Organ and tissue donation - authorisation requirements: guidance

Guidance on authorisation requirements for deceased organ and tissue donation and pre-death procedures, as introduced by the Human Tissue (Authorisation) (Scotland) Act 2019 from 26 March 2021. First edition published March 2021.


Chapter 6: Establishing whether a donation decision is in place

This chapter is about establishing whether donation is authorised by checking the ODR and through discussions with the potential donor's family (as part of the duty to inquire) to ensure that the latest views of the potential donor are taken into account.

Evidence of the potential donor's views may be in any form (including oral) and guidance is included on assessing the weight of the evidence brought forward.

This chapter also provides guidance on determining whether a person may be deemed to have authorised donation and whether they fall within an excepted category.

Checking whether a decision has been recorded

81. The HTS Act respects the principle that the decision to authorise donation rests first and foremost with the donor themselves (in relation to adults and children aged 12 and over). As such, the potential donor's valid express authorisation where this is recorded, or the potential donor's views about donation, including where authorisation may be deemed, should form an integral part of end-of-life care planning.

82. In every case where donation is a possibility, the SNOD/SR/TDC should establish whether, at the relevant time, there is a decision in force by the potential donor, in line with the requirements of the duty to inquire (see paragraphs 29-37).

83. The SNOD/SR/TDC should check the ODR to establish whether a decision has been recorded on it and if so, what the latest decision recorded there is. If a decision is recorded on the ODR, the SNOD/SR/TDC should communicate this to the potential donor's family and other individuals where relevant (see paragraphs 43-48 for more information on who information from the ODR may be shared with).

84. If there is no decision recorded in the ODR, the SNOD/SR/TDC should explore with the potential donor's family whether a decision may have been recorded elsewhere and gain a copy of it, if possible. If a donation decision has been recorded somewhere other than on the ODR, then it must be in writing. The HTS Act does not require written express authorisations or opt-out decisions to be witnessed, dated or signed. The HTS Act only requires a witness to be present where an express authorisation or opt-out decision is withdrawn in writing by a person who is blind or unable to write.[17]

Establishing whether a recorded decision permits donation to proceed

85. Where the potential donor has recorded their decision voluntarily, had the information they needed to make the decision, and had mental capacity or competence when they recorded it, then a donation decision recorded on the ODR or expressed in writing constitutes a valid decision at the time of recording. Unless there is a suggestion that this is not the case, then the assumption would be that the decision is valid. Any suggestion that the decision was not validly made should prompt further discussion and investigation. If a valid decision was made by a potential donor to authorise donation, this is sufficient to provide a lawful basis for donation to proceed, subject to the results of the inquiries about the potential donor's most recent views and the pre-death procedure requirements, as detailed in chapter 8.

86. The position for a child aged 12 or over, who was competent to record a decision before they died and who had authorised donation taking place after their death, is legally no different from that of an adult. The child's valid authorisation is sufficient to provide a lawful basis for donation to proceed, subject to the results of the inquiries about the child's most recent views and the pre-death procedure requirements, as detailed in chapter 8.

87. In circumstances where the potential donor has made an opt-out declaration, donation cannot proceed as authorisation is not in place. However, if when carrying out the duty to inquire, evidence that the potential donor would be willing to donate which meets the threshold is presented to a health worker, the potential donor is treated as though they have expressly authorised donation for the organ/tissue or purpose in question.

Establishing the potential donor's latest views

88. If a donation decision has been recorded, then the SNOD/SR/TDC must explore what the potential donor's latest views about donation were. As part of this, the SNOD/SR/TDC must explore not only views about donation in general but also what the potential donor's views would be in the specific circumstances. This may include views based on the way the death has manifested, for example for religious reasons (see paragraph 60 for more information).

89. The SNOD/SR/TDC should explore the potential donor's views with:

  • the potential donor's nearest relative[11] (in the case of an adult);
  • a person entitled to authorise donation on behalf of a child;[7]
  • any person who wishes to provide evidence of the potential donor's views;
  • any other person the SNOD/SR/TDC considers it appropriate to consult.

