TAB D Limited Sources Justification (LSJ) under FAR Part 8.405-6.pdf

CUI

Controlled by: Defense Health Agency (DHA) Controlled by: DHACA HCD-C CUI Category(ies): Source Selection Limited Dissemination Control: FED ONLY

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

Limited Sources Justification (LSJ) Federal Acquisition Regulation (FAR) Part 8.405-6

1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA), Healthcare Contracting Division-Central (HCD-C).

2. Nature and/or Description of Action being Approved: This is a request for a sole source to Sysmex Corporation. Subject to availability of funds, this requirement will purchased as a supply task order with an effective date of 1 October 2025.

3. Description of Supplies or Services and Estimated Value: The DHA requires the lease of the Sysmex Hematology Analyzers and all related and required maintenance and repair, supplies, and consumables for all machines at the 27th Special Operations Medical Group (SOMDG) at Cannon Air Force Base, 75th Medical Group (MDG) at Hill AFB, 10th Medical Group, at the US Air Force Academy (USAFA) and the 21st Medical Group at Peterson SFB. The vendor shall provide all required equipment, reagents, parts, control, and maintenance, and calibration materials required for the machine to perform full services. 75 MDG, 27 SOMDG, 21 MDG, and 10 MDG currently leases the Sysmex XN-Series Hematology Analyzers.

The XN-550 offers a six-part differential analysis that enables lab technicians to better identify immature blood cells. The clinical hematology analyzer is capable of performing patient-reportable immature granulocyte analysis as part of a six-part differential and utilizing fluorescent flow cytometry technology while sampling less than 26 uL of blood. The Sysmex XN-550 analyzer's dimensions and weight (17.72" W x 25.98" D x 17.72 H"/ 116.84 lbs).

Proposed Ordering Vehicle: FSS Contract Number V797D40235 Proposed Vendor: Sysmex America, Inc. 577 Aptakisic Road, Lincolnshire, IL Proposed Contract Type: Firm-Fixed Price Period of Performance: Six-month base period with four (4) one-year option periods

The estimated total contract value, including the 4 options is $589,633.20. The firm-fixed-price uses a fixed per month rate. The period of performance will be a six-month base period with four (4) one-year option. 75 MDG at Hill AFB will join the task order on option year one (1).

Source Selection Information - See FAR 2.101 and 3.104-4

Period CLIN Description Unit Unit Price QTY Total Price Base 0001 10 MDG USAFA Months $5,344.81 6 $32,068.86

Base 0002 21 MDG Peterson SFB Months $1,936.40 6 $11,618.40

Base 0004 27 SOMDG Cannon AFB Months $1,920.67 6 $11,524.02

Option 1 1001 10 MDG USAFA Months $5,344.81 12 $64,137.72

Option 1 1002 21 MDG Peterson SFB Months $1,936.40 12 $23,236.80

Option 1 1004 27 SOMDG Cannon AFB Months $1,920.67 12 $23,048.04

Option 1 1005 75 MDG Hill AFB Months $1,931.91 12 $23,182.92 Option 2 2001 10 MDG USAFA Months $5,344.81 12 $64,137.72

Option 2 2002 21 MDG Peterson SFB Months $1,936.40 12 $23,236.80

Option 2 2004 27 SOMDG Cannon AFB Months $1,920.67 12 $23,048.04

Option 2 2005 75 MDG Hill AFB Months $1,931.91 12 $23,182.92 Option 3 3001 10 MDG USAFA Months $5,344.81 12 $64,137.72

Option 3 3002 21 MDG Peterson SFB Months $1,936.40 12 $23,236.80

Option 3 3004 27 SOMDG Cannon AFB Months $1,920.67 12 $23,048.04

Option 3 3005 75 MDG Hill AFB Months $1,931.91 12 $23,182.92 Option 4 4001 10 MDG USAFA Months $5,344.81 12 $64,137.72

Option 4 4002 21 MDG Peterson SFB Months $1,936.40 12 $23,236.80

Option 4 4004 27 SOMDG Cannon AFB Months $1,920.67 12 $23,048.04

Option 4 4005 75 MDG Hill AFB Months $1,931.91 12 $23,182.92

Grand Total $589,633.20

4. Authority Cited: FAR 8.405-6(a)(1)(i)(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.

5. Rationale Justifying Use of Authority Cited: The Sysmex XN-550 Hematology Analyzer is the only analyzer that meets the 27 SOMDG, 75 MDG, 10 MDG and the 21 MDG mission and technical requirements. Sysmex is the only vendor that manufactures a clinical hematology analyzer capable of performing patient-reportable immature granulocyte analysis as part of a 6-part differential and utilizing fluorescent flow cytometry technology while sampling less than 26 uL of blood. These features provide the critical capability to detect and alert doctors of potential cancer cells, enabling the medical community to begin treatment immediately without purchasing an additional license or requiring additional reagents.

