Current through Reg. 50, No. 187; September 24, 2024
(1) The director
is the responsible head of the clinical laboratory and is responsible for the
overall operation and administration of the clinical laboratory, including the
employment of personnel who are competent to perform the procedures or tasks
assigned to them, and also including the prompt, accurate and proficient
performance, recording and reporting of test results, and is responsible for
assuring compliance with all applicable state and federal laws rules and
regulations.
(2) The director, if
qualified or licensed as applicable under Rule Chapter 64B3-5, F.A.C., may
perform the duties of a supervisor or technologist in the specialty(ies) for
which they are qualified or licensed or delegate these responsibilities to
personnel licensed according to Rule Chapter 64B3-5, F.A.C.
(3) A director not certified by the American
Board of Pathology in clinical pathology or by the American Board of Oral
Pathology, the American Board of Pathology, or the American Osteopathic Board
of Pathology who is directing a clinical laboratory performing highly complex
testing, shall ensure a co-director certified by the American Board of
Pathology in clinical pathology or by the American Board of Oral Pathology, the
American Board of Pathology, or the American Osteopathic Board of Pathology is
available to provide clinical consultation and technical supervision consistent
with the scope and volume of highly complex testing being performed as defined
in 42 C.F.R. §493.5 as published on October 1, 2007 and 42 C.F.R.
§493.17 as published on October 1, 2007, which are incorporated by
reference. Directors certified by the American Board of Oral Pathology, the
American Board of Pathology, or the American Osteopathic Board of Pathology
shall provide clinical consultation only in the specialty area(s) for which
they are board certified or have 4 years of pertinent clinical laboratory
experience.
(4) Each director shall
not direct more than 5 clinical laboratories.
(5) The director can delegate performance of
responsibilities to licensed supervisors, with the exception of the approval,
signing and dating of: initial procedure review; and substantive changes to
existing procedures. However, the director remains responsible for ensuring
that all duties are properly performed. The delegation of responsibilities must
be written and specific.
(6) The
laboratory director shall:
(a) Be accessible
to the clinical laboratory to provide onsite, telephone or electronic
consultation as needed. This responsibility may not be delegated except to a
clinical laboratory director.
(b)
Ensure that testing systems developed and used for each of the tests performed
in the clinical laboratory provide for quality clinical laboratory services for
all aspects of test performance which includes the preanalytic, analytic and
postanalytic phases of testing.
(c)
Ensure that the physical plant and environmental conditions of the clinical
laboratory are appropriate for the testing performed and provide a safe
environment in which employees are protected from physical, chemical and
biological hazards.
(d) Ensure that
the test methodologies selected have the capability of providing the quality of
results required for patient care.
(e) Ensure that verification procedures used
are adequate to determine the accuracy, precision, and other pertinent
characteristics of the method.
(f)
Ensure that clinical laboratory personnel are performing the test methods as
defined in the clinical laboratory's policies and procedures for accurate and
reliable results.
(g) Ensure that
the clinical laboratory successfully participates in a proficiency testing
program for the testing performed which meets the requirements of Rule Chapter
59A-7, F.A.C.
(h) Ensure that all
proficiency testing reports received are reviewed by the appropriate staff to
evaluate the clinical laboratory's performance and to identify any problems
that require corrective action.
(i)
Ensure that an approved corrective action plan is followed when any proficiency
testing result is found to be unacceptable or unsatisfactory.
(j) Ensure that quality control and quality
assurance programs are established and maintained to assure the quality of
clinical laboratory services provided and to identify and correct failures in
quality as they occur.
(k) Ensure
that acceptable levels of analytical performance for each test system are
established.
(l) Ensure that all
necessary remedial actions are taken and documented whenever significant
deviations from the clinical laboratory's established performance
characteristics are identified and that patient test results shall not be
reported until the system is functioning properly.
(m) Ensure that reports of test results
include pertinent information required for interpretation.
(n) Ensure that consultation is available to
the clinical laboratory's clients on matters relating to the quality of test
results reported, the methodology used, and their interpretation concerning
specific patient conditions.
(o)
Ensure that supervision is provided as specified in Rule Chapter 59A-7, F.A.C.,
by a supervisor or supervisors licensed pursuant to Rule
64B3-5.002, F.A.C.
(p) Assess laboratory staffing needs and
advise management when insufficient clinical laboratory personnel are employed
to provide appropriate consultation, supervision, and accurate performance of
tests and reporting of test results in accordance with the standards of
practice and responsibilities for clinical laboratory personnel defined in Rule
Chapters 64B3-10 and 64B3-13, F.A.C.
(q) Ensure that licensed clinical laboratory
personnel can perform all testing operations reliably in order to provide and
report accurate test results.
(r)
Ensure that policies and procedures are established for monitoring individuals
who conduct preanalytical, analytical and postanalytical phases of testing to
assure that they are competent and maintain their competency and, whenever
necessary, identify needs for corrective action including remedial training or
continuing education.
(s) Ensure
that a procedure manual approved, signed, and dated by the clinical laboratory
director is available to all personnel responsible for any aspect of the
testing process.
(t) Identify in
writing which examinations and procedures each individual is authorized to
perform including whether supervision is required for specimen processing, test
performance or result reporting and whether supervisor or director review is
required prior to reporting patient test results.
(u) Select the clinical laboratory's test
menu and methods, the schedule of testing, the criteria for specimen collection
and rejection and the methods for reporting results.
(v) Identify weaknesses in performance and
take necessary action to ensure minimum acceptable performance.
(w) Establish and maintain a patient
identification system.
(x) Design a
system for obtaining and managing financial resources for the clinical
laboratory and ensure accurate billing practices are maintained.
(y) In the specialty of cytology, in addition
to the above responsibilities, the Director shall:
1. Establish the workload limit for each
individual examining slides.
2.
Reassess the workload limit for each individual examining slides at least every
6 months and adjust as necessary.
3. Ensure that each individual examining
gynecologic preparations participates in a proficiency testing program approved
as specified in Rule Chapter 59A-7, F.A.C., and achieves a passing score as
specified in Rule Chapter 59A-7, F.A.C.
4. Ensure that no individual examines more
slides than that established pursuant to Rule Chapter 59A-7, F.A.C., regardless
of the location of testing.
(7) Only a clinical laboratory director
qualified pursuant to Chapter 483, Part II, F.S., may use the term "Clinical
Laboratory Director" in his or her job title.
Rulemaking Authority
483.805(4) FS.
Law Implemented 483.800,
483.813,
483.823,
483.825
FS.
New 12-6-94, Amended 3-28-95, Formerly 59O-13.001, Amended
4-7-02, 5-24-07, 5-11-08, 2-21-16.
