Organ and tissue donation - authorisation requirements: guidance

Chapter 8: Guidance on the authorisation and undertaking of pre-death procedures

This chapter explains the steps which must be taken before any predeath procedures (otherwise known as 'ante-mortem interventions') can be carried out in relation to potential organ and tissue donors who are still alive, but expected to die imminently, including as a result of the withdrawal of life-sustaining treatment. These patients will almost always be incapable of providing informed consent for any tests or procedures which may be necessary to enable donation to proceed.

This guidance outlines the legal position under the HTS Act in relation to such procedures being carried out on patients who are alive, including in donation following circulatory death (DCD) cases and in DBD cases before brain stem death has been confirmed. It is important to ensure processes are in place to help to facilitate donation where it is authorised (either expressly or through the operation of deemed authorisation), but also to ensure that a clear framework exists for safeguards to protect patients from any procedures (such as tests, interventions or administration of medication) where they are likely to cause harm or more than minimal discomfort to the patient.

The carrying out of pre-death procedures to facilitate transplantation is required for tissue-only donation far less frequently than in relation to organ donation. However, for completeness, the framework in the HTS Act covers both organ and tissue donation for transplantation as it may affect organ donors who are also expected to donate tissue, following circulatory death.

Background and clinical context

172. Any decision about whether or not treatment should be withdrawn must be made purely in the interests of the patient and independently of any consideration of possible donation. It is important to give the patient's family time to come to terms with the probable death of a loved one, and to be able to consider fully all end of life options, including donation.

173. Donation following circulatory death takes place when death has been established following irreversible cessation of the heart (i.e. following cardio-respiratory arrest). The Academy of Medical Royal Colleges issued guidance on the diagnosis and confirmation of death in 2008.^[30]

174. There are a number of steps that can be taken before a person has died, which can optimise the chances of a successful donation and subsequent transplant(s). These steps fall into the broad categories of actions to check the person's suitability to be a donor (such as blood tests), maintaining treatment and planning the timing of its withdrawal to coordinate with organ retrieval and introducing treatment or procedures that improve the chances of a successful transplant.

175. This guidance replaces the CMO guidance of 3 May 2010 (SGHD/CMO(2010)11) to reflect the provisions on pre-death procedures within the HTS Act.^[31] The new legislative provisions provide a statutory basis for pre-death procedures, which aims to provide greater clarity for health professionals and safeguards for potential donors, particularly in light of the introduction of deemed authorisation in Scotland.

The law

176. The HTS Act provides a new statutory framework^[32] for pre-death procedures, which is tailored to the practical and ethical issues relating to donation. A 'pre-death procedure' is defined as a medical procedure which is carried out on a person for the purpose of increasing the likelihood of successful transplantation of a part of their body after their death and which is not for the primary purpose of safeguarding or promoting the physical or mental health of the person.

177. It is essential to be clear that up until the point at which the patient is confirmed to have died, the requirements of the HTS Act (as discussed below) must be followed in relation to any pre-death procedure. Once death has been confirmed, these requirements no longer apply and so this guidance does not need to be considered in relation to patients who have already been declared dead following brain-stem death testing.

178. The HTS Act is based on the concept of authorisation. 'Authorisation' is the expression of the principle that a person has the right to specify, during their lifetime, their decision about what should happen to their body after their death, in the expectation that this decision will be respected.

179. The HTS Act makes provision for two different types of pre-death procedures - Type A and Type B procedures - to be undertaken to facilitate donation, as long as certain requirements are met. Type A procedures are those which are generally considered as routine procedures which would be needed to enable deceased donation to progress. Type B procedures are less routine and are generally more invasive. These are discussed further below.

Authorisation of pre-death procedures

180. Subject to the outcome of the duty to inquire, Type A procedures will be considered to be authorised by the donor when they have either expressly authorised deceased donation for transplantation (such as where they had opted in on the ODR) or where their authorisation for donation is deemed under the HTS Act. The HTS Act also enables a person to expressly authorise pre-death procedures.

