Organ and tissue donation - authorisation requirements: guidance

Chapter 2 - New principles introduced by the 2019 Act

20. As well as making provision for the purpose of introducing a deemed authorisation system and providing clarity on pre-death procedures, the 2019 Act introduced several new concepts and principles:

• Requirements as to who can carry out certain functions: The HTS Act permits specific functions to be carried out only by those meeting the definition of a 'health worker'. (See paragraphs 21-28 for more information)
• The duty to inquire: The HTS Act places a duty on certain health workers, who in most cases will be SNODs/SRs/TDCs, to make inquiries about a potential donor and their views. (See paragraphs 29-37 for more information)
• The concept of the 'relevant time': This replaces the references to 'immediately before death' in the 2006 Act to take account of the fact that a potential donor might not yet be deceased at relevant points during the authorisation process. (See paragraphs 38-42 for more information)
• The Organ Donor Register: The HTS Act places the NHS Organ Donor Register (ODR) on a statutory basis in Scotland and sets out with whom information from the ODR may be shared (see paragraphs 43-48 for more information). It also requires that donation decisions recorded other than on the ODR must be in writing.

'Health Worker' functions

21. The HTS Act requires that certain functions within the donation process must only be carried out by a 'health worker'. These functions are:

• Carrying out the duty to inquire – this will generally be done by a SNOD, a SR or TDC, or on rare occasions, and particularly in relation to tissue-only donation, by a clinician or nurse if the SNOD/SR/TDC is not available.
• Receiving authorisation (and where appropriate, withdrawal of authorisation) for donation from a nearest relative of an adult or a person entitled to authorise donation on behalf of a child^[7] – this will generally be done by a SNOD/SR/TDC or, on rare occasions, by a clinician or nurse if the SNOD/SR/TDC is not available.
• Carrying out or authorising a person to carry out pre-death procedures and ensuring that the requirements of the HTS Act are met before the procedure goes ahead (see chapter 8) – this will generally be done by a registered medical practitioner, registered nurse or a range of other appropriately skilled and trained health professionals, for example a radiographer.

22. The HTS Act also recognises that the responsibility for making assessments and decisions about a potential donor's condition and care in the context of pre-death procedures is a matter for a 'health worker'. In practice, these decisions will be made by a registered medical practitioner, for example an ICU consultant (see paragraph 190).

Meaning of 'Health Worker' and how a person may be authorised to carry out the functions of a Health Worker

23. The Act provides a definition of 'health worker' which encompasses the different professionals who may be involved in the donation process. Section 16J of the HTS Act defines a 'health worker' as a registered medical practitioner or a registered nurse.

24. In addition, a person or person within a description^[8] can be authorised to undertake some or all of the health worker functions. This will usually be done on a case by case basis by asking a person to carry out a certain task which is a health worker function. For example, an ICU consultant or SNOD/SR is able to authorise a radiographer to carry out an X–ray as a pre-death procedure, by requesting them to carry out this task.

25. The registered medical practitioner or registered nurse must consider that the person that they are authorising to undertake the task has the appropriate skills, qualifications or experience to perform the relevant function(s).

Role of health bodies in authorising a person to carry out health worker functions

26. Section 16J of the HTS Act also gives powers for authorisations to carry out health worker functions to be made by health bodies^[9] should it be necessary. This power is intended to provide additional flexibility should the circumstances require it. However, based on the current roles and responsibilities involved in the donation process, it is not envisaged that this will be necessary as all required authorisations can be made by an individual registered medical practitioner/registered nurse authorising an individual to carry out a specific health worker function.

Revoking authorisation of a person to carry out health worker functions

27. The HTS Act also enables authorisation of a person to carry out health worker functions to be revoked if required, for example if a person authorised to carry out a function is no longer qualified to do so. In practice revocation is unlikely to be necessary, particularly as most authorisations will be given on a case by case basis by virtue of asking a person to carry out a specific task.

28. In most cases, any person (a registered medical practitioner or registered nurse) or health body permitted to authorise can revoke an authorisation. It is only if a health body gives the authorisation to a description of person (for example, all radiographers working in a particular hospital) that it needs to be revoked by that health body.

Duty to inquire

29. The duty to inquire reflects current good practice whereby a discussion takes place with the potential donor's family about donation, including about the potential donor's views about donation, to ensure that donation doesn't proceed where it would be against a person's wishes.

30. The HTS Act requires that certain checks are undertaken before the carrying out of any pre-death procedure or retrieval can take place to determine a potential donor's status, any decisions which they may have recorded, and their views about donation and pre-death procedures.

31. The duty to inquire may only be carried out by a health worker, which in most cases will be a SNOD/SR/TDC. If the duty to inquire is being carried out by a health worker who isn't a SNOD/SR/TDC then they should do so following discussion with the SNOD/SR/TDC.

Inquiries which must be made

32. The SNOD/SR/TDC must ensure that the requirements of the duty to inquire,^[10] detailed below, are fulfilled, before the carrying out of any pre-death procedure or retrieval.

