RFQ 36C25725Q0871.pdf

PDF 880 KB Posted Sep 3, 2025

Attached to: 6550--Laboratory Linearity Kits
Solicitation number: 36C25725Q0871
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 17

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Written by GovTribe AI · Sep 3, 2025

This document is a Request for Quote (RFQ) 36C25725Q0871 issued by the Department of Veterans Affairs Veterans Health Administration for Linearity Material to support compliance testing for Roche COBAS Analyzers. The solicitation seeks to procure laboratory linearity kits for three healthcare facilities in Texas (Harlingen Health Care Center, Corpus Christi Specialty Clinic, and McAllen Outpatient Clinic), with a base year contract and four one-year option periods from November 1, 2025, to October 31, 2030.

The contract will cover multiple types of linearity kits including Chemistry/Lipid/Enzyme, Ligand Assay, Urine Chemistry, Therapeutic Drug Monitoring, and specialized tests such as Prostate-Specific Antigen, Vitamin D, and Cardiac markers. Vendors must provide ready-to-use kits compatible with specified instrumentation, meet analytical measurement range requirements, provide electronic result transmission, and submit formal evaluation reports. Quotes are due by September 23, 2025, at 12:00 PM CST, with submission required electronically via email. The procurement is classified under NAICS code 325413 and will be awarded through full and open competition as a Firm-Fixed Price contract.

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File	Type	Posted
36C25725Q0871 0003.pdf	PDF	Nov 3, 2025
RFQ 36C25725Q0871 0002.pdf	PDF	Oct 2, 2025
RFQ 36C25725Q0871 0001.pdf	PDF	Sep 23, 2025
36C25725Q0871_1.docx	DOCX document	Sep 3, 2025

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PAGE 1 OF 111 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

36C25725Q0871 09-03-2025

Kathryn Prose (kathryn.prose@va.gov) (254) 217-2835 09-23-2025

12:00 PM CDT

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

325413

1250 Employees

N/A

36C740

Department of Veterans Affairs Texas Valley Coastal Bend Healthcare System Harlingen Health Care Center (HCC) 2601 Veterans Drive Harlingen TX 78550

36C257

Department Of Veterans Affairs Network Contracting Office 17 5441 Babcock Road Ste. 302 San Antonio TX 78240

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.

This will be a Base Plus Four (4) Option Year contract with the anticipated Periods of Performance:

Base Year: 11/01/2025 to 10/31/2026 Base Year: 11/01/2026 to 10/31/2027 Base Year: 11/01/2027 to 10/31/2028 Base Year: 11/01/2028 to 10/31/2029 Base Year: 11/01/2029 to 10/31/2030

Technical questions regarding this solicitation are to be submitted in writing to Kathryn Prose, at kathryn.prose@va.gov, no later than 09/12/2025 at

10:00 AM CST.

See B.2 for the Statement of Work (SOW) See B.3 for Price/Cost Schedule See E.2 Addendum to FAR 52.212-1 for Instructions to Offeror See E.6 for FAR 52.212-2 for evaluation criteria

$0.00 See CONTINUATION Page

X X

X 1

36C25725Q0871

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 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025) (DEVIATION JUL 2025)

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 79

C.5 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.6 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.7 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

C.8 VAAR 852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899

(DEVIATION)(APR 2025)

C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.10 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 82

C.11 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.12 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)

E.3 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.5 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

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

SERVICES (NOV 2021)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION

FEB 2025)

E.8 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.9 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.10 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.11 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.12 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 5441 Babcock Road Ste. 302 San Antonio TX 78240

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 of Material

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 (VATVCBHCS), 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 VATVCBHCS, including Corpus Christi Specialty Clinic, Harlingen HCC, and McAllen Outpatient Clinic.

a. Harlingen Health Care Center (HCC), 2601 Veterans Drive, Harlingen, TX 78550 One (1) Cobas Pro and one (1) Cobas Pure

b. Corpus Christi Specialty Clinic, 205 S. Enterprize Parkway, Corpus Christi, TX 78405 One (1) Cobas C503

c. McAllen Outpatient Clinic, 901 E. Hackberry Ave., McAllen, TX 78503 One (1) Cobas Pure and one (1) Cobas C303

4. Requirement.

a. Provide the following specimens or materials for the Cobas Pure and Pro in quantities listed in the schedule.

1) Chemistry/Lipid/Enzyme. Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Calcium, Chloride, Cholesterol, CK, CKMB, CO2, Creatinine, Direct Bilirubin, GGT, Glucose, HDL, Iron, LDH, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Bilirubin, Total Protein, Triglycerides, Urea Nitrogen, Uric Acid, Ethanol, Ammonia, Lactate, Lithium, D-dimer, Procalcitonin, Lactic Acid, PTH (not intact), Cystatin C, LDL.

