What is required before performing a CLIA waived test?

What is required before performing a CLIA waived test?

• A. Medical director's certificate
• B. Patient consent
• C. Insurance pre-authorization
• D. A CLIA waived certification stating that your office meets all the standards to perform POCT.

Answer: (D)

CLIA certification is required to perform any clinical laboratory testing, and for tests that are waived, the facility must have a Certificate of Waiver. This certificate confirms the office is approved to conduct point-of-care (waived) testing and meets the basic quality standards. Without this certification, performing waived tests isn’t permitted. The other options—patient consent, a medical director’s certificate, or insurance pre-authorization—do not grant authorization to conduct CLIA‑waived testing.

CLIA certification is required to perform any clinical laboratory testing, and for tests that are waived, the facility must have a Certificate of Waiver. This certificate confirms the office is approved to conduct point-of-care (waived) testing and meets the basic quality standards. Without this certification, performing waived tests isn’t permitted. The other options—patient consent, a medical director’s certificate, or insurance pre-authorization—do not grant authorization to conduct CLIA‑waived testing.