36C25226Q0456.docx

36C25226Q0456

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

None 36C25226Q0456 06-03-2026 Teresa Beers 414-844-4865 06-12-2026 12:00

CDT

Department of Veterans Affairs 36C252 115 South 84th Street, Suite 101 Milwaukee WI 53214-1476 X 334516 1000 Employees N/A X CBOC's listed on SOW

Department of Veterans Affairs 36C252 Great Lakes Acquisition Center - HC 115 South 84th Street, Suite 101 Milwaukee WI 53214-1476

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page

BRAND NAME OR EQUAL PER STATEMENT OF WORK

See CONTINUATION Page X X X

TERESA BEERS

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: ______________________________________ (Contractor’s Name) ______________________________________ (Address) ______________________________________ (City-State-Zip) ______________________________________ (Point of Contact/Title)

PHONE NUMBER ______________________________________

E-MAIL ADDRESS ______________________________________

DUNS NUMBER NO. ______________________________________

MILWAUKEE WI 53214

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

52.232-34, Payment by Electronic Funds Transfer - Other than System for Award Management.

3. INVOICES: Invoices shall be submitted in arrears in accordance with:

a. 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

b. UPON ACCEPTANCE OF ITEMS

4. GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be submitted electronically in accordance with 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012)

FACSIMILE, E-MAIL, AND SCANNED DOCUMENTS ARE NOT ACCEPTABLE FORMS OF SUBMISSION FOR PAYMENT REQUESTS.

For assistance setting up e-Invoice, the below information is provided:

* Vendors must register online at http://www.tungsten-network.com/veteransaffairs/

* Tungsten Network Setup Information: 1-866-340-4980

* Tungsten Network email: VA.Registration@tungsten-network.com

* FSC Vendor Support Section Contact: 1-877-353-9791

* FSC Vendor Support Section email: vafsccshd@va.gov

Vendors can inquire on the status of payments by accessing VIS at: https://www.vis.fsc.va.gov/login.aspx?ReturnUrl=%2fDefault.aspx

SPECIAL NOTES:

This is an unrestricted solicitation limited to responsible parties with the ability to 100% meet the requirements set forth.

Prospective contractors must furnish the information listed herein with their quotations to ensure they receive full consideration.

CONTRACT ADMINISTRATION:

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitment or issue changes that will affect price, quantity or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in cost incurred thereof.

CONTRACTING OFFICER’S POINT OF CONTACT (POC):

The designated Danville VAMC CBOCs POC will be Ryan Hubbard The Danville VAMC CBOC POC will be designated to represent the Contracting Officer in furnishing technical guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer.

EVALUATION/BASIS OF AWARD:

The Government will select the quote that represents the best benefit to the Government at a price that can be determined reasonable. The Government will evaluate price and technical capabilities. These criteria are not listed in any relative order of importance.

After the solicitation closes, the Government will perform a comparative evaluation of the eligible quotes. All quotes must meet the minimum standards outline in this solicitation. For quotes that meet the minimum standards, the Government will perform a comparative evaluation by comparing quotes against one another to select the quote that best benefits the Government considering all factors. The VA will compare quotes against each other in an impartial and simplified manner based on FAR Part 13. Source selection techniques described in FAR part 15 will not be used.

Contractors may submit more than one quote; however, contractors are strongly encouraged to submit their best technical solutions and prices in response to this request for quote.

Once the Government determines there is/are a contractor(s) that can provide a service that meet(s) the requirements of this request for quote, the Government reserves the right to communicate with only those contractors quoting the best-suited service to address any remaining issues. The Government will evaluate quotes for award purposes by adding the total price for all ordering periods to the total price for the basic requirement.

TYPE OF CONTRACT: VA anticipates a Single Award, Firm-Fixed Price, Indefinite Delivery Indefinite Quantity (IDIQ) with a Five (5) One (1) Year Ordering Periods Contract based on the contents of this solicitation.

