36C25225Q0249.docx

36C25225Q0249

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 585-25-2-030-0003 36C25225Q0249 02-11-2025 Beers,Teresa 414-844-4865 02-21-2025 12:00

CST

Department of Veterans Affairs

GLAC (69D)

115 South 84th Street, Suite 101 Milwaukee

WI

53214-1476 X 334516 1000 Employees N/A X

Department of Veterans Affairs

GLAC-MILWAUKEE (69D)

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

PLEASE SEE STATEMENT OF WORK INCLUDED AND PROVIDE A FIRM

FIXED PRICE COST PER TEST RESULT.

See CONTINUATION Page X X X

TERESA BEERS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

36C25225Q0249

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 Iron Mountain VAMC POC will be Sarah Strickler.

The Iron Mountain VAMC 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 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 as a firm fixed priced Cost Per Test (CPT).

Minimum guarantee for this contract is $50,000.00.

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:

1. Specific Requirement Section, Item 1, bullet points a-e.

Provide evidence that the analyzer and assay has the following:

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

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

c. Capable of producing rapid (30 Minutes), accurate and reproducible results.

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

e. Has minimal sample manipulation and user hands on requirements.

2. Specific Requirement Section, Item 3.

Provide documentation of the instrument measurements. Instrument should be tabletop models and preferred to be approximately one cubic foot footprint.

3. Specific Requirement Section, Item 4.

Provide evidence the system requires a valid operator ID in order to run a patient test and access patient data.

4. Specific Requirement Section, Item 6.

Provide evidence 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.

5. Specific Requirement Section, Item 7.

Provide documentation if the instrument and/or data management system will alert the operator of out-of-range QC and expiring/expired reagents.

6. Specific Requirement Section, Item 8.

Provide documentation the software must be able to capture errors to prevent compromised data from reaching a patient’s medical record.

7. General Requirement Section, Item 4.

Provide document of the disposal system. Test system must comply with facility biohazardous regulated waste disposal requirements and shall not produce any chemical hazardous waste.

8. General Requirement Section, Item 3 Provide evidence that the desired RT-PCR test system will utilize an anterior nasal swab (ANS) specimen for the test.

9. General Requirement Section, Item 11.

Provide an equipment preventative maintenance/repair plan. Provide documentation of a procedure to erase/secure instrument data before returning broken instruments, if applicable.

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) Oscar G Johnson VA Medical Center Iron Mountain, MI Background:

The Oscar G Johnson 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. The testing platform must be a CLIA waived Point-of-Care (POC) instrument. The test system will be utilized at the various Oscar G Johnson 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 eight (8) RT-PCR test instruments, reagents, and service for performing Influenza A/B, RSV & Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). 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.

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.

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.

2. The vendor shall provide eight (8) 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:

· 3440 I-75 Business Spur, Sault Ste Marie, MI 49783

· 787 Market St. Suite 9, Hancock, MI 49930

· 639 West Kemp St. Rhinelander, WI 54501

· 1110 10th Avenue Suite 101, Menominee, MI 49858

· 629 West Cloverland Dr. Ironwood, MI 49938

· 913 East Lakeshore Dr. Manistique, MI 49854

· 1414 West Fair Ave Suite 285, Marquette, MI 49855

· 2001 Minneapolis Ave. Gladstone, MI 49837

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 (POC):

· The POC is Sarah Strickler, 906-774-3300 x33436 or Nicole Rios, 906-774-3300 x32207

· 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. Oscar G Johnson VA Medical Center – 325 East H Street, Iron Mountain MI 49801

a. Eight (8) 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.1 PRICE/COST SCHEDULE

ITEM INFORMATION

Provide eight (8) RT-PCR test instruments, reagents, and service for performing Influenza A/B, RSV & Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Preferably in a 4-plex testing cartridge. (cost per test/cost per reportable).

Contract Period: Option 1 POP Begin: 04-01-2025 POP End: 03-31-2026

Provide eight (8) RT-PCR test instruments, reagents, and service for performing Influenza A/B, RSV & Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Preferably in a 4-plex testing cartridge. (cost per test/cost per reportable).

Contract Period: Option 2 POP Begin: 04-01-2026 POP End: 03-31-2027

Provide eight (8) RT-PCR test instruments, reagents, and service for performing Influenza A/B, RSV & Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Preferably in a 4-plex testing cartridge. (cost per test/cost per reportable).

Contract Period: Option 3 POP Begin: 04-01-2027 POP End: 03-31-2028

Provide eight (8) RT-PCR test instruments, reagents, and service for performing Influenza A/B, RSV & Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Preferably in a 4-plex testing cartridge. (cost per test/cost per reportable).

Contract Period: Option 4 POP Begin: 04-01-2028 POP End: 03-31-2029

Provide eight (8) RT-PCR test instruments, reagents, and service for performing Influenza A/B, RSV & Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Preferably in a 4-plex testing cartridge. (cost per test/cost per reportable).

Contract Period: Option 5 POP Begin: 04-01-2029 POP End: 03-31-2030

B.2 DELIVERY SCHEDULE

1,920.00

1,920.00

325 EAST H STREET

IRON MOUNTAIN, MI 49801 4760

USA

1,920.00

325 EAST H STREET

IRON MOUNTAIN, MI 49801 4760

USA

1,920.00

1,920.00

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

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

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

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

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

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

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

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

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

(g) Invoice.

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

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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

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

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

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

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

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

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

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

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

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

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

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

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

(i) Payment.—

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

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

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

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

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

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

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.3 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation.

(End of Clause)

C.4 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…