Covance

  • CLIA Supervisor II - BioA

    Job Location(s) US-IN-Indianapolis
    Job Number
    2018-21689
    Job Category
    Scientific Mid-Level
    Position Type
    Full-Time
  • Job Overview

    Covance is seeking a CLIA (Clinical Laboratory Improvement Amendments) Supervisor II for our BioA Group in Indianapolis, IN.

     

    • The CLIA Supervisor is responsible for:
    • Verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system;
    • Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered;
    • Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results;
    • Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications;
    • Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly;
    • Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed;

     

    The CLIA Supervisor, if qualified, may perform the duties of the General Supervisor and Testing Personnel:

    • The general supervisor is responsible for day-to-day supervision or oversight of the CLIA laboratory operations and personnel performing testing and reporting test results.
      • Is accessible to testing personnel at all times testing is performed to provide on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the Laboratory Director or Technical Supervisor;
      • Is responsible for providing day-to-day supervision of high complexity test performance by qualified Testing Personnel;
      • Except as specified above, is onsite to provide direct supervision when high complexity testing is performed by any qualified individuals; and
      • Is responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.
      • Employs a sufficient 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 CLIA personnel responsibilities.
      • Ensures that an approved procedure manual is available to all personnel responsible for any aspect of the testing process.
      • Assuring that all remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications;
      • Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning;
      • Providing orientation to all testing personnel; and
      • Ensures the personnel competency assessment is performed and documented on all testing personnel and ensures that remedial training is performed and documented, if necessary.
      • Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently.
      • Ensures that the laboratory is enrolled in an HHS-approved proficiency testing program or an alternate proficiency test and reports results and evaluation.
      • Under the general direction of the Laboratory Director, supervise personnel and report findings, perform tests requiring special scientific skills, and, in the absence of the Laboratory Director, is held responsible for the proper performance of all lab procedures.
      • The General Supervisor must review the results of the work during the next duty day.
      • A record is maintained to reflect the actual review.
    • The testing personnel are responsible for specimen processing, test performance and for reporting test results.
      • Each individual performs only those high complexity tests that are authorized by the Laboratory Director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities.
      • Each individual performing high complexity testing:
      • Follows the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results;
      • Maintains records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens;
      • Adheres to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed;
      • Follows the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance;
      • Is capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the general supervisor, technical supervisor, clinical consultant, or director;
      • Documents all corrective actions taken when test systems deviate from the laboratory's established performance specifications

    Education/Qualifications

    • BS/BA degree in Science, or equivalent degree plus 3-4 years related experience. Experience may be substituted for education.

    Experience

     

    • Must have CLIA experience.
    • Knowledge of appropriate regulatory agency guidelines.
    • Working knowledge of laboratory operations and an understanding of the technical aspects of the laboratory and/or computers and computer software systems.
    • Demonstrates strong organizational and communication skills.

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