# 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.*