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Organ donation and transplantation seminar

Organ donation and transplantation seminar. 9 July 2013. The revised HTA living organ donation framework. 9 July 2013 Allan Marriott Smith. Living Organ Donation - Background. HTA role is to assess all applications for living organ donation

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Organ donation and transplantation seminar

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  1. Organ donation and transplantation seminar 9 July 2013

  2. The revised HTA living organ donation framework 9 July 2013 Allan Marriott Smith

  3. Living Organ Donation - Background • HTA role is to assess all applications for living organ donation • Questions from the community about more novel donor – recipient relationships • Legal advice in November 2010 – HTA duty to assess all cases referred against legal criteria • Need to put in place arrangements to address the regulatory risks

  4. Directed Altruistic Donation - Definition Directed altruistic donation: • No qualifying genetic relationship • No pre-existing emotional relationship Regulatory risk believed to be greater where you’re donating to someone you’ve no shared history with e.g. someone you met on Facebook for the purpose of donation, distant cousins – motivations are more opaque

  5. Directed Altruistic Donation - Requirements HTA tests remain identical in all cases • No reward has been given or is to be given • Consent for removal has been given • free from duress and coercion • by someone with capacity • Removal is otherwise lawful Only differences: • Who caries out the interview – IA with enhanced training • Who within the HTA assesses the case – a panel of three Authority Members

  6. Directed Altruistic Donation – Developments Enhanced IA assessment for Directed Altruistic Donation cases Significantly revised guidance to transplant units and IAs Revisions to Code 2 First Direct Altruistic Donation case approved October 2012 – 9 cases in total Formal review after ten DAD cases – later this year Matching websites e.g. matchingdonors.com New guidance on our website for people thinking of using a matching website

  7. Independent Assessment 9 July 2013 Andrew Hoy

  8. Independent Assessment • What? • Interview living organ donors and recipients to ensure legal requirements are met • Submit a report of the interviews to the HTA for assessment • Who? • Independent Assessors (IAs) appointed, trained and accredited by HTA • Senior healthcare professionals not working directly for the renal or transplant unit • Representative of HTA and advocate for the donor

  9. Independent Assessment • How? • Referral from Renal Unit consultant via Living Donor Coordinator • Proof of identity and relationship between donor and recipient • Informed consent: detailed understanding of procedure and risks • Absence of coercion, duress or financial inducement • Separate and combined interviews • Submission of electronic report to HTA usually the same day

  10. Approval • After HTA Living Donor Assessment Team scrutiny of IAs report for directed donations • After referral to HTA panel for paired/pooled and altruistic donations; donors lacking capacity and/or under 18 years; “complex” cases • Decision usually within 5 working days (record 20 minutes)

  11. September 2012 GuidanceWhat is new? • Requirement for copy or scan of Donor Declaration and Referral Letter in IA report • Increase in directed altruistic donations due to contact via a third party (press, social media etc.) • Better definition of a non-qualifying relationship e.g. cousin from abroad • Relaxation of the need for a psychiatric opinion for non-directed altruistic donations • Decision regarding use of organ if technically inappropriate for intended recipient

  12. Impact for Independent Assessors • Increase in non-qualifying donors particularly from abroad • Potential for inadequate photographic evidence from abroad • Need for skilled interpreters • Prior assessment by unit donor advocate in valuable • Donor declaration is that Guidance has been read • Donor declaration useful as gambit for duress/reward discussion • Concept of “potential economic dependence” useful • NHS difficulty in providing scanning facilities • Finally: assessment is inevitably relative and not absolute

  13. The regulation of organ donation and transplantation 9 July 2013 Imogen Swann

  14. Licensing • August 27 2012 – applications received (36) • Licensable Activities - procurement and/or transplantation • Donor/organ characterisation • Preservation of an organ • Making arrangements to transport an organ • Retrieval of an organ • Implantation of an organ

  15. Audits • 4 pilot audits – June to November 2012 • 17 audits – January to July • 9 audit reports published

  16. Findings to date • No critical shortfalls • No major shortfalls • 17 minor shortfalls • Advice and guidance

  17. Common shortfalls • National operating procedures adopted but not adapted to reflect local practice • Recording receipt of organs • Follow up for living donors • Identifying and reporting adverse events/reactions

