36C26026Q0167_1.docx

Combined Synopsis/Solicitation

GENERAL INFORMATION

Network Contracting Office 20 1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

POINT OF CONTACT*

Contracting Specialist Hector D. Gonzalez hector.gonzalez1@va.gov

PLACE OF PERFORMANCE

Seattle VA Healthcare System

1660 South Columbian Way

Seattle WA

COUNTRY

ADDITIONAL INFORMATION

36C26026Q0167

This is a combined synopsis/solicitation for commercial products prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.2, “Streamlined Procedures for Evaluation and Solicitation for Commercial Products,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This is a Request for Quote (RFQ), and the solicitation number is 36C26026Q0167. The Government anticipates awarding a firm-fixed price service order from this solicitation.

This is a solicitation for the distribution of BioRad BioPlex Laboratory Reagents. This is to be a five year Indefinite Delivery Indefinite Quantity Contract where items will be purchased through Delivery Orders on a yearly basis. The solicitation documents and incorporated provisions and clauses are those in effect through FAC 2025-06, (eff. 10/01/2025), FAR Deviation Nov 2025 (eff. 11/05/2025), VAAR Deviation (eff. 04/01/2025), VAAM Alert 26-01 (eff. 10/01/2025) and Acquisition Policy Flash 26-16 (eff. 11/05/2025).

This solicitation is 100% set aside for a small business. The associated North American Industrial Classification System (NAICS) code for this procurement is 325413 In-Vitro Diagnostic Substance Manufacturing, with a small business size of 1,250 employees, and the PSC is 6515, Medical and Surgical Instruments, Equipment, and Supplies.

The Department of Veterans Affairs, Veterans Healthcare Administration, Regional Procurement Office West, Network Contracting Office 20, on behalf of the Puget Sound (Seattle) Healthcare System, is seeking the following Supplies in compliance with the below Statement of Work.

PAGE 3 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

12-05-2025 Hector Gonzalez 360-553-7632 12-19-2025 17:00

PST

36C260 Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd

X

325413 1250 Employees

Net 30 Days

N/A

36C663 Department of Veterans Affairs Seattle VA PSHCS

1660 South Columbian Way Seattle WA 98108-1532 36C260 Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd

Dept of Veterans Affairs

FMS-VA-2(101)

Financial Services Center

PO BOX 149971

Austin TX 78714-9971

See CONTINUATION Page

1. Location: Seattle VA Medical Center.

2. Indefinite Delivery Indefinite Quantity solicitation for Bio-Rad Bio-Plex Reagents and consumables for the Puget Sound VA Health Care System.

3. This is to be a five year IDIQ with ordering periods.

Ordering Period 1: 02/01/2026 - 01/31/2027 Ordering Period 2: 02/01/2027 - 01/31/2028 Ordering Period 3: 02/01/2028 - 01/31/2029 Ordering Period 4: 02/01/2029 - 01/31/2030 Ordering Period 5: 02/01/2030 - 01/31/2031

4. Please see the Continuation Pages below for details regarding the submission of quotes.

5. For further information, please contact Hector Gonzalez at hector.gonzalez1@va.gov.

See CONTINUATION Page

Five Year IDIQ with Ordering Periods Pricing Table

Ordering Period 1-February 1st, 2026 – January 31st, 2027.

Distribution of Bio-Rad Bio-Plex reagents for Laboratory Tests to perform the Immunoassays in Chemistry for Patient Care.

Price total based on Attachment A price list.

1 YR

Ordering Period 2-February 1st, 2027 – January 31st, 2028.

Distribution of Bio-Rad Bio-Plex reagents for Laboratory Tests to perform the Immunoassays in Chemistry for Patient Care.

1 YR

Ordering Period 3-February 1st, 2028 – January 31st, 2029.

Distribution of Bio-Rad Bio-Plex reagents for Laboratory Tests to perform the Immunoassays in Chemistry for Patient Care.

