Clinical Laboratories

All facilities, including physician offices, performing any clinical laboratory testing, are required to obtain a state clinical laboratory license and a federal Clinical Laboratory Improvement Amendment (CLIA) certificate. The state clinical laboratory license must be issued before the laboratory is authorized to perform testing. The AHCA Laboratory Unit handles applications and changes for both the state laboratory licensure and federal CLIA certification programs. Initial and biennial inspections are required for facilities performing non-waived testing. Tests performed using a microscope are not waived. To determine whether a test is waived, see the "List of Waived Tests" under the section entitled "Links to other Websites..." below.

Florida Clinical Laboratory Applications:

• Renewal Application
  • Note: The renewal form will not be accepted if the laboratory license is expired. See the Reactivation after expiration if your license has expired.
• Initial Application
  • Note: Please complete the Initial Application if you wish to upgrade your Waived license to either Non-Waived or to add Provider-performed Microscopy.
    The initial application is also needed if you are downgrading your Non-Wavied lab to Wavied.
• Reactivation after expiration
• Change of Ownership
  • Note: Change in Ownership means an event in which the licensee changes to a different legal entity or in which 45 percent or more of the ownership, voting shares, or controlling interest in a corporation whose shares are not publicly traded on a recognized stock exchange is transferred or assigned, including the final transfer or assignment or multiple transfers or assignments over a 2-year period that cumulatively total 45 percent or greater. A change solely in the management company or board of directors is not a change of ownership. [see section 408.803(5), Florida Statutes]

Links to other websites for Clinical Laboratories:

• CMS CLIA website
• CLIA contractor and payment lockbox address for fee payments
• Federal CLIA information, includes application (FORM CMS-116)
• List of Waived Tests (.pdf)
• FDA website to check the complexity of a test
• List of Provider-performed Microscopy Procedures
• Florida Statutes (See Statutes and Constitution, Chapter 483, Part I for Clinical Laboratory Statute)
• Florida Administrative Code (See Chapter 59A-7 for Clinical Laboratory Rules)
• Florida Division of Corporations
• Florida Department of Health, Board of Clinical Laboratory Personnel
• Clinical Laboratory Personnel lookup
• Health Care Licensing Procedures Act

Background Screening:

Level 2 Background Screening must be completed for the laboratory director and the chief financial officer prior to approving the initial application and then repeated every five years. Please go to the background screening section of this web site for additional documentation that must be submitted with your application. Fingerprint cards are available by contacting the Laboratory Unit at 850-487-3109. Other fingerprint cards may not be acceptable.

Annual Affidavit of Background Screening Compliance

Each non - waived laboratory is required by section 435.04(05), Florida Statutes(2006) to submit an affidavit of compliance with this section. A recommended form is available at this the link below.

• Annual Background Screening Affidavit

Director’s Qualifications

Director qualifications must be submitted for all physician and non - physician laboratory directors.

The State of Florida requirements for laboratory directors can be found at the

Florida Administrative Code (See Chapter 59A-7 for Clinical Laboratory Rules) website:

http://www.flrules.org/gateway/ChapterHome.asp?Chapter=59A-7

CLIA requirements for directors of moderate complexity testing are at the following link: http://www.phppo.cdc.gov/clia/regs/subpart_m.aspx#493.1405,

CLIA requirements for directors of high complexity testing the requirements are at this link: http://www.phppo.cdc.gov/clia/regs/subpart_m.aspx#493.1443.

If after reviewing the application forms and statutory and rule requirements on our website you have additional questions, please call (850) 487-3109. Staff will be happy to answer questions that clarify the requirements as they apply to your specific situation, but cannot walk you through the application. Filling out the application is part of your responsibility as an applicant. The Agency's role in this process is to evaluate your application and, if there are elements missing from your application once submitted, provide you with an omissions response that gives you another opportunity to complete the application successfully. If you need extensive assistance in filling out your application, we would advise you to retain an attorney or a government relations consultant to assist you.