Management system for point of care testing

• US 9,792,572 B2
• Filed: 03/12/2014
• Issued: 10/17/2017
• Est. Priority Date: 03/15/2013
• 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, Emeric, Pierre, Molloy, Dan, Weber, Maureen, Fetters, Christopher
• Primary Examiner(s): Koneru, Sujay
• Assistant Examiner(s): Stewart, Crystol
• Application Number:
  US14/206,693
• Publication Number:
  US 20140278832A1
• Time in Patent Office: 1,315 Days
• Field of Search: None
• CPC Class Codes: G01N 35/00613 Quality control
• CPC Class Codes: G06Q 10/06395 Quality analysis or management
• CPC Class Codes: G06Q 10/06398 Performance of employee with respect to a job function
• CPC Class Codes: G06Q 30/018 Certifying business or products
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

The present invention relates to a method and system for quality compliance, system and operator verification, and process management for point of care biological sample testing systems used in hospitals and other medical delivery environments. Specifically, the present invention may be directed to a computing device configured to generate a plurality of attributes configured to assess a competency level of an operator to operate at least one sample testing instrument, obtain operator derived data pertaining to the operator'"'"'s ability to operate the at least one sample testing instrument, and determine a competency level of the operator for the at least one sample testing instrument based the plurality of attributes and the operator derived data.

Claims

1. A method implemented in a computer infrastructure having computer executable code tangibly embodied on a computer readable storage medium having programming instructions operable to:

generate a plurality of attributes configured to assess a competency level of an operator to operate at least one sample testing instrument operable to perform an analytical test;

set a compliance threshold for the at least one sample testing instrument;

obtain operator derived data pertaining to the operator'"'"'s ability to operate the at least one sample testing instrument, wherein the operator derived data comprises at least two attribute test results obtained by the operator;

determine a compliance status of the operator for each of at least two attributes of the plurality of attributes based on a comparison of each of the obtained at least two attribute test results to a set compliance status threshold for each of at least two attributes, respectively;

determine an overall compliance status of the operator based on the determined compliance status of the operator for each of the at least two attributes;

determine the competency level of the operator for the at least one sample testing instrument based on a comparison of the overall compliance status of the operator to the set compliance threshold; and

communicate the competency level of the operator to the at least one sample testing instrument, wherein when the competency level of the operator is indicative of non-compliance, the competency level causes the at least one sample testing instrument to lock out the operator from operating the at least one sample testing instrument,

wherein the generating the plurality of attributes comprises receiving a selection of the at least two attributes from the group consisting of;

a knowledge test for operation of the at least one instrument, a knowledge test for biological sample acquisition and disposition with the at least one instrument, a knowledge test on biological sample testing regulations, a practical test on obtaining biological sample test results with the at least one instrument, a practical test on quality control testing with the at least one instrument, a practical test on data entry and data handling with the at least one instrument,

wherein the at least one instrument comprises a disposable device, operating in conjunction with a hand-held analyzer, for performing the analytical test on blood or other fluids, and

wherein the analytical test is at least one selected from the group consisting of;

oxygen, carbon dioxide, pH, potassium, sodium, chloride, hematocrit, glucose, urea, creatinine, prothrombin time (PT), activated clotting time (ACT), activated partial thromboplastin time (APTT), cardiac troponin I (cTnI), brain natriuretic peptide (BNP), creatine kinase MB (CKMB) and lactate.

2. The method of claim 1, wherein:

the at least two attribute test results are linked to a corresponding operator identifier configured to identify the operator; and

the obtaining the operator derived data comprises receiving the at least two attribute test results and the operator identifier.

3. The method of claim 2, wherein:

the at least two attribute test results comprise a knowledge test result obtained by the operator participating in a knowledge test or training session;

the knowledge test result is linked to the corresponding operator identifier configured to identify the operator; and

the obtaining the operator derived data further comprises receiving the knowledge test result and the operator identifier from at least one of the at least one sample testing instrument and a computing device.

