NOI SAM Posting JA Sysmex Hematology Analyzer RFO Part 6 and Class Deviation 2026-O0017 Redacted.pdf

Source Selection Information - See FAR 2.101 and 3.104-4

1 OCT 2024

Justification and Approval (J&A) for Other than Full and Open Competition Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) Parts 6 and 12

Implemented by Class Deviation 2026-O0017, Revision 1

1. Identification of the Agency and Contracting Activity:

Defense Health Agency (DHA), DHA Contracting Activity (DHACA), Healthcare Contracting Division (HCD) - Southeast

2. Nature and/or Description of Action being Approved:

This is a follow on Cost-Per-Result-Reportable (CPRR) contract for HT940625FE031. This CPRR Automated Hematology Analyzer System requirement is for One (1) 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 for the Laboratory Department at Naval Medical Center Portsmouth. The CPRR Automated Hematology Analyzer System includes testing agreement, equipment, reagents, maintenance, and consumables to meet the requirement.

This is a Firm Fixed Price and class J&A.

3. Description of Supplies/Services and Estimated Value:

This Sysmex America CPRR Automated Hematology Analyzer System requirement is for One

(1) 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 for the Laboratory Department at Naval Medical Center Portsmouth. The CPRR Automated Hematology Analyzer System includes testing agreement, equipment, reagents, maintenance, and consumables to meet the requirement.

Period Delivery Period Estimated Value Type of Funding Base Period 01 July 2026 - 30 June 2027 $343,900.00 O&M Option Period 1 01 July 2027 - 30 June 2028 $343,900.00 O&M Option Period 2 01 July 2028 - 30 June 2029 $343,900.00 O&M Option Period 3 01 July 2029 - 30 June 2030 $343,900.00 O&M Option Period 4 01 July 2030 - 30 June 2031 $343,900.00 O&M

FAR 52.217-8 01 July 2031 31 December

$171,950.00 O&M

Total $1,891,450.00

4. Statutory Authority Permitting Other Than Full and Open Competition:

OCT 2024

RFO 6.103-1(b) One responsible source. Agencies may contract without providing for full and open competition when the supplies or services required by the agency are available from only one responsible source and no other type of supplies or services will satisfy agency requirements.

5. Rationale Justifying Use of Authority Cited:

The Sysmex XN-9100-202 utilizes fluorescent flow cytometry, which analyzes RNA and DNA content and intracellular cellular structures rather than relying solely on impedance and light scatter. This technology provides superior differentiation of white blood cell populations and improves identification of immature and abnormal cells, including blasts, atypical lymphocytes, and immature granulocytes. These capabilities support higher flagging accuracy, reduced manual smear reviews, and earlier clinical decision-making, directly impacting patient care quality and safety. Critically, lower flagging sensitivity in competing impedance-based platforms can produce false-negative results for blast cells, variant lymphocytes, and other critical findings.

Failure to flag these cells at the instrument level means that pathologic findings may not be escalated for manual review, resulting in missed or delayed diagnoses at the onset of a disease risk is clinically unacceptable. The Sysmex fluorescent flow cytometry methodology minimizes this risk by providing enumerated Immature Granulocyte (IG) counts and Immature Platelet Fraction (IPF) on every sample, enabling early identification of hematopoietic abnormalities before they become clinically apparent through other means.

Another feature for only the Sysmex product, is the RU 20 reagent dilution unit that has reduced diluent changes, inventory and storage. The RU is unique to Sysmex and offered by no other vendor. These features not only reduce the manual workload on minimal undermanned laboratory staff and minimal storage area needed, but increases, accuracy, efficiency, and laboratory.

Given these clinical and operational imperatives, no other hematology vendor currently offers the same combination of diagnostic accuracy, workflow automation, data integration, and platform standardization. Therefore, acquiring Sysmex as a sole source is not only justified but to high-quality patient care.

6. Efforts to Obtain Competition:

A Request for Information (RFI) was posted to SAM.gov on 10Mar2026 and closed on 25Mar2026. Two vendors responded to RFI- Sysmex America, INC. (OTSB) and Beckman Coulter, INC. (OTSB).

Sysmex America could meet all the requirements on 24Mar2026.

Beckman Coulter responded that they could meet requirement on 24Mar2026, but did not go line for line on the Statement of Work (SOW) that they could meet the requirement or explain fully in their capability statement. On 25Mar2026, Contract Specialist (CS), Lisa Wilk, emailed Beckman Coulter and asked for clarification that they could meet specific requirements per the SOW. Beckman Coulter did not respond with their answers until 31Mar2026, which was after the closing date of the RFI. They stated that certain requirements were unduly restrictive and to be removed from the SOW.

When the CS spoke with the End User, they stated that these requirements were essential to their patients and the laboratory. And from there it was determined to be a Sole Source environment and the package was moved forward in the current direction.

