Initial Clinical Laboratory Application

Initial Clinical Laboratory 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 or a specialty or subspecialty or to downgrade your Non-Waived lab to Waived. This application should be used by laboratories that did not renew their state license prior to the expiration date and wish to reapply. A "Self-Evaluation Survey" in included that may be competed if the laboratory has been surveyed within the past two years.)
Level II Background Screening for Non-Waived Providers: The Agency for Health Care Administration's Background Screening website now accepts submission of background screening requests and electronic payment of screening fees.

Required Clinical Laboratory Application Fees:

Laboratory application fees are dependent upon the type of laboratory and the volume of tests performed

 

Background Screening for Non-Waived Providers and Provider-Performed Microscopy:

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 for Non-Waived Providers and Provider-Performed Microscopy

Each non - waived laboratory is required by section 435.05(3), Florida Statutes(2006) to submit an affidavit of compliance with this section. A recommended form is available at this the link below.

 

Frequently Omitted Items from Applications:
We anticipate adding lists of frequently omitted items for other types of applications soon

NOTE: 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.

 

Separate forms are available for those responding to staff omission requisitions . Note: All applicants must complete the information in items 1 through 5. Laboratories performing waived testing and provider-performed microscopy procedures (PPMP) must also complete item 6. Directors and Financial Officers of nonwaived laboratories must complete item 7.

  1. Initial State Laboratory Licensure Application, checklist, fee schedule and test menu form (AHCA FORM 3000-4)
  2. Health Care Licensing Application
  3. Health Care Licensing Application Addendum
  4. Declaration of Proposed Test Menu
  5. Volunteer Board Member Affidavit
  6. Microscopy Evaluation Survey (complete if applying for "Provider-performed Microscopy" testing): (72kb.pdf)
  7. Self-Evaluation Survey (for laboratories that failed to renew and are seeking to reapply if surveyed within the past two years.
  8. Affidavit of Compliance with Background Screening Requirements
  9. CLIA Application Form CMS-116

 


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