Regulatory Requirements for Laboratory Personnel as Defined by CLIA

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Regulatory Requirements for Laboratory Personnel as Defined by CLIA

CLIA '88 defines personnel requirements for 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. 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 all personnel must meet the qualifications required by CLIA for the highest level of testing performed. A single test of a higher complexity level will require the 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 all qualified personnel to perform moderate complexity testing as specified by CLIA.
There is a subcategory of moderate complexity designated as provider performed microscopy (PPM) procedures. This subcategory will not be discussed any further as it has no specific personnel requirements above those for moderate complexity testing. PPM procedures do not meet the waived criteria as they are not simple procedures. Training and specific skills are required.
Each level of non-waived complexity, moderate and high, have specific positions that must be filled with qualified personnel. Personnel requirements as defined by CLIA are found in Subpart M of the Code of Federal Regulations (CFR). Specific location in the CFR for personnel qualifications is Title 42, part 493, Subpart M.
Moderate Complexity personnel requirements are specified in Sections 1403 - 1425 and High Complexity personnel in Sections 1441 - 1495.