Position Information

DUTIES AND RESPONSIBILITIES:

• Ensures that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic, and post-analytic phases of testing
• Ensures that the physical and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards
• Ensures that the test methodologies selected have the capability of providing the quality of results required for patient care
• Ensures that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method
• Ensures that laboratory personnel are performing the test methods as required for accurate and reliable results
• Ensures that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that-
  • The proficiency testing samples are tested as required by regulations
  • The results are returned within the timeframes established by the proficiency testing program
  • All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory performance and identify any problems that require corrective actions
  • An approved corrective action plan is followed when any proficiency testing results are found to be unacceptable or unsatisfactory
• Ensures that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory’s established performance specifications are identified, and that patient test results are reported only when the system is functioning properly
• Evaluates the competency of all testing personnel and assures that the staff maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently
• Responsible for the technical and scientific oversight of the laboratory