Table Of Content

Edition 8.0 Human Fertilisation and First published October 2009 Embryology Authority Revised April 2010, April 2011, 10 Spring Gardens October 2011, April 2012, London October 2013, October 2014, SW1A 2BU April 2015, October 2015, July t 020 7291 8200 2016, May 2017 e [email protected] w www.hfea.gov.uk Presented to Parliament pursuant to section 26(4) of the Human Fertilisation and Embryology Act 1990 © HFEA copyright 2017 Any enquiries related to this publication should be sent to: The text of this document (this excludes, where present, the Human Fertilisation and Royal Arms and all departmental Embryology Authority or agency logos) may be 10 Spring Gardens reproduced free of charge in any London format or medium provided that it SW1A 2BU is reproduced accurately and not t 020 7291 8200 in a misleading context. The e [email protected] material must be acknowledged w www.hfea.gov.uk as HFEA copyright and the document title specified. Edition 8.0 First published October 2009 Where third party material has Revised April 2010, April 2011, been identified, permission from October 2011, April 2012, the respective copyright holder October 2013, October 2014, must be sought. April 2015, October 2015, July 2016, May 2017 Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority Version 10.0 This table provides a record of revisions made to the 8th edition of the Code of Practice since it was published in October 2009. The table shows which sections have been revised and the date that they were implemented. Section Content change Date last revised Copyright page Revision May 2017 Removed reference to index Oct 2013 Contents Title of guidance note 25 Oct 2014 Added guidance note 33 Oct 2015 Removed reference to index Oct 2013 User guide to the Code Removed reference to regulatory Jul 2016 principles Regulatory principles for licensed Withdrawn Jul 2016 centres Mandatory requirements 1. Person responsible T7 Oct 2011 1.1-1.2, 1.5 T14, 2.15, 2.16, 2.18, 2.24c Oct 2014 2.14, 2.20, 2.22, 2.23, 2.24, 2.25, Oct 2015 2. Staff 2.26, 2.27, 2.28 2.25, 2.26, 2.27, 2.28 (renumbering) Jul 2016 Other legislation/information Mandatory requirements Oct 2011 T60, T61 3. Counselling Other legislation/information Oct 2013 3.13 Oct 2014 3A, 3.3, 3.5, 3.7a, 3.10 Oct 2015 4. Information to be provided prior 4.5 Oct 2014 to consent Other legislation/information Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority 4A, 4.4 Oct 2015 Other legislation/information Jul 2016 5A Apr 2010 5A, 5D, 5.21-5.22 Apr 2012 5A, 5H Oct 2013 5.4, 5.16 Oct 2014 5. Consent to treatment, storage, 5.6, 5.16, 5.19, 5.20 Apr 2015 donation, and disclosure of Mandatory requirements information Oct 2015 5A, 5H, 5.9, 2.25 Other legislation/information Jul 2016 Mandatory requirements 5A, 5.1, 5.3-5.40, 5D, 5G May 2017 Other legislation/information 6G Apr 2010 Mandatory requirements Oct 2011 T60, T61 6.1-6.6, 6.8, 6.9, 6.11, 6A, 6C, 6D, Oct 2013 6G, 6.12, Decision tree 6. Legal parenthood Mandatory requirements Oct 2015 6H Mandatory requirements 6.4-6.30, 6A, 6B, 6C, 6D, 6E, 6F, May 2017 6G, 6H, 6I, 6J, 6K, 6L 7A Apr 2010 7.1 Apr 2011 Mandatory requirements T123 Oct 2011 7. Multiple births 7.1-7.2 7.2 Oct 2013 Other legislation/information T123 Oct 2014 8.5 8. Welfare of the child Oct 2013 Other legislation/information Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority 8.5 Oct 2015 Mandatory requirements Oct 2011 T88, T89, T90 9. Preimplantation genetic 9.1-9.3, 9B screening (PGS) 9A, 9.1-9.8 Jul 2016 Other legislation/information Mandatory requirements Apr 2010 10.7-10.9 Mandatory requirements T88, T89 Oct 2011 10. Embryo testing and sex selection 10.4 Mandatory requirements Oct 2013 10A, 10.7-10.8, 10.10, 10.13, 10.15 Jul 2016 Other legislation/information Mandatory