Create sop: Standard Operating Procedure for Pediatric Blood Draws

SOPs/Lab/SOP-LAB-001-Pediatric-Blood-Draws.md

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+---
+title: "Standard Operating Procedure for Pediatric Blood Draws"
+author: ""
+date: 2025-12-29
+version: "1.0"
+status: "Draft"
+---
+
+## 1. Purpose
+The purpose of this Standard Operating Procedure (SOP) is to define standardized, safe, and compliant procedures for performing pediatric blood draws for the FXROOTS clinical research study. This SOP ensures participant safety, data integrity, regulatory compliance, and consistency across clinical research coordinators and rotating clinic staff.
+
+## 2. Scope
+This SOP applies to:
+- Clinical Research Coordinators (CRCs)
+- Licensed clinical staff performing venipuncture or capillary blood collection
+- Rotating clinic staff supporting the FXROOTS study
+
+This SOP covers:
+- Preparation
+- Participant interaction
+- Blood collection procedures
+- Pediatric-specific safety considerations
+- Post-procedure care
+- Documentation and deviation handling
+
+## 3. Regulatory and Quality References
+- FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures  
+- FDA 21 CFR Parts 50, 56, 312 – Human Subjects Protection and Clinical Investigations  
+- ICH E6(R2) Good Clinical Practice (GCP)  
+- ISO 9001 – Quality Management Systems  
+- ISO 13485 – Medical Devices (as applicable to collection devices)  
+- FXROOTS Study Protocol  
+- Institutional Review Board (IRB) Approval Letter  
+
+## 4. Definitions
+| Term | Definition |
+|-----|------------|
+| Pediatric Participant | A study participant under the age defined in the FXROOTS protocol |
+| CRC | Clinical Research Coordinator |
+| Venipuncture | Collection of blood from a vein |
+| Capillary Collection | Blood collection via fingerstick or heelstick |
+| Adverse Event (AE) | Any unfavorable medical occurrence during or after blood draw |
+
+## 5. Roles and Responsibilities
+| Role | Responsibility |
+|-----|----------------|
+| Principal Investigator (PI) | Overall medical oversight and protocol compliance |
+| Clinical Research Coordinator | Preparation, participant interaction, blood draw (if qualified), documentation |
+| Licensed Clinical Staff | Perform blood draws per licensure and SOP |
+| Study Nurse | Pediatric assessment, escalation of clinical concerns |
+| Quality Assurance | SOP compliance and audit readiness |
+
+## 6. Required Training and Competency
+- Current GCP training
+- Pediatric phlebotomy competency documentation
+- Study-specific FXROOTS protocol training
+- Training on this SOP with documented acknowledgment
+
+*Training records must be maintained in the study regulatory binder.*
+
+## 7. Materials and Equipment
+- Age-appropriate blood collection kits
+- Pediatric butterfly needles or lancets
+- Tourniquet (pediatric size)
+- Alcohol swabs
+- Sterile gauze and adhesive bandages
+- Topical anesthetic (if approved by protocol)
+- Sharps container
+- Study-labeled collection tubes
+- PPE (gloves, masks as required)
+
+## 8. Pre-Blood Draw Procedures
+### 8.1 Participant Verification
+- Confirm participant identity using two identifiers
+- Verify informed consent and assent (if applicable)
+- Confirm eligibility per FXROOTS protocol
+
+### 8.2 Environment Preparation
+- Ensure a calm, child-friendly environment
+- Allow caregiver presence when appropriate
+- Prepare all materials before participant arrival
+
+### 8.3 Pediatric-Specific Preparation
+- Explain procedure in age-appropriate language
+- Assess anxiety level and pain tolerance
+- Utilize distraction techniques (toys, videos, caregiver support)
+- Apply topical anesthetic if permitted and documented
+
+## 9. Blood Collection Procedures
+### 9.1 General Safety Notes
+- Perform hand hygiene before and after procedure
+- Use PPE according to institutional policy
+- Never exceed protocol-specified blood volume limits
+- Continuously observe participant for distress
+
+### 9.2 Venipuncture Procedure (Step-by-Step)
+- Position participant securely and comfortably
+- Apply tourniquet appropriately
+- Select suitable vein with minimal attempts
+- Clean site with alcohol swab and allow to dry
+- Perform venipuncture using pediatric-approved device
+- Collect required volume per FXROOTS protocol
+- Release tourniquet before needle removal
+- Apply gauze and gentle pressure
+- Secure bandage once bleeding has stopped
+
+### 9.3 Capillary Collection Procedure (If Applicable)
+- Warm collection site if needed
+- Clean site thoroughly
+- Perform fingerstick or heelstick per pediatric guidelines
+- Wipe away first drop of blood
+- Collect required samples
+- Apply pressure and bandage
+
+## 10. Pediatric-Specific Contingencies
+- **Unsuccessful Attempt**: Limit attempts per protocol and institutional policy; escalate to experienced staff
+- **Participant Distress**: Pause or discontinue procedure; notify PI if required
+- **Syncope or Adverse Reaction**:
+  - Stop procedure immediately
+  - Place participant in safe position
+  - Notify PI and document as AE
+- **Caregiver Withdrawal of Assent**: Discontinue procedure and document
+
+## 11. Post-Blood Draw Care
+- Observe participant for minimum required time
+- Assess site for bleeding, bruising, or swelling
+- Provide caregiver with post-procedure instructions
+- Thank participant and caregiver
+
+## 12. Documentation Requirements
+- Record date, time, and type of blood draw
+- Document volume collected
+- Record any deviations or complications
+- Ensure entries comply with FDA 21 CFR Part 11 if electronic
+- File documentation in source records and study database
+
+## 13. Deviations and Noncompliance
+- Document deviations immediately
+- Notify PI according to study procedures
+- Submit deviation reports per institutional and sponsor requirements
+
+## 14. Quality Control and Auditing
+- Periodic review of blood draw records
+- Monitoring for adherence to protocol and SOP
+- Corrective and Preventive Actions (CAPA) as needed
+
+## 15. Revision History and Change Management
+- All changes to this SOP must follow document control procedures
+- Superseded versions must be archived
+
+## Version Control
+| Version | Date | Description of Change | Author |
+|--------|------|----------------------|--------|
+| 1.0 | 2025-12-29 | Initial Draft | "" |
+
+## Approval Signatures
+| Name | Title | Signature | Date |
+|-----|-------|-----------|------|
+| "" | Principal Investigator | "" | "" |
+| "" | Quality Assurance | "" | "" |
+| "" | Study Sponsor Representative | "" | "" |