Management system for point of care testing

Patent metadata

Field	Value
Publication number	US-9792572-B2
Application number	US-201414206693-A
Country	US
Kind code	B2
Filing date	Mar 12, 2014
Priority date	Mar 15, 2013
Publication date	Oct 17, 2017
Grant date	Oct 17, 2017

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 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 com

Assignees

• Abbott Point Of Care Inc

Inventors

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

Classifications

• G16H10/40

  for data related to laboratory analysis, e.g. patient specimen analysis · CPC title

• G06Q30/018

  Certifying business or products · CPC title

• G06Q10/06398 Primary

  Performance of employee with respect to a job function · CPC title

• G06F19/00

  Physics · mapped topic

• G06F19/366

  Physics · mapped topic