Applications and appropriate fees should be mailed to:

Laboratory Unit
Agency for Health Care Administration
Bureau of Health Facility Regulation
2727 Mahan Drive, Mail Stop #32
Tallahassee, FL 32308

Florida Non-Waived Clinical Laboratory Applications

For information on "waived" clinical laboratory applications, click the "Waived Laboratories" link in the local navigation bar to the left.

changes Please review recent changes that impact this program.
A new licensure rule became effective July 14, 2010 and new background screening regulations are effective August 1, 2010.

Clinical Laboratory application forms can be found at: http://ahca.myflorida.com/MCHQ/Corebill/index.shtml.

The recommended clinical laboratory applications forms in Adobe Acrobat PDF format contain all of the licensing forms and the federal CMS 116 form. We suggest that the "recommended" PDF form be used. Please refer to the check list on the applications to determine what forms are required.

For initial, renewal and *change of ownership applications:
Clinical Laboratory Recommended Application Form (pdf)

For addition of specialty applications:
 Clinical Laboratory Recommended Addition of Specialty Form (pdf)

*change of ownership means:

  • An event in which the licensee sells or otherwise transfers its ownership to a different individual or entity as evidenced by a change in federal employer identification number or taxpayer identification number; or
  • An event in which 51 percent or more of the ownership, shares, membership, or controlling interest of a licensee is in any manner transferred or otherwise assigned. This paragraph does not apply to a licensee that is publicly traded on a recognized stock exchange.
    [see s. 408.803(5), Florida Statutes]
    NOTE: Change of ownership applications must be filed 60 days prior to the effective date of the change. [see s. 408.807, Florida Statutes and s. 59A-35.070, Florida Administrative Code]

NOTE: Agency letters are often sent to applicants by certified mail. All letters are sent to the mailing address provided on the application. After submitting your application, please be prepared to accept and sign for any certified mail sent by the Agency. If the certified letter is sent back to the Agency as undeliverable or, in the case of those sent to the post office box, not accepted or not picked up, the application could be denied.

REGARDING FEES:

  • For STATE AGENCIES ONLY: Journal Transfer Protocols
  • "Starter Checks" will not be accepted
  • Fees are based on volume. A fee is not always required with an addition of specialty/subspecialty application. To ensure that the application is accepted, please submit a cover letter indicating fee calculations and whether a fee is required with the application.
  • How to count tests and determine fees: Fees
  • Applicants must submit one check separately with each application.  Do Not Combine payment for multiple applications into a single check. 

What constitutes a kickback in a lab?

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.


Director’s Qualifications

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

Avoid Omission Letters

Frequently Omitted Items Listing

Separate forms for response to omissions :

  1. Microscopy Evaluation Survey (complete if applying for "Provider-performed Microscopy" testing): (72kb.pdf)
  2. Self-Evaluation Survey (for laboratories that failed to renew and are seeking to reapply if surveyed within the past two years.
  3. CLIA Application Form CMS-116

Reporting Changes

Reporting Requirements for Director Changes

Changes required to be reported PRIOR TO change or implementation:

  • Changes in ownership [Chapter 408, Part II, Chapter 483, Part I and 59A-7.021, 59A-35, F.A.C.] application must be submitted and effective date provided in application.
  • Establishment of collection stations [59A-7.024, F.A.C.] approval also required prior to change
  • Addition of specialty or sub specialty [59A-7.030 F.A.C.] application required and approval , including successful on-site survey,  also required prior to change
  • Change in name or location. [59A-7.021 and 59A-35, F.A.C.]
  • Impending closure [59A-7.021 and 59A-35, F.A.C.]

Unit Contacts
    Area maps and unit contacts

NOTE: If after reviewing the application forms and statutory and rule requirements on our web site 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. 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.


Reporting Medicaid Fraud