Fla. Admin. Code Ann. R. 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.
Notes
Rulemaking Authority 483.805(4) FS. Law Implemented 483.813, 483.823, 483.825 FS.
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.
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.