Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations: consultation analysis

Procedures not for inclusion (Q1)

Question 1: If there is anything in the Type A procedures list that you think should not be included, please comment here, giving reasons why.

30. The consultation paper sought views from respondents on whether the proposed Type A pre-death procedures list contained any procedures that should not be included.

31. Altogether, 13 respondents (six individuals and seven organisations) commented on Question 1, of which 10 directly commented on the question. One organisational response to Question 1 did not address the question directly, but overall their response did not highlight any specific requirement to remove any procedure proposed to be specified as Type A.

32. Four individuals did not respond to the question. Two organisations responded, but only to indicate either they had no comment or this question was not applicable for them.

33. Generally, organisational responses to the question were split on the theme of their reply i.e. on whether the list is comprehensive or requires change.

34. Individual respondents made reference to their own clinical experiences when considering this question and, as with organisational responses, variation emerged when answering this question.

35. However, consensus did emerge to a certain degree between both organisational and individual respondents around two procedures that were suggested for removal and this is set out below.

Procedures should be removed

36. Respondents commenting that procedures should be removed from the Type A procedure list fell into both organisational and individual categories, with no clear distinction between the two groups and respondent types as to their responses. Instead, the clinical experiences of each respondent informed both the views of individuals as well as organisational replies, with experience of working to achieve DCD donation.

37. Responses requesting the removal of procedures as Type A did however coalesce around two specific procedures: computerised tomography (CT) scanning and magnetic resonance imaging (MRI). Seven responses (three individuals and four organisations) requested these procedures should not be included in a prescribed Type A list.

CT and MRI

38. Respondents focused on and were consistent in explaining why CT and MRI should not be considered as a Type A procedure. It was generally set out that this was due to the risks associated with transferring a patient to carry out these procedures. Respondents set out that a number of wider considerations are also related to this and which also informed their recommendation that CT/MRI should be removed.

The movement of a patient

39. All respondents (both individual and organisational) recommending the removal of CT and MRI highlighted the risks associated with moving the patient from ICU, to the location where these scans would take place.

40. It was indicated by some respondents that, due to the need to move a patient, they would expect specific agreement to be sought from a donor's family before these procedures could be completed, rather than authorisation for the procedure to be deemed via being prescribed as a Type A procedure.

41. Discussions with clinical stakeholders throughout the consultation period provided further context to this point, highlighting that every ICU and hospital is potentially different in the location of imaging units. Some ICU's are immediately next to CT and MRI facilities, while others may be several floors away and these factors may currently be taken into account in deciding whether carrying them out would be appropriate.

Other considerations regarding CT/MRI

42. Respondents set out other considerations related to a requirement to move a patient, including:

• Balance of risk/benefit: some respondents, both individual and organisational, commented that the completion of a CT or MRI is not currently routine practice for facilitating DCD donation. It was also advised that similar results might be obtained reliably using other methods not requiring movement of the patient. Therefore, such respondents advised that there might not be sufficient justification for moving a patient outwith ICU.
• Potential impact on ICU staff: Two respondents linked the need to move the patient to a corresponding impact on the wider ability of the ICU to function effectively, describing an impact on staff time to complete such scans. This impact is as a result of the overall time consuming nature of completing these imaging techniques.
• Potential impact on donor family: One respondent referenced the impact it can have upon the donor family, in terms of time spent away from their loved one.

Ultrasound scanning

43. Related to the above responses regarding movement of a patient, two organisational respondents suggested the removal of ultrasound scanning from the Type A list.

44. Some ultrasound scanning can take place outwith ICU. Like the imaging procedures discussed above, this may require movement of a patient to the relevant unit. Other forms of ultrasound scanning can however be completed at the beside in ICU and will not require any movement of a patient.

45. These organisations advised they could not support the consulted Type A list if it would permit a patient being removed from ICU.

46. As discussed above, it was made clear by clinical stakeholders that in a clinical setting removal of a patient from ICU would routinely necessitate agreement of the family. In the view of respondents on this matter, deeming authorisation for patient removal from ICU may not align with such practice.

Other comment – faith

47. Similar comments regarding movement of a patient to those outlined above were made by a representative faith organisation.

48. The respondent set out the overall position for their faith community in relation to medical tests and end of life care, specifically addressing the movement of a person of that faith at the time of their death. It was explained that, in most circumstances, their faith requires that a person is neither touched nor moved when near to death to avoid hastening this moment, or touched immediately following death.

49. However the respondent acknowledged that for those of their faith who may be in ICU at the end of life, this context is different for such persons. The response highlighted that moving a patient at the end of life in a hospital setting may be required. The respondent noted that this potential medical requirement will have to be reconciled to the requirements of their faith during end of life care and is a consideration that person's family would have to address.

50. In this context, the respondent did not support prescribing any Type A pre-death procedures that involve potentially moving a patient outwith ICU.

List is comprehensive

51. Four respondents (two individuals and two organisations) indicated that the provided list was comprehensive in the context of DCD donation and the procedures within this list would be suitable to be categorised as Type A, under the new statutory framework.

52. Respondents who advised that the proposed list was comprehensive did so with reference to their own clinical experience, and with reference to the general requirements of DCD donation in a clinical setting.