Infected Blood Inquiry Report Oversight and Assurance Group minutes: June 2024

Attendees and apologies

Members

• Christine McLaughlin, Chair, Co-Director Population Health, Scottish Government
• Lynne Anderson, chair, Scottish National Blood Transfusion Committee
• Dr Emilia Crighton, Director of Public Health, NHS Greater Glasgow and Clyde, representing Directors of Public Health
• John Dearden, Co-chair, Haemophilia Scotland
• Dr Tracey Gillies, Medical Director, NHS Lothian and representing the Scottish Association of Medical Directors
• Tommy Leggate, Manager, Scottish Infected Blood Forum
• Robbie Pearson, Chief Executive, Healthcare Improvement Scotland
• Professor Nicola Steedman, Deputy Chief Medical Officer, Scottish Government
• Professor Marc Turner, Director, Scottish National Blood Transfusion Service (SNBTS)

Guests

• Caroline Pretty, Policy Manager, Sexual Health and Blood Borne Viruses, Scottish Government – for agenda item 3 – paper 6
• Professor Craig White,  Associate Director, Healthcare Quality and Improvement, Scottish Government – for agenda item 3 – paper 5

Secretariat

• Sam Baker, Unit Head, Organ and Blood Donation, Infected Blood and Abortion Policy, Scottish Government
• James How, Team Leader Blood, Organs and Tissue, Scottish Government
• Linda White, Policy Manager, Scottish Government

Items and actions

Welcome and introductions

The Chair welcomed members to the first meeting of the Oversight and Assurance Group (OAG) and the members introduced themselves.

Overview of the Infected Blood Inquiries (IBI's) findings and purpose of the group

IBI summary of findings

In order to help inform this first meeting and the work of the OAG, members were provided with a summary overview of the recommendations set out in the IBI final report, which was published on 20 May 2024. The summary was presented in the meeting.

Draft Terms of Reference (ToR)

The Chair referred to the draft ToR and invited comments from the OAG.

It was noted that the role of the OAG is to bring together key NHS, Scottish Government (SG) and infected blood stakeholders in order to oversee the effective delivery of the IBI’s recommendations, where those are recommendations to be implemented by SG, NHS Scotland or other associated organisations in Scotland.

The OAG is unlikely to deliver the recommendations directly and in most cases should not need to consider in detail how recommendations ought to be delivered, but will act as a mechanism to agree prioritisation of recommendations, taking account of feasibility and potential impacts on other Health Board work, and assign responsibility for taking forward individual or groups of recommendations to organisations, existing groups (where a relevant group exists) or teams. The OAG would then monitor progress in delivering the recommendations.

In relation to the first bullet point in the “Remit” section of the ToR, it was suggested that if there are modifications or additions that should be considered to any recommendation, or if there are particular reasons why further work on the recommendation is not felt to be appropriate/necessary in Scotland, then it would be important to provide reasons, in sufficient detail, for others to understand why it is not considered appropriate or necessary.

The importance of being clear about the impact of any changes made as a result of the recommendations, and describing what we are doing to make improvements as well as having an output from each recommendation, was highlighted.

The OAG agreed that the ToR would remain in draft form and that they would be reviewed by members at future meetings. This would be important at least for the next few meetings, particularly as the OAG worked to clarify how its work would align with that of other groups. 

With regards to the membership of the OAG, it was highlighted that various stakeholders had noted interest in joining the OAG and membership would be kept under review. It was agreed that the work of the OAG should be transparent for all stakeholders. The OAG agreed that finalised minutes of meetings would be published on the SG website, with the names of members included.

The OAG agreed that further consideration should be given as to how we engage with stakeholders as the work develops.

It was suggested that as progress is made on the more substantial recommendations it would be useful to pause the work and test out the intended outputs with stakeholders and invite their views.

With regards to the roles and responsibilities of the OAG, it was suggested that members declare any conflicts of interest and that, if approached by the press to speak about the implementation of the IBI recommendations, they should ensure they are clear whether they are speaking on behalf of the OAG or in another capacity. These points should be clarified in a revised version of the ToR.

