The Municipality of Budapest, District XV, announces a public procurement procedure for the acquisition of laboratory reagents to be used at the Central Laboratory of Dr. László Vass Healthcare Institution, ensuring the possibility for partial bids, in 2 parts. The bidders are required to provide, install, train the staff, and maintain factory new, previously unused automated laboratory devices suitable for conducting tests during the contract period. The costs for the placement and operation of the devices (including maintenance, repairs, and training) must be included in the prices of the offered reagents and supplementary items. The bidders may not charge any additional costs or fees related to the devices. The contracting authority stipulates that the offered automated laboratory devices, as well as the proposed reagents and supplementary items, must come from the same manufacturer. An exception is made for control materials used for internal quality control, for which the contracting authority accepts control materials from manufacturers independent of the device manufacturer. The contracting authority will conclude a framework purchase contract for the procurement of laboratory reagents, for the total amount specified below by parts. Regarding the framework quantity, the contracting authority specifies the total framework quantity based on the annual and the number of tests during the entire contract period calculated from the placement and commissioning of the laboratory automata: 1st part: Immunochemical tests: 49,150 pcs/year, totaling 196,600 pcs/48 months 2nd part: Clinical chemical tests: 699,000 pcs/year, totaling 2,796,000 pcs/48 months The contracting authority commits to redeem 70% of the total framework quantity specified above throughout the entire contract period, starting from the placement and commissioning of the laboratory automata (hereinafter: Mandatory Utilizable Framework Quantity). The contracting authority is not obliged to redeem portions exceeding the Mandatory Utilizable Framework Quantity; however, it is entitled to do so at any time during the contract period. Bidders can submit a full offer for all tests specified in the respective part! Partial offers within the respective part are not allowed. If a bidder does not make an offer for any test within the respective part, it results in the invalidity of the offer for that part. Offers may also be made for both parts. Providing devices suitable for performing tests is mandatory. It is the bidder's responsibility to bear the costs of providing (placing) the devices, including training of laboratory staff, maintenance, and servicing of the devices, as detailed in the draft contract. A so-called “package offer” cannot be submitted by merging parts; the contracting authority will not accept offers that tie the offer for the respective part to any condition (package proposal). The contracting authority will provide the Technical documentation in the public procurement documentation (KD) regarding both parts. The Technical documentation includes the technical minimum requirements related to each device and reagent, the reagent price lists to be priced by the bidders, and the device specification data sheets. The contracting authority draws bidders' attention to the fact that the worksheets of the Technical documentation, which must be submitted as part of the offer (worksheets 5, 6, and 8), qualify as a professional offer according to § 37 of Art. 3 of the Kbt, and if these documents are not submitted, they cannot be supplemented in the context of the deficiency correction as per § 71 of the Kbt. The contracting authority provides the remedy for deficiencies in this document category according to point b) of § 71 (8) of the Kbt. Technical requirements concerning both parts: due to character restrictions see the column BT-728. Considering the provisions of § 46 (3) of Gov. Decree 321/2015. (X. 30.), the contracting authority points out that if a clear and intelligible definition of the subject of public procurement necessitated a reference to a specific brand, origin, type of object, process, activity, person, patent, or trademark, such a mention was only made for the purpose of clearly defining the nature of the object, and alongside the mention, “or equivalent” is to be understood in all cases. The contracting authority draws attention to the fact that in the case of offering an equivalent object, the equivalence must be proven by the bidder in their offer. Detailed information can be found in the section “Description of the Procurement” for the respective part and in the Technical documentation.
LOT-0001
EKR001323432025/1
Immunochemical tests.
