36C25626Q0232.docx

STATEMENT OF WORK

GENERAL INFORMATION

Network Contracting Office 16 5075 Westheimer Road, Suite 750

Houston TX 77056-5643

POINT OF CONTACT*

Contract Specialist Rhonda Gibson rhonda.gibson2@va.gov 832-352-2915

ADDITIONAL INFORMATION

DESCRIPTION

The National Contracting Office No. 16 intends to negotiate a sole source, firm-fixed priced Contract for a period of base plus four years with a large business, Roche Diagnostic Corporation, 9115 Hague Road, Po Box 50457, Indianapolis, IN 46256-1025 The Contractor shall provide ImmunoHistoChemical (IHC) and compatible Special Stain (SS) Reagents for Roche UltraPlus (IHC) and Ventana BenchMark (SS) Stainers at the Overton Brooks VA Medical Center (OBVAMC), Pathology and Laboratory Medicine Service, Anatomic Pathology Section, Room 2E14, 510 E. Stoner Ave, Shreveport, LA 71101 in accordance with the attached Draft Statement of Work (SOW). Roche Diagnostic Corporation is the sole manufacturer for all Advanced Staining VENTANA instrumentation, reagents, and ancillaries. The Contractor shall provide the required supplies and associated accessories in accordance with the Draft SOW to fulfill this requirement for the Pathology and Laboratory Medicine Service, Anatomic Pathology Section, Room 2E14, 510 E. Stoner Ave, Shreveport, LA 71101.

Responses are due from 12-10-2025 at 10:00AM CST. All questions due 8 Dec 2025 at 10:00AM CST Special Notice Special Notice Please review all attached documents

Special Notice

Fax Number:

1. Contract Title Anatomic Pathology Diagnostic Staining Instrumentation Reagents, Related Stains, Consumables, and Service.

2. Objective.

The overall purpose is to provide ImmunoHistoChemical (IHC) and compatible Special Stain (SS) Reagents for Roche UltraPlus (IHC) and Ventana BenchMark (SS) Stainers at the Overton Brooks VA Medical Center (OBVAMC), Pathology and Laboratory Medicine Service, Anatomic Pathology Section, Room 2E14, 510 E. Stoner Ave, Shreveport, LA 71101. The instruments and reagents are required to perform specialized diagnostic stains on patient tissue samples and must meet stringent quality control and compliance standards.

3. Background.

Pathology and Laboratory Services has a requirement for a service agreement for a Ventana/Roche IHC system of instruments (Contractor Furnished Equipment (CFE)), supplies, and reagents for a Base Year and four (4) additional One (1) Year options (exercisable at the discretion of the Government). These reagents are essential to the OBVAMC pathology and diagnostics of patient care. The OBVAMC pathology uses these reagents to provide accurate and efficient diagnoses using formalin fixed, paraffin embedded (FFPE) preserved tissue samples, providing critical information about the specific biomarker’s expression in patient care. These IHC reagents include primary and secondary antibodies ready to use (RTU), which bind specifically to target antigens and detection systems that amplify the signal from the primary antibody. This requirement was previously performed on Ventana BenchMark Special Stain and Leica Bond III instruments. These systems have been in use at OBVAMC since October 2012 and there is a continued, continuous need to provide this diagnostic service.

Ventana Medical Systems, Inc., is dba. as the Roche Diagnostics Corporation, is the sole manufacturer for all Advanced Staining VENTANA instrumentation, reagents, and ancillaries.

All VENTANA detection reagents, ancillaries, antibodies, and probes are developed and validated for exclusive use on the fully automated VENTANA BenchMark IHC/ISH slide staining systems. VENTANA detection reagents (bulk solutions and detection kits) are compulsory elements for the operation of the UltraPlus (IHC) and BenchMark (SS) slide staining systems and cannot be substituted.

4. Scope.

4.1. The contractor shall provide the instruments (Contractor Furnished Equipment (CFE)), reagents, and supplies in support of support histological and cytological testing as well as an annual maintenance and service contract for the BenchMark Special Stain and ULTRA-PLUS instruments through the Reagent Acquisition Program (RAP) with Contractor Furnished Equipment (CFE). The Contractor shall be able to provide all reagents listed in Attachment A Ordering of reagents will be done on an as need basis dependent on the individual diagnostic need of a particular patient with shipments delivered within at least 5 business days. The Anatomic Supervisor will place the order with Roche based on reagent usage and need.

