California runs one of the most demanding state laboratory programs in the country. If your lab is in California — or if you're an out-of-state lab testing specimens from California patients — you need a California license on top of your CLIA certificate.

State agency

California Department of Public Health (CDPH), Laboratory Field Services (LFS) — the office that licenses laboratories and laboratory personnel in California.

License types

• Registration — for Certificate of Waiver and PPM testing.
• License (non-waived) — for Certificate of Compliance or Certificate of Accreditation testing; requires the full application package.
• Out-of-state license — required if your lab is outside California but tests specimens from California residents.

How to apply

Apply through the LFS online application portal, or by mail with the paper forms. The non-waived application package includes state forms (LAB 116, LAB 144A, LAB 1513, LAB 167, LAB 183) plus the federal CMS-116 and CMS-209. Documentation of the laboratory director's qualifications must accompany a non-waived application. Incomplete packages can be abandoned — and re-applying means paying the fee again.

Forms

Application forms — state forms live on the LFS mail-in applications page; always download the current version before filing.

• LAB 116 — Laboratory Personnel Report (PDF) — roster of directors and testing personnel (required for PPMP and non-waived).
• LAB 144A — Laboratory Testing Declaration (PDF) — declare your test menu by specialty and subspecialty.
• LAB 1513, LAB 167, LAB 183 — additional state schedules for non-waived applications; download from the LFS mail-in applications page.
• LAB 144B — additional clinical laboratory testing sites (multisite); download from the LFS mail-in applications page.
• Form CMS-116 — CLIA Application for Certification (PDF) — federal application, filed with LFS.
• Form CMS-209 — Laboratory Personnel Report (PDF) — federal personnel roster for non-waived labs.

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.
• LFS New License Application Checklist (PDF) — everything to have ready before you apply; doubles as a readiness checklist.
• CMS State Operations Manual, Appendix C (PDF) — federal survey procedures and interpretive guidelines.
• California LFS does not publish a standalone public inspection self-assessment checklist; prepare against the application checklist above and the CMS survey procedures.
• Generic CLIA Laboratory Test Menu & Methods form (PDF) — a blank, print-ready test menu any lab can use for inspection readiness; prepared by Zilgene.

Fees

Application and license fees apply; check the current LFS fee schedule before filing, since fees change.

Personnel requirements

California licenses laboratory personnel individually — a layer most states don't have. Key licenses include Clinical Laboratory Scientist (CLS), Medical Laboratory Technician, and Laboratory Director. Expect: official transcripts sent directly from the registrar, verification of training or experience signed by the training coordinator or lab director, a national certification exam, and California's online quiz on state laboratory laws and regulations.

Inspection

LFS surveys licensed laboratories for compliance with state law and regulations, in addition to any federal or accreditation inspections.

Renewal and changes

Licenses and personnel licenses must be renewed on schedule with fees and continuing education; notify LFS of changes (such as address changes) within required timeframes.

How California differs from federal CLIA

• Separate state lab license required in addition to the CLIA certificate.
• Out-of-state labs need California licensure to test California specimens.
• Individual personnel licensure (most states rely on CLIA personnel standards alone).
• Its own application forms and fee schedule on top of the federal process.

Official links

• CDPH Laboratory Field Services — mail-in applications and forms
• Clinical Laboratory Scientist license (CLS)
• Clinical Laboratory Director license

Last verified: October 2026