Chapter 1 · Result validation and authorisation

Before results are released, they must be validated — checked for clinical plausibility, delta check (consistency with previous results), and internal consistency within the request. Only authorised personnel may release results. Authorisation criteria must be documented. Autoverification (automated result release) is permitted under ISO 15189 provided criteria are documented, validated, and monitored.

Chapter 1 · Practical example

Result authorisation — who can authorise what

Only competent, specifically authorised staff may release patient results. Authorisation must be documented in personnel files and enforced by the LIS.

▲ The situation

A laboratory has set up its LIS so that any logged-in user can authorise and release results. During a busy shift, a healthcare support worker authorises and releases an urgent troponin result while the scientist is occupied.

Reference: ISO 15189:2022 Clause 7.5.1

✓
Good practice

On discovering this, the quality manager immediately revises LIS permissions: only scientists with documented competency in result interpretation are assigned authorisation rights. The HCSW’s permission is removed. A nonconformity is raised for the result released without authorisation, and the result is reviewed retrospectively by an authorised scientist.

✗
Poor practice

The practice continues because removing permissions would slow down urgent result release. Over the following months, several results are released by staff without the competency to assess whether the result is clinically plausible, whether a delta check flag needs review, or whether a critical value notification is required.

● What this means for your practice

Authorisation of clinical results is not a logistical step — it is a clinical judgement. The LIS must enforce that only trained, specifically authorised individuals can release results. Access permissions must reflect documented competency, not job convenience.