136 lines
3.1 KiB
Markdown
136 lines
3.1 KiB
Markdown
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# Work Instruction: [Title]
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| Document ID | WI-001 |
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|-------------|--------|
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| Title | [Title] |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | [DEPARTMENT] |
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---
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## 1. Purpose
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[Describe the purpose of this work instruction. If pediatric-specific, indicate applicable age ranges.]
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## 2. Scope
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[Define what activities this instruction covers and any age-specific or population-specific limitations.]
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## 3. Safety Precautions
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[List safety requirements, especially important for procedures involving children:]
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- [Personal protective equipment needed]
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- [Hazards to be aware of]
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- [Child safety considerations]
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- [Parent/guardian presence requirements]
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- [Emergency procedures]
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## 4. Equipment/Materials Required
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| Item | Specification |
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|------|---------------|
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[For pediatric procedures, specify age-appropriate sizes, child-friendly materials, etc.]
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## 5. Prerequisites
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[List required training, certifications, or competencies needed to perform this work instruction]
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- [GCP certification]
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- [Pediatric-specific training]
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- [Procedure-specific competency]
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## 6. Procedure
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### Step 1: [Title]
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[Detailed instructions including child-specific considerations]
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**Materials needed:** [List]
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**Personnel:** [Who performs this step]
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**Documentation:** [What to record]
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### Step 2: [Title]
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[Detailed instructions]
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**Age-specific modifications:**
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- **Neonates/Infants:** [Specific approach]
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- **Children:** [Specific approach]
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- **Adolescents:** [Specific approach]
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### Step 3: [Title]
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[Detailed instructions]
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### Step 4: [Additional steps as needed]
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[Continue with detailed step-by-step instructions]
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## 7. Pediatric-Specific Considerations
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### 7.1 Age-Appropriate Communication
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- [How to explain procedure to child]
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- [Language to use]
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- [Visual aids or demonstrations]
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### 7.2 Family Involvement
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- [Parent/guardian role during procedure]
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- [When to request family step out]
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- [Family support and reassurance]
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### 7.3 Child Comfort and Cooperation
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- [Strategies to reduce anxiety]
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- [Distraction techniques]
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- [Rewards or positive reinforcement]
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- [When to pause or reschedule]
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### 7.4 Developmental Considerations
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- [Positioning for different ages]
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- [Expected cooperation levels by age]
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- [Restraint considerations (if absolutely necessary)]
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## 8. Acceptance Criteria
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[Define what constitutes successful completion]
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- [Quality standards]
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- [Completeness requirements]
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- [Child tolerance/comfort]
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## 9. Troubleshooting
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| Issue | Solution |
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|-------|----------|
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| Child refuses procedure | [Steps to take] |
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| Parent anxious | [Approach] |
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| Technical difficulty | [Resolution] |
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## 10. Records
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| Record | Location | Retention |
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|--------|----------|-----------|
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## 11. Related Documents
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- [Related SOPs]
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- [Study protocols]
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- [Specifications]
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- [Forms]
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## 12. References
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[Include relevant pediatric references:]
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- [Clinical guidelines]
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- [Pediatric standards]
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- [Regulatory requirements]
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---
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## Revision History
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| Rev | Date | Description | Author |
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|-----|------|-------------|--------|
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| 1.0 | [DATE] | Initial release | [AUTHOR] |
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