Ventana SOW.pdf

Performance Work Statement

Ventana Reagents and Consumable Supplies

VISN 1 Pathology and Laboratory Medicine Service (PLMS) requires stain reagents kits and consumables for Anatomic Pathology Automated Ventana Staining Systems which process specimens for Anatomic Pathology testing in our VISN Laboratories. The Ventana system was purchased and is owned by each facility.

Ventana stains and consumable products are required for use on the present automated Ventana Staining Systems VISN 1 Anatomic Pathology Labs. The government reserves the right to add additional VISN 1 sites as requirements change.

The products listed in this performance work statement are open market, but only specific Ventana Reagents in original bar-coded reagent containers must be used, due to the laboratory instrumentation that is already in place at VISN1 locations.

This contract will be a Blanket Purchase Agreement with a base year and 4 option years.

Lab Sites and Points of Contact:

VA Connecticut Healthcare System West Haven Campus 950 Campbell Avenue West Haven, CT 06516

VA Connecticut Healthcare System Newington Campus 555 Willard Ave.

Newington, CT 06111

VA White River Junction 215 North Main Street White River Junction, VT 05009-001

VA Manchester 718 Smyth Road Manchester, NH 03104

VA Providence 830 Chalkstone Avenue Providence, RI 02908

VA Maine 1 VA Center Augusta, ME 04330

VA Boston Healthcare System West Roxbury Campus 1400 VFW Parkway West Roxbury, MA 02132

VA Central Western Massachusetts Healthcare System Northampton Campus 421 North Main Street Leeds, MA 01053

VA Boston Healthcare System Brockton Campus 940 Belmont Street Brockton, MA 02301

VA Central Western Massachusetts Healthcare System Worcester CBOC 605 Lincoln St, Worcester, MA 01605

VA Boston Healthcare System Jamaica Plain Campus 150 S. Huntington Avenue Boston, MA 02130

VA Bedford Healthcare System 200 Springs Road Bedford, MA 01730

Required:

