36C24826Q0158.pdf

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

36C24826Q0158 12-17-2025

Benjamin Amato 407-646-4005 01-09-2026

13:00 EST

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

X

334516

1000 Employees

N/A

X

36C675

Department of Veterans Affairs Orlando VA Healthcare System 13800 Veterans Way

Orlando FL 32827

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System

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 Automated Flow Cytometry Cost Per Reportable Result contract for the Orlando VA Healthcare System.

See section B.2 to quote items.

See section B.3 for delivery location.

See CONTINUATION Page

X X

36C24826Q0158

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 DELIVERY SCHEDULE

B.3 SCOPE OF WORK

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.217-5 EVALUATION OF OPTIONS (JUL 1990)

C.3 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.4 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...34

C.6 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.8 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.9 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (OCT 2025) (DEVIATION FEB 2025)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

E.2 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.3 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.4 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.6 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION

FEB 2025)

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: Benjamin M. Amato, benjamin.amato@va.gov

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System

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.

5. FSC MANDATORY ELECTRONIC INVOICE SUBMISSION: 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.

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.

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

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.

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.)

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

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

ESTIMATED

QUANTITY UNIT UNIT PRICE

ESTIMATED

AMOUNT

1.00 YR __________________ __________________

Automated Flow Cytometer System(s) 10-16 Color/3 Laser able to process Leukemia/Lymphoma panels and with a load/walk-away continuous system for Lymphocyte Enumeration/subset -24" Widescreen LCD Display -Color Laser USB Printer -Data Analytic software and with Remote Analytic capability -Uninterrupted Power supply (UPS) able to manage all test system/equipment needed. - Instrument Prep Workstation Included Contract Period: Base POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

696.00 EA __________________ __________________

Leukemia/Lymphoma Panel

Contract Period: Base POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

1,296.00 EA __________________ __________________

T Cell Lymphocyte Test

Contract Period: Base POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument

Manufacturing

648.00 EA __________________ __________________

B Cell Lymphocyte

Contract Period: Base POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

All monoclonals, reagents, and consumables listed under Attachment are included at no additional charge.

Contract Period: Base POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing process Leukemia/Lymphoma panels and with a load/walk-away continuous system for Lymphocyte Enumeration/subset -24" Widescreen LCD Display -Color Laser USB Printer -Data Analytic software and with Remote Analytic capability -Uninterrupted Power supply (UPS) able to manage all test system/equipment needed. - Instrument Prep Workstation Included Contract Period: Option 1 POP Begin: TBDTBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

720.00 EA __________________ __________________

Contract Period: Option 1 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

1,356.00 EA __________________ __________________

T Cell Lymphocyte Test Contract Period: Option 1 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

672.00 EA __________________ __________________

Contract Period: Option 1 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing are included at no additional charge.

Contract Period: Option 1 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing process Leukemia/Lymphoma panels and with a load/walk-away continuous system for Lymphocyte Enumeration/subset -24" Widescreen LCD Display -Color Laser USB Printer -Data Analytic software and with Remote Analytic capability -Uninterrupted Power supply (UPS) able to manage all test system/equipment needed. - Instrument Prep Workstation Included Contract Period: Option 2 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

744.00 EA __________________ __________________

Contract Period: Option 2 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

1,380.00 EA __________________ __________________

Contract Period: Option 2 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

696.00 EA __________________ __________________

Contract Period: Option 2 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing are included at no additional charge.

Contract Period: Option 2 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing process Leukemia/Lymphoma panels and with a load/walk-away continuous system for Lymphocyte Enumeration/subset -24" Widescreen LCD Display -Color Laser USB Printer -Data Analytic software and with Remote Analytic capability -Uninterrupted Power supply (UPS) able to manage all test system/equipment needed. - Instrument Prep Workstation Included Contract Period: Option 3 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

768.00 EA __________________ __________________

Contract Period: Option 3

POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

1,416.00 EA __________________ __________________

Contract Period: Option 3 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

720.00 EA __________________ __________________

Contract Period: Option 3 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing are included at no additional charge.