33. Under the duty, the SNOD/SR/TDC must take reasonable steps to inquire:

• whether there is an express authorisation for donation in place and
• whether there is an opt-out declaration in place.

34. Further, if the potential donor is an adult, and there is no recorded decision in place, the SNOD/SR/TDC must inquire into:

• whether the adult is in a category of persons in respect of which deemed authorisation does not apply ('an excepted category') (see paragraph 115).

35. In inquiring as to whether a potential donor is an adult who is incapable of understanding the nature and consequences of deemed authorisation (see paragraphs 133-141 for more information), the SNOD/SR/TDC must consult - so far as reasonably practicable - any person who has indicated a wish to provide evidence of the adult's incapacity.

36. In all cases, whether a donation decision is in place or not, the SNOD/SR/TDC must inquire about the potential donor's views about donation, both in general and in the specific circumstances, which may include views based on the way the death has manifested – either after circulatory death or brain-stem death – for example for religious reasons. The SNOD/SR/TDC must also inquire about the potential donor's views about the carrying out of pre-death procedures. This should be done by consulting the following people, as far as is reasonably practicable:

• the nearest relative^[11] of the potential donor (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.

37. Additionally, in a case where it is determined that an adult is incapable of understanding the nature and consequences of deemed authorisation, and a nearest relative is considering whether to authorise donation, the SNOD/SR/TDC must inquire not only as to the adult's most recent views, but also as to the adult's past wishes and feelings, so far as reasonably ascertainable.

Relevant Time

38. The 2019 Act introduces the concept of 'relevant time'^[12] which is used to define a point or period of time during the donation process. This replaces the 'immediately before death' terminology in the 2006 Act and reflects the growth in donation following circulatory death (DCD) since the introduction of the 2006 Act. 'Relevant time' applies to various aspects of the process and is defined differently depending on whether the potential donor is alive, (but expected to die, as in the case of DCD donation) or deceased (as in the case of donation after brain-stem death (DBD)).

39. Where the potential donor is alive, the 'relevant time' is when:

• in the view of the person primarily responsible for the potential donor's medical treatment, they are likely to die imminently, including as a result of the withdrawal of life-sustaining treatment if it is being administered;
• the decision has been taken by the person primarily responsible for the potential donor's medical treatment to withdraw life-sustaining treatment, if being administered; and
• the person primarily responsible for the potential donor's medical treatment is of the view that they are incapable by reason of ill health of making a donation decision (adults and children aged 12 and over).

40. Where the potential donor is deceased, the relevant time is:

• immediately before the potential donor's death.

41. The concept of 'relevant time' applies for the purposes of the HTS Act in relation to various aspects of the donation process. In particular, it is relevant when establishing the status of the potential donor and their decision about donation and pre-death procedures. For example:

• whether the potential donor is an adult or a child and, if a child, whether the child is under or over 12 years of age;
• whether a donation decision is in place in respect of a potential donor;
• how long an adult potential donor has been resident in Scotland;
• how long the potential donor has been incapable of understanding the nature and consequences of deemed authorisation;
• whether the carrying out of pre-death procedures has been expressly authorised by the potential donor.

42. The 'relevant time' is also relevant to establishing the status of a person who may authorise donation on behalf of the potential donor. For example:

• who the nearest relative of an adult potential donor is;
• who has parental rights and responsibilities in relation to a potential donor who is a child;
• if there is no person who has parental rights and responsibilities in relation to a child, or if they are incapacitated, who may authorise donation for the child (see paragraph 160 for more information).

Disclosure of information from the NHS Organ Donor Register

43. The HTS Act permits NHSBT (as the register organisation)^[13] to disclose information from the ODR to assist or enable certain persons to carry out functions under the Act which relate to the removal and use of a body part for the purpose of transplantation.

44. The information which can be disclosed from the register about an individual is:

• whether there is an express authorisation in place and its detail,
• whether there is an opt-out declaration in place and its detail, or
• that there is no information about a person held in the register.

45. Information can only be disclosed by NHSBT to the following persons:

• A registered medical practitioner,
• A person authorised under the Human Tissue (Removal of Body Parts by an Authorised Person)(Scotland) Regulations 2006^[14] to remove body parts, for example tissue retrievers (see paragraphs 210 for more information),
• A health worker carrying out the duty to inquire in respect of a potential donor who is an adult or a child, for example a SNOD/SR/TDC.

46. To facilitate the process of transplantation and as part of the duty to inquire, the information received from NHSBT may be shared amongst the persons listed above and disclosed onwards to:

• the nearest relative of the potential donor or, if the potential donor is a child, a person entitled to authorise donation on behalf of a child,
• any other person who has been consulted about the latest views of the potential donor.

47. In practice this means that the SNOD/SR/TDC or other health worker is able to inform the family of the potential donor whether there is a decision recorded on the ODR (as well as the details of that decision), as well as any other person who is asked about the potential donor's latest views.

48. As well as permitting information to be shared within Scotland, the HTS Act allows the register organisation to disclose information about a person from the register to a person operating outwith Scotland if it is done for the purpose of enabling or assisting that person to carry out functions that relate to the removal and use of a part of the body for transplantation.