S02 - PET Infusion System - IC - 36C26326Q0883.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C263-26-AP-2606

636-26-3-4154-0146

36C26326Q0883 07-06-2026

Dennis Salmonsen 916-923-4508 07-10-2026

17:00

36C568

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

VA BLACK HILLS HCS FORT MEADE CAMPUS

113 COMANCHE RD

FORT MEADE SD 57741

X

334517

1200 Employees

N/A

** SEE DELIVERY LOCATION BELOW **

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

VA BLACK HILLS HCS FORT MEADE CAMPUS

113 COMANCHE RD

FORT MEADE SD 57741

FMS-VA-2(101)

FINANCIAL SERVICES CENTER

PO BOX 149971

AUSTIN TX 78714-9971

See CONTINUATION Page

** SEE SECTION PRICE/COST SCHEDULE **

Quotes shall be submitted to Dennis Salmonsen at dennis.salmonsen@va.gov by: See Block 8

NOTE 1: Offers shall follow the submission instructions specified in FAR Provisions 52.212-1 and 52.212-2, and their addendums included in this solicitation. Failure to follow the instructions shall result in an unfavorable evaluation.

See CONTINUATION Page x (1)

Dennis Salmonsen

VA-VHA-RPOC-2025-0018

36C26326Q0883

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 52.212-4 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 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.4 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.5 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.7 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.8 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

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.3 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (OCT 2025) (DEVIATION)

E.4 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.5 52.225-4 BUY AMERICAN—FREE TRADE AGREEMENTS—ISRAELI TRADE ACT

CERTIFICATE (DEVIATION) (NOV 2025)

E.6 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

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:

b. GOVERNMENT: Contracting Officer 36C263 Dennis Salmonsen

NETWORK CONTRACTING OFFICE 23

VA BLACK HILLS HCS FORT MEADE CAMPUS

113 COMANCHE RD

FORT MEADE SD 57741

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 Delivery and Government Acceptance

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.

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

AMENDMENT NO DATE

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.

All invoices from the contractor shall be submitted electronically in accordance with VAAR

Clause 852.232-72 Electronic Submission of Payment Requests. VA’s Electronic Invoice

Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website:

http://www.tungsten-network.com/US/en/veterans-affairs/ to register and begin submitting electronic invoices, free of charge. The Department of Veterans Affairs Tungsten Number is:

AAA544240062 (this allows you to file invoices online for free.)

More information on the VA Financial Services Center is available at:

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

Vendor e-Invoice Set-Up Information:

If you have questions about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

• Tungsten e-Invoice Setup Information: 1-877-489-6135

• Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

• FSC e-Invoice Contact Information: 1-877-353-9791

• FSC e-invoice email: vafsccshd@va.gov

Important Notices

System for Award Management (SAM)

“System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action

Compliance, and paragraph (d) of 52.212-3, Offeror Representations and

Certifications—Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.”

VA Reorganization

Vendors are advised that VA reorganization may necessitate adding additional locations to this contract in the future if this contract is not a supply-only contract. Any such additions shall be completed by a bilateral modification.

B. 2 - Statement of Work

BACKGROUND

Iowa City VA Health Care System, Nuclear Medicine Dept., has a requirement for Medrad Intego PET Infusion System. The purpose of this requirement is to procure an automated F18 FDG infusion system for the Iowa City VA Health Care System. The procurement shall include all parts, materials, labor, travel, and training to complete the full installation of the F18 FDG infusion system at the location.

SALIENT CHARACTERISTICS

Specifications – Brand Name Only - Medrad Intego PET Infusion System

Minimum Specific Requirements:

a. Infusion System must have cleared indications for use for delivery of FDG and

NaF in the United States.

b. Technical Requirements

i. The procurement is for a quantity of 1 Medrad® Intego PET Infusion

System by Bayer Radiology Solutions.

ii. The automated F18 FDG infusion system will be installed for use in the

Iowa City VA Medical Center Nuclear Medicine Hot Lab, 2W23A.

iii. The infusion system will arrive with the following items to ensure device start-up:

1. 3 Vial shields

2. 1 Case Source Administration Sets

3. 1 Case Patient Administration Sets

4. 1 Power cord

5. 1 Power retainer cable

6. 1 Operating manual

c. Contractor will ensure radiation shielding and safety features are compliant with

Nuclear Regulatory Commission (NRC) and Food and Drug Administration (FDA) standards

i. Cleaning/Sterilization Requirements

1. The device shall be able to be cleaned with common hospital cleaning products.

2. The contractor shall provide cleaning instructions (Instructions for use – IFU); electronic versions are acceptable.

d. Delivery Requirements

i. Delivery is required 90 days from award of the contract.

