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 and High Complexity laboratories. Laboratories performing only Waived testing do not have specific personnel qualifications.
The PPM classification has requirements for the laboratory director and testing personnel; the Moderate Complexity classification has requirements for the laboratory director, clinical consultant, technical consultant and testing personnel; the High complexity classification has requirements for the laboratory director, clinical consultant, technical supervisor, general supervisor and testing personnel.
CLIA Personnel Requirements
Moderate Complexity
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
- Must possess a current license as a laboratory director 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 certified in anatomic or clinical pathology, or both by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent.
OR
- Be a doctor of medicine or osteopathy or doctor of podiatric medicine licensed to practice medicine or osteopathy or podiatry in the State in which the laboratory is located and have laboratory training or experience consisting of:
- At least one year of directing or supervising non-waived laboratory testing, or
- Have at least twenty continuing medical education credit hours, commensurate with the director responsibilities, or
- Have laboratory training equivalent to twenty continuing medical education credit hours, commensurate with the director responsibilities, obtained during medical residency.
OR
- Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and:
- Be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysts or the American Board of Medical Laboratory Immunology, or
- Have at least one year experience directing or supervising non-waived testing.
OR
- Have earned a 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, and
- In addition, have at least one year of supervisory laboratory experience in non-waived testing.
OR
- 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, and
- In addition, have a least two years of supervisory laboratory experience in non-waived testing
OR
- Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director on or before February 28, 1998.
OR
- Qualified under State law to direct a laboratory in the state in which the laboratory is located (on or before February 28, 1992).
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.
OR
- 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.
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 certified in anatomic or clinical pathology, or both by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent.
OR
- Be a doctor of medicine or osteopathy or doctor of podiatric medicine licensed to practice medicine or 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.
OR
- 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.
OR
- 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.
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 or osteopathy or doctor of podiatric medicine licensed to practice medicine or osteopathy or 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
OR
- Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution.
OR
- 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)
OR
- 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.
