Future opportunity

Structural Heart and VAD's

  • NHS Supply Chain Operated by Supply Chain Coordination Ltd (SCCL)

F01: Prior information notice (prior information only)

Notice reference: 2024/S 000-002250

Published 23 January 2024, 1:06pm



Section one: Contracting authority

one.1) Name and addresses

NHS Supply Chain Operated by Supply Chain Coordination Ltd (SCCL)

Wellington House, 133-155 Waterloo Road

London

SE1 8UG

Contact

Catherine Nuttall

Email

Catherine.nuttall@supplychain.nhs.uk

Country

United Kingdom

NUTS code

UKI4 - Inner London – East

Internet address(es)

Main address

https://www.gov.uk/government/organisations/department-of-health

Buyer's address

https://www.gov.uk/government/organisations/department-of-health/about/procurement

one.2) Information about joint procurement

The contract is awarded by a central purchasing body

one.3) Communication

Additional information can be obtained from another address:

NHS Supply Chain

Foxbridge Way

Normanton

WF6 1TL

Contact

Catherine Nuttall

Email

Catherine.nuttall@supplychain.nhs.uk

Country

United Kingdom

NUTS code

UKE4 - West Yorkshire

Internet address(es)

Main address

https://www.gov.uk/government/organisations/department-of-health

Buyer's address

https://www.gov.uk/government/organisations/department-of-health/about/procurement

Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at

https://nhssupplychain.app.jaggaer.com//

one.4) Type of the contracting authority

National or federal Agency/Office

one.5) Main activity

Health


Section two: Object

two.1) Scope of the procurement

two.1.1) Title

Structural Heart and VAD's

two.1.2) Main CPV code

  • 33100000 - Medical equipments

two.1.3) Type of contract

Supplies

two.1.4) Short description

NHSSC seeks to establish a non-exclusive Framework Agreement (FAG) via the E-Direct and Direct Route for supply of Structural Heart Devices and Consumables. Products include Heart Valves, Annuloplasty rings and bands, and Ventricular Assisted Devices. Sutureless Valves are one of the high cost tariff excluded devices under the NHS England HCTED programme. NHS Supply Chain is the mandated route for the HCTED programme, and trusts who are commissioned to provide this service are directed to purchase all their requirements through NHS Supply Chain. Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £30,000,000 in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement.

two.1.5) Estimated total value

Value excluding VAT: £120,000,000

two.1.6) Information about lots

This contract is divided into lots: Yes

Maximum number of lots that may be awarded to one tenderer: 2

two.2) Description

two.2.1) Title

Heart Valves and Annuloplasty Rings & Bands

Lot No

Lot 1

two.2.2) Additional CPV code(s)

  • 33100000 - Medical equipments
  • 33123000 - Cardiovascular devices
  • 33141000 - Disposable non-chemical medical consumables and haematological consumables
  • 33141210 - Balloon catheters
  • 33141240 - Catheter accessories
  • 33182000 - Cardiac support devices
  • 33182220 - Cardiac valve
  • 33182300 - Cardiac surgery devices
  • 33184100 - Surgical implants
  • 33184200 - Vascular prostheses
  • 33184300 - Artificial parts of the heart
  • 33184500 - Coronary endoprostheses
  • 33190000 - Miscellaneous medical devices and products

two.2.3) Place of performance

NUTS codes
  • UK - United Kingdom
Main site or place of performance

Various Locations in the UK

two.2.4) Description of the procurement

Products include, but are not limited to;

Annuloplasty band

Annuloplasty ring

Heart Valve Instruments

Heart valve mechanical

Heart valve root replacement

Heart valve sutureless

Heart valve sutures

Heart Valve Tissue

Heart valve tissue pericardial

Heart valve tissue porcine

Heart valve tissue stentless

Heart valve transcatheter

Mechanical valved non biological conduit

Pulmonary valved conduit

Tissue valved non biological conduit

Tissue valved tissue conduit

Valved conduit

Vascular Loop

two.2.14) Additional information

Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £20m-£25m in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement.

two.2) Description

two.2.1) Title

Ventricular Assisted Devices

Lot No

Lot 2

two.2.2) Additional CPV code(s)

  • 33100000 - Medical equipments
  • 33182200 - Cardiac stimulation devices
  • 33182230 - Ventricle
  • 33182300 - Cardiac surgery devices

two.2.3) Place of performance

NUTS codes
  • UK - United Kingdom
Main site or place of performance

Various Locations in the UK

two.2.4) Description of the procurement

Certain products within Lot 2 Ventricular assisted devices may be classified as high cost tariff excluded devices under the NHS England High Cost Tariff Excluded Devices (HCTED) programme. Trusts who are commissioned to provide specialised services in England are directed to purchase all their requirements through a national supply system through NHS Supply Chain.

Details of the product categories currently within scope of the HCTED programme, can be found using the following link: https://www.england.nhs.uk/commissioning/spec-services/key-docs/medical-devices/

In accordance with the specialised services commissioning policy, NHS Improvement and NHS England will determine which products are classified as excluded from tariff and which are made available under the NHSEngland High Cost Tariff Excluded Devices (HCTED) programme.

two.2.14) Additional information

Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £1m to £5m in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement.

two.3) Estimated date of publication of contract notice

29 May 2024


Section four. Procedure

four.1) Description

four.1.8) Information about the Government Procurement Agreement (GPA)

The procurement is covered by the Government Procurement Agreement: Yes


Section six. Complementary information

six.3) Additional 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 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover 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. Further information in respect of certification requirements will be set out in the notice for the forthcoming procurement. 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 d-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).

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).

The NHS has adopted PPN 06/20 (taking account of Social Value), and therefore this future Framework Agreement will include some qualitative evaluation questions on Social Value with a min. weighting of 10% towards the award. For more information please see:

https://www.gov.uk/government/publications/procurement-policy-note-0620-takingaccount-of-social-value-in-the-award-of-central-government-contracts. In addition, from April 2023: the NHS adopted the Government’s ‘Taking Account of Carbon Reduction Plans‘ (PPN 06/21) requiring all suppliers with new contracts for goods, services, and/or works with an anticipated contract value above £5 million per annum, to publish a carbon reduction plan for their direct emissions. From April 2024, the NHS will expand this requirement for all new contracts, irrespective of value. Suppliers bidding on NHS Supply Chain tenders will also be required to submit an Evergreen Assessment, please see https://www.england.nhs.uk/nhs-commercial/central-commercial-function-ccf/evergreen/.

PPN02/23 ""Tackling Modern Slavery in Government Supply Chains"" will also apply.

As part of its pre-tender strategy, NHS Supply Chain would also like to engage with suppliers of these products via a Request for Information (RFI). If you would like to complete the Request for Information document in respect of the products which are the subject of this procurement then please follow the below instructions;

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”.