Quality Management and Accreditation in Hematopoietic …

1 123 Mahmoud AljurfJohn A. SnowdenPatrick HaydenKim H. OrchardEoin McGrathEditors Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: The JACIE GuideQuality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular TherapyMahmoud Aljurf John A. Snowden Patrick Hayden Kim H. Orchard Eoin McGrathEditorsQuality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular TherapyThe JACIE GuideThis book is an open access 978-3-030-64491-8 ISBN 978-3-030-64492-5 (eBook) The Editor(s) (if applicable) and The Author(s) 2021 Open Access This book is licensed under the terms of the Creative Commons Attribution International License ( ), which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s)

2 And the source, provide a link to the Creative Commons license and indicate if changes were images or other third party material in this book are included in the book s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the book s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication.

3 Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional Springer imprint is published by the registered company Springer Nature Switzerland AGThe registered company address is: Gewerbestrasse 11, 6330 Cham, SwitzerlandEditorsMahmoud AljurfKing Faisal Specialist hospital and Research CentreRiyadh, Saudi ArabiaPatrick HaydenSt. James s HospitalDublin, IrelandEoin McGrathJACIE Accreditation Office EBMTB arcelona, SpainJohn A. SnowdenDepartment of HaematologyUniversity of SheffieldSheffield, UKKim H. OrchardUniversity hospital Southampton NHS FT and University of SouthamptonSouthampton, UKvIntroductionFor 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.

4 The FACT1 and JACIE2 Accreditation schemes stand out for the high take-up among centres not only in high-income countries but also the increasing interest in Quality among transplant professionals in low- to medium-income This success is testimony to the efforts of the community as a ongoing evolution of the standards over the years demands that Quality man-agement systems can adapt to new needs and requirements, not just for accredita-tion but also 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. The intended readers are not only centres at the beginning of their Quality journey but also those centres with the experience of sev-eral Accreditation cycles but with staff assuming new responsibilities for Quality chapters offer different perspectives on approaches to common challenges and the reader is invited to reflect on how to best incorporate and adapt them to the realities of their own institutions.

5 The topics include, among others, good documen-tation practice, internal audits, validation and qualification, outcome analysis, personnel requirements, performance measurement, tracking and traceability, adverse events and CAPAs, maintaining the Quality of Management programme and risk authors are all professionals working in Quality in cellular therapy with a combined wealth of practical the future, JACIE, as part of the EBMT, an international collaborative peer network of professionals working in centres and as individuals in the field of clinical bone marrow transplantation and cellular therapy, intends to issue revisions of this guide and to also assess how to exploit the contents as material for ongoing training and education as part of the EBMT s wider education (Joint Accreditation Committee ISCT & EBMT) is the EBMT commit-tee established for the purposes of assessment and Accreditation in the field of hae-matopoietic stem cell transplantation (HSCT).

6 The Committee was founded in 1998 by the then-European Group for Blood and Marrow Transplantation (EBMT) and European members of the International Society for Cellular Therapy (ISCT). JACIE largely modelled itself on the US-based Foundation for the Accreditation of Cellular Therapy (FACT), established in 1996 by the ISCT and the American Society for Blood and Marrow Transplantation (ASBMT). JACIE continues to actively collabo-rate with FACT on maintaining standards for the provision of Quality medical and laboratory practice in HSCT, and the two organisations jointly publish the FACT- JACIE international Co-editors Kim Orchard Mahmoud Aljurf Patrick Hayden John Snowden Eoin McGrathIntroductionviiContents 1 Quality and Standards for Haematopoietic Stem Cells Transplantation Programs .. 1 Eoin McGrath and Dunia Jawdat 2 Development of Organizational Quality Management System.

7 9 Phuong Huynh and Renza Monteleone 3 Document Development, Implementation, Review, Archive, and Disposal .. 17 Nick van Sinderen 4 Audits .. 25 Olga L pez-Villar and Julie Dolva 5 Qualification and Validation .. 35 Renza Monteleone and Dieter Klarmann 6 Outcome Analysis .. 43 Anne Emmett 7 Personnel Requirements Including Job Descriptions .. 53 Songul Tepebasi and Ilknur Kozanoglu 8 Third-Party Agreements .. 61 Anne Emmett 9 Performance Measurement .. 69 Amal Alseraihy, Waleed Rasheed, and Mahmoud Aljurf 10 Tracking and Traceability .. 83 Lex Van der Gouw 11 Adverse Events and Corrective and Preventive Actions .. 89 Phuong Huynh and Renza Monteleoneviii 12 Process Indicators .. 99 Olga L pez-Villar 13 Writing a Quality Management Plan .. 107 Mara Magri 14 The Accreditation Process.

