Justification FAR Part 13 (JUNE 2025)-VITRECTOMY_ REDACTED .docx

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JUSTIFICATION REVIEW DOCUMENT

FAR Part 13 Justification and Approval Simplified Procedures for Certain Commercial Items

SYNOPSIS OF INTENT AWARD BRAND NAME

1. Contracting Activity: US. Army Health Contracting Activity (USAHCA), JBSA Fort Sam Houston, Texas

2. Description of Action: Request approval to award a new contract action for (5) five Anterior Vitrectomy Systems, ancillary items, consumables, repair parts, repair trainings, user trainings, and manuals assembled by Oertli Instruments Inc. to complete the fielding requirement of (9) nine systems for the Army.

3.

4. Description of Supplies/Services: The requirement is crucial in supporting optometrists by removing vitreous bodies, other fluids, and debris from patients’ eyes in austere environments found within the Army Role of Care 3 environment. The requirement includes unique equipment required for the United States Army Command to accomplish retention of eyesight through ocular surgery. This requirement of (5) five systems is to complete the fielding requirement for the Army through a one-time delivery.

5. Authority Cited: Title 41 U.S.C. §1901(e)(2)- “Special Rules for Commercial Products and Commercial Services” as implemented in FAR 13.501(a)(1)(ii),”Special Documentation Requirements” the property or service(s) needed by the agency are available from only one responsible source or only from a limited number of responsible sources and no other type of property or services will satisfy the needs of the agency.

6. Reason for Authority Cited: In accordance with FAR 13.501, simplified acquisition procedures are authorized for the procurement of supplies and services that are particular brand-name, product, or a feature of a product that is peculiar to one manufacturer, due to the fact that the particular brand name, product, or feature is essential to the Government’s requirements. Market research indicates other companies’ similar products lack the unique features, do not meet, or cannot reasonably be modified to meet, the agency’s needs.

As such, the Army requires a vitrectomy system specifically designed to meet its unique operational requisites in austere environments. The current fielded vitrectomy system is insufficient to meet contemporary requirements, predominantly due to cut rates that pose a risk of ocular damage. Unlike commercial applications, the Army’s primary use for a vitrectomy system is to address ocular trauma rather than routine procedures such as cataract surgery.

a. Background: At present the field vitrectomy system is insufficient to meet present requirements, particularly due to cut rates that pose a risk of ocular damage. Because of the Army’s unique purpose for a vitrectomy system to address ocular trauma rather than routine procedures like cataract surgery normal commercial vitrectomy systems are not viable. Additionally, in a Role of Care 3 environment, there is no requirement for posterior or retinal surgery, rendering many capabilities of commercially available systems unnecessary. The Army also requires a system that is highly portable and mobile, as dedicated surgical spaces for ocular trauma patients are not available.

Given these unique requirements, the CataRHex 3 system, a commercial off-the-shelf (COTS) item offered by Oertli Instruments Inc., is identified as the only system capable of meeting the Army’s unique needs of portability, mobility, and being trauma- focused operative. The CataRHex 3 system is lightweight (37.19 lbs), compact (2.4 cubic feet), and self-contained, with an onboard compressor that eliminates the need for external compressed air. The system is specifically designed for use in rigorous environments, making it uniquely qualified to fulfill the Army’s requirements.

b. Alternatives: Some alternatives such as general commercial vitrectomy equipment considered is not practical or in the best interest of the Government. The market displayed commercial vendors could not meet the crucial characteristics outlined and pursuing another competitive acquisition would result in redundant efforts, additional costs, and delays without identifying a viable alternative. The Oertli Instruments system is specifically designed for use in rigorous environments, making it uniquely qualified to fulfill the Army’s prerequisites of flexibility, and mobility.

c. Impact if not approved: Procuring general commercial vitrectomy systems from a different manufacturer or model would result in significant challenges, such as with National Stock Numbers (NSNs), training requirements, cataloging repair parts or replacement parts, and other logistical concerns. Furthermore, the Original Equipment Manufacturer (OEM)- Oertli Instruments has confirmed that there are no authorized vendor resellers for this system other than the OEM itself. Obtaining a device from another manufacturer would result in unacceptable delays and additional costs to the Government due to redundant activities required for acquisition, training, and lifecycle management. These factors collectively support the necessity of limiting competition to the previously procured manufacturer and model to ensure operational continuity and cost efficiency.

7. Efforts to Obtain Competition: A request for information (RFI) was posted in to ensure transparency and provide an opportunity for all potential sources to respond as pertinent to market research. The Contracting Officer published the (RFI) on 10 July 2025 with a closing date of 21 July 2025; no commercial small or large businesses responded. Furthermore, as per FAR 13.105(b) “Synopsis and Posting Requirements”- When acquiring commercial products or commercial services, or supplies or services; the contracting officer may use a combined synopsis and solicitation. In these cases, a separate solicitation is not required. The contracting officer must include enough information to permit suppliers to develop quotations or offers.

8. Actions to Increase Competition: This action is a follow-on to contract W81XWH20P0111. To date there is no competition in the commercial market for the Oertli Instruments that can provide the same capabilities as their products. The previous contract was competed via Sam.gov. Oertli has also provided a letter dated 25 April 2025, filed in the PCF cabinet, that states they are the sole proprietor of their products, and no other individuals or organizations are authorized to resell the Oertli vitrectomy system. The government will continue to monitor the medical market for technological advancement in the vitrectomy systems that would meet the specifications outlined.

9. Market Research: IAW with FAR Part 10 and DFARS 210.001 extensive market research was conducted using the name vitrectomy and the NAICS code. Various market vehicles were utilized that included research of the mandatory and non-mandatory source like sam.gov, GSA and google website. Also, as part of the market research, a RFI was also issued to test for market interest. The research disclosed while the vitrectomy surgical instrument is a commercial item. Due to the requisites of the Army for the use of the product other companies and their specifications are not capable of meeting the requirement. Oertli Instrument is the only vendor that provides the capabilities required.

10. Interested Sources: To date, no other sources have written to express an interest.

11. Other Facts:

a. Procurement history.

Instruments, Inc..

1) Contract number W81XWH20P0111, awarded 26 June 2020

2) The competitive status of these actions was unrestricted competitive.

3) Due to unrestricted competition no authority previously needed.

4) In May 2021, the contract timeline necessitated the exercise of Option Year 1, during which four additional CataRHex 3 systems were procured. However, due to an increase in the unit cost resulting from updates in system configuration following operational evaluations, the Contracting Officer (KO) determined that exercising Option Year 2 would not be feasible, as it would place the contract outside the scope of the original cost estimates. As a result, Option Year 2 was not exercised, ensuring compliance with the contract’s original terms and cost parameters.

5) The above statement shows an unusual event that due to a cost increase for the unit which led to unexercised options for additional devices.

6) No protest was filed following the award decision.

b. Other facts. All factors are stated, no new factors

(Source Selection information - See FAR 2.101 and 3.104-4)

1 FEB 2025