Sync template from atomicqms-style deployment

SOPs/Donor-Services/SOP-BB-001-Donor-Screening.md

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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] |

SOPs/General/SOP-001-Document-Control.md

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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] |

SOPs/General/SOP-002-CAPA.md

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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] |

SOPs/General/SOP-003-Training.md

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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] |

SOPs/General/SOP-004-Internal-Audit.md

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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] |

SOPs/General/SOP-005-Management-Review.md

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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] |

SOPs/Safety/.gitkeep

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+# Placeholder

SOPs/Transfusion/SOP-BB-002-Blood-Transfusion.md

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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] |