Quality improvement tools for predictive testing in pathology

Over the last decades, personalized medicine has gained increasing importance in clinical oncology and several important biomarkers have been implemented in routine practice. Sound therapeutic decisions can only be obtained if molecular analysis of these biomarkers is accurate and reliable. Participation in external quality assessment (EQA) schemes aims to educate and support participating laboratories to reach accurate test results. Unfortunately, tumour analysis has shown to be prone to errors for metastatic colorectal cancer (mCRC) and non-small cell lung cancer (NSCLC), especially in the immediate period after introducing a new test. To date, no research has been conducted on the different types of errors and their root causes across all steps of the total biomarker testing process. This project will apply a longitudinal approach to identify, classify and analyse data on the error types, their frequency and severity for mCRC and NSCLC. In addition, the effectiveness of corrective actions as a part of the quality management system (QMS) will be evaluated. There will be a specific focus on error types and management during the implementation of upcoming techniques in clinical oncology. These topics will be investigated both during EQA participation and during routine practice for a selected subgroup of European laboratories. The last part concentrates on assembling and linking the different data to gain insight into the influence of EQA participation and QMS implementation on error reduction strategies, and could form the basis for the further development of European guidelines. Based on the outcome of this project, the quality of the testing process and organisation in medical laboratories can be optimised to increase patient safety in personalised medicine.nrpages: 398status: publishe