Systems and methods for assuring quality compliance of point-of-care instruments used with single-use testing devices
AssigneeAbbott Point of Care Inc.
InventorsPaul Glavina, Jody Ann Tirinato
Life of this patent
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Abstract
The present invention relates to systems and methods of determining quality compliance for one or more biological sample testing instruments used with one or more type of single-use blood testing cartridge, at the point-of-care in a hospital, or other location that deliver medical care. In particular, the systems and methods ensure that only instruments that pass a quality assurance protocol are used for point-of-care testing
Claims15
A method implemented in a computer infrastructure having computer executable code tangibly embodied on one or more non-transitory storage devices having programming instructions operable to:
- transmit a requirement for instrument calibration verification from a data manager to one or more instruments based on a predetermined schedule;
- in response to the request for the instrument calibration verification, perform the instrument calibration verification using:
- (i) a predetermined number and type of calibration fluids, a predetermined number of sample testing cartridges of a set of sample testing cartridges, and the one or more instruments, or (ii) an electronic simulator, to generate calibration verification data;
- transmit the calibration verification data from the one or more instruments to the data manager;
- determine a compliance status of the one or more instruments at the data manager based on whether the calibration verification data is within range of predetermined calibration target values;
- store the determined compliance status for the one or more instruments in a data table;
- transmit the data table from the data manager to each of the one or more instruments;
- enable use of the one or more instruments for performing one or more analytical tests on biological samples when the compliance status stored in the data table indicates the one or more instruments are in compliance;
- and
- at least partially disable use of the one or more instruments for performing the one or more analytical tests on the biological samples when the compliance status stored in the data table indicates the one or more instruments are not in compliance.
Dependencies are inferred from the claim text.