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CLIA Laboratory Director - Tatitlek Federal Services

Company: The Tatitlek Corporation
Location: Aberdeen
Posted on: April 10, 2021

Job Description:

CLIA Laboratory Director - Tatitlek Federal Services Tracking Code 4875-205 Job Description Job specifications are intended to present a descriptive list of the range of duties performed by employees. Specifications are not intended to reflect all duties performed within the job. The employer retains the right to change or assign other duties to this position.Essential Duties and Responsibilities:Essential functions are intended to present a descriptive list of the range of duties performed by employees. This list of essential functions is not intended to reflect every duty that may be performed within the job.

  • Serves as the--Clinical Laboratory Consultant for laboratories performing high complexity clinical analysis accredited under the Clinical Laboratory Improvement Program (CLIP).
  • Serves as a subject matter expert and provides expert consultation services with technical advice and guidance on matters relating to the quality of the clinical test results reported and their interpretation.
  • Ensure that the laboratories' clinical program is in compliance with the CLIP requirements and the laboratories' quality management system.
  • Ensure that clinical testing 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 quality control (QC) and quality assessment (QA) programs are maintained to assure the quality of laboratory services provided and recommend/develop corrective action plans when necessary to address deviations in the QC/QA program.
  • Provide briefings as appropriate upon request within their region.
  • Maintains clear lines of communication with the Lab Managers/Directors for awareness and feedback.
  • Responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations.
  • The laboratory consultant, if qualified, may perform the duties of the clinical consultant, and assist the testing personnel, or delegate these responsibilities to personnel.
  • If the laboratory consultant reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed.
  • The laboratory consultant must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed.
  • 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 that the test methodologies selected have the capability of providing the quality of results required for patient care;
  • Ensure verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and
  • Ensure 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 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; and 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 the consultation regarding high complexity test performance by testing personnel qualified under -- 493.1489(b)(4) as provided.
  • Ensure a sufficient number of laboratory personnel with the appropriate education and either experience or training are supporting the lab to provide appropriate consultation, properly oversee and accurately perform tests and report test results in accordance with the personnel responsibilities described in this sub- part. If not, is to bring this to the Government COR attention immediately for potential action.
  • Ensure that prior to testing samples, 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 preanalytical, 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.
  • Specify, in writing, the responsibilities and duties of each consultant and each lead, 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.
  • The clinical laboratory consultant responsibilities include providing consultation regarding the appropriateness of the testing ordered and interpretation of test results.
  • The clinical laboratory consultant must;
    • Be available to provide consultation to the laboratory's clients
    • Be available to assist the laboratory's clients in ensuring that appropriate tests are ordered to meet the clinical expectations
    • Ensure that reports of test results include pertinent information required for specific patient interpretation; and
    • Ensure that consultation is available and communicated to the laboratory's clients on matters related to the quality of the test results reported and their interpretation concerning specific patient conditions.Non-Essential Duties:
      • Other duties as assigned Required Skills Education and ExperienceThe Clinical Laboratory--Consultant must qualify under one of the following options:--
        • The laboratory consultant must be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine,
          osteopathy or podiatry in the State in which the laboratory is located and have at least one year of laboratory training during medical residency (for example,
          physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine).
        • The laboratory consultant must be a doctor of medicine, a doctor of
          osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located and have at least 2 years of experience directing or supervising high complexity clinical testing.
        • Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS.
          • List of boards approved by HHS:
            ABB - American Board of Bioanalysis
            ABB public health microbiology certification
            ABCC - American Board of Clinical Chemistry
            ABFT - American Board of Forensic Toxicology
            ABHI - American Board of Histocompatibility and Immunogenetics
            ABMGG - American Board of Medical Genetics and Genomics
            ABMLI - American Board of Medical Laboratory Immunology
            ABMM - American Board of Medical Microbiology
            NRCC - National Registry of Certified Chemists
          • Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and before February 24, 2003, served as a
            clinical consultant/director of a laboratory performing high complexity testing and must have at least two years of laboratory training or experience and two years of laboratory experience directing or supervising high complexity clinical testing.Physical Requirements:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While--performing the duties of this job, the employee is regularly required to stand;--walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; talk or hear. The employee must occasionally lift--and/or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, depth perception, and the ability to--adjust focus.Working Conditions:Work Environment characteristics described here are representative of those that must be borne by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Job is performed in an office setting with exposure to computer screens and requires extensive use of a computer, keyboard, mouse and multi-line telephone system.Additional Qualifying Factors:Must have a satisfactory background screening, negative drug test, positive references and proof of identity and legal authorization to work in the United States and for TTI are required.The Tatitlek Corporation gives hiring, promotion, training and retention preference to Tatitlek shareholders, shareholder descendants and shareholder spouses who meet the minimum qualifications for the job.As an equal opportunity employer, The Tatitlek Corporation recognizes that our strength lies in our people. Discrimination and all unlawful harassment, including sexual harassment, in employment is not tolerated. We encourage success based on our individual merits and abilities without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, disability, marital status, citizenship status, military status, protected veteran status or employment. We support and obey laws that prohibit discrimination everywhere we do business. Job Location Aberdeen Proving Grounds, Maryland, United States Position Type Full-Time/Regular

Keywords: The Tatitlek Corporation, Tuscaloosa , CLIA Laboratory Director - Tatitlek Federal Services, Executive , Aberdeen, Alabama

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