Hawaii's Class I Laboratory Permit

Hawaii's clinical laboratory rules, Hawaii Administrative Rules chapter 11-110.1, start broad: "No person shall establish, conduct, maintain, or operate a clinical laboratory in the State without a valid and effective clinical laboratory permit or license issued by the department" (HAR § 11-110.1-6(a)). The Department of Health's Office of Health Care Assurance (OHCA) runs both the state program and the federal CLIA program in Hawaii, so most new testing sites deal with one office for two approvals.

Which sites are exempt?

HAR § 11-110.1-5 lists them. The one that matters for most practices is a lab "Certified by CLIA pursuant to 42 C.F.R. part 493 subpart A and operated by a licensed physician at a stated location where clinical laboratory tests are performed exclusively for the physician's own patients. The licensed physician shall serve as the laboratory director for this laboratory." The others are federal labs, research and teaching labs with no patient services, police breath-alcohol testing, pulmonary function testing in a licensed medical facility, and approved public health studies.

OHCA reads the physician exemption narrowly. Its CLIA page sorts labs into physician office labs that meet that definition and "NON-PHYSICIAN OFFICE LABS (group practices, community clinics, FQHC, dialysis centers, skilled nursing facilities, hospitals, ambulatory surgery centers, home health agencies, dialysis centers, mobile test sites, independent labs)," which "need a Hawaii Clinical Lab Permit or License." A group practice is on the second list, even when physicians own it.

What is a Class I permit?

It is the state approval for waived and PPM testing. Under HAR § 11-110.1-7(a), a person may apply for a Class I permit if the lab "Performs only waived or provider performed microscopy procedures, or both," is certified under CLIA, and pays the fees. OHCA's page lays out the tiers:

• Waived tests only: CLIA Certificate of Waiver plus a Hawaii Class I permit.
• Waived and PPM: CLIA PPM certificate plus a Class I permit.
• Moderate complexity on a portable instrument in a licensed medical facility: CLIA Certificate of Compliance plus a Class II permit.
• Other moderate or high complexity testing: CLIA Certificate of Compliance or Accreditation plus a Hawaii clinical laboratory license.

Which forms make up the packet?

For a non-physician lab doing only waived tests, OHCA asks for the CMS-116, a Disclosure of Ownership and Control Interest Statement (Form 1513), and the Hawaii Department of Health Application for Clinical Lab Permit/License (OHCA 110.1). A PPM lab adds the Laboratory Personnel Report (CMS-209), listing the director and testing personnel with their Hawaii license numbers; OHCA notes that "Personnel performing PPMP must be licensed physicians, physician assistants, or nurse practitioners" and that people performing only waived tests need not be named.

The Class I application must include at least the lab's name and address, the owner's name and address, the director, a "laboratory consultant if the laboratory director is not a clinical laboratory director or medical technologist licensed by the State," and the list of tests, methods and annual volume (§ 11-110.1-7(b)). The department must approve or deny a complete application "no later than sixty calendar days" after receiving it (§ 11-110.1-6(d)).

The CMS-116 goes to the same office. CMS lists the Hawaii Department of Health, Office of Health Care Assurance, doh.ohcamco@doh.hawaii.gov and (808) 692-7420, as the State Agency.

What does a Class I director have to do?

This is the part that surprises groups used to federal CLIA, where a waiver lab's director has no qualification or visit rules. Under § 11-110.1-7(c), the director of a Class I lab shall:

• be accessible and give onsite, telephone or electronic consultation as needed;
• "Visit the laboratory at least two times per year";
• approve all tests and keep written protocols available to testing staff;
• "Prior to patient testing, provide training to testing personnel and document the personnel's competency";
• make sure specimens are properly collected, controls meet the manufacturer's criteria before patient results go out, and results are reported accurately and on time; and
• see that federal, state and county safety rules are followed.

The director may delegate those duties in writing to the lab's laboratory consultant (§ 11-110.1-7(d)). The department may inspect for initial approval and renewal, and a Class I lab must allow inspection "at any time during the laboratory's working hours" (§ 11-110.1-7(e)). A group adding five clinics should plan the director's travel schedule before the permits are filed.

How much, and for how long?

Hawaii's fee schedule for licensed health care facilities (HAR chapter 11-103.1, Exhibits A and B) lists a clinical laboratory at $150 for initial licensure and certification and $100 for renewal, as of October 2026. The schedule does not split the fee by permit class; confirm the amount for your permit with OHCA. A permit or license "shall be effective for a period of not more than twenty-four months" (§ 11-110.1-6(e)). The federal CMS fee is separate: $248 every two years for a Certificate of Waiver, as of October 2026.

Does each site need its own permit?

An application is required "for each address in which clinical laboratory tests are performed" (§ 11-110.1-6(b)), with three exceptions that track the federal ones: hospital labs in contiguous buildings under one director, labs "not at a fixed location" such as mobile units and health fairs, and not-for-profit or government labs doing limited public health testing of no more than 15 PPM, point-of-care or waived tests. The director notifies the department in writing within 30 days of a change in name, location, director or owner (§ 11-110.1-6(g)).

Can we prepare a Hawaii packet for you?

Yes. We prepare the CMS-116, Form 1513, the OHCA 110.1 application and, for PPM sites, the CMS-209, with the test list built from each kit's instructions. Your owner and director review and sign, the state and CMS fees are paid by your organization, and we can send the signed packet to OHCA. Our State Lab Registration service is $299 per state on top of the $399 Certificate of Waiver Application. The Hawaii requirements page has the OHCA contacts.