Method for automated exception-based quality control compliance for point-of-care devices
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United States of America Patent
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Jan 28, 2003
Grant Date -
N/A
app pub date -
Dec 30, 2000
filing date -
Dec 30, 2000
priority date (Note) -
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Abstract
A computer-implemented method to process POC information for potential QC compliance issues. A system and method for implementation of traditional laboratory analyzer based QC compliance in point-of-care (POC) environments is disclosed. A specific system and method to analyze data from POC testing to identify when the testing exceeds the variation expected under stable operation (i.e., the testing is 'out of control') is disclosed. This system and method is characterized by solving the QC compliance problem for POC devices by individuals not trained in traditional laboratory practices. This also provides the capability in real-time or near real-time to analyze POC testing information regarding the performance of each POC device, reagent kit (i.e., one kit per analyte tested) and/or lot, and operator so one can respond quickly to a particular device, reagent kit and/or lot, or operator that is not performing properly.
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