Chapter 3 · Result amendment

If a result must be amended after release, the amendment must clearly identify that it is an amendment, state the original result and reason, and be signed by an authorised person. The original result must be retained. Amended results must be communicated to the requesting clinician by the most appropriate means.

Chapter 3 · Practical example

Result amendment — traceable, visible, communicated

When a released result is incorrect, the correction must be traceable, flagged as an amendment, and communicated directly to the clinician — the original result must remain visible in the audit trail.

▲ The situation

A scientist discovers that a haemoglobin released 20 minutes ago is 142 g/L — it should be 74 g/L. A decimal point was entered incorrectly in the LIS. The clinician has not yet been contacted about the result.

Reference: ISO 15189:2022 Clause 7.8.3

✓
Good practice

The scientist notifies the section head immediately. A corrected report is issued in the LIS, clearly flagged as AMENDED — original value 142 g/L, corrected value 74 g/L, reason: data entry error. The section head calls the requesting clinician directly, explains the error, provides the corrected result, and confirms the clinician has seen the amended report. An incident report is completed.

✗
Poor practice

The scientist quietly changes the value in the LIS without adding an amendment flag, reasoning that the clinician probably has not seen it yet. In fact, the clinician has seen 142 g/L, taken it as normal, and discharged the patient. The corrected value of 74 g/L indicates severe anaemia requiring urgent management — but because there is no amendment flag, the clinician never realises a correction was made.

● What this means for your practice

Silent corrections in the LIS are not corrections — they are concealments, whether intentional or not. Every result amendment must be labelled as such, retain the original value, and be communicated verbally to the clinician when clinical management may be affected.