What to Do in a Temperature Excursion

Part of Clinical Laboratory (LAB) Training: Storage, Freezers and Excursions.

About 2 minutes. Free, in your language, no account needed.

Protect the samples first

Before you investigate anything, get the samples into conditions that meet the specification.

Every minute of deliberation is a minute of exposure. The investigation can happen after the samples are safe.

Then capture what actually happened

How far out of range, at the extreme. Not the current reading.

For how long, from the logger rather than from when somebody noticed.

Which samples were in that unit, by box and position.

Download the logger data before it is overwritten. Some devices hold a limited history, and the evidence is the temperature trace.

Do not decide whether the samples are usable

That judgment belongs to the sponsor, usually with the central laboratory. They know the analyte stability data and you generally do not.

A sample that looks fine may not be. A sample that was briefly warm may be perfectly acceptable for its assay.

Quarantine, document, report, and wait for the decision.

Quarantine means separated and labeled

Not just noted. Physically segregated, clearly marked, and unavailable for shipment until released.

Samples that stay in the normal flow while a question is open get shipped by somebody who did not know.

Report the same day

A temperature excursion is a protocol deviation. It goes to the sponsor promptly, with the data.

The report should say what happened, how long, which samples, what you did, and what you do not know.

Find the cause, not just the event

A door left ajar, a failing compressor, a blocked vent, a power interruption. The corrective action depends on which.

Recording "temperature excursion, samples quarantined" without a cause means the same excursion happens again next month.

The record after the event

The excursion, the trace, the affected samples, the notification, the sponsor's decision and the corrective action. Together they show a controlled response.

Missing the sponsor's decision is the most common gap, and it leaves the file looking like nobody closed it.