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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