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Update on Public Programmes Core to BIVDA Operational Activity

By June 1, 2022No Comments

NHS Supply Chain and Public Procurement Legislation

NHS England has recently re-stated the importance of procurement in achieving mature/ thriving network status for laboratories with the official line being that procurements should be made through the NHS Supply Chain category towers. BIVDA is working with the national pathology team at NHS England and the category tower to ensure that strategy, contract renewals and tenders are conducted in the most appropriate and competitive manner. We will be working on managed service provision with the national teams and at our up-coming Procurement Working party meeting on 9 June at the Royal College of Anaesthetists will have an update on the re-procurement of the NHS Supply chain pathology contract which will be coming up soon.

The new procurement legislation has been published and BIVDA has given detailed information during our March Procurement working party and has recently provided members with summary guidance.


Integrated Care Systems (ICS) and Community Diagnostics Centres (CDC)

It is widely acknowledged that these are still being developed and much of the detail is yet to be decided, however BIVDA will be continually keeping members updated. BIVDA held an ICS workshop in February.

Members heard from David Thorne, Director of NHS Insights at Mtech Access; Patrick McGinley, Head of Costing and Service Line Reporting at the Maidstone and Tunbridge Wells NHS Trust; and James Curtis, Divisional Director at Gloucestershire Hospitals NHS Foundation Trust. About the implementation of ICSs and their stated aims to the financial implications of the new changes. and important information regarding how the changes will potentially affect the diagnostics industry.

The presentations emphasised the focus on collaboration between ICSs now that competition within the NHS has been removed. This new approach aims to provide a structure of cooperation, while allowing the unique needs of each region to be met more adequately. The pandemic is seen to demonstrate how successful the NHS could be by working together.

From a financial perspective, the new rules move the NHS away from a payment by results model, which often failed to give due consideration to the impacts of costing. Hospitals will be given a financial incentive to treat patients off-site in an attempt to make care more local in scope and prevent hospitals from becoming needlessly congested at a time when space and beds are so valuable.

NHS England shared their current 4 aims on Community Diagnostics Centres which are to deliver at least one CDC per ICS system, support diagnostic elective recovery, improve efficiency and patient experiences, address health inequalities and improve access to diagnostics. This will be hub and spoke, with small, standard and large whilst building on existing locations, point of care and phlebotomy.


NHS Net Zero and Sustainability

As members progress towards the NHS targets and policy changes over the next 12m, the requirements will develop and change, BIVDA has appointed a Sustainability Programme Lead, supporting the programme with Helen, Ashleigh, Michael and the Chairs from the Procurement and Environmental working parties to provide topical and valuable coverage on these subjects. We have increased engagement with external experts to provide experience and knowledge to enhance members skills around Environmental and Social sustainability to help achieve success in tendering with contracting authorities.

Members are able to understand how to successfully complete tenders and provide solutions on how to comply with the ever-changing public procurement legislation, including the most recent requirements around Net Zero, Social Value and Environmental issues. At our Sustainability Seminar on the afternoon of the 9 June at the Royal College of Anaesthetists, we will be hearing from NHS England, UK CPI Research Innovation and the IBMS about how to work together to achieve these targets. Members will see the launch of the resource hub to help on the journey. We also took part in a Net Zero Webinar for the ACB where we discussed the challenges and requirements that laboratory personnel need to understand are placed on their supply chain.


GIRFT – Scan4 Safety

Getting It Right First Time (GIRFT) is a national programme designed to improve the treatment and care of patients through in-depth review of services, benchmarking, and presenting a data-driven evidence base to support change. GIRFT is part of an aligned set of programmes within NHS England and NHS Improvement and is an integral part of the Network strategy. At a recent BIVDA meeting, Bruce Daniel, South-West regional pathology lead discussed the clinical, operating and business models across the NHS and integration into clinical pathways, and the ongoing priorities to deliver GIRFT, effectiveness and PQAD and a single UKAs accreditation process. The NHS’s return to business as usual will include changes to covid use cases, testing regimes and technology and funding through this Summer, focus on network workplans development, focus on workforce Integration and externalising pathology into system/s wide diagnostics with a key theme of horizontal digital integration within between and across systems, delivering the Richards report, and a focus on the delivery of GIRFT outcomes and patient pathway benefits.

