Hematology and Reagents

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

To provide the Fox Army Health Center (FAHC) at Redstone Arsenal, AL, with two separate analyzers, a Hematology Analyzer, reagents, consumables, and a digital cell morphology platform for remote pathologist review.

• Provide non-personal services for a Hematology Analyzer system.

• Furnish all equipment, reagents, consumables, and controls on a Cost-Per-Reportable basis.

• Include delivery, installation, calibrators/standards, reagents, and quality control materials.

• The system must perform Complete Blood Count (CBC) and automated differentials.

• Must include a digital cell morphology platform for remote pathologist review.

• The Hematology Analyzer must have a Five Part Differential capability.

• Secondary device must perform digital cell morphology and interface with the Hematology Analyzer.

• Installation requirements include existing space limitations and 115V dedicated power (max width 30 inches, max depth 30 inches).

• Method validation must be conducted per the Department of Pathology's Quality Management Program standards.

• Quality Control (QC) and Quality Assurance (QA) procedures must be developed and maintained.

• Contractor must develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services.

• Service reports must be provided upon completion of maintenance services.

• Routine preventive maintenance must achieve 95% performance.

• Technical phone support must achieve 95% performance.

• Parts and Kits must be provided at no additional cost to the Government.

• Software updates and upgrades must be provided at no additional cost.

• Service reports must be provided at the conclusion of each service.

• Invoicing and payments must be submitted via a 2-n-1 invoice to PIEE.

• Base year beginning 15 April 2026, with four option years.

• Place of Performance: Fox Army Health Center, Department of Pathology, 4100 Goss Rd SW, Redstone Arsenal, AL 35809.

• Contractor must provide 24/7 telephonic technical support with a maximum 1-hour call back response time and on-site service within 24 hours if required.

• Personnel must be trained to operate the analyzer.

• Key personnel include a Program/Contract Manager, Quality Control Manager, and Systems Administrator with specific qualifications.

• Contractor personnel require installation access and must comply with security regulations.

• Anti-Terrorism (AT) Level I Training, OPSEC Training, and iWATCH Training are required for contractor employees.

• Compliance with Privacy Act, HIPAA, and federal information laws is required.

• Data Rights: Government has unlimited rights to all documents and materials produced.

• Non-Disclosure Requirements apply to proprietary government or contractor data.

Solicitation

This solicitation, W81K0026QA0810001, is for the procurement of a Hematology Analyzer Cost per Reportable Result (CPRR) - FAHC. The acquisition includes the lease of one hematology analyzer and one digital cell morphology platform. The contract will cover all requirements listed in the Performance Work Statement (PWS), including equipment, reagents, consumables, controls, shipping, delivery, and maintenance.

• Lease of (1) Hematology Analyzer and (1) Digital Cell Morphology Platform.

• Furnishing of all equipment, reagents, consumables, and controls.

• Shipping, delivery, and maintenance of furnished equipment.

• Capability for the analyzer system to interface with the Military Health System (MHS) Genesis.

• Risk Management Framework (RMF) compliance with Defense Health Agency (DHA) cybersecurity requirements.

• Complete Blood Count (CBC) capability, including a comprehensive list of parameters (WBC, RBC, PLT, HGB, HCT, MCH, MCV, MCHC, MPV, RDW, Lymphocytes, Eosinophils, Basophils, Monocytes, Neutrophils, NRBC).

• Contract Type: Cost-Per-Reportable basis for CPRR, with Firm Fixed Price for certain components.

• Period of Performance: Not explicitly stated in the provided pages, but option line items suggest multi-year performance.

• Estimated Value: Not explicitly stated in the provided pages.

• Offer Due Date: 09 APR 2026, 12:00 PM Local Time.

• Questions Due Date: 25 FEB 2026, 12:00 PM Central Standard Time.

• Submission Method: Electronic via email to renee.n.combs.mil@health.mil and rashonda.n.jones.civ@health.mil. Files larger than 20MB must be sent in separate emails.

• Evaluation Factors: Lowest Price Technically Acceptable (LPTA) process, considering Technical Capability, Price, and Past Performance.

• This acquisition is UNRESTRICTED.

• NAICS Code: 325413

• Size Standard: Not specified.

• The solicitation incorporates FAR clauses by reference, including 52.212-1 (Instructions to Offerors) and 52.212-4 (Terms and Conditions).

• DFARS clauses are also incorporated by reference.

• A Performance Work Statement (PWS) dated 23 MAR 2026 is attached as an exhibit.

