RFQ 36C24822Q0952.docx

36C24822Q0952

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

516-23-1-033-0001

Christina Blevins 727-514-0020 06-14-2022

1:00 PM

EDT

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Room 315, Bldg. 2 10,000 Bay Pines Blvd Bay Pines FL 33744

X

325413 1250 Employees

N/A

MCC: 90D

Department Of Veteran Affairs C.W. Bill Young VA Medical Center Bldg 100 Warehouse 10,000 Bay Pines Blvd.

Bay Pines FL 33744 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) C.W. Bill Young VA Medical Center 10000 Bay Pines Blvd. Room 315, Bldg. 2 Bay Pines FL 33744

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

The United States Department of Veterans Affairs Healthcare System, C.W. Bill Young VAMC, anticipates awarding a

Firm Fixed Price IDIQ (estimated quantities) contract for Histology Staining.

The Statement of Work identifies the annual estimated quantities used.

Christina Blevins

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT:

Contracting Officer 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Room 315, Bldg. 2 10,000 Bay Pines Blvd Bay Pines FL 33744

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Immunohistochemistry (IHC) Staining Protocols

• Cytokeratins including: Cytokeratin (AE1), Cytokeratin (AE3), CAM5.2, Dual stain = CAM5.2+MU, Dual Stain = CAM5.2+p63, CK5-6, CK7, CK20, CK34beta, Pankerkatin

• Epithelial Cell Antigens including: Arginase, BER-EP4, CA 19-9, CDX2, CEA, EMA, Glypican 3, Hepacyte Specific Antigen, MOC-31, Napsin A, TTF-1/Napsin dual stain, Napsin/p40 dual stain, p504S, p504s/p63 Dual Stain, p504s/CK34beta Dual Stain, p40, p63, PSA, PSAP, RCC, TTF-1, Uroplakin II

• Mesodermal Antigens including: CD117, CD68, Desmin, Muscle Actin, Vimentin V9, Calretinin, Mesothelial Cell, WT1

• Melanocytic Antigens including: HMB45(HMB45) Mouse Monoclonal, Melan-A, (MART-1) (A103) Mouse Monoclonal, Melan-A/CK34 Dual Stain, Melan-A/KI-67 Dual Stain, HMB45/MITF Dual Stain, Melanoma Triple Cocktail (HMB45, A103+ T311), MITF (C5/D5) Mouse Monoclonal, S-100, S-100 (DAB), CD57, Chromogranin, Synaptophysin, Thyroglobulin, CD34, CD31, Bcl-2, bcl-6, CD3, CD4, CD5, CD7, CD8, CD10, CD15, CD20, CD23, CD30, CD79, CD138, Cyclin D1, LCA, MUM-1

• Proliferative Index protocols including: KI-67, p16

• Micro-organisms including: Helicobacter Pylori and Treponema Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

In Situ Hybridization (ISH) Staining Protocols

• ISH Open Probes including: Kappa, Lambda, Negative Probe Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023

Special Staining Protocols

• Including: Alcian Blue, Congo Red, Giemsa, GMS II, Iron, Mucicarmine, PASD, PASF, PASH, PASH Alcian Blue, Retic, Trich II, Trich III Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023

All Instrumentation for tissue processing, embedding and Staining, Ancillary Bulk Supplies, Service, Installation and Training Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

Immunohistochemistry (IHC) Staining Protocols

• Cytokeratins including: Cytokeratin (AE1), Cytokeratin (AE3), CAM5.2, Dual stain = CAM5.2+MU, Dual Stain = CAM5.2+p63, CK5-6, CK7, CK20, CK34beta, Pankerkatin

• Epithelial Cell Antigens including: Arginase, BER-EP4, CA 19-9, CDX2, CEA, EMA, Glypican 3, Hepacyte Specific Antigen, MOC-31, Napsin A, TTF-1/Napsin dual stain, Napsin/p40 dual stain, p504S, p504s/p63 Dual Stain, p504s/CK34beta Dual Stain, p40, p63, PSA, PSAP, RCC, TTF-1, Uroplakin II

• Mesodermal Antigens including: CD117, CD68, Desmin, Muscle Actin, Vimentin V9, Calretinin, Mesothelial Cell, WT1

