QC Design
Dr. Westgard takes the theory and tools of quality planning and applies it to immunoassays. This was part of his presentation to the joint meeting of UK National External Quality Assessment Schemes (UK NEQAS) for Endocrinology and the European Ligand Assay Society (ELAS) in Edinburgh, Scotland, a paper that he delivered "virtually" to the conference.
Quality is often described as a journey. Too often our efforts describe where we've been and how we arrived at the present, rather than advancing to where we need to be in the future. Laboratory efforts need to advance quality with well-defined destinations, maps to guide us to those destinations, and careful planning to provide a smooth journey. The way is revealed.
Just as instruments have evolved from manual pipettes to vast automated instruments, so too has the technology for quality control. When we're using a fourth generation instrument, should be be doing first generation quality control (like the old standby, 1:2s), a practice that was introduced in the 1950's? Dr. Westgard charts the history and progress of QC technology and introduces new tools (QC Selection grids, OPSpecs charts, automated QC selection) that we can use for the 21st century.
If we're honest with ourselves, we know that the situation in the laboratory needs to be improved. But with all the time pressures, staff shortages, and other stresses, how can we find a quick way to put the quality back into quality control? How do we select methods that can guarantee error detection? Create purchase specifications to select instruments that can guarantee we meet our CLIA requirements? Design instruments with quality in mind? Dr. Westgard suggests practical steps that both users and manufacturers can take to bring quality into their design.
An updated version of this essay appears on the Nothing but the Truth about Quality book.
Everyone agrees that there should be quality control. But what does that mean? When we implement new methods in our laboratories, or develop new methods, or try to establish regulatory guidelines for performance of methods, or even inspect laboratories to assure that good quality management practices have been implemented, how do we specify bias, CV, the number of controls, the levels, etc.? Dr. Westgard introduces a way to sort it all out.