P03 - 36C257-26-AP-0810-FY26-1817 JOFOC NCO17 NTX Ventana Reagents - HCA Approved.pdf

36C257-26-AP-0810 1

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C257-26-AP-0810 JFOC Number: FY26 NCO 17-880

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 17, North

Texas Health Care System (VANTHCS), 4500 South Lancaster Road, Dallas, TX 78216-7167.

Purchase request number 549-26-3-190-0026.

2. Nature and/or Description of the Action Being Processed: NCO 17 intends to award a new firm-fixed price (FFP) Indefinite Delivery/Indefinite Quantity (IDIQ) contract for the acquisition of Ventana testing reagents and supplies from Roche Diagnostics Corporation. The proposed IDIQ contract will have five one-year ordering periods. Annual delivery orders placed under the IDIQ contract will be treated as standing orders. Requests for required items will be made on an as-needed basis throughout the IDIQ 's ordering period.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The proposed action is to provide Ventana reagents and supplies in support of the VANTHCS, Pathology & Laboratory Medicine Service. Accordingly, Ventana Medical Systems, Inc is the only firm capable of providing the supplies and services described in Section III above without the Veteran's Health Administration experiencing unacceptable delays in fulfilling its requirements.

The following items (estimated annual quantities) are required:

Item Description Item Number Quantity 1 Reagent, DAB Detection 760-500 25 2 Reagent, Stainer, Amplification 760-080 20 3 Reagent, Stainer, Reaction Buffer 950-300 40 4 Reagent, Hematoxylin 760-2021 26 5 Reagent, Bluing Agent 760-2037 26 6 Staining Solution, Protease 760-2018 7 7 10x EZ Stainer, Prep Solution, 2L 950-102 15 8 Benchmark Ultra LCS 650-210 80 9 Solution, Ultra, Cell CC1 950-224 14 10 Control, Negative Monoclonal 760-2014 6 11 Elastin Van Gieson Kit 50 Test Cat.

09592229001

12 Staining Kit, Complex Stains, Reticulum II

860-024 4

13 Staining Kit, Complex Stains, Special

860-028 4

14 DEPAR Solution, BMK Special Stains

860-036 6

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15 Liquid Coverslip, BMK Special Stains

860-034 10

16 Benchmark Special Stains Wash II Catalog 08309817001

17 Benchmark Special Stains I Cleaning Kit

860-049 7

18 Ventana H. Pylori (SP48) PAB 790-1014 24

19 CONFIRM ANTI-THRYOID

TRANSCRIPTION FACT

790-4398 8

20 Ribbon, Ebar Printer 1632900 3 21 Kit Pack Ebar 1418702 5 22 Confirm Cytokeratin7

Rabbitmono 790-4462 8

23 Antibody – KI 67 (30-9) Rabbit Monoclonal

790-4286 8

24 S IHC ANTIBODY ROUTINE:

CONFIRM ANTI-S100

(POLYCLONAL) PAB

760-2523 6

25 CONFIRM CYTOKERATIN 20

RABBIT MONO

790-4554 10

26 CONFIRM CYTOKERATIN 20

RABBIT MONO

790-4431 6

27 ANTI-CHROMOGRANIN A

(LK2H10) PAB

760-2519 4

28 CONFIRM CYTOKERATIN 20

RABBIT MONO

790-7061 4

29 CD-138 (B-A38) PAB, CELL

MARQUE

790-4248 4

30 CONFIRM ANTI-CD34 (QBEND/10)

PRIMARY ANTIBODY

790-2927 4

31 CONFIRM ANTI-CD3 (2GV6)

RABBIT MONOCLONAL

790-4341 4

32 CONFIRM ANTI-CD5 (SP19)

RABBIT MONO

790-4451 4

33 CONFIRM ANTI-CD20 (L26) PAB

760-2531 4

34 CD68 (SP251V18) RABBIT

MONOCLONAL AB

790-7248 4

35 VENTANA ANTI-CD10 (SP67) 790-4506 4

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36 CONFIRM ANTI-SYNAPTOPHYSIN

(SP11) RABBIT

790-4407 4

37 CYTOKERATIN (CAM 5.2) PAB 790-4555 4

38 IHC ANCILLARY, HEMATOXYLIN II

790-2208 2

39 IHC ANCILLARIES, OPTIVIEW

AMPLIFICATION KIT

760-099 2

40 IHC ANCILLARIES: OPTIVIEW DAB

DETECTION

KIT (250)

