Attachment 1 SCOPE OF WORK rev 36C25726Q0027.docx

SCOPE OF WORK

Contractor shall provide a mobile shielded PET/CT Scanner and technologist staffing at designated VA North Texas Health Care System (VANTHCS) facilities. The vendor must have the capability of providing a mobile unit to be available up to 5 days per week, Monday - Friday. The period of performance will begin no later than 60 calendar days after contract award up to one calendar year, with available option years. The scanner will include supporting equipment and software to provide the VANTHCS Nuclear Medicine Service a like system which will provide the same level of care our patients are presently receiving. The vendor will provide appropriate staffing for the Mobile Unit to include Board Certified and trained PET/CT CNMTs. The vendor can provide additional support staff, if deemed necessary. All services shall be provided in accordance with the specifications, terms and conditions contained herein.

1. SERVICES:

Contractor shall provide staffing and a vendor owned mobile PET/CT scanner (minimum features seen below) in a trailer that meets regulatory requirements and specifications. The vendor will transport the mobile PET/CT to and from the pre-determined locations and PACS Network connectivity/hook up. The entire offering of a PET/CT Mobile Trailer service shall meet all local, state, federal, industry, NHPP, NRC, Joint Commission NEC, NFPA, VA, OSHA, and other regulatory standards internal or external applicable to the VANTHCS.

The selected vendor is expected to provide specific services as follows:

· Mobile PET/CT must be operational NLT 90 days after contract award, pending completion of site prep work by VA when applicable for each location.

· Mobile PET/CT unit on site up to 5 days per week, not less than 2 days per week per clinical need, for an estimated 1 year (with possible additional option years).

· System manufacturer of the PET/CT must meet the minimum specifications (PET/CT System Requirements below).

· Vendor shall provide staff technologists familiar with DFW and outlying cities will operate the mobile PET/CT. It is required that the vendor provide documentation of staff certification and appropriate scanner applications training.

· Vendor technologists staff shall utilize VANTHCS Nuclear Medicine Service imaging protocols while performing the exams.

· VA Nuclear Medicine Physicians shall interpret the mobile PET/CT images.

· The Vendor shall provide a minimum of one certified PET/CT Nuclear Medicine Technologist, on all clinical days in operation. In an instance, where the PET/CT technologist is unable to provide coverage the vendor must provide suitable equivalent certified replacement/coverage. All technologist staff shall be PET certified by the Nuclear Medicine Technology Certification Board, and must be BLS certified (additional ACLS certification preferred), and appropriately trained on the equipment. All staff assigned to the contract must have documentation of completed background checks and required security and radiation safety training.

· The Vendor shall be responsible for transporting the unit to and from the determined locations.

· The Vendor shall be responsible for the maintenance of the unit by an OEM FSE, including all Preventative Maintenance (PM), and all Parts and Labor. After each service the OEM FSE must provide a vendor Engineering Service Report (ESR) to Biomed staff.

· VA contracted medical physicist(s) shall be given access to perform appropriate physics testing as necessary to maintain consistency with VA owned equipment or review appropriate documentation of completed testing to ensure adequacy. At a minimum ACR standards must be maintained for all imaging equipment.

· All equipment must be properly maintained and tested in accordance with NRC/NHPP guidelines.

· Vendor shall have a Reciprocal Agreement between the State of Texas and the NRC to use radioactive materials under their State License on any Federal or Federally-leased property.

· Vendor shall be responsible for posting Radioactive Material License (RAML) in mobile unit and providing a copy upon request to appropriate VANTHCS staff.

· The Vendor shall be responsible for cleaning and infection control measures and will provide documentation as necessary to VANTHCS.

· System must be able to transfer image and data to multiple modalities including PACs, MIM, and Cedars (when applicable). OEM FSE will establish network and printer connectivity at the site in coordination with local IT/PACs staff. Verification of connectivity must be made prior to the start of patient procedures.

· Vendor shall be responsible for deleting patient images on all owned devices after appropriate transfer and confirmation of receipt of such images.

· Vendor shall be responsible for inputting/deleting VA network information, such as IP address and AE Title, each instance the coach is brought onsite and taken offsite.

· System scan protocols must be verified and validated by VA North Texas Staff Nuclear Medicine Physicians.

· Vendor shall agree to cooperate with VA for quality control purposes.

· Upon removal of equipment from the VA custody, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units must remain in VA control and will not be removed from VA custody.

· Vendor shall order patient doses and is responsible for the receipt, use, storage, and disposal of all radioactive material IAW State and Federal regulations.

· Vendor shall make available PET PSMA and F18-FDG doses at the minimum for scheduled patients.

