NH DHHS CLIA Certification: Health Facilities Administration (Concord) Guide
CMS-116 to first survey for New Hampshire labs.
Book a free consultationShort answer: New Hampshire CLIA certification runs through the NH DHHS Health Facilities Administration CLIA program, 129 Pleasant Street, Concord, NH 03301 (CLIA@dhhs.nh.gov). File a CMS-116, pay the CMS fee coupon, and — for moderate or high complexity — prepare for a state or accreditation survey. Since March 1, 2026, coupons and certificates are delivered electronically, so the lab must register an email for notices.
CLIA certificate types
| Certificate | Testing | Survey |
|---|
| Waiver | FDA-waived tests only | No routine survey |
| Provider-Performed Microscopy | Specified microscopy by providers plus waived | No routine survey |
| Compliance | Moderate/high complexity | State agency survey every two years |
| Accreditation | Moderate/high complexity | CMS-approved accrediting organization (e.g., CAP, COLA, TJC) |
Filing sequence
- Confirm the test menu and complexity, then complete the CMS-116
- Send it to the HFA CLIA program with the director's qualifications
- Pay the fee coupon when issued; certificates arrive electronically
- In parallel, file the RSA 151 state application if He-P 808 or He-P 817 applies
- Build QC, PT enrollment, competency, and SOPs before first patient testing
- Rehearse the first survey and track any CMS-2567 findings to closure
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
Who handles CLIA certification in New Hampshire?
The CLIA program sits in the NH DHHS Health Facilities Administration at 129 Pleasant Street, Concord, NH 03301 (CLIA@dhhs.nh.gov). CMS-116 applications go there. After March 1, 2026, CLIA fee coupons and certificates are delivered electronically.
Do I still need a state license if I have CLIA?
Usually you still file. RSA 151:5-b, II deems CLIA-inspected labs licensed for those activities but requires the application and fee; waived and PPM labs need the full He-P 808 license unless exempt.
How do I respond to a CMS-2567 in New Hampshire?
Submit an acceptable plan of correction within the deadline in the survey letter, addressing each cited regulation, root cause, corrective action, monitoring, and responsible person.
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.