Hawaii Clinical Lab Permit (HAR 11-110.1) & DOH CLIA Certification Guide

Exactly which forms your Hawaii lab files.

Short answer: Hawaii labs usually need two approvals: a federal CLIA certificate and, unless they qualify as a physician office lab, a Hawaii clinical laboratory permit or license under HAR 11-110.1 — both filed with the Hawaii DOH Office of Health Care Assurance CLIA Program in Kapolei. Hawaii also licenses lab personnel: directors, medical technologists, clinical laboratory specialists, cytotechnologists, and medical laboratory technicians need a state license from the DOH State Laboratories Division.

State vs federal: the two Hawaii approvals

	Hawaii state permit/license (HAR 11-110.1)	Federal CLIA certificate
Who needs it	Non-physician labs: group practices, clinics, FQHCs, dialysis, SNFs, hospitals, ASCs, home health, mobile sites, independent labs. Qualifying physician office labs are exempt.	Every lab testing human specimens, including waived-only
Types	Permit Class I (waived/PPM), Permit Class II (moderate on portable instrument in a licensed medical facility), Clinical Lab License (other moderate or high complexity)	Waiver, PPM, Compliance, Accreditation
Form	OHCA 110.1	CMS-116 + Form 1513 (+ CMS-209, Hawaii Test Menu for non-waived)
Term	Up to 24 months; report changes within 30 days	2 years
Processed by	Hawaii DOH Office of Health Care Assurance CLIA Program, Kapolei (OHCA CLIA page)

Filing by lab type

Lab type	CLIA	State	Forms
Physician office lab (own patients, physician director)	Any	Exempt	CMS-116, 1513 (+CMS-209 if PPM/non-waived)
Non-physician, waived only	Waiver	Permit Class I	CMS-116, 1513, OHCA 110.1
Non-physician, PPM	PPM	Permit Class I	+ CMS-209
Moderate on portable instrument in a licensed facility	Compliance	Permit Class II	+ CMS-209, personnel proof, Test Menu
Other moderate or high complexity	Compliance or Accreditation	Clinical Lab License	+ CMS-209, personnel proof, Test Menu

Key HAR 11-110.1-6 rules: one application per testing address, decisions within 60 days of a complete application, permits/licenses valid up to 24 months, displayed prominently, with name, location, director, or owner changes reported within 30 days. Source: HAR Chapter 11-110.1. Infectious waste (HAR 11-104.1) and communicable disease reporting (HAR 11-156) rules also apply.

Related guides

Frequently asked questions

Is a physician office lab exempt in Hawaii?

Yes from the state permit if it is CLIA-certified, operated by a licensed physician who serves as director, and tests exclusively the physician's own patients.

How long is a Hawaii lab permit valid?

Up to 24 months.

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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.