include, but are not limited to:
- Glucometers for measuring blood sugar
- Handheld chemistry analyzers to perform tests such as creatinine, electrolytes, hemoglobin, troponin, cardiac enzymes, and blood gases
- Dipsticks for urine chemistry testing
- Testing strips for vaginal pH
- Refractometers for measuring specific gravity
Waived testing is laboratory testing that employs specific test methods designated under the Clinical Laboratory Improvement Amendments (CLIA) of the Food and Drug Administration (FDA) as "waived." Waived testing is designated by CLIA as simple tests that carry a low risk for an incorrect result. Waived tests include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA, using the CLIA criteria.
Sites performing only waived testing must have a CLIA certificate of waiver (COW) and follow the manufacturer’s instructions; other CLIA requirements do not apply to these sites.
POCT: Waived versus non-waived
For differentiation, POCT may be waived or non-waived. Waived testing may be performed at the POC or in a centralized facility. Non-waived testing is subcategorized as moderately complex and highly complex. The majority of non-waived POCT is moderately complex. The facility must be diligent regarding adherence to the manufacturer's operating/testing instructions. Regardless of CLIA classification, methods operated outside of manufacturer's recommendations become highly complex and must function under those federal, state, and applicable accreditation regulations and guidelines. POCT that is non-waived must follow all regulations for non-waived testing and have the appropriate CLIA certificate for compliance.