VisionGate is dedicated to saving lives through early cancer detection and prevention. The Cell-CT™ is a revolutionary automated 3D cell imaging platform that generates high-resolution 3D biosignatures from intact cells. They are currently recruiting for a CLIA Lab Director.
As laboratory director, you are responsible for the overall operation and administration of the CLIA laboratory, in accordance with all Federal Regulations and State laws governing clinical laboratories, including planning, development, organization, implementation, direction and ongoing evaluation of the laboratory operations and performance.
Duties and Responsibilities:
- The Laboratory Director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulation.
- 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; 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.
- 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 by CLIA; the results are returned within the timeframes established by the proficiency testing program; all proficiency testing reports 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 results are found to be unacceptable or unsatisfactory.
- Ensure that the quality control and quality assurance 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 specifications 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.
- Employ a sufficient number of laboratory personnel with 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 CLIA regulations.
- 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 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 the testing process.
- Specify in writing the responsibilities and duties of each consultant and 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 results reporting and whether consultant or director review is required prior to reporting patient test results.
- Establish operations standards for cost control, waste reduction, quality, safety, and complete on-time delivery.
- Oversee the development of the organization’s plans and programs in evaluation of long-range planning and regulatory action on operational performance. Foster a unified culture and promote a process for collaboration, cooperation, sharing of information and mutual teamwork.
- Monitor utilization patterns of lab services and advise Leadership and other appropriate staff of developing trends in clinical service needs.
- Establish and maintain lines of communication with internal and external customers in order to ensure a timely response to new clinical service trends and program planning.
- Ensure operational adherence to currently accepted technical service standards for laboratory medicine.
- Ensure operational adherence to applicable policies and procedures by all technical and operational staff.
- Participate in the development and implementation of operations budget to ensure compliance with organizational expenditure requirements.
- Advise, negotiate, manage and administer all contracts into which the lab may enter.
- Lead and direct the development, communication and implementation of effective growth strategies and processes.
- Perform other duties as required.
- Perform other responsibilities as mandated by Clinical Laboratory Improvement Amendments (CLIA) and any other pertinent local, state or federal regulations.
Education: Doctor of Medicine or D.O.
Experience: Eight to ten years related experience in a clinical laboratory, preferably in the cytopathology space.
License: Certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification.
An energetic, forward thinking and creative individual with high ethical standards and an appropriate professional image;
Knowledgeable of start-up companies and CLIA lab settings and a proven track record of successfully working in such settings;
Sound technical skills, analytical ability, good judgment and strong operational focus;
An intelligent, articulate team player who can relate to people at all levels of the organization and who possesses excellent communication skills.
For more information, contact:
275 N. Gateway Drive,
Phoenix, AZ 85034-1700