Frequently Omitted Items from Florida Applications for "Non-Waived" and Provider-Performed Microscopy Laboratories

• Applications for renewal, initial establishment or change of ownership CANNOT be accepted without payment. If an application is submitted without a check or money order made payable to "AHCA", it will be returned. If a check is received without an application, it will be returned. In the case of state agencies, a journal transfer must be properly made and proof of the transfer submitted with the application.
  
  
• The application must be signed by the Laboratory Director and submitted under oath.
  
  
• A "list of tests performed" must be properly completed. A list of the names of the tests the laboratory performs or intends to perform must be provided as well as the "test kit" or "instrument used". A "n/a" response or a notation simply indicating "urine" test, for example, will not be accepted. The name of the actual test is required. Example of a urine test system name: "Immunostics Inc., Detector Uristrip+ Analyzer".
  
  
• The Federal Tax ID number for the laboratory owner is requested in the application and must be provided. The name listed as the "owner" must be the same name/entity as the owner of the federal tax ID number. If John Doe has Tax ID # 1234 and that number is given in the application, then the owner listed must also be John Doe. The agency issues licenses to the laboratory owner. That individual/entity is a "licensee".
  
  • "Licensee" is defined in Chapter 408, Part II, Florida Statutes as an individual, corporation, partnership, firm, association, governmental entity, or other entity that is issued a permit, registration, certificate, or license by the agency. The licensee is legally responsible for all aspects of the provider operation.
    
    
    
• Initial applications and Change of Ownership applications require the submission of a Certificate of Status for corporate entities. This document verifies that Corporations, PA's and LLC's have complied with the Florida Department of State requirements and are authorized to conduct business in the State of Florida. This form can be obtained online at www.sunbiz.org . If your facility is a sole proprietorship, you should submit a copy of your W-9 instead of the Certificate of Status.
  
  
• Completion of all required forms. Applications are bundled on the clinical laboratory website for the applicant's convenience. Please complete all forms unless you are certain that one does not apply to your laboratory, please note the reason you believe it does not apply on the form and submit it.
  
  
• "Controlling Interest of Licensee" section of the application:
  • A "controlling interest" is defined under section 408.803 (7), Florida Statutes as (a) The applicant or licensee; (b) A person or entity that serves as an officer of, is on the board of directors of, or has a 5-percent or greater ownership in the applicant or licensee; or (c) A person or entity that serves as an officer of, is on the board of directors of, or has a 5-percent or greater ownership interest in the management company or other entity, related or unrelated, with which the applicant or licensee contracts to manage the laboratory.
    
    The term "controlling interest" does not include a voluntary board member.
    
    This section of the application is asking for information on the owner of the licensee as the word "licensee" is defined in section 408.403 (9), Florida Statutes, which is "an individual, corporation, partnership, firm, association, governmental entity, or other entity that is issued a permit, registration, certificate, or license by the agency. The licensee is legally responsible for all aspects of the provider operation." The "provider" is the laboratory. Therefore, if the licensee (the entity that holds the license), is ABS, Inc and the laboratory is called 123 Lab Services, then information in this section should be provided for whomever owns 5% or more of ABS, Inc. doing business as 123 Lab Services:
    
    If the owner of the licensee is a corporation, for example if JMB, Inc. owns ABS, Inc. doing business as 123 Lab Services, then the full name of the corporation, the corporation's business address and telephone number, the corporation's EIN number and the percentage of the licensee it owns need to be provided. In most cases, if a corporation does own the licensee, its ownership is 100%.
    
    If the owner of the licensee is a physician, for example if John Smith MD owns ABS, Inc. doing business as 123 Lab Services, then his or her full name, business address, telephone number, and if an EIN number has been obtained, the EIN number and the percentage of ownership.
    
    If the owner of the licensee is a number of different individuals, for example if John Smith MD with 59%, Jane Smith owns 10%, Bob Jones owns 30% and Kevin Casey owns 1% of ABS, Inc. doing business as 123 Lab Services, then this section should be completed with the name of each individual that owns 5% or more of the licensee. In this example, Kevin Casey's name does not need to be listed, but John and Jane Smith and Bob Jones do need to be listed.
    
    If no single corporation, limited liability company, individual or other entity owns 5% or more of the licensee, this should be noted and explained on an attached sheet. Further documentation may be required to demonstrate that multiple entities or individuals own very small percentages of the licensee.
    
