Tissue and Cell DonationAN ESSENTIAL GUIDE

EDITED BY

Ruth M. Warwick, MB, ChB, FRCP, FRCPathConsultant Specialist for Tissue Services, NHSBTTissue ServicesEdgware, Middlesex, UK

Deirdre Fehily, PhDInspector and Technical Consultant, Tissues and CellsNational Transplant CentreRome, Italy

Scott A. Brubaker, CTBSChief Policy Offi cer, American Association of Tissue BanksMcLean, Virginia, USA

Ted Eastlund, MDAssociate Medical DirectorLifeNet HealthVirginia Beach, Virginia, USA

A John Wiley & Sons, Ltd., Publication

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Tissue and Cell Donation

Tissue and Cell DonationAN ESSENTIAL GUIDE

EDITED BY

Ruth M. Warwick, MB, ChB, FRCP, FRCPathConsultant Specialist for Tissue Services, NHSBTTissue ServicesEdgware, Middlesex, UK

Deirdre Fehily, PhDInspector and Technical Consultant, Tissues and CellsNational Transplant CentreRome, Italy

Scott A. Brubaker, CTBSChief Policy Offi cer, American Association of Tissue BanksMcLean, Virginia, USA

Ted Eastlund, MDAssociate Medical DirectorLifeNet HealthVirginia Beach, Virginia, USA

A John Wiley & Sons, Ltd., Publication

This edition fi rst published 2009, © 2009 by Blackwell Publishing Ltd

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Library of Congress Cataloging-in-Publication DataTissue and cell donation : an essential guide / edited by Ruth M. Warwick . . . [et al.]. p. ; cm. Includes bibliographical references. ISBN 978-1-4051-6322-4 1. Tissue banks–Social aspects. 2. Human cell culture–Social aspects. I. Warwick, Ruth M. II. Title. [DNLM: 1. Tissue and Organ Procurement–ethics. 2. Tissue and Organ Procurement–organization & administration. 3. Biological Specimen Banks–ethics. 4. Biological Specimen Banks–organization & administration. WO 660 T6148 2009]

RD127.T568 2009 362.17’83–dc22 2008052029

ISBN: 978-1-4051-6322-4

A catalogue record for this book is available from the British Library.

Set in 9.25 on 12 pt Meridien by SNP Best-set Typesetter Ltd., Hong KongPrinted & bound in Singapore by Fabulous Printers Pte Ltd

1 2009

www.wiley.com/wiley-blackwell

Contents

Contributors, vii

Foreword, xi

Preface, xiii

1 Histories of Tissue Banking, 1Naomi Pfeffer

2 Recruitment for Tissue Donation, 18Martha W. Anderson and Esteve Trias

3 The Donor Family Dimension of Tissue and Cell Donation, 52Robin Cowherd and Jane Pearson

4 Consent, 67Annette Rid and Lisa Dinhofer

5 Gathering Donor History: Ensuring Safe Tissues for Transplant, 98Blanca Miranda, Alessandro Nanni Costa, Jacinto Sánchez-Ibáñez, and Eliana Porta

6 The Role of Testing in Determining Suitability of Donors and Tissues, 116Paolo Grossi and Michael Strong

7 The Management of Donor Test Results, 134Patricia Hewitt, Chris Moore, and David M. Smith

8 Case Studies from Diverse Cultural, Religious, and Economic Situations, 148Aziz Nather, Li Baoxing, Muhammed Cassim, Hamid Reza Aghayan, Arieh Eldad, and Ján Koller

v

9 Facilitating Donation – The Role of Key Stakeholders: The Medical Examiner, the Coroner, the Hospital Pathologist, and the Funeral Director, 160Charles V. Wetli, Diego Ponzin, Christopher Womack, and George McCann

10 Staff Development and Support in Roles Associated with Deceased Donation, 179Riva Miller and Pamela Albert

11 Ethical Issues in Unrelated Cord Blood and Bone Marrow Donation, 198Sally Gordon, Dorothy E. Vawter, and Jeremy Chapman

12 Ethical and Consent Issues in the Reproductive Setting: The Case of Egg, Sperm, and Embryo Donation, 222Sarah Franklin and Sharon R. Kaufman

13 Clinical Governance in Cell and Tissue Banking, 243Elaine Swanson, William Randell, and Danielle B. Freedman

Index, 264

vi Contents

Hamid Reza Aghayan, MDManaging Director, Iranian Tissue BankTehran University of Medical SciencesTehran, Iran

Pamela Albert, RN, BSN, CPTCDirector, Donor Family ServicesNew England Organ BankNewton, Massachusetts, USA