Contract Period: Option 3 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing process Leukemia/Lymphoma panels and with a load/walk-away continuous system for Lymphocyte Enumeration/subset -24" Widescreen LCD Display -Color Laser USB Printer -Data Analytic software and with Remote Analytic capability -Uninterrupted Power supply (UPS) able to manage all test system/equipment needed. - Instrument Prep Workstation Included Contract Period: Option 4 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

792.00 EA __________________ __________________

Contract Period: Option 4 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

1,452.00 EA __________________ __________________

Contract Period: Option 4 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

744.00 EA __________________ __________________

Contract Period: Option 4 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing are included at no additional charge.

Contract Period: Option 4 POP Begin: TBD POP End: TBD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

ESTIMATED GRAND

TOTAL

B.3 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION DELIVERY DATE

0001-

SHIP TO: Department of Veterans Affairs Orlando VA Healthcare System (Warehouse) 13800 Veterans Way Orlando, FL 32827

USA

TBD

MARK FOR: TBD

FOB: DESTINATION

1001-

SHIP TO: Department of Veterans Affairs Orlando VA Healthcare System (Warehouse) 13800 Veterans Way

2001-

SHIP TO: Department of Veterans Affairs Orlando VA Healthcare System (Warehouse) 13800 Veterans Way

3001-

SHIP TO: Department of Veterans Affairs Orlando VA Healthcare System (Warehouse) 13800 Veterans Way

4001-

SHIP TO: Department of Veterans Affairs

Orlando VA Healthcare System (Warehouse) 13800 Veterans Way

B.3 SCOPE OF WORK

Scope of Work: Cost Per Reportable Result (CPRR) Contract for Automated Flow Cytometer Instrumentation System, Reagents/Consumables, Support and Maintenance.

1. Objective:

1.1 It is the intent of the Orlando VA Healthcare System (OVAHCS) to establish a Cost Per Reportable Result (CPRR) Agreement for an Automated Flow Cytometry System. It is the intent of the Government to award this contract to a single contractor for a flow cytometry system. The contractor shall agree to the following terms of the CPRR exclusively with the OVAHCS facility.

1.2 The objective of this contract is to provide a comprehensive solution for the installation, maintenance, and operation of 10-16 Color Automated Flow Cytometer instrument(s) system, along with the necessary consumables and monoclonal antibodies required for performing Leukemia/Lymphoma panels, Lymphocyte Subsets, and T-cell enumeration tests. The vendor is responsible for providing all necessary instrumentation, automated systems, ancillary equipment, installation, validation, calibrations, technical support, training, repairs, upgrades, and maintenance services. All provided equipment, reagents, and consumables must be cleared for clinical diagnostic use. By following these guidelines and ensuring all equipment, reagents, and consumables are cleared up for clinical diagnostic use, the vendor will be able to provide a reliable, cost-effective, and efficient solution to meet the flow cytometry needs of the Orlando VA Healthcare System- Pathology and Laboratory Medicine Service.

1.3 All products ordered under this agreement, placed against this Contract(s), are subject to the terms and conditions of this scope of work. This agreement does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the agreement by authorized individuals.

1.4 Prices and Terms: Orlando VAMC estimates the volume of tests performed as reflected in Section 4.4. Firm fixed pricing shall be based on the AVERAGE YEARLY TEST VOLUME Per INSTRUMENT /ANALYZER. Pricing shall be based on the Cost per Reportable Result. The Government estimates the test volumes listed under the section 4.4 “Test Menu: Orlando VAMC Estimated annual test volumes for Flow Cytometry” as described per facility but does not guarantee volumes as listed; they are ESTIMATES

ONLY.

1.5 TERM OF AGREEMENT: The agreement shall be effective for the term of the Contract.

This agreement is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this agreement may be canceled with thirty (30) days written notice to the Contractor by the CO. This agreement shall be reviewed annually. Orlando VAMC intends to establish the base year of the agreement for the period of 12 months, and four 12-month option periods.