181. Where authorisation for donation for transplantation is given by the patient's nearest relative (or a person entitled to authorise donation on behalf of a child ),^[7] then that person must also authorise the carrying out of a Type A pre-death procedure before it can proceed. The person authorising would normally be expected to authorise these as a group during the authorisation process, rather than needing to consider and authorise each test or procedure separately. Such authorisation may be given in writing or it may also be given orally, if so it must be given to a health worker, who in most cases will be a SNOD/SR/TDC.

182. Authorisation may not be given if the person permitted to give it has knowledge that the potential donor would have been unwilling to undergo the procedure. The person who is considering whether to give authorisation should have regard to any evidence of the potential donor's views brought forward under the duty to inquire and be satisfied that if the potential donor were capable of making a decision about the procedure they would not be unwilling to undergo it.

183. Type B procedures, whilst common in other settings, are likely to be more rare or novel in a donation for transplantation setting, and are generally of a more invasive nature. They therefore require additional authorisation and further criteria to be fulfilled before they could be undertaken (see paragraph 197-202 for more details).

End of life decisions

184. Potential DCD donors will usually (but not always) be in critical care, with relatives close by. A clinician will make treatment decisions based on considering whether any treatment is for the patient's benefit and is expected to safeguard or promote the physical or mental health of the adult, which means considering all aspects of their condition and consulting their family. At some stage, clinicians may reach the view that there is no prospect of recovery and further active treatment would therefore not be for the patient's benefit, in which case a decision may be made to withdraw treatment.

185. Guidance on end of life decisions and withdrawing treatment is available in the GMC's Treatment and care towards the end of life: Good practice in decision making.^[33]

Checks required before undertaking any pre-death procedures

186. Pre-death procedures can only be carried out where the patient is likely to die imminently (including as a result of the withdrawal of life-sustaining treatment where a decision to withdraw treatment has been taken) and it is confirmed that authorisation is in place for deceased donation for the potential donor. This can either be express authorisation by the donor themselves (such as where they had opted in via the NHS Organ Donor Register (ODR)), via deemed authorisation or where appropriate, authorisation by a person entitled to authorise donation on behalf of an adult or a child. Such authorisation on behalf of a donor can be given orally and if so it must be given to a health worker, who in most cases will be a SNOD/SR/TDC. If it is in writing it must be signed (see paragraph 171).

187. In addition, where the potential donor is still alive at the point where authorisation for deceased donation is being ascertained and pre-death procedures are expected to be required, the SNOD/SR has a duty to inquire about whether the patient had expressed any views about pre-death procedures. Where the patient's family or friends provide evidence regarding the views of the patient in relation to pre-death procedures, this must be taken into account. For example, if a family member explains that the patient had previously said they did not want to undergo a particular form of procedure or provides any other evidence that indicates that the patient would have been unwilling to consent to that procedure, then those views must be respected.

188. In the case of patients for whom either express authorisation or deemed authorisation for donation for transplantation is in place, if, following inquiries by a SNOD/SR, there are no known objections by the patient to a pre-death procedure, then it can be considered to be authorised as long as all of the following apply:

• it is a type of procedure listed in regulations by the Scottish Ministers, which have been approved by the Scottish Parliament and brought into force (for a Type A procedure, the relevant regulations are the Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations 2020.^[34] (See paragraph 197 in relation to Type B procedures);
• the health worker who is to carry out or who has authorised another person to carry out the procedure has no actual knowledge that the patient was unwilling for the procedure to be carried out;
• the health worker who is to carry out or who has authorised another person to carry out the procedure has had regard to the person's past wishes and feelings so far as reasonably ascertainable (having had regard to any evidence brought forward under the duty to inquire); and
• the health worker who is to carry out or who has authorised another person to carry out the procedure is satisfied that if the person were capable of making a decision about the authorisation of the procedure, they would not be unwilling for it to be carried out.

189. In practice, if no evidence of objections by the patient has been brought forward under the duty to inquire, then it will be rare for these conditions not to be met. However, if there is any cause to doubt the position, this should be investigated before the procedure is carried out.

190. In addition to the authorisation requirements set out above in paragraphs 180-181 needing to be fulfilled, the clinician primarily responsible for the patient's medical treatment must be of the view that the patient is likely to die imminently, including as a result of the withdrawal of life-sustaining treatment where the decision to withdraw treatment has been taken. ('Imminently' is not defined in the legislation, but in this context can be taken as including any patient who is expected to die within a couple of days).

