Publication - Minutes

Infected Blood Oversight and Assurance Group Minutes: February 2025

Published: 17 April 2025
From: Minister for Public Health and Women's Health
Directorate: Population Health Directorate
Topic: Health and social care
Date of meeting: 26 February 2025
Date of next meeting: 8 April 2025

Minutes from the meeting of the group on 26 February 2025

Part of

Infected Blood Oversight and Assurance Group

Attendees and apologies

Members

Professor Nicola Steedman, Deputy Chief Medical Officer, Scottish Government (SG), OAG Deputy Chair (acting Chair in Christine McLaughlin’s absence)
Dr Tracey Gillies, Medical Director, NHS Lothian and representing the Scottish Association of Medical Directors
Tommy Leggate, Manager, Scottish Infected Blood Forum (SIBF)
Professor Marc Turner, Director, Scottish National Blood Transfusion Service
Dr Emma Watson, Medical Director, NHS Education for Scotland (NES)
Dr Lynne Anderson, Chair, Scottish National Blood Transfusion Committee

Guests

Dr Simon Watson, Medical Director, Healthcare Improvement Scotland (HIS) (representing Robbie Pearson)
Bill Wright OBE, former Chair Haemophilia Scotland (HS), representing John Dearden
Dr Stephen Barclay, Scottish Health Protection Network’s Viral Hepatitis Strategic Leads Group
Joanna Swanson, Healthcare Quality and Improvement, SG
Daniel Kleinberg, Population Health Resilience and Protection, SG
Rebekah Carton, Sexual Health & Blood Borne Viruses, SG
Caroline Pretty, Sexual Health & Blood Borne Viruses, SG
Nigel Robinson, Regulation of Healthcare Professionals, SG
Alex Dunn, Healthcare Quality and Improvement, SG

Secretariat

Sam Baker, Unit Head, Organ and Blood Donation, Infected Blood and Abortion Policy, SG
James How, Team Leader, Blood, Organs and Tissue, SG
Laura Mackay, Policy Manager, Blood Donation and Infected Blood, SG

Apologies

Christine McLaughlin, Co-Director, Population Health, SG
Robbie Pearson, Chief Executive, HIS
John Dearden, Chair, HS
Emilia Crighton, Directors of Public Health

Items and actions

Minutes of previous meeting and actions

The Chair welcomed attendees to the fifth meeting of the OAG and asked if the draft minutes of the previous meeting could be agreed.

Some minor revisions were requested as follows:

On item 2, update on proposed UK Government (UKG) report on implementation of the IBI’s recommendations:
- paragraph 9, line 3 should be amended to read ‘issues’ rather than ‘issued’.
- point 12, on previous clinical advice, should be amended to reflect that monitoring, if desired, will be available for hepatitis B patients.

It was agreed the minutes would be updated and re-circulated to those who had requested changes for comment before publication.

The Chair ran through progress on actions from the previous meeting:

Note of previous meeting - update minor revisions and recirculate the minutes for comment.

Complete. The minutes were amended and re-circulated to those who raised points for comment before being published on the SG website.

Update on proposed UKG report on implementation of the IBI’s recommendations - update the draft SG contributions to address the points raised above in the draft report.

Complete. SG response updated and returned to UKG. The UKG report was published on 17 December 2024.

Provide an update in the spring on progress regarding training.

In progress – NES would provide an update for the April OAG meeting.

Consideration of IBI recommendations

The OAG was informed that Cabinet Office has commissioned contributions ahead of producing a first draft of the May UKG report on progress on implementing the IBI recommendations. Therefore, it would be important to try to reach consensus in the OAG on the approach to be taken to recommendations 4 and 6, ahead of the publication of the May report.

Patient safety (recommendations 4a, b, c, and e and 10a(i))

Joanna Swanson briefed the OAG on the SG paper, which was developed in response to previous requests for a fuller scoping paper that would cover each of the eight recommendations relating to patient safety. The recommendations were mapped against HIS’ Scottish Patient Safety Programme Essentials of Safe Care, which are focussed around person-centred systems and approaches.

OAG members were asked to consider, at each point, whether they were content with the work that had been undertaken in each area.

In respect of recommendation 4a(ii) - the review of the operation of the organisational duty candour in Scotland - it was reported that the non-statutory guidance has recently been reviewed and that the revised guidance would be published soon. The proposal is that, once published and being used by health and social care organisations, a review of the impact of the effectiveness of the operation of the organisational duty of candour will be undertaken, starting in June 2025, and completing by mid-2026.

