SPECIAL NOTICE
66 -- NEW - Ventana Reagents
- Notice Date
- 12/11/2024 9:17:49 AM
- Notice Type
- Special Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- 257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
- ZIP Code
- 76006
- Solicitation Number
- 36C25725Q0155
- Response Due
- 12/13/2024 8:00:00 AM
- Archive Date
- 01/12/2025
- Point of Contact
- Susan Flores, Contract Specialist, Phone: (210) 694-6227
- E-Mail Address
-
Susan.flores2@va.gov
(Susan.flores2@va.gov)
- Awardee
- null
- Description
- Special Notice Special Notice Special Notice Notice of Intent to Award a Sole Source Procurement The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 17, intends to award a IDC Firm-Fixed priced contract to Roche Diagnostics Corporation for procurement of the following services: Technical Requirements The Immunohistochemistry reagents and supplies must be compatible with the Roche Ventana Benchmark Ultra instrumentation. The reagents and supplies must be ready to use, no reconstitution is needed. The reagents and supplies must meet all regulatory requirements set forth by the FDA, CLIA, CAP, and all other Federal Requirements. Due to the proprietary nature, only brand name Roche Diagnostics Corp. (Ventana Medical Systems, Inc.) reagents are the only acceptable reagents and supplies compatible with the Roche Ventana Benchmark Ultra instrumentation. Third-party reseller authorization must be provided if other vendors are to be considered. Roche Ventana Reagents and supplies required are listed below: Item # Description/Part Number* Qty 05266114001 Amplification Kit, CE (Catalog # 760-080) � 14 05280524001 Antibody Dilution Buffer, 250 mL (ADB250) � 2 05266769001 Bluing Reagent (760-2037) � 50 05266726001 Hematoxylin (760-2021) � 50 05277965001 Hematoxylin II (790-2208) � 2 06718663001 OptiView Amplification Kit (860-099) � 12 05266688001 Protease 1 (760-2018) � 3 05266718001 Protease 3 (760-2020) � 2 06440002001 Ventana Antibody Diluent with Casein (760-219) � 2 05278406001 Confirm Anti-ER (SP1) (790-4324) � 2 05277990001 Confirm Anti-PR (1E2) (790-2223) � 2 07862237001 MLH1 (M1) Mouse Monoclonal PAB US (790-5091) � 3 07862253001 MSH2 (G219-1129) Mouse Monoclonal PAB US (790-5093) � 3 07862245001 MSH6 (SP93) Rabbit Monoclonal PAB US (790-5092) � 3 07862261001 PMS2 (A16-4) Mouse Monoclonal PAB US (790-5094) � 3 06425607001 Ventana H. Pylori (SP48) PAB (790-1014) � 6 07007841001 Anti-CD30 (Ber-H2) (790-4858) � 4 05266980001 Anti-CD43 (L60) Primary Antibody (760-2511) � 2 05267056001 Anti-Chromogranin A (LK2H10) PAB (760-2519) � 3 05267145001 Anti-Keratin, Pan (AE1/AE3 & PCK26) PAB (760-2595) � 9 05267102001 Anti-P53 (Bp53-11) PAB (760-2542) � 5 08035130001 Anti-p504s (SP116) Rabbit Monoclonal PAB (790-6011) � 2 06732348001 Arginase-1 (SP156) PAB, Cell Marque (760-4801) � 2 06504612001 c-MYC (Y69) PAB (790-4628) � 4 05435684001 Calponin-1 (EP798Y) PAB, Cell Marque (760-7376) � 2 6680003001 Cintec Histology (50) (705-4793) � 8 06419160001 CD1a (EP3622) PAB, Cell Marque (760-4525) � 2 05463467001 CD2 (MRQ-11) PAB, Cell Marque (760-4377) � 2 06537847001 CD7 (SP94) PAB (790-4558) � 2 05463475001 CD31 (JC70) PAB, Cell Marque (760-4378) � 2 06433359001 CD56 (MRQ-42) PAB, Cell Marque (760-4596) � 4 05269083001 CD-138 (B-A38) PAB, Cell Marque (760-4248) � 4 05463491001 CDX-2 (EPR2764Y) PAB, Cell Marque (760-4380) � 3 06433316001 CEA (CEA31) PAB, Cell Marque (760-4594) � 3 05267188001 Cell Marque Reagent, Alpha-Fetoprotein (760-2603) � 2 05269008001 Cell Marque, BCL-6 (760-4241) � 3 05267242001 Cell Marque, CA19-9 (760-2609) � 3 05269059001 Cell Marque, CD21 (2G9) (760-4245) � 3 05267366001 Cell Marque, CD57 (760-2626) � 2 05267536001 Cell Marque, Gastrin (760-2643) � 2 05267692001 Cell Marque, Myeloperoxidase (760-2659) � 2 05267714001 Cell Marque, Neurofilament (760-2661) � 2 05267757001 Cell Marque, PLAP (760-2664) � 2 05267811001 Cell Marque, TDT (760-2670) � 2 05269393001 Cell Marque, Tryptase (G3) (760-4276) � 2 05278147001 CONFIRM Anti-ALK1 (ALK01) (790-2918) � 2 05278422001 CONFIRM Anti-CD3 (2GV6) Rabbit Monoclona (790-4341) � 5 05552737001 CONFIRM Anti-CD4 (SP35) Rabbit Mono (790-4423) � 2 05929903001 CONFIRM Anti-CD5 (SP19) Rabbit Mono (790-4451) � 3 05266904001 CONFIRM Anti-CD15 (MMA) PAB, IVD (760-2504) � 2 05267099001 CONFIRM Anti-CD20 (L26) PAB (760-2531) � 5 05479258001 CONFIRM Anti-CD23 (SP23) Rabbit Monoclon (790-4408) � 2 05278210001 CONFIRM Anti-CD34 (QBEnd/10) Primary Ant (790-2927) � 4 05266912001 CONFIRM Anti-CD45 (LCA) (RP2/18) PAB (760-2505) � 2 05278252001 CONFIRM Anti-CD68 (KP-1) Primary Antibod (790-2931) � 3 05913594001 CONFIRM Anti-CD99 Mouse Mono (790-4452) � 2 05267005001 CONFIRM Anti-Desmin (DE-R-11) PAB (760-2513) � 2 05479266001 CONFIRM Anti-Keratin (34E12) Mouse Mono (790-4373) � 2 05278384001 CONFIRM Anti-KI-67 (30-9) Rabbit Monoclon (790-4286) � 5 05479282001 CONFIRM Anti-Melanosome (HMB45) Mouse M (790-4366) � 2 05552729001 CONFIRM Anti-PAX5 (SP34) Rabbit Mono (790-4420) � 2 05266939001 CONFIRM Anti-PSA (polyclonal) Primary An (760-2506) � 2 05278104001 CONFIRM Anti-S100 (4C4.9) Primary Antibo (790-2914) � 4 05479312001 CONFIRM Anti-Thyroid transcription fact (790-4398) � 6 05278139001 CONFIRM Anti-Vimentin (V9) Primary Antib (790-2917) � 2 05986826001 CONFIRM BCL-2 (124) Mab (790-4464) � 4 05992184001 CONFIRM Calretinin (SP65) RbmAb (790-4467) � 3 05937248001 CONFIRM CD8 (SP57) Rabbit Mono (790-4460) � 2 05640296001 CONFIRM CD79a Rabbit Mono (790-4432) � 2 05587760001 CONFIRM Cytokeratin 20 Rabbit Mono (790-4431) � 7 05986818001 CONFIRM Cytokeratin 7 Rabbit Mono (790-4462) � 5 05878900001 CONFIRM EMA (E29) Mouse mAb (790-4463) � 2 05278350001 CONFIRM MART-1/melan A (A103) Primary An (790-2990) � 17 06478441001 Cytokeratin 5/6 (D5/16B4) (790-4554) � 5 06478425001 Cytokeratin (CAM 5.2) PAB (790-4555) � 2 05435676001 EP-CAM (Ber-EP4) Pab, Cell Marque (760-4383) � 4 06374409001 Epithelial Related Antigen (MOC-31) PAB (790-4561) � 3 05435692001 Factor XIIIa (AC-1A1) Pab, Cell Marque (760-4384) � 2 07107749001 GATA3 (L50-823) Pab, Cell Marque (760-4897) � 3 05269784001 Glial Fib Acidic Ptn (EP672Y), Cell Marque (760-4345) � 2 06483186001 Glypican 3 (GC33) PAB (790-4564) � 2 05269792001 Hepatocyte Spec Ant(OCH1E5), Cell Marque (760-4350) � 2 05973821001 IgD (polyclonal) Pab, Cell Marque (760-4444) � 2 05973813001 Mesothelial Cell (HBME-1) Pab, Cell Marque (760-4445) � 2 08313482001 MUM1 (EP190) PAb, Cell Marque (760-6082) � 2 07047720001 Napsin A (MRQ-60) Pab, Cell Marque (760-4867) � 5 05268303001 NexES, Reagent, Cell Marque, SM Actin (760-2833) � 3 07859759001 NKX3.1 (EP356) PAb, Cell Marque (760-5086) � 3 0653927001 PAX8 (MRQ-50) PAb, Cell Marque (760-4618) � 3 05463645001 Podoplanin (D2-40) Pab, Cell Marque (760-4395) � 2 06433324001 Synaptophysin (MRQ-40) PAb, Cell Marque (760-4595) � 3 05857856001 VENTANA Anti-CD10 (SP67) (790-4506) � 4 05862949001 VENTANA Anti-Cyclin D1 (SP4-R) (790-4508) � 3 05867061001 VENTANA Anti-P63 (4A4) (790-4509) � 4 06396500001 OptiView DAB Detection Kit (760-700) � 27 05269814001 Ultraview Universal AP Red Detection Kit (760-501) � 13 05273617001 Prep Kit 1, (100) BM, BM XT (783-2851) � 2 05273625001 Prep Kit 2, BenchMark (783-2852) � 2 05273633001 Prep Kit 3, BenchMark (783-2853) � 2 05273641001 Prep Kit 4, BenchMark (783-2854) � 3 05273650001 Prep Kit 5, BenchMark (783-2855) � 6 05273668001 Prep Kit 6, BenchMark (783-2856) � 6 05273676001 Prep