Personnel Requirements

CLIA Requirements for Lab Personnel

Effective December 28, 2024, CLIA regulations require a non-pathologist physician to:

Have at least one (or two*) year directing or supervising non-waived laboratory testing
AND complete 20 CE credit hours in laboratory director duties

The CLIA personnel requirements are found in Subpart M of the Code of Federal Regulations. This subpart addresses qualifications and responsibilities for provider performed microscopy (PPM), moderate complexity, and high complexity laboratories. Laboratories performing only waived testing do not have specific personnel qualifications.

However, waived laboratories need oversight to consistently achieve quality patient testing. The individual designated for oversight should have the technical knowledge and experience to problem-solve testing issues and provide support to testing personnel.

Requirements for a Moderate Complexity Lab

A moderate complexity laboratory is required to have personnel who meet the following qualifications (in most situations, the laboratory director is qualified to full multiple roles):

Laboratory Director Qualifications

MD/DO/DPM certified in anatomic or clinical pathology*

PhD/DCLS degree in fields such as biology, chemistry, clinical laboratory science, medical technology (MT), or medical laboratory science (MLS),* the individual must also:

Hold current board certification from an HHS approved entity
Have one year of experience directing or supervising non-waived testing
Earned 20 hours of continuing education in laboratory director duties

MD/DO/DPM not certified in pathology* must also:

Have one year of experience directing or supervising non-waived testing
Earned 20 hours of continuing education in laboratory director duties

Master’s degree in fields such as biology, chemistry, clinical laboratory science, medical technology (MT), or medical laboratory science (MLS), the individual must also:

Have one year of non-waived laboratory experience or training
Have one year of experience directing or supervising non-waived testing
Earned 20 hours of continuing education in laboratory director duties

Bachelor’s degree in fields such as biology, chemistry, clinical laboratory science, medical technology (MT), or medical laboratory science (MLS), the individual must also:

Have two years of non-waived laboratory experience or training
Have two years of experience directing or supervising non-waived testing
Earned 20 hours of continuing education in laboratory director duties

Degrees in fields other than those aforementioned may require transcripts so applicable coursework can be evaluated and approved.

Laboratory directors are responsible for the laboratory’s total compliance, even if responsibilities are delegated to others.

*—Laboratory directors of high complexity laboratories must have two years of experience directing high-complexity testing (verses one year of experience needed for moderate-complexity testing). See the federal register for more details if needed.

Technical Consultant

The laboratory must have a technical consultant qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties tested in the laboratory. The qualifications include:

Possess a current license issued by the state in which the laboratory is located, if such licensing is required.

AND

Be a doctor of medicine or osteopathy licensed to practice medicine or osteopathy in the state in which the laboratory is located and be certified in anatomic, clinical pathology, or both by the American Board of Pathology or the American Osteopathic Board of Pathology, or possess qualifications that are equivalent.

Be a doctor of medicine, osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the state in which the laboratory is located, and have at least one year of laboratory training or experience or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible.

Hold a doctoral or master’s degree in a chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution, and have at least one year of laboratory training or experience or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible.

Have earned a bachelor’s degree in a chemical, physical, or biological science or medical technology from an accredited institution, and have at least two years of laboratory training or experience or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible.

Clinical Consultant

The clinical consultant must be qualified to consult with and render opinions to the laboratory’s clients concerning the diagnosis, treatment, and management of patient care. The qualifications include:

Be qualified as the laboratory director.

Be a doctor of medicine, osteopathy, or podiatric medicine and possess a license to practice medicine, osteopathy, or podiatry in the state in which the laboratory is located.

Testing Personnel

The laboratory must have a sufficient number of individuals who meet the qualifications to perform the volume and complexity of tests performed. Qualifications include:

Possess a current license issued by the state in which the laboratory is located, if such licensing is required.

AND

Be a doctor of medicine, osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, podiatry in the state in which the laboratory is located, or have earned a doctoral, master’s, or bachelor’s degree in a chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution.

Have earned an associate degree in a chemical, physical, or biological science or medical laboratory technology from an accredited institution.

Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration, and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician).

Have earned a high school diploma or equivalent, and have documentation of training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has:
- The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens, and
- The skills required for implementing all standard laboratory procedures, and
- The skills required for performing each test method and for proper instrument use, and
- The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed, and
- A working knowledge of reagent stability and storage, and
- The skills required to implement quality control policies and procedures of the laboratory, and
- An awareness of the factors that influence test results, and the skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results.