· Vendor shall be able to supply specialty PET doses for patient use, including, but not limited to, Ga68 DOTATATE and F18 and Ga68 PSMA agents, F18 Beta-Amyloid. Vendors able to support Cardiac PET using Rb82, Ammonia, or F18-agent(s) are preferred.

Section A:

PET/CT Trailer

· Must provide industry-standard mobile unit; typical minimum size is 8’ 6’’ wide x 48’ long to accommodate full access inside trailer and around PET/CT scanner.

· Trailer must contain an ABA (Architectural Barriers Act) compliant Patient Injection Area.

· Hand washing sink.

· Must include HVAC system that meets manufacture requirements

· Handicapped accessible meeting all ADA guidelines.

· The PET/CT trailer shall provide the space sufficient for the monitoring of injected patients and conducting CPR and code, if needed. Adequate radiation shielding and security measures are requisite.

Section B:

PET/CT Scanner With Minimum Features:

· Siemens Trinion or GE 5-ring MI PET/CT Scanner to best match current digital system(s) in use at VA North Texas Health Care System [specifications described below]

· Must have LYSO crystal-based technology and minimum 64 slice (128 slice preferred) CTAC. Time of flight scanning with a timing resolution less than 600ps is requisite.

· QSuite or equivalent package

· QClear iterative reconstruction or equivalent technology

· QCORE Power upgrade when applicable or equivalent upgrade

· 2M Scan Range preferred

· Most current software level per vendor; studies to be read on MIM software

· Windows 7 or later version (Windows XP not acceptable)

· Metal Artifact Reduction preferred

· SnapShot imaging or equivalent package

· Q Static or equivalent package

· Motion Compensation Technology

· Advanced Scan tools for:

· Cardiac processing to include Myocardial blood flow and quantitation

· Cardiac Ca++ scoring

· Oncology

· Neuro

· PET Bone Imaging

· Low Dose CT Lung Screening

· Post-processing

· High Resolution LCD Monitor

· DICOM Workflow Management

· IHE Schedule Workflow

· Physiological Synchronization

· DVD read/write device

· DICOM Store/Query/Retrieve

· ACR Accredited system Section C:

Service Locations

· The Mobile PET/CT unit’s primary location will be at the Fort Worth VA Outpatient Clinic.

Fort Worth VA Outpatient Clinic 2201 SE Loop 820 Fort Worth, TX 76119

· Additional scanning sites include:

Sam Rayburn Memorial Veterans Center 1201 E. 9th St.

Bonham, TX 75418 Tyler VA Primary Care Clinic 7916 S. Broadway Ave.

Tyler, TX 75703

Dallas VA Medical Center 4500 S. Lancaster Rd.

Dallas, TX 75216

· Additional VANTHCS sites may be determined based on infrastructure availability and patient demand. It is highly preferred vendor provide staff familiar with DFW metroplex and surrounding cities.

2. DEFINITIONS/ACRONYMS:

J. CDRH - Center for Devices and Radiological Health.

K. VA - Department of Veterans Affairs.

L. OEM - Original Equipment Manufacturer

3. GOVERNMENT FURNISHED UTILITIES/SERVICES:

a. The Government will provide the following utilities/services to the Contractor if required for the operation of the mobile PET/CT unit.

1. Electricity*

2. Telephone Line(s) **

3. Data Port

* In accordance to the Original Equipment Manufacturers’ (OEM) electrical specifications.

** Use of telephone extension while mobile unit is on site to permit the unit to make and receive telephone call and to facilitate the movement of patients to and from the unit.

b. The professional component of the PET/CT exams will be provided by VA Nuclear Medicine Physicians.

c. VA staff will be responsible for scheduling the patients for the mobile unit. The patient schedule will be provided to the Mobile Unit staff a minimum of 24 hours in advance. It is expected that Vendor staff will provide patient reminder calls and prep instructions.

d. Contractor will utilize Nuclear Medicine Information System (NMIS) for all appropriate operational processes.

4. PREVENTIVE MAINTENANCE (PM):

A. Contractor shall ensure that the system has current PMs performed by the OEM and is meeting the manufacturer’s specifications.

B. The contractor shall furnish documentation, including all measurement and calibration data to certify that the system is performing in accordance with the performance specifications.

5. EMERGENCY MAINTENANCE:

The contractor will maintain that a greater than 95% uptime of the system is met and that there are provisions for emergency service during normal business hours. All maintenance will be performed by a contract agreement with the OEM.