requirements Oct 2011 T52, T53 11.40-11.42, 11.50-11.52 Apr 2012 11.2-11.6, 11.15-16, 11.18-11.20 Oct 2013 Mandatory requirements T52b 11. Donor recruitment, assessment Oct 2014 11.14b, 11.15, 11.22 and screening Other legislation/information Mandatory requirements Apr 2015 T52 Mandatory requirements Oct 2015 11.48 Other legislation/information July 2016 Mandatory requirements Apr 2012 12.1-12.27, 12.29-12.32 General Direction 0001 12. Egg sharing arrangements 12.1, 12.4, 12.5, 12.8, 12.19c, Oct 2015 12.27, 12.32 Other legislation/information Jul 2016 Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority Mandatory requirements May 2017 12.5 13. Payments for donors 13A, 13.1-13.7, 13B Apr 2012 Mandatory requirements Apr 2010 14.1 14. Surrogacy 14A, 14.1-14.3, 14.5-14.8 Oct 2013 Mandatory requirements Oct 2015 14.3 15A Apr 2010 Mandatory requirements Oct 2011 T66, T67 15D 15. Procuring, processing and Oct 2013 Other legislation/information transporting gametes and embryos T50, T51; 15D Oct 2014 Other legislation/information Mandatory requirements Apr 2015 T50 16.4-16.6 Apr 2010 16B Oct 2015 16. Import and exports Other legislation/information Jul 2016 16C May 2017 Mandatory requirements T84 Oct 2011 17.15 17B Apr 2012 Mandatory requirements 17. Storage of gametes and T51 Oct 2013 embryos 17A T50 17A, 17B Oct 2014 Other legislation/information T50 Apr 2015 17.11, 17.12, 17D, 17.15-17.18, Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority 17.20- 17.22 17.10 Oct 2015 Mandatory requirements May 2017 17C, 17D Mandatory requirements Oct 2011 T71 18.21 18.2-18.8, 18.10, 18.12, 18.21- 18. Witnessing and assuring patient 18.23, 18.26-18.29, 18.31, 18.32, and donor identification Oct 2013 18.35, 18.37, 18.38, 18.42 18.4m Oct 2015 Other legislation/information Jul 2016 19. Traceability T101 Oct 2014 Mandatory requirements Oct 2011 T54 20.1 Apr 2012 20. Donor assisted conception 20.1 Oct 2013 Other legislation/information Mandatory requirements Oct 2015 20.6, 20.10 21.4 Oct 2011 21. Intracytoplasmic sperm injection (ICSI) Other legislation/information Oct 2014 T96, T95 Oct 2011 Mandatory requirements Oct 2013 Other legislation/information 22. Research and training 22B Oct 2014 Other legislation/information Mandatory requirements Oct 2015 Other legislation/information Jul 2016 23. The quality management Mandatory requirements Oct 2011 system T36 24. Third party agreements Mandatory requirements Oct 2011 Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority T115, T116 T124, T125 Oct 2015 24.1 Mandatory requirements Oct 2011 T5, 25.9 T2 25. Premises, practices and 25.3, 25.4, 25.19-25.36 Oct 2014 facilities Other legislation/information T124, T125 Oct 2015 Other legislation/information Jul 2016 26.3-26.5 Oct 2014 26. Equipment and materials Other legislation/information Other legislation/information Jul 2016 27.1, 27.9 Oct 2011 27.9 Oct 2015 27. Adverse incidents Other legislation/information Jul 2016 27.1, 27A May 2017 Other legislation/information 28. Complaints Other legislation/information Jul 2016 New guidance note Apr 2011 29.8 Oct 2014 29. Treating people fairly Other legislation/information 29.3 Oct 2015 Other legislation/information Jul 2016 Mandatory requirements Oct 2011 T43 30.6-30.8 Oct 2014 30. Confidentiality and privacy 30A, 30B, 30.16 Oct 2015 Mandatory requirements May 2017 30B 31. Record keeping and document Mandatory requirements Oct 2013 control T39, T41

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Important: The Code of Practice does not provide a complete guide to the Act We have a duty to promote compliance with the Act and the Code of (ii) has at least two years' practical experience which is directly relevant to .. Association of Biomedical Andrologists: Laboratory andrology guidelines
