Pelvic Floor Registry Implementation Group minutes: April 2022

Attendees and apologies

Attendees

• Christine Hemming, Deputy MD for AcuteSector/DCD Med/Gynaecologist, NHS Grampian
• Susan Lloyd-MacGilp, Incident Reportin and Investigations Center (IRIC) Co-ordinator, National Services Scotland
• Alison Smith, Executive Director, BMI Healthcare
• Sara Davies, Public Health Consultant, Scottish Government
• Stuart Mcphail, Information Governance and Assurance Officer, Scottish Government
• Marie McInally, Practitioner Services Division, NHS National Services Scotland (NHS NSS)
• Danish Mahmood, Senior Project Manager Information Governance and Legal, NHS Digital
• Pam Cairns, IT and Business Delivery Manager, NHS Digital
• John Sturgeon, Head of Programmes and Development, eHealth, NHS Lothian
• Lynette Douglas, Urogynae Support Administrator, NHS Grampian
• Jill Burke, Project Manager, Unique Device Identifier (UDI) Taskforce, NHS NSS
• Iain Robertson, Chair UDI Taskforce, Scottish Government
• George Fernie, Senior Medical Reviewer, NHS Health Improvement Scotland
• Sheethal Madari, Consultant Gynaecologist, NHS Grampian
• Nicola Brown, Project Support Officer, NHS NSS

Apologies

• Julia Wilkens Consultant, Obstetrics and Gynaecology, NHS Lothian
• Tracey McKinley, Information Governance and Security Manager, NHS Lothian
• Richmond Davies, Information Consultant, Public Health Scotland
• Elena Beratarbide, Head of Information Assurance and Risk, Scottish Government
• Dyllis Bruce, Clinical Coding Manager-eHealth, NHS Grampian
• Tom Scott, Senior Project Manager, Information Governance and Legal, NHS Digital
• Veenu Tyagi, Clinician, Obstetrics and Gynaecology, NHS Greater Glasgow and Clyde
• Jennifer Stewart, Policy and Membership Development Officer, Health and Social Care Alliance Scotland
• Elizabeth MacDonald, Patient Member, Health and Social Care Alliance Scotland
• Helen Simpson, Consultant Urologist, NHS Fife
• Frankie Wallace, Programme Lead, Scan for Safety, Scottish Government
• Cowan Botha, Senior Project Manager – Devolved Administrations and Independent/Private Sector Lead, NHS Digital
• Martin Clunie, IT Security Manager, NHS Lothian
• Payal Narula, Senior Information Business Analyst Developer, NHS Grampian
• Stewart Whyte, Information Governance Manager, NHS Greater Glasgow and Clyde
• Rowen Paton, Strategy & Development Programme Manager, eHealth, NHS Greater Glasgow and Clyde
• Fiona Alcorn, Director of Clinical Services, Spire Edinburgh Hospitals, Murrayfield
• Linda Hodges, Director of Clinical Services, BMI, Ross Hall Hospital
• Sulisti Holmes, Head of Decontamination, NHS NSS
• Irene Oldfather, Director Strategic Partnerships and Engagement, Health and Social Care Alliance Scotland
• Alan Bell, Head of Information Governance and Data Protection, NHS Grampian
• Helen Storkey, Information Consultant, Public Health Scotland
• Jonathan Todd, Head of Information Management, NHS Greater Glasgow and Clyde
• Elizabeth MacDonald, Patient Member, Health and Social Care Alliance Scotland
• David Bishop, Mesh Team Leader, Scottish Government
• Michelle Campbell, Information Governance Manager, NHS Fife
• Kevin Irving, IT Security Manager, NHS Fife
• Peter Murphy, Data Manager, NHS Greater Glasgow and Clyde
• Paula Meechan, Practitioner Services Division, NHS NSS

Items and actions

Welcome

The Chair welcomed everyone to the meeting today, including any new members, and requested that Declaration of Interests be sent to the Project Support Officer.

