JA-25-0398 VR Simulator Eyesi Surgical Complete System_Redacted.pdf

FOR OFFICIAL USE ONLY· Source Selection Information -See FAR 2.101 and 3.104

Justification and Approval (J&A) for Federal Acquisition Regulation (FAR) Subpart 13.5

Other than Full and Open Competition Sole Source Acquisition ntle: One-time equipment purchase for a Virtual Reality Simulator Eyesi Surgical Complete System J&A Number: JA.25-()398 Created By: Collins, Jennifer E CIV DHA DHA CONTRACTING ACT (USA)

1. Identification of the agency and contracting activity:

San Diego Contracting Division

Additional POCs:

Navy Medical Center San Diego (NMCSD), Hea1tbcate Contracting Division-W� (HCO..'-A'), Dcfo1tst Hcahb Agci,cy C.Outracting Activity (DHACA).

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

new contract

Cdllns, Jennlfe< E CIV DHAOHA COl'ITRACTING ACT (USA)

Close pHACA, HCO-W intends to award a one-time, fixed-price supply purchase order contract on a sole source basis to Haag-Streit USA, Inc., 3535 Kings Mills Rd, Mason, Ohio 45040-2303, for commercial Items mentioned below.

J. Description of Supplies/ Services:

Haag-Streit USA, Inc. Is the sole manufacturer of the required Virtual Realty (VR) Surgical System equipment. The contractor shall provide the VR Simulator Eyesl Surgical Complete System, Complete Gold Software plan for 60 months and a CAT spare instrument set to replace current end of l�e system for NMCSD, The VR Surgical Simulator shall provide training for both cataract and vitreoretinal surgeries. lntraocular surgery is unique in that the operative space is extremely small (usually about 5mm). This necessitates a higher level of dexterity that the Eyesi supports by allowing residents to practice microsurgical skills for novice surgeons and other surgical procedures thus increasing patient safety and more positive surgical outcomes, The simulator Is also used by staff surgeons to fine-tune their surgical skllls and maneuvers, especially after periods of extended absence; such as, parental leave or n<>n-6urgical deployments. It allows for residents to gain surgical experience independent from patient/hospital flow, decreasing risks of complications such as vision loss and increasing the safety of surgery. The Eyesi Is the most prevalent of the commercially available VR surgical simulators in U.S. ophthalmic residency training programs. It Is the only one that has been validated in peer.,eviewed publications and available on the market for the training of both cataract and vitreoretinal surgeries. In addition to the built-in curriculum that a trainee must work through in a step.

\vise fashion, the Eyesl simulator Is also the only simulator available that comes with handheld Instruments that mimic the Instruments surgeons use Inside the eye.

Type of Contract (Primary):

FAR 16.202 Fir�Fixed•Price

Funding Type:

Operations & Maintenance (O&M)

4,, Statutory Authority Cited permitting other than full and open competition:

41 U.S.C. 1901 Simplified Acquisition Procedures

POP: From to

Estimated Value

� No

Number of Options:

POP (All options): From

Estimated Value (all options):

Extension of Services No

Clause:

Estimated Value:

Number of Months:

to cquisition of commercial item(s) conducted pursuant to FAR Subpart 13.5 in accordance with 41 U.S.C. 1901 Simplified Acquisition Procedures.

5. Rationale Justifying Use of the Statutory Authority Cited:

,iaaa•Sutit USA, Inc. ii: the only vendor capebJe of meet.in& lbe needs of the Government. a, the Eyes.i Sutaical Si.mulal.C)f Sysie:m. is uni4ut and hi.ably specialized. lotnliOCular IW'&etf ls unique lO tba1 lbe operative sp.ee: is exiremely ,mall (uMlly ab<lut fmm), Th.ii ociceuitatc::s a higher le\•el of dexterity that tbe Eyesi supports by .allowing residents to practic,,e m:kroswgical Wlls for novice wrgcom and o(bu surgical � lhus in�uiog p;ilic:ut s;ifcly and mon: p<nith·e surgii;al Ol.lfcomcs. Eyesi furgic•I Simulator Syucm. is the only one that bas been validated in peer-reviewed publieatiotu and available on the mart et for the training of both cataracl and vitrcoreciual surgeries. It i1 also the only 1ystem that that comes with bandbcld iostrumcuts that mimic the inscruments surgeon, use inside the eye. The Eycgi hardware cousisu of a model head ou an adjustable table with a mecbanicaJ eye that it wired to a computer inteif.aoe and a microscope. Th.is setup allows the surgical trainee to assume a realistic.

�sture. The Ryesi includes cataract surgical instruments and foot pedals. The mechanical eye has a setits of bolts in it for the trainee-'s iMlrllmenu k> enter. Residents need k> Jtam botb the band and foot controls as w-ell as how to lool: through the m�ope �urln& swiecy. Tho Eyosi abo i.ocJudos software fot- tralnecs to leam vitreoreti.nal procedum. not jalt cetaract surgery. Ila&J-Streit USA, Inc. is lbe ooly known &OuRie wil.b n<> knowo distribu«Ks of tbe spocifio eyHtqecy simulator system for tel.lnOI 8n4 vitrcomina.l surgeries. In accordmce with FAR .106-l(b), l lug•Streit USA. lnc-.. is the only responsible source of meeting the necch of NMCSo·s minimum roquimncnts.

6, Efforts to Obtain Competition:

�arl<et research was conducted by technical experts In December 2024. This research consisted of reviews of similar previous procurements, using search engines In an effort to find open market contractors, and reviewing mandatory sources. Search engines utilized Include SAM.gov, FPDS-NG, DHA Inventory, Excess Personal Property, Federal Prison Industries (FPI), Ability One, ECAT bLA, GSA Advantage, and the VA to identify potential sources that can meet the Government's requirements, Only Haag-Streit USA, Inc. is the only manufacturer that can provide this specialized equipment for NMCSD. Haag-Streit USA, Inc. also confirmed via OEM sole source letter that there are no authorized distributors.

A Notice of Intent (NOi) NOi # HT941025N0026 was posted on the System for Award Management website (SAM.gov) from 15 January 2025 and closed on 21 January 2025 in accordance with FAR Subpart 5,2, No additional sources submitted capabilities statements for the Government's consideration, 7, Determination that Anticipated Cost to the Government will be Fair and Reasonable: