CLIA certification is federal — but it's only half the picture. Many states layer their own licensure on top of CLIA, with their own applications, fees, personnel rules, and inspections. Some states even require out-of-state laboratories to hold a license before testing specimens from their residents.
This hub is our running reference for laboratory requirements in all 50 states. Each state page covers the agency in charge, license types, how to apply, fees, personnel requirements, inspections, renewals, and how the state's rules differ from federal CLIA. Every page carries a "last verified" date — regulations change, and we re-check these on a schedule.
States with their own licensure programs (start here)
- California — CDPH Laboratory Field Services; separate lab and personnel licensing, out-of-state licensure required
- Florida — Agency for Health Care Administration; lab and personnel licensure
- Maryland — Office of Health Care Quality; lab permit required, including out-of-state labs
- New York, Pennsylvania, Rhode Island — coming soon
Forms
Every lab needs the federal forms below regardless of state. Each state page has its own Forms section with that state's application forms and inspection-prep documents.
- Form CMS-116 — CLIA Application for Certification (PDF) — the federal CLIA application; filed with your state agency, not with CMS.
- Form CMS-209 — Laboratory Personnel Report (PDF) — personnel roster; CLIA surveyors require a current copy before inspection.
- CMS State Operations Manual, Appendix C (PDF) — federal survey procedures and interpretive guidelines; the playbook inspectors use.
- CMS proficiency testing program requirements — PT enrollment rules and CMS-approved cytology PT programs.
Inspection preparedness — have these ready before the surveyors arrive:
- Form CMS-116 — CLIA Application for Certification (PDF) — surveyors verify the specialties, sites, and director on file match current operations.
- Form CMS-209 — Laboratory Personnel Report (PDF) — current personnel roster; surveyors require it up to date.
- ACC 212 — CLIA lab test menu — the lab's controlled test menu listing every test by specialty; surveyors cross-check it against the certificate.
- Generic CLIA Laboratory Test Menu & Methods form (PDF) — a blank, print-ready test menu any lab can use for inspection readiness; prepared by Zilgene.
Remaining states: coming soon. In most other states, federal CLIA certification plus any state business registration is the core requirement — but personnel rules and fees still vary, and each state gets its own page.
Last verified: October 2026