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.
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):
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:
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:
The laboratory must have a sufficient number of individuals who meet the qualifications to perform the volume and complexity of tests performed. Qualifications include:
Share this page
Alert: Message field is required.
You must sign in before you can share a page on AAFP connection.
Clinical Laboratory Improvement Amendments (CLIA)