System and method for autoverifying laboratory test results

• US 8,112,232 B2
• Filed: 02/02/2007
• Issued: 02/07/2012
• Est. Priority Date: 02/02/2007
• Status: Active Grant

• Current Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Original Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Inventors: Parkhurst, Jason, Ashley, John M.
• Primary Examiner(s): Barbee, Manuel L
• Application Number:
  US11/701,677
• Publication Number:
  US 20080186133A1
• Time in Patent Office: 1,831 Days
• Field of Search: 702/22, 702 30- 32, 702/123, 705/2, 705/3, 717/109, 717/113, 715/967
• US Class Current: 702/22
• CPC Class Codes: G01N 35/00613 Quality control

Abstract

A method of autoverifying clinical test results comprises displaying an autoverification process as a flowchart on a graphical user interface. The autoverification process is defined by a plurality of nodes and a plurality of edges connecting the nodes. The autoverification process is configured to evaluate a result and determine if the test result meets a predetermined criteria. The method further comprises receiving the test result and automatically performing the autoverification process on the test result. A system for creating and implementing the autoverification processes comprises a graphical user interface configured to display the autoverification process as a flowchart. The system includes an input configured to receive the clinical test result from a laboratory analyzer. The system also includes a processor configured to analyze the clinical test result according to the defined autoverification process.

Claims

1. A method for creating an autoverification rule for generating and validating laboratory test results from a first analysis performable by a laboratory analyzer on patient samples, the method comprising:

presenting to a user a graphical user interface of a computer from which the user may select nodes and construct a flow chart representing the autoverification rule, the nodes including at least one of;

an order test node that directs a laboratory analyzer to perform a test on the patient sample;

a rerun node that directs the laboratory analyzer to automatically rerun the first analysis on the patient sample;

a range check node that determines if a value of the laboratory test results is inside, below, or above a validation range provided by the user based on the first analysis and the laboratory analyzer; and

a delta check node that retrieves prior laboratory test results generated by the first analysis and compares the laboratory test results and the retrieved prior laboratory test results;

receiving a plurality of user instructions for creating the flow chart including user selections of nodes and user entry of criteria for at least one node to be applied to the laboratory test results generated by the first analysis of patient samples by the laboratory analyzer;

generating a flow chart representing the autoverification rule specific to the first analysis performed by the laboratory analyzer based on the user selections;

displaying the flow chart representing the autoverification rule specific to the first analysis to the user; and

generating the autoverification rule corresponding to the displayed flow chart, wherein the autoverification rule is specific to the first analysis performed by the laboratory analyzer that generates the laboratory test results and is usable by an autoverification system to determine if the laboratory test results generated by the first analysis of the patient sample by the laboratory analyzer should be automatically released to an external information system.

2. The method of claim 1 further comprising:

storing the autoverification rule corresponding to the displayed flow chart;

automatically upon receipt of a test order to analyze a sample by the first analysis,

retrieving the autoverification rule corresponding to the displayed flow chart; and

executing the autoverification rule corresponding to the displayed flow chart to control, at least in part, the operation of the laboratory analyzer.

3. The method of claim 2 wherein the presented nodes further comprise a set value node that replaces a value in the test results with a predetermined value.

4. The method of claim 1 further comprising:

upon execution of the order test node, transmitting a command directing the laboratory analyzer to perform the first analysis on the sample; and

suspending execution of the autoverification rule until test results are received.

5. The method of claim 1 further comprising:

upon execution of the rerun node, transmitting a command directing the laboratory analyzer to automatically rerun the first analysis on the sample; and

suspending execution of the autoverification rule until new test results are received.

6. The method of claim 1 further comprising:

upon execution of the delta check node, retrieving prior test results generated by the first analysis on a prior sample associated with the patient; and

comparing current test results and the retrieved prior test results.

7. The method of claim 1 wherein the receiving operation includes receiving a user selection of at least two nodes including a validate node and the method further comprises:

storing the autoverification rule corresponding to the displayed flow chart;

automatically upon receipt of a test order to analyze a sample by the first analysis,

retrieving the autoverification rule corresponding to the displayed flow chart; and

executing the autoverification rule corresponding to the displayed flow chart to validate new test results stored on a laboratory information system, the new test results generated by performance of the first analysis on the sample; and

upon execution of the validate node, releasing the new test results.

8. The method of claim 7 wherein the releasing operation comprises:

providing access to the new test results to a hospital information system external to the laboratory information system.

9. The method of claim 8 wherein the releasing operation further comprises:

automatically transmitting the new test results to the hospital information system.

10. The method of claim 1, wherein receiving the plurality of user instructions comprises:

receiving a selection of an option associated with a given node; and

receiving data in a configuration box, the configuration box displayed in the graphical user interface, the configuration box prompting the user to insert data required to configure the given node.