Now that the Scan for Safety team has been disbanded many members feel disconnected from what is happening regarding the implementation of PEPPOL in the NHS.

BIVDA are currently working with some of the PEPPOL access point providers to re-engage.

There is a project being worked on to provide BIVDA members with information on the new PEPPOL UK authority and how that is now working, a list of Trusts who are now live with PEPPOL and also a strategy to collaboratively approach Trusts to engage with the implementation of PEPPOL which we will update members as soon as possible.


Accelerated Access Collaborative, Innovation, Uptake and Medtech Funding Mandate

Following agreement of the Medtech mapping project, it was agreed that further stakeholder engagement was required to advance the project scope and support data collection. The aims of the workshops are to widen awareness and understanding of the work within AAC partner organisations and stakeholders to expand inputs into the AAC and reach consensus on the accuracy of the flowchart mapping already undertaken, to help ‘quantify’ the flowchart, specifically to record the number and type of products passing through each stage, the timelines for each stage, and the costs for innovators (direct and indirect), to  identify issues throughout the innovation lifestyle that is preventing timely patient access to current and future innovative technologies, to develop solutions to any identified issues and to support prioritisation of issues to solve, by allow better use of resources.  BIVDA are co-hosting the Industry Workshop with from Medtech members from ABHI and IVD members from BIVDA on 10 June 2022. The scope of the workshop is to understand how to best enable industry to engage at each stage of pathway, how to align industry effort behind NHS needs throughout the pathway, and how can procurement be simplified with an examination of how can the pathway be improved to ensure UK remain internationally attractive? BIVDA will continue to drive the needs of members with regard to Innovation and access and keep members updated on a regular basis.

The Medtech Funding Mandate forward plan for 2022/23 has been shared with the governance structure, 23/24 criteria and a mandated procurement route through NHS Supply Chain developed in Q1. Equality and Health inequalities feature heavily in the programme and will be part of the plans in 2022. Q2 and Q3 are particularly demanding with several target workstreams being undertaken. There is AHSN and Technology supplier support being provided, the Future NHS and production of tools and guidance is underway, criteria and horizon scanning on companies meeting the criteria is to be commenced with due diligence and signalling to be provided after the summer followed by the publication of the guidance after final agreement with the oversight group.

There is a new reporting mechanism with NHS Supply Chain, strengthening the procurement route and any reimbursement mechanisms along with the development of a Model Health System compartment.


NHS Digital Programmes & Health Data Strategy

Members have asked BIVDA to seek clarification around the process and considerations by NHSX when they decide mandated changes which affect supplier instruments and operating systems, and how they impact contractual arrangements and IVD regulatory requirements.

At the procurement working party on the 9 June, there is an open discussion with members scheduled to understand the challenges with this process, to discuss the application of DCB0129 and also to discuss their current surveys on blockers to digital adoption to identify quantitative evidence and a prioritised list of blockers to adoption which will be used to develop further policy and measures for boosting standards adoption and interoperability, integration, data architecture issues and blockers in patient pathways that involve several care settings.



There are reports from the field that something has recently changed with the application of credentialling, and BIVDA is working with NHS Trusts, NHS England and potentially the Information Commissioners Office to determine the requirements. We have seen various mandated requirements for vaccinations and DBS over the past months that appear to vary from trust to Trust which does not align with the national expectations. The current BIVDA position statement can be found here which members are encouraged to reference. BIVDA negotiated a small discount with Intellicentrics of 10% for BIVDA members and have agreed with the vast majority of their Trusts that no DBS is required but there are a few that seem to be ignoring the guidance. Members can get an LSI only card from the Academy for Healthcare Science but they also ask for numerous credentials and DBS and BIVDA continues to be on the steering committee for this.

