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)
Â
14
05280524001
Antibody Dilution Buffer, 250 mL (ADB250)
Â
2
05266769001
Bluing Reagent (760-2037)
Â
50
05266726001
Hematoxylin (760-2021)
Â
50
05277965001
Hematoxylin II (790-2208)
Â
2
06718663001
OptiView Amplification Kit (860-099)
Â
12
05266688001
Protease 1 (760-2018)
Â
3
05266718001
Protease 3 (760-2020)
Â
2
06440002001
Ventana Antibody Diluent with Casein (760-219)
Â
2
05278406001
Confirm Anti-ER (SP1) (790-4324)
Â
2
05277990001
Confirm Anti-PR (1E2) (790-2223)
Â
2
07862237001
MLH1 (M1) Mouse Monoclonal PAB US (790-5091)
Â
3
07862253001
MSH2 (G219-1129) Mouse Monoclonal PAB US (790-5093)
Â
3
07862245001
MSH6 (SP93) Rabbit Monoclonal PAB US (790-5092)
Â
3
07862261001
PMS2 (A16-4) Mouse Monoclonal PAB US (790-5094)
Â
3
06425607001
Ventana H. Pylori (SP48) PAB (790-1014)
Â
6
07007841001
Anti-CD30 (Ber-H2) (790-4858)
Â
4
05266980001
Anti-CD43 (L60) Primary Antibody (760-2511)
Â
2
05267056001
Anti-Chromogranin A (LK2H10) PAB (760-2519)
Â
3
05267145001
Anti-Keratin, Pan (AE1/AE3 & PCK26) PAB (760-2595)
Â
9
05267102001
Anti-P53 (Bp53-11) PAB (760-2542)
Â
5
08035130001
Anti-p504s (SP116) Rabbit Monoclonal PAB (790-6011)
Â
2
06732348001
Arginase-1 (SP156) PAB, Cell Marque (760-4801)
Â
2
06504612001
c-MYC (Y69) PAB (790-4628)
Â
4
05435684001
Calponin-1 (EP798Y) PAB, Cell Marque (760-7376)
Â
2
6680003001
Cintec Histology (50) (705-4793)
Â
8
06419160001
CD1a (EP3622) PAB, Cell Marque (760-4525)
Â
2
05463467001
CD2 (MRQ-11) PAB, Cell Marque (760-4377)
Â
2
06537847001
CD7 (SP94) PAB (790-4558)
Â
2
05463475001
CD31 (JC70) PAB, Cell Marque (760-4378)
Â
2
06433359001
CD56 (MRQ-42) PAB, Cell Marque (760-4596)
Â
4
05269083001
CD-138 (B-A38) PAB, Cell Marque (760-4248)
Â
4
05463491001
CDX-2 (EPR2764Y) PAB, Cell Marque (760-4380)
Â
3
06433316001
CEA (CEA31) PAB, Cell Marque (760-4594)
Â
3
05267188001
Cell Marque Reagent, Alpha-Fetoprotein (760-2603)
Â
2
05269008001
Cell Marque, BCL-6 (760-4241)
Â
3
05267242001
Cell Marque, CA19-9 (760-2609)
Â
3
05269059001
Cell Marque, CD21 (2G9) (760-4245)
Â
3
05267366001
Cell Marque, CD57 (760-2626)
Â
2
05267536001
Cell Marque, Gastrin (760-2643)
Â
2
05267692001
Cell Marque, Myeloperoxidase (760-2659)
Â
2
05267714001
Cell Marque, Neurofilament (760-2661)
Â
2
05267757001
Cell Marque, PLAP (760-2664)
Â
2
05267811001
Cell Marque, TDT (760-2670)
Â
2
05269393001
Cell Marque, Tryptase (G3) (760-4276)
Â
2
05278147001
CONFIRM Anti-ALK1 (ALK01) (790-2918)
Â
2
05278422001
CONFIRM Anti-CD3 (2GV6) Rabbit Monoclona (790-4341)
Â
5
05552737001
CONFIRM Anti-CD4 (SP35) Rabbit Mono (790-4423)
Â
2
05929903001
CONFIRM Anti-CD5 (SP19) Rabbit Mono (790-4451)
Â
3
05266904001
CONFIRM Anti-CD15 (MMA) PAB, IVD (760-2504)
Â
2
05267099001
CONFIRM Anti-CD20 (L26) PAB (760-2531)
Â
5
05479258001
CONFIRM Anti-CD23 (SP23) Rabbit Monoclon (790-4408)
Â
2
05278210001
