P03 - 36C257-25-AP-0242-FY25-835 JOFOC NCO17 Ventana Reagents - HCA Approved.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification >SAT‐$7.5M under FAR13.5

Effective Date: 11/15/24

REVISION: 01

Acquisition ID#: 36C257‐25‐AP‐0242

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257‐25‐AP‐0242 JFOC Number: FY25‐NCO 17‐451

1. Contracting Activity: The Department of Veterans Affairs, Network Contracting Office (NCO) 17, 5441 Babcock Road, San Antonio, TX 78240 for the South Texas Veterans Health Care System (STVHCS), Pathology & Laboratory Medicine Service. Purchase Request Number: 671‐25‐2‐121‐ 0038.

2. Nature and/or Description of the Action Being Processed: This procurement is for an Indefinite Delivery Indefinite Quantity (IDIQ) contract, for immunohistochemical testing reagents and supplies for use on the Roche Ventana Benchmark instrumentation and such reagents are proprietary to Roche Diagnostics Corporation in accordance with FAR

13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303‐2. Ventana Medical Systems, Inc. and must be compatible with the Ventana system. The STVHCS request for the IDIQ with 5‐year ordering periods. This will be a new Firm Fixed Price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The vendor shall provide immunohistochemistry reagents and supplies listed below that are compatible with the government‐owned Roche Ventana Benchmark instrumentation. This requirement will allow the STVHCS Pathology and Laboratory Medicine Service to maintain the standard of care of current patient care services without incurring high fee basis testing costs. The estimated cost for procurement is as follows:

Ordering Period 1: $571,039.36 1 February 25‐ 31 January 26 (FY 25)

Ordering Period 2: $559,591.33 1 February 26‐ 31 January 27 (FY26) Ordering Period 3: $629,570.89 1 February 27‐ 31 January 28 (FY27) Ordering Period 4: $661,049.44 1 February 28‐ 31 January 29 (FY28) Ordering Period 5: $694,101.91 1 February 29‐ 31 January 30 (FY29)

Total: $3,115,352.93

Roche Diagnostic Corp. Ventana Medical Systems, Inc.

