Quality and accreditation in Cellular Therapy

Abstract

Quality in a Health System  as we know it today can trace its origins back to the early twentieth century, when a number of measures were taken to address great variations in medical education and care. The complexity of haematopoietic cell transplantation (HCT) as a medical technology and the frequent need for close interaction and interdependence between different services, teams and external providers (donor registries, typing laboratories, etc.) distinguish it from many other medical fields.

The implementation of a Quality Management program with its components including quality control, quality assurance, quality assessment and quality improvement advances the quality of service provided for patients and helps programs to address external threats and internal weaknesses, which could negatively impact services and products. In HCT, different stakeholders have been identifed as holding an interest in ensuring that patients receive quality care: patients and their families, referring physicians, payers, other community healthcare providers, commercial suppliers, regulatory authorities, insurance payers and professional and patient organizations. Evidence does exist for HCT, where studies using European HCT registry data have correlated the different phases of preparation for and achievement of accreditation at centre level with incremental improvements in patient survival and reduction in procedural mortality. It also proves the level of commitment to high-quality measures and monitoring cellular therapy practice and patient care. 

This Manual chapter will deepen the theme of quality in cell therapy, as discussed in the Consensus 2021 of SBTMO, in order to stimulate the development of quality in the centers, as well as to give a north in the proper deployments. We will briefly go through all the steps of the implementation of quality in a Stem Cell and Cell Therapy Center