SECURITY & PRIVACY CONTROL:

The Certification & Accreditation (C&A) requirements of VHA Handbook 6500.6 do not apply to this requirement; therefore, a Security Accreditation Package is not required. No C&A or MOU/ISA is required. Sensitive information exposure as part of this contract involves applicable security controls within the facility as part of the VA Information Security Program.

If there are any questions related to privacy, please have a member of your staff contact the VA Privacy Service at (202) 461-6309. If there are any questions related to the information security, please have a member of your staff contact the Office of Cyber Security at (304) 262-7733.

SUPPLIES OR SERVICES AND PRICES/COSTS:

The Contractor shall provide FDA‑approved or FDA‑authorized under an EUA, CLIA‑waived, rapid, PCR‑based, interfaced, point‑of‑care analyzers and assays for each of the following: detection of SARS‑CoV‑2, RSV, Influenza A & B viruses, and Strep A in a nasal swab specimen as a firm fixed‑priced Cost Per Test (CPT).

Minimum guarantee for this contract is $115,000.00.

Ceiling Amount for the entire life of the contract is $800,000.00.

Vendor will provide a response to the following as part of the Technical Review:

Provide evidence that the analyzer and assay has the following:

a. Instrumentation: footprint, system capabilities, and data management.

b. Assay Menu: FDA approval, specimen requirements, and test performance.

c. Preventative maintenance and service plan.

d. Implementation plan: timeline, training, and method validation.

Salient Characteristics for Roche LAIT (Brand Name or Equal) The offered system must meet or exceed the following minimum salient characteristics to be considered equal to the Roche LAIT platform:

1. Testing Technology

· Must utilize rapid, PCR‑based (NAAT) molecular technology.

· Must be CLIA‑waived for point‑of‑care use.

· Must be FDA‑approved or authorized under FDA EUA for all required assays.

2. Test Menu Capability

· Must provide assays capable of simultaneous detection of:

• SARS‑CoV‑2

• Influenza A

• Influenza B

• RSV

• Strep A

3. Analyzer Features

· Must be a point‑of‑care, benchtop or countertop analyzer with minimal sample preparation.

· Must offer automated processing with minimal operator steps.

· Must provide instrument‑to‑LIS/EHR interfacing capability (HL7 compatible or equivalent).

4. Specimen Requirements

· Must accept nasal or nasopharyngeal swab specimens consistent with the Roche LAIT system’s capabilities.

· Must utilize single‑use, self‑contained cartridges or assay consumables.

5. Performance Criteria

· Must deliver rapid turnaround time consistent with point‑of‑care clinical needs (≤30 minutes per test preferred).

· Must meet or exceed Roche LAIT’s established sensitivity and specificity for each pathogen.

6. Operational Requirements

· Must operate under standard clinic or ambulatory care environmental conditions.

· Must require minimal routine maintenance and no specialized calibration.

· Must include onboard quality control or system verification capability.

7. Connectivity & Data Management

· Must support bidirectional communication with facility LIS/EHR.

· Must store or transmit test results securely in compliance with HIPAA requirements.

8. Consumables & Accessories

· All required consumables, cartridges, controls, and accessories must be available through the vendor.

· Must be compatible with the analyzer without additional proprietary hardware not included in the offer.

STATEMENT OF WORK

Point of Care Respiratory Virus Testing: Influenza A/B, Respiratory Syncytial Virus (RSV), & Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Strep A Testing VA Illiana Health Care System Danville, IL 5/2026

Background:

The Illiana VA Medical Center Community Based Outreach Clinics (CBOCs) are in need of an automated rapid multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B, and respiratory syncytial virus (RSV) nucleic acid in an anterior nasal swab (ANS) specimen from individuals with signs and symptoms of respiratory tract infections. As well as Strep A testing. The testing platform must be a CLIA waived Point-of-Care (POC) instrument. The test system will be utilized at the various Illiana VA Medical Center CBOCs in order to improve the veteran experience by providing faster turnaround times, utilizing state of the art technology for rapid diagnosis and treatment of respiratory viral infections ultimately providing improved patient outcomes.

