Digital-Pathology-PWS.docx

U.S. Department of Veterans Affairs (VA) Veterans Health Administration (VHA)

Performance Work Statement (PWS)

PRE-DECISIONAL

PWS – Digital Pathology

DIGITAL PATHOLOGY

1. Introduction The purpose of this Performance Work Statement (PWS) is to detail the minimum technical requirements of the digital pathology system solicitation and define the tasks and responsibilities of the successful offeror for the procurement of a Food and Drug Administration (FDA) 510(k) cleared digital pathology system for participating Veterans Health Administration (VHA) laboratories.

2. Background The VA National Precision Oncology Program (NPOP) was established in 2016 with the goal of implementing standardized, streamlined methods for molecular testing of Veterans with cancer. The molecular testing technologies offered under NPOP include next generation sequencing (DNA and RNA-seq), immunohistochemistry, fluorescence in situ hybridization (FISH), PCR and microarray-based methods.

To accelerate the adoption of molecular diagnostics, in addition to testing more patients, there is also a need to build the VA infrastructure to support today's virtual healthcare environment, bringing VA-wide expertise together in the practice of precision medicine. More specifically, adoption of molecular testing and precision medicine must also be supported by educational efforts to bring together multidisciplinary experts in the form of a molecular tumor board. To accomplish this initiative, virtual tumor boards require pathology support with equipment that can capture images for broader distribution and interpretation of the patient's tumor tissue.

The procurement of a digital pathology system will provide the infrastructure required and the access to testing needed to deliver appropriate training and education, a second opinion consult service, a virtual molecular tumor board for clinician case-based learning and ongoing professional practice evaluation.

Overall, these efforts in molecular diagnostics strongly tie clinical care and research together in the broader VA precision oncology initiative where there are continuous learning opportunities for clinicians, researchers and patients and shared decision making with an ultimate goal of providing the highest quality oncology care to Veterans.

3. Scope The VA intends to award a single contract to the overall best-value contractor capable of meeting the requirements outlined herein for a complete, fully operational digital pathology system (including both hardware and software), the associated installation and configuration services, and the incorporated staff training requirement. The Contractor shall implement the system across twelve (12) VA Medical Centers in the base period, with option years to award additional VA Medical Centers.

The digital pathology system shall provide capability for large-scale real-time and archived collections of histopathology specimens requiring an image library server(s) for historical archives, remote viewing features for consultation, retrieval, digital management, and preservation of patient specimens referred for outside consultation.

Functionality shall include whole slide digital scanning, documentation, remote consultation, specialty consultation, and computer-assisted digital image analysis. The product must have FDA 510(k) clearance for basic surgical pathology functions including but not limited to: support for virtual tumor boards, consultative services; second review for newly diagnosed malignancies; coverage for pathologist absences; quality assurance review; and primary diagnoses.

The Contracting Officer shall conduct post-award orientations in accordance with FAR 42.503 and VAAM M842.503 within the first five (5) calendar days of the contract award date.

4. General System Requirements The minimum requirements for a Digital Pathology System, hereafter referred to as the "System," shall be met or exceeded by this acquisition. The Contractor shall provide narrative descriptions demonstrating FDA 510(k) clearance and compliance with all requirements below.

4.1 Clinical

4.1.1. The System shall have FDA 510(k) clearance for primary diagnosis using minimally hematoxylin and eosin (H&E) staining. (Contractor to provide a list of all cleared applications for consideration.)

4.1.2. The System shall provide all necessary equipment giving VHA facilities the ability to scan slides into their local system for both local and remote pathologist viewing when utilizing the same manufacturer's system.

4.1.3. The System shall include all items necessary to support a fully functioning system as follows:

· 4.1.3.1. Capable of purging scanned images at user-defined intervals or no less than thirty (30) days.

· 4.1.3.2. Ability to archive scanned slides for at least three (3) years.

· 4.1.3.3. Ability to read slide barcode data.

4.2 Hardware and Software

4.2.1. System server and test server platform at each site.

4.2.1.1. Contractor-provided or VA provided virtual server platform

4.2.2. The ability to support multiple concurrent users.

4.2.3. The ability of the server to host additional scanners/sites that can be supported with a 1 gigabit per second WAN bandwidth for future pathology expansion or be easily upgraded to provide this capability.

