Sync template from atomicqms-style deployment

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/Imaging-Procedures/SOP-RAD-001-CT-Protocol.md

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+# Standard Operating Procedure: CT Imaging Protocol
+
+| Document ID | SOP-RAD-001 |
+|-------------|-------------|
+| Title | Computed Tomography (CT) Imaging Protocol |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Radiology/Diagnostic Imaging |
+
+---
+
+## 1. Purpose
+
+To establish standardized procedures for performing computed tomography (CT) examinations to ensure patient safety, optimal image quality, and regulatory compliance with ACR, state, and federal requirements.
+
+## 2. Scope
+
+This procedure applies to all CT examinations including:
+- Non-contrast CT studies
+- Contrast-enhanced CT studies
+- CT angiography (CTA)
+- CT-guided procedures
+- Emergency/trauma CT
+
+## 3. Responsibilities
+
+### 3.1 CT Technologist
+- Screen patients for contraindications
+- Position patient properly
+- Select and execute protocols
+- Assess image quality
+- Monitor patient during examination
+
+### 3.2 Radiologist
+- Approve protocols
+- Supervise contrast administration
+- Interpret studies and generate reports
+- Manage contrast reactions
+
+### 3.3 Radiology Nurse (if applicable)
+- Assess IV access
+- Administer contrast
+- Monitor for reactions
+- Provide patient care
+
+### 3.4 Medical Physicist
+- Establish dose optimization protocols
+- Perform quality control
+- Monitor radiation exposure
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| CTDI | CT Dose Index - measure of radiation output |
+| DLP | Dose Length Product - total dose metric |
+| HU | Hounsfield Units - density measurement |
+| kVp | Kilovoltage peak |
+| mAs | Milliampere-seconds |
+| MPR | Multiplanar reconstruction |
+
+## 5. Equipment and Materials
+
+- CT scanner (accredited)
+- Power injector
+- Contrast media (iodinated)
+- IV supplies
+- Emergency equipment and medications
+- Shielding devices
+- Patient monitoring equipment
+
+## 6. Procedure
+
+### 6.1 Pre-Examination
+
+#### 6.1.1 Order Verification
+- [ ] Valid physician order present
+- [ ] Appropriate indication documented
+- [ ] Protocol selection appropriate for indication
+- [ ] Prior imaging reviewed (if available)
+
+#### 6.1.2 Patient Identification
+- Verify using two identifiers
+- Confirm exam matches order
+- Review clinical history
+
+#### 6.1.3 Safety Screening
+
+**For all patients:**
+- [ ] Pregnancy status (women of childbearing age)
+- [ ] Previous CT studies (cumulative dose awareness)
+- [ ] Ability to cooperate with positioning
+- [ ] Metal implants/devices in scan field
+
+**For contrast studies - additional screening:**
+
+| Risk Factor | Check |
+|-------------|-------|
+| Previous contrast reaction | ☐ Yes ☐ No |
+| Allergies (iodine, shellfish) | ☐ Yes ☐ No |
+| Kidney disease/elevated creatinine | ☐ Yes ☐ No |
+| Diabetes (metformin use) | ☐ Yes ☐ No |
+| Thyroid disease | ☐ Yes ☐ No |
+| Multiple myeloma | ☐ Yes ☐ No |
+| Age >70 years | ☐ Yes ☐ No |
+| Dehydration | ☐ Yes ☐ No |
+
+**Renal Function Assessment:**
+| eGFR Level | Risk | Action |
+|------------|------|--------|
+| ≥60 | Low risk | Proceed |
+| 45-59 | Moderate risk | Hydration, consider alternatives |
+| 30-44 | High risk | Alternative imaging preferred, radiologist approval |
+| <30 | Very high risk | Avoid unless emergent, nephrology consult |
+
+#### 6.1.4 Consent
+- Explain procedure and risks
+- Obtain informed consent for contrast (if applicable)
+- Document consent
+
+### 6.2 Patient Preparation
+
+#### 6.2.1 Preparation by Exam Type
+
+| Exam Type | Preparation Required |
+|-----------|---------------------|
+| Head CT | Remove metallic objects from head/neck |
+| Chest CT | Breathing instructions, arms above head |
+| Abdomen/Pelvis CT | Oral contrast (if ordered), full bladder (pelvic) |
+| CT Angiography | IV access, contrast protocol |
+| CT Colonography | Bowel preparation |
+
+#### 6.2.2 IV Access for Contrast
+- Assess vein suitability
+- 20-gauge or larger preferred for power injection
+- Verify patency with saline flush
+- Secure catheter properly
+
+### 6.3 Patient Positioning
+
+#### 6.3.1 Standard Positions
+
+| Body Part | Position | Gantry Entry |
+|-----------|----------|--------------|
+| Head | Supine, neutral | Head first |
+| Neck | Supine, neck extended | Head first |
+| Chest | Supine, arms up | Head or feet first |
+| Abdomen | Supine, arms up | Head first |
+| Pelvis | Supine, arms up | Feet first |
+| Extremity | Per protocol | Varies |
+
+#### 6.3.2 Positioning Considerations
+- Center patient in gantry
+- Use positioning aids as needed
+- Apply shielding where appropriate
