The Board proposes the rule amendments to update the rules due to legislative changes.

 

DEPARTMENT OF HEALTH

Board of Clinical Laboratory Personnel

RULE NOS.:RULE TITLES:

64B3-5.002Supervisor

64B3-5.003Technologist

64B3-5.004Technician

64B3-5.007Director; Limitations and Qualifications

PURPOSE AND EFFECT: The Board proposes the rule amendments to update the rules due to legislative changes.

SUMMARY: Due to legislative changes, the rules 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), 483.811(2), 483.823 FS.

LAW IMPLEMENTED: 381.0034(3), 381.0034, 483.800, 483.809, 483.811(2), 483.823, 483.823(1), 483.824 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:

 

64B3-5.002 Supervisor.

Qualifications and Responsibilities.

(1) No change.

(2) To be licensed as a supervisor, an applicant: shall be licensed or meet the requirements for licensure as a technologist; have a Board approved 2-hour course relating to the prevention of medical errors, which shall include root-cause analysis, error reduction and prevention, patient safety; complete a one-hour educational course acceptable to the Department on human immunodeficiency virus and acquired immune deficiency syndrome; and meet the requirements of one of the options set forth in subsection (3) below:

(3) through (4) No change.

Rulemaking Authority 483.805(4), 483.823 FS. Law Implemented 381.0034(3), 483.809, 483.823 FS. History–New 12-6-94, Amended 7-12-95, 12-4-95, Formerly 59O-5.002, Amended 5-26-98, 1-11-99, 6-10-99, 3-11-01, 9-19-01, 5-23-02, 10-14-02, 9-16-03, 4-20-04, 2-23-06, 5-25-06, 7-9-07, 2-7-08, 6-17-09, 1-30-12, 2-21-16,                             .

 

64B3-5.003 Technologist.

(1) Technologist Qualifications. Degrees or semester hours of academic credit required in this section shall be obtained at a regionally accredited college or university or, if foreign education, equated pursuant to subsection 64B3-6.002(6), F.A.C. Applicants for technologist licensure in the categories of microbiology, serology/immunology, chemistry, hematology, immunohematology, histocompatibility, blood banking, cytology, cytogenetics, histology, molecular pathology, andrology and embryology shall have a Board approved 2-hour course relating to the prevention of medical errors, which shall include root-cause analysis, error reduction and prevention, and patient safety, and such applicants shall complete a one hour educational course acceptable to the Department on human immunodeficiency virus and acquired immune deficiency syndrome.

(2) through (3) No change.

Rulemaking Authority 483.805(4), 483.811(2), 483.823 FS. Law Implemented 381.0034(3), 483.809, 483.811(2), 483.823 FS. History–New 12-6-94, Amended 7-12-95, 9-10-95, 12-4-95, Formerly 59O-5.003, Amended 5-26-98, 1-11-99, 7-5-01, 3-24-02, 10-29-02, 8-16-04, 5-15-05, 12-19-05, 5-25-06, 7-9-07, 2-7-08, 6-17-09, 1-30-12, 2-7-13, 10-3-13, 4-5-15, 6-16-15,                                            .

 

64B3-5.004 Technician.

(1) General Qualifications. Degrees or semester hours of academic credit required in this section shall be obtained at a regionally accredited college or university, or by foreign education equated pursuant to subsection 64B3-6.002(6), F.A.C. In order to be licensed as a laboratory technician, which includes the categories of microbiology, serology/immunology, chemistry, hematology, immunohematology, histology, molecular pathology, andrology and embryology, an applicant shall have a Board approved 2-hour course relating to the prevention of medical errors, which shall include root-cause analysis, error reduction and prevention, and patient safety. tThe applicant shall complete a one hour educational course acceptable to the department on human immunodeficiency virus and acquired immune deficiency syndrome.

(2) through (3) No change.

Rulemaking Authority 483.805(4), 483.811(2), 483.823 FS. Law Implemented 381.0034, 483.809, 483.811(2), 483.823 FS. History–New 12-6-94, Amended 7-12-95, 12-4-95, Formerly 59O-5.004, Amended 5-26-98, 9-20-98, 1-11-99, 8-31-99, 9-27-00, 12-26-00, 4-29-02, 10-29-02, 2-11-03, 4-20-04, 2-23-06, 5-25-06, 12-5-07, 1-30-12, 10-3-13,               .

 

64B3-5.007 Director; Limitations and Qualifications.

(1) All applicants for a Director license must have the qualifications for a High Complexity Laboratory Director, listed in 42 CFR 493.1443 as published on October 1, 2007, and complete a Board-approved 2-hour course relating to the prevention of medical errors, which shall include root-cause analysis, error reduction and prevention, and patient safety. Such applicants shall also complete a one hour educational course acceptable to the Department on human immunodeficiency virus and acquired immune deficiency syndrome.

(2) No change.

Rulemaking Authority 483.805(4) FS. Law Implemented 381.0034(3), 483.800, 483.809, 483.823(1), 483.824 FS. History–New 6-6-85, Formerly 10D-41.67, Amended 3-11-90, Formerly 10D-41.067, Amended 7-1-97, Formerly 59O-5.007, Amended 5-26-98, 3-2-99, 3-24-02, 10-14-02, 4-20-04, 2-23-06, 3-17-08, 6-17-09, 12-30-09, 1-30-12, 2-23-16, .

 

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: June 3, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 1, 2016