4.2.4. The capability of the System server and test server, to run VA-approved anti-virus software.

4.2.5. Evidence that the System server and test server are currently sold and supported by its original manufacturer.

4.2.6. The capability of the software to permit remote, web-based image viewing by authorized users.

4.2.7. The Contractor may be responsible for all operating system patching, anti-virus and security updates, and application updates/upgrades to meet VA security requirements/vulnerability remediation for all components of the System and compliance with Department of Homeland Security, Cybersecurity and Infrastructure Security Agency's Binding Operational Directive (BOD) 22-01 and its successors. The VA will designate the criticality of updates/upgrades, and the Contractor shall address them within the timeline identified per VA policy.

4.2.8. The ability to provide the necessary hardware, operating systems, driver software, computer accessories, and manuals required to operate the slide scanners, as well as all necessary cables and power unit components.

4.2.9. The ability to provide a local storage solution that is easily and highly scalable to provide additional storage to support pathology expansion.

4.2.10. Vendor shall supply all necessary hardware and software to support upgrade of existing digital pathology systems including migration of existing data and system configuration.

4.3 Network Security and Integration Requirements

4.3.1. Compliance of all hardware and software with VA network security and Enterprise Risk Analysis requirements. The Contractor shall supply responses to required documents for connection of medical devices to the VA network, including but not limited to the VA Directive 6550, ports and protocols, and services, application inventory, network diagram, and MSD2.

· 4.3.1.1. Contractor shall have a Memorandum of Understanding/Information Security Agreement (MOU/ISA) with the VA or the capability to obtain an MOU/ISA without creating significant implementation delays.

· 4.3.1.2. The hardware must meet all VA minimum specifications, and the software version must be approved for use on the VA network.

4.3.2. The capability of the System design and subsequent deployment to be installed on Medical Device Virtual Local Area Networks (VLANs) and behind Access Control Lists (ACLs) or firewalls.

4.3.3. All unused services on all deployed components are disabled. The System shall be hardened to the greatest extent possible without impacting clinical performance or utility.

4.3.4. The capability of slide image data transfer via a secure transmission protocol.

4.3.5. System deployment with Federal Information Processing Standards (FIPS) 140-2 (or its successor) compliant encryption of sensitive data at rest.

4.3.6. Any web-based applications shall be fully functional with VA baseline versions of Edge and Chrome browsers and accept the VA browser security settings.

4.3.7. The capability of the System server and test server to integrate with the VA's active directory and PIV/Single Sign On (SSO) system.

4.3.8. The capability of the System to integrate with VistA Imaging and Oracle CareAware MultiMedia (CAMM) and provide export of images to those repositories. The System shall be capable of producing and fully utilizing images in DICOM format for storage and export.

4.3.9. The ability of the System manufacturer, in conjunction with the VA, to develop and provide a validated bidirectional interface with the Laboratory Information System (LIS) (e.g., VistA, Oracle Health, or third-party Anatomic Pathology LIS) within an agreed-upon reasonable timeline after implementation. The System shall include outbound communication of result/information objects (i.e., scanned slide images) to the VA LIS conforming to DICOM standards. If the LIS vendor does not support a bidirectional interface, the Contractor shall develop and provide a validated unidirectional interface within the same agreed-upon timeline. For a unidirectional interface, the System shall use a non-proprietary HL7 interface capable of accepting patient demographic information (ADT) and order (ORM) messages from the VA LIS

5. Technical System Requirements The Contractor shall provide a System that meets the VHA Labs Technical System Performance Requirements outlined below. A response shall be provided that addresses qualitatively and/or quantitatively how specifications are met or exceeded.

5.1 Slide Image Manager/Viewing System

5.1.1. Digital pathology images reviewed through the image manager/viewing system shall meet medical grade image quality standards.

5.1.2. All participating facilities shall be able to read pathology slides for any other participating site for either primary diagnosis or consult as needed, even when not hosted on the same slide image system.

5.1.3. The System shall be capable of producing and fully utilizing images in DICOM format. The ability to save, review, and display multiple file formats such as JPG, TIFF, or JPEG2000 for upload/export to electronic health record or other applications is also required.

