The Board proposes the rule amendment to update the scope of practice relative to specialty of licensure.

 

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 scope of practice relative to specialty of licensure.

SUMMARY: The scope of practice relative to specialty of licensure 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: Joe Baker, Jr., Acting Executive Director, Board of Clinical Laboratory Personnel, 4052 Bald Cypress Way, Bin # C07, Tallahassee, Florida 32399-3257; or by telephone at [phone].

 

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) No change.

(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, and 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 specialties of infectious disease serology/immunology (except those procedures specific to immunohematology and histocompatibility).

(4) The purpose of the specialty of serology/immunology is to detect and quantitate antibodies, to infectious agents as well as microbial and non-microbial 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, tThe specialty also encompasses all laboratory procedures performed in the specialty of histocompatibility as defined in subsection (14) (15).

(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 except those specific to cytology, 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. Testing in this specialty may also encompass urine chemistries specific to routine urinalysis.

(6) The purpose of the specialty of immunohematology is to insure the best possible outcomes of blood or blood components and apheresis by the accurate performance of all pre-transfusion testing; to prevent transfusion transmitted infections; and to investigate and evaluate post-transfusion reactions. The specialty also encompasses all laboratory procedures performed in the specialty of histocompatibility as defined in subsection (15).

(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 constituents; including automated serologic immunoassays and blood gas analyses. Individuals employed in plasmapheresis centers who perform only total protein by refractometer are not required to hold a license in clinical chemistry if they meet the requirements of 42 C.F.R. §493.1423 as published on October 1, 2007, and can document appropriate training.

(8) The purpose of the specialty of blood donor testing banking is to perform all testing identified as being within the scope of the specialty of immunohematology as well as testing within the scope of microbiology, clinical chemistry, hematology and serology/immunology that pertains strictly to the processing of donor blood and blood products. Clinical laboratory personnel who are licensed in the specialties of immunohematology, microbiology, clinical chemistry, hematology and serology/immunology may perform all testing identified as being within the scope of the specialty of blood banking.

(9) The purpose of the specialty of radioassay is to perform qualitative and quantitative analyses on body fluids such as blood, urine, and other materials to measure certain chemical constituents using radionuclides as part of the assay. The scope of practice in this specialty is limited to radioassay procedures and is also contained in the scope of clinical chemistry.

(9)(10) 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. The purpose of the specialty of blood gas analysis is to evaluate pulmonary function by measuring pCO2, pO2, pH, and hemoglobin in arterial blood by automated techniques. Instrument calculated values such as base excess, P50, oxygen content, oxygen saturation and associated parameters are also encompassed in this specialty. The scope of practice in this specialty is limited to blood gas analysis and is also contained in the scope of clinical chemistry.

(11) through (13) shall be renumbered as (10) through (12) No change.

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

(14)(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 immunohematology may perform all testing as being within the scope of the specialty of histocompatibility.

(16) In the specialties of clinical chemistry, hematology, immunohematology, microbiology and serology/immunology, clinical laboratory personnel licensed at the technician level may perform testing identified within the scope of each specialty in subsections 64B3-10.005(3) and (7), F.A.C., in any specialty for which they hold licensure if the tests are classified as highly complex pursuant to 42 C.F.R. C.F.R. §493.17 as published on October 1, 2007, incorporated by reference herein, only when under the direct supervision of a licensed technologist, supervisor, or director unless the technician meets the minimum qualifications contained in 42 C.F.R. C.F.R. §493.1489 as published on October 1, 2007, incorporated by reference herein, and the requirements contained in Rule 64B3-5.004, F.A.C.

(17) There is no technician license available in radioassay, blood gases, cytogenetics, or histocompatibility. However, clinical laboratory technicians licensed in the specialties of radioassay, blood gas analysis or cytogenetics prior to March 28, 1995, may continue to perform such testing under direct supervision.

(18) Individuals using flow cytometry or molecular detection techniques must be able to demonstrate training or experience in this procedure, and must hold licensure in the specific discipline for which they are using flow cytometry and molecular detection techniques.

(15)(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, 6-29-21,                               .

 

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 11, 2022

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