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name: AtomicAI Blood Bank Assistant
on:
issue_comment:
types: [created]
issues:
types: [opened, assigned]
pull_request:
types: [opened, synchronize, assigned]
pull_request_review_comment:
types: [created]
jobs:
claude-assistant:
runs-on: ubuntu-latest
if: |
github.actor != 'atomicqms-service' &&
(
(github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') ||
(github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) ||
(github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) ||
(github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') ||
(github.event.action == 'assigned' && github.event.assignee.login == 'atomicai')
)
permissions:
contents: write
issues: write
pull-requests: write
steps:
- uses: actions/checkout@v4
with:
fetch-depth: 0
- name: Run AtomicAI Blood Bank Assistant
uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main
with:
trigger_phrase: '@atomicai'
assignee_trigger: 'atomicai'
claude_git_name: 'AtomicAI'
claude_git_email: 'atomicai@atomicqms.local'
custom_instructions: |
You are AtomicAI, an AI assistant specialized in Blood Bank and Transfusion Medicine Quality Management.
## Your Expertise
- AABB (Association for the Advancement of Blood & Biotherapies) standards
- FDA blood establishment regulations (21 CFR 606)
- Blood typing and crossmatching procedures
- Component preparation and storage
- Transfusion reaction investigation
- Donor screening and eligibility
- Therapeutic apheresis procedures
- Inventory management and wastage reduction
- Temperature monitoring and cold chain
- Lookback and traceability procedures
- Emergency release protocols
- Massive transfusion protocols
## Document Creation Guidelines
- Place Testing SOPs in SOPs/Testing/
- Place Component SOPs in SOPs/Components/
- Place Transfusion SOPs in SOPs/Transfusion/
- Place Donor Forms in Forms/Donor/
- Place Reaction Forms in Forms/Reactions/
- Place Policies in Policies/
## Numbering Convention
- SOP-BB-XXX for Blood Bank SOPs
- SOP-TRN-XXX for Transfusion SOPs
- SOP-APH-XXX for Apheresis SOPs
- SOP-DON-XXX for Donor SOPs
- POL-XXX for Policies
- FRM-XXX for Forms
Always create branches and submit changes as Pull Requests for review.
Prioritize patient safety, product integrity, and regulatory compliance.
allowed_tools: 'Read,Edit,Grep,Glob,Write'
disallowed_tools: 'Bash,WebSearch'

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# Document Change Request Form
| Form ID | FRM-001 | Revision | 1.0 |
|---------|---------|----------|-----|
---
## Section 1: Request Information
| Field | Entry |
|-------|-------|
| Request Date | |
| Requested By | |
| Department | |
## Section 2: Document Information
| Field | Entry |
|-------|-------|
| Document Number | |
| Document Title | |
| Current Revision | |
## Section 3: Change Description
### Type of Change
- [ ] New Document
- [ ] Revision to Existing Document
- [ ] Document Obsolescence
### Description of Change
*(Describe the proposed change in detail)*
### Reason for Change
*(Explain why this change is needed)*
## Section 4: Impact Assessment
### Affected Areas
- [ ] Training Required
- [ ] Other Documents Affected
- [ ] Process Changes Required
- [ ] Validation Impact
### List Affected Documents
## Section 5: Approvals
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Requester | | | |
| Document Owner | | | |
| Quality Assurance | | | |
---
*Form FRM-001 Rev 1.0*

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# Corrective and Preventive Action (CAPA) Form
| Form ID | FRM-003 | Revision | 1.0 |
|---------|---------|----------|-----|
---
## Section 1: CAPA Identification
| Field | Entry |
|-------|-------|
| CAPA Number | |
| Date Initiated | |
| Initiated By | |
| CAPA Owner | |
| Target Closure Date | |
## Section 2: Classification
### Type
- [ ] Corrective Action
- [ ] Preventive Action
### Source
- [ ] Customer Complaint
- [ ] Internal Audit
- [ ] External Audit
- [ ] Process Deviation
- [ ] Nonconforming Product
- [ ] Management Review
- [ ] Other: ____________
### Priority
- [ ] Critical (5 business days)
- [ ] Major (15 business days)
- [ ] Minor (30 business days)
## Section 3: Problem Description
*(Describe the nonconformity or potential nonconformity)*
## Section 4: Immediate Containment
*(Actions taken to contain the immediate impact)*
## Section 5: Root Cause Investigation
### Investigation Method Used
- [ ] 5 Whys
- [ ] Fishbone Diagram
- [ ] Fault Tree Analysis
- [ ] Other: ____________
### Root Cause Determination
## Section 6: Corrective/Preventive Actions
| Action | Responsible | Due Date | Status |
|--------|-------------|----------|--------|
| | | | |
| | | | |
| | | | |
## Section 7: Effectiveness Verification
| Criteria | Method | Result |
|----------|--------|--------|
| | | |
Verification Date: ____________
Verified By: ____________
## Section 8: Closure
| Role | Name | Signature | Date |
|------|------|-----------|------|
| CAPA Owner | | | |
| Quality Approval | | | |
---
*Form FRM-003 Rev 1.0*

