The Board proposes amendments for the academic qualifications of clinical laboratory personnel supervisors, technicians, and directors with regard to the category of molecular pathology and diagnostics.

DEPARTMENT OF HEALTH

Board of Clinical Laboratory Personnel

RULE NOS.: RULE TITLES:

64B3-5.002 Supervisor

64B3-5.004 Technician

64B3-5.007 Director; Limitations and Qualifications

PURPOSE AND EFFECT: The Board proposes amendments for the academic qualifications of clinical laboratory personnel supervisors, technicians, and directors with regard to the category of molecular pathology and diagnostics.

SUMMARY: The proposed rules will add molecular pathology to supervisor technician and director qualifications.

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: 483.051, 483.805(4), 483.811(2), 483.823 FS.

LAW IMPLEMENTED: 381.0034, 483.041(5), 483.051(1), 483.800, 483.809, 483.811(2), 483.815, 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 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:

 

64B3-5.002 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 complete a Board approved examination or complete 25 hours of Board approved continuing education in the area of administration and supervision, which includes examination(s) accumulated over no longer than five years prior to application for licensure, shall have one hour of Board approved HIV/ AIDS continuing education, 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 one of the following:

(a) through (g) No change.

(h) In the category of molecular pathology, have a minimum of a baccalaureate degree, with eight semester hours each of academic biological and chemical science included in a total of 24 semester hours of academic science and/or medical laboratory technology, and five years of pertinent clinical laboratory experience in molecular pathology.

(2) In lieu of one year of experience required by paragraphs 64B3-5.002(1)(b), and (c), and (h), F.A.C., an applicant may use Board certification obtained by examination in one or more of the laboratory specialties through the Board of Registry of the ASCP, National Credentialing Agency of Laboratory Personnel, National Registry of Clinical Chemistry, American Academy of Microbiology, American Medical Technologists, American Board of Bioanalysts, American Board of Clinical Chemistry, American Board of Medical Microbiology, American Board of Medical Genetics, American Board of Medical Laboratory Immunology, or American Board of Histocompatibility and Immunogenetics. This certification shall not substitute for the one year of pertinent clinical laboratory experience in an individual category for which licensure is sought.

(3) through (4) No change.

Specific Authority 483.805(4), 483.823 FS. Law Implemented 381.0034, 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,________.

 

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 genetics, andrology and embryology, an applicant shall have one hour of Board approved HIV/AIDS continuing education, 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, a minimum of a high school diploma or a high school equivalency diploma and one of the following:

(a) through (f) No change.

(g) Qualifications for Molecular Pathology Genetics Technician. To be licensed as a molecular pathologist genetics technician, an applicant shall have a minimum of a high school diploma or high school equivalent, and be licensed as a clinical laboratory technologist or technician in any specialty area.

(h) No change.

(2) No change.

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

 

64B3-5.007 Director; Limitations and Qualifications.

(1) through (4) No change.

(5) Approved examinations for licensure as a director: An applicant who qualifies for licensure as a director herein is required to pass a supervision and administration examination covering the subject matter of subsection 64B3-3.003(7), F.A.C., the Clinical Laboratory Director examination administered by the National Credentialing Agency for Laboratory Personnel (NCA), the examination for High Complexity Laboratory Director (HCLD) or one of the following:

(a) through (e) No change.

(f) In the specialty of molecular pathology genetics, the specialty examination in molecular diagnostics genetics prepared by the American Board of Medical Genetics.

(g) through (h) No change.

(6) No change.

Specific Authority 483.051, 483.805(4) FS. Law Implemented 483.041(5), 483.051(1), 483.809, 483.811(2), 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,________.

 

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