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 the 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, resolution of technical problems, and enrollment in an approved proficiency testing program for all appropriate testing. The technical consultant ensures 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 |
| Technical Consultant |
| Waived Testing | Moderate Complexity Testing | High complexity Testing |
| Not Applicable | 1. MD or DO with a current medical license to practice in the state of laboratory’s location and board certified in Anatomic or Clinical Pathology.2. OR an MD, DO, or DPM with a current medical license to practice in the state of laboratory’s location, possess a state laboratory director’s license (if applicable), AND 1 year of laboratory training or experience in non-waived testing, in the designated specialty or subspecialty area. 3. OR Possess a doctoral or master's degree in a chemical, biological, clinical or medical laboratory science OR hold an earned doctoral or master's degree and meet the educational semester hours of specific coursework. Both need to have 1 year of laboratory training or experience in non-waived testing in the designated specialty or subspecialty area. 4. OR Possess a bachelor's degree in a chemical, biological, clinical or medical laboratory science OR at least 120 semester hours that includes defined coursework. Both need to have 2 years of training or experience in non-waived testing in the designated specialty or subspecialty area. 5. OR Possess an associate's degree in medical laboratory technology, medical laboratory science, or clinical laboratory science and have 4 years of laboratory training or experience in non-waived testing in the designated specialty or subspecialty area. | Not Applicable |
MD = Doctor of Medicine; DO = Doctor of Osteopathy; DPM = Doctor of Podiatric Medicine
Note: CLIA made updates to its personnel qualifications that take effect on December 28, 2024. These updates are reflected accordingly. Individuals considered qualified as technical consultants prior to December 28, 2024, can continue to serve in that capacity.
