Attachment 1 Justification and Approval CENTURION VISION SYSTEM SAM.gov Redacted.pdf

General Services Administration Federal Acquisition Service, Southwest Supply Operations Center

JUSTIFICATION AND APPROVAL

FAR 13.106-1(b)(1)(i) Brand Name “ALCON CENTURION VISION SYSTEM”

USNS COMFORT (T-AH 20)

1. IDENTIFICATION OF THE AGENCY AND CONTRACTING ACTIVITY

Contracting Activity: General Services Administration (GSA) Federal Acquisition Service (FAS) Southwest Supply Acquisition Center, Large SOP 819 Taylor St., Fort Worth, TX 76102

Requiring Activity: Naval Medical Readiness Logistics Command Detachment Fort Detrick, MD

(NMRLC DET FTDMD)

ICO USNS COMFORT (T-AH 20)

Description of Requirement: Alcon, Centurion Vision System Inclusive Bundles Navy Hospital Ship Configuration

Brand Name: Alcon Vision, LLC 6201 South Freeway Fort Worth, TX 76134-2099

(817) 293-0450 www.alcon.com

Acquisition PIID: 47QSWC23K0110

Vendor: O.R. Elder Inc.

1270 Broadway, Suite 401 New York, NY 10001

(212) 695-2724

Procurement Vehicle: Open Market

Estimated Task Order Value: $

2. NATURE OR DESCRIPTION OF THE ACTION BEING APPROVED

This justification is for permitting other than full and open competition to support the brand name acquisition at a firm fixed price for two (2) ALCON, Centurion Vision System Inclusive Bundles – Navy Hospital Configuration.

These bundles have been specifically configured to meet Navy Hospital Ship requirements and are the same make and model as listed on the Naval Operating Forces’ Authorized Medical Allowance List (AMAL) approved by the Fleet Surgeon. This justification is in accordance with the following statutory authority:

a. Authority. 41 U.S.C. 1901

i) FAR 13.106-1(b)(1)(i) Soliciting from a single source. (1) For purchases not exceeding the simplified acquisition threshold. (i) 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).

The vendor, O.R. ELDER, Inc., is the designated Department of Veterans Affairs Certified, Service Disable Veteran Owned Small Business distributor for Alcon Vision Surgical products per Enclosure (1) and is the sole source distributor of the required Brand Name Alcon, Centurion Vision System Inclusive Bundle, Navy Hospital Ship Configuration.

3. DESCRIPTION OF SUPPLIES REQUIRED TO MEET THE AGENCY’S NEEDS

Each Alcon, Centurion Vision System Inclusive Bundle-Navy Hospital Ship Configuration includes:

a. One (1) Centurion Vision System with Active Sentry

b. Four (4) Centurion Active Sentry OZIL handpieces

c. Four (4) Ultraflow II/A handpieces

d. Installation and Freight

e. One-year factory warranty

Naval Medical Readiness Logistics Command (NMRLC) Detachment (DET) Fort Detrick, Maryland (FTDMD) has a need for two (2) Alcon, Centurion Vision System Inclusive Bundles-Navy Hospital Ship Configuration for the

USNS COMFORT (T-AH 20).

NMRLC DET FTDMD requires the issuance of a single award firm fixed price (FFP) Purchase Order (PO) for a total estimated cost of $ exclusive of GSA fees.

The required quantities, item numbers, and description are reflected in the table below.

QTY ITEM NUMBER DESCRIPTION

2 ORE090.795.914 Centurion Vision System Inclusive Bundles

Two (2) Centurion Vision System Inclusive Bundles Include:

2 900198090 Centurion vision System w/Active Sentry 8 8065752914 Centurion Active Sentry OZIL Handpiece 8 8065751795 Ultraflow II/A Handpiece 20 PPK 12416-01 USNS COMFORT Phaco Pack - Centurion 5 AS2277-26 Alcon House Standard Eye Pack Shipper (4 packs per Shipper) 2 N/A Standard One Year Factory Warranty 2 N/A Installation and Freight

The NMRLC has provided adequate funding by MIPR to GSA for this requirement.

