STATEMENT OF WORK

VISN 19 Magnetic Resonance Safety Expert (MRSE) Services

1. BACKGROUND

The Department of Veterans Affairs (VA), VISN 19 Health Care Systems (HCS) have a requirement for certified Magnetic Resonance Safety Expert (MRSE) services for oversight and MRSE duties supporting Health Care System (HCS) locations listed in TABLE 1. Each VA HCS must have a designated MRSE. The Contractor shall provide all MRSE services in accordance with the requirements, standards, governance, practice, and guidelines of sources listed in Section 2.

The MRSE shall serve as a resource for the Magnetic Resonance Medical Doctor (MRMD) and/or Magnetic Resonance (MR) Safety Officer (MRSO), for situations where the MRMD and/or MRSO need assistance, or are otherwise unable to answer, a MR related safety question or situation. The MRSE shall possess a significantly greater depth, breadth, and level of understanding of the physics aspects underlying the various MR safety issues, and shall be able to provide advanced guidance, information, calculations and quantification information, etc. regarding all matters pertaining to MR safety.

MRSE services are required both in person and remotely depending on severity of the requirement.

TABLE 1.

· VA Montana Health Care System 3687 Veterans Dr., Fort Harrison, MT 59636

· Cheyenne VA Health Care System 2360 E Pershing Blvd, Cheyenne, WY 82001

· VA Western Colorado Health Care System 2121 North Ave, Grand Junction, CO 81501

· Oklahoma City VA Health Care System 921 NE 13th St, Oklahoma City, OK 73104

· VA Salt Lake City Health Care System 500 Foothill Blvd, Salt Lake City, UT 84148

2. SCOPE:

The contractor shall provide and ensure that MRSE services are provided by an American Board of Magnetic Resonance Safety (ABRMS) certified expert and services provided meet or exceed standards and regulatory requirements for Magnetic Resonance Imaging (MRI), consistent with:

· National Health Physics Program (NHPP) (http://www.patientcare.va.gov/nhpp.asp)

· Joint Commission on Accreditationwww.jointcommission.org

· The American College of Radiology (ACR) practice guidelines http://www.acr.org/~/media/ACR/Documents/PGTS/standards/ElectronicPracticeMedImg.pdf

· Occupational Health and Safety Administration (OSHA); www.osha.gov

· VHA Master Materials License (MML) permit conditions for the VA HCS

· Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia updates/Vol_XVII_4/page2.htm

· The contractor shall adhere to the following policy/handbooks:

· VA Directive 1663: Health Care Resources Contracting - Buying http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347

· Veterans’ Health Administration (VHA) Directive 2006-041 “Veterans’ Health Care Service Standards” https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443

· VHA Directive 1105.05: Magnetic Resonance Safety

· https://dvagov.sharepoint.com/sites/VHADiagnosticservices/NRP2/SitePages/MRI-Directives-and-SOPs.aspx

· VHA Handbook 1100.17: National Practitioner Data Bank Reports - http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

· VHA Handbook 1100.18 Reporting And Responding To State Licensing Boards - http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

· VHA Handbook 1100.19 Credentialing and Privileging – http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

· VHA Directive 2012-030 Credentialing of Health Care Professionals – http://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=2815

· VHA Handbook 1907.01 Health Information Management and Health Records: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791

3. MANDATORY SERVICES TO BE PERFORMED IN PERSON/ON-SITE:

The functions of the MRSE shall be performed in-person/on site at each VA HCS location.

For each location, the VA HCS MRSE shall:

· Report- in-person, on-site, within 72 hours of notification of incidents/emergencies at VA HCS locations when the COR determines that MRSE presence is essential.

· Actively participate in the planning, installation, and acceptance testing of new systems and / or equipment for VA HCS sites to include but not limited to shield testing of MRI rooms. This service shall be done in-person/on-site; estimated 10 hours per year, per site.

4. SERVICES THAT MAY BE PERFORMED REMOTELY:

· Provide either written, or verbal information through Magnetic Resonance Imaging (MRI) Safety Committee meeting agenda items and meeting minutes quarterly.

· Provide MRI Implant Safety Review notes through the electronic medical record (EMR) showing an MRI Safety review for medically implanted device has been conducted. Contractor will include scanning parameter changes required for the safe scanning of an implanted device by using the MRI Safety Note template in the EMR. MRI Safety Committee meeting agenda and minutes quarterly will be shared with VA HCS Radiology Service Chief and MRSO upon completion.

· Collaboration / creation or assistance in providing written guidance to Radiology MRMD, Service Chief and or designated MRSO on administrative aspects of the safe use of Magnetic Resonance (MR) equipment; the development of local rules and procedures related to MR safety; nonroutine MR processes, including but not limited to implanted medical devices; and the development and maintenance of MR Safety programs and MR Quality Assurance programs Quarterly.

