4.1. The subject of the contract is the purchase and delivery to the Ordering Party's premises of blood collection and preparation kits as well as sets for hemapheresis procedures together with the lease of separators.
4.2. The Ordering Party has divided the subject of the contract into 6 parts, hereinafter referred to as packages. A detailed description of the subject of the contract was specified by the Contracting Authority in Annexes 2 – 2E to the SWZ.
4.3. The Ordering Party requires that the offered assortment has the required registration and current documents allowing for trading and use on the territory of the Republic of Poland in accordance with applicable law and the Contractor's qualification of the subject of the contract and European directives.
The order must be executed in accordance with the requirements set out in this CMS and with the Draft provisions of the contract.
Triple containers top-down with enrichment liquid (ADSOL or SAGM) – 135 000 pieces.Triple containers top-down with enrichment liquid (ADSOL or SAGM) – 135 000 pieces. A detailed description and quantities are contained in Annex 2 No SWZ.
Deliveries of the subject of the order will be carried out successively in quantities depending on the needs of the Ordering Party, at the expense and risk of the Contractor, its transport, within a maximum of 10 working days from the date of sending the order by e-mail. Working days should be understood as days from Monday to Friday, with the exception of public holidays.
The place of performance of the contract is the seat of the Ordering Party – Bydgoszcz, 8 Ks. Markwarta Street.
Measures of evidence in question
a) Description of the Subject of the contract – attachments No. 2-2E, depending on the Package for which the offer is submitted;
b) Proof of marketing in Polish, in accordance with the Act of 7 April 2022. on medical devices (Journal of Laws of 2022, item 974) and declarations of conformity in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
c) instructions for use in Polish, technical specification;
d) a certificate documenting compliance with the requirements of pharmacopoeial monographs – current edition – detailed description, the certificates must contain the numbers of the pharmacopoeial monographs to which they relate - Documents drawn up in a foreign language are submitted together with a translation into Polish, certified by the Contractor.
4.5. If the description of the subject of the contract has been described by indicating trademarks, patents or origin, source or a specific process that characterizes products or services provided by a specific contractor, the Ordering Party shall allow solutions equivalent to those described, and such indication shall be accompanied by the words "or equivalent". If the description of the subject of the contract refers to standards, technical assessments, technical specifications and technical reference systems referred to in Article 101 paragraph 1 point 2 and paragraph 3 of the Public Procurement Law, the Contracting Authority shall allow solutions equivalent to those described, and such reference shall be accompanied by the words "or equivalent".
If the description of the subject of the contract indicates the above-mentioned terms, the Ordering Party informs that they have been provided only for the purpose of determining the required quality parameters, which should at least be met by the ordered products / services. Such parameters, guaranteed by specific manufacturers, will allow the Ordering Party to maintain the standards necessary to ensure the required quality of tests. The contracting authority, describing the subject of the contract by indicating trade names, at the same time allows all their market equivalents, not worse than those indicated in the SWZ.
The phrase "equivalent" means that the Ordering Party allows a product or service similar in terms of technical or quality parameters to the product or service provided by a specific contractor, which does not mean identity with the product or service indicated in the description of the subject of the contract, but having similar features and functional parameters. The use of equivalent products must not impair the quality of the results achieved or adversely affect the correct use or functioning of the product or service for its intended purpose.
If the Contractor proposes in the offer products/services equivalent in quality to the products/services indicated by the Contracting entity, the Contractor is obliged to demonstrate that the offered solutions meet the requirements specified by the Contracting entity to an equivalent degree. The Contractor shall be fully liable for damage caused to the equipment and devices operated by the Contracting entity, resulting from equivalent products delivered by the Contractor, and in particular for damage to the apparatus used for laboratory analyses and tests.
Details in SWZ
Quadruple containers up-down with enrichment liquid (ADSOL or SAGM) with a built-in filter for KKCz – 28 000 pieces;Quadruple containers up-down with enrichment liquid (ADSOL or SAGM) with a built-in filter for KKCz – 28 000 pieces; A detailed description and quantities are contained in Annex 2A No SWZ
Deliveries of the subject of the order will be carried out successively in quantities depending on the needs of the Ordering Party, at the expense and risk of the Contractor, its transport, within a maximum of 10 working days from the date of sending the order by e-mail. Working days should be understood as days from Monday to Friday, with the exception of public holidays.
The place of performance of the contract is the seat of the Ordering Party – Bydgoszcz, 8 Ks. Markwarta Street.
