Required section · Section 3 of 6

Detection, correction versus corrective action, and when to escalate

Detect and contain the event first: preserve the affected specimens, reagents, instrument data, audit trail, and communications; hold further release while scope is assessed. Keep the event statement factual and free of blame.

Correction addresses the current event. Corrective action addresses a condition that could recur. Escalate through the current route when the event touches patient safety, privacy, a device or reagent/manufacturer obligation, or another applicable regulatory or leadership threshold. A critical-result notification remains immediate and independent whenever it applies.

Choose investigation depth from the evidence of harm, extent, detectability, and recurrence. If evidence supports a recurrence condition, assign systemic corrective action and verify its effectiveness. If the investigation finds no systemic cause, record that conclusion and why no systemic corrective action is assigned; do not invent one merely to close the record.

Route the event by what it touches, correct what has already reached a clinician, and document the evidence for either corrective action or no-systemic-cause closure.

Immediate correction versus corrective action, with examples from today's case
Category	What it addresses	Example from this case
Immediate correction	The problem in front of you, right now	Hold the potassium run, notify the ordering clinicians for the 3 already-reported results, issue corrected reports once repeat testing confirms accurate values
Corrective action	The underlying cause, to reduce recurrence	Revise the reagent lot-change procedure to require verification testing before patient release

CLIA record-retention minimums (federal floor, not a ceiling)
Record type	Minimum retention
Test requisitions and QC/analytic-system records	2 years
Original test reports	2 years after reporting
Pathology reports	10 years
Cytology slides	5 years
Histopathology slides	10 years
Pathology blocks	2 years
Tissue remnants	Until diagnosis is made

Knowledge checks

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Knowledge check 1

Revising the reagent lot-change procedure to require verification testing before patient release is an example of which category?

Choose one option.

Corrective action, because it addresses the underlying cause to reduce recurrence.

Immediate correction, because it fixes today's problem.

Containment, because it stops further release.

Closure, because the event record can now be closed.

Knowledge check 2

For the 3 potassium results already reported to ordering clinicians, which actions does federal regulation require?

Choose at least 3 options.

Promptly notify the ordering clinician of the error

Promptly issue a corrected report, clearly marked as corrected

Retain duplicates of both the original and the corrected report

Delete the original report so only the corrected value remains on file

Report the event to the FDA as a device recall

Section status

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