North Carolina has no state laboratory license and no lab personnel license. A site running waived tests needs only a federal CLIA Certificate of Waiver: it sends a CMS-116, signed by the laboratory director, to the Division of Health Service Regulation and pays the CMS fee from the emailed coupon. Each separate testing location needs its own certificate.
North Carolina is one of the clearest states on this question. The Division of Health Service Regulation (DHSR), which serves as the state's CLIA State Agency, answers it directly in its CLIA FAQ: "No, North Carolina follows the CLIA regulations and does not have separate state licensure requirements for laboratories or laboratory personnel." A physician practice, urgent care center, pharmacy or school clinic running waived tests in North Carolina needs a federal Certificate of Waiver and nothing from the state on top of it.
When does a North Carolina site need a certificate at all?
As soon as it tests. DHSR: "If you do not perform any test on-site you do not need a CLIA number. However, if you do even a simple test such as finger stick glucose or urine dip, you are required to have a CLIA certificate (number)." Volume does not change that: "a CLIA certificate is required if you do even one test in a year." Neither does payer mix. Asked whether a practice that does not bill Medicare or Medicaid still needs one, DHSR says "Yes, CLIA is a federal requirement that is not conditional upon Medicare/Medicaid billing."
A practice that only draws blood and ships it to a reference lab is a collection site, not a lab. The moment the same practice runs a urine dip or a rapid strep test while the patient waits, it is a lab and needs a certificate. Our post on why waived tests are not exempt explains where federal law draws the line.
Where does the application go, and who pays?
The CMS-116 goes to DHSR's CLIA Certification unit. CMS's State Agency list (updated May 2026) gives DHSR.CLIA@dhhs.nc.gov and (919) 855-4620. Send no money with it. DHSR: "No, do not send money to the state agency with your application. Once the application is keyed into the CMS/CLIA database, CMS will bill for the requested certificate type fees." Since March 1, 2026, CMS sends that bill, the fee coupon, by email, and the lab pays on pay.gov. The current CMS fee for a Certificate of Waiver, as of October 2026, is $248 for two years.
Who signs a North Carolina CMS-116?
DHSR's FAQ says "The 116 form must be signed by the laboratory director," and that a lab must file a new CMS-116 when moving from waived or PPM testing to nonwaived testing, with documentation of the director's education and experience. Federal rules allow an owner or authorized representative of the lab to sign, but DHSR is the office reviewing the form, so plan on the director's signature. A consultant cannot sign it for the lab: the signature carries the lab's attestation that it will meet CLIA and its consent to inspection.
What happens when a practice opens a second location?
It applies again. DHSR: "Yes, you must have a separate CLIA number for each separate physical location of testing." The FAQ describes two cases where several sites can share a certificate: a not-for-profit or government lab doing limited public health testing (no more than 15 moderately complex or waived tests per certificate), and a hospital with labs in contiguous buildings on one campus under common direction.
The federal rule, 42 CFR 493.35(b), also lists a third exception that DHSR's page leaves out: labs that are not at a fixed location, such as mobile units and temporary testing sites, which may be covered under their home base's certificate. A North Carolina group running a mobile van should read the federal rule, not only the FAQ. For a for-profit group of clinics or pharmacies, none of the exceptions applies, and each fixed site needs its own certificate and its own CMS fee. See one certificate per site, and the three exceptions.
Which parts of the DHSR FAQ are out of date?
The page was last modified April 25, 2019, and a few details have moved on:
- It tells labs to sign "on the last page (page 4)." The current CMS-116 (03/24 edition) puts the signature on page 5.
- It predates the 2024 fee rule and the March 2026 switch to emailed fee coupons and certificates, so it does not mention either.
- Its multiple-site answer omits the mobile and temporary site exception noted above.
None of that changes the main answer. North Carolina still has no state lab license, and the state's role is to process the federal application and, for nonwaived labs, survey them for CMS.
How do we help North Carolina sites?
For a single practice, our Certificate of Waiver Application is $399: the test list built from each kit's instructions, the CMS-116 prepared for your director to review and sign, and a walkthrough of the emailed coupon so your team pays CMS directly. For groups opening several North Carolina sites, the five-site package is $1,599. The North Carolina requirements page keeps the DHSR contact current.
Common questions
- Does North Carolina require a state lab license?
- No. DHSR's CLIA FAQ says North Carolina follows the CLIA regulations and has no separate state licensure for laboratories or laboratory personnel.
- Do I need a CLIA certificate for one fingerstick glucose a year?
- Yes. DHSR says a certificate is required if you do even one test in a year, and that billing Medicare or Medicaid has nothing to do with it.
- Do I send the CLIA fee to North Carolina?
- No. DHSR says not to send money with the application. CMS emails a fee coupon after the application is entered, and the lab pays CMS on pay.gov.
- Can two North Carolina clinics share one CLIA number?
- Usually not. Each separate physical testing location needs its own CLIA number unless it fits one of the federal exceptions, such as a hospital campus or limited public health testing by a not-for-profit or government lab.
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We prepare your CMS-116 and any state filing for your owner or director to sign, then track your certificate, changes and renewals.