NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST UMBILICAL CORD BLOOD COLLECTION AT NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST BY THIRD PARTIES POLICY

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1 NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST UMBILICAL CORD BLOOD COLLECTION AT NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST BY THIRD PARTIES POLICY Documentation Control Reference Date approved Approving Body TRUST BOARD Implementation date Supersedes N/A Consultation undertaken DIRECTORS GROUP Target audience Supporting Procedure(s) Review Date Lead Executive Author/Lead Manager Maternity Units, Midwives, Obstetricians. Human Tissues for Scheduled Purposes Policy (Ref GG/CM/034) MEDICAL DIRECTOR Dr. RHODRI JONES Further Guidance/Information Dr. RHODRI JONES ext

2 CONTENTS Paragraph Title Page 1. Introduction (Policy Statement) 3 2. Background & Definitions 3 3. The Licence 4 4. Relationship of the Designated Individual to the Host Organisation 5 5. Policy 6 6. Quality Manual 8 7. Equality and Diversity Statement 8 8. Monitoring and Review 8 Appendix 1 Sources of Information Relating to Cord Blood Collection and Stem Cell Transplantation Appendix 2 Employee Record of Having Read the Policy

3 1. Introduction This document sets out the Nottingham University Hospitals NHS Trust (the Trust ) policy on collecting umbilical cord blood at the Maternity Units of its Queen s Medical Centre and City campuses. Stem cells in umbilical cord blood are useful in the treatment of metabolic, immunological and haematological disease. It is speculated that they may one day be of wider application, for example in the treatment of degenerative disease, although procedures have yet to be developed and validated. Cells are more likely to be useful to other people than to the child from whose cord they are collected. The Trust does not collect umbilical cord blood. However, a number of independent organisations do offer parents such a service. The main elements comprise; cord collection, cell harvesting, freezing and storage. Some organisations store material for the exclusive use of the person from whom they were collected or members of that person s family. Other organisations provide that some or all of the material is made generally available for public use. While recognising the potential value of umbilical cord blood to public health, the Trust emphasises that the health of mother and baby is its paramount concern. Taking account of the concerns and recommendations of professional groups, it has therefore decided to permit a limited service to take place at certain of its premises, subject to the principles set out in this document. In its final form, this policy will be available for public inspection and will, where possible, be drawn to the attention of prospective parents at the antenatal stage. 2. Background and Definitions The removal, storage and use of human cells and tissues, including cord blood, is governed by the Human Tissue Act 2004 (the Act ), by the Directions and Codes of Practice of the Human Tissue Authority (the HTA ) and by legislation subordinate to the Act such as the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (the Regulations ). These Regulations implement provisions of the European Tissues and Cells Directive,- Directive 2004/23 -, (the EUTCD ) 3

4 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells intended for human application; a class which includes umbilical cord blood stem cells. As the UK s Competent Authority under the EUTCD, the HTA is responsible for licensing the collection of umbilical cord blood and associate activities such as packaging, storing and transporting ( Collection ). The individual designated in such a licence as the person under whose supervision Licensed Activities are authorised to be carried on is known as the Designated Individual ( DI ). Only those persons whose names have been notified to the HTA by the DI and which appear on the licence may carry out Licensed Activities ( Persons Designate ). 3. The Licence The HTA has granted the Trust a licence (No ,- the Licence ) under the Regulations to carry out Licensed Activities at the Maternity Units of the Trust s Queen s Medical Centre and City campuses (the Hospital ) in relation to umbilical cord stem cells. Under Trust policy, the DI will only approve Licensed Activities that have been endorsed by the Trust s Human Tissues Management Group ( HTMG ). 4

5 4. Relationship of the Designated Individual to the Host Organisation The DI for the use of tissues for human therapeutic application, under the Licence, is directly accountable to the Trust s Chief Executive and Board. Persons Designate under the Licence are directly accountable to the DI in relation to any activities pertaining to uses of human tissues for human application under the Regulations. The DI is a member of the HTMG. The HTMG is a committee within the Trust. The HTMG reports to the Clinical Risk Committee at NUHT. 5

6 5. Policy The Trust s paramount concern is the health and safety of mothers and babies in its care. The Trust encourages all expecting parents to consider the risks and benefits of cord stem cell collection carefully before agreeing to donate or save cells or incur costs. Independent advice is available from a number of sources (see Appendix 1). The Trust advises parents that cord blood collected by untrained personnel (e.g. fathers) is very unlikely to be usable and that such collection, though well-meant, may interfere with the health and safety of the mother and child at an important time. Only organisations permitted by the Trust ( Collectors ) may collect umbilical cord blood at the Hospital and Collection may only take place subject to the conditions set out in the Trust HTA Licence and under the supervision of the DI for therapeutic applications named in the Trust Licence. Collectors shall bear full responsibility for obtaining consent and shall in no circumstances seek to obtain consent after the mother s admission to the Hospital except with the permission of the midwife or obstetrician in charge of delivery ( Responsible Clinician ). The Collector s personnel and equipment are permitted to be present in the delivery room solely with the signed consent of the mother (using the approved consent form of the collection agency) and the consent of the clinician in charge of delivery. Collection may only be undertaken at the hospital by persons employed by the Collector with the consent of the mother and with the permission of the Responsible Clinician, which in either case may be withdrawn at any time. The judgment of the Responsible Clinician shall be final. No employee or equipment of the Trust shall take any part in Collection [except in exceptional circumstances in the absolute discretion of the Trust]. 6

7 Where Collection is recommended by a clinician (whether for the benefit of the newborn or otherwise) for the treatment or cure of a known genetic or acquired disease, the Trust will have absolute discretion over the conduct of such Collection. In general, such Collection will be carried out by arrangement between the Trust DI for therapeutic applications and NHS Blood and Transplant. 7

8 6. Quality Manual A Quality Manual is published for each of the Trust licences and describes the Quality Management System of HTMG. This Quality Manual fulfils two functions. It describes the Quality Management System, for the benefit of management and staff; it provides information for users and for inspection/accreditation bodies. Sections in the Quality Manual are arranged so that they equate with the HTA Standards. Under the title of each standard there is a brief description of the way in which the HTMG seeks to comply with the particular standard and references are given to appropriate procedures. 7. Equality and Diversity Statement The Trust is committed to ensuring that it treats its employees and patients fairly, equitably and reasonably and that it does not discriminate against individuals or groups on the basis of their ethnic origin, physical or mental abilities, gender, age, religious beliefs or sexual orientation. This policy does not discriminate in any such way. 8. Monitoring & Review The policy and its activities will be reviewed on an annual basis as part of a management review specified in the HTMG Quality Manual. A report will be tabled for consideration by the Clinical Risk Committee at NUHT. 8

9 Appendix 1 Sources of Information Relating to Cord Blood Collection and Stem Cell Transplantation. [There are many more sources of literature available in the public domain. The following are a selection which use published peer-reviewed scientific literature as their reference material]. Royal College of Obstetrics and Gynaecology Opinion Paper (June 2006) ( Royal College of Midwives Midwives Magazine (Aug/Sept 2008) ( International Society for Stem Cell Research. Patient Handbook on Stem Cell Therapies (December 2008). 9

10 Appendix 2 EMPLOYEE RECORD OF HAVING READ THE POLICY Title of Policy/Procedure: UMBILICAL CORD BLOOD COLLECTION AT NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST BY THIRD PARTIES POLICY I have read and understand the principles contained in the named policy. PRINT FULL NAME SIGNATURE DATE 10

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