We're now living in a time when sophisticated automated systems continuously produce patient test results. Yet typical QC practices are based around a batch of patient samples, or are set by default to a once daily, regulatory minimum. Take your laboratory into the era of patient risk management – with Bio-Rad as your partner.
In this article you will learn about building a QC system based around patient risk management. Related articles provide more detail on key concepts. There are links to useful references and resources. You also have links to: a catalog of independent third party Bio-Rad control materials; Product Inserts with Levels, Mean Values and Ranges; and the Unity™ Interlaboratory Program.
Regulation is changing from “One-size-fits all QC” to doing the “Right QC”
Regulation is changing. Centers for Medicare & Medicaid Services (CMS), has recognized that "One-size-fits-all QC" is no longer appropriate due to newer technologies now available in the laboratory. What is needed is "design of an appropriate and effective QCP (QC Plan) for each laboratory and each specific test; that is the 'Right' QC!" "This new QC protocol will not necessarily reduce QC requirements, but instead, will be the 'right' QC for [each] laboratory, its environment, patients, personnel, test systems, etc."1 For more information on Right QC see the related article One-size-fits-all QC vs. Right QC.
1 DHSS, CMS, Office of Clinical Standards and Quality/Survey and Certification Group, Ref: S&C: 12-03-CLIA, November 4, 2011.