Insulin Pumps, Continuous Glucose Monitoring, Products Contributing to the Delivery of Hybrid Closed Loop Pathways and Associated Products

Concepts

• devices and instruments
• hybrid closed loop pathways
• hybrid closed loop systems
• hybrid closed loop insulin delivery systems
• hybrid
• loop
• pathways
• transfusion and infusion
• infusion pumps
• infusion supplies

Location

Various Locations in the UK

Description

This Framework Agreement is for the supply of Insulin Pumps, Continuous Glucose Monitoring, Products Contributing to the Delivery of Hybrid Closed Loop Pathways and Associated Products. This includes but not limited to tethered and patch insulin pumps, continuous glucose monitoring devices, products that contribute to the functionality of hybrid closed loop insulin delivery systems, and consumables. Precise quantities are unknown. It is anticipated in the first year that spend will be approximately £210,000,000 - £250,000,000 GBP, however this is approximate only and may vary depending on requirements of bodies purchasing under the Framework. The Framework Agreement between NHS Supply Chain and successful suppliers will reserve the right to purchase the same or similar supplies from suppliers not appointed to the Framework at its sole discretion. Estimated total value over the 4 year agreement is approximately £960,000,000 to £1,067,000,000 Excluding VAT. Please note it is expected that the yearly spend for years 2 , 3 and 4 of the Framework Agreement will rise significantly. Following the National Institute for Health and Care Excellence (NICE) Technology Appraisal TA943 Overview | Hybrid closed loop systems for managing blood glucose levels in type 1 diabetes | Guidance | NICE published 19th December 2023 and the NHS England Implementation Plan https://www.england.nhs.uk/long-read/hybrid-closed-loop-technologies-5-year-impl... NHS Supply Chain intends to enter into arrangements under which it will be entitled to purchase supplies which it will make available for purchase by 1) any NHS Trust; 2) any other NHS entity; 3) any government department, agency or other statutory body and/or 4) any private sector entity active in the UK healthcare sector. Only NHS Supply Chain can order from the Framework Agreement and enter into contracts under it.

Lot Division

CPV Codes

• 33194000 - Devices and instruments for transfusion and infusion
• 33194110 - Infusion pumps
• 33194120 - Infusion supplies
• 48100000 - Industry specific software package

Indicators

Other Information

The following certification will be a requirement of the upcoming tender exercise and Applicants may be required to include evidence of this within their tender submission. -ISO 9001:2015 accredited by United Kingdom Accreditation or equivalent externally accredited and up-to-date quality standard certificate(s) covering all segments of the Applicant's (and the product's) supply chain. This should include but not be limited to manufacturing, storage, distribution and customer service. If such certificates are not in the name of the Applicant then the Applicant must supply a copy of agreements setting out the authority and responsibilities of all parties in the supply chain and provide evidence of ISO9001:2015 or equivalent for all relevant parties in the supply chain. -Public Liability Insurance cover of £5m per claim in the name of the Applicant -Product Liability Insurance cover in the name of the Applicant of £5m per claim or £5m per claim and in the annual aggregate -Declaration of Conformity and UKCA Certification to demonstrate compliance to UK Medical Device Regulations 2002 or Declaration of Conformity and CE Certification to demonstrate compliance to Medical Devices Directive 93/42/EEC or Medical Device Regulation 2017/745 (where applicable). -MHRA Registration number. If an Applicant commits to obtain ISO9001:2015 or equivalent quality standard certificate, Public Liability Insurance or Product Liability Insurance certification at the time of their tender submission then the requirement is that such certification is in place prior to the commencement date of the framework agreement (in order for NHS Supply Chain to place orders with the successful Applicant). NHS Supply Chain will be assessing Sustainability and Social Value requirements as part of the upcoming tender process: > Carbon reduction Plan – All suppliers of new contracts for goods, services and works are required to publish a Carbon Reduction Plan (CRP) (PPN 06/21). This will be a pass/fail requirement at SQ stage of the upcoming tender. > Social Value Requirements – This future Framework Agreement will include some qualitative evaluation questions on Social Value with a minimum weighting of 10% towards the award (PPN 06/20). > Evergreen Assessment – Suppliers bidding to be on any NHS Supply Chain Frameworks must have an Evergreen Assessment which has been completed within 12 months prior to the tender close date. Suppliers must complete the assessment annually and the maturity score will be valid for 12 months. This will be a pass/fail requirement at SQ stage of the upcoming tender. > NHS England Supplier Roadmap – The NHS net zero supplier roadmap sets out the steps suppliers must take to align with the NHS net zero ambition between now and 2030. > Modern Slavery – All Suppliers are required to have a Modern Slavery Assessment Tool (MSAT) completed within 12 months prior to the tender close date in line with PPN 02/23. The MSAT score must be 41% or above. This will be a pass/fail requirement at SQ stage of the upcoming tender. For further important information on how NHS Supply Chain will assess Sustainability and Social Value requirements as part of the upcoming tender process please refer to SQ_561 Note 1.1.3 - 'Important Information Sustainability and Social Value Requirements for the upcoming tender process' REGISTRATION 1.Use URL https://nhssupplychain.app.jaggaer.com// to access the NHS Supply Chain Procurement portal. 2.If not yet registered: - Click on the ‘Not Registered Yet’ link to access the registration page. - Complete the registration pages as guided by the mini guide found on the landing page. PORTAL ACCESS If registration has been completed: - Login with URL https://nhssupplychain.app.jaggaer.com// - Click on “SQs Open to All Suppliers” EXPRESSION OF INTEREST - Find SQ_561 RFI Insulin Pumps and click on the blue text. Select Express interest