Plenary Session WeP2

A survey on laboratory practice around the world

Uwe Christians

Session Description

Reliable, accurate and precise test methods for the clinical therapeutic drug monitoring (TDM) of small molecule immunosuppressants such as tacrolimus, cyclosporine, sirolimus and everolimus are essential in order to effectively monitor levels and to make proper dose adjustments. Data from proficiency testing programs have shown substantial inter-laboratory variability. The aim of this study was to systematically document current practices utilized for immunosuppressant drug TDM in clinical laboratories and to identify methodological and practice differences which may cause the variability observed among laboratories.
Data collection was conducted via a structured web-based survey distributed by IATDMCT. Surveys were completed by 76 laboratories in 14 countries.
The results of our survey suggested that inter-laboratory variability is a multifactorial problem and that there are three main reasons: 1) lack of standardization of laboratory procedures and workflows starting with sample collection and handling, 2) lack of use of appropriate reference materials (e.g. isotope-labeled internal standards for LC/MS-MS), and 3) poor compliance with internationally accepted good laboratory practice guidelines.
Technical level consensus and guidance on laboratory operational procedures, quality systems, and personnel training will be of great importance to improve quality and inter-laboratory comparability.

Learning Objectives

- To understand the problem of inter-laboratory variability of immunosuppressant TDM
- To recognize potential sources of variability in laboratory procedures
- To learn about common problems that will help in conducting root-cause analyses
- To understand the importance of continuous quality management and personnel training
- To discuss strategies how to efficiently improve quality and comparability of immunosuppressant TDM results.

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