133 lines
5.3 KiB
Markdown
133 lines
5.3 KiB
Markdown
# Blood Bank & Transfusion Services Quality Management System
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A comprehensive QMS template designed for blood banks, transfusion services, and blood component preparation facilities.
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## 🩸 Designed For
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- **Hospital Blood Banks** - Transfusion services and compatibility testing
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- **Blood Collection Centers** - Donor recruitment and phlebotomy operations
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- **Regional Blood Centers** - Component manufacturing and distribution
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- **Apheresis Centers** - Therapeutic and donor apheresis programs
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- **Cord Blood Banks** - Umbilical cord blood collection and processing
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- **Plasma Collection Facilities** - Source plasma operations
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- **Reference Laboratories** - Complex immunohematology testing
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## 📋 Regulatory Framework
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This template supports compliance with:
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- **FDA 21 CFR 606** - Current Good Manufacturing Practice for Blood and Blood Components
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- **FDA 21 CFR 630** - Requirements for Blood and Blood Components
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- **AABB Standards** - Standards for Blood Banks and Transfusion Services
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- **CAP** - College of American Pathologists accreditation requirements
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- **CLIA** - Clinical Laboratory Improvement Amendments
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- **The Joint Commission** - Hospital accreditation standards
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- **ISBT 128** - International coding standards for blood products
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- **OSHA Bloodborne Pathogens** - Employee safety requirements
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- **State Regulations** - State-specific blood banking requirements
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## Repository Structure
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```
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├── SOPs/
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│ ├── Donor-Services/ # Donor screening, phlebotomy, reactions
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│ ├── Component-Preparation/ # Manufacturing, labeling, pooling
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│ ├── Testing/ # Compatibility, infectious disease, antibody ID
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│ ├── Transfusion/ # Ordering, issuing, administration, reactions
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│ ├── Inventory-Management/ # Storage, expiration, look-back
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│ └── General/ # Document control, training, CAPA
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├── Forms/
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│ ├── Donor-Records/ # DHQ, consent, deferral forms
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│ ├── Testing-Logs/ # Crossmatch, antibody, QC records
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│ ├── Transfusion-Records/ # Order forms, consent, reaction reports
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│ ├── Temperature-Logs/ # Blood storage equipment monitoring
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│ ├── QC-Records/ # Reagent QC, equipment calibration
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│ └── Training/ # Competency assessments
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├── Policies/ # Institutional policies
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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-DON-XXX**: Donor Services SOPs
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- **SOP-CMP-XXX**: Component Preparation SOPs
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- **SOP-TST-XXX**: Testing SOPs
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- **SOP-TXN-XXX**: Transfusion SOPs
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- **SOP-INV-XXX**: Inventory Management SOPs
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- **WI-XXX**: Work Instructions
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- **FRM-XXX**: Forms and Records
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## 🤖 AI-Powered Assistance
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This repository includes **AtomicAI**, your blood bank QMS assistant. Mention `@atomicai` in any issue or pull request to:
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- Draft donor screening and collection SOPs
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- Create compatibility testing procedures
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- Generate transfusion reaction investigation protocols
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- Develop component preparation workflows
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- Create equipment validation and QC procedures
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- Review documents for FDA/AABB compliance
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### Example Prompts
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- "@atomicai create an SOP for ABO/Rh typing per AABB standards"
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- "@atomicai draft a massive transfusion protocol"
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- "@atomicai write a transfusion reaction workup procedure"
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- "@atomicai create an antibody identification SOP"
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- "@atomicai develop a platelet storage and monitoring procedure"
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- "@atomicai create a blood product irradiation SOP"
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## Getting Started
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1. **Review Regulatory Requirements** - Align with FDA and AABB standards
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2. **Customize Testing SOPs** - Adapt for your testing methodologies
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3. **Set Up Temperature Monitoring** - Configure equipment monitoring logs
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4. **Establish QC Program** - Implement reagent and equipment QC
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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. **ABO/Rh Typing SOP** - Foundation for compatibility testing
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2. **Crossmatch Procedure** - Immediate spin, IS, AHG methods
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3. **Blood Product Storage SOP** - Temperature requirements by component
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4. **Transfusion Reaction Workup** - Investigation and reporting procedure
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5. **Massive Transfusion Protocol** - Emergency release procedures
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6. **Donor Screening Questionnaire** - DHQ and mini-physical
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7. **Look-Back Procedure** - Post-donation information handling
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## Special Considerations for Blood Banking
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### Donor Management
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- Donor screening and eligibility criteria
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- Hemoglobin/hematocrit requirements
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- Deferral registry management
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- Adverse reaction documentation
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- Donor notification procedures
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### Component Preparation
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- Whole blood processing timelines
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- Component specifications (Hct, plt count, etc.)
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- Leukoreduction requirements
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- Irradiation and pathogen reduction
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- Labeling and ISBT 128 compliance
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### Compatibility Testing
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- Sample requirements and retention
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- Testing algorithm (type, screen, crossmatch)
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- Antibody identification workups
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- Computer crossmatch validation
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- Emergency release procedures
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### Transfusion Safety
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- Two-patient-identifier verification
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- Bedside compatibility check
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- Transfusion reaction recognition
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- Hemovigilance reporting
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- Near-miss documentation
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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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