+- Ensure patient comfort
+- Remove all artifacts from scan field
+
+### 6.4 Protocol Selection and Parameters
+
+#### 6.4.1 Dose Optimization Principles
+- ALARA (As Low As Reasonably Achievable)
+- Use automatic exposure control (AEC)
+- Size-appropriate protocols
+- Limit scan range to clinical question
+
+#### 6.4.2 Standard Protocol Parameters
+
+| Protocol | kVp | mAs | Slice Thickness | Pitch |
+|----------|-----|-----|-----------------|-------|
+| Head routine | 120 | Auto | 5mm | N/A (axial) |
+| Chest routine | 120 | Auto | 5mm/1.25mm | 1.0-1.5 |
+| Abdomen routine | 120 | Auto | 5mm/2.5mm | 1.0-1.5 |
+| CT Angiography | 100-120 | Auto | 0.625-1.25mm | 0.8-1.0 |
+| Low-dose chest | 100-120 | Reduced | 1.25mm | 1.0-1.5 |
+
+#### 6.4.3 Pediatric Considerations
+- Reduce kVp and mAs based on weight/age
+- Use pediatric-specific protocols
+- Apply "Image Gently" principles
+- Minimize number of phases
+
+### 6.5 Contrast Administration
+
+#### 6.5.1 Contrast Selection
+
+| Indication | Contrast Type | Concentration |
+|------------|---------------|---------------|
+| Routine enhanced | Low-osmolar | 300-350 mgI/mL |
+| CT Angiography | Low-osmolar | 350-370 mgI/mL |
+| High-risk patients | Iso-osmolar | 270-320 mgI/mL |
+
+#### 6.5.2 Contrast Volume and Rate
+
+| Exam Type | Volume | Rate |
+|-----------|--------|------|
+| Head with contrast | 100 mL | 1-2 mL/sec |
+| Chest with contrast | 100-125 mL | 2-3 mL/sec |
+| Abdomen with contrast | 100-150 mL | 2-3 mL/sec |
+| CT Angiography | 75-125 mL | 4-5 mL/sec |
+
+#### 6.5.3 Timing Methods
+- Fixed delay (empiric)
+- Bolus tracking (threshold trigger)
+- Test bolus (timing determination)
+
+### 6.6 Image Acquisition
+
+1. **Scout/Topogram**
+   - Acquire scout images
+   - Verify positioning and coverage
+   - Set scan range
+
+2. **Pre-Contrast (if applicable)**
+   - Acquire non-contrast images
+   - Assess for baseline findings
+
+3. **Contrast Injection (if applicable)**
+   - Verify IV patency
+   - Program injector parameters
+   - Monitor injection
+
+4. **Post-Contrast Acquisition**
+   - Acquire at appropriate phase(s)
+   - Arterial: 25-35 seconds
+   - Portal venous: 60-70 seconds
+   - Delayed: 3-5 minutes (as needed)
+
+5. **Image Review**
+   - Review images for quality
+   - Assess for artifacts
+   - Repeat if technically inadequate
+
+### 6.7 Post-Examination
+
+#### 6.7.1 Patient Care After Contrast
+- Monitor for 15-30 minutes
+- Assess IV site
+- Provide hydration instructions
+- Advise on potential delayed reactions
+- Metformin patients: follow institutional protocol
+
+#### 6.7.2 Documentation
+- Complete FRM-RAD-001 CT Procedure Log
+- Document dose metrics (CTDIvol, DLP)
+- Record contrast details
+- Note any adverse events
+- Submit images to PACS
+
+### 6.8 Image Post-Processing
+
+| Reconstruction | Application |
+|----------------|-------------|
+| Soft tissue | Routine interpretation |
+| Bone | Skeletal evaluation |
+| Lung | Pulmonary parenchyma |
+| 3D/MPR | Vascular, complex anatomy |
+| MIP | Angiography |
+
+## 7. Contrast Reaction Management
+
+### 7.1 Reaction Classification
+
+| Severity | Symptoms | Action |
+|----------|----------|--------|
+| Mild | Nausea, urticaria (limited), warmth | Observe, treat symptoms |
+| Moderate | Extensive urticaria, bronchospasm, hypotension | Medical treatment, monitor |
+| Severe | Anaphylaxis, cardiac arrest, seizure | Emergency response, call code |
+
+### 7.2 Emergency Equipment
+Available in CT suite:
+- Oxygen and suction
+- Emergency medications (epinephrine, diphenhydramine, etc.)
+- IV fluids
+- Defibrillator/AED
+- Crash cart
+
+## 8. Radiation Safety
+
+### 8.1 Dose Monitoring
+- Record CTDIvol and DLP for each exam
+- Compare to diagnostic reference levels
+- Investigate outliers
+
+### 8.2 Diagnostic Reference Levels
+
+| Exam | CTDIvol (mGy) | DLP (mGy·cm) |
+|------|---------------|--------------|
+| Head | 60 | 1000 |
+| Chest | 15 | 400 |
+| Abdomen | 20 | 700 |
+| Abdomen/Pelvis | 20 | 900 |
+
+## 9. Quality Control
+
+| Activity | Frequency |
+|----------|-----------|
+| Daily warm-up and calibration | Daily |
+| Water phantom QC | Daily/Weekly |
+| CT number accuracy | Weekly |
+| Spatial resolution | Monthly |
+| Physicist review | Annually |
+
+## 10. Documentation
+
+- FRM-RAD-001 CT Procedure Log
+- FRM-RAD-002 Contrast Administration Record
+- FRM-RAD-003 Adverse Reaction Report
+- Dose reports
+- QC logs
+
+## 11. References
+
+- ACR Practice Parameter for CT
+- ACR Manual on Contrast Media
+- Image Gently Campaign
+- AAPM CT Protocols
+- State radiation regulations
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/Safety/.gitkeep

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+# Placeholder