Human Transplantation (Wales) Act 2013.

How it works in clinical practice

Human Transplantation (Wales) Act 2013

• Human Transplantation (Wales) Bill received Royal Assent September 2013

• Sets out how consent is to be given in Wales to the donation of organs and tissues for transplantation.

• Believe a change in law to a soft opt out will result in a 25-30 % increase in organ donations or 15 additional donors.

• Will be effective from 1st December 2015

Creation of 2 types of legal consent from 1 December 2015

Express consent

Yes I want to donate my organs

No I don’t want to be an organ donor

Appoint/ nominate a representative

Deemed consent (opt out system/presumed consent)

Unless a person has taken the deliberate step of recording they do not want to be an organ donor after death, then they will be regarded as having no objection to organ donation and their consent will be deemed to have been given.

Deemed consent will apply to Adults:

• Over the age of 18

• Who have lived in Wales for 12 calendar months or more and are ordinarily resident in Wales in a voluntary capacity

• Who have not expressed or recorded a decision

• Who also die in Wales

Deemed consent will NOT apply to people….

< 18 years of age

Who lack capacity to understand the notion of deemed consent

Have lived in Wales <12 months or who are not ‘ordinarily residents’

Visitors to Wales

Or people who have….

Join the Organ Donor Register

0300 123 23 23

Appointed a representative to make a decision regarding donation on their behalf

Opted In or Out Family or friends that object because they know the deceased would not have consented

No

Not what he wanted

No

Welsh residents who die elsewhere

Novel Transplants

Making an approach that reflects the patients decision

and Welsh Legislation

Do Not want to be a donor

Do want to be

a donor

AppointedRepresentative

to make decision

No registration on the ODR

ODRRegistration

Yes- I Do want to be a donor

ODR Registration

•Presumptive approach empathising honouringpatient’s decision.

•Establish whether this was the patients last known decision

•Avoid any suggestion that the families permission is also required.

•Objective is to describe what will be required for patient’s decision to donate to be fulfilled.

•Ultimate aim is to encourage the family to accept patient’s donation decision to want to save lives through transplantation

Core Elements of Approach

NO - I Do Not want to

be a donor

ODR Registration

•Share recorded ODR decision with family.

•Establish whether this was the patients last known decision

•If family offer information that patient wanted to donate either written or verbal (witnessed) check what evidence exists to support this and if it is more recent then the ODR registration

•If more recent and evidence is reasonable then the ODR Registrationcould be overturned.

Core Elements of Approach

AppointedRepresentative

ODR Registration

• Frame the approach that the patient had made and recorded adecision for an Appointed Representative to make a decisionabout donation on their behalf (Due to data protection the identity of the Appointed Rep cannot be disclosed withoutseeking permission from them first)

Name/s & contact details of individual/s

whom patient has appointed will be

recorded on ODR

Core Elements of Approach

Establish with family/friends whether first person consent exists i.e. had the

patient made a decision in

regard to organ donation?

Establish with familywhether the patient

nominated/appointed a representative to

make a decision about donation on their

behalf

In Wales - establish if patient fulfils criteria to apply deemed consent

Family consent/authorisation from person in highest qualifying relationship

Sequence of obtaining consent when patient is Not

on the ODR1

2

3

4

If not

If not applicable

If not

Establish with family/friends whether first person consent exists i.e. had the patient made a

decision in regard to organ donation?

I am now going to talk to you about the unique position ...

...go on to save lives and transform the life of somebody

through O.D

...ever talked to you about O.D at any time

NoYes

Establish with family whether the patient nominated/appointed a representative to make a decision about donation on their

behalf

Checked ODR, has registered a decision Appointed a representative

That's someone to make the Decision about becoming an organ

Donor on his behalf

Do you know of anybody else s/he may have discussed

organ donation with

Not registered on theODR

Some people ask a friend not Necessarily immediate NOK To make this decision on their

behalf

In Wales - establish if patient fulfils criteria to apply deemed consent, no knowledge of

the Law

Ever talked to you about organ donation at any time?

The Law in Wales does not makeorgan donation compulsory

Made it easier for those who want to donate

The Law encourages people to think about what they would like to do,

register or share their decision

In Wales - establish if patient fulfils criteria to apply deemed consent, knows about the

Law

Ever talked to you about organ donation at any time?

It is really important for me to ask You a few questions

Establishing whether consent for deceased organ donation can be deemed (Wales only)

Is the patient in a Welsh hospital?

No

Consent cannot

be deemed

Has the patient lived in Wales for more than 12 months? Was the

patient an ordinarily resident in

Wales?

Consent may be deemed.

(For organs/tissues for transplantation purposes only- NOT for research)

Is the patient aged 18 or

over?

Has the patient recorded a

decision on the ODR to either donate, not to donate or has appointed a

representative to make the decision on their behalf?

Had the patient expressed a wish about

organ donation i.e. donor card/will/

discussed with family or friends?

Did the patient lack capacity

for a significant

period before their death?

Yes

No

No Yes

Yes

No Yes

Yes

Do the patient’s family or

friends object to donation

because they know the deceased

would not have consented?

No

Yes No

No Yes

No Yes

Explore what evidence supports this:-

Is it in writing or verbal? If verbal, when did the

conversation take place? What was the context of the

conversation etc? Seek advice from TM or RM

Family consent from person in highest qualifying relationship

If consent cannot be deemed consent must be sought from a person in

a qualifying relationship

This is how consent is obtained under theHTA 2004, the only difference is that

the donation conversation has establishedthe patient had not made a decision in life

and consent cannot be deemed

Implications for the UK

Welsh resident dying outside of Wales

•HTA 2004 or HTA (Scotland) 2006

•Need to check donor register (opt in, opt out or appointed rep

decision)

•Deemed consent will not apply outside of Wales (though a

presumptive approach could be made)

Non-Welsh resident dying in Wales

•They fail the 3-stage residency test

•Current rules and approach apply

•Will be able to opt out for the first time and appoint a representative