Required section · Section 6 of 6
What this case does and does not settle
This case supports a defined conclusion: under the stated rule set, the 11:00 run produced a same-side 2_2s rejection, most consistent with systematic error, and the correct response is stop, assess, investigate, correct, verify, document, then assess patient results released in the affected interval, not repeated reruns until a pass appears. That sequence, and the general behavior of 1_2s as a warning and 1_3s/2_2s/R_4s/4_1s/10x as rejection rules in the classic procedure, is supported by the cited Westgard and CLSI sources.
Which rules your own laboratory has enabled, whether each is warning or rejection, how a run is bounded, whether 2_2s, 4_1s, and 10x are evaluated within a run or across runs, how many control levels and what frequency apply, and whether an Individualized Quality Control Plan changes any of that are all local, documented, method-specific decisions. CLSI C24 does not define a single strategy for every device.
Method and local caveats: this case uses a method-neutral control value expressed in arbitrary units with no real analyzer, reagent, calibrator, or patient reference range attached. Production instrument-specific teaching would need to name the exact analyzer, assay, reagent lot family, calibrator, control manufacturer and lot, specimen type, and software version, per the manufacturer's instructions for use, before any of those specifics could be taught. CAP requires recorded corrective action when control results exceed defined acceptability limits; the parallel requirement in each discipline's checklist is testing-menu-specific, so verify your laboratory's own required response before treating this pattern as universal.
The pattern-reading and corrective-action logic here travels to any quantitative method; the actual rule set, run boundaries, frequency, and control material do not, and must come from your laboratory's own approved QC plan.
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