Does running more quality control lead to meeting quality goals?
not always Westgard has commented that many assays dont have sufficient quality as judged by analyzing proficiency testing data and that until better assays are provided, labs need to run more QC to improve quality and to meet quality requirements (1). His OpSpecs treatment is provided as his rationale (2). This essay addresses the assertion that if labs run more QC, quality will improve and quality requirements will be met. Ideally, when a lab considers using an assay, the lab should evaluate the assay to determine if the assay meets the clinical quality requirements for that analyte. Of course, one can ask how many labs actually have clinical quality requirements but thats another essay. In practice, many labs dont conduct this type of evaluation and rely on the manufacturers claims – the lab evaluation (often driven by regulation) is a verification that the assay is working as the manufacturer intends. The lab also establishes a quality control program for that analyte (also often d
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