Clinical Practice Guideline

Clinical Practice Guideline STEM CELL COLLECTION GUIDELINES FOR HEALTHCARE PROFESSIONALS Author Version Philippa Cox V2 Version Date March 2016 Implementation Date March 2016 Review Date March 2019 File Reference 170/swsh/mat/Stem Cell Collection /PC Table of Contents 20 Purpose 2 30 Introduction 2 40 Principles 2 50 Practice recommendations 2 51 Information for women 4 References / Bibliography 4 Appendix 1 - Guidance for private stem cell phlebotomists 5 Appendix 2 - Form A 8 Appendix 3 - Form B 10 Appendix 4 - Consultation 12 Appendix 5 Equality Impact Assessment 13 Document Control Summary 15 Signatures 16 Page 1 of 16

Version Control Box Version Date Author(s) Reason Ratification 1 July 2012 Philippa Cox 2 Feb 2016 Philippa Cox Update guidance COMMERCIAL UMBILICAL CORD BLOOD COLLECTION GUIDELINES FOR HEALTHCARE PROFESSIONALS 20 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 30 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 the joint statement issued by the Royal College of Midwives (RCM) and the Royal College of Obstetricians and Gynaecologists RCOG) (2011), that there is insufficient scientific evidence to support this practice and there are a number of significant practical concerns In addition, this procedure requires a license from the Human Tissue Authority (HTA) under the terms of the Human Tissue Act The hospital does not have this license 40 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 50 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: Page 2 of 16

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 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 t 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/RCM guidance in their position statement (2011) and to maximise safety of mother, baby and staff Midwives and Obstetricians must ensure: Page 3 of 16

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 eg there should be no pressure on clinical staff to avoid cutting the cord to allow delivery (eg 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 ie 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 51 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 (Appendix 1) More information can be found on the following websites: Human Tissue Authority Guidance for professionals https://wwwhtagovuk/guidance-professionals Human Tissue Authority Cord blood collection FAQs for parents: https://wwwhtagovuk/cord-blood-banking-guide-parents NHS cord blood bank website http://wwwnhsbtnhsuk/cordblood/cordblood/ REFERENCES/ BIBLIOGRAPY The RCM/RCOG joint position statement on umbilical cord blood collection and banking 2011, https://wwwrcmorguk/sites/default/files/joint%20statement%20-%20ucb%20- %20aug%2011%20(6)%20v2pdf Accessed on 29/2/16 Page 4 of 16

Appendix 1 Guidance for Independent Stem Cell Phlebotomist/Companies working within Trust premises 1 The Trust requires evidence of Independent stem cell phlebotomist s/company s Human Tissue Authority (HTA) licence to carry out commercial umbilical cord blood collection 2 Required evidence of recent CRB clearance (within last 3 years) 3 The Trust should receive prior notification of intent by 36/40 appointment from independent stem cell phlebotomist /company with information relating to company and named stem cell phlebotomist with evidence of above two criteria 4 Clear visible photographic means of identification must be displayed at all times 5 The Trust takes no responsibility for informing and notifying the Independent Stem Cell phlebotomist/company of onset of labour or imminent birth 6 Independent stem cell phlebotomist must wait in the reception area in the Delivery Suite until collected by birth partner 7 The Independent stem cell phlebotomist may be collected and brought to the sluice room at an appropriate time and as previously discussed and agreed with parents 8 Collection of cord bloods for Rhesus factor or any other medical reason must take precedence over stem cell blood collection which will be performed by midwifery/obstetric staff 9 Negotiation with Midwife/Obstetrician and parents as to the optimum opportunity for stem cell blood collection to take place 10 In the event of a medical emergency such as post partum haemorrhage, medical treatment MUST take priority over commercial umbilical cord blood collection 11 If at any point the independent stem cell phlebotomist is requested to vacate the birthing room this must be complied with 12 Once the blood sample is obtained, the sole responsibility of the sample lies with the independent stem cell phlebotomist 13 All equipment required for the commercial umbilical cord blood collection must be provided by the independent stem cell phlebotomist 14 Safe disposal and removal of sharps and syringes is the responsibility of the independent stem cell phlebotomist/company Guideline on staff involvement and responsibility with cord blood collection for stem 15 At all times, professional, discreet and courteous behaviour is expected and the Trust s Infection control policies must be adhered to Guideline on staff involvement and responsibility with cord blood collection for stem cells September 2011 Letter of understanding for engaging an Independent Cell Phlebotomist/Company To: Head of Midwifery Homerton University Hospital NHS Trust Homerton Row London Page 5 of 16

