Systems for assuring quality compliance of point-of-care single-use testing devices
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.
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.
2. The system of claim 1 , further comprising a configuration manager configured to obtain the predetermined cartridge test target values, and transmit an analyzer configuration profile including the predetermined target test values to the data manager.
3. The system of claim 2 , wherein the data manager is configured to transmit attributes to each of the plurality of analyzers, the attributes including the predetermined number and type of control fluids and the predetermined number of testing cartridges of the set of sample testing cartridges.
4. The system of claim 1 , wherein:
the set of sample testing cartridges have a predetermined expiration date;
the processor of each of the plurality of analyzers is further configured to determine the predetermined expiration date of the set of sample testing cartridges based on the information obtained pertaining to the set of sample testing cartridges;
use of the set of sample testing cartridges on each of the plurality of analyzers is enabled when: (i) the compliance status stored in the data table indicates the set of sample testing cartridges are in compliance, and (ii) a present date does not exceed the predetermined expiration date; and
use of the set of sample testing cartridges on each of the plurality of analyzers is at least partially disabled when: (i) the compliance status stored in the data table indicates the set of sample testing cartridges are not in compliance, or (ii) the present date exceeds the predetermined expiration date.
5. The system of claim 1 , wherein:
the set of sample testing cartridges are of a particular type selected from a plurality of types, and each type of the plurality of types is configured to measure one or more analytes in the biological samples;
the predetermined cartridge test target values are set by a user for each type of the plurality of types of sample testing cartridges;
the processor of the at least one analyzer is further configured to determine the particular type of the set of sample testing cartridges and transmit the determined particular type to the data manager with the quality control data; and
the data manager is further configured to obtain the predetermined cartridge test target values for the determined particular type of the set of sample testing cartridges.
6. The system of claim 5 , wherein the predetermined cartridge test target values are for incoming quality control, intermittent quality control, or daily quality control.
7. The system of claim 6 , wherein:
the predetermined cartridge test target values are set by the user for each type of the plurality of types of sample testing cartridges and the lot number assigned from the manufacturer;
the processor of the at least one analyzer is further configured to determine the lot number of the set of sample testing cartridges and transmit the determined lot number to the data manager with the quality control data: and
the data manager is further configured to obtain the predetermined cartridge test target values for the set of sample testing cartridges based on: (i) the determined particular type of the set of sample testing cartridges and (ii) the determined lot number of the set of sample testing cartridges.
8. The system of claim 7 , wherein the one or more analytes are selected from the group consisting of: sodium, potassium, chloride, total carbon dioxide, ionized calcium, glucose, blood urea nitrogen (BUN), creatinine, lactate, hematocrit, pH, partial pressure of carbon dioxide, partial pressure of oxygen, troponin I, troponin T, creatine kinase MB, procalcitonin, beta human chorionic gonadotropin (bHCG), human chorionic gonadotropin (HCG), N-terminal of the prohormone brain natriuretic peptide (NTproBNP), prohormone brain natriuretic peptide (proBNP), brain natriuretic peptide (BNP), myoglobin, parathyroid hormone, d-dimer, neutrophil gelatinase-associated lipocalin (NGAL), galectin-3, and prostate specific antigen (PSA).
9. The system of claim 1 , wherein the predetermined number of control fluids is one to five.
10. The system of claim 1 , wherein the predetermined number of sample testing cartridges of the set of sample testing cartridges is one to five.
11. The system of claim 1 , wherein the plurality of analyzers is two to a hundred instruments.
12. The system of claim 1 , wherein the plurality of analyzers is a subset of analyzers, and the subset includes two to five analyzers.