Immunoglobulin (IG) and T-cell receptor (TCR) clonality assays, IGHV somatic hypermutation assay and controls for IG/TCR assays

HUSLAB Laboratory of Genetics at HUS (Helsinki University Hospital) Diagnostic Center is an SFS-EN ISO 15189:2022 accredited laboratory providing diagnostic genetic testing services to all patients at Helsinki University Hospital area. The services include analysis of both constitutional samples and malignancies. The laboratory performs yearly approximately 300 immunoglobulin gene rearrangement …

CPV: 33000000 Medical equipments, pharmaceuticals and personal care products
Deadline:
Dec. 17, 2024, 10 a.m.
Deadline type:
Submitting a bid
Place of execution:
Immunoglobulin (IG) and T-cell receptor (TCR) clonality assays, IGHV somatic hypermutation assay and controls for IG/TCR assays
Awarding body:
HUS Group
Award number:
HUS 399-2024

1. Buyer

1.1 Buyer

Official name : HUS Group
Legal type of the buyer : Regional authority
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : Immunoglobulin (IG) and T-cell receptor (TCR) clonality assays, IGHV somatic hypermutation assay and controls for IG/TCR assays
Description : HUSLAB Laboratory of Genetics at HUS (Helsinki University Hospital) Diagnostic Center is an SFS-EN ISO 15189:2022 accredited laboratory providing diagnostic genetic testing services to all patients at Helsinki University Hospital area. The services include analysis of both constitutional samples and malignancies. The laboratory performs yearly approximately 300 immunoglobulin gene rearrangement studies, 450 T-cell receptor rearrangement studies, and 150 immunoglobulin gene V-region hypermutation studies. The HUS Group requests tenders for IG/TCR clonality and somatic hypermutation assay reagents and controls for these reagents. The procurement is divided into two (2) lots, as follows: 1. Immunoglobulin (IG) and T-cell receptor (TCR) clonality assays and IGHV somatic hypermutation assay 2. Controls for IG/TCR assays The tenderers may leave a tender to one or more lots as they decide. The products that are included to the procurement are described in more detail in below in the invitation to tender. The subject matter of the procurement also includes additional products related to the products tendered, such as additional sizes and accessories. In addition, during the contract period, products belonging to the product groups that are the subject of the contract, may be acquired in accordance with the estimated value of the contract, also when they are not specified in the product annex (please see draft agreement). This is not a joint procurement of several contracting entities and the products requested in this invitation to tender will be used by HUS Group (HUS). The total estimated value of the procurement (VAT 0 %) is approximately EUR 700 000. This is an estimate and the contracting entity does not commit neither to the stated euro amounts and nor the consumption figures indicated in the invitation to tender. The final order quantities may be higher or lower than stated. The subject matter and requirements of the procurement are described in detail in the invitation to tender and its annexes.
Procedure identifier : 34b26616-516c-4cb9-8934-eacc1015b7d8
Internal identifier : HUS 399-2024
Type of procedure : Open
The procedure is accelerated : no
Justification for the accelerated procedure :
Main features of the procedure : The procurement shall comply with the Act on Public Procurement and Concession Contracts (1397/2016, referred to as the Public Procurement Act). The procurement value exceeds the EU threshold value. The procedure shall be an open procedure as defined in section 32 of the Public Procurement Act. PROCESSING OF TENDERS The procedure shall include the following phases: Contracting entity 1. Opens the tenders 2. Verifies the suitability of the tenderer 3. Checks that the tenders conform to the invitation to tender 4. Compares the tenders and does the possible trial use 5. Requests and checks certificates and reports on the suitability of the winning tenderer(s) 6. Makes a procurement decision and communicates it to all the tenderers 7. Concludes an agreement with the selected tenderer(s) LANGUAGE OF THE COMPETITIVE TENDERING PROCEDURE The procurement documents are available in English. If a tenderer needs the documents in another language, the tenderer shall be responsible for translation and liable for the associated costs. Tenders must be prepared in English. PARTIAL TENDERS Partial tenders will not be accepted. PARALLEL TENDERS Parallel tenders are permitted. If a tenderer submits a parallel tender, the parallel tender must meet all the requirements of the invitation to tenders and have the required appendices. Parallel tenders must always be submitted as separate tenders. No more than one (1) parallel tender may be submitted.

