The Centers for Medicare and Medicaid Services (CMS) has incorporated key elements of risk management from CLSI EP23 into the new CLIA interpretive guidelines that offer a QC option called an Individualized Quality Control Plan (IQCP) (7). The CMS changes were launched in January 2014 and have a 2-year educational period. Beginning in 2017, laboratory tests, including POCT, will have two options for defining the frequency of QC for moderate- and high-complexity tests: either two concentrations of liquid QC each day, or developing an IQCP.
Clsi Guidelines 2014 Free 65
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