• Melanocytic Antigens including: HMB45(HMB45) Mouse Monoclonal, Melan-A, (MART-1) (A103) Mouse Monoclonal, Melan-A/CK34 Dual Stain, Melan-A/KI-67 Dual Stain, HMB45/MITF Dual Stain, Melanoma Triple Cocktail (HMB45, A103+ T311), MITF (C5/D5) Mouse Monoclonal, S-100, S-100 (DAB), CD57, Chromogranin, Synaptophysin, Thyroglobulin, CD34, CD31, Bcl-2, bcl-6, CD3, CD4, CD5, CD7, CD8, CD10, CD15, CD20, CD23, CD30, CD79, CD138, Cyclin D1, LCA, MUM-1

• Proliferative Index protocols including: KI-67, p16

• Micro-organisms including: Helicobacter Pylori and Treponema Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024

In Situ Hybridization (ISH) Staining Protocols

Contract Period: Option 1 POP Begin: 10-01-2023 POP End: 09-30-2024

Special Staining Protocols

• Including: Alcian Blue, Congo Red, Giemsa, GMS II, Iron, Mucicarmine, PASD, PASF, PASH, PASH Alcian Blue, Retic, Trich II, Trich III Contract Period: Option 1 POP Begin: 10-01-2023 POP End: 09-30-2024

All Instrumentation for tissue processing, embedding and Staining, Ancillary Bulk Supplies, Service, Installation and Training Contract Period: Option 1 POP Begin: 10-01-2023 POP End: 09-30-2024

Immunohistochemistry (IHC) Staining Protocols

• Cytokeratins including: Cytokeratin (AE1), Cytokeratin (AE3), CAM5.2, Dual stain = CAM5.2+MU, Dual Stain = CAM5.2+p63, CK5-6, CK7, CK20, CK34beta, Pankerkatin

• Epithelial Cell Antigens including: Arginase, BER-EP4, CA 19-9, CDX2, CEA, EMA, Glypican 3, Hepacyte Specific Antigen, MOC-31, Napsin A, TTF-1/Napsin dual stain, Napsin/p40 dual stain, p504S, p504s/p63 Dual Stain, p504s/CK34beta Dual Stain, p40, p63, PSA, PSAP, RCC, TTF-1, Uroplakin II

• Mesodermal Antigens including: CD117, CD68, Desmin, Muscle Actin, Vimentin V9, Calretinin, Mesothelial Cell, WT1

• Melanocytic Antigens including: HMB45(HMB45) Mouse Monoclonal, Melan-A, (MART-1) (A103) Mouse Monoclonal, Melan-A/CK34 Dual Stain, Melan-A/KI-67 Dual Stain, HMB45/MITF Dual Stain, Melanoma Triple Cocktail (HMB45, A103+ T311), MITF (C5/D5) Mouse Monoclonal, S-100, S-100 (DAB), CD57, Chromogranin, Synaptophysin, Thyroglobulin, CD34, CD31, Bcl-2, bcl-6, CD3, CD4, CD5, CD7, CD8, CD10, CD15, CD20, CD23, CD30, CD79, CD138, Cyclin D1, LCA, MUM-1

• Proliferative Index protocols including: KI-67, p16

• Micro-organisms including: Helicobacter Pylori and Treponema Contract Period: Base POP Begin: 10-01-2024 POP End: 09-30-2025

In Situ Hybridization (ISH) Staining Protocols

Contract Period: Option 2 POP Begin: 10-01-2024 POP End: 09-30-2025

Special Staining Protocols

• Including: Alcian Blue, Congo Red, Giemsa, GMS II, Iron, Mucicarmine, PASD, PASF, PASH, PASH Alcian Blue, Retic, Trich II, Trich III Contract Period: Option 2 POP Begin: 10-01-2024 POP End: 09-30-2025

All Instrumentation for tissue processing, embedding and Staining, Ancillary Bulk Supplies, Service, Installation and Training Contract Period: Option 2 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

Immunohistochemistry (IHC) Staining Protocols

• Cytokeratins including: Cytokeratin (AE1), Cytokeratin (AE3), CAM5.2, Dual stain = CAM5.2+MU, Dual Stain = CAM5.2+p63, CK5-6, CK7, CK20, CK34beta, Pankerkatin

• Epithelial Cell Antigens including: Arginase, BER-EP4, CA 19-9, CDX2, CEA, EMA, Glypican 3, Hepacyte Specific Antigen, MOC-31, Napsin A, TTF-1/Napsin dual stain, Napsin/p40 dual stain, p504S, p504s/p63 Dual Stain, p504s/CK34beta Dual Stain, p40, p63, PSA, PSAP, RCC, TTF-1, Uroplakin II

