MRI Mobile System Lease SOW v2.docx

MRI Mobile System Lease Statement of Work

Overview Mobile MRI Scanner Lease General: This document highlights the technical specifications and services being requested by the Minneapolis VA Health Care System for consideration towards the lease of a 1.5 Tesla MRI Mobile unit with a high-quality scanner and full range of operational MRI coils.

Performance Period Contractor shall complete the work required under this SOW during base year of 12 months, and 4 additional option years of 12 months length if exercised. Contractor shall work with Mpls. VA HCS Contracting Officer’s Representative (COR) or appointed point of contact (POC) to schedule work.

Contractor will provide a Point of Contact (POC) phone number for all corrective repairs and return all support/ trouble shooting calls within 10 minutes. Contractor shall plan a minimum of 2 scheduled preventative maintenance visits per (12) month term. Scheduled preventative maintenance will be coordinated with Mpls. VA MRI POC and done outside of scanning hours whenever possible to avoid disruption of patient care.

NOTE: Hardware/software update/upgrade installations will be scheduled and performed at a mutually agreed upon time at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the COR or Mpls. VA MRI POC.

Travel, labor, and replacement parts All Contractor transportation, lodging, and incidental expenses incurred by the Contractor shall be incorporated into the Contractor’s fees and are the sole responsibility of the Contractor. Contractor is responsible for costs related to travel, labor, and replacement parts for corrective maintenance and repair services. There shall be no additional charge for time spent at the site during or after the normal hours of coverage awaiting the arrival of repair parts.

Training Provided / Training Materials: On-site clinical applications training for technologists during go-live. Vendor to provide all appropriate training materials and equipment manuals for proper end user training and reference Service Requirements.

Place of Performance Tasks under this SOW shall be performed at the following location:

Minneapolis VA Health Care System 1 Veterans Drive Minneapolis, MN 55417 Changes to Statement of Work Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the Contractor through the actions of parties other than the CO shall be borne by the Contractor.

Scope of Work The Contractor shall provide One (1) 1.5T MRI system housed in a mobile coach. Under this proposal, the Contractor shall provide all software, hardware, accessories, and coils for the MRI scanner to include, but not limited to:

Requirements for the Mobile MRI Unit:

1) 1.5T top of the line MRI scanner and software offering a full range of clinical applications

2) The Contractor will build an enclosed shelter to connect the MRI coach to the existing Mpls. VA MRI walkway. Plans for the structure will be submitted prior to construction to show compliance with state building codes and undergo review by the Mpls. VA Engineering department. The design should be constructed using low-maintenance materials and connect the existing walkway and MRI coach seamlessly. The structure shall be weatherproof, constructed using aluminum or steel framing, insulated walls and roofing, and designed to withstand snow loads and wind speeds.

3) The Contractor will perform all site planning and provide delivery and removal of MRI mobile coach.

4) Vendor will provide cryogens, service, and preventive maintenance of the MRI equipment.

5) MRI Magnet Specifications:

a) Field strength 1.5T

b) Bore size 70 cm Open Bore design

c) Minimum room size 323 sq. ft.

d) RF Tim [204x48], [204x64]

e) Gradient strength XJ Gradients (33 mT/m @ 125 T/m/s)

f) XQ Gradients (45 mT/m @ 200 T/m/s)

6) The mobile coach must be climate controlled and fitted with a safety lift gate which can accommodate patients in wheelchairs and gurneys.

7) In Zone 3 inside the mobile coach, is seating for two MRI staff and a patient changing area with a secure/lockable space for patient belongings.