Shipping and handling terms are F.O. B. Destination. Inspection and acceptance shall be at a CONUS location.

Products for this purchase order have a required delivery date of 15 days after receipt of order.

4. IDENTIFICATION OF STATUATORY AUTHORITY

This acquisition is conducted under the authority of FAR 13.106-1(b), Soliciting from a single source, as the required brand name Alcon, Centurion Vision System Inclusive Bundles are only available from one (1) designated distributor, O.R. Elder, Inc. Acquisitions conducted under simplified acquisition procedures are exempt from the requirements of FAR Part 6, thus the requirement for full and open competition does not apply in accordance with FAR 13.501(a)(1). The Contracting Officer (CO) completed this justification and approval as required for a sole source (including brand name) acquisition by utilizing the format listed in FAR 6.302-2 as required by FAR 13.501(a)(1)(ii) and modified the format to reflect FAR 13.5 procedures that were used in accordance with 10 U.S.C. 3204(a)(1).

Approval at the specified levels in accordance with FAR 13.501(a)(2) will be obtained. This purchase will not exceed the simplified acquisition threshold. The Contracting Officer (CO) 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) in accordance with FAR 13.1061(b).

5. DEMONSTRATION THAT THE ACQUISITION REQUIRES THE USE OF THE AUTHORITY CITED

Vendor, O.R. ELDER, Inc., is Department of Veterans Affairs Certified, a Service Disable Veteran Owned Small Business and the designated sole distributor for Alcon Vision Surgical products per Enclosure (1) hence the sole source distributor of the required brand name Alcon, Centurion Vision System Inclusive Bundles, Navy Hospital Ship Configuration. These bundles have been specifically configured to meet Navy Hospital Ship requirements and are the same make and model as listed on the Naval Operating Forces’ Authorized Medical Allowance List (AMAL) approved by the Fleet Surgeon. The configuration of the equipment bundle is outlined in Section 3 of this document. Equipment contained within the Authorized Parts List (APL) is analyzed and procured to meet operability, maintainability, and sustainment for operations at sea and in expeditionary ashore environments. The Alcon, Centurion Vision System Inclusive Bundles are a part of the APL. Additionally, the Integrated Logistics Support (ILS) documentation was developed to support the Alcon, Centurion Vision System Inclusive Bundle which also includes Preventative Maintenance System (PMS) procedures, Navy Technical Manual number assignment to the vendor to provide Commercial Off the Shelf (COTS) operator and service manuals. APL development costs the Government between $2Kand $6K per APL depending on complexity of equipment. PMS development costs the Government between $4K and $8K depending on complexity of equipment. The assignment of Navy Technical Manual numbers incurs government costs of approximately $1K and $5K per manual depending on the size of manuals. These ILS products are a requirement for onboard equipment in accordance with OPNAV INST 4790.4D (Ship’s Maintenance and Material Management (3M) System Policy).

Purchase of equipment from another manufacturer other than Alcon would incur additional cost as well as add unnecessary time required to develop new Integrated Logistics Support (ILS) documentation, AMAL reconfiguration and approval and ultimately causing serious delays in patient care. Maintaining standardization and continuity will maximize the USNS COMFORT’s ability to provide critical and timely healthcare service to military personnel throughout the area of responsibility.

6. DESCRIPTION OF EFFORTS TO SOLICIT AS MANY OFFERS AS PRACTICABLE OR EXCEPTION

Market research was conducted in accordance with FAR Part 10 by technical experts in April 2023. This research consisted of reviews of similar previous procurements and a market survey through search engines of open market contractors and Federal Supply Schedule (FSS) contractors. Searches were conducted utilizing the following databases: DLAs’ Medical Master Catalog (MMC), Medical Contingency Requirements Workflow (MCRW), Electronic catalog System (ECAT), Web Federal Logistics Information System (WEBFLIS), Commercial and Government Entity Program (CAGE), SAM.gov and the Naval Medical Logistics Command Enterprise Business Environment. During market research it was discovered that O.R. Elder Inc. is the sole distributor of the Alcon, Centurion Vision Bundles configured for the Hospital Ships.

