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

 

DEPARTMENT OF HEALTH

Board of Clinical Laboratory Personnel

RULE NO.: RULE TITLE:

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

PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify the scope of practice relative to specialty of licensure.

SUMMARY: The scope of practice relative to specialty of licensure will be clarified.

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: Anthony Spivey, 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 (2) No change.

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

(4) through (6) No change.

(7) The purpose of the specialty of clinical chemistry is to perform qualitative and quantitative analyses on body fluids such as blood, urine, spinal fluid, feces, tissue, calculi and other materials to measure the chemical constituents; including but not limited to carbohydrates, proteins, lipids, enzymes, non-protein nitrogenous substances, electrolytes, blood gases, trace elements, inorganic compounds, therapeutic and drugs of abuse, hormones, vitamins, tumor markers, other including automated serologic immunoassays and blood gas other analyses. The specialty also encompasses urine microscopics and the chemical evaluation of liver, renal, lung, cardiac, neuromuscular, reproductive, bone, endocrine and other organ function and pathology and all testing included in the specialties of radioassay as defined in subsection (9) and blood gas analysis as defined in subsection (10). 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 CFR 493.1423 as published on October 1, 2007, and can document appropriate training.

(8) 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,       .

 

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: November 6, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 7, 2015