Essentials of Tissue Banking

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Edinburgh,Scotland GeorgeGalea Contents Part I Management of 1 Live Donors of Tissue . . . . . . . . . . . . . . . . . . . . . . . . . 3 RuthWarwick 2 Deceased Donors of Tissue. . . . . . . . . . . . . . . . . . . . . . . 23 AuroraNavarro 3 Banking of Cord Blood. . . . . . . . . . . . . . . . . . . . . . . . . 41 ElianeGluckman 4 Banking of Corneas. . . . . . . . . . . . . . . . . . . . . . . . . . . 59 W. JohnArmitage 5 Banking of Heart Valves. . . . . . . . . . . . . . . . . . . . . . . . 69 RobertParker 6 Banking of Skin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 EllenHeck Part II Principles of 7 Storage, Processing and Preservation. . . . . . . . . . . . . . . . . 95 JohnN. Kearney 8 Cryopreservation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 DavidPegg 9 Sterilisation by Irradiation . . . . . . . . . . . . . . . . . . . . . . 123 ArturKaminski,IzabelaUhrynowska-Tyszkiewicz, andWaclawStachowicz Part III Ensuring Safety by 10 Testing the Donor. . . . . . . . . . . . . . . . . . . . . . . . . . . . 141 AlanKitchenandJohnBarbara 11 Testing the Tissue and the Environment . . . . . . . . . . . . . . . 167 TedEastlundandMartellK. Winters vii viii Contents Part IV Ensuring Quality by 12 Establishing a Quality System. . . . . . . . . . . . . . . . . . . . . 191 ScottA. Brubaker 13 IT System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217 LindaLodge Part V Legal and Ethical Environment 14 Regulatory and Ethical Issues. . . . . . . . . . . . . . . . . . . . . 231 DavidPegg Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243 Contributors W. John Armitage CTSBristolEyeBank,UniversityofBristol,BristolEye Hospital,BristolBS12LX,UK,w. j. armitage@bristol. ac. uk John Barbara NHSBloodandTransplant,ColindaleAvenue,London NW95BG,UK,Marina. mobed@nhsbt. nhs. uk Scott A. Brubaker AmericanAssociationofTissueBanks,McLean,VA22101, USA,brubakers@aatb. org Ted Eastlund DepartmentofPathology,UniversityofNewMexicoSchool ofMedicine,Albuquerque,NM87131,USA,deastlund@salud. unm. edu Eliane Gluckman Eurocord,HematologyDepartment,APHPUniversityParis VII,Paris,France,eliane. gluckman@sls. aphp. Preface Contents Contributors Part I Management of 1 Live Donors of Tissue The Process of Making a Living Donation Circumstances of Living Donation: How Are Tissues from Live Donors Obtained? Femoral Head Donation Amniotic Membrane Donation Limbal Stem Cell Donation Cord Blood Donation Donor Selection: Evidence Base and General Considerations Exclusion of Living Donors of Bone Other Examples of Selection of Living Tissue Donors to Reduce Risk of Disease Transmission Males Who Have Had Sex with Males (MSM) Selection of Cord Blood Donors Microbiological Screening of the Mother and Cord HIV and Hepatitis B and C Other Types of Potential Disease Transmission by Cord Blood Genetic Disease Travel History Bacterial Risk References 2 Deceased Donors of Tissue Introduction Tissue Donor Detection Tissue Donor Selection and Evaluation Review Donor's Medical History General Donor Exclusion Criteria Tissue Absolute Contraindication and Age Criteria Heart Valves Vascular Skin Musculoskeletal Eye Tissues Family Consent Details and Donor's Social History Donor's Physical Examination Blood Sample Collection Biopsy/Autopsy Results Conclusion References 3 Banking of Cord Blood Introduction Cord Blood Collection and Banking Cord Blood Banks Development Unrelated Cord Blood Banks Sibling Donor Cord Blood Banks Autologous Cord Blood Banks Netcord Organization: Standards and Guidelines Description of Existing Guidelines Practical Aspects of Cord Blood Banking Informed Consent Collection Techniques Infectious Disease Testing Genetic Disease Testing HLA Typing Cell Processing Cryopreservation and Storage Ethical and Legal Aspects Clinical Experience with Related and Unrelated Umbilical Cord Blood Transplantation Clinical Results of Cord Blood Transplantation from Eurocord Registry Influence of Cell Dose and HLA on Transplantation Outcome Conclusion References 4 Banking of Corneas Eye Donation Corneal Transplantation Corneal Storage Hypothermia Organ Culture Limbal Stem Cells References 5 Banking of Heart Valves Introduction Selection Criteria Processing and Disinfection of Heart Valves Quality Assurance of Heart Valves Current Issues in Heart Valve Banking Viability and Storage Endothelial Cells Morphology of the Valves Mechanical Properties of Valves Conclusions References 6 Banking of Skin Acquisition Retrieval Preservation and Storage Conclusions References Part II Principles of 7 Storage, Processing and Preservation Introduction Tissue Replacement Autologous Versus Allogeneic Grafts Immunological Reponses to Tissue Allografts Principles of Tissue Preservation Preservation of Non Viable Tissue Grafts Causes of Degradation Reduction of Water Activity Cell Removal Preservation of Viable Tissue Grafts Principles of Disinfection and Sterilisation Definitions Disinfection Methods Viable Tissues Non-viable Tissues Sterilisation Methods Physical Methods Chemical Methods References 8 Cryopreservation Introduction Tissues that Do Not Require Living Cells for Effectiveness Tissues that May Not Require Living Cells Tissues that Do Require Living Cells Cryopreservation Cryopreservation of Multicellular Systems Cryopreservation by Vitrification Conclusions References 9 Sterilisation by Irradiation Introduction Specificity of Radiation Sterilisation with Gamma Rays and Electron Beams Dosimetry for Radiation Sterilisation Mechanisms Involved in the Inactivation of Micro-Organisms by Ionising Radiation Radiation Resistance of Micro-Organisms Factors Affecting the Effectiveness of Radiation Sterilisation and the Sensitivity of Micro-Organisms to Irradiation References Part III Ensuring Safety by 10 Testing the Donor Introduction Range of Infectious Agents Mandatory Screening Discretionary Screening Other Screening