Personnel Qualifications

Under the CLIA, requirements exist for laboratory personnel qualifications and/or experience. Perhaps the most important qualification requirements apply to the laboratory director. The director of a high-complexity laboratory such as a clinical molecular testing laboratory must hold a license in the state in which he or she works (if the state issues such licenses) and be a physician or osteopathic physician with board certification in pathology. Alternatively, the laboratory director can be a physician with at least one year of training in laboratory practice during residency, or a physician with at least two years of experience supervising or directing a clinical laboratory. A doctoral scientist holding a degree in a chemical, physical, biological, or clinical laboratory science field with board certification from an approved board may also serve as the laboratory director. There are also provisions that allow for grandfa-thering of persons who were serving as laboratory directors at the time of implementation of the CLIA. Currently, there are no specific CLIA-required qualifications for the director of a molecular diagnostics laboratory. There are, however, board examinations in this field or similar fields that are offered by the American Board of Pathology, the American Board of Medical Genetics, the American Board for Clinical Chemistry, the American Board of Medical Microbiology, and the American Board of Bioanalysts. It is possible that individual states may begin to require specific qualifications in molecular diagnostics in the future or even that changes to the CLIA may require such qualifications. Other personnel and their qualifications described in the CLIA for high-complexity laboratories are technical supervisor, clinical consultant, general supervisor, cytology supervisor, cytotechnologist, and testing personnel.

Project Management Made Easy

Project Management Made Easy

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