6. PARTS:

The contractor shall furnish and replace all parts at no additional cost to the Government. The contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be OEM and fully compatible with existing equipment. The contract shall include all parts with the exception of consumable or expendable items. The contractor shall use new or rebuilt parts. Used parts, those removed from another system, shall not be installed without approval by Biomedical Engineering and/or VA North Texas Medical Physicist.

7. REPORTING REQUIREMENTS:

The contractor shall contact Biomedical Engineering prior to performance of work under this contract. This check-in is mandatory and can be accomplished in person or by phone contact. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s).

8. ADDITIONAL CHARGES:

There will be no additional cost to the government for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts.

9. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:

The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify VA North Texas HCS of the existence or the development of any defects in, or repairs required to be scheduled. Documentation of repair and physics evaluation is required.

10. CONDITION OF EQUIPMENT:

The vendor shall provide equipment that at a minimum meets ACR standards and requirements.

11. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

A. Each respondent must have an established business with “fully qualified” FSE who is familiar with the equipment identified in Section B.

B. “Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment identified in Section B. For field experience, the FSE(s) shall have a minimum of one year of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on equipment identified in Section B.

C. The FSE(s) shall be authorized by the contractor to perform the maintenance services as required. All work shall be performed by "Fully Qualified" competent FSEs. The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for the make and model of the equipment leased to the VA North Texas. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VA North Texas equipment. The CO and/or the COR specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VA North Texas leased equipment.

12. TEST EQUIPMENT:

Prior to commencement of work on this contract, the contractor shall make available, if requested, a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by the VA North TX. Test equipment calibration shall be traceable to a national standard.

13. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS:

The contractor's FSE shall wear visible identification at all times while on the premises of the VANTHCS. It is the responsibility of the contractor to park the mobile unit in the appropriate designated parking areas. Designated parking areas will be determined in advance of mobile unit delivery. Additionally, information on parking will be available from the VA Police-Security Service. The VANTHCS will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VANTHCS. Possession of weapons is also prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

14. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD:

The contractor shall comply with the Federal/Texas OSHA Bloodborne Pathogens Standard. The contractor shall:

a. Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

b. Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens.

c. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

d. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

APPENDIX C — VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY LANGUAGE FOR INCLUSION IN CONTRACTS, AS APPROPRIATE NOTE: Any sections (1-14) which DO NOT apply should not be included in the Statement of Work (SOW), Performance Work Statement (PWS), Product Description (PD) or contract.

1. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

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

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C. § 5705, Confidentiality of medical quality- assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above- mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA.The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

e. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:

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

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

(3) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company- owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(4) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

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

(6) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA accesses will return VA- issued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO.

4. TRAINING. This entire section applies to all acquisitions which include section 3.

a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems:

(1) VA Privacy and Information Security Awareness and Rules of Behavior course (Talent Management System (TMS) #10176) initially and annually thereafter.

(2) Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and

(3) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role- based information security training].

b. The contractor shall provide to the COR/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the required training is complete.

5. SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT’s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following:

(1) The date and time (or approximation of) the Security Incident occurred.

(2) The names of individuals involved (when applicable).

(3) The physical and logical (if applicable) location of the incident.

(4) Why the Security Incident took place (i.e., catalyst for the failure).

(5) The amount of data belonging to VA believed to have been compromised.

(6) The remediation measures the contractor is taking to ensure no future incidents of a similar nature.

c. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

d. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

e. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG, and the VA Office of Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

f. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.

g. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA.

h. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages— Reimbursement for Data Breach Costs.

6. INFORMATION SYSTEM DESIGN AND DEVELOPMENT. This entire section applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (to include the subcomponents of each) designed or developed for or on behalf of VA by any non-VA entity.

a. Information systems designed or developed on behalf of VA at non-VA facilities shall comply with all applicable Federal law, regulations, and VA policies. This includes standards for the protection of electronic Protected Health Information (PHI), outlined in 45 C.F.R. Part 164, Subpart C and information and system security categorization level designations in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems and FIPS 200, Minimum Security Requirements for Federal Information Systems. Baseline security controls shall be implemented commensurate with the FIPS 199 system security categorization (reference VA Handbook 6500 and VA Trusted Internet Connections (TIC) Architecture).

b. Contracted new developments require creation, testing, evaluation, and authorization in compliance with VA Assessment and Authorization (A&A) processes in VA Handbook 6500 and VA Information Security Knowledge Service to obtain an Authority to Operate (ATO). VA Directive 6517, Risk Management Framework for Cloud Computing Services, provides the security and privacy requirements for cloud environments.

