36C24824Q0169.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER

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

36C24824Q0169

6. SOLICITATION ISSUE DATE

11-30-2023

Jessica Kiser 407-646-4006 12-12-2023

16:00 EST

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

X

325413

1250 Employees

N/A

X

36C672

Department of Veterans Affairs VA Caribbean Healthcare System 10 Casia Street

San Juan, PR 00921

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

Department of Veterans Affairs Financial Services Center

P.O. Box 149971 Austin TX 78714-9971

(877) 353-9791 (512) 460-5429

See CONTINUATION Page

Solicitation for Histology Staining System for the VA Caribbean Healthcare System, San Juan, PR.

See Section B.2 and Statement of Work to quote items.

See CONTINUATION Page

X

X

Jessica M. Kiser

36C24824Q0169

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE/ITEM INFORMATION

B.3 STATEMENT OF WORK

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (DEC 2022)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-21 REQUIREMENTS (OCT 1995)

C.6 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.7 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.9 VAAR 852.204-70 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL (MAY 2020)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.11 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.12 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.2 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.3 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)

E.6 52.216-1 TYPE OF CONTRACT (APR 1984)

E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.9 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.10 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

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:

POINT OF CONTACT:

PHONE NUMBER:

E-MAIL ADDRESS:

UEI #:

TAX ID (TIN) #:

b. GOVERNMENT: Contracting Officer: Jessica M. Kiser, Jessica.Kiser@va.gov

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or [] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly 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.

https://www.fsc.va.gov/einvoice.asp

5. FSC MANDATORY ELECTRONIC INVOICE SUBMISSION INSTRUCTIONS: Contractors are required to submit payment requests in electronic form in accordance with the submission instructions below.

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

a. Vendor Electronic Invoice Submission Methods:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests.

Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

mailto:Jessica.Kiser@va.gov https://www.fsc.va.gov/einvoice.asp

1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission.

Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org)

b. Vendor e-invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.

1. Tungsten e-Invoice Setup Information: 1-877-489-6135

2. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

3. FSC e-Invoice Contact Information: 1-877-353-9791

4. FSC e-invoice email: vafsccshd@va.gov

See https://www.fsc.va.gov/einvoice.asp for more information.

6. CONTRACT MODIFICATIONS: The Contractor is advised that only the Contracting Officer, acting within the scope of the contract and his/her duties and responsibilities and after advice and consultation with the point of contact has the authority to make changes that will affect contract prices, quantity, quality, delivery terms and conditions, or the term of the contract. In no event shall any understanding or agreement, modification, change order, or other matters in deviation from the terms of this contract between Contractor and a person other than the Contracting Officer be effective or binding upon the Government. All such actions must be formalized by the proper contractual document executed by the Contracting Office.

7. CONTRACT COORDINATOR: The Contractor shall identify in writing to the CO their contact person(s) who shall serve as liaisons between the Contractor and VA and who shall ensure that services are performed in accordance with the contract specifications. The Contractor’s contact person(s) shall be available during VA regular administrative work hours, exclusive of national holidays.

8. ESTIMATED QUANTITIES: All quantities listed in the Price Schedule are estimates only and are not to be considered a minimum or maximum. A delivery order shall be issued at the start of each performance period. The Government does not guarantee or imply that any fixed number of orders/referrals for services will be placed under the resultant contract.

9. GUARANTEED MINIMUM: The Government will order at least $1,000.00 in supplies during the base year of the contract. (Note: The guaranteed minimum order amount applies to the base year only. Award of the additional option years is not guaranteed nor is there a guaranteed minimum order amount in any given option year that is exercised.)

http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.x12.org/ mailto:VA.Registration@Tungsten-Network.com mailto:vafsccshd@va.gov https://www.fsc.va.gov/einvoice.asp

10. ORDERING PROCEDURES: The VA Contracting Officer may place Delivery Orders utilizing any of the procedures to the Ordering Clause.

11. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE/ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

ESTIMATED

QUANTITY UNIT UNIT PRICE

ESTIMATED

AMOUNT

12.00 MO __________________ __________________

Immunohistochemistry (IHC), In-Situ Hybridization (ISH) and Special

Stains Instrument rentals with Six workstations.

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies MANUFACTURER PART NUMBER (MPN): None

Automated Tracking Workflow System

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Digital Scanner

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Software Service

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Equipment Services

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

5,000.00 EA __________________ __________________

IHC/ISH Stainer Test (Estimated Quantity)

Contract Period: Base

POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

1,500.00 EA __________________ __________________

Special Stainer Tests (Estimated Quantity)

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Immunohistochemistry (IHC) and Special Stains Instrument Rental

Contract Period: Option 1 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Middleware Software

Contract Period: Option 1 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Service for Instruments

Contract Period: Option 1 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 1 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 1 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

Contract Period: Option 1 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 1 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 2 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 2 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 2 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Software Service Contract Period: Option 2 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 2 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 2 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 2 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 3 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 3 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 3 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 3 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 3 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 3 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 3 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 4 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 4 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 4 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 4 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 4 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 4 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Contract Period: Option 4 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies MANUFACTURER PART NUMBER (MPN): None

ESTIMATED

GRAND TOTAL

BASE ESTIMATED TOTAL $

OPTION ONE ESTIMATED TOTAL $

OPTION TWO ESTIMATED TOTAL $

OPTION THREE ESTIMATED TOTAL $

OPTION FOUR ESTIMATED TOTAL $

ESTIMATED GRAND TOTAL $

B.3 STATEMENT OF WORK

Automated Staining System

1. GENERAL: The Network Contracting (NCO) 8, VA Caribbean Healthcare System, Pathology and

Laboratory Medicine Service, Anatomic Pathology Department require a Cost Per Test (CPT) for Anatomic Pathology Automated Staining, Tracking Automated System and Digital Pathology System, reagents, calibrators, controls, consumable/disposable items, parts, and accessories in San Juan, Puerto Rico.

2. TERM OF AGREEMENT: This will be a single award, fixed price with one base of twelve months and four-twelve month options. Options will be exercised at the discretion of the government.

3. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK:

The Contractor shall provide Special Stainer, Immunohistochemistry (IHC), In Situ Hybridization (ISH), Digital Scanner, Software and Automated Tracking Workflow System to the VA Caribbean Healthcare System (VACHS) as outlined below. The system requested shall include equipment with latest technology for immunohistochemistry and special stains, automated tissue tracking system for and digital pathology with associated software that complies with Clinical and Laboratory Standards Institute (CLSI).

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

The IHC/ISH Staining System, Special Stainer, Automated Workflow Tracking System and Digital Pathology System shall have interconnectivity and interoperability capacity with the current laboratory systems.

The system shall be compatible with the Laboratory information system (LIS), approved Enterprise Risk Assessment (ERA) and Digital Imaging and Communications in Medicine (DICOM) connectivity to facilitate safe data transmission within VA network.

4. DEFINITIONS:

Cost per Test (CPT) - Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5 year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result, (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and

(4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge.

5. GENERAL REQUIREMENT:

5.1. Required Characteristics/ Functionality and Performance Specifications for Special

Stainer.

The Special Stains shall be fully automated and available at the time of offer. Stains include but are not limited to:

5.1.1. Acid-Fast Bacteria Stain (AFB III), Alcian Blue, Alcian Yellow, Congo Red, Elastic, Giemsa, Grocott Methenamine Silver (GMS) Fungus, GMS Pneumocystis, Iron, Jones Methenamine Silver Hematoxylin and Eosin (H&E), Jones Methenamine Silver Light Green, Mucicarmine, Periodic Acid Schiff (PAS) Light Green, PAS diastase, PAS Alcian blue, Reticulum, Steiner, Trichrome Blue, and Trichrome Green.

5.1.2. The Staining System shall include automated special stains processing with 25 reagent positions, 20 independent slide positions that supports 25 x 75mm, 1" x 3" or 26 x 76mm Superfrost Plus slides.

5.1.3. Shall comply with Clinical Laboratory Standards Institute (CLSI) guidelines. C3-A4 clinical laboratory reagent water, up to Four bulk fluids in three to six liter on-board containers and can be bench configured with a 20-liter waste container.

5.1.4. Electrical characteristics: 120 VACS plus or minus 10%, 8 amps, 60 Hz., Line voltage:

120 VAC (+/- 10%), 4 AMP circuit and Line frequency: 50/60 Hz, standard 3-prong grounded power connection.

5.1.5. Computer system (Central Processing Unit (CPU), Monitor, Keyboard, Printer, Speakers), label system, software revision upgrade.

5.1.6. The Stainer shall include a hardware staining instrument, reagents, host computer with system software, connectivity software, and system peripherals.

5.1.7. Up to 8 instruments may be controlled from one PC, including the CPU, monitor and keyboard.

5.1.8. Label system can be included in the equipment proposal.

5.1.9. All systems are installed with the most current software version to date. Subsequent mandatory software updates are implemented by the support team.

5.1.10. The systems shall be modular flexible with ability to reconfigure modules, and scalable to allow for volume increase in throughput and fit in limited bench space.

5.1.11. The system shall be an automated special stains system that integrates deparaffinization through slide staining with floor and benchtop configurations available.

5.1.12. Each system with 25 on-board reagent positions and 20 independent slide positions.

Additional capacity is addressed by use of multiple/additional systems.

5.2. Required Characteristics/Functionality and Performance Specifications for Immunohistochemical Stainer.

General instrument characteristics shall include automated IHC, ISH, baking, deparaffinization, cell conditioning and staining.

5.2.1. 1-30 slides with independent temperature control for 25 X 75mm, 1 x 3: or 26 x 76 mm, 25 reagent position in carousel.

5.2.2. Fully automated: Baking, deparaffinization, cell conditioning and staining, including

IHC, ISH, multiparameter IHC staining (dual, triple), counter stain and titration.

5.2.3. Slide position: 1–30 slides with independent processing/functionality and temperature control for each position

5.2.4. Reagent carousel: 35 reagent positions

5.2.5. Slides: 25 x 75 mm, 1 x 3 in or 26 x 76 mm positively charged slides

5.2.6. Bulk solutions: Up to 7 different bulk solutions can be changed “on the fly” without process interruption.

5.2.7. Waste: Two 20 L carboys; can be changed “on the fly” without process interruption

5.2.8. Temperature control: Ambient to 100ºC

5.2.9. Certifications: EC/EN 61010-1, IEC/EN 61010-2-010, IEC/EN 61010-2-101, IEC/EN

61010-2-081, EN 61326-2-6

5.2.10. Electrical characteristics: 120 VACS plus or minus 10%, 7 amps, 50/60 Hz. Voltage:

~100-120 VAC, Current: 7A and Frequency: 50/60 Hz

5.2.11. Computer system (CPU, Monitor, Keyboard, Printer, Speakers), label system, and software revision upgrade.

5.2.12. The system shall include a hardware staining instrument, reagents, host computer with system software, network connectivity software, and system peripherals.

5.2.13. Up to 8 instruments may be controlled from one PC, including the CPU, monitor and keyboard.

5.2.14. All systems are installed with the most current software version to date. Subsequent mandatory software updates are implemented by support team.

5.2.15. The system shall be barcode driven, random access, have a precision reagent delivery, precision heat induced staining reaction, horizontal kinetic mode Immunohistochemistry, and Chromogenic in situ Hybridization and Special Stains System.

5.2.16. The equipment shall have random-access slide-staining instrument that lets technicians add or remove slides and reagents. The platform allows laboratories to prioritize any patient sample, delivering added value to attending physicians and their patients with 30 individual slide staining chambers and individual slide heaters, which eliminates need to batch runs to provide lab to manages STAT requests with no impact to in-process slides.

5.2.17. The system should be modular, flexible, with the ability to reconfigure modules, and scalable to allow for volume increases in throughput and to fit in limited bench space.

5.2.18. Modularity: One to Four instruments

5.2.19. Configuration: Free standing

5.2.20. The equipment shall utilize self-contained, pre-diluted, Antibodies (AB) and detection kits that are ready to use out of the box offering 250+ assays and robust detection chemistries optimized for all IHC and ISH needs.

5.2.21. Individual slide heating and micro-controlled smart carousel with ambient, 37 and 42 deg. -> 100 deg C in under 3 min. and 100 deg ->37 deg C in under 7 minutes.

5.2.22. Heat output: 400 BTU/hour idle, 1000 BTU/hour running.

5.2.23. Room temperature: 68ºF to 90ºF

5.2.24. Humidity: 20% to 88%, non-condensing

5.2.25. Shall have at least 30 slide spaces that can each run IHC and ISH simultaneously. The system has 30 individual slide staining chambers, allowing technicians to add or remove slides and reagents. IHC and ISH testing can be run on each individual slide.

Each chamber can run IHC and ISH simultaneously.

