The Board proposes a rule amendment to substantially rewrite the director; limitations and qualifications.

 

DEPARTMENT OF HEALTH

Board of Clinical Laboratory Personnel

RULE NO.:RULE TITLE:

64B3-5.007Director; Limitations and Qualifications

PURPOSE AND EFFECT: The Board proposes a rule amendment to substantially rewrite the director; limitations and qualifications.

SUMMARY: Substantial rewrite of the director; limitations and qualifications.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

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.

RULEMAKING AUTHORITY: 483.805(4) FS.

LAW IMPLEMENTED: 381.0034(3), 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 THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Dayle Mooney, Executive Director, Board of Clinical Laboratory Personnel, 4052 Bald Cypress Way, Bin # C07, Tallahassee, Florida 32399-3257, [phone] or by email, [e-mail].

 

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 C.F.R. §493.1443, effective January 24, 2003, which is incorporated by reference and adopted herein, available at www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5.pdf or at http://www.flrules.org/Gateway/reference.asp?No=Ref-08716. The applicant shall complete a one hour educational course acceptable to the Board on human immunodeficiency virus and acquired immune deficiency syndrome or provide an affidavit that the course will be completed within six (6) months of licensure.

(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. Degrees not in a chemical or biological science must be reviewed by the board pursuant to subsection 64B3-6.002(8), F.A.C.

(a) All Specialties.

Option	Education	Certification	Training/Experience
1a	Florida Licensed Physician (does not require a separate laboratory director license)	ABP – Clinical Pathology; AOBP – Clinical Pathology	As required by certifying body.
1b	Florida Licensed Physician (does not require a separate laboratory director license)	ABIM – certified in pertinent specialty; AOBIM – certified in pertinent specialty; ABMM – certified in pertinent specialty; ABCC – certified in pertinent specialty; ABNM – certified in pertinent specialty; AOBNM – certified in pertinent specialty; ABMG – certified in pertinent specialty; ABB – certified in pertinent specialty; ABMLI – certified in pertinent specialty; ABHI – certified in pertinent specialty	As required by certifying body.
1c	Florida Licensed Physician  (does not require a separate laboratory director license)	Not required	Four (4) years of pertinent clinical laboratory experience (post-graduate), with two (2) years experience in the specialty to be directed.

(b) Histology, Cytology.

Option	Education	Certification	Training/Experience
1	Florida Licensed Physician (does not require a separate laboratory director license)	ABP – Anatomical Pathology or Cytopathology; AOBP – Anatomical Pathology or Cytopathology   For Dermatopathology Only: ABD – Dermatopathology; AOBD – Dermatopathology	As required by certifying body.

(c) Oral Pathology Laboratories.

Option	Education	Certification	Training/Experience
1	Florida Licensed physician or dentist (does not require a separate laboratory director license)	ABOP – Anatomical Pathology ABP – Anatomical Pathology AOBP – Anatomical Pathology	As required by certifying body.

(d) Microbiology.

Option	Education	Certification	Training/Experience
1	Doctoral Degree in chemical, biological, or clinical laboratory science	ABMM – Clinical Microbiology; HCLD(ABB) - Microbiology	As required by certifying body.

(e) Hematology.

Option	Education	Certification	Training/Experience
1	Doctoral Degree in chemical, biological, or clinical laboratory science	HCLD (ABB) - Hematology	As required by certifying body.

(f) Cytogenetics.

Option	Education	Certification	Training/Experience
1	Doctoral Degree in chemical, biological, or clinical laboratory science	ABMG – Clinical Cytogenetics	As required by certifying body.

(g) Serology/Immunology.

Option	Education	Certification	Training/Experience
1	Doctoral Degree in chemical, biological, or clinical laboratory science	ABMLI – Clinical Immunology HCLD(ABB) – Immunology ABHI Diplomate	As required by certifying body.

(h) Clinical Chemistry.

Option	Education	Certification	Training/Experience
1	Doctoral Degree in chemical, biological, or clinical laboratory science	ABCC – Clinical Chemistry; HCLD(ABB) -Chemistry; ABT Diplomate; NRCC – Clinical or Toxicological Chemist; F-ABFT – Clinical or Toxicological Chemist; ABFT - Toxicology	As required by certifying body.

(i) Andrology.

Option	Education	Certification	Training/Experience
1	Doctoral Degree in chemical, biological, or clinical laboratory science	HCLD (ABB) - Andrology	As required by certifying body.

(j) Embryology.

Option	Education	Certification	Training/Experience
1	Doctoral Degree in chemical, biological, or clinical laboratory science	ELD(ABB) – Embryology; HCLD(ABB) - Embryology	As required by certifying body.

(k) Histocompatibility.

Option	Education	Certification	Training/Experience
1	Doctoral Degree in chemical, biological, or clinical laboratory science	ABHI – Immunology HCLD(ABB) - Immunology	As required by certifying body.

(l) Molecular Pathology.

Option	Education	Certification	Training/Experience
1	Doctoral Degree in chemical, biological, or clinical laboratory science	ABCC – Molecular Pathology; ABMG – Molecular Genetics; HCLD(ABB) – Molecular Diagnostics	As required by certifying body.

Rulemaking Authority 483.805(4) FS. Law Implemented 381.0034(3), 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, 1-30-12, 2-23-16, 10-17-17, 5-26-21, _________.

 

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: August 24, 2022

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 19, 2022