Statement of Work DRAFT 7.20.2025.docx

Statement of Work Mobile MRI Services

(DRAFT)

1. General Information

1.1 Overview: This is a non-personal services requirement to provide Mobile MRI Scanner Services for the Department of Veterans Affairs, Carl Vinson VA Medical Center (CVVAMC), Radiology Service. The Government will not exercise any supervision or authority over the Contractor personnel providing these services. Contractor personnel rendering services under this requirement are not subject, either by the contract terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees. Such contract services providers shall be accountable solely to the Contractor who, in turn, is responsible for deliverance the products and services to the Government as stated herein.

1.2 Contract Type: Firm Fixed Price

1.3 Place of Performance: Carl Vinson VA Medical Center, Radiology Service 1826 Veterans Blvd. Dublin, GA 31021

1.4 Period of Performance: The services shall be provided for one (1) 12-month base period, and four (4) 12-month option periods.

1.5 Hours of Operation: The contractor shall provide the service during the hours of operation Monday-Friday 8:00 AM – 4:30 PM eastern standard time (EST) and is subject to change depending on the Governments need. Weekends may be added through contract modification if funds permit. The Government observes the following holidays:

Other Federal Holidays

Any other day specifically declared to be a national holiday (per Federal Statute, Executive Order, or by the President’s Proclamation).

2. Scope: The Contractor shall provide all personnel, equipment, materials, supplies, services, and supervision necessary to provide mobile MRI scanner services and qualified MRI technologists as detailed in the schedule of Supplies/Services and Price/Cost, all in accordance with the Statement of Work (SOW), terms and conditions described herein. to perform imaging procedures at the Carl Vinson VAMC, Dublin, GA as stated herein.

3. Performance Requirements: Mobile MRI scanner shall be outfitted with changing area and locker for patient use and a ‘szramp of lifting device for non-walking patients.

3.1 Specifications (Mobile MRI): The contractor shall provide a mobile magnetic resonance scanner (mobile MRI) to perform the following examinations:

A. Head (including brain, posterior fossa, temporomandibular Joint (TMJ), pituitary gland, and acoustic nerve, MRA and MRV capabilities.

B. Cervical spine (including spinal cord) C. Thoracic spine (including spinal cord) D. Lumbar spine (including spinal cord) E. Spine F. Extremities (multipurpose- flexible-lightweight coils) G. Abdomen (single flexible- lightweight coil) H. Pelvis (prostate) Array Coil

3.2 Mobile Equipment:

A. Minimum Requirements: The contractor shall deliver and remain on station, a clean well-maintained state-of-the-art mobile MRI unit with a minimum of a 1.5 tesla magnet system with a 70cm wide short bore, within a 12-foot wide by 60-foot- long trailer, containing a detachable table or an MRI safe stretcher for patient transfer (per safety protocol), designed to perform body, abdominal, neurological, vascular, and extremity and joint imaging. Mobile MRI scanner shall be outfitted with changing area and locker for patient use and a ‘szramp of lifting device for non-walking patients. The contractor will have available, at contractor expense, surface coils for performance or all imaging studies. The Contractor shall be responsible for maintenance of all connectivity cables from the unit to the fixed connectivity ports. The Dublin VAMC will provide well maintained fixed connectivity ports. The contractor shall be responsible for connecting and disconnecting power, phone, and network connections during each visit. The MRI acquisition environment will have a means of redundant backup of all patient data.

B. Communication with MRI workstation technology and Radiology service medical printers. The Dublin VAMC Radiology Service presently has Lexmark printers. The Contractor shall ensure that all software and licenses necessary to have full Digital Imaging Communications in Medicine (DICOM) communication between the MRI workstation technology and Dublin VAMC Radiology service medical printers are acquired and installed.

C. Communication between MRI systems and Radiology service Picture Archiving and Communication System (PACS). Contractor shall ensure that a convenient and robust means of DICOM transfer of MRI studies to the VAMC Radiology Service PACS is operational. The Contractor shall obtain and provide to VAMC any technology necessary to ensure that MRI studies can be conveniently read of the existing VAMC PACS display technology. Any peripherals and the VAMC does not have but that are needed to ensure convenient and timely display of MRI studies in the Dublin VAMC Radiology service will be obtained by the contractor, be installed, and maintained by the Contractor, and become the property of the VAMC. Such technology will be retained by the VAMC so that at future dates the archived studies can be reviewed. Each MRI study will be transferred to the VAMC PACS immediately following acquisition of the study so that it can, if necessary, be reviewed before the patient leaves the mobile MRI.