90. If it is a local authority which holds parental rights and responsibilities in relation to a child who has recorded a donation decision, the SNOD/SR/TDC should advise and guide the local authority through the requirements of the HTS Act. The local authority must, as far as is reasonably practicable, ascertain the child's most recent views by consulting:

  • the child's parents, and
  • such other persons as the local authority considers appropriate.

91. In practice, the relevant people are likely to be in attendance at the bedside and when this is the case, the local authority should discuss the child's most recent views with them, supported by the SNOD/SR/TDC.

If the potential donor's views have changed since recording their decision

92. The recorded decision by the potential donor may be treated as withdrawn if there is evidence of their views which is contrary to the recorded decision. This may be something that the potential donor has written or a recollection of a prior conversation held with the potential donor. In order for the recorded decision to be treated as withdrawn, evidence presented as part of the duty to inquire should meet the evidence threshold, that is it should be capable of leading a reasonable person to conclude that the potential donor's latest view was contrary to the recorded decision. For example, if an express authorisation has been recorded and evidence is given that the potential donor would be unwilling to donate which meets the evidence threshold, the express authorisation is treated as withdrawn and donation should not proceed. If an opt-out declaration has been recorded and evidence of the potential donor's willingness to donate, meeting this threshold, is produced, the opt out declaration is treated as withdrawn and the potential donor is treated as though they have expressly authorised donation for the organ/tissue or purpose in question.

93. Evidence may be presented which leads to the partial withdrawal of the potential donor's decision, either in relation to specific organs/tissue or specific purposes. Where this is the case, the decision is only withdrawn so far as it reflects those specific views and the remainder of the decision remains in force. For example, if a potential donor had authorised donation of their heart, lungs and liver for transplantation and subsequently changed their mind and no longer wanted to donate one of those organs for transplantation, then the authorisation for donation of that organ is treated as withdrawn. The remainder of the authorisation remains in force for the other organs for transplantation.

If there is express authorisation for donation and the family doesn't support donation proceeding

94. Where valid express authorisation has been given by the donor, but the family or others object to donation proceeding, then they should be sensitively supported to respect the potential donor's authorisation to ensure her or his decision is respected. A family's objection does not nullify valid authorisation for donation from the potential donor and only a potential donor themselves can revoke their legally valid authorisation or opt-out declaration.

95. The existence of valid authorisation by the potential donor permits donation to proceed, but does not mandate that it must. The final decision about whether to proceed with donation rests with the SNOD/SR/TDC, in conjunction with medical practitioners and through conversation with the potential donor's family.

If there is an express authorisation and there is no-one to consult about the potential donor's most recent views

96. There may be occasions where a potential donor has recorded an express authorisation for donation and, despite the best efforts of a SNOD/SR/TDC or other health worker, it does not prove possible to locate anyone who can be consulted about the potential donor's most recent views.

97. The HTS Act requires that inquiries must be made as to the potential donor's views about donation, as far as is reasonably practicable. The SNOD/SR/TDC should therefore seek out all available methods to establish whether there is a nearest relative or any other person who knew the potential donor recently to consult about the potential donor's views. After taking these steps, it may be apparent that there is no such person available or in existence.

98. In such a case, if the potential donor has recorded an express authorisation, lawful authorisation would be in place for the retrieval of the relevant organs/tissue to proceed. However, clinical consideration will be given as to whether there is sufficient information about the potential donor's medical and social history to inform an assessment of whether organ/tissue transplantation would pose risks for a potential recipient.

If no decision is in place - adults

99. If the SNOD/SR/TDC has established that there is no decision recorded on the ODR, or elsewhere in writing and the adult is not in an excepted category (see paragraph 115), then authorisation for donation may be deemed, subject to the results of the inquiries about the potential donor's views (see paragraphs 29-37).

100. Deemed authorisation does not apply where a person provides evidence to a health worker which would lead a reasonable person to conclude that the potential donor was unwilling to donate.