5.2.26. Shall have ability to use detection that is not polymer and does not use AB blocker.

5.2.27. Shall be able to run paraffin embedded slides (1 protocol), non-paraffin embedded slides (total of 2 protocols), slides using different type 1 cell conditioning (total of 3 protocols) and/or type 2 cell conditioning (total of 5 protocols) with and without enzyme digestion (total of 7 protocols) and enzyme digestion by itself (total of 8 protocols).

5.2.28. Shall be able to incubate Positive Abs for up to 2.5 hours.

5.2.29. The instrument shall have the capability to use the following slides:

5.2.30. -1 x 3-inch, 25 x 75 mm

5.2.31. 26 x 76 mm original Superfrost Plus charged slides for tissue sections.

5.2.32. Hologic slides for the Thin prep liquid-based application.

5.2.33. The self-contained dispenser vials shall be environmentally safe. The systems shall have a self-contained waste system.

5.2.34. The system shall use Liquid Coverslip, Air Vortex Mixing, and Buffer Jet Slide

Washing to include strict protocol timing to assure run-to-run consistency to improve overall staining quality, minimize slide-to-slide variability, and reduce background staining.

5.2.35. Shall possess a bi-directional, bar-coded computer interface compatible with the current VA Laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

5.2.36. Orders for panels and supplies/consumables will be placed either by e-mail, fax, or online portal.

5.2.37. The systems shall improve overall productivity in the Histology Lab, reduce the need to repeat testing thus reducing reagent waste. The system should not require monitoring during a run.

5.3. Required Characteristics/Functionality and Performance Specifications for Automated Workflow Tracking System.

The tracking system shall be capable to establish a chain of custody throughout the life of a sample to assure improved patient safety by reducing errors and minimizing the risk of mislabeling, positive patient identification, and single piece flow. Equipment shall possess state-of-the-art informatics and business intelligence to assure safe and VA compatible network connection. Promoting productivity and a lean workflow. The workflow management system is intended to support workflow automation within the anatomical pathology laboratory through the following capabilities:

5.3.1. Manage laboratory case information and process order requests from the Laboratory Information System (LIS).

5.3.2. Display laboratory case information to track specimen workflow.

5.3.3. Print specimen identifiers and labels.

5.3.4. Enable reporting of workflow events and inventory information.

5.3.5. The contractor shall provide the hardware and software required to provide a tracking system to VACHS in compliance with local and federal regulations.

5.3.6. Keep case contents together through entire accessioning process.

5.3.7. Accession one case at a time (Single Piece Flow).

5.3.8. Integrate cassette printer with the system to enable automatic block protocol prints.

5.3.9. Utilize segmented bins to maintain case integrity – place all case contents in its own area.

5.3.10. The system requires six (6) workstations.

5.3.11. The contractor shall provide a complete coverage of key steps in the histology workflow, including pre-analytic, staining, send-out, and pathologist review into archive.

5.3.12. Fully track lab operations for complete visibility into lab, anytime and safeguard patients through positive sample ID and complete chain of custody.

5.3.13. The system shall improve quality and performance by monitoring trends, problem areas and workload and minimize potential errors, facilitating identification of errors.

5.3.14. The system shall have accessories and consumables including cassette markers, label printers, direct to slide printers, barcode scanner and the contractor shall provide a list of compatible equipment prior to delivery and installation.

5.4. Required Characteristics/Functionality and Performance Specifications for Digital Pathology System.

5.4.1. The digital pathology technology shall be compatible with the VACHS Anatomic Pathology Laboratory recently implemented system.

5.4.2. Digital Pathology System shall possess a bi-directional, bar-coded computer interface compatible with the current VA Laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

5.4.3. High speed scanning- scans at 20X magnification in less than 49 secs and at 40X in less than 85 secs for 15 mm x 15 mm areas of interest

5.4.4. No slides handling- Load slides for scanning using a tray-based system.

5.4.5. High quality images- High resolution digital images

5.4.6. DICOM (Digital Imaging and Communications in Medicine) compatibility-

Standardized output file format for interoperability with Picture Archiving and Communication Server (PACS).

5.4.7. Color Management-ICC color standard profile generation in every scan

5.4.8. Dynamic focus-tracks tissue depth in real time and uses the data for high resolution.

5.4.9. Compatible with artificial intelligence (AI) logarithms connectivity.

5.4.10. Lab consolidation: Can manage multiple sites and communication with several

Laboratory Information Systems simultaneously. Consolidates individual connections into a single bridge linked to the LIS, then acts as a translator, enabling multiple systems to communicate and transfer data.

