The subject of the contract is the supply of qualitative tests for testing blood-borne infectious markers, i.e. HBsAg tests together with confirmation tests, anti-HCV tests, HIV Ag / Ab tests and anti-Treponema pallidum tests together with the required consumables, calibrators, internal controls and external and lease of analyzers for testing with fully automatic immunochemical methods, necessary to perform tests for 220,000 donations, together with software for sending test results and the required instrumentation, as well as connecting to the Employer's IT system. Note: Currently, the IT system is provided by Asseco Poland SA.
A detailed description of the subject of the contract is set out in Annex 3 to the ToR.
The contracting authority requires a deposit of PLN 10,000.00 (say: ten thousand PLN 00/100).
A short opz is included in section II.1.4) The scope of the contract includes in particular:
1) Installation, commissioning of analyzers with software for sending test results and the required equipment;
2) Ensuring the correct operation of the devices that are the subject of the contract during the lease, through their servicing, periodic validation, technical inspections and repairs in the event of a failure.
3) Bidirectional data transmission from the offered analyzers to the IT system used by the Employer.
4) Staff training after installing and running the analyzers.
2. A detailed description of the subject of the contract is set out in Annex 3 to the ToR
1) In order to confirm that the offered deliveries meet the requirements specified by the Employer, the Contractor (whose offer will be rated the highest) is obliged to submit, at the request of the Employer, within a designated, not less than 10 days, date valid as at the date of submitting statements or documents regarding the offered analyzers , reagents, calibrators and controls, and if it concerns consumable and consumable materials, i.e.
a) Declaration by the manufacturer or authorized representative on compliance with the essential requirements by the offered medical devices together with the certificate of the notified body, in cooperation with which the conformity assessment procedure of the offered medical devices listed in art. 29 paragraph 5 of the Act of 20 May 2010 on medical devices (Journal of Laws of 2019, item 175, as amended), hereinafter in the Act on medical devices.
b) Notification of the product to the President of the Office for Registration of Medicinal Products for Medical Devices and Biocidal Products (hereinafter the President of URPLWMiPB) or notification to the President of URPLWMiPB about the introduction of the product on the territory of the Republic of Poland in accordance with art. 58 of the Act of 20 May 2010 on medical devices or other document confirming the fulfillment of the obligation arising from art. 58 of the Medical Devices Act. If the Contractor is not subject to the obligation to make a notification / notification (referred to in the previous task), the Contractor's statement containing the grounds for the absence of this obligation.
In order to confirm the absence of grounds for exclusion referred to in art. 24 paragraph 1 point 23 of the PPL, W, within 3 days of posting the information referred to in Art. 86 section 5, is obliged to provide Z with a statement on belonging or not belonging to the same capital group as referred to in art. 24 paragraph 1 point 23, in accordance with the formula state. Annex 2 to the ToR.
In case of belonging to the same capital group, W may submit a document. be info confirming that links with others do not lead to a distortion of competition in progress. each of the W submitting a joint bid submits the document.
Z provides for the possibility of using the "reversed procedure" in accordance with Article 24aa section 1 with Pzp.
The contracting authority provides for the possibility of awarding contracts referred to in art. 67 section 1 point 7 of the PPL Act consisting in increasing current deliveries by no more than 20% of the estimated value of the basic order. The contract will be awarded in a single source. The order will be implemented on terms similar to those specified in the contract concluded after the conduct of the said procedure after arrangements with the Contractor.