4. The method of claim 3, wherein:

the programming instructions are further operable to generate an event profile for the operator;

the event profile comprises the at least two attribute test results and the event profile is linked to the operator identifier configured to identify the operator;

the event profile further comprises the compliance status of the operator for each of the at least two attributes and the competency level of the operator for the at least one instrument;

the compliance status of the operator for each of the at least two attributes comprises a preset limited duration; and

the programming instructions are further operable to receive new operator derived data and continuously update the event profile including the compliance status of the operator for each of the at least two attributes and the competency level of the operator based on the received new operator derived data.

5. The method of claim 1, wherein:

each attribute of the plurality of attributes comprises an electronic signature element; and

the determining the compliance status of the operator for each of at least two attributes further comprises determining whether the electronic signature element for each attribute is completed by an authorized user.

6. The method of claim 5, wherein:

each attribute of the plurality of attributes comprises an electronic log event element; and

the determining the compliance status of the operator for each of the at least two attributes further comprises recording the compliance status of the operator for each of the at least two attributes in the electronic log event element.

7. The method of claim 1, wherein the generating the plurality of attributes comprises setting each of the plurality of attributes to a default template.

8. The method of claim 1, wherein:

the set compliance threshold comprises any combination of the at least two attributes having a non-approved compliance status; and

the determining the competency level comprises;

when the overall compliance status includes the at least two attributes having a non-approved compliance status, determining the competency level to be non-compliant; and

when the overall compliance status includes less than the at least two attributes having a non-approved compliance status, determining the competency level to be compliant.

9. The method of claim 1, wherein:

the set compliance threshold comprises any combination of the at least two attributes having an approved compliance status; and

the determining the competency level comprises;

when the overall compliance status includes the at least two attributes having an approved compliance status, determining the competency level to be compliant; and

when the overall compliance status includes less than the at least two attributes having a non-approved compliance status, determining the competency level to be non-compliant.

10. The method of claim 1, wherein:

the set compliance threshold comprises a statistical combination of the plurality of attributes having an approved compliance status and a non-approved compliance status; and

the determining the competency level comprises;

when the compliance status is equal to or exceeds the statistical combination of the plurality of attributes, determining the competency level to be compliant; and

when the compliance status is less than the statistical combination of the plurality of attributes, determining the competency level to be non-compliant.

11. The method of claim 1, wherein:

the set compliance threshold comprises a statistical combination of the plurality of attributes having an approved compliance status and a non-approved compliance status; and

the determining the competency level comprises;

when the compliance status is equal to or exceeds the statistical combination of the plurality of attributes, determining the competency level to be non-compliant; and

when the compliance status is less than the statistical combination of the plurality of attributes, determining the competency level to be compliant.

12. The method of claim 1, wherein a service provider at least one of creates, maintains, deploys and supports the computer infrastructure.

13. The method of claim 1, wherein steps of claim 1 are provided by a service provider on a subscription and/or fee basis.

14. A system implemented in hardware, comprising:

a tracking module configured to;

generate a plurality of attributes configured to assess a competency level of an operator to operate at least one sample testing instrument operable to perform an analytical test;

set a compliance threshold for the at least one sample testing instrument;

obtain operator derived data pertaining to the operator'"'"'s ability to operate the at least one sample testing instrument, wherein the operator derived data comprises at least two attribute test results obtained by the operator;

determine a compliance status of the operator for each of at least two attributes of the plurality of attributes based on a comparison of each of the obtained at least two attribute test results to a set compliance status threshold for each of at least two attributes, respectively;

determine an overall compliance status of the operator based on the determined compliance status of the operator for each of the at least two attributes;

determine the competency level of the operator for the at least one sample testing instrument based on a comparison of the overall compliance status of the operator to the set compliance threshold; and

communicate the competency level of the operator to the at least one sample testing instrument, wherein when the competency level of the operator is indicative of non-compliance, the competency level causes the at least one sample testing instrument to lock out the operator from operating the at least one sample testing instrument,

