HHE Pathology and diagnostics supplement 2018 - Page 8

variant analysis, analytical phase for ALK analysis and post-analytical phase for ROS1 testing (data not shown). As mentioned above, the implementation of a quality management system and regular participation to EQA schemes, have shown to improve the quality performance of your laboratory. 8,11 Pathologists The pre-analytical problems observed for EGFR analysis, can be explained by the estimation of the percentage of neoplastic cells in the FFPE samples prior to analysis, which has already shown to be highly variable between observers. 15 So far, no gold standard exists. Incorrect estimations might lead to over- and underestimations, resulting in false-negative and In spite of improvement, additional research is important in the continuously evolving field of personalised medicine, where incorrect results could lead to incorrect therapy decisions false-positive results affecting patient safety. Therefore, large-scale data on these estimations are needed in order to define pre-set standards and guidelines to rule out a possible source of erroneous result relatively early in the test process. Additionally, reporting scores show that there is still room for improvement in correctly providing all required report elements as suggested in different guidelines and recommendations. 5,10,11,16–19 The ESP and other national societies are involved in ongoing projects with experts to improve the existing documents, to educate, and to communicate the importance of correctly reporting biomarker tests to the clinicians at oncology departments. EQA providers The role of EQA providers is to support the laboratories in providing tools to evaluate their performance and to improve their practice. For the future it would be good to evaluate how well EQA References 1 Hiley CT et al. Challenges in molecular testing in non- small-cell lung cancer patients with advanced disease. Lancet 2016;388(10048):1002–11. 2 Cagle PT, Allen TC, Olsen RJ. Lung cancer biomarkers: present status and future developments. Arch Pathol Lab Med 2013;2913. 137:8. 3 Cree IA et al; European Society of Pathology Task Force on Quality Assurance in Molecular Pathology; Royal College of Pathologists. Guidance for laboratories performing molecular pathology for cancer patients. J Clin Pathol 2014;67(11):923–31. 4 Tembuyser L, Dequeker E. Endorsing good quality assurance practices in molecular pathology: risks and recommendations for diagnostic laboratories and external quality assessment providers. Virchows Arch 2016;468(1):11. 5 International Organization for Standardization. ISO 15189:2012 Medical laboratories – Particular requirements for quality and competence. ISO, Geneva, 2012. 6 Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. 263a PL100-578, 1988. Laboratory Requirements, 2003, 42 C.F.R. Chapter IV, Part 493. 7 Tembuyser L et al. The relevance of external quality assessment for molecular testing for ALK positive non-small cell lung cancer: results from two pilot rounds show room for optimization. PloS one. 2014;9(11):e112159. 8 Keppens C et al. A stitch in can reflect the findings in routine molecular testing. This study can be done on two levels: first, by assessing if critical time points in the test process are identical in routine practice compared to EQA, or if specific problems could arise in routine practice. Because EQA participants receive pre-cut slides, not all phases of the pre-analytical process (for example, cutting, mounting and labelling of sections) can be assessed at the laboratory level during EQA. 2 Second, the complexity level of distributed EQA samples needs to be compared with those received in routine practice, to evaluate how specific sample characteristics might contribute to a lower quality of analysis results. In addition, schemes from different EQA providers should become harmonised to ensure equal assessment of all participating laboratories. Clinicians Besides the analytical results, additional research is needed to ensure quality not only within the laboratory. Clinicians exert an important role, during requesting the biomarker test 1 and translation of the test results to further treatment options. 2 To improve diagnostic services, it is advisable to evaluate if laboratories always receive sufficient and correct information to perform the biomarker test at the time of request, and how different laboratory structures might influence this, aiming to increase accessibility of precision medicine for clinicians and to increase patient safety. Although reporting scores have improved and guidelines or checklists on report elements have been published, it remains unclear whether clinicians find each element useful and correctly translate the report to the treatment decision. It is logical that incorrect interpretation of an unclear report might result in the selection of an incorrect patient therapy. Acknowledgements We would like to thank Pfizer for the research grant and the ESP for the recognition to coordinate the EQA programs by the BQA research unit of the University of Leuven. We would like to thank the assessors, the medical and technical experts, the validating/reference laboratories, and laboratories that provided tissue material and logistic support. Our gratitude goes to all our colleagues at the BQA research unit and the ESP office for the administrative/coordination support and proofreading of this manuscript. time saves nine: external quality assessment rounds demonstrate improved quality of biomarker analysis in lung cancer. 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