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

title, author, date, version, status

title	author	date	version	status
Standard Operating Procedure for Pediatric Blood Draws		2025-12-29	1.0	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	""	""