On 20 May 2020, organ donation in England changed to a ‘deemed consent’ system, which means adults who live and die in England are considered to be a donor after their death unless they have indicated that they did not want to be a donor. The Organ Donation (Deemed Consent) Act (2019) was implemented after Wales implemented a similar system in 2015, and Jersey in 2019. The Isle of Man, Guernsey and Scotland are expected to introduce a deemed consent (‘authorisation’ in Scotland) system in the next 18 months
With this wave of change in the UK, it is important that those working in critical care are fully aware of their important role and responsibility in understanding, supporting and implementing the new law.
The Act is more commonly referred to as ‘Max and Keira's law’ after the inspirational Keira Ball who died following a road traffic incident and her heart was transplanted into Max Johnson, a courageous young boy who had been dying from dilated cardiomyopathy. After a high-profile media campaign and cross-party political support for the proposed legislation, the Bill received royal assent, and became law on 15 March 2019.
Throughout 2019 and early 2020 NHS Blood and Transplant (NHSBT) has had a dedicated team to ensure organ donation staff are fully trained in the legislation as it relates to their specialised role. Specifically, this refers to the specialist nurse—organ donation (SNOD) or specialist requestor (SR). For the remainder of this article both these roles will be referred to as the specialist nurse.
Of all the NHS staff involved in the organ donation process, the specialist nurse is the expert in the delivery of the law. However, unless the specialist nurse has the opportunity and support to speak to a family where donation may be possible, the opportunity to save lives may be lost.
In the UK there are approximately 600 000 deaths each year. However, only about 7000 people die in circumstances where donation may be possible—for example, dying in an intensive care unit and having life-sustaining measures withdrawn or having death confirmed using neurological criteria. With so few life-saving opportunities for transplant, it is hoped that the new legislation maximises the number of people willing to donate.
Making a decision
In 2019 the NHS Organ Donor Register (ODR) reached its 25th anniversary. More than 27 million people have registered their donation decision. Since July 2015, and in preparation for Wales implementing the Human Transplantation (Wales) Act (2013), the function to record an opt-out decision has been available for all UK residents.
Alongside England's legislation sits the Human Tissue Authority's (HTA) code of practice (2020), which is the document that translates the technical nature of the law into bite-size and understandable sections, providing operational guidance to practitioners involved in the organ donation process. Being familiar with the code is essential to avoid unintentionally committing an unlawful act or omission.
What is an opt-in?
An opt-in can come in two forms: written or verbal. The written method can be done by registering directly online at the NHSBT organ donor website (https://www.organdonation.nhs.uk/), via a partner organisation such as the DVLA or the Boots Advantage Card, or formally in writing, whether that is in a will or via a specific written communication where the desire to be a donor is expressed (such as via email). Individuals can also ring the NHS organ donation line (0300 123 23 23) and have their decision recorded by a member of NHS staff. Although this is expressed orally, it is recorded on the ODR and thus considered written.
The verbal form is where a conversation has taken place and a decision to be a donor has been expressed verbally. In practice, it would be preferable if the family can cite that this was a witnessed conversation; however, in reality this is not always possible. It is important to note that an opt-in, whether it is written or verbal, carries the same weight in law and therefore the most important factor in the media campaign is for individuals to make a decision and to tell their loved ones what that decision is and pass it on.
What is an opt-out?
Equally, an opt-out comes in the same two forms. However, there is one minor difference in the written form. Opt-out registrations can only be recorded with NHSBT by telephone or via its website so as to reduce delays by going through a third party and thus any potential risk of a delayed recording of an opt-out being interpreted as a deemed consent. Using the DVLA or other partner feeds to provide opt-outs opens an avenue for risk that would erode public confidence in the system should there be an inadvertent donation because of a delayed registration.
What if people change their mind?
Both the former legislation (the Human Tissue Act, 2004) and the new deemed consent law give priority to a person's last known decision taking precedence. This allows for a donation decision to have been made previously but, subsequently, the individual changes their mind but does not get around to formally recording that updated decision.
It is very important to note that, if an individual has made a decision about organ donation, the deemed consent legislation does not apply to them. Only on occasions where there is no registration on the ODR, and the family confirms there has never been a donation conversation where the patient has expressed a view, can deemed consent be considered. This is referred to as the patient having no objection to donation.
