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US 11,994,526 B2Granted
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.
Claims13
A computer implemented method, comprising:
- transmitting a request for instrument calibration verification from a data manager to two or more instruments based on a predetermined schedule;
- in response to receiving the request for the instrument calibration verification, performing by the two or more instruments the instrument calibration verification according to the request for instrument calibration verification and using:
- (i) a predetermined number and type of calibration fluids and a predetermined number of sample testing cartridges of a set of sample testing cartridges, or (ii) an electronic simulator, to generate calibration verification data;
- transmitting the calibration verification data from the two or more instruments to the data manager;
- based on whether the calibration verification data is within range of predetermined calibration target values, determining at the data manager a compliance status for each of the two or more instruments as either compliant or non-compliant;
- storing at the data manager the determined compliance status for each of the two or more instruments in a data table, the data table comprising:
- (i) identification information associated with instruments of the two or more instruments, and (ii) the compliance status for each of the two or more instruments;
- transmitting the data table from the data manager to the two or more instruments;
- and
- enabling use of a first instrument from the two or more instruments for performing one or more analytical tests on a first biological sample when the compliance status for the first instrument stored in the data table indicates the first instrument from the two or more instruments is in compliance;
- or
- at least partially disabling use of a second instrument from the two or more instruments for performing the one or more analytical tests on a second biological sample when the compliance status for the second instrument stored in the data table indicates the second instrument from the two or more instruments is not in compliance.
9 more elements
Dependencies are inferred from the claim text.