New Hampshire He-P 808 Laboratory and He-P 817 Collection Station Licensing
Who must license, who is exempt, and what goes in the packet.
Book a free consultationShort answer: New Hampshire licenses labs that test human samples under RSA 151:2, I(c) and He-P 808, and specimen-only draw sites under He-P 817. CLIA-inspected labs are deemed licensed under RSA 151:5-b, II but still file and pay; waived and PPM labs are not covered by that shortcut. Physician offices, other licensed-practitioner offices, and community health clinics are excluded by RSA 151:2, II.
| Your New Hampshire setting | State license under RSA 151? | What usually applies |
|---|
| Independent or reference lab testing human specimens (moderate/high complexity) | Yes — RSA 151:2, I(c); He-P 808 | CLIA Certificate of Compliance or Accreditation plus a state lab license application and fee. If CLIA-inspected, RSA 151:5-b, II treats the lab as deemed licensed for those inspected activities and exempts it from state RSA 151:6-a inspections. |
| Lab running only CLIA-waived tests or PPM | Yes, unless another exemption applies | The RSA 151:5-b deemed-license route does not cover waived or PPM labs, so He-P 808 licensing and state inspection apply in full. |
| Physician office, office of another NH-licensed health professional, or community health clinic | No — RSA 151:2, II(e)–(g) | Still needs the correct CLIA certificate (CMS-116) through NH DHHS HFA. |
| Hospital lab on the licensed hospital premises | Covered by the hospital license — He-P 808.02(g) | CLIA certificate; hospital rules under He-P 802. |
| Patient service center / draw site that only collects specimens | Yes — collection station, He-P 817 | Floor plan, local health/building/zoning/fire sign-offs dated within 90 days, administrator résumé, fee. Mobile vans follow He-P 817.21. Not needed if the site is already licensed under He-P 808 or He-P 806. |
| Forensic-only, state-operated, or EMS (RSA 153-A) testing; waived tests solely for risk assessment | Exempt — He-P 808.02 | Confirm CLIA status separately. |
He-P 817 collection station packet checklist
- Application for Residential and/or Health Care License (Laboratories and Collecting Stations), March 2026 edition, signed by the owner or authorized officers
- Floor plan of the collection station
- NH Secretary of State proof of authority, formation, or trade name where applicable
- Fee under RSA 151:5, payable to the Treasurer, State of New Hampshire
- Résumé and licenses of the collection station administrator
- Written local health officer, building official, zoning officer, and fire chief approvals dated within 90 days (fire chief confirms NFPA 101 compliance)
- Mobile collection vans: separate requirements in He-P 817.21
He-P 808 lab licensing essentials
- One license per premises; licenses are not transferable and must be posted
- $150 per year for each category of testing licensed
- Construction or structural changes and ownership or organizational changes trigger notice requirements under He-P 808.07 and 808.08
- Inspections under He-P 808.09 unless deemed licensed via RSA 151:5-b
- Records, requisitions, and reports (He-P 808.16), infection control (808.19), physical environment (808.20)
New Hampshire rules that shape every clinical lab project
- RSA 151:2, I(c) — laboratories testing human samples and collection stations must be licensed; RSA 151:2, II(e)–(g) excludes physician offices, offices of other NH-licensed health professionals, and community health clinics.
- RSA 151:5-b, II — a CLIA lab with compliance or accreditation inspections is deemed licensed for those activities and exempt from RSA 151:6-a state inspections, but still files the application and fee. Waived and PPM labs cannot use this route.
- He-P 808 Laboratories and Laboratory Services Rules — licensing, inspections, records, test requisitions and reports, infection control, and physical environment. State lab license fee under RSA 151 is $150 per year for each category of testing licensed.
- He-P 817 Collection Station Rules (readopted effective March 31, 2026) — draw sites and mobile collection vans.
- NH DHHS Health Facilities Administration CLIA program — 129 Pleasant Street, Concord; CMS-116 filings, certificate changes, and electronic certificates after March 1, 2026.
- He-P 301 communicable disease reporting and the NH Public Health Laboratories at 29 Hazen Drive, Concord — shipping a specimen to the state lab does not by itself satisfy the reporting duty.
- Env-Sw 904 infectious waste — labeled containers, secured storage, a 72-hour room-temperature storage limit, and transfer only to authorized facilities.
- 42 CFR Part 493 — federal CLIA personnel, QC, proficiency testing, and quality system requirements.
Frequently asked questions
Does New Hampshire require a state laboratory license in addition to CLIA?
Yes for most labs. RSA 151:2, I(c) requires a license for laboratories that test human samples and for collection stations, administered under He-P 808 and He-P 817. Physician offices, offices of other NH-licensed health professionals, and community health clinics are carved out by RSA 151:2, II. CLIA-inspected labs are deemed licensed under RSA 151:5-b, II but still file the application and fee.
What is the difference between He-P 808 and He-P 817?
He-P 808 is the rule for laboratories and laboratory services that perform testing. He-P 817, readopted effective March 31, 2026, covers collection stations that only collect specimens, including mobile collection vans. A lab already licensed under He-P 808 does not need a separate collection station license to collect its own specimens.
Do mobile phlebotomy vans need a New Hampshire license?
Yes, a mobile collection van operating as a collection station is addressed by He-P 817.21 of the Collection Station Rules effective March 31, 2026.
Are waived-only labs exempt in New Hampshire?
Not automatically. Waived and PPM labs are excluded from the RSA 151:5-b deemed-license route. Only waived testing done solely for risk assessment, with results not used for diagnosis or treatment, is exempt under He-P 808.02(e).
Work with a New Hampshire clinical lab consultant
Sound Lab Consultants is headquartered at 25 Arizona Pl, Chandler, AZ 85225 and works with New Hampshire clinical laboratories remotely and on-site. We are an independent consulting firm with no affiliation to NH DHHS, CMS, CDC, FDA, CAP, COLA, or The Joint Commission.
Book a free consultationLast reviewed: November 2026. Rules cited from official New Hampshire and federal sources; confirm current versions before filing.