CLIA Application Processing
Application Processing Service + Rates
We specialize in helping startups and growing laboratories complete their applications for CLIA and COLA certification and accreditation. We understand that this process can be long, complex, and frustrating. With our extensive experience, we can streamline the process from start to finish.
How We Can Help
We help clients navigate the complex Federal and State regulatory landscape when starting a new lab or growing the test menu of their existing laboratory.
Our comprehensive approach includes recruiting a qualified Laboratory Director, determining the test menu, enrolling with deemed agencies, ownership disclosures, validation plans, and filing the CMS 116 application.
We consult and offer strategic guidance along the way to ensure our clients are able to quickly and compliantly start testing.
We successfully filed over 100 CLIA applications last year (in 2020) with most of our clients receiving their CLIA Certificate of Registration in less than a month.
Comprehensive CLIA, COLA, and state license application processing services rates are as follows:
- CLIA – Starts at $1,000
- CMS Region VI Toxicology Specialty – $3,500
- COLA – $1,000
- NPI – $500
- Medicare – $5,500
- California – $5,500
- Maryland – $3,000
- New York – Starts at $5,500
- Nevada – Starts at $4,500
- Pennsylvania – $2,500
- Rhode Island – $2,500
NOTE: Prices may vary
Many states allow out-of-state laboratories to accept specimens, but a number require special licensure or permitting. Our team helps laboratories apply in every state they plan to enter, so your team can focus on your lab’s operations and growth.