Attachment 1 Requirement Specifications.docx

FA301022R0038

Attachment 1 – Requirement Specifications Dated: 23 June, 2022

REQUIREMENT: CHEMISTRY AND SPECIAL CHEMISTRY TESTING, KEESLER AFB, MS

Contractor shall provide chemistry analyzers, special chemistry analyzers and automated specimen track system including use of all equipment, services, supplies and reagents needed to perform automated specimen processing that will consolidate and integrate approximately 550,000 reportable patient tests per base contract year in chemistry, immunology, Hemoglobin A1C and immunoassay special chemistry. All analyzers, automated specimen track system and bidirectional contractor supplied computer interface must have ability to connect to Composite Health Care System and Cerner Genesis Lab Information System. Training will be provided with purchase. Tests billed by monthly invoice and payments will be provided in 12 installments per year. Cost-Per-Reportable-Result pricing is billed per patient result calculated from Keesler Air Force Base Medical Center Laboratory Information system and submitted to the contractor at the beginning of the following month. Analyzers must be in place and ready to use on or before 1 January 2023. No actual patient testing will be performed prior to 1 January 2023. Please include price breakdown and any applicable fees. Performance period is 1 January 2023 - 31 December 2027.

Contractor shall complete delivery, installation and validation studies of the chemistry analyzers, special chemistry analyzers and bidirectional contractor supplied computer interface prior to the current contract end date of 31 December 2022. Contractor shall complete delivery, installation and validation studies of the automated specimen track system within 6 month from the award of the contract.

1. The following shall be included in the Cost-Per-Reportable-Result pricing:

1.1. All Consumables, parts and accessories needed by the analyzers to function and process all patient testing.

1.2. All calibrators, calibration verification materials and quality control materials, contractor supplied quality controls, consumables, and accessories should meet the College of American Pathologist (CAP) requirements.

1.2.1. In the event a method does not have multipoint calibrations that span the full method range meeting College of American Pathologist requirements, Contractor shall supply calibration verification materials at no additional charge.

1.3. Parts used to complete instrument repairs in accordance within manufacturer recommendations supplied at no additional charge.

1.4. Installation of Bio Rad Unity Real Time (or equivalent) quality control software and annual subscriptions. Equivalent quality control software programs must meet or exceed Bio-Rad Unity Real Time capabilities.

1.5. Usage of two clinical chemistry analyzers, two immunoassay chemistry analyzers, and one automated track system with specimen storage module.

1.6. Usage of one middleware system with 4 additional computers with points of access to the middleware network.

1.7. Usage of all computer components, printers (or the ability to connect to existing printers) and accessories needed to operate instruments, middleware and track system.

1.8. Must have middleware network that includes:

1.8.1. Specimen storage and retrieval.

1.8.2. Moving averages of patient data to monitor shifts in instrument performance and assay performance.

1.8.3. Bi-directional communication to fully utilize the capabilities of Bio-Rad Unity Real Time or equivalent Quality Control software.

1.8.4. Turnkey custom rules build, auto validations, calculations, normal ranges, critical ranges, and delta checks will be programmed and installed by the contractor.

1.8.5. A real-time dashboard system that allows monitoring of all laboratory instruments and automation systems.

1.8.6. As needed Middleware and software service. IT specialist will be dispatched to Customer location to perform on-site service. Coverage includes IT specialist’s labor, per-diem and travel.

1.8.7. Reagent Inventory control software system.

1.8.8. Dual Lab information system connections/license provided. This will allow validation of Cerner Genesis Lab information system while continue use of Composite Health System (CHCS).

1.8.9. Turnkey middleware validation with Composite Health System (CHCS) Lab information system.

1.8.10. Turnkey middleware validation with Cerner Genesis Lab information system.

1.8.11. Live technical telephone support: 24-hour, 7-days/week including holidays.

1.8.12. A full service contract, to cover any service required on the middleware computer system, will be included in the cost.

1.9. Contractor provides routine shipping and handling of all reagents, calibrators, controls, parts, and supplies.

1.10. Contractor to provide analyzer training for 4 laboratory personnel off-site training (initial training in base period to be scheduled after award) with an annual off-site training for 2 laboratory personnel (annual training offered in each option period).

1.11. Contractor to provide middleware training for 2 laboratory personnel off-site training (initial training in base period to be scheduled after award) with an annual off-site training for 2 laboratory personnel (annual training offered in each option period).

1.12. Any modification needed to the facility must be provided with your proposal.

1.13. As needed, the Contractor provides the installation and continues service support for any air compressors, and deionized water systems.

1.14. Uninterruptible power supply (UPS) for each instrument, computer and equipment. Contractor must provide continued service support.

1.15. As needed, technical application specialist is dispatched to Customer location to perform on-site new method validations to include initial installation, updates to existing methods, addition of new methods and validation studies. Technical application specialist will provide service and training. Coverage includes Technical application specialist’s labor, per-diem and travel.

