Laboratory Directors of Moderate and High Complexity Laboratories Qualifications

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Laboratory Directors of Moderate and High Complexity Laboratories Qualifications

Laboratory directors bear the responsibility for all operations and administration of the laboratory. The laboratory director may delegate some of responsibilities in writing to other appropriate qualified laboratory personnel. Responsibilities include providing appropriate personnel for all positions, 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 high complexity laboratories, the director must be:
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, 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 one of the following:
  • a.) 1 year of experience supervising non-waived testing;
  • b.) a minimum of 20 CME credits in laboratory practice about laboratory director responsibilities;
  • c.) training equivalent through medical residence of at least 20 CME credits in laboratory operation and supervision (such as board certification in hematology or medical
2. OR Possess a doctoral degree in a chemical, physical, biological or clinical laboratory science and board certified in Medical Microbiology, Clinical Chemistry, Bioanalysis, Medical Laboratory Immunology, or one year supervising non-waived testing
3. OR Master's Degree in a chemical, physical, biological, or clinical laboratory science and 1 year laboratory training or experience and 1 year of supervisory experience in non-waived laboratory.
4. OR Bachelor's Degree in a chemical, physical, biological or clinical laboratory science and 1 year training or experience and 1 year of supervisory experience in non-waived laboratory
5. OR Serving as a laboratory director and previously qualified or could have qualified as a laboratory director on or before February 28, 1998.
6. OR qualified under state law to be serving as a laboratory director prior to February 28, 1992.
1. 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 one of the following:
  • a.) Board certified in Anatomic or Clinical Pathology or possess equivalent qualifications;
  • b.) 2 years of experience directing or supervising high complexity testing;
  • c.) 1 year of laboratory training during medical residency that includes laboratory operation and supervision
2. OR, possess a doctoral degree in a laboratory science with certification in each specialty or subspecialty, for which direction is performed, by an HHS approved board.
3. OR, until 12/31/2002, possess at least 2 years of laboratory training or experience or both and 2 years of experience directing o or supervising high complex testing.
4. OR, qualified under State law to be serving as a Laboratory Director prior to Feb. 28, 1992.
NOTE: The final CLIA regulations were published on February 28, 1992. Individuals previously qualified as a laboratory director could continue to serve in that capacity. The individual would not have to re-qualify with the newly implemented regulations.