Chapter 2 · Data integrity and security

Patient data in the LIS is subject to data protection law. Access must be role-based and documented. Passwords must meet complexity requirements and be changed at defined intervals. The laboratory must have a documented information security policy. Unauthorised access must be treated as a reportable breach. Staff must not share login credentials under any circumstances.

Chapter 2 · Practical example

Data integrity and security — protecting results from error and interference

The LIS must protect result integrity at every step: from analyser transmission to final report. Transcription errors and unauthorised access must be systematically prevented.

▲ The situation

A laboratory is manually transcribing haematology results from an analyser that is not connected to the LIS. A scientist enters a haemoglobin of 142 g/L but accidentally types 14.2 g/L.

Reference: ISO 15189:2022 Clause 7.8.6

✓
Good practice

The section head, reviewing results before release, checks the haemoglobin against the printed analyser output. The discrepancy is immediately visible — the LIS shows 14.2, the printout shows 142. The error is corrected before release, documented in the transcription error log, and the root cause addressed: all manually transcribed results now require a second scientist to verify against the original printout before release.

✗
Poor practice

The result is released as 14.2 g/L — a value that falls within the laboratory’s female reference interval for haemoglobin (115 to 165 g/L for this lab). The clinician sees a normal result and takes no action. The patient’s true haemoglobin of 142 g/L is also normal — so in this case no harm results. But the process failure is invisible because the error happened to produce a plausible value.

● What this means for your practice

Transcription errors are most dangerous when they produce plausible values. Build verification into every manual transcription workflow — source against destination, checked by a second person before release. LIS connectivity to analysers eliminates this risk entirely; prioritise direct interface wherever possible.