JA_Analyzers final redact_Redacted.pdf

CUI

Control Number: FY25-0405

Controlled by: Defense Health Agency (DHA) Controlled by: HCD-W

CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON

POC: Shannon.lacom2.civ@health.mil

Source Selection Information - See FAR 2.101 and 3.104-4

1 NOV 2024

Justification and Approval (J&A) Modified for Federal Acquisition Regulation (FAR) 13.501

1. Identification of the agency and contracting activity: This justification for an exception to fair opportunity is executed by the Defense Health Agency (DHA), DHA Contracting Activity (DHACA), Healthcare Contracting Division – West (HCD-W) on behalf of Naval Medical Readiness Training Command (NMRTC) Yokosuka.

2. Nature and/or Description of Action being approved: Firm Fixed Price, Single Award, Purchase Order. This is an individual J&A Modified for FAR 13.501.

This requirement is for the consumables, leasing and maintenance for three Arkray AE-4060 and AI-4510 urinary sediment bridge systems, which function as an integrated solution for comprehensive urine sediment analysis at NMRTC Yokosuka.

3. Description of Supplies/Services: This requirement is for Cost Per Reportable Result (CPR) consumables, leasing, and maintenance services for the Arkray AE-4060 and AI-4510 urinary sediment bridge systems at NMRTC Yokosuka. The following Arkray consumables are required on a recurring schedule (monthly, quarterly, bi-annually, and annually) as detailed in the attached requirement package:

73527 – Arkray AutoCheck Plus 106846 – Arkray URIFLET 9ub 79053 – Arkray Concentrated Washing Solution 3 100672 – S.G. Calibrator H 106839 – Auto Sticks 10067 – Thermal Paper 105582 – Auto Eye Sheath Solution 105638 – Auto Eye Control Solution 105639 – Auto Eye Calibrator 106378 – Filter Set 10374 – Filter and O-Ring

The contractor shall provide all scheduled and unscheduled maintenance for each leased machine. Contractors must submit a comprehensive service report, in English, following each maintenance service.

Control Number: FY25-0405

Controlled by: Defense Health Agency (DHA) Controlled by: HCD-W

CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON

POC: Shannon.lacom2.civ@health.mil

Source Selection Information - See FAR 2.101 and 3.104-4

3 NOV 2024

Sysmex: Their representative in Japan confirmed via email (documentation retained) that while they sell urine analyzers in Japan, they do not offer leasing arrangements and do not sell consumables directly to customers in Japan. This precludes Sysmex from meeting the Government’s requirements for a combined lease/consumable/maintenance solution.

Arkray is the only identified source capable of providing a complete, integrated solution encompassing leased equipment, delivery of consumables, and on-site maintenance within Japan, ensuring minimal downtime and continued operational capability at NMRTC Yokosuka.

Therefore, the only source capable of meeting the Governments needs of providing consumables, leased equipment and on-site maintenance in Japan is Arkray.

6. Efforts to Obtain Competition: The Government published a notice to Contract Opportunities on 29 August 2025 under notice number HT941025N0142. The notice closed on 4 Sept 25. The government did not receive any capabilities statements.

The government reached out to each known manufacturer in Japan for similar urine analyzers.

As specified above, only Arkray can meet the Government’s needs of consumables, leasing and maintenance support in Japan.

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

Despite continuous market research and notices to Contract Opportunities, the Government is currently unaware of any other similarly situated company capable of meeting these unique requirements. If other sources become known to the Government for future procurements, a competitive procurement will be considered.

8. Market Research: Market research conducted was through Mandatory Sources; GSA, Medical Master Catalog as well as manufacturers Arkray, Sysmex, and Beckman Coulter. The market research was conducted between February 2024 through August 2025. The Government is currently unaware of any other similarly situated company capable of meeting these unique requirements.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? Yes.