A Biospecimen Proficiency Testing Program for Biobank Accreditation: Four Years of Experience

A. Gaignaux G. Ashton, D. Coppola, Y. De Souza, A. De Wilde, J. Eliason, W. Grizzle, F. Guadagni, E. Gunter, Koppandi Iren, K. Shea, T. Shi Tim, J.A. Stein, M.E. Sobel, G. Tybring, G. Van den Eynden, F. Betsou and the ISBER Proficiency Testing Advisory Group

Biopreservation and Biobanking, 19 May 2016  [Epub ahead of print] doi:10.1089/bio.2015.0108.

Biobanks produce and distribute biospecimens, ensuring their fitness for purpose and accurately qualifying them before distribution. In their efforts toward professionalization, biobanks can nowadays seek certification or accreditation. One of the requirements of these standards is regular participation in Proficiency Testing (PT) programs. An international Proficiency Testing program has been developed and provided to biobanks and other laboratories that perform specific tests to qualify different types of biospecimens. This Proficiency testing program includes biospecimen testing schemes, as well as biospecimen processing interlaboratory exercises. This PT program supports the development of biobank quality assurance by providing the possibility to assess biobank laboratory performance and useful insights into biobank laboratory method performance characteristics and thus fulfill the demands from accreditation authorities.