136 lines
5.5 KiB
Markdown
136 lines
5.5 KiB
Markdown
# Biobank & Specimen Repository Quality Management System
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A comprehensive QMS template designed for biobanks, tissue repositories, and specimen management programs supporting clinical care and research.
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## 🧬 Designed For
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- **Hospital Biobanks** - Clinical specimen repositories
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- **Research Biorepositories** - Academic and institutional collections
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- **Tissue Banks** - Organ and tissue preservation programs
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- **Cord Blood Banks** - Umbilical cord blood storage facilities
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- **Cancer Tissue Banks** - Oncology specimen collections
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- **Population Biobanks** - Large-scale epidemiological collections
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- **Commercial Biorepositories** - Fee-for-service specimen storage
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## 📋 Regulatory Framework
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This template supports compliance with:
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- **ISBER** - International Society for Biological and Environmental Repositories Best Practices
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- **CAP BAP** - College of American Pathologists Biorepository Accreditation Program
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- **FDA 21 CFR Part 1271** - Human Cells, Tissues, and Cellular and Tissue-Based Products
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- **CLIA** - Clinical Laboratory Improvement Amendments (if clinical testing)
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- **HIPAA** - Health Insurance Portability and Accountability Act
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- **Common Rule (45 CFR 46)** - Human subjects research protections
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- **GDPR** - General Data Protection Regulation (EU specimens)
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- **NCI Best Practices** - National Cancer Institute biospecimen guidelines
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- **OSHA** - Occupational safety for specimen handling
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- **DOT/IATA** - Specimen shipping and transport regulations
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## Repository Structure
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```
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├── SOPs/
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│ ├── Specimen-Collection/ # Procurement, consent, collection procedures
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│ ├── Processing/ # Aliquoting, preservation, extraction
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│ ├── Storage/ # Freezer management, LN2 handling, inventory
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│ ├── Distribution/ # Request handling, shipping, chain of custody
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│ ├── Quality-Control/ # QC testing, temperature monitoring, audits
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│ └── General/ # Document control, training, CAPA
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├── Forms/
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│ ├── Consent-Forms/ # Informed consent templates
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│ ├── Collection-Records/ # Specimen accessioning logs
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│ ├── Storage-Logs/ # Temperature and inventory records
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│ ├── Distribution/ # Material transfer agreements, shipping logs
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│ ├── QC-Records/ # Quality control test results
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│ └── Training/ # Competency assessments
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├── Policies/ # Institutional policies and governance
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├── Work-Instructions/ # Step-by-step procedures
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└── Templates/ # Document templates
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```
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## Document Numbering Convention
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- **POL-XXX**: Policies
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- **SOP-COL-XXX**: Collection SOPs
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- **SOP-PRC-XXX**: Processing SOPs
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- **SOP-STR-XXX**: Storage SOPs
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- **SOP-DST-XXX**: Distribution SOPs
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- **SOP-QC-XXX**: Quality Control SOPs
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- **WI-XXX**: Work Instructions
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- **FRM-XXX**: Forms and Records
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- **MTA-XXX**: Material Transfer Agreements
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## 🤖 AI-Powered Assistance
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This repository includes **AtomicAI**, your biobank QMS assistant. Mention `@atomicai` in any issue or pull request to:
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- Draft specimen collection and processing SOPs
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- Create informed consent templates for biobanking
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- Generate freezer management and monitoring procedures
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- Develop quality control testing protocols
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- Create material transfer agreements
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- Review documents for ISBER/CAP compliance
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### Example Prompts
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- "@atomicai create an SOP for FFPE tissue block processing"
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- "@atomicai draft a biobank informed consent template"
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- "@atomicai write a -80°C freezer failure response procedure"
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- "@atomicai create a specimen request and distribution workflow"
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- "@atomicai develop a DNA extraction quality control SOP"
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- "@atomicai create a liquid nitrogen safety procedure"
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## Getting Started
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1. **Establish Governance** - Define biobank policies and oversight structure
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2. **Customize Consent Forms** - Adapt for your specimen types and uses
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3. **Set Up Inventory System** - Configure specimen tracking forms
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4. **Implement QC Program** - Establish quality metrics and testing
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5. **Train Personnel** - Use competency assessment forms
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## Key Documents to Create First
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1. **Specimen Accessioning SOP** - Foundation for sample intake
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2. **Informed Consent Template** - IRB-approved consent language
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3. **Freezer Temperature Monitoring SOP** - Critical for sample integrity
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4. **Aliquoting and Processing SOP** - Standardized sample handling
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5. **Material Transfer Agreement** - Template for specimen sharing
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6. **Chain of Custody Form** - Sample tracking documentation
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7. **Emergency Freezer Failure Response** - Critical contingency plan
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## Special Considerations for Biobanking
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### Specimen Types
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- Blood and blood components (serum, plasma, buffy coat)
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- Tissue (fresh, frozen, FFPE)
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- DNA/RNA extracts
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- Cell lines and primary cultures
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- Body fluids (urine, CSF, saliva)
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- Derivatives (protein lysates, slides)
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### Storage Requirements
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- Ultra-low temperature (-80°C) maintenance
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- Liquid nitrogen (-196°C) handling and safety
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- Refrigerated storage (2-8°C)
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- Room temperature controls
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- Backup power and alarm systems
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### Quality and Integrity
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- Pre-analytical variable documentation
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- Ischemia time tracking
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- Freeze-thaw cycle monitoring
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- Sample quality metrics (RIN, DIN, etc.)
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- Long-term stability testing
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### Ethical and Legal
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- Informed consent management
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- Participant withdrawal procedures
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- Data privacy and de-identification
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- Access governance and oversight
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- Commercial use considerations
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---
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*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*
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