Oxford Immunotec, Inc.

Medical Director

Job Location US-MA-Norwood
Posted Date 2 weeks ago(2/9/2018 2:40 PM)
ID
2017-1836
# of Openings
1
Department
Norwood Lab

Overview

The Medical Director will provide technical oversight of the Oxford Immunotec clinical service lab. This person will have overall responsibility for quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results. The Medical Director will report to the Director of U.S. Operations.

Responsibilities

The medical director must ensure that all the duties are properly performed and applicable CLIA regulations are met as follows:

  • 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 pre-analytic, analytic, and post-analytic 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
  • Ensure;
    • 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; and
    • Laboratory personnel are performing the test methods as required for accurate and reliable results;
    • Adequate and appropriate equipment and supplies are available for the selected test methodologies
  • Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the testing performed and;
    • The proficiency testing samples are tested as required under subpart H of this part
    • 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's performance and to identify any problems that require corrective action
    • An approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory
  • Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;
  • Ensure the establishment 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 that patient test results are reported only when the system is functioning properly;
  • 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 consultation is available to all applicable government agencies relating to maintaining appropriate licensure and regulatory compliance for the laboratory operations;
  • Ensure that a general supervisor provides on-site supervision of high complexity test performance by testing personnel qualified under Sec. 493.1489(b)(4);
  • Employ 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 the personnel responsibilities described in this subpart;
  • Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results;
  • Ensure that policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical, and post-analytical 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 the testing process; and
  • Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the pre-analytic, analytic, and post-analytic 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. 
  • Ensures sufficient on site availability to perform these requirements and to participate in Oxford Diagnostic Laboratories business reviews and strategic planning.
  • Follows all company safety policies & other safety precautions within work area.

Qualifications

  • Requires a degree in Medicine and Certification in Anatomic or Clinical Pathology, or both, by the American Board of Pathology.
  • Requires an active license in Massachusetts and eligibility for all certifications required to serve as Medical Director in a clinical laboratory accepting specimens all states.

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