Deemed authorisation

101. In cases where a decision of a potential donor regarding authorisation for donation has not been recorded on the ODR or elsewhere in writing, then authorisation for donation for transplantation may be deemed, subject to certain exceptions. Deemed authorisation can only apply where the potential donor is an adult (aged 16 or over). Authorisation cannot be deemed if:

  • the potential donor is an excepted adult (see paragraph 115) or a child;
  • evidence (oral or written) is provided to a health worker that would lead a reasonable person to conclude that the potential donor would have been unwilling to donate, either in general or in the specific circumstances;
  • it is in relation to body parts which are excluded from deemed authorisation, as specified by the Scottish Ministers in regulations (see paragraph 165-166 for more detail);
  • it is in relation to purposes other than transplantation.

102. As outlined in paragraphs 82-84, steps must be taken to determine whether a decision of the potential donor has been recorded on the ODR or elsewhere. If a potential donor recorded a decision in regard to donation for transplantation purposes when they were alive, their authorisation cannot be deemed. As outlined in paragraphs 88-93, steps must also be taken to establish the potential donor's latest views about donation, as part of the duty to inquire.

103. Evidence may be presented to a health worker which may lead a reasonable person to conclude that the potential donor's most recent view was that they were unwilling to donate specific organs/tissue or that they would be unwilling to donate in the circumstances. Where this is the case, authorisation may only be deemed for those organs/tissue for which there is no evidence of unwillingness to donate. For example, if a potential donor is deemed to have authorised donation, but evidence is produced that would lead a reasonable person to conclude that they would have been unwilling to donate a particular organ, then authorisation could be deemed for organs/tissue other than that organ.

If authorisation can be deemed and the potential donor's family doesn't support donation proceeding

104. Where it has been established that authorisation may be deemed, but the potential donor's family or others object to organ or tissue donation proceeding, then they should be sensitively supported to respect the fact that in the absence of a recorded decision by the potential donor not to donate, and in the absence of evidence of unwillingness to donate, the law permits donation to proceed - a family's objection does not nullify deemed authorisation.

105. The existence of authorisation by the potential donor, including deemed authorisation, permits donation to proceed, but does not mandate that it must. The final decision about whether to proceed with the activity rests with the SNOD/SR/TDC, in conjunction with medical practitioners and through conversation with the family.

If authorisation can be deemed and there is no-one to consult about the potential donor's most recent views

106. There may be occasions where a potential donor has not recorded a decision and, despite the best efforts of the SNOD/SR/TDC or other health worker, it does not prove possible to locate anyone who can be consulted about the potential donor's most recent views.

107. The HTS Act requires that inquiries must be made as to the potential donor's views about donation, as far as is reasonably practicable. The SNOD/SR/TDC should therefore seek out all available methods to establish whether there is a nearest relative or any other person who knew the potential donor recently to consult about the potential donor's views. After taking these steps, it may be apparent that there is no such person available or in existence. In this case, the Scottish Government's policy position is that donation should not proceed as the risks to public confidence in the donation process may outweigh the benefits of proceeding with donation in these specific circumstances.

Evidence that would lead a reasonable person to reach a conclusion about the potential donor's views

108. In the case where a decision has been recorded or where authorisation is potentially deemed, the SNOD/SR/TDC should explore the potential donor's latest views about donation, as required by the duty to inquire. The SNOD/SR/TDC should consult, as far as is reasonably practicable, the persons required by the duty to inquire (see paragraph 36).

109. In some circumstances, those the SNOD/SR/TDC consults will confirm that the potential donor's latest view remained in line with their recorded decision to expressly authorise or opt-out of donation, or that the potential donor had no objection to authorisation being deemed.

110. However, in some circumstances, those consulted as part of the duty to inquire may note that they believe the potential donor's recorded view had changed or that in a case where authorisation could potentially be deemed, the potential donor would not be willing to donate. In these circumstances, the SNOD/SR/TDC must consider whether the evidence presented to them would lead a reasonable person to conclude that the potential donor was unwilling, or as the case may be, willing, to donate.

