Does an out-of-state lab need a New York permit?

Yes. CLEP says only labs holding a New York State clinical laboratory permit may test specimens originating from New York. A Single Use Permit, applied for by the testing lab, covers only unique tests not available from permitted labs.

Do out-of-state labs need a Pennsylvania permit?

Yes, since Act 122 of 2013. The Bureau of Laboratories says any lab, in state or out of state, testing specimens collected in Pennsylvania must be licensed, and it publishes a separate out-of-state application with a $100 fee.

Does Illinois require out-of-state labs to be licensed?

No. IDPH says the lab must be CLIA certified and in good standing and must give submitters collection instructions and a copy of its CLIA certificate.

Does a telehealth company that ships kits need these licenses?

Usually the processing lab does, not the company that ships kits, since collection alone is not lab testing under CLIA. Confirm the lab holds every state license your specimen sources require.

Testing Specimens From Other States

Federal CLIA certifies a lab where it sits. A lab in Texas with a Certificate of Compliance can, as far as CLIA is concerned, test a swab mailed from anywhere. Some states disagree for their own residents. They require any lab testing specimens collected in the state to hold that state's license or permit too, wherever the lab is located. For a telehealth company shipping collection kits nationwide, or a lab building a national client list, this is the rule that decides which states it can serve on launch day.

This mostly concerns reference labs, which usually hold Compliance or Accreditation certificates. A waived testing site tests its own patients on the spot. But it matters to the practices and telehealth companies choosing where to send specimens, because several states also bar collecting specimens for an unlicensed lab.

Which states require their license for out-of-state labs?

New York

New York's Clinical Laboratory Evaluation Program (CLEP): "Only laboratories that hold a New York State clinical laboratory permit are authorized to perform testing on specimens originating from New York." For a test no permitted lab offers, CLEP has a Single Use Permit, which since January 2026 "must be submitted by the TESTING LABORATORY using eCLEP"; CLEP "will no longer accept requests from the REFERRING ENTITY." A patient-specific Single Use Permit needs "a separate application... for each specimen." It is a narrow route for unique tests, not a way around the permit for routine testing.

Pennsylvania

Since Act 122 of 2013, the Bureau of Laboratories' FAQ says, "any person or clinical laboratory, either in-state or out-of-state, that tests specimens in the Commonwealth or collected within the Commonwealth must be licensed by the Department." The Bureau publishes a separate permit application for out-of-state labs with a $100 fee, and it "may exempt or limit the inspection process" for out-of-state labs certified under CLIA and by their home state. Permits run to August 15 each year. See Pennsylvania's clinical laboratory permit.

California

Business and Professions Code § 1241(a): the chapter "applies to all clinical laboratories in California or receiving biological specimens originating in California for the purpose of performing a clinical laboratory test or examination." An out-of-state lab therefore needs a California license or registration, and § 1300(q) adds that a lab "located outside the State of California shall reimburse the department for travel and per diem to perform any necessary onsite inspections." See California's registration.

Maryland

Health-General § 17-205(a) requires a Maryland license before a person may "Offer or perform medical laboratory tests or examinations on specimens acquired from health care providers in this State at a medical laboratory located outside this State," or "Represent or service in this State a medical laboratory regardless of the laboratory's location."

Rhode Island

216-RICR-60-05-4.5(F)(3): "Any out-of-state laboratory performing clinical laboratory tests on specimens collected in Rhode Island shall be licensed in accordance with the requirements stated in this Part." The fee is $650 per approved specialty every two years, as of October 2026. Before licensing, the Department checks federal certification and the home-state license. The Director may grant immediate licensure to a CLIA-certified lab licensed in another state for a service no Rhode Island licensed lab offers.

District of Columbia

D.C. Code § 44-202(a-1)(2) makes it unlawful, without a DC license, to perform or offer "clinical laboratory tests or examinations on specimens acquired in the District of Columbia, regardless of the location of the clinical laboratory at which the tests or examinations are performed."

Where is a CLIA certificate enough?

Illinois. IDPH: an out-of-state lab does not need an Illinois certificate or permit; "The requirements are for your facility to be CLIA certified and in good standing; however, you must provide instructions for specimen collection, processing, and a copy of your CLIA certificate to the submitter(s)."
Michigan. LARA: "There are no licenses/approvals needed to accept, collect, or process patient samples from Michigan residents in an out of state laboratory. The receiving laboratory must be CLIA certified in accordance with federal law."
States without a lab license. Where a state has no lab license at all, such as Texas, North Carolina and Florida, there is nothing for an out-of-state lab to obtain beyond its CLIA certificate.

Other states fall in between. Massachusetts bars a lab from maintaining a specimen collection station for an out-of-state lab unless that lab "has been accredited or is licensed in accordance with federal law" (M.G.L. c. 111D § 8(10)). New Jersey bars anyone from collecting or receiving specimens "for analysis by an unlicensed laboratory" (N.J.S.A. 45:9-42.42(b)). Maine's Act covers labs operating in Maine and requires reports on referred specimens to name the out-of-state lab (22 M.R.S. § 2015). Check each state you serve; the state requirements index lists what is confirmed.

Does mobile testing across state lines work the same way?

No. A lab that drives into another state to test on site is performing testing there, not receiving specimens. Michigan says a lab with a CLIA certificate from another state may run mobile testing in Michigan "only if the CLIA certificate has requested a multiple site exception." Tennessee's CLIA program asks out-of-state facilities doing temporary testing, such as health screens, to send a CMS-116 marked "For Information Only" with a cover sheet for each event and to check state licensure with the Medical Laboratory Board. See mobile units and temporary testing sites.

What does this mean for a telehealth kit program?

The telehealth company that ships kits usually is not the lab, and collection alone is not lab work under CLIA. The processing lab needs its CLIA certificate and every state license its specimen sources require. Before launch:

List every state you will ship kits to.
For each, confirm whether the processing lab needs that state's license and holds it. Ask the lab for copies, not assurances.
Pay particular attention to New York, where a permit is required to test any New York specimen.
Recheck when you add a state, and when the lab changes ownership or location, since several states tie licenses to both.

White Glove Telemedicine covers the clinical side of choosing a lab; see its guide to lab partners for telehealth. Our post on mail-in collection kits and the processing lab covers the CLIA side.

Can we map the states for your lab?

Yes. For labs testing specimens from several states, we map which state licenses apply, prepare each state's application for your director and owner to sign, and track their different renewal dates. You pay each state directly. Our State Lab License or Permit service is $699 per state, or $299 where the state's filing is a registration, and Renewal and Compliance Tracking is $299 per year.