Future opportunity

Microbiology Serology Testing

  • NHS Blood and Transplant

F01: Prior information notice (prior information only)

Notice reference: 2021/S 000-031951

Published 21 December 2021, 4:03pm



Section one: Contracting authority

one.1) Name and addresses

NHS Blood and Transplant

203 Longmead Rd, Avon

Bristol

BS16 7FG

Contact

Claire Barnes

Email

claire.barnes@nhsbt.nhs.uk

Country

United Kingdom

NUTS code

UKK12 - Bath and North East Somerset, North Somerset and South Gloucestershire

Internet address(es)

Main address

https://www.nhsbt.nhs.uk

Buyer's address

https://www.nhsbt.nhs.uk

one.3) Communication

Additional information can be obtained from the above-mentioned address

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

http://health.atamis.co.uk

one.4) Type of the contracting authority

Body governed by public law

one.5) Main activity

Health


Section two: Object

two.1) Scope of the procurement

two.1.1) Title

Microbiology Serology Testing

Reference number

NHSBT1475

two.1.2) Main CPV code

  • 71900000 - Laboratory services

two.1.3) Type of contract

Services

two.1.4) Short description

This Prior Information Notice (PIN) follows KEG PIN released on 7th October 2020 reference 2020/S 198-481270 and a further PIN for Microbiology Serology Managed Service Contract released on 28th January 2021 reference 2021/S 000-001795 and all information herein supersedes this.

This Prior Information Notice (PIN) is separate to any tender opportunity and not related in any form whatsoever to any subsequent activity that NHSBT may wish to pursue. The purpose of this PIN is to inform the market of NHSBT’s intention to tender, to improve NHSBT’s knowledge on the status of manufacturer(s) or economic operator(s) that can supply a commercially available Microbiology Serology Provision and to gauge market interest in the new provision of this service. It is the intention of NHSBT to further engage with only those manufacturer(s) and economic operator(s) who meet the outline requirements.

two.1.5) Estimated total value

Value excluding VAT: £80,000,000

two.1.6) Information about lots

This contract is divided into lots: No

two.2) Description

two.2.2) Additional CPV code(s)

  • 33124130 - Diagnostic supplies
  • 33124130 - Diagnostic supplies
  • 33141625 - Diagnostic kits
  • 33696500 - Laboratory reagents
  • 33698100 - Microbiological cultures
  • 48921000 - Automation system
  • 85111800 - Pathology services
  • 71900000 - Laboratory services

two.2.3) Place of performance

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

Filton and Manchester

two.2.4) Description of the procurement

NHSBT requires a direct contractual relationship with either a manufacturer or any other economic operator for a complete end-to-end integrated solution for the Microbiology Serological screening/testing of blood and non-blood donations , which must include all the necessary equipment, installation, maintenance, consumables, reagents, software including an inter-operability provision with NHSBTs existing IT infrastructure and overall ongoing support mechanism that may be required to carry out the necessary testing as stated below. All invitro diagnostic medical devices, for example, instruments, consumables and reagents must be CE/UKCA marked. GB will continue to recognise CE marking under the IVDD or IVDR until 30 June 2023 and from 1 July 2023 devices placed on the GB market must be UKCA marked under the UK MDR 2002 as amended. The end-to-end solution must be capable of producing test results in a format that can be utilised by NHSBT’s host IT system (PULSE) without the need for changes to PULSE.

The current contract held with NHSBT for the Microbiology Serology Service includes the supply of the mandatory and selective serology assays, consumables, instrumentation, uninterruptable power supply and software required for result management and interface(s) with host systems; including servers to support the IT infrastructure.

Mandatory testing is undertaken on all blood and non-blood donations. The assays required include: Hepatitis B (HBsAg), Human immunodeficiency virus (HIV 1&2 Ab/Ag), Hepatitis C (anti-HCV), syphilis antibodies, and anti-HBc for non-blood donations. These tests are undertaken on high throughput automated equipment. Additional discretionary testing is also undertaken on select donations. These include testing for human T- lymphotropic virus (anti-HTLV), cytomegalovirus (anti-CMV), malarial antibody (anti-malaria), Hepatitis B antibodies (anti-HBc & anti-HBs) and Trypanosome cruzi (anti-T. cruzi). Deceased (non-heart beating) donor screening is performed at Microbiology Services Laboratory (MSL), Colindale and the assays used in MSL Colindale must be suitable for deceased donor screening.


Kit Evaluation Group (KEG) approval of the assays must be obtained prior to the award of the contract.

There is a requirement for automated instrumentation to enable high throughput testing of mandatory and discretionary testing for blood and non-blood donors, archiving and long-term storage of plasma samples as part of this contract. Instrumentation for sample sorting is also for consideration.

All Microbiology Serology testing requirements must be in accordance with the Guidelines for the Blood Transfusion service in the United Kingdom (https://www.transfusionguidelines.org/red-book) and rules and guidance for pharmaceutical manufacturers and distributors.

NHSBT undertakes Microbiology Serology testing on approximately 1,700,000 donations per annum across two prinicipal testing sites, namely Manchester and Filton, and also at the Microbiology Services Laboratory at Colindale.

It is NHSBT's intention to engage with the market to understand the market capabilities and interest in tendering for this service. The format for further activities associated with this service will be communicated to those that respond to this PIN.

Expressions of interest should be e-mailed to claire.barnes@nhsbt.nhs.uk by no later than 1600 hours on Monday 10th January 2022. Interested manufacturers and economic operators are requested to provide the following information:

• Company name

• Address

• Contact details

• A brief paragraph to i) summarise your company’s information outlining the principal line of business; ii) an explanation of your suitability to provide this service to NHSBT; and iii) confirmation of your interest in participating in the tender.

two.3) Estimated date of publication of contract notice

21 December 2021


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