Attachment 1 Single Source Justification MPT to SAT_Pascal Scanning Laser System.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 2

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C242-23-AP-1001

1. Contracting Activity: Department of Veterans Affairs, VISN 02, Network Contracting Office, Appletree Business Park, 2875 Union Road, Suite 3500 Cheektowaga, NY 14227, in support of Department of Veterans Affairs, VISN 2, Samuel S. Stratton VA Medical center, located at 113 Holland Avenue, Albany, NY 12208.

PR # 528-23-2-8085-0088

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Pascal Synthesis (532) Photocoagulator system (PA04) model # SA-06454. The system is intended for use by trained Ophthalmologists for diagnosis and treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation, and grid photocoagulation for vascular and structural abnormalities of the retina and choroid.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

Pascal Synthesis (532) Photocoagulator system’s Endpoint Management software uses a proprietary algorithm to control power and duration, giving greater flexibility and control. The shorter duration pulses result in faster procedures with less pain, collateral damage, and scarring. The unique fiber delivery system results in a uniform spot that is easier to focus. Precision spots with multi-fiber beam technology is easier to focus predictable and uniform spots with rapid pattern scanning laser delivery. Enhanced laser delivery slit lamp. Pattern Scanning Laser Trabeculoplasty (PSLT)1 for IOP reduction is a tissue-sparing laser treatment for reducing intraocular pressure in open angle glaucoma. PSLT provides a rapid, precise, and minimally traumatic computer-guided treatment that applies a sequence of patterns onto the trabecular meshwork. Endpoint Management for sub-threshold treatment the Arrhenius Integral coupled with extensive data on retinal laser-tissue interactions define the algorithms for Endpoint Management.

4. Description of market research conducted and results or statement why it was not conducted:

Contract Specialist conducted three searches of FPDS. The first search utilized NAICS Code 339112 and keywords “Pascal Laser,” which resulted with L1 Enterprises Incorporated (SDVOSB), Melling

Medical (SDVOSB), Topcon Medical Systems Inc.(Large Foreign Owned), and Optimedica

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 2 of 2

Corporation, which has been inactive in SAM.gov since 2014. The second search utilized NAICS Code 333314 and keywords “Pascal Laser,” which resulted with L1 Enterprises Incorporated (SDVOSB) and Topcon Medical Systems, Inc. (Large Foreign Owned). The third search utilized keywords “Pascal Synthesis 532” which resulted with L1 Enterprises Incorporated (SDVOSB).

Contract Specialist searched GSA using keywords “Photocoagulator system” which did not provide any results. A search using keywords “Pascal Synthesis 532” did not provide any relevant results. A search of part number “SA-06454” which did not return any results.

Iridex Corporation, the manufacturer of the Pascal distributor Pascal Synthesis (532) Photocoagulator System, provided a letter to certify that L1 Enterprises Inc, is an authorized sole source distributor for all Lasers And accessories for Ophthalmic use.

Contract Specialist confirmed that L1 Enterprises Inc. is an SDVOSB vendor using VetCert.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name Date Title

Myra Florisa N. Green 742176

Digitally signed by Myra Florisa N. Green 742176 Date: 2023.05.02 14:56:08 -04'00'