Kit 7, BenchMark (783-2857) � 2 05273684001 Prep Kit 8, BenchMark (783-2858) � 2 05273692001 Prep Kit 9, BenchMark (783-2859) � 1 05273706001 Prep Kit 10, BenchMark (783-2860) � 2 05273714001 Prep Kit 11, BenchMark (783-2861) � 8 05273722001 Prep Kit 12, BenchMark (783-2862) � 2 05273749001 Prep Kit 13, BenchMark (783-2863) � 1 05273757001 Prep Kit 14, BenchMark (783-2864) � 2 05273765001 Prep Kit 15, BenchMark (783-2865) � 2 05273773001 Prep Kit 16, BenchMark (783-2866) � 2 05273781001 Prep Kit 17, BenchMark (783-2867) � 2 05273790001 Prep Kit 18, BenchMark (783-2868) � 3 05273803001 Prep Kit 19, BenchMark (783-2869) � 3 05273811001 Prep Kit 20, BenchMark (783-2870) � 2 05273820001 Prep Kit 21, BenchMark (783-2871) � 1 05273838001 Prep Kit 22, BenchMark (783-2872) � 1 05273846001 Prep Kit 23, BenchMark (783-2873) � 1 05273854001 Prep Kit 24, BenchMark (783-2874) � 1 05273862001 Prep Kit 25, BenchMark (783-2875) � 1 05273889001 Prep Kit 26, BenchMark (783-2876) � 1 05273897001 Prep Kit 27, BenchMark (783-2877) � 1 05273919001 Prep Kit 28, BenchMark (783-2878) � 1 05273927001 Prep Kit 29, BenchMark (783-2879) � 1 05273935001 Prep Kit 30, BenchMark (783-2880) � 1 05273943001 Prep Kit 31, BenchMark (783-2881) � 1 05273951001 Prep Kit 32, BenchMark (783-2882) � 2 05273960001 Prep Kit 33, BenchMark (783-2883) � 2 05279771001 10X EZ Prep Solution, 2L (950-102) � 80 05353947001 10X SSC Solution, 2L (950-110) � 30 05424569001 Benchmark Ultra CC1 (950-224) � 30 05424542001 Benchmark Ultra CC2 (950-223) � 15 05424534001 Benchmark Ultra LCS (650-210) � 250 05353955001 Reaction Buffer Concentrate (10X) (950-300) � 150 05917557001 HybReady Solution (780-4409) � 10 05272165001 ISH Negative Solution (780-2902) � 5 05273315001 ISH Protease 1 (780-4147) � 6 05272017001 Red Counterstain II (780-2218) � 10 05266181001 ISH, iVIEW Blue Plus Detection Kit (760-097) � 10 06543472001 EBER 1 DNP Probe, ASR PTO (760-1209) � 6 06543391001 Kappa DNP Probe (495-524), ASR (760-1201) � 6 06543405001 Kappa DNP Probe (538-567), ASR (760-1202) � 6 06543413001 Kappa DNP Probe (597-626), ASR (760-1203) � 6 06543421001 Kappa DNP Probe (637-666), ASR (760-1204) � 6 06543430001 Lambda DNP Probe (664-693), ASR (760-1205) � 6 06543448001 Lambda DNP Probe (704-733), ASR (760-1206) � 6 06543456001 Lambda DNP Probe (768-797), ASR (760-1207) � 6 06543464001 Lambda DNP Probe (826-855), ASR (760-1208) � 6 06543499001 U6 DNP Probe, ASR (760-1210) � 15 07734115001 RNA ISH Probe 1 (243-5066) � 5 07734123001 RNA ISH Probe 2 (243-5067) � 5 07734140001 RNA ISH Probe 3 (243-5068) � 3 07734760001 RNA ISH Probe 4 (243-5069) � 8 5271843001 Option-1 (771-751) � 3 5271886001 Option-5 (771-755) � 7 5248850001 E Bar label kit � 10 Item* Description Quantity Unit of Measure X001 Nodify XL2 - Immunology CPT Code: 0080U 96 Each X002 Nodify CDT - Immunology CPT Code: 81599 96 Each *X represents the base year (0) and option periods (1-4). Scope The STVHCS needs Immunohistochemistry (IHC) reagents/supplies for the government-owned Roche Ventana Benchmark instrumentation housed in the Anatomic Pathology Laboratory of the Pathology & Laboratory Medicine Service at Audie L. Murphy VA Hospital. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy as determined by FDA approval for use for IHC slide staining on the fully automated Ventana Benchmark systems for patient testing. These reagents shall be name-brand Roche Diagnostics Corp. (Ventana Medical Systems, Inc.) and compatible with the Roche Ventana Benchmark analyzers. The expiration date shall be marked on reagents, standards, and control containers. Third-party reseller authorization shall be provided if other vendors are to be considered. Refer to Attachment A for a full listing of required reagents and supplies. The Contractor shall provide a continuously stocked inventory of Immunohistochemistry reagents and supplies, and any other materials required to properly perform IHC testing such that laboratory operations are not interrupted. These items shall be of the highest quality, to assure precision and accuracy. The expiration date shall be marked on all supplies. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts shall be forwarded to the designated individuals determined at contract award. Special handling for emergency orders of supplies: If the supplies are found to be defective and unsuitable for use with the Roche/Ventana equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor shall deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s Core Laboratory equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. Location These reagents and supplies will be used on the Roche Ventana Benchmark Ultra instrumentation in the Anatomical Pathology laboratory located in the Pathology and Laboratory Medicine Service at the STVHCS, Audie L. Murphy VA Hospital, 7400 Merton Minter, San Antonio, TX, 78229. Reagents and supplies will be ordered as needed. Period of Performance Base + 4 years Deliverables/Supplies As needed name brand Roche Diagnostics Corp. (Ventana Medical Systems, Inc.) reagents and supplies for Immunohistochemistry testing on the Roche Ventana Benchmark Ultra instrumentation. See Attachment A for the full list of reagents and supplies. Government Inherent Functions: The contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy. General Duties, Requirements, and Expectations: The contractor shall be an authorized manufacturer of reagents and supplies requested. Services provided under the terms of this contract are required to be in compliance with the American Association of Blood Banks (AABB) and the College of American Pathologists (CAP). The requested items are for the purchase of a Nodify Lung Cancer Screening to be provided to the Pathology and Laboratory Medicine Service (P&LMS) of South Texas Veterans Healthcare System (STVHCS) in San Antonio, Texas. The testing must be for pre-diagnosis lung cancer testing. The vendor must be CAP-approved and have an active CLIA certification, demonstrating they are able to perform testing services in the United States. Failure to have a CLIA certification or CAP accreditation could create potential patient safety issues. This notice is not to be considered a request for quotations or proposals. A contract will not be awarded based on an offer received in response to this notice; however, all responsible sources may submit a capability statement, proposal, or quotation, by email, to the point of contact and referencing the Notice ID 36C25724Q0155, which shall be considered by the agency. Proposals or offers received will be used to determine if a comparable source is available and more advantageous to the Government. If no affirmative written response is received within 5 business days from the publication of this notice, a contract/order will be issued to, Inc., without any further notice. The proposed contract action is for testing services, which the Government intends to negotiate with only one source. The anticipated statutory authorities permitting other than full and open competition for the requirement is 41 USC §3304(a)(1) as implemented by FAR 6.302-1, only one responsible source is capable of providing the services at the required level because the services are unique or highly specialized. The proposed sole source procurement will be made by a pricing agreement with Roche Diagnostics Corporation.
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