5.1.4. Workflow management tools in the proprietary viewer software shall include, at minimum:

· 5.1.4.1. Ability to make image annotations.

· 5.1.4.2. Ability to take accurate measurements.

· 5.1.4.3. Ability to bookmark slides for quick access for tumor board and panel discussions.

5.1.5. The slide image manager/viewing system shall be accessible through a web browser.

5.1.6. A work list for each pathologist of their assigned caseload that can be sorted by patient name, number of slides per case, and tissue type.

5.1.7. A full resolution image shall be available for viewing within no more than three (3) seconds across the Local Area Network (LAN).

5.2 Digital Pathology Scanner System

5.2.1. Scan at a minimum of 40X magnification.

5.2.2. A minimum scanning throughput of 50 slides per hour at 40X magnification.

5.2.3. Perform continuous auto-focusing when scanning.

5.2.4. Allow for continuous loading of slides into the digital pathology scanner.

· 5.2.4.1. The ability to prioritize slides is highly desirable.

5.2.5. A fully automated load and walkaway functionality.

5.2.6. Integration with proprietary viewer software to allow the scanner operator to assign individual cases to one or more local or remote pathologists for viewing, consultation, and interpretation.

5.2.7. An image preview of the scan so the scanner operator can assess image quality and accurate identifying information before uploading to servers for local and remote access.

5.2.8. Read barcoded slides.

5.2.9. A barcode read accuracy of 99% or greater.

5.2.10. High quality scanned images with less than a 2% failure rate for:

· 5.2.10.1. Color reproducibility

· 5.2.10.2. Spatial resolution

· 5.2.10.3. Focusing tests

· 5.2.10.4. Whole slide image coverage

· 5.2.10.5. Stitching error

5.2.11. Ability to perform Z-stacking to capture multiple focal layers of a tissue sample

5.3 Display Monitor

5.3.1. A minimum 27" diagnostic display screen utilizing a medical grade high resolution image display for primary and other diagnostic work. The display's front consistency sensor shall automatically align image quality every time the display is switched on. The Contractor shall provide the display monitor if it is part of the FDA 510(k) clearance for primary diagnosis. If the display monitor is not part of the FDA 510(k) clearance, the Contractor shall provide specifications to the VA.

6. Other System Support Items

6.1. An uninterruptible power supply (UPS) shall be supplied with a line conditioner for each scanner provided. Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails, and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records.

6.2. A scanner table/bench shall be provided that minimizes scanner noise and vibrations.

7. System Support Features

7.1 Warranty

7.1.1. All equipment service programs shall be provided, including preventative maintenance, corrective maintenance, remote diagnostics, and software updates for all instrumentation and ancillary items within the pathology system.

7.1.2. The System and accessories shall be covered under the manufacturer's warranty and shall minimally include all OEM parts and labor for at least one (1) year following acceptance by the VAMC. This warranty must include scheduled preventative maintenance as required by the manufacturer. The manufacturer's factory-trained field service engineers shall perform installation and maintenance during the warranty period.

7.1.3. A technical assistance center shall be available by telephone during normal business hours of operation, Monday through Friday, with a maximum callback response time of four (4) hours.

7.1.4. All equipment, including ancillary equipment, repair service shall be provided Monday through Friday during laboratory business hours. The Contractor is required to coordinate services with the designated facility points of contact.

7.1.5. Preventative maintenance shall be performed as frequently as published in the manufacturer's operator's manual and within a timely manner with regard to scheduled due dates to ensure compliance with accrediting agency requirements:

· 7.1.5.1. Quarterly/every quarter = every 3 months (90 days), plus or minus 10 days.

· 7.1.5.2. Every 6 months = 6 months (180 days) from the last event, plus or minus 20 days.

· 7.1.5.3. Annually/every 12 months = 1 year from the last event, plus or minus 30 days.

