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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 
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  <cac:TenderingProcess>
    <cbc:Description languageID="ENG">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
5.     Test uses the software as a part of the tender quality comparison
6. Requests and checks certificates and reports on the suitability of the winning tenderer(s)
7. Makes a procurement decision and communicates it to all the tenderers
8. 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.

PARALLEL TENDERS
Parallel tenders are not permitted. 

PARTIAL TENDERS
Partial tenders are not permitted.</cbc:Description>
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    <cbc:ID schemeName="InternalID">HUS 101-2024</cbc:ID>
    <cbc:Name languageID="ENG">Tertiary data analysis software for reporting germline and/or somatic genetic variants and biomarkers</cbc:Name>
    <cbc:Description languageID="ENG">The HUS Group requests tenders for Tertiary data analysis software for reporting germline and/or somatic genetic variants and biomarkers. The products are described in more detail in Appendix 4 to the call for tenders (Description of the Procurement). The estimated sample amounts per year on the Appendix 2 (Prices) and the Description of the Implementation Project (Appendix 6) also provide information on the scope of the procurement.

Laboratory of Genetics at HUS Diagnostic Center is an SFS-EN ISO 15189:2013 accredited laboratory providing diagnostic genetic testing services mainly to patients at the city of Helsinki and the rest of Uusimaa province. The laboratory employs more than 100 professionals including 21 clinical laboratory geneticists and clinical geneticists. The services include analysis of both constitutional samples and malignancies. The laboratory uses mainly local sequencing capacity (e.g. Illumina NovaSeq 6000 and Ion Torrent S5 equipment) for its services. The laboratory also provides array CGH-based diagnostics using ISCA v2 array (Agilent Technologies) and RNA-based diagnostics using targeted and untargeted sequencing methods.

HUS Laboratory of Genetics is seeking a data analysis software service for analyzing, interpreting the clinical significance, and reporting germline and somatic genetic alterations covering whole genome, whole exome and/or genes with the most common clinically relevant alterations (e.g. gene panels). This tender is intended for solutions covering germline (sub-section A) and/or somatic (sub-section B) diseases. Provider’s data analysis software does not have to be capable of both analysis types to respond to this tender.

The procurement is divided into lots, as follows:
- A. germline analysis
- B. somatic analysis.

The tenderers may leave a tender to one or more lots as they decide. 

The goal of this competitive procurement is to simplify the analysis software repertoire and make analysis of multiple data types possible with as few software as possible. This tender is not intended for interpretation services, but the laboratory will carry out sequencing, data analysis and interpretation in-house. 

RELATED CONTRACT PERIOD AND POSSIBLE OPTIONS

See Agreement of the call for tenders for details.

The agreement shall be valid for a fixed term of two (2) years, after which it shall continue for an indefinite period.

The subject matter and requirements of the procurement are described in detail in the invitation to tender and its appendices. </cbc:Description>
    <cbc:ProcurementTypeCode listName="contract-nature">supplies</cbc:ProcurementTypeCode>
    <cac:MainCommodityClassification>
      <cbc:ItemClassificationCode listName="cpv">48000000</cbc:ItemClassificationCode>
    </cac:MainCommodityClassification>
    <cac:RealizedLocation>
      <cac:Address>
        <cbc:Region>anyw-eea</cbc:Region>
      </cac:Address>
    </cac:RealizedLocation>
  </cac:ProcurementProject>
  <cac:ProcurementProjectLot>
    <cbc:ID schemeName="Lot">LOT-0001</cbc:ID>
    <cac:TenderingTerms>
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                <cbc:CriterionTypeCode listName="selection-criterion">ef-stand</cbc:CriterionTypeCode>
                <cbc:Name languageID="ENG">The general annual turnover of the tenderer</cbc:Name>
                <cbc:Description languageID="ENG">The turnover of the tenderer for the most recent certified financial year must be at least EUR 500 000.

A group [of economic operators] can fulfil this criterion together. </cbc:Description>
                <cbc:CalculationExpressionCode listName="usage">used</cbc:CalculationExpressionCode>
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              <efac:SelectionCriteria>
                <cbc:CriterionTypeCode listName="selection-criterion">ef-stand</cbc:CriterionTypeCode>
                <cbc:Name languageID="ENG">Risk classification</cbc:Name>
                <cbc:Description languageID="ENG">The tenderer must have adequate economic resources for the size and quality of the procurement. This characteristic is evaluated based on information received regarding the tenderer’s solvency, profitability, and creditworthiness. 

This criterion applies to all members of a group and to any subcontractor, participating in the deliveries/service, on whose capacities the tenderer relies.

In principle, the tenderer is deemed to have sufficient capacity if it has a risk class of 1-3 according to Suomen Asiakastieto Oy’s risk indicator, or an equivalent economic risk rating according to a rating report, financial statement information, or other similar report of another well-known risk rating provider.