Automatically stain histologic sections of formalin-fixed, paraffin-embedded (FFPE) specimens on microscope slides.

4.2. Fully automated process of baking, deparaffinization, and staining.

4.3. Barcoded slides and reagents.

4.4. Instrument Manager Maintenance & Support.

4.5. Professional Services include:

A. Installation:

i. Inspection and placement of instrumentation.

ii. Establish installation project plan and timeline.

iii. Run quality checks of instrumentation systems

B. Staff Training:

i. Assist customers to use instrumentation controllers for proper use.

ii. Assist customer with preparation of test builds for validation of reagents.

iii. Provide staff training on the proper use of the instrument, including reagent management, use and monitoring.

iv. Provide staff training on appropriate instruments, maintenance and management allowing for appropriate use.

v. Assist with troubleshooting as necessary while the customer executes their validation plan for all tests performed.

vi. Assist customer with migration of testing protocols from old to new staining instrumentation.

5. Specific Tasks.

5.1. THE VENDOR SHALL AND MUST PROVIDE THE FOLLOWING:

A. The Contractor shall provide fully automated slide staining instrumentation for special stain and immunohistochemical stains.

B. The Contractor shall provide all proprietary bulk reagents, ready to use (RTU) antibodies and staining kits necessary for completion of the requested testing protocols and FDA compliance.

C. The Contractor shall provide that all proprietary ordered items above (bullet point “B”) have an expiration date of no less than 18 months beyond the date they are shipped from the vendor.

D. The Contractor shall provide and install operational updates as they become available and upgrades as warranted, including but not limited to the control module, printer, hardware, and instrumentation as necessary for proper operation during diagnostic testing cycles.

E. The Contractor shall assist the customer with configuration of the current testing protocols performed on existing instrumentation for optimization and validation on the new instrumentation.

F. The Contractor shall format the barcodes as requested by the customer.

G. The Contractor shall provide extended technical overview and training on the proper use and maintenance of the instrumentation.

H. The Contractor shall assist and train staff with troubleshooting problems as necessary while the customer executes their optimization and validation of established staining protocols on the new instruments.

I. The Contractor shall train staff regarding daily, weekly, monthly and as needed preventive maintenance in accordance with the manufacturer’s standards.

J. The Contractor shall service agreement with timely repair service and support of the equipment, within two-hour telephone call back service and replacement parts as needed.

K. The Contractor shall provide 24/7 phone technical support for the instrumentation.

5.2. INSTRUMENTATION SALIENT CHARACTERISTICS

A. Shall perform fully automated onboard baking, deparaffinization, cell conditioning (retrieval), reagent titration and counter staining of slides as determined by the selected staining protocol.

B. Shall perform various staining procedures at 100% instrument efficiency if staining 1 slide.

C. Shall allow and provide a means for the use of third party immunohistochemical antibodies on the instrumentation D. The special staining (ss) instrumentation must not exceed 30” in width and the IHC/ISH instrumentation must not exceed 60” in width.

E. One computer controller must control both instruments performing the requested staining protocols.

F. The special staining instrument must be compatible with our current inventory of established staining reagents and protocols.

G. SS - Individual slide staining to eliminate cross-contamination H. SS - Automated baking through staining, with ready-to-use reagents I. SS - Automation and minimal daily maintenance J. SS - Automated baking, deparaffinization, and staining, combined with ready-to-use reagent kits K. SS - 25 reagent positions and 20 individual slide positions with independent slide heat L. SS and IHC - Flexible and customizable staining protocols that allow assays to be optimized to suit pathologist’s preference.

M. SS and IHC - Individual slide heating, vortex mixing, and liquid coverslip N. SS & IHC - Independent slide heating to eliminate temperature-dependent batching.

O. SS & IHC - Barcoded kit components to enable automated reagent auditing and ensure adequate supply and valid expiration dates.

P. SS & IHC - Delayed start capability Q. SS & IHC - Bulk fluid volume sensing to detect waste fluid levels.

R. SS & IHC - Automatic locking of the hood to prevent accidental opening of the hood during staining.

S. IHC and ISH slide processing with 30 independent slide positions and 35 reagent positions T. IHC Turnaround time of up to 90 slides in eight hours U. IHC - Floor model with two 20-liter waste bottles V. IHC - Seven different bulk reagents with internal reservoirs and external bulk bottles W. IHC - Random processing to stain any slide with any process, independently.

