Hawaii CLIA and State Lab Requirements

Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states

What testing sites miss in Hawaii

The director of a Class I lab must visit it at least twice a year and train and document competency of testing staff before patient testing begins, even though CLIA sets no such rule for waiver labs.
A physician-owned group practice is treated as a non-physician lab and needs a permit unless it fits the single-physician, own-patients exemption.
The department must approve or deny a complete permit application within 60 days.

Does Hawaii require a state lab license on top of CLIA?

Every clinical lab in Hawaii needs a state permit or license unless exempt. A lab doing only waived tests or PPM procedures applies for a Class I permit; portable moderate complexity testing needs a Class II permit; other nonwaived testing needs a license. Group practices, clinics, FQHCs, home health agencies and mobile sites are not exempt.

Clinical laboratory permit, Class I (waived or PPM only)
Issued by Hawaii Department of Health, Office of Health Care Assurance
Reaches labs doing only waived tests

Citation: Haw. Admin. R. 11-110.1-5, -6, -7

Who is exempt in Hawaii?

A CLIA-certified lab run by a licensed physician who serves as its director and tests only that physician's own patients needs no state permit. Federal, research-only, police breath-alcohol and pulmonary-function labs are also exempt.

Citation: Haw. Admin. R. 11-110.1-5

What does Hawaii charge?

Clinical laboratory: $150 initial licensure and certification fee, $100 renewal (fee schedule dated May 1, 2022). The schedule does not split the fee by permit class.

Citation: Haw. Admin. R. ch. 11-103.1, Exhibits A and B

How often does a Hawaii lab registration renew?

Due A permit or license is effective for no more than 24 months

Does Hawaii add a form to the CMS-116?

Non-physician labs send the CMS-116 with Form 1513 (Disclosure of Ownership and Control Interest) and the state application OHCA 110.1; PPM labs add the CMS-209 personnel report.

Where does a Hawaii CMS-116 go?

Hawaii Department of Health, Office of Health Care Assurance, CLIA Program
Email: doh.ohcamco@doh.hawaii.gov
Phone: (808) 692-7420

Opening a testing site in Hawaii?

We prepare the CMS-116 and any Hawaii filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.