8) The Contractor shall provide all software, hardware, accessories, and a full set of functioning MRI coils, to include at a minimum:

a) 16 channel or greater RF head coil

b) 8 or 16 channel knee coil

c) 8 or 16 channel Neuro Vas coil

d) 16 channel spine coil

e) 8 or 16 channel shoulder coil (small and large)

f) 8 or 16 channel foot / ankle coil

g) 8 or 16 channel hand / wrist coil

h) 8 channel small body array coil or equivalent

i) 16 channel large/XL body array coil or equivalent

9) The Contractor shall provide a top-of-the-line programmable injector with pressure monitor, brand name Medrad Spectrics, or equal, having the following capabilities: scan delay, Multiphase option, protocol storing, and pause hold functionality. *To include a single injector kit. (In order for the same kit can be ordered via inventory)

10) The Contractor shall provide a Pulse Oximeter

11) The Contractor must maintain MRI equipment at an “up-time” of 90% or better

12) The Contractor will provide a plan for repairs of the MRI trailer to include:

a) A point of contact for reporting system issues, on-site response time for service call back within 2 hours of notification.

b) If the event requires a Field Engineer (FE) the vendor will have the FE onsite within 24hrs after the vendor is notified and it is determined a FE is required.

c) Resolution for the event will be no greater than 72 hours from the issue being reported.

d) Once the repairs are completed a report needs to be generated to reflect what repairs were completed. This report needs to be presented to the VA POC or COR to keep for our records.

13) The mobile scanner system shall be equipped with an outlet connection capable of transmitting data and voice through a Government provided category (CAT 5 or 6a) cable to communicate with the VA’s system.

14) The Contractor’s mobile scanner system must be able to connect to the commercial PACS system and Electronic Health Record network and must be able to transmit all images to both systems with DICOM 3 imaging standard compatibility.

15) The Contractor’s MRI mobile scanner system Image Quality should be free of system artifacts, meet industry standards, and be of diagnostic quality comparable to MRI images performed in the Minneapolis VA hospital facility using a similar scanner/software combination.

Minneapolis VA Health Care System will be responsible for providing electrical and network connections, network connection software, and hardware connections :

The Government will provide the connection required for the transmission of images, data and voice.

MVAHCS will provide cabling for three (3) voice and three (3) data connections to mobile MRI trailer with weatherproof RJ-45 connectors

All services performed shall be in accordance with the original equipment manufacturer (OEM) specifications. Product delivery will be the responsibility of the vendor working with the VA MRI Biomed POC.

The vendor will be responsible for delivery and installation of the equipment. Summary of Service & Equipment Specifications: Equipment, Software, Hardware, Labor, Travel, Delivery & Installation of a Windows 10 compatible MRI console workstation will be provided by vendor.

VPN/Remote Access The vendor shall provide any and all equipment service programs, such as remote diagnostics, during the lease period. The system shall provide vendor remote diagnostics via VPN. The vendor shall either utilize the VA national site-to-site VPN or work with the Office of Cyber and Information Security and the VAMC Information Systems Security Officer to establish a client-based VPN. Service and Operator Manuals The vendor shall provide the following documentation for the proposed systems: Two (2) copies of operator instruction manuals (one (1) electronic and one (1) physical copy) Two (2) copies of a service manuals (one (1) electronic and one (1) physical copy) Minimum Warranty The system and accessories shall be covered under the manufacturer s warranty and shall include all parts and labor for the period of this lease This warranty must include PMs as required by the manufacturer. The manufacturer s factory-trained field service representatives shall perform installation and maintenance during the lease period.

Conformance Standards: Contractor shall provide service and ensure that the equipment functions in accordance with the equipment manufacturer’s technical performance specifications. Contractor shall conform to all regulations to include but not be limited to federal, state, and local governing any chemicals, equipment or work which may be used or performed in the work under this contract.

Preventative Maintenance: Perform system scheduled maintenance inspections as outlined in the user’s manual developed by the manufacturer for the main devices and any peripheral devices of the system. Parts & Software Exchange: All parts and software required for the installation of the system (excludes instruments and accessories) are covered. Part Protection: Preferred pricing on repairs or replacement due to accidental damage.