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# Internal Audit Checklist
| Form ID | FRM-006 | Revision | 1.0 |
|---------|---------|----------|-----|
---
## Audit Information
| Field | Entry |
|-------|-------|
| Audit Number | |
| Audit Date | |
| Area/Process Audited | |
| Lead Auditor | |
| Auditee(s) | |
---
## Checklist Items
| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes |
|---|---------------------|-----------|---------|----------------|
| 1 | Are current versions of applicable procedures available? | SOP-001 | | |
| 2 | Are personnel trained on applicable procedures? | SOP-003 | | |
| 3 | Are training records current and complete? | SOP-003 | | |
| 4 | Are records properly maintained and retrievable? | SOP-001 | | |
| 5 | Are nonconformities being documented and addressed? | SOP-002 | | |
| 6 | Are CAPAs being completed on time? | SOP-002 | | |
| 7 | Is equipment calibrated and maintained? | | | |
| 8 | Are process controls being followed? | | | |
| 9 | Are quality objectives being monitored? | | | |
| 10 | | | | |
**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable
---
## Findings Summary
| Finding # | Type | Description | Clause Reference |
|-----------|------|-------------|------------------|
| | | | |
| | | | |
---
## Auditor Signature
| Auditor | Signature | Date |
|---------|-----------|------|
| | | |
---
*Form FRM-006 Rev 1.0*

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# Compatibility Testing Log
| Form ID | FRM-BB-001 | Revision | 1.0 |
|---------|-------------|----------|-----|
---
## Patient Information
| Field | Entry |
|-------|-------|
| Patient Name | |
| MRN | |
| Date of Birth | |
| Sex | ☐ Male ☐ Female |
| Location/Unit | |
| Ordering Physician | |
| Date of Request | |
| Time of Request | |
---
## Specimen Information
| Field | Entry |
|-------|-------|
| Date Collected | |
| Time Collected | |
| Collected By | |
| Phlebotomist ID | |
| Tube Type | ☐ EDTA ☐ Clot ☐ Both |
| Specimen Acceptable? | ☐ Yes ☐ No (reason: _______) |
| Previous Records Available? | ☐ Yes ☐ No ☐ N/A |
---
## ABO/Rh Typing
### Current Sample
| Test | Result | Interpretation |
|------|--------|----------------|
| Anti-A | ☐ Pos ☐ Neg | |
| Anti-B | ☐ Pos ☐ Neg | |
| Anti-D | ☐ Pos ☐ Neg | |
| A1 Cells | ☐ Pos ☐ Neg | |
| B Cells | ☐ Pos ☐ Neg | |
**ABO Type:** ☐ A ☐ B ☐ AB ☐ O
**Rh Type:** ☐ Positive ☐ Negative
**Weak D Testing (if applicable):**
☐ Not performed ☐ Positive ☐ Negative
### Historical Results (if available)
| Date | ABO | Rh | Source |
|------|-----|----|--------|
| | | | |
| | | | |
**Results Consistent?** ☐ Yes ☐ No (see discrepancy resolution)
---
## Antibody Screening
| Field | Entry |
|-------|-------|
| Method | ☐ Tube ☐ Gel ☐ Solid Phase |
| Enhancement | ☐ LISS ☐ PEG ☐ None |
| Screen Cell Lot # | |
| Expiration Date | |
### Screen Cell Results
| Cell | Immediate Spin | 37°C | AHG | CC |
|------|----------------|------|-----|-----|
| I | | | | |
| II | | | | |
| III | | | | |
**Antibody Screen Result:** ☐ Negative ☐ Positive
**If Positive, Antibody Identified:**
---
## Antibody Identification (if screening positive)
| Field | Entry |
|-------|-------|
| Panel Lot # | |
| Method | |
| Antibody(ies) Identified | |
| Clinical Significance | ☐ Yes ☐ No |
| Phenotyped Units Required? | ☐ Yes ☐ No |
| Phenotype Requirements | |
| Panel Cell | Results | Antigen Correlation |
|------------|---------|---------------------|
| 1 | | |
| 2 | | |
| 3 | | |
| 4 | | |
| 5 | | |
| 6 | | |
| 7 | | |
| 8 | | |
| 9 | | |
| 10 | | |
| 11 | | |
---
## Crossmatch
### Unit 1
| Field | Entry |
|-------|-------|
| Unit Number | |
| ABO/Rh | |
| Expiration Date | |
| Antigen Typed? | ☐ Yes: _______ ☐ No ☐ N/A |
| Phase | Result | Interpretation |
|-------|--------|----------------|
| Immediate Spin | ☐ Compatible ☐ Incompatible | |
| 37°C | ☐ Compatible ☐ Incompatible | |
| AHG | ☐ Compatible ☐ Incompatible | |
| Coombs Control | ☐ Valid ☐ Invalid | |
**Final Result:** ☐ Compatible ☐ Incompatible
### Unit 2
| Field | Entry |
|-------|-------|
| Unit Number | |
| ABO/Rh | |
| Expiration Date | |
| Antigen Typed? | ☐ Yes: _______ ☐ No ☐ N/A |
| Phase | Result | Interpretation |
|-------|--------|----------------|
| Immediate Spin | ☐ Compatible ☐ Incompatible | |
| 37°C | ☐ Compatible ☐ Incompatible | |
| AHG | ☐ Compatible ☐ Incompatible | |
| Coombs Control | ☐ Valid ☐ Invalid | |
**Final Result:** ☐ Compatible ☐ Incompatible
### Unit 3
| Field | Entry |
|-------|-------|
| Unit Number | |
| ABO/Rh | |
| Expiration Date | |
| Antigen Typed? | ☐ Yes: _______ ☐ No ☐ N/A |
| Phase | Result | Interpretation |
|-------|--------|----------------|
| Immediate Spin | ☐ Compatible ☐ Incompatible | |
| 37°C | ☐ Compatible ☐ Incompatible | |
| AHG | ☐ Compatible ☐ Incompatible | |
| Coombs Control | ☐ Valid ☐ Invalid | |
**Final Result:** ☐ Compatible ☐ Incompatible
---
## Electronic Crossmatch (if applicable)
| Field | Entry |
|-------|-------|
| Two ABO/Rh on file? | ☐ Yes ☐ No |
| Results consistent? | ☐ Yes ☐ No |
| Antibody screen negative? | ☐ Yes ☐ No |
