S02 Attachment 1 SOW.docx
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- J065--Siemens Medical Solutions | Siemens Skyra 3T MRI Imaging and DTS Chiller Services 36C26126Q0184
- Solicitation number
- 36C26126Q0184
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This is a Statement of Work (SOW) for preventive maintenance and emergency repair services for a Siemens Skyra 3T MRI imaging system (Serial Number 45205) and a Dimplex Thermal Solutions DTS Chiller (Serial Number W224945-001) located at the San Francisco VA Medical Center (SFVAHCS), Building 203, Radiology Research. The contract is structured as a Base plus 4 Option Year arrangement and falls under NAICS Code 811210 (Medical Equipment Repair and Maintenance Services).
The contractor must maintain the equipment to ensure 95% operational uptime during normal operating hours (8:00 AM to 5:00 PM, Monday through Friday, excluding federal holidays), with an 8-hour on-site response requirement for emergency repairs. Phone response is required within 60 minutes of notification, and any needed parts must be delivered by the next business day. Preventive maintenance will be performed according to manufacturer recommendations and must include equipment cleaning, software diagnostics, calibration, lubrication, part replacement, electrical and mechanical inspection, and detailed documentation via Engineering Service Reports (ESRs). All parts, tools, service manuals, and test equipment are the contractor's responsibility; labor and travel for after-hours work (outside 8 AM–5 PM Monday–Friday) are billable at contracted rates, though parts and scheduled maintenance updates are included in the contract price. The contractor must assign a fully qualified Field Service Engineer with a minimum of two years' experience and a backup, both trained on the specific equipment models. Comprehensive information security and privacy requirements apply, including VA Handbook 6500 compliance, background checks, Rules of Behavior training, security incident reporting within one hour, and Business Associate Agreement execution for handling protected health information. Additional requirements include general liability and property damage insurance ($500,000 minimum per occurrence), mobile media scanning protocols, facility access procedures (identification badges, parking restrictions, smoking prohibitions), and compliance with all applicable NFPA-99, UL, VA, and CDRH conformance standards.
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STATEMENT OF WORK
ENTRY NUMBER 304144, DTS CHILLER
TITLE SIEMENS SKYRA 3T MRI IMAGING AND DTS CHILLER CONTRACT
CATEGORY SERVICE CONTRACTING
LOCATION SFVAHCS Bldg. 203 Radiology Research, MR: BA30
STATEMENT OF WORK
SIEMENS IMAGING EQUIPMENT
DESCRIPTION/SPECIFICATIONS
FOR PREVENTIVE MAINTENANCE/EMERGENCY SERVICE
FOR MEDICAL EQUIPMENT
1. BACKGROUND: - The Siemens Skyra 3T MRI system (serial 45205) is a whole body, state-of-the-art research MRI system that supports research being performed not only at the San Francisco VA, but also by researchers at the University of California, San Francisco, and the University of California, Berkeley.
They are capable of generating images of much higher resolution than a traditional MRI scanner which enhances the precision of diagnoses and quality of treatment monitoring/planning. The purpose of the service contract is to maintain both the 3T MRI system in peak operating condition so that it continues to meet its operating specifications. This requirement is for a Base + 4 Option Year contract.
2. PROJECT SCOPE: - The Contract is service contracts for the Siemens Skyra 3T MRI and DTS Chiller system which is overseen by the VA Advanced Imaging Research Center at the San Francisco VA. The Contract includes regularly scheduled visits by Siemens trained service personnel to ensure that the instrument continues to perform to its operating specifications, and to make repairs if any specifications are not met. In addition, in the case of any failures, Siemens personnel are required to respond by phone within one hour of being notified of such failure, and in person within four to eight hours of notification, over the duration of the principle coverage period (8:00am to 5:00pm, M-F for MRI and 8:00am to 10:00pm, M-F for DTS Chiller). Any needed parts must be delivered by the next day.
3. EQUIPMENT IDENTIFICATION:
MANUFACTURER: SIEMENS MEDICAL SYSTEMS, INC.