191. Finally, either the person carrying out the procedure or the person who has authorised another person to carry out the procedure (who could be, for example, a SNOD, the clinician responsible for the patient's care or another member of staff within the Critical Care Unit) needs to be satisfied that:

• the procedure(s) is/are included in the list of procedures specified in regulations by the Scottish Ministers, which have been approved by the Scottish Parliament and brought into force (see paragraph 195 in relation to Type A procedures). Where the procedure is a Type B procedure, there are additional authorisation requirements, as set out in paragraph 197.
• the procedure is necessary for the purpose of ascertaining whether a part of the person's body is suitable for transplantation, or for the purpose of increasing the likelihood of successful transplantation of a part of the person's body.
• that carrying out of the procedure is not likely to cause more than minimal discomfort to the patient, nor is it likely to harm them.

192. In practice, this means that certain routine tests, (those listed at paragraph 196), can be carried out when the requirements of paragraphs 188 to 191 have been met, as donation could not normally be expected to be able to proceed without them. While all of the permitted Type A procedures (see list at paragraph 196) are routine, the person carrying out or authorising someone to carry out the procedure(s) must still be satisfied that the requirements of paragraph 191 are met in respect of every proposed procedure. In particular, they should consider that the procedure is necessary – to determine whether an organ/ organs or tissue are safe or suitable for transplantation or to improve the likelihood of a successful transplant(s), for example by improving the condition of the organ(s).

Assessing the risk associated with individual procedures

193. While all Type A procedures should not cause more than minimal discomfort to a patient or be likely to harm them, whoever is performing or authorising another person to perform the procedure needs to consider if any pre-existing medical conditions or other particular circumstances (such as allergies) might increase the risk of harm or discomfort to the patient from a particular procedure. If, in the view of the person performing, or authorising another person to perform the procedure, it is considered likely to cause more than minimal discomfort or to cause harm to the patient, then it may not be carried out.

Discussing pre-death procedures with family

194. As is the case with other aspects of end of life care, it is good practice to discuss planned pre-death procedures with the potential donor's family in advance of them being carried out. This is in addition to the requirements to consult the family about the potential donor's views about pre-death procedures as part of the duty to inquire.

Type A Procedures

195. The Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations 2020^[34] specify those procedures which are classified as Type A. The regulations list the specific procedures which may be carried out as type A procedures. For example the regulations list as a procedure the 'taking of a blood sample' but do not specify by which method that blood sample should be taken. This is in order to enable the most appropriate method to be undertaken, based on clinical assessment as well as taking into account the requirements in the Act, including consideration of the likely discomfort or harm associated with carrying out the procedure. If there is no method specified, the regulations do not place any restriction on the method by which the procedure may be carried out, and would permit the insertion or reinsertion of any peripheral or central lines if required. However, where more than one method is available the method which involves the more minimal interference with the potential donor should be pursued wherever possible and appropriate.

196. The current permitted 'Type A' procedures are shown in figure 3. In figure 3:

• "arterial line" means a cannula inserted into an artery;
• "blood component" means any of the following constituents of human blood
  • red cells,
  • white cells,
  • platelets, and
  • plasma;
• "blood product means any therapeutic product derived from human blood or plasma;
• "intravenous fluids" means any electrolyte solution intended for intravenous administration;
• "pre-established airway and ventilatory support" means any method of airway or ventilatory support administered to the person for the primary purpose of the person's medical treatment prior to any decision to withdraw life sustaining treatment;
• "pre-established suprapubic catheter" means a suprapubic catheter inserted into the person for the primary purpose of the person's medical treatment prior to any decision to withdraw life sustaining treatment.

