Quality Assurance System and Method for Point-of-Care Testing
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Accused Products
Abstract
An improved quality assurance system and method for point-of-care testing are disclosed. The present invention provides quality assurance for laboratory quality tests performed by a blood analysis system or the like at the point of patient care without the need for running liquid-based quality control materials on the analysis system. Quality assurance of a quantitative physiological sample test system is performed without using a quality control sample by monitoring the thermal and temporal stress of a component used with the test system. Alert information is generated that indicates that the component has failed quality assurance when the thermal and temporal stress exceeds a predetermined thermal-temporal stress threshold. Alternatively, the present invention provides quality assurance for laboratory quality tests performed by a blood analysis system or the like at the point of patient care by minimizing the need for running liquid-based quality control materials on the analysis system.
5 Citations
42 Claims
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1-32. -32. (canceled)
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33. A system for evaluating thermal and temporal stress quality assurance of a quantitative electrochemical physiological sample test system, comprising:
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a first electrochemical sensor; and a second electrochemical sensor, wherein the first and second electrochemical sensors are contacted with a calibrant fluid, wherein the first electrochemical sensor is configured to determine a first calibration voltage associated with the concentration of a first analyte in the calibrant fluid in accordance with a first check threshold, wherein the second electrochemical sensor is configured to determine a second calibration voltage associated with the concentration of a second analyte in the calibrant fluid in accordance with a second check threshold, and wherein the test system is disqualified from performing a physiological sample test when both the first and second check thresholds are exceeded. - View Dependent Claims (34)
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35. A system for thermal and temporal stress quality assurance of a quantitative electrochemical physiological sample test system, comprising:
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a plurality of electrochemical sensors, wherein the plurality of electrochemical sensors are contacted with a calibrant fluid; and a calibration circuit in communication with the plurality of electrochemical sensors, wherein the calibration circuit is configured to determine a calibration parameter associated with a concentration of an analyte in the calibrant fluid for each electrochemical sensor of a subset of the plurality of electrochemical sensors in accordance with a predetermined check threshold, and wherein the calibration circuit is configured to disqualify the test system from performing a physiological sample test when the predetermined check threshold is exceeded for each electrochemical sensor of the subset. - View Dependent Claims (36, 37, 38, 39, 40, 41)
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42-91. -91. (canceled)
Specification