Guideline for staff involvement and responsibility with cord blood collection for stem cells (GL811) Approval Approval Group Job Title, Chair of Committee Date Maternity & Children s Services Clinical Governance Committee Chair, Maternity Clinical Governance Committee 5 th February 2016 Change History Version Date Author, job title Reason 1.0 Sept 2011 Gill Valentine (Director of Midwifery) 2.0 Oct 2013 Gill Valentine (Director of Midwifery) 3.0 January 2016 Gill Valentine (Director of Midwifery) Trust requirement Reviewed Reviewed This document is valid only on Last printed 22/02/2016 16:24:00 Page 1of 10
Introduction Stem cells are cells from which other types of cells can develop and can be found in the bone marrow, in peripheral blood and in the placenta. Placental blood contains high concentrations of haemopoietic stem cells, which can be used to replenish the supply of red blood cells, white blood cells and platelets. Routine commercial collection and storage of blood and stem cells from umbilical cords after babies are born cannot be currently justified on scientific grounds. Midwives and Obstetricians should acquaint themselves with the evidence and the issues around stem cell harvesting so they can discuss them with women and families as appropriate. On the advice of the RCM, RCOG and the NHS Litigation Authority, The Royal Berkshire Foundation Trust (the Trust) does not support commercial umbilical cord blood collection. In the circumstances the Trust has not applied to the Human Tissue Authority for a licence for the collection or storage of stem cells from umbilical cord blood for commercial purposes. Staff are therefore not permitted to collect stem cells from umbilical cord blood samples for commercial purposes. Practitioners who choose to do so will act illegally and will not be indemnified against death, injury or any incident which occurs as a result of this activity. Furthermore, internal disciplinary procedures may result and a referral may be made to the practitioner s relevant professional body. Definitions Medically indicated umbilical cord blood samples are taken from infants whose mothers are rhesus negative or have antibodies. Cord blood collection may also be recommended for infants where there is familial history of genetic disorder, which may be treated by stem cell transplantation if the child develops the disease. Stem cells from infants can also be used to treat acute lymphoblastic leukaemia in affected siblings. This would be undertaken by Trust clinicians. Commercial umbilical cord blood collection refers to a service offered by for-profit companies to harvest and store stem cells for families, even if there is no known medical indication. It is promoted as insurance against any future health problems that children may develop. This document is valid only on Last printed 22/02/2016 16:24:00 Page 2 of 10
Issues arising from commercial umbilical cord blood collection on demand and guidance for staff It is acknowledged that stem cell harvesting may appeal to some parents; however, the practice poses a number of logistical, legal and ethical questions and problems for midwives, obstetricians, parents and NHS Trusts. 1. It is vital that the obstetrician or midwife are not distracted from the immediate care of the mother and baby during the third stage of labour; and the management of the third stage is not altered or compromised. There is also the issue of the timing of the clamping of the cord as this will have an effect on the collection of cord blood. Evidence suggests that immediate cord clamping in preterm babies may be harmful to them. In healthy newborns, deferred clamping may enhance placental transfusion and reduces jaundice and low iron stores at birth4. Both the RCOG and RCM strongly believe that interference with the third stage of labour needs to be kept at a minimum to ensure good outcome for both mother and baby. 2. The Human Tissue Authority requires that all centres obtaining and storing stem cells from umbilical cord blood are licensed and that staff collecting the stem cells have received specific training. Their requirements are set out in Regulation 7, 11 and 12 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (the 2007 Regulations). The Trust does not hold a license for the collection or storage of stem cells from umbilical cord blood. If Trust staff were to collect stem cells from umbilical cord blood, both the individual member of staff and the Trust would commit an offence which may be punishable by a fine, imprisonment or both (Regulation 11 of the 2007 Regulations). Under no circumstances must Trust staff collect or assist in the collection of stem cells from umbilical cord blood for commercial purposes. 3. Notwithstanding the above, the procedure for collecting such samples is cumbersome and detracts from the primary important task of 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. 4. Because of the complexity of this collection it may not be possible to adhere to the necessary instructions and get either enough blood or avoid contamination. 5. The collection should be made by an independent trained technician not involved with the care of mother or baby. This document is valid only on Last printed 22/02/2016 16:24:00 Page 3 of 10
6. The health and safety implications related to introducing additional needles during the third stage of labour and the increased risk of needle stick injury. Therefore maternity staff must not be involved at any stage with the collection. 7. The Trusts should not be liable for any mishaps which may occur during the procedure that is not clinically indicated, e.g. failure to obtain specimen, insufficient blood collection, mislabelling, contamination or delay in transportation or storage. 8. Stem cell collection must only be taken once cord bloods for neonatal wellbeing have been taken e.g. cord gases, Kleihauer. 9. If the woman or other birth supporters wish to pursue Commercial umbilical cord blood collection, the lead midwife/obstetrician receiving the request on behalf of the Trust, will ask for a disclaimer to be signed and the responsibility for engaging an independent stem cell company/phlebotomist becomes the woman s/birth supporters responsibility (Appendix 2). The Independent stem cell company must agree to abide by the Trust guidance (Appendix 1) and sign the disclaimer at Appendix 3. 10. Women should be advised of the Trust s position on commercial umbilical cord blood collection when requests are made known. It should be made clear from the outset that neither the Trust nor its staff will participate in the collection of stem cells for commercial purposes or be responsible/liable for the quality or quantity of the sample collected or any delay in transportation or storage. The Trust will not support or permit family members or friends to undertake stem cell collection even if medically trained. References 1. Human Tissue (Quality and Safety for Human Application) Regulations 2007 2. RCM (2011) RCOG/RCM statement on umbilical cord blood collection and banking. RCM This document is valid only on Last printed 22/02/2016 16:24:00 Page 4 of 10
