TY - JOUR
T1 - A Biospecimen Proficiency Testing Program for Biobank Accreditation
T2 - Four Years of Experience
AU - Gaignaux, Amélie
AU - Ashton, Garry
AU - Coppola, Domenico
AU - De Souza, Yvonne
AU - De Wilde, Annemieke
AU - Eliason, James
AU - Grizzle, William
AU - Guadagni, Fiorella
AU - Gunter, Elaine
AU - Koppandi, Iren
AU - Shea, Katheryn
AU - Shi, Tim
AU - Stein, Julie A.
AU - Sobel, Mark E.
AU - Tybring, Gunnel
AU - Van Den Eynden, Gert
AU - Betsou, Fay
AU - ISBER Proficiency Testing Advisory Group
PY - 2016/10/1
Y1 - 2016/10/1
N2 - 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.
AB - 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.
KW - accreditation
KW - external quality assessment
KW - method comparison
KW - performance assessment
KW - quality control
UR - http://www.scopus.com/inward/record.url?scp=84992127830&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84992127830&partnerID=8YFLogxK
U2 - 10.1089/bio.2015.0108
DO - 10.1089/bio.2015.0108
M3 - Article
AN - SCOPUS:84992127830
VL - 14
SP - 429
EP - 439
JO - Biopreservation and Biobanking
JF - Biopreservation and Biobanking
SN - 1947-5535
IS - 5
ER -