Medical Devices Safety - programme support and point of care traceability pilots

Description

Summary of the work Medical Devices Safety Programme including supply of teams to provide programme support and business case development; strategic service design and electronic point of care traceability pilots in multiple NHS trusts Latest start date Monday 8 November 2021 Budget Range Up to £455,250 (plus VAT) Why the Work is Being Done In 2018 following serious incidents involving pelvic mesh, an external review was commissioned to review these interventions. The Independent Medicines & Medical Devices Safety (IMMDS) Review was established to examine how the health system responds to patients' reports about harmful side effects from medicines and medical devices. The Secretary of State for Health and Social Care has asked NHSX to lead work to consider how technology and data can be utilised to address shortfalls in public health caused by implantable medical devices. This work does not just focus on pelvic mesh but also covers high risk devices in classes IIb and III. Problem to Be Solved Support for a programme covering different but interdependent work streams, that will facilitate service pilots in NHS provider organisations. The deliverables include: Deliverable 1: Programme governance support and business case The programme is currently led by the NHSX Digital Transformation team with consultancy support while recruitment for 5 permanent programme roles is underway. This work would need to include extensive clinical, industry and patient group engagement over the business case development period, given the complex nature of the clinical work. Deliverable 2: Electronic point of care traceability pilots in 5 to 8 trusts Building on the discovery work done in 2021/22 by NHSX, supporting electronic ‘barcode’ scanning to record the patient, the implanted medical device, caregivers and location data that will subsequently be sent to the Medical Device Information System. In 2021/22, 5 to 8 scanning pilots will have been delivered across a variety of Trusts, with the learnings from these pilots to be collected to inform subsequent national rollout. A multi-disciplinary digital development agency team with product, service design, change management and digital programme expertise to support the programme and business case development and deliver electronic point of care traceability pilots in 5 to 8 NHS trusts. Who Are the Users Clinicians and patients Work Already Done We have already run an Alpha and pre Beta and have lined up 8 pilot projects with local NHS Trusts. Existing Team There is an existing NHSX programme team in place: an interim programme director, an interim programme manager, a product manager, plus consultancy support. We are currently recruiting additional people to the programme team, with the target of having them in post by January 2022. Current Phase Beta Skills & Experience • ● Demonstrate experience in delivering complex and multi-stakeholder projects to time and cost • ● Demonstrate experience of designing inclusive services • ● Demonstrate experience of leading agile and digital technology delivery projects • ● Demonstrate experience in working with and delivering digital and technology services in NHS provider sites Nice to Haves • ● Demonstrate experience in delivering programmes where both MSP and Agile approaches are used • ● Demonstrate experience in translating government policy into real life outcomes • ● Demonstrate experience in developing prototypes and meeting GDS standards, including passing Service Assessments • ● Demonstrate experience in challenging the status quo in complex organisations Work Location Services will be carried out remotely, on site in NHS hospital trusts and occasionally at the NHSX London SE1 office depending on local restrictions relating to Covid-19. Working Arrangments Working times are 09:00 to 17:30, 5 days a week. Meetings and collaboration currently happen remotely using Google Suite, Trello, Teams and other tools - NHSX accounts will be created for all project members. Security Clearance BPSS will be required before work can start Additional T&Cs Expenses will be paid in alignment to Department of Health and Social Care terms and conditions where prior authorisation has been obtained. Expenses will not be payable for London or where the resource is home-based. No. of Suppliers to Evaluate 5 Proposal Criteria • Team Structures and timeframes, including skills and experience [12%] • Approach to identifying and managing risks and dependencies [12%] • Outline approach to delivering electronic point of care traceability pilots in multiple NHS Trusts [12%] • Approach to support and governance of the programme, including methodologies and business case experience [12%] • Approach to managing a complex stakeholder environment across multiple organisations [12%] Cultural Fit Criteria • Work as a team with our organisation and multiple stakeholders at pace and in an environment where medical terminology and standards are used [10%] • Work transparently and collaboratively whilst retaining confidentiality [10%] Payment Approach Capped time and materials Assessment Method • Case study • Presentation Evaluation Weighting Technical competence 60% Cultural fit 20% Price 20% Questions from Suppliers 1. Due to unforeseen absence there remain some outstanding clarification questions that we are unable to answer today. Due to unforeseen absence there remain some outstanding clarification questions that we are unable to answer today. 2. If it was an external supplier, please confirm if they will still be involved in the Beta phase, and in what capacity. The current supplier's contract comes to an end in December 2021, so there will be handover period to the new supplier. 3. Who delivered the Alpha/Beta service? The current supplier in place is The PSC 4. Your brief states “There is an existing NHSX programme team in place: an interim programme director, an interim programme manager, a product manager, plus consultancy support.” Please provide more details on the consultancy support you have used to date on this programme including who it is and the nature of the support they have provided. The current supplier in place is the PSC, they have supported the existing Beta phase, in addition to the NHSx interim programme team. NHSx are currently recruiting for a permanent programme team for this project. 5. A budget value is stated but there is no indication of contract length – is it possible to estimate at this stage? We estimate that this will run until March 2022 6. The “Existing Team” references consultancy support. Please can you advise which 3rd parties have provided this support? And which have contributed to any other aspects of work undertaken to date. The current supplier in place is The PSC 7. Which Trusts have been lined up as potential pilot participants? We have 8 NHS hospital trusts lined up, we cannot name these at this stage. 8. The tender states “We are currently recruiting additional people to the programme team, with the target of having them in post by January 2022” Are you expecting any change in the make-up of the bidder’s team at this point in time as a result of these appointments? No 9. What is the scope of the consultancy support currently in place? The current supplier in place is the PSC, they have supported the existing Beta phase, in addition to the NHSx interim programme team. NHSx are currently recruiting for a permanent programme team for this project. 10. Is the intention that this consultancy support will continue when the 5 permanent programme roles have been recruited? Yes, the successful supplier will work alongside the permanent team. 11. Is the intention that the existing team will remain in place during this project? i.e. programme director, programme manager, product manager. NHSx are currently recruiting for a permanent programme team for this project. The existing interim team will roll off the project when the permanent roles are in place. 12. The ‘latest start date’ is listed as 8th November 2021, but the target for additional people for programme team is January 2022 – can any further information be provided around the difference between these dates and anticipated timeline? NHSx are currently recruiting for a permanent programme team for this project. The existing interim team will roll off the project when the permanent roles are in place. 13. Understanding more about the scope is key to allowing us to price our support:a. Have the 5 – 8 NHS hospital trusts been identified?b. Have the hospital trusts signed-up to the pilot?c. Can the identity of the trusts be shared (or at least the geographical location)? We have 8 NHS hospital trusts lined up, we cannot name these at this stage. 14. Is the intention that the pilots build on the Scan4Safety programme? Yes