For Rule 64B3-3.002, F.A.C., the Board proposes the rule amendment to update requirements regarding the certification required in Rule 64B3-5.002(3), F.A.C. For Rule 64B3-3.003, F.A.C., the Board proposes the rule amendment to clarify the curriculum ...

 

DEPARTMENT OF HEALTH

Board of Clinical Laboratory Personnel

RULE NOS.:RULE TITLES:

64B3-3.002Personnel of Clinical Laboratory Personnel Training Programs

64B3-3.003Curriculum Requirements for Clinical Laboratory Personnel Training Programs

PURPOSE AND EFFECT: For Rule 64B3-3.002, F.A.C., the Board proposes the rule amendment to update requirements regarding the certification required in Rule 64B3-5.002(3), F.A.C. For Rule 64B3-3.003, F.A.C., the Board proposes the rule amendment to clarify the curriculum requirements for Clinical Laboratory Personnel Training Programs.

SUMMARY: For Rule 64B3-3.002, F.A.C., the requirement regarding the certification required in Rule 64B3-5.002(3), F.A.C. will be updated. For Rule 64B3-3.003, F.A.C., the curriculum requirements for Clinical Laboratory Personnel Training Programs 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), 483.811(2) FS.

LAW IMPLEMENTED: 483.800, 483.809, 483.811 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:

 

64B3-3.002 Personnel of Clinical Laboratory Personnel Training Programs.

(1) No change.

(2) Instructors of clinical laboratory science courses in each program shall teach only in areas in which they have pertinent clinical laboratory or teaching experience and shall either:

(a) No change.

(b) Have a minimum of three (3) years of pertinent clinical laboratory experience or experience in clinical laboratory science education and holds national certification from any Board listed in subsection 64B3-5.002(3), F.A.C.

(3) through (4) No change.

Rulemaking Authority 483.805(4), 483.811(2) FS. Law Implemented 483.800, 483.809, 483.811 FS. History–New 12-28-94, Amended 3-28-95, 7-12-95, 4-24-96, Formerly 59O-3.002, Amended 9-20-98, 12-13-98, 11-15-99, 12-7-11,     .

 

64B3-3.003 Curriculum Requirements for Clinical Laboratory Personnel Training Programs.

(1) All programs shall provide instruction in pre-analytical, analytical, and post-analytical testing processes. laboratory practice covering specimen collection, handling and storage, including collection of venous, capillary and arterial specimens (when practical), laboratory mathematics, statistical applications, general instrumentation, reagent preparation and storage, quality control, instrument maintenance and calibrations, reporting results, documentation techniques, laws, regulations, monitoring systems for results and errors, ethics, communication skills, interpersonal skills, computer skills, correlation of laboratory data with common physiological conditions for the purpose of assessing validity of the results and laboratory safety.

(2) All programs not accredited by the National Accrediting Agency for Clinical Laboratory Science (NAACLS), the Council on Accreditation of Allied Health Education Programs (CAAHEP), or the Accrediting Bureau of Health Education Schools (ABHES) except for those in the categories of cytology, cytogenetics, histocompatibility, embryology or andrology shall adopt the 2017-2018 2008-09 curriculum frameworks for Health Science Education set forth by the Florida Department of Education at http://www.fldoe.org/academics/career-adult-edu/career-tech-edu/curriculum-frameworks/2017-18-frameworks/health-science.stml http://www.fldoe.org/workforce/dwdframe/he_cluster-frame08.asp which are incorporated by reference herein (curriculum frameworks) and available at http://www.flrules.org/Gateway/reference.asp?No=     . All programs must meet the curriculum frameworks number 1-25.  for the categories in which training occurs. as follows:

(3) Each specialty shall comply with the relevant curriculum frameworks:  

(a) For molecular pathology, curriculum framework numbers 26 and 40; For the categories of clinical chemistry, hematology, immunohematology, microbiology, and serology/immunology, the associate degree medical laboratory technology program standards or the certificate medical laboratory technology program standards.

(b) For urinalysis, curriculum framework number 27; For the category of histology, the histologic technology standards.

(c) For hematology, curriculum framework numbers 28, 29, 34 and 35;

(d) For immunology, curriculum framework numbers 30 and 38;

(e) For clinical chemistry, curriculum framework numbers 31 and 37;

(f) For immunohematology, curriculum framework numbers 32 and 39;

(g) For microbiology, curriculum framework numbers 33 and 36.

(3) through (8) re-designated (4) through (9) No change.

(9) For the category of molecular pathology, technologist level program shall at a minimum include instructions in the following competencies:

(a) Applies knowledge of basic and special laboratory procedures, sources of error, fundamental characteristics of molecular theory, molecular biology, and molecular genetics.

(b) Selects appropriate courses of actions for method and test requested.

(c) Selects and prepares appropriate methods, instruments, reagents, controls and appropriate procedures to verify test results.

(d) Calculates results and assesses test results by correlating laboratory data with clinical data, quality control data, and physiological process to validate results and procedures.

(e) Evaluates laboratory data to recognize health and disease states, make identifications, verify test results, resolve inconsistent results and sources of error, take corrective actions, and recognize the need for additional testing.

(10) Technologist level programs shall include education administration and supervision instruction  and management. which for purposes of this rule shall include:

(a) General administrative management (planning, supervision, evaluation);

(b) Personnel management (position specification, personnel practices, recruitment, workload assessment, staffing, employment, evaluation, discipline);

(c) Financial management;

(d) Critical management abilities (problem solving, test reporting and review);

(e) Quality assurance/quality control (reference material/standards, error, statistics, method selection and evaluation, instrumentation, corrective action, and proficiency testing);

(f) Federal and state laws and regulations;

(g) Risk management.

(11) Technologist level programs shall additionally cover all pertinent topics listed in the following competencies:

(a) Evaluate the systems and procedures for controlling, verifying, and correcting laboratory performance for optimum efficiency and minimum cost.

(b) Evaluate new procedures and instruments.

(c) Implement and monitor laboratory safety protocols.

(d) Implement patient and specimen identification and control procedures fulfilling applicable policies and regulations including medico-legal custodial responsibilities.

(e) Demonstrate knowledge of the principles of curriculum development, instructional methodologies and evaluation strategies.

(f) Demonstrate knowledge concerning State and Federal regulations, licensure, inspection, liability, and the Patient’s Bill of Rights.

(g) Demonstrate written communication skills and skills necessary to read and comprehend scientific journals, papers and reports.

Rulemaking Authority 483.805(4), 483.811(2) FS. Law Implemented 483.800, 483.809, 483.811 FS. History–New 5-9-95, Amended 12-4-95, 4-24-96, Formerly 59O-3.003, Amended 3-19-98, 9-20-98, 1-11-99, 10-30-02, 7-18-04, 2-23-06, 1-6-09,       .

 

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 2, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 18, 2017