1.6 IDENTIFICATION: Delivery Orders issued shall be identified by Purchase Order Number under the Contract Number.

1.7 ORDERING METHOD: Orlando VAMC may order products via Electronic Data Interchange (EDI), telephone, email, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1 The desired instrumentation/system shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability and be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

2.2 The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control bottles. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals, lab manager and/or service chief.

2.3 Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the contractor’s equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the contractor shall deliver to the government site in the most expeditious manner possible without additional cost to the government, the necessary consumables in sufficient quantity as required to allow operation of the contractor’s equipment for one week (under normal government test load volume). If additional requests for emergency supply delivery are required by the government, they shall be honored by the contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

3. DEFINITIONS

3.1 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 (a) equipment use, (b) all reagents, standards, 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, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

3.2 Cost per Reportable Result (CPRR) The per patient reportable result price shall include costs covering: (1) Base year, and up to (4) option years 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 of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (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.

3.3 Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation/system, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation/system and must meet all of technical specifications of this solicitation.

Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment.

3.4 Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of the VHA facility, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI).

VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with everyone that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

4. Description/Specifications/Scope of Work:

4.1 Instruments and Equipment:

Automated Flow Cytometer Instrument(s):

o The contractor shall provide a 10-16 color fluorescence automated flow cytometer instrument system(s) with an additional 2 channels for light scatter properties, capable of independently testing Leukemia/Lymphoma panels and T cell enumeration. The automated instrumentation/system shall have a three-laser system with fixed optical alignment, at minimum.

o The contractor shall provide a fully load/walk-away continuous automated system, with capability for automated lymphocyte enumeration or CD4/CD8 counts with minimal or no sample preparation required is preferred.

o Equipment must require minimal maintenance and steps on daily analyzer start up such that the analyzer is not required to be down for more than 60 minutes per day. The system must be capable of sustaining 24hrs/7-days operations and run safely with minimal specialty training.

o The main automated flow cytometer system and its ancillary equipment must be capable of providing temperature control mechanisms that can regulate internal temperature and humidity fluctuations. It must be able to provide alerts/flags to the testing personnel whenever unsafe conditions arise that prompts to halt testing to ensure accurate results.

o The automated system must have the flexibility to process tubes of different size/volumes, such as any 12x75 tubes, including glass or plastic.

o Capable of individually mixing each sample tube before being delivered to the system.

o The automated instrumentation/system must have the capability to allow testing personnel to review and interpret data while the instrument is still sampling, testing and acquiring data from other patient samples on board.

o The contractor shall provide a stand-alone, automated/semi-automated sample preparation system capable of reagent addition, incubation, washing (if necessary) and fixative addition, or an integrated sample prep module, automated reagent monitoring and barcode scanning, continuous loading with pipeline sample processing, data analysis, bidirectional LIS connectivity and automated QC.

o The system should provide a quality control package used for daily monitoring of system performance and must alert the operator when the system is found in suboptimal conditions for patient testing due to QC failure or system failure.

o The system must provide the ability to customize test panels.

o The automated flow cytometer data management system shall allow automatic and manual compensation, and shall allow real time compensation, data analysis and gating.

o The system should offer data analytic software that meets the VHA OIT requirements. The data analytic software must have authorization to operate and be approved by VHA OIT.

o The hardware must meet all VA minimum specifications, and the operating system software version must be currently sold and supported. Windows versions no longer supported (e.g. Windows XP) shall not be proposed.

o All provided equipment, reagents, and consumables must be cleared for clinical diagnostic use. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

o The contractor shall supply all necessary monoclonal antibodies for performing Leukemia/Lymphoma panels, lymphocyte subsets and T cell enumerations.

o The contractor must provide all additional required consumables and instrument parts that are required to ensure uninterrupted operation of the flow cytometer instruments for patients and its quality assurance/control program.

o The contractor must be able to provide monoclonal prefixed/precoated antibody “cocktail” test tubes. This is to reduce the time technologists spend in the setup of a flow cytometry patient sample, minimize manual pipetting errors, standardize the results, keep track of reagent use and increase accuracy and provide the most accurate flow cytometry test results.