ii. Large deliveries are to be coordinated in advance with the COR to ensure necessary planning takes place.

iii. Contractor is to provide the COR with shipment tracking information.

iv. The following is the delivery location: Iowa City VA Health Care System

Medical Center, 601 Hwy 6 West, Iowa City, Iowa 52246.

e. Installation Requirements

i. Full installation of the system shall be included as a part of this contract.

ii. All parts, materials, tools, labor, and travel to complete the installation shall be included as a part of this contract.

iii. Contractor shall provide validation that the system is fully functional upon completion of the installation/implementation.

iv. Patient Health Information

1. The Contractor shall safeguard patient health information.

2. The Contractor shall report to the Biomedical Engineering

Department any issues with disclosed or unsecure patient health information.

WARRANTY

i. The equipment shall have a warranty of one (1) year from the full installation/acceptance of the equipment.

ii. Warranty support shall include repair of the system.

iii. Warranty support shall include all parts, materials, labor, and travel to complete the repair, or replacement of a defective/broken device.

iv. Requests for warranty support shall be made to the telephone support number provided by the Contractor.

v. Warranty support requests shall be responded to within 2 days.

vi. Contractor shall provide a copy of the service report, complete with test data, to the contract COR within five working days after completion of any services.

vii. Service reports shall include identifying information about the equipment, all services provided during the service visit, any issues found during the visit, the technician/engineer names of the personnel performing work, and the date service was provided.

viii. On-Site Procedures

1. Contractor personnel arriving on-site to perform work shall report to the Biomedical Engineering Department.

2. Contractor personnel shall sign in using the department’s vendor sign-in sheet or vendor check-in QR code, filling out all required information.

3. Contractor personnel’s tool bags are subject to inspection by the

Biomedical Engineering Department upon arrival and upon departure.

4. Contractor personnel shall sign out upon completion of visit.

5. Prior to departure, Contractor personnel are required to, at a minimum, verbally report any issues with the equipment to the

Biomedical Engineering Department, especially noting if the system is still down or not fully repaired.

6. The VA campus is non-smoking. Contractor personnel are required to comply with this policy.

7. Parking. It is the responsibility of the Contractor to park in the appropriate designated parking areas.

INSTALLATION

Installation is required by the Contractor. Contractor shall contract the Point-of-Contact within ten (10) business days from issuance of award to schedule installation.

i. Full installation of the system shall be included as a part of this contract.

ii. All parts, materials, tools, labor, and travel to complete the installation shall be included as a part of this contract.

iii. Contractor shall provide validation that the system is fully functional upon completion of the installation/implementation.

iv. Patient Health Information

1. The Contractor shall safeguard patient health information.

2. The Contractor shall report to the Biomedical Engineering

Department any issues with disclosed or unsecure patient health information.

TRAINING

On-Site Training is required. Contractor shall contact the Point-of-Contact within ten (10) business days from issuance of award to schedule the On-Site Training.

i. Contract shall include training for the end-users in the operation of the system.

Training shall be on the function and use of the device.

ii. Contract shall include training for the technical professionals (Biomedical Equipment

Support Specialists). Training shall cover the maintenance, troubleshooting, and repair of the system.

CONTRACTOR REQUIREMENTS:

• All Contractor personnel performing installation services of the equipment shall have factory training and experience in the implementation of the equipment.

• Contractor shall provide copies of training certificates for the Contractor personnel performing work on-site upon the request of the Government.

SAFETY AND ON-SITE SECURITY

i. Contractor shall follow all Occupational Safety and Health Administration (OSHA) laws and regulations. The Contractor is responsible for reporting any hazards they come across to their point of contact.

ii. Contractor shall follow all local procedures concerning infection control. Should the

Contractor be unsure of the requirements, COR can provide the specific information and procedures.

iii. Contractor personnel shall wear visible identification at all times while on VA property.

Contract personnel are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials.

iv. Property Damage

3. The contractor shall take all necessary precautions to prevent damage to any

Government property.

4. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken.

5. Any damaged material (i.e., trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the Government, upon approval of the Contracting Officer.

QUALITY ASSURANCE

a. End-users, i.e., Technologists & Radiation Safety Officer (RSO), Biomedical

Engineering, and/or the contract COR shall perform system verification tests to ensure the system is fully functional.

b. Issues with the quality of the Contractor’s work will be communicated through the

Contracting Officer to the Contractor point of contact for resolution.

c. Documentation will be completed in the Government systems.