2. Chemistry /Special Chemistry analyzers shall meet the following minimum requirements:

2.1. Capable of processing the full chemistry and immunoassay test menu performed at Keesler AFB with all reagents needed to perform the total of all patient results specified for each fiscal year. In the event Contractor does not have a test in the menu, Contractor will provide an alternate method allowing Keesler AFB to perform testing in house.

2.2. Floor standing with Continuous Access of Reagents, Calibrators, Controls, and Consumables

2.3. Sample and Reagent bar-code reading capability.

2.4. On-board test auto inventory, automatic dilution of patient samples and user configurable automatic rerun/reflex.

2.5. Short Sample, Clot, and Bubble Detection.

2.6. Hemolysis, Lipemia and Icteria detection with no impact on sample throughput.

2.7. Ability to perform all tests in inventory.

2.7.1. In the event Contractor does not have a test in the menu, Contractor to provide an alternate method allowing Keesler AFB to perform testing in house.

2.8. Mirror image analyzer backup with capability of running the full test menu. For any test not available on the analyzer, Contractor shall supply alternate mirror image analyzers for tests awaiting Food and Drug Administration (FDA) clearance.

2.9. All analyzers must connect to automated track system.

2.10. 90% of reagents are liquid ready-to-use.

2.11. Reagents must meet susceptible to biotin interference threshold equal to or less than 10% deviation.

2.12. Allows for open channel testing with the ability to add third party reagents and have full tracking capability of those reagents.

2.12.1. Full tracking capability must include the ability to identify reagents loaded on one analyzers and share/load those reagents with other analyzers.

2.13. On Board Maintenance Records.

2.14. Quality Control, Linearity and Precision program that will meet College of American Pathologist (CAP) requirements.

2.15. An extensive Quality Control system which uses

2.15.1. Bar-code identification with the ability to use third party bar-coded control material.

2.15.2. Quality Control timeout.

2.15.3. Bio-Rad Unity Real Time or equivalent Quality Control program and annual subscription supplied. Equivalent Quality Control program must meet or exceed all Bio-Rad unity real-time capabilities. If proposing equivalent Quality Control program, must include detailed capability statement for Quality Control program.

2.15.4. Ability to setup, process and correlate multiple quality control lots simultaneously by having simultaneously lots on board the analyzer.

2.15.5. On board or access to a quality control statistical program to include Daily/monthly Levy-Jennings quality control graphs available for review and printing or saving to backup disks.

2.16. 90% of calibrators are liquid ready for use.

2.17. The ability to continually load and unload bar-coded calibrators at any time, store at least 50% of liquid calibrators in a refrigerated reagent compartment on the system, and automatically run liquid calibrators at user-defined intervals.

2.18. The ability to continually load and unload bar-coded liquid third party quality control material at any time, store at least 50% of liquid controls in a refrigerated reagent compartment on the system , and automatically run liquid controls at user-defined intervals.

2.19. Ability to program quality control ranges, calibration set points and system parameters without stopping or pausing the system.

2.20. Ability to continually load and unload supplies, reagents, and patient samples without stopping or pausing the system.

2.21. Load up to 150 samples and up to 65 clinical chemistry and 45 immunoassay reagents per module.

2.22. Ability to correlate reagent lot to lot runs by having simultaneous lots on board the analyzer.

2.23. Reagents must be designed to allow for error proof loading. Safety measures must be in place preventing capped reagent loading errors such as failure to remove cap causing probe crash.

2.24. Error free reagent loading where Bulk reagents are keyed and color coded for designated locations.

2.24. Must have acceptance by the Defense Health Agency for the ATO (Authority to Operate) on a Government network and must provide applicable eMass numbers.

2.25. Contractor must comply with Defense Health Agency (DHA) Cyber Logistics Cybersecurity/Risk Management Framework Requirements at Attachment 7.

2.26. Contractor to provide a project manager to perform/oversee system installation, correlation, and validation. Contractor also to provide all validation reagent/materials needed to perform these tasks.

3. The automated track system must have the ability to do the following:

3.1. Process multiple tube sizes.

3.2. Process multiple sample tube types from multiple tube suppliers. Tube types include lithium heparin tubes (Green Cap), serum tubes (Red or Gold Cap), urine tubes (White Cap), EDTA tubes (Purple Cap) and Oxalate tubes (Grey Cap).

3.3. Ability to identify sample tube type by tube cap color and analyze tube type for proper patient testing.

3.4. Connect and interface with all analyzers.

3.5. Continuous loop system with lane bypasses.

3.6. Front end processing to include sample priority sorting with a single input and output module and on-board decapping.

3.7. Priority centrifugation. A centrifuge must be located on the track system.

3.8. Automatic sample rerun and reflex.

3.9. On-board test auto inventory.

3.10. Back end processing to include

3.10.1. On-board recapping/sealing

3.10.2. On-board decapping/desealing.

3.11. Adequate number of trays to be used for archiving capabilities.

3.12. If training for the automated track system is separate from the analyzer training, contractor to provide initial track system training for 2 laboratory personnel and annual track system training for 1 laboratory personnel. Training may be conducted on-site or off-site and will be scheduled after award.