64B3-13.001. Responsibilities of Directors

(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. History–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.