Reagents for analysis of genetic markers in human DNA

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 using multiple automated diagnostic laboratory processes. Currently Laboratory of Genetics …

CPV: 33696500 Laborreagenzien
Frist:
28. Februar 2025 10:00
Art der Frist:
Angebotsabgabe
Ausführungsort:
Reagents for analysis of genetic markers in human DNA
Vergabestelle:
HUS-yhtymä
Vergabenummer:
HUS 325-2024

1. Buyer

1.1 Buyer

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

2. Procedure

2.1 Procedure

Title : Reagents for analysis of genetic markers in human DNA
Description : 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 using multiple automated diagnostic laboratory processes. Currently Laboratory of Genetics is seeking for a Mastermix / Supermix reagent used in large scale testing using quantitative PCR. The process is a LDT process. The source material in most cases is DNA isolated from EDTA-blood samples. The reagents offered must be compatible with pipetting using Tecan and Hamilton pipetting robots and amplification/analysis using Thermo ABI QuantStudio series and Roche LightCycler series Real-Time PCR cyclers. The expected annual test volume is 40-45 000 reactions / year
Procedure identifier : 8234e531-36e0-4baa-93ac-7299a1a9d605
Internal identifier : HUS 325-2024
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: The Procurement authority 1) Opens the tenders 2) Verifies the suitability of the tenderers 3) Verifies the conformance of the tenders to the call for tenders 4) Compares the tenders 5) Requests and checks the certificates and statements regarding the suitability of the winning tenderer 6) Makes the procurement decision and informs all tenderers of the decision 7) Makes the agreement with the selected tenderer The Procurement authority may wholly or partially interrupt the procurement procedure for legitimate and justifiable reason (Section 125 of the Act on Public Contracts). No compensation will be paid to companies for participating in the tendering process. LANGUAGE OF THE PROCUREMENT PROCEDURE The procurement documents are available in English. If the tenderer needs the documents in another language, the tenderer is responsible for the translation and its costs. Tenders and all attachments to the tender must be drawn up in English. PARALLEL AND ALTERNATIVE TENDERS Submitting parallel and alternative tenders is prohibited. SUBCONTRACTING The tenderer may use subcontractors. The tenderer is responsible for the work of the subcontractor as if it were their own in relation to the client. The client will sign the procurement contract only with the company that submitted the tender. Subcontractors used in the procurement must be named. The following information must be provided for the named subcontractors: The official name and business ID of the subcontractor The role of the subcontractor in the procurement Contact information (including the country, if other than Finland) Information about the subcontractor must be provided in a separate attachment, which will be uploaded as part of the tender. This requirement also applies to resource subcontractors. Named subcontractors are considered the tenderer's resources. Therefore, the tenderer must commit to ensuring that the named subcontractors in the tender are available for the execution of the procurement if the tenderer is selected. The Procurement authority may require a security clearance, as defined by the Security Clearance Act, for the The Procurement authority's and the The Procurement authority's subcontractors’ personnel, as stated in the contract terms. The winning tenderer must provide certificates and reports about the subcontractors participating as requested, as required in the call for tender, before signing the contract.

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33696500 Laboratory reagents

2.1.2 Place of performance

Country : Finland
Anywhere in the given country

2.1.4 General information

Additional information : The Agreement is in force for a fixed period of four (4) years, and thereafter until terminated.
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-0000

Title : Reagents for analysis of genetic markers in human DNA
Description : 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 using multiple automated diagnostic laboratory processes. Currently Laboratory of Genetics is seeking for a Mastermix / Supermix reagent used in large scale testing using quantitative PCR. The process is a LDT process. The source material in most cases is DNA isolated from EDTA-blood samples. The reagents offered must be compatible with pipetting using Tecan and Hamilton pipetting robots and amplification/analysis using Thermo ABI QuantStudio series and Roche LightCycler series Real-Time PCR cyclers. The expected annual test volume is 40-45 000 reactions / year
Internal identifier : HUS 325-2024

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33696500 Laboratory reagents

5.1.2 Place of performance

Country : Finland
Anywhere in the given country
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)
Additional information : The Agreement is in force for a fixed period of four (4) years, and thereafter until terminated.

