Laboratory Director Information
- 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:
Change in Lab Director:
- All changes must be reported within 21 days of change. [see R.59A-35.110(1)(c), Florida Administrative Code]
- 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
- A CLIA Application for Certification (Form CMS-116) marked “Other Changes”.
NOTE: The entire CMS-116 must be completed.
- A copy of the new director’s professional license (i.e. medical license or laboratory director’s license)
- 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]
- Proof of Compliance with Level 2 Background Screening for the new laboratory director.
- Sent to the Laboratory Licensure Unit