CLIA-waived labs
CLIA-waived lab paperwork, prepared.
What clia-waived labs in Texas, Florida and Arizona renew and keep on file, from official sources, and what we prepare for each.
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The short answer
A site that runs waived tests holds a CLIA Certificate of Waiver, which renews every 2 years for $248; CMS mails a fee coupon before it expires, and paying it renews the certificate. When your lab director, address, ownership or test menu changes, you file a CMS-116 change notice. Staff with exposure need an OSHA bloodborne pathogens plan, reviewed at least yearly, and annual training. Florida has no separate state lab license (it ended Jul 1, 2018). For Texas and Arizona, we confirm with you during the Clinic Check whether anything beyond CLIA applies.
Checked November 2, 2026 against the official sources below. General information, not legal or medical advice; your medical director and attorney confirm what applies to your clinic.
The list
What’s on the calendar, with sources.
Which of these apply depends on your services, devices and ownership. We confirm the list with you before anything goes on your calendar.
| Requirement | When | Fee | Official source |
|---|---|---|---|
| CLIA Certificate of WaiverSites that run waived tests | Every 2 years. CMS mails a fee coupon before it expires; paying it renews. | $248 / 2 yrs | CMS fee schedule |
| CLIA change notice (Form CMS-116)CLIA certificate holders | When the director, address, ownership or test menu changes | — | CMS QSO-24-03 |
| CLIA PPM certificateProvider-performed microscopy | Every 2 years | Per CMS schedule | CMS fee schedule |
| OSHA bloodborne pathogens exposure control planEmployers whose staff have occupational exposure | Reviewed at least once a year | — | 29 CFR 1910.1030 |
| OSHA bloodborne pathogens trainingStaff with occupational exposure | At assignment, then every year. Training records kept 3 years. | Course seats at cost | 29 CFR 1910.1030 |
| State clinical lab licenseLabs, including waived-test sites | None since Jul 1, 2018; CLIA still applies | — | AHCA clinical laboratories |
Why dates matter
- OSHA serious violation up to $16,550; willful or repeated up to $165,514 OSHA 2025 penalty adjustment (unchanged for 2026)
Maximums set by the agency. Listed so you know what’s at stake, not as a prediction.
What we do
We prepare. You sign.
- Build your calendar from the official sources above, confirmed with you
- Fill in each renewal with your clinic’s details, ready to sign
- Remind you at 90, 60, 30 and 7 days before each deadline
- Keep your inspection binder current, with proof of each filing
- Send clinical questions to your medical director and legal ones to your attorney
5coming due in 12 months
2look missing
1for your medical director
- Looks missingBloodborne pathogens plan: no annual review on fileOSHA 29 CFR 1910.1030
- Looks missingPrivacy training roster: none found for this yearYour training records
- For your medical directorSupervision paperwork: confirm it matches your current servicesAsk before you sign
- Coming dueLaser hair removal facility certificate · Mar 14TDLR · $750 / 2 yrs
How much does a CLIA Certificate of Waiver cost?
$248 every 2 years, according to the CMS fee schedule. CMS mails a coupon before it expires.
Do you act as our CLIA lab director?
No. We never act as your lab director, medical director or laser safety officer, and we never sign on your behalf. We prepare the paperwork they review and sign.
Free Clinic Check
Find out what your clinic owes this year.
A one-page list of what’s due and what looks missing, in 3 business days. No patient information, no obligation.