Salary: $63,268.00 to $157,400.00 /year
- LA State License Required
- Moderate ot High Complexity Laboratory
- Remote position.
General Position Description:
The clinical laboratory director is responsible for the technical and scientific oversight of the laboratory in addition to the overall operation and administration of the laboratory and must ensure compliance with federal and state laws and regulations. Clinical laboratory director services are to be provided in accordance with CLIA regulations, Subpart M—Personnel and Part 493- Laboratory Requirements, and any state requirements that may apply. In addition adherence to all accreditation policies and guidelines pertaining to the laboratory.
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.
In addition, the director shall fulfill the following responsibilities:
- Be accessible to the clinical laboratory to provide on-site, telephone, or electronic consultation as needed. This responsibility may not be delegated except to a clinical laboratory director
- 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 post-analytic phases of testing
- 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
- Ensure that the test methodologies selected have the capability of providing the quality of results required for patient care
- Ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent characteristics of the method
- 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
- Ensure that the clinical laboratory successfully participates in a proficiency testing program for the testing performed which meets all requirements
- 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.
- Ensure that an approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory
- 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
- Ensure that acceptable levels of analytical performance for each test system are established
- 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
- Ensure that reports of test results include pertinent information required for interpretation
- 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
- Ensure that supervision is provided as specified in CLIA by a supervisor or supervisors
- 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 as defined in regulations
- Ensure that licensed clinical laboratory personnel can perform all testing operations reliably in order to provide and report accurate test results
- Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and post-analytical 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
- Ensure that a procedure manual approved, signed, and dated by the clinical laboratory director both initially and biennially thereafter is available to all personnel responsible for any aspect of the testing process
- 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 a supervisor or director review is required prior to reporting patient test results
- 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
- Identify weaknesses in performance and take necessary action to ensure minimum acceptable performance
- Establish and maintain a patient identification system
- The director can delegate performance of responsibilities to qualified supervisors, with the exception of the approval, signing, and dating of procedures. However, the director remains responsible for ensuring that all duties are properly performed. The delegation of responsibilities must be written and specific.
Education and Experience
- Education and experience are in accordance with CLIA regulations, Subpart M—Personnel, and any state requirements that may apply.