S02 - RFQ-Attachment B - Brand Name Justification.pdf

MEMORANDUM TO THE FILE

Subj: JUSTIFICATION FOR USE OF OTHER THAN FULL AND OPEN

COMPETITION AS A BRAND NAME ONLY ACQUISITION UNDER THE

SIMPLIFIED ACQUISITION THRESHOLD

1. Agency and the contracting activity:

Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Veterans Integrated Service Network (VISN) 22, Network Contracting Office (NCO) 22.

2. Description of Action being approved:

This requirement is for a firm fixed price purchase for an Ocular Flourophotometer, Eye (Inner- Ocular) Imaging, Angiography Computerized Zeiss OS / Cirrus HD-OCT (Model 5000) with AngioPlex / Angiography Version 11, and an Anterior Segment Premier Module for the VA Los Angeles Healthcare System as Brand Name Only.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value):

VA Los Angeles Healthcare System requires a new ocular testing instrument/s to augment their current VA-owned Zeiss systems to provide better care and increase services and throughput for the veteran patient population supported by this facility. This requirement has a direct impact on patient care and must be procured in a timely manner.

The items being requested are as follows:

PRODUCT DESCRIPTION PART # UNIT QTY

Zeiss OS / Cirrus HD-OCT (Model 5000) 266002-1160-390 EA 1 Zeiss OS / Anterior Segment Premier Module 266002-1157-764 EA 1

Unit/Equipment nomenclature/description:

4. An identification of the statutory authority permitting other than full and open competition.

_X_13.501 Special documentation requirements. Brand name acquisition conducted under simplified acquisition procedures are exempt from the requirements in FAR Part 6.

However, contracting officers must prepare brand name justifications using the format at 6.303-2, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C.1901 or the authority of 41 U.S.C.1903

(a) FAR 13.106-1(b)(1)(i) states for purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization).

(b) As required by FAR 13.106-3(b)(i), this memorandum explains the limitation of sources for this acquisition, as only one brand name will be solicited for this requirement (or for a portion of the requirement) and the requirement (or portion of the requirement to be sole-sourced) is not expected to exceed the simplified acquisition threshold.

5. Determination for use of other than full and open competition:

A. _X_ BRAND NAME

This acquisition is restricted to the following Source/Manufacturer: Carl Zeiss Meditec USA, Inc., 5300 Central Parkway, Dublin, CA 94568 http://www.zeiss.com/meditec/us/customer-care.html.

Manufacturer POC, Phone Number and Email: Parker Bellinger, (818) 207-4979, parker.bellinger@zeiss.com.

6. A demonstration of the proposed Brand Name equipment, software and/or service that provides a unique qualification or the nature of the acquisition and why it requires use of the authority cited.

• VA Los Angeles Healthcare System (VAGLAHCS) currently uses VA-owned Zeiss equipment/instruments to provide veteran patient care. Zeiss has proprietary software and technology for which only other Zeiss equipment/instruments are compatible.

• VAGLAHCS eye clinics currently have two (2) new Zeiss Cirrus HD-OCT 5000 instruments in their clinics. Originally, a request for three (3) instruments was made to replace very antiquated 20-year-old systems in the Eye Clinics, two (2) for West Los Angeles (WLA) and one (1) for Los Angeles Ambulator Care Eye Clinic (LAACC). The Eye Clinics only received two (2) new Zeiss Cirrus HD-OCT 5000 machines, one (1) for WLA and one (1) for LAACC. The second machine at the WLA Eye clinic is still 20 years old and needs to be replaced, as it is currently not working and has a huge impact on patient care in the clinic, as 1/3 of all patients coming to these Eye Clinics require a test on these machines.

• This purchase is identical to the two (2) new Zeiss Cirrus HD-OCT 5000 machines in the clinics. It will replace the second 20-year-old machine in the WLA Eye Clinic.

• The two (2) new Zeiss Cirrus HD-OCT 5000 machines were procured competitively in October 2022, and procurement of the needed third instrument is a logical follow on to the station’s original bona-fide need for three (3) instruments. This will be a direct replacement of an identical system.

• These systems are very complex and introducing disparate systems into the patient care environment for just this one (1) unit will require doctors to switch between different complex systems when treating patients, increasing the likelihood of medical errors, and creating an unacceptable risk to VA and its patients.

http://www.zeiss.com/meditec/us/customer-care.html mailto:parker.bellinger@zeiss.com

7. Description of the market research conducted and the results or a statement of the reason market research was not conducted.

The GSA website was consulted to see if other manufacturers of Ocular Flourophotometers exist and none were identified. Carl Zeiss Meditec USA, Inc. does not have a GSA/FSS contract for Ocular Flourophotometers. Consulted the Internet for manufacturers of Ocular Flourophotometers, which returned two (2) vendors on the first two (2) Internet pages. First, the OcuMetrics Fluorotron Master Ocular Flourophotometer. A review of the equipment’s capabilities and vendor’s website information did not reveal if it was compatible or could be integrated with Zeiss equipment. Second, the Bridge Tronic Global Shimadzu RF 1501 Flourophotometer. A review of the equipment’s capabilities and vendor’s website information did not reveal if it was compatible or could be integrated with Zeiss equipment.

8. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized.

In order to promote competition to the maximum extent practicable for this procurement, the VA intends to competitively source the brand name items to be purchased.

An RFI sources sought 36C26223Q0801 was issued on 03/30/2023 to Contract Opportunities (SAM.gov) to ensure that it was publicized and available to identify interested and capable vendors. The RFI Sources Sought, resulted in two (2) response from Corps Biologicals LLC (SDVOSB) and PROAIM America’s (Small Business) for the exact brand name, make, and model. Both vendors provided current pricing.

9. Determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

After reviewing VetCert, GSA, WSNC, SCMC and RFI data, the market research has shown that the pricing the vendors submitted in their responses to the RFI is consistent with market pricing for the items to be purchased such that the contracting officer can rely upon the prospect of competition for this procurement to ensure that the cost to the Government will be fair and reasonable.

10. List of the sources, if any, that expressed, in writing, an interest in this acquisition.

The Sources that expressed interest in this acquisition:

Carl Zeiss Meditec USA, Inc. (Large): Exact Brand Name, Make and Model PROAIM America’s (Verified SB): Exact Brand Name, Make and Model Corps Biologicals LLC (Verified SDVOSB): Exact Brand Name, Make and Model

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

When the currently installed system(s) reach end-of-life and a new procurement is required, VA will issue a solicitation that will allow for products of all manufacturers who meet the system criteria to be considered for contract award.

12. Certifications

As the Contracting Officer, I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

ROBERT W. HUTCHISON

Contracting Officer NCO 22, Pathology & Laboratory Acquisitions