HT941026N0085 Justification and Approval RFO Part 6 FY26-FY26-0846.pdf

CUI

Control Number: FY26-0846

Controlled by: Defense Health Agency (DHA) Controlled by: Healthcare Contracting Division – West (HCD-W) CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON POC: Barrett Taylor, Barrett.s.taylor.ctr@health.mil

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

1 OCT 2024

Justification and Approval (J&A) for Other than Full and Open Competition Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) Parts 6 and 12

Implemented by Class Deviation 2026-O0017, Revision 1

1. Identification of the Agency and Contracting Activity:

This justification is executed by the Defense Health Agency Contracting Activity (DHACA), Healthcare Operations Division - West (HCD-W), San Diego, CA, on behalf of the Navy to meet the requirements of Naval Medical Center San Diego (NMCSD) Refractive Surgery Clinic 34800 Bob Wilson Dr, San Diego, CA 92134.

2. Nature and/or Description of Action being Approved:

The Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division – West (HCD-W), intends to negotiate and award a firm-fixed-price purchase order for an emergency, sole-source acquisition to procure proprietary equipment directly from the manufacturer, Alcon Vision, LLC. Specifically, this requirement encompasses 40 units of Product #8065998401 (Wavemaker EX500 US Gold 20), 20 units of Product #8065000452 (Easypack FS200), Wavelight treatment cards (Product #8065998437), and height-adjustable tables (Product #8065990650). Alcon is the sole authorized Government distributor for this equipment, which is required to operate the Military Treatment Facility's (MTF) existing refractive lasers for patient vision correction; the laser platforms are completely inoperable without them. These proprietary Alcon cards are the only consumables compatible with the MTF's current systems. Each laser platform requires a distinct treatment card to function: a single EX500 card contains 20 treatments (sufficient for bilateral refractive surgery on 10 patients), and a single FS200 card provides 20 flaps. Because these components are proprietary and distributed exclusively by the Original Equipment Manufacturer (OEM), there is no reasonable expectation of receiving quotes from two or more small businesses.

3. Description of Supplies/Services and Estimated Value:

Naval Medical Center San Diego (NMCSD) Refractive Surgery has an urgent need for:

Line Material Description UOM Qty Unit Price Total Funding

00001 Wavemaker EX500 US Gold 20 (Product #8065998401)

EA 40 $5,000.00 $200,000.00

00002 Easypack FS200 (Product #8065000452):\

EA 20 $3,600.00 $72,000.00

mailto:Barrett.s.taylor.ctr@health.mil

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2024

Line Material Description UOM Qty Unit Price Total Funding

00003 Wavelight Treatment Cards (Product #8065998437)

EA 1 $85,000.00 $85,000.00

00004 Height-Adjustable Table (Product #8065990650)

EA 1 $4,863.91 $4,863.91

Total Value: $357,000.00

Delivery Dates:

14 Days ARO (CLIN 0001 AND 0002) 30 Days ARO (CLIN 0003 and 0004) Total value: $357,000.00 Type of Funding: Operations and Maintenance (O & M) Contract Type: Firm-fixed-price Delivery Location: Naval Medical Center San Diego Interventional Radiology and Vascular Medical Center San Diego (NMCSD) Refractive Surgery Clinic.

4. Statutory Authority Permitting Other Than Full and Open Competition:

Statutory Authority Cited permitting other than full and open competition: Acquisition of commercial item(s) conducted pursuant to RFO 12.201-1(e)(3) in accordance with 41 U.S.C.

1901 Simplified Acquisition Procedures.

5. Rationale Justifying Use of Authority Cited:

This sole source justification is prepared using the format at RFO 6.103-1(c)(2)(i), modified to reflect the procedures in RFO 12.201-1(e)(3) in accordance with 41 U.S.C. 1901. Based on extensive market research and previous acquisition history, it has been determined that the only vendor capable of meeting the Government’s requirements is Alcon Vision, LLC. (an other-than-small/large business; UEI: PHBTLNJ4WCM5; CAGE: 8CJP0).

The Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division – West (HCD-W), intends to negotiate and award an emergency, firm-fixed-price purchase order on a sole-source basis to the Original Equipment Manufacturer (OEM), Alcon Vision, LLC. This requirement procures proprietary refractive laser treatment equipment, consumables, and certified installation services critical to sustaining surgical operations at the Naval Medical Center San Diego (NMCSD) and Naval Training Center (NTC) Refractive Surgery Center.

Specifically, this acquisition encompasses 40 units of Product #8065998401 (Wavemaker EX500 US Gold 20), 20 units of Product #8065000452 (Easypack FS200), 1 unit of Product #80665998437 (Innoveyes Sightmap), and 1 unit of Product #8065990650 (Height Adjust Table 115V Multi) to add to the clinic's existing inventory.