• Mesodermal Antigens including: CD117, CD68, Desmin, Muscle Actin, Vimentin V9, Calretinin, Mesothelial Cell, WT1

• Melanocytic Antigens including: HMB45(HMB45) Mouse Monoclonal, Melan-A, (MART-1) (A103) Mouse Monoclonal, Melan-A/CK34 Dual Stain, Melan-A/KI-67 Dual Stain, HMB45/MITF Dual Stain, Melanoma Triple Cocktail (HMB45, A103+ T311), MITF (C5/D5) Mouse Monoclonal, S-100, S-100 (DAB), CD57, Chromogranin, Synaptophysin, Thyroglobulin, CD34, CD31, Bcl-2, bcl-6, CD3, CD4, CD5, CD7, CD8, CD10, CD15, CD20, CD23, CD30, CD79, CD138, Cyclin D1, LCA, MUM-1

• Proliferative Index protocols including: KI-67, p16

• Micro-organisms including: Helicobacter Pylori and Treponema Contract Period: Base POP Begin: 10-01-2025 POP End: 09-30-2026

In Situ Hybridization (ISH) Staining Protocols

Contract Period: Option 3 POP Begin: 10-01-2025 POP End: 09-30-2026

Special Staining Protocols

• Including: Alcian Blue, Congo Red, Giemsa, GMS II, Iron, Mucicarmine, PASD, PASF, PASH, PASH Alcian Blue, Retic, Trich II, Trich III Contract Period: Option 3 POP Begin: 10-01-2025 POP End: 09-30-2026

All Instrumentation for tissue processing, embedding and Staining, Ancillary Bulk Supplies, Service, Installation and Training Contract Period: Option 3 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

Immunohistochemistry (IHC) Staining Protocols

• Cytokeratins including: Cytokeratin (AE1), Cytokeratin (AE3), CAM5.2, Dual stain = CAM5.2+MU, Dual Stain = CAM5.2+p63, CK5-6, CK7, CK20, CK34beta, Pankerkatin

• Epithelial Cell Antigens including: Arginase, BER-EP4, CA 19-9, CDX2, CEA, EMA, Glypican 3, Hepacyte Specific Antigen, MOC-31, Napsin A, TTF-1/Napsin dual stain, Napsin/p40 dual stain, p504S, p504s/p63 Dual Stain, p504s/CK34beta Dual Stain, p40, p63, PSA, PSAP, RCC, TTF-1, Uroplakin II

• Mesodermal Antigens including: CD117, CD68, Desmin, Muscle Actin, Vimentin V9, Calretinin, Mesothelial Cell, WT1

• Melanocytic Antigens including: HMB45(HMB45) Mouse Monoclonal, Melan-A, (MART-1) (A103) Mouse Monoclonal, Melan-A/CK34 Dual Stain, Melan-A/KI-67 Dual Stain, HMB45/MITF Dual Stain, Melanoma Triple Cocktail (HMB45, A103+ T311), MITF (C5/D5) Mouse Monoclonal, S-100, S-100 (DAB), CD57, Chromogranin, Synaptophysin, Thyroglobulin, CD34, CD31, Bcl-2, bcl-6, CD3, CD4, CD5, CD7, CD8, CD10, CD15, CD20, CD23, CD30, CD79, CD138, Cyclin D1, LCA, MUM-1

• Proliferative Index protocols including: KI-67, p16

• Micro-organisms including: Helicobacter Pylori and Treponema Contract Period: Base POP Begin: 10-01-2026 POP End: 09-30-2027

In Situ Hybridization (ISH) Staining Protocols

Contract Period: Option 4 POP Begin: 10-01-2026 POP End: 09-30-2027

Special Staining Protocols

• Including: Alcian Blue, Congo Red, Giemsa, GMS II, Iron, Mucicarmine, PASD, PASF, PASH, PASH Alcian Blue, Retic, Trich II, Trich III Contract Period: Option 4 POP Begin: 10-01-2026 POP End: 09-30-2027

All Instrumentation for tissue processing, embedding and Staining, Ancillary Bulk Supplies, Service, Installation and Training Contract Period: Option 4 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

6-Month Extension Pricing for all Line Items

GRAND TOTAL

B.3 DELIVERY SCHEDULE

0001 - 0003

Bay Pines VA Healthcare System C.W. Bill Young VAMC 10,000 Bay Pines Blvd Bay Pines, FL 33744

USA

1001 - 1003

Bay Pines VA Healthcare System C.W. Bill Young VAMC 10,000 Bay Pines Blvd Bay Pines, FL 33744

USA

2001 - 2003

Bay Pines VA Healthcare System C.W. Bill Young VAMC 10,000 Bay Pines Blvd Bay Pines, FL 33744

USA

3001 - 3003

Bay Pines VA Healthcare System C.W. Bill Young VAMC 10,000 Bay Pines Blvd Bay Pines, FL 33744

USA

4001-4003

Bay Pines VA Healthcare System C.W. Bill Young VAMC 10,000 Bay Pines Blvd Bay Pines, FL 33744

USA

5001- 5003

Bay Pines VA Healthcare System C.W. Bill Young VAMC 10,000 Bay Pines Blvd Bay Pines, FL 33744

USA

Page 1 of Page 1 of

B.4 STATEMENT OF WORK

STATEMENT OF WORK

1. SCOPE:

The contractor shall provide fully automated Histology Special Staining, Immunohistochemistry (IHC)/In Situ Hybridization (ISH) Staining Systems for the Bay Pines VA HCS (BPVAHCS) Department of Pathology and Laboratory Medicine Service (P&LMS). All instrumentation and software must be from the same vendor.

All work is to be performed in accordance with the guidelines established by Federal, State and local ordinances, with the FDA and manufacturer's guidelines, and with all terms, conditions, provisions, schedules and specifications provided herein.

The Bay Pines VA HCS anticipates the award of a firm, fixed-price Cost Test (CPT) contract from this Request for Quote (RFQ).

2. GENERAL REQUIREMENTS:

a) Under the CPT contract, the contractor is required to furnish all of the following:

1) Instrumentation hardware and software (analyzers, operating system, printers, monitors, etc.).

2) Reagents, Quality Control, and Calibrators.

3) All consumables and user-defined replacement parts necessary to operate the contractor's equipment.

4) Upgrades to and maintenance of hardware or software necessary to maintain full operation of the system.

5) Training for end users and key operators.

6) Delivery and installation of equipment at no additional charge as well as return shipping costs at end of contract.

7) Equipment / assay installation, and full validation of system hardware and software as well as assay performance studies (full correlations to existing instrumentation).

b) Under the CPT contract:

1) Annual test volumes provided are based upon historical reported result data and are not a guaranteed minimum.

2) New tests may be added as requested as baseline cost per test (CPT).

3) All stains and ancillary supplies for installation staining correlation studies and equipment validations are to be supplied by the vendor at no additional cost to the government.

4) If at any time during the contract period, testing for the defined test menu is not available on this list, the Contractor shall reimburse Bay Pines VA HCS any additional costs associated with the procurement of another source of test performance (i.e. reference laboratory).

c) Parameter Definitions:

1) IHC – Immunohistochemistry Stain

2) ISH – In Situ Hybridization Stain

3) SS – Special Stain

d) Required Protocols and estimated annual volumes (based on previous year workload):

Cytokeratins

Cytokeratin (AE1)

IHC

Cytokeratin (AE3)

IHC

CAM5.2

Dual stain = CAM5.2+MU Dual Stain = CAM5.2+p63

IHC

Epithelial Cell Antigens

Mesodermal Antigens

Melanocytic Antigens

HMB45(HMB45) Mouse Monoclonal

IHC

Melan-A, (MART-1) (A103) Mouse Monoclonal

IHC

HMB45/MITF Dual Stain

IHC

MITF (C5/D5) Mouse Monoclonal

IHC

S-100

IHC

S-100 (DAB)

IHC

Proliferative Index

Microorganisms

ISH Open Probes

Special Stains

NOTE: Annual test volumes provided are based upon 2019 historical reported result data and are not a guaranteed minimum. New tests will be added as requested as baseline cost per test (CPT) without instrumentation or service costs added or a reduced rate CPRR.

