Implement and maintain standards set by the Centers for Medicare and Medicaid Services (CMS) and other accrediting agencies, such as the College of American Pathologists (CAP). Responsible for the overall administration of the laboratories, assuring the employment and training of competent personnel that can perform test procedures, record and report test results promptly, accurately and proficiently.
Oversee the technical and scientific oversight of the laboratories, assuring compliance with applicable federal and state regulations. Consult on the appropriateness of the testing ordered and the interpretation of test results. Oversee quality assurance and compliance for the assisted reproduction program.
Responsible for all aspects of test performance, to include the pre-analytic, analytic and post-analytic phases of testing. Assure the enrollment in an approved proficiency testing program, the appropriate execution and evaluation of proficiency testing, and the establishment and maintenance of quality control and quality assurance programs.
Take and document all necessary remedial actions upon the identification of significant deviations from the established laboratory performance characteristics, and report patient test results only when the system functions properly.
Assure the complete and accurate reporting of test results, and then consult with the clients regarding the quality and the interpretation of the test results. Assure the following of the appropriate enterprise and laboratory policies and procedures, and the availability of an approved procedure manual to all personnel.
Select the appropriate methodology for clinical use, verify all procedures performed and the establishment performance characteristics, including the precision and accuracy of each method. Resolve technical problems and assure the taking of remedial actions when test systems deviate from the established laboratory performance specifications.
Identify the training needs and ensure that each individual performing tests receives regular in-service training appropriate for the type and complexity of the laboratory services performed. Evaluate the competency of all testing personnel to ensure that they maintain their competency to perform test procedures and report test results promptly, accurately and proficiently.
Assist laboratory clients to ensure clinical expectations the ordering of the appropriate tests and that the test results reports include pertinent information required for specific patient interpretation.
Perform laboratory procedures and testing as needed. Implement and review the quality laboratory objectives, ensuring accuracy and precision. Review laboratory quality control activities and implement corrections and improvements as necessary. Seek out and evaluate new quality assurance concepts, and evaluate new technologies, methods and equipment with respect to improved quality.
Genetics lab should be similar, with wording about specialty, to include genetics or reproductive. Clinical Laboratory Improvement Act/Amendment.
Solves a wide range of complex mathematical problems using a variety of techniques. Manages conflicting priorities effectively. Delivers written and oral communication, responds to questions and concerns, and produce specific outcomes and impact. Deals effectively with ambiguity and uncertainty; recovers from disappointments and setbacks. Implements programs as needed to comply with diverse healthcare laws or regulations. Monitors regulatory compliance of all healthcare practices to ensure no violations. Operates quality testing equipment and verifies collected data. Utilizes quality control techniques to monitor and maintain laboratory equipment. Participates in research studies for area of specialization or function.
Doctor of Philosophy (PhD) or Medical Doctor (MD) degree required.
Experience working in a Clinical Laboratory Improvement Amendments (CLIA) certified medical laboratory is desired.
Must be Board Certified or Board Eligible in Molecular Genetics by the American Board of Medical Genetics or equivalent agency.