8 123 Mara Magri and Raquel Espada Mart n 15 Data Management .. 137 Fazal Hussain, Riad El Fakih, and Mahmoud Aljurf 16 Maintaining the Quality Management Program .. 147 Nick van Sinderen 17 Training Programme .. 157 Ilknur Kozanoglu and Songul Tepebasi 18 Risk Management .. 165 Joaquim Vives and Judit Amposta Index .. 177 ContentsixContributorsMahmoud Aljurf Oncology Center, King Faisal Specialist hospital & Research Centre, Riyadh, Kingdom of Saudi ArabiaAmal Alseraihy Department of Pediatric Hematology Oncology, King Faisal Specialist hospital & Research Centre, Riyadh, Kingdom of Saudi ArabiaJudit Amposta Freelance Quality Consultant, Matar , Barcelona, SpainJulie Dolva Hematology Department, Oslo University hospital , Oslo, NorwayRiad El Fakih Oncology Center, King Faisal Specialist hospital & Research Centre, Riyadh, Kingdom of Saudi ArabiaAnne Emmett BMT, Blood, Cells and Cancer, great Ormond Street hospital for children NHS Foundation Trust, London, UKFazal Hussain College of Medicine, Alfaisal University, Riyadh, Saudi ArabiaPhuong Huynh Hematology Service, Institut Jules Bordet, Brussels, BelgiumSPF Securit sociale DG-HAN, Brussels.

9 BelgiumDunia Jawdat Cord Blood Bank, Saudi Stem Cell Donor Registry, King Abdullah International Medical Research Center, Riyadh, Saudi ArabiaDepartment of Science, College of Science and Health Professions, King Saud bin Abdulaziz University for Health Sciences, Ministry of National Guard Health Affairs, Riyadh, Saudi ArabiaDieter Klarmann Klinik f r Kinder- und Jugendmedizin, Universit tsklinikum Frankfurt, Goethe-Universit t, Frankfurt am Main, GermanyIlknur Kozanoglu Department of Physiology, Baskent University Medical Faculty, Ankara, TurkeyAdana Adult Bone Marrow Transplantation Centre, University of Baskent, Adana, TurkeyxMara Magri Hematology & BM Transplant Unit, ASST Papa Giovanni XXIII, Bergamo, ItalyRaquel Espada Mart n JACIE Accreditation Office, EBMT, Barcelona, SpainEoin McGrath JACIE Accreditation Office, EBMT, Barcelona, SpainRenza Monteleone Transfusion Service-Stem Cell Transplant Program, Grande Ospedale Metropolitano Bianchi Melacrino Morelli , Reggio Calabria, ItalyWaleed Rasheed Oncology Center, King Faisal Specialist hospital & Research Centre, Riyadh, Kingdom of Saudi ArabiaSongul Tepebasi Department of Quality Management , Adana Adult Bone Marrow Transplantation Centre, Adana, TurkeyLex Van der Gouw Cell Therapy Facility (CTF)

10 , University Medical Center Utrecht, Utrecht, The NetherlandsNick van Sinderen Cellular Therapy, Antoni van Leeuwenhoek, National Cancer Institute, Amsterdam, The NetherlandsOlga L pez-Villar Hematology and Hemotherapy Department, University hospital of Salamanca, Salamanca, SpainJoaquim Vives Servei de Ter pia Cel lular, Banc de Sang i Teixits, Edifici Dr. Frederic Duran i Jord , Barcelona, SpainMusculoskeletal Tissue Engineering Group, Vall d Hebron Research Institute (VHIR), Universitat Aut noma de Barcelona, Barcelona, SpainDepartament de Medicina, Universitat Aut noma de Barcelona, Barcelona, SpainContributors1 The Author(s) 2021M. Aljurf et al. (eds.), Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy, 1 Quality and Standards for Haematopoietic Stem Cells Transplantation ProgramsEoin McGrath and Dunia Jawdat QualityThe word Quality emerged in the fourteenth century from the Latin qualis and the French qualitie [1].