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,___________.