It was confirmed that the Infected Blood Compensation Scheme is not in scope of the OAG’s ToR as the recommendations in this area will be delivered at UK level.  It was, however, noted that the OAG has a key interest in this work and ongoing discussions will be progressed following the UK General Election.  The Chair advised that SG would consider any implications from this work and that the ToR would be amended to clarify that the OAG does have an interest in the future of the Scottish Infected Blood Support Scheme.

With regards to the reporting of the OAG to the existing Quality Assurance Group (QAG), the Chair clarified that the QAG is an internal group within the Health and Social Care Directorate General in SG, which is responsible for considering actions from other ongoing or past Inquiries, and assessing the co-ordination, oversight and strategic leadership of work to support the delivery of safe and effective care. The Chair advised that the section in the ToR which refers to the reporting to the QAG would be reworded in the next version to clarify the relationship between the OAG and the QAG.

Action 1: Further consideration to be given as to how we engage stakeholders in the work of the OAG (Secretariat and Chair).

Action 2: Finalised minutes of all OAG meetings to be published on the SG website (Secretariat).       

Action 3: To review and update the section in the ToR which refers to reporting to the QAG (Secretariat).

Action 4: To review and update the ToR to take account of the points made above. The ToR to be kept in draft and considered again at future meetings (Secretariat).

Summary status of recommendations for SG/OAG consideration

The Chair referred to the proposed list of recommendations on which the OAG should focus, and those that will be primarily taken forward at a UK level.

Members noted a paper setting out an initial summary of work being done on each recommendation and it was noted that some recommendations were still at the early stages of being considered; an updated version of the paper would be provided for the next meeting.

Initial consideration of recommendations

The Chair advised that the focus of this first meeting is on the following three key recommendations, given they are all likely to be quite challenging and where some early discussion is required on how best to address the Inquiry’s concerns in Scotland. Future meetings would consider the other recommendations.

Achieving a safety culture (candour and regulation in healthcare) (recommendations 4(a), (b), (c) and (e))

The OAG was given an update on this recommendation, with suggested next steps, including on work that is already ongoing on in these areas. The IBI’s final report recommends that a review of the operation of the organisational duty of candour is carried out; that duty of candour is extended to leaders, particularly executives and Board members; that there is a requirement for leaders to record and respond to concerns about healthcare where there are risks of harm, and to be personally accountable; that the culture of defensiveness, lack of openness, failure to be forthcoming, and dismissiveness about patient safety concerns be addressed; that leaders should be accountable for how the culture operates and the way in which it involves patients; that external regulation of safety in healthcare should be simplified across the UK; that the four nations explore the development and implementation of Safety Management Systems (SMS) and that the four nations co-ordinate their approach to identification of patterns of harm and co-ordinate responses.

It was suggested that it would be helpful to focus on measures of implementation as well as measures of effectiveness and to outline what we have in place now and how we expect any recommendations to be implemented.

There was discussion on the requirement for leaders to record and respond to concerns about healthcare where there are risks of harm and what this means, as it was noted that all healthcare involves some risks, which need to be managed all the time.

With regards to transparency and culture it was noted that transparency can be challenging in an intensely political environment and that these challenges needed to be managed. For this to happen, the SG and NHS Boards would need to promote a supportive culture. With respect to SMS, the Group would need to look at the evidence base to consider fully whether taking forward a new SMS was the best way of ensuring patient safety.

The OAG agreed that a paper should be developed which captures the complexities across all the different recommendations in this area. A scoping exercise should be carried out for each of the recommendations, stating what is happening now and what still needs to happen and what we need to change. This scoping should also include details on how this work is to be monitored, along with timescales for implementation. This will allow the Group to work towards achieving a single response to this whole area of work, allowing us to put a challenge out to NHS Boards about what kind of culture change we want.

Action 5: Scoping exercise to be arranged and paper to be developed for submission to a future OAG meeting for consideration (Craig White).

