RFQ 36C25726Q0079.pdf

PAGE 1 OF 31 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

36C25726Q0079 11-05-2025

Kathryn Prose (kathryn.prose@va.gov) (254) 217-2835 11-19-2025

1:00 PM EST

36C257 Department Of Veterans Affairs Network Contracting Office (NCO) 17 5441 Babcock Road Ste. 302 San Antonio TX 78240

X

325413

1250 Employees

N/A

X

36C740

Department of Veterans Affairs Texas Valley Coastal Bend Healthcare System Harlingen Health Care Center (HCC) 2601 Veterans Drive Harlingen TX 78229-4401

36C257

Department Of Veterans Affairs Network Contracting Office (NCO) 17

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

This solicitation is for the procurement of Linearity Material to support compliance testing for Roche COBAS Analyzers.

Technical questions regarding this solicitation are to be submitted in writing to Kathryn Prose, at kathryn.prose@va.gov, no later than 11/12/2025 at

1:00 PM CST.

Anticipated Period of Performance is 12/05/2025 to 12/04/2026

See B.2 for the Statement of Work (SOW) See E.2 Addendum to FAR 52.212-1 for Instructions to Offeror See E.3 for FAR 52.212-2 for evaluation criteria

See CONTINUATION Page

X X

X 1

36C25726Q0079

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

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

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (DEVIATION NOV

2025)

C.4 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.5 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 24

C.8 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.9 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

1998) E.2 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (SEP 2023) (DEVIATION AUG 2025) ... 27

E.3 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021) (DEVIATION AUG 2025)

E.4 52.225-4 BUY AMERICAN—FREE TRADE AGREEMENTS—ISRAELI TRADE

ACT CERTIFICATE (NOV 2023) ALTERNATE II (JAN 2025) (DEVIATION SEP 2025) 30

E.5 VAAR 852.273-70 LATE OFFERS (NOV 2021)

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: POC Name: _____________________________ Address: _______________________________ City/State/Zip: ___________________________ POC Phone: ____________________________ POC Email: _____________________________

b. GOVERNMENT: Contracting Officer 36C257

Department Of Veterans Affairs Network Contracting Office (NCO) 17

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Upon receipt and acceptance by the Government

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. This is accomplished through the Tungsten Network, located at:

http://www.fsc.va.gov/einvoice.asp. This is mandatory and the sole method for submitting invoices.

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

AMENDMENT NO DATE

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

B.2 STATEMENT OF WORK

1. Background. Many testing systems within Pathology and Laboratory Medicine Service

(P&LMS) require validation of the Analytical Measurement Range (AMR) for an analyte both initially and at least every six months thereafter. This can be accomplished through the procurement of linearity material that is both matrix specific and spans the range of the AMR for each analyte when required. This is addressed in 42 Code of Federal Regulation (CFR)

493.1255 (b), the College of American Pathologists (CAP) standard CHM.13600, AMR Verification, and The Joint Commission (TJC) standard, QSA.02.03.01, Calibration Verification.

2. Purpose. The overall purpose of this requirement is to procure linearity materials, which are not already provided through P&LMS Veterans Affairs Central Office (VACO) funding. This will ensure that all laboratory testing sites that perform patient testing, within the Veterans Affairs Texas Valley Coastal Bend Health Care System (VAVATVCBHCS), follow Veterans Health Administration (VHA) Handbook 1106.01, 42 CFR 493 Subpart H & K requirements, CAP accreditation standards, and TJC standards.

3. Locations. The linearity materials will be utilized for compliance testing in the P&LMS

Department of the VAVATVCBHCS, including Corpus Christi Specialty Clinic (CCSC), Harlingen Health Care Center (HCC), and McAllen Outpatient Clinic (MOC).