• Offerors must be registered in the System for Award Management (SAM).

Performance Work Statement (PWS)

To provide Fox Army Health Center (FAHC) at Redstone Arsenal, AL, with a Hematology Analyzer system, including reagents, consumables, and maintenance services, on a Cost-Per-Reportable Result (CPRR) basis. The goal is to upgrade the existing analyzer to sustain medical needs and provide high-quality healthcare.

• Non-personal services contract for a Hematology Analyzer with the capability to interface with a digital cell morphology platform for remote pathologist review.

• Contractor is responsible for providing all equipment, reagents, consumables, controls, and maintenance.

• Includes delivery, installation, calibrators, standards, reagents, and quality control materials.

• Requirement is for a base year (Jan 1, 2026 - Dec 31, 2026) with four option years.

• Analyzer Capabilities: Must perform Complete Blood Count (CBC) and automated differentials with a Five Part Differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils). Must have a WBC Analytical Measuring Range of 0.2 – 100 x 10³ with integrity check flags.

• Interface: Capability to interface with a digital cell morphology platform for remote pathologist review.

• Physical Requirements: Analyzer must fit within 30 inches width and 30 inches depth, requiring 115V dedicated power.

• Method Validation: Must conform to FAHC's Quality Management Program protocols, aligned with CLSI and CAP standards.

• Cost Structure: Cost-Per-Reportable Result (CPRR) basis.

• Support: 24/7 telephone technical support and on-site service within 24 hours when required. Technical assistance center staffed with English-fluent personnel.

• Training: Operator and key operator training required.

• Software: All software upgrades provided at no additional cost.

• Data Rights: Government has unlimited rights to all contract-produced materials.

• Security: Contractor personnel must comply with installation access requirements, including potential background checks and Common Access Card (CAC) issuance if duties require.

• Training: Anti-Terrorism (AT) Level I, OPSEC, and iWATCH training required for personnel requiring access to Army installations.

• Quality Control (QC) & Quality Assurance (QA): Contractor must develop and maintain QC/QA plans.

• Service Reports: Required upon completion of services, detailing malfunction, corrective action, time, labor costs, and parts.

• Parts: New or refurbished parts must meet OEM specifications and FDA recalls.

• Reagent Updates: Provided in writing within 5 business days.

• Recalls: Notify laboratory within 24 hours of manufacturer recalls.

• Response Times: Max 1-hour callback for telephone support; on-site service not to exceed 24 hours after determination.

• Base Year: January 1, 2026, or date of award, through December 31, 2026.

• Option Years: Four additional years.

• Place of Performance: Fox Army Health Center, Department of Pathology, 4100 Goss Rd SW, Redstone Arsenal, AL 35809.

• Key Personnel: Contract Manager, Alternate Contract Manager, Quality Control Manager, Systems Administrator required, with specific qualifications.

• Data Privacy: Compliance with Privacy Act, HIPAA, and DoD issuances regarding PII/PHI is mandatory.

• OCI: Contractor must address potential Organizational Conflict of Interest.

• Transition Plan: Required with quotation, detailing transition of testing materials, reagents, supplies, and training within 60 days of award.

References numerous CLSI standards for laboratory automation, testing, and data management.

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

To provide Fox Army Health Center (FAHC) at Redstone Arsenal, AL, with a Hematology Analyzer system capable of interfacing with a digital cell morphology platform for remote pathologist review of blood smears, reagents, and consumables.

• Furnish all equipment, reagents, consumables, and services for a Cost-Per-Reportable basis.

• Provide delivery, installation, calibrators/standards, reagents, and quality control materials.

• The system must perform Complete Blood Count (CBC) and automated differentials with digital cell morphology interface.

• The system must provide a Five Part Differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils) with specific reportable ranges and white cell viability indicators.

• Analyzer installation must conform to space limitations (30-inch width, 30-inch depth) and require 115V dedicated power.

• Method Validation must be conducted according to CLSI and/or CAP standards.

• Develop and maintain a Quality Control (QC) and Quality Assurance (QA) plan.

• Provide 24/7 telephonic technical support and in-house service (8x5) as needed.

• Ensure system compatibility with Cerner Millenium/Military Health System-Genesis (MHS-G) LIS.

• Provide a type-one reagent grade water system.

• Performance Requirements Summary (PRS) in Technical Exhibit A details acceptable quality levels (AQLs) for various objectives including preventive maintenance (95%), technical phone support (95%), parts and kits (95%), software updates (100%), service reports (98%), and invoicing (100%).