Item # Description

5247829001 LABEL, BLANK, FLAP, 540 ROLL

5248850001 KIT PACK, EBAR (US/EUROPE)

5250889001 RIBBON, EBAR PRINTER

5250935001 ASSY, PREP KIT, BM, BM XT, BM LT

5251451001 ASSY,REAG.DISP.CARD,PREPKIT 12,BENCHMARK

5261899001 ANTIBODY DILUENT

5264839001 LCS

5266092001 ENDOGENOUS BIOTIN BLOCKING KIT, CE

5266114001 AMPLIFICATION KIT, CE

5266157001 iView DAB Detection Kit 5266181001 iView Blue Plus

5266181001 ISH, IVIEW BLUE PLUS DETECTION KIT

5266670001 NEGATIVE CONTROL MONOCLONAL

5266688001 PROTEASE 1

5266726001 HEMATOXYLIN

5266769001 BLUING REAGENT

5266840001 ANTI-PAN KERATIN PRIMARY ANTIBODY, 25 ML

5266882001 CONFIRM ANTI-ACTIN MUSCLE (HUC1-1) PAB

5266904001 CONFIRM ANTI-CD15 (MMA) PAB, IVD

5266912001 CONFIRM ANTI-CD45 (LCA) (RP2/18) PAB

5266939001 CONFIRM ANTI-PSA (polyclonal) Primary An

5266947001 ANTI-CEA (TF-3H8-1) PAB

5266980001 ANTI-CD43 (L60) PRIMARY ANTIBODY

5267005001 CONFIRM ANTI-DESMIN (DE-R-11) PAB

5267013001 CONFIRM anti-Kappa Rabbit Polyclonal Pri 5267021001 CONFIRM anti-Lambda Rabbit Polyclonal Pr

5267056001 ANTI-CHROMOGRANIN A (LK2H10) PAB

5267072001 CONFIRM ANTI-S100 (POLYCLONAL) PAB

5267099001 CONFIRM ANTI-CD20 (L26) PAB

5267102001 ANTI-P53 (BP53-11) PAB

5267145001 ANTI-KERATIN, PAN (AE1/AE3 & PCK26) PAB

5267161001 CELL MARQUE, MUSCLE SPECIFIC ACTIN

5267188001 CELL MARQUE REAGENT, ALPHA-FETOPROTEIN

5267242001 CELL MARQUE, CA19-9

5267323001 CELL MARQUE, CD34

5267366001 CELL MARQUE, CD57

5267439001 CELL MARQUE, COLLAGEN TYPE-IV

5267471001 CELL MARQUE, CK,35 BETAH11

5267757001 CELL MARQUE, PLAP

5267820001 CELL MARQUE, THYROGLOBULIN

5268303001 NEXES, REAGENT, CELL MARQUE, SM ACTIN

5268311001 NexES, Reagent, Cell MArque, Inhibin

5269008001 CELL MARQUE, BCL-6

5269016001 CELL MARQUE, BETA-CATENIN

5269059001 CELL MARQUE, CD21 (2G9)

5269083001 CD-138 (B-A38) PAB, CELL MARQUE

5269091001 CELL MARQUE, CD61

5269172001 CELL MARQUE, GLYCOPHORIN A

5269334001 CELL MARQUE, PSA (ER-PR8)

5269342001 Cell Marque, PSAP (PASE/4LJ)

5269369001 CELL MARQUE,RENAL CELL CARCINOMA (PN-15)

5269440001 CELL MARQUE, CYTOKERATIN 19

5269784001 GLIAL FIB ACIDIC PTN(EP672Y),CELL MARQUE

5269792001 HEPATOCYTE SPEC ANT(OCH1E5),CELL MARQUE

5269806001 ultraView Universal DAB Detection Kit 5269814001 Ultraview Universal AP Red Detection Kit

5269814001 ULTRAVIEW UNIVERSAL AP RED DETECTION KIT

5272017001 RED COUNTERSTAIN II

5272165001 ISH Negative Control

5273331001 ISH PROTEASE 3

5273617001 Prep Kit 1, (100) BM, BM XT 5273625001 Prep Kit 2, BenchMark 5273633001 Prep Kit 3, BenchMark 5273641001 Prep Kit 4, BenchMark 5273650001 Prep Kit 5, BenchMark 5273668001 Prep Kit 6, BenchMark 5273676001 Prep Kit 7, BenchMark 5273684001 Prep Kit 8, BenchMark 5273692001 Prep Kit 9, BenchMark 5273706001 Prep Kit 10, BenchMark 5273714001 Prep Kit 11, BenchMark 5273722001 Prep Kit 12, BenchMark