If information on the tenderer's risk rating is not available from generally known credit rating agencies, the Contracting Authority will request a clarification on the tenderer's financial situation. This must be provided in the form of certified financial statements for the last 3 financial years.

If the tenderer is young company and financial statements are not yet available, a clarification on the financial conditions and financing of operations must be provided.</cbc:Description>
                <cbc:CalculationExpressionCode listName="usage">used</cbc:CalculationExpressionCode>
              </efac:SelectionCriteria>
              <efac:SelectionCriteria>
                <cbc:CriterionTypeCode listName="selection-criterion">ef-stand</cbc:CriterionTypeCode>
                <cbc:Name languageID="ENG">Professional risk indemnity insurance</cbc:Name>
                <cbc:Description languageID="ENG">The insured amount in tenderer's professional risk indemnity insurance is the following: minimum 500 000 euro.
</cbc:Description>
                <cbc:CalculationExpressionCode listName="usage">used</cbc:CalculationExpressionCode>
              </efac:SelectionCriteria>
              <efac:SelectionCriteria>
                <cbc:CriterionTypeCode listName="selection-criterion">other</cbc:CriterionTypeCode>
                <cbc:Name languageID="ENG">Environmental management measures</cbc:Name>
                <cbc:Description languageID="ENG">The tenderer has read the appendix “HUS climate road map summary” and 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.</cbc:Description>
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                <cbc:CriterionTypeCode listName="selection-criterion">sui-act</cbc:CriterionTypeCode>
                <cbc:Name languageID="ENG">Enrolment in a trade register</cbc:Name>
                <cbc:Description languageID="ENG">The tenderer is enrolled in the relevant trade registers of its Member State of establishment.</cbc:Description>
                <cbc:CalculationExpressionCode listName="usage">used</cbc:CalculationExpressionCode>
              </efac:SelectionCriteria>
              <efac:SelectionCriteria>
                <cbc:CriterionTypeCode listName="selection-criterion">tp-abil</cbc:CriterionTypeCode>
                <cbc:Name languageID="ENG">References</cbc:Name>
                <cbc:Description languageID="ENG">[OHJE: MUOKKAA TARPEEN MUKAAN TAI POISTA JOS EI VAADITA]
The tenderer must have at least one reference, for a university hospital, regarding the deliveries of the products (and services) offered, with which it can demonstrate its experience in distribution on an equivalent scale … Equivalent is … / … is considered as equivalent …

.. The reference must not be older than 3 years counting [backwards] from the date of submitting tenders. The tenderer may use resources from the subcontractor [,on whose capacities the tenderer relies,] or the group to fulfil the criterion..
</cbc:Description>
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      <cbc:FundingProgramCode listName="eu-funded">no-eu-funds</cbc:FundingProgramCode>
      <cbc:MultipleTendersCode listName="permission">allowed</cbc:MultipleTendersCode>
      <cac:CallForTendersDocumentReference>
        <cbc:ID>Link to procurement documents</cbc:ID>
        <cbc:DocumentType>non-restricted-document</cbc:DocumentType>
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      <cbc:ID schemeName="InternalID">A</cbc:ID>
      <cbc:Name languageID="ENG">A. Germline analysis</cbc:Name>
      <cbc:Description languageID="ENG">The software must be able to support analysis of SNVs, indels, copy number variations (CNVs), structural variations (SVs) and regions of loss of heterozygosity (LOH). Specifically for somatic analysis, requirements also include reporting of gene fusions, microsatellite instability (MSI), homologous recombination deficiency (HRD), and tumor mutation burden (TMB). Tests are based on analysis of nucleic acids (DNA and/or RNA) extracted from patient tissue or blood samples using next generation sequencing (NGS) on either Ion Torrent or Illumina sequencers as well as array CGH based data (ISCA v2 array, Agilent Technologies), where applicable.</cbc:Description>
      <cbc:ProcurementTypeCode listName="contract-nature">supplies</cbc:ProcurementTypeCode>
      <cbc:Note languageID="ENG">The Software Mandatory and Additional Requirements are to be found in Appendix 3. The tenderer must fill in the Prices (Appendix 2) for the germline sub-section (A).
</cbc:Note>
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          <cbc:Region>anyw-eea</cbc:Region>
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    <cac:TenderingTerms>
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                <cbc:Name languageID="ENG">The general annual turnover of the tenderer</cbc:Name>
                <cbc:Description languageID="ENG">The turnover of the tenderer for the most recent certified financial year must be at least EUR 500 000.

A group [of economic operators] can fulfil this criterion together. </cbc:Description>
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              <efac:SelectionCriteria>
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                <cbc:Name languageID="ENG">Risk classification</cbc:Name>
                <cbc:Description languageID="ENG">The tenderer must have adequate economic resources for the size and quality of the procurement. This characteristic is evaluated based on information received regarding the tenderer’s solvency, profitability, and creditworthiness. 