Procurement of laboratory reagents for Immunochemical tests under a framework sales contract for 49,150 pcs test number/year, totaling a framework quantity of 196,600 pcs throughout the entire duration of the contract starting from the placement and commissioning of the laboratory automata. The contracting authority commits to redeem 70% of the total framework quantity specified above throughout the entire contract period (Mandatory Utilizable Framework Quantity: 137,620 pcs). The contracting authority is not obliged to redeem portions exceeding the Mandatory Utilizable Framework Quantity; however, it is entitled to do so at any time during the contract period. In the first part of the procedure, the following device must be supplied and put into operation: 1 piece, with a performance of at least 350 tests/hour, a fully automated random-access immunoassay analyzer, factory new, which has not been previously put into operation. It must simultaneously have a capacity for at least 30 reagents, with barcode sample identification and automatic reagent identification. The implementation of automatic reflex tests and a re-measurement function, along with continuous replenishment capabilities (for samples, reagents, consumables) is required. The contracting authority informs the bidders that due to the size and weight of the laboratory automata necessary for immunochemical tests, as well as the facility's characteristics in which the laboratory automaton must be installed, the contracting authority has prepared a structural expert opinion indicating that the weight of the laboratory automaton can be at most 384 kg/m2 in relation to m2 value. According to the structural expert opinion, the weight of the laboratory automaton can be maximum 405 kg/m2 provided that a load distribution plate (plastic-based coating for cleaning purposes) of 5 mm thickness and 10 cm width is installed. The winning bidder is obliged to ensure the load distribution plate, regarding which it is requested that the bidder declare this fact in their offer. Types of tests (for the annual framework quantity determined, see the Technical documentation 5. “Reagent price list” worksheet): - Determination of insulin (ultrasensitive) - Determination of intact parathyroid hormone - Determination of free T4 - Determination of free T3 - Determination of supersensitive Thyroid-Stimulating Hormone - Determination of Follicle Stimulating Hormone (FSH) - Determination of Luteinizing Hormone (LH) - Determination of Prolactin - Determination of estradiol (sensitive) - Determination of Human Chorionic Gonadotropin (total) in serum - Determination of progesterone - Determination of total testosterone - Determination of carcinoembryonic antigen (CEA) - Determination of CA 15-3 - Determination of CA 125 - Determination of CA 19-9 - Determination of folic acid - Determination of B12 vitamin - Determination of prostate-specific antigen (PSA) - Determination of free prostate-specific antigen (fPSA) - Determination of AFP - Determination of total 25(OH) D-vitamin. The bidder must offer the reagents necessary for the performance of the above tests in their offer, which must include: - the name and manufacturer of the proposed product (the contracting authority draws attention to the fact that the offered laboratory automated device(s) and the proposed reagents and supplementary items must come from the same manufacturer. Exceptions are control products used for internal quality control, for which the contracting authority accepts control items from manufacturers independent of the device manufacturer). - the offered quantity for the projected test number, the recommended packaging, and quantity unit, - the net unit price of the offered product and the VAT rate applicable to the product. The contracting authority emphasizes that the price of the offered reagents must include all costs, including the delivery to the site of the offered laboratory automata, their commissioning, and the training of the operating staff. The bidder must provide the laboratory automata at the performance site throughout the entire duration of the contract and maintain the installed device(s) in accordance with the manufacturer's specifications regarding quality and time intervals, as well as free-of-charge repairs of any failures and all necessary consumables and worn items used in repairs, including parts required for repairs regardless of cost. The bidder is responsible for work and transportation fees incurred concerning the above. The bidder must start the repair of the faulty device or water purification equipment within 24 hours from the contracting authority's notification and complete it as soon as possible. If the installed device or water purification equipment is not fully operational by the fifth business day following its malfunction, then the bidder must provide a replacement device/equipment equivalent to the faulty one free of charge on the fifth day. The reagents, tests, calibrators, controls, supplementary materials/equipment necessary for recalibrations after repairs resulting from the device(s)' outage or malfunction must be provided free of charge by the bidder. Detailed information can be found in the Technical Document table that is part of the Procurement Documentation and in the draft contract.
LOT-0002
EKR001323432025/2
Clinical chemical tests.