5277957001 PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONO

5277965001 HEMATOXYLIN II

5277990001 CONFIRM ANTI-PR (1E2)

5278074001 CONFIRM ANTI-P53 (DO-7)

5278139001 CONFIRM ANTI-VIMENTIN (V9) PRIMARY ANTIB

5278210001 CONFIRM ANTI-CD34 (QBEND/10) PRIMARY ANT

5278244001 CONFIRM anti-CD45RO (UHCL-1) Primary Ant

5278252001 CONFIRM ANTI-CD68 (KP-1) PRIMARY ANTIBOD

5278317001 ASSY, Kit Pack, Pathway C-Kit

5278350001 CONFIRM MART-1/MELAN A (A103) PRIMARY AN

5278384001 CONFIRM ANTI-KI-67 (30-9) RABBIT MONOCLO

5278406001 CONFIRM ANTI-ER (SP1)

5278422001 CONFIRM ANTI-CD3 (2GV6) RABBIT MONOCLONA

5279186001 ALC BLUE STAINING KIT PH2.5

5279194001 ALCIAN BLUE FOR PAS

5279208001 DIASTASE KIT

5279216001 ELASTIC STAINING KIT

5279224001 GIEMSA STAINING KIT

5279259001 IRON STAINING KIT

5279267001 LIGHT GREEN FOR PAS

5279275001 MUCICARMINE STAINING KIT

5279291001 PAS STAINING KIT

5279305001 SPECIAL STAINS WASH SOL. CONC. (10X)

5279313001 SPECIAL STAINS CLEANING KIT

5279330001 STEINER STAINING KIT

5279364001 Special Stains Trich.III Blue Staining K

5279399001 RETICULUM II STAINING KIT

5279402001 Steiner Cleaning Kit

5279429001 CONGO RED STAINING KIT

5279771001 10X EZ PREP SOLUTION, 2L

5353947001 10X SSC SOLUTION, 2L

5353955001 REACTION BUFFER CONCENTRATE (10X)

5412749001 SPECIAL STAINS GMS II STAIN KIT PACK

5424534001 BENCHMARK ULTRA LCS

5424542001 BENCHMARK ULTRA CC2

5424569001 BENCHMARK ULTRA CC1

5435676001 EP-CAM (BER-EP4) PAB, CELL MARQUE

5463475001 CD31 (JC70) PAB, CELL MARQUE

5463491001 CDX-2 (EPR2764Y) PAB, CELL MARQUE

5463556001 MUC2 PAB, CELL MARQUE

5463564001 MUC5AC PAB, CELL MARQUE

5463572001 MUC6 PAB, CELL MARQUE

5463645001 PODOPLANIN (D2-40) PAB, CELL MARQUE

5479258001 CONFIRM ANTI-CD23 (SP23) RABBIT MONOCLON

5479266001 CONFIRM ANTI-KERATIN (34E12) MOUSE MONO

5479282001 CONFIRM ANTI-MELANOSOME (HMB45) MOUSE M

5479304001 CONFIRM ANTI-SYNAPTOPHYSIN (SP11) RABBIT

5479312001 CONFIRM ANTI-THYROID TRANSCRIPTION FACT

5552729001 CONFIRM ANTI-PAX5 (SP34) RABBIT MONO

5552737001 CONFIRM ANTI-CD4 (SP35) RABBIT MONO

5587760001 CONFIRM CYTOKERATIN 20 RABBIT MONO

5640296001 CONFIRM CD79A RABBITMONO

5857856001 VENTANA ANTI-CD10 (SP67)

5862949001 VENTANA ANTI-CYCLIN D1 (SP4-R)

5867061001 VENTANA ANTI-P63 (4A4)

5878519001 CONFIRM ANTI-CD56 (123C3) MAB

5878900001 CONFIRM EMA (E29) MOUSE MAB

5905290001 VENTANA ANTI-E CADHERIN (36)

5913594001 CONFIRM ANTI-CD99 MOUNSE MONO

5917557001 HYB READY

5929903001 CONFIRM ANTI-CD5 (SP19) RABBIT MONO

5937248001 CONFIRM CD8 (SP57) RABBITMONO

5973864001 GLYPICAN-3 (1G12) PAB, CELL MARQUE

5986818001 CONFIRM CYTOKERATIN7 RABBITMONO

5986826001 CONFIRM BCL-2 (124) MAB

5992184001 CONFIRM CALRETININ (SP65) RBMAB

6364497001 VENTANA BASAL CELL COCKTAIL (34BE12+P63)

6374409001 EPITHELIAL RELATED ANTIGEN (MOC-31) PAB

6375375001 PROBE DILUENT

6396500001 OPTIVIEW DAB DETECTION KIT

6396518001 OPTIVIEW AMPLIFICATION KIT

6419208001 MUM1 (MRQ-43) PAB, CELL MARQUE

6425607001 VENTANA H. PYLORI (SP48) PAB

6433316001 CEA (CEA31) PAB, CELL MARQUE

6433359001 CD56 (MRQ-42) PAB, CELL MARQUE

6447325001 ASSY RGT DSPNR CARD ISH PRB 1 _50_

6447341001 ASSY RGT DSPNR CARD ISH PRB 2 _50_

6447554001 ISH PROBE 1 (50)

6447562001 ISH PROBE 2 (50)

6478441001 CYTOKERATIN 5/6 (D5/16B4)

6521894001 STEINER II STAINING KIT

6521908001 TRICHROME STAINING KIT

6523072001 BMK SPEC STAINS LIQUID COVERSLIP

6523102001 BMK SPEC STAINS DEPAR SOLUTION (10X)

6523927001 PAX8 (MRQ-50) PAB, CELL MARQUE

6543391001 KAPPA DNP PROBE (495-524), ASR

6543405001 KAPPA DNP PROBE (538-567), ASR

6543413001 KAPPA DNP PROBE (597-626), ASR

6543421001 KAPPA DNP PROBE (637-666), ASR

6543430001 LAMBDA DNP PROBE (664-693), ASR

6543448001 LAMBDA DNP PROBE (704-733), ASR

6543456001 LAMBDA DNP PROBE (768-797), ASR

6543464001 LAMBDA DNP PROBE (826-855), ASR

6544304001 VENTANA HE 600 EOSIN

6544312001 VENTANA HE 600 WASH

6544339001 VENTANA HE 600 DIFFERENTIATING SOLUTION

6544347001 VENTANA HE 600 BLUING

6544380001 VENTANA HE 600 TRANSFER FLUID

6640613001 TTF-1 (SP141) PAB

6649327001 SPECIAL STAINS CLEAN PLUS

6680003001 CINTEC HISTOLOGY (50)

6683380001 RABBIT MONO NEG CTL LG

6711138001 VENTANA HE600 GLASS COVERSLIPS

6732348001 ARGINASE-1 (SP156) PAB, CELL MARQUE

7007841001 CONFIRM Anti-CD30 (Clone Ber-H2) Primary