Measures of evidence in question
a) Description of the Subject of the contract – attachments No. 2A
b) Proof of marketing in Polish, in accordance with the Act of 7 April 2022. on medical devices (Journal of Laws of 2022, item 974) and declarations of conformity in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
c) instructions for use in Polish, technical specification;
d) a certificate documenting compliance with the requirements of pharmacopoeial monographs – current edition – detailed description, the certificates must contain the numbers of the pharmacopoeial monographs to which they relate - Documents drawn up in a foreign language are submitted together with a translation into Polish, certified by the Contractor.
4.5. If the description of the subject of the contract has been described by indicating trademarks, patents or origin, source or a specific process that characterizes products or services provided by a specific contractor, the Ordering Party shall allow solutions equivalent to those described, and such indication shall be accompanied by the words "or equivalent". If the description of the subject of the contract refers to standards, technical assessments, technical specifications and technical reference systems referred to in Article 101 paragraph 1 point 2 and paragraph 3 of the Public Procurement Law, the Contracting Authority shall allow solutions equivalent to those described, and such reference shall be accompanied by the words "or equivalent".
If the description of the subject of the contract indicates the above-mentioned terms, the Ordering Party informs that they have been provided only for the purpose of determining the required quality parameters, which should at least be met by the ordered products / services. Such parameters, guaranteed by specific manufacturers, will allow the Ordering Party to maintain the standards necessary to ensure the required quality of tests. The contracting authority, describing the subject of the contract by indicating trade names, at the same time allows all their market equivalents, not worse than those indicated in the SWZ.
The phrase "equivalent" means that the Ordering Party allows a product or service similar in terms of technical or quality parameters to the product or service provided by a specific contractor, which does not mean identity with the product or service indicated in the description of the subject of the contract, but having similar features and functional parameters. The use of equivalent products must not impair the quality of the results achieved or adversely affect the correct use or functioning of the product or service for its intended purpose.
If the Contractor proposes in the offer products/services equivalent in quality to the products/services indicated by the Contracting entity, the Contractor is obliged to demonstrate that the offered solutions meet the requirements specified by the Contracting entity to an equivalent degree. The Contractor shall be fully liable for damage caused to the equipment and devices operated by the Contracting entity, resulting from equivalent products delivered by the Contractor, and in particular for damage to the apparatus used for laboratory analyses and tests.
Details in SWZ
Set of transfer containers 4 x 150 ml; empty transfer containers for storing KKCz and plasma with a capacity of 300ml; empty transfer containers for storing KKCz and plasma with a capacity of 600mlTransfer containers:
Set of transfer containers 4 x 150 ml in each set – 1000 sets
Transfer containers empty for storing KKCz and plasma with a capacity of 300ml - 24000pcs
Transfer containers empty for storing KKCz and plasma with a capacity of 600ml – 1000 pieces
A detailed description and quantities are contained in Annex 2B No SWZ
Deliveries of the subject of the order will be carried out successively in quantities depending on the needs of the Ordering Party, at the expense and risk of the Contractor, its transport, within a maximum of 10 working days from the date of sending the order by e-mail. Working days should be understood as days from Monday to Friday, with the exception of public holidays.
The place of performance of the contract is the seat of the Ordering Party – Bydgoszcz, 8 Ks. Markwarta Street.
Measures of evidence in question
a) Description of the Subject of the Order – attachments No. 2B
b) Proof of marketing in Polish, in accordance with the Act of 7 April 2022. on medical devices (Journal of Laws of 2022, item 974) and declarations of conformity in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
c) instructions for use in Polish, technical specification;
d) a certificate documenting compliance with the requirements of pharmacopoeial monographs – current edition – detailed description, the certificates must contain the numbers of the pharmacopoeial monographs to which they relate - Documents drawn up in a foreign language are submitted together with a translation into Polish, certified by the Contractor.
4.5. If the description of the subject of the contract has been described by indicating trademarks, patents or origin, source or a specific process that characterizes products or services provided by a specific contractor, the Ordering Party shall allow solutions equivalent to those described, and such indication shall be accompanied by the words "or equivalent". If the description of the subject of the contract refers to standards, technical assessments, technical specifications and technical reference systems referred to in Article 101 paragraph 1 point 2 and paragraph 3 of the Public Procurement Law, the Contracting Authority shall allow solutions equivalent to those described, and such reference shall be accompanied by the words "or equivalent".
If the description of the subject of the contract indicates the above-mentioned terms, the Ordering Party informs that they have been provided only for the purpose of determining the required quality parameters, which should at least be met by the ordered products / services. Such parameters, guaranteed by specific manufacturers, will allow the Ordering Party to maintain the standards necessary to ensure the required quality of tests. The contracting authority, describing the subject of the contract by indicating trade names, at the same time allows all their market equivalents, not worse than those indicated in the SWZ.