1 YR

Ordering Period 4-February 1st, 2029 – January 31st, 2030.

Distribution of Bio-Rad Bio-Plex reagents for Laboratory Tests to perform the Immunoassays in Chemistry for Patient Care.

Price total based on Attachment A price list

1 YR

Ordering Period 5-February 1st, 2030 – January 31st, 2031.

Distribution of Bio-Rad Bio-Plex reagents for Laboratory Tests to perform the Immunoassays in Chemistry for Patient Care.

1 YR

TOTAL

STATEMENT OF WORK (SOW)

INTENT: It is the intent of the Pathology Laboratory Medicine of the Seattle VAMC, Department of Veterans Affairs (herein afterwards referred to as Seattle VAMC) to establish a contract for the distribution of BioRad BioPlex laboratory reagents. The Government will award contract to a single Contractor for Automated Immunoassay Instrumentation. Contractor agrees to the following terms of the contract exclusively with the Seattle VAMC listed by Attachment and awarded in the final contract. The instrument shall be able to perform immunoassays for ANA Screens, Syphilis IgG and RPR, Measles/Mumps/Rubella/Varicella, Herpes Simplex virus (HSV) antibodies, Cytomegalovirus (CMV) antibodies, Epstein-Barr Virus (EBV) antibodies, Vasculitis Panel, Anti-CCP Panel, Celiac Panels, Antiphospholipid Panels, HIV Antibody Panel and Toxoplasma. Vendor will provide methodology for differentiation the of HIV 1 and HIV 2. Additional tests/reagents/instrumentation may be added to the contract as new technology becomes available on the market and added to the contract.

ORDERS: All products ordered under this contract, placed against an Indefinite Delivery Indefinite Quantity Contract (IDIQ), are subject to the terms and conditions of the contract. This contract does not obligate any funds, the Delivery Orders made in accordance with the IDIQ will.

PRICES AND TERMS: Seattle VAMC will provide an estimated volume by test. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility.

TERM OF AGREEMENT: This will be a single award, firm-fixed price contract for one years and shall be effective for the term of the Contract including additional extensions. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the contract upon which this contract is based, is no longer in force.

IDENTIFICATION: Delivery Orders issued shall be identified by their applicable Contract Number and Delivery Order Number.

ORDERING METHOD: The Seattle VAMC may order products via E-mail, telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

STATEMENT OF WORK TO BE PROVIDED:

1. GENERAL REQUIREMENTS:

1.1. The vendor(s) shall furnish all clinical laboratory supplies, materials, equipment necessary for the performance of the work as described herein to the Seattle VAMC.

1.2. A list of the estimated yearly quantities by the Seattle VAMC will be provided under this agreement as reflected in Attachment A. The quantity listed is an estimate based upon prior history of the actual volume and is intended to provide the potential contractor a basis for calculating their pricing. It is not a guaranteed minimum.

1.3. The pricing shall be based on new equipment. Remanufactured or used models will not be accepted.

1.4. The analyzer shall streamline all aspects of testing, thereby enhancing operational efficiency, improving turnaround time, supporting improved patient outcomes, and improving the productivity of the using facility.

1.5. Vendors shall provide the participating facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibrators, and any consumable part necessary for analyzing/testing. Vendor shall list the consumable parts provided.

2. SYSTEM REQUIREMENTS:

2.1. Offered analyzer must be capable of producing accurate and reproducible results by established diagnostic methods. The analyzer shall provide accurate test assay results without excessive malfunctions, breakdowns, or service calls.

2.2. Total time to analyze a single test shall be less than 1 hour.

2.3. Vendor must provide at least two levels of commercial quality controls to be analyzed to meet facility and regulatory agency requirements.

2.4. Analyzer shall have the capability of providing printouts for all patient results, calibrators, and controls.

2.5. All consumable supplies (reagents, calibrators, controls, disposable, etc…) required for the proper operation of the contractor’s equipment and that are necessary to perform tests on the equipment shall be included and furnished by the contractor.