| Computer system validated? | ☐ Yes |
---
## Special Requirements
| Requirement | Ordered? | Provided? |
|-------------|----------|-----------|
| CMV Negative | ☐ | ☐ |
| Irradiated | ☐ | ☐ |
| Leukoreduced | ☐ | ☐ |
| Washed | ☐ | ☐ |
| Volume Reduced | ☐ | ☐ |
| HbS Negative | ☐ | ☐ |
| Antigen Negative: _______ | ☐ | ☐ |
---
## Results Summary
| Field | Entry |
|-------|-------|
| ABO/Rh | |
| Antibody Screen | ☐ Negative ☐ Positive |
| Antibodies Identified | |
| Units Crossmatched | |
| Units Compatible | |
| Units Available for Issue | |
---
## Verification
### Performed By
| Field | Entry |
|-------|-------|
| Technologist Name | |
| Tech ID | |
| Date | |
| Time | |
| Signature | |
### Reviewed By (if required)
| Field | Entry |
|-------|-------|
| Reviewer Name | |
| Date | |
| Signature | |
---
## Discrepancy Resolution (if applicable)
| Field | Entry |
|-------|-------|
| Type of Discrepancy | |
| Investigation Performed | |
| Resolution | |
| Resolved By | |
| Date | |
| Supervisor Review | |
---
*Form FRM-BB-001 Rev 1.0 - Compatibility Testing Log*

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# Training Record Form
| Form ID | FRM-004 | Revision | 1.0 |
|---------|---------|----------|-----|
---
## Section 1: Employee Information
| Field | Entry |
|-------|-------|
| Employee Name | |
| Employee ID | |
| Department | |
| Job Title | |
## Section 2: Training Information
| Field | Entry |
|-------|-------|
| Training Title | |
| Training Date | |
| Training Duration | |
| Trainer Name | |
| Trainer Qualification | |
### Training Type
- [ ] Initial Training
- [ ] Retraining
- [ ] Refresher
- [ ] Procedure Update
### Delivery Method
- [ ] Classroom
- [ ] On-the-Job
- [ ] Self-Study
- [ ] Computer-Based
- [ ] Other: ____________
## Section 3: Training Content
*(List topics covered or attach training materials)*
## Section 4: Assessment
### Assessment Method
- [ ] Written Test
- [ ] Practical Demonstration
- [ ] Verbal Assessment
- [ ] Observation
### Assessment Results
| Metric | Result |
|--------|--------|
| Score (if applicable) | |
| Pass/Fail | |
## Section 5: Signatures
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Trainee | | | |
| Trainer | | | |
| Supervisor | | | |
---
*Form FRM-004 Rev 1.0*

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# Quality Policy
| Document ID | POL-001 |
|-------------|---------|
| Title | Quality Policy |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
---
## 1. Policy Statement
[ORGANIZATION NAME] is committed to providing products and services that consistently meet customer requirements and applicable regulatory requirements. We strive for continual improvement of our Quality Management System to enhance customer satisfaction.
## 2. Quality Objectives
Our organization commits to:
1. **Customer Focus**: Understanding and meeting customer needs and expectations
2. **Regulatory Compliance**: Maintaining compliance with all applicable regulations and standards
3. **Continuous Improvement**: Continually improving the effectiveness of our QMS
4. **Employee Engagement**: Ensuring all employees understand their role in quality
5. **Risk-Based Thinking**: Identifying and addressing risks and opportunities
## 3. Management Commitment
Top management demonstrates commitment to the QMS by:
- Ensuring the quality policy is appropriate to the organization's purpose
- Ensuring quality objectives are established and compatible with strategic direction
- Ensuring integration of QMS requirements into business processes
- Promoting the use of the process approach and risk-based thinking
- Ensuring resources needed for the QMS are available
- Communicating the importance of effective quality management
- Ensuring the QMS achieves its intended results
- Engaging, directing, and supporting persons to contribute to QMS effectiveness
## 4. Scope
This policy applies to all employees, contractors, and processes within the scope of our Quality Management System.
## 5. Communication
This policy shall be:
- Communicated and understood within the organization
- Available to relevant interested parties as appropriate
- Reviewed for continuing suitability
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# blood-bank
# Blood Bank & Transfusion Services Quality Management System
A comprehensive QMS template designed for blood banks, transfusion services, and blood component preparation facilities.
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
---
*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*

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# Standard Operating Procedure: Blood Donor Screening
| Document ID | SOP-BB-001 |
|-------------|-------------|
| Title | Blood Donor Screening and Eligibility |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Donor Services |
---
## 1. Purpose
To establish standardized procedures for screening potential blood donors to ensure donor safety and the safety of the blood supply in accordance with FDA, AABB, and state regulations.