· Quarterly for VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City: Input and or creation of Quarterly MRI Safety Meeting Agenda, topics to discuss in accordance with National Radiology Program Office and Joint Commission Requirements.

· Reporting MRI Level I and MRI Level II training deficiencies, issues & employee access to MRI Zones I, II, III, and IV.

· Employee training opportunities for screening patients and employees who enter the MRI environment.

· Reporting of adverse events in MRI for the quarter to include MRI close calls, radiofrequency burns, inappropriately scanned implanted devices, and breaches to MRI Zone IV involving staff, equipment, and supplies.

· MRI contrast reaction drills and mock codes.

· Equipment failures, maintenance downtime, and new equipment activations.

· Policies and process changes such as MRI ordering guidelines, Standard Operating Procedures, Pacemaker Processes, MRI Safety Directive Changes, MRI protocol changes, and scheduling changes directly impacting the safety of patients and Staff.

· Reporting trends noticed involving MRI Safety review and screening by providers and technologist staff. MRI Screening processes, implants changing from conditional to unsafe or unsafe to conditional.

· Create or provide assistance to each participating site with consultation to the Magnetic Resonance Safety Officer (MRSO) and Magnetic Resonance Medical Doctor (MRMD) on the development of Magnetic Resonance Imagining (MRI) protocols to allow the safe imaging of patients with MRI conditional implanted devices for each facility through Outlook, Teams, EMR MRI Safety notes as requested by the participating facilities with or without Magnetic resonance safety officers.

· Actively create and/or participate and approve new protocols as needed when alerted by participating facilities Chief or Radiology, MRMD, or MRSO. Estimated 5 hours per year for each participating site: VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City.

· Provide written and/or verbal guidance to VISN 19 HCS and service Chiefs on clinical and administrative aspects of the safe use of MRI equipment. Estimated 12 hours per year for each of the following locations: VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City.

· Create and/or assist in the development of local rules and procedures related to MR Safety; non-routine MRI processes, including but not limited to implanted medical devices. Estimated 12 hours per year for each site: VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City.

· Create and /or assist in development and maintenance of MR Safety programs and MR Quality Assurance Programs at each VA HCS location through Teams, Outlook, or in-person (MRI Safety meetings, and Annual Reviews): VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City.

· Complete and provide oversight into the MRI Safety program through Annual reviews and audits, to include:

· Annually review the MRI safety program review as specified in 10 CFR 20.1101 to include locations of use with emphasis on decommissioning records as specified in 10 CFR Part 30 in conjunction with the MRSO.

· Review or audit events, related to scanned implants, Specific Absorption Rate (SAR) exposure, MRI Safety Trained employees (Level 1 & Level 2) and Quality Assurance scans Quarterly.

· Evaluate results from audits, reviews and inspections to determine possible generic issues or trends. Identify root causes, specify corrective actions and actions to prevent recurrence Quarterly.

· Provide oversight and follow-up to resolve health and safety issues and MRI Safety program deviations as needed by participating facilities, reported Quarterly through participating facility specific MRI Safety Quarterly meetings.

· Serve as the Subject Matter Expert (SME) for root cause analyses or administrative investigations related to adverse MRI events. Examples include and are not limited to; patient safety incidences aka Joint Patient Safety Reporting (JPSR) , magnet quench, and implanted device safety questions for VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City. Estimated 6 hours per year per site via Teams or Outlook. Total estimated hours for participating VISN 19 sites is 30 hours.

· Attend and participate as subject matter expert (SME) of MRI safety topics and incidences in Quarterly MRI Safety meetings and Annual Risk assessments for the following participating sites: VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City. Estimated 7 hours, per site per year to include 1 hour per quarter, per site, via Teams calls/meeting. A total of 35 estimated hours per year for all 5 participating VISN 19 facilities.

· Collaborate and review MRSO & MRMD report of findings discussed in quarterly MRI Safety Committee meetings to the Safety Committee on compliance to National Health Physics Program (NHPP), The Joint Commission (TJC), and Veterans Health Administration (VHA) standards for Magnetic Resonance Imaging. This is done through HCS participating locations and their respective Safety Committee meetings performed Quarterly for the following participating VISN 19 sites: VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City.

· Ensure that VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City meet all NHPP, Nuclear Regulatory Commission (NRC), state, federal, and Joint Commission requirements and exist in a state of compliance for all inspections government inspections.

· The contractor shall consult with VA HCS MRMD and MRSO quarterly regarding facility sites’ status of compliance and or propose changes in regulations, processes or procedures to ensure each participating site complies. MRMD, MRSE and RSO for each VA HCS will determine if compliance is met for each Participating site: VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City. A copy of this report shall be kept by the specific Site MRSO and or MRMD and shared with the MRSE in accordance with NRC 10 CFR 20.1101. Each participating site may require a specific approved format for their individual report. For sites that do not have an MRSO, the MRSE shall create, provide, and archive the required information.