Definitions:

Ancillary Testing Coordinator (ATC): A medical professional responsible for the coordination of laboratory testing performed outside of the clinical laboratory. ATC is interchangeable with Point-of-Care Coordinator (POCC).

Respiratory Virus: Influenza A/B (FLU A/B), Respiratory Syncytial Virus (RSV), & Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).

Anti-Viral Therapy: Medication prescribed by the provider as appropriate.

RT-PCR Based Technology: Reverse transcriptase polymerase chain reaction (RT-PCR) technology is a laboratory nucleic acid amplification technique that amplifies a specific region of a DNA strand (the DNA target) and is considered the gold standard throughout the industry.

CLIA Waived: A simple test with a low risk for an incorrect result.

Cost per Test/Cost per Reportable: The per test cost, inclusive of all aspects of performance which are built into the price for the point of care test kits.

The acquisition of a RT-PCR based respiratory virus test system will provide trained health care professionals with an accurate patient result in order to provide appropriate intervention in a timely manner, i.e. prescribing antiviral therapy. This practice will enhance patient care and public health practices as it provides well timed review of results in addition to the continuity of care needed from other VISN12 facilities. The acquisition of a RT-PCR respiratory virus test system will also remove the need for patients to report to the local urgent care when presenting with signs and symptoms of a respiratory tract infection eliminating additional exposures and decreasing community spread.

RT-PCR respiratory virus test installation is approved at each clinical site requesting POC testing. All sites must comply with current standards of laboratory accreditation by Joint Commission (JC) and VHA. The approval for the installation of POC testing at each site, and the technical direction of such testing, is the responsibility of the Pathology and Laboratory Medicine (PLM) Medical Director. The Ancillary Testing Coordinator (ATC) will facilitate the installation of the test system at their respective site(s) in collaboration with the program/area personnel that have requested the POC test.

A full validation of the test system will be required upon selection to ensure comparability of test results to current VISN12 laboratory PCR test systems for respiratory viruses. Testing will not be implemented for the selected system if the validation fails statistical studies as determined by our Pathology and Laboratory Medicine (PLM) Medical Director.

Objectives:

1. Obtain a rapid reliable RT-PCR test system, reagents, and service agreement for testing clinical laboratory specimens on a reagent rental agreement (cost per test/cost per reportable).

2. The desired duration of the contract is a base year + 4 option years.

3. Provide six (6) RT-PCR test instruments, reagents, and service for performing Influenza A/B, RSV & Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Strep A Testing. Preferably in a 4-plex testing cartridge.

4. Provide a test system that is compact so operators can perform testing at VISN12 CBOC locations.

5. Provide a test system with connectivity to enable electronic transmission of patient results directly to the patient chart.

6. Provide a secure information management system that readily connects to VISN12 computer systems with no additional cost to the Government.

7. If a POC Middleware system is in place, the instruments must connect with the POC Middleware. VISN12 currently has RALS connectivity.

8. Provide a system that correlates with testing specifications of the core clinical laboratory for the duration of the contract.

Performance Period:

Base year option beginning August 1, 2026 through July 31, 2027, with 4 one year options for renewal thereafter.

General Requirements: Cost per test requirement for FDA-approved or authorized by FDA under an EUA, CLIA-waived, rapid, PCR based, interfaced, point of care analyzers and assays for each of the following: detection of SARS-CoV-2, RSV, and Influenza A & B viruses simultaneously in a nasal swab specimen. Strep A testing.

1. The preferred RT-PCR test system is CLIA Waived with bidirectional capability.

2. Results must interface through our RALS middleware to the facility’s electronic health record (VistA/CPRS).

3. The desired RT-PCR test system will utilize an anterior nasal swab (ANS) specimen for the test and is proven to be capable of producing accurate and reproducible results by established in-vitro diagnostic method comparisons and analysis.

4. Disposal requirement: Test system must comply with facility biohazardous regulated waste disposal requirements and shall not produce any chemical hazardous waste.