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Edition 8.0 Human Fertilisation and First published October 2009 Embryology Authority Revised April 2010, April 2011, 10 Spring Gardens October 2011, April 2012, London October 2013, October 2014, SW1A 2BU April 2015, October 2015, July t 020 7291 8200 2016, May 2017 e [email protected] w www.hfea.gov.uk Presented to Parliament pursuant to section 26(4) of the Human Fertilisation and Embryology Act 1990 © HFEA copyright 2017 Any enquiries related to this publication should be sent to: The text of this document (this excludes, where present, the Human Fertilisation and Royal Arms and all departmental Embryology Authority or agency logos) may be 10 Spring Gardens reproduced free of charge in any London format or medium provided that it SW1A 2BU is reproduced accurately and not t 020 7291 8200 in a misleading context. The e [email protected] material must be acknowledged w www.hfea.gov.uk as HFEA copyright and the document title specified. Edition 8.0 First published October 2009 Where third party material has Revised April 2010, April 2011, been identified, permission from October 2011, April 2012, the respective copyright holder October 2013, October 2014, must be sought. April 2015, October 2015, July 2016, May 2017 Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority Version 10.0 This table provides a record of revisions made to the 8th edition of the Code of Practice since it was published in October 2009. The table shows which sections have been revised and the date that they were implemented. Section Content change Date last revised Copyright page Revision May 2017 Removed reference to index Oct 2013 Contents Title of guidance note 25 Oct 2014 Added guidance note 33 Oct 2015 Removed reference to index Oct 2013 User guide to the Code Removed reference to regulatory Jul 2016 principles Regulatory principles for licensed Withdrawn Jul 2016 centres Mandatory requirements 1. Person responsible T7 Oct 2011 1.1-1.2, 1.5 T14, 2.15, 2.16, 2.18, 2.24c Oct 2014 2.14, 2.20, 2.22, 2.23, 2.24, 2.25, Oct 2015 2. Staff 2.26, 2.27, 2.28 2.25, 2.26, 2.27, 2.28 (renumbering) Jul 2016 Other legislation/information Mandatory requirements Oct 2011 T60, T61 3. Counselling Other legislation/information Oct 2013 3.13 Oct 2014 3A, 3.3, 3.5, 3.7a, 3.10 Oct 2015 4. Information to be provided prior 4.5 Oct 2014 to consent Other legislation/information Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority 4A, 4.4 Oct 2015 Other legislation/information Jul 2016 5A Apr 2010 5A, 5D, 5.21-5.22 Apr 2012 5A, 5H Oct 2013 5.4, 5.16 Oct 2014 5. Consent to treatment, storage, 5.6, 5.16, 5.19, 5.20 Apr 2015 donation, and disclosure of Mandatory requirements information Oct 2015 5A, 5H, 5.9, 2.25 Other legislation/information Jul 2016 Mandatory requirements 5A, 5.1, 5.3-5.40, 5D, 5G May 2017 Other legislation/information 6G Apr 2010 Mandatory requirements Oct 2011 T60, T61 6.1-6.6, 6.8, 6.9, 6.11, 6A, 6C, 6D, Oct 2013 6G, 6.12, Decision tree 6. Legal parenthood Mandatory requirements Oct 2015 6H Mandatory requirements 6.4-6.30, 6A, 6B, 6C, 6D, 6E, 6F, May 2017 6G, 6H, 6I, 6J, 6K, 6L 7A Apr 2010 7.1 Apr 2011 Mandatory requirements T123 Oct 2011 7. Multiple births 7.1-7.2 7.2 Oct 2013 Other legislation/information T123 Oct 2014 8.5 8. Welfare of the child Oct 2013 Other legislation/information Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority 8.5 Oct 2015 Mandatory requirements Oct 2011 T88, T89, T90 9. Preimplantation genetic 9.1-9.3, 9B screening (PGS) 9A, 9.1-9.8 Jul 2016 Other legislation/information Mandatory requirements Apr 2010 10.7-10.9 Mandatory requirements T88, T89 Oct 2011 10. Embryo testing and sex selection 10.4 Mandatory requirements Oct 2013 10A, 10.7-10.8, 10.10, 10.13, 10.15 Jul 2016 Other legislation/information