Implementation

Data entry - Cannabis

Data Entry Overview

Samples can be processed either singly or in batches. Processing in batches provides a way to perform the same process step to multiple samples at once, for example, a GCMS or other instrument analysis. 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, sample type, status and patient name.

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. See Instrument-Parameter Mappings, Test parameter management and Instrument management.

Data Entry List Screen.png

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 - Canna 1.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 - Canna 2 By Test.png


The Process Data Entry by Test screen displays. Enter data into Raw Results column for all desired samples (again, if the instrument is interfaced, these results will be automatically entered).

Data Entry Canna 3 By Test.png


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

Data Entry Canna 4 By Test.png


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

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

Out-of-range alert

Data Entry Canna 4 By Test - Blown Limit.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 Canna 5 By Test - Calc.png

  • NOTE: Any calculated results whose formulas require a result value from another parameter will display "No Calc". Once the required results have been entered, the calculation will work:

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 Canna 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 Canna By Sample 2.png


Click the Data Entry By Sample Data Entry by Sample Button.png button. The Sample Data Entry screen is displayed (note: this is also the Non-Batch Samples Data Entry screen for any samples that are processed singly rather than in batches).

Data Entry Canna 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.

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

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

Out-of-range alert

Data Entry Canna 4 By Test - Blown Limit.png


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

Data Entry Canna 4 By Test - Blown Limit Detail.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 Canna 5 By Test - Calc.png

  • NOTE: Any calculated results whose formulas require a result value from another parameter will display "No Calc". Once the required results have been entered, the calculation will work.

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 Complete Results Entry

Once data are entered and saved for all samples and tests in a batch, click Commit Commit ButtonPOL.png. The results no longer display and the samples 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 LIMS, 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 Canna - Approve 1.png


Tests "opened" to display all parameters

Data Entry Canna - Approve 2.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 samples - 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 sample for all tests including all analytes/parameters, or by individual analyte/parameter or for an entire test (all samples in that batch).

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

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

Data Entry Canna - Approve 3.png


The Results for that sample for that test all turn green and the word "Approve" displays.

Data Entry Canna - Approve 4.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 Sample Number where it says "No Action". The Results for that sample for that test all turn yellow and the word "Re-run" displays.

Data Entry Canna - Approve 5.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 Canna - Approve 6.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 Sample Number where it says "No Action". The Results for that sample for that test all turn red and the word "Cancel" displays.

Data Entry Canna - Approve 7.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 Canna - Approve 8.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 Sample/All Analytes, All Tests in the Batch

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

Data Entry Canna - Approve 9.png

Data Entry Canna - Approve 10.png

Data Entry Canna - Approve 11.png

Data Entry Canna - Approve 12.png

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

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

Data Entry Canna - Approve 13.png


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

Data Entry Canna - Approve 14.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 Canna - Approve 15.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. Audit trail function will mandate a reason be entered, and the identity of the user, date and time, old result value and new result value will be captured and stored. If a result has been approved, it may not be changed.

However, a new test run may be added, even if the sample has reached "Complete" status. Simply click on the test in the completed sample (in Sample Receiving detail screen):


Change Result Canna 1.png


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


Change Result Canna 2.png


Click Done Done Button.png to return to the Sample 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 Sample

Change Result Canna 3.png


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


Canceling the original test

Change Result Canna 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 Canna 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. You have the option for it to include all samples, only QC samples or only regular samples.

Batch Summary Canna 1.png


Batch Summary or Bench Worksheet Report

Batch Summary Canna 2 - Bench Worksheet.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.