Automated Sample Preparation/Management (Pipettors and Cell Washing Systems):

o Supply automated pipettors to ensure precise sample handling.

o Provide automated cell washing capabilities to enhance sample preparation efficiency.

o System must be capable of verifying and track barcode labeled specimens and tubes through the sample process.

o Continuous processing – can load and unload carousels and samples without halting operation.

o Closed-tube sampling; ability to run whole blood, body fluids and tissue.

o Capacity to have full range of on-board reagents including antibodies, lysing reagent, flow-count, buffers and diluents.

o Must guarantee minimal sample carryover for sample pipetting.

Ancillary Equipment:

o Hardware: A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

o Computers (compatible with the software provided) and printers.

o All monitors/screens/LCDs shall clearly display information in all light conditions. A 24” widescreen or bigger display is preferred.

o Software licenses:

Ability to remotely review test results, gating, without the use of a USB or toggle key or a VHA OIT unapproved device.

Shared or team license which supports the number of concurrent users within the same facility or healthcare system as defined (for a minimum of 5-6 concurrent users).

A system that includes software for remote data analysis, manipulation, interpretation and troubleshooting by technologists, Hematopathologists and/or technical service is preferred. The remote data analysis software must have authorization to operate and be approved by VHA OIT.

o Printer(s): A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID) for each instrument or device provided. An efficient, simple use of color printer that will use a single toner with no additional waste units and displays minimally two forms of patient identification on the test report.

o Uninterruptible Power Supplies (UPS): An uninterruptible power supply (UPS) with line conditioner and surge suppressor for each instrument or device provided. Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails, and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records. This UPS must be inspected annually by the vendor and replaced when found suboptimal.

o Bi-directional interfacing with current VA LIS (for example, VA VistA or Oracle

Health).

o Connectivity and Conformance:

The Contractor supplies responses to required documents to add systems to the VA network including but not limited to the Enterprise Risk Analysis (ERA) VA Form 6550, Access Control List (ACL) Communication Protocol, and MSD2.

Must be capable of connecting to an HL7 interface and must comply with the VHA Lab HL7 Interface Specifications Document.

The contractor’s performance must be in compliance with all applicable state, federal and local laws and regulations.

The contractor provides any and all software and hardware updates as needed to meet optimal operation and security compliance at no additional expense to VA.

The contractor communicates and coordinates all software and hardware updates to the laboratory prior to installation, providing related release notes and applicable validation recommendations/requirements.

Any software solutions supplied and installed on VA workstations by the contractor must appear as approved technology on the most current VA Technical Reference Model (TRM) or must be within 2 lifecycles of the most recent TRM approved version or the contractor must have the capability to obtain TRM approval without impacting installation timeframes as described.

o Barcoding: Contractor shall ensure barcode functionality meets the following capabilities:

The accuracy of the barcode reading must have less than a 0.5 % failure rate.

Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

Clinical Diagnostic Clearance:

o Ensure that automated flow cytometer instrument system(s) and related equipment are cleared for clinical diagnostic use. All provided equipment combination, reagents, and consumables must be cleared for clinical diagnostic use.

4.2 Consumables and Reagents: The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control bottles. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals, lab manager and/or service chief.

Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the contractor’s equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the contractor shall deliver to the government site in the most expeditious manner possible without additional cost to the government, the necessary consumables in sufficient quantity as required to allow operation of the contractor’s equipment for one week (under normal government test load volume). If additional requests for emergency supply delivery are required by the government, they shall be honored by the contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

Monoclonal Antibodies and consumables:

o The contractor shall supply all necessary monoclonal antibodies for performing Leukemia/Lymphoma panels, lymphocyte subsets and T cell enumerations.

o The contractor must provide all additional required consumables and instrument parts that are required to ensure uninterrupted operation of the flow cytometer instruments for patients and its quality assurance/control program.

o The contractor must be able to provide monoclonal prefixed/precoated antibody “cocktail” test tubes. This is to reduce the time technologists spend in the setup of a flow cytometry patient sample, minimize manual pipetting errors, standardize the results, keep track of reagent use and increase accuracy and provide the most accurate flow cytometry test results.

