Single Source Justification_Pentacam Altoona_Redacted22.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1

For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($2SOK)

Acquisition Plan Action ID: 36C244-22-AP-3825

1. Contracting Activity: Department of Veterans Affairs, VISN 04, James E. Van Zandt Veterans' Administration Medical Center 2907 Pleasant Valley Boulevard, Altoona, PA 16602-4305.

Purchase Request Number: 503-22-2-225-0124.

2. Brief description of supplies required, the intended use, and estimated amount: This new brand name only requirement for an Oculus Pentacam HR 70925-G is to support the Altoona VA Surgical

Eye Clinic. This equipment provides exact, dependable measurements of the eye for diagnosis and lens sizing for cataract surgery. The Oculus provides images five times faster than the other

Pentacam models, enabling the Pentacam HR to deliver impressive representations of the intraocular lens and phakic intraocular lens.

PentacamHR provides results within two seconds. The Pentacam supplies precise diagnostic data on the entire anterior eye segment. The degree of corneal or crystalline lens density is made visible by the light-scattering properties of the crystalline lens and is automatically quantified by the software.

Measurement of the anterior and posterior corneal surfaces supplies the total refractive power and the thickness of the cornea over its entire area. The data on the posterior surface provides optimal assistance in the early detection of corneal changes.

The rotating scan supplies many data points in the center of the cornea. A supplementary pupil camera captures eye movements for subsequent automatic correction of measured data during the examination.

The total estimated contract value:-

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: This Brand name-only requirement will support continuity with other Medical Center's equipment and standardize equipment for operational, safety, and maintenance purposes. Different units and brands can create confusion and doubt amongst providers (MDs, NPs, PAs, and Residents), trained and untrained providers. A mix of brands and different procedures would make it challenging to perform effectively and consistently. Preventative maintenance checks, repairs, sterilization, and life-cycle procedures would become more complicated with other units due to different parts, the longevity of equipment, training requirements, and vendor procedures.

Oculus is the only brand name capable of meeting these needs without substantial duplication of cost. Maintaining brand continuity within the medical center would require additional training and the replacement of working/functional units of parts currently in inventory.

• Dimensions: (W x D x H) 275 x 320 to 400 x 500 to 530 mm

• Camera: Digital CCD Camera

• Blue LED Light source

Capable of 100 Images per 2sec Interface: USB-2 Fast Screening report Topography maps of the anterior and posterior corneal surface Pachymetry maps, absolute and relative Elevation maps of the anterior and posterior corneal surface Overview of all captured Scheimpflug images 3D Anterior chamber analysis Anterior segment tomography Topometric keratoconus classification Belin ABCD keratoconus staging Iris image and corneal diameter (HWTW) Four Maps Refractive Display Comparative and differential analysis of two examinations Contact lens fitting software including sagittal elevation and Fourier Cataract and Refractive Package included Holladay Report and EKR65 Detail Report Motorized Hardware table 21.5” All-in-One PC Network license key with viewing software Measuring range Curvature: 9 to 99 D Accuracy: plus or minus 0.1 D Reproducibility: plus or minus 0.1 D Working distance: 80 mm 10yr lifecycle expectancy

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

Market research was conducted utilizing Vendor Information Page (VIP), Strategic Acquisition Center (SAC), Federal Procurement Data System – Next Generation (FPDS-NG), and system for Award Management (SAM). The Original Equipment Manufacturer (OEM) for the Oculus Pentacam HR product line is Oculus (Small Business) and their sole authorized distributor was verified, Melling Medical as a SDVOSB through Vetbiz.

Market Research was conducted and a sources sought notice 36C24422Q0616 was published in beta.SAM, closed on 4/19/2022 and no additional results identified. A search on FPDS and Vetbiz yielded two SDVOSB's L1 Enterprises and Hurt Vet Subcontrcating, LLC, both SDVOSB's were contacted, and neither could provide a product that was a brand name or equal to the Oculus Pentacam HR. The Pentacam HR is manufactured by OCULUS and Melling, LLC d/b/a MellingMedical a small buisness, a Service Disabled Veteran Owned Small Business (SDVOSB), is the only authorized distributor for the Pentacam HR. Melling Medical has been determined to be a responsible source with respect to performance and the business meets eligibility requirements in 819.7003.

A search on FPDS-NG yielded the following results:36C25021P0813 (3/15/21), 36C24221P0587 (3/16/21), 36C25021P0834 (3/19/21), 36C24121P0599, (5/15/21), 36C26121P1132 (6/21/21) and 36C24421P0818, (7/21/21) All five are Sole Sourced to Melling Medical.

Based on the Market Research, Oculus Inc., manufacture (small) and Melling LLC (SDVOSB) as its only authorized sole distributor, this requirement will be solicited under simplified acauisition procedures as a small business set-aside in accordance with the Non Manufacture rule and the justification will be posted with the solicitation in accordance with FAR FAR 5.102

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.