7007841001 ANTI-CD30 (BER-H2)

7024282001 VENTANA HE 600 HEMATOXYLIN

7047720001 NAPSIN A (MRQ-60) PAB, CELL MARQUE

7095163001 VENTANA HE 600 ORGANIC SOLUTION

7107749001 GATA3 (L50-823) PAB, CELL MARQUE

7257538001 VENTANA HE 600 CLEANING SOLUTION

7394420001 ANTI-P40 (BC28) MOUSE MONOCLONAL PAB

7475144001 ASSY, LP PREP KIT

7534396001 VENTANA HE600 COVERSLIP ACTIVATOR(2PACK)

7560389001 SOX-10 (SP267) PAB, CELL MARQUE

7859759001 NKX3.1 (EP356) PAB, CELL MARQUE

7862237001 MLH1 (M1) MOUSE MONOCLONAL PAB US

7862245001 MSH6 (SP93) RABBIT MONOCLONAL PAB US

7862253001 MSH2 (G219-1129) MOUSE MONOCLONAL PAB US

7862261001 PMS2 (A16-4) MOUSE MONOCLONAL PAB US

7862270001 BRAF V600E (VE1) MOUSE MONOCLONAL PAB US

8035130001 ANTI-P504S (SP116) RABBIT MONOCLONAL PAB

8309817001 BENCHMARK SPECIAL STAINS WASH II

8313482001 MUM1 (EP190) PAB, CELL MARQUE

8432503001 BENCHMARK SPECIAL STAIN AFB STAINING KIT

8763909001 CD117(EP10) RABBIT MONOCLONAL PAB

9476580001 BENCHMARK SPECIAL STAINS CLEANING KIT

9592229001 ELASTIC VAN GIESON

1. Supplies will be ordered on an as needed basis.

2. Consult point of contact prior to providing an alternate product. These tests are highly specialized and specific to the analyzer.

3. The government reserves the right to add additional Ventana reagents and supplies during the life of this agreement.

4. Volumes are estimates only. Annual quantities may vary during the life of the contract.

5. All reagents should have the longest outdates possible, preferably 9 months before expiration when received on site.

6. All reagents shall provide uniform results in staining quality from lot-to-lot

7. All reagents and kits shall be in ready-to-use form for the Ventana stainers with no manual dilutions or adaptations required.

8. Vendor must be able to provide coverslips that are compatible with the Ventana instrumentation.

9. All Benchmark reagents are to have barcode compatibility with the systems in place.

10. All reagents are to be xylene free.

11. Vendor shall be able to supply reagent kits that are customizable for the VA patient population.

12. Safety Data Sheets (SDS) are required. Any product formulation changes must be accompanied with an updated SDS.

13. The Contractor will supply a semi-annual report to the Contracting Officer’s Representative

(COR) that indicates the products and quantities purchased each month by site. The report shall consist of a breakdown which includes: the facility name, products obtained under the agreement, and the volume per month.

14. All pricing includes FOB destination with 2-day shipping upon order.

15. In the event of a recall, the vendor must comply with all applicable rules and regulations regarding notice to customers. The vendor shall provide sufficient replacement items to resolve the problem so that there is no break in service. The vendor shall reimburse the customer for any costs actually incurred by customer to comply with recall instructions and process provided by the vendor including but not limited to sequestering, packaging, and returning the affected products, as applicable.

16. The vendor will support and cover additional costs for the use of alternative reagents if required due to recall, supply chain issues, or multiple performance issues.

17. In the case of a company merger and/or acquisition, the vendor will immediately notify the Contracting Officer for this BPA and provide a contingency plan of services to assure that no break in service is experienced by the participating facilities.

18. Advanced notice will be provided for any future part number changes or discontinuations to allow sufficient time for contracting to process modifications to the BPA.

19. Each site will be invoiced individually for their own delivery orders utilizing Tungsten electronic invoicing system. The vendor will provide direct delivery to the requesting lab at the contractor’s expense. The laboratory department will order using their usual procedures and referencing the purchase agreement. Each laboratory may order any of the reagents and supplies listed on this contract.

Records Management Language for Statement of Work (SOW):

The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33;

Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974.

These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.