A02-JA FAR 13.5-FINAL-REDACTED.pdf

CUI

Control Number: FY25-0347

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

NOV 2024

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: The contracting activity for this action is the US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD 21702.

2. Description of Action: This requirement is for a new Firm Fixed Price contract for a base year and four option years for the United States Naval Medical Readiness and Training Command (USNMTRC)Yokosuka and Branch Health Clinics. Funding for this effort will utilize Fiscal Year 2025 Operations & Maintenance Funding.

3. Description of Supplies/Services: The Contractor shall supply all laboratory reagent requirements for the USNMTRC Yokosuka Laboratory Department, as well as for all associated Branch Health Clinics (BHCs). These reagents will support the operation of various government-owned laboratory equipment, including but not limited to analyzers used in Urinalysis, Chemistry, Histology, Hematology, and Microbiology. These reagents are critical supply items that enable the department to perform essential analysis for the purposes of physician diagnosis, treatment, and care of active duty, family members and other eligible beneficiaries assigned to U.S. Forces Japan. It is essential that we obtain these items in a timely manner to guarantee the arrival of reagents to avoid any delays or setbacks of patient treatment. Required items needs to deliver to each MTF directly.

Controlled by: Defense Health Agency (DHA) Controlled by: USAMRAA CUI Category(ies): Source Selection Limited Dissemination Control: FED Only POC: Christopher L. Cook

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Source Selection Information - See FAR 2.101 and 3.104-4

Period of Performance: 01 October 2025 - 30 September 2030 (Base Year plus 4 Option Years)

Period Period of Performance

Base Period 01 Oct 2025-30 Sep 2026

Option Period 1 01 Oct 2026-30 Sep 2027

Option Period 2 01 Oct 2027-30 Sep 2028

Option Period 3 01 Oct 2028-30 Sep 2029

Option Period 4 01 Oct 2029-30 Sep 2030

4. Statutory Authority Permitting the Sole Source Acquisition: 41 United States Code 1901 as implemented in Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Rationale Justifying Use of Authority Cited: Based on the results of market research, we contacted all local potential sources after thoroughly reviewing mandatory sources, but none were able to meet the requirements. A list of contractors was considered based on their prior business dealings with the Government or their ability to fulfill the consumable needs of NMRTC Yokosuka and its Branch Health Clinics (Atsugi, Iwakuni, Sasebo, and Diego Garcia) locally. The consumables must be maintained at a temperature between -1°C and 8°C during delivery and must have a minimum shelf life of three months. Expired items are not acceptable. Considering the time required to procure these items from the U.S. or other countries, only a local source can meet these stringent requirements. Nichiei Tokai Co. has previously conducted business with the Government and meets the requirements. Alfresa, which has had contracts with the Government in the past, is no longer able to support our needs due to changes in their company policy. Sunmedix was also contacted; however, they can only supply some, but not all, of the consumables required by NMRTC Yokosuka and its Branch Health Clinics. As a result of the market research conducted by NMRTC Yokosuka, Nichiei Tokai Co. is the sole source capable of meeting the requirements.

6. Efforts to Obtain Competition: Based on the results of market research, Nichiei-Tokai Co., Ltd has been identified as the sole capable source to provide the required services.

Other known sources were contacted, but their responses indicated that they are unable to supply the full range of consumables from various manufacturers necessary to meet the requirements.

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

Nichiei-Tokai Co., Ltd., has been identified as the sole source capable of providing the required consumables. Other potential sources were contacted but confirmed their inability to meet the specified requirements. Comprehensive market research was conducted, including a review of mandatory Government sources, which yielded no

CUI

Source Selection Information - See FAR 2.101 and 3.104-4 viable alternatives. Additionally, a search through the General Services Administration (GSA) was performed but did not produce any results for the required consumables.

8. Market Research: In accordance with FAR Part 10 and DFARS 210.001, market research was conducted among known sources, including Nichiei-Tokai Co., Ltd, Alfresa Co., Ltd, and Sunmedix Co., Ltd, to identify potential vendors capable of supporting this requirement. Alfresa Co. indicated that they could not support this action due to their inability to provide the required consumables in the future. Similarly, Sunmedix Co., Ltd stated that they were unable to handle the specific consumables needed for this requirement. Nichiei-Tokai Co., Ltd was the only company that responded affirmatively, confirming their ability to meet all the necessary requirements.

9. Other Facts:

a. Procurement history: N/A

10. Interested Sources: A Notice of Intent to award a Sole Source will be posted on the Federal Business Opportunities website for 15 days to afford the public an opportunity to respond with a Capability Statement. No responses are expected.

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

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

Signature: _____________________________ Typed Name: Title:

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

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable in accordance with the Federal Acquisition Regulation (FAR) 15.404, Proposal Analysis. Techniques to be used will be comparison with the Independent Government Estimate and historical pricing on previous purchases. As part of this basis, Certified Cost and Pricing Data IS NOT required in accordance with FAR 15.403-1(b)(3).

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Concurrence

Jennifer S. Bassett Contracting Officer

USMARAA