Quality Management Sessions - Tuesday, March 22, 08:00 - 15:30 CET
QM1 Center's Session - Tuesday, March 22, 09:00 - 10:15 CET, Virtual Hall 6
In the session QM1-02, basic quality management concepts will be covered by Quality Manager Songül Tepebaşı, Baskent University School of Medicine, Adana Adult BMT Center, Ankara, Turkey.
She will discuss that haematopoietic stem cell transplantation and cellular therapies are very complex clinical procedures. “The published data demonstrates a promising improvement in the clinical outcomes related to the quality management system,” explains Songül. “The four main components of quality management include quality planning, quality control, quality assurance, and quality improvement.”
In her talk, Songül will cover each of these themes in turn. For quality planning, the goals and the baseline standards need to be identified first. The quality standards, the requirements necessary to meet these standards, and the methods required for assessing the execution of these standards should be determined thereafter.
For quality control, she explains this is the process of physically inspecting and testing what is laid out in the planning stage in order to make sure it is achievable. For quality assurance, this involves processes to prevent errors in the future, while quality improvement incorporates the process of continuous improvement and must contain regular cycles of planning, execution and evaluation.
Songül concludes: “Quality components are useless if you are not willing to make changes when they are necessary. So, collect all your data, re-evaluate the processes, always keep compliance in mind and then begin the process again. With each cycle, you will end up with better services, and happier patients and donors.”
The talk by Songül will be followed by one by her colleague at the same institution, Professor Ilknur Kozanoglu, who will discuss labelling and traceability. “The concept of traceability is that a product or service can be traced backwards in terms of management systems,” explains Prof Kozanoglu, who is Professor in Physiology and Head of the Hematology Laboratory. “Traceability in healthcare services will contribute to ensuring that the service will be accurate, of good quality, and controlled in every sense.”
The main controller of traceability is the quality management system that controls all steps of the service system, including itself. The minimum requirements for coding, processing, protection, storage and distribution of the product related to human tissue and cell transplantation, as well as traceability requirements and notification of undesirable adverse effects and incidents, are defined by directives 2006/86 / EC of the European Parliament and Council of 24 October 2006.
In recent years, many new treatment modalities, especially chimeric antigen receptors, virus-specific T lymphocytes, natural killer cell and T regulatory cell therapies, have been put into practice. “All stages, including the collection of cellular products from the patient or donor to their transport, and the long-term follow-up of the patient and the donor, must be planned and regulated in accordance with internationally accepted standards,” concludes Prof Kozanoglu. “In fact, it will be possible to make many processes that are extremely complex and sometimes unrelated to each other simpler, but only by providing traceability criteria. In short, traceability is the final form of a great ‘puzzle’ that has been meticulously and carefully put together and tabulated.”
References
1. Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.
2. International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, And Administration Accreditation Manual Book Version 8.0 May 2021.
3. Boga C, Maytalman E, Gereklioglu C, Asma S, Kandemir F, Aytan P, Korur A, Yeral M, Kozanoglu I, Özdogu H. Implementation of an ISBT 128 Compatible medical records system to facilitate traceability of stem cell products. Turk J Haematol. 2017 Aug 2;34(3):280-281.
4. Slaper-Cortenbach I. ISBT 128 coding and labelling for cellular therapy products. Cell Tissue Bank 2010 Nov: 11(4): 375-8
5. Ashford P, Distler P, Gee A, Lankester A, Larsson S, Feller I, Loper K, Pamphilon D, Poston L, Rabe F, Slaper-Cortenbach I, Szczepiorkowski Z, Warkentin P. ISBT 128 implementation plans for cellular therapy products.; International Cellular Therapy Coding and Labeling Advisory Group. J Clin Apher. 2007; 22 (5): 258-64.