5.4.11. Accreditation and certification: Documentation of all actions in the lab improves visibility and

5.4.12. traceability while reducing error rates through automation.

5.4.13. Remote support: enables customer support to monitor, troubleshoot, and resolve issues remotely to minimize system downtimes.

6. DELIVER INSTRUCTION OF SUPPLIES

Contractor shall deliver equipment, reagents, calibrators, controls, consumable/disposable items, parts, and accessories as required. On the first day of each month or the next business day following weekend or Federal Holiday, the contractor shall ensure the laboratory is furnished with sufficient consumable supplies to produce a volume of test equal to that slated in the task order.

In the event the consumables are found to be defective and unsuitable for use with the contractor’s equipment, or the contractor has failed to comply with requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four (24) hours after receipt of the verbal notification for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the Government site the next day without any additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the contractor’s equipment for one (1) week (under normal Government test load volume). If additional request for emergency supply delivery is required by the Government, they shall be honored by the contractor until the arrival of the monthly standing order/routine supplies is delivery at the Government facility.

The contractor shall immediately notify the Microbiology Supervisor of any changes in reagents or equipment modifications by electronic means as well as by postal mail with supporting documentation of the change and, detailed guidance on implementation within twenty-four (24) hours of its application or according to FDA guidelines.

Delivery to: ATTN: Name to be Determined.

VA Caribbean Healthcare System Pathology and Laboratory Medicine Services (113) 10 Casia Street San Juan, PR 00921-3201

7. DAYS AND HOURS OF OPERATIONS: Delivery of equipment, reagents, calibrators, controls, consumable/disposable items, parts, and accessories should be delivered from Monday to Friday during regular working hours (6:00 am-5:30pm), excluding federal holidays when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings or for designated training. List of recognized Federal holidays are as follows:

New Years Day Dr. Martin Luther King’s Birthday Presidents Day Memorial Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

8. UPGRADES: The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of-the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the contract; however, it does refer to significant changes in the hardware operational capability. The Contractor shall at all times maintain compatibility of systems with whatever host LIS or TCP/IP interface is in place, especially when contractor software is upgraded.

All models shall perform satisfactorily at any laboratory temperature between 59- and 86-degrees F (15 and 30 degrees Celsius). All models shall perform satisfactorily at any laboratory relative humidity between 10 and 70%.

9. TRAINING: The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the statement of work. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair for a minimum of one operator per outpatient facility and 2 operators for the 24/7 hospital facility. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. The contractor shall provide on-site refresher instrument training in years two through five of the agreement, provided the agreement remains in effect during years two through five.

9.1.1. In addition, (a) Basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable. (b) The contractor shall provide supplemental operator training 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.

9.1.2. The contractor shall assist with staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. The technical support specialist shall be available for installation/set-up/validation studies/training by virtual or in person at no additional cost to the government.

10. EQUIPMENT PREVENTATIVE MAINTENANCE/REPAIR/SERVICE: The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, offered according to the following terms:

10.1.1. The vendor shall perform every 6 months or more analyzer preventive maintenance as per our regulatory agencies CAP (College of American Pathologists) and Joint Commission regulations.

10.1.2. The vendor shall provide full technical service available 24 hours/day, 7 days a week including holidays. Emergency repair services shall not to exceed 24 hours of the time of malfunction notification.

10.1.3. Request for service is to be made through one vendor for all components of the analyzer.

10.1.4. The Contractor shall provide a preventative maintenance schedule to include a minimum of two scheduled preventative visits per year for the duration of the contract.

10.1.5. Service shall include all travel, parts for repair or replacement, and labor.

10.1.6. The Contractor shall provide all replacement parts at no charge and any components necessary for the operation of the instrument(s) to produce patient results.

10.1.7. The Contractor shall provide instrument support service and provide assistance with troubleshooting and repair of the analyzers during the contract’s period of performance. The following service options shall be available: 24 hours/day, 7 days/week basis for hospitals, and 5 days/week basis for outpatient clinics.

10.1.8. The support service shall follow-up all down calls within 1 hour. The Facility Service Representative (FSR) at all times shall keep the facility/clinic informed of the repair completion timeline. All repairs on instrument shall be complete (at no cost to the facility) within 24 hours from the time the field service engineer arrives.

