Hysbysiad gwybodaeth ymlaen llaw
Hysbysiad gwybodaeth ymlaen llaw yn unig yw hwn
Adran I:
Endid
contractio
I.1) Enw a chyfeiriad
NHS Blood and Transplant
500 North Bristol Park
Bristol
BS34 7QH
UK
Person cyswllt: Samantha Rix
Ffôn: +44 7385972251
E-bost: samantha.rix@nhsbt.nhs.uk
NUTS: UKK11
Cyfeiriad(au) rhyngrwyd
Prif gyfeiriad: https://www.nhsbt.nhs.uk/
Cyfeiriad proffil y prynwr: https://www.nhsbt.nhs.uk/
I.3) Cyfathrebu
Gellir cael gwybodaeth ychwanegol o'r cyfeiriad uchod
Mae cyfathrebu electronig yn gofyn am ddefnyddio offer a dyfeisiau nad ydynt ar gael yn gyffredinol. Mae mynediad uniongyrchol anghyfgyfyngiedig a llawn i'r offer a dyfeisiau hyn yn bosibl, yn rhad ac am ddim, yn:
https://health-family.force.com/s/Welcome
I.4) Y math o awdurdod contractio
Corff a lywodraethir gan gyfraith gyhoeddus
I.5) Prif weithgaredd
Iechyd
Adran II: Gwrthrych
II.1) Cwmpas y caffaeliad
II.1.1) Teitl
non-DEHP Blood Pack Validation
Cyfeirnod: C238220
II.1.2) Prif god CPV
33141613
II.1.3) Y math o gontract
Cyflenwadau
II.1.4) Disgrifiad byr
Following a change in EU legislation, DEHP plasticiser will be removed from medical devices, including blood packs. NHSBT wishes to commence a validation process in early 2024 for non-DEHP primary collection and ancillary blood packs. The project will have a duration of 2 calendar years from commencement.<br/><br/>Primary collection systems are for the collection of whole blood in two configurations ('bottom and top' and 'top and top').<br/><br/>Ancillary systems are for secondary manufacturing processes and subsequent storage, such as for pooled platelet concentrates or small volume neonatal components.
II.1.5) Cyfanswm gwerth amcangyfrifedig
Gwerth heb gynnwys TAW: 48 000.00 GBP
II.1.6) Gwybodaeth am lotiau
Mae’r contract hwn wedi’i rannu’n lotiau:
Na
II.2) Disgrifiad
II.2.3) Man cyflawni
Cod NUTS:
UK
Prif safle neu fan cyflawni:
United Kingdom, Europe and World Wide
II.2.4) Disgrifiad o’r caffaeliad
Please note that this is not the start of a procurement process. A separate contract notice will be published to cover this requirement. The purpose of this Prior Information Notice (PIN) is to inform the market of prospective requirements, as far as the details are known at this time.<br/><br/>This PIN is being published by NHSBT on behalf of itself and potentially in collaboration with other Blood Services.<br/><br/>NHSBT seeks to understand the market’s ability to supply non-DEHP primary and ancillary blood packs and to validate these packs in order to support a potential future tender.<br/><br/>Subject to satisfactory agreements, the validation may be in collaboration with other Blood Services, potentially within the European Blood Alliance (EBA) or the Alliance of Blood Operators (ABO). To support validation of the blood packs and avoid duplication across multiple Blood Services, NHSBT will participate in the European Blood Alliance data sharing agreements, and will adopt the published EBA validation strategy as a framework for its own validation activities.<br/><br/>NHSBT intends to validate all non-DEHP blood pack systems that have received CE marking under EU MDR, or which have a credible application and timeline for receipt of the accreditation within the timeline of this validation project. Validation will consist of phase 0 and phase 1 activities. No components will be issued to patients.<br/><br/>Suppliers should contact Samantha Rix, samantha.rix@nhsbt.nhs.uk by 14 March 2024 to express their interest or for further information, should the Supplier have (or is likely to have) non-DEHP primary and ancillary blood packs which meet the criteria and timescales stated above.
II.2.14) Gwybodaeth ychwanegol
Validation Project Timeline - April 2024 to March 2026<br/>Phase 0 = Physical examination of pack<br/>Phase 1 = small scale product/pack tests
II.3) Dyddiad amcangyfrifedig ar gyfer cyhoeddi’r hysbysiad contract:
24/01/2024
Section IV: Gweithdrefn
IV.1) Disgrifiad
IV.1.8) Gwybodaeth am Gytundeb Caffael y Llywodraeth (GPA)
The procurement is covered by the Government Procurement Agreement:
Na
Section VI: Gwybodaeth ategol
VI.5) Dyddiad anfon yr hysbysiad hwn
12/02/2024