What does the law cover?
Table 1 sets out what is included and excluded under deemed consent (Department of Health and Social Care, 2020). Where material falls under the excluded section, this is not to say that it cannot be donated, just that express consent is required from the family. There is often surprise that corneas or skin are on the included list, but in fact these are two of the most common transplants and are considered routine.
| Included under deemed consent | Excluded under deemed consent | ||
| Organs | Tissues | Brain | Face |
| Heart | Corneas | Genitals | Spine |
| Lungs | Skin | Reproductive organs | Toes |
| Liver | Bone | Fingers | Upper arm |
| Kidneys | Tendon | Thigh | Lower leg |
| Pancreas | Ligament | Lower arm | Mouth |
| Small bowel | Heart tissue | Trachea | All research |
Who is included under deemed consent?
The new law says all adults who live and die in England could be considered a donor unless they fall into one of the excluded groups:
Under 18
This exclusion is straightforward in that deemed consent cannot apply to a child. If, however, a child would like to register a donation decision this would be honoured. A person is considered 18 from midnight on the day of their 18th birthday.
Mental capacity
The Mental Capacity Act (2005) tells health professionals that mental capacity should be assumed unless there is evidence to the contrary. When dealing with potential donors, almost all of them are ventilated and are incapacitated by their injury, illness or sedation. However, it is not at this point in time that mental capacity is being assessed but the 12 months immediately prior to their death. In this case it may be that someone has been leading an active life and would have been capable of understanding the new law. This section of the legislation can be quite nuanced when presented with individuals whose mental capacity is reported to have deteriorated in the 12 months prior to their death, which is why the conversation with the family is so important and a multidisciplinary team approach to introducing donation to the family is essential.
Ordinarily resident
Where an individual has lived in England for 12 months prior to their death and England is the place where they live for settled purposes, they could have their consent deemed. If an individual does not fulfil those criteria, their consent cannot be deemed. Where it becomes more intricate is the case of students from outside England, or individuals who perhaps live on the Welsh or Scottish border but work in England. These individuals are considered on a case-by-case basis and the outcome is determined by information from the family.
The ordinary resident test also includes asylum seekers, the victims of human trafficking, prisoners, military personnel and diplomats. For consent to be deemed, an individual must be living in England on a legal and voluntary basis. Asylum seekers cannot be considered ordinarily resident until their application is accepted; human trafficking victims are in England neither lawfully nor voluntarily. Prisoners may well be incarcerated in England, which is where they might normally be ordinarily resident, but cannot now voluntarily leave and it is a similar case for the armed forces and diplomats in that they may be posted anywhere in the UK or the world and would have little or no say about whether they want to go.
Each of these scenarios would have to be considered on a case-by-case basis and the family conversation will help unpick all the details around this and, again, this is best planned and approached with the critical care nurse, the consultant and the specialist nurse.
Changes for critical care nurses
The legislation change shifts the focus of the donation conversation with the family to supporting the last known decision or a lack of objection of the deceased/dying patient. Hulme et al (2016) highlighted factors influencing the consent rate in the UK, identifying the importance of the specialist nurse being involved early in the process.
The organ donation service relies heavily on critical care colleagues to identify potential donors and refer them in a timescale that allows the specialist nurse to be involved. There is long-standing guidance relating to the identification and referral of potential donors (NHSBT, 2014), and approaching families about organ donation (NHSBT, 2015). National Institute for Health and Care Excellence (NICE) guidance 135 (NICE, 2016) supports this practice. Learning from the Welsh experience tells us that families get a better overall experience of organ donation when the right people are in the room having a planned and deliberate conversation about end-of-life options (Noyes et al, 2017).
Overall, the role of the critical care nurse has changed very little, with their importance being in identifying and referring potential donors. However, there is a chance that, because of publicity about the change in the law, families may raise the topic of donation before the clinical team is ready to discuss it.
Rationale for the team approach
This triumvirate approach of critical care nurse, consultant and specialist nurse provides the most holistic care for the patient and family when discussing organ donation. The consultant will lead on the breaking of bad news and answer questions about the treatment the patient has received. The critical care nurse will be carrying out end-of-life care, supporting the bereaved family and, where donation is supported, will be pivotal in the success of the donation and subsequent transplants. The specialist nurse carries a similarly important role by being the expert in the room in relation to organ donation. They will have had advanced communication training that supports the flow and delivery of this important conversation, as well as having the experience to answer detailed questions about the donation process.