c. VA IT contractors, subcontractors and third-party service providers shall address and/or integrate applicable VA Handbook 6500, VA Handbook 6517, Risk Management Framework for Cloud Computing Services and Information Security Knowledge Service specifications in delivered IT systems/solutions, products and/or services. If systems/solutions, products and/or services do not directly match VA security requirements, the contractor shall work though the COR/CO to identify the VA organization responsible for governance or resolution. Contractors shall comply with FAR 39.1, specifically the prohibitions referenced.

d. The contractor (including producers and resellers) shall comply with Office of Management and Budget (OMB) M-22-18 and M-23-16 when using third-party software on VA information systems or otherwise affecting the VA information. This includes new software purchases and software renewals for software developed or modified by major version change after the issuance date of M- 22-18 (September 14, 2022). The term “software” includes firmware, operating systems, applications and application services (e.g., cloud-based software), as well as products containing software. The contractor shall provide a self- attestation that secure software development practices are utilized as outlined by Executive Order (EO)14028 and NIST Guidance. A third-party assessment provided by either a certified Federal Risk and Authorization Management Program (FedRAMP) Third Party Assessor Organization (3PAO) or one approved by the agency will be acceptable in lieu of a software producer's self- attestation.

e. The contractor shall ensure all delivered applications, systems and information systems are compliant with Homeland Security Presidential Directive (HSPD) 12 and VA Identity and Access management (IAM) enterprise identity management requirements as set forth in OMB M-19-17, M-05-24, FIPS 201-3, Attachment 1: SCOPE OF WORK- Mobile shielded PET/CT Scanner and technologist staffing/ Solicitation Num. 36C25726Q0027

Personal Identity Verification (PIV) of Federal Employees and Contractors (or its successor), M-21-31 and supporting NIST guidance. This applies to Commercial Off-The-Shelf (COTS) product(s) that the contractor did not develop, all software configurations and all customizations.

f. The contractor shall ensure all contractor delivered applications and systems provide user authentication services compliant with VA Handbook 6500, VA Information Security Knowledge Service, IAM enterprise requirements and NIST 800-63, Digital Identity Guidelines, for direct, assertion-based authentication and/or trust-based authentication, as determined by the design and integration patterns. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV and/or Common Access Card (CAC), as determined by the business need and compliance with VA Information Security Knowledge Service specifications.

g. The contractor shall use VA authorized technical security baseline configurations and certify to the COR that applications are fully functional and operate correctly as intended on systems in compliance with VA baselines prior to acceptance or connection into an authorized VA computing environment. If the Defense Information Systems Agency (DISA) has created a Security Technical Implementation Guide (STIG) for the technology, the contractor may configure to comply with that STIG. If VA determines a new or updated VA configuration baseline needs to be created, the contractor shall provide required technical support to develop the configuration settings. FAR 39.1 requires the population of operating systems and applications includes all listed on the NIST National Checklist Program Checklist Repository.

h. The standard installation, operation, maintenance, updating and patching of software shall not alter the configuration settings from VA approved baseline configuration. Software developed for VA must be compatible with VA enterprise installer services and install to the default “program files” directory with silently install and uninstall. The contractor shall perform testing of all updates and patching prior to implementation on VA systems.

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

j. The contractor-delivered solutions shall reside on VA approved operating systems. Exceptions to this will only be granted with the written approval of the COR/CO.

k. The contractor shall design, develop, and implement security and privacy controls in accordance with the provisions of VA security system development life cycle outlined in NIST 800-37, Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy, VA Directive and Handbook 6500, and VA Handbook 6517.

l. The Contractor shall comply with the Privacy Act of1974 (the Act), FAR 52.224- 2 Privacy Act, and VA rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish a VA function.

m. The contractor shall ensure the security of all procured or developed information systems, systems, major applications, minor applications, enclaves and platform information technologies, including their subcomponents (hereinafter referred to as “Information Systems”) throughout the life of this contract and any extension, warranty, or maintenance periods. This includes security configurations, workarounds, patches, hotfixes, upgrades, replacements and any physical components which may be necessary to remediate all security vulnerabilities published or known to the contractor anywhere in the information systems (including systems, operating systems, products, hardware, software, applications and firmware). The contractor shall ensure security fixes do not negatively impact the Information Systems.

n. When the contractor is responsible for operations or maintenance of the systems, the contractor shall apply the security fixes within the timeframe specified by the associated controls on the VA Information Security Knowledge Service. When security fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the contractor shall provide written notice to the VA COR/CO that the patch has been validated as to not affecting the Systems within 10 business days.

7. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE OR USE.

