Ireland-Dublin: TSCD®-II — Sterile Tubing Welder

Type of document: Voluntary ex ante transparency notice
Country: Ireland
OJEU Ref: (2020/S 127-310570/EN)
Nature of contract: Supply contract
Procedure: Negotiated without a call for competition
Regulation of procurement: EU – with participation by GPA countries
Type of bid required: Not applicable

Voluntary ex ante transparency notice
Supplies

Section I: Contracting authority
I.1) Name and addresses
Official name: Irissh Blood Transfusion Service
Postal address: National Blood Centre, James’s Street
Town: Dublin
Postal code: D08 NH5R
Country: Ireland
Contact Person: Paul Behan
Telephone: +353 14322800
Email: paul.behan@ibts.ie
Fax: +353 1432930
Internet address(es):
Main address:

I.4) Type of the contracting authority
Body governed by public law
I.5) Main activity
Health

Section II: Object
II.1) Scope of the procurement
II.1.1) Title: TSCD®-II — Sterile Tubing Welder
II.1.2) Main CPV code: 33194210
II.1.3) Type of contract Supplies
II.1.4) Short Description:
The TSCD II is used across various processes in Blood Establishments, including:
Component pooling
Leukoreduction
Pathogen reduction
Collection set modification
Component aliquoting
Quality control sampling.
II.1.6) Information about lots
The contract is divided into lots: no
II.1.7) Total value of the procurement(excluding VAT)
Value:628500.00
Currency:EUR
II.2) Description
II.2.3) Place of performance
Nuts code: IE, UKL, UKM, UKN, UK Main site or place of performance:Ireland, Scotland, Northern Ireland, Wales and England.

II.2.4) Description of the procurement
The TSCD 11s are currently in use in various Blood Establishments (BEs) in Europe, including the Irish Blood Transfusion Service, Scottish National Blood Transfusion Service, Northern Irish Blood Transfusion Service, Welsh Blood Service and the National Health Service Blood & Transplant.
Each BE identified above has a fleet of devices of varying ages, the number of devices used is based on the throughput of processing for each BE. Devices greater than 10 years old will no longer be supported by the manufacturer Terumo.
In order to ensure continuity of production and compliance with EU Blood Directive 2005/62/EC (standards of quality safety) and the Red Book, the BEs need to replace these older devices and have fully comprehensive maintenance on the systems.There is a contract in place with Terumo and the above BES for the provision of comprehensive Maintenance for TSCD II (United Kingdom-Bristol: repair and maintenance services of medical and precision equipment — 2019/S 126-309240). Quantities will be in the region of 98 devices over a term of 4 years. The BEs reserve the right to procure extra devices if required from a safety or operational perspective over the term.
Terumo is the end manufacturer of the TSCD II, it is not operationally feasible or clinically acceptable to have more than one supplier to provide the device and maintenance support for the same technology (TSCD II) from a risk perspective. BEs need to ensure that the appropriate indemnities are in place in the case of any claims, having more than one supplier of the same technology and maintenance increases exposure of the BEs.
Terumo BCT Europe NV are the sole manufacturers and providers of TSCDII devices and the maintenance for these devices in UK and Ireland there are no other authorised distributors, agents or sellers for the UK or Ireland.

II.2.5) Award criteria
II.2.11) Information about options
Options: no
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14) Additional information:
Each of the BEs have current commitment contracts for the supply of wafers used in the TSCD II, changing to new technology to replace these units will result in extra cost, extra administration from validating, standard operating procedures, training and contract management.
Actual contract award date will be the 1 August 2020.

Section IV: Procedure
IV.1) Description
IV.1.1) Type of procedure
Negotiated procedure without prior publication(in accordance with Article 32 of Directive 2014/24/EU)
IV.1.3) Information about framework agreement
The procurement involves the establishment of a framework agreement
IV.1.8) Information about the Government Procurement Agreement(GPA)
The procurement is covered by the Government Procurement Agreement: yes
IV.2) Administrative information

Section V: Award of contract/concession
Contract No: IBTS/011/2020
Title: Replacement — TCDSII

V.2) Award of contract/concession
V.2.1) Date of conclusion of the contract/concession award decision:2020-06-25
V.2.2) Information about tenders
V.2.3) Name and address of the contractor
Official name: Terumo BCT Europe NV
Postal address: Ikaroslaan 41
Town: Zaventem
Postal code: 1930
Country: Belgium
Nuts code: BE
The contractor is an SME: no

V.2.4) Information on value of the contract/lot/concession(excluding VAT)
for framework agreements – total maximum value for this lot
for contracts based on framework agreements, if required – value of contract(s) for this lot not included in
previous contract award notices

Section VI: Complementary informationVI.4) Procedures for review
VI.4.1) Review body
Official name: The High Court
Postal address: Four Courts
Town: Dublin 7
Country: Ireland

VI.4.4) Service from which information about the review procedure may be obtained
Official name: The High Courts
Postal address: Four Courts
Town: Dublin 7
Country: Ireland

VI.5) Date of dispatch of this notice:
2020-06-29

Justification for the award of the contract without prior publication of a call for
competition in the Official Journal of the European Union
1.Justification for the choice of the negotiated procedure without prior publication of a call for competition in accordance with Article
32 of Directive 2014/24/EU
The works, supplies or services can be provided only by a particular economic operator for the following reason:
absence of competition for technical reasons

3.Explanation
Please explain in a clear and comprehensive manner why the award of the contract without prior publication in the Official Journal of the European Union
is lawful, by stating the relevant facts and, as appropriate, the conclusions of law in accordance with the directive:
The BEs have maintenance/supply of consumables contract with Terumo for existing devices. Within each fleet of devices one solder than 10 years will no longer be maintained. In order to ensure continuity of operations and to comply with the European Blood Directive with respect to maintenance for devices. Int this case the exiting units need to be replaced by the same technology, there are no authorised distributers or resellars for the UK and Ireland and Terumo supplies direct to these BEs.