A frequent question asked by critical care nurses is why the specialist nurse in organ donation is introduced to the family as a ‘specialist nurse’, without using their full title. There is concern that this is somehow being dishonest about their intentions. To answer this, the NHSBT team use the following analogy. A person has a gastrointestinal problem and attends hospital for an endoscopy. At a later date they return for an appointment with the consultant. When arriving, they are greeted by the consultant who is accompanied by a colleague who is introduced as the cancer specialist nurse. The person has just been told they have cancer in the worst possible way.
Of course, this is an extreme example and not meant to be a representation of the amazing work undertaken in oncology. However, the example works on many levels when we compare it to organ donation. Introducing a colleague by their job title is not essential when it can do the family a disservice by delivering bad news in a clumsy, thoughtless way. The family must be in a position to understand and accept that death has happened or is going to happen, as well as having the time to process all the information they have been given. Only at that point would a transition into a donation conversation as per the plan made between the consultant and the specialist nurse take place.
The other common question is about what to do if the family raises the subject of donation themselves. As in the cancer example above, a patient might ask whether cancer could be a possibility after undergoing a procedure. If a nurse does not have the knowledge and experience of that specialty to guide the patient through the possible diagnosis, treatment options, prognosis and likely outcomes, it would be foolhardy to enter that conversation without involving the experts. Likewise, the specialist nurse for organ donation will provide the necessary level of knowledge, expertise and experience to guide a family through the process.
The advice in this scenario is to simply thank the family for raising it but say that it cannot be discussed until the diagnosis is clear, or until all treatment options have been exhausted as it would not be right to talk about end-of-life interventions until the team is certain that point has been reached. From experience, this satisfies the question raised while also reinforcing that everything is being done to save the life of their loved one.
The Welsh experience
Following the introduction of deemed legislation, an independent research study was funded by Health and Care Research Wales to track the attitudes and actions of individuals from both the medical and nursing professions, as well as families who had sadly lost a relative and had been approached about organ donation (Noyes et al, 2017).
The results of this study have changed practice in Wales, as well as informing the implementation process in England and other territories. Specifically, it had been presented that by doing nothing (not registering a donation decision nor discussing a decision with your family) constituted a choice to be a donor by having consent deemed. However, feedback from families demonstrated this was confusing and opened up a technical conversation about the law during an emotionally difficult time in the family's lives—–‘how can doing nothing be an active choice to do something?’ As such, lessons have been learnt from this approach and have changed the training delivery in England to presenting a non-registration or known decision about donation as indicating a lack of objection to donation.
The results of the Noyes et al (2019) study show that consent rates rose from 48.5% in 2014/15 to 61% in the 18 months following the legislation change. However, by 2018/19 consent rates in Wales had reached 79.8% (NHSBT, 2019). Additionally, this same comparative study presented by NHSBT (2019) illustrates that the consent rate moved to a point where it reached statistical significance in donation after brain death (DBD) when compared with the English consent rate of the same period. Over a period of 12 consecutive quarters, both DBD and donation after circulatory death (DCD) consent rates were tracked and an increase of greater than 10% was shown in the DBD consent rate but not DCD. The study concluded that deemed consent had an obvious impact in DBD consent and there is likely a delayed response with DCD. Again, this has informed the way a statistical study monitoring consent rate progress as the English (and other) laws change will be conducted, and a period of ‘bedding-in’ will be built into the study.
Conclusion
Deemed consent legislation came into effect in England on 20 May 2020 amid the COVID-19 pandemic and many have questioned whether it was appropriate to bring in this law at such a time. Any discussion about delaying the implementation must be understood in the wider context of the political landscape, that being, the post COVID-19 recovery will dominate parliamentary time for education, aviation, finance, business and the wider health system. As such, the law would have been unlikely to receive the necessary parliamentary time for debate for between 6 and 18 months. Despite COVID-19 having an arresting effect on the donation and transplant programme across the UK, we are now in a period of recovery and starting to see the life-saving benefits of Max and Keira's law.