PERIOD OF PERFORMANCE:

90 DAY ARO

TYPE OF CONTRACT

This is a Firm-Fixed-Priced, one-time supply contract with no option year(s).

POINT-OF-CONTACT (POC)

This contract is assigned a POC and will provide general instructions for administrating the contract. The POC is not authorized to grant permission(s) to change the scope of the project. The POC that is assigned for this contract will ensure that the supplies/services provided by this company are received based on the contractual terms and conditions.

Location VA Iowa City Health Care System

POC: See Award Email

DELIVERABLES OR DELIVERY SCHEDULE

The vendor shall deliver the equipment via standard delivery with F.O.B. destination as scheduled. See Section C for delivery schedule period-of-performance.

The equipment shall be delivered to the following address:

Iowa City VA Health Care System

601 Highway 6 West, Iowa City, IA 52246

Work Hours:

a. Hours of Operation: Normal business hours are Monday through Friday 8:00 a.m. to 4:00 p.m. excluding holidays. Should the Contractor require work after hours, the Contractor shall arrange in advance with the Contracting Officer’s Representative (COR).

b. Delivery Hours: The Warehouse is open to receive deliveries Monday through Friday 8:00 a.m. to 4:00 p.m., excluding holidays.

c. National Holidays: The holidays observed by the Federal Government are: New Year’s

Day, Martin Luther King Day, President’s Day, Memorial Day, Juneteenth, Independence

Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day and any other day specifically declared by the President of the United States to be a national holiday. Contractors may work on holidays with prior communication and coordination.

CHANGES TO CONTRACT

Before performing any action in a non-contractual nature or is considered out-of-scope, the

Contractor shall contact the Point of Contact (POC) and the Contract Officer identifying the reason(s) for change. All changes shall have prior authorization from a VA Contract Officer in the form of a written modification.

POST-AWARD PERFORMANCE CONFERENCE

The POC, Contract Specialist, or Contract Officer may schedule a post-award performance conference with Contractor, if deemed necessary, for contract orientation purposes.

SECURITY

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.

VA INFORMATION CUSTODIAL LANGUAGE.

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.

a. 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.

b. 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.

c. 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.

d. 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.

e. 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.

f. 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.

g. 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.

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

i. 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.

j. 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.

k. 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.

l. 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.

m. 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.

n. 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 POC /CO within 30 business days of termination of the contract.

o. 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.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS.

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.

a. Contractors and subcontractors shall sign the VA Information Security Rules 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.

b. 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).

c. 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.

d. 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:

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

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

(3) 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.

(4) 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.

(5) Contractor/subcontractor personnel have their authorization to work in the United States revoked.

(6) 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.

e. 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 COR/CO immediately to initiate access removal.

f. Contractors/subcontractors who no longer require VA access 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.

TRAINING.

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.

SPECIALIZED DEVICES/SYSTEMS (MEDICAL DEVICES, SPECIAL PURPOSE

SYSTEMS, RESEARCH SCIENTIFIC COMPUTING).

a. Contractor supplies/delivered Medical Devices, Special Purpose Systems- Operational Technology (SPS-OT) and Research Scientific Computing Devices shall comply with all applicable Federal law, regulations, and VA policies. New developments require creation, testing, evaluation, and authorization in compliance with processes specified on the Specialized Device Cybersecurity Department Enterprise Risk Management (SDCD-ERM) Portal, VA Directive 6550, Pre-Procurement Assessment and Implementation of Medical Devices/Systems, VA Handbook 6500, and the VA Information Security Knowledge Service. Deviations from Federal law, regulations, and VA Policy are identified and documented as part of VA Directive 6550 and/or the VA Enterprise Risk Analysis (ERA) processes for Specialized Devices/Systems processes.

b. All contractors and third-party service providers shall address and/or integrate applicable VA Handbook 6500 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 for governance or resolution.

c. The contractor shall certify to the COR/CO that devices/systems that have completed the VA Enterprise Risk Analysis (ERA) process for Specialized Devices/Systems are fully functional and operate correctly as intended.

