Justification Roche_Redacted.pdf
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- Solicitation number
- 36C24226Q0551
About this file
This is a Sole Source Justification document for a simplified procedures acquisition under RFO FAR 12 for commercial items.
The Department of Veterans Affairs, through the Northport VA Medical Center Pathology and Laboratory Services, is procuring Roche Immunohistochemistry (IHC) reagents and supplies compatible with the facility's Roche Ventana HE 600 automated stainer. The contract will be awarded as a firm-fixed-price requirements contract to Roche Diagnostics Corporation, a large business, as the sole manufacturer and distributor of the required products. Deliveries occur on an as-needed basis across five pricing periods spanning from June 1, 2026 through May 31, 2031. The procurement includes ten specific Roche Ventana HE 600 products with estimated quantities per pricing period, including bluing solution, cleaning solution, differentiating solution, eosin, hematoxylin, organic solution, transfer fluid, wash, coverslip activators, and glass coverslips. All products are manufactured in the United States.
Competition is restricted under 41 U.S.C. § 1901 based on the determination that only one responsible source exists and no other supplies or services will satisfy agency requirements. The Contracting Officer confirmed with the OEM on April 20, 2026 that Roche is the sole supplier, posted an Intent to Sole Source Notice (36C24226Q0551) to SAM.gov from April 20–28, 2026 with zero responses, and determined pricing is fair and reasonable by comparison to a previously awarded similar contract (36C24225D0090). Market research included SBA small business searches, FPDS, GSA, SCMC, and ADDS UP searches, all yielding no alternative sources or competing products.
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| File | Type | Posted |
|---|---|---|
| 36C24226D0059_1.docx | DOCX document |
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Acquisition ID#: 36C242-26-AP-2621 Page 2 of 4
4. Statutory Authority Permitting Restricted Competition:
RFO FAR 12 ACQUISITION OF COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES. The statutory authority for applying the Simplified Procedures for Commercial Items of RFO FAR 12 is 41 U.S.C. § 1901 and is implemented by RFO FAR 12.201-1 for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:
(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;
( ) (2) Unusual and Compelling Urgency per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;
( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;
( ) (4) International Agreement per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;
( ) (5) Authorized or Required by Statute per 41 U.S.C. § 1901 as implemented by RFO FAR
12.201-1;
( ) (6) National Security per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;
( ) (7) Public Interest per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;
5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This requirement will be a firm-fixed price contract for brand name only Roche Diagnostics Ventana Stain and Consumables serving Northport VA Medical Center. Roche Diagnostics Ventana Stain and Consumables are compatible with the existing Roche Ventana HE 600 automated stainer currently in use at the medical center.
Roche is the sole manufacturer and distributor of the Roche Diagnostics Ventana Stain and Consumables and products are only available for purchase in the United States if purchased directly from the OEM. There are no other reagents and consumables that are compatible with the Roche Ventana HE 600 analyzers. The Roche Ventana HE 600 is designed to use only reagents and consumables made by Roche. All Roche Diagnostics Ventana Stain and Consumables are made in the United States of America.
6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:
On April 20th, the CO reached out to the OEM (Roche) to confirm that they are the sole manufacturer and distributor of the requested Roche Diagnostics Ventana Stain and Consumables. On 4/20/2026, Roche responded and provided the CO with a sole source letter confirming they are the only vendor that can provide the required Roche Diagnostics Ventana Stain and Consumables to the government.
CO posted an Intent to Sole Source Notice (36C24226Q0551) to SAM.gov from 4/20/26-4/28/26. The notice received zero (0) responses.
7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:
This requirement will be awarded as a sole source to OEM Roche Diagnostics Corporation, a large business. Roche provided the program office and the CO with a sole source letter to confirm they are the sole manufacturer and distributor of the required Roche Diagnostics Ventana Stain and Consumables. Pricing is considered fair and reasonable as quoted price for this acquisition is comparable to previously awarded similar requirements (see VA contract 36C24225D0090).
File details come from the government source that posted it. Updated .