JA SS - Hematology - Redacted.pdf

DHA PGI 213.5, Attachment 1 (06-21-2018)

5. Rationale Justifying Use of the Statutory Authority Cited:

This sole source justification is prepared using the format at FAR 6.303-2, modified to reflect the procedures in FAR Subpart 13.106 in accordance with 41 U.S.C. 1901. According to market research, Sysmex America, Inc. is the Original Equipment Manufacturer (OEM) of Hematology Analyzer and sole proprietor of the requested reagents and consumables. These items are proprietary to Sysmex America Inc.

Sysmex is the only vendor that manufactures a clinical hematology analyzer that samples <26 uL of blood, performs patient reportable immature granulocytes as part of a 6-part diff utilizing fluorescent flow cytometry technology. These features provide the critical capability to detect cancer cells, allowing the medical community the ability to begin treatment immediately, all without purchasing an additional license or require additional reagents. Additionally, the Sysmex XN-550 analyzer meets the following dimensions and weight (17.72” W X 25.98” D X 17.72 H”/ 116.84 lbs) that will fit on the lab's limited countertop space. Service for the equipment is also required by the vendor as, the vendor is familiar with the extensive technical, physical and performance requirements of the analyzer.

A sole source proprietary letter was received from Sysmex stating they are the sole source supplier of the hematology, reagents and supplies.

6. Efforts to Obtain Competition:

Contract specialist conducted a mandatory search through November-December 2024 and determined via internet searches that this requirement is customarily available in the commercial marketplace. Through research and mandatory sources: AbilityOne, UNICOR, ECAT/DLA, VA, MMC, GSA FSSI. A small business dynamic search for small business firms meeting the requirement resulted in negative results under NAICS code 334516 and search terms hematology analyzer. A search on GSA Advantage found availability through federal supply schedule (FSS) for Sysmex America Inc. under FSS V797D-40235. End user reached out to multiple vendors to verify if anyone else could meet the Government’s requirement. As a result, none of these companies have the equipment to meet our requirement.

A Notice of Intent (NOI) to Sole Source under solicitation number HT941025N0016 was issued on 03 December 2024 and closed 13 December 2024 allowing potential vendors to provide capability statements meeting the Government's minimum requirements. No responses were received, and no additional sources submitted capabilities statements for the Government consideration.

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable:

In accordance with the basis for award procedures at FAR 13.106-3, the Contracting Officer will utilize a comparison of the proposed price found reasonable on previous purchases and a comparison of the price to the Independent Government Cost Estimate (IGCE) provided by the requiring activity to determine the vendor's quoted price fair and reasonable.

8. Market Research:

As stated above, several market research methods were used to include the review of mandatory sources, reviews of similar previous procurements, using online search engines reviewed by Joint Base Pearl Harbor-Hickam and DHA Western Healthcare Operations Contracting Division in June 2024. A Notice of Intent to Sole Source was posted on SAM.gov under solicitation number HT941025N0016 from 03 December 2024 and closed 13 December 2024, resulting in the identification of no additional sources capable of meeting the Government's minimal requirement.

9. Other Facts:

None.

10. Interested Sources:

Sysmex America, Inc. is the only source identified that can meet the Government's minimum requirements. Additional market research and the posting of a Notice of Intent to Sole Source did not identify any additional interested parties.

11. Actions to overcome barriers:

Joint Base Pearl Harbor-Hickam and the DHA Western Healthcare Operations Contracting Division will continue to survey and engage the market of any potential vendors that can provide the hematology analyzer and will consider competing future requirement if there are other vendors capable of meeting the requirements. In addition, review and due diligence will be conducted by the Government for any vendor submitting capability statements for hematology analyzer, reagents and consumables.

COORDINATION:

12. Technical/Functional Representative:

I certify that the information provided in this justification, is accurate and complete to the best of my knowledge and belief.

13. Requirements Certification:

I certify that the information provided in this justification, is accurate and complete to the best of my knowledge and belief.

14. Fair and Reasonable Cost Determination:

I have determined that the anticipated cost to the Government for this contract action is fair and reasonable.

APPROVAL:

15. Contracting Officer:

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

Date