Moderate Complexity Lab Technical Consultant

Moderate Complexity Lab Technical Consultant

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The Laboratory Director position is responsible for the overall operation and administration of the laboratory, including the employment of competent personnel, equipment, safety, laboratory policies, quality assurance, all testing (including proficiency testing) and test reports. The Director may, if qualified, perform the duties of the technical consultant, technical supervisor, clinical consultant, general supervisor, and testing personnel.

• Be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed.
• Ensure that the physical plant and environmental conditions are appropriate for the testing performed.
• Provide a safe environment that protects employees from physical, chemical, and biological hazards.
• Ensure compliance with applicable regulations (federal, state, accrediting agency).
• Verify that responsibilities that can be delegated are properly performed if they are delegated.

• Ensure testing systems provide quality laboratory services for pre‑analytic, analytic, and post‑analytic phases of testing.
• Ensure test methods selected have the capability of providing quality results.
• Ensure verification procedures used are adequate to determine accuracy, precision, and other pertinent performance characteristics of the method.
• Ensure that 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.
• Ensure that an approved procedure manual is available to all personnel.
• Ensure that laboratory personnel are performing the test methods as required for accurate and reliable results.

• Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, supervision, and accurate performance of tests and reporting of test results.
• Ensure that only qualified personnel perform testing, and that prior to testing patient specimens, all personnel receive the appropriate training for the type and complexity of services offered, and demonstrate that they can perform all testing operations reliably to produce and report accurate results.
• Specify in writing the list of responsibilities and duties for everyone performing pre‑analytic, analytic, and post‑analytic phases of testing that states the level of activity each is authorized to perform, whether supervision is required, and whether consultant or director review is required prior to reporting patient test results.
• Ensure that policies and procedures are established for monitoring individuals who conduct pre‑analytical, analytical, and post‑analytical phases of testing to verify that they maintain competency to:
  • Process specimens
  • Perform test procedures.
  • Report test results promptly and proficiently
• Identify needs for remedial training or continuing education to improve skills whenever necessary.
• Ensure that a general supervisor provides on‑site supervision of high complexity test performance by testing personnel who have qualified by certain means.

• Ensure that the laboratory is enrolled in an approved proficiency testing (PT) program.
• Ensure that PT samples are tested in the same manner as patient samples.
• Ensure that PT samples are tested in compliance with regulations prohibiting referral of specimens and communication or sharing of results.
• Ensure that PT results are returned on time to the PT program.
• Ensure that PT results are reviewed by the appropriate staff and a corrective action plan is followed when PT results are unsatisfactory.

• Ensure that a quality control program is established and maintained to identify failures in quality as they occur.
• Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.
• Ensure…