Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Massachusetts
- DPH announced the waived-only exemption in an October 2022 memo after a statute change; a DPH FAQ page still says CLIA waived status does not affect state licensure, which conflicts with the current statute.
- Waived-only labs must still report infectious disease findings to DPH and follow chapter 111D's list of prohibited practices.
Does Massachusetts require a state lab license on top of CLIA?
Massachusetts licenses clinical labs outside licensed hospitals and clinics, but a lab performing only CLIA-waived tests is exempt. A lab adding any non-waived test, PPM procedures included, needs a state license unless a physician office exemption applies.
- Clinical laboratory license
- Issued by Massachusetts Department of Public Health
- Does not reach waived-only labs
Citation: M.G.L. c. 111D, 4, 5; 105 CMR 180.000
Who is exempt in Massachusetts?
Waived-only labs; physician labs testing only their own patients, with the physician or a supervised assistant doing all testing and only tests DPH lists as exempt; research and teaching labs; insurance and employee exam testing; and health promotion screening programs.
Citation: M.G.L. c. 111D, 4
How often does a Massachusetts lab registration renew?
- Due A full license runs no more than two years
Do labs in other states need a Massachusetts license to test its specimens?
The license requirement covers clinical labs maintained in Massachusetts; no license for out-of-state labs was found in chapter 111D.
Citation: M.G.L. c. 111D, 4
Where does a Massachusetts CMS-116 go?
- Massachusetts Department of Public Health, Clinical Laboratory Program
- Email: CLIALab@mass.gov
- Phone: (617) 660-5385
Opening a testing site in Massachusetts?
We prepare the CMS-116 and any Massachusetts 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.