HHE 2018 | Page 140

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

5 , 10 , 11 , 16 – 19 recommendations .

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 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 .