The Human Tissue (Authorisation) (Scotland) Act 2019: qualitative research - October 2019 to January 2020

Introduction

This report presents the findings from qualitative research undertaken with NHS staff involved in donation processes, in relation to the ‘The Human Tissue (Authorisation) (Scotland) Act 2019’ (hereafter referred to as ‘the Act’, ‘the law’ or ‘the legislation’). The Act introduces a system of 'deemed authorisation' for organ and tissue donation for transplantation. This means that if someone dies in circumstances where they potentially could become a donor, and they have not recorded a decision on donation, they would be presumed to be willing to donate unless their family provides information that the potential donor was unwilling to do so. The Act is predicated on the views of the donor taking primacy.

A five year Monitoring and Evaluation Plan is in place that outlines the outcomes that the Act is expected to influence and the data sources that will be used to measure progress. The primary aim of the Act is to increase donation authorisation rates, alongside a package of supporting implementation activities to raise awareness, knowledge, skills, and support for the legislation and opt-out authorisation processes. A number of the Act’s intended outcomes relate specifically to the views, confidence, and practices of staff who are involved in donation. Correspondingly, some of the implementation activities focus on NHS specialist staff recruitment, engagement, and training.

In order to understand the potential impact of the legislation, baseline information was collected prior to the Act’s implementation. Existing data on organ and tissue donation in Scotland was primarily quantitative (e.g. donation rates or public attitudes). This information did not give insights into NHS staff perspectives or the landscape of donation processes that can affect donor referral or authorisation processes. This research fills an evidence gap about the views held by NHS staff involved in donation about donation generally, and the move to a deemed authorisation system more specifically.

It is important to address this gap because research on organ and tissue donation systems outside Scotland shows that, alongside a transition to an opt-out authorisation system, infrastructure improvements appear to be important factors in contributing to increased organ donation and transplant rates (Organ Donation Taskforce, 2008; Rithalia et al., 2009; Willis, 2014). In addition, international research shows medical staff play a prominent role in increasing organ donation rates (Glasper, 2018). More information from the international data can be found in the Annex.

This report presents findings from qualitative research conducted with NHS staff about their awareness of, knowledge about, and attitudes toward the Act, organ and tissue donation, current donation procedures, changes that will be made to this process once the law goes into effect, and training sessions support NHS staff’s delivery of these changes. The data presented in this report addresses the specific workforce related outcomes in the Monitoring and Evaluation Plan. Note that the findings presented here do not cover all aspects of the Act or the infrastructure to support it, and some discrepancies may arise between staff views in advance of the Act’s implementation and the exact stipulations of the legislation.

The findings of this report are based on 28 one-to-one interviews and 9 focus groups conducted with 63 NHS staff involved in organ donation across Scotland. The research was carried out between October 2019 and January 2020. Further information on the types of professionals interviewed is provided in the section on methods and sampling.

Research Questions

This report presents the findings in relation to the following research questions:

1. What are NHS staff members’ views on, understanding and awareness of the new opt-out authorisation system?

2. What are NHS staff’s views on the NHS organ and tissue donation system, and donation as part of end-of-life care?

3. How can successful early identification and referral of potential donors, and successful authorisation processes best be supported? What supports a reduction in missed donation opportunities? What are barriers to the successful realisation of these aims?

4. What are key areas that training should target to raise awareness and knowledge of, and support for tissue and organ donation, and opt-out authorisation among NHS staff?

It is important to note that due to the nature of qualitative research, findings outwith the scope of the above questions emerged, and have been reported on in this report.

Methods and Sampling

This research uses a qualitative approach as it allows for a deeper understanding of the contextual factors grounding the experience, views, and perspectives shared by participants. A qualitative approach also ensures that the context of different specialist NHS staff roles within the larger donation process can be considered, so that a multifaceted understanding can be created based on the findings of this project. Interviews and focus groups also allowed the researcher to ask follow-up questions so participants could clarify and reflect on their insights into the donation process and opt-out authorisation, thereby producing clearer, more comprehensive, and contextualised data.

Interviews and focus groups were conducted in person by a Scottish Government researcher, between October 2019 and January 2020, on or near NHS sites to create as minimal inconvenience to NHS staff as possible. Project participants were interviewed individually or in focus groups, and asked to discuss: their role within the donation process; what helps and hinders them in this role; their understanding of, knowledge of, and views on donation and opt-out; and their approach to authorisation from families for organ and tissue donation, and referral of potential donors to SNODs/TDCs. The aim was to identify some of the factors which play a role in the success of the donation process, specifically those which affect missed opportunities of donor referral, and donor family authorisation rates.

In this report, the term ‘NHS staff’ refers to all of the staff groups, listed below, who participated in this project. 28 one-to-one interviews and 9 focus groups were conducted across Scotland with:

• 8 Clinical Leads for Organ Donation (CLODs)
• 10 Specialist Nurses for Organ Donation (SNODs)
• 23 Intensive Care Unit (ICU) consultants
• 15 ICU nurses
• 2 Emergency Department (ED) consultants
• 1 ED nurse
• 4 Tissue Donation Coordinators (TDCs)

The initial sampling aim was to gain equal representation of staff from both ICU and ED contexts. However, a greater number of those working within ICU settings, than ED settings were recruited for the study. This is due to contextual issues of the ED work setting. Due to the nature of emergency medicine, ED staff members’ work patterns are unpredictable and it is challenging for them to schedule reliable time periods for interviews or focus groups. As such, only a few ED staff contacted the researcher of this project expressing interest and availability for participation at NHS sites during their work hours. Indeed, 2 of the 3 ED staff who participated did so during their off-hours. Further, as explained by the ED staff that were able to provide interviews, ED settings do not have as robust of an infrastructure around facilitating donation as ICU settings do, such as lead consultants for organ donation or embedded SNODs to maintain and promote awareness of donation within the department.

Data Analysis Approach

The interviews and focus groups were audio recorded (with permission from the participants) and professionally transcribed. The transcripts were analysed using a content analysis approach, with use of the NVivo qualitative data analysis software programme. The data was systematically organised (into themes and categories) so that the similarities and differences between participants’ responses could be compared. The content analysis approach is well suited to analysing nuanced information about organisational procedures and social phenomenon, and fits with the type of data collected by the interviews and focus groups and with the purpose of this research, namely producing key insights about NHS staff’s differing values, understandings, and perceptions. Further information on the content analysis process can be found in the Annex. Findings are presented thematically, in relation to the different research questions, and quotations from interviews and focus groups are used to illustrate key points.

Ethics

A Research, Innovation and Novel Technologies Advisory Group (RINTAG) Service Evaluation application (ODT Study N#9) was submitted for ethical approval prior to the start of this qualitative project. Ethical approval was obtained on 26 September 2019 from the Transplant Quality Improvement Group, NHS Lothian, and on 15 October 2019 from the Research, Innovation and Novel Technologies Advisory Group (RINTAG) of the Organ Donation and Transplantation Directorate of NHS Blood and Transplant (NHSBT).