Item # Description/Part Number (Catalog #) Qty

5266114001 Amplification Kit, CE (Catalog # 760‐080) 14

Effective Date: 11/15/24

REVISION: 01

5280524001 Antibody Dilution Buffer, 250 mL (ADB250) 2

5266769001 Bluing Reagent (760‐2037) 50

5266726001 Hematoxylin (760‐2021) 50

5277965001 Hematoxylin II (790‐2208) 2

6718663001 OptiView Amplification Kit (860‐099) 12

5266688001 Protease 1 (760‐2018) 3

5266718001 Protease 3 (760‐2020) 2

6440002001 Ventana Antibody Diluent with Casein (760‐219) 2

5278406001 Confirm Anti‐ER (SP1) (790‐4324) 2

5277990001 Confirm Anti‐PR (1E2) (790‐2223) 2

7862237001 MLH1 (M1) Mouse Monoclonal PAB US (790‐5091) 3

7862253001 MSH2 (G219‐1129) Mouse Monoclonal PAB US (790‐5093) 3

7862245001 MSH6 (SP93) Rabbit Monoclonal PAB US (790‐5092) 3

7862261001 PMS2 (A16‐4) Mouse Monoclonal PAB US (790‐5094) 3

6425607001 Ventana H. Pylori (SP48) PAB (790‐1014) 6

7007841001 Anti‐CD30 (Ber‐H2) (790‐4858) 4

5266980001 Anti‐CD43 (L60) Primary Antibody (760‐2511) 2

5267056001 Anti‐Chromogranin A (LK2H10) PAB (760‐2519) 3

5267145001 Anti‐Keratin, Pan (AE1/AE3 & PCK26) PAB (760‐2595) 9

5267102001 Anti‐P53 (Bp53‐11) PAB (760‐2542) 5

8035130001 Anti‐p504s (SP116) Rabbit Monoclonal PAB (790‐6011) 2

6732348001 Arginase‐1 (SP156) PAB, Cell Marque (760‐4801) 2

6504612001 c‐MYC (Y69) PAB (790‐4628) 4

5435684001 Calponin‐1 (EP798Y) PAB, Cell Marque (760‐7376) 2

6680003001 Cintec Histology (50) (705‐4793) 8

6419160001 CD1a (EP3622) PAB, Cell Marque (760‐4525) 2

5463467001 CD2 (MRQ‐11) PAB, Cell Marque (760‐4377) 2

6537847001 CD7 (SP94) PAB (790‐4558) 2

5463475001 CD31 (JC70) PAB, Cell Marque (760‐4378) 2

6433359001 CD56 (MRQ‐42) PAB, Cell Marque (760‐4596) 4

5269083001 CD‐138 (B‐A38) PAB, Cell Marque (760‐4248) 4

5463491001 CDX‐2 (EPR2764Y) PAB, Cell Marque (760‐4380) 3

6433316001 CEA (CEA31) PAB, Cell Marque (760‐4594) 3

5267188001 Cell Marque Reagent, Alpha‐Fetoprotein (760‐2603) 2

5269008001 Cell Marque, BCL‐6 (760‐4241) 3

5267242001 Cell Marque, CA19‐9 (760‐2609) 3

5269059001 Cell Marque, CD21 (2G9) (760‐4245) 3

5267366001 Cell Marque, CD57 (760‐2626) 2

5267536001 Cell Marque, Gastrin (760‐2643) 2

5267692001 Cell Marque, Myeloperoxidase (760‐2659) 2

5267714001 Cell Marque, Neurofilament (760‐2661) 2

Effective Date: 11/15/24

REVISION: 01

5267757001 Cell Marque, PLAP (760‐2664) 2

5267811001 Cell Marque, TDT (760‐2670) 2

5269393001 Cell Marque, Tryptase (G3) (760‐4276) 2

5278147001 CONFIRM Anti‐ALK1 (ALK01) (790‐2918) 2

5278422001 CONFIRM Anti‐CD3 (2GV6) Rabbit Monoclona (790‐4341) 5

5552737001 CONFIRM Anti‐CD4 (SP35) Rabbit Mono (790‐4423) 2

5929903001 CONFIRM Anti‐CD5 (SP19) Rabbit Mono (790‐4451) 3

5266904001 CONFIRM Anti‐CD15 (MMA) PAB, IVD (760‐2504) 2

5267099001 CONFIRM Anti‐CD20 (L26) PAB (760‐2531) 5

5479258001 CONFIRM Anti‐CD23 (SP23) Rabbit Monoclon (790‐4408) 2

5278210001 CONFIRM Anti‐CD34 (QBEnd/10) Primary Ant (790‐2927) 4

5266912001 CONFIRM Anti‐CD45 (LCA) (RP2/18) PAB (760‐2505) 2

5278252001 CONFIRM Anti‐CD68 (KP‐1) Primary Antibod (790‐2931) 3

5913594001 CONFIRM Anti‐CD99 Mouse Mono (790‐4452) 2

5267005001 CONFIRM Anti‐Desmin (DE‐R‐11) PAB (760‐2513) 2

5479266001 CONFIRM Anti‐Keratin (34E12) Mouse Mono (790‐4373) 2

5278384001 CONFIRM Anti‐KI‐67 (30‐9) Rabbit Monoclon (790‐4286) 5

5479282001 CONFIRM Anti‐Melanosome (HMB45) Mouse M (790‐4366) 2

5552729001 CONFIRM Anti‐PAX5 (SP34) Rabbit Mono (790‐4420) 2

5266939001 CONFIRM Anti‐PSA (polyclonal) Primary An (760‐2506) 2

