Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Alabama
- The Alabama rules waive state proficiency testing for CLIA-waived tests even for licensed independent labs.
Does Alabama require a state lab license on top of CLIA?
Alabama licenses independent clinical laboratories: labs that operate apart from other licensed health care facilities and test specimens on referral, plus specimen collection stations. Physician offices are excluded from the collection station definition. Whether a practice, pharmacy or clinic running waived tests for its own patients needs this license was not confirmed.
- Independent clinical laboratory license
- Issued by Alabama State Board of Health (Alabama Department of Public Health)
Citation: Code of Ala. 22-21-20 et seq.; Ala. Admin. Code ch. 420-5-8
Who is exempt in Alabama?
The rules exclude federal and state laboratories and labs run under the Department of Mental Health. Physician offices are excluded from the definition of a collection station.
Citation: Ala. Admin. Code r. 420-5-8-.01
What does Alabama charge?
Each license application carries a fee "as mandated by statute"; the amount was not confirmed.
Citation: Ala. Admin. Code r. 420-5-8-.02(2)(b)
Where does a Alabama CMS-116 go?
- Alabama Department of Public Health, Division of Health Care Facilities, CLIA Program
- Email: CLIAAlabama@adph.state.al.us
- Phone: (334) 206-5120
Opening a testing site in Alabama?
We prepare the CMS-116 and any Alabama filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.