Reviewing QC Batches |
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Overview |
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After Evaluation, the QC Batch can be Reviewed in one of two ways:
• | Automatic Review
If "Automatic Review on Success" is "Yes" on the QC Method, LabVantage automatically performs the Review. If all evaluation checks have passed, the QC Batch status changes to "Reviewed" and the QC Batch moves to the Historical Batch list page. |
• | Manual Review
If "Automatic Review on Success" is "No" a manual Review must be performed. Once all data is entered (QC Batch Params must also be entered if defined) the QC Batch status changes to "Data Entered" and the QC Batch is added to the QC Batch Review list for Review. |
Automatic Review |
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This automatically reviews the QC Batch after it has been Evaluated, and all evaluation checks have passed. No further user intervention is required.
Manual Review |
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To manually Review a QC Batch, navigate to LIMS → AQC → QC Batch Review. The QCBatch Review List page displays.
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Select a QC Batch and click "Review". The Review QC Batch page displays.
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Depending on the outcome of the Evaluation, choose a Review Disposition:
Disposition | Description |
Approved | Approval Steps are passed for all Data Sets in the QC Batch that require Approval. |
Rejected | Indicates that the QC Batch has been Rejected. |
Retested | Indicates that the QC Batch is in the process of being Retested. |
Upon Saving, the QC Batch status changes to Reviewed and moves to the Historical QC Batch List page.
Approving Tests |
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To manually approve specific Data Sets in a QC Batch, select Samples from the "Batch Items" detail, then click "Test Approval". This provides the flexibility to manually approve the entire QC Batch (all Samples), or only the selected Samples.
Functionality of the resulting Test Approval page is similar to the "Approve Tests" page for "Tests".
Clicking "Test Approval" shows only data entered in the QC Batch.
Retest |
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You can retest the entire QC Batch (all Samples) or only selected Samples by clicking "Retest".
As you retest, new instances of the existing Data Sets are created with a status of "Initial". They are not linked with the current QC Batch. These newly created Data Sets can be added to any other new QC Batch.
After clicking the "Retest" button, the page refreshes and the following confirmation message displays:
Retest with New Batch |
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As you retest, you can also create a new QC Batch. The new QC Batch will include all Unknown Samples with the retested Data Sets (new instances of the existing Data Sets are created with a status of "Initial"). Select the entire QCBatch (all Samples) or only selected Samples, then click "Retest with New Batch".
The page refreshes and a confirmation message displays, along with the newly created QC Batch Id.
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Publish Parameters |
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Control limits (Target Value and Standard Deviation) are stored on the QCMethod. These control limits default to any new QCBatches created using the QCMethod. During Review you can optionally change the control limits, then publish the new values back to the QC Method.
In the QC Batch Sample Types tab select a QCSampleType. Click "View Parameters".
The QC Sample Type View Maintenance page opens.
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Here you can view Parameter details for the selected QC Batch Sample Type and optionally make changes to the Target Value or SD values.
Choose to "Save" or "Publish":
Button | Description |
Save | Saves the new values at the QC Batch level. |
Publish | Updates the QC Method (specifically for the QCMethodSampleType) with the new values. |
Historical QC Batch |
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QC Batches that have been Reviewed display on the Historical QC Batch list.
From here you can continue to Review the QC Batch and initiate any Retests, or view QC Batch Params.