Sole Source Justification HT001426QE034 - Automated Refraction Systems_Redacted.pdf

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Control Number: FY26-0905

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Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2024

threshold (SAT), document the decision that only one source is reasonably available to meet the agency's needs and the basis for the decision.

5. Rationale Justifying Use of Authority Cited: The Nidek Global refraction equipment (branded as Marco

Lombart EPIC 6100 Refraction Workstation and TRS-6100) is being requested as a sole source purchase due to its required compatibility and integration with the ophthalmology diagnostic equipment currently in use within our department, combined with the manufacturer's exclusive distribution network.

The department has recently acquired new Marco Lombart autorefractors, which are designed to integrate directly with the EPIC 6100 workstation and the RT 6100 M Photosphere, Head and Digital

Refraction System. The EPIC 6100 provides a centralized, integrated platform for performing refractions and transferring patient measurements and data between the autorefractors and the digital refraction system. Purchasing this exact workstation will allow us to fully utilize the functionality of the new autorefractors and maintain an integrated ophthalmic examination workflow. The workstation is specifically designed to communicate with and support the existing equipment, reducing the need for duplicate data entry, minimizing potential transcription errors, and improving efficiency and consistency in the patient examination process.

An alternative workstation from another manufacturer will not provide the direct integration or interoperability required with the existing government-owned systems. Selecting an incompatible or non-integrated workstation would require additional software, interfaces, manual data entry, or workflow modifications, resulting in increased costs and reduced operational efficiency. Standardizing the refraction equipment on this platform also provides continuity with the equipment already purchased, allows staff to utilize a consistent workflow, and maximizes the value and functionality of our existing ophthalmology equipment investment.

Because Nidek Global manufactures these items and Marco Lombart is the sole authorized distributor able to sell them in North America, no other vendors are authorized to fulfill this requirement.

Therefore, this action must be executed as a Sole Source procurement.

6. Efforts to Obtain Competition: In accordance with RFO guidelines, the solicitation will be completed as a Sole Source acquisition since Marco Lombart is the exclusive North American distributor for the required Nidek Global equipment. To increase transparency and market visibility, a Notice of Intent to

Sole Source will be published to SAM.gov. Furthermore, to promote future transparency, a redacted copy of this finalized J&A will be posted to SAM.gov following the contract award.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: To overcome barriers to competition for future requirements, the Government will continuously conduct market research to determine if alternative commercial ophthalmic refraction platforms achieve FDA clearance and warranty-backed compatibility with current autorefractors. The Contracting Activity will also

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Source Selection Information - See FAR 2.101 and 3.104-4 maintain communication with OEMs like Nidek Global to track their network of authorized distributors, ensuring that future solicitations are structured to promote competition if distribution models change.

8. Market Research: Market research included the Contracting Officer’s Representative and Technical

Expert reaching out to industry and conducting a review of the internet, including global manufacturer directories. Market research confirmed that the required systems are manufactured by Nidek Global.

The manufacturer's published directories and corporate documentation confirm that Marco Lombart is the exclusive distributor for these refraction products in the United States. Because strict compatibility with existing equipment is required, and Marco is the only authorized seller of the Nidek systems that meet this requirement, there is only one responsible source.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No

(2) If 9.a.(1) is No, was the action just prior to this one competed? Unknown – the existing equipment dates to 2012 with an unknown purchase history

(3) If 9.a.(2) is Yes, what has changed where this action cannot be completed? Not applicable.

b. Additional Information: None

10. Interested Sources: To date, no other manufacturers or distributors have written to express interest, as Marco holds exclusive distribution rights for this product line in the region.

11. Technical/Requirements 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.

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Source Selection Information - See FAR 2.101 and 3.104-4

12. Contracting Officer Determination of Fair and Reasonable Pricing and Certification of Accuracy and Completion.

Fair and Reasonable Cost Determination:

I hereby determine the anticipated cost to the Government for this contract will be fair and reasonable.

Basis for Determination: The Contracting Officer will determine the price to be fair and reasonable prior to award. The basis for this determination will be established through a comparison of the proposed prices to historical prices paid and the Independent Government Cost Estimate (IGCE). The estimated value of this effort is $ This estimate was made in support of commercial items using commercial sources including commercial quotes, The IGE contains a certification that the Government independently developed the IGE prior to seeking formal proposals from contractors.

Contracting Officer Certification:

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

Contracting Officer

Healthcare Contracting Division- Northeast

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Source Selection Information - See FAR 2.101 and 3.104-4

Approval

Based on the foregoing justification, I hereby approve the procurement of the Marco Lombart refraction system and workstations on a Sole Source basis pursuant to the authority of RFO 12.102(a):

For acquisitions valued at or below the simplified acquisition threshold (SAT), document the decision that only one source is available and the basis for the decision, subject to availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

Lorena Cruz

Contracting Officer

Healthcare Contracting Division- Northeast