After the approval of this J&A a Notice of Intent to Sole Source will be posted with this J&A included on SAM.gov.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition:

Contract Specialist posted a RFI on SAM.gov on 10Mar2026 with closing date 25Mar2026, only one vendor response was able to meet the full requirement for CPRR Automated Hematology Analyzer System.

FAR 8.405-6(a)(1)(B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

8. Market Research:

Market research was conducted by the End User to evaluate hematology analyzer platforms automation requirements, staffing limitations, physical space constraints, and accreditation obligations.

Vendors reviewed included Sysmex, Beckman Coulter, Siemens Healthineers, and Abbott Diagnostics. While multiple vendors offer FDA-cleared hematology analyzers, only the Sysmex XN-9100- cent flow cytometry-based normal and immature cell differentiation without introducing unacceptable operational, clinical, staffing, accreditation, and financial risk.

Vendor Platform Throughput

>200 samples p/h)

Advanced

CBC

Parameters

Automation /

LIS

Integration

Testing Methodology Alignment With

Lab Requirements

Sysmex XN-9100

Supports high-throughput testing suitable for peak workload demand.

(configuration-dependent)

100-300 samples/h

Broad set of FDA-cleared advanced CBC parameters

Supports automation and LIS integration

Fluorescent flow cytometry

Meets all of defined clinical and operational requirements

Beckman Coulter DxH 900

Supports moderate- to high-volume testing (configuration-dependent)

100-300 sample/h

FDA-cleared CBC and differential parameters

Supports automation and LIS integration

Enhanced Coulter Principle (impedance), VCS 360 with DataFusion

Meets many requirements; Does not fully align clinical parameter requirements

Siemens Healthineers

Atellica Hema 580

Up to 120 samples/h

FDA-cleared CBC and differential parameters

Supports automation and LIS integration

Impedance variation and fluorescence flow cytometry

Does not fully align with throughput and clinical parameter requirements

Abbott Diagnostics Alinty h)

119/hr for CBC + Differential

70/hr for CBC + Differential + Reticulocyte

FDA-cleared CBC and differential parameters

Supports automation and LIS integration

WBC and Differential Optical Scatter and Fluorescence

RBC Optical Scatter and Fluorescence

Platelet Optical Scatter

Reticulocytes Optical Scatter and Fluorescence

Does not fully align with throughput and clinical parameter requirements

Clinical Necessity and Technology Requirements

The Sysmex XN-9100-202 utilizes fluorescent flow cytometry, which analyzes RNA and DNA content and intracellular cellular structures rather than relying solely on impedance and light scatter. This technology provides superior differentiation of white blood cell populations and improves identification of immature and abnormal cells, including blasts, atypical lymphocytes, and immature granulocytes. These capabilities support higher flagging accuracy, reduced manual smear reviews, and earlier clinical decision-making, directly impacting patient care quality and safety. Critically, lower flagging sensitivity in competing impedance-based platforms can produce false-negative results for blast cells, variant lymphocytes, and other critical findings.

Failure to flag these cells at the instrument level means that pathologic findings may not be escalated for manual review, resulting in missed or delayed diagnoses at the onset of a disease unacceptable. The Sysmex fluorescent flow cytometry methodology minimizes this risk by providing enumerated Immature Granulocyte (IG) counts and Immature Platelet Fraction (IPF) on every sample, enabling early identification of hematopoietic abnormalities before they become clinically apparent through other means.

Impedance-based systems evaluated during market research do not provide equivalent diagnostic sensitivity or specificity and would increase reliance on manual differentials and technologist intervention. Under current staffing conditions, NMCP cannot support the additional workload associated with these systems. Fluorescent flow cytometry represents the current standard for high-complexity hematology testing and exceeds the clinical capabilities of alternative platforms.

workforce largely composed of junior Medical Laboratory Technicians who are not authorized to perform analyzer validation, system verification, or complex middleware configuration. Loss of the incumbent Sysmex platform would require extensive administrative and technical effort, including:

Full analyzer validation and method comparison studies

Development, review, and approval of new SOPs

LIS and middleware interface rebuilds

Comprehensive staff retraining across all shifts

Accreditation documentation updates

These activities cannot be absorbed by existing staff without diverting resources away from patient testing, resulting in delayed turnaround times, reduced throughput, and increased risk of error. Additionally, because of the limited time left on the current contract, any vendor other than Sysmex would go against the known urgent and compelling need that exists to continue full scale hematology services at NMCP without interruption, and following the otherwise procedures would result in unacceptable delays and additional cost to the Government.

The Sysmex XN-9100-202 mitigates these risks through automation and standardization, including:

BT-50 automation, which automates quality control, startup, shutdown, and routine maintenance, reducing manual handling and supporting regulatory compliance.

