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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 Clinical Non-Waived Laboratory Applications

There are 3 types of non-waived applications: : (Effective July 1, 2009, there is no longer a requirement to hold a State of Florida license for waived testing only. If a microscope is used, then the laboratory is a non-waived laboratory and must hold a valid State of Florida license before beginning operations.)

  1. Initial clinical laboratory applications
  2. Applications to renew the laboratory's license (submitted 60 days prior to expiration)
  3. Change of Ownership applications (submitted 60 days prior to effective date of change)
    Change in 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 the licensee is in any manner transferred or otherwise assigned. This does not apply to a licensee that is publicly traded on a recognized stock exchange. [see section 408.803(5), Florida Statutes]

1. Initial Clinical Laboratory Application (click link to download in Adobe PDF format) This application must be submitted with the appropriate fee* to be accepted and is used for clinical laboratories applying to:

  • Open a non-waived laboratory (check fee schedule and determine how to count tests for non-waived applications)
  • Reopen a non-waived (check fee schedule and determine how to count tests for non-waived applications)
    Note: 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" is included that may be competed if the laboratory has been surveyed within the past two years.
  • Add a specialty or subspecialty to a licensed non-waived (check fee schedule and determine how to count tests for non-waived applications)

    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.

2. Renewal Application (click link to download in Adobe PDF format) This application must be submitted with the appropriate fee* to be accepted and is used for clinical laboratories applying to:

  • Renew the clinical laboratory license. (check fee schedule and determine how to count tests for non-waived applications)
  • Renew and add a specialty or subspecialty to the non-waived license. (check fee schedule and determine how to count tests for non-waived applications)

3. Change of Ownership Application (click link to download in Adobe PDF format) This application must be submitted with the appropriate fee* to be accepted and is used for clinical laboratories applying to:

  • Change the owner of a currently licensed clinical laboratory. [see section 408.803(5), Florida Statutes]. Ownership can only be changed if the current owner holds a license that has not expired.

New
Requirements Effective 7/1/2009:

  • Voluntary Board Member Affidavits are no longer required. (see page 67 in changes in law)
  • The Laboratory Director, Chief Financial Officer and controlling interest as defined under section 409.803 (7), Florida Statutes, must submit social security numbers. Forms are currently being revised, but until they can be revised, please use recommended form "Health Care Licensing Application Addendum". [see section 408.806(1)(a), Florida Statutes]
  • Affidavit for background screening for covered employees may be submitted with the application rather than annually.
  • Renewal applications submitted more than 120 before the expiration date must be returned to the applicant and cannot be accepted by the Agency.

*For STATE AGENCIES ONLY: Journal Transfer Protocols
*"Starter Checks" will not be accepted

The Agency is currently revising licensing applications. DRAFTS of the 3 non-waived applications are below. Once these applications have been adopted in section 59A-7.021, Florida Administrative Code by reference, they willl be available for use:

Voluntary Board Member Affidavites are no longer required (see page 67 in changes in law)

Level II Background Screening for Non-Waived & Provider-Performed Microscopy Providers:(click link for information) The Agency for Health Care Administration's Background Screening website now accepts submission of background screening requests and electronic payment of screening fees.

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.
  • Affidavit of Compliance with Background Screening ( form) for the Laboratory Driector and Chief Financial Officer is required at licensure renewal. If the Laboratory Director and CFO are the same individual, please note that in the application.
  • Fingerprint cards are often rejected by the FBI because they can not be read .  This can be caused by frequent hand washing over a number of years.  The FBI requires the submission of a second fingerprint card in order to complete the screening.  The Agency’s Background Screening Unit will send a letter to the director of the clinical laboratory requesting a new fingerprint card for the individual . If the new card is submitted within 21 days of the date of the Agency’s request, it will be   processed at no additional charge. If it is not submitted within 21 days of the Agency’s request, the individual will have to begin again and repay for the screening.  The Agency’s Background Screening Unit typically knows within 72 hours if  the second set of finger prints will be rejected and will immediately request a “Name Check Only” search through the FBI . It may take several weeks before the Agency receives the result of a “Name Check Only” from the FBI.

The law regarding background screening changed effective July 1, 2009 (see pages 69-70 in this PDF document). One of those changes allows the submittion of the "annual" Affidavit of Background Screening for Covered Employees for Non-Waived Providers and Provider-Performed Microscopy to be submitted with each licensure renewal every two years. 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.

Director’s Qualifications
Documentation required to support the director's qualification must include copies of the director's curriculum vitae.

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

 

Avoid Omission Letters

Frequently Omitted Items from Applications:

 

Separate forms are available for those responding to staff omission requisitions .

  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 - NO LONGER REQUIRED (see 2009 changes in Florida law page 67)
  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
  10. Affidavit of Background Screening for Covered Employees

     

Unit Contacts
    Area maps and unit contacts

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. 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.