학술논문

Essential requirements for setting up a stem cell processing laboratory.
Document Type
Article
Source
Bone Marrow Transplantation. Aug2014, Vol. 49 Issue 8, p1098-1105. 8p.
Subject
*HEMATOPOIETIC stem cell transplantation
*LABORATORIES
*BONE marrow transplantation
*TECHNOLOGISTS
*COMMERCIAL product testing
*TOTAL quality management
Language
ISSN
0268-3369
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. [ABSTRACT FROM AUTHOR]