This recommendation has therefore been accepted in full. The OAG signalled it was content with this approach.

In respect of recommendations 4a(iv) and (v) - that the duties of candour should be extended to cover individuals in leadership positions in the NHS and that individuals in leadership positions should be required to consider and respond to any concern about the healthcare being provided, or the way it is being provided - the preference was to take forward this work on a UK wide basis. This would provide consistent expectations around services and approaches. To that end, SG was waiting for the outcome of the findings of the consultation being undertaken by the Department of Health and Social Care (DHSC). In response to a question about why there was not a separate Scottish consultation, it was clarified that as the English consultation was undertaken at quite short notice, there had been no time for Scottish officials to have some input to it. In addition, following the outcome of the consultation, Scottish Ministers would need to take their own decisions about whether to legislate in this area and, if so, a further Scottish consultation would be expected to take place at that stage.

This recommendation has been accepted in principle. The OAG signalled it was content with the proposed approach, on the proviso that the issue would come back to the OAG once further decisions are taken, if useful.

Action 1: SG to update Scottish Ministers on outcomes of DHSC’s consultation and bring back to OAG so OAG has the opportunity to comment on final advice on the way forward.

In respect of recommendation 4b on cultural change, the scoping paper focussed on three main areas. First, the Independent National Whistleblowing Officer for NHS Scotland is now in place, whose role is underpinned by legislation and supported by the National Whistleblowing Standards. Second, a programme of work is underway on improving wellbeing, working culture, and developing new leaders following the publication in July 2024 of “Improving Wellbeing and Working Cultures”. And third, the Patient Safety Commissioner, once appointed, will produce, and publish a Patient Safety Charter to set out what the Commissioner expects of health care providers in terms of standards and good practice.

Some clarification was sought about next steps on appointing the Commissioner and the situation in Wales and Northern Ireland, given the challenges involved in making such appointments. The challenges were acknowledged, but the appointment process itself is the responsibility of the Scottish Parliament.

This recommendation was accepted in principle and the OAG signalled it was content with the proposed approach.

In respect of recommendation 4c(i) – that external regulation of safety in healthcare be simplified - SG is keen to take forward this work on a UK-wide basis via the proposed Patient Safety Group, which will soon be established.

This recommendation has been accepted in principle.

In respect of recommendation 4c(ii) – development of safety management systems - this recommendation will be taken forward in Scotland by HIS through the existing Quality Management System (QMS), which aims to support health and social care organisations to apply a consistent and coordinated approach to the management of the quality of health and care services.

In response to a request for clarification about whether the QMS would be adopted across Scotland, Simon Watson agreed to provide a further assurance update in the future.

This recommendation was accepted in principle and the OAG signalled it was content with the proposed approach.

Action 2: HIS will provide a further assurance update in due course.

In relation to recommendation 4e - consideration of further co-ordination of approaches to patient safety across the four nations - this recommendation has been accepted in full and will be taken forward via further four nations discussions.

In relation to recommendation 10 – that clinical audit should as a matter of routine include measures of patient satisfaction or concern - it was reported that work is currently underway between SG and Public Health Scotland (PHS) to agree that the Scottish National Audit Programme should develop a strategy that will include a requirement that the patient voice and the patient experience is taken into account when developing any new audits. The future work of the Patient Safety Commissioner and the further development of Care Opinion, the independently managed online feedback system which has been available in the NHS in Scotland since 2013, was also highlighted in response to this recommendation.

In discussion, it was highlighted that the role of Care Opinion needs to be publicised more widely, although it was also noted that Care Opinion was not always the best means of getting patient input and ensuring patients’ views are taken into account upfront in designing services. The QMS is probably more important as a way of giving patients a voice.

This recommendation was accepted in principle previously but will be accepted in full by the SG at the point of the May UK progress report. The OAG was content with the approach outlined.

Action 3: SG will consider how the role of Care Opinion should be publicised more widely.

Monitoring liver damage for those with Hepatitis C – Viral Hepatitis Report (recommendation 6)

The OAG received an update from Rebekah Carton in response to a request from an earlier OAG for further information, particularly around the risks and benefits of monitoring liver damage for patients with fibrosis, and to report what was happening in response to this recommendation in the other four nations.

In relation to recommendation 6a(i) - that those diagnosed with cirrhosis should receive lifelong monitoring – this is already in line with current practice and guidelines. Whilst the recommendation only relates to those infected with chronic hepatitis C who have achieved a sustained viral response, it was clarified that monitoring should also be offered to those with hepatitis B in line with clinical guidance.

