Board of Clinical Laboratory Personnel
RULE NO.: RULE TITLE:
64B3-5.002: Supervisor
64B3-5.003: Technologist
64B3-5.004: Technician
64B3-5.007: Director; Limitations and Qualifications
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 43 No. 79, April 24, 2017 issue of the Florida Administrative Register.
The changes are in response to written comments submitted by the staff of the Joint Administrative Procedures Committee and from a vote by the Board at a duly noticed public meeting held on June 2, 2017. The rules shall now read as follows:
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; complete a one-hour educational course acceptable to the Board Department on human immunodeficiency virus and acquired immune deficiency syndrome or provide an affidavit that the course will be completed within six (6) months of licensure; and meet the requirements of one of the options set forth in subsection (3) below:
(3)(a) Microbiology, Serology/Immunology, Clinical Chemistry, Hematology, Immunohematology, Blood Banking (Donor Processing), Cytogenetics.
Education
Option
Training/Experience
Certification
Doctoral Degree
in Clinical Laboratory, Chemical or Biological Science
1a
1 year of pertinent clinical laboratory experience in the specialty area in which licensure is sought, and 25 hours of Board-approved continuing education in supervision and administration or GS(ABB)
As required for technologist licensure.
1b
1 year of pertinent clinical laboratory
experience in the specialty area in which licensure is sought
DLM (ASCP) or
SC(ASCP) for clinical chemistry SH (ASCP) for hematology and SBB(ASCP) for blood banking and immunohematology
SM (ASCP) for microbiology
TS(ABB) for specialty sought
Masters Degree
in Clinical Laboratory,
Chemical or Biological Science
2a
3 years of pertinent clinical laboratory experience, with at least 1 year experience in the specialty area in which licensure is sought, and
25 hours of Board-approved continuing education in supervision and administration or GS(ABB)
As required for technologist licensure.
2b
3 years of pertinent clinical laboratory experience, with at least 1 year experience in the specialty area in which licensure is sought
DLM (ASCP) or SC(ASCP) for clinical chemistry SH (ASCP) for hematology and SBB(ASCP) for blood banking and immunohematology SM (ASCP) for microbiology TS(ABB) for specialty sought
Bachelors Degree in Clinical Laboratory, Chemical or Biological Science with 24 semester hours of academic science including
8 semester hours
of biological sciences and 8 semester hours of chemical sciences
3a
5 years of pertinent clinical laboratory experience, with at least 2 years experience at the Technologist level, and at least 1 year experience in the specialty area in which licensure is sought, and 25 hours of Board-approved continuing education in supervision and administration or GS(ABB)
As required for technologist licensure.
3b
5 years of pertinent clinical laboratory experience, with at least 2 years experience at the Technologist level, and at least 1 year experience in the specialty area in which licensure is sought
DLM (ASCP) or SC(ASCP) for clinical chemistry SH (ASCP) for hematology and SBB(ASCP) for blood banking and immunohematology SM (ASCP) for microbiology TS(ABB) for specialty sought
(b) through (f) No change.
(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 complete a one hour educational course acceptable to the Board Department on human immunodeficiency virus and acquired immune deficiency syndrome or provide an affidavit that the course will be completed within six (6) months of licensure.
(2) All applicants for a Technologist license must satisfy the requirements for High Complexity Testing under CLIA Amendments, 42 CFR 493.1489, (2011) effective April 24, 1995, which is incorporated by reference and adopted herein and and available at http://www.gpo.gov.fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5-sec493-1489.pdf or at http://www.flrules.org/Gateway/reference.asp?No=Ref- .
(3) In addition, at least one of the following requirements must be met for specific areas of licensure. In some cases there are multiple options for meeting the requirement.
(a) Microbiology, Serology/Immunology, Clinical Chemistry, Hematology, Immunohematology. A Generalist Technologist license includes the specialties of microbiology, serology/immunology, clinical chemistry, hematology, and immunohematology.
