Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B3 - Board of Clinical Laboratory Personnel › Chapter 64B3-13 - RESPONSIBILITIES OF CLINICAL LABORATORY PERSONNEL › Section 64B3-13.001 - Responsibilities of Directors

Current through Reg. 50, No. 138; July 16, 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.