The XN-550 is also the only analyzer offering a six-part differential analysis that enables lab technicians to better identify immature blood cells. This function eliminates the cost and 5-10 day turnaround time associated with off-site pathologist review. This shortened turnaround time is required because this is a military clinic, where rapid medical clearances are essential for short-notice deployments of military personnel. Additionally, the Sysmex XN-550 analyzer's dimensions and weight (17.72" W x 25.98" D x 17.72 H"/ 116.84 lbs) allow it to fit within each lab's limited counter space.

The Sysmex XN-550 is an ATO approved hematology analyzer for the lab size, population, and workload. Sysmex is the only company that offers an FDA approved six-part differential, fully automated reticulocyte analysis, and reticulocyte hemoglobin measurement. The system uses state of the art technology, such as fluorescent flow cytometry for white blood cell (WBC), WBC differential, nucleated red blood cell (NRBC) detection, and reticulocyte identification and enumeration and state of the art reagent management technology, such as RFID, which is standard with the reagent system.

The requirement for a Complete Blood Count (CBC) analyzer at the 27 SOMDG, 75 MDG, 10MDG and the 21 MDG Laboratories necessitates the procurement of the Sysmex XN-550 due to its unique combination of essential features not available in other commercially available hematology analyzers. Market research, including queries of GSA Advanta.ge, a Sources Sought synopsis, internet searches, and review of product literature from manufacturers like Beckman Coulter, Mindray, and Dynacount supports this conclusion. Procuring the XN-550 enhances interoperability with key regional healthcare partners.

Specifically, the Sysmex XN-550 offers:

• Proprietary Reagent System and Unique Measurement Methods: The XN-550 utilizes unique hydrodynamic focusing (DC detection), flow cytometry, and SL-S Hemoglobin measurement methods, requiring proprietary reagents solely manufactured by Sysmex America Inc. No other manufacturer possesses proprietary data or specialized equipment to produce comparable reagents. This ensures consistent and reliable performance specifically optimized for the XN-550 system.

• Expanded Diagnostic Parameters: The XN-550 provides six-part differential analysis and is critical for assisting pathologists in determining the need for further testing, such as bone marrow analysis or flow cytometric, enabling early disease detection. With no pathologist on site, the ability to analyze immature blood cells can give local providers early indications of cancer and/or disease. This comprehensive analysis from a single platform streamlines workflow, reduces turnaround time for pathologist review, reduces blood draws for patients with potentially life-altering conditions, and reduces the need for additional, potentially more invasive, diagnostic procedures.

• Compact Footprint Essential for Lab Space Constraints: The XN-550's compact footprint (17.72" W X 25.98" DX 17.72 H"/ 116.84 lbs) is critical for placement within the limited space available in the 27 SOMDG, 75 MDG, 10MDG and the 21 MDG’s Laboratories. With this space already dedicated to the current analyzers, lengthy and expensive construction may be needed or a complete redesign of laboratories workflow to facilitate a different analyzer. No modification to the facility will be required for the XN- 550.

• Simplified Reagent Management: The XN-550 eliminates the need for additional reagents to determine all 31 parameters within a single complete blood count and differential analysis. This simplified reagent management reduces complexity, minimizes waste, and streamlines laboratories operations.

• Automation and Standardization: The Sysmex XN-550 is part of the Sysmex XN- Series platform, which allows for seamless integration, automation, and standardization across laboratory sites. This ensures consistent results, reduced operator variability, and efficient workflow, which are critical for mission readiness and patient safety.

• Unique Workflow Performance: The XN-550 includes onboard reflex testing capability, minimizing repeat testing and turnaround time.

• Compatibility with Existing Laboratory Systems: Many DOD facilities already standardize on Sysmex hematology platforms, allowing for harmonized QC, training, LIS connectivity, and service support. Use of a non-Sysmex system would introduce interoperability challenges, require retraining, and increase the risk of inconsistent results between sites.

• Risk of Multiple Platforms: Combining multiple hematology vendors would result in differing reference ranges, validation requirements, reagent inventories, and quality control materials. This would complicate accreditation compliance (CAP/CLIA), increase operating costs, and reduce efficiency

The combination of these salient characteristics, available only in the Sysmex XN-550, is essential for the subject MDG’s Laboratories to provide comprehensive and efficient hematology diagnostic se1vices, suppo11ing the health and readiness of base personnel. Therefore, the nature of this acquisition requires the use of the authority cited above to justify the procurement of the Sysmex XN-550.