111. The reasonable person test enables the SNOD/SR/TDC to assess different, potentially conflicting evidence, decide how much weight to place on the evidence presented and make an objective assessment about its validity. This involves the SNOD/SR/TDC assessing whether a reasonable person would be led to a particular conclusion by weighing up the evidence, rather than deciding whether they themselves are led to that conclusion. Evidence from which the potential donor's views can be inferred, rather than being known absolutely should not be excluded from the assessment if it is produced.

Questions to guide the SNOD/SR/TDC in assessing evidence

112. In order to assess the weight of the evidence presented, the following questions may guide the SNOD/SR/TDC and assist them in assessing whether the evidence presented would be capable of leading a reasonable person to make conclusions:

  • Is the evidence in writing? If this is the case, then this is likely to be a decision by the potential donor and it should be considered whether it reflects their most recent view – for example, does it post-date any previous decision made by the potential donor, as recorded in the ODR or elsewhere and do those consulted as part of the duty to inquire recognise this as reflecting the potential donor's most recent views?
  • Is the evidence of the potential donor's views an account of views provided orally by the potential donor? If so, is it confirmed by more than one person? What level of detail is provided about the scenario in which the views were voiced? Where the evidence is an account of the potential donor's views which were provided orally, this would constitute evidence of views rather than a decision;
  • Is the evidence presented as reflecting the views of the potential donor, or the views of the person presenting it? The test requires that evidence presented must be of the potential donor's view. Therefore, weight should only be given to evidence which is presented as reflecting that potential donor's view; if the SNOD/SR/TDC is not satisfied that the evidence presented to them constitutes the views of the potential donor, it may be discounted;
  • How well does the person providing the evidence know the potential donor? Somebody who knew the potential donor well may have more insight into their views, however, it is important to note that the quality of the evidence presented to the SNOD/SR/TDC is the over-riding consideration, rather than the relationship to the potential donor of the person presenting it;
  • How recent is the evidence? The SNOD/SR/TDC should establish when the record was made, or the conversation took place.

113. If an opt-out declaration has been recorded, but there is evidence of willingness for donation to proceed which causes the opt-out declaration to be treated as withdrawn and the potential donor to be treated as though they have expressly authorised donation, the SNOD/SR/TDC should make a note of the evidence provided so there is a record in order to enable the retriever to be satisfied that the requirements of the HTS Act have been met.

114. It is important to note that the evidence produced to the SNOD/SR/TDC must relate to the potential donor's willingness or, as the case may be, unwillingness to donate. Information that the potential donor was not aware that deemed authorisation affected them is not sufficient, on its own, to lead a reasonable person to conclude that the potential donor would have been unwilling to donate. Similarly, the fact that the potential donor had not made or recorded a decision about donation, is not sufficient, on its own, to lead a reasonable person to conclude that the potential donor would have been unwilling to donate.

Establishing whether the potential donor is an excepted adult

115. For excepted adults, authorisation cannot be deemed and authorisation should, in these circumstances, be sought from the potential donor's nearest relative. An 'excepted adult' is:

  • a person who was not ordinarily resident in Scotland for a period of at least 12 months ending immediately before the relevant time (a "non-resident adult"),[18]
  • an adult who, for a significant period ending immediately before the 'relevant time', was incapable of understanding the nature and consequences of deemed authorisation ("an adult who lacks capacity").[19]

Adults ordinarily resident in Scotland for less than 12 months

116. Deemed authorisation does not apply to non-resident adults. A non-resident adult is a potential donor who has not been ordinarily resident in Scotland for at least 12 calendar months ending immediately before the relevant time, which in practice will be when end of life discussions are taking place. The duty to inquire requires that checks must be undertaken to establish whether a potential donor may be categorised in this way.

