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

Introduction and background

14. Between 30 October and 11 December 2019 the Scottish Government undertook a public consultation to gather views on a list of medical procedures that will be prescribed as Type A pre-death procedures in regulations. Undertaking consultation is a requirement set out by the 2019 Act.^[1] The regulations will be enacted on the same day the new deemed authorisation system ('opt out') is implemented in autumn 2020.

15. The consultation paper contained four questions, which sought views on whether a proposed list of medical procedures that will form the content of the Human Tissue (Authorisation) (Specified Type A Procedures) (Scotland) Regulations was both accurate and comprehensive.

16. Pre-death procedures are routine medical procedures and tests normally completed in an ICU to facilitate donation and transplantation of organs and tissue from a potential donor.^[2] In the clinical community these are also referred to as ante-mortem interventions.

Policy context

17. In practice, solid organs for transplant have to be removed immediately after the death of a donor and quickly transported to the transplanting hospital. This means there are significant time constraints and some of the procedures that are necessary to assess the suitability of organs and tissue for transplantation, or to increase the likelihood of successful transplantation for the recipient, need to be carried out shortly before death, such as in the case of patients who donate following circulatory death (DCD donation).

18. Pre-death procedures include, for example, the taking of a blood or urine sample, completion of an x-ray or tests on the heart such as an electrocardiogram or echocardiogram. All of these medical procedures may be considered to be routine in a clinical setting. For example, patients in intensive care will have had a urinary catheter inserted.

19. The 2019 Act sets out a clear and dedicated statutory framework for the authorisation and carrying out of these procedures. In order for any pre-death procedure to be completed the requirements of the statutory framework must be met. This includes that the procedures must be authorised, which for specified Type A procedures will include by virtue of a potential donor authorising donation, (either expressly or deemed). Additionally, the framework requires that a duty to inquire is carried out before the completion of pre-death procedures and that there is no suggestion that the person would have objected to these being carried out. In practice the duty to inquire will mean that procedures will not be carried out without the consultation of a potential donor's family.

20. The 2019 Act requires that such procedures must be prescribed by regulation, and can either be defined as Type A or Type B procedures. The purpose of this consultation was to determine those medical procedures that would be appropriate to be specified as a Type A pre-death procedure and are also reflective of current clinical practice.

About the respondents and responses

21. The consultation was sent to all NHS Boards, NHS Organ Donation Committees, NHS Blood and Transplant (NHSBT), the Scottish National Blood Transfusion Service (SNBTS) and a number of clinical representative organisations such as the Scottish Intensive Care Society. The consultation received 19 responses, which included a response submitted via e-mail.

22. Responses were submitted by nine organisations and ten individuals (Table 1.0). These figures do not include clinical stakeholders and organisations that the Scottish Government engaged with during the consultation period (Table 1.2).

Table 1.0: Types of respondent

Category	Number of respondents
Organisations	9
Individuals	10
Grand total	19

23. All individual respondents to this consultation were working within the clinical community. Organisational respondents included NHS organisations and representative bodies, one local authority and one faith representative organisation.

24. A list of organisational respondents is provided in Annex C of this report. For the purposes of analysis, the organisational respondents were grouped into five categories, as shown in Table 1.1

Table 1.1: Organisation/ Group Type

Category	Number of respondents
NHS Bodies	2
NHS Organ Donation Committee	3
Professional representative organisation	2
Local authority	1
Faith/religion organisation	1

Engagement Exercises

25. In addition to responses received by the Scottish Government the Scottish Government met with the relevant NHS bodies and others involved in delivering deceased donation and transplantation detailed in Table 1.2.

26. The outcomes of these meetings have been included in the qualitative analysis in this report and are referred to only where they contributed distinctive, or new, information and/or views.

Table 1.2: Engagement with stakeholders

Date	Organisation/ Group
08 November 2019	Scottish National Blood Transfusion Service
12 November 2019	NHS Lothian, Director, Edinburgh Transplant Centre
15 November 2019	Golden Jubilee National Hospital, Surgical Transplant Team
22 November 2019	NHS Blood and Transplant

Responses to individual questions

27. As shown in Table 1.3, response rates to individual questions varied, with the most responses in relation to Questions 1 and 2.

Table 1.3: Question response

Question		Number of responses
Q1	If there is anything in the Type A procedures list that you think should not be included?	13
Q2	If there is anything missing from the Type A procedures list?	14
Q3	If any amendments to the wording in the Type A procedures list are required?	9
Q4	If you would like to comment on any other aspect of this consultation?	11

28. Not all of the comments made in relation to each question were necessarily directly relevant to the question being posed – some related to other consultation questions, or to other issues not directly covered by any of the questions in the consultation document, but to wider points regarding the implementation of the 2019 Act. These points were primarily put forward in response to Question 4.

Approach to the analysis

29. All consultation questions were open questions, with 'free text' boxes for respondents. Comments made in response to each question were analysed qualitatively. The aim was to identify the main themes and the full range of views expressed in relation to each question, together with areas of potential agreement or disagreement in the views of different types of respondent. This analysis seeks to ensure that differing views on the consulted list, from both professionals and organisations, are presented in a fair and balanced way.