Alcon Vision, LLC is the sole authorized Government distributor for this equipment. These proprietary treatment cards are the only consumables compatible with the Military Treatment

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

Facility's (MTF) existing Alcon refractive lasers; without them, the systems are completely inoperable, and refractive surgery at NTC would not be possible. Each laser platform requires a distinct treatment card to function: a single EX500 card contains 20 treatments (sufficient for performing bilateral refractive surgery on 10 patients), and a single FS200 card provides 20 flaps. The NMCSD Refractive Center maintains a high operational tempo, performing approximately 15 surgeries per week divided among SMILE, LASIK, and PRK procedures. A standard daily surgical caseload consumes 4 flaps on the FS200 (supporting 2 LASIK patients) and 8 treatments on the EX500 (supporting both LASIK and PRK patients). Furthermore, Alcon is the sole source capable of meeting the Government’s minimum requirements to provide the requested proprietary equipment and requisite certified installation services at NMCSD.

This requirement is an emergency acquisition due to the rapid depletion of the clinic's current consumable inventory. If standard procurement lead times are observed or this sole-source award is delayed, the clinic anticipates a complete stoppage of refractive surgical capabilities by 3 August 2026. This disruption will force the cancellation of scheduled surgeries, directly degrading the medical readiness and deployability of active-duty service members who require vision correction. Because these are highly specialized, proprietary components distributed and serviced exclusively by the OEM, there is no reasonable expectation of receiving competitive quotes from two or more small businesses. Accordingly, the acquisition strategy is to execute this procurement immediately on a sole-source basis under the authority of Other Than Full and Open Competition to prevent unacceptable delays in mission-critical military medical services.

6. Efforts to Obtain Competition:

Extensive market research was conducted to identify potential alternative sources of supply and determine if competition could be obtained. This research included reviewing technical specifications, consulting with subject matter experts, and searching government and industry databases. However, because Alcon Vision, LLC is the sole proprietor, manufacturer, and distributor of the required EX500 and FS200 treatment cards and the supplementary Innoveyes Sightmap system, no other brand or vendor can provide the compatible consumables required to operate NMCSD's existing refractive laser platforms. There are no authorized third-party distributors or alternative manufacturers capable of producing these proprietary components or providing OEM-certified installation services. Consequently, any efforts to compete this requirement would result in a failure to meet the Government's minimum technical requirements, cause a severe delay in patient care, and incur unnecessary costs. Therefore, no viable alternative sources exist, and Alcon Vision, LLC remains the only capable source.

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

In accordance with the basis for award procedures at RFO 6.104-2, the Contracting Officer will utilize a comparison of the proposed price with prices found reasonable on previous purchases and a comparison of the price to the independent Government estimate provided by the requiring activity to determine the vendor's quoted price fair and reasonable. Additionally, the Government has historical pricing information from similar contracts that provided similar services. The cumulative data available to the Contracting Officer provides for the ability to determine a fair and reasonable price in accordance with RFO 6.104-1(a)(7).

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

8. Market Research:

The requiring activity has an urgent requirement for a 12-month supply purchase request for the Alcon treatment cards as needed to operate and treat patients requiring refractive surgery, and for the Wavelight Innoveyes Sightmap and Height Adjustable Multiview Table. NTC Refractive Surgery Clinic treats patients across the Pacific commands as well as patients from overseas, across all branches of the military. Without this equipment, the refractive lasers would be inoperable, and refractive surgery would need to be suspended until the treatment cards arrive at the facility for normal clinic operations to continue. Supplies currently on-hand will only last through July 2026. Treatment cards were lapsed from the ECAT system and await a contract renewal. In June 2026, market research was conducted across mandatory procurement sources, including AbilityOne, UNICOR, the Small Business Administration (SBA) Dynamic Small Business Search (DSBS), and the Defense Logistics Agency (DLA) Electronic Catalog (ECAT);

all queries yielded negative results for this specific requirement. Additional internet-based market research confirmed that only one vendor, Alcon Vision, LLC . (an other-than-small/large business; UEI: PHBTLNJ4WCM5; CAGE: 8CJP0), can satisfy the Government's urgent technical requirements. Alcon Vision, LLC is currently the only vendor that offers the equipment required by the clinic. A Notice of Intent (NOI) HT941026N0085 to sole source was posted on sam.gov from 17 to 30 July 2026. Based on these market research findings, this requirement will be sole-sourced to Alcon Vision, LLC in accordance with regulatory authorities.

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? No

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? N/A

b. Additional Information:

DHACA HCD-W will continue to survey and engage the market for any potential vendors.

10. Interested Sources:

No additional sources submitted capabilities statements for the Government's consideration.