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.
  
  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) Submit 60 days prior to expiration of existing license. If not received by the Agency 60 days prior to expiration, the laboratory will be fined for late submission. 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)
  
  NOTE: Renewal applications are not accepted for laboratories that do not hold a current State of Florida license.

3. Change of Ownership Application (click link to download in Adobe PDF format) Submit 60 days prior to the effective date of the change in ownership. 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.

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]

4. Addition of Specialty or Subspecialty 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:

• Add a specialty or subspecialty to a licensed non-waived laboratory (check fee schedule and determine how to count tests for non-waived applications).

* 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.

 

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 Director and Chief Financial Officer is required at licensure renewal. If the Laboratory Director and CFO is the same individual, please note that in the application.
  
• Affidavit of Background Screening for Covered Employees must be signed by the Laboratory Director.
  
• Fingerprint cards are often rejected by the FBI because they cannot 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.

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The law regarding background screening changed effective July 1, 2009 (see pages 69-70 in this PDF document). One of those changes allows the submission 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 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 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 the following link: http://www.phppo.cdc.gov/clia/regs/subpart_m.aspx#493.1443.

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.