The Clarity LIMS automated QC system is configurable. This allows administrators to determine which QC master steps and steps are required for aggregation, the criteria to apply to each master step/step, and the field values to be copied up to aggregation.
The following features are provided:
Preconfigured protocols for DNA Initial QC and RNA Initial QC that include master step templates for Bioanalyzer, NanoDrop, Qubit, PicoGreen, CaliperGX, TapeStation, and Aggregate QC.
Custom field-based storage of key QC results for both automated and spreadsheet-based manual storage.
Custom field-based criteria (Source Data Field, Operator, and Threshold Value) for QC steps that allow for automatic assignment of QC flags triggered on the storage of a QC result file.
QC protocol filter configuration that allows you to determine to which QC step samples are queued and which must be completed before aggregation can occur.
Automated aggregation of QC results and assignment of QC flags, from individual step right up to the sample undergoing QC, with the option of using custom field-based configuration to update Concentration (and other fields) from a particular QC result.
Easy access to individual sample QC measurements and flags, allowing you to review results, see the criteria evaluated, and the resulting QC flags assigned.
Excel-based log files, attached to the aggregation step, clearly show the criteria evaluated, the resulting QC flag assigned, and which individual QC test results were used to update the custom field values on the sample undergoing QC.
Follow these steps to configure the out-of-the-box QC solution to meet the needs of your lab:
Remove unnecessary QC steps. (See #removingunnecessaryqcprotocolsteps-removeaqcprotocolstep )
Configure master step fields for QC aggregation. (See #configure-master-step-fields-for-qc-aggregation)
Configure QC evaluation criteria. (See #configure-qc-evaluation-criteria)
Specify QC master step field values to copy up to aggregation. (See #copy-master-step-fields)
Clarity LIMS includes preconfigured RNA Initial QC, DNA Initial QC, and Library Validation QC protocols, each containing a sequence of steps. You can modify these protocols, and remove steps that your lab does not use.
On the main menu, click Configure.
On the LIMS configuration screen, click the Lab Work tab.
The Workflow, Protocol, Step, and Master Step navigation panel displays.
In the Protocol list, select the protocol you want to modify.
The Workflow, Protocol, Step, and Master Step navigation panel displays.
To delete a step, select it and click the Delete button.
You cannot remove a step if it contains samples that are currently in progress, or if there are samples queued for it.
In this scenario, you must move the samples before proceeding with the deletion. For details, see #manually-moving-samples-to-the-next-step.
In the default BaseSpace Clarity LIMS configuration, the Aggregate QC step aggregates the results of all QC steps in the protocol—if they are available.
If a step has been removed from a QC protocol, it is ignored and aggregation still occurs for the remaining steps. No error is generated.
The following flowchart shows the logic behind the default configuration of QC aggregation.
Often, this default configuration is acceptable and there is no need to make any changes. However, you can configure alternate QC master step field values that overwrite these defaults. For example, you may want to:
Make a particular step required for aggregation.
Increase the priority of the results of a particular step – a step whose results are considered more accurate, for example.
Make one/both of the changes listed above, and then lock down values so that users cannot modify them.
The Aggregate QC master step includes a master step field for each QC step to be considered for aggregation.
The value for the QC master step field may be one of two values:
Use if available: If the QC step was run for a sample, its value will be used in the aggregation calculation; if the QC step was not run, it will be ignored.
Required: The step is required for aggregation. If it has not been run for a sample, the QC value cannot be calculated and aggregation will not proceed.
The default setting for all QC steps is Use if available.
The Required and Use if available master step field values can have an additional (Priority n) suffix.
To be an acceptable value, the value for 'n' may be any value between 1–99, where 1 is the highest priority and 99 is the lowest priority. Master step fields without a priority value defined are assigned a priority of 99.
The default priority value for all QC steps is (Priority 5).
If sample measurements exist for multiple QC steps, all of which have been assigned the same level of priority (as is the case in the default system) the QC flags are evaluated such that any failure results in an overall fail flag for QC aggregation.
Sometimes, however, a particular QC technology may be considered more accurate and you may want its results to take precedence.
For example, a lab may run Bioanalyzer and NanoDrop QC steps on all samples. If one of these steps results in a QC fail, a PicoGreen assay is run on the failed sample and its result is then considered more accurate. In this case, set Bioanalyzer and NanoDrop at priority 5 and PicoGreen at priority 3.
All QC aggregations are logged in an Excel workbook log file and attached to the Aggregate QC step.
Subsequent invocations of the aggregation script results in a new sheet being created in the workbook, in the first sheet position. This new sheet automatically becomes the active sheet.
The best practice method for configuring alternate master step field values for QC aggregation is to create a group of defaults. The fields defined in the group overwrite the default configuration values.
For details, see #add-and-configure-custom-fields.
The aggregate QC script treats any custom field that does not begin with 'Copy' as a priority master step field. Therefore, you are restricted from adding fields that are not priority fields. Any new priority fields must contain default values of Required and Use if available.
If you do not want lab scientists to be able to manually edit a master step field value, lock it down by setting the Custom Entries toggle switch to No. At run time, the lab scientist must select a value from the predefined drop-down list.
In the default Clarity LIMS system, each QC master step has two sets of QC evaluation criteria defined. These are displayed in the Record Details screen when the QC step is run.
Each set of criteria comprises three master step fields: Source Data Field, Operator, and Threshold Value.
When the QC protocol step is run, the lab scientist selects from the prepopulated drop-down lists of Source Data Field and Operator values, and then types a numeric value into the Threshold Value field.
You may want to restrict the values available for selection from the Source Data Field and Operator lists, or set default criteria values that cannot be changed.
The best practice method for configuring the criteria used to evaluate QC protocol steps is to create a group of defaults. The master step fields defined in the group overwrite the default configuration values.
For details, see #configure-groups-of-defaults.
In the default Clarity LIMS system, when QC aggregation is executed, the Record Details screen allows lab scientists to (optionally) select one or two master step field values to be copied up from a QC protocol step.
Generally, this is a concentration value.
If necessary, you can specify the master step field values to be copied.
The best practice method of setting master step fields to be copied up to aggregation is to create a group of defaults. For details, see #configure-groups-of-defaults.
Setting QC master step fields to copy up to aggregation is an optional step. If you do not require this feature, leave the default system as is. Note also that if the Copy task fields are left empty, no values are copied up and no errors are generated. Similarly, if you specify a QC step that has not been run or a field that contains no value, no errors are generated.