CLIA outlines personnel qualifications based on the laboratory's level of testing complexity. The six types of laboratory personnel include laboratory directors, technical consultants, clinical consultants, technical supervisors, general supervisors, and testing personnel.
Laboratory directors bear the responsibility for all operations and administration of the laboratory. This includes developing and overseeing a quality assurance program to verify accurate test results. The directors retain the responsibility for all testing, reporting, and patient test results. To work in moderate and high complexity testing laboratories, laboratory directors are required to have a doctorate of some kind (MD, DO, DPM, or PhD).
Clinical consultants serve in a referral role to provide consultation regarding clinical issues, including diagnoses, treatment, and management of patient conditions and care. Clinical consultants verify that test results and reports are complete and contain all appropriate information. To work in moderate and high complexity testing laboratories, clinical consultants are required to have a doctorate of some kind (MD, DO, DPM, or PhD).
Technical consultants select test methods, establish performance criteria for those methods, and oversee and verify test performance. Technical consultants also play a large role in quality control; they enroll the laboratory in an approved proficiency testing program and ensure that all personnel are trained and assessed for competency at appropriate intervals for all test methods. To work in moderate and high complexity testing laboratories, technical consultants are required to have a combination of higher level education and years of experience in a nonwaived testing laboratory: an MD, DO, DPM, or PhD and 1 year of experience, an MS and 1 year of experience, or a BS and 2 years of experience.
Technical supervisors have the same responsibilities as technical consultants; they provide technical and scientific oversight of the high complexity laboratory, establish test performance criteria, and oversee quality control. To work in high complexity testing laboratories, technical supervisors are required to have a combination of higher level education and years of experience in a high complexity laboratory: an MD, DO, DPM, or PhD and 1 year of experience, an MS and 2 years of experience, or a BS and 4 years of experience.
General supervisors provide daily oversight and supervision of testing, monitor specimen handling and analyses, verify testing performance and analyses, and perform administrative and supervisory duties as delegated. To work in a high complexity testing laboratory, general supervisors must qualify as laboratory directors or technical supervisors of high complexity testing, obtain an MS or BS and 1 year of experience, or obtain an associate's degree and 2 years of experience.
Testing personnel are responsible for specimen processing and handling, test performance, and result reporting. Testing personnel should perform only duties as authorized by the laboratory director and appropriate for their degree of training, experience, and abilities. To work in a moderate complexity testing laboratory, testing personnel are required to have at least a high school diploma with recorded laboratory training and a current state license, where applicable. To work in a high complexity testing laboratory, testing personnel are required to have at least an associate's degree and a current state license, where applicable. Depending on the testing performed, personnel may be required to have higher levels of education, up to a doctorate.