X. IHC - Continuous processing to add new slides and remove completed ones, without interrupting the processing of other slides still in progress Y. IHC -Independent drawers for:

i. Add new orders when drawers are available

ii. Remove slides upon completion

iii. Initiate a new run while other slides are still processing Z. IHC - Color-coded slide drawers AA. IHC - Slide status lights – Real-time visualization of slide status AB. IHC - Case identification

5.3. INSTRUMENT DELIVERABLES AND REAGENTS

A. New Instruments - Contractor Furnished Equipment (CFE)

i. One (1) BenchMark ULTRA-PLUS

ii. One (1) BenchMark Special Stains Full B. Trade-In Instrument

i. One (1) BenchMark Special Stains C. Reagent Acquisition Program

i. See Attachment

ii. Reagents/supplies to be ordered and shipped as needed.

iii. Instruments are Contractor Furnished Equipment (CFE).

D. Primary staining reagents shall be prepackaged, ready-to-use and barcoded in the vendor dispenser for quick use and comprehensive quality control and require no titration.

Item No.

Description of Equipment or Supplies (Base plus four years)

5.4. ESTIMATED QUANTITIES

Based on historical data taken from our current instrumentation, we have performed 866 special stain and 6,565 immunohistochemical (IHC) staining procedures between January 1, 2023, and July 1, 2025. Overton Brooks VAMC Pathology and Laboratory Medicine Service attempts to be as accurate as possible when providing estimates of quantities that will be used, however, actual quantities required may vary from quantities as listed based on the needs of a particular patient.

5.5. CUSTOMER SERVICE

There shall be 24 hours / 7 days per week / 365 days per year phone support available for technical support. If resolution cannot be obtained by phone support, then a service technician shall be dispatched to the facility no more than 24 hours later to resolve the issue.

5.6. EQUIPMENT MANUAL(S)

The Contractor shall furnish User Manuals and Reference Guides for the instrumentation once installation is complete and prior to training staff.

5.7. WARRANTY AND REPAIR SERVICE

A. Maintenance: The contractor shall perform preventative maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance includes the following:

i. Inventory and recording of systems components.

ii. Monthly deliverables shall be received in full.

iii. Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer’s specifications.

iv. After Preventative Maintenance (PM), the contractor shall submit a detailed work report for notice at no additional cost to the government.

v. Delivery of PM parts or materials: the contractor shall provide all preventative service materials at no additional cost to the government.

B. Repairs and support

i. Technical support: Support Personnel will be available by telephone from 08:00 to 17:00 each business day.

ii. On site repairs: Contractor will dispatch on-site support personnel within 24 business hours of determining that phone support is insufficient to correct problem. After repair, the contractor shall submit a detailed work report to include all required materials at no charge to the facility.

iii. For the delivery of repair parts or materials, the contractor shall provide all parts and materials at no additional cost to the government.

iv. Contractor shall remove all parts, equipment or materials replaced, or upgraded by the contractor due to, but not limited to, repairs, replacements, recall, and upgrades without any cost to the government.

6. Training:

The contractor will provide (on-site, off-site) training for appropriate operation and maintenance of their instrumentation.

7. Safety:

Contractor shall immediately notify the service of any changes in reagents, kit composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulation.

8. Reagent Performance:

All reagents, procedures, and equipment must perform at manufacturer specifications. Deviations from the performance specifications shall be corrected by the contractor.

8.1. All reagent performance will be evaluated by and not limited for performance thru peer comparison, quality control, and College of American Pathology CAP peer evaluation. The Contractor shall provide warranty coverage for all repairs and maintenance that will ensure high-quality, stained slide production and the instrumentation to perform at the expected standards for the duration of the contract award and elected option years.

8.2. PRODUCT QUALITY AND GOVERNMENT ACCEPTANCE TEST

All products offered to Overton Brooks VAMC, Pathology and Laboratory Medicine Service shall be new and not refurbished and be of the same consistent high quality as would be offered to the general commercial public in the United States. The products made available for use on the instrument provided by the vendor shall have no less than a two-year expiration date from the time of order until the time of expiration.

8.3. ORDERING PROCEDURES

Orders will be made on an as needed basis determined by Overton Brooks VA Medical Center’s Pathology and Laboratory personnel. The order shall be invoiced for payment no more than 60 days after the purchased date.

