OUR EXPERTISE / PREPARE FOR THE TESTING YOU PLAN TO OFFER.
Application preparation for Florida practices and facilities planning to perform only CLIA-waived laboratory tests.
Discuss your current stage, relevant support, and next steps. By appointment · English & Spanish.
FLORIDA REQUIREMENTS & AUTHORITIES
A CLIA Certificate of Waiver is a federal laboratory certificate. Florida AHCA serves as the state agency for application processing. Match the certificate to the actual tests and devices your facility will use; “point of care” does not automatically mean a test is waived.
Reviewed October 22, 2026. Check the agency’s current forms and instructions for your application.
01 / HOW WE CAN HELP
Organize the exact test systems and intended services so the certificate pathway can be reviewed before application preparation.
Bring test and device names, the testing address, and an overview of the practice.
02 / HOW WE CAN HELP
SDC assists with organizing the CMS-116 information, application checklist, and administrative follow-up.
Discuss the proposed director, ownership, testing schedule, and estimated test volume.
03 / HOW WE CAN HELP
Plan for certificate maintenance, renewal reminders, and changes to laboratory information or testing scope.
Share the current certificate status and any notices or planned changes.
YOUR QUESTIONS, ANSWERED
AHCA states that Florida’s state clinical laboratory licensing requirement ended July 1, 2018. Federal CLIA requirements remain in effect; other applicable facility and professional requirements must still be considered.
AHCA distinguishes collection-only locations from facilities performing tests. A location that only collects specimens for testing elsewhere does not need a CLIA certificate for that collection activity.
CMS directs applicants to submit CMS-116 to their state agency, pay the certificate invoice, and receive the certificate before beginning testing. Certificates are effective for two years.
LET’S FIND YOUR NEXT STEP
Share your plans or the issue you’re working through.
We’ll discuss the support that fits your business.
