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Quality Control

The laboratory quality control module in the GoRev LIS is a powerful, managed process that is capable of producing Levy-Jennings graphs of quality control statistic data provided by instruments utilizing either rolling average targets or fixed statistical means and standard deviations.

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1: Getting Started

To get started, go to the Lab Modules tab on the GoRev Home screen and select the Quality Control button.
qc-homedialog.png

Overview

This will bring you to the Quality Control module in GoRev where you may have data as seen on my screens or you may have a completely blank environment. Before we get too far into the process, a quick overview of the user interface is necessary:
qc-screenoverview.png

Starting from the left side of the screen with the filters:

  • Instruments: All quality control data within GoRev is separated by instrument. Selecting an instrument here will change the data that you are interacting with. Take note of the more menu at the top right corner of this box.

  • Material Lots: QC data is further separated by tested material which we refer to as a Material Lot in GoRev. Take note of the more menu at the top right corner of this box.

  • Date Range: Use this area to filter quality control data down to a specified range of testing dates.

  • Tests Performed: Lastly, select the laboratory test that you need to manage data for.

Moving back to the top of the screen, take note of the available tabs that switch between each part of the QC process:

  • Approve Data: The first step of the QC process, this is where you approve QC result data and associate that result data with the currently selected Material Lot.

  • Graphs: The statistical analysis of the data as well as where you can create static target ranges.

  • Tabular Data: All data in the current filter set. Make any changes to approval / rejection state here.

With that out of the way, lets get started with the process.

2: Approve the Result Data

Go to the Approve Data tab of the Quality Control module and ensure that you have the correct Material Lot selected in the filters on the left hand side. Approving QC results will associate them with the selected material. As such, it is very important to be aware of which lot you are working with.

Now select one or more test results to approve by using keyboard shortcuts or clicking and dragging to select multiples. Once you've selected the rows to approve, click the Approve button in the toolbar at the top. Your screen should now look similar to mine:
qc-approve.png

Now use the popup dialog to finish the result approval process by entering any relevant notes that you would like to make and also taking notice of the material lot that you are approving the results to.

Once you've finished, GoRev will perform the approve operation and the approved results will be removed from the pending QC results section and will now be included in the Levy-Jennings graphs of the next step.

Note: Similarly to approving results, you can reject QC results just as easily by pressing the Reject button in the toolbar at the top.

3: Set Fixed Reference Ranges

For this step, navigate to the Graphs tab in the Quality Control module with the Instrument, Material Lot and Laboratory Test selected that you would like to analyze data for. With the recently approved data, you should see a chart similar to mine:
qc-graphs.png

By default, this will be a Standard Deviation Levey-Jennings graph drawn with the approved QC result data. This can be changed by clicking one of the other graph types in the toolbar at the top:

  • Standard Deviation Levey-Jennings: This is a graph of result data plotted against +/- 2 standard deviations (default).

  • Concentration Levey-Jennings: Similar to the Standard Deviation graph. Values plotted are listed in actual variance as opposed to number of deviations. As a result, only one QC level at a time can be plotted on this graph. Select the other QC levels in the Statistical Summaries box at the bottom right to switch levels.

  • Percentage Deviation: This graph plots the QC levels in percentage variance versus the mean within a +/- 20% range.

Now that we have graphs, we need to setup the QC module to fall in line with the lab's quality control policy. By default, GoRev's QC module will plot the graphs based on a rolling reference range (mean, standard deviation will both be calculated live from the data being graphed). This functionality is intended to help with the calculation of the target ranges by allowing you to collect QC data from a sizable sample set over the course of 20-30 days. These automatically calculated ranges show up in the Statistical Summaries box at the bottom right of the QC module.

In my image above, you can see that our current reference range for QC0039 is:

  • Mean: 94.00

  • Standard Deviation: 4.5

Now, scrolling to the right in this grid we expose a few more columns: ActualMean and ActualStandardDeviation.
qc-statsum.png

In this case, we see that we have exactly the same Actual Mean and Standard Deviation as our Mean and Standard Deviation columns. While not always the case, this is a good indicator of the graph operating on a rolling reference range instead of a fixed reference range.

To reach an ideal setup, we need to configure fixed reference ranges for all QC levels across all tests. Fortunately, we can do this directly in the QC module by pressing the Edit Range button at the top right of the Statistical Summaries box. This will bring up the reference range that is currently in place and allow us to edit it to set manufacturer recommended ranges or custom established ranges.
qc-edit_range.png

I am setting mine to a range slightly narrower than my test results (mean: 95, standard deviation: 3) in order to demonstrate the warnings feature. When setting up your reference ranges, follow the policies in place at the lab. Here is my final graph after editing the reference range:
qc-warnings.png

Notice how the final two tests are just below the -2 deviations mark and are now outliers. This is reflected by GoRev in the Warnings box just below the graph.

Repeat these steps for any additional QC levels that you need to apply a fixed reference range to.

Note: Fixed reference ranges must be set each time a new QC material is introduced to the system and are unique to each Instrument, Laboratory Test and Quality Control Name.

4: Reviewing Approved Data

There will come a time at which you may need to double check and make sure something was approved or rejected properly. To do this navigate to the Tabular Data tab on QC screen in GoRev. From here, you will be able to edit items to set them back to needing approval or rejecting them from the data set.

Exporting Data

For record keeping purposes, GoRev includes built in exports for both the graphs and the tabular data associated with those graphs. To export data from the QC module, follow the steps below.

Graphs

  1. Navigate to the Graphs tab on the QC screen.

  2. Select the Instrument, Material Lot, Laboratory Test and Graph Type that you want to export.

  3. Press the Export button in the toolbar and save the PDF file to your computer system.

Tabular Data

  1. Navigate to the Tabular Data tab on the QC screen.

  2. Press the Export As button in the toolbar and select the desired file type. We recommend XLSX but your needs may vary.

  3. Save the file to your computer system to store the data for your records.

Bulk exporting multiple analytes QC data

Select the Instrument Name and Material Lot you wish to bulk export QC data for Then, select the Bulk Export tab towards the upper middle of the Quality Control screen.

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Either Select and existing export profile or click New to create a new profile. A list of all analytes with QC data for the specific instrument is then displayed. Set your Graph and Tabular export modes on each analyte. TIP: you can use the up/down arrows and type into the box to quickly set these values. For example, if you want to quickly set analytes to Do Not Export simply click the down arrow + D and keep repeating this action.

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Once you have your export modes specified click the Save button, specify your export profile name and click Ok. You can now open this export profile at any time by clicking it in the list and clicking Load.

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With your export profile loaded you can now click one of the three bulk export buttons at the bottom. Export graphs will generate a single PDF with all of your selected analytes graphs in it. Print graphs will bring up the standard select printer screen and allow you to physically print all graphs. Export Tabular data will generate a spreadsheet containing a worksheet for each analyte with all QC values within it.

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GoRev Support Team

If you have any additional questions or concerns regarding this tutorial, please contact the GoRev Support Team by phone at (317) 794-3900 or by email at ask@gorev.com

Note: Always submit an IT Support Ticket detailing the problem that you are experiencing with this portion of GoRev, if possible, as this will give GoRev Support Agents access to information that will help expedite the resolution of your issue. If you are unsure how to submit an IT Support Ticket in GoRev, please see the IT Support Ticket Creation tutorial for assistance.

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