E9 6SR I, (Full name) of, (Full address) intend to arrange for the collection of my stem cell blood using (Name of Independent Stem Cell Company/Phlebotomist) Homerton University Hospital NHS Foundation Trust The Trust has a Policy that it will not become involved in stem cell collection other than for medical purposes Furthermore, the Trust understands there is no clinical reason for this procedure to be considered on the NHS If you remain committed to arranging the procedure at your own cost, then the Trust will not prevent this happening This has to be on the basis that the Trust and its staff are in no way involved in the procedure, and it is also very clear that we are not condoning it Effectively this is a procedure, which we do not consider necessary which commercial supplier is now being asked to undertake/assist in Disclaimer I acknowledge and understand that under the Trust s current policy on commercial umbilical cord blood collection, the Trust will only support stem cell collection on its premises where a clinician has evidence that there is a clinical benefit to the collection I understand that the Trust is not licensed by the Human Tissue Authority to participate in the collection or storage of stem cells from umbilical cord blood for commercial purposes and as a result of the above I am aware that the Trust will not become involved in commercial umbilical cord blood collection (ie where a patient of the Trust is arranging for the stem cell blood to be collected privately) I understand and acknowledge that in connection with my care, treatment and support on admission to and whilst at Homerton University Hospital: Guideline on staff involvement and responsibility with cord blood collection for stem cells September 2011 1 The Trust and its staff will have no involvement in or responsibility for the commercial umbilical cord blood collection procedure that is to be carried out by an independent stem cell phlebotomist/company 2 The independent stem cell phlebotomist/company will be made aware by myself / partner of the guidance as laid down by the Trust and the expectation of their compliance with the guidance 3 The Trust has an overriding duty to preserve my health and safety and that of my baby/babies The Trust s staff may therefore direct that it is necessary in the best interests of myself and/or my baby/babies to abandon the commercial umbilical cord blood collection procedure In the event that the procedure is abandoned, I confirm that I shall not seek to hold the Trust responsible for any liabilities, costs, damages, expenses or losses suffered or incurred by me or my partner/ independent stem cell phlebotomist/company as a result 4 My independent stem cell phlebotomist not, and is not acting as, an employee, servant or agent of the Trust Page 6 of 16

5 To the extent permitted by law, the Trust is not responsible for any acts or omissions of mine and my partner/ my independent stem cell phlebotomist which result in death, injury or other loss in relation to the commercial umbilical cord blood collection 6 If the stem cells collected are found to be inadequate in any way, at any time in the future, due to any cause which may or may not be associated with my antenatal care or the delivery, the Trust shall not, except as required by law, be responsible for any liabilities, costs, damages, expenses or losses suffered or incurred by me or my partner/ independent stem cell phlebotomist /company as a result Name: Name: (both parents) Signature: Signature: Date: Estimated date of delivery (EDD) of your baby: Hospital number: (Found at the top of your name and address label, affixed to your notes) Name of company engaged to take the cord sample: After completion, please return to: Head of Midwifery at Homerton University hospital, Homerton Row, London, E9 6SR Page 7 of 16