## 2. Scope
This procedure applies to:
- Whole blood donations
- Apheresis donations (platelets, plasma, red cells)
- Autologous donations
- Directed donations
## 3. Responsibilities
### 3.1 Donor Registration Staff
- Verify donor identity
- Complete registration process
- Explain donor education materials
### 3.2 Donor Screening Personnel
- Conduct health history interview
- Perform mini-physical examination
- Determine donor eligibility
### 3.3 Medical Director
- Establish deferral criteria
- Review complex eligibility questions
- Authorize exceptions when appropriate
## 4. Definitions
| Term | Definition |
|------|------------|
| Allogeneic | Donation intended for another person |
| Autologous | Donation for one's own use |
| Deferral | Temporary or permanent exclusion from donation |
| DHQ | Donor History Questionnaire |
## 5. Equipment and Materials
- FDA-approved Donor History Questionnaire
- Blood pressure monitor (calibrated)
- Thermometer
- Hemoglobin/hematocrit testing device
- Venipuncture supplies for sample collection
- Donor education materials
- Deferral registry access
## 6. Procedure
### 6.1 Donor Registration
1. **Identity Verification**
- Require valid government-issued photo ID
- Verify name, date of birth
- Check against deferral registry
- Record donor identification number
2. **Educational Materials**
- Provide donor education materials
- Ensure donor has read and understood:
- Risk behaviors
- Signs/symptoms requiring self-deferral
- Post-donation instructions
- Document acknowledgment
### 6.2 Health History Interview
1. **Questionnaire Administration**
- Use current FDA-approved DHQ version
- Conduct in private setting
- Allow donor to self-complete or assist as needed
- Review all responses with donor
2. **Key Assessment Areas**
**General Health**
- [ ] Feeling healthy today
- [ ] Weight ≥110 lbs (50 kg)
- [ ] Age requirements met
- [ ] No recent illness/infection
**Medical History**
- [ ] Medications (prescription and OTC)
- [ ] Chronic conditions
- [ ] Recent surgeries/procedures
- [ ] Cancer history
- [ ] Heart/lung conditions
- [ ] Bleeding disorders
**Infectious Disease Risk**
- [ ] Fever in past 3 days
- [ ] Travel history (endemic areas)
- [ ] Vaccinations (recent)
- [ ] Tattoos/piercings (recent)
- [ ] Contact with infectious diseases
**Risk Behaviors**
- [ ] Sexual history per FDA guidance
- [ ] IV drug use
- [ ] Incarceration history
3. **Interview Documentation**
- Record date and time
- Interviewer signature
- Donor signature affirming truthfulness
### 6.3 Mini-Physical Examination
| Parameter | Acceptable Range | Action if Outside Range |
|-----------|------------------|------------------------|
| Temperature | ≤99.5°F (37.5°C) | Defer |
| Blood Pressure | Systolic 90-180 mmHg, Diastolic 50-100 mmHg | Defer if outside |
| Pulse | 50-100 bpm, regular | Defer if irregular or outside range |
| Hemoglobin | ≥12.5 g/dL (female), ≥13.0 g/dL (male) | Defer |
| Weight | ≥110 lbs | Defer |
| Arms | Free of lesions, track marks | Defer if concerning |
1. **Temperature**
- Measure oral temperature
- Wait 10 min if donor consumed hot/cold beverages
2. **Blood Pressure and Pulse**
- Donor seated 2-3 minutes before measurement
- Use appropriate cuff size
- Record all values
3. **Hemoglobin Testing**
- Perform fingerstick using approved device
- Follow manufacturer instructions
- Record result and device lot number
4. **Arm Inspection**
- Examine both arms
- Check for:
- Skin lesions or infections
- Track marks
- Suitable veins
### 6.4 Eligibility Determination
1. **Eligible to Donate**
- All criteria met
- No deferral conditions identified
- Document approval
- Proceed to collection
2. **Temporary Deferral**
- Document specific reason
- Calculate reinstatement date
- Provide deferral notice to donor
- Record in deferral registry
- Common reasons:
| Reason | Deferral Period |
|--------|-----------------|
| Low hemoglobin | 56 days minimum |
| Tattoo/piercing | Per state/facility policy |
| Recent vaccination | Varies by vaccine |
| Travel to endemic areas | Varies by location |
| Medication | Varies by drug |
3. **Permanent Deferral**
- Document reason
- Notify donor in writing
- Record in deferral registry
- Offer post-donation counseling if appropriate
### 6.5 Confidential Unit Exclusion
- Offer confidential opportunity to self-exclude
- Provide private means (ballot, sticker, phone call)
- Document without identifying donor choice
- Units designated for discard are processed but not used
## 7. Special Situations
### 7.1 Therapeutic Phlebotomy
- Prescription required
- Separate eligibility criteria may apply
- Label units appropriately
### 7.2 Autologous Donation
- Less stringent hemoglobin requirements
- Must meet basic safety criteria
- Physician order required
### 7.3 Directed Donation
- Same eligibility criteria as allogeneic
- Document relationship to recipient
## 8. Documentation
- FRM-BB-001 Donor Registration Form
- Donor History Questionnaire (completed)
- FRM-BB-002 Mini-Physical Results
- Deferral notification (if applicable)
- Consent for donation
## 9. Quality Control
| Activity | Frequency |
|----------|-----------|
| Hemoglobin device QC | Per manufacturer |
| BP monitor calibration | Annually |
| DHQ version check | Monthly |
| Staff competency | Annually |
## 10. References
- FDA Guidance for Industry: Blood Establishment Registration
- AABB Standards for Blood Banks and Transfusion Services
- 21 CFR Part 606 - Current Good Manufacturing Practice for Blood
- State regulations for blood collection
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Document Control
| Document ID | SOP-001 |
|-------------|---------|
| Title | Document Control |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To establish a procedure for the creation, review, approval, distribution, and control of documents within the Quality Management System.
