The proposed rule amendment clarifies the qualifications of directors.  


  • RULE NO: RULE TITLE
    64B3-5.007: Director; Limitations and Qualifications
    PURPOSE AND EFFECT: The proposed rule amendment clarifies the qualifications of directors.
    SUBJECT AREA TO BE ADDRESSED: Directors.
    SPECIFIC AUTHORITY: 483.051, 483.805(4) FS.
    LAW IMPLEMENTED: 483.041(5), 483.051(1), 483.809, 483.811(2), 483.823(1), 483.824 FS.
    IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE WEEKLY.
    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Joe Baker, Jr., Executive Director, Board of Clinical Laboratory Personnel, 4052 Bald Cypress Way, Bin #C07, Tallahassee, Florida 32399-3257

    THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

    (Substantial Rewording of Rule 64B3-5.007 follows. See Florida Administrative Code for present text.)

    64B3-5.007 Director; Limitations and Qualifications.

    (1)  All applications for a Director license must have the qualifications for a High Complexity Laboratory Director, listed in 42 CFR 493.1443.

    (2)  In addition, at least one of the following requirements must be met for specific areas of licensure.  In some cases, there are multiple options for meeting the requirements.

     

    Specialty

    Option

    Education

    Training/Experience

    Certification

     

    All Specialties

     

    1

     

    Licensed physician (does not require a separate laboratory director license)

     

     

    Certification in Clinical Pathology by the ABP or AOBP

     

     

    2

     

    Licensed physician (does not require a separate laboratory director license)

     

     

    Certification in the pertinent laboratory specialty by ABIM, AOBIM, ABMM, ABCC, ABNM, AOBNM, ABMG, ABB, ABMLI, ABHI

     

     

    3

     

    Licensed physician (does not require a separate laboratory director license)

     

    Four years pertinent clinical laboratory experience (post-graduate), with two years experience in the specialty to be directed

     

     

    Histology, Cytology

     

     

    Licensed physician (does not require a separate laboratory director license)

     

     

    Certification in Anatomical Pathology or Cytopathology by ABP or AOBP. For dermatopathology only, certification in Dermatopathology by the ABD or AOBD

     

    Oral Pathology Laboratories

     

     

    Licensed physician or dentist (does not require a separate laboratory director license)

     

     

    Certification in Anatomical Pathology by ABOP, ABP, or AOBP

     

    Microbiology

     

     

    Doctoral Degree in a chemical, biological, or clinical laboratory science

     

     

    Certification in Clinical Microbiology by ABMM, HCLD(ABB) with certification in Microbiology, or CLDir(NCA) as Generalist or with certification in Microbiology

     

    Hematology

     

     

     

    Doctoral Degree in a chemical, biological, or clinical laboratory science

     

    HCLD(ABB) in Hematology or CLDir(NCA) as Generalist of with certification in Hematology

     

     

    Cytogenetics

     

     

    Doctoral Degree in a chemical, biological, or clinical laboratory science

     

     

    Certification in Clinical Cytogenetics by ABMG

     

    Serology/Immunology

     

     

     

    Doctoral Degree in a chemical, biological, or clinical laboratory science

     

     

    Certification in Clinical Immunology by ABMLI, HCLD(ABB) with certification in Immunology, or CLDir(NCA) as Generalist

     

    Clinical Chemistry

     

     

    Doctoral Degree in a chemical, biological, or clinical laboratory science

     

     

    Certification in Clinical Chemistry by ABCC,  HCLD(ABB) with certification in Chemistry, or CLDir(NCA) as Generalist or with certification in Chemistry

     

    Andrology

     

     

    Doctoral Degree in a chemical, biological, or clinical laboratory science

     

     

    HCLD(ABB) with certification in Andrology

     

    Embryology

     

     

    Doctoral Degree in a chemical, biological, or clinical laboratory science

     

     

    ELD(ABB)

     

    Histocompatibility

     

     

    Doctoral Degree in a chemical, biological, or clinical laboratory science

     

     

    Diplomate of the ABHI

     

    Molecular Pathology

     

     

    Doctoral Degree in a chemical, biological, or clinical laboratory science

     

     

    Certification in Molecular Pathology by ABCC, certification in Molecular Genetics by ABMG, or HCLD(ABB) with certification in Molecular Diagnostics

     

    Specific Authority 483.051, 483.805(4) FS. Law Implemented 483.041(5), 483.051(1), 483.809, 483.811(2), 483.823(1), 483.824 FS. History–New 6-6-85, Formerly 10D-41.67, Amended 3-11-90, Formerly 10D-41.067, Amended 7-1-97, Formerly 59O-5.007, Amended 5-26-98, 3-2-99, 3-24-02, 10-14-02, 4-20-04, 2-23-06,___________.

Document Information

Subject:
Directors.
Purpose:
The proposed rule amendment clarifies the qualifications of directors.
Rulemaking Authority:
483.051, 483.805(4) FS.
Law:
483.041(5), 483.051(1), 483.809, 483.811(2), 483.823(1), 483.824 FS.
Contact:
Joe Baker, Jr., Executive Director, Board of Clinical Laboratory Personnel, 4052 Bald Cypress Way, Bin #C07, Tallahassee, Florida 32399-3257
Related Rules: (1)
64B3-5.007. Director; Limitations and Qualifications