4.3 Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall assist the Government with all validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity. All materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, VHA/TJC/CAP Standards and Federal Regulations.

4.4 Test Menu: Orlando VAMC Estimated Annual Test Volumes for Flow Cytometry and desired test/markers menu:

Leukemia

Lymphom a Panels

Lymphocyte Subsets / T-Cell Panels

Lymphocyte B

Orlando VAMC Test Base 700 1,300 648 Orlando VAMC Test Option 1 721 1,339 672 Orlando VAMC Test Option 2 743 1,380 696

Orlando VAMC Test Option 3 765 1,421 720 Orlando VAMC Test Option 4 788 1,463 744

Note: All quantities are estimated – an increase of 3% has been added to each option year to plan for anticipated increase in quantities. The Government estimates the volumes listed in the test menu per facility but does not guarantee volumes as listed;

they are ESTIMATES ONLY.

The minimal capability of reporting the following tests/markers:

4.5 Support and Maintenance:

A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum callback response time of two (2) hours. Contractor can provide remote diagnostic troubleshooting through a current VA approved Memorandum of Understanding/ Interconnection Security Agreement/ (MOU/ISA). The Contractor shall provide all hardware and software in order to implement the remote support system.

During the term of the CPRR, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with the manufacturer’s instructions, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 90% in each month of the term of the agreement.

Technical Support:

o Provide ongoing technical support to ensure optimal performance of all instruments and systems.

Preventive Maintenance:

o Conduct regular preventive maintenance to minimize downtime and extend the lifespan of the equipment.

o All preventative maintenance and repair service shall be coordinated between the Contractor and VA laboratory personnel (Technical Supervisor or Technical Specialist) of the specific laboratory section.

o Preventative maintenance will be performed as frequently as published in the manufacturer’s operator manual and completed promptly by the scheduled due date to ensure compliance with accrediting agencies and documentation provided.

Emergency Service:

o Offer 24/7 emergency on-site service for repairs to address any critical issues promptly.

o Emergency repairs shall be performed after notification that the equipment is inoperable.

o Certain circumstances may dictate the need for repair service to be conducted outside defined repair service hours. The contractor shall ensure adequate repair engineers (field service engineers) cover the geographical area.

o Equipment repair response time shall be no more than 4 hours.

o Each notification for an emergency repair service call shall be treated as a separate and new service call.

o A service report (both preventative and emergency repair) shall be furnished to the Laboratory upon completion of each service call. Each notification for an emergency repair service shall be treated as a separate and new service call. The report shall include, as a minimum, the following:

Date and time notified Date and time of arrival Serial number, type and model number of equipment Time spent on repair Description of malfunction and repair Evidence of successful repair, e.g. documentation of calibrations, a sample run of quality control verifying acceptable performance, etc.

Upgrades - The Contractor shall provide, without additional charge to the Government, all enhancements to the technology (equipment hardware and software) such as device corrections and/or upgrades to the equipment hardware and operating system software that are offered at no expense to other commercial customers.

o These enhancements to the contractor's equipment shall be delivered to the Government site and installed within sixty (60) days of their issuance or date of first commercial availability.

o Any upgrade that is supplemental and retrofitted to the initial contracted features of the model (e.g. connection with another piece of equipment, new specimen tracking system, new module that adds new tests and or different methodologies to their instrument, expansion of their reagent storage capabilities, etc.) AND is being marketed to their commercial customers at a cost, would not be included in the contracted cost of the equipment.

o 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 BPA if newer models are released; however, it does refer to significant changes in the hardware operational capability. This does not rule out upgrading to replacing existing equipment if the initial proposed equipment fails to meet laboratory testing demands or uptime performance requirements. Updates/upgrades shall be scanned for viruses upon request by the Government.