5278104001 CONFIRM Anti‐S100 (4C4.9) Primary Antibo (790‐2914) 4

5479312001 CONFIRM Anti‐Thyroid transcription fact (790‐4398) 6

5278139001 CONFIRM Anti‐Vimentin (V9) Primary Antib (790‐2917) 2

5986826001 CONFIRM BCL‐2 (124) Mab (790‐4464) 4

5992184001 CONFIRM Calretinin (SP65) RbmAb (790‐4467) 3

9780041001 CD8 (SP239) Rabbit Monoclonal PAB 2

5640296001 CONFIRM CD79a Rabbit Mono (790‐4432) 2

5587760001 CONFIRM Cytokeratin 20 Rabbit Mono (790‐4431) 7

5986818001 CONFIRM Cytokeratin 7 Rabbit Mono (790‐4462) 5

5878900001 CONFIRM EMA (E29) Mouse mAb (790‐4463) 2

5278350001 CONFIRM MART‐1/melan A (A103) Primary An (790‐2990) 17

6478441001 Cytokeratin 5/6 (D5/16B4) (790‐4554) 5

6478425001 Cytokeratin (CAM 5.2) PAB (790‐4555) 2

5435676001 EP‐CAM (Ber‐EP4) Pab, Cell Marque (760‐4383) 4

6374409001 Epithelial Related Antigen (MOC‐31) PAB (790‐4561) 3

5435692001 Factor XIIIa (AC‐1A1) Pab, Cell Marque (760‐4384) 2

7107749001 GATA3 (L50‐823) Pab, Cell Marque (760‐4897) 3

5269784001 Glial Fib Acidic Ptn (EP672Y), Cell Marque (760‐4345) 2

6483186001 Glypican 3 (GC33) PAB (790‐4564) 2

5269792001 Hepatocyte Spec Ant(OCH1E5), Cell Marque (760‐4350) 2

5973821001 IgD (polyclonal) Pab, Cell Marque (760‐4444) 2

Effective Date: 11/15/24

REVISION: 01

5973813001 Mesothelial Cell (HBME‐1) Pab, Cell Marque (760‐4445) 2

8313482001 MUM1 (EP190) PAb, Cell Marque (760‐6082) 2

7047720001 Napsin A (MRQ‐60) Pab, Cell Marque (760‐4867) 5

5268303001 NexES, Reagent, Cell Marque, SM Actin (760‐2833) 3

7859759001 NKX3.1 (EP356) PAb, Cell Marque (760‐5086) 3

6523927001 PAX8 (MRQ‐50) PAb, Cell Marque (760‐4618) 3

5463645001 Podoplanin (D2‐40) Pab, Cell Marque (760‐4395) 2

6433324001 Synaptophysin (MRQ‐40) PAb, Cell Marque (760‐4595) 3

5857856001 VENTANA Anti‐CD10 (SP67) (790‐4506) 4

5862949001 VENTANA Anti‐Cyclin D1 (SP4‐R) (790‐4508) 3

5867061001 VENTANA Anti‐P63 (4A4) (790‐4509) 4

6396500001 OptiView DAB Detection Kit (760‐700) 27

5269814001 Ultraview Universal AP Red Detection Kit (760‐501) 13

5273617001 Prep Kit 1, (100) BM, BM XT (783‐2851) 2

5273625001 Prep Kit 2, BenchMark (783‐2852) 2

5273633001 Prep Kit 3, BenchMark (783‐2853) 2

5273641001 Prep Kit 4, BenchMark (783‐2854) 3

5273650001 Prep Kit 5, BenchMark (783‐2855) 6

5273668001 Prep Kit 6, BenchMark (783‐2856) 6

5273676001 Prep Kit 7, BenchMark (783‐2857) 2

5273684001 Prep Kit 8, BenchMark (783‐2858) 2

5273692001 Prep Kit 9, BenchMark (783‐2859) 1

5273706001 Prep Kit 10, BenchMark (783‐2860) 2

5273714001 Prep Kit 11, BenchMark (783‐2861) 8

5273722001 Prep Kit 12, BenchMark (783‐2862) 2

5273749001 Prep Kit 13, BenchMark (783‐2863) 1

5273757001 Prep Kit 14, BenchMark (783‐2864) 2

5273765001 Prep Kit 15, BenchMark (783‐2865) 2

5273773001 Prep Kit 16, BenchMark (783‐2866) 2

5273781001 Prep Kit 17, BenchMark (783‐2867) 2

5273790001 Prep Kit 18, BenchMark (783‐2868) 3

5273803001 Prep Kit 19, BenchMark (783‐2869) 3

5273811001 Prep Kit 20, BenchMark (783‐2870) 2

5273820001 Prep Kit 21, BenchMark (783‐2871) 1

5273838001 Prep Kit 22, BenchMark (783‐2872) 1

5273846001 Prep Kit 23, BenchMark (783‐2873) 1

5273854001 Prep Kit 24, BenchMark (783‐2874) 1

5273862001 Prep Kit 25, BenchMark (783‐2875) 1

5273889001 Prep Kit 26, BenchMark (783‐2876) 1

5273897001 Prep Kit 27, BenchMark (783‐2877) 1

5273919001 Prep Kit 28, BenchMark (783‐2878) 1

Effective Date: 11/15/24

REVISION: 01

5273927001 Prep Kit 29, BenchMark (783‐2879) 1

5273935001 Prep Kit 30, BenchMark (783‐2880) 1

5273943001 Prep Kit 31, BenchMark (783‐2881) 1

