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: http://ahca.myflorida.com/MCHQ/Central_Services/Background_Screening/
7. All changes should be sent to:
AHCA, Laboratory Licensure Unit
2727 Mahan Drive, MS 32
Tallahassee, Florida 32308