Notice of Proposed Rule

DEPARTMENT OF HEALTH
Board of Clinical Laboratory Personnel
RULE NO: RULE TITLE
64B3-5.002: Supervisor
64B3-5.003: Technologist
64B3-5.007: Director; Limitations and Qualifications
64B3-5.008: Public Health Laboratory Personnel
PURPOSE AND EFFECT: The purpose of this notice is to: (1) incorporate a new version of the application form for those seeking licensure as Public Health Laboratory Scientists; (2) require those seeking initial licensure as a Clinical Laboratory Director to complete a 2-hour course on the prevention of medical errors; (3) amend the requirements for those seeking licensure as Public Health Laboratory Personnel; (4) add molecular pathology as a specialty for technicians; and (5) require that those seeking licensure as Clinical Laboratory Supervisors, Technologists, Technicians, or Directors complete a course on HIV/AIDS.
SUMMARY: The proposed rules: (1) incorporate a new version of the application form for those seeking licensure as Public Health Laboratory Scientists; (2) require those seeking initial licensure as a Clinical Laboratory Director to complete a 2-hour course on the prevention of medical errors; (3) amend the requirements for those seeking licensure as Public Health Laboratory Personnel; (4) add molecular pathology as a specialty for technicians; and (5) require that those seeking licensure as Clinical Laboratory Supervisors, Technologists, Technicians, or Directors complete a course on HIV/AIDS.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Costs was prepared. The Board determined the proposed rule will not have an impact on small business.
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), 483.823 FS.
LAW IMPLEMENTED: 381.0034(3), 483.800, 483.809, 483.811(2), 483.812, 483.815, 483.823, 483.824 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE 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 RULE IS:

64B3-5.002 Supervisor.

Qualifications and Responsibilities.

(1) Qualification. 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 supervisor, an applicant shall be licensed or meet the requirements for licensure as a technologist, and 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 an educational course acceptable to the Department on human immunodeficiency virus and acquired immune deficiency syndrome, and one of the following:

(a) through (f) No change.

(2) through (4)(i) No change.

Rulemaking Specific Authority 483.805(4), 483.823 FS. Law Implemented 381.0034(3), 483.800, 483.809, 483.815, 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, ________.

 

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 an educational course acceptable to the Department on human immunodeficiency virus and acquired immune deficiency syndrome.

(2) through (3)(h) No change.

Rulemaking Specific Authority 483.805(4), 483.811(2), 483.823 FS. Law Implemented 381.0034(3), 483.800, 483.809, 483.811(2), 483.815, 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, ________ .

 

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 an educational course acceptable to the Department on human immunodeficiency virus and acquired immune deficiency syndrome.

(2) No change.

Rulemaking Specific 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, ________.

 

64B3-5.008 Public Health Laboratory Personnel.

(1) Applicants for director level licensure in the category of public health must meet the requirements in Rule 64B3-5.007, F.A.C., for licensees at the Director level in chemistry or microbiology who are registered by the National Registry in Clinical Chemistry or the American Society for Microbiology shall pass the supervision and administration examination.

(2) Applicants for supervisor level licensure in the category of public health must meet the requirements in Rule 64B3-5.002, F.A.C., for licensure at the supervisory level who are registered by the National Registry in Clinical Chemistry or the American Society for Microbiology at the technologist level shall pass the supervision and administration examination.

(3) No change.

(4) All applicants for licensure as a Public Health Laboratory Scientist shall apply to the Department on Form #DH-MQA 3001 (11/08) “Applicant for Public Health Laboratory Scientist” which is incorporated by reference herein, copies of which can be obtained from the Board office at 4052 Bald Cypress Way, Bin #C07, Tallahassee, Florida 32399-3257 or from its website at http://www.doh.state.fl.us/mqa/ClinLab/index.html.

Rulemaking Specific Authority 483.805(4) FS. Law Implemented 483.809(2), 483.812 FS. History–New 5-26-98, Amended 4-20-04, ________.


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 14, 2008
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: March 27, 2009