Under a framework purchase agreement, the procurement of laboratory reagents for clinical chemical investigations will be conducted, with an annual examination number of 699,000, which means a total framework quantity of 2,796,000 from the start of placement and commissioning of the laboratory automaton throughout the contract duration. The contracting authority commits to calling off 70% of the total framework quantity specified above (Mandatory Exhaustible Framework Quantity: 1,957,200 units) starting from the placement and commissioning of the laboratory automaton. The contracting authority is not obligated to call off any part beyond the Mandatory Exhaustible Framework Quantity; however, it retains the right to do so at any time during the contract's duration. In the second part of the subject procedure, the following device must be delivered and commissioned: 1 unit, a chemical automaton with a performance of at least 800 photometric tests/hour excluding electrolyte measurements, with a minimum hourly capacity for electrolytic (Na, K, Cl) tests being 50% of the capacity for chemical tests. The number of tests that can be measured simultaneously must be at least 60. It must have barcode sample identification and automatic reagent identification. It should also be suitable for measurements from small sample volumes. Continuous sample dispensing must be possible, and the reagents should be refillable in measurement mode. The contracting authority informs the bidders that, considering the size and weight of the laboratory automata required for clinical chemical investigations and the conditions of the room where the automatons are to be installed, a static expertise has been prepared indicating that the weight of the laboratory automaton may be a maximum of 384 kg/m2 relative to the m2 value. According to the static expertise, the maximum weight of the laboratory automaton may be 405 kg/m2 if a load distribution plate is installed with a coating layer of 5 mm thickness and 10 cm width (plastic-based painting for cleaning purposes). The load distribution plate must be provided by the winning bidder, and we request the bidder to declare the fact of this in their offer. Types of examinations (for the planned examination numbers defined in the annual framework quantity of 699,000, see the Technical documentation 5 'Reagent Price List' worksheet): - Total protein measurement in serum - Albumin measurement in serum, by dye binding method - C-reactive protein (CRP) quantitative measurement, immunoturbidimetric method with latex reagent - Urea measurement in serum - Uric acid measurement - Creatinine measurement by enzymatic method, from serum - Creatinine measurement from urine, by enzymatic method - Total bilirubin measurement in serum - Conjugated (direct) bilirubin measurement in serum - Glucose measurement by hexokinase method - Measurement of triglycerides - Measurement of total cholesterol - Measurement of HDL cholesterol by direct method - Measurement of sodium - Measurement of potassium - Measurement of total calcium - Measurement of phosphorus - Measurement of chloride - Measurement of magnesium - Measurement of total protein in urine - Albumin measurement by immunoturbidimetric method in urine (microalbumin) - Lactate dehydrogenase (LDH) measurement - Aspartate aminotransferase (ASAT, GOT) measurement - Alanine aminotransferase (ALAT, SGPT) measurement - Creatine kinase (CK) measurement - Gamma-glutamyl transferase measurement - Alpha-amylase measurement - Lipase measurement - Alkaline phosphatase measurement - Pseudocholinesterase measurement - Anti-streptolysin O titer quantitative measurement, immunoturbidimetric method with latex reagent - Rheumatoid factor quantitative measurement, immunoturbidimetric method with latex reagent - Iron binding capacity measurement - Iron measurement - Total transferrin measurement - Ferritin measurement - LIH reagent (qualitative determination of Lipemia-Jaundice-Hemolysis index) The bidder must propose the necessary reagents for the above examinations in their offer, including to specify: - the name and manufacturer of the proposed product (The contracting authority calls attention to the fact that the proposed laboratory automaton devices, as well as the proposed reagents and additional items, must come from the same manufacturer. Control preparations used for internal quality control are excluded, for which the contracting authority accepts control preparations from manufacturers independent of the device manufacturer). - the quantity proposed for the planned annual examination number, the recommended packaging and unit quantity, - the net unit price of the proposed product and the VAT rate applicable to the product. The contracting authority draws attention to the fact that the price of the proposed reagents must include all costs, including the delivery of the proposed laboratory automaton to the site, commissioning, and the training of operating personnel. The bidder must ensure the laboratory automaton at the performance site for the entire duration of the contract and must also provide maintenance of the installed device(s) according to factory specifications in terms of quality and time intervals, as well as repair of any malfunctions and all necessary consumables, regardless of cost limits, and must provide free of charge any parts used in necessary repairs. The bidder incurs all labor and transportation costs arising in connection with these issues. The bidder is obliged to start repairing the malfunctioning device or water purification apparatus within 24 hours from the notification by the contracting authority and to complete it as soon as possible. If the installed device or water purification apparatus is not completely operational by the fifth business day after its malfunction, then the bidder is obliged to provide a replacement device or equipment equivalent to the malfunctioning device free of charge by the fifth day. Continuation in the Additional information section (BT-300).