Martha W. Anderson, BAExecutive Vice President, Donor ServicesMusculoskeletal Transplant FoundationEdison, New Jersey, USA

Li BaoxingShanxi Provincial Tissue BankTaiyuan, Shanxi Province, China

Muhammed Cassim, FRCSMedical DirectorSri Lanka Eye Donation SocietyDr Hudson Silva Eye Donation HeadquartersColombo, Sri Lanka

Jeremy Chapman, OAM, MD, MB, BChir, FRACP, FRCPClinical Professor and University of Sydney DirectorAcute Interventional MedicineWestmead HospitalWestmead, New South Wales, Australia

Alessandro Nanni Costa, MDDirectorItalian National Transplant CentreRome, Italy

Contributors

vii

viii Contributors

Robin Cowherd, CT, MPA, BADirector, Donor Family ServicesLifeNet HealthVirginia Beach, Virginia, USA

Lisa Dinhofer, MA, CT, CTBSKoDen, LLCTM, ConsultantHood College, Adjunct, Frederick, Maryland, USA

Arieh Eldad, MDProfessor of Plastic Surgery (Retired)Hebrew University School of MedicineJerusalem, Israel

Sarah Franklin, MA, PhDProfessor of Social Studies of BiomedicineLondon School of Economics and Political ScienceLondon, UK

Danielle B. Freedman, MB, BS, FRCPathMedical DirectorLuton & Dunstable Hospital NHS Foundation TrustLuton, UK

Sally Gordon, RN, BANational Executive Offi cerAustralian Bone Marrow Donor RegistrySydney, New South Wales, Australia

Paolo Grossi, MD, PhDProfessor of Infectious DiseasesUniversity of Insubria, Varese, Italy;Infectious Disease Expert Advisor to the Italian National Transplant CentreRome, Italy

Patricia Hewitt, MB, ChB, FRCP, FRCPathNBS Consultant Specialist in Transfusion MicrobiologyNHS Blood and TransplantLondon, UK

Sharon R. Kaufman, PhDProfessor, Medical AnthropologyDepartment of Anthropology, History and Social MedicineDepartment of Social and Behavioral SciencesUniversity of CaliforniaSan Francisco, California, USA

Ján Koller, MDAssociate Professor of SurgeryTeaching Department of Burns and Reconstructive SurgeryUniversity Hospital Bratislava, Ruzinov HospitalBratislava, Slovakia

Contributors ix

George McCann, MD, CTBSLicensed Embalmer and Funeral DirectorEducation DirectorMusculoskeletal Transplant Foundation (MTF)Edison, New Jersey, USA

Riva Miller, BASystemic Psychotherapist (individual, couple, and family)Haemophilia Centre Royal Free HospitalLondon, UK;Consultant, National Blood and Tissue ServiceLondon, UK

Blanca Miranda, MD, PhDDirector of Transplant Services Foundation and the Transplant Coordination Unit Hospital ClinicBarcelona, Spain

Chris Moore, BSc, MB, BSAssociate Specialist in Transfusion MicrobiologyNHS Blood and TransplantLondon, UK

Aziz Nather, FRCSAssociate Professor and Senior ConsultantDepartment of Orthopaedic SurgeryYong Loo Lin School of MedicineNational University of Singapore and National University HospitalSingapore

Jane Pearson, RNAssistant Director – NursingNHS Blood and TransplantNBS LeedsBridle PathSeacroft, Leeds, UK

Naomi PfefferProfessor of Social and Historical Studies of MedicineDepartment of Applied Social SciencesLondon Metropolitan UniversityLondon, UK

Diego Ponzin, MDMedical DirectorFondazione Banca degli Occhi del VenetoVenice, Italy

Eliana Porta, MDLead Inspector, Tissues and CellsItalian National Transplant CentreRome, Italy

x Contributors

William Randell, BA(Open), RGNClinical Risk ManagerLuton & Dunstable Hospital NHS Foundation TrustLuton, UK

Annette Rid, MDAssistant ProfessorInstitute of Biomedical Ethics, Centre for EthicsUniversity of ZurichZurich, Switzerland

Jacinto Sánchez-Ibáñez, MDDirector, Regional Transplant Coordination Offi ceGalicia, A Coruña, Spain

David M. Smith, MDMedical Director and Chief Executive Offi cerCommunity Blood Center Community Tissue ServicesDayton, Ohio, USA

Michael Strong, MT(ASCP), PhDFormerlyNorthwest Tissue Center/Puget Sound Blood CenterSeattle, Washington, USA