Appendix 2 Homerton University Hospital Maternity department Homerton Row London E9 6SR Form A Tel: [insert telephone number] Email: [insert email address] Private umbilical cord blood collection to be signed and returned to the Trust 8 I acknowledge and understand the Trust s policy on private umbilical cord blood collection I understand that the Trust is not licensed by the Human Tissue Authority ( HTA ) to participate in the collection or storage of stem cells from umbilical cord blood for private purposes 9 I am aware that the Trust will not become involved in umbilical cord blood collection for private purposes and that the Trust and its staff will have no involvement in or responsibility for the umbilical cord blood collection procedure that is to be carried out on my behalf 10 I understand that my chosen private bank must be licensed by the HTA and that the cord blood collection must be carried out by an independent stem cell phlebotomist that is employed by the chosen private bank or otherwise has a Third Party Agreement in place with them 11 I understand that the management of the third stage of delivery will not be altered or delayed by the Trust to promote successful cord blood collection 12 As the Trust has an overriding duty to ensure the health and safety of me and my baby, I understand that the Trust s staff may direct that it is necessary in my and/or my baby s best interests to abandon the umbilical cord blood collection procedure In the event that the procedure is abandoned, I confirm and agree that the Trust has no liability for any direct or indirect losses, costs or expenses howsoever incurred by me or my partner or my chosen private bank 13 I acknowledge and agree that the stem cell collection is the responsibility of the independent stem cell phlebotomist and my chosen private bank Therefore, if any stem cells collected are found to be inadequate or insufficient in any way at any time in the future, I acknowledge and agree that the Trust shall, except as required by law, have no liability for any direct or indirect losses, costs or expenses howsoever incurred by me or my partner or my chosen private bank 14 I have sent Form B to my chosen private bank and requested that they sign and return this Form to the Trust I understand that if my chosen private bank does not return this form to you in advance of my baby's delivery or if my chosen private bank and/or independent stem cell phlebotomist otherwise refuse to comply with any requirements that you may have (including, for the avoidance of doubt, on the day of delivery itself), you may deny the independent stem cell phlebotomist access to the delivery room for the purposes of private cord blood collection or otherwise require them to leave I confirm and agree that the Trust has no liability for any direct or indirect losses, costs or expenses howsoever incurred by me or my partner or my chosen private bank if private cord blood collection is unable to occur as a result of any of these circumstances Page 8 of 16

Please complete the details overleaf to confirm you have read, understood and agree to the above (to be completed by both parents where relevant): Name Name: Signature Signature Date Date Estimated date of delivery (EDD) of your baby: Hospital number: (Found at the top of your name and address label, affixed to your notes) Details of company I / we have engaged to take the cord sample: Please return your completed Form A to: Head of Midwifery at Homerton University hospital, Homerton Row, London, E9 6SR Page 9 of 16

Appendix 3 Homerton University Hospital Maternity department Homerton Row London E9 6SR Tel: [insert telephone number] Email: [insert email address] FORM B Private umbilical cord blood collection: to be signed and returned to the Trust by the private bank Name of patient: Address: Hospital number: The Homerton University Hospital NHS Foundation Trust ( the Trust ) has been notified that the above named patient has engaged your organisation to collect umbilical cord blood for the purposes of stem cell storage The Trust is not licensed by the Human Tissue Authority ( HTA ) to undertake the collection or storage of stem cells from umbilical cord blood for private purposes The Trust requires that you comply with and agree to the following in order for you to attend our premises for the purposes of cord blood stem cell collection: 15 You must provide the Trust will the following as soon as possible and by week 36 at the latest: confirmation that you have been engaged to arrange cord blood collection in respect of the above patient; a copy of your Human Tissue Authority (HTA) licence; confirmation of the independent stem cell phlebotomist(s) ("collector") that are likely to attend the Trust for the purposes of cord blood stem cell collection together with confirmation that they are a registered healthcare professional trained in cord blood collection and that they are duly authorised to collect cord blood on your behalf (eg that they are employed by you or otherwise have a duly signed Third Party Agreement in place); confirmation of your insurance arrangements and professional indemnity cover in respect of the relevant collector(s); confirmation that an appropriate CRB check has been carried out in respect of the relevant collector(s) and details of any information that has been revealed as a result of such check By signing this Form B, you acknowledge and agree: that the Trust will not become involved in the umbilical cord blood collection and that the Trust and its staff will have no involvement in or responsibility for the cord blood collection procedure; Page 10 of 16

