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 POC: (Insert POC)

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 for a follow-on requirement to Contract number FA700020A0015 that expires 30 September 2025.

3. Description of Supplies or Services and Estimated Value: The DHA requires the lease of the Sysmex XN-3100-111 Hematology Analyzer and lease of the Sysmex DI-60 Automated Digital Cell Morphology System and all related and required maintenance and repair, supplies, and consumables for both machines at Evans Army Community Hospital, (EACH), Colorado. The vendor shall provide all required equipment, reagents, parts, control, and maintenance, and calibration materials required for the machine to perform full services. EACH currently leases both of these integrated pieces of equipment: one (1) Sysmex XN-3100-111 Hematology Analyzer and one (1) Sysmex DI-60 Automated Digital Cell Morphology System.

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 $731,692.26. 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

Period Period of Performance Estimated Value Base Period 1 October 2025 to 31 March 2026 $82,449.54 Option Period 1 01 April 2026 to 31 March 2027 $162,310.68 Option Period 2 01 April 2027 to 31 March 2028 $162,310.68 Option Period 3 01 April 2028 to 31 March 2029 $162,310.68 Option Period 4 01 April 2029 to 31 March 2030 $162,310.6

Total $731,692.26

Source Selection Information - See FAR 2.101 and 3.104-4

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-3100-111 Hematology Analyzer is the only analyzer that meets all of EACH’s mission and technical requirements to provide an automated hematology analyzer that can perform laboratory testing and connect to the lab information system. While other analyzers may offer similar basic CBC functionality, the XN-3100-111 possesses specific, essential characteristics vital to the EACH’s mission. All parameters of the Sysmex XN3100's test menu are FDA approved including body fluid two-part differential mononuclear & polynuclear percentage and counts, unique to Sysmex.

The Sysmex DI-60 adds complete automation of the manual WBC differential process and can only integrate with the Sysmex Analyzers. The Analyzer requested can only integrate with Sysmex automation products. Combining two vendor products would not meet the requirements because there would be no known probability of test results. Use of Sysmex hematology systems is required to meet the laboratory’s mission needs, as the equipment provides a fully integrated and automated solution. Procuring separate instruments from multiple vendors would result in workflow fragmentation, increased manual interventions, and interface compatibility risks that could compromise testing accuracy, turnaround times, and staff efficiency. A mixed-vendor approach would undermine the continuity of automation, quality control, and data management that are essential for reliable hematology testing in support of patient care. Therefore, Sysmex is the only source that can provide the complete end-to-end automation necessary to meet the laboratory’s operational requirements.

The ATO Approved XN-3100-111 is the only automated hematology system pairing one XN10 and one XN20 fully automated hematology analyzers with an integrated SP-50 Slide Maker/Stainer, and an integrated DI-60 Automated Digital Cell Morphology System. The XN-20 module has unique added technology to differentiate between blast and atypical lymph cells.

This differentiation is a mission requirement.

Automated analyzers not interfaced with the laboratory information system will require manual entry of results, which increases the safety risks of clerical errors. Manual entry of results also requires second verification prior to reporting, which increases the turn-around-time for reporting results to providers and cause delays in patient care. It would also increase commercial lab testing costs and need to cover the gap in the lab’s testing capability.

If another analyzer was able to meet EACH’s mission requirements, EACH would still need to establish new processes and procedures to run blood tests, including training on the use of the machine. EACH 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

Source Selection Information - See FAR 2.101 and 3.104-4 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 EACH, and not merely provide the items as supply.

6. Market Research: 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 at Evans Army Community Hospital the Government found many sole sources to Sysmex XN-3100-111 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. 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 follow-on and/or

Source Selection Information - See FAR 2.101 and 3.104-4 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.

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.

Jesse King Date Contract Manager, COR Colorado Military Health System (CMHS)

Legal Review:

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

Jessica Volsey Date Attorney

DHA OGC KLAW

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

9/18/2025

9/18/2025

9/18/2025