CONFIRM Anti-CD34 (QBEnd/10) Primary Ant (790-2927)
Â
4
05266912001
CONFIRM Anti-CD45 (LCA) (RP2/18) PAB (760-2505)
Â
2
05278252001
CONFIRM Anti-CD68 (KP-1) Primary Antibod (790-2931)
Â
3
05913594001
CONFIRM Anti-CD99 Mouse Mono (790-4452)
Â
2
05267005001
CONFIRM Anti-Desmin (DE-R-11) PAB (760-2513)
Â
2
05479266001
CONFIRM Anti-Keratin (34E12) Mouse Mono (790-4373)
Â
2
05278384001
CONFIRM Anti-KI-67 (30-9) Rabbit Monoclon (790-4286)
Â
5
05479282001
CONFIRM Anti-Melanosome (HMB45) Mouse M (790-4366)
Â
2
05552729001
CONFIRM Anti-PAX5 (SP34) Rabbit Mono (790-4420)
Â
2
05266939001
CONFIRM Anti-PSA (polyclonal) Primary An (760-2506)
Â
2
05278104001
CONFIRM Anti-S100 (4C4.9) Primary Antibo (790-2914)
Â
4
05479312001
CONFIRM Anti-Thyroid transcription fact (790-4398)
Â
6
05278139001
CONFIRM Anti-Vimentin (V9) Primary Antib (790-2917)
Â
2
05986826001
CONFIRM BCL-2 (124) Mab (790-4464)
Â
4
05992184001
CONFIRM Calretinin (SP65) RbmAb (790-4467)
Â
3
05937248001
CONFIRM CD8 (SP57) Rabbit Mono (790-4460)
Â
2
05640296001
CONFIRM CD79a Rabbit Mono (790-4432)
Â
2
05587760001
CONFIRM Cytokeratin 20 Rabbit Mono (790-4431)
Â
7
05986818001
CONFIRM Cytokeratin 7 Rabbit Mono (790-4462)
Â
5
05878900001
CONFIRM EMA (E29) Mouse mAb (790-4463)
Â
2
05278350001
CONFIRM MART-1/melan A (A103) Primary An (790-2990)
Â
17
06478441001
Cytokeratin 5/6 (D5/16B4) (790-4554)
Â
5
06478425001
Cytokeratin (CAM 5.2) PAB (790-4555)
Â
2
05435676001
EP-CAM (Ber-EP4) Pab, Cell Marque (760-4383)
Â
4
06374409001
Epithelial Related Antigen (MOC-31) PAB (790-4561)
Â
3
05435692001
Factor XIIIa (AC-1A1) Pab, Cell Marque (760-4384)
Â
2
07107749001
GATA3 (L50-823) Pab, Cell Marque (760-4897)
Â
3
05269784001
Glial Fib Acidic Ptn (EP672Y), Cell Marque (760-4345)
Â
2
06483186001
Glypican 3 (GC33) PAB (790-4564)
Â
2
05269792001
Hepatocyte Spec Ant(OCH1E5), Cell Marque (760-4350)
Â
2
05973821001
IgD (polyclonal) Pab, Cell Marque (760-4444)
Â
2
05973813001
Mesothelial Cell (HBME-1) Pab, Cell Marque (760-4445)
Â
2
08313482001
MUM1 (EP190) PAb, Cell Marque (760-6082)
Â
2
07047720001
Napsin A (MRQ-60) Pab, Cell Marque (760-4867)
Â
5
05268303001
NexES, Reagent, Cell Marque, SM Actin (760-2833)
Â
3
07859759001
NKX3.1 (EP356) PAb, Cell Marque (760-5086)
Â
3
0653927001
PAX8 (MRQ-50) PAb, Cell Marque (760-4618)
Â
3
05463645001
Podoplanin (D2-40) Pab, Cell Marque (760-4395)
Â
2
06433324001
Synaptophysin (MRQ-40) PAb, Cell Marque (760-4595)
Â
3
05857856001
VENTANA Anti-CD10 (SP67) (790-4506)
Â
4
05862949001
VENTANA Anti-Cyclin D1 (SP4-R) (790-4508)
Â
3
05867061001
VENTANA Anti-P63 (4A4) (790-4509)
Â
4
06396500001
OptiView DAB Detection Kit (760-700)
Â
27
05269814001
Ultraview Universal AP Red Detection Kit (760-501)
Â
13
05273617001
Prep Kit 1, (100) BM, BM XT (783-2851)
Â
2
05273625001
Prep Kit 2, BenchMark (783-2852)
Â
2
05273633001
Prep Kit 3, BenchMark (783-2853)
Â
2
05273641001
Prep Kit 4, BenchMark (783-2854)
Â
3
