P03 Sole Source Justifcation-Atlanta Core Lab Integration redacted_Redacted.pdf

Request for Sole Source Format >SAT GSAM/R 538.7104-3(b) Sole Source Justifications - Federal Supply Schedule Ordering

Procedures

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SOLE SOURCE JUSTIFICATION

GSAM/R 538.7104-3(b)

This justification aligns with the deviation outlined in the Revolutionary FAR Overhaul (RFO) for FAR 8.4 - Ordering under the Federal Supply Schedule and GSAM/R 538.71, as required by Executive Order (E.O.) 14275, Restoring Common Sense to Federal Procurement, signed April 15, 2025. Deviation effective date: November 3, 2025.

Acquisition Plan Action ID:_36C247-27-AP-0119

1. Contracting Activity: Department of Veterans Affairs, VISN 07, Network Contracting Office 7 (NCO 7), Atlanta VA Health Care System (AVAHCS) 2237: 508-27-1-2043-0002

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).

The AVAHCS Pathology & Laboratory Medicine Service (PLMS), in coordination with Facilities, Biomedical Engineering, and Health Informatics, is undertaking a multi-phase modernization of the core laboratory to address aging instrumentation, manual pre-analytic workflows, space constraints, and growing test volumes. The project covers three phases:

Phase 1 infectious disease transition, Phase 2 Chem/IA/ID automation in temporary Room 2B-174, and Phase 3 relocation into a new permanent core lab in Room 2B-170.

This is a follow-on requirement to task order 36C24722N0054 which ends September 2026.

This task order will be Firm-Fixed Price (FFP) for a base year and 4 one-year option periods.

Order against: FSS Contract Number: 36F797-19-D0024

Name of Proposed Contractor: Abbott Laboratories Inc.

Street Address: 100 Abbott Park Rd D934 City, State, Zip: Abbott Park, IL 60064

3. Description of Supplies or Services:

The Government requires an integrated core laboratory solution acquired under a cost-per-reportable-result (CPRR) model, in which VHA is invoiced solely based on the number of reported patient test results rather than capital equipment purchases. The solution must provide high-throughput chemistry and immunoassay testing, vendor-neutral track automation, and unified middleware/analytics within the physical constraints of rooms 2B-174 and 2B-170, while embedding all equipment, service, reagents, consumables, middleware, and automation costs into a single CPRR rate.

Procedures

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GSAM/R 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

GSAM/R 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;

The following provide details/rationalization of why this is necessary.

An RFI was issued to multiple companies that provide immunoassay analyzers and core lab automation. However, the vendors differ significantly

, including tracking from outreach/ phlebotomy sites through result release. Abbott Laboratories is the only vendor that demonstrated all three capabilities in a way that is feasible for AVAHCS’s actual rooms and phased implementation.

Research was also conducted to see if there are any licensed distributors of the proposed Abbott equipment to meet this requirement. It was verified that Abbott, as the OEM, does not have any authorized distributors for the VA. Therefore, a sole source to Abbott Laboratories is necessary to meet this requirement.

producing comparable integrated OEM platforms; small businesses participate primarily as distributors or providers of ancillary services not as designers or manufacturers of core analyzers, automation tracks, or middleware.

The VA already utilizes much of the necessary equipment and the additional cost to procure a completely new system is not advantageous or cost effective for the Government. The additional cost(s) for designing/developing a new system to meet this requirement would not only cause a delay in providing the necessary services for our Veterans, but cost additional money to do so.

GSAM/R 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.

GSAM/R 538.7104-3(b)(1)(iv): It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA; or

GSAM/R 538.7104-3(b)(1)(v): A law expressly authorizes or requires that the purchase be made from a specified source.

Procedures

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GSAM/R 538.7104-4: Items peculiar to one manufacturer:

5. Describe Why You Believe the Order Represents the Best Value consistent with GSAM/R 538.7102-2(b)(4) to aid the contracting officer in making this best value determination: Price/costs are determined fair and reasonable as this award will be issued under the GSA FSS. All prices have been negotiated by GSA and were found fair and reasonable at time of award. Options will also be priced in accordance with FSS pricing.

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 for this acquisition included: review of prior AVAHCS and VA contracts for core lab and IVD equipment; release and analysis of an RFI to five major vendors (Abbott, Siemens, Roche, Beckman Coulter, Ortho); vendor-submitted technical proposals and CAD layouts; and internal site visits/virtual sessions focused on space and workflow feasibility. The team also reviewed published product literature, industry documentation on analyzer/track performance, and VA/VHA experience with digital middleware platforms.

The Contracting Officer and Small Business Specialist conducted database checks (SAM, VetCert, DSBS) to identify VetCert-certified SDVOSB/VOSB and other small business distributors; however, the underlying Chem/IA/ID automation systems and middleware are OEM-controlled solutions not developed or manufactured by small businesses. No AbilityOne, FPI, or mandatory Government sources were identified that could provide a comparable integrated core lab automation ecosystem.

7. Any Other Facts Supporting the Justification:

The proposed vendor is currently providing multiple systems to provide diagnostics for our Veterans. This requirement provides additional equipment to provide seamless collection/diagnostics/reportables across the facility thus enhancing veteran experience while saving time and money of consolidating results.

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: At this time the requirement cannot be satisfied through competitive methods. However, for future requirements thorough market research shall again be conducted to ensure, if possible, the requirements will be competed if viable.