5. The per test cost shall be inclusive of all aspects of performance which are built into the price of the point of care test kits. This includes provisions for the following at no additional cost:

· Point of care analyzers including all hardware and software required for testing and result transmission to network software that can download the patient result into the VA electronic patient record.

· All reagents, supplies, parts, accessories, and any other items required for the proper operation of the contractor’s equipment.

· All quality control, calibration, and correlation study testing as prescribed by Clinical and Laboratory Standards Institute (CLSI)

· All necessary maintenance to keep the equipment in good operational condition to include preventative maintenance and emergency repairs.

· Delivery, installation, verification, and removal of equipment.

· Provide all upgrades to the equipment hardware and operating system software in order to maintain the integrity of the system.

6. The device is compact and able to fit within the designated space for testing.

7. Analyzers shall provide accurate test assay results for samples without excessive malfunctions, breakdowns, or service calls. The analyzers shall be current state-of-the- art equipment. Discontinued models will not be accepted.

8. Exchange program for malfunctioning units and guarantee for a replacement unit to be sent within 24 hours of notification.

9. Provide technical support service to assist in troubleshooting.

10. On-site service provided following determination that site service is required.

11. Provide a procedure to erase/secure instrument data before returning broken instruments, if applicable. Broken instruments without an erase feature would be kept by the VA and destroyed. If a system uses a hard drive, it will be retained by the VA Medical Center in the event the instrument needs to be returned to the supplier.

12. Must be able to establish a system for supply, delivery, and billing as appropriate.

13. The vendor will work with the facility Laboratory Information Managers (LIM) and Information Security Officer (ISO) to establish secure connectivity for all VISN12 sites utilizing the system.

14. The selected vendor will provide initial training to all VISN12 sites requiring a system. An operator’s manual will be supplied to all locations within VISN12 that utilize the test system. Updates to manuals shall be provided by the vendor in a timely manner.

Specific Requirements:

1. Analyzer and assay must be:

· FDA-approved or authorized by FDA under an EUA.

· Considered waived complexity by CLIA & approved for point of care testing.

· Capable of producing rapid (~30 minutes), accurate and reproducible results.

· SARS-CoV-2, RSV, and Influenza A & B viruses simultaneous testing by established molecular in-vitro diagnostic methods using a nasal swab specimen.

· Have minimal sample manipulation and user hands on requirements.

· Capable of Strep A testing

2. The vendor shall provide six (6) instruments for performance of test services.

3. Instrument should be tabletop models; approximately one cubic foot footprint is preferable.

4. The system must require a valid operator ID in order to run a patient test and access patient data in the instrument(s).

5. For patient safety, the system will have an alpha/numeric keypad and/or barcode scanner to reliably enter or scan an operator ID and patient ID prior to running the test. Any operator or patient identification that is not recognized in data transfer must be held in the data management system and trigger an alert rather than being reported directly to the patient chart.

6. The system has a data management system whereby results are transmitted to the Laboratory Information System (LIS) and is able to connect to RALS middleware.

7. The instrument and/or data management system must alert operator(s) of out of range QC and expiring/expired reagents.

8. Software must be able to capture errors to prevent compromised data from reaching a patient’s medical record. Alerts can be configured to hold such results in the data management system. Erroneous or questionable results must be able to be held and reviewed prior to entry in the patient medical record and alerted in the interface for review.

Security Requirements:

1. Information Security: The desired system will have a secure data transfer system. If necessary, the vendor shall include in their response, the appropriate certificates for their products use in a government facility (e.g. FIPS 140-2).

2. Laboratory Information Managers and ISOs will be among the evaluators of the system specifications to prove compatibility with the LIS, middleware, and the VHA’s VISTA system.

3. The system is required to have an operating system that is currently supported with necessary fixes and security updates, that includes if the system uses a third party operating system (OS), for example Windows or Linux.

4. Vendor is required to address any identified security vulnerabilities in a timely manner when under contract.

5. In order to be deployed on the VA network, the system will have an approved Enterprise Risk Analysis (ERA). If the supplier does not have a current approved ERA, they must be able to furnish the required documents to initiate that process which includes, but is not limited to: VA Form 6550 Appendix A, NIST form MDS2, a software inventory, a ports and protocols, and a topology diagram of the system.

