Setting up QC lots, control levels and targets

Add a QC lot for live analytes, define up to five control levels, and choose how target means and SDs are set, from package insert to precision study.

Quality control in Legion Diagnostics is organized the way the bench is: site group, lab area, analyzer, QC lot and analyte. You find it under "Quality management", with tabs for QC runs, the three review stages, and QC lots.

Adding a QC lot

Click "Add New QC Lot" and enter the control name, lot number and expiration, and optionally the people assigned to it. If the lot replaces one already in use, choose that lot under "Replaces QC lot"; see Changing to a new QC lot.

Then pick the analytes the control covers. Only live, quantitative analytes from the Test Directory can have QC; an analyte that is not live yet is shown but cannot be chosen. Each analyte can have up to five control levels, each with its own target and units.

Finally, choose whether the lot uses your "Global Rules" or its own Westgard rules; see Westgard rules and Sigma.

Setting targets

Each level needs a target mean and SD, and you choose how they are set:

• Package-insert targets are taken from the control's insert.
• A precision experiment is the recommended route for a new control. Run a precision study on the material and apply its results.
• Targets can come from this lot's own QC data, once enough has been collected.
• Targets established elsewhere suit labs moving from another system, with a note saying where they came from.

You can set minimums for how many separate days and results per level are needed before data-based targets are proposed. Changing a lot's targets later asks for a reason.

A new lot starts as preliminary: results are run and checked, but the lot is not in effect until it is finalized and signed.

The lot menu

Open a lot's menu to edit the lot, add an analyte, set lot rules, replace or close the lot, add QC data, import historical monthly statistics, or archive it.