760-700 2

Anticipated Periods of Performance: Estimated Pricing:

Ordering Period 1: 04/19/2026 to 04/18/2027 $224,436.09 Ordering Period 2: 04/19/2027 to 04/18/2028 $235,657.89 Ordering Period 3: 04/19/2028 to 04/18/2029 $247,440.79 Ordering Period 4: 04/19/2029 to 04/18/2030 $259,812.83 Ordering Period 5: 04/19/2030 to 04/18/2031 $272,803.47

Total: $1,240,151.07 Ceiling: $1,400,000.00

4. Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The Pathology & Laboratory Medicine Service of the VANTHCS operates a Ventana HE600 system.

The reagents for the Ventana HE600 system are brand name and indispensable components required for its operation and cannot be substituted. In a letter dated 04/10/2025, Roche Diagnostics Corporation affirmed that in North America, Ventana Medical Systems, Inc., a member of the Roche Group, is the exclusive manufacturer for all Ventana primary staining and Advanced Staining instrumentation. This establishes that only Ventana Medical Systems Inc is capable of

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supplying the necessary brand name and proprietary reagents, supplies and instrumentation compatible with the Ventana HE600 system, justifying the use of a sole-source acquisition from Roche Diagnostics Corporation. Ventana reagents and supplies require FDA review (either 510(k) clearance or PMA approval) based on product code and intended clinical use.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Special Notice (intent to sole source) was posted to SAM.Gov from 02/03/2026 to 02/09/2026. The notice stated that all responsible sources may submit a capability statement, which would be considered by the agency to determine if a comparable source is available and more advantageous for the government. Received one response from Roche Diagnostics Corporation, they provided sole-source letter, dated 04/10/2025. Letter states that Ventana Medical Systems, Inc., a member of Roche Group is currently the only authorized provider of service for Ventana Reagents to customers in North America. No other responses were received.

No SDVOSB or small businesses replied to special notice.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The Contracting Officer will determine pricing to be fair and reasonable based on a comparison of proposed prices with prices found reasonable in previously awarded contracts and procurements. The comparison will be made with pricing from awards similar to this requirement.

Market price will be determined fair and reasonable based on procurement history within NCO 17 and Independent Government Cost Estimate (IGCE).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted pursuant to RFO Part 10 and VA Acquisition Regulation (VAAR) 810.001-70 Market Research Policy. Market research was conducted from 10/15/2025 to 03/24/2026. A search of mandatory and non-mandatory sources and websites did not identify other vendors that can provide the requested Ventana Reagents.

Posted Special Notice from 02/03/2026 - 02/09/2026 and Roche Diagnostic responded and provided proprietary letter dated 04/10/2025, expressing that Ventana Reagents are developed and validated for exclusive use on Ventana fully automated systems. Ventana HE600 system reagents are compulsory elements for the operation of the Ventana HE600 system and cannot be substituted. In addition, no small business in any of the other targeted socio-economic groups are authorized to provide Ventana Reagents. Buy American Statute/Trade Agreements; Roche Diagnostics Corporation is an American company, and all Ventana Reagents are manufactured in Tucson, Arizona. No nonavailability determination is required and Trade Agreements are exempted for sole source acquisitions justified in accordance with 12.102. It’s anticipated that this will be awarded to Roche Diagnostics Corporation in accordance with RFO FAR 6.103-1.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None

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

Roche Diagnostics Corporation (large business) 115 Hague Road

Indianapolis, IN 46256

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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:

Market research will be conducted annually and prior to placing a new order to determine if there have been any changes to the marketplace. As of now, Roche Diagnostics Corporation is the only company capable of providing the required name brand reagents and supplies for VANTHCS.

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.

Shayla Powell Date Supervisory Medical Technologist North Texas Health Care System

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.

Jose Campa Date Contracting Officer

NCO 17

https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

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b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K):

I certify the justification meets requirements for other than full and open competition.

Michael J. Tusinger Date Branch Chief NCO 17 Laboratory Services Support

c. Director of Contracting:

I certify the justification meets requirements for other than full and open competition.

Mark A. Layman Date Director of Contracting Network Contracting Office 17

d. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $90 million) or approve ($900K to $90 million) for other than full and open competition.

Curtis M. Jordan Date Executive Director, Regional Procurement Office West VHA Head of Contracting Activity (HCA)