8.4. PRODUCT SUBSTITUTION

No product substitutions will be accepted without the prior approval of the Overton Brooks VA Medical Center’s Pathology and Laboratory Service and the Contracting Officer. Any substitutions of product shall have the written approval of the VAMC Pathology & Laboratory Service and the Contracting Officer or his/her designee.

8.5. CHANGES / MODIFICATIONS

If any product awarded under this requirement requires modification, is removed or recalled by the Contractor or manufacturer, or if any required modification, removal or recall is suggested or mandated by a regulatory or official agency, the following steps will immediately be taken by the Contractor or manufacturer:

A. Notify the Contracting Officer, in writing, by the most expeditious manner possible. Provide two copies of the notification which shall include, but not be limited to the following:

i. Complete item description and/or identification, order numbers from customers, and the contract number assigned as a result of an award on this Statement of Work.

ii. Reasons for modifications, removal or recall.

iii. Necessary instructions for return for credit, replacement or corrective action.

B. Provide the above information to all agencies and VA Facilities who purchased the product. The Contracting Officer Representative shall be provided with a copy of the notification in ii. above, and a list of all agencies and/or VA facilities notified.

C. Contractor shall be responsible for any costs associated with the above.

Changes in the terms and conditions of this contract may be made only by written agreement of Overton Brooks VA Medical Center Pathology and Laboratory Service. Any and all modifications for changes in the prices, terms or conditions of this contract, shall be prepared for signature by the VA Contracting Officer.

8.6. RECALLED AND DEFECTIVE PRODUCTS

The Contractor shall immediately notify the Contracting Officer Representative of any recalls of product or other important product safety issues. The Contractor shall replace and/or reimburse recalled/defective products at no cost to the Government. The Contractor shall be liable for the costs of processing recalls, i.e., administrative, and clinical services to replace recalled/defective products.

8.7. DELIVERY

All test kits shall be delivered to:

Overton Brooks VA Medical Center Attn: Warehouse 510 E. Stoner Ave Shreveport, LA 71101 All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain vendor’s name, purchase order number, date of order, date of delivery, itemized list of products furnished including product description and quantity shipped.

Shipping terms: Prepaid and add; FOB Distribution

8.8. SITE CONDITIONS

A. There shall be no smoking, eating, or drinking inside the Laboratory at any time.

B. Business Hours: All work and delivery shall take place during clinical hours (Monday through Friday, 8:00 am to 4:30 pm (CST) excluding weekends and federal holidays).

C. FEDERAL HOLIDAYS ARE: New Year’s Day; Martin Luther King Jr.’s Birthday; President’s Day, Memorial Day, Juneteenth, Independence Day; Veteran’s Day; Labor Day; Columbus Day; Thanksgiving Day, and Christmas Day. When a holiday falls on a Sunday, the following Monday will be observed as a legal holiday. When a holiday falls on a Saturday, the preceding Friday is observed by the US government agencies.

D. Use of Cell Phones: The use of cellular phones is permitted within certain areas of the medical center. All contractors are required to ask either the Contracting Officer (CO) or the Contracting Officer’s Representative (COR) if there is doubt in the usage of cellular phones.

E. Smoke Free Facility: The Overton Brooks VA Medical Center is a smoke free facility. Smoking is prohibited inside any building and on the facility grounds. Violators shall be removed from the premises permanently.

8.9. PROTECTION OF PROPERTY

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

8.10. OPERATOR TRAINING

The purpose of this contract is to establish a means to secure the necessary consumables for continued patient sample processing for an accurate diagnosis without excessive delay using our current instruments. There are no new instruments or processes that require staff training. The vendor will provide on-site and off-site training to staff for proper operation and maintenance of the instrumentation.

9. Performance Monitoring.

The performance of the vendor will be monitored by the PLMS Pathologists’ Assistant based on the following criteria:

A. Ability of the vendor to consistently provide technical support of requests in a timely manner.

B. Ability of the vendor to execute deliverables stated in scope and specific tasks.

C. Ability of the vendor to repair and maintain instruments, keeping them operational and functioning properly.

10. Security Requirements.

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 VA-approved 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.