MODEL: SKYRA 3T
SERIAL NUMBER: 45205
EQUIPMENT I.D. NUMBER: 304144
ACQUISITION DATE: DEC 22, 2011
LOCATION: SFVAHCS BLDG 203 RM BA-30, RADIOLOGY RESEARCH
MANUFACTURER: Dimplex Thermal Solutions
MODEL: W02-2-10000-2P-NF-L-M-407C
SERIAL NUMBER: W224945-001
EQUIPMENT I.D. NUMBER: Siemens 400-655400 ACQUISITION DATE: Installed September 25, 2019 LOCATION: Adjoining building 203
4. DEFINITIONS/ACRONYMS:
A. Biomedical Engineer(ing) - Supervisor or designee.
B. CO - Contracting Officer
C. COR – Contracting Officer Representative
D. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.
E. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises.
F. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.
G. Acceptance Signature - VA employee who is authorized to sign-off on the ESR which indicates that the PM has been concluded or is still pending completion, or that the Emergency Repair has been accomplished or is still in a pending status.
H. Authorization Signature - COR signature; indicates COR accepts work status as stated in ESR.
I. NFPA - National Fire Protection Association.
J. CDRH - Center for Devices and Radiological Health.
K. VAMC - Department of Veterans Affairs Medical Center
L. VAH - Department of Veterans Affairs Hospital
M. VAARC – VA Advanced Imaging Research Center
5. CONFORMANCE STANDARDS: - Contract service shall ensure that the equipment functions in conformance with the latest published edition of NFPA-99, UL, VA, CDRH.
6. OPERATIONAL UPTIME - REQUIREMENTS: - The imaging equipment shall be operable and available for use 95% of the normal operating hours of the equipment as detailed in paragraph V., HOURS OF COVERAGE.
The imaging equipment shall be operable and available for use 95% of the normal operating hours of the equipment as detailed in paragraph V., HOURS OF COVERAGE. On-site response will be 8 hours.
The imaging equipment shall be operable and available for use 95% of Normal work hours.
Downtime will be computed from notification of problem during normal work hours. Scheduled maintenance will be excluded from downtime. (Normal work hours are 08:00 AM to 05:00 PM, Monday thru Friday, excluding federal holidays). Operational Uptime will be computed during a month-long time period. Repeated failure to meet this requirement can subject the contractor to DEFAULT action.
7. HOURS OF COVERAGE:
A. Normal hours of coverage are Monday through Friday from 08:00 AM to 05:00 PM, excluding federal holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by COR or his designee.
B. Preventive maintenance will be performed in accordance with manufacturer’s recommendations. Preventive maintenance will be performed during normal hours of coverage (or as agreed to by SIEMENS and COR or designee).
C. Work performed outside the normal hours of coverage at the request of COR or designee will be billed at the price listed in Vendor Contract. Billing will include service time plus one (1) hour for travel time, and exclude parts, as they are included in the Vendor Contract. Work performed outside the normal hours of coverage at the request of FSE will be considered service during normal hours of coverage.
NOTE: - Hardware/software update/upgrade installations will be scheduled and performed during normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by COR or designee). Government provides software/hardware upgrade/update.
D. Federal Holidays observed by the VAMC are:
New Years' Day Martin Luther King Day Presidents' Day Memorial Day Independence Day Labor Day Columbus Day Veterans' Day Thanksgiving Day Christmas Day
8. UNSCHEDULED MAINTENANCE (Emergency Repair Service):
A. Contractor shall maintain the equipment in accordance with the manufacturer's specifications. The Contractor will provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be furnished, with the exemption of the detector or consumables (batteries, leads, padding, storage media, cassettes, etc.).
B. The CO, COR or designated alternate has the authority to approve/request a service call from the Contractor.
C. Response Time: - Contractor's FSE must respond with a phone call to COR or designee within 60 minutes after receipt of telephoned notification during normal hours of coverage. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within 8 hours after receipt of this second notification and will proceed progressively to completion without undue delay. For example, if hours of coverage are 08:00 AM to 05:00 PM, Mon. thru Fri., an 8-hour response means, if a call is placed at 8:15 AM., Monday August 10th; the FSE must start on-site service before 4:15 PM, Monday, August 10th. Emergency Repairs performed outside the normal hours of coverage, at the request of COR or designee will be billed at the price listed in Section B.
