Which statement is true regarding CLIA waived testing?

• A. It requires certification showing the office meets standards to perform POCT.
• B. It requires no certification
• C. It is only for hospitals
• D. It cannot be performed in private practice

Answer: (A)

CLIA waived testing is designed for simple, low-risk tests that can be done outside a full diagnostic lab. To perform these tests, the facility must hold the appropriate CLIA certification—a certificate of waiver. This shows the office meets the minimum standards to perform point-of-care testing and to do so safely, following the test manufacturer’s instructions and basic quality-control practices. Hospitals aren’t the only places that can use waived testing; private practices and clinics can do it too, as long as they have the waiver. The key idea is that some certification is required to perform waived tests, not that certification is unnecessary, and not that waived testing is restricted to hospitals.