· Create and/or assist the VISN 19 HCS MRSO, and MRMD in completion of annual MRI Safety training report through the Talent Management System (TMS) with hands on training of Level one and Level two staff for each VISN 19 facility (VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City). This can be done through Teams, or on-site. Documentation of all training will be compiled by the local MRSO or MRMD unless the participating VISN 19 HCS does not have a designated MRSO. MRMD will be required to furnish this information to the MRSE.

· Review, at minimum, every 6 months, any identified health and safety issues and determine the need for MRI safety program deviations from regulatory compliance or required practices for the following VISN 19 participating sites: VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City.

· Remain compliant and up-to-date with any requirement changes as mandated by all agencies having jurisdiction such as Joint Commission, National Radiology Program Office, American College of Radiology, and National Regulatory Committee.

· Provide timely communication; return all urgent phone calls from participating VISN 19 sites within two (2) hours for emergent needs. Return non-emergent phone calls within twenty-four (24) hours to the participating VISN 19 sites (VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City).

· Assist each VA HCS MRSO and MRMD by reviewing, suggesting areas for improvement, updating policies, and or Medical Center Memorandums pertaining to MRI Safety, procedures, and any service level guidelines. MRSO and MRMD must ensure documentation has been approved through proper channels and disseminated to appropriate stakeholders. Policies, Standard Operating Procedures (SOP)’s, and Medical Center Memorandums must be saved for the following participating sites: VA Montanna, VA Cheyenne, VA Western Colorado, VA Oklahoma City, and VA Salt Lake City on their respective S drives and / or Radiology SharePoint sites for ease of reference.

5. LOCATIONS:

VISN 19 Site Magnets:

· VA Salt Lake City, Utah - Siemens 1.5T Sola & 3T Skyra

· VA Cheyenne, Wyoming - Cannon 1.5T

· VA Oklahoma City, Oklahoma - Siemens 1.5T & 1.5T GE

· VA Grand Junction, Colorado - 1.5T Trailer

· VA Fort Harrison, Montana - 1.5T Philips Total magnets: 7

6. GOVERNMENT RESPONSIBILITES:

· Provide reports

· Share the safety program

7. QUALIFIED PERSONNEL:

MRSE performing services under this contract shall be a (1) Board-Certified Medical Physicist or a (2) Board-Certified Radiologist with ABRMS certification. Certification shall be maintained throughout the contract performance period.

Contractor shall provide the VA Contracting Officer’s Representative (COR) documentation of certification compliance upon request.

7.1 QUALIFICATIONS OF A BOARD-CERTIFIED MEDICAL PHYSICIST:

1. Medical Physicists shall be Board Certified in Diagnostic Medical Physics by one of the following approved certifying bodies and provide documentation of certification to the COR on an annual basis:

a. American Board of Magnetic Resonance Safety (ABMRS)

b. Diagnostic Medical Physicist through the American Board of Radiology (ABR).

2. Physicists shall maintain licensure with the Board of Licensure for Professional Medical Physicists.

3. Education – Physicists must have a master’s degree or higher. The degree must be in a physics, science, or engineering discipline recognized by an accredited college or university with at least 30 semester hours in medical physics, health physics, radiological science, physics, engineering, chemistry, or biology; or an equivalent foreign degree and coursework substantiated by the National Association of Credential Evaluation Services.

a. Contractor(s) shall provide the COR copies of current continuing medical education (CME)s.

b. Contractor(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. CME hours shall be reported to the VA credentialing office for tracking. These documents are required for initial and renewal privileging. Failure to provide shall result in loss of privileges.

7.2 QUALIFICATIONS OF A BOARD-CERTIFIED RADIOLOGIST

1. BOARD-CERTIFIED RADIOLOGIST shall be Board Certified and licensed by the American Board of Radiology and provide documentation of certification and licensure to the COR on an annual basis:

a. American Board of Magnetic Resonance Safety (ABMRS)

2. VA Education Requirement–Completion of a medical degree from an accredited medical school.

Residency: Completion of a residency in radiology, which typically lasts four years.

Board Certification: Obtaining board certification in radiology or a radiologic specialty.

Fellowship: Optional fellowship in a radiology sub-specialty for further specialization.

Certification: Certification in radiologic procedures, such as X-rays, MRIs, and CT scans is required for positions that involve these modalities.

a. Contractor(s) shall provide the COR copies of current continuing medical education (CME)s.

b. Contractor(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. CME hours shall be reported to the VA credentialing office for tracking. These documents are required for initial and renewal privileging. Failure to provide shall result in loss of privileges.