9. SCHEDULED MAINTENANCE:
A. The Contractor shall perform PM Service to ensure that equipment listed in the schedule performs in accordance with Section 3, Conformance Standards. (An outline of the PM procedures and schedule shall be provided to COR or designee). The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). This documentation shall be provided to COR at the completion of the PM (preferably in electronic format). The contractor shall provide written description of Preventive Maintenance Inspections (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but need not be limited to, the following:
| 1) | Cleaning of equipment. |
| 2) | Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Section 3, Conformance Standards or the manufacturer's specifications. |
| 3) | Calibrating and lubricating the equipment. |
| 4) | Performing remedial maintenance of non-emergent nature. |
| 5) | Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail or become worn. |
| 6) | Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying. |
| 7) | Inspecting, and replacing where indicated, all mechanical components which may include, but is not limited to: X-ray tube mounting hardware, patient restraints and support devices, cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, keyboards, and patient couches for mechanical integrity, safety, and performance. |
| 8) | Returning the equipment to the operating condition [defined in Section 3, Conformance Standards]. |
| 9) | Providing documentation of services performed. |
| 10) | Inspecting and calibrating the hard copy image device. |
B. PM Services shall be performed in accordance with, and during the hours defined in, the preventive maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with COR or designee.
C. Any charges for parts, services, manuals, tools, or software required to successfully complete scheduled PM are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise.
10. PARTS: - The Contractor shall furnish and replace parts to meet uptime requirements. The Contractor has ready access to all Original Equipment Manufacture parts, including unique and/or high mortality replacement parts. All parts supplied shall be from the Original Equipment Manufacturer. The contract shall include all parts except X-Ray tubes and detectors. All parts shall be of current manufacture and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications.
11. SERVICE MANUALS/TOOLS/EQUIPMENT: - The SFVAHCS shall not provide tools, (test) equipment, service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation (such as; operational and service manuals, schematics, and parts list) which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name and/or the manuals themselves shall be provided to the CO upon request.
12. DOCUMENTATION/REPORTS: - The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with Section 3, Conformance Standards or the manufacturer's specifications. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. The ESR will consist of a separate PM report for the item(s) covered under the "specific" contract. Grouping different equipment from different contracts on "one" ESR is prohibited. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail:
A. Name of contractor and contract number.
B. Name of FSE who performed services.
C. Contractor service ESR number/log number.
D. Date, time (starting and ending), equipment downtime and hours on-site for service call.
E. VA purchase order number(s) covering the call if outside normal working hours.
F. Description of problem reported by COR or designee /user (if applicable).
G. Identification of equipment to be serviced:
| 1) | Inventory ID number, |
| 2) | Manufacturer's name, |
| 3) | Device name, |
| 4) | Model number, |
| 5) | Serial number, |
| 6) | Any other manufacturer's identification numbers. |
H. Itemized Description of Service Performed (including, if applicable, Costs associated with after normal working hour services) including:
| 1) | Labor and Travel, |
| 2) | Parts (with part numbers), |
| 3) | Materials and Circuit Location of problem/corrective action. |
I. Total Cost to be billed (if applicable - i.e., part(s) not covered or service rendered after normal hours of coverage).
J. Signatures:
| 1) | FSE performing services described. |
| 2) | Authorized VA Employee who witnessed service described. |
NOTE: - Any additional charges claimed must be approved by COR before service is completed.
13. REPORTING REQUIREMENTS: - The Contractor shall be required to report to Biomedical Engineering to log in. This check in is mandatory. 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 Frank Ung or designee. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to COR or designee for an "authorization signature". If COR or designee is unavailable, a signed, authorized copy of the ESR will be sent to the Contractor after the work can be reviewed (if requested or noted on the ESR).
ADDITIONALLY, all services will need to be coordinated with An (Joseph) Vu—Advanced Imaging Technologies Director, or Designee.