Severe Acute Respiratory Syndrome (SARS) Chikungunya Lymphochoriomeningitis Virus (LCMV) Leishmania Screening Strategy Sample Quality Samples from Living Tissue Donors Samples from Cadaveric (Non Heart-Beating) Donors Screening Serological Screening Molecular Screening Residual Risk Window Period Conclusions References 11 Testing the Tissue and the Environment Introduction Microbal Testing of Tissues Recovered Prior to Processing Testing Tissue from Deceased Donors Testing of Tissue from Living Donors Postmortem Blood Cultures Environmental Monitoring of Cleanrooms Used for Tissue Processing Cleanroom Classification Sampling of Cleanroom Air for Viable Particulates Passive Air Sampling: Settling Plates Active Air Sampling Sampling of Cleanroom Surfaces for Microbes: Contact Plates Sampling of Cleanroom Surfaces for Microbes: Swabbing Sampling Locations Sampling Timing Trend Analysis and Action Levels Final Microbial Testing of Allografts After Processing Final Allograft Testing Sampling Methods -- Swab Sampling Swab Efficiency Validation Sampling Methods -- Whole Allograft Immersion and Extraction (Bioburden Testing) Sampling Methods -- Destructive Testing Bacteriostasis/Fungistasis (B/F) Testing Final Testing of Sterilized Allografts Process Validation and Sterility Assurance Process Control Testing In Lieu Of Final Tissue Testing Microbial Testing of the Tissue Allograft Immediately Prior to Implantation Summary References Part IV Ensuring Quality by 12 Establishing a Quality System Quality Tools A Sequential, Historical Perspective -- Standards and Regulations Significant Quality Projects Practical Applications of QMS and QC for Tissue Establishments General Quality Management Responsibilities Considerations for a Tissue Establishment's QMS Examples of Third-Party Agreements (Written Contracts or Other Arrangements) Tissue Establishment Functions or Practices That Could Be QC'ed (Written Procedures Required for All Functions) Examples of Tissue Establishment QC Programs Measuring Assurance and Expectations Determining Critical Points of Tissue or Cell Processing Future Considerations Conclusion A Note from the Author References 13 IT System What Are the Operational Requirements? Why Use an IT System? The Benefits of an IT System Developing the Operational Requirements Document (ORD) Technology Solutions Barcodes Linear Bar Codes 2-Dimensional Bar Codes Radio Frequency Identification (RFID) Electronic Data Interchange (EDI) Database Management Technology Selecting an IT System Cost of an IT System Implementing an IT System Money and People Physical Implementation System Validation User Training Managing an IT System Conclusions References Part V Legal and Ethical Environment 14 Regulatory and Ethical Issues Introduction Ethical Uses of Human Tissues: Transplantation and Transfusion The Crucial Nature of Consent The Question of Ownership Living donors Consent to Donation Consent to Use Consent to the Consequences of Donation Withdrawal of Consent Deceased Donors Disposal of Tissue Obtained from Deceased Donors The Passage of Information Between Recipient and Donor The Law Presumed Consent References Index Tissue banking is undergoing a paradigm shift. There are now a plethora of guidance and regulatory documents, in response to recent regulation. There is however, relatively little information on the scientific and technical principles on routine tissue banking practices. The information that exists is relatively old and in somewhat obscure journals. This book attempts to provide a coherent and up to date approach. Each author, who is a recognized expert in their field, was asked to illustrate the processes involved in modern tissue banking practices. Where these are based on evidence and science, they were asked to explain this in a clear and concise manner. Where evidence it is not available, the authors were asked to provide the reasons why they believe practices have developed the way they have. This could range from the precautionary principle, custom and practice, common sense approach etc. This book has been split into 5 sections: Management of donors and the banking of common tissues and cells, principles of storage and processing of tissues, ensuring safety of the products by testing the donor, the tissue and the environment, ensuring quality of the products by establishing a quality system and an IT infrastructure and the Regulatory and ethical environment in which we operate. Although it is possible to bank all types of cells, including stem cells, these are not covered in this book. The organisation and target audiences for stem cells are quite different from those of tissues. Cord blood banking, on the other hand is very similar and they have therefore been included. The intention of this book is to cover the basis of current practices, rather than future developments, such as embryonic cell developments, tissue engineering and gene therapy. These are more akin to cellular therapies. Although they share many banking similarities to tissues, their inclusion in this book would have made it too cumbersome. With the very recent (2005/6) introduction of the European Directive on cell and tissue banking, a paradigm shift is taking in raising standards on all aspects of tissue banking from procurement to processing, from storage to clinical usage. A number of monographs have appeared giving guidance on GMP and quality systems that should be adhered to. There are also good guidelines on the significance of the new regulations that have been enacted. However, there is a significant lack of information on the scientific basis and rationale on why tissue banking practices have developed the way they hav This book provides a coherent and up-to-date review of the scientific and technical principles in routine tissue banking practices, incorporating a plethora of new guidance and regulatory documents produced in response to recent regulation.