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.