05273650001
Prep Kit 5, BenchMark (783-2855)
Â
6
05273668001
Prep Kit 6, BenchMark (783-2856)
Â
6
05273676001
Prep Kit 7, BenchMark (783-2857)
Â
2
05273684001
Prep Kit 8, BenchMark (783-2858)
Â
2
05273692001
Prep Kit 9, BenchMark (783-2859)
Â
1
05273706001
Prep Kit 10, BenchMark (783-2860)
Â
2
05273714001
Prep Kit 11, BenchMark (783-2861)
Â
8
05273722001
Prep Kit 12, BenchMark (783-2862)
Â
2
05273749001
Prep Kit 13, BenchMark (783-2863)
Â
1
05273757001
Prep Kit 14, BenchMark (783-2864)
Â
2
05273765001
Prep Kit 15, BenchMark (783-2865)
Â
2
05273773001
Prep Kit 16, BenchMark (783-2866)
Â
2
05273781001
Prep Kit 17, BenchMark (783-2867)
Â
2
05273790001
Prep Kit 18, BenchMark (783-2868)
Â
3
05273803001
Prep Kit 19, BenchMark (783-2869)
Â
3
05273811001
Prep Kit 20, BenchMark (783-2870)
Â
2
05273820001
Prep Kit 21, BenchMark (783-2871)
Â
1
05273838001
Prep Kit 22, BenchMark (783-2872)
Â
1
05273846001
Prep Kit 23, BenchMark (783-2873)
Â
1
05273854001
Prep Kit 24, BenchMark (783-2874)
Â
1
05273862001
Prep Kit 25, BenchMark (783-2875)
Â
1
05273889001
Prep Kit 26, BenchMark (783-2876)
Â
1
05273897001
Prep Kit 27, BenchMark (783-2877)
Â
1
05273919001
Prep Kit 28, BenchMark (783-2878)
Â
1
05273927001
Prep Kit 29, BenchMark (783-2879)
Â
1
05273935001
Prep Kit 30, BenchMark (783-2880)
Â
1
05273943001
Prep Kit 31, BenchMark (783-2881)
Â
1
05273951001
Prep Kit 32, BenchMark (783-2882)
Â
2
05273960001
Prep Kit 33, BenchMark (783-2883)
Â
2
05279771001
10X EZ Prep Solution, 2L (950-102)
Â
80
05353947001
10X SSC Solution, 2L (950-110)
Â
30
05424569001
Benchmark Ultra CC1 (950-224)
Â
30
05424542001
Benchmark Ultra CC2 (950-223)
Â
15
05424534001
Benchmark Ultra LCS (650-210)
Â
250
05353955001
Reaction Buffer Concentrate (10X) (950-300)
Â
150
05917557001
HybReady Solution (780-4409)
Â
10
05272165001
ISH Negative Solution (780-2902)
Â
5
05273315001
ISH Protease 1 (780-4147)
Â
6
05272017001
Red Counterstain II (780-2218)
Â
10
05266181001
ISH, iVIEW Blue Plus Detection Kit (760-097)
Â
10
06543472001
EBER 1 DNP Probe, ASR PTO (760-1209)
Â
6
06543391001
Kappa DNP Probe (495-524), ASR (760-1201)
Â
6
06543405001
Kappa DNP Probe (538-567), ASR (760-1202)
Â
6
06543413001
Kappa DNP Probe (597-626), ASR (760-1203)
Â
6
06543421001
Kappa DNP Probe (637-666), ASR (760-1204)
Â
6
06543430001
Lambda DNP Probe (664-693), ASR (760-1205)
Â
6
06543448001
Lambda DNP Probe (704-733), ASR (760-1206)
Â
6
06543456001
Lambda DNP Probe (768-797), ASR (760-1207)
Â
6
06543464001
Lambda DNP Probe (826-855), ASR (760-1208)
Â
6
06543499001
U6 DNP Probe, ASR (760-1210)
Â
15
07734115001
RNA ISH Probe 1 (243-5066)
Â
5
07734123001
RNA ISH Probe 2 (243-5067)
Â
5
07734140001
RNA ISH Probe 3 (243-5068)
Â
3
07734760001
RNA ISH Probe 4 (243-5069)
Â
8
5271843001
Option-1 (771-751)
Â
3
5271886001
Option-5 (771-755)
Â
7
5248850001
E Bar label kit
Â
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.