Cancer Council NSW Biobank - ISO:9001:2008 Accreditation
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Cancer Council NSW Biobank - ISO:9001:2008 Accreditation

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Cancer Council NSW biobank processes, stores and despatches biological samples from cancer patients and controls in large epidemiological studies. As a result of ISO accreditation, we now offer a......

Cancer Council NSW biobank processes, stores and despatches biological samples from cancer patients and controls in large epidemiological studies. As a result of ISO accreditation, we now offer a blood processing and storage service for researchers external to Cancer Council NSW.

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  • 1. Cancer Council NSW Biobank - ISO:9001:2008 Accreditation Verity Hodgkinson and Freddy Sitas. Cancer Research Division, Cancer Council NSW Background Cancer Council NSW biobank processes, stores and despatches biological samples from cancer patients and controls in large epidemiological studies. Currently, we have biological samples from 28,000 people in storage. A breakdown of aliquots per study, currently held by the biobank, can be seen in Table 1. Samples are linked to comprehensive self-reported questionnaire data covering lifestyle, demographic and health related information. Aims Our aims were to improve quality in the biobank ensuring that international best practice is followed through the development and implementation of a quality management system (QMS) and, achieve ISO 9001:2008 accreditation. The decision to pursue ISO accreditation was influenced by the experience of biobanks overseas and the positive contribution that accreditation made towards achievement of government contracts, improving the quality of biospecimens available for research, best practice in biobanking, enhancing interoperability between biobanks and lack of an internationally recognised biobank specific accreditation option. Methods QMS implementation involves a comprehensive review of documentation and systems and closure of identified gaps. The two step formal accreditation process follows system implementation and is conducted by an accredited external reviewer. The first step includes an audit of documents to ensure compliance with ISO standards. The second step involves an observational audit of operations to ensure that the documented procedures are followed. Accreditation follows if these standards are met. Results The process of accreditation has significant benefits for staff engagement, consumer confidence, standardisation and continuous improvement of processes, ultimately ensuring use of high quality biospecimens and better research outcomes. Conclusions As a result of ISO accreditation, we now offer a blood processing and storage service for researchers external to Cancer Council NSW. Triennial accreditation will ensure that these benefits continue into the future. For further information please contact Verity Hodgkinson, Program Manager, Biobanking, at verityh@nswcc.org.au Table 1: Inventory of aliquots currently held by Cancer Council NSW Biobank for public health research Aliquot type (500ul) Study Name CLEAR Study* Skin Health Study Cervical Health Study 45 and Up Study* CCNSW Biobank Stability Study Johannesburg Cancer Case Control Study Serum Plasma Buffy Coat EDTA Red Cells 45049 101402 18679 X X 18779 10667 5335 15420 X X X X 26776 10667 3425 6634 15405 2705 954 10424 X X X X: sample type not collected; * open access resource