36C25626Q1228.pdf

PAGE 1 OF1. 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

36C25626Q1228 08-18-2026

William Shaver 601-362-4471 08-24-2026

07:00 CDT

36C256 Department of Veterans Affairs Network Contracting Office 16

715 South Pear Orchard Road Ridgeland MS 39157

X

334516

1000 Employees

N/A

X

00586

Department of Veterans Affairs G.V. (Sonny) Montgomery VAMC

1500 E. Woodrow Wilson Drive Jackson MS 39216

10N16

Department of Veterans Affairs Network Contracting Office 16

715 South Pear Orchard Road Ridgeland MS 39157

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 invoice must be submitted electronically

1-877-489-6135

See CONTINUATION Page

This is a solicitation for commercial supplies prepared in accordance with the format in RFO FAR 12.2, as supplemented with additional information included in this notice.

See Price/Cost Schedule, Statement of Work, Addendum to FAR 52.212-1 Instructions to Offerors-Commercial Products and Commercial Services, and 52.212-2 Evaluation-Commercial Products and Commercial Services.

Submit all question to William.Shaver@va.gov. All questions must be submitted by 08/19/2026, at 09:30 CDT.

Due to the urgency of this requirement, time extensions will not be provided.

See CONTINUATION Page

X X

X 1(One)

36C25626Q1228

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.1 PRICE/COST SCHEDULE

ITEM INFORMATION

B.2 DELIVERY SCHEDULE

B.3 STATEMENT OF WORK

1.0 PURPOSE

2.0 SCOPE

3.0 SALIENT CHARACTERISTICS

c. Aerobic & Anaerobic Database, Mycobacteria Database, Filamentous Fungi Database, Bioterrorism Database

4.0 DELIVERY AND INSTALLATION a. DELIVERY

b. INSTALLATION

5.0. INSPECTION AND ACCEPTANCE

6.0. DELIVERABLES

7.0 OPERATOR TRAINING

8.0 PROTECTION OF PROPERTY

9.0 SECURITY REQUIREMENTS

10.0 WARRANTY

7. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE OR USE. This entire section

9. PRODUCT INTEGRITY, AUTHENTICITY, PROVENANCE, ANTI-COUNTERFEIT AND

ANTI-

13. SPECIALIZED DEVICES/SYSTEMS (MEDICAL DEVICES, SPECIAL PURPOSE

SYSTEMS,

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

C.2 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS

(DEVIATION APR 2026)

C.3 52.223-23 SUSTAINABLE PRODUCTS (NOV 2025) (DEVIATION)

C.4 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.5 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

E.2 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS- COMMERCIAL PRODUCTS and COMMERCIAL SERVICES

E.3 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.4 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021)

E.5 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (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: ___________________ Phone: _____________________ Email: ______________________ DUNS Number: ______________ Tax ID Number: ______________

b. GOVERNMENT: William Shaver, Contract Specialist

Department of Veterans Affairs Network Contracting Office 16 715 South Pear Orchard Road Ridgeland MS 39157 E-mail: William.Shaver@va.gov

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] After acceptance of all items.

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.

Invoicing shall be in accordance with the requirements of The Department of Veterans Affairs (VA) Financial Services Center (VAFSC). The latest information shall be used for invoicing and payments and may change during the Period of Performance of this acquisition. Current Invoicing information is located at http://www.fsc.va.gov/einvoice.asp

5. SECURE FAX: Please review VA Handbook 6500 that requires the following statement on all fax cover sheets be included:

This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.

6. Mandatory written disclosures required by FAR clause 52.203-13 to the Department of Veterans Affairs, Office of Inspector General (OIG) must be made electronically through the VA OIG Hotline at https://www.va.gov/oig/hotline/ and clicking on "FAR clause 52.203-13 Reporting." If you experience difficulty accessing the website, call the Hotline at 1-800-488-8244 for further instructions.

7. The Contracting Officer will issue a post award orientation letter (in lieu of a conference) for contract orientation purposes in accordance with FAR 42.504.