• Method validation accuracy for automated differentials must be no less than the current system's accuracy.

• Place of Performance: Fox Army Health Center, Department of Pathology, Redstone Arsenal, AL 35809.

• Period of Performance: Base year beginning April 1, 2026 (or date of award) through September 30, 2026, with four option years.

• Security: Personnel require installation access authorization and may be subject to security checks. Common Access Cards (CAC) may be issued based on duties. Background checks may be required.

• Training: Anti-Terrorism (AT) Level I, OPSEC, and iWATCH training are required for contractor employees.

• Key Personnel: Program/Contract Manager, Alternate Program/Contract Manager, Quality Control Manager, Systems Administrator, and Special Qualifications personnel are required, with specific qualifications and training.

• Data Rights: Government has unlimited rights to all documents and materials produced.

• Non-Disclosure: Contractor must protect proprietary and sensitive information.

• Organizational Conflict of Interest (OCI): Contractor must comply with OCI mitigation requirements.

• Breach Response: Procedures for handling PII/PHI breaches and cybersecurity incidents are detailed.

Solicitation / RFP / RFQ

This solicitation (W81K0026QA081) is for the procurement of Hematology Analyzer services, specifically a Cost-per-Reportable Result (CPRR) model. The services include the lease of hematology analyzers, furnishing of all associated equipment, reagents, consumables, controls, shipping, delivery, and maintenance. The acquisition also covers the provision of Complete Blood Count (CBC) tests and the capability for the analyzer system to interface with the Military Health System (MHS) Genesis.

• Lease of CPRR Hematology Analyzer(s).

• Provision of all necessary equipment, reagents, consumables, and controls.

• Shipping, delivery, and maintenance services for the equipment.

• Performance of Complete Blood Count (CBC) tests, including a comprehensive list of parameters.

• Capability for the analyzer system to interface with the MHS Genesis.

• Compliance with Defense Health Agency (DHA) Cybersecurity Risk Management Framework (RMF) requirements.

• Solicitation Number: W81K0026QA081

• Solicitation Issue Date: February 26, 2026

• Offer Due Date: March 5, 2026, 12:00 PM Central Standard Time.

• NAICS Code: 325413

• Contract type appears to be Firm Fixed Price for equipment and services, with a Cost-Per-Reportable basis for the CBC tests.

• Offerors must submit quotes via email to renee.n.combs.mil@health.mil and rashonda.n.jones.civ@health.mil.

• Quotes must be held firm for at least 90 days from the due date.

• Potential contractors must be registered in the System for Award Management (SAM).

• Evaluation will be based on the Lowest Price Technically Acceptable (LPTA) process, considering Technical Capability, Price, and Past Performance.

• Questions deadline: March 2, 2026, 12:00 PM CST.

• The acquisition is currently set as Unrestricted.

• The Performance Work Statement (PWS) contains detailed requirements.

• Several FAR and DFARS clauses are incorporated by reference and in full text, including those related to WAWF payment instructions, item unique identification, and hazardous material identification.

• The document includes multiple line items and option periods for the hematology analyzers and CBC tests.

Solicitation / RFP / RFQ

This document is a combined synopsis/solicitation for commercial items for the procurement of a Hematology Analyzer with Reagents. It is for full and open competition and constitutes the only solicitation for proposals; a separate written solicitation will not be issued.

• Procurement of Hematology Analyzer w/ Reagents.

• Quantities are detailed within the solicitation document.

• The contract will include a base period plus four (4) option years.

• Contract Type: Not explicitly stated, but implied to be a fixed-price contract for commercial items.

• Period of Performance: Base plus four option years.

• Estimated Value: Not stated.

• Proposal Submission Deadline: 12:00 PM CST on 5 March 2026.

• Proposals must be submitted via email to the points of contact listed.

• Evaluation Criteria: Offers will be evaluated as identified in FAR Clause 52.212-2.

• Questions Deadline: 12:00 PM CST on 2 March 2026, submitted via email.

• Full and open competition.

• NAICS Code: 325413

• Size Standard: 1,000 employees.

• Offerors must register with the Wide Area Workflow (WAWF).

• System For Award Management (SAM) registration is required.

• Offerors must include their Tax ID and CAGE Code.

• Offeror Representations and Certifications (FAR Clause 52.212-3) must be completed or referenced from SAM.

• Payment will be made via electronic funds transfer through DFAS.

• Invoices must be submitted electronically via WAWF.

• Points of Contact for submission and questions are MAJ Renee Combs and Ms. Rashonda Jones.