Maintenance and repairs to be performed by Certified Trained Technicians: Technicians shall include fully qualified Facility Service Engineers (FSE) and a fully qualified FSE who will serve as the backup and show proof of competency, as shown by training conducted on said system. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment identified in this statement of work. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance. Proof of training shall be provided upon demand and be immediately sent via fax, upon demand to the COR. All FSE s and technicians shall be authorized by the Contractor to perform the maintenance services. All work shall be performed by "Fully Qualified" competent FSE's. The COR and/or designated representative specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment. It is anticipated that any hospital regulatory inspections (TJC, etc.) will have the vendor providing proof that they meet industry standards of quality, and traceable standards, as used to calibrate this device- system, at the time of the maintenance event. Service Manuals/Tools/Equipment: All required service manuals, tools, and equipment are to be provided by the vendor.

FSE Check in Requirements: The Contractor’s Field Service Engineer must report to the Biomedical Engineering Department to obtain a badge and sign in with the Biomedical Engineering Service before work begins. Submit any mobile media devices that would be used on the system to a virus scan. Upon completion of work, the Field Service Engineer must report to the Biomedical Engineering Service to sign out and brief Biomedical Staff or Supervisor if Biomedical Staff is unavailable concerning completion of service. At the end of briefing Field Service Engineer will return the badge and sign out in the Biomedical Engineering Department.

Documentation: Contractor shall furnish a detailed field service report upon completion of work to Biomedical Staff in the Biomed Department. Payment will not be processed until a properly completed service report is received. The service report shall contain, at a minimum, the following information:

Identification of equipment to be serviced:

· VA EE Number

· Vendor Inventory ID number

· Manufacturer Name, Device Name, Model Number, Serial Number / System ID

· Name of contractor and contract number

· Name of FSE who performed services

· Contractor service ESR number/log number

· Date, time (starting and ending), equipment downtime and hours on-site for service call

· VA purchase order number(s) covering the call if outside normal working hours

· Total time spent performing maintenance.

· Detailed narrative and itemized description of the services required and performed including: Labor and travel Parts (with part numbers)

· Materials Location, Corrective Action, Copies of all test reports, Complete list of parts replaced (when applicable)

· Date and time the repair/support was completed

· Total Cost to be billed (if applicable i.e., part(s) not covered, or service rendered after normal hours of coverage).

· Signatures: FSE performing services described

· Authorized VA employee who witnessed service described

NOTE: - Any additional charges claimed must be approved by the COR or designated representative before service is completed!

The service report shall itemize every item in the specification. Each item shall state the "as found" condition or values, the "calibrated to" or "adjusted to" values, the factory design tolerances, and a complete description of all work performed concerning the items. Included will be a list of new parts used and recommended future repairs.

FSE Reporting Requirements: When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to the COR or designated representative. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR or designated representative for an "authorization signature". If COR or designated representative is unavailable, a signed, authorized copy of the ESR will be left with the MRI POC.

Contracting Officer Representatives: Prior to contract award, the Contracting Officer shall designate a VA Health Care System employee as the COR. The Contractor shall be provided a copy of the letter of delegation authorizing the COR at the commencement of the term of the contract. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer.

Information Technology Security Requirements: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. The contractor shall comply with all Federal laws and regulations the VA has developed when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor. The information made available to the contractor by VA for the performance of this contract will be used only for the purposes of performance under this contract. The certification and accreditation requirements do not apply to this requirement and a security accreditation package is not required.

Security Statement: Sensitive VA information is contained within the systems covered by this contract. Biomedical Engineering shall perform virus scans on all removable media prior to use on VA medical equipment. This includes all types of removable media, including media (e.g., USB devices, CDs, dongles, etc.) that has been issued by VA, media not issued by VA, and media brought in by vendors or independent service organizations. Within accordance of VA Directive 6500, Information Security Program, September 2007 the Vendor will not transfer any VA information to a location outside the VA and only to VA locations determined by the VA System Administrator. The information in these systems may be covered by the Privacy Act 1974 which contains criminal penalties of abuse of information. During onsite service, the Vendor shall be chaperoned by VA Personnel. However, the vendor shall not be issued a User ID/Password. Non-volatile memory devices, working or non-working, shall NOT be removed from the Mpls. VA HCS until the ISO has certified that the data has been destroyed. For magnetic devices and media, the data destruction will be by degaussing. Other forms of cleansing will be used for non-magnetic media. The vendor will not have remote access to complete the repair(s) and preventive maintenance. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

Terms of Agreement

1. Replacement Parts and Additional Charges. Contractor shall supply necessary parts, provided replacement of the parts is required because of normal wear and tear or otherwise deemed necessary by Contractor and Mpls. VA HCS. All parts will be new, standard parts, or used, reworked or refurbished parts that comply with applicable performance and reliability specifications.