Recommendation 6a(i) was accepted in full.

In relation to recommendations 6a(ii) and (iii) – that those who have fibrosis should receive the same care - clinical advice for those with low level fibrosis (F0-2) is that monitoring is not needed (in the absence of any other risk factors) due to the risk of liver cancer being extremely low. It could also cause additional harms and is therefore not recommended. For those with significant fibrosis (F3), it was suggested that consideration should be given to whether those who had chronic hepatitis C who are likely to have been treated with infected blood and who have since achieved a sustained viral response should be offered further assessment and review, as current international clinical guidance differs in terms of this cohort (American Association for the Study of Liver Diseases and British Society of Gastroenterology vs European Association for the Study of the Liver).

HS and SIBF did not agree with this proposed approach on the basis that patient choice had to be paramount in all cases. While it was acknowledged that waiting for tests and results could cause anxiety for some, in their view, ultrasounds can do no harm, and such monitoring will always be useful for those who want it in terms of reducing anxiety and providing reassurance. They argued that NHS Scotland has to follow the IBI’s recommendations in full.

Dr Barclay advised that surveillance could cause significant risks of false positives and therefore cause harms in terms of extra anxiety and unnecessary further tests, including invasive tests for patients. Guidelines were in place to prevent such harms to low-risk patients. The IBI itself had revised its position about the use of fibroscans. Overall, he argued that the NHS has to ensure consistency of approach with other conditions and that, if clinicians thought such monitoring would be useful, they would advocate for it themselves.

It was agreed that further discussion on this was needed in order to understand the concerns highlighted in more detail.

Action 4: separate discussions would be arranged with those most interested in this recommendation to discuss the detail of the concerns highlighted relating to recommendations 6a(ii) and 6a(iii).

In relation to recommendation 6a(iv) – that fibroscan technology should be used for liver monitoring rather than other methods - Dr Barclay confirmed this is standard clinical practice for measuring the degree of fibrosis or cirrhosis. However, other assessments may have been used for patients who were treated before the introduction of this technology. Liver biopsy was more accurate than a fibroscan, but was invasive and harmful to patients so not recommended in this context. It was agreed that clinical leads should be asked in the first instance to confirm that all relevant patients had received liver assessment.

Action 5: ask clinical leads to provide assurance that all patients who had chronic hepatitis C who are likely to have been treated with infected blood and who have since achieved a sustained viral response have received an assessment of liver scarring to provide reassurance to the OAG.

In relation to recommendation 6a(v) – that patients with hepatitis C attributed to infected blood or blood products should be offered at least one appointment with a consultant hepatologist - not all Health Boards in Scotland have a consultant hepatologist, but current practice is that all patients are overseen within a multi-disciplinary care team.

The OAG agreed that a consultant appointment should be offered to patients in this cohort, if they had not seen a consultant at any point in their treatment, although any communications making such an offer should be carefully worded so as not to cause alarm. Consideration was given to whether Near Me could be used to allow patients to see a hepatologist from another NHS Board, however it was agreed by the OAG that an appointment with a consultant from an associated speciality with experience in liver care (such as a gastroenterologist) would be appropriate.

In relation to recommendation 6a(vi) – that those bodies responsible for commissioning hepatology services should publish the steps they have taken to satisfy themselves that the services they are commissioning meet the particular needs of the group - it was noted that hepatology services are not commissioned in Scotland. Options for SG to take forward this recommendation in Scotland include a review of National Clinical Guidelines and asking Public Health Scotland (PHS), who have data on this cohort of patients, to carry out a data linkage exercise to show what the long-term outcomes are for these patients. Both of these options were supported.

Action 6: those clinical guidelines on hepatitis C which are due (or overdue) to be updated should be reviewed and updated as soon as is practicable. PHS to be asked what would be involved in a data linkage exercise including timescales and quality of data.

Blood Transfusions – Account for Blood IT system (recommendations 7f(i) and (ii))

Due to time constraints, it was agreed that this paper would be deferred to the next OAG meeting; however, any immediate comments on the paper could be sent to the OAG secretariat for consideration.

Updated OAG workplan

Due to time constraints, there was no substantive decision on the workplan during the meeting; however, any comments could be sent to the group secretariat for consideration.

Agreement on next steps, timing of next meeting, and feedback on the meeting

The Chair confirmed that that the next meeting was scheduled for 8 April 2025.

Any other business

There was no other business.

Summary of action points