3. EQUIPMENT:

The purpose of this solicitation is to identify the characteristics (space, functionality and performance-based requirements) of the Automated IHC/ISH and Special Stain Systems. The proposal shall provide descriptive literature that meets the following specifications:

a) General Characteristics for Automated Analyzers:

1) Automated IHC / ISH Staining Systems:

a. The systems should be barcode driven, random access, have a precision reagent delivery, precision heat induced staining reaction, horizontal kinetic mode Immunohistochemistry, and Chromogenic in situ Hybridization

b. Maximum Space Allocations for all instruments to meet minimum throughput, including mandatory clearances, 200" (W) x 48" (D) x 78” (H)

c. Throughput: IHC/ISH stainer minimum throughput of 175 IHC slides per 8-hour shift.

d. IHC/ISH system must perform baking, deparaffinization, cell conditioning, dual / triple staining of slides, and counterstaining in the same platform.

e. IHC/ISH stainer must have the capacity to run IHC and ISH simultaneously

f. Minimal requirements for reagent preparation with maximum on board stability – the systems should utilize self-contained, pre-diluted, Antibodies and Detection kits that are ready to use

g. The systems should utilize flash memory technology and barcodes on dispensers or other similar system to track reagents and for quality control and quality assurance

h. Must have the capacity to add/remove slides and reagents randomly without workflow interference

i. Must have independent slide pads for up to 90 slides

j. Internal self-diagnostics with log of error messages and codes

k. Remote monitoring with the vendor

l. Must include a minimum of 2 staining systems to ensure redundancy during periods of equipment downtime.

2) Automated Special Staining Systems:

a. Maximum Space Allocations for all instruments to meet minimum throughput, including mandatory clearances, 100" (W) x 42" (D) x 78” (H)

b. Throughput:

c. Minimal requirements for reagent preparation with maximum onboard stability – the systems should utilize self-contained, pre-diluted, Antibodies and Detection kits that are ready to use

d. The systems should utilize flash memory technology and barcodes on dispensers or other similar system to track reagents and for quality control and quality assurance

e. Must have the capacity to add/remove slides and reagents randomly without workflow interference

f. Must have independent slide pads for up to 40 slides for the Special Stain System with independent temperature control for each position

g. Must have automated cover slipping

h. Internal self-diagnostics with log of error messages and codes

i. Remote monitoring with the vendor

j. Must include a minimum of 2 staining systems to ensure redundancy during periods of equipment downtime.

3) Automated Tissue Processor (if available – Best Added Value):

a. Must have continuous load and rapid processing of human tissue for routine clinical histology

b. Throughput: Up to 120 cassettes per hour – Standard: Up to 40 cassettes every 20 minutes & Extended: Up to 40 cassettes every 40 minutes

c. Must have a Standard 1-hour protocol (tissues up to 2 mm thick) & an Extended 2-hour protocol (tissues between 2-3 mm thick)

d. Must have Password Protection

e. Internal self-diagnostics with log of error messages and codes

f. Remote monitoring with the vendor

g. Maximum Space Allocation: 72” (W) x 30” (D) x 72” (H)

4) Automated Tissue Embedder (if available – Best Added Value):

a. Must have continuous load and automated embedding of human tissue for routine clinical histology

b. Throughput: continuously load a minimum of 100 cassettes per hour

c. Must have the ability to remove excess paraffin from the frames and from the cassettes to produce high quality blocks

d. Remote monitoring with the vendor

e. Maximum Space Allocation: 48” (W) x 30” (D) x 72” (H)

5) Ambient Temperature: 60 to 85°F (15 to 30°C)

6) Relative Humidity: 10% to 85%

7) Site preparation specifications shall be furnished in writing by the contractor as part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer's claimed specifications. The government shall prepare the site at its own expense and in accordance with the specifications furnished by the contractor. Any alterations or modifications in site preparation which are attributable to incomplete or erroneous specifications provided by the contractor which would involve additional expense to the government, shall be made at the expense of the contractor.

b) System Data Management Hardware / Software:

1) Each system must include at least one (1) printer that has the capability of printing reports and one (1) slide label printer.

2) If available – Best Added Value – The equipment will have the capability to connect to Data Innovations Data Management System for specimen trackability.

c) General Specifications for all Equipment:

1) Should have an onboard reagent inventory system to track reagent lots and expiration date.

2) Analyzers must have capability of monitoring reagent usage and stability, be capable of maintaining/storing on board supplies/reagents, and provide reagent inventory upon request, in real time.

