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

Attendees and apologies

Members

• Christine McLaughlin, Co-Director Population Health, Scottish Government (SG), Chair
• Dr Emilia Crighton, Director of Public Health, NHS Greater Glasgow and Clyde, representing Directors of Public Health
• John Dearden, 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 (HIS)
• Professor Nicola Steedman, Deputy Chief Medical Officer (DCMO), SG
• Professor Marc Turner, Director, Scottish National Blood Transfusion Service (SNBTS)

Guests

• Peter Croan, Finance Director, NHS National Services Division (NSD) – for agenda item 4
• Hugh Edwards, Consultant Haematologist, NHS Forth Valley (deputising for Lynne Anderson)
• Caroline Pretty, Policy Manager, Sexual Health and Blood Borne Viruses, SG – for agenda item 4
• Ryan Rogers, NHS Greater Glasgow and Clyde and Chair of the Scottish Inherited Bleeding Disorders Network (SIBDN) – for agenda item 4

Secretariat

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

Apologies

• Lynne Anderson, chair, Scottish National Blood Transfusion Committee (SNBTC)

Items and actions

Minutes of Previous Meeting and Actions

The Chair welcomed attendees to the second meeting of the Oversight and Assurance Group (OAG). The Chair ran through the actions from the previous meeting, many of which would be dealt with under subsequent agenda items, and it was confirmed that attendees were content with the draft minutes of the previous meeting. These minutes would now be published on the Scottish Government website.

Updated Terms of Reference (ToR)

The Chair presented a revised version of the ToR. The Chair suggested that Nicola Steedman should take on the role of Deputy Chair of the OAG. It was pointed out that not all comments made on the ToR at the last meeting had been taken on board. It was confirmed that this was an omission and that the correct version would be sent out for agreement after the meeting. The Chair confirmed that, once agreed, the ToR would be published on the Scottish Government website.

Draft OAG Workplan

The OAG was asked to note the copy of the updated spreadsheet of Infected Blood Inquiry (IBI) recommendations that had been circulated ahead of the meeting, revised to include suggested timings for when the OAG should next discuss each recommendation. The spreadsheet also sets out next steps and an expected implementation date for each of the recommendations, making the progress on each recommendation easier to monitor. The OAG did not have concerns with the suggested timescales.

The OAG was also asked to note that the UK Government intended to provide an interim report on the IBI recommendations to the UK Parliament in December. The OAG agreed in principle with the suggestion that Scottish Government should both contribute to the UK response as needed and also provide a high-level update to the Scottish Parliament and to wider stakeholders at the same time as the UK report.

It was also noted that some discussions have taken place in respect of recommendation 2 on a memorial to those infected and affected and that further details would be given at a future OAG. In addition, the requested paper from the Scottish Health Protection Network on monitoring liver damage in people previously infected with Hepatitis C had just been received. This paper would be discussed at the next OAG.

Consideration of IBI recommendations

Finding those not yet diagnosed with Hepatitis C (recommendations 8(a) and (b))

The OAG received an update on progress on recommendation 8, including that a Chief Medical Officer (CMO) letter has been issued, providing guidance to NHS Boards and GP practices in relation to the very small number of individuals who may have been exposed to Hepatitis C Virus via blood transfusion who have not already been tested. Colleagues have checked with Boards that it has been a) issued to relevant staff in secondary care and b) circulated to all GP practices. The SG is still waiting to hear back from a few Boards to confirm this.

Safety of the Clinical Transfusion Process (recommendation 7)

The OAG received an update from Scottish National Blood Transfusion Service (SNBTS) on the safety of the clinical transfusion process, including on work that has been done in this area and further work required. Whilst it was noted that significant progress had been made in some areas, data from the Serious Hazards of Transfusion (SHOT) reports did show a recent trend of increasing numbers of adverse events and near misses relating to transfusion in the UK. The OAG then discussed the three main areas of potential action proposed by SNBTS.

First, regarding recommendation 7b), there were no concerns about SNBTS’s plans to update its internal transfusion team strategy as per the Inquiry’s recommendation. The group discussed the merits of the SNBTS recommendation that an NHS Scotland transfusion strategy should be produced. The OAG had some questions about what such a strategy would deliver, how it would respond to the specific IBI recommendations, whether a strategy was the best means to deliver the actions needed, and who would be best placed to produce it. If taken forward, it was noted that a delivery plan might be more useful than a strategy.

The OAG confirmed it was content in principle with the suggested actions in relation to recommendation 7d) on working with partners to update undergraduate/staff training materials relating to transfusion. It was confirmed that NHS Education for Scotland (NES) is involved in discussions and work in this area with other UK bodies.

With respect to the proposal that Deputy Chief Medical Officer (DCMO) should undertake a review of Scottish National Blood Transfusion Committee (SNBTC) governance, it was agreed that SNBTC needed to have sufficient authority, and that NHS Boards needed to engage with it fully. SNBTC currently reports into the CMO and before any action is taken in this area DCMO would discuss the issue with the CMO, including to determine if the DCMO was the right person to undertake any such review.

Finally, the OAG discussed the suggestion that a working group should be set up to consider recommendation 7e) on ensuring recommendations from SHOT annual reports are implemented. It was noted that some SHOT recommendations, although valid, are aspirational and so very challenging to implement, including for financial reasons. It would be helpful for NHS Boards to have central advice, probably from SNBTC, identifying which recommendations should be implemented as quickly as possible and which could be implemented over the longer term. The SHOT recommendations should also be graded to help identify which ones would most mitigate risks.

