When You May Start Testing

Every new site asks the same timing question: the clinic opens Monday, so when can the nurse start running strep tests? The short federal answer is when the lab holds the right certificate. CMS's CLIA Certification Quick Start Guide (March 2026) says labs "are generally required to have the appropriate certificate before they can begin testing," and CMS's application page says the certificate arrives by email "after we receive your payment. You can begin testing once you receive it."

What has to happen before the first patient test?

The owner or director signs the CMS-116, and it reaches the State Agency complete. Incomplete applications "will be returned to the facility."
The State Agency processes it and CMS emails a fee coupon with the new CLIA number.
The lab pays the coupon on pay.gov; CMS says payment "gets processed overnight."
CMS emails the certificate, which can also be viewed and printed online.
Any state license, registration or permit that applies is also in hand.

Under 42 CFR 493.3(a), a lab that tests without a current certificate "applicable to the category of examinations or procedures performed" is out of compliance, and 493.655(a) says "the appropriate certificate is not issued until the applicable fees have been paid."

Is proof of payment enough in some states?

At least one State Agency says so. Minnesota's CLIA FAQ answers "When can a new facility begin testing?" with: "As soon as you receive verification payment was received by CMS. You do not need to wait until you receive the certificate, as long as you have verification from MDH that CMS received your payment." Minnesota also says a facility that started without a certificate "must cease testing until your fee has been paid" and receipt is verified.

That is one state's practice, not a federal rule. Ask your own State Agency before relying on payment alone. See your CLIA State Agency.

How long does approval take?

CMS does not publish a processing standard, and it varies by State Agency and by how complete the application is. CMS estimates the CMS-116 itself takes about an hour to complete; most delay comes from what happens after. The things that slow files down are within the applicant's control:

missing sections, a P.O. box as the facility address, or a vague test list;
for PPM and nonwaived applications, missing director documents (the instructions warn that missing them "will delay the processing");
an email address no one watches, so the fee coupon sits unpaid; and
a state supplement or state license that was not started in parallel.

Nobody can promise a date, including us. Build the opening plan around submitting a complete file early, then checking with the State Agency.

Do state licenses add a second gate?

They can. CMS's waiver brochure says you "generally may begin testing once you have received your CLIA certificate, but you need to check with your State Agency since some states have additional state-based requirements." In those states, holding the CLIA certificate is not enough by itself. Check the state requirements index and read state lab licensing on top of CLIA.

Does the answer differ for nonwaived testing?

The gate is the same: the right certificate first. A lab moving into moderate or high complexity testing operates under a Certificate of Registration until its survey or accreditation, and CMS's brochure says "you cannot begin nonwaived testing until you have paid the appropriate fee, and have received the appropriate certificate." A waiver lab must also notify the State Agency before performing any test outside its certificate (493.39(a)). See the Certificate of Registration.

What can a site do while it waits?

Collect specimens and send them to a reference lab; collection-only sites are not labs under 493.2.
Train staff on each kit's instructions and set up quality control and storage logs.
Confirm each kit's waived categorization and keep the records. See how to tell whether a test is CLIA-waived.
Get billing ready: the CLIA number goes on lab claims. See putting the CLIA number on claims. Getting the new site into payer files is credentialing work; White Glove Credentialing covers it in facility credentialing for clinics.

How can White Glove CLIA help a new site open on time?

We prepare a complete CMS-116 and the state filings at the same time, so neither waits on the other, and we can send the signed CMS-116 to the State Agency. The lab pays the CMS coupon on pay.gov from its own inbox. A Certificate of Waiver Application is $399 per site; a State Lab Registration is $299 per state. We do not guarantee approval or a processing time, because the State Agency and CMS decide both. Start with the Certificate of Waiver, start to finish.

Common questions

Can I start testing after I mail the CMS-116?

No. The lab needs the certificate for its testing first. After the State Agency processes the CMS-116, CMS emails a fee coupon; once the fee is paid on pay.gov, CMS emails the certificate, and CMS says testing can begin when you receive it.

How long does it take to get a CLIA Certificate of Waiver?

CMS does not publish a processing standard, and timing varies by State Agency. A complete application, a monitored email address for the fee coupon and prompt payment are what an applicant can control.

Can a new clinic collect specimens before its CLIA certificate arrives?

Yes, if it only collects and sends specimens to another lab. Under 42 CFR 493.2, facilities that only collect or prepare specimens, or only serve as a mailing service, are not laboratories.

Is paying the CLIA fee enough to start testing?

At least one State Agency, Minnesota's, allows testing once CMS's receipt of payment is verified. That is a state practice, not a federal rule, so confirm with your own State Agency.