64B3-10.005: Scope of Practice Relative to Specialty of Licensure
PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify which specialties may perform certain testing.
SUMMARY: Which specialties may perform certain testing will be clarified.
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: 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 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:
64B3-10.005 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, and molecular pathology may perform all testing identified as being within the scope of the specialty of molecular pathology.
(15) The purpose of the specialty of histocompatibility is to insure the best possible results of the determination of tissue compatibility, prevent transmitted infections, and to investigate and evaluate post-transplant problems. The specialty encompasses blood typing, HLA typing, HLA antibody screening, disease markers, Cluster Designation specific to tissue compatibility, flow cytometry, crossmatching, HLA antibody identification, lymphocyte immunophenotyping, immunosuppressive drug assays, allogenic, isogeneic and autologous bone marrow processing and storage, mixed lymphocyte culture, stem cell culture, cell mediated assays, and assays for the presence of cytokines. This specialty would also encompass all testing within the scope of serology/immunology, microbiology, hematology and immunohematology that pertain strictly to the processing of organ, tissue and bone marrow donors, and pre- and post- transplant patients. Clinical laboratory personnel who are licensed in the specialties of histocompatibility, serology/immunology or and immunohematology may perform all testing as being within the scope of the specialty of histocompatibility.
(16) through (19) No change.
Rulemaking Authority 483.805(4) FS. Law Implemented 483.813, 483.823, 483.825 FS. HistoryNew 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,_________.
