CLIA '88 defines personnel requirements for the laboratory. The CLIA regulations provide regulatory guidance for Personnel Categories/specific positions required for compliance. Prior to qualifying laboratory personnel for employment in a laboratory, the CLIA complexity of the laboratory must be determined or verified. The laboratory's test complexity determines specific positions required. CLIA classifies individual tests into two categories of test complexity: waived testing and non-waived testing. Waived testing laboratories do not have personnel requirements but are required to have a laboratory director named. This individual will be named on the certificate and is accountable for compliance.
Non-waived testing is further subdivided into Moderate Complexity and High Complexity. The laboratory is designated by the highest complexity level of testing. Tests categorized as a lower level of complexity may be performed in the laboratory, but there must be personnel who meet the qualifications required by CLIA for the highest level of testing performed. A single test of a higher complexity level will require a higher level of compliance. For example, moderate complexity testing is performed in a physician's office laboratory. Waived testing is also performed. The laboratory must have qualified personnel to perform moderate complexity testing as specified by CLIA.
