Organ donation and transplantation seminar

9 July 2013

Protective

Marking

None

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

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

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

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

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

Independent Assessment

9 July 2013

Andrew Hoy

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

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

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)

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

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

The regulation of organ donation and transplantation

9 July 2013

Imogen Swann

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

Audits

4 pilot audits – June to November 201217 audits – January to July9 audit reports published

1 2 3 4 50

1

2

3

4

5

6

7

8

9

Number of different organ types being retrieved and/or transplanted by each establishments

Number of estab-lishments

Number of different organ types being retrieved and/or transplanted by each establish-ment

Findings to date

No critical shortfalls No major shortfalls 17 minor shortfalls

Advice and guidance

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

Next steps…

Review findings from audits – August – October

Develop audit strategy for 2014/15

Workshop for sector – February – March 2014

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)

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’

With all sides working together we can achieve better things ahead And meet new challenges – Live donation, Paired Organ sharing,

Tissue-engineered organs

Transplant centres

Organ Advisory Groups(e.g. Liver AG)

Professional bodiesPatient & Public feedback

Deemed consent in Wales – the role of the HTA

9 July 2013

Vicky Marshment

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

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

The Welsh Government’s experience

9 July 2013

Pat Vernon,

Head of Policy for Organ and Tissue Donation Legislation

Communicating and engaging to ensure public and professional confidence

9 July 2013

Shaun Griffin

Communications strategic priorities for 2013/14

“To develop and consolidate productive stakeholder relationships with the public and professionals”

Principles of HTA communications

Understanding Trust Consistency Openness Engagement Consultation

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

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)

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

Living organ donation

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

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

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

Deemed consent in Wales

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

Questions?

www.hta.gov.uk

http://twitter.com/HTA_UKhttp://www.Facebook.com/HumanTissueAuthority