64B3-13.002. Responsibilities of Supervisors

(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. History–New 12-6-94, Amended 3-28-95, Formerly 59O-13.002, Amended 4-10-01, 4-7-02, 10-1-19.