State Lab Licensing on Top of CLIA

Every testing site in the country needs to answer two questions before it runs its first rapid strep test. The federal one is easy to state: which CLIA certificate does it need? For a site running only waived tests, that is a Certificate of Waiver, applied for on the CMS-116 and paid for at the current CMS fee of $248 every two years, as of October 2026. The state question is harder, because there is no single answer. A state may add its own registration, permit or license for that same site, replace CLIA with its own program, require a notice, or ask for nothing at all.

The rules below come from each state's statutes, regulations and health department pages. We have not checked every state to the same depth, and we do not publish a count of how many states license labs; the state requirements index shows what is confirmed for each state and what is still open.

Which states replace CLIA with their own program?

Two. CMS treats New York and Washington as exempt from CLIA because their own laboratory programs do the job.

• Washington licenses every "test site" under RCW 70.42. A waived-only site holds the Medical Test Site license's Certificate of Waiver type, $260 every two years under WAC 246-338-990 (as of October 2026), and CMS's State Agency list says not to send a CMS-116. See Washington's Medical Test Site license.
• New York splits sites. Physician office labs owned and operated by the practitioners Public Health Law § 579(1) lists file the CMS-116 with the Wadsworth Center's POLEP program and follow federal rules. Everyone else running waived or PPM tests registers as a Limited Service Laboratory, $200 per location every two years under § 579(3). See physician office labs in New York and the Limited Service Laboratory registration.

Where does a state license reach a waived-only site?

In these states, a site running only waived tests can need a state filing on top of its Certificate of Waiver, depending on who owns it:

• California. Every lab with a Certificate of Waiver or PPM certificate registers with CDPH (Bus. & Prof. Code § 1265(a)(2)), with no physician office exemption. $155 a year for waived, $235 with PPM, as of October 2026. See California's registration.
• Pennsylvania. A permit is required to operate any clinical lab (28 Pa. Code § 5.11). A practitioner's office is excluded only if it runs nothing beyond a 1976 list of tests, which leaves out rapid strep, flu, A1c and most modern waived tests. See Pennsylvania's permit.
• Hawaii. Labs other than a single physician testing their own patients need a Class I permit for waived or PPM testing (HAR § 11-110.1-7). Group practices, clinics and FQHCs included. See Hawaii's Class I permit.
• Maryland. Every test performed in the state needs a license; a physician office or point-of-care lab running only CLIA-waived tests holds a letter of exception (COMAR 10.10.03.02), with daily quality control. See Maryland's letter of exception.
• Maine. A waived-only lab receives a limited license unless physicians, physician associates, family nurse practitioners, rural health clinics or group practices are testing their own patients (22 M.R.S. § 2013-A). Pharmacies are not exempt. See Maine's limited license.
• Kentucky. "Except as otherwise provided by KRS 333.040 no person shall operate any medical laboratory in this Commonwealth without first obtaining the appropriate license" (902 KAR 11:010). KRS 333.040 exempts physician labs serving only their own patients and permitted pharmacies doing CLIA-waived tests, but not employer clinics or other sites. $155 to apply and $80 to renew, as of October 2026.
• District of Columbia. "It shall be unlawful to operate a clinical laboratory in the District of Columbia... unless licensed by the Mayor" (D.C. Code § 44-202(a)), and the exemptions in § 44-202(b) cover only federal, nonclinical research and teaching labs.

Tennessee sits slightly apart. Its Medical Laboratory Board rule 1200-06-03-.17 requires clinical labs and other state-licensed health care facilities doing waived tests to notify the Board on form PH-3653 and meet training and record rules, while a 2021 law exempts pharmacies holding a Certificate of Waiver from the Act. See Tennessee's rules for waived testing. Ohio requires state approval for one waived test, blood lead, with proficiency testing (OAC 3701-82-02); see Ohio's blood lead approval.

Which states license labs but exempt waived-only sites?

