Summary of Roles and Responsibilities of the Medical Director per ASHI and CLIA standards:
Provides overall management and direction of the laboratory.
Ensures 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.
Employs sufficient and qualified personnel
Ensures compliance with all applicable regulations
Provides appropriate consultation and supervision to ensure accurate testing and reporting of test results for all aspects of services provided by the laboratory
Ensures that 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.
Responsible for the technical and scientific oversight of the laboratory including:
Selection of the test methodology that is appropriate for the clinical use of the test results.
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.
Provides clinical consultation to the laboratory’s clients
Provides consultation regarding the appropriateness of the testing ordered and clinical interpretation of test results in a timely manner
Assists the laboratory’s clients in ensuring that appropriate tests are ordered to meet the clinical need.
Ensures that reports of test results include pertinent information required for specific patient interpretation.
Ensures 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 in a timely manner appropriate to the testing performed.
HLA, Bone Marrow and COVID Testing Medical Director
Oversees the day-to-day technical and administrative functions of the laboratory.
Plans, assigns, and supervises laboratory work as needed.
Reviews test and QC data for accuracy and completeness as needed.
Reviews and signs out laboratory reports as needed.
Assures the smooth operation of the laboratory including adequate supplies and troubleshooting technical problems.
Assures training of new employees and the provision of in-service education including lab safety training.
Oversees regular review of quality control and quality assurance data to verify testing and the maintenance of services at the highest level of quality.
Ability to follow Standard Operating Procedures as set by the company, regulatory agencies
Ensure departmental staff is adhering to Standard Operating Procedures.
Develops strategic plan and adheres to and executed on its strategic initiatives.
Researches and develops new channels of business.
Evaluates new products and improves procedures.
Maintains and updates procedure manuals.
Participates in the preparation of lab budget and special reports as needed.
Works closely with physicians, nurses and transplant personnel. Has contact with other laboratories and state/federal government agencies.
Monitors compliance of laboratory and personnel with federal/state regulations and standards of accrediting professional agencies.
Performs duties of Histocompatibility Technologist and other related duties as required.
Recognizes and guards against disclosure of highly sensitive and confidential patient records and test results, i.e., compatibility results, HIV status, and organ donor identification.
Performs other duties as assigned
SKILLS & ABILITIES
Education: Meet at least one of the following educational requirements. Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution. Be a Doctor of Medicine or osteopathy licensed to practice medicine or osteopathy in the state, country, or other jurisdiction in which the laboratory is located, if such licensing is required by law.
Experience: Have at least 2 years full-time post-doctoral laboratory training or experience in immunology, histocompatibility, immunogenetics, or a related field, or a residency in clinical or combined anatomic/clinical pathology or other related medical specialty, and have at least 2 years fulltime post-doctoral training in directing or supervising high complexity testing in human histocompatibility and immunogenetics in an ASHI accredited approved laboratory.
Computer Skills: Proficient in MS office and software related to clinical applications.
Certificates & Licenses: Nevada State Licensed as a Laboratory Director. Meet at least one of the following certification requirements for areas of accreditation regulated by CLIA. Be certified and continue to be certified in clinical or combined anatomic/clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or other appropriate medical board. Be certified and continue to be certified by a Board approved by Health and Human Services (HHS). Directors who also serve as clinical consultants need to meet board certification requirements if applicable, even if they were serving as directors prior to February 24, 2003.
Other Requirements: The Laboratory Director must meet all qualifications to act as Laboratory Director, Technical Supervisor and Clinical Consultant under American Society of Histocompatibility and Immunogenetics (ASHI) or College of American Pathologists (CAP) or the State of Nevada regulations. ASHI or CAP will be used for deemed status with Centers for Medicare and Medicaid Services (CMS) / Clinical Laboratory Improvement Amendments (CLIA). If the Laboratory tests drug or food analytes, Food and Drug Administration requirements must also be met.
Internal Number: 20201
About Nevada Donor Network
Nevada Donor Network is a federally designated 501(c)3 not-for-profit organ procurement organization (OPO) also responsible for facilitating tissue and cornea donation statewide. Founded in 1987, our core purpose is to provide hope strength and life to more than 2 million people in the state of Nevada and thousands of potential transplant recipients across the country.