The starting point of any further work should be to focus on what is preventing implementation of SHOT recommendations, producing an audit of what implementation is currently taking place across the NHS in Scotland. It was suggested that Health Improvement Scotland (HIS) should be involved in framing the parameters for this work. There should then, once the problems have been set out, be an options appraisal of possible actions.

It was agreed that as a first step SNBTS, working in collaboration with others from the OAG, should produce a more detailed proposal for a Short Life Working Group (SLWG) to analyse the current situation in respect of SHOT reports and suggest what further actions are needed to support NHS Boards in this area. This SLWG should have a defined remit and should report back to the OAG as needed. Given the connections between the various recommendations in this area, the SLWG should first make recommendations before further actions are taken forward in respect of a possible NHS Scotland Transfusion Strategy/delivery plan, undergraduate/staff training, and any review of SNBTC governance.

Improving Haemophilia Care (recommendation 9)

The OAG received an update on improving haemophilia care, which is provided by Health Boards through haemophilia centres. In terms of the IBI’s recommendations on the frequency of peer reviews of the centres, the OAG was content with the situation in Scotland. It would not be possible to have formal United Kingdom Haemophilia Centre Doctors’ Organisation-arranged peer reviews of the smaller centres in Dundee, Aberdeen and Inverness for some time, but as an interim measure the Scottish haemophilia centres were making arrangements to do their own peer reviews of these centres in the next year. It was agreed that the OAG would make clear to the five Health Boards covered by the reviews that findings from peer reviews should be considered by their Healthcare Governance Committees and should be properly considered (in line with the IBI’s recommendation).

The OAG was asked to note that, through the existence of Scottish Inherited Bleeding Disorders Network (SIBDN), the requirements of the recommendation to have in place a multidisciplinary clinical network that involves patients in discussion of practice and improvements for inherited bleeding disorders care are already being fulfilled. In addition, the National Haemophilia database continues to be funded through the risk share arrangement managed by National Services Division (NSD). It was noted NHS England was believed to be currently reviewing the requirements in relation to the database and the OAG should request an update on this to check if there are any implications for Scotland.

In respect of the recommendation on making recombinant coagulation factor products available for all bleeding disorder patients where clinically appropriate, in principle the requirement is currently being met (except for the relatively few patients for whom no suitable recombinant product exists as yet). The only current concern is in respect of von Willebrands disease, where the recombinant drug Veyvondi is only licenced by the Medicines and Healthcare products Regulatory Agency for use in those aged 18 years or above, meaning its use for children is not covered by the NHS risk share funding arrangements. A regional approach to prescribing Veyvondi for children is, however, being taken, with clinicians submitting Individual Patient Treatment Requests (IPTRs) to their Board to allow them to prescribe the drug ‘off label’ for paediatric patients.

The OAG was generally content with this regional approach as Boards seemed to be agreeing these IPTRs, but noted some concerns that individual Boards could turn down requests for the drug. The OAG stressed that consistency was desirable in this respect and that the OAG/Scottish Government should make clear to Health Boards its ‘expectation’ that the drug will be provided for children (wherever it is appropriate for them). It was noted that similar considerations should be applied to any new drugs in future if they were similarly not licenced for children (due to clinical trials of these drugs generally not including children). Separately NSD would also contact NHS England in case of updates to the commissioning guidelines for England in respect of this drug.

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

The Chair confirmed that that the next meeting of the OAG was scheduled for Wednesday 09 October, between 15:00 and 16:30. The Chair also suggested that, to make progress and allow for updates to the UK and Scottish Parliaments in December, the Secretariat will aim to arrange a fourth meeting in November.

It was agreed that Carolyn Low, Director for the Scottish Infected Blood Support Scheme (SIBSS), could be invited to any future OAG meeting that discussed matters in relation to SIBSS.

Any other business

No other business was raised.

Summary of Action Points

Revised Terms of Reference (ToR)

Action 1: Revised version of the ToR to be circulated for comments after the meeting.

Finding those not yet Diagnosed with Hepatitis C (recommendation 8)

Action 2: Provide update to Oversight and Assurance Group (OAG) on dissemination of the advice, which will complete work on this recommendation.

Safety of the Clinical Transfusion Process (recommendation 7)

Action 3: Proposal for a review of Scottish National Blood Transfusion Committee (SNBTC) governance. Deputy Chief Medical Officer (DCMO) to discuss the issue with the Chief Medical Officer (CMO))

Action 4: Proposal for a Short Life Working Group (SLWG) on implementation of Serious Hazards of Transfusion (SHOT) reports to be produced; the SLWG should give consideration to an NHS Scotland Delivery Plan to help ensure implementation of SHOT recommendations and other associated elements of the Infected Blood Inquiry’s recommendation 7

Action 5: Scottish National Blood Transfusion Service (SNBTS) to take forward agreed actions to review and update their existing transfusion team strategy and work with partners to update learning materials related to transfusion.

Improving Haemophilia Care (recommendation 9)

Action 6: The OAG Chair to write to the five Boards with haemophilia centres, possibly at the time of the December update to the Scottish Parliament and to stakeholders, asking them to fully consider peer review recommendations

Action 7: Contact the Department of Health and Social Care/NHS England to check the position in relation to any review of the National Haemophilia database

Action 8: Communicate to Boards the OAG’s expectation that Veyvondi will be available to children.