7.1.6. A malfunction incident report shall be furnished to facility points of contact including Laboratory and Healthcare Technology Management, upon completion of each repair call. The report shall include, at a minimum:

· 7.1.6.1. Date and time notified

· 7.1.6.2. Date and time of arrival

· 7.1.6.3. Serial number, type, and model number of equipment

· 7.1.6.4. Time spent on repair

· 7.1.6.5. Proof of repair including supporting documentation of acceptable performance

· 7.1.6.6. Brief description of problem/issue, parts/items replaced, adjustments or realignments performed, and any other relevant information

· 7.1.6.7. Any equipment calibrations and other analyses required following service/repairs/PMs shall be performed by the service engineer

· 7.1.6.8. The service call shall include a discussion communicating repair and outcomes with appropriate on-duty staff

· 7.1.6.9. Each notification for an emergency repair service call shall be treated as a separate and new service call

· 7.1.6.10. Supplemental or support equipment that is not cost effective to repair shall be replaced the next business day at Contractor expense

· 7.1.6.11. Contractor shall promptly provide a return goods authorization for return of equipment being replaced

7.1.7. Contractor shall ensure no more than forty-eight (48) continuous hours of downtime. If equipment downtime cannot be resolved within 48 hours, an alternative solution shall be offered by the Contractor.

7.1.8. Service and Operator Manuals shall be provided for the proposed systems at no additional charge to the Government:

· 7.1.8.1. Two (2) copies of operator instruction manuals: one (1) electronic and one (1) physical copy.

· 7.1.8.2. Two (2) copies of a service manual: one (1) electronic and one (1) physical copy.

7.1.9. Remote diagnostics support shall be provided via VPN. The VA national site-to-site VPN shall be utilized, or the Contractor shall engage with the Office of Cyber and Information Security and the VAMC Information Systems Security Officer to establish a client-based VPN.

7.2 Training

7.2.1. The Contractor shall provide a comprehensive on-site System training program that is coordinated with and timely to the equipment installation. Training shall include initial on-site training for scanner operators, pathologists, and Healthcare Technology Management staff.

· 7.2.1.1. On-site clinical staff training on use, user maintenance, and troubleshooting of the digital slide scanner.

· 7.2.1.2. On-site provider training on software used for review of digital slides for primary diagnosis, consultation, tumor board/conferences, and workload management. Operator training shall be provided by the Contractor on-site for all operators.

· 7.2.1.3. On-site Healthcare Technology Management staff training on the maintenance of the pathology system.

· 7.2.1.4. Any additional support material routinely provided to equivalent commercial customers that assists in regulatory compliance, e.g., computer disc(s) containing an easily editable standard operating procedure in CLSI format or an online procedure within the instrument software.

7.2.2. The Contractor shall provide supplemental advanced training and continuing educational opportunities. If training involves off-site travel, the Contractor shall include the cost of airfare, room, and board for each participant.

7.3 Upgrades/Updates

Updates shall be provided on both equipment hardware and software to maintain the integrity of the System and the state-of-the-art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time they are provided to commercial customers. This requirement applies only to "System updates" that enhance the model of equipment being offered (e.g., new software versions, correction of hardware defects, updates offered to commercial customers at no additional charge, or upgrades to replace models no longer Contractor-supported). This does not refer to replacing the original equipment provided but does refer to significant changes in hardware operational capability.

7.4 Implementation

A mutually agreeable implementation schedule shall be established between the Contractor and VA within thirty (30) days of the post-award kickoff meeting. Comment by Moxam, Tyler: Add additional implementation language.

Add delivery language (to be coordinated with local site).

Add acceptance criteria. Comment by Moxam, Tyler: Discuss with Contracting if acceptance criteria is needed The contractor shall perform software and hardware installation, configuration, implementation, and testing of the pathology System at the specified VHA facilities throughout the entire period of performance to include but not limited to the following:

· Pathology software suite and all required support services

· All required integration and interface software and support services

· All other required third-party software, hardware, and all required support services to operate the pathology software to enable seamless support for the Pathology and Laboratory Medicine program The contractor will make every effort to meet the facility installation requirement barring any unforeseen issues with shipping or physical access to the VAMC. Shipping to be coordinated with local points of contact, including Laboratory and Healthcare Technology Management prior to shipment of hardware.

8.0 Operating constraints

Due to local dependencies regarding timeline and installations process, the VA has the discretion to modify the order based on facility requirements throughout the implementation process.