8. CONTRACTOR ACCESS & TRAINING REQUIREMENTS

All Contractor employees dispatched to or working at any of the HCS designated sites identified herein shall obtain and wear a VA issued badge (PIV Card) while performing services. VA badges are to be obtained through coordination with the COR/POC. The process to obtain a PIV Card may include fingerprints as well as any required background checks.

Contractor staff shall complete the following TMS based trainings annually: TMS 10203 - Privacy and HIPPA and TMS 10176 – Privacy and Information Security and National Rules of Behavior.

9. BUSINESS HOURS AND HOLIDAYS:

Most of the work determined under this contract shall be performed during the VA Health Care System (VAHCS) regular administrative working hours of 8:00 AM through 4:30 PM, Monday through Friday excluding Federal Holidays. However, there may be times when the Contractor may be needed after regular working hours.

Federal Holidays: The holidays observed by the Federal Government are:

New Years' Day Martin Luther King Jr. Day Presidents' Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans’ Day Thanksgiving Day Christmas Day Any other day specifically declared by the President of the United States to be a Federal Holiday.

When one of the holidays falls on Sunday, the following Monday shall be observed as a Federal Holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

10. MANAGEMENT, SUPERVISION, AND TRAINING:

Contractor shall be responsible for supervising the daily services of their personnel provided under this Contract; and shall provide and document orientation and training programs for all employees regarding safety, equipment management, and patient confidentiality appropriate to the service provided.

The Contractor shall have written policies and procedures regarding staff credentials.

Contractor should provide orientation to designated staff to agency policy and procedures, and any agency processes necessary to cooperative functioning between the agency and facilities with the Veterans Integrated Service Network (VISN). Updates and refreshers shall be provided upon request and when policy, procedures, or processes change.

Contractor shall complete background investigations to ensure that employees do not have a record of criminal offenses or substantiated incidents of patient abuse; and, if required to perform their duties, employees are properly licensed and insured to operate motor vehicles.

11. QUALITY CONTROL

The Contractor shall develop a Quality Control Plan which will provide the Contractor’s strategy for monitoring performance internally, providing performance information to the Government, and reporting in compliance with the Statement of Work (SOW). Within the Quality Control Plan, the Contractor shall propose and maintain an established reporting system to promptly notify VA of any problems, issues, risks, or concerns with workflow performance, programmatic improvement, security, and schedule adherence. Quality control is the exclusive responsibility of the Contractor.

The work performed under this contract shall be subject to evaluation by the Contracting Officer’s Representative (COR) in accordance with the contract terms and conditions.

12. PERFORMANCE STANDARDS

The table below defines the Performance Standards and Acceptable Levels of Performance associated with this effort.

· Efficient and effective in meeting requirements

· Meets technical needs and mission requirements.

· Provides quality services.

Satisfactory or higher as observed by COR, MRMD and/or MRSO

· Personnel possess necessary knowledge, tools, skills, and abilities to perform the services.

· MRSE performs SME services.

Satisfactory or higher as observed by COR, MRMD and/or MRSO

· MRSE responds timely to communications Satisfactory or higher as observed by COR, MRMD and/or MRSO

Acceptable Performance: The Government shall document positive or negative performance. Any report may become a part of the supporting documentation for any contractual action.

Unacceptable Performance: When unacceptable performance occurs, the COR shall work with the Contracting Officer (CO) to inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case, the COR shall document the discussion and place it in the COR file.

To ensure that the contractor receives impartial, fair, and equitable treatment under this contract, the COR will work with the contractor to increase performance to an acceptable level. When the COR and CO determine formal written communication is required, the COR and CO shall prepare a Notification (Letter or Concern (LOC), Cure Notice, Show Cause Notice) and present it to the Contractor.

1. The contractor shall acknowledge receipt of the LOC Notice in writing.

2. The LOC will specify if the contractor is required to prepare a corrective action plan (CAP) to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The Notice will also state how long after receipt the contractor shall present this corrective action plan to the CO.

3. The Government shall review the contractor's corrective action plan to determine acceptability.

Any Notice may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

13. VA INFORMATION AND INFORMATION SYSTEM SECURITY & PRIVACY LANGUAGE

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 qualityassurance 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 abovementioned 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.

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 M22-18 (September 14, 2022). The term “software” includes firmware, operating systems, applications and application services (e.g., cloud-based software), as well as products containing software. The contractor shall provide a selfattestation that secure software development practices are utilized as outlined by Executive Order (EO)14028 and NIST Guidance. A third-party assessment provided by either a certified Federal Risk and Authorization Management Program (FedRAMP) Third Party Assessor Organization (3PAO) or one approved by the agency will be acceptable in lieu of a software producer's selfattestation.

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. X

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…