Elaine Swanson, DCR, BSc(Hons) Health SciencesClinical Quality and NICE Guidance ManagerLuton & Dunstable Hospital NHS Foundation TrustLuton, UK

Esteve Trias, MDMedical DirectorProcessing Facilities, Transplant Services FoundationBarcelona, Spain

Dorothy E. Vawter, PhDAssociate DirectorMinnesota Center for Health Care EthicsSt. Paul, Minnesota, USA

Charles V. Wetli, MDFormerlyChief Medical Examiner and Director of Forensic Sciences (retired)Suffolk County Government, Happauge, New York, USA;Clinical Professor of Pathology (retired)State University of New YorkStony Brook, New York, USA

Christopher Womack, MB, BS, FRCPathPathologistHistologix LtdNottingham, UK

Foreword

Transplantation of human tissues and cells has become increasingly frequent and successful in recent years, not just with respect to the number of implanted grafts but also in the number of therapeutic indications. Each year, all around the world, thousands of patients receive transplants of tissue and cells of human origin. These transplants are made up fi rstly of ‘tradi-tional transplants’, the therapeutic value of which has been recognized for decades (corneas, skin, blood vessels, heart valves, hematopoietic cells, bone marrow, etc.) and secondly of biotechnological advances which are currently undergoing rapid development (cell culture, tissue engineering).

There is a general agreement that the use in medicine of products of human origin demands that the quality and safety of the whole process of tissue and cell donation, procurement, testing, processing, preservation, storage, and distribution be ensured in order to prevent the transmission of diseases. In fact, this has been the focus of the EU Tissue and Cell Directives, now in the implementation phase, and of similar regulations in other parts of the world. However, these kinds of therapies also involve specifi c consid-erations related to the origin of the transplant material: respect for the donor’s consent, anonymity, and non-remuneration for the donor.

As Arthur Caplan testifi ed before the US Congress . . . ’what is truly dis-tinctive about transplantation is not technology or cost, but ethics. This is the only area in medicine which cannot exist without the participation of the public. It is the individual citizen who, while alive, or after death, makes organs and tissues available for transplantation. If there were no gift of organs or tissues, transplantation would come to a grinding halt’. Both aspects – technical quality standards and ethics – are and should always be strictly linked in order to assure a solid foundation for a transplant system and the best opportunities and results for the patients.

xi

This book is the fi rst comprehensive text that focuses on the donation-related aspects of tissue and cell banking and transplantation. That is prob-ably its main value and what makes it attractive. In a fi eld that is changing so rapidly, it is really diffi cult to fi nd all the necessary up to date information written by a selected global group of experts from fi ve continents presented in a very didactic way. I am sure that this volume will be really useful in meeting the training needs of professionals working in the fi eld of human tissue and cell donation.

My sincere congratulations to the editors for this important initiative, and to all the authors for a job well done for the benefi t of many patients.

Rafael Matesanz, MD, PhD National Transplant Coordinator Spanish National Transplant Organization (ONT) Madrid, Spain

xii Foreword

Preface

The banking of human tissues and cells has many facets and involves profes-sionals with a wide range of skills and knowledge. They include experts with training in medical, technical, scientifi c, psychological, and communications fi elds. This book focuses on the human dimension – the many aspects of donation in cell and tissue banking. The issues raised are relevant on a global stage. Tissue banks and procurement agencies, and the professionals who work within them, are the guardians of the altruistic gifts that donors and their families have entrusted to them for the benefi t of others, to save and improve lives. The donations range from bone marrow, cord blood, femoral head bone, and amniotic membrane from living donors to many types of tissue from deceased donors including corneas, heart valves, skin, bone, and tendons. These donations have enabled the development of a fi eld of health care that is often scientifi cally and technically sophisticated, which repre-sents a success story for the hundreds of thousands of patients who have regained sight or mobility, had pain alleviated, or even had their lives saved by tissue or cell transplantation. The application of “business management” models and, in some cases, for-profi t processing and supply to hospitals has created an element of commercialism that can sit awkwardly with the donor or the donor family’s motivation.

The primary obligations of the professionals involved are to ensure that donors and their families are well informed and are not coerced, and that donated tissues and cells are distributed fairly, on the basis of clinical prior-ity, are affordable, and are not wasted. Clinical effectiveness and recipient safety must, at the same time, be maximized. In some circumstances, the protection of donor autonomy can confl ict with the public good, creating a tension between the approach that focuses on achieving a free and unfet-tered decision by the donor, as highlighted in Chapter 4, as opposed to the approach that allows for the recipients’ needs to be a signifi cant factor in

xiii