BIVDA does not actively endorse any credentialing register but considers the LSI Register to be the most appropriate for future support at the current time but will continue to work with all providers to make it easier for members across the board.


Coronavirus Test Devices Assessment (CTDA)

BIVDA regularly meets with the CTDA management team to try and drive through some of the experiences our members have with the process. The current protocol ended on 31 May and the approvals are based on the Public Health need. We have provided several letters which highlight anonymised experiences and there has recently been a reduction in resource and a change of leadership. Some of our suggestions have been taken into consideration, but the relationship and information is specific to member companies and CTDA are unable to share specific outcomes with us as they are made directly to companies. We continue to argue for a better framework of regulation, and the improvement of the service for which is a paid for service. We also continue to push back that there is overwhelming support for this in the industry and have provided detailed evidence to demonstrate. There is work ongoing on the development of the new UK regulations and a workshop is planned to discuss future regulation which is intended to feed into the CTDA review process due to take place later this year which BIVDA are on the expert panel. There still are a large number of applications still in progress. Members are updated through the Infectious Disease Working party as anything is released. BIVDA is due to host another webinar with UKHSA to update industry in the near future.


Infectious Diseases, AMR and Covid

BIVDA recently held the first Infectious disease working party, where AMR, Covid-19 and Public Health issues will be covered. Our AMR working party has been expanded to cover the above themes and the scope and terms of reference and a new chair and vice-chair will be agreed shortly. We have had speakers from the MDC CF AMR Syndicate on the development of Patient-focused Target Product Profiles (TPP) for Lung Microbiological Diagnostic Tests in Cystic Fibrosis, and NHS England on the Blood Culture pathway, both of which will continue to feature in this meeting. Until now, all Covid-19 related issues have been dealt with through the Covid-19 Task Force, this has also been combined into this group as we aim to work more closely with UKHSA on pandemic preparedness and lessons learned.


UK Manufacturing Capability and UK Diagnostics Strategy

The Medtech directorate came to BIVDA’s AGM in March to provide an update on the UK Diagnostics Strategy and BIVDA continues to represent the IVD industry in discussion and consultations whilst the Strategy is being developed. BIVDA attends a regular update meeting with the Department of Health and Social Care and has a one-one meeting scheduled this month for a final discussion prior to publication. There will be sector specific focus for Diagnostics under 4 main headings; Elective Recovery including Community Diagnostics Centres, enhanced digital solutions and interoperability and a workforce plan, there is a sub-section for Early Diagnosis with an aim to improve patient outcomes by diagnosing people earlier and more accurately. Use additional capacity effectively and to direct R&D at diagnostics to maximise impacts. Another stream is Pandemic Preparedness, which will be led by UKHSA with an aim to ese the legacy of investment during the pandemic to ensure preparedness for next challenge and to maintain and utilise changed public behaviour, which captures some of BIVDA’s Emerging from the Pandemic Paper the final stream is Industry & Innovation – which aims to align on national clinical leadership, demand signalling and evaluation, to grow and harness the UK diagnostics sector with the NHS to provide clear demand signalling to industry on detailed priorities for innovation by product segment and there will be a push through innovation to ask a next generation challenge to industry and academia. Following actions and activities undertaken during the Covid-19 pandemic, this is the boldest statement made by DHSC on the Diagnostics Strategy as they seek to enable a collaborative partnership with industry, government and clinical teams within an environment for frank discussion and transparency. BIVDA’s role is to ensure that mistakes and actions are not repeated so that we can ensure a stronger and robust manufacturing sector that is not brought to its knees by government action.


Further Information

The BIVDA Team is available by email, phone or in person at any one of our events to discuss any of the BIVDA programme issues affecting your company in detail, and you are able to see archived updates in the “Archive” section of the newsletter or through the members area of our website.

Ben Kemp