Alex RKA reminder that the Organ Donation (Deemed Consent) Act 2019 comes fully into force in England today, 20 May. The equivalent in Wales (The Human Transplantation Wales Act 2013) came into effect on 1 December 2015. There is no equivalent in Northern Ireland or, at present, in Scotland (this will be changing in March 2021).
If you are 18 and over and have lived in England for more than 12 months you will be deemed to consent to organ and tissue donation if you die in England.
People who lack capacity to understand the new system will not have their consent deemed and the system does not apply to people who never had the capacity to understand deemed consent. It also does not apply to those who have developed a condition that stops them understanding the system such as dementia. There is also a requirement that you live in England and Wales voluntarily.
The Human Tissue Authority has published a revised Code of Practice F: Donation of solid organs and tissue for transplantation, along with a short public guide. Paragraphs 178-188 of the Code of Practice address the question of mental capacity in context, and, for ease of reference, are reproduced below:
Mental capacity
178. Deemed consent does not apply to people who, for a significant period before their death (see paragraphs 185-188), lacked the capacity to understand that consent to donation can be deemed.
179. Where the potential donor does not have capacity, interventions before death are governed by the Mental Capacity Act 2005, rather than the HT Act 2004.
180. If a potential donor lacked capacity to understand that consent can be deemed for a significant period before their death, then the person is an excepted adult, and their consent cannot be deemed. Therefore, consent should be sought from a nominated representative or a person in a qualifying relationship (see paragraph 136).
181. If, at the point at which a potential donor lost capacity, deemed consent did not apply to them, for example, they were a child or did not live in England, then their consent cannot be deemed.
182. In some cases, it will be evident that a potential donor lacked capacity for a significant period before their death as they may, for example, have been suffering from a persistent disorder of consciousness (coma, vegetative or minimally conscious state).
183. In other cases, to establish whether a potential donor lacked capacity for a significant period before their death, the SN [Specialist Nurse] should take the following steps:
a) Check the medical records of the potential donor to establish whether there was any history of conditions or illness, which may have affected the potential donor’s capacity to understand that consent could be deemed. It is important to note that a record of an episode, or episodes, of such an illness would not necessarily mean that a potential donor lacked capacity to understand that consent could be deemed. However, it should prompt further investigation by the SN.
b) If there is no indication in the medical records of a condition or illness, which may have impacted the potential donor’s capacity to understand that consent could be deemed, or any assessment of the potential donor’s capacity to understand this, the SN should document this on the consent form and/or medical records.
c) If there is an indication in the medical records of a condition or illness that may have affected the potential donor’s capacity to understand that consent could be deemed, the SN should undertake further investigations of the condition or illness. The issue of mental capacity should be raised by the SN when speaking to the family to ascertain if the potential donor had the capacity to understand that consent to organ and tissue donation could be deemed.
d) Where there is information about a condition that may have affected the potential donor’s capacity to understand that consent could be deemed, in most cases it will be the family who are able to provide the SN with the most accurate information as to whether the potential donor had the capacity to understand that consent to organ and tissue donation could be deemed. The SN should ask the family whether they believe the potential donor had the capacity to understand that their consent could be deemed. This may be a detailed discussion, and if at the end of this the SN is not satisfied that the potential donor had the capacity to understand that consent could be deemed, then consent should not be deemed.
184. If the potential donor had been in hospital for some time it may be appropriate to speak to a member of the team caring for them about their capacity.
Significant period
185. The potential donor will be an excepted adult only if they lacked capacity to understand that consent could be deemed for a significant period prior to their death.
186. The HT Act says that a ‘significant period’ means a sufficiently long period as to lead a reasonable person to conclude that it would be inappropriate for consent to be deemed. The significant period test is, therefore, based on what a reasonable person would consider to be a sufficiently long period, given the circumstances of each case and the facts presented.
187. In practice, as guidance a ‘significant period’ should mean that the potential donor did not have capacity to understand that consent could be deemed for a period of twelve months immediately before their death. The twelve month period is provided as guidance in this first Code of Practice that covers deemed consent in England in order to provide regulatory certainty to SNs and other practitioners, and is consistent with how deemed consent works in Wales.
188. The lack of capacity to understand that consent can be deemed for a significant period only negates deemed consent. If the potential donor had made an expressed decision to consent, or not to consent, while they had capacity to make that decision then that decision remains valid regardless of a subsequent loss of capacity.
