Contract amendment: adding a device to the contract regarding NIPT devices

HUS has competed NIPT devices (non-invesive prenatal testing) and there has been made a contract "Agreement between HUS and PerkinElmer Finland Oy on the procurement of diagnostic NIPT testing process equipment". It is necessary to amend the existing contract as follows: one (1) device will be added to the contract. Under section 136, subsection 2, paragraph 2 of the Act on Public Procurement and Concession Contracts, the contract and the framework agreement may be amended without a new procurement procedure if it is necessary for the original contractual partner to perform additional work, services or extraordinary deliveries of goods that were not included in the original agreement, and a change of contractual partner is not possible for financial or technical reasons and would cause significant inconvenience or a significant overlap of costs for the contracting entity. The value of the amendment shall not exceed 50% of the value of the original agreement (each amendment shall be assessed independently). The current contract covers three pieces of NIPT equipment and it is now necessary to add one (1) equivalent piece of equipment to the contract. A pilot study was carried out in early 2024 to pilot the use of the equipment in a method to screen pregnancies. However, using this method means an increase in the number of samples compared to the previous situation, therefore the examination that utilised the equipment was carried out as a follow-up examination to the previous screening method. Therefore, additional capacity is needed for the laboratory. The NIPT examinations carried out with the equipment are IVDR marked and equipment from another supplier cannot be used to increase the capacity. Therefore, it is not possible to change the contracting partner for technical reasons. In addition, it would not be possible to procure similar equipment from another supplier as parallel equipment, as this would result in significant overlapping costs in terms of acquisition, maintenance and facility costs. The original total value of the procurement HUS 701-2020 was EUR 6,580,000. Thus, the value of the contract change is EUR 233,000 (VAT 0%) which is approximately 3.5% of the value of the original contract.

The current contract covers three pieces of NIPT equipment and it is now necessary to add one (1) equivalent piece of equipment to the contract. A pilot study was carried out in early 2024 to pilot the use of the equipment in a method to screen pregnancies. However, using this method means an increase in the number of samples compared to the previous situation, therefore the examination that utilised the equipment was carried out as a follow-up examination to the previous screening method. Therefore, additional capacity is needed for the laboratory. The NIPT examinations carried out with the equipment are IVDR marked and equipment from another supplier cannot be used to increase the capacity. Therefore, it is not possible to change the contracting partner for technical reasons. In addition, it would not be possible to procure similar equipment from another supplier as parallel equipment, as this would result in significant overlapping costs in terms of acquisition, maintenance and facility costs.

Under section 136, subsection 2, paragraph 2 of the Act on Public Procurement and Concession Contracts, the contract and the framework agreement may be amended without a new procurement procedure if it is necessary for the original contractual partner to perform additional work, services or extraordinary deliveries of goods that were not included in the original agreement, and a change of contractual partner is not possible for financial or technical reasons and would cause significant inconvenience or a significant overlap of costs for the contracting entity. The value of the amendment shall not exceed 50% of the value of the original agreement (each amendment shall be assessed independently). The current contract covers three pieces of NIPT equipment and it is now necessary to add one (1) equivalent piece of equipment to the contract. A pilot study was carried out in early 2024 to pilot the use of the equipment in a method to screen pregnancies. However, using this method means an increase in the number of samples compared to the previous situation, therefore the examination that utilised the equipment was carried out as a follow-up examination to the previous screening method. Therefore, additional capacity is needed for the laboratory. The NIPT examinations carried out with the equipment are IVDR marked and equipment from another supplier cannot be used to increase the capacity. Therefore, it is not possible to change the contracting partner for technical reasons. In addition, it would not be possible to procure similar equipment from another supplier as parallel equipment, as this would result in significant overlapping costs in terms of acquisition, maintenance and facility costs. The original total value of the procurement HUS 701-2020 was EUR 6,580,000. Thus, the value of the contract change is EUR 233,000 (VAT 0%) which is approximately 3.5% of the value of the original contract.