that the collection of umbilical cord blood should not impact adversely on the quality of midwifery/medical care or the immediate care of the mother and baby In particular, the management of the third stage of delivery will not be altered or delayed to promote successful cord blood collection; in the event of a medical emergency such as post partum haemorrhage, medical treatment shall take priority over commercial umbilical cord blood collection; that the collection of cord blood for Rhesus factor or any other medical reason which will be performed by midwifery/obstetric staff shall take precedence over commercial umbilical cord blood collection Your collector must display appropriate ID at all times whilst on the Trust's premises If the collector does not have the ID available, he may be denied access to the Trust and/or the delivery suite/ward/theatre Your collector with liaise with the Midwife/Obstetrician and patient/birth partner in relation to the optimum opportunity for stem cell blood collection to take place It is anticipated that the collection of cord blood by your collector will take place within the delivery suite/ward/theatre but outside of the delivery room Your collector must vacate the delivery room or delivery suite/ward/theatre (as appropriate) if asked to do so by a member of the Trust s staff It is your collector s responsibility to obtain consent for the procedure Your collector must adhere to the Trust s policies for the prevention of needle stick injuries and infection control and any other policies or procedures (including, for the avoidance of doubt, any health and safety policies) duly notified by the Trust to the collector The sole responsibility for the sample of cord blood which your collector obtains remains with you at all times All equipment required for the commercial umbilical cord blood collection must be provided by you Your collector is responsible for the safe disposal and removal of sharps and syringes At all times, the Trust expects your collector to behave professionally, discreetly and courteously 16 You agree that the Trust has no liability for any direct or indirect losses, costs or expenses howsoever caused in connection with the collection of the cord blood Please complete the details below to confirm you have read, understood and agree to the above on behalf of your company and return the duly completed form with the information requested in paragraph 1 above to the Head of Midwifery at Homerton University hospital, Homerton Row, London, E9 6SR Name Signature Date Page 11 of 16

Appendix 4 First and second consultation Clinical Risk Management Lead Delivery Suite Modern Matron Maternity Clinical Risk Manager Consultant Neonatologists Junior obstetricians Lead consultant Gynaecologist User Representative &/or PALS Representative Consultant Obstetricians Consultant Anaesthetists Consultant Gynaecologists Practice Development Midwife Consultant Midwife Supervisor of Midwives Labour Ward Midwife Team Leader for Delivery Suite Relevant specialist midwife Final Consultation Supervisors of Midwives Head of Midwifery Obstetric Consultants CNST Lead Midwife Risk management Team Delivery Suite Matron Joint Prescribing & Medicines Management Group (JPG) Page 12 of 16

Appendix 5 - EQUALITIES IMPACT ASSESSMENT This checklist should be completed for all new Corporate Policies and procedures to understand their potential impact on equalities and assure equality in service delivery and employment Policy/Service Name: Authors and Roles: Directorate: Stem Cell Collection Guideline Philippa Cox Consultant midwife / Supervisor of midwives SWSH Date March 2016 Equalities Impact Assessment Question 1 How does the attached policy/service fit into the trusts overall aims? 2 How will the policy/service be implemented? 3 What outcomes are intended by implementing the policy/delivering the service? 4 How will the above outcomes be measured? Yes Comment Improved pathways for women Supported by NICE Guidance At midwifery training week Labour ward forum Delivery suite handover To appropriately manage the Latent Phase of labour Review of maternity notes 5 Who are they key stakeholders in respect of this policy/service and how have they been involved? 6 Does this policy/service impact on other policies or services and is that impact understood? 7 Does this policy/service impact on other agencies and is that impact understood? 8 Is there any data on the policy or service that will help inform the EqIA? 9 Are there are information gaps, and how will they be addressed/what additional information is required? Equalities Impact Assessment Question All Doctors and Midwives within the maternity department Page 13 of 16

10 Does the policy or service development have an adverse impact on any particular group? 11 Could the way the policy is carried out have an adverse impact on equality of opportunity or good relations between different groups? 12 Where an adverse impact has been identified can changes be made to minimise it? 13 Is the policy directly or indirectly discriminatory, and can the latter be justified? 14 Is the policy intended to increase equality of opportunity by permitting Positive Action or Reasonable Adjustment? If so is this lawful? EQUALITIES IMPACT ASSESSMENT FOR POLICIES AND PROCEDURES 1 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 HR & Environment to develop a more detailed assessment of the Policy s impact and, where appropriate, design monitoring and reporting systems if there is any uncertainty 2 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 Page 14 of 16

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 29/2/16 Planned implementation date: Purpose/Aim of Document Circulated to March 2016 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 March 2019 Approved By Archive of earlier versions of the guideline Maternity Risk Management Review Group yes 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 (has been approved by Trust for ratification? solicitors) Page 15 of 16

STEM CELL COLLECTION GUIDELINES FOR HEALTHCARE PROFESSIONALS Signature Page Page 16 of 16