3.3 The equipment shall have the capabilities necessary to perform the following:

A. Dedicated imaging protocols for head and spine applications. optimum water or fat selective excitation imaging, in multi-slice or 3D volume technique.

B. Pre-pulses that achieve suppression of blood signal for optimum lumen visualization in vascular imaging.

C. Dedicated imaging protocols for orthopedic applications with metal suppression software.

D. High quality imaging for assessment of lesions in all anatomical areas.

E. Complete clinical studies that are selectable at a single touch.

F. Performance of automatic planning method based on flexibility to chose three anatomical landmarks.

G. Copying of all examination parameters from any previous scan to a new acquisition.

H. Selection of image matrix sizes freely up to 1024 X 1024.

I. Dynamic studies with all imaging methods allowing entire scans to be repeated multiple times.

J. Manual start controlled from the gantry or operator’s console.

K. Various motion and artifact reduction techniques.

L. Spin Echo M. Fast field echo N. Turbo spin echo O. Echo planar imaging P. Inversion recovery Time of flight imaging Q. Phase contrast imaging R. Quantitative flow studies S. Imaging using 3D k-space shutter T. Pre-pulses (pre-saturation, magnetization transfer contrast, fat saturation) U. Movie for sequential display of up to 24 slices of dynamics/phases V. Rapid T2 Weighted MR imaging W. The MRI shall be capable of performing 1mm thick scan images.

3.4 Pre-operation Tests of Mobile Unit: The Contractor and Dublin VAMC personnel will conduct tests of the mobile units when they are first located. The tests will be performed to ensure the units are working properly, to ensure proper connectivity and functioning before the contract begins.

3.5 Equipment Maintenance: The Contractor shall have, throughout the period of the contract, a service contract with the vendors of the mobile units. These service contracts will include service on the MRI, and on any peripherals required to ensure connectivity to the Dublin VAMC Radiology Service PACS. No routine maintenance will be scheduled or performed such that it conflicts with the imaging schedules of the mobile MRI. No maintenance will be scheduled or performed during scheduled scanning hours except to address emergency failures of the mobile units. Service response time to emergency failures shall be within two hours.

3.6 Supplies:

A. The Contractor shall be responsible for providing all necessary cryogen.

B. The Contractor shall provide a clean mobile MRI and dispose of trash in a responsible manner.

3.7 Contractor Personnel

A. Mobile Unit Staffing: The Contractor shall be solely responsible for hiring, training, and compensation the MRI technologists and assistants needed to perform MRI examinations. It is required that staffing levels be such that the mobile units operate competently, professionally, and efficiently. All technologists shall have all credentials necessary to work as such within the VA system. All technologists must have current certifications in basic life support procedures. All technologists must maintain all immunizations required of practicing medical professionals. All technologists must adhere to all relevant radiation safety practices and relevant magnetic safety practices. All technologists must always work in a professional manner.

B. MRI Technologist (Qualifications)

(1) Must be registered under the American Registry of Radiologic Technologists (ARRT).

(2) Must be Basic Life Support (BLS) certified

(3) Must be Cardiopulmonary Resuscitation (CPR) certified

(4) Preferably at least three (3) years’ experience.

(5) All training and certifications must be up to date and maintained through the life of the contract.

4. Tasks:

A. Contractor shall provide mobile MRI Services utilizing equipment meeting the minimum specifications listed under Paragraph 3.

B. Contractor shall be available and provide patient exams five (5) days per week, excluding Federal Holidays listed below.

C. Contractor shall perform arrival and departure such that the fixed mobile MRI unit operates full days (8AM-4:30PM EST).

D. Contractor shall verify that equipment is used for federal government contract work only.

E. Contractor shall be solely responsible for all driver-staffing issues related to the mobile MRI.

F. Contractor shall perform arrival, set-up, take-down, and departure of mobile MRI in a manner that results in limited or no disruption to normal operations of the Dublin VAMC.

