The Board proposes to amend requirements for clinical laboratory personnel programs and curriculum requirements, and include molecular pathology.

DEPARTMENT OF HEALTH

Board of Clinical Laboratory Personnel

RULE NOS.: RULE TITLES:

64B3-3.001 General Requirements of Clinical Laboratory Personnel Training Programs

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

PURPOSE AND EFFECT: The Board proposes to amend requirements for clinical laboratory personnel programs and curriculum requirements, and include molecular pathology.

SUMMARY: The proposed rules will add a molecular pathology subcategory to curriculum requirements and training programs.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.

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.

SPECIFIC 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 FAW.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULES IS: Joe Baker, Jr., Executive Director, Board of Clinical Laboratory Personnel, 4052 Bald Cypress Way, Bin # C07, Tallahassee, Florida 32399-3257

 

THE FULL TEXT OF THE PROPOSED RULES IS:

 

64B3-3.001 General Requirements of Clinical Laboratory Personnel Training Programs.

(1) through (4) No change.

(5) Each training program shall:

(a) through (p) No change.

(q) In the category of molecular pathology, a minimum of six months of instruction.

(r)(q) No change.

(6) No change.

Specific Authority 483.805(4), 483.811(2) FS. Law Implemented 483.800, 483.809, 483.811 FS. History–New 12-28-94, Amended 7-12-95, 4-24-96, Formerly 59O-3.001, Amended 1-11-99, 11-15-99, 9-29-02, 2-2-04, 12-5-04, ________.

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

(1) through (8) 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.

(9) through (10) renumbered (10) through (11) No change.

Specific 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, ________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Clinical Laboratory Personnel

NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Board of Clinical Laboratory Personnel

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 7, 2005

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: November 10, 2005