The Board proposes the rule amendment to update the definitions applicable to clinical laboratory personnel.

 

DEPARTMENT OF HEALTH

Board of Clinical Laboratory Personnel

RULE NO.:RULE TITLE:

64B3-2.003Definitions

PURPOSE AND EFFECT: The Board proposes the rule amendment to update the definitions applicable to clinical laboratory personnel.

SUMMARY: The definitions applicable to clinical laboratory personnel will be updated.

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, based upon the expertise and experience of its members, 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), 483.811(2) FS.

LAW IMPLEMENTED: 483.803, 483.811, 483.821, 483.823 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: Christina McGinnis, Executive Director, Board of Clinical Laboratory Personnel, 4052 Bald Cypress Way, Bin # C07, Tallahassee, Florida 32399-3257, [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

64B3-2.003 Definitions.

(1) through (4) No change.

(5) Academic science is a science course with a chemical or biological science prefix. Acceptable courses include general chemistry, organic chemistry, biochemistry, qualitative or quantitative analysis, general biology, zoology, physiology, comparative anatomy, bacteriology, parasitology, cell biology, cellular metabolism, virology, physics, and immunology, microbiology, genetics, and molecular/celluar biology. For purposes of this rule, the courses of geology, astronomy, entomology, environmental testing including water testing, oceanography, marine biology and physical science, or remedial, preparatory or introductory science courses shall not be acceptable.

(6) Applied science is a physical, chemical or biological science course which is specific to a major and directly prepares the individual for performance in a specific profession. Examples of such courses are chemistry for health science majors or nurses, pharmacy, clinical chemistry, clinical microbiology, clinical hematology, advanced entomology, and oceanography.

(7) Pertinent clinical laboratory experience is experience in a clinical laboratory as defined in Section 483.803(2), F.S. If acquired in-state Florida or in a state where personnel licensure is required, experience must be accrued while licensed and working in a Clinical Laboratory Improvement Amendments (CLIA) certified licensed laboratory, or unless in an exempt laboratory as defined by Section 483.801, F.S. otherwise authorized by the administrative rules of this Board. Experience acquired as a part of a training program may not be used as pertinent clinical laboratory experience. Exempt experience may not be utilized with the exception of experience in federal laboratories. For purposes of this rule, eExperience in a training program, industrial laboratory, or research laboratory laboratories is not considered pertinent clinical laboratory experience. Experience in research laboratories is not considered pertinent clinical laboratory experience. unless the research experience involved human subjects and used methodologies, quality control and quality assurance techniques comparable to those of clinical laboratories. If all of these requirements are met the Board will review the research experience to determine if it is relevant experience. If research experience was acquired under an exemption clause, it may not be utilized as pertinent clinical laboratory experience. Experience acquired in an exclusive use laboratory environment, waived laboratory environment or alternate site testing environment is generally unacceptable unless specifically authorized by rules of this Board.

(8) through (17) No change.

Rulemaking Authority 483.805(4), 483.811(2) FS. Law Implemented 483.803, 483.811, 483.821, 483.823 FS. History–New 11-4-93, Formerly 61F3-2.003, Amended 11-21-94, 11-30-94, 12-26-94, 5-3-95, 7-12-95, Formerly 59O-2.003, Amended 3-19-98, 12-13-98, 3-28-99, 9-12-99, 11-15-99, 3-24-02, 10-30-02, 2-1-04, 1-8-06, 8-14-06, 1-30-12, 2-7-13, 11-25-14, 2-23-16, 7-29-19, 12-31-19,______________________.

 

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: July 23, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 1, 2021