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

Amélie Gaignaux*, Garry Ashton, Domenico Coppola, Yvonne De Souza, Annemieke De Wilde, James Eliason, William Grizzle, Fiorella Guadagni, Elaine Gunter, Iren Koppandi, Katheryn Shea, Tim Shi, Julie A. Stein, Mark E. Sobel, Gunnel Tybring, Gert Van Den Eynden, Fay Betsou, ISBER Proficiency Testing Advisory Group

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

21 Citations (Scopus)

Abstract

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 PT program has been developed and provided to biobanks and other laboratories that perform specific tests to qualify different types of biospecimens. This PT 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.

Original languageEnglish
Pages (from-to)429-439
Number of pages11
JournalBiopreservation and Biobanking
Volume14
Issue number5
DOIs
Publication statusPublished - 1 Oct 2016

Keywords

  • accreditation
  • external quality assessment
  • method comparison
  • performance assessment
  • quality control

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