Blood Bank & Transfusion Services Quality Management System

A comprehensive QMS template designed for blood banks, transfusion services, and blood component preparation facilities.

🩸 Designed For

• Hospital Blood Banks - Transfusion services and compatibility testing
• Blood Collection Centers - Donor recruitment and phlebotomy operations
• Regional Blood Centers - Component manufacturing and distribution
• Apheresis Centers - Therapeutic and donor apheresis programs
• Cord Blood Banks - Umbilical cord blood collection and processing
• Plasma Collection Facilities - Source plasma operations
• Reference Laboratories - Complex immunohematology testing

📋 Regulatory Framework

This template supports compliance with:

• FDA 21 CFR 606 - Current Good Manufacturing Practice for Blood and Blood Components
• FDA 21 CFR 630 - Requirements for Blood and Blood Components
• AABB Standards - Standards for Blood Banks and Transfusion Services
• CAP - College of American Pathologists accreditation requirements
• CLIA - Clinical Laboratory Improvement Amendments
• The Joint Commission - Hospital accreditation standards
• ISBT 128 - International coding standards for blood products
• OSHA Bloodborne Pathogens - Employee safety requirements
• State Regulations - State-specific blood banking requirements

Repository Structure

├── SOPs/
│   ├── Donor-Services/        # Donor screening, phlebotomy, reactions
│   ├── Component-Preparation/ # Manufacturing, labeling, pooling
│   ├── Testing/               # Compatibility, infectious disease, antibody ID
│   ├── Transfusion/           # Ordering, issuing, administration, reactions
│   ├── Inventory-Management/  # Storage, expiration, look-back
│   └── General/               # Document control, training, CAPA
├── Forms/
│   ├── Donor-Records/         # DHQ, consent, deferral forms
│   ├── Testing-Logs/          # Crossmatch, antibody, QC records
│   ├── Transfusion-Records/   # Order forms, consent, reaction reports
│   ├── Temperature-Logs/      # Blood storage equipment monitoring
│   ├── QC-Records/            # Reagent QC, equipment calibration
│   └── Training/              # Competency assessments
├── Policies/                  # Institutional policies
├── Work-Instructions/         # Step-by-step procedures
└── Templates/                 # Document templates

Document Numbering Convention

• POL-XXX: Policies
• SOP-DON-XXX: Donor Services SOPs
• SOP-CMP-XXX: Component Preparation SOPs
• SOP-TST-XXX: Testing SOPs
• SOP-TXN-XXX: Transfusion SOPs
• SOP-INV-XXX: Inventory Management SOPs
• WI-XXX: Work Instructions
• FRM-XXX: Forms and Records

🤖 AI-Powered Assistance

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

• Draft donor screening and collection SOPs
• Create compatibility testing procedures
• Generate transfusion reaction investigation protocols
• Develop component preparation workflows
• Create equipment validation and QC procedures
• Review documents for FDA/AABB compliance

Example Prompts

• "@atomicai create an SOP for ABO/Rh typing per AABB standards"
• "@atomicai draft a massive transfusion protocol"
• "@atomicai write a transfusion reaction workup procedure"
• "@atomicai create an antibody identification SOP"
• "@atomicai develop a platelet storage and monitoring procedure"
• "@atomicai create a blood product irradiation SOP"

Getting Started

1. Review Regulatory Requirements - Align with FDA and AABB standards
2. Customize Testing SOPs - Adapt for your testing methodologies
3. Set Up Temperature Monitoring - Configure equipment monitoring logs
4. Establish QC Program - Implement reagent and equipment QC
5. Train Personnel - Use competency assessment forms

Key Documents to Create First

1. ABO/Rh Typing SOP - Foundation for compatibility testing
2. Crossmatch Procedure - Immediate spin, IS, AHG methods
3. Blood Product Storage SOP - Temperature requirements by component
4. Transfusion Reaction Workup - Investigation and reporting procedure
5. Massive Transfusion Protocol - Emergency release procedures
6. Donor Screening Questionnaire - DHQ and mini-physical
7. Look-Back Procedure - Post-donation information handling

Special Considerations for Blood Banking

Donor Management

• Donor screening and eligibility criteria
• Hemoglobin/hematocrit requirements
• Deferral registry management
• Adverse reaction documentation
• Donor notification procedures

Component Preparation

• Whole blood processing timelines
• Component specifications (Hct, plt count, etc.)
• Leukoreduction requirements
• Irradiation and pathogen reduction
• Labeling and ISBT 128 compliance

Compatibility Testing

• Sample requirements and retention
• Testing algorithm (type, screen, crossmatch)
• Antibody identification workups
• Computer crossmatch validation
• Emergency release procedures

Transfusion Safety

• Two-patient-identifier verification
• Bedside compatibility check
• Transfusion reaction recognition
• Hemovigilance reporting
• Near-miss documentation

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