## 2. Scope
This procedure applies to all controlled documents including:
- Policies
- Standard Operating Procedures (SOPs)
- Work Instructions
- Forms and Templates
- Specifications
- External documents of external origin
## 3. Responsibilities
### 3.1 Document Owner
- Responsible for document content and accuracy
- Initiates document creation and revision
- Ensures periodic review is performed
### 3.2 Quality Assurance
- Maintains the document control system
- Assigns document numbers
- Manages document distribution
- Archives obsolete documents
### 3.3 Approvers
- Review and approve documents before release
- Ensure documents are adequate for intended purpose
## 4. Procedure
### 4.1 Document Creation
1. Identify the need for a new document
2. Request document number from Quality Assurance
3. Draft document using appropriate template
4. Include all required header information
5. Submit for review and approval
### 4.2 Document Review and Approval
1. Route document to appropriate reviewers
2. Reviewers provide comments within 5 business days
3. Author addresses all comments
4. Final approval by designated approver
5. Quality Assurance releases document
### 4.3 Document Numbering
Documents shall be numbered according to the following convention:
| Type | Prefix | Example |
|------|--------|---------|
| Policy | POL | POL-001 |
| SOP | SOP | SOP-001 |
| Work Instruction | WI | WI-001 |
| Form | FRM | FRM-001 |
### 4.4 Revision Control
1. All changes require documented justification
2. Changes follow same review/approval process as new documents
3. Revision number increments with each approved change
4. Revision history maintained in document footer
### 4.5 Document Distribution
1. Current versions available in document control system
2. Obsolete versions marked and archived
3. Training on new/revised documents as needed
### 4.6 Periodic Review
1. Documents reviewed at least every 2 years
2. Review documented even if no changes made
3. Reviews may result in revision or reaffirmation
## 5. Related Documents
- FRM-001 Document Change Request Form
- FRM-002 Document Review Record
## 6. Definitions
| Term | Definition |
|------|------------|
| Controlled Document | Document managed under document control system |
| Obsolete | Document no longer valid for use |
| Revision | Updated version of a document |
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Corrective and Preventive Action (CAPA)
| Document ID | SOP-002 |
|-------------|---------|
| Title | Corrective and Preventive Action |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To establish a systematic process for identifying, investigating, correcting, and preventing nonconformities and potential nonconformities.
## 2. Scope
This procedure applies to:
- Product and process nonconformities
- Customer complaints
- Audit findings
- Process deviations
- Potential nonconformities identified through risk analysis
## 3. Definitions
| Term | Definition |
|------|------------|
| Corrective Action | Action to eliminate the cause of a detected nonconformity |
| Preventive Action | Action to eliminate the cause of a potential nonconformity |
| Root Cause | Fundamental reason for a nonconformity |
| Effectiveness Check | Verification that implemented actions achieved desired results |
## 4. Responsibilities
### 4.1 CAPA Owner
- Investigates the issue
- Identifies root cause
- Develops and implements corrective/preventive actions
- Verifies effectiveness
### 4.2 Quality Assurance
- Manages CAPA system
- Assigns CAPA numbers
- Tracks CAPA status
- Reviews and approves CAPAs
- Reports CAPA metrics to management
### 4.3 Management
- Provides resources for CAPA implementation
- Reviews CAPA trends
- Ensures timely closure
## 5. Procedure
### 5.1 CAPA Initiation
1. Identify nonconformity or potential nonconformity
2. Document issue on CAPA Form (FRM-003)
3. Classify severity and priority
4. Assign CAPA owner
### 5.2 Investigation
1. Gather relevant data and evidence
2. Interview personnel involved
3. Review related documents and records
4. Use appropriate investigation tools:
- 5 Whys
- Fishbone Diagram
- Failure Mode Analysis
### 5.3 Root Cause Analysis
1. Identify potential root causes
2. Verify root cause through evidence
3. Document root cause determination
4. Consider systemic implications
### 5.4 Action Development
1. Develop corrective/preventive actions
2. Assign responsibilities and due dates
3. Assess actions for:
- Appropriateness to problem severity
- Impact on other processes
- Resource requirements
### 5.5 Implementation
1. Execute approved actions
2. Document implementation evidence
3. Update affected documents/processes
4. Provide training as needed
### 5.6 Effectiveness Verification
1. Define effectiveness criteria
2. Allow sufficient time for actions to take effect
3. Collect and analyze data
4. Document verification results
5. If ineffective, reopen CAPA for further action
### 5.7 Closure
1. Review all CAPA documentation
2. Verify all actions completed
3. Confirm effectiveness verified
4. Obtain approval for closure
## 6. CAPA Metrics
Quality Assurance shall track and report:
- Number of open CAPAs
- CAPA aging
- On-time closure rate
- Effectiveness rate
- CAPAs by category/source
## 7. Related Documents
- FRM-003 CAPA Form
- SOP-003 Nonconforming Product Control
- SOP-004 Customer Complaints
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Training and Competence
| Document ID | SOP-003 |
|-------------|---------|
| Title | Training and Competence |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Human Resources / Quality |
---
## 1. Purpose
To ensure personnel performing work affecting product quality are competent based on appropriate education, training, skills, and experience.