2.6. The system shall have a design that supports the result integrity/removes the possibility of sample carryover.

2.7. The vendor shall state the open date stability for the reagents/supplies in the kit.

2.8. The vendor shall supply equipment that shall perform satisfactorily at any laboratory relative humidity between 15 and 85 percent and any laboratory temperature between 50º and 90º Fahrenheit (10º to 30º Celsius).

2.9. The system shall have a design that support on demand testing.

2.10. The system shall have the design to utilize ready to use reagents

2.11. The system shall be able to process 2200 samples per hour.

2.12. The system robotic arm should possess clot detection.

2.13. The system shall have automated calibration

2.14. The system shall have the design for Bi-directional LIS connectivity

2.15. The system shall have the design to run autoimmune and infectious disease tests in single test format

3. INSTRUMENTATION AND SOFTWARE:

3.1. The vendor is to conduct and complete the Medical Equipment Pre-procurement Assessment (VA Directive 6550 Appendix A) for the Office of Information Technology (OI&T) for the facility for any medical device that will be connected to the VA information network. The vendor then shall provide evidence of VACO approved remote network communication system that continuously collects and monitors performance data of the analytical systems following all the policies and procedures outlined in the VA Directive 6500, Information Security Program, and its handbooks to ensure appropriate security controls are in place.

3.2. The equipment shall include 120 volt UPS that has a 2-3 hour back-up capability. The vendor shall be responsible for replacing the UPS should it become dysfunctional and provide battery replacement as needed.

3.3. The system shall support multiple barcode formats including but not limited to Code 39, Code 128, and Codabar or current VA standardized barcode that may be enabled concurrently.

3.4. The system shall have a barcode reader for sample identification. The barcode reader must be able to read current standardized VA barcode formats.

3.5. VA patient information cannot reside at the vendor’s location or on removable media. Only the instrument configuration can be stored on removable media.

3.6. The vendor shall provide all upgrades to the equipment hardware, software, and operating systems without additional charge to the Government.

3.7. Requests for upgrades or replacement, due to workload increase, excessive instrumentation/test kit failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually by the facility with communication to the vendor for modification of the contract. A high incidence of problems with any instrumentation/ test kits may indicate probable non-compliance with the terms of this contract and will entitle the facility to replacement with equipment/test kits that can produce the required criteria of this contract satisfactorily to the user.

3.8. The contractor shall remove all equipment within 90 days after notification of the expiration of the terms of this contract but not until the completion of new vendor’s equipment installation inclusive of completed cross over studies. The facility, per their protocol, will be responsible for the removal/erasing of the hard drive at analyzer removal/upgrade. If the Seattle VAMC chooses to retain the hard drive, it will be at no additional cost to the VA.

3.9. The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce’s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST’s Web site at: http://checklists.nist.gov

3.10. To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in “VA Information and Information System Security/Privacy Requirements for IT Contracts” located at the following Web site: http://www.iprm.oit.va.gov

4. INSTALLATION AND VALIDATION:

4.1. The vendor shall provide the participating facility with all reagents, calibrators, controls, linearity material, and any supplies needed at installation and during training of staff. The vendor shall pay all shipping costs for the analyzers and all supplies needed for the installation, correlation studies and training of staff.

4.2. At installation of new equipment, vendor will provide all of the manpower and the technical support specialist(s) to assist in equipment installation/set-up, correlation studies (evaluation/comparison of data sufficient to satisfy CAP standards, CLSI and related documents, and Federal Regulations), staff training, methodology problems, and questions. Method Performance/Comparison shall include but is not limited to:

4.3. Accuracy studies for the analyte: A minimum of 30 samples, consisting of an adequate number of both high and low samples will be run by the present and the proposed method. Contractor will analyze results and provide data to support acceptance of the new method. The evaluation will include validation of accuracy, in concordance to current method and meet current standards defined by CLSI.

4.4. Precision study using low and high control material: This will consist of a within run precision study of at least 10 low and 10 high controls.

