The Board proposes the rule amendment to update the examinations for clinical laboratory personnel.

DEPARTMENT OF HEALTH
Board of Clinical Laboratory Personnel

Rule No.: RULE TITLE
64B3-5.007: Director; Limitations and Qualifications
PURPOSE AND EFFECT: The Board proposes the rule amendment to update the examinations for clinical laboratory personnel.
SUMMARY: Examinations for clinical laboratory personnel will be updated.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board has determined that the proposed rule amendments will not have an adverse impact on small business, nor will the proposed rule amendments be likely to directly or indirectly increase regulatory costs in excess of $200,000 in the aggregate in this state within 1 year after the implementation of the rule.
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: 381.0034(3), 483.800, 483.809, 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: Bruce Deterding, 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:

64B3-5.007 Director; Limitations and Qualifications.

(1) No change.

(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, or Diplomate of ABHI.
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.

 

Rulemaking Authority 483.805(4) FS. Law Implemented 381.0034(3), 483.800, 483.809, 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, 3-17-08, 6-17-09, 12-30-09,____________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Clinical Laboratory Personnel
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Clinical Laboratory Personnel
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 3, 2010
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: December 31, 2009