4. Shipping. The Government anticipates fuel surcharges under this effort. All mailed deliverables, which include linearity materials, shall be shipped Freight on Board (FOB) Destination (paid by contractor) The shipping costs must be included as part of the firm-fixed price for each line item. All supplies shall be shipped to the following address:

Harlingen Health Care Center (HCC) 2601 Veterans Drive Harlingen, TX 78550

5. Requirement.

a. The vendor must provide linearity kits that will support the Roche Cobas System to include cobas c303, cobas c503, cobas e402, and cobas e801.

b. The vendor must provide the linearity material that meets the analytical range described below. The vendor must provide pricing in their own kit configuration that will meet the requirement.

General Chemistry Test Name Range Annual Quantity

Albumin L0.20, H6.00 g/dL 10 Alkaline Phosphatase L5.00, H1200.00 U/L 10

ALT L5.00, H700.00 U/L 10

Ammonia L17.00, H1703.00 µg/dL 10 Amylase L3.00, H1500.00 U/L 10

AST L5.00, H700.00 U/L 10

Calcium L0.80, H20.10 mg/dL 10 Chloride L60.00, H140.00 mmol/L 10 Cholesterol L3.86, H800 mg/dL 10

CK L7, H2000 U/L 10

CO2 L2.00, H50.00 mmol/L 10 Creatinine L0.06, H30.50 mg/dL 10 CRP L3.4, H350.0 mg/L 10 Cystatin C L0.40, H6.80 mg/L 10 D-dimer L0.15, H9.0µg FEU/ml 10 Direct Bilirubin L0.20, H10.00 mg/dL 10 Direct LDL L3.86, H548.00 mg/dL 10 Ethanol L10.1, H498 mg/dL 10

GGT L3.00, H1200.00 U/L 10

Glucose L2.00, H750.00 mg/dL 10 HDL L3.09, H150.00 mg/dL 10 Iron L5.00, H1000.00 µg/dL 10 Lactic Acid L0.2, H15.5 mmol/L 10

LDH L10.00, H1000.00 U/L 10

Lipase L3.00, H300.00 U/L 10 Lithium L0.1, H3.0 mmol/L 10 Magnesium L0.5, H4.72 mg/dL 10 Phosphorus L0.31, H20.00 mg/dL 10 Potassium L1.50, H10.00 mmol/L 10 Procalcitonin L0.02, H100 ng/mL 10 PTH (not intact) L1.20, H5000.00 pg/mL 10 Sodium L80.00, H180.00 mmol/L 10 Total Bilirubin L0.15, H35.10 mg/dL 10 Total Protein L0.20, H12.00 g/dL 10 Triglycerides L8.85, H885.00 mg/dL 10 Urea Nitrogen L1.40, H112.00 mg/dL 10 Uric Acid L0.20, H25.00 mg/dL 10

Urine Chemistry Test Name Range Annual Quantity

Microalbumin L12.00, H400.00 mg/L 10 Urine Creatinine L1.10, H610.00 mg/dL 10 Urine Protein L4.00, H200.00 mg/dL 10

Immunoassay

B12 L150.00, H2000.00 pg/mL 6 Ferritin L 0.5, H2000.00ng/mL 6 Folate L2.00, H20.00 ng/mL 6 Free T4 L0.10, H7.77 ng/dL 6

Transferrin L10.00, H520.00 mg/dL 6 TSH L0.005, H100.00 uIU/mL 6 PSA L0.01, H100.00 ng/mL 6

Therapeutic Drug Monitoring

Carbamazepine L2.00, H20.00 µg/mL 4 Digoxin L0.30, H5.00 ng/mL 4 Phenobarbital L2.40, H60.00 µg/mL 4 Phenytoin L0.80, H40.00 µg/mL 4 Theophylline L0.80, H40.00 µg/mL 4 Valproic Acid L2.80, H150.00 µg/mL 4 Vancomycin L4.00, H80.00 µg/mL 6

Cardiac

Pro-BNP L36.00, H35000.00 pg/mlL 6 Hs-Troponin 1 L6.00, H10000.00 ng/L 6 CKMB L1.00, H300.00 ng/mL 6 Vitamin D L6.00, H120.00 ng/mL 6