## 2. Scope
This procedure applies to:
- All employees performing quality-affecting activities
- Contractors and temporary personnel
- Personnel requiring GxP training
## 3. Responsibilities
### 3.1 Supervisors/Managers
- Identify training needs for their personnel
- Ensure training is completed before performing tasks
- Evaluate competence of personnel
- Maintain department training records
### 3.2 Human Resources
- Coordinate training programs
- Maintain central training database
- Track training compliance
- Archive training records
### 3.3 Quality Assurance
- Develop QMS-related training
- Approve training curricula for GxP activities
- Audit training compliance
### 3.4 Employees
- Complete assigned training on time
- Maintain current qualifications
- Report training needs to supervisor
## 4. Procedure
### 4.1 Training Needs Assessment
1. Identify competence requirements for each role
2. Document requirements in job descriptions
3. Assess current competence of personnel
4. Identify training gaps
### 4.2 Training Curriculum Development
1. Define learning objectives
2. Develop training materials
3. Identify delivery method:
- Classroom
- On-the-job
- Self-study
- Computer-based
4. Define assessment criteria
5. Obtain approval from Quality (for GxP training)
### 4.3 Training Delivery
1. Schedule training session
2. Document attendance
3. Deliver training per curriculum
4. Assess comprehension through:
- Written test (minimum 80% passing)
- Practical demonstration
- Supervisor observation
### 4.4 Training Documentation
Training records shall include:
- Employee name and ID
- Training title and date
- Trainer name and qualifications
- Assessment results
- Signatures
### 4.5 Retraining Requirements
Retraining is required when:
- Significant document revisions occur
- Performance deficiencies identified
- Extended absence from job function
- Periodic requalification due
### 4.6 New Employee Orientation
All new employees shall complete:
1. Company orientation
2. Quality system overview
3. Job-specific training
4. SOP read and understand for applicable procedures
## 5. Training Records Retention
- Training records maintained for duration of employment
- Records retained 3 years after employee departure
- Records available for regulatory inspection
## 6. Related Documents
- FRM-004 Training Record Form
- FRM-005 Training Assessment Form
- Job Descriptions
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Internal Audit
| Document ID | SOP-004 |
|-------------|---------|
| Title | Internal Audit |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To establish a systematic approach for conducting internal audits to verify the effectiveness of the Quality Management System.
## 2. Scope
This procedure covers:
- QMS process audits
- Compliance audits
- Product audits
- System audits
## 3. Definitions
| Term | Definition |
|------|------------|
| Audit | Systematic, independent examination to determine conformance |
| Auditor | Person qualified to perform audits |
| Finding | Observation of conformance or nonconformance |
| Observation | Noted item not rising to level of finding |
## 4. Responsibilities
### 4.1 Lead Auditor
- Plans and schedules audits
- Prepares audit checklists
- Conducts audit activities
- Reports audit findings
### 4.2 Quality Manager
- Maintains audit program
- Qualifies auditors
- Reviews audit reports
- Reports to management
### 4.3 Auditee
- Provides access to areas/records
- Responds to findings
- Implements corrective actions
## 5. Procedure
### 5.1 Annual Audit Schedule
1. Develop annual audit schedule considering:
- Previous audit results
- Process criticality
- Regulatory requirements
- Changes to processes
2. Ensure all QMS processes audited at least annually
3. Obtain management approval
4. Communicate schedule to affected areas
### 5.2 Auditor Qualification
Auditors shall:
- Complete auditor training course
- Conduct at least 2 audits under supervision
- Be independent of area being audited
- Maintain competence through ongoing audits
### 5.3 Audit Preparation
1. Review applicable procedures and standards
2. Review previous audit reports
3. Prepare audit checklist
4. Notify auditee of audit scope and schedule
5. Confirm auditor availability
### 5.4 Conducting the Audit
1. Hold opening meeting with auditee
2. Execute audit checklist
3. Gather objective evidence:
- Document review
- Personnel interviews
- Process observation
4. Document findings with evidence
5. Classify findings:
- Major Nonconformance
- Minor Nonconformance
- Observation
6. Hold closing meeting
### 5.5 Audit Reporting
1. Complete audit report within 5 business days
2. Report shall include:
- Audit scope and criteria
- Personnel interviewed
- Findings with evidence
- Recommendations
3. Distribute report to auditee and management
### 5.6 Finding Resolution
1. Auditee responds with corrective action plan within 10 business days
2. Quality reviews and approves plan
3. Auditee implements corrective actions
4. Auditor verifies effectiveness
5. Close finding upon verification
## 6. Audit Records
Maintain for 5 years:
- Audit schedules
- Checklists
- Reports
- Corrective action records
## 7. Related Documents
- FRM-006 Audit Checklist Template
- FRM-007 Audit Report Template
- SOP-002 CAPA
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Management Review
| Document ID | SOP-005 |
|-------------|---------|
| Title | Management Review |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |
---
## 1. Purpose
To ensure top management reviews the Quality Management System at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.