Figure 3: Type A pre-death procedures

Class of procedure / Type of procedure

Collection of bodily fluids and microbiological samples

• Taking of a blood sample
• Taking of a urine sample including by way of a pre-established suprapubic catheter
• Taking of a chest secretion sample (excluding bronchoscopy)
• Swabbing or scraping of the body including inside of the mouth, nostril or ear canal but excluding the swabbing or scraping of any part of any other body orifice

Radiological imaging

• Carrying out of an X-Ray without transferring the patient from their existing location
• Carrying out of ultrasound imaging without transferring the patient from their existing location
• Carrying out of transthoracic echocardiography without transferring the patient from their existing location

Cardiovascular Monitoring

• Carrying out of electrocardiogram (ECG)
• Cardiac output monitoring by way of an arterial line
• Carrying out of central venous pressure monitoring
• Arterial blood pressure monitoring including by way of an arterial line

Respiratory Monitoring and Support

• Measuring of oxygen saturation
• Sustaining the appropriate operation of any pre-established airway and ventilatory support

Administration of medication or other product

• Administration of antimicrobials
• Administration of intravenous fluids
• Administration of medication to manage blood pressure
• Administration of blood, blood components and blood products

Type B Procedures

197. The Human Tissue (Authorisation) (Specified Type B Procedures) (Scotland) Regulations 2021^[35] specify those procedures which are classified as Type B. The Regulations also set out how those procedures may be authorised and the conditions which must be met before they can be carried out, in addition to those required by the HTS Act as set out above in paragraphs 188 to 191.

198. The current permitted 'Type B' procedures are shown in figure 4.

Figure 4: Type B pre-death procedures

Class of procedure / Type of procedure

Collection of bodily fluids and microbiological samples

• Swabbing or scraping of a bodily orifice other than the mouth, nostril or ear canal

Radiological imaging

• Carrying out of Magnetic Resonance Imaging (MRI) scan
• Carrying out of Computerised Tomography (CT) scan
• Carrying out of an X-Ray where the patient is transferred from their existing location
• Carrying out of ultrasound imaging where the patient is transferred from their existing location
• Carrying out of a transthoracic echocardiography where the patient is transferred from their existing location

Tissue sampling

• Taking of a skin biopsy

Endoscopic procedure

• Carrying out of a bronchoscopy

199. In addition to meeting the requirements set out above in paragraphs 188 to 191, the following conditions must be met before a Type B procedure may be carried out:

• two Registered Medical Practitioners (RMPs) must be of the view that the conditions set out in section 16E(2)(c) to (e) of the 2019 Act are met, namely:
  • the carrying out of the procedure is necessary;
  • the carrying out of the procedure is not likely to cause more than minimal discomfort to the person, and;
  • the carrying out of the procedure is not likely to harm the person; and
• the two RMPs must also be of the view that it is not possible to obtain the required information by carrying out a Type A procedure.

200. One of the RMPs must be the health worker primarily responsible for the person's medical treatment, which in most cases will be an ICU consultant. Neither of the RMPs can be part of the team involved in the retrieval or transplant process. A record of the agreement between the two RMPs must be made in writing.

Authorisation of Type B procedures

201. Authorisation for the Type B procedure in question must be in place before it can be carried out. Authorisation may be given expressly by the donor themselves or by their nearest relative (or person entitled to give authorisation on behalf of a child). It is likely that in the vast majority of cases there will not be an express authorisation by the potential donor, however if such an authorisation is given then it must be in writing. An authorisation given by the nearest relative (or person entitled to give authorisation on behalf of a child) must be either in writing, or, if it is given orally, it must be given to a health worker, who will, in this case, normally be the SNOD/SR.

202. Authorisation may not be given if the person permitted to give it has knowledge that the potential donor would have been unwilling to undergo the procedure. The person who is considering whether to give authorisation should have regard to any evidence of the potential donor's views brought forward under the duty to inquire and be satisfied that if the potential donor were capable of making a decision about the procedure they would not be unwilling to undergo it.

Additional considerations

203. It is important to emphasise that pre-death procedures for the purpose of facilitating donation cannot be carried out if they are not included in the list of either Type A or Type B procedures. Even where they are listed as a Type A or Type B procedure, they can only be carried out where the requirements of paragraphs 186 to 191 are met.

204. Note, however, that where a procedure or test would be undertaken anyway for the purposes of caring for or treating the patient even if donation was not being considered, it is not necessary to consider the requirements of the HTS Act, but instead whether the procedure is for the patient's benefit. For example, if a test has been undertaken as part of the patient's care, the results can then be used for considering the viability of donation without needing to consider the requirements above.

