Abstract
This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.
Highlights
For over 20 years, transplant professionals all over the world have been working with the FACT-Joint Accreditation Committee of International Society for Cell and Gene Therapy (ISCT) and European Society for Blood and Marrow Transplantation (EBMT) (JACIE) Standards for haematopoietic stem cellular (HSC) therapy as a means to improve the care and services provided to their patients and donors and as a framework within which to pursue continuous improvement
Example 1 Types of incident reported Category Medication errors ABO incompatible blood products Malfunction/misuse of equipment Contaminated drugs, devices or products provided by facilities Labelling of products Samples missing or delivered to wrong laboratory Results not provided in adequate time Signing of drug charts Verification of cytotoxic drugs Bag damage during thawing of cellular product Deviations from policy or procedure if unplanned Severe reaction during infusion of cellular product Transport issues Product found to have positive microbial culture Failed engraftment
We present a case whereby a product from an unrelated donor was potentially contaminated due to infection of the donor with a tropical disease
Summary
For over 20 years, transplant professionals all over the world have been working with the FACT-JACIE Standards for haematopoietic stem cellular (HSC) therapy as a means to improve the care and services provided to their patients and donors and as a framework within which to pursue continuous improvement. The ongoing evolution of the standards over the years demands that quality management systems can adapt to new needs and requirements, not just for accreditation and to meet changing regulations and best practice This handbook aims to be a professional resource on how to approach those challenges faced by many transplant programmes worldwide. Implementing a quality management system and achieving accreditation in the field of cellular therapy by a transplant centre prove the level of commitment to high-quality measures and monitoring cellular therapy practice and downstream patient care This provides reassurance to patients and their families, healthcare professionals, commercial suppliers, regulatory authorities and insurance payers. Braithwaite et al propose the need for a new generation of standards that do not just assess compliance and enable healthcare system transformation and sustainability [16]
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