wherein the generating the plurality of attributes comprises receiving a selection of the at least two attributes from the group consisting of;

a knowledge test for operation of the at least one instrument, a knowledge test for biological sample acquisition and disposition with the at least one instrument, a knowledge test on biological sample testing regulations, a practical test on obtaining biological sample test results with the at least one instrument, a practical test on quality control testing with the at least one instrument, a practical test on data entry and data handling with the at least one instrument,

wherein the at least one instrument comprises a disposable device, operating in conjunction with a hand-held analyzer, for performing the analytical test on blood or other fluids, and

wherein the analytical test is at least one selected from the group consisting of;

oxygen, carbon dioxide, pH, potassium, sodium, chloride, hematocrit, glucose, urea, creatinine, calcium, prothrombin time (PT), activated clotting time (ACT), activated partial thromboplastin time (APTT), cardiac troponin I (cTnI), brain natriuretic peptide (BNP), creatine kinase MB (CKMB) and lactate.

15. The system of claim 14, wherein:

the at least two attribute test results are linked to a corresponding operator identifier configured to identify the operator; and

the obtaining the operator derived data comprises receiving the at least two test attribute results and the operator identifier.

16. The system of claim 15, wherein:

the at least two attribute test results comprise a knowledge test result obtained by the operator participating in a knowledge test or training session;

the knowledge test result is linked to the corresponding operator identifier configured to identify the operator; and

the obtaining the operator derived data further comprises receiving the knowledge test result and the operator identifier from at least one of the at least one sample testing instrument and a computing device.

17. The system of claim 16, wherein:

the tracking module is further configured to generate an event profile for the operator; and

the event profile comprises the at least two attribute test results and the event profile is linked to the operator identifier configured to identify the operator.

18. A computer program product comprising a non-transitory computer readable storage medium having readable program code embodied in the storage medium, the computer program product includes at least one component operable to:

generate a plurality of attributes configured to assess a competency level of an operator to operate at least one sample testing instrument operable to perform an analytical test;

set a compliance threshold for the at least one sample testing instrument;

obtain operator derived data pertaining to the operator'"'"'s ability to operate the at least one sample testing instrument, wherein the operator derived data comprises at least two attribute test results obtained by the operator;

determine a compliance status of the operator for each of at least two attributes of the plurality of attributes based on a comparison of each of the obtained at least two attribute test results to a set compliance status threshold for each of at least two attributes, respectively;

determine an overall compliance status of the operator based on the determined compliance status of the operator for each of the at least two attributes;

determine the competency level of the operator for the at least one sample testing instrument based on a comparison of the overall compliance status of the operator to the set compliance threshold; and

communicate the competency level of the operator to the at least one sample testing instrument, wherein when the competency level of the operator is indicative of non-compliance, the competency level causes the at least one sample testing instrument to lock out the operator from operating the at least one sample testing instrument,

wherein the generating the plurality of attributes comprises receiving a selection of the at least two attributes from the group consisting of;

a knowledge test for operation of the at least one instrument, a knowledge test for biological sample acquisition and disposition with the at least one instrument, a knowledge test on biological sample testing regulations, a practical test on obtaining biological sample test results with the at least one instrument, a practical test on quality control testing with the at least one instrument, a practical test on data entry and data handling with the at least one instrument,

wherein the at least one instrument comprises a disposable device, operating in conjunction with a hand-held analyzer, for performing the analytical test on blood or other fluids, and

wherein the analytical test is at least one selected from the group consisting of;

oxygen, carbon dioxide, pH, potassium, sodium, chloride, hematocrit, glucose, urea, creatinine, calcium, prothrombin time (PT), activated clotting time (ACT), activated partial thromboplastin time (APTT), cardiac troponin I (cTnI), brain natriuretic peptide (BNP), creatine kinase MB (CKMB) and lactate.