117. For the purposes of the HTS Act, "in Scotland" means within a Scottish local authority area. Local authority boundary maps can be viewed on the Local Government Boundary Commission website.[20]

118. In most cases, a SNOD/SR/TDC will be able to establish where the potential donor lived, and whether they were resident at an address or several addresses in Scotland, either from medical records or through discussions with family and friends.

119. Where it is established that a person lived at an address in Scotland, it must then be considered whether they could be described as "ordinarily resident" there in the 12 calendar months leading up to the relevant time.

120. If, following investigation, it is not possible for the SNOD/SR/TDC to ascertain that the potential donor lived in Scotland, they cannot be assumed to be ordinarily resident in Scotland and authorisation should not be deemed. For example, if it is not possible to access information which would detail a potential donor's address (e.g. medical records) within a timeframe which would enable donation to proceed, and the potential donor cannot safely be assumed to be resident in Scotland, then authorisation should not be deemed.

Period of residence

121. The twelve month period test does not involve counting the number of days a potential donor had lived in Scotland. Rather, it is necessary to establish that a potential donor had been ordinarily resident in Scotland for at least twelve calendar months before the relevant time.

122. In some cases, it may not be possible to establish the exact date a potential donor became ordinarily resident in Scotland. For example, the potential donor's family/friends may not be able to remember exactly when the potential donor moved to Scotland, but they may know it was within the last ten to fourteen months.

123. When this is the case and there is no clear evidence available to confirm the time when the potential donor started living in Scotland, then authorisation should not be deemed.

124. A period of time during which a person was ordinarily resident in Scotland immediately before the age of 16 may be included in the calculation of the 12 calendar months to determine whether deemed authorisation could apply.

"Ordinarily Resident"

125. The HTS Act does not define what is meant by "ordinarily resident", however the term has been subject to extensive case law which gives it its meaning. Whether a person has been ordinarily resident in a place will be a question of degree in each case, but is not achieved by extraordinary, occasional or temporary residence.

126. A potential donor will be "ordinarily resident" in Scotland when that residence is lawful, adopted voluntarily, and for settled purposes as part of the regular order of their life for the time being. Residence can be of long or short duration, but deemed authorisation will not apply unless someone has been resident for at least 12 calendar months ending immediately before the relevant time. The SNOD/SR/TDC will need to ask questions to gather information to establish the quality of a person's residence. For the "ordinary residence" test to be met, it must be established that:

  • The potential donor's residence in Scotland is lawful: British citizens will always have a right to live in Scotland, so will always be in Scotland lawfully. Some Commonwealth citizens also have an automatic right to live in Scotland. For people who do not have an automatic right, they will need permission to be in Scotland to be lawfully resident, for example, immigration permission. A person awaiting determination of their claim for asylum is likely to be considered lawfully resident in Scotland. A person whose claim for asylum has been refused cannot be considered to be lawfully resident in Scotland.
  • The residence was adopted voluntarily: It will be rare for a person not to be in Scotland voluntarily. For example, the fact that the potential donor chose to come to Scotland at the request of an employer, rather than seek another job, is unlikely to make their presence in Scotland involuntary.
  • The potential donor was resident in Scotland for settled purposes: There must be an identifiable purpose for their residence in Scotland with a sufficient degree of continuity to properly be described as "settled". Business, education, employment and family can all provide a settled purpose, but this list is not exhaustive. There may be one purpose or several, and it may be for a limited period.
  • The potential donor's residence in Scotland supported the regular order of their life for the time being: There is no requirement for any person to be living in Scotland permanently or indefinitely. The potential donor may have had temporary absences from Scotland and still be considered resident. It is also possible to be resident in more than one place. In such cases, care should be taken to ensure that residence has been established.

127. These requirements must be assessed on a case-by-case basis weighing up the relevant information. Whether the requirements have been satisfied will primarily be a question of fact. In many cases the SNOD/SR/TDC will be able to establish easily whether the potential donor's residence was characterised by the requirements above. When residence is initially unclear, it is recommended that there is a sensitive discussion with family/friends to gain more information about how the potential donor would have characterised their residence.

