Florida Administrative Code
64 - DEPARTMENT OF HEALTH
64B3 - Board of Clinical Laboratory Personnel
Chapter 64B3-13 - RESPONSIBILITIES OF CLINICAL LABORATORY PERSONNEL
Section 64B3-13.002 - Responsibilities of Supervisors
Universal Citation: FL Admin Code R 64B3-13.002
Current through Reg. 50, No. 187; September 24, 2024
(1) The supervisor is responsible for fulfilling the responsibilities of the director as assigned and for monitoring compliance with all applicable regulations of the board and of the Department.
(2) In addition, the supervisor shall fulfill the following responsibilities:
(a) Performs
the duties of a technologist in the specialty or specialties in which licensure
is held, as needed.
(b) Assigns, if
needed, performance of his or her direct supervision responsibilities to
licensed technologists, however, the supervisor remains responsible for
ensuring that direct supervision is properly performed. The assignment of
responsibilities from the supervisor to the technologist must be written and
specific.
(c) Evaluates the
competency of technologists and technicians and assures that the staff maintain
their competency to perform test procedures and report test results promptly,
accurately and proficiently. The procedures for evaluation of the competency of
the staff shall include:
1. Direct observation
of routine test performance including patient preparation, if applicable, and
specimen handling, processing and testing.
2. Monitoring the recording and reporting of
test results.
3. Reviewing the
intermediate test results or worksheets, quality control records, proficiency
testing results, and preventive maintenance records.
4. Direct observation of performance of
instrument maintenance and function checks.
5. Assessment of test performance through
testing previously analyzed specimens, through internal blind testing samples
or through external proficiency testing samples.
6. Assessment of problem solving
skills.
(d) Evaluates and
documents the performance of individuals responsible for testing at least
semiannually during the first year the individual tests patient specimens.
Thereafter, evaluations must be performed at least annually unless test
methodology or instrumentation changes have occurred, in which case, prior to
reporting patient test results, the individuals performance must be reevaluated
and documented to include the use of the new test methodology or
instrumentation.
(e) Is accessible
to clinical laboratory personnel at all times testing is performed and provides
on-site telephone or electronic consultation to resolve technical problems in
accordance with approved polices and procedures of the clinical
laboratory.
(f) Provides day-to-day
supervision of test performance by technologists and technicians.
(g) Ensures onsite direct supervision when
testing is being performed by those technicians who are required to work under
direct supervision.
(h) Monitors
test analyses and specimen examinations to ensure that acceptable levels of
analytic performance are maintained.
(i) Assures that all remedial actions are
taken whenever test systems deviate from the clinical laboratory's established
performance specifications.
(j)
Ensures that patient test results are not reported until all corrective actions
have been taken and the test system is properly functioning.
(k) Provides orientation to all testing
personnel.
(l) Identifies weakness
in performance and takes necessary action to insure minimal acceptable
performance.
(m) Establishes and
maintains systems for the accession, identification, transport, storage and
disposal of specimens adhering to internal and external policies and
regulations including medico-legal custodial responsibilities.
(n) Determines the need for, selects,
utilizes and evaluates referral services as appropriate to laboratory resources
and/or priorities.
(o) Establishes
protocols for performance of confirmatory and additional procedures as
indicated.
(p) Establishes a system
for providing patients with blood and blood products in accordance with
internal and external policies and regulations.
(q) Devises a plan for management and
scheduling of clinical laboratory personnel.
(r) Establishes and communicates short term
goals and objectives for delivery of clinical laboratory services.
(s) Monitors compliance with institutional
policies and regulations and standards of external agencies.
(t) Designs and/or implements a quality
assurance program to monitor variables which affect the quality of clinical
laboratory services.
(u) Prepares
and periodically updates policy and procedure manuals.
(v) Establishes and evaluates the preventive
maintenance program for instrumentation and equipment.
(w) Establishes and periodically evaluates
safety measures in accordance with internal and external regulations.
(x) Evaluates and selects chemicals,
biologicals and radionucleotides for clinical use and establishes monitoring
systems for handling, processing, and storing these supplies and
reagents.
(y) Designs a plan for
administration of education programs in the clinical laboratory sciences for a
variety of settings including academic, clinical, alternate site, exclusive
use, in-service, and continuing education.
(z) Designs research in the clinical
laboratory sciences by obtaining and utilizing resources and by reporting
results as appropriate.
(aa) In the
specialty of Cytology, in addition to the above responsibilities, the
supervisor shall, if responsible for screening cytology slide preparations,
document the number of cytology slides screened in 24 hours and the number of
hours devoted during each 24 hour period to screening of cytology slides. The
supervisor shall be responsible for and be required to provide this information
to any laboratory for which the individual screens
slides.
Rulemaking Authority 483.805(4) FS. Law Implemented 483.813, 483.823, 483.825 FS.
New 12-6-94, Amended 3-28-95, Formerly 59O-13.002, Amended 4-10-01, 4-7-02, 10-1-19.
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