Required section · Section 5 of 6
Write the statement, choose containment, name the affected records
You are the technologist who caught the pattern. Three things need to happen in the next several minutes, and the order matters: write an objective event statement, take a containment action, and identify which records are affected before anyone starts asking why the QC failure was overridden.
The objective event statement states facts only: what happened, when, the values involved, the requirement not met, and what was affected. It does not name a person, does not assume intent, and does not assert a cause. Cause is established later, by investigation. A statement that opens with "the technologist carelessly overrode..." has already assigned blame before anyone has looked at why the override happened or what controls should have stopped it.
Containment means stopping further internal release and clinician reporting, preserving evidence, and notifying the supervisor. It does not wait for root-cause findings, and it is distinct from correcting the three results already reported to clinicians.
Draw the boundary at the 09:05 hold: 14 results were internally released, 3 were reported to clinicians and need notification and corrected reports, and 11 were contained before clinician reporting and corrected internally before release.
The exercise below sequences the actions for this case. Some of them can only happen after the ones before them; getting the order backward either destroys evidence or delays a patient-facing correction that should have gone out immediately.
Write the facts, hold the run, and notify on what already reached a clinician, all before you know why the QC failure happened; root-cause work follows, it does not gate the first three.
Illustrative drawing — this picture was drawn rather than captured.
Ordering exercise
Put these actions from the potassium case in the order they should actually happen.
1. Investigate the underlying cause
Trace the QC failure back to the 07:45 reagent lot change and the missing verification step.
2. Implement and monitor corrective action
Revise the lot-change procedure to require verification before release, then track the QC pass rate and delta-check flag rate for 30 days before closing the record.
3. Hold the run
Stop releasing further potassium results and quarantine results from the affected analyzer.
4. Notify clinicians and issue corrected reports
For the 3 already-reported results, notify the ordering clinicians and issue corrected reports once repeat testing on a verified system confirms accurate values.
5. Determine scope and document the record
Identify all 14 affected specimens, note which 3 were already reported, and write the objective event statement.
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