Immunosuppressive Drug

Tacrolimus L0.75, H30 ng/mL 6

Reproductive Endocrinology

Testosterone L2.50, H1500.00ng/dL 6 HCG L1.0, H10,000.0mIU/mL 6

Serum Proteins

Complement C3 L4, H500 mg/dL 4 Complement C4 L2, H100 mg/dL 4 Rheumatoid Factor L10, H130 IU/mL 4

CCP L8, H500 U/L 4

c. The vendor must provide a mechanism to notify of any linearity material updates. The mechanism must include the capability to notify the Government Program Manager, Laboratory Manager, Quality Medical Technologist (QMT), and each laboratory point of contact (POC). Specific contact information will be provided after contract award.

d. The vendor must provide an established event calendar and/or scheduled shipping table that identifies the date each linearity is scheduled to be shipped to the laboratory. The shipping schedule must be at a minimum at six-month intervals and no sooner than each occurrence.

e. The vendor is to ensure that linearity materials are shipped at the proper temperature to ensure the viability of specimens when they arrive at the testing laboratory.

f. The vendor must have a mechanism that allows each laboratory to transmit linearity results electronically via a secured website or by facsimile.

g. The vendor must have a formal evaluation of the results for each test.

h. The vendor must have a plan for the replacement of defective or damaged linearity materials.

i. Provide a glossary of terms when technical terminology is used in a calibration/linearity verification kit.

j. Have an electronic method (i.e., website, fax, email) for receipt of VA-furnished correspondence. Contract prices should include any costs associated with electronic data transmission.

6. Deliverables. Mailed, Written Correspondence, Database Files.

a. All mailed deliverables, which include linearity materials, shall be shipped FOB Destination (paid by contractor) and shipped to the address in paragraph 4 of this SOW.

b. Written correspondence may be shipped FOB Destination (paid by the contractor) or delivered electronically to the Government Program Manager, QMT, Laboratory Manager, laboratory POC, and accrediting agency. The electronic format must mirror the contents of a paper format. Written or electronic correspondence must be sent for the following:

1) Linearity updates will be provided within 10 working days of the change.

2) Linearity manuals, catalogs, and event calendars (with shipping tables) will be made available to all the above parties within 10 working days of the award.

3) Linearity formal evaluation reports will be made available to all the above parties within 30 calendar days of the evaluation.

c. Database files (i.e., XML, Excel, HTML) shall be submitted to the Government Program

Manager, QMT, and laboratory POCs electronically.

1) Linearity ordering, shipping, pricing information (to include updates/changes), and cut-off dates shall be provided to the Government Program Manager, QMT, Laboratory Manager, and laboratory POC within 10 working days.

2) Summary/Confirmation of all order changes and a running balance report shall be provided monthly (30 calendar days) to the Government Program Manager and Laboratory Manager.

3) The contractor shall provide linearity performance data in both a paper format and XML format through a secure FTP server connection.

d. The contractor shall submit any required documentation to the laboratory’s accrediting organization using a format that is routinely accepted by the accrediting organization.

7. Authorized Ordering Offices. Orders will be made and managed by the Government

Program Manager. Any changes to the required linearity material must be made by contract modification through the Contracting Officer. The actual (running) balance will be reconciled between the contractor and the Government Program Manager as required.

8. Government Furnished Items.

a. Each VAVATVCBHCS Laboratory provides linearity testing results to the contractor via the electronic method(s) determined by the contractor.

b. The QMT will provide respective laboratory POC(s) and other demographics using forms provided by the contractor.

c. The Government Program Manager will provide contact information for the Laboratory

Manager post-award.

d. The Government Program Manager will provide the initial linearity material order in the format and period determined by the contractor, using the forms provided by the contractor.

e. The Government Program Manager will provide any order changes, via electronic transmission, within a week when needed.