G. Contractor shall perform an estimated sixteen to twenty (16-20) MRI studies per day.

H. Contractor shall provide an accurate screening form for each patient.

I. Contractor shall provide an “Average” patient scan time of thirty (30) minutes.

J. Contractor shall provide a system that is compatible with Vista Imaging.

K. Contractor shall transfer images to Vista Imaging immediately on completion of each scan via network connection.

L. Contractor shall abide by all VA hospital rules and regulations, to include all VA Information and Security guidelines.

M. Contactor shall maintain all training, licenses, and certifications to perform this service and provide technologist that meet the qualifications in paragraph 3.

N. Contractor shall be solely responsible for all technologist and other staffing issues related to operation of the mobile MRI.

O. Contractor shall provide each day a clean mobile MRI and dispose of trash in a responsible manner.

P. Contractor shall adhere to all Health Insurance Portability and Accountability Act (HIPPA) and Occupational Safety and Health Administration (OSHA) requirements and regulations.

Q. Contractor shall communicate effectively with radiologist and physicians.

R. Contractor shall provide excellent customer service to all patients and staff.

S. Contractor shall provide back-up MRI technologists when needed to limit and downtime.

5. Government Responsibilities:

5.1 Utilities and Government Furnished Items:

A. Fiber reinforced concreate pad B. Power outlet located approximately 25 feet from the pad. (The contractor must provide the needed power requirements. An example of power requirements would be 480 volts, 3 phase, 150 amps, 112kVA).

C. Water for MRI unit, if needed D. One (1) telephone line located near the power outlet.

E. One computer terminal with Dublin VAMC Radiology PACS network access.

F. Telephone instruments as needed for the mobile unit(s) G. Restroom facilities within a reasonable walking distance H. Provide all supplies, including basic consumables and linens required to perform the MRI examinations.

5.2 Site Maintenance: The Dublin VAMC will be responsible for maintenance of a concrete pad appropriate for support and location of the mobile units. The Dublin VAMC will be responsible for maintenance of connectivity ports appropriate for linking the mobile units to power, computer network, and local-access phone/modem/fax as needed. The telephone technology will include one line dedicated for direct access to the code emergency response line in the Dublin VAMC. The emergency phone line must be a dedicated sole sure line. The Dublin VAMC will be responsible for connectivity from within the Dublin VAMC to connectivity ports located outside the Dublin VAMC facility at the site of the pad. The Contractor shall be responsible for connectivity from within the mobile units to the connectivity ports of the Dublin VAMC.

6. Other Requirements:

6.1 Study Quality: The Contractor shall provide the Dublin VAMC a study-quality standard (a binder and/or CD of data and studies) that reflects the quality of the studies the contractor is prepared to ensure will be maintained throughout the duration of the contract. Examples of most, if not all, study types to be performed will be included in the study-quality standard.

6.2 Medical Records: Clinical and/or other medical records, including images in DICOM form, of VA beneficiaries treated by the Contractor must be forwarded to Dublin VAMC and shall remain the property of the USD Government. The Dublin VAMC will own solely the data/images of the examinations and studies performed on the mobile unit.

6.3 Insurance: The Contractor shall provide proof of liability and workers’ compensation, a certificate of insurance providing evidence of liability coverage including the name of the insurance carrier, limits of liability and type of coverage (Ref: VAAR 852.237-7, Indemnification and Medical Liability Insurance). Standard requirement, $200,000.00 per person and $500,000.00 per occurrence for bodily injury and $20,000.00 per occurrence for property damage as well.

6.4 Medical Emergencies: The Contractor shall provide to the Dublin VAMC written emergency plans addressing emergencies such as patient codes, personal injury, fire, and disruptive behavior. A crash cart will be appropriately located within the Dublin VAMC. All emergencies will be handled by Dublin VAMC code Team. The mobile Contractor shall provide to the Dublin VAMC written emergency pans addressing emergencies such as patient coded, personal injury, fire and disruptive behavior.

6.5 Regulatory Adherence: The Contractor shall adhere to all relevant regulations regarding patient care, medical practice, use of contract agents, use of radiopharmaceuticals, operation of PET technology, CT technology, and MRI technology. Examples of relevant regulations of those of National Health Physics Program (NHPP), Occupational Safety and Health Administration (OSHA), TJC, National Research Council (NRC), VHA, and various other federal agencies.

