JA Brand Name FAR 13.5 Stago-AR - Redacted.pdf

[ Enter security markings here -- or delete this text. ] FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

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

ATTACHMENT 1

JUSTIFICATION AND APPROVAL (J&A) TEMPLATE

for

Sole-Source (Including Brand-Name) Acquisitions of Commercial Items Conducted Pursuant to FAR Subpart 13.5

(June 21, 2018)

Justification and Approval for Other than Full and Open Competition Sole Source Acquisition

J&A Tracking No.

1. Identification of the agency and contracting activity: Laboratory U.S. Navy Medical Readiness & Training Command, Guam.

2. Nature and/or Description of Action being approved: This document outlines a supply and equipment procurement initiative. The proposed action is being carried out under the authority granted by the Multiple Award Schedule Program, as stipulated in Title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 251, et seq.) and Title 40 U.S.C.

501, which pertains to Services for Executive Agencies. This procurement constitutes a limited source action. The focus of this order is the acquisition of two (2) The Stago Compact Max 2, an automated clinical coagulation laboratory analyzer along with the necessary supplies to support its operation for the Naval Medicine Readiness and Training Command (NMRTC) Guam.

The contract will encompass a base period of 12 months and includes the option for four additional years, allowing for continued support and procurement flexibility as requirements evolve. This strategic approach ensures that NMRTC Guam has access to the most current technological solutions and essential supplies, enhancing the efficiency and effectiveness of clinical laboratory services.

3. Description of Supplies/Services: The proposed action involves the establishment of a Contractual Purchase Request and Requisition (CPRR) for two advanced automated coagulation analyzers, along with the necessary supplies and preventative maintenance specifically for the NMRTC Guam laboratory. This initiative is scheduled to commence on November 1, 2024, and will run through September 30, 2025, incorporating a base contract with the option for four additional years.

The required analyzer is specified to be a comprehensive single-platform system, proficient in conducting a range of important coagulation tests, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (PTT), D-Dimer, and Fibrinogen analysis. It is crucial that this system is designed for seamless integration with the military health system's electronic health record platform, MHS Genesis, ensuring complete compatibility and zero interruptions in

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

[ Enter security markings here -- or delete this text. ] FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104 connectivity during data transmission. This integration is vital for maintaining the flow of patient information and enhancing the efficiency of laboratory operations.

- Services requested includes labor cost and biomedical training courses.

- total price encompassing all 5 years if we so chose to exercise options,

- Requirement is not for a repair part.

- Technical data was submitted via LogiCole.

4. Statutory Authority Cited permitting other than full and open competition: Acquisition of commercial item(s) conducted pursuant to FAR Subpart 13.5 in accordance with 41 U.S.C.

1901 Simplified Acquisition Procedures. Item peculiar to one manufacturer with multiple distributors/resellers IAW FAR 13.501(a).

5. Rationale Justifying Use of the Statutory Authority Cited: The use of the specific authority cited under FAR 13.501(a) for a brand name acquisition of the Stago Coagulation analyzer provides a detailed rationale that demonstrates why this product is essential and why no other product can meet the requirements. Given the geographical location of NMRTC Guam, the current vendor and only authorized vender, stands out as the sole provider capable of delivering corrective and preventive maintenance as well as supplies to our facility within 24 hours. This is due to the logistical challenges associated with our remote setting, which makes it difficult for other suppliers to meet our urgent needs effectively. As a result, maintaining a partnership with this vendor is essential for ensuring that we receive timely support and resources necessary for our operations. Given the local vendor only provides this make/model of coagulation analyzers, the Stago Compact Max 2 (Qty 2) is the only brand name acceptable to sustain services for our hospital’s patients.

6. Efforts to Obtain Competition: Efforts have been made by conducting an extensive market research to identify potential sources. IAW FAR 5.202(a)(10) The proposed contract action is made under conditions regarding brand name commercial items for authorized resale. Market research was conducted in August 2024 and determined via internet searches that this requirement is customarily available in the commercial marketplace. Research of mandatory sources AbilityOne, UNICOR, GSA Advantage did not yield any results. A small business dynamic search for additional small business firms meeting the requirement resulted in negative results. A search on ECAT and MMC yielded no options. The local vendor was the only option for 24-hour response to corrective maintenance or supply needs. The recommendation is a 100% small business set-aside with a brand name basis.

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 and 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: Several market research methods were used to include the review of mandatory sources, reviews of similar previous procurements, using online engines reviewed by the Naval Hospital Guam and DHA HCD-W. A combined synopsis/solicitation with a small business set-aside under solicitation # HT941024P0043 will be posted on SAM.gov as a brand name only acquisition. The use of such description in the acquisition is essential to the Government's requirements, thereby precluding consideration of a product manufactured by another company.

9. Other Facts: The Stago brand, along with several other reputable brands, boasts distinct capabilities and specialized expertise that are crucial for successfully fulfilling the procurement process. However, the unique geographical location of NMRTC Guam poses a challenge, as no other manufacturers possess the required qualifications or relevant experience to adequately meet the government's strict requirements. This limitation underscores the necessity of working with Stago, whose capabilities align perfectly with the specific needs of the facility. Efforts to identify additional sources have been unsuccessful. These facts justify the use of other than full and open competition, demonstrating that it is in the government's best interest to limit competition in specific circumstances.

10. Interested Sources: N/A

11. Actions to overcome barriers: Naval Hospital Guam and the DHA Healthcare Contracting Division - West will continue to survey and engage the market of any potential vendors that can provide the Stago Compact Max 2 coagulation capabilities and accessories 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 the products. Furthermore, making the item available through various distributors or prime vendors will remove and overcome the barriers to competition. Will conduct ongoing market research to identify new potential sources and solicit feedback from vendors on the procurement process and use this information to make continuous improvements.

NOTE: Review/Approval Requirements are based on dollar threshold and whether or not the action is a Bridge Action (see DHA PGI 213.5 for details). Delete all informational and instructional text (i.e., italicized text) in final draft, prior to review and coordination.