Whether you are adding rapid tests to a practice, opening urgent care sites or starting test-and-treat in a pharmacy, we prepare your CLIA certificate, any state registration and every change after that. Your owner or director signs; you pay CMS directly; we do the rest.
Published prices, from $399 per site for a Certificate of Waiver. We never serve as your director or collect a government fee.
Waived tests are not exempt from CLIA. The Certificate of Waiver, explained →
We confirm which certificate you need, check every test on your menu against FDA's waived categorization, look for your state's add-ons and check whether any site fits a multiple-site exception. $149, credited toward your first filing.
We prepare the CMS-116 and any state filing for your owner or director to sign, and can send the signed application to your state agency. CMS emails you a fee coupon and you pay on pay.gov; we follow it until your certificate arrives.
A new director, address, owner or test needs a notice, most within 30 days, and a new test before you run it. We prepare each change and watch your renewal dates and coupons, so nothing lapses and no look-alike invoice gets paid.
17 jurisdictions show a verified state lab filing on top of, or in place of, CLIA. Pick a state for its requirements, exemptions, fees and where the CMS-116 goes.
Practices, urgent care groups, pharmacies, telehealth companies, med spas and IV clinics, schools, employers, home health agencies and FQHCs that run patient tests. Adding a CLIA number to payer files is handled by our sister team at whiteglovecredentialing.com.
Yes. The CMS-116 says waived tests are not exempt from CLIA; a site running only waived tests needs a Certificate of Waiver. The waiver, explained.
Your owner or director signs the CMS-116, which carries your lab’s attestation and consent to inspection. CMS emails your fee coupon and you pay on pay.gov. We prepare everything and can send the signed application, but never collect a government fee.
No. The director is a regulated role your lab fills. A waiver lab has no federal director qualifications; PPM and nonwaived labs do, and we prepare the director’s documents for the application.
Usually not. Each fixed site needs its own certificate. Only mobile or temporary sites, limited public-health testing by not-for-profit or government labs, and a hospital campus can share one.
Some do. California, Pennsylvania, Hawaii, Maryland and Maine add filings that can reach waived testing, and New York and Washington run their own programs in place of CLIA for most labs. Look up your state.
A change in ownership, name, location or director needs a notice within 30 days. A waiver or PPM lab must notify the state agency before running a test outside its certificate.
No, and nobody honestly can. The state agency and CMS decide, on their own schedule. What we control is a complete application with a test menu that matches the FDA categorization of every test you run.
White Glove CLIA takes the paperwork out of testing. We build your test menu from each kit's instructions, prepare the CMS-116 and any state filing for your owner or director to sign, and track every certificate, change and renewal after that.
The rules are simple and easy to miss: waived tests still need a certificate, a for-profit chain needs one per site, a new director or address needs a notice within 30 days, and some states add their own registration. Since March 2026 CMS sends coupons and certificates by email only, and it has warned labs about look-alike invoices.
We never serve as your laboratory director, collect a government fee or send anything that looks like a CMS bill. Adding your CLIA number to payer files is handled by our White Glove Credentialing sister team.
A missing certificate has real costs: tests you cannot bill, a site that cannot open its testing, a change notice nobody filed.
233,448
labs holding a CLIA Certificate of Waiver
That is 81.6% of every lab outside New York and Washington, and 84,829 of them are physician offices. Waived testing is the norm, and it still needs a certificate.
$248
the CMS fee for a two-year Certificate of Waiver, as of October 2026
The lab pays it on pay.gov from the coupon CMS emails it. Since March 1, 2026 coupons and certificates arrive by email only.
30 days
to report a new director, owner, name or address
And a waiver lab must tell its state agency before it runs a test outside its certificate. Missed notices are the most common way a simple certificate goes wrong.
"A CLIA waiver looks like one form, and for one site it nearly is. Then a practice opens a second location, hires a new director, adds a flu test, or crosses into a state with its own registration, and each change has its own notice and deadline. We built White Glove CLIA to keep every site's certificate right so clinics can keep testing."
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