Validation and Installation:

1. The vendor shall provide each facility with validation supplies such as reagents, QC, and calibrators.

2. The vendor shall provide a technical support specialist who shall assist with the system validation studies at all sites to minimally include installation/set-up of the instrument(s), correlation studies sufficient to satisfy JC & VHA standards.

3. The Laboratory Director must approve all instrumentation/testing based on the validation data obtained.

4. Post-validation: Once the test system is approved, the vendor will work with the ATCs to schedule and conduct training for testing personnel. Training will minimally include instrument function, maintenance, QC plan, limitations of the test and troubleshooting.

· Installation and training required at the following locations:

· Bob Michel VA Outpatient Clinic 7717 N Orange Prairie Rd, Peoria, IL 61615

· Bloomington VA Clinic 207 Hamilton Rd, Bloomington, IL 61704

· Springfield VA Clinic 5850 South 6th Street Suite A, Springfield, IL 62703-5162

· Decatur VA Clinic 792 North Sunnyside Road, Decatur, IL 62522-1156

· Mattoon VA Clinic 501 Lakeland Boulevard Suite D, Mattoon, IL 61938-5283

· Champaign VA Clinic 1702 S. Mattis Ave., Suite #101, Champaign, IL 61821

5. The vendor shall define daily, weekly, monthly, and ‘as needed’ maintenance and the estimated time required to perform each maintenance task and shall designate each task as ‘user level’ or ‘service level’.

Service and Maintenance:

1. Service shall be included in the cost of each device/strip or can be offered separately. This information should be submitted with your quotes; see General Requirements, #2.

2. Service shall include 24/7 technical support via hotline and the ability to send replacement instrumentation via overnight transport when troubleshooting does not solve an issue to the satisfaction of the Government.

3. Inventory Control Reagents, Supplies and Disposables: The contractor shall maintain on Government-provided space a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform tests on the offered equipment. These items shall be of the highest quality ensuring sensitivity and specificity, and tested to assure precision and accuracy. The quality of the products shall satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission (TJC).

4. In the event that the consumables are found to be defective and unsuitable for use with the contractor’s equipment or the contractor has failed to comply with the requirements for routine supply delivery (such as temperature monitoring), the contractor shall deliver the replacement consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. The vendor shall deliver the replacement supply without additional cost to the Government. The supply sent shall match the supply that was defective. If the vendor would like the defective supply returned, the vendor must supply the facility with a FedEx or UPS prepaid shipping label.

5. In the event of a product or lot recall, the information must be communicated as soon as possible by the vendor to the ATCs. The vendor must assist the affected sites in obtaining replacement supplies so as not to affect patient care.

6. Failure to reserve adequate inventory based on contracted volume may result in contract default.

7. Upon award of the contract, the vendors must submit a formal implementation plan for each site to include a basic timeline for items such as instrument and consumable receipt, validations, and training.

Performance Monitoring:

· Performance monitoring will be performed by the Ancillary Testing Coordinators (ATC’s) in conjunction with trained operators. The ATC’s will be knowledgeable of delivery issues, will monitor downtimes and device errors utilizing the data management system and gain insight to any other problems that the employees feel make the system inoperable or unnecessarily tough to use.

· Issues will be reported to the Contracting Officer (CO) and the Contracting Officer’s Representative (COR). The contractor will provide support until the product is fully operable to the Government’s approval.

Point of Contact:

· The POC is Ryan Hubbard, 309-589-6800 x37180

· No government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The POC shall clarify technical points or supply relative technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification.

Deliverable/Installation Schedule:

The contractor will provide safe and timely delivery and installation of all materials as outlined. Delivery and installation is to occur no later than 30 days after calendar receipt of Notice of Award and/or purchase order.