Mandatory requirements Oct 2011 T52, T53 11.40-11.42, 11.50-11.52 Apr 2012 11.2-11.6, 11.15-16, 11.18-11.20 Oct 2013 Mandatory requirements T52b 11. Donor recruitment, assessment Oct 2014 11.14b, 11.15, 11.22 and screening Other legislation/information Mandatory requirements Apr 2015 T52 Mandatory requirements Oct 2015 11.48 Other legislation/information July 2016 Mandatory requirements Apr 2012 12.1-12.27, 12.29-12.32 General Direction 0001 12. Egg sharing arrangements 12.1, 12.4, 12.5, 12.8, 12.19c, Oct 2015 12.27, 12.32 Other legislation/information Jul 2016 Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority Mandatory requirements May 2017 12.5 13. Payments for donors 13A, 13.1-13.7, 13B Apr 2012 Mandatory requirements Apr 2010 14.1 14. Surrogacy 14A, 14.1-14.3, 14.5-14.8 Oct 2013 Mandatory requirements Oct 2015 14.3 15A Apr 2010 Mandatory requirements Oct 2011 T66, T67 15D 15. Procuring, processing and Oct 2013 Other legislation/information transporting gametes and embryos T50, T51; 15D Oct 2014 Other legislation/information Mandatory requirements Apr 2015 T50 16.4-16.6 Apr 2010 16B Oct 2015 16. Import and exports Other legislation/information Jul 2016 16C May 2017 Mandatory requirements T84 Oct 2011 17.15 17B Apr 2012 Mandatory requirements 17. Storage of gametes and T51 Oct 2013 embryos 17A T50 17A, 17B Oct 2014 Other legislation/information T50 Apr 2015 17.11, 17.12, 17D, 17.15-17.18, Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority 17.20- 17.22 17.10 Oct 2015 Mandatory requirements May 2017 17C, 17D Mandatory requirements Oct 2011 T71 18.21 18.2-18.8, 18.10, 18.12, 18.21- 18. Witnessing and assuring patient 18.23, 18.26-18.29, 18.31, 18.32, and donor identification Oct 2013 18.35, 18.37, 18.38, 18.42 18.4m Oct 2015 Other legislation/information Jul 2016 19. Traceability T101 Oct 2014 Mandatory requirements Oct 2011 T54 20.1 Apr 2012 20. Donor assisted conception 20.1 Oct 2013 Other legislation/information Mandatory requirements Oct 2015 20.6, 20.10 21.4 Oct 2011 21. Intracytoplasmic sperm injection (ICSI) Other legislation/information Oct 2014 T96, T95 Oct 2011 Mandatory requirements Oct 2013 Other legislation/information 22. Research and training 22B Oct 2014 Other legislation/information Mandatory requirements Oct 2015 Other legislation/information Jul 2016 23. The quality management Mandatory requirements Oct 2011 system T36 24. Third party agreements Mandatory requirements Oct 2011 Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority T115, T116 T124, T125 Oct 2015 24.1 Mandatory requirements Oct 2011 T5, 25.9 T2 25. Premises, practices and 25.3, 25.4, 25.19-25.36 Oct 2014 facilities Other legislation/information T124, T125 Oct 2015 Other legislation/information Jul 2016 26.3-26.5 Oct 2014 26. Equipment and materials Other legislation/information Other legislation/information Jul 2016 27.1, 27.9 Oct 2011 27.9 Oct 2015 27. Adverse incidents Other legislation/information Jul 2016 27.1, 27A May 2017 Other legislation/information 28. Complaints Other legislation/information Jul 2016 New guidance note Apr 2011 29.8 Oct 2014 29. Treating people fairly Other legislation/information 29.3 Oct 2015 Other legislation/information Jul 2016 Mandatory requirements Oct 2011 T43 30.6-30.8 Oct 2014 30. Confidentiality and privacy 30A, 30B, 30.16 Oct 2015 Mandatory requirements May 2017 30B 31. Record keeping and document Mandatory requirements Oct 2013 control T39, T41

Description:
Important: The Code of Practice does not provide a complete guide to the Act We have a duty to promote compliance with the Act and the Code of (ii) has at least two years' practical experience which is directly relevant to .. Association of Biomedical Andrologists: Laboratory andrology guidelines
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