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

AMENDMENT NO DATE

(End of B.1 Contract Administration Information)

B.1 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVIC

ES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1.00 EA _____________

BD BRUKER MALDI BIOTYPER SIRIUS ONE SYSTEM in accordance with the Statement of Work.

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

LOCAL STOCK NUMBER: 1890233

0002 1.00 EA _____________

HIGH SPEED MIRCOCENTRRIFUGE 12 PLACE ROTO in accordance with the Statement of Work.

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

LOCAL STOCK NUMBER: CHC1612

GRAND TOTAL _____________

B.2 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION

QUANTIT

Y

DELIVERY

DATE

0001 1.00 Please See

SOW

0002 1.00 Please See

SOW

B.3 STATEMENT OF WORK

Statement of Work Bruker MALDI Biotyper Sirius CA System

G.V. “Sonny” Montgomery V.A. Medical Center Jackson, MS 39216

1.0 PURPOSE

a. The G.V. “Sonny” Montgomery V.A. Medical Center (GVSMVAMC) Pathology and Medicine

Laboratory Service requires a capital purchase of a brand name Bruker MALDI Biotyper Sirius CA System or equivalent to support clinical microbial identification through Matrix Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry technology (MALDI- TOF mass spec).

b. The instrument must meet all performance, regulatory, IT security, installation, warranty, and integration requirements defined in this Statement of Work. This system will significantly decrease the time needed to identify pathogenic organisms and allow more efficient and effective patient treatment.

2.0 SCOPE

a. The Contractor shall provide, transport, deliver, install, and fully test the Bruker MALDI

Biotyper Sirius CA System or equivalent and all associated components. All products must meet all salient characteristics defined in this statement of work.

b. The Contractor shall furnish all supplies, equipment, facilities and services necessary for complete delivery, installation, and operational readiness of the system.

c. The Contractor shall provide all required parts, accessories and any other items/peripherals required for the successful operation of the analyzer.

d. The Contractor shall provide all shipping, transport, installation services, reagents, and products necessary to test and verify proper system performance.

e. All equipment, installation, and performance specifications must comply with manufacturer requirements, VA requirements, and regulatory standards including CLIA and CLSI for accuracy, precision, and analytical performance.

f. All reagents, consumables, calibrators, controls, and related materials required for use with the analyzer must be available for purchase and FDA‑cleared and suitable for clinical MALDI‑TOF microbial identification workflows.

g. The system shall support validated workflows for routine identification of bacteria, yeast, and other clinically relevant organisms.

h. The Contractor shall provide software compliant with 21 CFR Part 11, supporting secure, auditable, and regulated data handling.

i. The Contractor is responsible for providing any missing parts or components required for complete installation and operation, even if not explicitly listed in the purchase order.

j. The Contractor shall include all hardware, software, accessories, reagents, controls, calibration materials, and consumables required to establish full operation and complete system validation to include the required mini centrifuge with the following characteristics or compatible:

I. Parameter: 15,500 rpm, 16,100 g II. Feature: Incremental 100 rpm 100 rcf, timer 20 sec to 99 min, to hold 12 1.5/2.0 mL tubes, 12 sec acceleration; 10 sec deceleration.

III. Dimensions – 10.6 in.(27cm) x 8.7 in. (22 cm.) x 5.9 in. (15 cm) IV. Weight- 10.5 lb.

(4.8 kg)

3.0 SALIENT CHARACTERISTICS

a. Technical Requirements:

Matrix Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry Analyzer.

Bruker MALDI Biotyper Sirius CA System or equivalent product. The instrument, associated workflow software (including MBT Compass HT CA or equivalent), and FDA‑cleared reference database must have FDA 510(k) clearance for clinical identification of microorganisms (bacteria/yeasts/anaerobes) using MALDI‑TOF. Provide FDA 510(k) numbers and Indications for Use (e.g., Bruker MBT‑CA K130831; MBT Compass HT CA/FAST Shuttle K251495) or equal.

