Tenders Are Invited For Delivery Of Reagents For Analyzes In The Field Of Clinical Biochemistry And Immunochemistry, As Well As Auxiliary Materials And Equipment, Along With The Lease Of A System Consolidating These Tests For The Purposes Of Zdl

The Subject Of The Order Includes: A) Delivery Of Two Identical Analytical Systems (Analytical Platforms) On Which All Biochemical And Immunochemical Analyzes Listed In Annex 5 Will Be Performed. All System Elements Must Be Duplicated In Order To Secure The Continuity Of Laboratory Operation. Each Analytical Platform Must Enable Biochemical And Immunochemical Tests To Be Performed From One Sample, Administered From One Place, Without The Operator Having To Manually Transfer The Sample Between Modules. The Ordering Party Does Not Allow For The Possibility That Any Reagent, Calibrator, Working Solution, Replaceable Part, Etc. From One Apparatus Will Not Fit The Other (Twin) Working In Parallel. B) The Numbers Of Determinations Given In Annex 5 Do Not Include Quality Control Tests In The Necessary Quantities, And Tests For Necessary Calibrations Are Not Included Because They Are Related To A Specific Analytical System, Calibration Durability And Durability Of Reagents On Board The Apparatus And Must Be Reliably Calculated And Added By The Bidder. On The Cost Side, The Contractor Should Also Include The Cost Of Appropriate Small-Capacity System Vessels Necessary To Perform Calibration, Control And Pediatric Samples. The Number Of Small Vessels Dedicated To The System Should Be Estimated As 10% Of The Total Number Of All Analyses. C) The Contractor Should Attach A List And Costs Of Appropriate Proprietary Control Material To Conduct Internal Quality Control Of All The Determinations Listed In Annex 5. The Frequency And Number Of Levels Of Control Within The Laboratory Quality Control Are Given In Annex No. 6. D) The Technical And Functional Parameters Of The Analyzers, Equipment And Auxiliary Equipment As Well As Other Requirements Of The Ordering Party Are Described In Annexes No. 7 And 8 To The Swz. E) The Products Offered In The Procedure Must Be Approved For Use In The Territory Of The Republic Of Poland And Have Valid Documents Confirming Their Admission To Marketing In The Territory Of The Republic Of Poland In Accordance With The Act Of April 7, 2022 On Medical Devices And Implementing Acts To The Act, If Applicable. F) Other Requirements Regarding The Implementation Of The Order And The Principles Of Cooperation Between The Ordering Party And The Contractor Are Specified In The Draft Provisions Of The Public Procurement Contract, Constituting Annexes No. 3A And 3B To The Swz.