Management system for point of care testing

Patent metadata

Field	Value
Publication number	US-10984366-B2
Application number	US-201715702924-A
Country	US
Kind code	B2
Filing date	Sep 13, 2017
Priority date	Mar 15, 2013
Publication date	Apr 20, 2021
Grant date	Apr 20, 2021

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.

First claim

We claim:

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 wi

Assignees

• Abbott Point Of Care Inc

Inventors

• Glavina Paul
• Tirinato Jody Ann
• Emeric Pierre
• Molloy Dan
• Weber Maureen
• Fetters Christopher

Classifications

• G16H40/20

  for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms · CPC title

• G16H40/60

  for the operation of medical equipment or devices · CPC title

• G06Q10/06395

  Quality analysis or management · CPC title

• G01N35/00613

  Quality control · CPC title

• G16Z99/00

  Subject matter not provided for in other main groups of this subclass · CPC title