7. DEMONSTRATION BY THE CONTRACTING OFFICER THAT THE ANTICIPATED COST TO THE

GOVERNMENT WILL BE FAIR AND REASONABLE

The contracting officer has determined the establishment of a delivery order represents the best value (as defined in FAR 2.101) to the Government and will result in the lowest overall cost alternative (considering price, special features, administrative costs, etc.) to meet the Government’s needs.

The Contracting Officer anticipates the use of variety of price analysis techniques to substantiate price reasonableness and evaluation of the items requested in accordance with FAR 13.106-3(a)(2). These techniques included, but are not limited to the following:

(2) If only one response is received, include a statement of price reasonableness in the contract file. The contracting officer may base the statement on-

(i) Market research;

(ii) Comparison of the proposed price with prices found reasonable on previous purchases;

(iii) Current price lists, catalogs, or advertisements. However, inclusion of a price in a price list, catalog, or advertisement does not, in and of itself, establish fairness and reasonableness of the price;

(iv) A comparison with similar items in a related industry;

(v) The contracting officer’s personal knowledge of the item being purchased;

(vi) Comparison to an independent Government estimate; or

(vii) Any other reasonable basis.

8. DESCRIPTION OF THE MARKET RESEARCH CONDUCTED

AbilityOne, Green Procurement List, and UNICOR were all checked and do not offer the required Alcon, Centurion Vision System Bundles. A MRAS Rapid Review request was made on July 6, 2023. A total of zero (0) vendors were included in the results for vendors with GSA MAS contracts. Additional market research of the GSA e-library identified two (2) IDIQ VA contracts 36F79720D0234 and 36F79722D0040 for Alcon Vision equipment. On July 9, 2023, Jonathan Dilenno, National Accounts Director for Alcon, confirmed that the required items are not on Alcon’s Federal Supply Schedule and that they are being handled by their 3rd party distributor, O.R. ELDER, Inc. Robert S.

Elder also confirmed they are the designated distributor for Alcon Vision products providing a letter via email. On July 11, 2023, Robert Elder also indicated that the required Alcon products are not available for GSA purchase through either of those IDIQ contracts but rather on a direct contract basis. A sources sought was posted on Sam.gov on July 6, 2023, closing July 14, 2023. One (1) response was received from on overseas company, Jordan Sea Company, which upon further investigation did not have a MAS contract nor were they a viable source of supply.

Market research revealed O.R. ELDER, Inc., a Service-Disabled Veteran Owned small business, to be the only officially designated distributor of the required brand name Alcon, Centurion Vision System Inclusive Bundles, Navy Hospital Ship Configuration.

Based on all market research this requirement will be procured following FAR Part 13 procedures (Simplified Acquisition Procedures). A solicitation and the justification and approval will be posted through the Government Point of Entry (GPE) on Sam.gov for fifteen (15) days.

9. ANY OTHER FACTS SUPPORTING THE JUSTIFICATION

All facts supporting this justification are provided above.

10. LIST OF SOURCES THAT EXPRESSED AN INTEREST IN THE ACQUISITION

O.R. ELDER, Inc.

11. STATEMENTS OF ACTION TO OVERCOME BARRIERS TO COMPETITION

To overcome barriers of competition, NMRLC will continue to evaluate and assess capabilities of other brands/models and vendors through continuing market research to meet mission requirements. Furthermore, the Government will continue to encourage competition from multiple sources of supply while also synopsizing any intent to limit sources for future requirements, thereby involving industry in possible solutions for the required items. Continued efforts in this regard will ensure the Government utilizes the most efficient and economical provider.

GSA conducts continuous market surveys on products to determine the availability of qualified sources for meeting mission-critical objectives.