Appendix 1 Guidance for Independent Stem Cell Phlebotomist/Companies working within Trust premises 1. Required evidence of Independent Stem Cell Phlebotomist s/company s Human Tissue Authority licence to carry out Commercial Umbilical Cord Blood Collection. 2. Required evidence of recent CRB clearance (within last 3 years). 3. 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 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 either on the Midwifery Led Unit or Delivery Suite until collected by birth partner. 7. The Independent Stem Cell Phlebotomist may be collected and brought to the birth room at an appropriate time and as previously discussed and agreed with parents. 8. Collection of cord bloods for DAT screening and Rhesus factor must take precedence over stem cell blood collection and 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 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. 15. At all times, professional, discreet and courteous behaviour is expected and the Trust s Infection Control policies must be adhered to. Copy to be provided alongside this guidance. This document is valid only on Last printed 22/02/2016 16:24:00 Page 5 of 10
Appendix 2 To: Director of Midwifery Letter of understanding for engaging an Independent Cell Phlebotomist/Company Royal Berkshire NHS Foundation Trust London Road Reading Berkshire RG1 5AN 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) Royal Berkshire 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 (i.e. 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 Royal Berkshire Hospital: This document is valid only on Last printed 22/02/2016 16:24:00 Page 6 of 10
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 is not, and is not acting as, an employee, servant or agent of the Trust. 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:. (both parents) Name: Signature: Date:.. Estimated date of delivery (EDD) of your baby:. Signature:.. Hospital number: (Found at the top of your name and address label, affixed to your notes) Name of company we have engaged to take the cord sample:.. After completion, please return to: Director of Midwifery at Royal Berkshire Hospital, Level 2 Maternity Block, London Road, Reading, Berkshire RG1 5AN This document is valid only on Last printed 22/02/2016 16:24:00 Page 7 of 10
Appendix 3 Independent Cell Phlebotomist/Company Disclaimer To: Director of Midwifery Royal Berkshire NHS Foundation Trust London Road Reading Berkshire RG1 5AN I,... (Name of Independent Stem Cell Phlebotomist) of,. (Name of Independent Stem Cell Company) Have been contracted by (Full name of woman) 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 (i.e. where a patient of the Trust is arranging for the stem cell blood to be collected privately). In the circumstances, I confirm that: 1. (Name of Independent Stem Cell Phlebotomist /Company) is licensed by the Human Tissue Authority to collect and store stem cells from umbilical cord blood pursuant to section 7 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 ( the 2007 Regulations ). 2. I am fully trained in accordance with the requirements of section 11 and 12 of the 2007 Regulations and am legally able to collect stem cells from the umbilical cord blood. 3. I have read and understood the Trust s current policy on Commercial Umbilical Cord Blood Collection ( Guideline for Staff Involvement and Responsibility with Cord Blood Collection for Stem Cells ) and accept the conditions set out in Appendix 1 to that Guideline. This document is valid only on Last printed 22/02/2016 16:24:00 Page 8 of 10
4. As... (Name of Independent Stem Cell Phlebotomist / Company) have entered into a contract with (Name of woman) to collect stem cells from her umbilical cord blood, I (or insert name of Independent Stem Cell Company) accept(s) that I / its staff members cannot be held to be an employee, agent or servant of the Trust. 5. (Name of Independent Stem Cell Phlebotomist / Company) understand(s) that the Trust will not be liable for any death, injury or other loss arising from or relating to the collection of stem cells from umbilical cord blood by myself / its staff members. Name:... Company: Signature:.. Date:.. After completion, please return to: Director of Midwifery at Royal Berkshire Hospital, Level 2 Maternity Block, London Road, Reading, Berkshire RG1 5AN This document is valid only on Last printed 22/02/2016 16:24:00 Page 9 of 10
Appendix 4 Flow Chart of Instructions for Staff Request for Stem Cell Collection received by midwife / obstetrician Trust position explained with help of the Guideline Document in notes If request persistent provide the guidance for Independent Stem Cell Phlebotomist/Company to the woman/birth supporter to pass onto the Independent Stem Cell Phlebotomist/Company Document in notes that this has been provided Trust disclaimer to be issued to woman/birth supporter and Independent Stem Cell Phlebotomist/Company for completion Document in notes that it has been given For Commercial Umbilical Cord Blood Collection to take place the disclaimers must be completed by the 36/40 week antenatal visit and evidence specified in Appendix 1 must be provided by the Independent Stem Cell Phlebotomist/Company. Midwife / Obstetrician receiving the disclaimer(s) and evidence of compliance at 36/40 must ensure it is placed within the woman s notes and clearly documented Midwife caring for the woman during labour must ensure that the guideline has been followed and the Delivery Suite co-ordinator is aware of the request and the plan in place. This document is valid only on Last printed 22/02/2016 16:24:00 Page 10 of 10