    If the owner of the laboratory is a corporation, for example, then the corporate CEO and other officers would be listed. If these officers were also owners, the percentage of ownership should also be provided.
    
    If the owner of the laboratory is an individual and there was no "board" or there were no officers, then that should be noted. Additional documentation may be requested if information provided though-out the application does not consistently describe the same ownership.
    
    Section on "Voluntary Board Members and Officers of Licensee": This section is solely for those owners that have voluntary boards. Voluntary means no remuneration. This is often true of universities, for example.
    
    
• Health Care Licensing Application Addendum This separate application was created to protect individual social security numbers.
  
  • Applicants often provide conflicting information on this form when compared with similar information provided under "controlling interest" in other sections of the licensing application. For example, CEO information is requested in two areas of the application, in one area the percentage of ownership, if any, for the CEO is requested and in another the social security number is requested. When two different names are given as CEO of the same entity, this must be corrected before the application can be considered complete.
    
    Social security numbers of certain individuals must be provided according to section 408.806, Florida Statutes, which requires applicants for clinical laboratories and other facilities licensed under this section of the Florida Statutes to provide the name, address and social security number of the applicant and each controlling interest if the applicant or controlling interest is an individual. The statute also requires the name, address and federal employer identification number or taxpayer identification number of the applicant and each controlling interest if the applicant or controlling interest is not an individual. [refer to the definition of controlling interest provided above].
    
    
• Use of "N/A": This is often placed in areas of the application when information on the Department of State's website or other information within the application itself suggest that the response should not be "N/A". If there is a question about the information submitted, the applicant will be asked to explain in writing with supporting documentation, or at a minimum, a resubmitted notarized page that explains why the information is not applicable will be required. To avoid receiving an omission letter requesting clarification regarding the "N/A", it is better to explain initially why this is not applicable and provide any supporting documents.
  
  
• Demonstration that the laboratory administrator and chief financial officer (CFO) have had a Level II background screening within the past 5 years is often not provided properly. If the screening was done through the Department of Health or other state agency within the past 5 years, the Agency needs proof that Level II screening has been done so that we can see the results of the screening. If the screening has not been done, an on-line application description and payment option is available at: http://ahca.myflorida.com/MCHQ/Long_Term_Care/Background_Screening/index.shtml. In your application, please indicate that you have filed the Level II background screening request with the Agency's Background Screening Unit and give the date you filed with the Background Screening Unit, as well as the names and social security numbers of the individuals so that laboratory staff can check for results.
  
  
• An Affidavit of Compliance with Background Screening Requirements must also be filed with the application. This form is bundled with the application for your convenience but is also available at: http://ahca.myflorida.com/MCHQ/Corebill/index.shtml.
  
  
• The Provider-Performed Microscopy evaluation must be completed by laboratories seeking to obtain a Provider-Performed Microscopy license. This evaluation form is included within the application for your convenience.
  
  

Recommendations for Application Submission

• Review the application to ensure that you have properly entered Tax ID numbers and other information and that it is properly signed and notarized, prior to mailing.
  
  
• It is also suggested that any correspondence submitted to the Agency be sent with some type of mail receipt so that proof of date of delivery can be demonstrated.
  
• Ensure that you have paid any outstanding fine to the agency. If you are on a payment plan, make sure that you are current in your payments. If you owe the Agency monies, your license will be not issued until the monies are paid, or your payments are current, if on a payment plan.
  
  
• Ensure that you have submitted the proper application. If you are mailing your "renewal" application to the Agency on the day your current license expires, for example, even if sending it overnight, it cannot be accepted as a "renewal" application. In that case you must submit an "initial" application even though the application was mailed on the day your license expired because the Agency will not receive it until after your license expired.
  
  
• Ensure that your physical location is ready for survey prior to the Agency scheduling the survey.
  
  
• Ensure that you have paid your CLIA fees. Applicants wishing to establish non-waived laboratories will not be surveyed until their CLIA fee is paid.
  
  
• Fines are imposed on existing laboratories that fail to file an application at least 60 days before the expiration of the current license. The fine can be as much as $500.
  
  
• Changes of ownership applications must also be filed 60 days prior to the effective date of the change and must always be filed prior to the effective date of the change. If an application is not filed prior to the effective date of the change, the new owner cannot operate the laboratory without a license, and may be fined up to $1,000 per day with each day constituting a separate violation.