Laboratory directors bear the responsibility for all operations and administration of the laboratory. The laboratory director may delegate some of the responsibilities in writing to other appropriate qualified laboratory personnel. Responsibilities include providing appropriate personnel for all positions and developing and overseeing a quality assurance program to verify accurate test results and quality laboratory operations for all aspects of the laboratory. The director, however, retains the responsibility for all testing, reporting, and patient test results.
As specified, the qualifications for moderate or high complexity laboratories, the director must be:
Table 2. Personnel Requirements: Laboratory Director.| Personnel Requirements by Test Complexity |
| Laboratory Director |
| Waived Testing | Moderate Complexity Testing | High complexity Testing |
| No Federally defined qualifications. Accreditation, state or local agencies may impose additional qualifications. | 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 possess the following: - a.) 1 year of experience supervising non-waived testing;
- b.) a minimum of 20 CE credits in laboratory practice about laboratory director responsibilities.
3. OR Possess a doctoral degree in a 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 possess the following: - a.) Certified by a board approved by HHS;
- b.) 1 year of experience supervising non-waived testing;
- c.) a minimum of 20 CE credit hours in laboratory practice about laboratory director responsibilities.
4. OR Possess a master's degree in a chemical, biological, clinical or medical laboratory science OR meet bachelor's degree equivalency and have the educational semester hours of defined graduate level coursework. Both need to possess the following: - a.) 1 year laboratory training or experience in non-waived testing;
- b.) 1 year of experience supervising non-waived testing;
- c.) a minimum of 20 CE credits in laboratory practice about laboratory director responsibilities.
5. 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 possess the following: - a.) 2 years of training or experience in non-waived testing;
- b.) 2 years of supervisory experience in non-waived laboratory;
- c.) a minimum of 20 CE credits in laboratory practice about laboratory director responsibilities.
| 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 possess the following: - a.) 2 years of experience directing or supervising high complexity testing;
- b.) a minimum of 20 CE credit hours in laboratory practice about laboratory director responsibilities.
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 possess the following: - a.) Certified by a board approved by HHS;
- b.) 2 years laboratory training or experience in high complexity testing;
- c.) 2 years supervising high complexity testing;
- d.) a minimum of 20 CE credits in laboratory practice about laboratory director responsibilities.
|
MD = Doctor of Medicine; DO = Doctor of Osteopathy; DPM = Doctor of Podiatric Medicine; CE = Continuing Education; HHS = Health and Human Services
Note: CLIA made updates to its personnel qualifications that take effect on December 28, 2024. These updates are reflected accordingly. Individuals considered qualified as laboratory directors prior to December 28, 2024, can continue to serve in that capacity.