Monitoring liver damage for Hepatitis C patients (recommendation 6)

The OAG was given an update on this recommendation, with suggested next steps. The IBI report recommends that all patients who contracted Hepatitis C via a blood transfusion or as a result of receiving blood products, and who are diagnosed with cirrhosis or any degree of fibrosis, should receive lifetime monitoring including six-monthly scans and annual clinical review. It also makes recommendations on use of fibroscan technology and that patients in this group should be seen by a consultant hepatologist rather than a more junior member of staff wherever practicable. The report also recommends that the body responsible for commissioning hepatology services should publish details of steps taken to ensure that services meet the needs of this group of patients.

The OAG agreed to commission specialist clinical advice from the Scottish Health Protection Network’s Viral Hepatitis Strategic Group on how these recommendations could be implemented in Scotland and whether or not they should all be taken forward.

In discussion, it was noted that the group should look at these recommendations through the Realistic Medicine framework lens and ensure we are taking an evidence-based approach. This evidence-based approach would need to be communicated in whatever response we make to the recommendations. It was also noted that the IBI may have been confused in relation to its suggestion that fibroscans should be used rather than ultrasound scans. The OAG agreed also to ask for clinical advice on what follow up liver monitoring should be offered to those infected with chronic Hepatitis B (HBV).

Action 6: Specialist clinical advice from the Scottish Health Protection Network’s Viral Hepatitis Strategic Group on these recommendations to be commissioned, including advice on HBV (Caroline Pretty).

Safety of blood transfusion practices (recommendation 7)

The OAG was given an overview of this group of recommendations, with suggested next steps, focussing on the areas of sustainability of Hospital Blood Banks, clinical transfusion practice, and electronic traceability of donations.

In discussions, it was noted that advice would also be needed on the IBI recommendation that tranexamic acid be offered as a treatment to minimise the likelihood of needing blood transfusions for all patients having eligible forms of surgery, given it was not clear that this was appropriate in all situations and there were also other options staff could offer patients to reduce the likelihood of the patient needing a transfusion.

Due to the complexity of each area of work identified by the IBI, it was agreed that Scottish National Blood Transfusion Service (SNBTS) would produce a separate paper for each area for discussion at future meetings which would outline the system-wide issues as well as the short, medium and long-term actions with suggested timescales for implementation.

Action 7:  SNBTS to develop four papers for discussion at future meetings of the OAG 1. Sustainability of Hospital Blood Banks 2. Clinical transfusion practice 3. Electronic traceability of donated blood 4. Reducing the need for blood transfusions (including tranexamic acid) (Marc Turner).

Agreement on next steps and timing of next meeting

The OAG agreed that the recommendations should be prioritised and timescales for implementation developed to better understand at what stage each recommendation will be progressed and which recommendations could be implemented more quickly. It was agreed that this should be presented at the next meeting of the group, which was likely to be arranged for mid to late August. A workplan for the Group would therefore be developed.

Action 8: Further timescales for implementation of the recommendations to be developed (Secretariat to lead on updating the spreadsheet of recommendations to include more information on this).

Any other business

No other business was raised.

Summary of Action Points

Draft Terms of Reference (TOR)

• Action 1: Further consideration to be given as to how we engage stakeholders in the work of the OAG
• Action 2: Finalised minutes of all OAG meetings to be published on the SG website
• Action 3: To review and update the section in the ToR which refers to reporting to the QAG
• Action 4: Update the TOR and send out the next version with the papers for discussion at the second meeting of the OAG

Achieving a safety culture (candour and regulation of healthcare) (recommendations 4(a), (b), (c) and e))

• Action 5: Scoping exercise to be arranged and paper to be developed for submission to a future OAG meeting for consideration

Monitoring liver damage for hepatitis C patients (recommendation 6)

• Action 6: Paper considering the appropriate follow up patients whose Hepatitis C has been treated to be agreed by the Viral Hepatitis Strategic Group for consideration at a future OAG meeting

Safety of blood transfusion practices (recommendation 7)

• Action 7: SNBTS to develop four papers for discussion at future meetings of the OAG 1. Sustainability of Hospital Blood Banks 2. Clinical transfusion practice 3. traceability of donated blood 4. Reducing the need for blood transfusions (including tranexamic acid)

Agreement on next steps and timing of next meeting

• Action 8: Further timescales for implementation of the recommendations to be developed