9. Contractor Security Contract Requirements.

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

b. Access to VA Information and VA Information Systems

1) A contractor/subcontractor shall request logical (technical) or physical access to

VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

2) All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information.

The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

3) Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts.

The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

4) Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

5) The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

10. VA Information Custodial Language.

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in the performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractor’s/subcontractor’s information systems or media storage systems to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed by VA’s sanitization requirements. VA reserves the right to conduct on- site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures comply with VA directive requirements.

c. Before termination or completion of this contract, the contractor/subcontractor must not destroy information received from VA or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of the VA by a contractor/ subcontractor must be done by National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose, and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations, and policies. If Federal or VA information confidentiality and security laws, regulations, and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates are applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. NOTE: NO VA DATA OF ANY TYPE SHALL BE

TRANSFERRED FROM THE VA.

f. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

11. Information Systems Officer, Information Protection. The contractor will not have access to VA Desktop computers and will not have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

12. Privacy Officer. The contractor will not have access to protected Patient Health Information

(PHI) and will not have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses are de-identified.

13. Records Officer.

a. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a).

These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

b. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

c. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

d. VAVATVCBHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VATVCBHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VAVATVCBHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

e. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment are properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VATVCBHCS control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

f. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VATVCBHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VATVCBHCS policy.

h. The Contractor shall not create or maintain any records containing any non-public VATVCBHCS information that are not specifically tied to or authorized by the contract.

i. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

j. VATVCBHCS owns the rights to all data and records produced as part of this contract.

All deliverables under the contract are the property of the U.S. Government for which VATVCBHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

k. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

(End of Statement of Work)

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Pricing must be submitted on the offerors’ preferred quote form. Pricing must include Unit Price, Extended Price and Total Price.

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 LT _____________ ________________

General Chemistry Linearity Kits

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

0002 1.00 LT _____________

Urine Chemistry Linearity Kits

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

0003 1.00 LT _____________

Immunoassay Linearity Kits

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

0004 1.00 LT _____________

Therapeutic Drug Monitoring Linearity Kits

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

0005 1.00 LT _____________

Cardiac Linearity Kits

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

0006 1.00 LT _____________

Immunosuppressive Drug Linearity Kits

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic

Substance Manufacturing

0007 1.00 LT _____________

Reproductive Endocrinology Linearity Kits

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

0008 1.00 LT _____________

Serum Proteins Linearity Kits

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

GRAND

TOTAL

B.4 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001 SHIP

TO:

Department of Veterans Affairs Harlingen Health Care Center (HCC) 2601 Veterans Drive Harlingen, TX 78550

USA

1.00 LT Anticipated

12/05/2025 to 12/04/2026

FOB: DESTINATION

SECTION C - CONTRACT CLAUSES

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

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_252_2 and http://www.va.gov/oal/library/vaar/index.asp.

(End of Clause)

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE

(DEVIATION NOV 2025)

OCT 2018

52.209-6 PROTECTING THE GOVERNMENT'S INTEREST WHEN

SUBCONTRACTING WITH CONTRACTORS DEBARRED,

SUSPENDED, PROPOSED FOR DEBARMENT, OR

VOLUNTARILY EXCLUDED (DEVIATION NOV 2025)

JAN 2025

52.209-10

52.212-4

PROHIBITION ON CONTRACTING WITH INVERTED

DOMESTIC CORPORATIONS (DEVIATION NOV 2025)

CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEVIATION

AUG 2025)

NOV 2015

NOV 2023

52.219-4 NOTICE OF PRICE EVALUATION PREFERENCE FOR

HUBZONE SMALL BUSINESS CONCERNS (DEVIATION

SEP 2025)

OCT 2022

52.222-3 CONVICT LABOR JUN 2003

52.222-19 CHILD LABOR—COOPERATION WITH AUTHORITIES

AND REMEDIES (DEVIATION SEP 2025)

JAN 2025

52.222-36 EQUAL OPPORTUNITY FOR WORKERS WITH

DISABILITIES (DEVIATION SEP 2025)

