The technical supervisor is responsible for the technical and scientific oversight of the high complexity 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 supervisor ensures that all personnel are trained and assessed for competency at appropriate intervals for all test methods.
The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical supervision for each of the specialties and subspecialties in which the laboratory performs high complexity testing. The laboratory director of a high complexity lab may function as the technical supervisor provided they meet the qualifications specified.
Table 5. Personnel Requirements: Technical Supervisor Role.| Personnel Requirements by Test Complexity |
| Technical Supervisor |
| Waived Testing | Moderate Complexity Testing | High complexity Testing |
| Not Applicable | 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, and have 1 year of laboratory training or experience in high complexity testing within the specialty or subspecialty. 3. OR Possess a doctoral degree in chemical, biological, clinical or medical laboratory science OR hold an earned doctoral degree and meet the educational semester hours of specific coursework. Both need to have at least 1 year of laboratory training or experience in high complexity testing within the specialty or subspecialty. 3. OR Possess a 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 2 years of laboratory training or experience in high complexity testing within the specialty or subspecialty. 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 4 years of training or experience in high complexity testing within the specialty or subspecialty. Note: Microbiology requires an additional minimum of 6 months in the subspecialty of service. |
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 supervisor prior to December 28, 2024, can continue to serve in that capacity.
