64B3-3.001. General Requirements of Clinical Laboratory Personnel Training Programs

(1) Each clinical laboratory personnel training program, hereinafter referred to as program, shall apply to the board for initial approval on Form #DH-MQA 3007 (03/19) “Initial Application for Clinical Laboratory Personnel Training Program,” http://www.flrules.org/Gateway/reference.asp?No=Ref-10813, which is incorporated by reference herein and pay the fee set forth in subsection 64B3-9.001(3), F.A.C. For renewal, each clinical laboratory personnel training program shall apply for renewal to the board on Form DH5030-MQA (02/2018) “Renewal Application for Clinical Laboratory Personnel Training Program, http://www.flrules.org/Gateway/reference.asp?No=Ref-09999, which is incorporated by reference herein and pay the fee set forth in subsection 64B3-9.004(6), F.A.C.

(2)(a) Programs shall submit a proof of accreditation verification documentation from the National Accrediting Agency for Clinical Laboratory Science (NAACLS), the Council on Accreditation of Allied Health Education Programs (CAAHEP), or the Accrediting Bureau of Health Education Schools (ABHES).

(b) Programs that are pending national accreditation shall submit proof of accreditation status with the application.

(3) All trainee’s names shall be reported to the Board upon acceptance into the clinical laboratory personnel training program and at the time of the program’s biennial renewal. The program director shall notify the Board when a trainee withdraws.

(4) Each training program shall:

(a) Designate space and laboratory equipment for proper training of students.

(b) Maintain a file on each student which shall contain a completed application, evidence of high school graduation or completion of college courses, if applicable, attendance records, grades, instructor evaluations of laboratory practice, the trainee’s registration, and a copy of the student’s certificate of completion or official transcript.

(c) Maintain current examinations and laboratory evaluation instruments utilized by the program.

(d) Provide the student with a certificate or letter of graduation or a transcript indicating the degree granted. Certificates or letters of graduation shall be signed by the program director.

(e) Include instruction in human immunodeficiency virus and acquired immunodeficiency syndrome.

(f) Include instruction on the prevention of medical errors, which shall include root-cause analysis, error reduction and prevention, and patient safety.

(g) Upon initial application and at each biennial renewal, the training program shall provide: a current copy of the Clinical Laboratory Improvements Act of 1988 (CLIA) certification; State of Florida license verification for each clinical affiliate; and the names, addresses, license numbers, personnel rosters of all affiliates that provide clinical training for the trainees enrolled in the program.

(h) Include course objectives, course descriptions, course outlines, assessment of outcomes, student evaluations and graduate evaluations in the curriculum.

(i) Utilize educational resources for teaching the affective, cognitive, and psychomotor domains.

(j) Employ systematic procedures for assessing learning outcomes in the affective, cognitive, and psychomotor domains.

(k) Have a practicum in a clinical laboratory where current laboratory procedures, instrumentation and diversity of specimens are available for a variety of analyses and are in sufficient quantity to provide competent training for the student.

(l) Include instruction on Florida laws and rules governing clinical laboratories and clinical laboratory personnel.

(5) Clinical training programs that are not nationally accredited but were approved by the Board must submit; a curriculum outline including the number of lecture hours, lab, and clinical hours; copies of national certification of faculty; national certification examination pass rates; program completion rates; and graduate placement rates and graduate employment survey results for the three (3) years prior to the submission of the renewal application.

(6) A clinical laboratory personnel training program which is not in compliance with chapter 64B3-3, F.A.C., shall be denied approval or a prior approval shall be rescinded.

Rulemaking Authority 483.805(4), 483.811(2) FS. Law Implemented 456.065(3), 483.807, 483.809, 483.811 FS. History–New 12-28-94, Amended 7-12-95, 4-24-96, Formerly 59O-3.001, Amended 1-11-99, 11-15-99, 9-29-02, 2-2-04, 12-5-04, 2-23-06, 4-29-13, 7-20-14, 6-7-16, 11-14-18, 8-19-19.