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33000000 Medical equipments, pharmaceuticals and personal care products

2.1.2 Place of performance

Anywhere

2.1.4 General information

Legal basis :
Directive 2014/24/EU

2.1.6 Grounds for exclusion

Analogous situation like bankruptcy under national law : The economic operator is in any analogous situation like bankruptcy arising from a similar procedure under national laws and regulations.
Bankruptcy : The economic operator is bankrupt.
Corruption : The economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for corruption, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable.
Arrangement with creditors : The economic operator is in arrangement with creditors.
Participation in a criminal organisation : The economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for participation in a criminal organisation, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable.
Agreements with other economic operators aimed at distorting competition : The economic operator has entered into agreements with other economic operators aimed at distorting competition.
Breaching of obligations in the fields of environmental law : The economic operator has breached its obligations in the field of environmental law.
Money laundering or terrorist financing : The economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for money laundering or terrorist financing, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable.
Fraud : The economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for fraud, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable.
Child labour and other forms of trafficking in human beings : The economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for child labour and other forms of trafficking in human beings, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable.
Insolvency : The economic operator is the subject of insolvency or winding-up.
Breaching of obligations in the fields of labour law : The economic operator has breached its obligations in the field of labour law.
Assets being administered by liquidator : The assets of the economic operator are being administered by a liquidator or by the court.
Guilty of misrepresentation, withheld information, unable to provide required documents and obtained confidential information of this procedure : The economic operator can confirm that: a) It has been guilty of serious misrepresentation in supplying the information required for the verification of the absence of grounds for exclusion or the fulfilment of the selection criteria, b) It has withheld such information, c) It has not been able, without delay, to submit the supporting documents required by a contracting authority or contracting entity, and d) It has undertaken to unduly influence the decision making process of the contracting authority or contracting entity, to obtain confidential information that may confer upon it undue advantages in the procurement procedure or to negligently provide misleading information that may have a material influence on decisions concerning exclusion, selection or award.
Purely national exclusion grounds : Any person who is a member of the economic operator’s administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for work safety offence, working hours offence, work discrimination, extortionate work discrimination, violation of the right to organise or unauthorised use of foreign labour.
Conflict of interest due to its participation in the procurement procedure : The economic operator is aware of any conflict of interest, as indicated in national law, the relevant notice or the procurement documents due to its participation in the procurement procedure.
Direct or indirect involvement in the preparation of this procurement procedure : The economic operator or an undertaking related to it has advised the contracting authority or contracting entity or otherwise been involved in the preparation of the procurement procedure.
Guilty of grave professional misconduct : The economic operator is guilty of grave professional misconduct.
Early termination, damages or other comparable sanctions : The economic operator has experienced that a prior public contract, a prior contract with a contracting entity or a prior concession contract was terminated early, or that damages or other comparable sanctions were imposed in connection with that prior contract.
Breaching of obligations in the fields of social law : The economic operator has breached its obligations in the field of social law.
Payment of social security contributions : The economic operator has breached its obligations relating to the payment social security contributions, both in the country in which it is established and in Member State of the contracting authority or contracting entity if other than the country of establishment.
Business activities are suspended : The business activities of the economic operator are suspended.
Payment of taxes : The economic operator has breached its obligations relating to the payment of taxes, both in the country in which it is established and in Member State of the contracting authority or contracting entity if other than the country of establishment.
Terrorist offences or offences linked to terrorist activities : The economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for terrorist offences or offences linked to terrorist activities, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable.

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Immunoglobulin (IG) and T-cell receptor (TCR) clonality assays and IGHV somatic hypermutation assay
Description : In this lot 1 the contracting entity requests tenders for IG/TCR clonality and somatic hypermutation assay reagents.
Internal identifier : 1

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33000000 Medical equipments, pharmaceuticals and personal care products

5.1.2 Place of performance

Anywhere
Additional information :

5.1.3 Estimated duration

Duration : 48 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes
This procurement is also suitable for small and medium-sized enterprises (SMEs)

5.1.7 Strategic procurement

Approach to reducing environmental impacts : The transition to a circular economy
Approach to reducing environmental impacts : The protection and restoration of biodiversity and ecosystems
Social objective promoted : Human rights due diligence in global supply chains

