SYSTEMS AND METHODS FOR ASSURING QUALITY COMPLIANCE OF POINT-OF-CARE SINGLE-USE TESTING DEVICES

• US 20160356800A1
• Filed: 05/04/2016
• Published: 12/08/2016
• Est. Priority Date: 06/05/2015
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Glavina, Paul, Tirinato, Jody Ann
• Granted Patent: US 10,557,862 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: G01N 35/00663 of consumables
• CPC Class Codes: G01N 35/00871 Communications between instruments or with remote terminals
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

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.

Claims

1. 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:

perform one or more quality control tests using a predetermined number and type of control fluids, a predetermined number of sample testing cartridges of a set of sample testing cartridges, and at least one of a plurality of instruments to generate quality control test data;

transmit the quality control test data from the at least one of the plurality of instruments to a data manager;

determine a compliance status of the set of sample testing cartridges at the data manager 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;

transmit the data table from the data manager to each of the plurality of instruments;

enable use of the set of sample testing cartridges on each of the plurality of instruments for performing one or more analytical tests on biological samples when the compliance status stored in the data table indicates the set of sample testing cartridges are in compliance; and

at least partially disable use of the set of sample testing cartridges on each of the plurality of instruments when the compliance status stored in the data table indicates the set of sample testing cartridges are not in compliance.

2. The method of claim 1, wherein the programming instructions are further operable to:

receive attributes at each of the plurality of instruments from the data manager, 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; and

receive an instrument configuration profile at the data manager from a configuration manager, the configuration profile including the predetermined cartridge test target values.

3. The method of claim 1, wherein:

the set of sample testing cartridges have a predetermined expiration date;

the programming instructions are further operable to determine the predetermined expiration date of the set of sample testing cartridges;

use of the set of sample testing cartridges on each of the plurality of instruments 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 instruments 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.

4. The method 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; and

the programming instructions are further operable to determine the particular type of the set of sample testing cartridges and determine the predetermined cartridge test target values for the determined particular type of the set of sample testing cartridges.

5. The method of claim 4, wherein the predetermined cartridge test target values are for incoming quality control, intermittent quality control, or daily quality control.

6. The method of claim 5, wherein:

each sample testing cartridge from the set of sample testing cartridges has a same lot number assigned from a manufacturer;

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; and

the programming instructions are further operable to determine the lot number of the set of sample testing cartridges and determine the predetermined cartridge test target values for the determined particular type and the lot number of the set of sample testing cartridges.

7. The method of claim 6, 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).

8. The method of claim 1, wherein the predetermined number of control fluids is one to five.

9. The method of claim 1, wherein the predetermined number of testing cartridges of the set of sample testing cartridges is one to five.

10. The method of claim 1, wherein the plurality of instruments are all connected to one another in a wireless network, and the plurality of instruments is two to a hundred instruments.

11. The method of claim 10, wherein the at least one of the plurality of instruments is a subset of instruments of the plurality of instruments, and the subset includes two to five instruments.

12. 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 one or more analyzers of the plurality of analyzers is configured 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 each of the plurality of analyzers is further configured to;

when the compliance status stored in 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 stored in 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.

13. The system of claim 12, 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 manger.

14. The system of claim 13, 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.

15. The system of claim 12, wherein:

the set of sample testing cartridges have a predetermined expiration date;

each of the plurality of analyzers is further configured to determine the predetermined expiration date of 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.

16. The system of claim 12, 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;

each of the plurality of analyzers is further configured to determine the particular type of the set of sample testing cartridge and transmit the determined particular type to the data manager with the quality control data; and

the data manager is further configured to determine the predetermined cartridge test target values for the determined particular type of the set of sample testing cartridges.

17. The system of claim 16, wherein the predetermined cartridge test target values are for incoming quality control, intermittent quality control, or daily quality control.

18. The system of claim 17, wherein:

each sample testing cartridge from the set of sample testing cartridges has a same lot number assigned from a manufacturer;

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;

each of the plurality of analyzers is further configured to determine the lot number 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 determine the predetermined cartridge test target values for the determined particular type and the lot number of the set of sample testing cartridges.

19. The system of claim 18, 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).

20. The system of claim 12, wherein the predetermined number of control fluids is one to five.

21. The system of claim 12, wherein the predetermined number of sample testing cartridges of the set of sample testing cartridges is one to five.

22. The system of claim 12, wherein the plurality of analyzers is two to a hundred instruments.

23. The system of claim 12, wherein the one or more analyzers of the plurality of analyzers is a subset of analyzers of the plurality of analyzers, and the subset includes two to five analyzers.

24. A computer implemented method comprising:

performing one or more quality control tests to generate quality control test data, the one or more quality control tests being performed using;

(i) a predetermined number and type of control fluids, (ii) a predetermined number of sample testing cartridges of a set of sample testing cartridges, and (iii) at least one analyzer of a plurality of analyzers;

transmitting the quality control test data to a data manager;

receiving a data table from the data manager, the data table comprising;

(i) a lot number for the set of sample testing cartridges, and (ii) a compliance status for the set of sample testing cartridges that is determined based on the quality control test data;

connecting to a sample testing cartridge selected from the set of sample testing cartridges;

determining a lot number of the sample testing cartridge and comparing the lot number for the sample testing cartridge to the lot number for the set of sample testing cartridges in the data table to determine the compliance status of the sample testing cartridge;

when the compliance status stored in the data table indicates the sample testing cartridge is in compliance, enable use of the sample testing cartridge for performing one or more analytical tests on a biological sample; and

when the compliance status stored in the data table indicates the sample testing cartridge is not in compliance, at least partially disable use of the sample testing cartridge for performing the one or more analytical tests on the biological sample.

25. A portable clinical analyzer for in vitro analysis, the analyzer comprising:

a port configured to receive a sample testing cartridge of a set of sample testing cartridges; and

a computing device configured to;

perform one or more quality control tests to generate quality control test data, the one or more quality control tests being 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;

transmit the quality control test data to a data manager;

receive a data table from the data manager, the data table comprising;

(i) a lot number for the set of sample testing cartridges, and (ii) a compliance status for the set of sample testing cartridges that is determined based on the quality control test data;

connect to the sample testing cartridge from the set of sample testing cartridges at the port;

determine a lot number for the sample testing cartridge and compare the lot number for the sample testing cartridge to the lot number for the set of sample testing cartridges in the data table to determine the compliance status of the sample testing cartridge;

when the compliance status stored in the data table indicates the sample testing cartridge is in compliance, enable use of the sample testing cartridge for performing one or more analytical tests on a biological sample; and

when the compliance status stored in the data table indicates the sample testing cartridge is not in compliance, at least partially disable use of the sample testing cartridge for performing the one or more analytical tests on the biological sample.