April 5, 2005

Jan Krouwer, PhD

Equivalent quality control (EQC) allows labs to reduce QC frequency to once a month. Obviously this saves money in the clinical laboratory, which is good, but will the quality of reported results suffer? More importantly, how good are the processes we rely on to prevent laboratory error, and how sure are we that we can address those errors before they affect patient health? This presentation addresses the theory and practicalities of EQC by focusing on internal monitoring systems (IMS) of in vitro diagnostic devices. These IMS are the cornerstone of a recent shift in CMS policy that, in some cases, allows labs to meet federal QC requirements by incorporating EQC protocols and reducing the frequency of traditional QC procedures.