5273951001 Prep Kit 32, BenchMark (783‐2882) 2

5273960001 Prep Kit 33, BenchMark (783‐2883) 2

5279771001 10X EZ Prep Solution, 2L (950‐102) 80

5353947001 10X SSC Solution, 2L (950‐110) 30

5424569001 Benchmark Ultra CC1 (950‐224) 30

5424542001 Benchmark Ultra CC2 (950‐223) 15

5424534001 Benchmark Ultra LCS (650‐210) 250

5353955001 Reaction Buffer Concentrate (10X) (950‐300) 150

5917557001 HybReady Solution (780‐4409) 10

5272165001 ISH Negative Solution (780‐2902) 5

5273315001 ISH Protease 1 (780‐4147) 6

5272017001 Red Counterstain II (780‐2218) 10

5266181001 ISH, iVIEW Blue Plus Detection Kit (760‐097) 10

6543472001 EBER 1 DNP Probe, ASR PTO (760‐1209) 6

6543391001 Kappa DNP Probe (495‐524), ASR (760‐1201) 6

6543405001 Kappa DNP Probe (538‐567), ASR (760‐1202) 6

6543413001 Kappa DNP Probe (597‐626), ASR (760‐1203) 6

6543421001 Kappa DNP Probe (637‐666), ASR (760‐1204) 6

6543430001 Lambda DNP Probe (664‐693), ASR (760‐1205) 6

6543448001 Lambda DNP Probe (704‐733), ASR (760‐1206) 6

6543456001 Lambda DNP Probe (768‐797), ASR (760‐1207) 6

6543464001 Lambda DNP Probe (826‐855), ASR (760‐1208) 6

6543499001 U6 DNP Probe, ASR (760‐1210) 15

7734115001 RNA ISH Probe 1 (243‐5066) 5

7734123001 RNA ISH Probe 2 (243‐5067) 5

7734140001 RNA ISH Probe 3 (243‐5068) 3

7734760001 RNA ISH Probe 4 (243‐5069) 8

5271843001 Option‐1 (771‐751) 3

5271886001 Option‐5 (771‐755) 7

5248850001 KIT PACK, EBAR (US/EUROPE) 10

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106‐1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

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

Effective Date: 11/15/24

REVISION: 01

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): The Roche Ventana Medical Systems, Inc. is the sole source provider of the extensive menu of pre‐diluted primary antibodies, reagents, and supplies that are packaged in dispensers ready for use on the Roche Ventana Benchmark instrumentation that is already in place at STVHS. The immunohistochemical testing reagents and supplies for use on the Ventana Benchmark systems are the only ones compatible and approved for use by the FDA. Immunohistochemistry testing is based on methods, reference ranges, and physician input, and only approved, reagents and supplies must be used to meet the standard of care of the Joint Commission. The proposed vendor, Roche Diagnostics Corp., Ventana Medical Systems, Inc., would meet our laboratory's capacity needs and can supply reagents continuously without interrupting patient testing.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Conducted market research to identify if other potential vendors could provide all the regents and supplies needed but did not identify other possible vendors. Historically, this vendor has provided a sole source letter attesting to being the sole manufacturer and distributor for the brand name reagents and supplies needed. Third‐party reseller authorization must be provided if other possible vendors are to be considered. Posted a special notice that the government intends to award sole source to Roche Diagnostics on December 6, 2024, and closed on December 13, 2024. Roche Diagnostics Corporation was contacted and spoke with Julie Kiker, Anatomic Pathology Solution Manager, and confirmed that Ventana Medical Systems is the sole manufacturer and distributor for all Ventana instrumentation, reagents, and ancillaries in a letter dated 27 May 2021. Julie Kiker confirmed this letter is still current and up‐to‐date information.

