Clinical Practice Guideline

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1 Clinical Practice Guideline COMMERCIAL UMBILICAL CORD BLOOD COLLECTION GUIDELINES FOR HEALTHCARE PROFESSIONALS Author Version Philippa Cox V1 Version Date July 2012 Implementation Date July 2012 Review Date 2015 File Reference Table of Contents 2.0 Definition Introduction Objectives Practice recommendations Information for women References / Bibliography 5 Appendix 1 Consultation 6 Appendix 2 Equality Impact Assessment 7 Document Control Summary 9 Signatures 10 1

2 COMMERCIAL UMBILICAL CORD BLOOD COLLECTION GUIDELINES FOR HEALTHCARE PROFESSIONALS 2.0 Purpose The purpose of these guidelines is to confirm Homerton University NHS Foundation Trust s ( the Trust ) position on commercial collection of umbilical cord blood in order to support midwives and doctors in relation to their professional practice. 3.0 Introduction The Trust does not support the commercial collection of umbilical cord blood for the purpose of retrieving and storing stem cells. The Trust s position is based on recommendations of both the Royal College of Midwives (2011) and the Royal College of Obstetricians and Gynaecologists (2006). There is insufficient scientific evidence to support this practice and there are a number of significant practical concerns. In addition, this procedure will require a license from the Human Tissue Authority (HTA) under the terms of the Human Tissue Act. The hospital does not have this license. 4.0 Principles All women will be advised of the Trust s position on stem cell retrieval when requests are made known. It is not acceptable to expect healthcare professionals and the Trust to be responsible or liable for the quality or quantity of the sample collected or any delay in transportation or storage, as there are many concerns around this procedure and this is a commercial operation. 5.0 Practice recommendations Issues/Risk Factors arising from commercial umbilical cord blood collection on demand It is acknowledged that stem cell harvesting may appeal to some expectant parents; however, the practice poses a number of logistical, legal and ethical questions and problems for midwives, obstetricians, parents and NHS Trusts: 1 The procedure for collecting such samples is cumbersome and detracts from the primary important tasks performed by the midwife/obstetrician during the third stage of labour. A considerable volume of blood has to be collected from the umbilical cord requiring multiple syringes with strict aseptic technique. Because of the complexity of this collection, it may not be possible to adhere to the necessary instructions and obtain either sufficient blood quantity or avoid contamination. 2 The collection is made during the third stage of labour, a point when both the mother and the newborn baby require close attention. Attempting this collection could distract attention from the primary purpose of providing appropriate care for the mother and baby. 2

3 3 The collection of the cord blood may distract labour ward staff from the care of other patients. 4 There are health and safety implications related to introducing additional needles during the third stage of labour and the increased risk of needle stick injury. 5 NHS Trusts should not be liable for any adverse incidents or other problems, which may occur during a procedure that is not clinically indicated. For example, failure to obtain specimen, insufficient blood collection, mis-labelling, contamination or delay in transportation or storage Requirements for Midwives and Obstetricians Midwives and Obstetricians must: 1 Familiarise themselves with the Trust s policy and the evidence and the issues around stem cell harvesting so they can discuss them with women and families as appropriate. 2 Explain to parents that the Trust does not support commercial stem cell collection. 3 Inform parents that the Trust does not have the required HTA license. 4 Inform parents that the Trust will not help or hinder parents who make their own private arrangement. 5 Make clear and accurate records detailing any discussion held with parents. 6 Send the standard letter attaching Forms A and B to the expectant parents and record that this has been done in the medical records (see appendix 1). 7 Not under any circumstances collect commercial umbilical cord blood samples. In the event of a woman wishing to arrange for the collection of stem cells using a private company they may only do this on the Trust s premises if they and their chosen private organisation comply with the obligations set out in Form A and Form B. This includes: Providing the Trust with written confirmation in advance, to the Head of Midwifery, that the commercial company with whom they have made a private arrangement holds a valid HTA licence; and Confirmation they have made arrangements for a phlebotomist or trained technician from the commercial company to obtain the sample or confirm that the person to take the blood has a third party agreement (TPA) with the commercial company; Returning a signed copy of Form A and Form B. In order to comply with RCOG guidance and to maximise safety of mother, baby and staff Midwives and Obstetricians must ensure: 3

4 1 Intended collection of cord blood should not proceed where the attending clinician believes it is contraindicated, such as where there is a nuchal cord or maternal haemorrhage. 2 Usual clinical practice should take precedence over elective cord blood collection e.g. there should be no pressure on clinical staff to avoid cutting the cord to allow delivery (e.g. when the cord is around the neck) and taking of umbilical blood samples for blood gas analysis should not be delayed. 3 Collection of cord blood should be made from the ex-utero separated placenta i.e. the blood must not be taken while staff are attempting to deliver the placenta. 4 There should be no alteration or delay in the usual management of the third stage of labour or the management of complications such as postpartum haemorrhage. 5 The person attending to take the blood should agree to abide by the Trust s health and safety policies and to take safe responsibility for the safe disposal of any needles/sharps. 6 Collection of blood should take place within the delivery suite/ward/theatre but outside of the delivery room. 7 Even if the phlebotomist/trained technician is not present or does not arrive in time, Trust staff must not take the blood. 1.1 Information for women Women should be advised of the Trust s position on stem cell retrieval and the need for formal notification of commercial collection if the issue is raised. Any woman considering private stem cell collection must be sent the letter and forms at Appendix 1. More information can be found on the following websites: Human Tissue Authority Position statement on cord blood collection (March 2010) - Human Tissue Authority Cord blood collection FAQs for parents: rpatienttreatment/cordbloodcollectionfaqsforparents.cfm RCOG Cord Blood banking: information for parents REFERENCES/ BIBLIOGRAPY The Royal College of Midwives position statement- Commercial cord blood collection, The Royal College of Obstetricians and Gynaecologists Scientific Advisory Committee, London. (2006) Umbilical Cord Blood Banking. Opinion Paper 2, June 2006 Available at: The Royal College of Obstetricians and Gynaecologists (2006) RCOG advice on Umbilical Cord Blood Banking and Storage. 4