4.5. Specificity Studies: Manufacturer’s package insert, including any limitations and/or interferences, will be provided by the contractor.

4.6. Sensitivity Studies: Manufacturer’s package insert will be provided by the contractor.

4.7. Carryover Studies: Presence of assay carryover shall be ruled out during the contractor’s instrument validation process. Documentation of carryover studies performed during the validation process will be provided by the vendor.

4.8. At installation/set-up the vendor/technical support specialist shall perform and place in a labeled binder all validation studies including: installation/set-up, correlation studies, linearity and cross-over studies. Evaluation/comparison data shall be sufficient to satisfy CAP standards and shall be completed within two weeks of installation at the facility. The support specialist shall assist with staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions.

4.9. The vendor shall provide equipment installation and possible reinstallation costs if the equipment is required to be moved due to construction or laboratory redesign.

4.10. The vendor shall supply a quarterly shipment and indicate how much storage space would be needed. The vendor shall ensure that all reagents/supplies received quarterly shall have at least a six month expiration date. The vendor shall work with the facility to adjust reagent supply to match workload changes and to provide the option annually for the facility to adjust the shipment table. The vendor shall state what their policy is in regards to adjusting a standing order or ordering an additional shipment of supplies.

5. SUPPORT SYSTEMS (SERVICE, PREVENTATIVE MAINTENANCE AND SHIPPING OF SUPPLIES)

5.1. Vendor will provide technical support services at no additional charge to the facility. Technical support by telephone shall be available 7 days a week, 24 hours a day. Technical support shall return all downtime calls within one hour. Should on-site service be required, the contractor’s field service organization shall provide on-site service response within 24 hours after being contacted. The repair person shall also, prior to departure, provide the visited site with written documentation of services performed.

5.2. Technical support shall place a service call for repairs if the technologist is unable to repair the analyzer within one hour of trouble-shooting with the hotline or on weekends/holidays/irregular tours when technologists may be unable to work with the hotline due to the facilities staffing.

5.3. Service is to include, at no charge, all labor, travel, and parts necessary to make repairs.

5.4. The vendor shall provide instrument support service sufficient to provide assistance with troubleshooting and repair of the analyzer. The vendor may list their service options available. Or the following service option may be available: 24 hours/day, 7 days/week. The support service shall follow-up all down calls within 1 hour. The FSR at all times shall keep the facility informed of the time line for when repairs are to be completed. All repairs on instrument shall be complete (at no cost to the facility) within 24 hours from the time the field service engineer arrives.

5.5. The vendor shall pay for the laboratory testing at a reference facility if the equipment requiring repair is inoperative due to malfunction through no fault or negligence of the facility for a total of more than 24 hours. Downtime for each incident shall start from the time the facility makes a bona fide attempt to contact the vendor’s designated representative until the analyzer is returned to good operating order.

5.6. In the event that the consumables are found to be defective and unsuitable for use with the vendor's equipment, or the vendor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the requesting facility, in the most expeditious manner possible, without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal Government test load volume).

5.7. Vendor will pay all routine shipping fees for all supplies, consumables, and equipment to perform testing.

5.8. The vendor must provide replacement parts at no charge and any components necessary for the operation of the instrument(s) to produce patient results.

5.9. The vendor’s technical service representatives must comply with the facility’s requirements for onsite vendor representatives. This may require a low risk background investigation by federal authorities paid for by the vendor.

6. TRAINING AND PROCEDURES:

6.1. Vendor must provide all education/training on site during installation or update to the equipment. Training to include staff on all requested shifts. Training must include basic operation, quality control, interpretation, and reporting of results, required user performed maintenance, and troubleshooting. Vendor must provide a documented record of training (training checklist) completed for all trained staff before leaving site following installation at the site.

6.2. The vendor shall provide initial in-depth training for two key operators. Key operator training is to include all costs of off-site training, i.e., transportation (air and ground), room and board, etc.

