64B3-2.003. Definitions

(1) Accredited means accredited by a regional accrediting agency for colleges and universities recognized by the U.S. Department of Education.

(2) Approved laboratory means a federally certified clinic.

(3) Year means a calendar year of twelve months duration except in the phrase “one year of full time experience.”

(4) One year of full time experience means a minimum of 1,500 hours amassed in not less than twelve months nor more than thirty-six months.

(5) Academic science is a science course with a chemical or biological science prefix. Acceptable courses include general chemistry, organic chemistry, biochemistry, qualitative or quantitative analysis, general biology, zoology, physiology, comparative anatomy, bacteriology, parasitology, cell biology, cellular metabolism, virology, physics, immunology, microbiology, genetics, and molecular/celluar biology. For purposes of this rule, the courses of geology, astronomy, entomology, environmental testing including water testing, oceanography, marine biology and physical science or remedial, preparatory or introductory science courses shall not be acceptable.

(6) Applied science is a physical, chemical or biological science course which is specific to a major and directly prepares the individual for performance in a specific profession. Examples of such courses are chemistry for health science majors or nurses, pharmacy, clinical chemistry, clinical microbiology, clinical hematology, advanced entomology, and oceanography.

(7) Pertinent clinical laboratory experience is experience in a clinical laboratory as defined in Section 483.803(2), F.S. If acquired in Florida or in a state where personnel licensure is required, experience must be accrued while licensed and working in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory, or in an exempt laboratory as defined by Section 483.801, F.S. For purposes of this rule, experience in a training program, industrial laboratory, or research laboratory is not considered pertinent clinical laboratory experience. If research experience was acquired under an exemption clause, it may not be utilized as pertinent clinical laboratory experience. Experience acquired in an exclusive use laboratory environment, waived laboratory environment or alternate site testing environment is generally unacceptable unless specifically authorized by rules of this Board.

(8) Accredited program means a clinical laboratory personnel training program that is accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS), Commission on Accreditation of Allied Health Education Programs (CAAHEP), or Accrediting Bureau of Health Education Schools (ABHES).

(9) Independent practice means the authority to perform clinical laboratory tests and release the results of such tests without direct supervision.

(10) Semester hour means one hour of credit in an accredited college or university, pursuant to subsection 64B3-2.003(1), F.A.C., or foreign education equated, pursuant to subsection 64B3-6.002(6), F.A.C.

(11) Sexual misconduct is any direct or indirect physical contact by any clinical laboratory personnel and a patient which is intended to erotically stimulate either person or which is likely to cause such stimulation. Sexual misconduct includes sexual intercourse, fellatio, cunnilingus, masturbation or anal intercourse. Sexual misconduct also includes: making suggestive, lewd or lascivious remarks to a patient or performing such acts in the presence of a patient and intentionally touching a patient’s breast(s) or sexual organs for non-laboratory related purposes regardless of whether the patient is clothed.

(12) High complexity testing is clinical laboratory testing as defined in 42 C.F.R. §493.5 and 42 C.F.R. §493.25, which are incorporated by reference.

(13) Moderate complexity testing is clinical laboratory testing as defined in 42 C.F.R. §493.5 and 42 C.F.R. §493.20, which are incorporated by reference.

(14) Waived testing is clinical laboratory testing as defined in 42 C.F.R. §493.5 and 42 C.F.R. §493.15, which are hereby incorporated by reference.

(15) Board approved program is a training program or a continuing education program approved by the Board pursuant to this chapter.

(16) Screening for Blood Banks or Plasmapheresis Centers means interviewing prospective donors in a blood bank or plasmapheresis center during which a hemoglobin test using a method classified as waived, a spun hematocrit or a total protein by the refractometer method may be performed.

(17) Manual Pretesting means pre-analytical procedures, including specimen collection, labeling, and processing. Additional duties may include slide preparation from a primary specimen, direct primary inoculation of microbiology cultures, cytopreparatory staining, preventative maintenance, and loading specimens onto automated instruments or systems which are verified by licensed personnel or autoverified by the laboratory information system. It does not include any quality control procedures.

Rulemaking Authority 483.805(4), 483.811(2) FS. Law Implemented 483.803, 483.811, 483.821, 483.823 FS. History–New 11-4-93, Formerly 61F3-2.003, Amended 11-21-94, 11-30-94, 12-26-94, 5-3-95, 7-12-95, Formerly 59O-2.003, Amended 3-19-98, 12-13-98, 3-28-99, 9-12-99, 11-15-99, 3-24-02, 10-30-02, 2-1-04, 1-8-06, 8-14-06, 1-30-12, 2-7-13, 11-25-14, 2-23-16, 7-29-19, 12-31-19, 12-6-21.