Corazon Locsin Montelibano Memorial Regional Hospital doh R6 Tender

Description Item Description Abc Unit Quantity 1 Hbs-ag (enhanced Chemiluminescence) 655,200.00 Test 3,600.00 2 Hcv (enhanced Chemiluminescence) 1,702,800.00 Test 3,600.00 3 Syphilis (enhanced Chemiluminescence) 475,200.00 Test 3,600.00 4 Hiv-ag/ab (enhanced Chemiluminescence) 990,000.00 Test 3,600.00 Department Of Pathology Technical Specifications And Conditions For The Procurement Of Reagents And Related Supplies For Automated Transfusion Transmissible Infection (tti) Testing By Enhanced Chemiluminescence Assay (eclia) (august 05, 2024) This Is Lot Bid The Supplier Awarded To Supply The Reagents Shall Adhere To The Technical Specifications And Conditions Stated Below: 1. Shall Provide For Free Latest Model Of Fully Automated Equipment Necessary For The Testing, Data Processing And Analysis, Generation Of Results, And Efficient System Operation With The Following Features: A. Batch And Random-access Analyzer Using Enhanced Chemiluminescence Assay As Test Methodology, Using Samples Such As: Serum, Plasma Or Whole Blood, Using Levy – Jennings, And Westgard Rules For Quality Controls; B. Quantitative Detection Of Transfusion Transmissible Infection (tti) Markers For Hepatitis B, Hiv, Hcv, And Syphilis (e.g. Hbsag, Hcv Antibody And Antigen, Hiv 1 And 2 Antibodies And P24 Antigen, And Anti-tp) In Serum Or Plasma Samples; C. Preferred Reagents Shall Have Specificity And Sensitivity Levels Of Not Less Than 99.5%. D. Must Be Capable Of Sample And Reagent Identification By Barcode Scanner E. All Assays Shall Have A Current And Valid Certificate Of Product Registration From The Food And Drug Administration (fda). F. All Assays Shall Have A Current Or Latest Proof Of Kit Evaluation From Std Aids Cooperative Central Laboratory (saccl) Or From The National Reference Laboratory For Transfusion Transmissible Infections (research Institute For Tropical Medicine); G. Uses E-connectivity Technology: H. Uses Single-use Tips And Single Use Cuvettes Or Microwells; I. Must Be Able To Detect For Clots, Bubbles And Short Samples; J. No Preparation, No Mixing Or Reconstitution Required For Reagents; K. On Board Stability Of Reagents Should Be Two Months Or More; L. No Manual Primes, Purges, Washes, Or Tubing Maintenance; M. No Water Or Drain Required And With Self-contained Onboard Waste Management; N. No Daily Calibrations Or Calibration Checks (stable Calibration For Up To 20 Days Or More) O. Capable Of Running Small Sample Volume (not More Than 100 Ul Per Assay) P. Dimension Of Analyzer Shall Fit In The Allotted Space In The Designated Area In The Blood Bank Section. 2. Shall Provide And Replenish Consumables Including Controls For Free; 3. Shall Assure Replacement Of Unused Reagents And Consumables (delivered Within Six Months Of Expiration Date) Before Expiration; 4. Shall Replace Reagents And Consumables With One-month Remaining Shelf Life Before The Expiration Date; 5. Shall Provide Free Transport, Installation (including Minor Civil Works) And Regular Maintenance And Calibration Of All Equipment And Replacement Of Parts Or Units Duly Coordinated With Concerned Laboratory Staff And Efm Personnel; 6. Supplier Shall Issue A Commitment Statement That It Shall Provide Free Training And Seminar And/or Re-training Of Laboratory Staff To Make Them Competent In The Use Of The Equipment; Shall Issue Certificates Of Training To The Personnel Concerned; 7. Shall Perform Verification/validation Of Equipment In Conjunction With Laboratory Staff, And Provision Of Free Reagents And Consumables For That Purpose; 8. Has The Capacity To Upgrade The Equipment Provided When Necessary Or When The Need Arises Upon Request By End User Without Additional Costs To Procured Reagents; 9. Shall Provide Connection For Laboratory Information System (lis) Of Choice Of End User And/or Hospital Information System (his) For Free 10. Analyzer And Accessory Equipment Must Be Brand New (equipment Not More Than Three Years Old Are Acceptable); 11. Shall Provide For Free Barcode Printer, Thermal Paper And Ink Including Maintenance And Replacement If Malfunctioning Or Depleted; 12. Shall Provide For Free Printer With Scanner, Paper And Ink Including Maintenance And Replacement If Malfunctioning Within Forty-eight Hours From Notice; 13. Shall Provide For Free Compatible Uninterruptible Power Supply (ups) And Automatic Voltage Regulator (avr) For The Analyzer As Well As Corresponding Computer Hardware And Software Integrated With The Analyzer; 14. Supplier Or Distributor Shall Be Responsible For Securing The Equipment And Its Accessories From Rodents And Other Pests And Shall Immediately Repair Or Replace The Equipment And Its Accessories Should Damage Occur Due To These Pests Within Forty-eight (48) Hours From Notice; 15. Shall Provide Free Regular Or Scheduled Preventive Maintenance Or Calibration And Asap Repair Or Replacement Of Parts Or Units Of The Equipment For Free Duly Coordinated With Concerned Laboratory Staff And Efm Personnel; 16. Shall Ensure Prompt Response By Designate Engineer/s For Correction Of Equipment Failure Or Malfunction; 17. Shall Provide A Back-up Machine For Free, Including Transportation And Installation, In Case Of Machine Breakdown Which Cannot Be Resolved Within 48 Hours From Notice; 18. Shall Shoulder The Cost Or Reimburse The Expenses For Examinations Sent Out Related To Equipment Failure Or Defects In The Reagents Or Consumables Which Cannot Be Resolved Within Forty-eight Hours From Notice; 19. Shall Replenish Consumed Reagents And Consumables Incidental To Repeated Test Runs Due To Equipment Failure Or Malfunction Including That Of The Ups And Avr, Defects In Reagent Or Consumables; Or Due To Trial Runs During Trainings Or Retraining; Or During Scheduled Preventive Maintenance Or Calibration Of Equipment; 20. Shall Provide Updated Material Safety Data Sheet (msds) For Chemical Reagents Upon Delivery Of The Item; 21. Manufacturing Or Reagents And Equipment Are Covered By Relevant Iso Certification Or Quality Certification Of Similar Nature. 22. Products Carried Are Covered By Current Certificate Of Product Registration Or In The Absence Of The Former, Proof Of Renewal Or Updated Certificate Of Exemption Issued By The Philippine Fda; 23. The Supplier Shall Have Installations Of The Same Equipment And Its Accessories And Using The Same Reagents In The Philippines. A Certification From At Least One Institution Having Such Installation Shall Be Provided. 24. The Supplier Shall Submit A Certificate Of Distributorship From The Principal Manufacturer Of The Equipment And Reagents; 25. Shall Allow Delivery On Staggered Or As Per Need Basis; 26. Supplier /distributor Is Preferably, But Not Necessarily, Iso 9001:2015 Certified; 27. Should There Be Persistence Of Erroneous, Invalid, Or Inconsistent Results That May Jeopardize The Safety Of The Patients Or The Quality Of Services Provided Despite Attempts To Repair, The Contract Shall Be Terminated At The Discretion Of The Department. The Supplier Shall Refund Whatever Is Paid Equivalent To The Value Of Unused Reagents Or Wasted Reagents Due To Repeat Analyses Or Repairs; Or If Not Yet Paid, Shall Not Be Paid For The Said Reagents. The Supplier Shall Be Compelled To Immediately Remove The Equipment From The Section; And 28. The Moa Shall Cover A Period Of Three (3) Months With Extended Use Of Machine For Free In Case Procured Reagents Are Not Consumed Within Three (3)months; And When Consumed But Contract Is Not Renewed Or Supplier Failed To Bid, The Department Has The Option To Compel The Supplier To Remove The Equipment And Its Accessories From The Section.