As well as the agenda, the flash report and previous minutes were sent out. The Chair asked for any concerns on the accuracy of the minutes or any comments. The minutes and flash report were approved.

Information governance

Update on information governance - NHS Digital have sent their impact assessment and the Scottish impact assessment is nearly finished. This will be handed over to Sara Davies and Stuart MacPhail. It will be included in the pack for Boards to use.

S255 have been sent to NHS Digital from NHS NSS. Unfortunately the information governance lead at NHS Digital has unexpectedly passed away. All send their condolences to NHS Digital colleagues. We may be able to get a response at the end of the month with the Data Protection Impact Assessment (DPIA) tie up, and the Scotland wide information governance.

Will the Impact Assessment go to the independent sector? The independent sector are not included in S255 or DPIA. It is assumed that the independent sector will do their own as they are UK based. The independent sector is to make the decision.

The Chair is very saddened to hear about the bereavement, and this isn’t a time to pressure anyone. Please pass on condolences to the whole group.

Pilot Board updates

The Chair invited representatives from the four pilot boards to provide update.

NHS Grampian

No update.

For information - A blank copy of the Op Note was shared with the group, not all of the information that is needed has been included. Doctors complete the Op Note in theatre, including patient details and plans for follow up. The information is drawn from Opera which helps to reduce the transcription errors and increase accuracy. There are templates for each procedure that can be adapted for each procedure.

NHS Fife

No representative.

NHS Greater Glasgow and Clyde

No representative.

NHS Lothian

Nothing new.

Independent sector update

Tracking well against GS1 Standards and digital patient notes. We are confident that the local digital team is connecting with both NHS Digital and NHS Scotland, so they will be able to comply by the end of the year. Pam Cairns is going to work with Nuffield on a Gap Analysis, but is currently unsure if this has been undertaken. The Gap analysis will allow a timeline. This is Alison Smith’s last meeting as the site has been purchased by NHS Scotland and is no longer part of the independent sector. Alison wished the team luck in the future and advised that there will be a new representative going forward on behalf of the independent sector.

The Chair thanked Alison for all of her help and support throughout.

Evaluation Report Review

The evaluation report is very useful and there were four main comments from the evaluation report review:

• better engagement with certain groups. There has been a meeting with the patient representatives who have developed questions for the second evaluation
• project manager not appointed to the group. This is due to funding and to encourage teams and different specialists to work together across Boards
• local support for collecting, preparing and submitting the data. Some of the Boards have been able to find support within their own systems
• request for further engagement with NHS Digital. NHS Digital have been keen and willing to join

NHS Digital report

Starter pack - has been reviewed and awaiting the updated version of the user guide to be signed off. This will then be issued.

Organisational codes – currently the new NHS Digital system does not include Scottish codes. Work is due to commence on this soon and this should have a quick turnaround time. The codes will be same as those used by the NHS and independent sector for the breast and cosmetic implant registry.

Patient leaflets – approval received on creating a printable patient leaflet, but patients should be referred to the webpage in the first instance to ensure update information is given. This will be adapted for Scotland and Scottish patients. NHS Digital will happily collaborate developing the leaflet

Reports to clinicians – developing reports at NHS Digital, but this is mostly at an organisation level. If needed, NHS Digital will present the products and reports that have been developed.

Interaction with The British Society of Urogynaecology (BSUG) – NHS Digital are currently in conversation with BSUG, on the strategic direction. NHS Digital would prefer the information to be sent directly, and then be sent out to different registries.

There has been a proposal sent to BSUG on a solution to prevent duplication. BSUG themselves will create a report/extract that clinicians can access.

The Chair will take this proposal to the Accountable Officers Group for discussion, but will highlight that this is an outline draft.

Commend Danish on the work that has been carried out. Although there is a great privacy notice, is there an opt out facility? If not, should there be a notice explaining why? What is lacking is a formal transparency notice. There is a patient information page, but intend to have this formalised in the website. NHS England don’t have an opt out option.

