About acceptance decisions

An acceptance limit is the limit your laboratory sets for one estimate, such as "Bias within ±2 mg/dL". Every decision compares the saved estimate with a limit you entered or adopted. The outcomes, decision rules and limit types are listed in Acceptance limits, and adding a limit is covered in Set acceptance limits.

Each limit gets its own outcome, and together the outcomes give the study one status. A single limit that is not met makes the study Criteria not met. Criteria met needs every limit that applies to be met, so it tells you the saved results meet the limits you entered.

Undecided means the limit applies but the data cannot settle it: there are too few independent specimens, the limit's unit differs from the estimate's, an estimate or interval could not be calculated, or a specimen has no result or no limit. Not evaluated means the limit could not be assessed, for example a concentration-dependent limit when no range covers its target. Either outcome keeps the study Undecided unless another limit is not met. A missing limit, too little data or a failed fit never produces Met. The reason beside the outcome identifies what to check in the setup or data before recalculating. Analysis problems covers what to do for each reason.

Every decision uses the full-precision estimate; the screen and report round for reading. When the rounded number looks equal to the limit, or appears on the wrong side of it, the † mark identifies hidden digits that decide the outcome. Raise Display decimal places to see them. The decision does not change with the display. A value above the limit you typed is never shown as met.

The same data can meet a limit on a point estimate and fail one on a confidence bound. A completed qualitative study with 34 agreements among 37 reportable pairs has overall agreement of 91.9%, which meets "at least 90%", but the lower end of its 95% Wilson CI is 78.7%, which does not. Use a limit on the lower bound when you need confidence that the true performance reaches the limit. An interference effect works the same way: it is met only when its whole interval lies within the limits.

In method, instrument and lot comparison, each specimen's difference is checked against its own allowance. The count within allowances decides acceptance; means and intervals help interpret the comparison. A specimen that cannot be evaluated still counts. With 20 specimens and a 95% rule, one failure plus one specimen not evaluated is Undecided, because 19 could still pass. Two failures settle it as Not met.

In method comparison, bias at a medical decision level comes from the fitted line. A decision level outside the measured comparative range would be an extrapolation, so it stays Undecided. On the example comparison file (comparative results 52.1 to 365.9 mg/dL), a limit at 600 mg/dL is Undecided, and the bias table marks that level as outside the studied range. Collect specimens across a range that includes the decision level.

Sign-off is optional and changes no outcome, so an undecided or descriptive result reads the same after it. Signing off puts the approving account's name, if it has one, its verified email address and the date in the signature lines at the foot of page 1.