6.3. The vendor shall provide on-site refresher instrument training in renewal option years of the contract if so exercised.

6.4. Vendor must supply all necessary procedure manuals, troubleshooting manuals, operator manuals, and SDSs (also available on CD format or on-line). Procedures must be in the Clinical and Laboratory Standards Institute (CLSI) format. Vendor must provide assistance in creating preventive maintenance and quality control records or logs to meet the needs of the facility.

7. OTHER TERMS AND CONDITIONS:

7.1. Vendor shall specify calibration frequency, time required to perform calibration and any specific steps that must be followed prior to calibration.

7.2. Vendor shall state if the instrument paper is included in the consumable parts.

7.3. Vendor shall provide documented evidence confirming the system design removes the possibility of any sample carryover.

7.4. The vendor shall list the frequency and the supplies needed to check the pipetting mechanism of the instrument.

7.5. The vendor shall list all of the reagents/supplies needed for testing, state if the reagents/supplies are stored at room temperature or refrigerated, state if the reagent/supplies are color-coded and state the size of the kit (as it relates to the amount of storage space required for a quarterly shipment).

7.6. The vendor is to define the actual hands on maintenance time required for daily, weekly, monthly, quarterly, and as needed maintenance. The vendor is to include the analyzer/technologist time required to perform each maintenance task. The vendor shall list which tasks are user level and which tasks are service level.

7.7. The vendor shall list analyzer/utility requirements (electrical, water, plumbing, reagent and bio-hazardous disposal, etc.).

7.8. The vendor shall provide weight and dimensions of proposed analyzer. Footprint of system should be small and fit on a typical laboratory counter top.

7.9. The vendor shall indicate any routine and/or special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: paper, printer cartridges, drainage systems, surge suppressors, UPS, etc. Any items excluded by the vendor shall be delineated in their proposal. The cost of the excluded items must be incorporated in the price proposal.

7.10. Provide information if the system has a data management system that allows the user to monitor and analyze data and quality control. System includes flags for unusual results and failed quality control.

7.11. The vendor shall indicate if electronic operating manuals and troubleshooting guide as well as a preventive maintenance guide and log are provided to the labs.

ATTACHMENT A

Estimated Volume by Test

Please see Attachment A Test List BioRad BioPlex 36C26026Q0167 for list of tests and prices.

SECTION A – REQUIRED FAR PROVISIONS, AS APPLICABLE

A.1 52.212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)

INFORMATION SECURITY LANGUAGE

The C&A requirements do not apply, and a Security Accreditation Package is not required.

The following solicitation provisions apply to this acquisition:

FAR 52.212-1, “Instructions to Offerors–Commercial Products” ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL “System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.”

SUBMISSION INSTRUCTIONS

1. Contract Type: FAR 12 Indefinite Delivery Indefinite Quantity Contract.

2. Evaluation: The ordering activity shall evaluate all responses received using the evaluation criteria provided to the scheduled contractors. The ordering activity is responsible for considering the level of effort and the mix of labor proposed to perform a specific task being ordered, and for determining that the total price is reasonable. Place the order with the schedule contractor that represents the best value. After award, ordering activities should provide timely notification to unsuccessful offerors. If an unsuccessful offeror requests information on an award that was based on factors other than price alone, a brief explanation of the basis for the award decision shall be provided.

3. Responsive and Responsible: A Quoter will be selected that is deemed responsive and responsible in accordance with the Federal Acquisition Regulation (FAR) 9.104-1 and whose quote conforms to the RFQ’s requirements.

4. SAM Registration: Quoter must be registered in the System for Award Management (SAM). No contract will be entered into with an unregistered Contractor. Internet access allows registration by completing an electronic on-line registration application at https://www.sam.gov/. Ensure that your registration is current and ensure that the applicable NAICS code (325413 In-Vitro Diagnostics Substance Manufacturing) is included in the SAM profile prior to submission of quote.

