Abstract
The RCPA QAP Molecular Genetics Program (in association with the Human Genetics Society of Australasia) provides external quality assurance programs (EQA), quality assessment and educational modules to public and private pathology laboratories in Australasia and further afield. The Program obtained NATA accreditation to the ISO/IEC 17043:2010 Conformity Assessment - General Requirements for Proficiency Testing Standard in 2013. The Program also administers molecular genetics modules from the European Molecular Quality Network, based in the UK, and the CF Network, based in Belgium. A fundamental aim of the Program is to further improve the quality of molecular genetics testing and reporting in Australasia by establishing guidelines with the assistance of key opinion leaders and subject matter experts. A significant focus area for the Molecular Genetics program is the Somatic Cancer Mutation detection module incorporating EGFR, KRAS and BRAF genes. An overview of participants' performance, specifically with respect to genotyping and associated clinical interpretations in this and other Molecular Genetics modules will be presented. Examples of rare disorders and infrequently tested markers such as anaplastic lymphoma kinase (ALK) translocations in non-small cell lung carcinoma (NSCLC) and medulloblastoma, which are being addressed in the form of a sample exchange, will also be discussed.
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