I. The Mass Spectrometer instrument shall be supplied with the necessary starter kit materials and equipment needed to use Matrix Assisted Laser Desorption Ionization - Time of Flight (MALDI-TOF) Mass Spectrometry (MS) to measure unique protein signatures or molecular fingerprints of microorganisms for organism identification. Linear-mode MALDI Time-of-Flight Mass Spectrometer.

II. The instrument shall perform rapid (within minutes) identification of clinically significant gram positive and gram negative aerobic and anaerobic bacteria, yeasts, and other filamentous fungi isolated from human specimens using MALDI-TOF technology.

III. The system shall have a streamlined workflow which requires only a few simple steps to generate high quality microorganism identification.

IV. The Vendor shall ensure the system being offered is in current production as of July 2026. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer is being manufactured as new equipment. Discontinued models and parts that are only being made available as remanufactured equipment shall not be acceptable.

V. The system and database including aerobic gram positive and gram-negative organisms, yeasts and anaerobic organisms, shall have FDA 510(k) clearance. IVD‑cleared system and database for aerobic gram‑positive and gram‑negative organisms, anaerobes, and yeasts; identification outside IVD scope must be explicitly flagged as RUO and not used for patient care.

VI. The system shall allow for full sample traceability using uniquely barcoded disposable or nondisposable target slides and software-based guidance to identify organisms.

VII. The system shall have a database which includes ASM and CLSI clinically relevant organisms to include aerobic and anaerobic gram-positive and gram-negative bacteria, mycobacteria, filamentous fungi, and bioterrorism organisms.

VIII. The system shall have software which automates the process of acquiring mass spectrum and performing database matching. Audit trails, access controls, and e‑signature/record features shall support 21 CFR Part 11 compliance in regulated workflows.

IX. The system shall use a superior pattern matching approach based on true statistical multi-variant analysis to ensure the highest possible level of accuracy and reproducibility.

X. The system shall have a database where organisms that are identified in the research use only ROU mode.

XI. The system shall generate reports with easy to interpret identification results and with an explanation of result acceptability by confidence value or scoring.

Audit trails, access controls, and e‑signature/record features shall support 21 CFR Part 11 compliance in regulated workflows.

XII. The Vendor shall provide upgrades to both the equipment, hardware and software in order to maintain the integrity of the system and the state-of-the-art technology at no additional cost to the Government. These updates shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, including database upgrades, correction of hardware defects, upgrades offered to commercial customers at no additional charge, upgrades to replace model of equipment that is no longer Vendor supported, etc.

XIII. Characterization of hazardous waste - The Contractor shall provide a statement and description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations that addresses the elements and criteria listed in the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et al. The description shall address the following:

1. Waste toxicity (Reference 40CFR261.11 and 40CFR261.24)

2. Waste ignitability (Reference 40cfr261.21)

3. Waste corrosivity (Reference 40CFR261.22)

4. Waste reactivity (Reference 40CFR261.23)

5. Hazardous waste from non-specific sources (F-listed) Reference

40CFR261.31)

6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference

40CFR261.33)

b. Software to support instrument automation and organism identification.

I. The system must include MBT

Compass HT CA software II. Full IVD microorganism identification workflow support.

III. FDA 21 CFR Part 11 compliance-supporting functionality.

IV. Secure‑Software Attestation: “For software developed or major‑version‑changed after Sept 14, 2022, the producer shall submit the OMB M‑22‑18 secure software attestation (SSDF), per

OMB M‑23‑16 timelines; where attestation is not immediately available, provide POA&M. Include SBOM consistent with NTIA minimum elements.

c. Aerobic & Anaerobic Database, Mycobacteria Database, Filamentous Fungi Database, Bioterrorism Database

I. The system must Produce accurate microorganism identification results comparable to CAP peer group standards.

II. Provide FDA 510(k) summary or acceptance letter for the knowledge base version proposed. d. Operational Requirements:

I. The system must require minimal daily/weekly maintenance due to automated source cleaning. II. The system must support high-throughput and rapid workflow for 24/7 laboratory operations.

