STAGO Sole Source Justifcation GSAM.71043_b over SAT Redacted.docx

36C244-26-AP-3142 | VISN 4 | New VISN Coagulation BPA

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: 36C244-26-AP-3142

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 04, located at 1010 Delafield Road, Pittsburgh, PA 15215, in support of VISN 04 VA Health Care System.

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 proposed action will be a 60-month Firm Fixed Priced, FSS BPA where the requested supplies will be ordered as needed. VISN 04 facilities included in this requirement are: Altoona, Butler, Coatesville, Erie, Lebanon, Philadelphia, Pittsburgh, and Wilmington.

Base Year: 09/01/2026 – 08/31/2027 Option Year 1: 09/01/2027 – 08/31/2028 Option Year 2: 09/01/2028 – 08/31/2029 Option Year 3: 09/01/2029 – 08/31/2030 Option Year 4: 09/01/2030 – 08/31/2031

Order against: |X| FSS Contract Number: 36F797-18-D0351

3. Description of Supplies or Services:

The estimated value of the proposed action is

The contractor is required to furnish laboratory instruments, systems, UPS, reagents, consumables, services, maintenance, training, and support to produce reportable results. The number of tests is determined by the clinical needs at each site.

For the base year and the five option years, each year’s totals break down as follows:

Annual Total:

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.

|X| 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 VISN coagulation instruments are on the Beckman Coulter DXA automation line. This contracted automation line supports all the primary testing instrumentation for the VISN 4 laboratories and can only be supported by the Stago STA R Max coagulation instruments. This coagulation monitoring is sensitive and must remain consistent throughout the VISN. The current Stago instrumentation and reagents have been installed and validated at this facility, and any change in reagent or instrument source would require the laboratories to revalidate testing before results could resume being reported, risking discontinuity in available testing during that transition. Additionally, Diagnositica Stago Inc is the sole distributor in the US for the entire range of Stago in-vitro diagnostics reagents, disposables, instruments, and spare parts. A copy of the manufacturer’s Certificate of Exclusive Distributorship is in the contract file.

5. Describe Why You Believe the Order Represents the Best Value consistent with GSAM/R 538.7102-2(4) to aid the contracting officer in making this best value determination:

This sole source represents the best value because pursuing full and open competition would result in substantial duplication of cost that could not be expected to be recovered through competition, as well as unacceptable delays in fulfilling the VISN's coagulation testing requirements. The only way to ensure continuity of services and testing is to use the equipment that is currently on site and validated for testing at each facility. The validations are contingent on the use of the same brand and type of reagents that were used during the original assessment of instrument performance. The material and service must be compatible in all aspects (form, fit and function) with existing systems presently installed and performing, and this instrumentation can only utilize reagents from this vendor. Competing this requirement would require the VISN to acquire entirely new coagulation instrumentation and revalidate testing at each facility, duplicating costs already invested in the current system and interrupting testing availability during the transition period. Therefore, awarding Diagnostica Stago Inc. is the best value decision because it is the only option that allows continuation of coagulation testing without interruption, without substantial duplication of cost, or risking regulatory violation

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 in accordance with FAR Part 10.

Pricing was obtained through the VA Federal Supply Schedule (FSS), Contract No. 36F79718D0351, as well as an informal quote provided by DIAGNOSTICA STAGO INC.

Diagnositica Stago Inc is the sole distributor in the US for the entire range of Stago in-vitro diagnostics reagents, disposables, instruments, and spare parts. A copy of the manufacturer’s Certificate of Exclusive Distributorship is in the contract file.

7. 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:

For future requirements, additional market research will be completed to see if market conditions or agency’s needs have changed. Once other sources enter the marketplace, future procurements may be competitive.

8. 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 sole source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by GSAM/R 538.71 as directed by FAR 8.4.

Supervisory Clinical Laboratory Scientist

9. Approvals in accordance with the :

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

KERI HESTER

NCO4, Contracting Officer

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $900k): I certify the justification meets requirements for other than full and open competition.

NCO4, Branch Chief, Services 5

HIGHER LEVEL APPROVAL (Required for orders over $900,000)

c. VHA RPO HCA Review and Approval (over $900,000 to $90 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by GSAM/R 538.71 ordering procedures as directed by FAR 8.4.