  18. Next steps… • Review findings from audits – August – October • Develop audit strategy for 2014/15 • Workshop for sector – February – March 2014

  19. Meet the Regulators - The Challenges of the Organ Donor Directive and Transplant Licence Audit A story of Every Day Life in UK Transplantation – a Personal View Barry Fuller Royal Free Hospital & UCL Medical School Division of Surgery & Interventional Sciences(HTA Transplant Licence Lead)

  20. The Organ Donor Directive – Safety and Quality of Organs for Transplantation Organ transplantation in UK over the past 30 years has become an invaluable clinical treatment with sophisticated robust connecting pathways between the units – for Organ retrieval / Transplantation / Oversight (NHSBT ODT) – organs and information Unified oversight under HTA / ODD can bring advantages – raise service quality, safety, assist education and training BUT!!............... .............24 hours to make this work – Improve systems – yes √ – but confusion – no  Make sure no-one gets ‘frozen in the headlights’

  21. Transplant centres Organ Advisory Groups (e.g. Liver AG) Professional bodies Patient & Public feedback With all sides working together we can achieve better things ahead And meet new challenges – Live donation, Paired Organ sharing, Tissue-engineered organs

  22. Deemed consent in Wales – the role of the HTA 9 July 2013 Vicky Marshment

  23. Background • Welsh Government’s manifesto commitment to introduce a presumed consent system for organ donation • Period of engagement and consultation • HTA providing advice and guidance throughout • Human Transplantation (Wales) Bill laid in late 2012

  24. Activity in 2013 • Evidence to Health and Social Care Committee in January 2013 • Request to produce Code of Practice for the final stages of scrutiny • Draft Code of Practice available on the last day of May 2013 • Consultation later this year

  25. The Welsh Government’s experience 9 July 2013 Pat Vernon, Head of Policy for Organ and Tissue Donation Legislation

  26. Communicating and engaging to ensure public and professional confidence 9 July 2013 Shaun Griffin

  27. Communications strategic priorities for 2013/14 “To develop and consolidate productive stakeholder relationships with the public and professionals”

  28. Principles of HTA communications • Understanding • Trust • Consistency • Openness • Engagement • Consultation

  29. HTA external communications channels • Website • Enquiries (more than 3000 in 2012/13) • HTA newsletter (8000 subscribers) • Independent Assessor Bulletin • Stakeholder engagement • Media • Social media Communications is as much about what you don’t see as what you do see

  30. Changes to the living organ donation framework • Providing advice and guidance to IAs and transplant units • Providing advice and guidance to public on ‘matching’ websites (Nov 2012)

  31. Changes to the living organ donation framework • Media around directed altruistic donation – reactive and proactive • Issued statement on organ matching website (August 2012) • Briefed the media about our role and the legal and regulatory requirements in advance of broadcast • Conducted media interviews • Social media – e.g. during TV broadcast

  32. Living organ donation

  33. Licensing of organ donation and transplantation • Working with the sector • Meetings with DH, NHSBT • Workshops and events to develop framework • Each Unit allocated Regulation Manager • Audit process and feedback • Informing through website e-newsletter and communications e.g. • Framework and SAEARS guidance document

  34. Licensing of organ donation and transplantation • Communicating key milestones • Announcing we were Authority required by Government to implement EU legislation and by agreement with Devolved administrations • Parallel consultation • HTA on framework • DH on regulations • Announcing first licences

  35. Deemed consent in Wales • Communications and stakeholder engagement • Media interest about changes • Addressing stakeholder concerns • Working with Welsh Assembly Government • Written and oral evidence • Contribute to policy and communications meetings • Future consultation on HTA code of Practice

  36. Deemed consent in Wales

  37. Conclusion • Mix of communications and stakeholder relations varies depending on the issue – are we responding, advising, raising awareness or influencing • Key principles • Communication balancing public, professional, and legal requirements • Evaluate public and professional confidence and professional advocacy

  38. Questions?

  39. www.hta.gov.uk http://twitter.com/HTA_UK http://www.Facebook.com/HumanTissueAuthority

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