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : Yearly turnover
Description : Minimum requirement: The turnover of the tenderer for the most recent certified financial year must be at least 200 000 euro. A group of tenderers may jointly satisfy this requirement.
Criterion :
Type : Suitability to pursue the professional activity
Name : Enrolment in a relevant professional register
Description : The tenderer is enrolled in the relevant professional registers kept in the Member State of its establishment.
Criterion :
Type : Technical and professional ability
Name : Environmental management measures
Description : Requirements for environmental management measures: The tenderer commits to improving its operations and promoting low-carbon and environmentally sustainable activities over the contract period. The tenderer has an environmental management scheme that guides its activities, which is at minimum a plan for managing its activities in relation to environmental matters. For a more detailed description, see the 'Other conditions' section of the call for tenders.

5.1.10 Award criteria

Criterion :
Type : Price
Name : Price
Description :
Criterion :
Type : Quality
Name : Quality
Description :
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

Deadline for requesting additional information : 27/11/2024 10:00 +00:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of tenders : 17/12/2024 10:00 +00:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 17/12/2024 10:15 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Required
Electronic ordering will be used : yes
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Markkinaoikeus
TED eSender : Hansel Oy (Hilma)

5.1 Lot technical ID : LOT-0002

Title : Controls for IG/TCR assays
Description : In this lot 2 the contracting entity requests tenders for controls for IG/TCR clonality.
Internal identifier : 2

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33000000 Medical equipments, pharmaceuticals and personal care products

5.1.2 Place of performance

Anywhere
Additional information :

5.1.3 Estimated duration

Duration : 48 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes
This procurement is also suitable for small and medium-sized enterprises (SMEs)

5.1.7 Strategic procurement

Approach to reducing environmental impacts : The transition to a circular economy
Approach to reducing environmental impacts : The protection and restoration of biodiversity and ecosystems
Social objective promoted : Human rights due diligence in global supply chains

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : Yearly turnover
Description : Minimum requirement: The turnover of the tenderer for the most recent certified financial year must be at least 200 000 euro.
Criterion :
Type : Suitability to pursue the professional activity
Name : Enrolment in a relevant professional register
Description : The tenderer is enrolled in the relevant professional registers kept in the Member State of its establishment.
Criterion :
Type : Technical and professional ability
Name : Environmental management measures
Description : The tenderer commits to improving its operations and promoting low-carbon and environmentally sustainable activities over the contract period. The tenderer has an environmental management scheme that guides its activities, which is at minimum a plan for managing its activities in relation to environmental matters. For a more detailed description, see the 'Other conditions' section of the call for tenders.

5.1.10 Award criteria

Criterion :
Type : Price
Name : Price
Description :
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

Deadline for requesting additional information : 27/11/2024 10:00 +00:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of tenders : 17/12/2024 10:00 +00:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 17/12/2024 10:15 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Required
Electronic ordering will be used : yes
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Markkinaoikeus
TED eSender : Hansel Oy (Hilma)

8. Organisations

8.1 ORG-0001

Official name : Markkinaoikeus
Registration number : 3006157-6
Postal address : Radanrakentajantie 5
Town : Helsinki
Postcode : 00520
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Telephone : +358 295643300
Roles of this organisation :
Review organisation

8.1 ORG-0002

Official name : HUS Group
Registration number : 1567535-0
Postal address : Uutistie 5 (PO Box 441, 00029 HUS)
Town : Vantaa
Postcode : 01770
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Contact point : HUS Procurement
Telephone : +358 94711
Internet address : http://www.hus.fi
Roles of this organisation :
Buyer

8.1 ORG-0003

Official name : Hansel Oy (Hilma)
Registration number : FI09880841
Postal address : Mannerheiminaukio 1a
Town : Helsinki
Postcode : 00100
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Contact point : eSender
Telephone : 029 55 636 30
Roles of this organisation :
TED eSender

11. Notice information

11.1 Notice information

Notice identifier/version : a56c38d2-fdd3-4e1d-bdb3-f58ca41708c4 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 12/11/2024 12:14 +00:00
Notice dispatch date (eSender) : 12/11/2024 12:16 +00:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00689808-2024
OJ S issue number : 221/2024
Publication date : 13/11/2024