Out-of-State Reference Labs Accepting Hawaii Specimens
Checklist for mainland labs.
Book a free consultationShort answer: HAR 11-110.1 requires a permit or license to operate a clinical laboratory in Hawaii, issued per testing address. Mainland labs testing specimens collected in Hawaii must hold their own CLIA certificate and should confirm directly with the Hawaii Department of Health whether any Hawaii approval applies to their situation — for example, if they place staff, collection sites, or testing equipment in Hawaii. Any testing performed in Hawaii falls under the state permit or license rules.
Mainland lab checklist
- Valid CLIA certificate for the tests offered
- Written confirmation from Hawaii DOH on any state requirement
- Collection sites in Hawaii: specimen-collection-only vs testing
- Validated transport stability from the islands
- Result reporting and communicable disease reporting (HAR 11-156) obligations
Related guides
- State Permit & CLIA Guide
- Personnel Licensing
- Honolulu Waived & POL
- Neighbor Islands
- Hire a Lab Director
- Out-of-State Labs
- Mock Inspections & 2567
- Hawaii lab consultant on soundlabconsult.com
- Hawaii CLIA & state license guide
Frequently asked questions
Does a California lab need a Hawaii permit to test Hawaii specimens?
Confirm with Hawaii DOH; testing performed in Hawaii clearly requires one, while mainland-only testing should be confirmed case by case.
Last reviewed: November 2026. Sound Lab Consultants is an independent consulting firm and is not affiliated with the Hawaii Department of Health, CMS, CDC, FDA, CAP, COLA, or The Joint Commission. Regulatory summaries are educational; confirm requirements with the agency.