Practical implementation – Essential elements resource tool

摘要

Hematopoietic stem cell transplantation (HSCT) is an established treatment for patients with severe congenital or acquired hemato-/oncological disorders. Despite major improvements, HSCT remains associated with substantial morbidity and mortality. Implementation of a quality management system has become standard practice not only for industries when their products or services are associated with significant risks to human safety but also in the healthcare sector. The use of a quality management system contributes to better products and services and improved patient’s outcome after medical interventions. Members of the Alliance for Harmonization of Cellular Therapy Accreditation prepared the document Essential Elements , which is intended to serve as a guide for establishing a quality program for new or developing HSCT programs. It is intended for use as a resource and does not contain the full requirements of all standards but seeks to provide clear examples of compliance to support basic quality system elements. The content is based on common elements found in already existing standards with a major focus on the establishment of a quality program that applies to the entire transplant program. Essential Elements is structured as an explanation helping to understand the intent of the element giving guidance what is needed, and examples showing how the element applies. Centers seeking accreditation are subjected to a detailed document review, on-site inspection and follow-up procedure. In conclusion, new and developing stem cell transplantation programs should focus on quality and safety and step on the path towards full accreditation. The HSCT community must continue its efforts to offer education and training to support developing programs to attain accreditation.