VA Biomedical Contact Person(s): Currently David Dea or Eng Help Desk_ ____ Location (Building/Room Number): Building 6, Room 11, Biomedical Engineering Shop_ Telephone Number & Extension(s): 415-221-4810 Ext 22009 _____________________
VAARC Contact Person(s): An (Joseph) Vu ________________ Location (Building/Room Number): Building 203, Room 38A _ Telephone Number & Extension(s): 408-636-8375______________________________
14. REMOTE SUPPORT: The contractor shall have proper access and control to remotely monitor all equipment as required in Section 5. This includes background checks and Information Security Officer approval as required by Directive 6500. The contractor must demonstrate active security clearance before award.
15. PAYMENT: - Invoices will be paid in arrears on a monthly basis. Invoices, MUST INCLUDE, at a minimum, the following information: Contract No., Purchase Order No., Item(s) covered (to include serial #'s) by the PMI and covered period of service. Each invoice must be provided in triplicate.
16. ADDITIONAL CHARGES: - There will be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional FSE and/or delivery of parts.
17. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE: - The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the CO and COR (in writing) of the existence or the development of any defects in, or repairs required, to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish the CO and COR or designee with a written estimate of the cost to make necessary repairs.
18. CONDITION OF EQUIPMENT: - The Contractor accepts responsibility for the equipment described in Section C, paragraph I., in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract.
19. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:
A. Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.
B. "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 the Section B schedule. 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.
C. The FSE's shall be authorized by the Contractor to perform the maintenance services. All work shall be performed by "Fully Qualified" competent FSE’s. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSE’s for each make and models the Contractor services at the VAMC. The CO may authenticate the training requirements, request training certificates or credentials from the Contractor at any time for any personnel who are servicing or installing any VAMC equipment. The CO and/or COR specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment.
D. If subcontractor(s) are used, they must be approved by the CO; the Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.
20. TEST EQUIPMENT: - Upon request, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to a national standard.
21. MOBILE MEDIA SCANNING: - The Contractor will identify if removable media (i.e. USB or DVD/CD Device) is required to perform his/her duties. Personally owned USB thumb drive utilization is prohibited. Non-VA support personnel must furnish their own FIPS140-2 certified USB thumb drives, and only with the permission of a designated VA supervisor. All USB drives must be scanned with an antivirus program running current virus definitions by the local VA staff, prior to connection to any VA device. COR or designee will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device system. The computer system for scanning removable media is located in the biomedical engineering shop, Building 6, Room 11.
22. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: - The Contractor's FSE’s shall wear visible identification at all times while on the premises of the VAMC. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VAMC will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the VAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.
23. INSURANCE:
A. Worker compensation and employer's liability: Contractors are required to comply with applicable Federal and State Worker Compensation and occupational disease statutes.
B. General Liability: Contractors are required to have Bodily Injury Liability Insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.
C. Property Damage Liability: Contractors are required to have Property Damage Liability insurance coverage of at least $500,000.
24. Information Security :
VA HANDBOOK 6500.6 APPENDIX C
| 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. |
C-4
| (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. |
| 5. | SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any Information Security and Privacy language. |
| a. | The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT’s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD. |
| b. | To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following: |
| (1) | The date and time (or approximation of) the Security Incident occurred. |
| (2) | The names of individuals involved (when applicable). |
| (3) | The physical and logical (if applicable) location of the incident. |
| (4) | Why the Security Incident took place (i.e., catalyst for the failure). |
| (5) | The amount of data belonging to VA believed to have been compromised. |
| (6) | The remediation measures the contractor is taking to ensure no future incidents of a similar nature. |
| c. | After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination. |
| d. | VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation. |
| e. | In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG, and the VA Office of Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. |
| f. | The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches. |
| g. | With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA. |
| h. | If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages— Reimbursement for Data Breach Costs. |
| 6. | INFORMATION SYSTEM DESIGN AND DEVELOPMENT. This entire section |
applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (to include the subcomponents of each) designed or developed for or on behalf of VA by any non-VA entity.