If another analyzer was able to meet the MTF’s mission requirements, the MTF would still need to establish new processes and procedures to run blood tests, including training on the use of the machine. The MTF’s would also require a new lab configuration for any other potential replacement and may not be able to support the size and processing area for another machine.

Sysmex America Inc. is the sole manufacturer of the Sysmex line of hematology analyzers as well as the reagents and supplies used by those systems in the United States. These items are proprietary to Sysmex America Inc. Sysmex service engineers and individuals trained under the Sysmex biomedical engineer training program are trained and specifically certified by Sysmex to service Sysmex equipment. There are no other authorized providers for the service of the Sysmex analyzers. Federal Supply System Contract V797D40235 with Sysmex identifies that Sysmex does have some authorized participating distributors; however, Sysmex does not provide the proprietary information to distributions required to, and does not authorize those distributors to provide, the required maintenance services. Even if a non-Sysmex individual may have the knowledge to perform maintenance, they will not have the right tools to access the latest software updates. No other provider can service or maintain this equipment due to the proprietary nature of the analyzer. A non-authorized servicer/maintainer can also void the warranty of the leased equipment.

Furthermore, the required reagents and supplies are only manufactured and provided by Sysmex.

Even if there was another source for a machine or supply that met the mission needs, the requirement is for the vendor to also meet in-person technical needs, service response times, and maintenance requirements that would be available to travel to the MDG, and not merely provide the items as supply.

6. Market Research: Market research, including queries of GSA Advantage, a Sources Sought synopsis, internet searches, and review of product literature from manufacturers like Beckman Coulter, Mindray, and Dynacount, supports the justification for procuring the Sysmex XN-550 and reagents. The Government reviewed contracts for the same service awarded by other Government agencies, the Federal Procurement Data System, Federal Supply Schedules, and other sole source justifications posted to SAM.gov Contract Opportunities. There are many sole sources for different locations, some for this company, some for others because each MTF has different requirements and different space allocations. The Government reviewed other potential sources discovered during this research. For requirements very similar to this requirement the Government found many sole sources to Sysmex XN-550 existed. Research also included the open market options through internet and industry website searches.

The Government posted a Notice of Intent to Limited Sources by intention to make an award to Sysmex on SAM.gov on 25 April 2025 which closed on 8 May 2025. No questions nor responses were received. This research did not reveal any other company, besides Sysmex, that would meet this MTF’s needs. Alternative analyzers considered lacked the XN-550's specific capabilities and compatibility with existing infrastructure and regional partnerships, as detailed in Section V. Therefore, no other commercially available analyzer currently meets the MDG’ Laboratories full operational needs. Additionally, posting requirements under IAW FAR 8.405- 6(a)(2) and FAR 5.203(a) will be followed after place the order. This posting may year more market research for future option decisions or future buys.

7. Other Facts: The current ending requirement was awarded as sole source blanket purchase agreement order to Sysmex America, Inc under FA700020A0015. Because that was an Air Force purchase and this is not a DHA requirement, I was not able to gain access to the entire file of prior market research for the current services. However, throughout market research was done and current services were reviewed and confirmed to be acceptable or better.

8. Actions to Remove or Overcome any Barrier to Competition: I reviewed the expiring acquisition’s justification for limited sources in this analysis. Prior to any new efforts, the agency will notify the customer to provide a requirements package in a more timely manner to ensure enough lead time for other sources to compete and to obtain the required ATO for this requirement, and additional market research will be performed to identify other sources capable of providing hematology analyzers and maintenance.

Source Selection Information - See FAR 2.101 and 3.104-4

Technical 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.

9/19/2025 Date

9/19/2025 Date

9/19/2025 Date

JESSE A. KING

Contract Manager, COR Colorado Military Health System (CMS)

Urssula Locket, SSgt, USAF Contracting Officer Representative 21 MDG Peterson SFB

ROBYN L. EDWARDS, TSgt, USAF Contracting Officer Representative 27 SOMDG Cannon AFB

Contracting Officer:

I have reviewed this justification and find it adequate to support limited sources. Consistent with FAR 8.404(d) Pricing and supplemental Department of Defense requirements, I hereby determine the action described herein represents the best value to the Government. As evidenced by the signature below, I have determined this document to be both accurate and complete to the best of my knowledge and belief. Based on the foregoing justification, I hereby approve limiting sources in this acquisition pursuant to the authority stated herein, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Shanna M. Guillen Date Contracting Officer DHA, Contracting Division-Central

9/19/2025