Management system for point of care testing

• US 10,984,366 B2
• Filed: 09/13/2017
• Issued: 04/20/2021
• Est. Priority Date: 03/15/2013
• 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, Emeric, Pierre, Molloy, Dan, Weber, Maureen, Fetters, Christopher
• Primary Examiner(s): Stewart, Crystol
• Application Number:
  US15/702,924
• Publication Number:
  US 20180005162A1
• Time in Patent Office: 1,315 Days
• 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 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• 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 of deploying a system for compliance monitoring, comprising:

providing a computer infrastructure, being operable to;

generate a plurality of attributes configured to assess a competency level of an operator to operate at least one sample testing instrument, wherein the plurality of attributes comprises at least one practical test of the operator'"'"'s ability to analyze a biological sample with the at least one sample testing instrument, wherein the at last one practical test generates an attribute test result;

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

obtain operator derived data pertaining to the competency level of the operator to operate the at least one sample testing instrument, wherein the operator derived data comprises the attribute test result obtained by the operator, and a corresponding operator identifier configured to identify the operator;

determine a compliance status of the operator for the plurality of attributes based on the obtained operator derived data;

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

communicate the competency level of the operator to the at least one sample testing instrument; and

providing the at least one sample testing instrument, being operable to;

receive input including the operator identifier configured to identify the operator;

analyze the biological sample;

determine at least one analytical test result for the biological sample;

communicate the at least one analytical test result to the computer infrastructure;

receive the competency level of the operator; and

lock the operator from operating the at least one sample testing instrument when the competency level is non-compliant.

2. The method of claim 1, wherein the generating the plurality of attributes comprises selecting at least two attributes from the group consisting of:

a practical test on obtaining biological sample test results with the at least one sample testing instrument, a practical test on quality control testing with the at least one sample testing instrument, a practical test on data entry and data handling with the at least one sample testing instrument.

3. The method of claim 1, wherein

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

4. The method of claim 3, 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.

5. The method of claim 4, wherein:

the computer infrastructure is 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 and the competency level of the operator for the at least one sample testing instrument;

the compliance status of the operator comprises a preset limited duration; and

the computer infrastructure is further operable to receive new operator derived data and continuously update the event profile including the compliance status of the operator and the competency level of the operator based on the received new operator derived data.

6. 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 further comprises determining whether the electronic signature element for each attribute is completed by an authorized user.

7. The method of claim 6, wherein:

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

the determining the compliance status of the operator further comprises recording a compliance status of the operator for each attribute in the electronic log event element.

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

9. The method of claim 1, wherein:

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

the determining the competency level comprises;

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

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

10. The method of claim 1, wherein:

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

the determining the competency level comprises;

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

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

11. The method of claim 1, wherein:

the set overall 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.

12. The method of claim 1, wherein:

the set overall 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.

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

14. A system comprising:

at least one sample testing instrument configured to;

receive input including an operator identifier configured to identify an operator of the at least one sample testing instrument;

analyze a biological sample;

determine at least one analytical test result for the biological sample; and

communicate the at least one analytical test result; and

a tracking module configured to;

generate a plurality of attributes configured to assess a competency level of the operator to operate the at least one sample testing instrument, wherein the plurality of attributes comprises at least one practical test of the operator'"'"'s ability to analyze the biological sample with the at least one sample testing instrument, wherein the at last one practical test generates an attribute test result;

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

obtain operator derived data pertaining to the competency level of the operator to operate the at least one sample testing instrument, wherein the operator derived data comprises the attribute test results obtained by the operator;

determine a compliance status of the operator for the plurality of attributes based on the obtained operator derived data;

determine the competency level of the operator for the at least one sample testing instrument based on a comparison of the 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 the at least one sample testing instrument is further configured to receive the competency level of the operator, and lock the operator from further operating the at least one instrument when the competency level is non-compliant.

15. The system of claim 14, wherein the system further comprises a user interface configured to receive input from a user and communicate the input to the tracking module.

16. The system of claim 14, wherein the biological sample is selected from the group consisting of:

blood, plasma, serum, sputum, cerebrospinal fluid, tears, urine, body tissue, and fecal matter.

17. The system of claim 14, wherein:

the at least one sample testing instrument is further configured to mate with a single-use cartridge;

the analyzing the biological sample comprises performing an analytical test on the biological sample using the single-use cartridge; and

the biological sample is contained within the single-use cartridge.

18. The system of claim 17, wherein the single-use cartridge comprises at least one electrochemical sensor.

19. The system of claim 14, wherein the generating the plurality of attributes comprises a user selecting each attribute of the plurality of attributes such that the plurality of attributes are configured specific to the operator.

20. A computer system for assessing competency of an operator to operate at least one sample testing instrument, the computer system comprising:

a CPU, a computer readable memory and a computer readable storage media;

program instructions to generate a plurality of attributes configured to assess the competency level of the operator to operate the at least one sample testing instrument, wherein the plurality of attributes comprises at least one practical test of the operator'"'"'s ability to analyze a biological sample with the at least one sample testing instrument, wherein the at last one practical test generates an attribute test result;

program instructions to set a compliance threshold for each attribute of the plurality of attributes;

program instructions to set an overall compliance threshold for the at least one sample testing instrument;

program instructions to obtain operator derived data pertaining to the competency level of the operator to operate the at least one sample testing instrument, wherein the operator derived data comprises attribute test result obtained by the operator;

program instructions to compare the operator derived data to the set compliance threshold for each attribute of the plurality of attributes;

program instructions to determine a compliance status of the operator for each attribute based on a comparison of the operator derived data to the set compliance thresholds;

program instructions to generate an overall compliance status of the operator based on the determined compliance status of the operator for each attribute;

program instructions to compare the overall compliance status of the operator to the set overall compliance threshold for the at least one sample testing instrument;

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

program instructions to communicate the competency level of the operator to the at least one sample testing instrument; and

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

wherein all the program instructions are stored on the computer readable storage media for execution by the CPU via the computer readable memory.