10.1.9. The service report shall include; Date and time notified; date and time arrived; serial number, type and model number of equipment; time spent for repair, proof of instrument repair including documentation of a sample run of quality control verifying acceptable performance.

10.1.10. Technical support shall place a service call for repairs if the technologist is unable to repair the analyzer within one hour of troubleshooting with the hotline or on weekends/holidays/irregular tours when the technologists may be unable to work with the hotline due to the facility’s staffing.

10.1.11. The Contractor’s technical service representatives shall comply with each facility’s requirements for on-site contractor representatives. This may require a low-risk background investigation by federal authorities paid for by the vendor, annual compliance with completing the required VA Talent Management System (TMS) Privacy and HIPAA Focused Training (10203) and VA Privacy and Information Security Awareness and Rules of Behavior (10176).

11. INTERFACE REQUIREMENTS: The contractor shall provide the following for all primary analyzers:

11.1.1. The analyzer LIS physical connection and translation (drivers).

11.1.2. Routing shall be fully supported by all laboratory instrument interface systems.

11.1.3. Any additional hardware and software needed to interface the analyzer(s) and technical assistance with interfacing the analyzer(s).

11.1.4. Any required (additional) interface connection license(s)

11.1.5. Instrument – LIS interface shall be bi-directional.

11.1.6. Interface shall be hosting query to download sample IDs, test requests, and patient demographics.

11.1.7. Instrument interface shall transmit test results to the host computer system via automatic upload.

11.1.8. Automatic host query shall seamlessly integrate with onboard patient sample barcode scanning and translation.

11.1.9. In lieu of an LIS interface, the vendor may provide a TCP/IP interface pre-approved/certified by VACO for use with VA computer systems and applications such as VistA. Proof of certification must be provided. The vendor shall provide all necessary information (including logical ports) for VA staff to write an access control list.

11.1.10. Provide documentation of successful interfacing with other VA facilities (provide two

(2) VAMC references to include contact person, address, telephone number and email address.

12. COMMERCIAL OFFERINGs - The Contractor shall provide any additional support material, e.g., procedure manuals, trouble-shooting manuals, or an operator’s manual, that is routinely provided to equivalent commercial customers and assist in the regulatory compliance, e.g., computer disc containing this material in the Clinical and Laboratory Standards Institute (CLSI) format or an on-line procedure manual in the instrument software.

13. INSTALLATION/IMPLEMENTATION/TRANSITION TIMEFRAME –

13.1. Site Preparation: Site preparation specifications shall be furnished in writing by the contractor as a part of the equipment solicitation. 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.

13.2. Space Requirements, System Specifications, etc.: Configuration of the proposed equipment shall be able to conform to the space previously allotted for this function. System specifications shall all be disclosed in the proposed space. Crossover from current to new instrumentation shall be performed timely with no interruption in patient care and laboratory service. Installation shall not require extensive renovations to allocated space in all laboratory locations. Reference Attachment B for drawing and dimensions.

13.3. Installation: 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 in coordination with the facility biomedical engineer. 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 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.

13.4. Upon completion of installation the equipment shall 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 will accept installation with guaranteed date commencing ten calendar days after installation.

13.5. Vendor shall provide equipment relocation and installation at no cost if the equipment is required to be moved due to construction or laboratory redesign at any of the VA Caribbean Healthcare System or outpatient clinics.

13.6. Implementation: The implementation of the services /requirements described in this solicitation shall be completed no later than days after the contract is awarded. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

13.7. Upon award of the contract, the transition period to have all equipment and peripherals installed and operational shall be from date of award through days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

13.8. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed days for the transition of all services under the awarded contract including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract.

13.9. At the end of days from award of the contract, the awarded Contractor shall have full and sole responsibility for services under the awarded contract.

14. Government’s Responsibility – The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

15. Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) 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, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

15.1.1. The Contractor will identify if removable media is required to perform their duties.

The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

15.1.2. Prior to termination or completion of this contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control

Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the contract.

15.1.3. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per

6500.1 requirements. This must be completed within 30 days of termination or completion of the contract or disposal or return of the IT equipment, whichever is earlier.

15.1.4. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

15.1.4.1. Contractor must accept the system without the drive;

15.1.4.2. VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or

15.1.4.3. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

15.1.4.4. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

15.1.4.5. The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

15.1.4.6. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation.

Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

15.1.5. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

B.4 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task…