III. The system must provide traceable calibration and quality control materials meeting CLSI and CAP standards.

IV. The vendor must supply MALDI Biotyper Sirius CA System User Manual (Operational, Technical, and Maintenance Manuals)

V. On-site training at no cost for 3 key operators and VA technical staff.

VI. Contractor shall provide on‑site training for at least three operators. Optional off‑site course seats may be included; all training costs must be part of the contract price (no vendor‑funded travel/meals outside the contract). Any off‑site training requires CO approval and scheduling within 6 months of installation.

VII. 1-year warranty on the entire system, where service is available 7 days a week, 24 hours per day.

VIII. Extended warranty or Service Agreement for two years

e. Vendor must supply Color Printer and UPS

I. Printer & UPS must comply with VA IT baseline and Section 508 documentation requirements.

4.0 DELIVERY AND INSTALLATION a. DELIVERY

I. The Contractor shall deliver all equipment/analyzer and accessories to G.V

(Sonny) Montgomery VA Medical Center, Microbiology Department, Basement Level, Room F-47, 1500 E Woodrow Wilson Ave, Jackson, MS 39216.

II. Deliver materials in manufacturer’s original sealed containers with brand name marked thereon.

III. Package to prevent damage or deterioration during shipment, handling, storage, and installation. Maintain protective covering in place and in good condition until removal is necessary.

IV. Deliver analyzer and specified items only when the site is ready for installation work to proceed. V. Store products in dry condition inside enclosed facility.

VI. Any Government requested delayed delivery up to 90 days after initial award delivery date, shall be at no additional cost to the Government.

VII. A pre-delivery meeting will be conducted 30-60 days ARO for verification of delivery and installation dates.

VIII. Delivery and Installation will be coordinated through the COR or designated personnel.

Instrumentation shall be delivered to the requesting facility no later than 90 days ARO.

IX. The Contractor shall conduct a joint inspection with the COR or designated personnel.

upon delivery of the equipment.

b. INSTALLATION I. All equipment shall be mounted by Contractor upon deliver unless otherwise noted above.

II. Install all equipment to manufacturer’s specifications maintaining Federal, and

Local safety standards.

III. Installation must be completed on the date scheduled. All work shall be completed between 8:00 a.m. and 4:30 p.m. Monday-Friday. All federal holidays, excluded. Federal holidays are available at the Federal Holiday OPM Site.

IV. If there is an operational conflict with installation, night or weekend installation may be required. Government will provide a 72 hours’ notice of installation hours.

V. The Contractor shall coordinate all deliveries, staging areas, installations, and parking arrangements with the COR or designated personnel.

VI. The Contractor shall remove all related shipping materials, debris, and cleanup any construction associated with delivery and installation of the specified items.

Contractor shall remove all packaging from the GVSMVAMC premises after installation of the instrument.

The Contractor shall be responsible for any damage to the building that occurs due to Contractor’s error or neglect. VII. Equipment must pass BioMed inspection prior to installation. c. SITE CONDITIONS

I. There shall be no smoking, eating or drinking inside the Microbiology laboratory at any time.

5.0. INSPECTION AND ACCEPTANCE

a. The Contractor shall conduct a joint inspection with the COR upon delivery.

b. The Contactor shall provide the VA COR a list of missing and damaged items found upon inspection and have those items replaced at no cost to the Government.

c. Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s)

d. The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the VA Contracting Officer.

6.0. DELIVERABLES

a. Operation and Maintenance Manuals:

I. The Contractor shall provide two sets of printed service, technical, operating manuals upon delivery and installation of equipment.

II. The Contractor shall provide two sets of digital service, technical, operating manuals upon delivery and installation of equipment.

III. The Contractor shall deliver a compilation of all manufacturer recommended maintenance schedules and operation materials packaged in binder(s) to COR upon completion of installation.

IV. The Contractor shall provide and deliver all clinical organisms, reagents, calibrators, controls, consumables, disposables items, parts, and accessories required to establish operation and perform all validation studies and method comparison studies. When shipping clinical organisms or materials, the contractor shall comply with 49 CFR 173.199 (UN 3373) triple packaging, marking, and training requirements and applicable IATA Infectious Substances Regulations. Provide proof of trained personnel (hazmat/infectious substances) and use compliant packaging for any Category B shipments.

