Notice of Intent to Sole Source Cost-Per-Result-Reportable Automated Hematology Analyzer System for Naval Medical Center Portsmouth

Justification and Approval (J&A) for Other than Full and Open Competition

This document provides the justification for a sole-source contract award for a CPRR Automated Hematology Analyzer System for the Defense Health Agency (DHA) at Naval Medical Center Portsmouth (NMCP). The requirement is for a follow-on contract for Sysmex America, Inc.

• One (1) Sysmex XN9100-202, RU-20, One (1) BT-50 terminal, Two (2) CellaVision DI-60 with Advanced RBC and Body Fluid Software Applications, & CellaVision Remote Review Software Teams Edition (5 concurrent licenses), Turn Unit (TU), and TS-10.

• The system includes testing agreement, equipment, reagents, maintenance, and consumables.

• The contract will be Firm Fixed Price.

• Base Period: July 1, 2026 - June 30, 2027

• Option Periods: Four (4) option periods through June 30, 2031.

• FAR 52.217-8 Option: July 1, 2031 - December 31, 2031.

• Estimated Total Value: $1,891,450.00

• Type of Funding: Operations & Maintenance (O&M)

• A Request for Information (RFI) was posted to SAM.gov on March 10, 2026, closing March 25, 2026.

• Only Sysmex America, Inc. responded and met the full requirement.

• Beckman Coulter, Inc. responded but did not meet all requirements and requested changes that were deemed essential by the end-user.

• A Notice of Intent to Sole Source will be posted on SAM.gov.

• This action is justified under FAR 8.405-6(a)(1)(B) as only one source is capable of providing the unique or highly specialized supplies or services required.

• The Sysmex XN-9100-202 is justified due to its superior diagnostic accuracy (fluorescent flow cytometry), automation capabilities, and ability to meet NMCP's specific clinical, staffing, and operational requirements without introducing unacceptable risk.

• Standardization with existing Sysmex platforms in the Core Laboratory and Donor Center is critical for mission support and operational continuity.

• Transitioning to a new vendor would require significant validation, installation, and accreditation efforts, exceeding the current limited staffing capacity and potentially leading to duplicative government spending.

Statement of Work (SOW)

To provide a complete Hematology Automation Line with Testing Agreement, including reagents, consumables, and maintenance support services for the Naval Medical Center Portsmouth (NMCP). The system must support advanced testing for high-acuity patient populations, including oncology and immunocompromised individuals.

• Lease and installation of a complete Hematology Automation Line.

• Provision of all personnel, equipment, supplies, and services necessary for installation, validation, and implementation.

• Supply of reagents, controls, consumables, and spare parts for user-level maintenance.

• Maintenance support services.

• Advanced software applications including RBC and Body Fluid Software Applications, and Differential Remote Review Software Teams Edition (5 concurrent licenses).

• The system must be FDA-approved and compliant with OSHA requirements.

• Analyzers must be compatible with HL7, TCP/IP, and MHS Genesis.

• Must provide a full CBC test panel using FDA-approved fluorescence flow cytometry methodology.

• Capable of analyzing RNA and DNA content for improved identification of abnormal cells (blasts, atypical lymphocytes, immature granulocytes).

• Automated reticulocyte count, nucleated RBC (NRBC) enumeration, Immature Granulocyte count, and Immature Platelet Fraction.

• Specific linearity ranges for WBC, platelet, Body Fluid WBC, and Body Fluid RBC.

• Throughput of at least 200 CBC specimens per hour.

• Integrated automated QC module.

• Reagents must have at least a six-month shelf life and be FDA-cleared.

• Quality control materials must have at least 80 days of lot stability.

• Middleware must support comprehensive rule creation, auto-validation, manual differential reporting, and integration with MHS Genesis.

• Period of Performance: June 1, 2026 – May 31, 2027, with four 1-year option periods and a potential 6-month extension.

• Place of Performance: Naval Medical Center Portsmouth, Virginia.

• Cost-Per-Reportable-Result (CPRR) agreement.

• Contractor personnel must comply with DBIDS requirements and wear identification badges.

• Adherence to IT and cybersecurity requirements, including RMF and B2B Gateway connectivity.

• Contractor must provide training for personnel.