Human Tissue (Authorisation) (Specified Type B Procedures) (Scotland) Regulations: analysis of consultation responses

Executive summary

Introduction

1. Between 8 October and 20 November 2020 the Scottish Government undertook a public consultation to gather views on a list of medical procedures to be prescribed as Type B pre-death procedures, which will be specified by the Human Tissue (Authorisation) (Specified Type B Procedures) (Scotland) Regulations.

2. Type B procedures are medical procedures which are likely to be less routine, or more novel, in the context of transplantation. This means they may need some additional authorisation or additional requirements before they could be undertaken and the consultation also sought views on these aspects of the regulations.

The respondents

3. The consultation received 15 responses. Responses were submitted by 5 organisations and 10 individuals.

4. All individual respondents had knowledge of deceased organ and tissue donation. Organisational respondents were largely those working to deliver deceased donation or clinical representative organisations.

Overview of findings

5. The consultation was undertaken to establish if the proposed medical procedures to be specified were both accurate and comprehensive and to seek views on the proposed authorisation methods and additional requirements. Taking into account the relatively small number of respondents, there was little overarching variation or groupings which could be consistently drawn between organisational and individual respondents, to the questions posed.

Question 1 – procedures not for inclusion

6. In response to Question 1, which asked if any proposed procedures for inclusion in the Type B regulations should be removed, the majority of respondents commented that no procedures needed to be removed from the Type B list. A smaller number of responses (2 individuals) indicated that X-ray, Ultrasound, Transthoracic echocardiography be removed from the list because they can be performed at the bedside. It was also suggested by an individual that MRI be removed as the transportation and time needed to perform this procedure would not bring benefit.

Question 2 – missing procedures

7. In response to Question 2, which asked if there were any medical procedures that may be missing from the proposed Type B procedure list, over half of respondents responded that the list was comprehensive and no other procedures needed to be included. Responses from just under half of respondents suggested the inclusion of a procedure. The procedures proposed for inclusion included Transoesophageal echo, Lumbar Puncture, and blood drawing for the purpose of genetic testing. Adding Transoesophageal echo to the list was suggested by both individual and organisational respondents.

8. One organisational response also suggested clarification on paragraph 39 of the Type B consultation, in relation to moving patients to carry out imaging procedures, as the intention of the statement is not clear in regard to whether it is the moving of the patient that introduces risk, or the nature of the procedure itself.

Question 3 – amendments to wording

9. In response to Question 3, which invited respondents to consider the wording of the procedures on the proposed Type B list, the majority of responses indicated that no amendments were needed. A smaller number of respondents indicated that clarification on the stipulation for movement of patients and intention behind this stipulation was needed.

Question 4 – Type B carried out only if Type A is insufficient

10. In response to Question 4, all respondents indicated that they agreed with the proposed condition that a Type B procedure may only be carried out if there is no Type A procedure which can provide the necessary information.

Question 5 – Two registered medical practitioners to confirm requirements

11. Question 5 asked respondents to share their views on the proposed condition that the agreement of 2 registered medical practitioners (RMPs), which will confirm the requirements for the Type B procedure to be carried out have been met, must be obtained and that the existence of such agreement must be recorded in writing.

12. The majority of respondents agreed with this condition, with and without notes or caveats. Three respondents disagreed with this condition, which centred mainly on the perceived lack of necessity of the condition. One organisational respondent did not express direct support or disagreement with the condition, but sought clarity on a number of points.

13. There were some themes which ran across the comments expressed by those in favour of this condition, those in disagreement, and those seeking clarification. Comments centred on the potential challenges or appropriateness posed by a transplant clinician fulfilling the role of RMPs and clarification needed on the seniority of staff fulfilling the RMP role.

Question 6 – Conditions applied to all specified procedures

14. In response to Question 6, which invited respondents to share their views on the approach that the conditions should apply to all specified procedures, the majority of respondents agreed with the approach that these conditions should apply to all specified procedures.

15. About a quarter did not agree with the approach for reasons centring on challenges in achieving the approach in practice.

Question 7 – Express authorisation or nearest relative authorisation

16. Question 7 invited respondents to share their views on the proposition that all specified procedures are able to be carried out either with express authorisation by the individual or with nearest relative authorisation.

17. The majority of respondents agreed with the proposition set out in the question, with and without caveats and clarifications to their support.