The following VISN 12 sites will require the following hardware for initial validation in addition to reagent and QC needed for validation. The consumables needed for validation at each site will be calculated by the vendor based on their validation plan. The Laboratory Director may require more QC and correlation samples be run in addition to the vendor estimate. The consumables should be added to the vendor calculation and received by the following sites to proceed with validation studies.

1. Bob Michel VA Outpatient Clinic 7717 N Orange Prairie Rd, Peoria, IL 61615

2. Bloomington VA Clinic 207 Hamilton Rd, Bloomington, IL 61704

3. Springfield VA Clinic 5850 South 6th Street Suite A, Springfield, IL 62703-5162

4. Decatur VA Clinic 792 North Sunnyside Road, Decatur, IL 62522-1156

5. Mattoon VA Clinic 501 Lakeland Boulevard Suite D, Mattoon, IL 61938-5283

6. Champaign VA Clinic 1702 S. Mattis Ave., Suite #101, Champaign, IL 61821

a. Six (6) instruments and associated hardware and connections and materials required to perform validation studies.

Contractor Qualifications:

· The successful contractor shall be able to provide an FDA-approved, or authorized by FDA under an EUA, CLIA waived test system to fulfill the test requirements listed within the Statement of Work.

· Submit a proposal on company letterhead for the above outlined products and services. Material, installation and delivery charges are to be listed separately. Only EQUAL or Better items on GSA schedule will be considered.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Point of Care Analyzers and Annual Service Lease Bundle with Reagents Contract Period: Option 1 POP Begin: 08-01-2026 POP End: 07-31-2027

1000AA

SARS COV2 FLU AB RSV TEST

1000AB

Strep A Test

1000AC

Point of Care Analyzers Quality Control Supplies

Point of Care Analyzers and Annual Service Lease Bundle with Reagents Contract Period: Option 2 POP Begin: 08-01-2027 POP End: 07-31-2028

2000AA

SARS COV2 FLU AB RSV TEST

2000AB

Strep A Test

2000AC

Point of Care Analyzers Quality Control Supplies

Point of Care Analyzers and Annual Service Lease Bundle with Reagents Contract Period: Option 3 POP Begin: 08-01-2028 POP End: 07-31-2029

3000AA

SARS COV2 FLU AB RSV TEST

3000AB

Strep A Test

3000AC

Point of Care Analyzers Quality Control Supplies

Point of Care Analyzers and Annual Service Lease Bundle with Reagents Contract Period: Option 4 POP Begin: 08-01-2029 POP End: 07-31-2030

4000AA

SARS COV2 FLU AB RSV TEST

4000AB

Strep A Test

4000AC

Point of Care Analyzers Quality Control Supplies

Point of Care Analyzers and Annual Service Lease Bundle with Reagents Contract Period: Option 5 POP Begin: 08-01-2030 POP End: 07-31-2031

5000AA

SARS COV2 FLU AB RSV TEST

5000AB

Strep A Test

5000AC

Point of Care Analyzers Quality Control Supplies

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from 08/01/2026 through 07/31/2031.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of Clause)

C.3 52.216-22 INDEFINITE QUANTITY (NOV 2025) (DEVIATION)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the ordering period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order, which may include order options to be exercised after the ordering period of this contract but before the end of the period of performance of the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order, including options exercised, to the same extent as if the order were completed during the contract's ordering period; provided, that the Contractor shall not be required to make any deliveries under this contract after 07/31/2031.

(End of Clause) 52.222‑90 Addressing DEI Discrimination by Federal Contractors (APR 2026)

(a) Definitions. As used in this clause—

· Program participation means membership in, or access to: training, mentoring, or leadership development programs; educational opportunities; clubs; associations; or similar opportunities sponsored by the Contractor or subcontractor.

· Racially discriminatory diversity, equity, and inclusion (DEI) activities means disparate treatment based on race or ethnicity in the recruitment, employment (e.g., hiring, promotions), contracting, program participation, or allocation or deployment of resources.

(b) Compliance Requirements. In connection with the performance of work under this contract, the Contractor agrees to:

1. Not engage in any racially discriminatory DEI activities.

2. Furnish all information and reports, including access to books, records, and accounts, as required by the Contracting Officer to determine compliance.

