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Step 1

Be familiar with the regulations

Review applicable statutes and rules to ensure that you understand how to complete the application and what is required to hold a state clinical laboratory license and federal CLIA certificate.

Federal Regulations

Federal Clinical Laboratory Improvement Amendments (CLIA) regulations contained in 42 Code of Federal Regulation 493:
http://www.cms.gov/CLIA/03_Interpretive_Guidelines_for_Laboratories.asp#TopOfPage

State Regulations

Agency standard licensing requirements for all facilities are contained in Chapter 408, Part II, Florida Statutes.
State clinical laboratory regulations contained in Chapter 483, Part I, Florida Statutes.
Agency rules specific to clinical laboratories are contained in Chapter 59A-7, Florida Administrative Code.
Agency rules for all faciilties including clinical laboratories are contained in Chapter 59A-35, Florida Administrative Code.
Florida Statutes website:

Florida Administrative Code website:

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