Test complexity categories. Source: 42 CFR 493.5
Moderate vs high complexity scoring. Source: 42 CFR 493.17
CLIA certificate program. Source: CMS CLIA
Every U.S. site that tests human specimens to diagnose, prevent or treat disease needs a CLIA certificate, and the right certificate depends on the most complex test you perform. This page explains the three complexity categories, the five certificate types, and how to choose.
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1. Waived tests (§493.15): simple tests with a low risk of an incorrect result, cleared by the FDA for home use or waived under FDA criteria
2. Moderate complexity (§493.20), which includes the provider-performed microscopy (PPM) subcategory (§493.19).
3. High complexity (§493.25).
Under §493.15(e) and the certificate rules in §493.35 through §493.39, a CoW lab must:
1. Perform only waived tests
2. Follow the manufacturer's instructions for each test, including QC, specimen type, storage and limitations
3. Hold a current Certificate of Waiver, applying with Form CMS-116 and paying the certificate fee every two years
4. Notify the State Agency of changes in ownership, name, location or director within 30 days, and apply before adding tests that aren't waived
5. Permit announced or unannounced inspections by CMS or its agents, for example to investigate a complaint or determine whether nonwaived testing is being performed
CoW labs aren't routinely surveyed and don't have CLIA personnel qualification, PT or QC frequency requirements beyond the manufacturer's instructions.
CLIA doesn't set educational qualifications for the director of a waived lab, but someone must be named on the CMS-116 and take responsibility. State law may add requirements.
CDC's Ready? Set? Test! materials and CMS waived-testing brochures recommend:
Keeping current manufacturer instructions at the testing site
Training staff and checking competency before they test patients
Running QC as the manufacturer directs, and documenting it
Checking expiration dates and storage temperatures
Confirming patient identification and recording results accurately
Keeping a test log
These aren't all federal requirements for CoW labs, but they prevent the most common waived-testing errors. Accreditors and some states may require them. See our guide to waived test quality control.
Each testing location generally needs its own CLIA certificate. Limited exceptions exist, for example for mobile units, certain not-for-profit or government sites doing limited public health testing, and some hospital campuses (§493.35(b)). If you run several clinics, confirm with your State Agency how each site should be certified.
Running a test that has been modified or isn't waived for that specimen type
Ignoring manufacturer QC instructions
Expired reagents or kits stored at the wrong temperature
Adding a moderate complexity analyzer without changing the certificate
An expired certificate after a missed fee payment
If you want to bring higher-value tests in-house, such as a CBC or chemistry panel, you'll need a Certificate of Compliance or Accreditation, a qualified director, a technical consultant, and nonwaived QC, PT and personnel compliance. See upgrading from waived and CLIA certificate types.
Do waived labs need a CLIA certificate?
Are waived labs inspected?
Yes. Any site testing human specimens for health assessment or diagnosis, including waived-only sites, needs a CLIA certificate unless the state has a CLIA-exempt program.
They aren't routinely surveyed, but CMS can perform announced or unannounced inspections, for example after a complaint.
Do waived labs need proficiency testing?
Do waived-lab staff need special qualifications?
CLIA doesn't require PT for waived tests. Some accreditors and states do.
CLIA sets no personnel qualifications for waived testing, but staff must follow manufacturer instructions. State law may add rules.
Sound Lab Consultants provides lab director and technical consultant services, inspection readiness and mock surveys, deficiency and sanctions response, new lab startup, and waived-to-moderate/high complexity upgrades.
Book a free 20-minute consultation, or start with a free CLIA readiness check.