Laboratory Director Information

Carlton Enfinger
Manager, Laboratory Licensure Unit

Bureau of Health Facility Regulation
2727 Mahan Drive - Mail Stop #32
Tallahassee, FL 32308
(850) 412-4500
(850) 410-1511 Fax

Qualifications:

Change in Lab Director:

  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:
    1. State of Florida Clinical Laboratory License Number (this number begins in 8000_____)
    2. 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.
    3. Name of the outgoing director
    4. Name of the new director
    5. 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.
  7. Sent to the Laboratory Licensure Unit
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