5. Questions: Submit solicitation questions via email to hector.gonzalez1@va.gov with Subject Line: 36C26026Q0167 Questions. Questions are due by December 19th, 17:00 Hours Pacific Time. Telephonic questions will not be accepted.

6. Quotation Submission Checklist:

6.1 Specific Instructions: Submit quotations via email to hector.gonzalez1@va.gov with Subject: 36C26026Q0167. All quotes shall be legible and prepared in the format referenced below in Parts I thru V below.

______Part I EXECUTED REQUEST FOR QUOTATIONS: Quoter shall complete blocks 17a (in block 17a include company name, address, phone number, corresponding Dun and Bradstreet number, and Tax ID Number), 30a, 30b, and 30c, on SF 1449, which is Page 3 of this Document. Quoter must acknowledge any Amendments that may be issued.

_______Part II TECHNICAL: Quoter must meet or exceed the standards listed in the Statement of Work (SOW) _______Part III PRICE: Quoter must submit their price quote. All prices shall be represented in two decimal positions only. Example: $0.27, not $0.27458.

Note: Quantities listed are estimated and does not commit the Government to that quantity. The Contractor shall invoice only for services/products requested by the Government and provided by the Contractor.

(End of Addendum to 52.212-1)

A.2 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):

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html http://www.va.gov/oal/library/vaar/index.asp

“System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.”

A.3 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) The Government may 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. In accordance with FAR 9.104-2, the special standards of responsibility described below apply to this procurement. Offerors who fail to meet any special standards of responsibility will not be eligible to receive contract award. The following factors shall be used to evaluate offers:

Special Standards of Responsibility: (Per FAR 9.104-2) The following special standards of responsibility apply to this procurement:

1. The candidates must comply with the technical requirements established in the Statement of Work in this document pages 3 through 9.

2. Price – The price will be evaluated based on the total of all contract line items, including option years. A price will be determined reasonable if, in its nature or amount, it does not exceed what would be incurred by a reasonably prudent person. Adherence to the technical requirements in compliance with the Statement of Work and meeting the special standards is more important than price. Any offer not meeting these standards will not be evaluated for price.

(b) 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 offeror'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.

All Service-Disabled Veteran Owned Businesses or Veteran Owned Businesses must be registered/certified with the U.S Small Business Administration at Veteran Small Business Certification Veteran Small Business Certification (sba.gov).

SECTION B

The following contract clauses apply to this acquisition:

FAR 52.212-4, “Contract Terms and Conditions–Commercial Products” (OCT 2018) ADDENDUM to FAR 52.212-4 – The following clauses are included as a part of the addendum:

http://www.acquisition.gov/far/index.html (FAR) http://www.va.gov/oal/library/vaar/index.asp (VAAR)

B.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/

B.2 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025) (DEVIATION)

(a) Definitions. As used in this clause— American Security Drone Act-covered foreign entity means an entity included on a list that the Federal Acquisition Security Council (FASC) develops and maintains and publishes in the System for Award Management (SAM) at https://www.sam.gov (section 1822 of Pub. L. 118-31, 41 U.S.C. 3901 note prec.).

Backhaul means intermediate links between the core network, or backbone network, and the small subnetworks at the edge of the network (e.g., connecting cell phones/towers to the core telephone network). Backhaul can be wireless (e.g., microwave) or wired (e.g., fiber optic, coaxial cable, Ethernet).

Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.

Covered article, as defined in 41 U.S.C. 4713(k), means:

(1) Information technology, as defined in 40 U.S.C. 11101, including cloud computing services of all types;

(2) Telecommunications equipment or telecommunications service, as those terms are defined in section 3 of the Communications Act of 1934 (47 U.S.C. 153);

(3) The processing of information on a Federal or non-Federal information system, subject to the requirements of the Controlled Unclassified Information program (see 32 CFR part 2002); or

(4) Hardware, systems, devices, software, or services that include embedded or incidental information technology.

Covered foreign country means The People’s Republic of China.

