Honolulu & Oahu CLIA-Waived and Physician Office Lab Consultant
For small medical offices doing waived or PPM testing.
Book a free consultationShort answer: A small Honolulu medical office doing only CLIA-waived tests needs a CLIA Certificate of Waiver (CMS-116 plus Form 1513, filed with DOH OHCA in Kapolei). If it is a physician office lab — a licensed physician operating it as director and testing only their own patients — no Hawaii state permit is needed. Group practices, clinics, and other non-physician settings also need a Hawaii Clinical Lab Permit Class I (OHCA 110.1). PPM adds a CMS-209 personnel report.
What we deliver for small Oahu offices
- Determine POL exemption vs Permit Class I
- Complete CMS-116, Form 1513, OHCA 110.1, CMS-209
- Manufacturer-instruction compliance, QC logs, and training for waived tests
- Upgrade path to moderate complexity
Related guides
- State Permit & CLIA Guide
- Personnel Licensing
- Honolulu Waived & POL
- Neighbor Islands
- Hire a Lab Director
- Out-of-State Labs
- Mock Inspections & 2567
- Hawaii lab consultant on soundlabconsult.com
- Hawaii CLIA & state license guide
Frequently asked questions
Does a waived-only Honolulu clinic need a lab consultant?
Not always, but help with POL exemption vs Permit Class I and correct forms prevents delays.
Do waived testers need a Hawaii personnel license?
Waived testers are not listed on CMS-209; licensed categories apply to non-waived roles.
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.