The phrase "equivalent" means that the Ordering Party allows a product or service similar in terms of technical or quality parameters to the product or service provided by a specific contractor, which does not mean identity with the product or service indicated in the description of the subject of the contract, but having similar features and functional parameters. The use of equivalent products must not impair the quality of the results achieved or adversely affect the correct use or functioning of the product or service for its intended purpose.
If the Contractor proposes in the offer products/services equivalent in quality to the products/services indicated by the Contracting entity, the Contractor is obliged to demonstrate that the offered solutions meet the requirements specified by the Contracting entity to an equivalent degree. The Contractor shall be fully liable for damage caused to the equipment and devices operated by the Contracting entity, resulting from equivalent products delivered by the Contractor, and in particular for damage to the apparatus used for laboratory analyses and tests.
Details in SWZ
Sets for plasma collection by automatic plasmapheresis with necessary accessories – dialysis needles and a 4% sodium citrate solution with the lease of 6 pieces of plasma separatorsSets for collecting plasma by automatic plasmapheresis in the amount of 24,000 pieces with the necessary accessories – dialysis needles in the amount of 24,000 pieces and a 4% sodium citrate solution in the amount of 24,000 pieces with the lease of 6 pieces of plasma separators. A detailed description and quantities can be found in Annex 2C No SWZ
Deliveries of the subject of the order will be carried out successively in quantities depending on the needs of the Ordering Party, at the expense and risk of the Contractor, its transport, within a maximum of 10 working days from the date of sending the order by e-mail. Working days should be understood as days from Monday to Friday, with the exception of public holidays.
The place of performance of the contract is the seat of the Ordering Party – Bydgoszcz, 8 Ks. Markwarta Street.
The place of delivery of equipment within the scope of Package IV will be:
• Regional Branch of RCKiK in Toruń, Gagarina 212-216; 87-100 Torun ( 2 pieces)
• RCKiK Regional Branch in Włocławek, Lunewil 15, 87-800 Włocławek (2 pieces).
• Regional Branch of RCKiK in Inowrocław, ul. Miechowicka 3, 88-100 Inowrocław (1 piece).
• Regional Branch of RCKiK in Brodnica, Wiejska 12B, 87-300 Brodnica (1 piece).
Measures of evidence in question
a) Description of the Subject of the Order – Annexes No. 2C
b) Proof of marketing in Polish, in accordance with the Act of 7 April 2022. on medical devices (Journal of Laws of 2022, item 974) and declarations of conformity in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
c) instructions for use in Polish, technical specification;
d) a certificate documenting compliance with the requirements of pharmacopoeial monographs – current edition – detailed description, the certificates must contain the numbers of the pharmacopoeial monographs to which they relate - Documents drawn up in a foreign language are submitted together with a translation into Polish, certified by the Contractor.
4.5. If the description of the subject of the contract has been described by indicating trademarks, patents or origin, source or a specific process that characterizes products or services provided by a specific contractor, the Ordering Party shall allow solutions equivalent to those described, and such indication shall be accompanied by the words "or equivalent". If the description of the subject of the contract refers to standards, technical assessments, technical specifications and technical reference systems referred to in Article 101 paragraph 1 point 2 and paragraph 3 of the Public Procurement Law, the Contracting Authority shall allow solutions equivalent to those described, and such reference shall be accompanied by the words "or equivalent".
If the description of the subject of the contract indicates the above-mentioned terms, the Ordering Party informs that they have been provided only for the purpose of determining the required quality parameters, which should at least be met by the ordered products / services. Such parameters, guaranteed by specific manufacturers, will allow the Ordering Party to maintain the standards necessary to ensure the required quality of tests. The contracting authority, describing the subject of the contract by indicating trade names, at the same time allows all their market equivalents, not worse than those indicated in the SWZ.
The phrase "equivalent" means that the Ordering Party allows a product or service similar in terms of technical or quality parameters to the product or service provided by a specific contractor, which does not mean identity with the product or service indicated in the description of the subject of the contract, but having similar features and functional parameters. The use of equivalent products must not impair the quality of the results achieved or adversely affect the correct use or functioning of the product or service for its intended purpose.
If the Contractor proposes in the offer products/services equivalent in quality to the products/services indicated by the Contracting entity, the Contractor is obliged to demonstrate that the offered solutions meet the requirements specified by the Contracting entity to an equivalent degree. Details of SWZ
UKKP collection kits by automatic thrombapheresis, sets for therapeutic plasma exchange, collection sets 2j. UKKCz with SAGM fluid for separators owned by the Ordering PartySets for collecting UKKP by automatic thrombapheresis in the amount of 1500 pieces,
sets for therapeutic plasma exchange in the amount of 150 pieces
collection sets 2j. UKKCz with SAGM liquid in the amount of 48 pieces
to MCS+ separators owned by the Ordering Party
A detailed description and quantities are contained in Annex 2D No SWZ
Deliveries of the subject of the order will be carried out successively in quantities depending on the needs of the Ordering Party, at the expense and risk of the Contractor, its transport, within a maximum of 10 working days from the date of sending the order by e-mail. Working days should be understood as days from Monday to Friday, with the exception of public holidays.