VA Acquisition Regulation Solicitation Provision and Contract Clause

1. Information Technology Security Requirements

1.1. 839.201 Contract clause for Information and Information Technology Security

· Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media).

1.2. 852.273-75 - Security Requirements for Unclassified Information

· The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

VA Information and Information System Security and Privacy Language

1. General 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.

1.1. VA Information Custodial 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.

1.2. Access to VA Information and VA Information Systems

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.

1.3. Training

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:

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

8. 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

9. 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.

1.4. Security Incident Investigation

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:

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

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

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

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

14. The amount of data belonging to VA believed to have been compromised.

15. 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.

1.5. Viruses, Firmware and Malware

a. The contractor shall execute due diligence to ensure all provided software and patches, including third-party patches, are free of viruses and/or malware before releasing them to or installing them on VA information systems.

b. The contractor warrants it has no knowledge of and did not insert, any malicious virus and/or malware code into any software or patches provided to VA which could potentially harm or disrupt VA information systems. The contractor shall use due diligence, if supplying third-party software or patches, to ensure the third-party has not inserted any malicious code and/or virus which could damage or disrupt VA information systems.

c. The contractor shall provide or arrange for the provision of technical justification as to why any “false positive” hit has taken place to ensure their code’s supply chain has not been compromised. Justification may be required, but is not limited to, when install files, scripts, firmware, or other contractor-delivered software solutions (including third-party install files, scripts, firmware, or other software) are flagged as malicious, infected, or suspicious by an anti-virus vendor.

d. The contractor shall not upload (intentionally or negligently) any virus, worm, malware or any harmful or malicious content, component and/or corrupted data/source code (hereinafter “virus or other malware”) onto VA computer and information systems and/or networks. If introduced (and this clause is violated), upon written request from the VA CO, the contractor shall:

16. Take all necessary action to correct the incident, to include any and all assistance to VA to eliminate the virus or other malware throughout VA’s information networks, computer systems and information systems; and

17. Use commercially reasonable efforts to restore operational efficiency and remediate damages due to data loss or data integrity damage, if the virus or other malware causes a loss of operational efficiency, data loss, or damage to data integrity.

1.6. Cryptographic Requirement

a. The contractor shall document how the cryptographic system supporting the contractor’s products and/or services protect the confidentiality, data integrity, authentication and non-repudiation of devices and data flows in the underlying system.

b. The contractor shall use only approved cryptographic methods as defined in FIPS 140-2 (or its successor) and NIST 800-52 standards when enabling encryption on its products.

c. The contractor shall provide or arrange for the provision of an automated remote key-establishment method which protects the confidentiality and integrity of the cryptographic keys.

d. The contractor shall ensure emergency re-keying of all devices can be remotely performed within 30 business days.

e. The contractor shall provide or arrange for the provision of a method for updating cryptographic primitives or algorithms.

1.7. Patching Governance

a. The contractor shall provide documentation detailing the patch management, vulnerability management, mitigation and update processes (to include thirdparty) prior to the connection of electronic devices, assets or equipment to VA’s assets. This documentation will include information regarding the follow:

(2) The resources and technical capabilities to sustain the program or process (e.g., how the integrity of a patch is validated by VA); and

(3) The approach and capability to remediate newly reported zero-day vulnerabilities for contractor products.

b. The contractor shall verify and provide documentation all procured products (including third-party applications, hardware, software, operating systems, and firmware) have appropriate updates and patches installed prior to delivery to VA.

c. The contractor shall provide or arrange the provision of appropriate software and firmware updates to remediate newly discovered vulnerabilities or weaknesses for their products and services within 30 days of discovery. Updates to remediate critical or emergent vulnerabilities will be provided within seven business days of discovery. If updates cannot be made available by contractor within these time periods, the contractor shall submit mitigations, methods of exploit detection and/or workarounds to the COR/CO prior to the above deadlines.

d. The contractor shall provide or arrange for the provision of appropriate hardware, software and/or firmware updates, when those products, including open-source software, are provided to the VA, to remediate newly discovered vulnerabilities or weaknesses. Remediations of products or services provided to the VA’s system environment must be provided within 30 business days of availability from the original supplier and/or patching source. Updates to remediate critical vulnerabilities applicable to the Contractor’s use of the thirdparty product in its system environment will be provided within seven business days of availability from the original supplier and/or patching source. If applicable third-party updates cannot be integrated, tested and made available by Contractor within these time periods, mitigations and/or workarounds will be provided to the COR/CO before the above deadlines.

