Validating Results

Overview
The need to validate a result depends upon the scheme analyte's Status Active and QC Active flags, and the type of sample: unknown (UNK) sample, or quality control (QC) sample of either duplicate (DUP), replicate (REP), blank (BLK), standard (STD), spike (SPK), reread (RRD) sample.
After results are entered using the Data Entry or Online application, the system assesses quality control (QC) to return a worklist status of either:
- Quality failure high (QFH)—Applied to a QC sample where the result is above a critical upper limit.
- Quality failure low (QFL)—Applied to a QC sample where the result is below a critical lower limit.
- Quality warning high (QWH)—Applied to a QC sample where the result is above an upper warning limit but below any critical upper limit.
- Quality warning low (QWL)—Applied to a QC sample where the result is below a lower warning limit but above any critical lower limit.
- Not validated (NVL)—Applied where validation is required, to an UNK sample or QC sample as per the following table.
- Completed (CPL)—Applied where validation is not required, to an UNK sample or QC sample as per the following table.
Status active? | Y | Y | N | N |
QC active? | Y | N | Y | N |
QC sample outside expected failure limits |
QFH |
NVL |
QFH |
CPL |
QC sample outside expected warning limits but within expected failure limits |
QFH
|
NVL | QFH or QFL |
CPL |
UNK sample, or QC sample inside acceptable limits | NVL | NVL | CPL | CPL |
Note: If a CUID scheme analyte has a listed but not received (LNR), not analysed (NA) or insufficient sample (IS), then quality control is not assessed.
Where a result for a QC sample falls outside of the quality control limits, then the cell background is highlighted.
A CUID scheme analyte that has a NVL worklist status requires validation. This is done using the Data Entry application.
Upon successful validation, a NVL worklist status becomes validated (VAL) which is a transient state because as soon as the spreadsheet data is aved, then any VAL worklist statuses become CPL. Results are not reportable until the CUID scheme analyte's workflist status is CPL.
Process
Ignoring a Quality Control Failure on a Result
Where a CUID scheme analyte's result is assessed as a quality failure high or quality failure low, then the operator either addresses any measurement issues (instrument calibration, sample preparation, contamination) to take another reading that is within acceptable limits, or ignores the QC failure, with good reason, and where permitted to do so.
Ignore a quality control failure on results
Validating Results
Once there are no more quality control failures on CUID scheme analytes, the must be validated to become reportable.
Updating Job Status
Where the LIMS is not configured to automatically update the job status after data is saved, it is necessary to do this manually to allow the job to complete.