Patient representative update

No representative.

National Audit Board and Medical Device / Scan for Safety feedback

National Audit Board

Presented to the National Audit Board at the last meeting. One of the asks was to raise with the National Audit Board the opportunity that was given for new data sources to incorporate medical device data into future national audits and registries. This will be important to prevent transitional issues and make the data as robust as possible. The other consideration for the National Audit Board is to ask them to consider what role they would have in terms of the national consideration of future registries for the Medical Devices Information System. All the asks are being considered and will stay on the National Audit Board agenda.

Scan for Safety update

Scan for Safety is a new NHS Scotland programme which is led by NHS NSS which incorporates Genesis and aligns with Board medical device data capture. There are five workstreams; GS1 Standards, Supplier Engagement, Inventory Management System, Medical Device Data Hub and Medical Equipment Database.

This programme had their first Programme Board recently which was focused on how the programme will be managed and early milestones. There is a complex management structure with the Chief Medical Officer and Health and Social Care behind it. This programme will run over four to five years. The area of particular interest is the implementation of the Genesis system, with the first pilot sites up and running this year. For members that work in NHS Boards, there will be more information shared in the next few months.

The slides were shared with the group on the governance structure.

Is there any further information on new CHI number or is it too far down the line? Little down the line, but there is no direct link with the programme so unable to provide an update.

AOB

Update on the Pick Lists on National Data Form or the creation of the app, just to keep an update on how that is progressing. Anything to increase data capture would be beneficial. This may have been involved in the PIM work, which has currently slowed down. We need this database to be set which is on pause as we wait for the Medical Device Safety Board's response.

We don’t have an NHS Inform website yet, so the question is whether the privacy notice would be hosted on individual Board's systems?

For the two stage identification for access to the web form, the Caldicott Guardian will be needed to sign off the clinicians access to the website. There is a Caldicott Guardians site and details are on the Forum.

Summary

The Chair summarised outcomes as follows:

• Sara Davies went over the evaluation review and identified key points that we will share
• almost there with S255, sadly there has been a bereavement for NHS Digital team which will delay things and send over condolences to NHS Digital team
• minimal updates from the Boards. The confirmed rollout of Genesis on a National basis will connect Track and Opera. There will be the impact of legacy systems
• independent sector are doing well creating new platforms ready for digital activity. NHS Digital assistance has been requested for the gap analysis
• Thank you to Alison as this is her last meeting
• NHS Digital has provided an update regarding the starter pack including organisation codes, patient leaflet and also the transfer of information from Public Health Scotland and to Public Health Scotland.
• interaction with BSUG - there is a proposal that will be discussed and NHS Digital will send the Chair the proposal to share as a draft with the Accountable Officers
• still need the data mapping and gap analyses by Boards, with Pam’s help. We need to get teams working with her
• no patient representative
• Iain provided a flow diagram relating to the National Audit Board and Scan for Safety
• we will try and provide more information on the application and keen for NHS Digital to give more detail to contact any Trust
• Privacy Notice hosting is ideally in one place and should be on NHS Nation website rather than individual Boards website
• we will be able to receive a list of the updated names of the Caldicott Guardians

The Chair thanked everyone for their attendance and input.

The next meeting is the 1 June 2022 at 10:30. There will be a review of the days alternating between Tuesday’s and Wednesday’s after the next meeting, following the request from the patient representatives.

Actions

• send Evaluation Review Report to wider group – Nicola Brown
• share the update starter pack with Sara Davies – Pam Cairns
• share the slides that have been shared (If permission is granted) – Nicola Brown
• share the link to the Caldicott Guardian forum – George Fernie
• share the Op Note with the Minutes – Nicola Brown
• contact Pam and the Board to make arrangements on the data mapping needs locally – Nicola Brown
• send outline BSUG proposal to the Chair – Danish Mahmood