SSJ_Redacted.pdf

Effective Date: 12/30/2025 Page 1 of 4 Revision: 02 Acquisition ID#:

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH REVOLUTIONARY FAR

OVERHAUL (RFO) 12.201-1

Acquisition Plan Action ID:

RPOW JOFOC Tracker:

1. Contracting Activity: Department of Veterans Affairs, Network Contract Office

(NCO) 21 on behalf of Veterans Integrated Service Network (VISN) 21, VA Southern Nevada Health Care System (VASHCS), Las Vegas VA Medical Center (VAMC), 6900 N Pecos Road, North Las Vegas, NV 89086-4400 2237:

2. Nature and/or Description of the Action Being Processed: This procurement is a Cost-Per-Test (CPT) requirement for a clinical laboratory immunohistochemistry (IHC) and an in-situ hybridization (ISH) analyzer that is a continuous, automated slide staining system for analysis, data review, and reporting of IHC/ISH test results.

This is a new, firm fixed price requirement. This will be a one year base plus four, one year option periods. FAR 52.217-8 Option to Extend Services will be incorporated. The requirement is in accordance with RFO FAR 12.201-1 Simplified Procedures for Certain Commercial Items and specifically RFO FAR 12.102(b), where acquisitions conducted under Simplified Acquisition Procedures require a justification using the format of RFO FAR 6.104.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This contract will be a five year contract, one (1) year base period of performance, and four (4) one (1) year option periods for automated IHC/ ISH slide staining system (Cost per test): Per test ICH/ISH cost per test all-inclusive of instrumentation, reagents, consumables, service, and training. Period of performance is planned as follows:

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

The estimated total value for the base and all option periods is , with estimated for the base year.

4. Statutory Authority Permitting Restricted Competition:

RFO FAR 12.201-1 Simplified Procedures. The statutory authority for applying the Simplified Procedures is 41 U.S.C. § 1901 and is implemented by FAR 12.102(b) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

Effective Date: 12/30/2025 Page 2 of 4

Acquisition ID#:

(x) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research

Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Roche Diagnostics’ BenchMark ULTRA system is the only automated IHC/ ISH slide staining system that will fit in the “footprint” or space that’s available in the current lab and is compatible with the configuration of the utilities as follows:

- IHC must fit on existing end cap within approximate dimensions of

44”Wx60”Hx33”D

- ISH stainer must attach to existing cover slip and be approximately

50”Wx25”Hx28”D

- Instruments must fit voltage requirements between 110-230V

Due to the current lab’s electrical and plumbing systems, the facility is unable to install any new equipment unless construction occurs to correct any operational infrastructure deficiencies. If this analyzer were not procured, there would be a cost associated with sending lab specimens outside the lab for testing if the Roche Diagnostics equipment were not put into place with a degradation of Veteran care due to the increased wait times for lab results. Roche has confirmed there is no distribution model for proprietary reagents and supplies for the necessary staining system.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: As only Roche Diagnostics can provide the necessary equipment, reagents and supplies under a CPT agreement for equipment that meets the current space limitations, no other sources can be considered. This requirement will be synopsized with a notice of intent to sole source to Roche posted at the Government Point of Entry (SAM.gov). The Justification and Approval will be publicized as well as an award notice.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated unit rates can be found fair and reasonable based on comparison to previous contracts awarded for Automated IHC/ ISH slide staining system (Cost per test).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research included a review of recent IHC requirement awarded under IDIQ 36C26126D0004. In this case, extensive market research occurred, including sources sought, to locate devices of similar size given that lab footprints are set and historically can limit which devices can be considered. Market research under

Effective Date: 12/30/2025 Page 3 of 4

Acquisition ID#:

36C26126D0004 showed multiple responses to sources sought but identified only large business Original Equipment Manufacturers (OEMs) able to lease equipment with necessary reagents and supplies under Cost-Per-Test pricing. Additionally, while there were three such large businesses who responded to a sources sought, only Roche provided a quote response during solicitation.

A VA National Acquisition Center (NAC) search was carried out on several of the required tests both by part number and name against GSA Elibrary for V797D-70105 to confirm the open market nature of these items. The SBA Small Business Database was searched under North American Industry Classification System (NAICS) 325413 resulting in 26 SDVOSB and VOSB vendors. SBA Small Business Database returned no results in a search for Roche Diagnostics under Unique Entity Identification (EUI) JDMDFEZBYH36. A Review of GSA Advantage for the term “Immunohistochemistry” returned multiple results but these results were for reagents/stains only and/or instruments/equipment only while this requirement includes all equipment and supplies under a CPT structure. Similarly, the VA Supply Chain Master Catalog was searched for “Immunohistochemistry” which produced many results, including VA NAC contracts, Service only Contracts, NCO specific contracts and even VISN 21 contracts which are specific to other stations. None of the results from the Supply Chain Master Catalog point towards alternative vendors capable of meeting the specific analyzer space requirements or providing a complete CPT offering.

Roche has previously provided the lease of necessary equipment as well as reagents and other supplies to allow for necessary instrumentation and testing.

Performance by Roche has been satisfactory.

Given that only Roche can provide the necessary instruments, equipment, supplies and reagents, this shall be a sole source procurement via the open market to the large business OEM, the only source capable of providing an acceptable solution. A sole source justification will be affected for this procurement. The rule of two has not been met.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

There are no other facts.

10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Roche Diagnostics Corporation, JDMDFEZBYH36, Large Business

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: No other vendor is able to service the VASNHCS within the current space provided for automated IHC/ ISH slide staining system at this time. If this analyzer were not procured, there would be a cost associated with sending lab specimens outside the lab for testing if the Roche Diagnostics equipment were not put into place with a degradation of patient care due to the increased wait times for lab results.

Effective Date: 12/30/2025 Page 4 of 4

Acquisition ID#:

12.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 and belief.

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

b. One Level Above the Contracting Officer (Required over $350K but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.