11. PRODUCT INTEGRITY, AUTHENTICITY, PROVENANCE, ANTI-COUNTERFEIT AND ANTI-TAMPERING.

This entire section applies when the acquisition involves any product (application, hardware, or software) or when section 6 or 7 is included.

a. The contractor shall comply with Code of Federal Regulations (CFR) Title 15 Part 7, “Securing the Information and Communications Technology and Services (ICTS) Supply Chain”, which prohibits ICTS Transactions from foreign adversaries. ICTS Transactions are defined as any acquisition, importation, transfer, installation, dealing in or use of any information and communications technology or service, including ongoing activities, such as managed services, data transmission, software updates, repairs or the platforming or data hosting of applications for consumer download.

b. When contracting terms require the contractor to procure equipment, the contractor shall purchase or acquire the equipment from an Original Equipment Manufacturer (OEM) or an authorized reseller of the OEM. The contractor shall attest that equipment procured from an OEM or authorized reseller or distributor are authentic. If procurement is unavailable from an OEM or authorized reseller, the contractor shall submit in writing, details of the circumstances prohibiting this from happening and procure a product waiver from the VA COR/CO.

c. All contractors shall establish, implement, and provide documentation for risk management practices for supply chain delivery of hardware, software (to include patches) and firmware provided under this agreement. Documentation will include chain of custody practices, inventory management program, information protection practices, integrity management program for sub-supplier provided components, and replacement parts requests. The contractor shall make spare parts available. All contractor(s) shall specify how digital delivery for procured products, including patches, will be validated and monitored to ensure consistent delivery. The contractor shall apply encryption technology to protect procured products throughout the delivery process.

d. If a contractor provides software or patches to VA, the contractor shall publish or provide a hash conforming to the FIPS Security Requirements for Cryptographic Modules (FIPS 140-2 or successor).

e. The contractor shall provide a software bill of materials (SBOM) for procured (to include licensed products) and consist of a list of components and associated metadata which make up the product. SBOMs must be generated in one of the data formats defined in the National Telecommunications and Information Administration (NTIA) report “The Minimum Elements for a Software Bill of Materials (SBOM).”

f. Contractors shall use or arrange for the use of trusted channels to ship procured products, such as U.S. registered mail and/or tamper-evident packaging for physical deliveries.

g. Throughout the delivery process, the contractor shall demonstrate a capability for detecting unauthorized access (tampering).

h. The contractor shall demonstrate chain-of-custody documentation for procured products and require tamper-evident packaging for the delivery of this hardware.

12. VIRUSES, FIRMWARE AND MALWARE.

This entire section applies when the acquisition involves any product (application, hardware, or software) or when section 6 or 7 is included.

a. The contractor shall execute due diligence to ensure all provided software and patches, including third-party patches, are free of viruses and/or malware before releasing them to or installing them on VA information systems.

b. The contractor warrants it has no knowledge of and did not insert, any malicious virus and/or malware code into any software or patches provided to VA which could potentially harm or disrupt VA information systems. The contractor shall use due diligence, if supplying third-party software or patches, to ensure the third-party has not inserted any malicious code and/or virus which could damage or disrupt VA information systems.

c. The contractor shall provide or arrange for the provision of technical justification as to why any “false positive” hit has taken place to ensure their code’s supply chain has not been compromised. Justification may be required, but is not limited to, when install files, scripts, firmware, or other contractor-delivered software solutions (including third-party install files, scripts, firmware, or other software) are flagged as malicious, infected, or suspicious by an anti-virus vendor.

d. The contractor shall not upload (intentionally or negligently) any virus, worm, malware or any harmful or malicious content, component and/or corrupted data/source code (hereinafter “virus or other malware”) onto VA computer and information systems and/or networks. If introduced (and this clause is violated), upon written request from the VA CO, the contractor shall:

1) Take all necessary action to correct the incident, to include any and all assistance to VA to eliminate the virus or other malware throughout VA’s information networks, computer systems and information systems; and

2) Use commercially reasonable efforts to restore operational efficiency and remediate damages due to data loss or data integrity damage, if the virus or other malware causes a loss of operational efficiency, data loss, or damage to data integrity.

13.Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

No GFE/GFI shall be provided to the contractor.

14. Other Pertinent Information or Special Considerations.

The vendor shall have the proprietary access codes associated with the requested instrumentation needed to perform service and maintenance on the administrator level.

