What are CLIAs QC (process control) requirements?
CLIA was implemented to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. QC requirements, which include calibration, calibration verification, remedial actions and documentation are identified for test complexity and, in some cases, specific analytes. • How are CLIA’s proficiency testing requirements met? Under CLIA, PT is mandated as an external assessment tool for all test sites performing moderate and high complexity tests. CLIA specifies which professional organizations or states can provide PT; what analytes must be evaluated by PT; how PT samples are to be handled; what constitutes successful, passing performance; and what sanctions are applied for PT failure. • What are CLIA’s requirements for personnel training and on-going competency assessment? Essential components to ensuring quality test results are training and competency assessment. Initial training and at least yearly, on-going competency assessments must
