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CLIA waiver state checklist
CLIA Certificate of Waiver requirements in Hawaii for med spas and clinics.
Hawaii: submit (1) CLIA Application for Certification (CMS-116); (2) Disclosure of Ownership and Control Interest Statement; and (3) Hawaii Department of Health Application for Clini…
Last reviewed 2026-07-03
This page is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device.
State overlay checklist
- Submit
- CLIA Application for Certification (CMS-116)
- Disclosure of Ownership and Control Interest Statement
- Hawaii Department of Health Application for Clinical Lab Permit/License
- State note: Note: Director must meet qualifications listed in HAR 11-110.1-25
Fee and timing note
Plan for the federal CLIA certificate fee billed by CMS after processing, plus any Hawaii state application or license fee. Fee amounts change and are not quoted here — verify current CMS and state fees and processing time on the official state page before filing.
Check my test menuPrep steps
- 1Prepare CMS-116 with each waived analyte, test name, manufacturer, and estimated annual test volume.
- 2Keep a device-specific FDA waived-status printout for every test system in your internal prep file.
- 3Complete the Hawaii state application listed above before ordering in-house testing supplies.
- 4Confirm current fees and processing time with the Hawaii laboratory program (linked below) before you file.