Appendix K Best Practices for Repositories International Society for Biological and Environmental Repositories These Best Practices are reviewed periodically and revised to incorporate improved application and research findings that would affect repository work. The reader is referred to the International Society for Biological and Environmental Repositories (ISBER) Web site (www.isber.org) for the most current guidelines. INTRODUCTION The desire to preserve biological and environmental specimens for research purposes and to ensure species biodiversity requires the development of methods for long-term storage that will enable their effective future use. Sharing successful strategies for accomplishing this goal was one of the early driving forces for ISBER. In addition, ISBER fosters education and research and promotes quality and safety in all activities relating to specimen collection, storage, and dissemination. ISBER’s Best Practices for Repositories (Best Practices) reflect the collective experience of its members to provide repository professionals with a comprehensive foundation for the guidance of repository activities. These practices reflect input from individuals within and outside of ad hoc committees. Best Practices will be reviewed periodically and will be revised to reflect advances in research and technology. All revisions are subject to approval by the ISBER Board of Directors. These practices reflect the most effective approaches to the establishment and running of specimen collection facilities and are not intended as required practices. TABLE OF CONTENTS SECTION A: GENERAL INFORMATION A1.000 ADHERENCE TO ISBER BEST PRACTICES A2.000 DEFINITION OF TERMS   SECTION B: GENERAL ORGANIZATIONAL REQUIREMENTS OF A REPOSITORY B1.000 GENERAL INSTITUTIONAL REQUIREMENTS     B1.100 Institutional Identity and Affiliations     B1.200 Contracted Laboratory Services B2.000 FUNCTIONAL COMPONENTS OF A REPOSITORY     B2.100 Director     B2.200 Technical Staff   SECTION C: RECORDS MANAGEMENT C1.000 GENERAL     C1.100 Availability for Inspection     C1.200 Record Retention     C1.300 Security     C1.400 Archival System     C1.500 Corrections and/or Changes   SECTION D: FACILITIES D1.000 GENERAL D2.000 HEATING, VENTILATION, AND AIR CONDITIONING     D2.100 Temperature     D2.200 Air Flow and Circulation D3.000 LIGHTING     D3.100 General Lighting     D3.200 Task Lighting D4.000 SECURITY SYSTEMS     D4.100 General     D4.200 Fire     D4.300 Access D5.000 BACKUP POWER     D5.100 Uninterruptable Power Supplies     D5.200 Generators   SECTION E: OPERATIONS E1.000 STANDARD OPERATING PROCEDURES (SOPs) MANUAL     E1.100 Purpose and Design     E1.200 Contents     E1.300 Implementation     E1.400 Modifications     E1.500 Review     E1.600 Staff Access and Review E2.000 FREEZER AND REFRIGERATOR MONITORING E3.000 INVENTORY VERIFICATION E3.000 EMERGENCY PREPAREDNESS E3.000 STORAGE ENVIRONMENTS     E3.100 Backup Storage Capacity     E3.200 Cryogenic Freezers     E3.300 Mechanical Freezers     E3.400 Refrigerators     E3.500 Safety Features for Walk-in Freezers and Refrigerators     E3.600 General Use of Dry Ice E4.000 MAINTENANCE     E4.100 General     E4.200 Calibration     E4.300 Validation   SECTION F: QUALITY ASSURANCE AND QUALITY CONTROL F1.000 DEFINITIONS     F1.100 Quality Assurance     