2) Ligand Assay. B12, Folate, TSH, Ferritin, Free T4, Transferrin

3) Urine Chemistry. Uric Acid, Chloride, Ethanol, Glucose, Potassium, Sodium, Urine

Total Protein, Urine Urea Nitrogen, Calcium, Creatinine, Magnesium, Phosphorus

4) Prostate-Specific Antigen. PSA

5) Therapeutic Drug Monitoring. Carbamazepine, Digoxin, Phenobarbital, Phenytoin, Theophylline, Valproic Acid, Vancomycin

6) Reproductive Endocrinology. Testosterone

7) Cardiac. Pro-BNP, HS-Troponin T

8) Vitamin D

9) Immunosuppressive Drug. Tacrolimus

10) Urine Albumin. Microalbumin, Amylase, Pancreatic Amylase

11) Serum Proteins. Complement C3, Complement C4, Rheumatoid Factor, CCP

b. Include a mechanism for the contractor to notify the following in the VATVCBHCS System: TVCBHCS Contract Officer Representative (COR), TVCBHCS Laboratory Manager, TVCBHCS Quality Medical Technologist (QMT), and each laboratory point of contact (POC) of any linearity updates.

c. Include a contractor-established event calendar and/or scheduled shipping table that identifies the date each linearity is scheduled to be shipped to the laboratory.

VATVCBHCS requests at the minimum at six-month intervals and no sooner than each occurrence.

d. The contractor 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.

e. Have a mechanism that allows each laboratory to transmit linearity results electronically via a secured website or by facsimile.

f. Include a formal evaluation of the results for each test.

g. Provide a plan for the replacement of defective or damaged linearity materials.

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

i. 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.

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

a. All Mailed deliverables, which include linearity materials, shall be shipped Freight on Board (FOB) Destination (paid by contractor) and shipped directly to the performing laboratory.

b. Written correspondence may be shipped FOB Destination (paid by the contractor) or delivered electronically to the COR, 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 COR, QMT, and laboratory POCs electronically.

1) Linearity ordering, shipping, pricing information (to include updates/changes), and cut-off dates shall be provided to the COR, 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 COR 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.

6. Shipping. The Government anticipates fuel surcharges under this effort to perform the tasks associated with the effort through the period of performance. Include all estimated fuel surcharge costs in your firm-fixed-price line items. These costs will not be directly reimbursed by the Government. All supplies shall be shipped to the following address:

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

7. Authorized Ordering Offices. Orders for all individual VATVCBHCS laboratories, will be made and managed by the Contracting Officers Representative (COR). Modifications to linearity material can be made during the course of the contract. The actual (running) balance will be reconciled between the contractor and the COR every month.

8. Government Furnished Items.

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

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

c. The COR will provide contact information for the Laboratory Manager post-award.

d. The COR 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 COR 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 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. TVCBHCS 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 TVCBHCS 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 TVCBHCS. 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 TVCBHCS 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 TVCBHCS 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 TVCBHCS policy.

h. The Contractor shall not create or maintain any records containing any non-public TVCBHCS 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. TVCBHCS 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 TVCBHCS 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

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0.00

Harlingen VA Clinic Linearity Kits Contract Period: Base POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

MANUFACTURER PART NUMBER (MPN): ______________

0001AA

2.00 KT __________________ __________________

DIRECT LDL

0001AB

PTH

0001AC

1.00 KT __________________ __________________

CCP

Contract Period: Base POP Begin: 11-01-2025

POP End: 10-31-2026 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 0001AE

D-DIMER CVLD

CHEMISTRY/LIPID/ENZYME CVL

THERAPEUTIC DRUG MONITORING CVL

LIGAND ASSAY CVL

URINE CHEMISTRY CVL

IMMUNOLOGY CALIBRATION VERIFICATION / LINEARITY

REPRODUCTIVE ENDOCRINOLOGY CVL

SERUM ETHANOL CVL

C-REACTIVE PROTEIN CVL

URINE ALBUMIN CVL

PROSTATE-SPECIFIC ANTIGEN CVL

B-TYPE NATRIURETIC PEPTIDE CVL

IMMUNOSUPPRESSIVE DRUGS CVL

AMMONIA CVL

Contract Period: Base POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 0001AS

VITAMIN D CVL

PROCALCITONIN CVL

HIGH-SENSITIVITY TROPONIN T CVL

CYSTATIN C CVL

THYROID PANEL CVL

Contract Period: Base

POP End: 10-31-2026

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, McAllen Outpatient Clinic Linearity Kits

BLOOD GAS/CRITICAL CARE CVL LN13C

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 0002AE

URINE CHEMISTRY CVL

REPRODUCTIVE ENDOCRINOLOGY CVL

Contract Period: Base POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

0002AN

Contract Period: Base POP Begin: 11-01-2025 POP End: 10-31-2026

PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 0002AS

Contract Period: Base

POP End: 10-31-2026

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 0003AC

POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 0003AH

Contract Period: Base POP Begin: 11-01-2025 POP End: 10-31-2026 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Contract Period: Option 1 POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 1001AA

PTH

Contract Period: Option 1 POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

1001AG

Contract Period: Option 1 POP Begin: 11-01-2026 POP End: 10-31-2027

PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 1001AL

Contract Period: Option 1 POP Begin: 11-01-2026 POP End: 10-31-2027

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 1001AQ

Contract Period: Option 1

POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 1001AV

Contract Period: Option 1 POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Contract Period: Option 1 POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 1002AA

PTH

Contract Period: Option 1 POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing

1002AG

Contract Period: Option 1 POP Begin: 11-01-2026 POP End: 10-31-2027

PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 1002AL

Contract Period: Option 1 POP Begin: 11-01-2026 POP End: 10-31-2027

PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 1002AQ

POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, 1003AA

Contract Period: Option 1 POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6550 - In…

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