The Board proposes the rule amendment to update the specialties of licensed clinical laboratory personnel who may perform all molecular pathology procedures that are classified within the scope of the license specialty.

 

DEPARTMENT OF HEALTH

Board of Clinical Laboratory Personnel

RULE NO.:RULE TITLE:

64B3-10.005Scope of Practice Relative to Specialty of Licensure

PURPOSE AND EFFECT: The Board proposes the rule amendment to update the specialties of licensed clinical laboratory personnel who may perform all molecular pathology procedures that are classified within the scope of the license specialty.

SUMMARY: The specialties of licensed clinical laboratory personnel who may perform all molecular pathology procedures that are classified within the scope of the license specialty 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) FS.

LAW IMPLEMENTED: 483.813, 483.823, 483.825 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.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B3-10.005 Scope of Practice Relative to Specialty of Licensure.

The following rules are not intended to prevent collection and storage of specimens or the performance of manual pretesting procedures by persons who are exempt by statute or statutorily authorized within their scope of practice. Clinical laboratory personnel qualified as a physician director, a licensed director, supervisor, technologist or technician in the specialty or specialties indicated can perform testing identified as being within the specialty. Tests which are not yet classified shall be assigned by the Board upon review.

(1) through (13) No change.

(14) The purpose of the specialty of molecular pathology is the use of molecular techniques for the characterization of gene expression (protein, RNA), genetic lesions (DNA) in cells, gene products (proteomics) and analysis on human DNA, RNA and chromosomes to detect heritable or acquired disease-related genotypes, mutations, and phenotypes. It includes the study of how the changes found lead to the disease process, monitoring of the effectiveness of therapy, and detection of residual disease. Techniques included are but not limited to immunohistochemistry, in situ hybridization, mutational analysis, protein analysis, polymerase chain reactions, cell culture and isolation, expression profiling, blotting and microarrays. Clinical laboratory personnel who are licensed in the specialties of microbiology, serology/immunology, clinical chemistry, hematology, immunohematology, histocompatibility, histology or molecular pathology may perform all molecular pathology procedures that are classified within the scope of the license specialty.

(15) through (19) No change.

Rulemaking Authority 483.805(4) FS. Law Implemented 483.813, 483.823, 483.825 FS. History–New 2-7-95, Amended 3-28-95, 7-12-95, 12-4-95, Formerly 59O-10.005, Amended 3-19-98, 1-28-99, 11-24-99, 2-15-01, 2-20-02, 10-30-02, 4-27-04, 2-23-06, 11-25-08, 12-30-09, 1-30-12, 2-21-16, 10-18-18,                                 .

 

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: February 12, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 5, 2021