Essentials of Tissue Banking

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