6.6 Conflict of Interest: The Contractor shall not employ any person who is an employee of the Untired States Government if the employment of that person would create a conflict of interest. The contractor shall not employ any person who is an employee of the Department of Veterans Affairs, nor shall the Contractor employ any person who is a member of the immediate family of a VA employee, if the employment of that family member would create a conflict of interest, or the appearance of a conflict of interest, particularly with regard to influencing the contract negotiations, terms of the contract or the work carried out under the contract. In any such case, VA must review the matter and give its approval in accordance with agency ethics rules.

7. Quality and Contract Monitoring Procedures: The Contracting Officer (CO) will appoint a Contracting Officer Representative (COR) to assist with the contract monitoring requirements. The COR will monitor such items as quality of services, timeliness of performance, customer service, cost control, and business relations. The COR is not authorized to make or approve any changes to the contract. Any changes can only be made by the Contracting Officer.

7.1 Quality Control Plan: The contractor is responsible for performance of ALL terms and conditions of the contract. The Contractor shall be responsible for Contractor performance management and quality control actions to ensure performance complies with all requirements stated in the contract. The Contractor shall develop a quality control plan (QCP) to ensure services are performed in accordance with this SOW and provide a copy of the QCP to the Contracting Officer Representative (COR). The Contractor shall have readily available several phantoms that can be used to determine MRI parameters. Phantom studies must be conducted as needed to test and ensure study quality.

7.2 Quality Assurance: The performance standards outlined in the Government’s Quality Assurance Surveillance Plan (QASP) define desired services and will be used to determine the level of contractor performance in the elements defined. The Performance Requirement Summary (PRS) Matrix (para 7.3) lists performance standards and Acceptable Quality Levels (AQL) to determine if the contractor exceeds, meets, or does not meet the standards.

A. The COR will be responsible for monitoring contractor performance under this contract to ensure all services comply with all requirements. CORs will provide contract progress reports quarterly to the Contracting Officer (CO) reflecting performance on this plan and all other aspects of the resultant contract. The COR will document and notify the Contracting Officer (CO) of any noncompliance immediately upon his/her gaining knowledge of any such situation or incident. Initial communication of such may be communicated by telephone. After such communication, the COR will provide a written statement to the CO along with any supporting documentation regarding the performance failure noticed.

B. Both parties will jointly conduct a review of Contractor’s performance to evaluate if services being provided are in accordance with the contract terms and if payments and billings are being properly handled. This review shall include but is not limited to analysis of all billings, payments, costs, administrative issues, patient satisfaction, quality of care, and other related documentation that identifies that services have been received. Any concerns need to be brought to the Contractor/COR’s attention at the time noted rather than an agreement reached prior to the expiration of services provided and consideration being received are satisfactory.

C. Upon conclusion of each contract period, including the final contract period, the Government will prepare and submit a past performance evaluation electronically in the Contractor Performance Assessment Reporting System (CPARS). The CPARS will be available for Contractor review. These evaluations, including any contractor-submitted information, become available for source selection officials not later than 14 days after the date on which the contractor is notified of the evaluation's availability for comment.

7.3 Performance Requirements Summary Matrix

Requirement (Task/Objective)

SOW

Reference

Level (AQL)

in past performance reports (CPARS), and/or contract termination.

Adhere to HIPPA requirements

COR and Radiology management A positive or negative performance will be documented in past performance reports (CPARS), and/or contract termination

documented in past performance reports (CPARS), and/or contract termination

documented in past performance reports (CPARS), and/or contract termination

4H Complete all scheduled exams

in past performance reports (CPARS), and/or contract termination

8. IT Contract Security: VA Information and Information System Security/Privacy

8.1 General

A. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

8.2 Access to VA Information and Information Systems

A. A contractor/subcontractor shall request logical (technical) or physical access to VA information and FA information system for their employees, subcontracts, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

B. All contractors, subcontractor4s, and third-party servicers, associates working in the VA are subject to the same investigative 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 must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

C. Contract personnel who require access to national security programs must have a calid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations Security and Preparedness.

D. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan deemed to be acceptable by VA, specially to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

E. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

8.3 VA Information Custodial Language:

A. Information made available to the contractor or subcontractor by VA for performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause limits the contractor/subcontractor’s rights to use data as described in Rights in Data- General, FAR 52-227-14(d)(1).

B. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

C. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in FA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

D. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose, and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and polices become applicable to the VA information of information systems after execution of the contract, or if NISTR issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and polices in the contract.

E. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used y the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

F. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provision of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under FAR part 12.

G. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

H. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

I. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

J. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations. (i) in response to a qualifying order of a court competent jurisdiction, or (ii) with VA’s proper written approval. The contractor/subcontractor must refer all requires for, demands for production, or inquiries about VA information and information systems to the VA Contracting Officer for response.

K. Notwithstanding the provision above, the contractor/subcontractor 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 health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders of other requests to the VA Contracting Officer for response.

L. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

8.4 Information System Design and Development

A. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, Outlined in 45 C.F.R. part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VCA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed provided to the COR and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

B. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future version as required.

C. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VCA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

D. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

E. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development lifecycle as outline in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

F. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

G. The contractor/subcontractor agrees to: (1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies (a) The Systems of Records (SOR) and (b) The design, development, or operation work that the contractor/subcontractor is to perform. (2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act. (3) Include this Privacy Act clause, including this subparagraph (3, in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

H. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function for purposed of the Act, when the contract is for the operation of a SOR on individuals to accomplish and agency function, the contractor/subcontractor is considered to be an employee of the agency.

I. “Operation of a System of Records” means performance of any of the activities associated with maintain the SOR, including the collection, use maintenance, and dissemination of records.

J. “Record: means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person’s name, or identifying number, symbol, or any other identifying particular assigned to the individual such as a fingerprint or voiceprint, or photograph.

K. “Systems of Records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

L. The vendor shall ensure the security of all procured or developed systems and technologist including their subcomponents (here in after referred to as “Systems”), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

M. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical but in no event longer than 30 days.

N. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 30 days.

O. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

8.5 Information System Hosting, Operation, Maintenance, or Use

A. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine, vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

B. Adequate security controls for collecting, processing, transmitting, and storin of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VCA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

C. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems of network operations, telecommunications services, or other managed services requires certification and accreditation (authorizations) (C&A) of the contractor’s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

D. The contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must by provided to the VA contracting officer and the ISO for entry into VA’s POA&M management process. The contractor/subcontractor must use VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies procedures, and practices, and the completion of those activities Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA official, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all the documentation (PIA, System Security Plan, Contingency Plan). The Certification Office can provide guidance on whether a new C&A would be necessary.

E. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

F. VA prohibits the installation and use of personally owned or contractor/subcontractor owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW, or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with and use approved antivirus (AV) software and personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and firewall on the non-VA owned OE.

G. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, access VA information must be handled in adherence with VA Handbook 6500.1. Electronic Media Sanitization upon: (1) completion or termination of the contract or (2) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

H. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: (1) Vendor must accept the system without the drive, (2) VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn in. or (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

I. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for th VA to retain the hard drive, then (1) the equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being retuned physically intact and (2) any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

J. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (1) and (2) controls above are in place and completed. The ISO needs to maintain the documentation.

8.6 Security Incident Investigation

A. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contend in system(s) to which the contractor/subcontractor has access.

B. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

C. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

D. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently repost the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the FVA OIG and 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 third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

8.7 Liquidated Damages for Data Breach

A. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the even of a data breach or privacy incident involving any SPI, the contractor/subcontractor processes or mains under this contract.

B. The contractor/subcontractor shall provide notice to VA of a “security incident” asset forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term “data breath” means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

C. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the even (loss, theft, unauthorized access), (2) Description of the event including, date of occurrence, data elements involved, including an PII, such as full name, social security number, date of birth, home address account number or disability code, (3) Number of individuals affected or potentially affected, (4) Names of induvial or groups affected or potentially affected, (5) Ease of logical data access to the lost, stolen improperly accessed data in light of the degree of protection for the data, e.g., encrypted,, plain text.(6) Amount of time the data has been out of VA control, (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons), (10) data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate, and (11) Whether credit protection services may assist record subjects in avoiding or mitigation the results of identity theft based on the sensitive personal information that may have been compromised.

D. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount $200,000.00 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following, (1) Notification, (2) One year of credit monitoring services consisting of automatic daily monitoring or at least 3 relevant credit bureau reports, (3) Data breach analysis, (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes to assist affected individuals to bring matters to resolution, (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible, and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

8.8 Security Controls Compliance Testing

A. On a periodic basis, VA including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government sponsored security controls assessment at each location wherein VA information is processed or store, or information systems are developed, operated, maintained, or sued on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

8.9 Training

A. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information…