2. Inspection. An initial inspection will be conducted to ensure the equipment is in working order prior to any work being performed. Any deficiencies discovered, or conditions listed in the specified exclusions will not be covered under the Service Warranty Policy.

3. Access to Equipment. Contractor’s authorized representatives shall coordinate with the VA POC or COR to schedule any routine service or maintenance. The Contractor’s Service Representative may charge for time waiting for equipment availability after a sixty (60) minute wait beyond the scheduled time.

4. Warranty. Repairs made during the term of this agreement are warranted for the period remaining on and under the conditions of this agreement or for ninety (90) days, whichever is longer.

General Requirements

1. The Contractor shall provide the COR with a list of contractor employees expected to enter building. While on VA premises, all contractor personnel shall comply with the rules, regulations, and procedures governing the conduct of personnel and the operation of the facility.

2. An access badge will be given to the contractor’s employee upon entrance into VA buildings. The contractor employee must safeguard the access badge and immediately report any lost, stolen, or destroyed badges to the COR. All contract personnel must properly display their access badges. Access badges must always be worn at or above the waist (facing forward) in the facility. The contractor’s employees must return the access badge(s) to the COR or designee when the work is complete.

3. It is the responsibility of the contractor’s personnel to park in the appropriate designated parking areas. Parking information shall be coordinated with each facility COR.

4. Mpls. VA HCS does not validate or make reimbursement for parking violations of the contractor’s personnel under any circumstance.

GOVERNMENT RESPONSIBILITIES:

The Government shall be responsible for making the equipment available to the Contractor during normal business hours. If there is a need for work to be done after hours, the Government will make arrangements for the Contractor to have access to the equipment.

CONTRACTOR PERSONNEL SECURITY REQUIREMENTS:

The contractor shall be required to comply with all security policies/requirements. All security policies/requirements must be met, and employees cleared prior to the contractor performing work under this contract. Employees that cannot meet the security and clearance requirements shall not be allowed to perform work under this contract.

1. The following security language is applicable to Contractor staff who will enter MVAHCS facilities.

2. Contractor staff will utilize a temporary vendor’s security badge until a permanent security PIV badge can be issued. Temporary badge use will not exceed 30 calendar days.

3. The Contractor shall comply with MVAHCS security, access, and badging requirements. Employees must provide fingerprints and be able to pass a background check so they can obtain a security access badge.

4. All Contractor staff will need a valid individual personal or professional email account that can be easily checked. Notifications regarding fingerprint scheduling/appointments, background investigation tasks, and Training Management System (TMS) required classes will be sent to their email address throughout the badging process.

5. Appropriate vendor staff (as determined by the VA) performing the duties of the Statement of Work shall complete the computer-based training course “TMS 10176 Infosec/Rules of Behavior” and “TMS 10203 HIPAA.”

6. Contractor staff shall be escorted while on VHA property.

7. The Contractor will submit all required security badging documents for each employee within five (5) business days from the award date of contract. All documents must be legible. The following documents will be sent to the Contractor via email after contract is awarded.

a) OF 306 – Must be Typed. Submission of handwritten forms will not be acceptable.

b) Self-Certification

c) VA 10-2417

d) Employee Fingerprint Resource Form

INTERFERENCE TO NORMAL FUNCTION:

Contractor may be required to interrupt their work at any time so as not to interfere with the normal functioning of the facility, including utility services, fire protection systems, and passage of facility patients, personnel, equipment, and carts.

1. In the event of an emergency, contractor services may be stopped and rescheduled at no additional cost to the government.

2. Contractor personnel shall inform the COR or the designee of the need to gain access to secured areas. If access is required to secure areas, prearranged scheduling will be made with COR or designee.