| a. | Information systems designed or developed on behalf of VA at non-VA facilities shall comply with all applicable Federal law, regulations, and VA policies. This includes standards for the protection of electronic Protected Health Information (PHI), outlined in 45 C.F.R. Part 164, Subpart C and information and system security categorization level designations in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems and FIPS 200, Minimum Security Requirements for Federal Information Systems. Baseline security controls shall be implemented commensurate with the FIPS 199 system security categorization (reference VA Handbook 6500 and VA Trusted Internet Connections (TIC) Architecture). |
| b. | Contracted new developments require creation, testing, evaluation, and authorization in compliance with VA Assessment and Authorization (A&A) processes in VA Handbook 6500 and VA Information Security Knowledge Service to obtain an Authority to Operate (ATO). VA Directive 6517, Risk Management Framework for Cloud Computing Services, provides the security and privacy requirements for cloud environments. |
| c. | VA IT contractors, subcontractors and third-party service providers shall address and/or integrate applicable VA Handbook 6500, VA Handbook 6517, Risk Management Framework for Cloud Computing Services and Information Security Knowledge Service specifications in delivered IT systems/solutions, products and/or services. If systems/solutions, products and/or services do not directly match VA security requirements, the contractor shall work though the COR/CO to identify the VA organization responsible for governance or resolution. Contractors shall comply with FAR 39.1, specifically the prohibitions referenced. |
| d. | The contractor (including producers and resellers) shall comply with Office of Management and Budget (OMB) M-22-18 and M-23-16 when using third-party software on VA information systems or otherwise affecting the VA information. This includes new software purchases and software renewals for software developed or modified by major version change after the issuance date of M- 22-18 (September 14, 2022). The term “software” includes firmware, operating systems, applications and application services (e.g., cloud-based software), as well as products containing software. The contractor shall provide a self- attestation that secure software development practices are utilized as outlined by Executive Order (EO)14028 and NIST Guidance. A third-party assessment provided by either a certified Federal Risk and Authorization Management Program (FedRAMP) Third Party Assessor Organization (3PAO) or one approved by the agency will be acceptable in lieu of a software producer's self- attestation. |
| e. | The contractor shall ensure all delivered applications, systems and information systems are compliant with Homeland Security Presidential Directive (HSPD) 12 and VA Identity and Access management (IAM) enterprise identity management requirements as set forth in OMB M-19-17, M-05-24, FIPS 201-3, |
Personal Identity Verification (PIV) of Federal Employees and Contractors (or its successor), M-21-31 and supporting NIST guidance. This applies to Commercial Off-The-Shelf (COTS) product(s) that the contractor did not develop, all software configurations and all customizations.
| f. | The contractor shall ensure all contractor delivered applications and systems provide user authentication services compliant with VA Handbook 6500, VA Information Security Knowledge Service, IAM enterprise requirements and NIST 800-63, Digital Identity Guidelines, for direct, assertion-based authentication and/or trust-based authentication, as determined by the design and integration patterns. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV and/or Common Access Card (CAC), as determined by the business need and compliance with VA Information Security Knowledge Service specifications. |
| g. | The contractor shall use VA authorized technical security baseline configurations and certify to the COR that applications are fully functional and operate correctly as intended on systems in compliance with VA baselines prior to acceptance or connection into an authorized VA computing environment. If the Defense Information Systems Agency (DISA) has created a Security Technical Implementation Guide (STIG) for the technology, the contractor may configure to comply with that STIG. If VA determines a new or updated VA configuration baseline needs to be created, the contractor shall provide required technical support to develop the configuration settings. FAR 39.1 requires the population of operating systems and applications includes all listed on the NIST National Checklist Program Checklist Repository. |
| h. | The standard installation, operation, maintenance, updating and patching of software shall not alter the configuration settings from VA approved baseline configuration. Software developed for VA must be compatible with VA enterprise installer services and install to the default “program files” directory with silently install and uninstall. The contractor shall perform testing of all updates and patching prior to implementation on VA systems. |
| i. | Applications designed for normal end users will run in the standard user context without elevated system administration privileges. |
| j. | The contractor-delivered solutions shall reside on VA approved operating systems. Exceptions to this will only be granted with the written approval of the COR/CO. |
