Notice of Development of Rulemaking

DEPARTMENT OF HEALTH
Board of Clinical Laboratory Personnel
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,___________.