• Massachusetts has exempted "a clinical laboratory performing only CLIA-waived tests" since 2022 (M.G.L. c. 111D § 4(c)). See Massachusetts licensing.
• Rhode Island exempts "Any person performing only limited-function tests," defined as CLIA-waived tests, and pharmacists running them (R.I. Gen. Laws § 23-16.2-3). See Rhode Island licensing.
• Illinois says its Clinical Laboratory and Blood Bank Act "shall not be construed to apply to tests classified as waivered tests" (210 ILCS 25/1-103). See CLIA in Illinois.

In each, adding microscopy or any nonwaived test can bring the license back.

Where is the answer still unsettled?

New Jersey excludes facilities whose only testing is point-of-care testing (N.J.S.A. 45:9-42.33(e)), but its fee rule still lists a $200 waived-only license (N.J.A.C. 8:45-1.3). See New Jersey's license. Connecticut requires a license for any clinical laboratory (Conn. Gen. Stat. § 19a-565(c)), and its published regulations list no waived exemption, but we have not confirmed how the Department of Public Health applies that to waived-only sites. In both, ask the department in writing before opening.

Which states have no general lab license?

Some states say so directly. Texas HHSC: "Laboratories are not state licensed." North Carolina's Division of Health Service Regulation: the state "does not have separate state licensure requirements for laboratories or laboratory personnel." Florida ended its lab license on July 1, 2018. Georgia's House Bill 93 of 2021 was passed "to eliminate duplicative state licensure and regulation of clinical laboratories." Several other states' health departments describe only the federal certificate. See Texas, North Carolina and Florida.

No state license does not mean no state paperwork. Texas will not process a CMS-116 without its Form 3225, and some State Agencies require the lab director's signature or mailed originals. See state forms filed with the CMS-116.

Why are the exemptions narrower than they look?

Most state exemptions are written for a physician testing their own patients, and the details exclude a lot of real sites:

• Ownership. Hawaii's exemption covers a lab "operated by a licensed physician" who is its director; the state treats group practices as non-physician labs. Maine excludes labs "incorporated for the mutual use" of several practices. New York's physician office route requires the practice to be "entirely owned and operated" by listed practitioners.
• Who runs the test. Rhode Island's physician exemption requires the physicians to "make the tests... personally." Massachusetts's requires the physician or a supervised assistant to perform all testing.
• Referred work. Kentucky's physician and pharmacy exemptions end "if any referred work is received or performed."
• Which tests. Pennsylvania's office exemption is a fixed list from 1976.

Pharmacies, med spas, IV clinics, employer clinics, schools and telehealth-owned testing sites are the ones most often caught. A national chain usually meets a different answer in each state.

Do state licenses follow the same calendar as CLIA?

Rarely. The federal certificate runs two years from its own date. State licenses run on their own clocks: California registrations last one year; Pennsylvania permits run to August 15 each year; New Jersey licenses expire every December 31; Kentucky licenses expire December 31 after issue; Maine licenses last three years; Washington licenses all expire June 30 of odd-numbered years; Tennessee licenses renew on the anniversary of issue. Change rules differ too. California revokes a registration 30 days after a major director or ownership change unless a new application is filed, New York voids a Limited Service Laboratory registration on a change of owner or location, and Maine wants a new license before the change happens.

Labs that test specimens mailed from other states face one more layer: New York, Pennsylvania, California, Maryland, Rhode Island and DC each require their license for labs located elsewhere. See testing specimens from other states.

How should a group check a state before opening?

1. Write down the test menu from the kits and analyzers you will actually stock, including any microscopy.
2. Note who owns the site and who will run the tests. Most exemptions turn on those two facts.
3. Read the state's statute or rule, not a summary. Several states changed course since 2018, and older guides are wrong for Florida, Georgia and Massachusetts.
4. Where the text is unclear, ask the state agency in writing and keep the answer.
5. Put every state renewal date and change rule next to the CLIA date for that site.

What do we prepare?

For each site, we confirm the federal certificate and every state filing it needs, prepare them for your owner or director to sign, and track the dates. Your organization pays CMS and each state directly. A Certificate of Waiver Application is $399 per site; state filings are $299 per state for a registration and $699 for a full license or permit; and Renewal and Compliance Tracking is $299 per year for the first lab and $99 for each added site. Details on the pricing page.