Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Connecticut
- The owner, or a responsible officer of the owning company, signs the state license application.
- A change of ownership follows the state's general health care facility rule (19a-493), and a change of director must be reported to the commissioner.
Does Connecticut require a state lab license on top of CLIA?
No person or business may operate a clinical laboratory in Connecticut unless the Department of Public Health licenses or approves it. The statute and the published regulations list no exemption for waived-only labs or physician offices, but whether DPH licenses those sites in practice was not confirmed.
- Clinical laboratory license
- Issued by Connecticut Department of Public Health
Citation: Conn. Gen. Stat. 19a-565 (formerly 19a-30); Regs. Conn. State Agencies 19a-36-D20 to D38
Who is exempt in Connecticut?
The regulations exempt federal labs, research-only labs, forensic-only labs and labs doing only tests that are exempt from CLIA. A 1994 law removed the old exception for labs in practitioners' offices.
Citation: Regs. Conn. State Agencies 19a-36-D21(b); P.A. 94-174
What does Connecticut charge?
$200 nonrefundable fee with each license or renewal application (as of October 2026); government-owned labs are exempt from the fee.
Citation: Conn. Gen. Stat. 19a-565(f)
How often does a Connecticut lab registration renew?
- Renews every two years
- Due Renewal application due within the 20th month of the current license
Where does a Connecticut CMS-116 go?
- Connecticut Department of Public Health, Facility Licensing and Investigations Section
- Email: DPH.FLISLab@ct.gov
- Phone: (860) 509-7400
Opening a testing site in Connecticut?
We prepare the CMS-116 and any Connecticut filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.