Covered telecommunications equipment or services means—

(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities);

(2) For the purpose of public safety, security of Government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities);

(3) Telecommunications or video surveillance services provided by such entities or using such equipment; or

(4) Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a covered foreign country.

Critical technology means—

(1) Defense articles or defense services included on the United States Munitions List set forth in the International Traffic in Arms Regulations under subchapter M of chapter I of title 22, Code of Federal Regulations;

(2) Items included on the Commerce Control List set forth in Supplement No. 1 to part 774 of the Export Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations, and controlled—

(i) Pursuant to multilateral regimes, including for reasons relating to national security, chemical and biological weapons proliferation, nuclear nonproliferation, or missile technology; or

(ii) For reasons relating to regional stability or surreptitious listening;

(3) Specially designed and prepared nuclear equipment, parts and components, materials, software, and technology covered by part 810 of title 10, Code of Federal Regulations (relating to assistance to foreign atomic energy activities);

(4) Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal Regulations (relating to export and import of nuclear equipment and material);

(5) Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9 of such Code, or part 73 of title 42 of such Code; or

(6) Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control Reform Act of 2018 (50 U.S.C. 4817).

FASC-prohibited unmanned aircraft system means an unmanned aircraft system manufactured or assembled by an American Security Drone Act—covered foreign entity.

FASCSA order means any of the following orders issued under the Federal Acquisition Supply Chain Security Act (FASCSA) requiring removing covered articles from executive agency information systems or excluding one or more named sources or named covered articles from executive agency procurement actions, as described in 41 CFR 201-1.303(d) and (e):

(1) The Secretary of Homeland Security may issue FASCSA orders that apply to civilian agencies, to the extent not covered by paragraph (2) or (3) of this definition. This type of FASCSA order may be referred to as a Department of Homeland Security (DHS) FASCSA order.

(2) The Secretary of Defense may issue FASCSA orders that apply to the Department of Defense (DoD) and national security systems other than sensitive compartmented information systems. This type of FASCSA order may be referred to as a DoD FASCSA order.

(3) The Director of National Intelligence (DNI) may issue FASCSA orders that apply to the intelligence community and sensitive compartmented information systems, to the extent not covered by paragraph (2) of this definition. This type of FASCSA order may be referred to as a DNI FASCSA order.

Information technology, as defined in 40 U.S.C. 11101(6)—

(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a contractor under a contract with the executive agency that requires the use—

(i) Of that equipment; or

(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;

(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but

(3) Does not include any equipment acquired by a Federal contractor incidental to a Federal contract.

Intelligence community, as defined by 50 U.S.C. 3003(4), means the following—

(1) The Office of the Director of National Intelligence;

(2) The Central Intelligence Agency;

(3) The National Security Agency;

(4) The Defense Intelligence Agency;

(5) The National Geospatial-Intelligence Agency;

(6) The National Reconnaissance Office;

(7) Other offices within the Department of Defense for the collection of specialized national intelligence through reconnaissance programs;

(8) The intelligence elements of the Army, the Navy, the Air Force, the Marine Corps, the Coast Guard, the Federal Bureau of Investigation, the Drug Enforcement Administration, and the Department of Energy;

(9) The Bureau of Intelligence and Research of the Department of State;

(10) The Office of Intelligence and Analysis of the Department of the Treasury;

(11) The Office of Intelligence and Analysis of the Department of Homeland Security; or

(12) Such other elements of any department or agency as may be designated by the President or designated jointly by the Director of National Intelligence and the head of the department or agency concerned, as an element of the intelligence community.

Interconnection arrangement means arrangements governing the physical connection of two or more networks to allow the use of another’s network to hand off traffic where it is ultimately delivered (e.g., connecting a customer of telephone provider A to a customer of telephone company B) or sharing data and other information resources.

Kaspersky Lab-covered article means any hardware, software, or service that—

(1) Is developed or provided by a Kaspersky Lab-covered entity;

(2) Includes any hardware, software, or service developed or provided in whole or in part by a Kaspersky Lab-covered entity; or

(3) Contains components using any hardware or software developed in whole or in part by a Kaspersky Lab-covered entity.