Contracting Requirements

REMOTE ACCESS:

If required, Contractor must comply with all VA Office of Information and Technology security requirements. Contractor must contact Mpls. VA HCS before accessing the system remotely.

REPORTING:

For repairs or services that will be performed during normal working hours, the Contractor’s repairman must report to the Biomedical Engineering Section by telephone at 612-467-2012, and while on station an identification badge shall always be worn. During the repair process, once the problem is identified, the Contractor shall notify VA Biomedical Engineering before replacement parts are installed. After all work is completed, the Contractor’s repairman must again report to the Biomedical Engineering Section and provide a complete report of services or repairs performed for each item of equipment and must also include a listing of replacement parts, when applicable.

NOTE: Payment of invoices may be delayed if the appropriate reports are not properly completed and submitted to the Biomedical Engineering Section as required above.

HOURS OF WORK:

If it is deemed necessary that work be done outside of normal business hours due to clinic schedule, the contract will be flexible and decide – with Mpls. VA HCS staff – on a time that does not impact patient care.

ADDITIONAL SERVICES:

The Contractor guarantees all equipment covered in this contract shall be in optimum working condition at the contract expiration date, provided the Contractor is notified of deficiencies at least one (1) day before the contract expiration date. All changes, updates or retrofits made on any component or system shall be annotated on station equipment manuals and records. Services also include recording all routine work, corrections, and repair work in the equipment log.

AUTHORIZED SERVICES:

Only those services specified within the contract are authorized. Before performing any service or repair of a non-contract nature, the CO or his/her designee must be advised of the reason for this additional work. If appropriate, the CO or his/her designee may authorize the additional services or repairs under a separate purchase authorization. Contractor is cautioned that only the CO or his/her designee may authorize additional services or repairs and reimbursement will not be made unless this prior authorization is obtained.

DISCONTINUANCE OF SERVICE:

The Government reserves the right to terminate service on a particular machine meeting replacement criterion upon thirty (30) days written notice to the Contractor with payment to be prorated.

TEST EQUIPMENT:

Mpls. VA HCS will not furnish parts and/or test equipment for the performance of this contract. It is the responsibility of the Contractor to bring the appropriate equipment and/or supplies necessary to complete the work as required within.

PERFORMANCE CONFERENCE:

If appropriate, the CO will schedule a performance conference for contract orientation purposes with the Contractor receiving award.

SPECIAL CONTRACT REQUIREMENTS:

Contractor must follow all Department of Veterans Affairs, Joint Commission, OSHA, and NFPA regulations when working on VA equipment.

CONTRACTOR SUBMITTALS:

Within fifteen calendar days after award date, but not later than performance of the first servicing of equipment, the Contractor will furnish two (2) copies of its preventive maintenance procedures manual which will be used during the preventive maintenance services of this contract to the COR. These manuals are required by the Government as a condition of the facility’s Joint Commission accreditation and must be received before any invoice can be certified for payment.

OBSOLETE MACHINES:

Services under a resulting contract will not cover obsolete machines where parts for such obsolete machines are not available under the original manufacturer’s commercial price list, unless mutually agreed to by the CO and the Contractor.

ORDERS:

The Contractor’s repairman will report to the office of the Contracting Officer’s Representative (COR) prior to start of work and after completing the services required during that call. Services to be rendered will be directed by the COR and any changes must receive concurrence of the Contracting Officer and/or the COR.

Security The contractor and their personnel shall be subject to the same Federal laws, regulations, standards, and VA policies as VA personnel, regarding information and information system security. These include but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce’s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST’s Web site at: http://checklists.nist.gov

If access to sensitive information involved with this contract. Tier 1 investigation is needed. SAC is required for 6mo or less. NACI is required for over 6mo to 5 years.

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.

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. 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. 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:

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.

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.

RECORDS MANAGEMENT OBLIGATIONS:

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal Record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes Mpls. VA HCS records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their Mpls. VA HCS contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

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

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

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

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

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

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

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

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

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

10. The Mpls. VA HCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which the Minneapolis VA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11.Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take Mpls. VA HCS -provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.