Devices/systems must follow the VA ERA authorized configuration prior to acquisition and connection to the VA computing environment. If VA determines a new VA ERA needs to be created, the contractor shall provide required technical support to develop the configuration settings. Major changes to a previously approved device/system will require a new ERA.

d. The contractor shall comply with all practices documented by the Food Drug and Administration (FDA) Premarket Submission for Management of Cybersecurity in Medical Devices and Postmarket Management of Cybersecurity in Medical Devices.

e. The contractor shall design devices capable of accepting all applicable security patches with or without the support of the contractor personnel. If patching can only be completed by the contractor, the contractor shall commit the resources needed to patch all applicable devices at all VA locations. If unique patching instructions or packaging is needed, the contractor shall provide the necessary information in conjunction with the validation/testing of the patch. The contractor shall apply security patches within 30 business days of the patch release and have a formal tracking process for any security patches not implemented to include explanation when a device cannot be patched.

f. The contractor shall provide devices able to install and maintain VA-approved antivirus capabilities with the capability to quarantine files and be updated as needed in response to incidents. Alternatively, a VA-approved whitelisting application may be used when the contractor cannot install an anti-virus / anti-malware application.

g. The contractor shall verify and document all software embedded within the device does not contain any known viruses or malware before delivery to or installation at a VA location.

h. Devices and other equipment or systems containing media (hard drives, optical disks, solid state, and storage via chips/firmware) with VA sensitive information will be returned to the contractor with media removed. When the contract requires return of equipment, the options available to the contractor are the following:

(1) The contractor shall accept the system without the drive, firmware and solid state.

(2) VA’s initial device purchase includes a spare drive or other replacement media which must be installed in place of the original drive at time of turn- in; or

(3) Due to the highly specialized and sometimes proprietary hardware and software associated with the device, if it is not possible for VA to retain the hard drive, firmware, and solid state, then:

(a) The equipment contractor shall have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact.

(b) Any fixed hard drive, Complementary Metal-Oxide- Semiconductor (CMOS), Programmable Read-Only Memory (PROM), solid state and firmware on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the solicitation, contract, or order.

PRIVACY

No privacy language required

End of Statement of Work

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 EA __________________ __________________

Medradr Intego PET Infusion System

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary

LOCAL STOCK NUMBER: 87978443

3.00 EA __________________ __________________

VIAL SHIELD,30H,SILVER,SNAP RING,MC,NB

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

LOCAL STOCK NUMBER: 85278150

Medradr Intego software application - Worklist

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

LOCAL STOCK NUMBER: 3035637

Installation - Medradr Integor PET Infusion System with RDMS

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus

Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

LOCAL STOCK NUMBER: 85124099

Medradr Intego software application - IR PACS

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

LOCAL STOCK NUMBER: 3036144

Medradr Intego software application - RDPACS

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

LOCAL STOCK NUMBER: 3036143

Medradr Intego Source Administration Sets

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

LOCAL STOCK NUMBER: INT CSS

Professional Services Project Management

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

LOCAL STOCK NUMBER: 85124102

Medradr Intego Patient Administrations Sets

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

LOCAL STOCK NUMBER: INT CPS

Intego Power Cord

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

LOCAL STOCK NUMBER: 535-0243-012

Product Information Package

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

LOCAL STOCK NUMBER: 60720418

Intego Power Retainer Cable

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

LOCAL STOCK NUMBER: 85264664

MAN,OP,INTEGO SYS 200,ENGLISH,LR,4ED

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

LOCAL STOCK NUMBER: 86472953

1.00 JB __________________ __________________

INSTALLATION

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

1.00 JB __________________ __________________

TRAINING

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 334517 - Irradiation Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and

GRAND TOTAL __________________

B.4 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

ALL SHIP TO: Iowa City VA Health Care System 601 Highway 6 West Iowa City, IA 52246

USA

ALL 90 DAY ARO

MARK FOR: TBD

FOB: DESTINATION

SECTION C - CONTRACT CLAUSES

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

PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

(a) Definitions. The clause at Federal Acquisition Regulation (FAR) 52.202-1, Definitions, is incorporated by reference.

(b) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The

Government must exercise its post acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(c) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31

U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(d) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(e) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause FAR 52.233-1, Disputes, which is incorporated in this contract by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence. Examples of occurrences include acts of God or the public enemy, acts of the

Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. When an excusable delay occurs, the Contractor shall—

(1) Notify the Contracting Officer in writing as soon as possible;

(2) Remedy the delay as quickly as possible; and

(3) Notify the Contracting Officer when the occurrence is over.

(g) Invoice. The Government will handle invoices according to the Prompt Payment Act (31

U.S.C. 3903) and 5 CFR part 1315. The Contractor shall submit invoices to the address designated in the contract to receive invoices. An invoice must include the information required by 5 CFR part 1315.9(b).

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees, and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark, or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt

Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date that appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(4) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable;

(D) Contractor point of contact; and

(ii) Provide a copy of the remittance and supporting documentation to the Contracting

Officer.

(5) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the

Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by FAR part 33 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see FAR part 32).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a termination for cause.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on-

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures for interest credits prescribed in FAR part 32 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon—

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the

Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor,…