Poster Presentation ABNA - Biobanking: Shaping the Future Together

192.  Value of centralised risk management, incident reporting, and internal audit program in a multi-site biobank (#4)

Samantha Higgins 1 2 , Milon SH Pang 1 2 , Susan Hume 1 3 , Samantha Cauberg 1 4 , Jhoseph Marquez 1 5 , Leanne Graham 1 6 , Angela J Mountain 1 7 , Wayne Ng 1 2
  1. Victorian Cancer Biobank, Melbourne, VIC, Australia
  2. Cancer Council Victoria, Melbourne, Victoria
  3. Eastern Health Tissue Bank, Eastern Health, Box Hill, Victoria , Australia
  4. Peter Macallum Cancer Centre, Parkville, Victoria, , Australia
  5. Monash Health, Clayton, Victoria, Australia
  6. Royal Melbourne Hospital, Parkville, Victoria, Australia
  7. Austin Health, Heidelburg, Victoria, Australia

Biomedical research, particularly within rare disease and low-survival cancer domains, requires coordinated multi-site specimen accrual to scales that can meet research unmet needs. Controlling biospecimen conditions is paramount - it is well-established that pre-analytical variability affects quality of downstream research. For multi-site biobanks, robust operational workflows and biobanking infrastructure can be of equal importance to enable timely and seamless utilisation of specimens.  

International quality programs (e.g. CTRNet certification; ISO 20387 Requirements for Biobanking) and best practices (e.g. ISBER Best Practices; IARC Technical Standards for Cancer Research) are widely adopted for guiding high-quality and ethical biospecimen management. Despite advances with resources, many biobanks remain operating in silos, and examples of coordinating quality through a multi-site biobanking lens are limited.  

The Victorian Cancer Biobank (VCB) is a consortium of 5 hospital-embedded biobanks and one Lead Agency. VCB delivers harmonised operations across consent, collection, storage and distribution workflows. VCB services archival, prospective or clinical trials for over 100 National and International projects annually, with 50% requiring multi-site project delivery.  

Quality Assurance (QA) tools for continuous improvement of our multi-site program have been deployed to increase program efficiency, research quality and client satisfaction.  

Centralised QA implementations and consortium-wide outcomes in the last 2 years include: 

  • Risk register – coordinated mitigation of 18 multi-site risk areas 
  • Incident reporting – provision of impartial corrective/preventative action recommendations and trends for ~17 incidents/year  
  • Internal audit program – identifying non-conformities (2 major; 8 minor); and continuous improvement (7 observations and 26 Opportunities) 

Program benefits include stronger reassurance to funder, governing body and consumers; increase in quality mindset and transparency within staff; strong client (researcher) satisfaction. VCB’s QA program highlights the important role quality tools play, in ensuring effective delivery of complex multi-site biobanking. Such tools could be deployed nationally or globally to improve interoperability and alignment of biobanks with similar goals/collection activities.