8.3. INSPECTION AND ACCEPTANCE CRITERIA

A review of the vendor’s credentials will be reviewed prior to finalization of the award for consumables and services.

15. SDS, Hazardous Materials and Waste Analysis.

The Contractor is required to provide a list identifying any “hazardous materials” defined as Hazardous under the latest version of Federal Standard No. 313 that may be provided as a part of this contract. Safety Data Sheets (SDS) shall be submitted for all products.

The Contractor will provide a complete chemical analysis of waste, to include Mercury, sodium azides, carcinogens, reproductive toxins, acute toxins and all other waste that may be considered ignitable, corrosive, reactive or toxic.

The Contractor will also be required to provide additional subsequent waste analysis studies in the case of any new test or new test formation introductions. Documentation of all analysis will be provided to the VA Contracting Officer for review by the VISN 16 Green Environmental Management Systems (GEMS) Coordinator prior to contract award or introduction of new product after award.

16.Risk Control.

All employees, contractors, and visitors are required to abide by local infection control procedures.

17. Place of Performance. The agreement is for the purchase of this staining instrumentation, ancillary items, and continued customer support is based on a Reagent Rental agreement for 1 base year followed by 4 option years upon adequate vendor performance and will be reviewed annually by Overton Brooks VA Medical Center Contracting Office at minimum of thirty days prior to the anniversary date.

Period of performance shall be:

Base Year: January 1, 2026, through December 31, 2026 Option Year 1: January 1, 2027, through December 31, 2027 * Option Year 2: January 1, 2028, through December 31, 2028 * Option Year 3: January 1, 2029, through December 31, 2029 * Option Year 4: January 1, 2030, through December 31, 2030 * *Denotes: Exercisable at the discretion of the Government and availability of funds.

Working hours are between 8:00a.m. – 4:30p.m., Monday through Friday. All federal holidays excluded.

The VA follows all Federal holidays that are set by law (USC Title 5 Section 6103).

The Government hereby provides notice, and Contractor hereby acknowledges receipt that Government personnel observe the listed days as holidays:

In addition to the days designated as holidays, the Government observes the following days:

1. Any other day designated by Executive Order.

2. Any other day designated by the President’s Proclamation; and

3. Any other day designated by Federal Statute.

Place of Performance Overton Brooks VA Medical Center (OBVAMC) 510 E. Stoner Ave, Shreveport, LA 71101 POC: Laboratory Manager: Michael Salinas, 318-990-5482/Pathologists’ Assistant: Anthony Tanner, 318-990-5331 Email: anthony.tanner@VA.GOV

Delivery and installation will be coordinated through the COR and/or the Laboratory Manager, or Pathologists’ Assistant.

18. Equipment Delivery Schedule.

The contract is to reestablish the consumables for use with the Benchmark Special Stain Instrument, reagents, related stains, consumables, and the service contract. This contract shall be used by the laboratory to purchase reagents as needed for continued patient care and to allow oversight for proper inventory of needed consumables. All consumables shall be shipped as deemed appropriate by the manufacturer as to not interfere with the accuracy of diagnostic staining results. Items must be shipped same day when orders are placed before 3 pm EST, Monday through Thursday. Orders should not be shipped when the delivery date would fall on a weekend or Federal observed holiday. The vendor shall notify Contract Officer Representative or designated staff member when orders are not available for delivery as previously described at which time an alternate delivery will be negotiated.

19. List of Kits and Estimated Annual Quantities.

Variable based on the diagnostic needs of the individual patient. Price list submitted as a separate attachment.

20. INVOICE AND PAYMENT

Contractor shall invoice the Overton Brooks VA Medical Center in arrears only after acceptance of all Deliverables identified in this Statement of Work. Invoice shall be properly prepared and sent to the:

VA Financial Service Center P.O. Box 149971 Austin, Texas 78714-8971 The invoice shall be properly prepared in accordance with FAR 52.212-4, contain sufficient details, and at a minimum, include the following details:

1) IFCAP Obligation Number

2) Contract Number

3) Description of the supply/service rendered

4) Billing period/date when the supply/services were rendered and

5) Invoice number and date Payments will be made in accordance with the Prompt Payment Act out of the Government annual appropriated funds obligated in an order which will be issued after the contract is awarded.

Note: Invoices that are not in compliance with the aforementioned requirements under this paragraph will be rejected for payments and required to be resubmitted.

END OF STATEMENT

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