Salient Characteristicss Attachment I.pdf

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Blood Gas Analyzers for Department of Pathology, TAMC
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W81K0225QA058
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This document is a detailed Minimum Requirements specification for Blood Gas Analyzers (BGA) for the Department of Pathology at Tripler Army Medical Center in Hawaii. The requirements specify a comprehensive set of 34 technical and operational specifications for the blood gas analyzer, including critical features such as a full test menu capable of executing 19 different analytes in 120 seconds or less, using only 150 microliters of sample, with automated quality control, calibration, and maintenance. Key technical requirements include mobile capability (under 30 pounds), compatibility with MHS Genesis, 24/7 vendor support, integrated barcode reader, self-cleaning probe, waste collection system, and the ability to accept multiple sample types including arterial, venous, capillary, pleural fluid, and mix-venous specimens. The specification emphasizes automation, ease of use, comprehensive data management, and seamless integration with laboratory workflows and information systems.

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Minimum Requirements For Blood Gas Analyzers for Department of Pathology, Tripler Army Medical Center, Hawaii

Salient Characteristics:

1. The reagent test cartridge shall be compatible with its corresponding BGA and provide the following analytes in one full test menu that can be executed all at once: pH, pO2, pCO2, Na+, K+, ionized calcium, Cl-, glucose, lactate, hemoglobin, total hemoglobin, hematocrit, BUN, Creatinine, SO2, O2Hb, HHb, COHb, MetHb.

2. Test cartridges shall require no reagent preparation to test on the BGA. This requirement is also necessary for the BGA's corresponding calibrator.

3. The BGA test menus, while providing the full test menu (pH, pO2, pCO2, Na+, K+, ionized calcium, Cl-, glucose, lactate, hemoglobin, total hemoglobin, hematocrit, BUN, Creatinine, SO2, O2Hb, HHb, COHb, MetHb) shall be customizable.

4. The BGA shall have an on-board clot detector that detects clots before causing the instrument to become inoperable.

5. The BGA vendor shall provide technical and software support 24 hours 7 days a week including holidays and shall have on-island service support.

6. The BGA shall NOT require gas tanks and bottled reagents. Analyzer shall be mobile or considered benchtop. The total dimensions of the analyzer including any storage shall not exceed: Width – 2 feet, 2 feet, 3 feet.

7. The BGA shall have mobile capability, be lightweight (no more than 30 pounds) and fit securely, with its UPS (uninterrupted power supply) in a tip-proof cart.

8. The BGA shall have a complete data manager system capability to actively track number of patients tested, number of valid QC results, number of proficiencies and offline training for competencies evaluation.

9. The BGA shall have its own data management system or be compatible with a data management system that is compatible with MHS Genesis and can actively manipulate multiple instruments, monitoring real-time system status, and sequester statistical data from a centralized location.

10. The BGA shall have a centralized data manager workstation capable of allowing a supervisor or QA to manipulate all analyzers for user lockouts, alerts, maintenance, forcing QC and Calibration.

11. The BGA shall have configurable/customizable system alert screen that signals sample condition, device warnings, operator certification, etc.

12. The BGA shall have a large peer group comparison for CAP Survey material. CAP is the accrediting agency for the laboratory.

13. The BGA shall have an automatic onboard quality control and calibration. This shall be done automatically requiring no operator intervention.

14. The BGA shall require no reagent preparation, reagents and calibrators are ready to use.

Instrument shall have automated maintenance, calibrators, and QC that requires no or minimum tech’s hands-on, or vendor must perform quarterly maintenance.

15. The BGA shall be FDA approved and accept the following sample types: arterial, venous, capillary, pleural fluid, and mix-venous.

16. The BGA shall have the ability to test pH of pleural fluid.

17. The BGA shall possess an onboard event log. Analyzer shall have the ability to have built-in

QC and calibrators with auto QC and calibrators run.

18. The BGA shall be able to execute the full test menu (pH, pO2, pCO2, Na+, K+, ionized calcium, Cl-, glucose, lactate, hemoglobin, total hemoglobin, hematocrit, BUN, Creatinine, SO2, O2Hb, HHb, COHb, MetHb) in 120 seconds or less.

19. The BGA shall be able to execute the full test menu (pH, pO2, pCO2, Na+, K+, ionized calcium, Cl-, glucose, lactate, hemoglobin, total hemoglobin, hematocrit, BUN, Creatinine, SO2, O2Hb, HHb, COHb, MetHb) with a sample size no larger than 150 microliters.

20. The BGA shall be able to accept specimens from a capillary tube, test tube or syringe at a single port.

21. The BGA shall be able to stop or interrupt QC and calibration operations to allow testing of

STAT specimens.

22. The BGA shall have sample aspiration that is automated and consistent to eliminate variability in sample technique among operators.

23. The BGA shall have self-cleaning probe.

24. The BGA shall have a specimen identification with an integrated barcode reader that shall read current patient ID labels and have individual log in credentials.

25. The BGA shall have training and trouble-shooting modules on-board.

26. The BGA shall have the ability to physically print patient results with all required demographic data when connection to the Laboratory Information System in inoperable.

27. The BGA shall have the ability for the TAMC staff to limit operators to only those who have been trained.

28. The BGA shall have QC lockout ability, that is, if QC is not run or fails, the instrument will not test a patient specimen.

29. The BGA shall have a contained waste collection system in order reduce exposure to biohazards and a disposal mechanism that requires no more than a few minutes to complete.

30. The BGA shall provide associated calculated results automatically, in addition to measured results.

31. The BGA shall allow for entry of FiO2 and temperature and calculates corrected results for pH, pCO2 and pO2 automatically.

32. The Vendor shall be responsible for any IT related cost e.g. Authorization to Operate (ATO).

33. Installation validation shall be completed by the vendor according to College of American Pathologists standards. Validation shall include whole blood, and different body fluids.

34. Initial instrument training shall be provided by the vendor.

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