Kaspersky Lab-covered entity means—

(1) Kaspersky Lab;

(2) Any successor entity to Kaspersky Lab, including any change in name, e.g., “Kaspersky”;

(3) Any entity that controls, is controlled by, or is under common control with Kaspersky Lab; or

(4) Any entity of which Kaspersky Lab has a majority ownership.

National security system, as defined in 44 U.S.C. 3552, means any information system (including any telecommunications system) used or operated by an agency or by a contractor of an agency, or other organization on behalf of an agency—

(1) The function, operation, or use of which involves intelligence activities; involves cryptologic activities related to national security; involves command and control of military forces; involves equipment that is an integral part of a weapon or weapons system; or is critical to the direct fulfillment of military or intelligence missions, but does not include a system that is to be used for routine administrative and business applications (including payroll, finance, logistics, and personnel management applications); or

(2) Is protected at all times by procedures established for information that have been specifically authorized under criteria established by an Executive order or an Act of Congress to be kept classified in the interest of national defense or foreign policy.

Roaming means cellular communications services (e.g., voice, video, data) received from a visited network when unable to connect to the facilities of the home network either because signal coverage is too weak or because traffic is too high.

Sensitive compartmented information means classified information concerning or derived from intelligence sources, methods, or analytical processes, which is required to be handled within formal access control systems established by the Director of National Intelligence.

Sensitive compartmented information system means a national security system authorized to process or store sensitive compartmented information.

Source means a non-Federal supplier, or potential supplier, of products or services, at any tier.

Subsidiary means an entity in which more than 50 percent of the entity is owned directly by a parent corporation or through another subsidiary of a parent corporation.

Substantial or essential component means any component necessary for the proper function or performance of a piece of equipment, system, or service.

Unmanned aircraft means an aircraft that is operated without the possibility of direct human intervention from within or on the aircraft (49 U.S.C. 44801(11)).

Unmanned aircraft system means an unmanned aircraft and associated elements (including communication links and the components that control the unmanned aircraft) that are required for the operator to operate safely and efficiently in the national airspace system (49 U.S.C. 44801(12)).

(b) Prohibitions on providing or using specific products or services in performance of contract. Unless a waiver or exception applies, the Contractor is prohibited from providing any products or services to the Government or using in the performance of the contract any of the following:

(1) A covered application on any information technology owned or managed by the Government, or on any information technology used or provided by the Contractor under this contract, including equipment provided by the Contractor’s employees (section 102 of Division R of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328));

(2) A Kaspersky Lab-covered article (Section 1634 of Division A of the National Defense Authorization Act for Fiscal Year 2018 (Pub. L. 115-91));

(3) Covered telecommunications equipment or services used as a substantial or essential component of any system, or as critical technology as part of any system (paragraphs (a)(1)(A) of section 889 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232)). This does not prohibit contractors from providing—

(i) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Prohibition on unmanned aircraft systems manufactured or assembled by American Security Drone Act—covered foreign entities.

(1) Prohibition. The Contractor is prohibited from—

(i) Delivering any FASC-prohibited unmanned aircraft system, which includes unmanned aircraft (i.e., drones) and associated elements (sections 1823 and 1826 of American Security Drone Act of 2023, within the National Defense Authorization Act for Fiscal Year 2024, Pub. L. 118-31, Div. A, Title XVIII, Subtitle B, 41 U.S.C. 3901 note prec.);

(ii) On or after December 22, 2025, operating a FASC-prohibited unmanned aircraft system in the performance of the contract (section 1824 of Pub. L. 118-31); and

(iii) On or after December 22, 2025, using Federal funds to procure or operate a FASC-prohibited unmanned aircraft system (section 1825 of Pub. L. 118-31).

(2) Procedures. The Contractor shall search SAM for the FASC-maintained list of American…