Education
Option
Training/Experience
Certification
Bachelors Degree
(or higher) in Clinical Laboratory, Chemical, or
Biological Science with 24 semester hours of academic science including 6 semester hours of biological sciences and 6 semester hours of chemical sciences
1
Clinical laboratory training program, or 3 years pertinent clinical laboratory experience with a minimum of 6 months in each specialty for which licensure is sought
MLS(ASCP),
MT(ASCPi),
MT(AMT),
MT(AAB)
NRCC examinations or specialist examinations in single discipline for licensure in that specialty area
90 semester hours
college credit
with 24 semester hours of academic science including 6 semester hours of biological sciences and
6 semester hours of chemical sciences
2
Clinical laboratory training program
MLS(ASCP),
MT(ASCPi),
MT(AMT),
MT(AAB), or specialist examinations in single discipline for licensure in that specialty area
Associate Degree
in Clinical/Medical
Laboratory Technology including 6 semester hours of academic biological sciences and 6 semester hours of academic chemical sciences
3
as required by certifying body
MT(AAB) examinations, including specialist examinations, in single disciplines for licensure in that specialty area
Associate Degree including 6 semester hours of academic biological sciences and 6 semester hours of academic chemical sciences
4a
Successfully completed a Department of Defense clinical laboratory training program
MT(AAB) examinations, including specialist examinations, in single disciplines for licensure in that specialty area
4b
5 years of pertinent clinical laboratory experience with one year of experience in each specialty area for which licensure is sought
MT(AAB) examinations, including specialist examinations, in single disciplines for licensure in that specialty area
(b) Blood Banking
(Donor Processing)
Education
Option
Training/Experience
Certification
Bachelors Degree (or higher) in Medical Technology with 24 semester hours of academic science including 6 semester hours of biological sciences and 6 semester hours of chemical sciences
1
as required by certifying body
MLS(ASCP),
MT(ASCPi),
BB(ASCP),
SBB(ASCP),
MT(AAB),
MT(AMT)
Bachelors Degree
(or higher) in Clinical Laboratory, Chemical, or Biological Science with 24 semester hours of academic science including 6 semester hours of biological sciences and 6 semester hours of chemical sciences
21
pertinent clinical laboratory experience Medical Technology Training program, or Board approved training program in Blood Banking, or 3 years experience in clinical laboratory experience in the areas of Chemistry, Serology/Immunology, Hematology, and Immunohematology and Blood Banking
MLS(ASCP),
MT(ASCPi),
BB(ASCP),
SBB(ASCP),
MT(AAB),
MT(AMT)
(c) through (e) No change.
(f) Andrology, Embryology.
Education
Option
Training/Experience
Certification
Bachelors Degree (or higher) with 24 semester hours of academic science including 6 semester hours of academic biological sciences and 6 semester hours of academic chemical sciences
1
Board approved training program in Andrology/Embryology or 1 year of pertinent clinical laboratory experience
MT(AAB) Andrology/Embryology examination
Associate Degree including 6 semester hours of academic biological sciences and 6 semester hours of academic chemical sciences
2
3 years of pertinent clinical laboratory experience
MT(AAB) Andrology/Embryology examination
(g) through (h) 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, the applicant shall complete a one hour educational course acceptable to the Board department on human immunodeficiency virus and acquired immune deficiency syndrome or provide an affidavit that the course will be completed within six (6) months of licensure.
(2) All applicants for a Technician license must satisfy the requirements for Moderate Complexity Testing under CLIA Amendments, 42 CFR 493.1423, effective January 19, 1993, which is incorporated by reference herein and available at http://www.gpo.gov.fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5-sec493-1423.pdf or http://www.flrules.org/Gateway/reference.asp?No=Ref- as published on October 1, 2007. Technicians performing high complexity testing as defined in 42 CFR 493.5 and 493.17, both effective April 24, 1995, which is incorporated by reference herein and available at https://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5.pdf or http://www.flrules.org/Gateway/reference.asp?No=Ref- as published on October 1, 2007, and who have been licensed after September 1, 1997, shall meet the minimum educational and training qualifications provided in 42 CFR 493.1489, effective April 24, 1995, which is incorporated by reference herein and available at http://www.gpo.gov.fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5-sec493-1489.pdf or http://www.flrules.org/Gateway/reference.asp?No=Ref- as published on October 1, 2007, incorporated herein by reference, including a minimum of an associate degree in laboratory science, medical laboratory technology, or equivalent education and training.
(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 (2011), which is incorporated by reference and adopted herein, available at and www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5.pdf or at http://www.flrules.org/Gateway/reference.asp?No=Ref- . The applicant shall complete a one hour educational course acceptable to the Board department on human immunodeficiency virus and acquired immune deficiency syndrome or provide an affidavit that the course will be completed within six (6) months of licensure.
(2) In addition, at least one of the following requirements must be met for specific areas of licensure. In some cases, there are multiple options for meeting the requirements.
(a) through (g) No change.
(h) Clinical Chemistry
Education
Option
Training/Experience
Certification
Doctoral Degree in chemical, biological, or clinical laboratory science
1
as required by certifying body
Certification in Clinical Chemistry by ABCC, HCLD(ABB) with certification in Chemistry; or certification as a in Clinical Chemistry or Toxicological Chemistry by NRCC or F-ABFT certification in Forensic Toxicology by ABFT.
(i) through (l) 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, .
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Anthony B. Spivey, Executive Director, Board of Clinical Laboratory Personnel, 4052 Bald Cypress Way, Bin # C07, Tallahassee, Florida 32399-3257.
