State and Federal Reporting Requirements
 Non-Waived Laboratory Director Changes

What is required:

1. All changes must be reported within 21 days of change. [see R.59A-35.110(1)(c), Florida Administrative Code]

2. The license holder must submit letter on the laboratory’s company letterhead that includes:

  • State of Florida Clinical Laboratory License Number (this number begins in 8000_____)
  • CLIA Identification Number (this number begins in 10D________)
    NOTE: Out-of-State laboratories should report director changes to the CLIA state agency where the laboratory is located.
  • Name of the outgoing director
  • Name of the new director
  • Effective date of the change

3. A CLIA Application for Certification (Form CMS-116) marked “Other Changes”. NOTE:  The entire CMS-116 must be completed.

4. A copy of the new director’s professional license (i.e. medical license or laboratory director’s license)

5. A copy of the director’s CV documenting his/her laboratory director qualifications – OR-  copies of board certifications, training, education, etc. verifying his/her laboratory director qualifications. (i.e. American Board of Pathology certification)  [see Rule 64B3-5.007, Florida Administrative Code & CLIA subpart M]

6. Proof of Compliance with Level 2 Background Screening for the new laboratory director. NOTE:  Florida law requires laboratory director’s to undergo Level 2 Background Screening every five (5) years.  Subsection 408.809(4), F.S. and Subsection 435.05(1)(a), F.S. require a licensee with a newly employed Laboratory Director (or Chief Financial Officer)  to notify the Agency and submit a request for Level 2 background screening or proof of compliance with background screening requirements within five (5) working days of the individual starting to work.     Acceptable proof is a copy of the results of this screening.  If you believe that the new laboratory director has been screened through this Agency within the past five years but, do not have a copy of the results –OR- if you need to request a screening please contact the Agency’s Background Screening Unit by telephone at (850) 412-4503 or at their website at:
7. All changes should be sent to:

AHCA, Laboratory Licensure Unit
 2727 Mahan Drive, MS 32
Tallahassee, Florida 32308

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