What Is a Laboratory Consultant in Hawaii? The HAR 11-110.1 Definition and Role

When a Hawaii permit application must name one, and what the role does.

Short answer: Under HAR § 11-110.1-2, a Hawaii laboratory consultant is a clinical laboratory director or medical technologist licensed under chapter 11-110.1. Class I and Class II permit applications must name one when the lab director is not a Hawaii-licensed clinical laboratory director or medical technologist, and the director may delegate duties to the consultant in writing.

When Hawaii requires a laboratory consultant

Permit	Who it fits	Consultant on the application
Class I permit	Labs performing only waived and/or PPM procedures, CLIA-certified	Required if the director is not a Hawaii-licensed clinical laboratory director or medical technologist (HAR 11-110.1-7(b))
Class II permit	Labs maintained by a licensed medical facility, testing only that facility's patients with waived, PPM or point-of-care tests	Same rule (HAR 11-110.1-8(b))
Clinical Laboratory License	Other moderate or high complexity labs	License application lists a state-licensed director and personnel

Director duties a consultant can take on by written delegation

Being accessible for on-site, telephone or electronic consultation
Visiting the laboratory at least two times per year
Approving all tests and keeping written protocols available
Training testing personnel and documenting competency before patient testing
Ensuring proper specimen collection and acceptable controls before results are reported
Ensuring accurate, timely reports and safety compliance

Source: HAR § 11-110.1-8(c) and (d). Sound Lab Consultants places Hawaii-licensed professionals in this role and supports them with SOPs, competency programs and survey preparation. See hire a lab director and quality system and competency.

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Frequently asked questions

What is a laboratory consultant under Hawaii rules?

HAR § 11-110.1-2 defines a laboratory consultant as a clinical laboratory director or medical technologist licensed under chapter 11-110.1.

Does every Hawaii lab need a laboratory consultant?

No. Class I and II permit applications name one when the laboratory director is not a Hawaii-licensed clinical laboratory director or medical technologist.

Can the director delegate to the consultant?

Yes. HAR allows the director of a Class I or II lab to delegate director duties in writing to the lab's laboratory consultant.

Sources

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Last reviewed: November 11, 2026. Hawaii Lab Consultant (hawaiilabconsultant.com) is published by Sound Lab Consultants, an independent consulting firm. It is not affiliated with, endorsed by or acting for the Hawaii Department of Health, CMS, CDC, FDA, CAP, COLA or The Joint Commission. Regulatory summaries are educational, not legal advice; confirm current requirements with the agency.