CLIA Certificate

Key facts

Legal basis

Clinical Laboratory Improvement Amendments of 1988; 42 CFR Part 493

Issued by

CMS, with state survey agencies handling applications and surveys

Certificate types

Waiver, PPM, Registration, Compliance, Accreditation

CLIA number format

10 characters: two-digit state code, the letter D, seven digits

Validity

Two years, then renewal

What is a CLIA certificate?

Every facility that tests human specimens to diagnose, prevent or treat disease or assess health must hold a CLIA certificate, unless it performs only research testing or operates under the CLIA-exempt state programs of New York or Washington. A certificate generally covers one physical location, with limited exceptions such as mobile units and certain temporary testing sites.

Each certificate carries a unique CLIA number. Medicare requires the CLIA number on claims for laboratory services and denies tests that fall outside what the certificate type permits.

Types of CLIA certificates

The certificate type follows the most complex testing the laboratory performs:

• Certificate of Waiver: allows only waived tests, which are simple tests with a low risk of error, such as many rapid strep and glucose tests.
• Certificate for Provider-Performed Microscopy Procedures (PPM): allows physicians, midlevel practitioners and dentists to perform certain microscopy tests during patient visits, plus waived tests.
• Certificate of Registration: a temporary certificate that lets a new moderate or high complexity laboratory operate until its compliance is determined.
• Certificate of Compliance: issued after a state survey agency inspection finds the laboratory meets CLIA requirements.
• Certificate of Accreditation: issued to laboratories accredited by a CMS-approved organization, such as the College of American Pathologists, COLA or the Joint Commission.

Why the CLIA certificate matters

CLIA data is one of the few national lists of testing sites:

• Certificate type is a quick proxy for capability: a waiver site cannot run moderate or high complexity tests, while laboratories with compliance or accreditation certificates can.
• Diagnostics sales teams use CLIA records to find physician office laboratories and point-of-care sites that could adopt a new waived test.
• Payers and auditors check CLIA numbers on claims, and mismatches between billed tests and certificate type trigger denials.
• CMS publishes laboratory certification data by CLIA number, which analysts join to NPI and facility records using names and addresses.