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : ECONOMIC AND FINANCIAL STANDING
Description : In the latest confirmed financial statement, the turnover of the tenderer is more or equal to 200 000 euros.
Criterion :
Type : Economic and financial standing
Name : Indemnity insurance
Description : The insured amount in its professional risk indemnity insurance is the following: 100 000 EUR.
Criterion :
Type : Economic and financial standing
Name : The tenderer's financial conditions
Description : The tenderer's financial conditions must be sufficient in relation to the size and quality of the procurement. This characteristic is assessed based on information obtained about the tenderer's solvency, liquidity, profitability, and creditworthiness. This requirement applies to all members of the consortium as well as to any subcontractor involved in the delivery whose resources the tenderer relies on. The tenderer is deemed to have sufficient resources if it has a risk class of 1-3 according to the Suomen Asiakastieto Oy risk indicator, or an equivalent financial risk classification according to another well-known risk classifier’s rating report, financial statements, or other similar documentation. If information about the tenderer’s risk class is not available from well-known credit rating agencies, the contracting authority will request a report on the tenderer’s financial situation. The report must include the confirmed financial statements for the last three fiscal years. If the tenderer is a start-up company and financial statements are not yet available, a report on the financing of operations and financial conditions must be provided.
Criterion :
Type : Suitability to pursue the professional activity
Criterion :
Type : Technical and professional ability
Name : References
Description : The tenderer must have full responsibility for the references provided, but the tenderer may have used subcontractors for the deliveries. If the tenderer is a consortium, not all members of the consortium need to meet the set reference requirements; it is sufficient that the members of the consortium together meet them or that one member of the consortium meets them. If the tenderer uses a resource subcontractor, the resource subcontractor does not need to meet the set reference requirements; it is sufficient that the tenderer and the resource subcontractor together meet them. Deliveries made to the tenderer himself, companies of the same group, offered subcontractors or members of the group are not accepted as references. The same reference may only be presented once. The contracting authority will check the references from the reference laboratory.Self-made references or references produced and implemented for an organization within the tenderer’s own corporate structure are not accepted. No more than three (3) years must have elapsed since the end of the reference contract, calculated from the deadline for submitting tenders. The reference must meet the following mandatory requirements: 1. The tenderer must have at least two (2) references indicating experience in delivering the offered qPCR reagents to diagnostic or service laboratories in the EU/EEA, Great Britain or Switzerland. 2. The offered products are used in the customer laboratory for diagnostic genotyping of human samples using Taqman probe-based assays. 3. The use of qPCR reagents in the customer laboratory has continued for at least 6 months and included at least 2 deliveries.

5.1.10 Award criteria

Criterion :
Type : Price
Name : Price
Description : The most economically advantageous tender shall be selected. The criterion for determining the most economically advantageous tender shall be the lowest price. The tenderer shall provide their tender price in the section "Procurement Object Criteria".
Fixed value (total) : 100
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 : 07/02/2025 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 : Not allowed
Deadline for receipt of tenders : 28/02/2025 10:00 +00:00
Deadline until which the tender must remain valid : 4 Month
Information about public opening :
Opening date : 28/02/2025 10:05 +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 : HUS-yhtymä
Registration number : 1567535-0
Postal address : Uutistie 5
Town : vantaa
Postcode : 01770
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Contact point : Irina Lev
Telephone : +358 94711
Internet address : http://www.hus.fi
Roles of this organisation :
Buyer

8.1 ORG-0002

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-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 : f6891cc4-870f-4756-b03b-2923b9961750 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 24/01/2025 07:04 +00:00
Notice dispatch date (eSender) : 24/01/2025 07:30 +00:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00054053-2025
OJ S issue number : 18/2025
Publication date : 27/01/2025