2.2 Blood sampling can be done for various tests depending on the clinical research study.

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1 Document Number: SOP/07/V3 Title: Obtaining a Blood Sample (capillary) in children and young people Author: Liz Waxman Version 3 Effective Date: 16/5/2014 Periodic Review Date: 15/5/2017 Superseded version number and date (if applicable): Version 2 21/5/ Background 1.1 Capillary blood sampling from a finger, heel or (rarely) ear lobe may be performed on patients of any age, but are more commonly used in neonates and children. 1.2 This method is used for specific tests and where small quantities of blood are required. 1.3 Site selection for this method is dependent upon age and weight of the child/young person. 1.4 This method can be painful, but can also be quicker and less distressing as venepuncture. 2.0 Purpose 2.1 This Standard Operating Procedure (SOP) describes the correct procedure for obtaining capillary blood samples in children and young people for clinical research studies. Where blood specimens are required for a clinical research study all effort will be made to ensure this coincides with blood sampling for routine clinical investigations to decrease the risk of infection, trauma and distress to the child. 2.2 Blood sampling can be done for various tests depending on the clinical research study. 2.3 The risks to the participant associated with this procedure include discomfort, bruising or if an incorrect technique is used, it can lead to localised swelling, tenderness or increased hyper-sensation and growth disturbances of the hind part of the foot. 3.0 Scope This SOP applies to the correct procedure to be followed when obtaining capillary blood samples in children and young people for all studies. Page 1 of 5

2 4.0 Responsibilities 4.1 Only study staff appropriately trained in the procedure will be responsible for capillary blood sampling of participants as per section 2.8 of the ICH GCP guidelines. 4.2 All bodily fluids should be considered as potentially infectious material and should be handled accordingly. 5.0 Procedures 5.1 Equipment: lancet, topical anaesthetic cream, appropriate cleansing agent, blood specimen containers, sealable bag, foil tray, sharps bin, disposable gloves, cotton wool balls or gauze squares, plasters. 5.2 Inform the participant of the need for the procedure and obtain verbal consent before obtaining blood samples. Ask if the participant requires a topical anaesthetic cream applied to the intended puncture site this should be done 1 hour prior to blood sampling for emla cream and 45 minutes prior to blood sampling for ametop and must be covered with a waterproof dressing. 5.3 Enquire if the participant has any previous experience of adverse reaction to needle/sight of blood etc. (if so, then offer to carry out the procedure while the participant lies down on a bed or couch). 5.4 Observe the participant throughout the process to for pallor/sweating, which may indicate a tendency to faint. 5.5 Wash and dry hands thoroughly. 5.6 Have at hand the tray with all the required equipment, blood bottles, sharps bin, etc. 5.7 Selecting a site: Heel pricks should only be performed on babies under four months of age. The technique cannot be performed on poorly perfused, oedematous, inflamed or swollen tissues. Never obtain a sample from the fingers of neonates as they will become damaged due to their delicate nature. Do not use a previous puncture site as the blood flow will be reduced and tissue damage can occur to the finger or heel. Page 2 of 5

3 When obtaining a sample from the heel the most medial or lateral portion of the heel should be identified. Punctures should never be made on the posterior curvature of the heel below the Achilles tendon, where the bone is closest to the skin or the arch of the foot. Correct puncture site for a heel prick Correct puncture site for a finger prick Diagrams taken from RCN Workbook: Capillary Blood Sampling and Venepuncture in Children and Young People 5.8 Clean skin as per local policy. Disposable gloves should be worn. 5.9 Hold the lancet firmly at the chosen site and release the needle to puncture the skin, discard the lancet in the sharps bin Collect the required amount of blood directly into the appropriate blood tube. Apply pressure on the puncture site to stem the flow of blood. Pressure should be applied until bleeding has ceased (this can be done by the participant themselves or their parent or guardian). Apply a plaster if required. Page 3 of 5

4 5.11 Invert the blood tubes if required Blood samples should then be accurately labelled with the information required and sent to the laboratory or stored in a freezer at the temperature described in the protocol until there are enough samples to be sent to the laboratory Document the date and time of obtaining the sample in the CRF and participant s medical file if appropriate along with any results once known. This is in accordance with section 2.10 of ICH GCP guidelines. Additional information: If sufficient blood has not been collected then a second site needs to be punctured. A maximum of two attempts can be made then assistance must be obtained from medical staff. If the puncture site is milked, this can result in a haemolysed sample, which may give abnormal or inaccurate results. If the participant feels faint during the procedure, STOP immediately. Lay him/her flat and elevate legs. Stay with them until they feel well again. Arrange to take the sample at a later time or date and document as an Adverse Event. 6.0 Related Documents & references Study protocol Case Report Form ICH/GCP Directive/guidelines Capillary Blood Sampling and Venepuncture in Children and Young People, RCN Workbook to Assist Practitioners in Developing Competence RCN Competencies: an education and training competency framework for capillary blood sampling and venepuncture in children and young people. WHO Guidelines on drawing blood: best practices in phlebotomy Appendices No appendices, diagrams included in content Page 4 of 5

5 8.0 Approval & sign off Author: Name: Liz Waxman Position: Lead Paediatric Nurse, Glasgow Signatures: Date: 16/5/2014 Approved by: Name: Pam Dicks Position: Network Manager Signature: Date:16/5/2014 Authorised by: Name: Prof Stephen Greene Position: Network Director Signature: Date: 16/5/2014 Revision History Document number and version SOP3/V3 SOP3/V3 Reviewer Comments and/or changes References updated, no changes to content New SOP template, no changes to content Date of Review Reviewers Signature 5/5/14 Liz Waxman 22/5/14 Susan MacFarlane Page 5 of 5