4.6 Training:

Initial 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 contract. This shall include training of both the technical staff and pathologists on the operation of the system, data manipulation, and basic trouble shooting and repair.

o The contractor shall provide initial training for the staff working in the area at the time of installation. This training must cover the operation, maintenance, and troubleshooting of the flow cytometer instruments and associated equipment.

o 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/system 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 for 2 primary operators, shall include the cost of airfare, room and board for each participant. All training shall be provided by the Contractor at no additional cost to the Government.

o In addition, the contractor shall provide supplemental operator training to

Government personnel, without additional charge to the government, upon installation of any upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished under this solicitation.

Ongoing Training:

o In addition, the Contractor shall provide additional on-site training 6-12 months after test implementation, if requested.

o Offer ongoing training sessions to ensure that all staff are up-to-date with the latest techniques, software updates, and best practices. This training can be conducted either on-site or off-site as needed.

5. Deliverables:

5.1 The contractor must provide:

A detailed implementation plan including delivery, installation, validation and testing of all instruments and equipment.

Delivery and Installation shall be performed by the contractor. Contractor shall provide a delivery and installation timeline for new equipment. Installation shall be in accordance with the manufacturer’s installation and operation manuals/instructions, and shall include, as a minimum:

o Unpacking the analyzer from the shipping crate and removal of all packing and shipping material(s).

o Taking system component (and accessories) inventory and performing inspection to ensure that all required analyzer components are present, in working order, and undamaged.

o Assembling the analyzer into its normal operational configuration; this includes making any required connections for electrical power, drain or vent lines, gas/compressed air, water, etc. and software installation (loading into computer based/controlled analyzers any operating/configuration software).

o Performing a complete system operation check (including, at minimum, all system diagnostics, standardization/calibration of the analyzer, method performance/validation requirements, and making any required electrical or mechanical adjustments).

o Providing the Government with a copy verifying the analyzer’s operation performance (the level of performance must be within the manufacturer's specifications for a new analyzer).

Delivery schedule and inventory management plan for consumables and monoclonal antibodies.

A comprehensive training program for laboratory staff, including initial and ongoing training.

Documentation of technical support and maintenance activities performed, including service reports and maintenance logs.

Technical Support and Emergency service contact information and response protocols.

The Contractor shall provide, install and maintain, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary)), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the vendor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

The contractor shall provide any additional information, support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance by providing written documentation such as but not limited to procedure manuals, user’s technical manuals, on-line procedure/technical manuals, Safety Data Sheets (SDSs), reagents/calibrators/QC material package inserts, instrument system software manuals, system updates notifications, technical bulletins, recall notifications, among others.

Characterization of hazardous waste – The Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et al. The description shall address the following:

o Waste toxicity (Reference 40CFR261.11 and 40CFR261.24) o Waste ignitability (Reference 40CFR261.21) o Waste corrosivity (Reference 40CFR261.22) o Waste reactivity (Reference 40CFR261.23) o Hazardous waste from non-specific sources (F-listed) (Reference

40CFR261.31)

o Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33)

6. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the CPRR. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the 90-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

6.1 Upon award of a CPRR, the transition period for the awarded CPRR to have all equipment and peripherals installed, validated and operational shall be from date of award through 90 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed.

6.2 Offerors shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded CPRR 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 confirm the transition period shall be considered as sufficient cause to terminate CPRR for cause under the Termination for Cause clause of the CPRR.

6.3 At the end of 90 days from the award of the CPRR, the awarded contractor shall have full and sole responsibility for services under the awarded CPRR.

7. Standard and Quality of Performance Requirements: This paragraph establishes a standard of performance that shall be met before any equipment listed on the delivery order [or CPRR] is accepted by the government. This also includes replacement, substitute equipment and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the contractor’s technical specification or as quoted in any CPRR at an effectiveness level of 90% or more.

7.1 In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

7.2 If the equipment fails…