7.0 OPERATOR TRAINING

a. The Contractor shall provide Vendor led, on-site, instrument training at the time of the instrument installation. This training shall include training of the all VA technical staff on the operation of the hardware and software systems, data manipulation, basic troubleshooting and repair, instrument validation and method comparison studies, as well as basic trouble shooting and repair. The contractor shall be responsible to ensure three VA key operators (Technical Staff) shall be fully trained and competent to operate and troubleshoot the analyzer system. All training costs must be part of the contract price (no vendor‑funded travel/meals outside the contract).

b. The Contractor shall install, test, train VA employees, and complete all quality assessment of the MALDI-TOF analyzer by March 2027. All work shall be completed between 8:00 a.m. and 4:30 p.m. Monday-Friday. All federal holidays, excluded.

Federal holidays are available at the Federal Holiday OPM Site.

c. The Contractor shall provide three training slots for off-site training on the MALDI-TOF instrument (or equivalent instrument) for three VA key Operators. Optional off‑site course seats may be included; all training costs must be part of the contract price (no vendor‑funded travel/meals outside the contract). Any off‑site training requires CO approval and scheduling within 6 months of installation.

d. The Contractor shall coordinate training so that it is timely to the equipment installation, be consistent with the size and scope of the facility’s services and be minimally equivalent to that offered in the commercial marketplace. The contractor will provide annual training for at least two VA operators per year or according to established FSS contract if applicable.

8.0 PROTECTION OF PROPERTY

a. The Contractor shall protect all items from damage. The Contractor shall take precaution against damage to the building(s), ground and furnishings. The Contractor shall repair or replace any items related to building(s) or grounds damaged accidently or on purpose due to actions by the Contractor.

b. The Contractor shall perform an inspection of the building (s) and grounds with the COR prior to commencing work, to ensure the Contractor shall be able to repair or replace any items, components, building(s) or grounds damaged due to negligence and/or actions taken by the Contractor. The source of all repairs beyond simple surface cleaning is the facility construction contractor (or appropriate subcontractor), so that building warranty is maintained. Concurrence from the VA Facilities Management POC and COR is required before the Contractor may perform any significant repair work. In all cases, repairs shall utilize materials of the same quality , size, texture, grade, and color to match adjacent existing work.

c. The Contractor shall be responsible for security of the areas in which the work is being performed.

d. The Contractor shall provide floor protection while working in all VA facilities. All material handling equipment shall have rubber wheels.

9.0 SECURITY REQUIREMENTS

a. The Certification & Accreditation (C&A) and Assessment & Authorization (A&A) leading to Authority to Operate (ATO) are required.

b. All software, electronic documentation, and support services shall conform to

Section 508 and 36 CFR 1194. Provide an Accessibility Conformance Report (VPAT/ACR) at proposal and updated with each major release.

c. The MALDI Biotyper system and vendor must meet all VA-mandated security and privacy controls, including but not limited to:

d. VA Directive 6500 and NIST 800-53 compliance. Compliance with NARA records management requirements. e. Required contractor cybersecurity training.

f. Return or destruction of all VA data at contract completion. VA retains all hard drives at end of equipment life.

g. Incident reporting within required timeframes. Media sanitization meeting NIST 800‑88 standards.

h. Return or destruction of all VA data at contract completion.

i. Complete VA Directive 6550 Pre‑Procurement Assessment and ERA (if applicable) prior to connection. Incorporate VAAR 839.101 cybersecurity clauses and the VA 6500 series as contract requirements

10.0 WARRANTY

a. The Contractor shall provide a one-year manufacturer’s warranty on all parts and labor.

b. The warranty shall include all travel and shipping costs associated with any warranty repair.

c. The Contractor shall provide standard warranty response on instrumentation, and software as required which shall include preventative maintenance during the warranty period.

d. The Contractor shall provide an enhanced warranty for an additional year which includes service seven days a week and twenty-four hours per day. This enhanced warranty shall include and cover all replacement parts, service fees, and travel and shipping costs associated with any warranty repair. Refurbished replacement parts are not acceptable;

only new replacement parts will be acceptable.