## 2. Scope
This procedure applies to the periodic management review of the QMS, including all processes and quality objectives.
## 3. Frequency
Management reviews shall be conducted:
- At least annually
- More frequently if significant changes occur
- As needed based on quality performance
## 4. Responsibilities
### 4.1 Quality Manager
- Prepares management review agenda and materials
- Facilitates the meeting
- Documents meeting minutes and action items
- Tracks completion of action items
### 4.2 Top Management
- Attends management review meetings
- Reviews QMS performance data
- Makes decisions on QMS improvements
- Allocates resources as needed
### 4.3 Department Managers
- Provides input data for their areas
- Attends management review
- Implements assigned action items
## 5. Management Review Inputs
The following shall be considered:
### 5.1 Actions from Previous Reviews
- Status of action items
- Effectiveness of implemented actions
### 5.2 Changes in Context
- Internal changes (organization, resources)
- External changes (regulations, market)
### 5.3 QMS Performance
- Customer satisfaction and feedback
- Quality objectives achievement
- Process performance metrics
- Nonconformities and corrective actions
- Audit results
- Supplier performance
### 5.4 Resource Adequacy
- Personnel
- Infrastructure
- Work environment
### 5.5 Risk and Opportunities
- Risk assessment results
- Effectiveness of risk controls
- New opportunities identified
### 5.6 Improvement Opportunities
- Process improvements
- Product improvements
- QMS enhancements
## 6. Management Review Outputs
Decisions and actions related to:
- Improvement of QMS and processes
- Product improvement
- Resource needs
- Changes to quality policy or objectives
## 7. Documentation
### 7.1 Meeting Minutes
- Date and attendees
- Items discussed
- Decisions made
- Action items with owners and due dates
### 7.2 Record Retention
- Management review records retained for 5 years
- Available for regulatory inspection
## 8. Related Documents
- FRM-008 Management Review Agenda Template
- FRM-009 Management Review Minutes Template
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: Blood Transfusion Administration
| Document ID | SOP-BB-002 |
|-------------|-------------|
| Title | Blood Transfusion Administration |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Transfusion Services |
---
## 1. Purpose
To establish standardized procedures for the safe administration of blood and blood components to minimize transfusion errors and adverse reactions.
## 2. Scope
This procedure applies to the administration of:
- Packed red blood cells (PRBCs)
- Fresh frozen plasma (FFP)
- Platelets (random donor and apheresis)
- Cryoprecipitate
- Granulocytes
## 3. Responsibilities
### 3.1 Ordering Physician
- Determine transfusion indication
- Order appropriate blood component
- Obtain informed consent
- Respond to transfusion reactions
### 3.2 Blood Bank/Transfusion Service
- Perform compatibility testing
- Issue blood products
- Maintain inventory
- Investigate transfusion reactions
### 3.3 Nursing Staff
- Verify patient identity and blood product
- Administer transfusion
- Monitor for reactions
- Document transfusion
## 4. Definitions
| Term | Definition |
|------|------------|
| Crossmatch | Compatibility test between donor RBCs and recipient serum |
| Type and Screen | ABO/Rh typing and antibody screen |
| Transfusion Reaction | Adverse response to blood transfusion |
| Emergency Release | Issue of uncrossmatched blood in emergencies |
## 5. Procedure
### 5.1 Pre-Transfusion
1. **Physician Order Review**
- Verify order includes:
- Patient identification
- Blood product type
- Number of units
- Rate/duration
- Special requirements (irradiated, CMV-negative, etc.)
- Confirm indication appropriate
2. **Type and Screen/Crossmatch**
- Collect sample per specimen requirements
- Label at bedside with two identifiers
- Complete blood bank request form
- Allow time for testing (45 min - 1 hour typical)
3. **Informed Consent**
- Explain benefits and risks
- Discuss alternatives
- Answer patient questions
- Obtain written consent (FRM-BB-003)
- Document in medical record
4. **Pre-Transfusion Assessment**
- Baseline vital signs:
- Temperature
- Pulse
- Respiratory rate
- Blood pressure
- Assess IV access (18-20 gauge preferred)
- Review history of previous reactions
### 5.2 Blood Product Issue
1. **Request Blood from Blood Bank**
- Verify order and patient identification
- Note any special requirements
- Confirm expected time of transfusion
2. **Blood Bank Verification (Issue)**
- Match unit to patient (ABO, Rh, crossmatch)
- Check expiration date
- Inspect unit for abnormalities:
- Hemolysis
- Clots
- Discoloration
- Bag integrity
3. **Transport**
- Transport promptly (within 30 minutes)
- Do not store in nursing unit refrigerators
- Return to blood bank if transfusion delayed >30 min
### 5.3 Bedside Verification (CRITICAL)
**Two qualified staff must verify at bedside:**
| Item to Verify | Check |
|----------------|-------|
| Patient wristband name matches blood bag | ☐ |
| Patient wristband MRN matches blood bag | ☐ |
| Patient wristband DOB matches blood bag | ☐ |