3. Acknowledge that noncompliance may result in cancellation, termination, or suspension of the contract, and possible ineligibility for future Government contracts.

4. Report any subcontractor’s known—or reasonably knowable—conduct that may violate this clause and take remedial actions as directed.

5. Inform the Contracting Officer if a subcontractor sues the Contractor in a manner that questions the validity of this clause.

6. Recognize that compliance is material to the Government’s payment decisions under 31 U.S.C. 3729(b)(4).

(c) Subcontract Flow‑Down. The Contractor must include this clause, in substance, in all subcontracts at any tier—including those for commercial products and services—where delivery or performance occurs in the United States.

(End of Addendum to 52.212-4)

36C25226Q0456

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SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Provision)

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

E.2 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)

(a) Any protest filed by an interested party shall—

(1) Include the name, address, fax number, email and telephone number of the protester;

(2) Identify the solicitation and/or contract number;

(3) Include an original signed by the protester or the protester’s representative and at least one copy;

(4) Set forth a detailed statement of the legal and factual grounds of the protest, including a description of resulting prejudice to the protester, and provide copies of relevant documents;

(5) Specifically request a ruling of the individual upon whom the protest is served;

(6) State the form of relief requested; and

(7) Provide all information establishing the timeliness of the protest.

(b) Failure to comply with the above may result in dismissal of the protest without further consideration.

(c) Bidders/offerors and Contracting Officers are encouraged to use alternative dispute resolution (ADR) procedures to resolve protests at any stage in the protest process. If ADR is used, the Department of Veterans Affairs will not furnish any documentation in an ADR proceeding beyond what is allowed by the Federal Acquisition Regulation.

(End of Provision)

E.3 52.225-2 BUY AMERICAN CERTIFICATE (OCT 2022)

(a)(1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c) of this provision contains a critical component.

(2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select ‘‘no’’.

(3) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105).

(4) The terms ‘‘commercially available off-the-shelf (COTS) item,’’ ‘‘critical component,’’ ‘‘domestic end product,’’ ‘‘end product,’’ and ‘‘foreign end product’’ are defined in the clause of this solicitation entitled ‘‘Buy American—Supplies.”

(b) Foreign End Products:

[List as necessary]

(c) Domestic end products containing a critical component:

Line Item No.

(d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation.

(End of Provision) (End of Addendum to 52.212-1)

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

(1) Technical Capability

(2) Price

(b) Evaluation Approach. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2(b)(3), where quotations will be compared to one another to determine which provides the best benefit to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed the minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government is not requesting or accepting alternate quotations. The evaluation will consider the following:

(1) Technical Capability: The quotations will be evaluated in an impartial manner to determine whether offerors can meet or exceed government requirements as outlined in the solicitation and based on the information requested in the instructions to offerors section of the solicitation (52.212-1).

(2) Price: The Government will evaluate price for the base and all ordering periods to determine reasonableness.

(c) Options & Ordering Periods. The Government will evaluate offers for award purposes by adding the total price for all ordering periods. The Government may determine that an offer is unacceptable if any ordering period prices are significantly unbalanced. For the purposes of the award of this Contract, the Government intends to evaluate the option to extend services, provided under FAR 52.217-8, as follows: The evaluation will consider the possibility that the option can be exercised at the end of the Final Ordering Period, and can be exercised in increments of one to six months, but for no more than a total of six months. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be at the same rates as those in Ordering Period 6. The evaluation will therefore assume that the addition of the price or prices of any possible extension or extensions under FAR 52.217-8 to the total price for the basic requirement has the same effect on the total price of all quotes relative to each other, and will not affect the ranking of quotes based on price, unless, after reviewing the quotes, the Government determines that there is a basis for finding otherwise. Evaluation of options shall not obligate the Government to exercise the option(s).

(d) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION FEB 2025) The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision— Covered telecommunications equipment or services has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR 127, and the concern is identified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430,…