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION

INTO CONTRACTS

1. GENERAL. This entire section applies to all acquisitions requiring any Information

Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA

Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with

Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VAapproved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor shall not release VA records protected by Title

38 U.S.C. § 5705, Confidentiality of medical quality-assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with

National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA.The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO.

Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.)

used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance 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 shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance.

Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR

852.204-71(d);

Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S.

services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

e. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:

I. Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems.

II. Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.

III. Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company-owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

IV. Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

V. Contractor/subcontractor personnel have their authorization to work in the United States revoked.

VI. Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to):

removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA accesses will return VA-issued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO.

4. TRAINING. This entire section applies to all acquisitions which include section 3.

a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems: (1) VA Privacy and Information Security Awareness and Rules of Behavior course (Talent Management System (TMS) #10176) initially and annually thereafter.

(2) Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and

(3) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role-based information security training].

b. The contractor shall provide to the COR/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the required training is complete.

5. SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT’s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following:

(1) The date and time (or approximation of) the Security Incident occurred.

(2) The names of individuals involved (when applicable).

(3) The physical and logical (if applicable) location of the incident.

(4) Why the Security Incident took place (i.e., catalyst for the failure).

(5) The amount of data belonging to VA believed to have been compromised.

(6) The remediation measures the contractor is taking to ensure no future incidents of a similar nature.

c. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

d. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

e. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG, and the VA Office of Security and Law Enforcement.

The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

f. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.

g. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA.

h. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages—Reimbursement for Data Breach Costs.

6. INFORMATION SYSTEM DESIGN AND DEVELOPMENT. This entire section applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (to include the subcomponents of each) designed or developed for or on behalf of VA by any non-VA entity.

a. Information systems designed or developed on behalf of VA at non-VA facilities shall comply with all applicable Federal law, regulations, and VA policies. This includes standards for the protection of electronic Protected Health Information (PHI), outlined in 45 C.F.R. Part 164, Subpart C and information and system security categorization level designations in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems and FIPS 200, Minimum Security Requirements for Federal Information Systems. Baseline security controls shall be implemented commensurate with the FIPS 199 system security categorization (reference VA Handbook 6500 and VA Trusted Internet Connections (TIC) Architecture).

b. Contracted new developments require creation, testing, evaluation, and authorization in compliance with VA Assessment and Authorization (A&A) processes in VA Handbook 6500 and VA Information

Security Knowledge Service to obtain an Authority to Operate (ATO). VA Directive 6517, Risk

Management Framework for Cloud Computing Services, provides the security and privacy requirements for cloud environments.

c. VA IT contractors, subcontractors and third-party service providers shall address and/or integrate applicable VA Handbook 6500, VA Handbook 6517, Risk Management Framework for Cloud Computing Services and Information Security Knowledge Service specifications in delivered IT systems/solutions, products and/or services. If systems/solutions, products and/or services do not directly match VA security requirements, the contractor shall work though the COR/CO to identify the VA organization responsible for governance or resolution. Contractors shall comply with FAR 39.1, specifically the prohibitions referenced.

d. The contractor (including producers and resellers) shall comply with Office of Management and Budget (OMB) M-22-18 and M-23-16 when using third-party software on VA information systems or otherwise affecting the VA information. This includes new software purchases and software renewals for software developed or modified by major version change after the issuance date of M-22-18 (September 14, 2022). The term “software” includes firmware, operating systems, applications and application services (e.g., cloud-based software), as well as products containing software. The contractor shall provide a selfattestation that secure software development practices are utilized as outlined by Executive Order (EO)14028 and NIST Guidance. A third-party assessment provided by either a certified Federal Risk and Authorization Management Program (FedRAMP) Third Party Assessor Organization (3PAO) or one approved by the agency will be acceptable in lieu of a software producer's self-attestation.

e. The contractor shall ensure all delivered applications, systems and information systems are compliant with Homeland Security Presidential Directive (HSPD) 12…