RU-20 concentrated diluent system, where one box of CellPack DST replaces approximately 25 boxes of standard diluent, significantly reducing reagent change frequency, storage requirements, waste volume, and staff ergonomic strain.

Standardized reagents, workflows, and QC across the XN platform, minimizing retraining needs and operational variability.

While Sysmex is the incumbent vendor, continuity is cited not as preference but as risk clinical, staffing, and operational requirements within the required timeframe.

Quantified Operational Impact: Labor Savings and Staffing Risk

NMCP-specific instrument utilization data confirms that the unique analytical capabilities of the Sysmex XN-9100 platform provide quantifiable and operationally significant labor savings that cannot be replicated by current competing platforms. Analysis of NMCP XN-9100-202 data from February 2026 (~1,986 CBC results) demonstrated the following:

Immature Granulocyte (IG) Enumeration: 108 additional smear reviews per week would be required without the Sysmex enumerated IG result. On competing platforms, IG is included in the neutrophil count rather than reported as a distinct parameter, artificially inflating the NEUT result and obscuring clinically significant findings. The IG parameter alone represents approximately 9 hours of additional manual labor per week if eliminated.

Fluorescent Platelet Count (PLT-F): 97 additional slide reviews per week would be required without the PLT-F reflex. Impedance-only platelet counting is susceptible to interference from RBC fragments, microcytic RBCs, and large platelets, producing falsely elevated or suppressed counts. Without PLT-F, Immature Platelet Fraction (IPF) would also be lost, potentially impacting platelet transfusion decision-making. This capability represents approximately 8 hours of additional manual labor per week if eliminated.

Automated Specimen Sorting and Archiving (TS10): Without automated sample sorting, all 1,986 specimens per week would require manual racking and sorting post-analysis, adding approximately 8 hours of manual labor per week at 15 seconds per sample.

In total, the combined loss of IG enumeration, PLT-F, and automated specimen sorting would add a minimum of 205 additional smear reviews and 25 additional hours of manual labor per week, equivalent to 0.63 additional FTE required annually. At a time when NMCP Core Laboratory is operating at approximately 50% staffing, of which 25% have less than 2 years of high complexity testing experience. This additional burden is operationally unsustainable and constitutes a direct threat to laboratory throughput, turnaround time, and patient care delivery.

Beyond the time cost, the loss of automated objective reporting introduces subjective, inexperienced technician variability that can affect result consistency and quality.

Additionally, the Sysmex RU-20 Reagent Concentration System reduces annual diluent consumption from 445 boxes to 7 boxes (a 98 percent reduction), recovering approximately 4.6 square feet of laboratory storage space, reducing ergonomic strain from reagent handling, and eliminating approximately 45 minutes of daily maintenance burden. The XN-Check QC material provides three levels of all-inclusive quality control with an 84-day lot expiration, compared to competing platforms requiring separate controls for reticulocyte with one-month lot expirations.

This longer lot stability reduces the frequency of lot-to-lot correlation studies and associated validation labor by more than half annually.

Total Laboratory Automation, Space Constraints, and Concurrent Chemistry Recompete

The hematology analyzer is part of an automated laboratory environment that shares physical space, infrastructure, and staffing resources with the chemistry automation line. The chemistry platform is currently in recompete and will require significant validation, installation, and accreditation effort from the same limited staffing pool.

The Sysmex XN-9100-202 is capable of direct into Total Laboratory Automation track systems, allowing automated sample transport, sorting, and routing without manual intervention. This integration supports priority handling, reduced hands-on time, improved turnaround time, and compatibility with post-analytical storage systems.

modification, and additional validation effort. Concurrent implementation of two new analyzer platforms would exceed available staffing capacity and significantly increase the likelihood of schedule delays, workflow disruption, and incomplete validation for one or both systems.

Financial Impact, Bridge Risk, and Cost Avoidance

-dated bridge contracts. Transitioning away from the incumbent Sysmex platform would likely require an additional bridge contract to maintain uninterrupted testing while validation and installation activities are completed.

Based on budgetary analysis, bridging again to meet validation and installation requirements would result in duplicative Government spending, consisting of the cost of the hematology analyzer acquisition plus the cost of an additional bridge contract, estimated at $238,287.04. This outcome would result in the Government paying twice to meet the same requirement solely due to avoidable transition delays.

Sole-source award to Sysmex avoids this duplication of cost while providing predictable, fixed pricing that includes equipment, service, reagents, quality control, calibration, installation, and implementation, supporting fiscal responsibility and operational stability.

Standardization and Mission Redundancy

The NMCP Donor Center currently operates a Sysmex XN-1000 Blood Bank (BB) analyzer.

