Regulatory Requirements for Laboratory Personnel as Defined by CLIA, continued

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Regulatory Requirements for Laboratory Personnel as Defined by CLIA, continued

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) has 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). The 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.