Fla. Admin. Code Ann. R. 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.
Notes
Rulemaking Authority 483.805(4), 483.811(2) FS. Law Implemented 456.065(3), 483.807, 483.809, 483.811 FS.
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.
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