205. In addition, as noted in paragraph 191, pre-death procedures are only permissible for transplantation purposes and so cannot be carried out only to support the other purposes for which organs or tissue can be donated after death (research, education and training, audit or quality assurance). Therefore, a procedure may be permitted if it is carried out to facilitate transplantation, but the results may also subsequently be used for other purposes (e.g. a blood sample sent for testing being used later for audit purposes), but the procedure cannot be permitted under this pre-death procedures framework prior to the patient's death where it is only going to be used for a purpose not related to facilitating transplantation.

Timing and location of withdrawal of treatment

206. Decisions about the timing and location of withdrawal of treatment are not considered as 'pre-death procedures' within the HTS Act, so are not subject to the requirements set out above. It is generally understood and accepted that there are a number of reasons for flexibility in the timing of withdrawal of treatment, for example to allow family members to be present or to make sure the relevant healthcare professionals are available to oversee the process. In practice, the timing is a matter of discussion and agreement between a patient's family and clinicians. An important aspect of timing may be the need to allow time for absent family members and friends to be present when withdrawal happens. This recognises that a person has an interest in the manner in which they die and in how they are remembered.

207. There will almost invariably be a lapse of time between reaching agreement on the withdrawal of treatment and the actual moment at which treatment is withdrawn, for the reasons given in the previous paragraph. During that period, keeping the patient stable would be reasonable, so as not to cause distress to the relatives. Their ongoing care is not covered by the pre-death procedure requirements as it would be likely to happen anyway even if the patient was not a potential donor; donation may well affect the timing of withdrawal of treatment, but is only one factor in this.

208. Since it is necessary to begin organ retrieval very soon after death has been declared in relation to DCD donors, this means in practice that the surgical retrieval team must be ready in an operating theatre before cardio-respiratory support is withdrawn. Because it commonly takes some hours for arrangements for retrieval to be completed, this requires withdrawal of cardio-respiratory support to be delayed if DCD is to be possible. For similar reasons, local circumstances may necessitate moving the patient to a different location within the hospital, close to or within the operating theatre complex, ahead of withdrawal of treatment.

Figure 5: Steps to be taken before Type A and Type B pre-death procedures may be carried out – see paragraphs 199-200 for more detail in relation to Type B procedures requirements

Is the PDP listed in regulations?

• The procedure must be listed in regulations in order to be carried out

Are the following conditions met?

• Patient is likely to die imminently (including as a result of withdrawal of life sustaining treatment)
• Where the patient is receiving life sustaining treatment, a decision to withdraw that treatment has been taken
• The PDP is necessary (to assess suitability for transplantation or to increase the likelihood of successful transplantation)*
• The PDP is not likely to cause more than minimal discomfort*
• The PDP is not likely to harm the patient*

*For Type B, two RMPs must agree that these conditions have been met, and agree that a Type A procedure couldn't be used instead

Is authorisation for donation in place?

• Express authorisation for donation (for example on the ODR)
• Deemed authorisation for donation
• Authorisation from the Nearest Relative or person entitled to authorise on behalf of a child

Is authorisation for PDPs in place?

• Type A pre-death procedures are authorised when: Donation is expressly authorised (for example on the ODR) / Authorisation for donation is deemed / Authorisation is given by Nearest Relative/person entitled to authorise on behalf of a child (where they are permitted to authorise donation) / Authorisation is given expressly for the PDP by the patient
• Type B pre-death procedures are authorised when: Authorisation is given expressly for the PDP by the patient / Authorisation is given by Nearest Relative/person entitled to authorise on behalf of a child

Has the duty to inquire been carried out?

• Following the carrying out of the duty to inquire there is no suggestion that the patient would have objected to donation or the carrying out of PDPs

Is the Health Worker requesting /carrying out the PDP satisfied of the following?

• They have no actual knowledge the patient was unwilling for PDPs to be carried out
• They have had regard to the patient's past wishes and feelings regarding PDPs
• If the patient was capable of making a decision about PDPs they would not be unwilling for them to be carried out