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

• US 20200132705A1
• Filed: 12/23/2019
• Published: 04/30/2020
• Est. Priority Date: 06/05/2015
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Inventors: Glavina, Paul, Tirinato, Jody Ann
• Granted Patent: US 11,249,097 B2
• Time in Patent Office: Days
• 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 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, and (ii) a predetermined number of sample testing cartridges of a set of sample testing cartridges;

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 being iwithin range of predetermined cartridge test target values;

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, enabling 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 disabling use of the sample testing cartridge for performing the one or more analytical tests on the biological sample.

2. The method of claim 1, further comprising receiving attributes for the one or more quality control tests 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.

3. The method of claim 1, further comprising determining a predetermined expiration date of the sample testing cartridge, wherein the use of the sample testing cartridge is enabled when:

(i) the compliance status stored in the data table indicates the sample testing cartridge is in compliance, and (ii) a present date does not exceed the predetermined expiration date; and

the use of the sample testing cartridge is at least partially disabled when;

(i) the compliance status stored in the data table indicates the sample testing cartridge is 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 via performing the one or more analytical tests on the biological samples; and

the predetermined cartridge test target values are set by a user for each type of the plurality of types of sample testing cartridges.

5. The method of claim 4, further comprising determining the particular type of the set of sample testing cartridges and transmitting the determined particular type of the set of sample testing cartridges to the data manager with the quality control data, 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, further comprising determining a lot number of the set of sample testing cartridges and transmitting the determined lot number of the set of sample testing cartridges to the data manager with the quality control data and the particular type 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. A system comprising:

one or more data processors; and

a non-transitory computer readable storage medium containing instructions which, when executed on the one or more data processors, cause the one or more data processors to perform actions including;

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, and (ii) a predetermined number of sample testing cartridges of a set of sample testing cartridges;

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 being within range of predetermined cartridge test target values;

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, enabling 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 disabling use of the sample testing cartridge for performing the one or more analytical tests on the biological sample.

9. The system of claim 8, wherein the actions further include receiving attributes for the one or more quality control tests 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.

10. The system of claim 8, wherein the actions further comprise determining a predetermined expiration date of the sample testing cartridge, wherein the use of the sample testing cartridge is enabled when:

(i) the compliance status stored in the data table indicates the sample testing cartridge is in compliance, and (ii) a present date does not exceed the predetermined expiration date; and

the use of the sample testing cartridge is at least partially disabled when;

(i) the compliance status stored in the data table indicates the sample testing cartridge is not in compliance, or (ii) the present date exceeds the predetermined expiration date.

11. The system of claim 8, 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 via performing the one or more analytical tests on the biological samples; and

the predetermined cartridge test target values are set by a user for each type of the plurality of types of sample testing cartridges.

12. The system of claim 11, wherein the actions further comprise determining the particular type of the set of sample testing cartridges and transmitting the determined particular type of the set of sample testing cartridges to the data manager with the quality control data, wherein the predetermined cartridge test target values are for incoming quality control, intermittent quality control, or daily quality control.

13. The system of claim 12, wherein the actions further comprise determining a lot number of the set of sample testing cartridges and transmitting the determined lot number of the set of sample testing cartridges to the data manager with the quality control data and the particular type of the set of sample testing cartridges.

14. The system of claim 13, 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).

15. A computer-program product tangibly embodied in a non-transitory machine-readable storage medium, including instructions configured to cause one or more data processors to perform actions including:

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, and (ii) a predetermined number of sample testing cartridges of a set of sample testing cartridges;

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 being within range of predetermined cartridge test target values;

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, enabling 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 disabling use of the sample testing cartridge for performing the one or more analytical tests on the biological sample.

16. The computer-program product of claim 15, wherein the actions further include receiving attributes for the one or more quality control tests 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.

17. The computer-program product of claim 15, wherein the actions further comprise determining a predetermined expiration date of the sample testing cartridge, wherein the use of the sample testing cartridge is enabled when:

(i) the compliance status stored in the data table indicates the sample testing cartridge is in compliance, and (ii) a present date does not exceed the predetermined expiration date; and

the use of the sample testing cartridge is at least partially disabled when;

(i) the compliance status stored in the data table indicates the sample testing cartridge is not in compliance, or (ii) the present date exceeds the predetermined expiration date.

18. The computer-program product of claim 15, 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 via performing the one or more analytical tests on the biological samples; and

the predetermined cartridge test target values are set by a user for each type of the plurality of types of sample testing cartridges.

19. The computer-program product of claim 18, wherein the actions further comprise determining the particular type of the set of sample testing cartridges and transmitting the determined particular type of the set of sample testing cartridges to the data manager with the quality control data, wherein the predetermined cartridge test target values are for incoming quality control, intermittent quality control, or daily quality control.

20. The computer-program product of claim 19, wherein the actions further comprise determining a lot number of the set of sample testing cartridges and transmitting the determined lot number of the set of sample testing cartridges to the data manager with the quality control data and the particular type of the set of sample testing cartridges.