Method for automated exception-based quality control compliance for point-of-care devices
First Claim
1. A method of providing automatic quality control (QC) compliance for point-of-care (POC) devices, comprising the steps of:
- storing test results received from each of a plurality of POC devices, including an association with the operator of the POC device and/or a reagent used in obtaining the test results;
processing the results to detect any random and/or systemic exception from results that have previously been stored;
automatically disabling a questionable POC device based on detection of a QC compliance exception.
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Accused Products
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.
280 Citations
26 Claims
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1. A method of providing automatic quality control (QC) compliance for point-of-care (POC) devices, comprising the steps of:
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storing test results received from each of a plurality of POC devices, including an association with the operator of the POC device and/or a reagent used in obtaining the test results;
processing the results to detect any random and/or systemic exception from results that have previously been stored;
automatically disabling a questionable POC device based on detection of a QC compliance exception. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A method of providing automatic quality control (QC) compliance for point-of-care (POC) devices, comprising the steps of:
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storing test results received from each of a plurality of POC devices, including an association with the operator of the POC device and/or a reagent used in obtaining the test results;
processing the results to detect any random and/or systemic exception from results that have previously been stored;
automatically invalidating a reagent lot that has established a QC exception by configuring a selected POC device. - View Dependent Claims (8, 9, 10, 11, 12)
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13. A method of providing automatic quality control (QC) compliance for point-of-care (POC) devices, comprising the steps of:
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storing test results received from each of a plurality of POC devices, including an association with the operator of the POC device and/or a reagent used in obtaining the test results;
processing the results to detect any random and/or systemic exception from results that have previously been stored;
automatically invalidating an operator who has established a QC exception by configuring a selected POC device. - View Dependent Claims (14, 15, 16, 17, 18)
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19. A method of providing automatic quality control (QC) compliance for point-of-care (POC) devices, comprising the steps of:
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storing test results received from each of a plurality of POC devices, including an association with the operator of the POC device and/or a reagent used in obtaining the test results, and processing the results to detect any random and/or systemic exception from results that have previously been stored; and
graphically presenting QC exceptions. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26)
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Specification