title: A Biospecimen Proficiency Testing Program for Biobank Accreditation: Four Years of Experience.
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.
authors.affiliation: 1 Integrated Biobank of Luxembourg , Luxembourg, Luxembourg .
authors.forename: Amélie
authors.initials: A
authors.lastname: Gaignaux
authors.affiliation: 2 Cancer Research UK Manchester Institute , Manchester, United Kingdom .
authors.forename: Garry
authors.initials: G
authors.lastname: Ashton
authors.affiliation: 3 Moffitt Cancer Center , Tissue Core, Tampa, Florida.
authors.forename: Domenico
authors.initials: D
authors.lastname: Coppola
authors.affiliation: 4 AIDS Specimen Bank, University of California , San Francisco, San Francisco, California.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: De Souza
authors.affiliation: 5 Tumorbank, MOCA, University Hospital of Antwerp , Antwerp, Belgium .
authors.forename: Annemieke
authors.initials: A
authors.lastname: De Wilde
authors.affiliation: 6 Great Lakes Stem Cell Innovation Center , Detroit, Michigan.
authors.forename: James
authors.initials: J
authors.lastname: Eliason
authors.affiliation: 7 Tissue Collection and Banking Facility, University of Alabama , Birmingham, Birmingham, Alabama.
authors.forename: William
authors.initials: W
authors.lastname: Grizzle
authors.affiliation: 8 BioBIM (Multidisciplinary Interinstitutional Biobank) IRCCS San Raffaele , Rome, Italy .
authors.forename: Fiorella
authors.initials: F
authors.lastname: Guadagni
authors.affiliation: 9 Specimen Solutions LLC , Tucker, Georgia .
authors.forename: Elaine
authors.initials: E
authors.lastname: Gunter
authors.affiliation: 10 Cellular Technology Limited , Shaker Heights, Ohio.
authors.forename: Iren
authors.initials: I
authors.lastname: Koppandi
authors.affiliation: 11 Precision Bioservices , Frederick, Maryland.
authors.forename: Katheryn
authors.initials: K
authors.lastname: Shea
authors.affiliation: 12 GlobalMD Network Corporation , Catonsville, Maryland.
authors.forename: Tim
authors.initials: T
authors.lastname: Shi
authors.affiliation: 13 PPD Vaccines and Biologics Lab , Wayne, Pennsylvania.
authors.forename: Julie A
authors.initials: JA
authors.lastname: Stein
authors.affiliation: 14 American Society for Investigative Pathology , Bethesda, Maryland.
authors.forename: Mark E
authors.initials: ME
authors.lastname: Sobel
authors.affiliation: 15 Karolinska Institutet Biobank , Stockholm, Sweden .
authors.forename: Gunnel
authors.initials: G
authors.lastname: Tybring
authors.affiliation: 16 Molecular Immunology Unit, Institut Jules Bordet , Brussels, Belgium .|17 Pathobiology Group , EORTC, Brussels, Belgium .
authors.forename: Gert
authors.initials: G
authors.lastname: Van den Eynden
authors.affiliation: 1 Integrated Biobank of Luxembourg , Luxembourg, Luxembourg .
authors.forename: Fay
authors.initials: F
authors.lastname: Betsou
mesh_terms: D000068:Accreditation; D018070:Biological Specimen Banks / Q000458:organization & administration* / Q000592:standards; D006801:Humans; D011786:Quality Control; D013048:Specimen Handling / Q000592:standards*
keywords: accreditation; external quality assessment; method comparison; performance assessment; quality control