Practice Tools
CLIA Waiver Application Tool
Get your practice certified to run in-office point-of-care tests. This tool prepares your CLIA Certificate of Waiver application in about five minutes.
- Fills out your federal CMS-116 for you
- Routes it to the right agency in your state
- Writes a ready-to-send cover email
- You review, sign, and send
About 5 minutes3 short stepsAll 50 states
The Tests This Waiver Covers
These are the three point-of-care tests that require a CLIA Certificate of Waiver. Once your waiver is on file, your practice can run and bill all three.
Tear Osmolarity
ScoutPro Osmolarity System
Bausch + Lomb point-of-care tear osmolarity for dry eye testing.
MMP-9 Inflammation
InflammaDry
Quidel in-office test that detects elevated MMP-9, a marker of ocular surface inflammation.
Adenovirus
QuickVue Adenoviral Test
Quidel rapid test that helps identify adenoviral conjunctivitis at the point of care.
Why These Tests Need a Waiver
Running even one test on a human sample to guide diagnosis or treatment makes your office a laboratory under federal law. Tear osmolarity, MMP-9, and adenovirus tests all qualify, so you need a CLIA certificate before you run them.
Read the FDA's official CLIA overview if you want the full federal detail.
A Certificate of Waiver just needs a named lab director, with no federal education or experience requirement for that role. Source: CMS, How to Apply for a CLIA Certificate, cms.gov 2026.
Why Dry Eye Rescue Built This
Most distributors sell the test and leave the paperwork to you. Getting the waiver right for your state is what slows practices down, so we built the tool to fill it out and route it, so you can start testing sooner.
Important Disclaimer
This tool helps you prepare a federal application. It is not legal advice, and Dry Eye Rescue is not affiliated with the Centers for Medicare and Medicaid Services or any state agency. You are responsible for reviewing every entry for accuracy and for signing the application before you send it. State requirements can change, so confirm the current attachments and submission details with your state agency. The lab director or owner signs the CMS-116 under penalty of law, so read the completed form carefully before submitting. Product and brand names referenced on this page are trademarks of their respective owners.
Frequently Asked Questions
What is a CLIA Certificate of Waiver?
It is the federal certificate that lets your practice legally perform tests that the FDA has categorized as waived, meaning simple and low risk. InflammaDry, ScoutPro Osmolarity, and the QuickVue Adenoviral test are all waived, so a Certificate of Waiver covers them. For the full federal overview, see the FDA's CLIA page.
Which Dry Eye Rescue tests need a waiver?
The three point-of-care tests we distribute that require CLIA are InflammaDry (MMP-9), the ScoutPro Osmolarity System (tear osmolarity), and the QuickVue Adenoviral Conjunctivitis test (adenovirus). This tool lists all three so you can include the ones you plan to run.
How much does it cost to apply?
You send no money with the application. After your state agency processes the CMS-116, it issues a fee coupon, and you pay the Certificate of Waiver fee at that point. Fees are set by CMS and billed on a two-year cycle.
How long does approval take?
It varies by state, but many practices receive a CLIA number within a few weeks of the state agency receiving a complete application. Sending a complete, accurate form with the right attachments is the best way to avoid delays.
Do I need a lab director?
Yes. A Certificate of Waiver still requires a named laboratory director, usually the practice owner or a doctor at the practice. For a waiver there are no federal education or experience requirements for that role, so most practices name a doctor already on staff.
What do I attach besides the CMS-116?
For a straightforward Certificate of Waiver, the CMS-116 is often enough, but some states ask for extra items such as an ownership disclosure form or a copy of your tax identification letter. The tool shows the checklist for your state on the final screen.
My state runs its own program. What changes?
A few states, including New York and Washington, run their own laboratory licensing programs alongside CLIA. If you choose one of those states, the tool flags it and points you to the right program and any extra steps, so you do not send your form to the wrong place.
Does Dry Eye Rescue submit the application for me?
No. The tool fills out the form and prepares the cover email, but you review and sign it, then send it yourself. A CLIA application is a signed federal document, so it has to come from you. We can answer questions along the way.
Start Your CLIA Waiver
Fill out your CMS-116 in about five minutes, then stock the point-of-care tests it covers.
