P03 FAR 8 LSJ 36C242-22-AP-3377_Redacted1.pdf

36C242-22-AP-3377

Effective Date: 02/01/2022 Page 1 of 5

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C242-22-AP-3377

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 02, located at James J. Peters VA Medical Center 130 West Kingsbridge Road, Bronx, NY 10468, in support of Veterans Integrated Service Network 02, VA New York/New Jersey Healthcare System, James J. Peters, Northport, Buffalo, Canandaigua, Syracuse, Bath, Samuel S. Stratton Albany and Hudson Valley FDR VAMCs, seeks to purchase Abbott BinaxNOW COVID-19 antigen card tests with 2237# 526-23-2-145-0012, 528-23-2-7307-0006, 561-23-2-040-0017, 620-23-2- 124-0013 and 632-23-2-080-0010 funded actions.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). This sole source justification and approval are for the award of an FSS five (5) year Blanket Purchase Agreement (BPA) for brand name Abbott BinaxNOW ag card portable rapid protein diagnostic tests for VA New York/New Jersey Healthcare System VISN 2 South and North facilities. These required test kits are currently in use throughout the facilities and will serve as critical diagnostic equipment, allowing medical and healthcare professionals rapid detection results of SARS-COV-2 (hereafter referred to as COVID-19), within the first seven days of symptom onset. Its functionality, workflow flexibility, portability and ease-of-use make it an ideal solution for settings with laboratory personnel.

Order against: FSS Contract Number: 36F79721D0073

Name of Proposed Contractor: Abbott Rapid DX North America, LLC

Street Address: 30 S Keller Rd STE 100

City, State, Zip: Orlando, FL 32810

Phone: 224-668-2076

(3) Description of Supplies or Services:

The estimated value of the proposed action is

Period of Performance:

Base Year-December 22, 2022 - December 21, 2023 - Year 1- December 22, 2023 - December 21, 2024 -

Effective Date: 02/01/2022 Page 2 of 5

Year 2- December 22, 2024 - December 21, 2025 - Year 3- December 22, 2025 - December 21, 2026 - Year 4- December 22, 2026 - December 21, 2027 -

Veterans Integrated Service Network (VISN 2) South and North facilities have a follow-on requirement to establish an FSS Blanket Purchase Agreement (BPA) to continue the qualitative detection and diagnosis of COVID-19 point-of-care (POC) results in 15 minutes or less on symptomatic patients and enable healthcare workers to identify infectious individuals and trace their contacts. This testing requires rigid oversight by each Pathology and Laboratory Medicine Service to maintain regulatory compliance with the Joint Commission (TJC) and Clinical Laboratory Improvement Amendments (CLIA). This test is currently performed by 313 trained VA employees in 42 sites throughout VISN 2. The FSS NAC contract expires on 01/03/2026, but CO called NAC Contracting Officer and received confirmation that the NAC will exercise the next option period 2027

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

Abbott Rapid DX North America, LLC. is the only vendor that can provide point-of-care test kits for the rapid detection of SARS CoV-2 (hereafter referred to as COVID-19), with positive and negative quality control swabs in each box and the ability to visually read the test results without need for a reader device. This specific test was chosen for VISN 2 due to the need to set up and also move testing sites based on the COVID-19 positivity rate, thereby allowing testing at the point of contact or service which greatly enhances infection control standards by keeping the spread of COVID-19 disease in limited areas of each medical center.

Each site expended considerable resources to train staff to perform this test and to maintain competency of staff ongoing. This test is ideal for these purposes because it is a visual test not requiring purchase of a reading device each time a new site is needed.

For this reason, Abbott BinaxNOW rapid Antigen Card test would continue to meet the agency’s need for continuity of care.

Effective Date: 02/01/2022 Page 3 of 5

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

IAW FAR Part 8.404(d); GSA has determined the price of supplies/services under schedule to be fair and reasonable. I hereby determine that the proposed BPA action will represent the best value to the Government. Abbott Rapid DX proposed prices will be compared to the (FSS) contract number 36F79721D0073 prices. This comparison will ensure that the proposed prices do not exceed those prices, and the Government will request a discount pursuant to FAR 8.405-

4. Given the fact that the demand continues to rise, and VA has an immediate need to procure the Abbott BinaxNOW COVID-19 test kits, this will enable VA to be able to continue to meet the diagnostic needs of its healthcare facilities and Veterans at VA facilities.

(6) Describe the Market Research Conducted

Market research was conducted, which included searches in Veterans Information Pages (VIP), posting notices in Contract Opportunities and GSA E-buy, searching SBA Small Dynamics business search tool (DSBS), ECAT, MSPV catalog, VA National Acquisition Center contracts, FPDS and SAC mandatory contracts. The result of the search in VIP showed one (1) source potentially capable of providing the test kits. Sources sought notices posted in Contract Opportunities from 11/07/2022 – 12/05/2022 yielded five (5) responses from ( and GSA E-buy from November 07, 2022, through December 05, 2022, yielded zero (0) responses. Searches on DSBS, MPV catalog, SAC mandatory contracts yielded zero (0) potential vendors. Search on FPDS and National Acquisition Center (NAC) resulted in showing Abbott Rapid DX North America, LLC as the vendor providing the test cards under FSS#36F79721D0073. A search on ECAT showed that the product is available through and but since the procurement is over SAT and FSS has the tests in its catalog, ordering through ECAT is not