3) Must have barcode driven technology to allow automatic input of data for the reagent delivery system with the associated slide protocol label.

4) Systems must have a computer system that allows full equipment operation, protocol orders, slide barcoded label creation and printing, and maintenance performance and tracking.

5) The system should not require monitoring during a run and should be a 100% "walk-away" system

6) The system must have the capability to backup / archive stored patient result data, quality control, instrument configuration, and calibration information. It must be easily and readily retrieved and readable within a time frame consistent with patient care needs.

7) The system should have the capability of remote instrument support to include: real-time remote instrument monitoring, remote troubleshooting and training, system software upgrades over a secure internet connection and proactive customer contact to maintain optimum instrument performance levels

d) Additional System Requirements:

1. Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, excessive instrumentation failures / malfunctions, breakdowns, or service calls will be evaluated as needed / annually with communication to the Contractor for modification of the contract. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with other analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. Removal of instrument by the Contractor shall be performed within 30 days after request.

2. Upgraded Software / Equipment: The Contractor shall provide all upgrades to the equipment hardware and operating system software without additional charge to the government. These enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

3. Instrument Interfaces: Instrument interfaces, if applicable, should have the capability to connect to Data Innovations.

4. GENERAL REQUIREMENTS:

The contractor is required to provide new state-of the art automated immunoassay analyzer equipment. Discontinued models are not acceptable. The contractor will provide all operational upgrades to the equipment hardware and operating system software that materially affects the performance of the equipment, without additional charge to the government. These enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

a) Site Preparation specifications shall be furnished in writing by the contractor as part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer's claimed specifications. The government shall prepare the site at its own expense and in accordance with the specifications furnished by the contractor. Any alterations or modifications in site preparation which are attributable to incomplete or erroneous specifications provided by the contractor which would involve additional expense to the government, shall be made at the expense of the contractor.

b) Ownership of Equipment shall remain with the contractor. All equipment accessories (hardware are software) furnished by the contractor shall accompany the equipment when returned to the contractor. The contractor, upon expiration of order(s) at termination and/or replacement of equipment, will remove the equipment. The contractor will disconnect the equipment and will be responsible for all packing and shipping required to remove the equipment within ten business days. The hard drive will remain within the VA.

c) Standard and Acceptance of performance shall begin on the installation date. It shall end on the earlier date of when a certificate of acceptance has been signed or the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformation with the contractor's technical specification or as quoted in any contract at an effectiveness level of 90% or more. In the event the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance test shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order upon mutual agreement.

d) Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fine attempt to contact the contractor's designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition.

e) During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The government shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operations use time and downtime shall be measured in hours and whole minutes.

f) Government's Responsibility: The user will perform daily, weekly and monthly routine operation maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The user shall maintain appropriate daily records to satisfy the requirements of this paragraph.

5. PREVENTATIVE MAINTENANCE:

a) The contractor shall provide maintenance (travel, labor and parts) to keep the equipment in good operating condition and subject to security regulations.

b) The government shall provide the contractor access to the equipment to perform maintenance services.

c) Preventive maintenance by contractor will provide regular, scheduled maintenance to assure the continued reliable operation of the equipment.

d) The preventive maintenance visits shall be of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment.

e) Contractor shall have remote access to system for troubleshooting purposes

6. SERVICE AND SUPPORT:

a) Contractor shall provide full service on-site technical support for all vendor-owned components to keep the equipment in good operating condition and subject to security regulations. 10 hours/day (7am-5pm), Monday – Friday.

b) Telephone technical support shall be available 24 hours/day, Monday – Friday with follow up on all calls within one hour of initial call. Following determination that service is required, technical on-site support must be provided within 24 hours.

c) The government shall provide the contractor access to the equipment to perform the repair.

d) The contractor will provide all parts and labor needed to repair the malfunction.

e) Travel, per diem and other expenses associated with the repair will be borne by the contractor.

f) The contractor shall furnish a malfunction incident report to the institution upon completion of each maintenance call. The report shall include, as a minimum, the following; (a) date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. Parts (e) and (f) shall be written verification of quality control for a sample run.

7. AVAILABILITY OF SERVICE: The contractor guarantees availability of servicing and replacement parts for the term of this contract.

