# Biobank & Specimen Repository Quality Management System

A comprehensive QMS template designed for biobanks, tissue repositories, and specimen management programs supporting clinical care and research.

## 🧬 Designed For

- **Hospital Biobanks** - Clinical specimen repositories
- **Research Biorepositories** - Academic and institutional collections
- **Tissue Banks** - Organ and tissue preservation programs
- **Cord Blood Banks** - Umbilical cord blood storage facilities
- **Cancer Tissue Banks** - Oncology specimen collections
- **Population Biobanks** - Large-scale epidemiological collections
- **Commercial Biorepositories** - Fee-for-service specimen storage

## 📋 Regulatory Framework

This template supports compliance with:

- **ISBER** - International Society for Biological and Environmental Repositories Best Practices
- **CAP BAP** - College of American Pathologists Biorepository Accreditation Program
- **FDA 21 CFR Part 1271** - Human Cells, Tissues, and Cellular and Tissue-Based Products
- **CLIA** - Clinical Laboratory Improvement Amendments (if clinical testing)
- **HIPAA** - Health Insurance Portability and Accountability Act
- **Common Rule (45 CFR 46)** - Human subjects research protections
- **GDPR** - General Data Protection Regulation (EU specimens)
- **NCI Best Practices** - National Cancer Institute biospecimen guidelines
- **OSHA** - Occupational safety for specimen handling
- **DOT/IATA** - Specimen shipping and transport regulations

## Repository Structure

```
├── SOPs/
│   ├── Specimen-Collection/   # Procurement, consent, collection procedures
│   ├── Processing/            # Aliquoting, preservation, extraction
│   ├── Storage/               # Freezer management, LN2 handling, inventory
│   ├── Distribution/          # Request handling, shipping, chain of custody
│   ├── Quality-Control/       # QC testing, temperature monitoring, audits
│   └── General/               # Document control, training, CAPA
├── Forms/
│   ├── Consent-Forms/         # Informed consent templates
│   ├── Collection-Records/    # Specimen accessioning logs
│   ├── Storage-Logs/          # Temperature and inventory records
│   ├── Distribution/          # Material transfer agreements, shipping logs
│   ├── QC-Records/            # Quality control test results
│   └── Training/              # Competency assessments
├── Policies/                  # Institutional policies and governance
├── Work-Instructions/         # Step-by-step procedures
└── Templates/                 # Document templates
```

## Document Numbering Convention

- **POL-XXX**: Policies
- **SOP-COL-XXX**: Collection SOPs
- **SOP-PRC-XXX**: Processing SOPs
- **SOP-STR-XXX**: Storage SOPs
- **SOP-DST-XXX**: Distribution SOPs
- **SOP-QC-XXX**: Quality Control SOPs
- **WI-XXX**: Work Instructions
- **FRM-XXX**: Forms and Records
- **MTA-XXX**: Material Transfer Agreements

## 🤖 AI-Powered Assistance

This repository includes **AtomicAI**, your biobank QMS assistant. Mention `@atomicai` in any issue or pull request to:

- Draft specimen collection and processing SOPs
- Create informed consent templates for biobanking
- Generate freezer management and monitoring procedures
- Develop quality control testing protocols
- Create material transfer agreements
- Review documents for ISBER/CAP compliance

### Example Prompts

- "@atomicai create an SOP for FFPE tissue block processing"
- "@atomicai draft a biobank informed consent template"
- "@atomicai write a -80°C freezer failure response procedure"
- "@atomicai create a specimen request and distribution workflow"
- "@atomicai develop a DNA extraction quality control SOP"
- "@atomicai create a liquid nitrogen safety procedure"

## Getting Started

1. **Establish Governance** - Define biobank policies and oversight structure
2. **Customize Consent Forms** - Adapt for your specimen types and uses
3. **Set Up Inventory System** - Configure specimen tracking forms
4. **Implement QC Program** - Establish quality metrics and testing
5. **Train Personnel** - Use competency assessment forms

## Key Documents to Create First

1. **Specimen Accessioning SOP** - Foundation for sample intake
2. **Informed Consent Template** - IRB-approved consent language
3. **Freezer Temperature Monitoring SOP** - Critical for sample integrity
4. **Aliquoting and Processing SOP** - Standardized sample handling
5. **Material Transfer Agreement** - Template for specimen sharing
6. **Chain of Custody Form** - Sample tracking documentation
7. **Emergency Freezer Failure Response** - Critical contingency plan

## Special Considerations for Biobanking

### Specimen Types
- Blood and blood components (serum, plasma, buffy coat)
- Tissue (fresh, frozen, FFPE)
- DNA/RNA extracts
- Cell lines and primary cultures
- Body fluids (urine, CSF, saliva)
- Derivatives (protein lysates, slides)

### Storage Requirements
- Ultra-low temperature (-80°C) maintenance
- Liquid nitrogen (-196°C) handling and safety
- Refrigerated storage (2-8°C)
- Room temperature controls
- Backup power and alarm systems

### Quality and Integrity
- Pre-analytical variable documentation
- Ischemia time tracking
- Freeze-thaw cycle monitoring
- Sample quality metrics (RIN, DIN, etc.)
- Long-term stability testing

### Ethical and Legal
- Informed consent management
- Participant withdrawal procedures
- Data privacy and de-identification
- Access governance and oversight
- Commercial use considerations

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*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*