F1.200 Quality Control F2.000 QUALITY MANAGEMENT PLAN     F2.100 Staff Responsibilities     F2.200 Quality Standards     F2.300 Audits   SECTION G: SAFETY G1.000 GENERAL G2.000 REGULATIONS G3.000 CONSIDERATIONS G4.000 SAFETY INFRASTRUCTURE G5.000 TRAINING G6.000 SPECIFIC AREAS OF CONCERN     G6.100 Biological Safety     G6.200 Chemical Safety     G6.300 Electrical Safety     G6.400 Fire Safety     G6.500 Physical Safety     G6.600 Radiologic Safety G7.000 KEY STEPS IN DEVELOPING A BIOSAFETY PROGRAM G8.000 MANDATED ELEMENTS OF A CHEMICAL HYGIENE PLAN     G8.100 Safety and Health SOPs   SECTION H: TRAINING H1.000 GENERAL H2.000 TRAINING INFRASTRUCTURE     H2.100 Training Program     H2.200 Administrator Responsible for Training     H2.300 Trainers     H2.400 Training Documentation     H2.600 Cross-training     H2.700 Training Records   SECTION I: SPECIMEN TRACKING I1.000 GENERAL I2.000 LABELS     I2.100 Barcoding     I2.200 Labels for Human Specimens     I2.300 Labels for Animal Specimens, Specimens from in Vitro Models of Human Diseases, and Environmental Specimens I3.000 INVENTORY SYSTEMS     I3.100 Specimen Location     I3.200 Other Specimen Descriptors     I3.300 Additional Information for Human Tissues     I3.400 Additional Information for Environmental Specimens     I3.500 Validation I4.000 SHIPPING LOG   SECTION J: PACKAGING AND SHIPPING J1.000 GENERAL J2.000 TRANSPORT SPECIFICATIONS     J2.100 Regulatory Requirements     J2.200 Temperature Requirements     J2.300 Humidity Requirements     J2.400 Light Sensitivity Requirements     J2.500 Arrival Time Requirements     J2.600 Sample Quantities J3.000 VALIDATION OF SHIPPING CONDITIONS     J3.100 Review of Packaging Test Report     J3.200 Validation of Packaging     J3.300 Test Shipments     J3.400 International Shipments J4.000 TRACKING SHIPMENTS DURING TRANSPORT     J4.100 General     J4.200 Notification of Shipment     J4.300 Shipping Manifest     J4.400 Confirmation of Receipt   SECTION K: SPECIMEN COLLECTION, PROCESSING, AND RETRIEVAL K1.000 GENERAL     K1.100 Pilot Studies and Proof of Performance Studies K2.000 SPECIMEN TYPES     K2.100 Human Specimens K3.000 COLLECTION PROCEDURES     K3.100 Special Considerations for All Specimen Collection Protocols     K3.200 Blood     K3.300 Urine     K3.500 Tissues     K3.600 Nail Clippings     K3.700 Saliva     K3.800 Breast Milk K5.000 ALIQUOTING FROZEN SPECIMENS     K5.100 Plasma, Serum, and Urine K6.000 SPECIMEN RETRIEVAL     K6.100 Locating Specimens in Storage     K6.200 Specimen Retrieval     K6.300 Documentation of Retrieval     K6.400 Special Safety Considerations   SECTION L: HUMAN SUBJECTS L1.000 BACKGROUND L2.000 APPLICABLE REGULATIONS L3.000 UNRESOLVED ISSUES     L3.100 Need for Harmonization   APPENDIX A: SPECIMEN COLLECTION AND PROCESSING PROTOCOLS AND REFERENCES A. COLLECTING BUCCAL CELLS B. PROCESSING BUCCAL CELLS C. PREPARATION OF SERUM AND CLOTS FROM RED TOP VACUTAINERS D. CRYOPRESERVATION OF WHOLE BLOOD E. COLLECTION OF FECAL MATERIAL F. PREPARATION OF PLASMA, BUFFY COAT, RED BLOOD CELL/GRANULOCYTE FRACTIONS G. ESTABLISHMENT OF CELL LINES H. SKIN BIOPSY COLLECTION FOR THE ESTABLISHMENT OF FIBROBLAST CELL LINES I. PROCESSING URINE SAMPLES   APPENDIX B: INTERNET RESOURCES ON SAFETY APPENDIX C: REFERENCES

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