Systems for assuring quality compliance of point-of-care single-use testing devices
First Claim
Patent Images
1. A system comprising:
- a set of sample testing cartridges, wherein each sample testing cartridge from the set of sample testing cartridges has a same lot number assigned from a manufacturer;
a plurality of analyzers in communication with one another via a wireless network, wherein a processor of at least one analyzer of the plurality of analyzers is configured to control the at least one analyzer to;
perform one or more quality control tests to generate quality control test data, wherein the one or more quality control tests are performed using;
(i) a predetermined number and type of control fluids, and (ii) a predetermined number of sample testing cartridges of the set of sample testing cartridges; and
transmit the quality control test data;
a data manager that is in communication with each of the plurality of analyzers via the wireless network, wherein the data manager is configured to;
determine a compliance status of the set of sample testing cartridges based on whether the quality control test data is within range of predetermined cartridge test target values;
store the determined compliance status for the set of sample testing cartridges in a data table; and
transmit the data table to each of the plurality of analyzers, wherein the transmit of the data table is performed independent of whether the determined compliance status for the set of sample testing cartridges is in compliance or not in compliance,wherein a processor of each of the plurality of analyzers is configured to;
receive the data table and store the data table in a memory;
obtain information pertaining to the set of sample testing cartridges;
obtain the compliance status for the set of sample testing cartridges from the data table based on the information obtained pertaining to the set of sample testing cartridges;
when the compliance status obtained from the data table indicates the set of sample testing cartridges is in compliance, enable use of the set of sample testing cartridges for performing one or more analytical tests on biological samples; and
when the compliance status obtained from the data table indicates the set of sample testing cartridges is not in compliance, at least partially disable use of the set of sample testing cartridges for performing the one or more analytical tests on the biological samples.
1 Assignment
0 Petitions
Accused Products
Abstract
The present invention relates to systems and methods of determining quality compliance for a set of biological sample testing devices used with one or more test instruments at the point-of-care in a hospital or other location that delivers medical care. In particular, the systems and methods ensure that only biological sample testing devices that pass a quality assurance protocol are used for point-of-care testing.
-
Citations
12 Claims
-
1. A system comprising:
-
a set of sample testing cartridges, wherein each sample testing cartridge from the set of sample testing cartridges has a same lot number assigned from a manufacturer; a plurality of analyzers in communication with one another via a wireless network, wherein a processor of at least one analyzer of the plurality of analyzers is configured to control the at least one analyzer to; perform one or more quality control tests to generate quality control test data, wherein the one or more quality control tests are performed using;
(i) a predetermined number and type of control fluids, and (ii) a predetermined number of sample testing cartridges of the set of sample testing cartridges; andtransmit the quality control test data; a data manager that is in communication with each of the plurality of analyzers via the wireless network, wherein the data manager is configured to; determine a compliance status of the set of sample testing cartridges based on whether the quality control test data is within range of predetermined cartridge test target values; store the determined compliance status for the set of sample testing cartridges in a data table; and transmit the data table to each of the plurality of analyzers, wherein the transmit of the data table is performed independent of whether the determined compliance status for the set of sample testing cartridges is in compliance or not in compliance, wherein a processor of each of the plurality of analyzers is configured to; receive the data table and store the data table in a memory; obtain information pertaining to the set of sample testing cartridges; obtain the compliance status for the set of sample testing cartridges from the data table based on the information obtained pertaining to the set of sample testing cartridges; when the compliance status obtained from the data table indicates the set of sample testing cartridges is in compliance, enable use of the set of sample testing cartridges for performing one or more analytical tests on biological samples; and when the compliance status obtained from the data table indicates the set of sample testing cartridges is not in compliance, at least partially disable use of the set of sample testing cartridges for performing the one or more analytical tests on the biological samples. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
-
Specification