| ABO/Rh on blood bag matches compatibility label | ☐ |
| Unit number on blood bag matches compatibility label | ☐ |
| Expiration date is valid | ☐ |
| Blood product type matches order | ☐ |
| Blood bag appears normal (no clots, hemolysis) | ☐ |
| Patient confirms identity (if possible) | ☐ |
**DO NOT TRANSFUSE IF ANY DISCREPANCY EXISTS**
### 5.4 Transfusion Administration
1. **Blood Administration Set**
- Use blood administration set with 170-260 micron filter
- Prime set with normal saline only
- Never add medications to blood products
- Maximum hang time: 4 hours
2. **Compatible IV Fluids**
| Compatible | NOT Compatible |
|------------|----------------|
| 0.9% Normal Saline | Lactated Ringer's |
| | Dextrose solutions |
| | Medications |
3. **Infusion Rates**
| Product | Initial Rate (first 15 min) | Routine Rate | Maximum Time |
|---------|---------------------------|--------------|--------------|
| PRBCs | 2 mL/min (50 mL) | Per order/tolerance | 4 hours |
| FFP | 2 mL/min | 10 mL/min or per order | 4 hours |
| Platelets | 2 mL/min | Per tolerance | 4 hours |
| Cryoprecipitate | 2 mL/min | Per tolerance | 4 hours |
4. **Monitoring Schedule**
| Time | Action |
|------|--------|
| Pre-transfusion | Baseline vital signs |
| 15 minutes | Vital signs + assessment |
| 30 minutes | Vital signs |
| Hourly | Vital signs |
| Post-transfusion | Final vital signs + assessment |
### 5.5 Transfusion Reaction Management
**Signs/Symptoms Requiring Immediate Action:**
- Fever (≥1°C rise)
- Chills/rigors
- Hypotension or hypertension
- Tachycardia
- Dyspnea/respiratory distress
- Chest or back pain
- Hives/urticaria/rash
- Nausea/vomiting
- Hemoglobinuria (dark urine)
- Anxiety/sense of doom
**Immediate Response:**
1. STOP the transfusion immediately
2. Keep IV line open with normal saline
3. Notify physician immediately
4. Check vital signs
5. Verify patient/blood product identities
6. Notify blood bank
7. Complete FRM-BB-004 Transfusion Reaction Report
8. Return blood bag and tubing to blood bank
9. Collect post-reaction blood and urine samples
**Reaction Workup**
| Sample | Purpose |
|--------|---------|
| EDTA tube (lavender) | DAT, visual hemolysis check |
| Clot tube (red/gold) | Repeat crossmatch, visual hemolysis |
| First voided urine | Hemoglobinuria |
| Blood cultures | If bacterial contamination suspected |
### 5.6 Post-Transfusion
1. **Documentation**
- Product type and unit number
- Start and end times
- Volume transfused
- Vital signs (all)
- Adverse reactions (or "none")
- Patient response
2. **Disposition of Blood Bag**
- Per facility policy (typically to blood bank)
- Retain for minimum time specified
## 6. Special Situations
### 6.1 Emergency/Massive Transfusion
- O-negative PRBCs for females of childbearing potential
- O-positive PRBCs for others acceptable in emergencies
- Type-specific blood as soon as available
- Activate massive transfusion protocol if indicated
### 6.2 Pediatric Transfusion
- Adjusted volumes (10-15 mL/kg)
- Smaller filter volumes
- Consider irradiated products
## 7. Documentation
- FRM-BB-003 Transfusion Consent Form
- FRM-BB-004 Transfusion Reaction Report
- Transfusion Record (in EMR or paper)
- Blood bank compatibility record
## 8. References
- AABB Standards for Blood Banks and Transfusion Services
- AABB Technical Manual
- FDA regulations 21 CFR 606
- Circular of Information for Blood and Blood Components
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Standard Operating Procedure: [Title]
| Document ID | SOP-XXX |
|-------------|---------|
| Title | [Title] |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | [DEPARTMENT] |
---
## 1. Purpose
[State the purpose of this procedure]
## 2. Scope
[Define the scope and applicability]
## 3. Responsibilities
### 3.1 [Role 1]
- [Responsibility]
- [Responsibility]
### 3.2 [Role 2]
- [Responsibility]
- [Responsibility]
## 4. Definitions
| Term | Definition |
|------|------------|
| | |
## 5. Procedure
### 5.1 [Section Title]
[Procedure steps]
### 5.2 [Section Title]
[Procedure steps]
## 6. Related Documents
- [List related procedures, forms, etc.]
## 7. References
- [External standards, regulations, etc.]
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |

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# Work Instruction: [Title]
| Document ID | WI-001 |
|-------------|--------|
| Title | [Title] |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | [DEPARTMENT] |
---
## 1. Purpose
[Describe the purpose of this work instruction]
## 2. Scope
[Define what activities this instruction covers]
## 3. Safety Precautions
- [List any safety requirements]
- [Personal protective equipment needed]
- [Hazards to be aware of]
## 4. Equipment/Materials Required
| Item | Specification |
|------|---------------|
| | |
| | |
## 5. Procedure
### Step 1: [Title]
[Detailed instructions]
### Step 2: [Title]
[Detailed instructions]
### Step 3: [Title]
[Detailed instructions]
## 6. Acceptance Criteria
[Define what constitutes successful completion]
## 7. Records
| Record | Location | Retention |
|--------|----------|-----------|
| | | |
## 8. References
- [Related SOPs]
- [Specifications]
- [Standards]
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |