Healthcare

Data entry – HCP

Data Entry Overview

Any Sample Groups/Batches (or Non-Batch Samples) in any process step are displayed on the Data Entry list screen. These are displayed in three ways via three tabs:

  1. Active Batches – This is the default tab displayed, showing all batches the user has profile access to view, by Process Group Number (Batch Number) showing which process the batch is for, created date/time, who created it and which (if any) instrument is associated with it.
  2. Active Processes – All batches the user has profile access to view, by Process showing Process Group Number (Batch Number), created date/time, who created it and which (if any) instrument is associated with it.
  3. Non Batch Samples – This is a list of samples whose assigned test includes the non-batching process (they are processed individually). The list displays sample number, specimen type, status and patient name.

Data Entry 1 875.png

Results may be entered manually by selecting the desired batch and then proceeding as described in this section. Results may also be entered automatically if instruments are interfaced with the LIMS.

To Enter Test Results

On the Data Entry list screen (main screen displayed by choosing Data Entry menu item), click on the batch that contains the samples for which you wish to enter data. If necessary, use the Filter to find it. The Batch Result Entry screen displays.

Data Entry 2.png

There are two ways to enter results data manually: (1) by Test and (2) by Sample.

To Enter Results by Test

On the Batch Results Entry screen, click on the Test for which you would like to enter results (this will display all Samples assigned that Test).

Data Entry 3.png

The Process Data Entry by Test screen displays. Enter data into Raw Results column for all desired samples.

Data Entry 4.png

Click Save Save ButtonPOL.png. The LIS populates Calc and Report results and displays according to pre-defined sig figs and resolution.

Data Entry 5.png

  • NOTE: If any results are out of the pre-defined parameter range, the icon column will change color and the LIMIT EXCEEDANCE icon will display:

Out-of-range alerts

Data Entry 6.png

Hovering over the icon displays information about the exceedence. Additional information can be viewed by clicking the icon.

Data Entry 7.png

If any results have calculations associated with them, select them (click their checkbox) and click Calculate Calculate Button.png button to display calculated values.

Data Entry 8.png

Select all sample runs whose results are satisfactory and click Approve Approve Button.png. The selected samples are moved to be available for the next Process and no longer display.

To Enter Results by Sample

On the Batch Results Entry screen, click on the Sample for which you would like to enter results.

Data Entry by Sample 1.png

The Data Entry by Sample screen is displayed. This will display all Tests assigned to that Sample. *Note: Authorized users may add or delete tests here even at this stage if necessary.

Data Entry by Sample 2.png

Click the Data Entry By Sample Data Entry by Sample Button.png button. The Sample Data Entry screen is displayed.

Data Entry by Sample 3.png

Enter results in the Raw Result column for the tests for which you have results, and click Save Save Button.jpg.

If any results are outside of pre-defined parameters, a color-coded alert and icon will display. Hovering over the exceedance icon will display information about the exceeded limit.

Limit Violation

Data Entry by Sample 4.png

Hovering over icon will display more information about the limit.

Data Entry by Sample 5.png

Clicking the icon will display still more information about the limit.

Data Entry by Sample 6.png

To Complete Results Entry

Once data are entered and saved for all specimens and tests, click Commit Commit ButtonPOL.png. The results no longer display and the specimens are complete for that batch.

Results Review

To Approve/Rerun/Cancel Results

Results may be approved, sent for re-test (another run created) or canceled (discard results).

NOTE: Even if results are canceled, all records remain in the LIS, in compliance with regulatory standards. However, the results are NOT available for reporting.

In the Batch Result Entry screen (accessed by clicking on a batch in the Data Entry list screen), click the Open All Open All Button New.png button.

All Tests and Samples are displayed with each parameter shown.

Data Entry Open All.png

Normally one or more Process steps of Review are created and added to a Path which is assigned to a given test and then assigned to appropriate specimens – and approval review is done in that process batch. However, it may also be done for any batch regardless of process step.

Results can be approved, sent for re-test (another run created) or canceled (discard results) either by individual sample for a given test (all analytes/parameters in that test), individual specimen for all tests including all analytes/parameters, or by individual analyte/parameter or for an entire test (all specimens in that batch).

To Approve, Send for Rerun or Cancel by Specimen/All Analytes, Single Test

To Approve, click ONCE in the yellow background area of the cell immediately below the Specimen Number where it says “No Action”:

Data Entry Approve 1.png

The Results for that specimen for that test all turn green and the word “Approve” displays.

Data Entry Approve 2.png

Click the Commit Commit ButtonPOL.png button to finalize.

To Send for Re-Test/Rerun, click TWICE in the yellow background area of the cell immediately below the Specimen Number where it says “No Action”:

Data Entry Approve 1.png

The Results for that specimen for that test all turn yellow and the word “Re-run” displays.

Data Entry Approve 3.png

Click the Commit Commit ButtonPOL.png button to finalize.

Since result changes are audited for regulatory compliance purposes, the Add/Edit Comment dialog popup requires a reason be entered:

Data Entry Rerun Reason.png

Enter reason and click Save Save ButtonPOL.png

To Cancel Run, click THREE TIMES in the yellow background area of the cell immediately below the Specimen Number where it says “No Action”:

Data Entry Approve 1.png

The Results for that specimen for that test all turn red and the word “Cancel” displays.

Data Entry Approve 4.png

Click the Commit Commit ButtonPOL.png button to finalize.

Since result changes are audited for regulatory compliance purposes, the Add/Edit Comment dialog popup requires a reason be entered:

Data Entry Cancel Reason.png

Enter reason and click Save Save ButtonPOL.png

The sample run is canceled and you may complete the remaining items in the batch.

To Approve, Send for Rerun or Cancel by Specimen/All Analytes, All Tests in the Batch

Follow the directions in To Approve, Send for Rerun or Cancel by Specimen/All Analytes, Single Test above, except instead of clicking in the area under the Specimen Number, click on the question mark symbol (?).

Data Entry Question Mark.png

Data Entry Question Mark1 Approve.png

Data Entry Question Mark2.png

Data Entry Question Mark3.png

To Approve, Send for Rerun or Cancel by Test/All Analytes, All Specimens in the Batch

Follow the directions in To Approve, Send for Rerun or Cancel by Specimen/All Analytes, Single Test above, except instead of clicking in the area under the Specimen Number or on the Question Mark, click in the Action column for the appropriate Test row (where it says “No Action”).

Data Entry Approve by Test1.png

Clicking once approves that test (including all analytes/parameters) for all specimens it is assigned to:

Data Entry Approve by Test2.png

To create another run or cancel, click twice or three times, respectively, then click Commit Commit ButtonPOL.png button to finalize.

If approving, the test results are initially approved (there may be additional review steps in the Test Path, however) and it disappears from the batch, ready for its next Process step in its Path.

As with all Re-runs or Cancels, since result changes are audited for regulatory compliance purposes, the Add/Edit Comment dialog popup requires a reason be entered:

Data Entry Cancel Reason2.png

Enter reason and click Save Save ButtonPOL.png

To Change a Result

Any entered result may be changed, even after saving, if it has not been approved. If a result has been approved, it may not be changed. However, a new test run may be added, even if the specimen has reached “Complete” status. Simply click on the test in the completed specimen:

Change Result 1.png

In the screen that opens, simply select one or more additional test runs to add:

Change Result 2 (New Test Run).png

Click Done Done Button.png to return to the Specimen screen, where the new run will display. From here you can proceed to enter the correct result in the new run as normal.

New Run Added to Specimen

Change Result 3.png

You can now cancel the original run by clicking on it and then selecting Cancel Test:

Canceling the original test

Change Result 4.png

The originally completed test run will now instead have a status of Cancelled and will not report. Completing the new test run will release that new run to the report.

Original run with “Cancelled” status

Change Result 5.png

To Add Report Comments

To add comments you would like displayed on the report for a batch, click the Comments Comments Button.png button, then add whatever comments you would like in the popup text area (*Note: Make sure popup blockers are off).

Add Report Comments.png

Note: You can add pre-defined or “canned” comments by clicking the icon.

Add Report Comments-Canned.png

Batch Summary Report

Users can quickly generate a Bench Worksheet in the Batch Results Entry screen by clicking the Batch Summary Batch Summary Button.png button.

Batch Summary or Bench Worksheet Report

Batch Summary Report.png

This may be printed and used by the technician to keep track of any manual results or other data. Any data already present for items in the batch will be pre-populated on the sheet, along with user, date, process, batch, etc.