This criterion applies to all members of a group and to any subcontractor, participating in the deliveries/service, on whose capacities the tenderer relies.

In principle, the tenderer is deemed to have sufficient capacity if it has a risk class of 1-3 according to Suomen Asiakastieto Oy’s risk indicator, or an equivalent economic risk rating according to a rating report, financial statement information, or other similar report of another well-known risk rating provider.

If information on the tenderer's risk rating is not available from generally known credit rating agencies, the Contracting Authority will request a clarification on the tenderer's financial situation. This must be provided in the form of certified financial statements for the last 3 financial years.

If the tenderer is young company and financial statements are not yet available, a clarification on the financial conditions and financing of operations must be provided.</cbc:Description>
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              <efac:SelectionCriteria>
                <cbc:CriterionTypeCode listName="selection-criterion">ef-stand</cbc:CriterionTypeCode>
                <cbc:Name languageID="ENG">Professional risk indemnity insurance</cbc:Name>
                <cbc:Description languageID="ENG">The insured amount in tenderer's professional risk indemnity insurance is the following: minimum 500 000 euro.
</cbc:Description>
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              </efac:SelectionCriteria>
              <efac:SelectionCriteria>
                <cbc:CriterionTypeCode listName="selection-criterion">other</cbc:CriterionTypeCode>
                <cbc:Name languageID="ENG">Environmental management measures</cbc:Name>
                <cbc:Description languageID="ENG">The tenderer has read the appendix “HUS climate road map summary” and 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.</cbc:Description>
                <cbc:CalculationExpressionCode listName="usage">used</cbc:CalculationExpressionCode>
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              <efac:SelectionCriteria>
                <cbc:CriterionTypeCode listName="selection-criterion">sui-act</cbc:CriterionTypeCode>
                <cbc:Name languageID="ENG">Enrolment in a trade register</cbc:Name>
                <cbc:Description languageID="ENG">The tenderer is enrolled in the relevant trade registers of its Member State of establishment.</cbc:Description>
                <cbc:CalculationExpressionCode listName="usage">used</cbc:CalculationExpressionCode>
              </efac:SelectionCriteria>
              <efac:SelectionCriteria>
                <cbc:CriterionTypeCode listName="selection-criterion">tp-abil</cbc:CriterionTypeCode>
                <cbc:Name languageID="ENG">References</cbc:Name>
                <cbc:Description languageID="ENG">[OHJE: MUOKKAA TARPEEN MUKAAN TAI POISTA JOS EI VAADITA]
The tenderer must have at least one reference, for a university hospital, regarding the deliveries of the products (and services) offered, with which it can demonstrate its experience in distribution on an equivalent scale … Equivalent is … / … is considered as equivalent …

.. The reference must not be older than 3 years counting [backwards] from the date of submitting tenders. The tenderer may use resources from the subcontractor [,on whose capacities the tenderer relies,] or the group to fulfil the criterion..
</cbc:Description>
                <cbc:CalculationExpressionCode listName="usage">used</cbc:CalculationExpressionCode>
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      <cbc:FundingProgramCode listName="eu-funded">no-eu-funds</cbc:FundingProgramCode>
      <cbc:MultipleTendersCode listName="permission">allowed</cbc:MultipleTendersCode>
      <cac:CallForTendersDocumentReference>
        <cbc:ID>Link to procurement documents</cbc:ID>
        <cbc:DocumentType>non-restricted-document</cbc:DocumentType>
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        <cac:SpecificTendererRequirement>
          <cbc:TendererRequirementTypeCode listName="reserved-procurement">none</cbc:TendererRequirementTypeCode>
        </cac:SpecificTendererRequirement>
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      <cbc:ID schemeName="InternalID">B</cbc:ID>
      <cbc:Name languageID="ENG">B. Somatic analysis</cbc:Name>
      <cbc:Description languageID="ENG">The software must be able to support analysis of SNVs, indels, copy number variations (CNVs), structural variations (SVs) and regions of loss of heterozygosity (LOH). Specifically for somatic analysis, requirements also include reporting of gene fusions, microsatellite instability (MSI), homologous recombination deficiency (HRD), and tumor mutation burden (TMB). Tests are based on analysis of nucleic acids (DNA and/or RNA) extracted from patient tissue or blood samples using next generation sequencing (NGS) on either Ion Torrent or Illumina sequencers as well as array CGH based data (ISCA v2 array, Agilent Technologies), where applicable.</cbc:Description>
      <cbc:ProcurementTypeCode listName="contract-nature">supplies</cbc:ProcurementTypeCode>
      <cbc:Note languageID="ENG">The Software Mandatory and Additional Requirements are to be found in Appendix 3. The tenderer must fill in the Prices (Appendix 2) for the somatic sub-section (B). </cbc:Note>
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        <cbc:ItemClassificationCode listName="cpv">33100000</cbc:ItemClassificationCode>
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          <cbc:Region>anyw-eea</cbc:Region>
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</ContractNotice>