To obtain your CLIA License you lab will need a Director.
- Testing systems in the laboratory provide quality services in all aspects of test performance, i.e., the pre-analytic, analytic, and post-analytic phases of testing and are appropriate for your patient population.
- Confirming that the physical and environmental conditions of the laboratory are adequate and appropriate for the testing performed.
- Ensuring the environment for employees is safe for physical, chemical, and biological hazards as well as safety and biohazard requirements are followed.
- Sanction that the general supervisor (high complexity testing) is capable to provide day-to-day supervision of all testing personnel and reporting of test results as well as provide on-site supervision for specific minimally qualified testing personnel when they are performing high complexity testing; sufficient numbers of appropriately educated, experienced, and / or trained personnel who provide appropriate consultation, properly supervise, an accurately perform tests and report test results in accordance with the written duties and responsibilities specified by you, are employee’s by laboratory (a dangling thought).
- New test procedures are reviewed, included in the procedure manual and followed by personnel; and each employee’s responsibilities and duties are specified in writing.