11. A system for generating and autoverifying an electronic laboratory test result of an analysis of a sample, the system comprising:

a laboratory analyzer that performs a first analysis on the sample and generates the electronic laboratory test result;

an autoverification rule editor that presents a user interface through which a user may create autoverification rule flow charts specific to analyses performed by the laboratory analyzer based on user selections and that generates autoverification rules corresponding the created flow charts, each of the flow charts represented by a plurality of connected nodes, the plurality of connected nodes including one or more of;

an order test node that directs a laboratory analyzer to perform a user-selected analysis on the patient sample;

a rerun node that directs the laboratory analyzer to automatically rerun the first analysis on the patient sample; and

a range check node that determines if a value of the laboratory test result is inside, below, or above a validation range provided by the user based on the first analysis and the laboratory analyzer; and

a delta check node that retrieves a prior laboratory test result generated by the first analysis and compares the laboratory test result and the retrieved prior test result;

one or more autoverification rules generated by the autoverification rule editor from flow charts created by a user including a first autoverification rule specific to the first analysis performed by the laboratory analyzer corresponding to a flow chart specific to the first analysis; and

a processor having access to the electronic laboratory test result and the first autoverification rule that releases the electronic laboratory test result to an information system based on the first autoverification rule specific to the first analysis performed by the laboratory analyzer.

12. The system of claim 11 wherein the processor further automatically identifies and executes the first autoverification rule upon receipt of a test order requesting performance of the first analysis on a sample.

13. The system of claim 12 wherein the computer commands the laboratory analyzer to perform at least one of the following:

automatically perform the first analysis on the sample in response to an order test node in the flow chart;

automatically rerun the first analysis on the sample in response to a rerun node in the flow chart;

automatically cancel a previously ordered first analysis on the sample in response to an cancel test node in the flow chart;

automatically dilute and rerun the first analysis on the sample in response to a dilute node in the flow chart;

automatically determine if a value of the electronic laboratory test result is inside, below, or above a validation range provided by the user based on the first analysis and the laboratory analyzer in response to a range node in the flow chart, and automatically releases the electronic laboratory test result to an information system in response to a validate node.

14. The system of claim 11 wherein the plurality of connected nodes includes:

a validate node that directs the processor to automatically release the laboratory test result to the information system and that stores an indication that the test result is validated.

15. The system of claim 11 wherein the plurality of connected nodes includes:

a dilution node that causes the processor to automatically command the laboratory analyzer to dilute the sample by a user-selected amount and rerun the first analysis on the sample.

16. The system of claim 11 wherein the plurality of connected nodes includes:

a cancel test node that causes the processor to cancel performance of a user-selected analysis by the laboratory analyzer on the sample.

17. The system of claim 11 wherein the plurality of connected nodes includes:

a manual workflow node that causes the processor to request an action to be performed by a laboratory technician.

18. The system of claim 11 wherein the plurality of connected nodes further includes a set value node that replaces a value in the laboratory test results with a predetermined value.

19. The system of claim 11 wherein the computer controls the operation of the laboratory analyzer based on the flow chart specific to the first analysis generated by the autoverification rule editor from user inputs.

20. The system of claim 11, wherein the autoverification rule editor displays options associated with the plurality of nodes, receives a selection of a given one of the options, the given one of the options associated with a given node in the plurality of nodes, the autoverification rule editor inserting the given node into a given one of the flow charts, displaying output edges for each outcome of the given node, and reminding the user to connect each of the outcomes to a resulting node.

21. A method for creating a computer-executable autoverification rule for verifying laboratory test results generated by a first analysis performable by a laboratory analyzer on patient samples, the method comprising:

receiving a first user definition of a reference range for a plurality of laboratory analyses including a first analysis, the first user definition identifying a first name and an independently selected range for each of the plurality of laboratory analyses including a first range associated with the first analysis;

presenting to a user a graphical user interface from which the user may select nodes and construct, by connecting selected nodes, a flow chart representing steps of an autoverification rule, wherein the presented nodes include at least one common node through which the user may select the first name of the reference range;

receiving a plurality of user instructions for creating a flow chart for the first analysis including an identification of the first analysis and, as part of a user'"'"'s selection of a common node during construction of the flow chart for the first analysis, a user selection of the first name of the reference range;

generating the flow chart specific to the first analysis performed by the laboratory analyzer based on the user selections;

displaying the flow chart specific to the first analysis to the user via the graphical user interface; and

generating an autoverification rule executable by a computer, the autoverification rule corresponding to the displayed flow chart, wherein the autoverification rule is specific to the first analysis performed by the laboratory analyzer that generates the test results and the autoverification rule includes a comparison of the test results with the first range associated with the first analysis for the reference range having the first name.

22. The method of claim 21 further comprising:

retrieving the first range associated with the first analysis for the reference range corresponding to the first name from memory.

23. The method of claim 21 wherein receiving the first user definition further comprises:

receiving a plurality of user definitions of reference ranges for a plurality of laboratory analyses including the first user definition, wherein each user definition identifies a name and an independently selected range for each of the plurality of laboratory analyses; and

storing the plurality of user definitions in memory.

24. The method of claim 21 further comprising:

storing the autoverification rule corresponding to the displayed flow chart;

automatically upon receipt of a test order to analyze a sample by the first analysis,

retrieving the autoverification rule corresponding to the displayed flow chart; and

executing the autoverification rule corresponding to the displayed flow chart to control, at least in part, the operation of the laboratory analyzer.