In 2011, CLSI published “EP23 Laboratory Quality Control Based on Risk Management.” In 2013, CMS revised the CLIA Interpretive Guidelines to include risk assessment in all aspects of laboratory testing. CMS requested that the Clinical Laboratory and Standards Institute (CLSI) develop a document to address QC and risk. 1 Although EQC was adopted by many laboratories, over time it proved to have technological limitations. While still following the manufacturers’ QC frequency recommendations, EQC allowed laboratories to decrease external QC while saving dollars in laboratory supplies and labor. In 2003, CMS introduced Equivalent Quality Control (EQC) to offer laboratories an option to decrease the frequency of external controls for nonwaived tests that have an internal control. Over time, Congress passed the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88), which further regulated personnel performing cytology examination, and set standards for all aspects of laboratory testing encompassing personnel, patient specimen collection and processing, quality control (QC), proficiency testing (PT), and quality assurance (QA) for all laboratory disciplines. Individualized quality control plan, IQCP, quality control requirementsįor a brief historical review, the Centers for Medicare and Medicaid Services (CMS) in 1967 created the Clinical Laboratory Improvement Act of 1967 (CLIA ‘67) to regulate laboratories that performed Medicare billing and/or engaged in interstate commerce.
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