External Quality Assurance Schemes: The Impact of Participation in the UK Versus Rest of the World: 5 Year Data from the UK National External Quality Assurance Scheme.

Abstract

Abstract The American Society of Clinical Oncology/College of American Pathologists guidelines highlighted the critical importance of quality assurance in diagnostic testing for HER2.Unstained formalin-fixed, paraffin-embedded human breast carcinoma cell line sections were circulated to scheme participants on 15 occasions over 5 years. “Reference laboratories” reported results for the HER2/chromosome 17 ratio and HER2 copy number for 5 years for each cell line. Results from the 5th years participants (3 runs 13, 14, 15) were assessed for the pass rate in UK versus rest of the world (EU, US, Asia, etc). The number of participants was 76-78 laboratories/run (UK 30-35, ROW 43-46).Results: The percentage of laboratories achieving “appropriate” results ranged from 78-82% overall. Significantly higher performance was observed over 3 runs for UK laboratories (91-97%, “appropriate” results) versus ROW laboratories (67-74% “appropriate” results), p = 0.004. All methods used by scheme participants in UK Laboratories had excellent performance rates (Pathvysion, PharmDx, Ventana SISH/Inform, Kreatech Posieden). However in the ROW there was evidence of poor performance, which may be related to the assay format, although numbers of comparisons are relatively small.Participation in external quality assurance schemes is a valuable mechanism for evaluation and benchmarking of performance between laboratories. It also serves to improve consistency of HER2 testing by in situ hybridization. Using data from the UK NEQAS scheme we identified that laboratories whose performance is monitored and linked to an intergrated corrective action component(UK laboratories) perform consistently better than laboratories where performance data alone is provided (ROW). In the UK both participation and adequate performance in a national EQA scheme is required for laboratory accreditation. Whilst, in the context of robust EQA there is no evidence that different methods affect performance, in the ROW implementation of some assays appears sub-optimal. This poor performance does not, however, identify fundamental flaws with these methods, which are currently very well controlled amongst UK users but suggests greater attention to EQA results and change to improve laboratory performance is required in the rest of the world. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 6010.