This entire section applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (cloud and non- cloud) hosted, operated, maintained, or used on behalf of VA at non-VA facilities.

a. The contractor shall comply with all Federal laws, regulations, and VA policies for Information systems (cloud and non-cloud) that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities. Security controls for collecting, processing, transmitting, and storing of VA sensitive information, must be in place. The controls will be tested by VA or a VA sanctioned 3PAO and approved by VA prior to hosting, operation, maintenance or use of the information system or systems by or on behalf of VA. This includes conducting compliance risk assessments, security architecture analysis, routine vulnerability scanning, system patching, change management procedures and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures shall be the same as procedures used to secure VA-operated information systems.

b. Outsourcing (contractor facility, equipment, or staff) of systems or network operations, telecommunications services or other managed services require Assessment and Authorization (A&A) of the contractor’s systems in accordance with VA Handbook 6500 as specified in VA Information Security Knowledge

Service. Major changes to the A&A package may require reviewing and updating all the documentation associated with the change. The contractor’s cloud computing systems shall comply with FedRAMP and VA Directive 6517 requirements.

c. The contractor shall return all electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) on non-VA leased or non-VA owned IT equipment used to store, process or access VA information to VA in accordance with A&A package requirements. This applies when the contract is terminated or completed and prior to disposal of media. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Information Security Knowledge Service requirements and NIST 800-88. The contractor shall send a self-certification that the data destruction requirements above have been met to the COR/CO within 30 business days of termination of the contract.

d. All external internet connections to VA network involving VA information must be in accordance with VA Trusted Internet Connection (TIC) Reference Architecture and VA Directive and Handbook 6513, Secure External Connections and reviewed and approved by VA prior to implementation. Government-owned contractor-operated systems, third party or business partner networks require a Memorandum of Understanding (MOU) and Interconnection Security Agreements (ISA).

e. Contractor procedures shall be subject to periodic, announced, or unannounced assessments by VA officials, the OIG or a 3PAO. The physical security aspects associated with contractor activities are also subject to such assessments. The contractor shall report, in writing, any deficiencies noted during the above assessment to the VA COR/CO. The contractor shall use VA’s defined processes to document planned remedial actions that address identified deficiencies in information security policies, procedures, and practices. The contractor shall correct security deficiencies within the timeframes specified in the VA Information Security Knowledge Service.

f. All major information system changes which occur in the production environment shall be reviewed by the VA to determine the impact on privacy and security of the system. Based on the review results, updates to the Authority to Operate (ATO) documentation and parameters may be required to remain in compliance with VA Handbook 6500 and VA Information Security Knowledge Service requirements.

g. The contractor shall conduct an annual privacy and security self-assessment on all information systems and outsourced services as required. Copies of the assessment shall be provided to the COR/CO. The VA/Government reserves the right to conduct assessment using government personnel or a third-party if deemed necessary. The contractor shall correct or mitigate any weaknesses discovered during the assessment.

h. VA prohibits the installation and use of personally owned or contractor-owned equipment or software on VA information systems. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW, PWS, PD or contract. All security controls required for government furnished equipment must be utilized in VA approved Other Equipment (OE). Configuration changes to the contractor OE, must be funded by the owner of the equipment. All remote systems must use a VA-approved antivirus software and a personal (host-based or enclave based) firewall with a VA-approved configuration. The contractor shall ensure software on OE is kept current with all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-virus software and the firewall on the non-VA owned OE. Approved contractor OE will be subject to technical inspection at any time.

i. The contractor shall notify the COR/CO within one hour of disclosure or successful exploits of any vulnerability which can compromise the confidentiality, integrity, or availability of the information systems. The system or effected component(s) need(s) to be isolated from the network. A forensic analysis needs to be conducted jointly with VA. Such issues will be remediated as quickly as practicable, but in no event longer than the timeframe specified by VA Information Security Knowledge Service. If sensitive personal information is compromised reference VA Handbook 6500.2 and Section 5, Security Incident Investigation.

j. For cases wherein the contractor discovers material defects or vulnerabilities impacting products and services they provide to VA, the contractor shall develop and implement policies and procedures for disclosure to VA, as well as remediation. The contractor shall, within 30 business days of discovery, document a summary of these vulnerabilities or defects. The documentation will include a description of the potential impact of each vulnerability and material defect, compensating security controls, mitigations, recommended corrective actions, root cause analysis and/or workarounds (i.e., monitoring). Should there exist any backdoors in the products or services they provide to VA (referring to methods for bypassing computer authentication), the contractor shall provide the VA CO/CO written assurance they have permanently remediated these backdoors.

k. All other vulnerabilities, including those discovered through routine scans or other assessments, will be remediated based on risk, in accordance with the remediation timelines specified by the VA Information Security Knowledge Service and/or the applicable timeframe mandated by Cybersecurity & Infrastructure Security…