Laboratory Director Information

Laboratory Director Information

Qualifications:

• Director qualifications must be submitted for all physician and non-physician Laboratory directors.
• Documentation required to support the director's qualification must include copies of the director's curriculum vitae (CV).
• State of Florida requirements
• CLIA requirements for directors:
• Florida Administrative Code
• Moderate complexity testing
• High complexity testing

Change in Lab Director:

1. All changes must be reported within 21 days of change.
2. The license holder must submit letter on the Laboratory’s company letterhead that includes:
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) 
6. Proof of Compliance with Level 2 Background Screening for the new Laboratory director.
7. Sent to the Laboratory Licensure Unit
8. State of Florida Clinical Laboratory License Number (this number begins in 8000_____)
9. 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.
10. Name of the outgoing director
11. Name of the new director
12. Effective date of the change