The technical consultant is required by CLIA for moderate complexity testing but not for waived or high complexity testing. The technical supervisor performs many of the same responsibilities in the high complexity laboratory. The technical consultant is responsible for technical and scientific oversight of the laboratory. This includes but is not limited to selection of test methods (may be in conjunction with the laboratory director), establishing performance criteria for all methods and oversight of test performance, as well as verification of test performance, upon inception of the method and during the utilization of the method in the laboratory. Additional responsibilities include oversight of quality control for the laboratory and resolution of technical problems, as well as enrollment in an approved proficiency testing program for all appropriate testing. The technical consultant assures that all personnel are trained and assessed for competency at appropriate intervals for all test methods.
Table 3: Personnel Requirements - Technical Consultant Role
|Personnel Requirements by Test Complexity|
|Waived Testing||Moderate Complexity Testing ||High complexity Testing|
1. MD, DO, or DPM with a current medical license to practice in the state of laboratory’s location, AND 1 year of laboratory training or experience in non-waived testing in the areas of the designated specialty/subspecialty area.
2. OR, possess a doctoral or master's degree in a chemical, physical, biological or clinical laboratory science with one year of laboratory training or experience in non-waived testing in the designated specialty/subspecialty area.
3. OR, bachelor's degree in a chemical, physical, biological or clinical laboratory science, and 1 year laboratory training or experience in non-waived testing in the designated specialty/subspecialty area.
| Not Applicable |