1.8. Specialized Devices/Systems (Medical Devices, Special Purpose Systems, Research Scientific Computing)

a. Contractor supplies/delivered Medical Devices, Special Purpose Systems-Operational Technology (SPS-OT) and Research Scientific Computing Devices shall comply with all applicable Federal law, regulations, and VA policies. New developments require creation, testing, evaluation, and authorization in compliance with processes specified on the Specialized Device Cybersecurity Department Enterprise Risk Management (SDCD-ERM) Portal, VA Directive 6550, Pre-Procurement Assessment and Implementation of Medical Devices/Systems, VA Handbook 6500, and the VA Information Security Knowledge Service. Deviations from Federal law, regulations, and VA Policy are identified and documented as part of VA Directive 6550 and/or the VA Enterprise Risk Analysis (ERA) processes for Specialized Devices/Systems processes.

b. All contractors and third-party service providers shall address and/or integrate applicable VA Handbook 6500 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 for governance or resolution.

c. The contractor shall certify to the COR/CO that devices/systems that have completed the VA Enterprise Risk Analysis (ERA) process for Specialized Devices/Systems are fully functional and operate correctly as intended. Devices/systems must follow the VA ERA authorized configuration prior to acquisition and connection to the VA computing environment. If VA determines a new VA ERA needs to be created, the contractor shall provide required technical support to develop the configuration settings. Major changes to a previously approved device/system will require a new ERA.

d. The contractor shall comply with all practices documented by the Food Drug and Administration (FDA) Premarket Submission for Management of Cybersecurity in Medical Devices and Postmarket Management of Cybersecurity in Medical Devices.

e. The contractor shall design devices capable of accepting all applicable security patches with or without the support of the contractor personnel. If patching can only be completed by the contractor, the contractor shall commit the resources needed to patch all applicable devices at all VA locations. If unique patching instructions or packaging is needed, the contractor shall provide the necessary information in conjunction with the validation/testing of the patch. The contractor shall apply security patches within 30 business days of the patch release and have a formal tracking process for any security patches not implemented to include explanation when a device cannot be patched.

f. The contractor shall provide devices able to install and maintain VA-approved antivirus capabilities with the capability to quarantine files and be updated as needed in response to incidents. Alternatively, a VA-approved whitelisting application may be used when the contractor cannot install an anti-virus / anti-malware application.

g. The contractor shall verify and document all software embedded within the device does not contain any known viruses or malware before delivery to or installation at a VA location.

h. Devices and other equipment or systems containing media (hard drives, optical disks, solid state, and storage via chips/firmware) with VA sensitive information will be returned to the contractor with media removed. When the contract requires return of equipment, the options available to the contractor are the following:

1. The contractor shall accept the system without the drive, firmware and solid state.

2. VA’s initial device purchase includes a spare drive or other replacement media which must be installed in place of the original drive at time of turn-in; or

3. Due to the highly specialized and sometimes proprietary hardware and software associated with the device, if it is not possible for VA to retain the hard drive, firmware, and solid state, then:

a. The equipment contractor shall 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 returned physically intact.

b. Any fixed hard drive, Complementary Metal-Oxide-Semiconductor (CMOS), Programmable Read-Only Memory (PROM), solid state and firmware 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 solicitation, contract, or order.

1.9. Data Center Provisions

a. The contractor shall ensure the VA network is accessed by in accordance with VA Directive 6500 and IAM security processes specified in the VA Information Security Knowledge Service.

b. The contractor shall ensure network infrastructure and data availability in accordance with VA information system business continuity procedures specified in the VA Information Security Knowledge Service.

c. The contractor shall ensure any connections to the internet or other external networks for information systems occur through managed interfaces utilizing VA approved boundary protection devices (e.g., internet proxies, gateways, routers, firewalls, guards or encrypted tunnels).

d. The contractor…