128. When a SNOD/SR/TDC has reasonable cause to doubt that the potential donor was resident in Scotland, then authorisation should not be deemed and authorisation should be sought from the nearest relative.

Students

129. Education can have the quality of a settled purpose and a student may be regarded as resident in the place in which they are studying or the place they consider home. Students could be considered ordinarily resident in Scotland as soon as they begin studying there, but their authorisation could only be deemed after at least 12 calendar months of being so resident, ending immediately before the relevant time.

130. It will be for the SNOD/SR/TDC to discuss with the potential donor's family/friends to determine whether the student's residence in Scotland had the necessary qualities described above before deciding whether deemed authorisation could apply.

Prisoners

131. People who die in prison cannot have their authorisation for organ and tissue donation deemed.

Other groups

132. There are other groups of people, for example those detained under mental health legislation, who may or may not reside in Scotland voluntarily. There are also those who live in Scotland lawfully but not for a settled purpose and/or as part of the regular order of their lives. For example, diplomats, armed forces personnel or other posted workers who spend a portion of their time in Scotland but who do not regard it as their home. It will be for the SNOD/SR/TDC to ask questions of family/friends to establish whether the person was ordinarily resident in Scotland on a case-by-case basis.

Adults without capacity to understand deemed authorisation

133. Almost all potential donors will lack capacity at the point at which discussions about donation are taking place as they will be critically ill. However, the protection in the HTS Act is in relation to adults who lack capacity to understand deemed authorisation over a significant period, rather than incapacity related to critical illness at the end of their life.

134. Deemed authorisation does not apply to a potential donor who, over a significant period ending immediately before the relevant time (which in practice will be when end of life discussions are taking place), lacked the capacity to understand the nature and consequences of deemed authorisation (referred to in this guidance as an 'adult who lacks capacity'). This means that the adult must have been incapable of understanding that they may be deemed to have authorised removal and use of part of their body for transplantation and that if authorisation were so deemed, part of their body could be used for transplantation purposes after death.

135. The HTS Act does not define what constitutes a "significant period". This is to enable the specific circumstances in each case to be taken into account and to recognise that capacity may fluctuate over time. Whether or not the potential donor falls into the category of an adult who lacks capacity will be a matter for the SNOD/SR/TDC to assess based on the available information, including evidence presented as part of the duty to inquire.

136. The duty to inquire requires that, in all cases where authorisation for donation could potentially be deemed, checks must be undertaken to establish whether a potential donor may be categorised as an adult who lacks capacity.

137. An example of when a person may be an adult who lacks capacity is when there is evidence available to a SNOD/SR/TDC (including any evidence gathered as part of the duty to inquire) that would lead a reasonable person to conclude that the adult is so incapable. In this scenario, the adult must be categorised as such and authorisation for donation cannot be deemed.

138. In order to establish whether a potential donor is an adult who lacks capacity, the SNOD/SR/TDC should take the following steps:

  • Where possible, 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 authorisation could be deemed and what that would mean. 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 would not have been able to understand this. However, it should prompt further investigation.
  • Where there is evidence of an illness that may have affected the potential donor's capacity to understand that authorisation could be deemed, in most cases it will be the family/friends who are able to provide the SNOD/SR/TDC with the most accurate information. The SNOD/SR/TDC should ask the family/friends whether they believe the potential donor had a level of capacity to understand deemed authorisation.

139. 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 to establish their level of understanding of medical and authorisation issues generally.

140. If there is any doubt about whether the potential donor lacked capacity to understand deemed authorisation over a significant period, then authorisation should not be deemed and authorisation should be sought from the nearest relative.

141. The fact that the potential donor was incapable of understanding the nature and consequences of deemed authorisation in terms of the HTS Act means that deemed authorisation cannot apply. However, if the potential donor had recorded an express authorisation or opt-out declaration while they had capacity to make that decision, then that decision remains valid regardless of a subsequent loss of capacity.

Contact

Email: fern.morris@gov.scot

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