FAR 8 Sole Source Justification - 36C242-27-AP-0135 Redacted.pdf

Acquisition ID#: 36C242-27-AP-0135

SOURCE JUSTIFICATION

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FAR PART 8.401(b) GSAR 538.7104-3

Acquisition Plan Action ID: 36C242-27-AP-0135

Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 2 located at 2094 Albany Post Road, Montrose, New York 10548 in support of Organizational Activity: VISN 2 New York Harbor Healthcare System Pathology and Laboratory department located at 423 East 23rd Street New York, New York 10010 seeks to purchase brand name Abbott reagent kits/consumables and supplies through 2237#630-27-1-035-0001 funded action.

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).

Name of Proposed Contractor: Abbott Laboratories, Inc.

Street Address: 1300 E. Touhy Avenue City, State, Zip: Des Plaines, IL 60018 Phone: 224-361-7726

(3) Description of Supplies or Services:

The proposed action is to provide reagents and consumables for the Alinity M PCR Analyzer system owned by VA and manufactured by Abbott Laboratories, Inc. The consumables will allow the New York Harbor Margaret Cochran Corbin campus to test for SARS-CoV-2 (COVID- 19), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human immunodeficiency Virus (HIV)- 1 onsite. The request is for essential, diagnostic consumables to be used for panel tests for the above diseases. The vendor has proprietary rights to the reagent kits and consumables needed for this award.

Period of Performance:

Base Year: 10/01/2026 through 09/30/2027-$ .

Option Year 1: 10/01/2027 through 09/30/2028- .

Option Year 2: 10/01/2028 through 09/30/2029- .

Option Year 3: 10/01/2029 through 09/30/2030- Option Year 4: 10/01/2030 through 09/30/2031-

The estimated value of the proposed action is $

(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. (CHECK THE APPLICABLE AUTHORITY BELOW AND COMPLETE)

FAR 8.401(b) IAW GSAR 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.401(b) IAW GSAR 538.7104-3(b)(1)(ii): 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.

Margaret Cochran Corbin VAMC owns one (1) Abbott M PCR analyzer system, which is used for all required testing for blood-borne diseases and COVID-19, and there is in place, which expires on 0 This requirement will ensure a seamless continuation following that BPA. Abbott Laboratories is the sole manufacturer of the reagent kits and consumables, and there are no other sources capable of meeting the requirements, thereby precluding consideration of products manufactured by another company. The reagent kits will provide superior testing and patient care through:

The ability to manage most routine PCR tests on a single platform.

Driving standardization through simple, universal design elements.

Innovative technology is underpinned by robust design to provide accurate, consistent results.

Multiplex technology enabling improving workflow and increasing productivity.

Real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) diagnostics.

FAR 8.401(b) IAW GSAR 538.7104-3(b)(1)(iii): 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 8.401(b) IAW GSAR 538.7104-3(b)(1)(iv): Items peculiar to one manufacturer:

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 8.401(b) to aid the contracting officer in making this best value determination:

As the Contracting Officer, I determine that this sole-source requirement represents the best value to the Government. I evaluated the proposed pricing by comparing several items on BPA agreement No. 36C24221A0036 to the established rates under Abbott Laboratories’ FSS Contract No. 36F79724D0201. CO confirmed that the BPA pricing does not exceed the applicable Schedule pricing, a few items are priced , and the FSS schedule will be extended past 09/30/2031. This comparison demonstrates price reasonableness and ensures the Government receives fair, compliant pricing under the FSS program. The VA currently owns and operates an Abbott analyzer that is fully compatible with the required reagents and consumables. These reagents are FDA- for this equipment and are essential to maintain operability. Transitioning to a different vendor’s testing platform would require purchasing new analyzers, retraining personnel, conducting full validation studies, and acquiring new consumables, resulting in high additional costs and operational disruption. Maintaining the existing Abbott platform avoids these unnecessary costs, ensures uninterrupted laboratory operations, and fully leverages the Government’s prior investment in the equipment, supporting fiscal responsibility and overall cost efficiency. Additionally, IAW GSAR 538.7102-2(c) (2), before issuing orders under the new BPA, CO will seek further discounts to ensure price optimization throughout the performance period. For these reasons, the sole-source requirement under this BPA clearly represents the best value to the Government.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market research was conducted, which included searching in the SBA Small Business Search Tool (formerly DSBS), Medical Surgical Prime Vendor mandatory list (MSPV), DLA Medical Electronic Catalog (ECAT), VA National Acquisition Center contracts (VANAC), GSA E-buy, contract opportunities (SAM.gov), and consulting with OEM Abbott Laboratories seeking additional sources for the reagents. This was the result of the above. The SBA small business search using the NAICS 325413 keyword “Alinity M Reagent Kits” returned zero (0) SDVOSB, zero (0) VOSB, and zero (0) small business sources capable of providing the reagent kits. A search in mandatory MSPV listing using the keywords “HIV-1” and “HPV Amp kit” showed zero

(0) sources available. A search was conducted in ECAT using the catalog numbers “08N45-095, 08N45-085, and 08N47-95, resulting in zero (0) potential sources. A search of the VA National

Acquisition Center contracts found that Abbott Laboratories, Inc., holds FSS schedule contract No. 36F79724D0201 for all reagent kits and consumables required for this procurement. A notice of intent to sole source #36C24226Q0498 was posted to contract opportunities from April 01, 2026, through April 30, 2026, which yielded zero (0) responses. A notice of intent to sole source notice #RFI1803886 was posted on GSA E-buy from April 01, 2026, through April 30, 2026, which yielded zero (0) responses. CO consulted OEM and received a sole-source letter from Abbott Laboratories showing that there are no authorized distributors of the reagent kits or consumables. With this information, the Contracting Officer concluded from the results of the market research that there were insufficient SDVOSB or VOSB with both interest and capability to meet the VA Rule of Two as defined by VAAR 819.70. Therefore, a set-aside for SDVOSB or VOSB providers is not a viable strategy for this procurement. Based on the above criteria of lines 4, 5, and 6, it is in the Government’s best interest to sole source this requirement.

(7) Any Other Facts Supporting Justification:

None.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

In order to remove or overcome barriers to competition in future acquisitions for this requirement, the agency would have to continue to review the marketplace to determine if new products are such that could be cost-effective to replace the entire existing physiological PCR testing equipment and supplies.

(9) Requirements Certification: I certify that the requirement outlined in this justification is a bona fide need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by .

Date Medical Laboratory Manager Margaret Cochran Corbin campus

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

BYRD