64B3-5.007: Director; Limitations and Qualifications
PURPOSE AND EFFECT: The proposed rule amendment clarifies the qualifications of directors.
SUMMARY: This proposed rule sets forth the licensure requirements for those clinical laboratory personnel who are responsible for and assure the overall operation and administration of a clinical laboratory and fulfill the responsibilities specified in Rule 64B3-13.002, F.A.C.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 483.805(4) FS.
LAW IMPLEMENTED: 483.800, 483.809, 483.815, 483.823(1), 483.824 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Joe Baker, Jr., Executive Director, Board of Clinical Laboratory Personnel, 4052 Bald Cypress Way, Bin # C07, Tallahassee, Florida 32399-3257
THE FULL TEXT OF THE PROPOSED RULE 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 applicants 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 of 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 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, CLDir(NCA) as Generalist or with certification in Chemistry, or certification in Clinical Chemistry or Toxicological Chemistry by NRCC. |
|
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) or HCLD(ABB) with certification in Embryology. |
|
Histocompatibility |
|
Doctoral Degree in a chemical, biological, or clinical laboratory science |
|
Diplomate of the ABHI or HCLD(ABB) with certification in Immunology. |
|
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 483.800, 483.041(5), 483.051(1), 483.809, 483.811(2), 483.815, 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,___________.