Ventana Medical Systems, Inc. is a branch of Roche Diagnostics; therefore, the awardee will still be Roche Diagnostics no awards are made directly with Ventana Medical Systems. No responses were received therefore, it is advantageous to procure all of the items listed above from a sole vendor to ensure there are no delays in the shipment of regents and supplies needed to perform patient testing.

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

Reasonable: The Contracting Officer shall determine pricing to be fair and reasonable based on a comparison of the proposed prices with prices found reasonable in previously awarded contracts and or procurements.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market Research conducted pursuant to FAR Part 10, VAAR Part 810, and

PPM 2016‐05 (revised Aug 2019. Search engines such as VetCert, FPDS, Dynamic Small Business (DSBS) and Interagency Contract Directory (ICD) were utilized when conducting market research. A search

Effective Date: 11/15/24

REVISION: 01

utilizing NAICS code 325413 in VetCert with the keyword Ventana reagents resulted in no socioeconomic groups able to provide these reagents. FPDS was searched and found 36C25720D0026 awarded 20 December 2024 Indefinite Delivery contract for total a value of $1,963,596.60 awarded to Roche Diagnostics Corporation a large business. Searched (ICD) and found two contracts 36C24825D0025 for NCO 9 (36C249) and 36C224122D0027 for NCO 1 (36C241) only individual agency are allowed to utilize these IDC contracts. DSBS search was conducted using NAICS code 325412, keyword Ventana Reagents. The search resulted in zero (0) SDVOSB, zero (0) VOSB, and zero (0) Self‐ Certified Small Disadvantaged Businesses.

Market research revealed that Roche Diagnostics Corp., Ventana Medical Systems Inc. is the sole manufacturer and distributor of the brand name reagents and supplies needed to perform immunohistochemistry testing on the Roche Ventana Benchmark instrumentation. By evaluating new testing methods as technologies improve, STVHCS can adapt its practices, enhance patient care, and ensure that it is utilizing the most effective up‐to‐date approaches. This proactive stance not only aids in improving services but also helps in better resource allocation, and strategic planning, and promotes competition.

The Buy American statute applies; use clause 52.225‐1 Buy American‐Supplies and provision 52.225‐2 Buy American Certificate. This is a domestic end product made in the United States;

therefore, according to Subpart FAR 25.4 Trade Agreement Act does not apply.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This is a critical requirement in nature of the brand name supply orders for FDA approved reagents needed for the Roche Ventana Benchmark instrumentation. These materials are essential for immunohistochemistry testing, which plays a vital role in diagnosing various types of cancer and monitoring critically ill patients. Any delays in obtaining these reagents and supplies could significantly disrupt testing processes, ultimately affecting patient care.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Due to the proprietary nature of the reagents and supplies authorized to be used on Roche Ventana Benchmark instrumentation, Roche Diagnostics Corp., Ventana Medical Systems Inc. a branch of Roche Diagnostics of has provided a sole source letter dated 27 May 2021 as the sole manufacturer and supplier of reagents and supplies needed for patient testing. This letter was received from Roche Diagnostics on 06 December 2024 and is still confirmed as accurate information. There are no other sources have expressed interest in this requirement.

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: The VA will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed and to potentially include other manufacturer instruments within the marketplace that would meet the standard of care currently in place.

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.

Effective Date: 11/15/24

REVISION: 01

Susana Lara Cruz QM Medical Technologist/COR Pathology & Laboratory Medicine Service South 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 D. Campa

Contracting Officer NCO 17

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Michael J. Tusinger Director of Contracting

Network Contracting Office 17

c. Director of Contracting: I certify the justification meets requirements for other than full and open competition.

Mark A. Layman Director of Contracting Network Contracting Office 17

c. 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 approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

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