The Royal College of Pathologists of Australasia Quality Assurance Program: Immunohistochemistry Breast Marker Audit Overview 2005-2015

Haffajee, Zenobia; Kumar, Beena; Francis, Glenn; Peck, Martyn; Badrick, Tony

doi:10.1097/pai.0000000000000621

Cited by 1 publication

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“…Several national and international EQA schemes are available for testing common predictive biomarkers in NSCLC and mCRC, such as those by the European Society of Pathology (ESP) [ 5 ], the European Molecular Genetics Quality Network in Europe [ 6 ], the College of American Pathologists (CAP) in the USA [ 7 ], NordiQC [ 8 ], the Royal College of Pathologists of Australasia Quality Assurance Programs for Australasia [ 9 ], and national schemes organized in Canada, Germany, France, Italy, Spain, the United Kingdom, the Netherlands, and Belgium [ 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ].…”

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confidence: 99%

Managing Deviating EQA Results: A Survey to Assess the Corrective and Preventive Actions of Medical Laboratories Testing for Oncological Biomarkers

2020

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Laboratories testing predictive biomarkers in lung and colorectal cancer are advised to participate in external quality assessment (EQA) schemes. This study aimed to investigate which corrective actions were taken by laboratories if predetermined performance criteria were not met, to ultimately improve current test practices. EQA participants from the European Society of Pathology between 2014 and 2018 for lung and colorectal cancer were contacted, if they had at least one analysis error or test failure in the provided cases, to complete a survey. For 72.4% of 514 deviating EQA results, an appropriate action was performed, most often including staff training (15.2%) and protocol revisions (14.6%). Main assigned persons were the molecular biologist (40.0%) and pathologist (46.5%). A change in test method or the use of complex techniques, such as next-generation sequencing, required more training and the involvement of dedicated personnel to reduce future test failures. The majority of participants adhered to ISO 15189 and implemented suitable actions by designated staff, not limited to accredited laboratories. However, for 27.6% of cases (by 20 laboratories) no corrective action was taken, especially for pre-analytic problems and complex techniques. The surveys were feasible to request information on results follow-up and further recommendations were provided.

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