The place of performance of the contract is the seat of the Ordering Party – Bydgoszcz, 8 Ks. Markwarta Street.
Measures of evidence in question
a) Description of the Subject of the Order – attachments No. 2D
b) Proof of marketing in Polish, in accordance with the Act of 7 April 2022. on medical devices (Journal of Laws of 2022, item 974) and declarations of conformity in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
c) instructions for use in Polish, technical specification;
d) a certificate documenting compliance with the requirements of pharmacopoeial monographs – current edition – detailed description, the certificates must contain the numbers of the pharmacopoeial monographs to which they relate - Documents drawn up in a foreign language are submitted together with a translation into Polish, certified by the Contractor.
4.5. If the description of the subject of the contract has been described by indicating trademarks, patents or origin, source or a specific process that characterizes products or services provided by a specific contractor, the Ordering Party shall allow solutions equivalent to those described, and such indication shall be accompanied by the words "or equivalent". If the description of the subject of the contract refers to standards, technical assessments, technical specifications and technical reference systems referred to in Article 101 paragraph 1 point 2 and paragraph 3 of the Public Procurement Law, the Contracting Authority shall allow solutions equivalent to those described, and such reference shall be accompanied by the words "or equivalent".
If the description of the subject of the contract indicates the above-mentioned terms, the Ordering Party informs that they have been provided only for the purpose of determining the required quality parameters, which should at least be met by the ordered products / services. Such parameters, guaranteed by specific manufacturers, will allow the Ordering Party to maintain the standards necessary to ensure the required quality of tests. The contracting authority, describing the subject of the contract by indicating trade names, at the same time allows all their market equivalents, not worse than those indicated in the SWZ.
The phrase "equivalent" means that the Ordering Party allows a product or service similar in terms of technical or quality parameters to the product or service provided by a specific contractor, which does not mean identity with the product or service indicated in the description of the subject of the contract, but having similar features and functional parameters. The use of equivalent products must not impair the quality of the results achieved or adversely affect the correct use or functioning of the product or service for its intended purpose.
If the Contractor proposes in the offer products/services equivalent in quality to the products/services indicated by the Contracting entity, the Contractor is obliged to demonstrate that the offered solutions meet the requirements specified by the Contracting entity to an equivalent degree. The Contractor shall be fully liable for damage caused to the equipment and devices operated by the Contracting entity, resulting from equivalent products delivered by the Contractor, and in particular for damage to the apparatus used for laboratory analyses and tests.
Details in SWZ
Pob kits UKKP or UKKP in enrichment solution; Pob sets. end. granulocytic; vending machine sets. bone marrow cleaning;sets for pob. hematopoietic cells, ACD-A fluid;Collection kits for low-fat platelet cell concentrate (UKKP) or low-fat platelet cell concentrate (UKKP) in enrichment solution in the amount of 1000 pieces;
sets for collecting granulocytic concentrate with an adapter for anticoagulant in the amount of 60 pieces
sets for automatic bone marrow cleaning with accessories in the amount of 12 pieces for Spectra Optia separators owned by the customer;
kits for collecting hematopoietic cells from peripheral blood in the amount of 148 pieces;
ACD-A fluid used in all the above-mentioned procedures in the amount of 1220 pieces
lease of 2 cell separators;
A detailed description and quantities are contained in Annex 2E No SWZ
Deliveries of the subject of the order will be carried out successively in quantities depending on the needs of the Ordering Party, at the expense and risk of the Contractor, its transport, within a maximum of 10 working days from the date of sending the order by e-mail. Working days should be understood as days from Monday to Friday, with the exception of public holidays.
The place of performance of the contract is the seat of the Ordering Party – Bydgoszcz, 8 Ks. Markwarta Street.
Measures of evidence in question
a) Description of the Subject of the Order – Annexes No. 2E
b) Proof of marketing in Polish, in accordance with the Act of 7 April 2022. on medical devices (Journal of Laws of 2022, item 974) and declarations of conformity in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
c) instructions for use in Polish, technical specification;
d) a certificate documenting compliance with the requirements of pharmacopoeial monographs – current edition – detailed description, the certificates must contain the numbers of the pharmacopoeial monographs to which they relate - Documents drawn up in a foreign language are submitted together with a translation into Polish, certified by the Contractor.