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) The scope of practice for licensed clinical laboratory personnel includes specimen collecting, processing, storing, shipping and performing manual pretesting procedures.

(2) The scope of practice for licensed clinical laboratory technicians, technologists, supervisors and directors includes interpretation of clinical laboratory test results.

(3) The purpose of the specialty of microbiology is to provide diagnostic testing for and optimum management of infectious disease in patients and to prevent the spread of infection to other individuals. Testing shall include procedures performed to culture, isolate, identify and determine the susceptibility of microbes. Testing also encompasses direct examination and microbial antigen detection methods. The term microbes includes bacteria, fungi, mycobacteria, viruses, rickettsia, parasites and emerging, unclassified infectious agents. Directors, supervisors, technologists, and technicians licensed in the specialty may provide consultation in the areas of infection control and epidemiology and administer intra-dermal skin tests and vaccines. Testing in this specialty also encompasses all laboratory procedures performed in the areas of infectious disease serology/immunology.

(4) The purpose of the specialty of serology/immunology is to detect and quantitate antibodies, to infectious agents as well as antigens. The specialty encompasses all the serological techniques (except those specific to immunohematology) used to detect the interaction of antigens with antibodies for evaluation of the consequences of the immune response. For those licensed in this specialty prior to February 11, 2022, the specialty also encompasses all laboratory procedures performed in the specialty of histocompatibility as defined in subsection (14).

(5) The purpose of the specialty of hematology is to quantitatively and qualitatively evaluate cells in peripheral blood and bone marrow, their production, maturation and release; their morphology, chemistry and function; and diagnostic testing for optimum management of primary and secondary hematological disorders. Testing in this specialty also encompasses all the routine and special procedures, including flow cytometry performed to evaluate the numbers, morphology and function of cells in body fluids including urine and the evaluation of hemostasis and thrombosis and the management of anticoagulant therapy.

(6) The purpose of the specialty of immunohematology is to insure the best possible outcomes of blood or blood components by the accurate performance of all pre-transfusion testing; to prevent transfusion transmitted infections; and to investigate and evaluate post-transfusion reactions.

(7) The purpose of the specialty of clinical chemistry is to perform qualitative and quantitative analyses on blood and body fluids and other materials to measure the chemical analytes; including blood gas analyses.

(8) The purpose of the specialty of blood donor testing is to perform all testing that pertains strictly to the processing of donor blood and blood products.

(9) All those licensed in blood gas analysis prior to February 11, 2022, shall be issued a limited license in Clinical Chemistry for blood gas analysis only.

(10) The purpose of the specialty of histology is to process cellular and tissue components through methods of fixation, dehydration, embedding, microtomy, frozen sectioning, staining, and other related procedures and techniques employed in the preparation of smears, slides, and tissues. This specialty also encompasses methods for antigen detection and other molecular hybridization testing methods where the purpose is analysis and/or quantification of cellular and tissue components for interpretation by a qualified physician. Technicians licensed in histology are limited to the performance of specimen processing, embedding, cutting, routine and special histologic staining, frozen sectioning and mounting of preparations under the general supervision of a director, supervisor, or technologist.

(11) The purpose of the specialty of cytology is to process and interpret cellular material derived from the human body delineating data regarding human cytopathological disease. Cytology includes:

(a) Review and interpretation of gynecological cytology preparations in accordance with the provisions of paragraph 64B3-13.003(2)(j), F.A.C.;

(b) Screening of non-gynecological cytology preparations where final review and interpretation is the responsibility of a qualified physician; and,

(c) Process, perform, review and correlate diagnostic techniques ancillary to liquid based cytology.

(12) The purpose of the specialty of cytogenetics is to determine the presence or absence of quantitative (numerical) and qualitative (structural) chromosome abnormalities relating to constitutional and acquired disorders. Laboratory personnel providing counseling associated with the results of cytogenetics testing shall be licensed in cytogenetics at the director level.

(13) 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, cytogenetics or molecular pathology may perform all molecular pathology procedures that are classified within the scope of the license specialty.

(14) 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. Clinical laboratory personnel who are licensed in the specialties of histocompatibility, serology/immunology or immunohematology may perform all testing as being within the scope of the specialty of histocompatibility.

(15) The purpose of the specialties of andrology and embryology is to quantitatively and qualitatively evaluate gametes and embryos as well as their associated fluids and tissues, their production, maturation and release, their morphology, numbers and motility, chemistry and function, cellular development, and diagnostic testing for optimum management of primary and secondary infertility, fertility assessment, and fertility preservation. This would encompass all testing and procedures involved in the production and storage of gametes and embryos, including micro-techniques and cryopreservation of gametes, embryos, associated fluids and tissues. Simple sperm count and motility could be excluded from the category of andrology.

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, 6-29-21, 5-2-22.