PURCHASE OF SCREENING SETS FOR NEWBORNS FOR SEVERE CONGENITAL IMMUNE DEFICIENCIES AND SPINAL MUSCULAR ATROPHY (SCID/SMA)
1. Reagent kits for screening newborns for spinal muscular atrophy and congenital immune deficiencies, including SCID and hypogammaglobulinemia, for a total of 362,880 tests on microplates, each containing 96 wells. The kits are based on real-time quantitative PCR technology and allow for the simultaneous assessment of the presence of a homozygous deletion of exon 7 of the SMN1 gene and the quantitative evaluation of TREC and KREC molecule counts. The kits must include: appropriate controls and a set of samples to generate a curve for quantitative determination of TREC and KREC molecule counts; reagents and plates necessary for DNA isolation for testing purposes; reagents containing polymerase and oligonucleotides that allow the identification of exon 7 of the SMN1 gene, TREC and KREC, and a reference gene.
2. When selecting the most advantageous offer, the Ordering Party reserves the right to reduce the purchase of reagents by no more than 20% of the aforementioned subject of the order, in case the amount allocated for the execution of the order is exceeded or due to objective and justified circumstances, especially the anticipated reduction in the number of births and tests...
3. The Contractor is obliged to deliver kits packaged in groups of 96 tests or more - in multiples of 96 tests (1 plate).
4. In accordance with Article 257 of the Public Procurement Law (Pzp), the Ordering Party reserves the right to annul the public procurement procedure if the funds intended to finance all or part of the order are not granted.
5. The order must be executed in accordance with the requirements specified in this SWZ, the draft conditions of the contract, and the remaining procurement documentation.

LOT-0001
PURCHASE OF SCREENING SETS FOR NEWBORNS FOR SEVERE CONGENITAL IMMUNE DEFICIENCIES AND SPINAL MUSCULAR ATROPHY (SCID/SMA)
PURCHASE OF SCREENING SETS FOR NEWBORNS FOR SEVERE CONGENITAL IMMUNE DEFICIENCIES AND SPINAL MUSCULAR ATROPHY (SCID/SMA).
SUBJECT EVIDENCE:
1. Based on Articles 105 and 106 of the Pzp law, to confirm the compliance of the offered supplies with the requirements, features, or criteria specified in the description of the subject of the order or criteria for evaluating offers or requirements related to the implementation of the order, the Ordering Party requires Contractors to submit the following documents:
1.1. Declaration of conformity issued by the manufacturer of the product,
1.2. CE-IVD certificate/certificates from notified bodies that participated in the conformity assessment process - if applicable
1.3. Statement about the obligation to notify product information to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products under Article 58(1) or Article 58(2) of the Medical Devices Act of May 20, 2010 (Journal of Laws of 2021, item 1565, as amended), in connection with Article 138 of the Medical Devices Act of April 7, 2022 (Journal of Laws of 2022, item 974, as amended) and alternatively
a) if the bidder is a manufacturer based in Poland, submission of a statement confirming compliance with the notification obligation under Article 58(1) or Article 58(2) of the Medical Devices Act of May 20, 2010 (Journal of Laws of 2021, item 1565, as amended), in connection with Article 138 of the Medical Devices Act of April 7, 2022 (Journal of Laws of 2022, item 974, as amended);
b) if the bidder is an importer or distributor who introduces the product to the territory of Poland for the first time, submission of a statement confirming compliance with the obligation to notify under Article 58(3) of the Act along with a statement about whether such notification has been made or whether it will be made in accordance with the provisions of the Act, i.e. within 7 days from the date of the introduction of the first product into the territory of Poland;
c) if the bidder is a distributor or manufacturer not having a registered office in Poland, submission of a statement indicating the grounds for the absence of this obligation along with the source of purchase of the offered product - if applicable;
1.4. Document issued by the Institute of Mother and Child confirming that clinical tests of the offered order item have been conducted in Poland, establishing norms for the population based on a study of at least 1,000 newborns - tests were conducted on DNA samples isolated from blood collected on filter paper for screening tests (minimum of 1000 tests), among which there were at least 10% of samples from patients with a homozygous deletion of exon 7 of the SMN1 gene or samples for which the analysis performed using the PCR-HRM technique yielded an inconclusive result that needed verification by an alternative technique.
1.5. Statement from the Contractor about the filter paper used to create standards and controls for the test;
1.6. Statement from the Contractor regarding the availability of dedicated software prepared by the reagent manufacturer to facilitate the interpretation of analysis results (correctness of standard and control curves, automatic marking of samples with potentially positive test results)
1.7. Inclusion with the submitted offer of the complete instructions for the offered test, which includes the following information:
a. Composition of the test reagents, including a description of attached standards and controls as well as information regarding reagent storage,
b. List of materials necessary to perform the test that are not included in the kit,
c. Description of the DNA extraction procedure for the test,
d. Description of the diagnostic test procedure,
e. Description of result interpretation along with suggested cut-off points,
f. Discussion of the principles of operation of the diagnostic test.
- If the complete instructions for the offered test do not include the information specified in points 2.1.7 a)-f), the Contractor is required to present other informational materials from the manufacturer containing the required information.
2. The documents referred to above are submitted in the form of an original electronic document or a copy certified as true to the original by the Contractor using a qualified electronic signature.
3. According to Article 107(1) of the Pzp Act, the Contractor is required to submit the aforementioned subject evidence along with the offer and must ensure that these documents are complete and contain all necessary information to allow the Ordering Party to verify their correctness.
4. The documents mentioned above must have a validity period covering the entire duration of the order execution.
5. The documents referred to above are submitted in the manner prescribed by the regulations issued under Article 70 of the Pzp Act, i.e., in the Regulation of the Prime Minister of December 30, 2020, on the manner of preparing and transmitting information and technical requirements for electronic documents and means of electronic communication in public procurement proceedings or competitions.
6. According to Article 107(2) of the Pzp Act, the Ordering Party provides for the possibility of supplementing the subject evidence referred to in points 1.1., 1.2., 1.3., 1.4., 1.6., 1.7. once, within the time specified by the Ordering Party.
7. According to Article 107(3) of the Pzp Act, the Ordering Party does not anticipate the possibility to supplement the subject evidence mentioned in points 1.5., 1.6., as this subject evidence will serve to confirm compliance with the features or criteria specified in the evaluation criteria description.
8. Documents prepared in a foreign language must be submitted with a translation into Polish.