DUTIES AND RESPONSIBILITIES:

• Ensure 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 preanalytic, analytic, and postanalytic phases of testing.
• Ensure that the physical plant 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.
• The test methodologies selected have the capability of providing the quality of results required for patient care;
  • Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method.
  • Laboratory personnel are performing the test methods as required for accurate and reliable results.
  • Ensure 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 under Subpart H of the regulations.

• The results are returned within the time frames established by the proficiency testing program.
• All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective actions; and
• An approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory.
• Manage the quality control and quality assurance programs are established and maintained to assure the quality of laboratory services provided and to identify failure in quality as they occur.
• Establish and maintenance of acceptable levels of analytical performance for each test system.
• Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified, and the patient test results are reported only when the system is functioning properly;
• Monitor reports of test results include pertinent information required for interpretation.
• Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions.
• Confirm that a general supervisor provides on-site supervision of high complexity test performance by testing personnel qualified under SECTION 2. F.
• Employ a sufficiency number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities.
• Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.
• Enforce 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 to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills.
• Ensure that an approved procedure manual is available to all personnel responsible for any aspect of testing process.
• Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results.