| k. | The contractor shall design, develop, and implement security and privacy controls in accordance with the provisions of VA security system development life cycle outlined in NIST 800-37, Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy, VA Directive and Handbook 6500, and VA Handbook 6517. |
| l. | The Contractor shall comply with the Privacy Act of1974 (the Act), FAR 52.224- 2 Privacy Act, and VA rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish a VA function. |
| m. | The contractor shall ensure the security of all procured or developed information systems, systems, major applications, minor applications, enclaves and platform information technologies, including their subcomponents (hereinafter referred to as “Information Systems”) throughout the life of this contract and any extension, warranty, or maintenance periods. This includes security configurations, workarounds, patches, hotfixes, upgrades, replacements and any physical components which may be necessary to remediate all security vulnerabilities published or known to the contractor anywhere in the information systems (including systems, operating systems, products, hardware, software, applications and firmware). The contractor shall ensure security fixes do not negatively impact the Information Systems. |
| n. | When the contractor is responsible for operations or maintenance of the systems, the contractor shall apply the security fixes within the timeframe specified by the associated controls on the VA Information Security Knowledge Service. When security fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the contractor shall provide written notice to the VA COR/CO that the patch has been validated as to not affecting the Systems within 10 business days. |
| 7. | INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE OR USE. |
This entire section applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (cloud and non- cloud) hosted, operated, maintained, or used on behalf of VA at non-VA facilities.
| a. | The contractor shall comply with all Federal laws, regulations, and VA policies for Information systems (cloud and non-cloud) that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities. Security controls for collecting, processing, transmitting, and storing of VA sensitive information, must be in place. The controls will be tested by VA or a VA sanctioned 3PAO and approved by VA prior to hosting, operation, maintenance or use of the information system or systems by or on behalf of VA. This includes conducting compliance risk assessments, security architecture analysis, routine vulnerability scanning, system patching, change management procedures and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures shall be the same as procedures used to secure VA-operated information systems. |
| b. | Outsourcing (contractor facility, equipment, or staff) of systems or network operations, telecommunications services or other managed services require Assessment and Authorization (A&A) of the contractor’s systems in accordance with VA Handbook 6500 as specified in VA Information Security Knowledge |
Service. Major changes to the A&A package may require reviewing and updating all the documentation associated with the change. The contractor’s cloud computing systems shall comply with FedRAMP and VA Directive 6517 requirements.
| c. | The contractor shall return all electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) on non-VA leased or non-VA owned IT equipment used to store, process or access VA information to VA in accordance with A&A package requirements. This applies when the contract is terminated or completed and prior to disposal of media. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Information Security Knowledge Service requirements and NIST 800-88. The contractor shall send a self-certification that the data destruction requirements above have been met to the COR/CO within 30 business days of termination of the contract. |
| d. | All external internet connections to VA network involving VA information must be in accordance with VA Trusted Internet Connection (TIC) Reference Architecture and VA Directive and Handbook 6513, Secure External Connections and reviewed and approved by VA prior to implementation. Government-owned contractor-operated systems, third party or business partner networks require a Memorandum of Understanding (MOU) and Interconnection Security Agreements (ISA). |
| e. | Contractor procedures shall be subject to periodic, announced, or unannounced assessments by VA officials, the OIG or a 3PAO. The physical security aspects associated with contractor activities are also subject to such assessments. The contractor shall report, in writing, any deficiencies noted during the above assessment to the VA COR/CO. The contractor shall use VA’s defined processes to document planned remedial actions that address identified deficiencies in information security policies, procedures, and practices. The contractor shall correct security deficiencies within the timeframes specified in the VA Information Security Knowledge Service. |
| f. | All major information system changes which occur in the production environment shall be reviewed by the VA to determine the impact on privacy and security of the system. Based on the review results, updates to the Authority to Operate (ATO) documentation and parameters may be required to remain in compliance with VA Handbook 6500 and VA Information Security Knowledge Service requirements. |
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