8. CONTRACTOR TESTING AND INSPECTION: The Contractor is responsible for performing all inspections and tests necessary to substantiate that the equipment, supplies and services furnished under the contract conform to contract requirements. The VA has the right to test all services ordered under the contract. Government testing and inspection will not unduly delay any Contractor work being performed nor will it create a defect in services covered by this contract.

9. TRAINING AND TECHNICAL SERVICE: The contractor, without additional charge to the government, shall provide on- or off-site Advanced Operator training for at least two (2) personnel per instrument at the time of installation of the contractor's equipment and annually with new contract awards. In addition, the contractor shall provide on-site supplemental operating training to government personnel, without additional charge to the government, upon installation of an upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.

· Training of Operating Personnel: The contractor shall provide the services of a qualified technical person, at the time of equipment installation for on-site orientation and training to designated personnel in: operation and care of equipment; techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action will in no way jeopardize the Government's rights under contract guarantee clause.

10. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE: The VA shall require the contractor to deliver the equipment ordered under this contract not later than THIRTY (30) calendar days after receipt of notice of award. The VA reserves the right to thoroughly inspect and investigate the contractor and manufacturer business reputations and other qualifications, and to reject any bid, irrespective of price, that shall be administratively determined lacking in any of the essentials necessary to assure acceptable standards of performance. Acceptance will normally be consummated upon delivery and, when applicable, installation and completion of personnel training. The VA reserves the right to request a one hundred eighty (180) day test and evaluation of one or both pieces of equipment prior to placing a delivery order under the contract. If the test and evaluation is not successful as determined by the CO and COR, the VA will not be required to continue with placing a delivery order under this contract, and no default or penalty will accrue.

· Reagents Delivery Terms: The VA shall require the delivery of reagents for all services required under this contract. The contractor shall deliver reagents directly to the laboratory, shipping costs included, as needed, including emergency orders within 24 hours from the time of call.

· Quality of Reagents, Supplies, and Disposables: The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality result. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and The Joint Commission. In the event that the supplies to include consumables are found to be defective and unsuitable for use with the contractor's equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 48 hours of receipt of the verbal order for priority delivery from the government activity. This will be done at no cost to the government, insufficient quantity as required to allow operation of the contractor's equipment for one week (under normal government test load volume).

· Returned goods: The VA is responsible for inspecting all products shipped hereunder and will give the contractor written notice of rejection within thirty (30) calendar days following receipt or installation by the contractor.

· Installation procedures: The contractor shall be responsible for installation, which consists of in-house delivery, positioning and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation, or which will affect optimum performance once installation is completed. If progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

· Final Acceptance at Installation: Upon completion of installation the equipment will be turned over to the hospital for use. Final acceptance of the equipment and installation will be based upon an inspection and test to be performed within ten (10) calendar days from date of installation. If equipment passes inspection or if acceptance inspection is not conducted within ten (10) calendar days from installation, the Government shall accept installation with guaranteed date commencing ten calendar days after installation.

11. REGULATORY REQUIREMENTS: If the product(s) included in this solicitation are considered medical devices by the US Food and Drug Administration, the manufacturer shall be in compliance with the Food, Drug and Cosmetic Act, as amended, and regulations promulgated there under.

12. TECHNICAL INDUSTRY STANDARDS: The contractor certifies that all applicable equipment offered under this contract shall conform to all common industry standards.

13. MANUFACTURED PRODUCTS: Materials furnished shall be of the current productions of manufacturers regularly engaged in manufacture of such items. Approval by Contracting Officer is required of deviation from products and manufacturers as shown in the schedule of items. Shelf-life of all consumables shall be at least ONE YEAR from shipping date unless FDA requires different expiration date.

14. REFERENCE SPECIFICATIONS AND PUBLICATIONS: Where an item is required to conform to certain requirements, conformance shall be evidenced by seal, label, stamp, or approval listing from such agency, or by a certified test report from an independent testing laboratory acceptable to the Government, that the item has been tested and conforms to requirements of referenced agency.

15. RECALLS: If at any time during the term of the contract, the FDA or the Contractor, or subcontractor initiates an item recall or FDA withdraws its approval to manufacture an item, the contractor will issue a notice to indicate the complete item description and identification of the recall with necessary instructions for return for credit or replacement.

16. CONTRACT ADMINISTRATION DATA: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the contracting officer, the change shall be considered to have been made without authority and no adjustment will be made in contract price to cover any increase in costs incurred as a result thereof.

Histology Staining

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the…