JUN 2020

52.222-50 COMBATING TRAFFICKING IN PERSONS (DEVIATION

OCT 2025)

OCT 2025

52.223-23 SUSTAINABLE PRODUCTS AND SERVICES (DEVIATION

FEB 2025)

MAY 2024

52.225-3 BUY AMERICAN—FREE TRADE AGREEMENTS—ISRAELI

TRADE ACT ALTERNATE II (DEVIATION SEP 2025)

NOV 2023

52.226-8 ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT

MESSAGING WHILE DRIVING

MAY 2024

52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER—

SYSTEM FOR AWARD MANAGEMENT

OCT 2018

52.233-3 PROTEST AFTER AWARD (DEVIATION NOV 2025) AUG 1996

52.233-4

52.244-6

APPLICABLE LAW FOR BREACH OF CONTRACT CLAIM

(DEVIATION NOV 2025)

SUBCONTRACTS FOR COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES.(DEVIATION NOV 2025)

OCT 2004

OCT 2025

https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_252_2 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_252_2 http://www.va.gov/oal/library/vaar/index.asp

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within .

(End of Clause)

C.3 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (DEVIATION

NOV 2025)

(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 https://www.sam.gov/ 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 arrangements 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 Security Drone Act—covered foreign entities before proposing, or using in performance of the contract, any unmanned aircraft system. Also, the Contractor shall ensure any effort or expenditure associated with a FASC-prohibited unmanned aircraft system is consistent with a corresponding exemption, exception, or waiver determination expressly stated in the contract.

(3) Exemptions, exceptions, and waivers. The prohibitions in paragraph (c) of this clause do not apply where the agency has determined an exemption, exception, or waiver applies, and the contract indicates that such a determination has been made. See sections 1823 through 1825 and 1832 of Public Law 118-31 for statutory requirements pertaining to exemptions, exceptions, and waivers.

(d) Prohibition on using or providing specific products or services or conducting certain transactions regardless of connection to contract.

(1) Certain telecommunications and video surveillance equipment, systems, or services.

(i) Unless an applicable waiver has been issued by the Government, the Contractor cannot use any equipment, systems, or services that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system (paragraph (a)(1)(B) of section 889 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232)).

(ii) This prohibition applies to using covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. This does not prohibit the contractor from using—

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

(B) 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.

(2) Office of Foreign Assets Control Restrictions.

(i) Except as authorized by the Office of Foreign Assets Control (OFAC) in the Department of the Treasury, the Contractor shall not acquire, for use in the performance of this contract, any supplies or services if any proclamation, Executive order, or statute administered by OFAC, or if OFAC’s implementing regulations at 31 CFR chapter V, would prohibit such a transaction by a person subject to the jurisdiction of the United States.

(ii) Except as authorized by OFAC, most transactions involving Cuba, Iran, and Sudan are prohibited, as are most imports from Burma or North Korea, into the United States or its outlying areas.

(A) For lists of entities and individuals subject to economic sanctions, see OFAC’s List of Specially Designated Nationals and Blocked Persons at https://home.treasury.gov/policy-issues/financial-sanctions/specially-designated-nationals-and-blocked-persons-list-sdn-human-readable-lists.

https://home.treasury.gov/policy-issues/financial-sanctions/specially-designated-nationals-and-blocked-persons-list-sdn-human-readable-lists https://home.treasury.gov/policy-issues/financial-sanctions/specially-designated-nationals-and-blocked-persons-list-sdn-human-readable-lists https://home.treasury.gov/policy-issues/financial-sanctions/specially-designated-nationals-and-blocked-persons-list-sdn-human-readable-lists

(B) For more information about these restrictions, as well as updates, see OFAC’s regulations at 31 CFR chapter V and at https://home.treasury.gov/policy-issues/office-of-foreign-assets-control-sanctions-programs-and-information.

(C) To conduct electronic screens of potential parties to regulated transactions, see the consolidated screening list at…