CLIA Certificate Fee Structure

^{Each CLIA Certificate Cycle Is Typically Two Years (Biennial), And Laboratories Receive Two Separate Fee Coupons During This Period For Different Reasons:}

1. Certificate Fee Coupon (Issued at Renewal or Initial Application):

• This is the standard fee for obtaining or renewing a CLIA certificate.
• It covers administrative costs and helps fund CLIA compliance monitoring.
• The amount varies depending on the certificate type, number of specialties, and annual test volume.

2. Compliance/Inspection Fee Coupon (For Moderate & High Complexity Labs):

• This is an additional fee required for labs performing non-waived (moderate or high complexity) testing, such Mycology, Parasitology, Virology, Mohs and Routine Pathology.
• It helps cover costs related to on-site inspections, compliance assessments, and regulatory enforcement.
• Certificate of Waiver and PPM labs do not receive this fee coupon because they are not subject to routine inspections.

Summary:

• Labs with waived tests or PPM receive only 1 fee coupon per cycle.
• Moderate & high complexity labs receive 2 fee coupons per cycle—one for certification and one for compliance/inspection.
• Payment of both fees is required to maintain CLIA certification and regulatory compliance.

CLIA Certificate Types

The fee coupons a laboratory receives depend on its CLIA certificate type. CLIA recognizes several certificate types, including the Certificate of Waiver for laboratories performing only waived testing, the Certificate of Compliance for laboratories undergoing routine CMS or state inspections, and the Certificate of Accreditation for laboratories inspected through an approved accrediting organization such as CAP or COLA instead of direct CMS inspection.

Knowing your certificate type is the first step in understanding your CLIA certificate cost, fees, and payment schedule.

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