The purpose of this notice is to correct errors that were present in the version of this rule that became effective on July 9, 2007.

DEPARTMENT OF HEALTH
Board of Clinical Laboratory Personnel

RULE NO: RULE TITLE
64B3-5.002: Supervisor
PURPOSE AND EFFECT: The purpose of this notice is to correct errors that were present in the version of this rule that became effective on July 9, 2007.
SUMMARY: This rule sets forth the qualifications and responsibilities of those responsible for the day-to-day supervision and oversight of technical and scientific operations in a clinical laboratory.
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), 483.823 FS.
LAW IMPLEMENTED: 483.800, 483.809, 483.815, 483.823 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, and patient safety, and one of the following:

 

Specialty	Option	Education	Training/Experience	Examination
(a) Microbiology, Serology/ Immunology, Clinical Chemistry, Hematology, Immunohematology, Blood Banking (Donor Processing), and Cytogenetics	1	Doctoral Degree in Clinical Laboratory, Chemical or Biological Science	One year of pertinent clinical laboratory experience in the  category in which licensure is sought, and 25 hours of Board-approved continuing education in supervision and administration
	2	Doctoral Degree in Clinical Laboratory, Chemical or Biological Science	One year of pertinent clinical laboratory experience in the category in which licensure is sought	DLM(ASCP) or CLSup(NCA) for all categories, SC(ASCP) for clinical chemistry, SH(ASCP) for hematology and SBB(ASCP) for blood banking and immunohematology
	3	Masters Degree in Clinical Laboratory, Chemical or Biological Science	Three years of pertinent clinical laboratory experience, with at least 1 year experience in the category in which licensure is sought, and 25 hours of Board-approved continuing education in supervision and administration
	4	Masters Degree in Clinical Laboratory, Chemical or Biological Science	Three years of pertinent clinical laboratory experience, with at least 1 year experience in the category in which licensure is sought		DLM(ASCP) or CLSup(NCA) for all categories, SC (ASCP) for clinical chemistry, SH(ASCP) for hematology and SBB(ASCP) for blood banking and immunohematology
	5	Bachelors Degree with 24 semester hours of academic science including 8 semester hours of biological sciences and 8 semester hours of chemical sciences	Five years of pertinent clinical laboratory experience, with at least 2 years experience at the Technologist level, and at least 1 year experience in the category in which licensure is sought, and 25 hours of Board-approved continuing education in supervision and administration
	6	Bachelors Degree with 24 semester hours of academic science including 8 semester hours of biological sciences and 8 semester hours of chemical sciences	Five years of pertinent clinical laboratory experience, with at least 2 years experience at the Technologist level, and at least 1 year experience in the category in which licensure is sought		DLM(ASCP) or CLSup(NCA) for all categories, SC(ASCP) for clinical chemistry, SH(ASCP) for hematology and SBB(ASCP) for blood banking and immunohematology
(b) through (c)	No change
(d) Andrology, Embryology	1	Doctoral Degree in Clinical Laboratory, Chemical or Biological Science.	One year of pertinent clinical laboratory experience, and 25 hours of Board-approved continuing education in supervision and administration.
	2	Doctoral Degree in Clinical Laboratory, Chemical or Biological Science.	One year of pertinent clinical laboratory experience in the category in which licensure is sought.		TS(ABB) for specialty sought.
	3	Masters Degree in Clinical Laboratory, Chemical or Biological Science.	Three years of pertinent clinical laboratory experience, and 25 hours of Board-approved continuing education in supervision and administration.
	4	Masters Degree in Clinical Laboratory, Chemical or Biological Science.	Three years of pertinent clinical laboratory experience, with at least 1 year experience in the category in which licensure is sought.		TS(ABB) for specialty sought.
	5	Bachelors Degree in Clinical Laboratory, Chemical or Biological Science.	Five years of pertinent clinical laboratory experience, with at  least 2 years experience in the category in which licensure is sought, and 25 hours of Board-approved hours continuing education in supervision and administration.
	6	Bachelors Degree in Clinical Laboratory, Chemical or Biological Science.	Five years of pertinent clinical laboratory experience, with at least 2 years experience in the category in which licensure is sought.		TS(ABB) for specialty sought.
(e)	No change
(f) Molecular Pathology	1	Doctoral Degree in Clinical Laboratory, Chemical or Biological Science	One year of pertinent clinical laboratory experience in the category in which licensure is sought, and 25 hours of Board-approved continuing education in supervision and administration
	2	Doctoral Degree in Clinical Laboratory, Chemical or Biological Science.	One year of pertinent clinical laboratory experience in the category in which licensure is sought.		The Molecular Diagnostics examination given by ABB.
	3	Masters Degree in Clinical Laboratory, Chemical or Biological Science.	Three years of pertinent clinical laboratory experience, and 25 hours of Board-approved continuing education in supervision and administration.
	4	Masters Degree in Clinical Laboratory, Chemical or Biological Science.	Three years of pertinent clinical laboratory experience, with at least 1 year experience in the category in which licensure is sought.		The Molecular Diagnostics examination given by ABB.
	5	Bachelors Degree wWith 16 semester hours of academic science.	Five years of pertinent clinical laboratory experience, and with at least 2 years experience at the Technologist level and 25 hours of  Board-approved continuing education in supervision and administration.
	6	Bachelors Degree wWith 16 semester hours of academic science.	Five years of pertinent clinical laboratory experience, and with at least 2 years experience at the Technologist level		The Molecular Diagnostics examination given by ABB.

 

(2) In lieu of one year of experience required by subsection 64B3-5.002(1), 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, The American Society for Clinical Pathology, National Credentialing Agency of Laboratory Personnel, National Registry of Clinical Chemistry, The National Registry of Certified Chemists, American Academy of Microbiology, American Medical Technologists, American Board of Bioanalysis Misanalysis Biocatalysts, American Association of Bioanalysts, American Board of Bioanalysis, 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) No change.

(4) The Board approved Supervision and Administration examinations, used in lieu of the required 25 hours of supervision and administration continuing education are:

(a) through (h) No change.

(i) The National Registry of  Certified Chemists (NRCC).

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, 2-23-06, 5-25-06, 7-9-07,_________.

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: March 2, 2007
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: October 19, 2007