title: Essential requirements for setting up a stem cell processing laboratory.
abstract: The Graft Processing subcommittee of the Worldwide Network for Blood and Marrow Transplantation wrote this guideline to assist physicians and laboratory technologists with the setting up of a cell processing laboratory (CPL) to support a hematopoietic stem cell transplant program, thereby facilitating the start-up of a transplant program in a new location and improving patient access to transplantation worldwide. This guideline describes the minimal essential features of designing such a laboratory and provides a list of equipment and supply needs and staffing recommendations. It describes the typical scope of services that a CPL is expected to perform, including product testing services, and discusses the basic principles behind the most frequent procedures. Quality management (QM) principles specific to a CPL are also discussed. References to additional guidance documents that are available worldwide to assist with QM and regulatory compliance are also provided.
authors.affiliation: Hoxworth Blood Center, University of Cincinnati Academic Health Center, Cincinnati, OH, USA.
authors.forename: T
authors.initials: T
authors.lastname: Leemhuis
authors.affiliation: Human Cellular Therapy Laboratory Mayo Clinic, Rochester, MN, USA.
authors.forename: D
authors.initials: D
authors.lastname: Padley
authors.affiliation: Department of Medicine, Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI, USA.
authors.forename: C
authors.initials: C
authors.lastname: Keever-Taylor
authors.affiliation: Division of Hematology and Medical Oncology, University of Leipzig, Johannisallee 32A, Leipzig, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Niederwieser
authors.affiliation: Department of Hematology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Teshima
authors.affiliation: Section of Hematology & BMT unit, Hospital of Cremona, Cremona, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Lanza
authors.affiliation: Institut Paoli-Calmettes & Inserm CBT-510, Marseilles, France.
authors.forename: C
authors.initials: C
authors.lastname: Chabannon
authors.affiliation: Division of Blood and Marrow Transplantation and Cellular Therapies Children's Hospital of Pittsburgh of UPMC, One Children's Hospital Drive, Pittsburgh, PA, USA.
authors.forename: P
authors.initials: P
authors.lastname: Szabolcs
authors.affiliation: Department of internal Medicine and BMT program, American University of Beirut Medical Center, Beirut, Lebanon.
authors.forename: A
authors.initials: A
authors.lastname: Bazarbachi
authors.affiliation: 1] Stem Cell Transplant Programme, St George's Hospital and Medical School, London, UK [2] Blood Services Group, Health Sciences Authority, Outram Road, Singapore.
authors.forename: M B C
authors.initials: MB
authors.lastname: Koh
mesh_terms: D018380:Hematopoietic Stem Cell Transplantation; D006412:Hematopoietic Stem Cells; D006801:Humans; D007755:Laboratories, Hospital / Q000458:organization & administration* / Q000592:standards*; D017056:Medical Laboratory Personnel / Q000458:organization & administration* / Q000592:standards* / Q000600:supply & distribution; D017410:Practice Guidelines as Topic