Standardization of the Sysmex platform across both the Core Laboratory and the Donor Center is critical for mission support and operational continuity. Shared platform technology enables cross-utilization of reagents and quality control materials between sections, reducing inventory complexity, minimizing waste, and ensuring reagent availability during supply disruptions.

Standardized methodology across analyzer models also ensures result comparability between the Core Lab and Donor Center, which is essential for blood bank pre-transfusion testing and donor eligibility determination. In the event of an instrument outage in either section, shared platform training and identical operating procedures allow staff to cross-cover across departments without additional retraining. Award to any other vendor would eliminate this operational redundancy, requiring dual inventory management, separate QC programs, and incompatible SOPs creating additional workload and regulatory risk for the same understaffed laboratory workforce.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No

(2) If 9.a.(1) is No, was the action just prior to this one competed? No

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? Not applicable.

b. Additional Information: N/A.

10. Interested Sources:

Sysmex America, INC.- Can meet all of the requirement.

Beckman Coulter, INC. Cannot meet all of the requirement.

- Beckman Coulter, INC. cannot meet the following requirements:

o Must provide a full CBC test panel using an FDA-approved fluorescence flow cytometry methodology. This CBC panel will include White Blood Cell (WBC) count, Red Blood Cell (RBC) count, RBC indices (measured or calculated), platelet count, and six-part WBC differential.

o Must utilize fluorescent flow cytometry to analyze RNA and DNA content and intracellular cellular structures to provide differentiation of white blood cell populations and improved identification of immature and abnormal cells, including blasts, atypical lymphocytes, and immature granulocytes. In addition, will provide an automated reticulocyte count, nucleated RBC (NRBC) enumeration, Immature Granulocytes, IG Absolute count, nRBC Absolute count, and Immature Platelet Fraction.

o Must be able to identify Immature Granulocytes (IG) per CBC differential analysis. The system must provide an enumerated IG count (IG% and IG#) as a distinct reportable parameter on every CBC differential. If unmet, IG cells are absorbed into the neutrophil count on competing platforms, masking clinically significant left shifts and delaying detection of disease progression, early sepsis, and hematopoietic malignancy in NMCP's oncology population o Must achieve HCT linearity (Analytical Measurement Range) of 0.0 75.0% and a Reportable Range (Limit of Quantitation) of 0.1 75.0%. The system must directly measure HCT rather than calculate it from indices. A calculated HCT is subject to compounded error in the presence of cold agglutinins, abnormal morphology, or lipemia, compromising transfusion triggering decisions for both severely anemic and neonatal patients at NMCP.

o Must have the ability to identify Immature Platelet Fraction (IPF) and provide fluorescent platelet count for low platelet counts. The system must provide a secondary fluorescent platelet methodology (PLT-F) and report IPF as a distinct parameter. Absence of this capability produces falsely elevated or suppressed counts in the presence of RBC fragments or giant platelets, risking inappropriate transfusion decisions and removing a key marker used to differentiate hypoproductive from destructive cell states.

o Must achieve PLT linearity of 0 5000 x 10³/µL and Reportable Range (LoQ) of 2 5000 x 10³/µL. A system that cannot report across this full range requires manual dilutions at both extremes, adding turnaround time and error risk. Most critically, the inability to accurately enumerate counts as low as 2 x 10³/µL directly compromises transfusion threshold decisions in severely thrombocytopenic patients, risking life-threatening bleeding from undertransfusion or unnecessary blood product utilization from overtransfusion.

11. Technical and Requirements Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

LT Justin Washington Acting Lab Manager Naval Medical Center Portsmouth

12. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

Associate General Counsel Defense Health Agency- Office of General Counsel

14. Contracting Officer Determination of Fair and Reasonable Pricing and Certification of Accuracy and Completion.

Fair and Reasonable Cost and Basis for Determination:

The Contract Specialist was able to use historical information collected from HT940625FE031 to

John Summers dated 08/31/2025 for the same equipment in an Automated Hematology System to another facility.

This invoiced system has a fixed monthly cost of $24,047.90. And per John Summers an annual volume of 121,910 CBC & Retic tests.

121,910 / 12 months = 10,159.16 = 10,160 tests per month.

$24,047.90 / 10,160 = $2.36 cost per test.

The Sysmex Automated Hematology Analyzer System quoted to NMCP has an annual cost of $343,900.00 for 190,000 CBCs.

$343,900 / 190,000 = $1.81 cost per test

$2.36 (invoiced to another facility) - $1.81 (quoted for NMCP) = $0.55 less for NMCP.

I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable and that follow on should be awarded to Sysmex America, INC..

Contracting Officer Certification:

I certify this justification is accurate and complete to the best of my knowledge and belief.

Carol Uebelacker Contracting Officer Defense Health Agency Contracting Activity