5 Appendix 1 List of all staff consulted as part of guideline development First Consultation Head of Midwifery Joan Douglas Clinical lead Katrina Erskine Consultant Obstetrician Maryam Parisaei Maternity clinical risk manager Annette Anderson Consultant midwife Philippa Cox Supervisor of Midwives: Beavle Scantlebury, Jocelyn Walder, Audrey Crawford, Shona Solly, Rosabell Ramesar, Esther Boye, Jane Kennedy, Sarah Latham, Paula Griffin (St SoM) and Dona Thomas (St SoM). Delivery suite matron Janet Bradley Final Consultation Head of Midwifery Joan Douglas Clinical lead Katrina Erskine Consultant Obstetrician Maryam Parisaei Maternity clinical risk manager Annette Anderson Consultant midwife Philippa Cox Supervisor of Midwives: Beavle Scantlebury, Jocelyn Walder, Audrey Crawford, Shona Solly, Rosabell Ramesar, Esther Boye, Jane Kennedy, Sarah Latham, Paula Griffin (St SoM) and Dona Thomas (St SoM). Delivery suite matron Janet Bradley Legal Services manager Nicola Havutcu Bevan Brittan solicitors Tracy Saunby 5

6 Appendix 2 EQUALITIES IMPACT ASSESSMENT FOR CLINICAL POLICIES AND GUIDELINES 1. This checklist should be completed to determine if the proposed Policy is relevant to the Trust s duties under its Equalities Schemes. Policy name: Commercial umbilical cord blood Collection. Author: Philippa Cox Designation: Consultant Midwife / SoM Directorate: Date: 20/6/12 Check Yes No Will the proposed policy involve or have consequences for the patients or staff of the Trust and could these consequences differ according to people s racial group, gender or disability, for example, because they have particular needs, experiences or priorities? Is there any reason to believe that people could be affected differently by the proposed policy, according to their racial group, gender or disability, for example in terms of access to a service, or the ability to take advantage of proposed opportunities? Is there any evidence that any part of the proposed policy could discriminate unlawfully, directly or indirectly, against people from some racial groups, a particular gender or those with a disability? Is there any evidence that people from some racial groups, or people with a disability or of a particular gender, may have different expectations of the policy in question? Is the proposed policy likely to affect relations between certain racial groups, gender, or people with a disability, for example it is seen as favouring a particular group or denying opportunities to another? Is the proposed policy likely to damage relations between any particular racial group(s), gender or people with a disability and your authority? 6

7 EQUALITIES IMPACT ASSESSMENT FOR CLINICAL POLICIES AND GUIDELINES 2. If any of the questions are answered yes, then the proposed policy is likely to be relevant to the Trust s responsibilities under the equalities duties. Please provide the ratifying committee with information on why yes answers were given and whether or not this is justifiable for clinical reasons. The author should consult with the Director of Corporate Development and/or the Director of HR to develop a more detailed assessment of the Policy s impact and, where appropriate, design monitoring and reporting systems if there is any uncertainty. 3. A copy of the completed form should be submitted to the ratifying committee when submitting the document for ratification. The Committee will inform you if they perceive the Impact to be sufficient that a more detailed assessment is required. In this instance, the result of this impact assessment and any further work should be summarised in the body of the Policy and support will be given to ensure that the policy promotes equality. 7

8 Document Title Author (s) and Grade (s) Department Document Control Summary Commercial collection of umbilical cord blood Philippa Cox Consultant Midwife / Supervisor of Midwives Maternity Date of Production 20/6/12 Planned implementation date: Purpose/Aim of Document Circulated to NB: The CNST group will not accept any CPG without circulation list 2/7/12 To inform Trust staff and women who use the maternity service of the Trust s position on the commercial collection of umbilical cord blood. See appendix 1 for staff consulted Status Update Frequency 3yrs unless new evidence requires and earlier update Next Review Date June 2015 Approved By NB: The CNST group will not accept any CPG without minutes verifying local/expert approval Archive of earlier versions of the guideline No previous guideline Document Checklist to be filled in by Ratifying Committee Is the Document using the correct Yes Template? Is the Circulation List Representative? Yes Is there an Evidence Base (where Yes required)? Is it signed off at the appropriate level? Does it have an Equalities Impact Yes Assessment that is satisfactory? Does it need to go to other committees No (has been approved by Trust for ratification? solicitors) Name. Version and version date Page 8 of 9.

9 COMMERCIAL UMBILICAL CORD BLOOD COLLECTION GUIDELINES FOR HEALTHCARE PROFESSIONALS These guidelines have been signed off by the Maternity Risk Management Group Signed: Date: Signed by Head of Midwifery Signed: Date: Signed by Clinical Director Signed: Date: Signed by Supervisor of Midwives (For guidelines with Trust wide scope.) These guidelines have been approved by the Chair of the Trusts Clinical Governance Committee Signed: Date: Charlie Sheldon Director of Nursing and Quality Name. Version and version date Page 9 of 9.

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