FY26 Hematology Analyzer Lease

Statement of Work (SOW) / Performance Work Statement (PWS)

To provide an equipment lease/service program for a hematology analyzer system at McConnell AFB Clinic to perform approximately 4,500 annual patient tests.

• Provide a new, FDA-approved hematology analyzer with an auto-loading feature.

• System must perform at least 75 complete blood counts (CBCs) with 5-part differential per hour.

• Analyzer must fit within an 18" by 26" countertop space.

• Capable of processing adult and pediatric micro-samples (requiring no more than 100 uL of whole blood).

• Utilize optical and/or laser technology for cell enumeration and differentiation (WBCs, RBCs, platelets).

• Measure and report RBC indices (hemoglobin, hematocrit, MCV, MCHC, MCH, RDW).

• Enumerate immature granulocytes and nucleated red blood cells (NRBCs), and flag variant lymphocytes, blast cells, platelet clumps, and giant platelets.

• Analyze WBCs up to 200K/uL with 97% precision and platelets up to 3000K/uL with 96% precision.

• Provide on-board tracking of reagents and controls, calibration material, and at least three levels of control material.

• Offer options for user-defined patient parameters.

• Offer items with an existing Authorization to Operate (ATO) or undergo the DoD Information Assurance (IA) approval process.

• Provide Safety Data Sheets (SDSs) and Instructions for Use (IFUs) for all required supply items.

• Provide all necessary materials, accessories, reagents, calibrators, and ancillary products on a cost-per-test or cost-per-reportable basis.

• Provide all software and hardware necessary to operate the analyzer and manage integrated software.

• Analyzer must meet specified precision levels for WBCs and platelets.

• Scheduled maintenance (PMs and calibrations) to be performed biannually with minimal disruption.

• Unscheduled maintenance response time within one business day if telephone support fails.

• Unscheduled downtime for non-preventative maintenance/repairs shall not exceed 3% of total operational time.

• Place of Performance: McConnell AFB Clinic, 57950 Leavenworth Ave, Wichita, Kansas, 67221.

• Maintenance services to be performed during normal duty hours (0730-1630, Monday-Friday), excluding federal holidays.

• Compliance with CLIA, OSHA, CDC, and FDA requirements.

• Provide scheduled preventative maintenance (PMs), calibrations, and on-site repair services.

• Provide telephone customer service for analytical equipment Monday-Friday, 0730-1630 CST (excluding federal holidays).

• Provide an Uninterrupted Power Supply (UPS) for the analyzer and supporting equipment.

• Installation support personnel to complete daily and final clean-up of the work area.

• Provide a dedicated representative for installation, set up, and method verification studies.

• Contractor personnel must have a designated point of contact available Monday-Friday, 7:30 AM-4:30 PM, excluding Federal Holidays.

• Provide on-site or off-site advanced operator training for government employees.

• Contractor representatives must possess a valid driver's license and comply with installation access provisions.

• Furnish all items needed to perform the contract, including supplies for correlation, precision, and linearity studies for approximately 10,500 reportable patient CBCs per year.

• All equipment, parts, materials, and services must conform to applicable safety standards (CFR, OSHA).

Statement of Work (SOW) / Performance Work Statement (PWS)

To provide and install equipment necessary for performing Hematology testing.

• Provide and install FDA-approved Hematology testing equipment.

• Equipment must be capable of bidirectional interface with existing LIS and CHCS.

• System must fit within an 18" by 26" countertop space.

• Provide one Uninterruptible Power Supply (UPS) unit.

• Instrument software must be Windows-based.

• Provide service and technical support during normal business hours (8:00 AM - 4:00 PM CST), with on-site service available within 24 hours of notification. Defective parts and software to be replaced at no charge.

• Provide semiannual and as-needed preventive maintenance, including instrument calibration.

• Provide software/hardware upgrades at no cost during the contract term.

• Provide off-site training for two key operators in the first contract year (including transportation, food, and lodging).

• Provide additional on-site training as necessary at no extra charge.

• Perform correlation, precision, linearity, and other installation studies, providing all necessary materials at vendor's expense.

• Instrument must have automatic reagent expiration date tracking and on-board user manuals.

• Instrument must use a single probe for automated and manual specimen sampling.

• Reagents and calibrators must be ready-to-use with 2D bar-coded labels.

• Analyzer must have a minimum throughput of 40 tests per hour.

• Analyzer must achieve a lower linearity down to 0 for WBC, RBC, and Platelet parameters.

• Analyzer must perform full hematology tests with as little as 25 µL of sample.

• On-board software must store 2 years of quality control data with Levey Jennings charts and include patient moving averages (Xbar).

• Analyzer must support the specified test menu without changes and be upgradeable for future needs.

• The bid must include cost per reportable pricing, covering equipment, service, reagents, quality control, training, and consumables.

• WBC, RBC Count, HGB, HCT, MCV, MCH, MCHC, PLATELET COUNT, RDW, MPV, NEUT%, LYMPH%, MONO%, EOS%, BASO%, NEUT#, LYMPH#, MONO#, EOS#, BASO#

Not specified in the document.

• FDA approval for equipment.
• Bid must include cost per reportable pricing.
• Upgradeable system for future testing needs.