Our Mission

The SKML is an independent External quality assessment organisation for medical tests, recognised and valued by all stakeholders. SKML provides insight to both medical laboratories and the in vitro diagnostics (IVD) industry on whether they meet the required analytical performance specifications (APS) including metrological traceability. Where available we use APSs based on clinical performance specifications. In this way, SKML contributes to a safe and meaningful healthcare.

Our Vision

SKML advocates uniform interpretation of medical laboratory diagnostic outcomes. It strives for interchangeability of results from all medical laboratory analysis by comparing the outcomes of participating laboratories with each other and with truth verification using reference methods, all within tolerances based on medical necessity.

This applies not only to individual laboratory results but also to the accompanying interpretations and recommendations. To achieve this, SKML uses, wherever possible, commutable materials in its surveys, with target values that are metrologically traceable to reference methods, with tolerances based on what is medically acceptable, considering clinical application.

Therefore, SKML also promotes the harmonisation of units in which results are expressed and the use of harmonised reference intervals.

This vision is represented by the three pillars on which SKML builds its ambition for optimal quality assurance:

1. Commutable samples

Samples that behave like regular patient samples used in routine patient diagnostics. Only then external quality assessment allows to investigate whether laboratories produce the same results in patient material. SKML is committed to use commutable materials where possible.

2. Target values traceable to reference methods

By comparing laboratories not only to the consensus of all participants but, where possible, also to the true value, established using reference methods and/or in reference laboratories, SKML ensures target values that are beyond dispute.

3. Reports on analytical performance based on sample-transcendingreports with tolerances based on what is medically acceptable

Unlike most external quality assurance organisations, SKML reports are based on the results of multiple samples. For quantitative tests, this enables the distinction between random and systematic sources of error. The analytical performance specificationsare based on international guidelines.

For the in vitro diagnostics (IVD) industry, SKML reports are useful in monitoring whether their product claims are met in practice. In this way SKML contributes to the legal meet the obligation of IVD manufacturers to perform post market surveillance of theirs products as required by the European IVD Regulation (IVDR).