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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 27, 2019 FBO #6545
DOCUMENT

D -- VISN 8 Live Data PeriOp - Attachment

Notice Date: 10/25/2019
Notice Type: Attachment
NAICS: 541519 — Other Computer Related Services
Contracting Office: Department of Veterans Affairs;Technology Acquisition Center;23 Christopher Way;Eatontown NJ 07724
ZIP Code: 07724
Solicitation Number: 36C10B20Q0021
Response Due: 11/5/2019
Archive Date: 1/4/2020
Point of Contact: joseph.jones6@va.gov
E-Mail Address: Joseph.Jones6@va.gov
(Joseph.Jones6@va.gov)
Small Business Set-Aside: N/A
Description: Surgical Workflow Planning System for VISN 8 Network Page 14 of 33 Department of Veterans Affairs (VA) Technology Acquisition Center (TAC) is seeking information concerning the availability of capable contractors to provide all software, hardware and services to fully implement a surgical workflow planning system to Veterans Integrated Service Network 8 (VISN 8). VISN 8 already implemented LiveData PeriOp/DSS in three of eight VA Medical Centers (VAMC s) located in Tampa, Orlando, and Miami. VA now requires continued maintenance for the three sites with a deployed system and new implementation for the remaining five VAMCs in VISN 8 or the ability to transition to a new surgical workflow planning system for all VISN 8 VAMC s. The VA is seeking sources capable of providing installation, configuration, testing, training, warranty, hosting maintenance, and deploying the system. This is a request for information (RFI) only. Do not submit a proposal or quote. There is no obligation on the part of the Government to acquire any products or services described in this RFI. Your response to this RFI will be treated only as information for the Government to consider. You will not be entitled to payment for direct or indirect costs that you incur in responding to this RFI. This request does not constitute a solicitation for proposals or the authority to enter into negotiations to award a contract. No funds have been authorized, appropriated or received for this effort. Interested parties are responsible for adequately marking proprietary, restricted or competition sensitive information contained in their response. The Government does not intend to pay for the information submitted in response to this RFI. If interested, please provide the following: 1. A capabilities statement that addresses the questions below by Monday, October 28, 2019. If additional information is required by VA to determine a contractor s capability to provide the full requirement and the economic feasibility of the information provided, additional information may be requested later. A draft version of the requirement is below. Please direct all responses to Joe Jones, joseph.jones6@va.gov and Debra Clayton, debra.clayton2@va.gov. 2. Rough Order of Magnitude (ROM) estimate to include pricing models that would be most advantageous to the Government; 3. Breakout of software, hardware and services necessary for the installation of system; 4. Describe the options for hosting your system 5. Provide timeline for how long it will take to install the solution at all required VISN 8 sites. VA anticipates a phased, sequential installation 6. With respect to training on your solution, provide your recommendations as to when training should occur; format (i.e, virtual or face to face); frequency; and identify for which functional roles training is recommended. 7. Any Contract Vehicle of which you are a part that can be used to acquire your solution as well as the company business size and status for each vehicle as designated by the NAICS 541519 and the U.S. Small Business Administration (i.e., Large Business, Small Business, Service-Disabled Veteran Owned Small Business, Small Disadvantaged Business, Women-Owned Small Business, Hub Zone Small Business, etc.) PRODUCT REQUIREMENTS Currently three of eight Department of Veterans Affairs Medical Centers (VAMC) in the Veterans Integrated Service Network (VISN) 8 Health Care Systems (Tampa, Orlando, and Miami) are using Document Storage Systems LiveData PeriOp Surgical Workflow Planning System. The LiveData PeriOp Surgical Workflow Planning Solution is a Veterans Health Information Systems and Technology Architecture (VistA)-integrated, graphical user interface designed to provide a constant integrated view of patient status in real-time, manage perioperative complexity, improve team communication, enhance patient safety, and improve operational efficiency by streamlining documentation and updating Veterans Health Information Systems and Technology Architecture (VistA). VA now requires continued maintenance for the three sites (Tampa, Orlando, and Miami) with a deployed system and new implementation for the remaining five VAMCs in VISN 8. The Contractor shall provide all software, hardware and services to fully implement a surgical workflow planning system solution that meets the salient characteristics of section 1.1 for the following five sites: West Palm Beach VAMC POC: Dr. Ernest Shwayri Address: West Palm Beach VAMC 7305 N. Military Trail West Palm Beach, FL 33410 Voice: 561-422-7341 E-mail: Ernest.Shwayri@va.gov Go live date: 30 days after award Ready for VA use within 60 DAC Malcom Randall VAMC (Gainesville, FL) Name: TBD Address: Malcolm Randall VAMC 1601 S.W. Archer Rd. Gainesville, FL 32608 Voice: xxxxxxx E-mail: xxxxxxx Go live date: 60 days after award Ready for VA use within 120 DAC Lake City VAMC Name: TBD Address: Malcolm Randall VAMC 1601 S.W. Archer Rd. Gainesville, FL 32608 Voice: xxxxxxx E-mail: xxxxxxx Go live date: 90 days after award Ready for VA use within 180 DAC C.W. Bill Young VAMC (Bay Pines, FL) Name: Dr. Cynthia Fisher Address: C.W. Bill Young VAMC 10000 Bay Pines Blvd. Bay Pines, FL 33744 Voice: 727-398-6661 E-mail: Cynthia.Fisher@va.gov Go live date: 120 days after award Ready for VA use within 240 DAC San Juan VAMC Name: Dr. Norma Santiago Address: San Juan VAMC 10 Casia St. San Juan, Puerto Rico 00921-3201 Voice: 787-614-5162 E-mail: norma.santiago@va.gov Go live date: 150 days after award Ready for VA use within 240 DAC PERIOD OF PERFORMANCE The Contractor shall install the surgical workflow planning system within 12-month base period including installation, configuration, testing, training, warranty and maintenance. Four 12-month option periods are needed for continued training as well as warranty and maintenance. INSTALLATION AND CONFIGURATION The Contractor shall provide the following installation services: Conduct site surveys of each of the designated locations within thirty (30) days following contract award. Each site survey shall include all electrical and IT cable drops necessary. Provide an Implementation Plan that addresses each site and is based on the findings from the site surveys and shall be submitted with within 10 business days after all site surveys have been completed. Complete installation of each display board workstation: Mounting of monitor and associated PC Any necessary Data line pulls Any necessary electrical work required to power monitor and associated PC Configure the system including interface testing with VISTA/CPRS, with the following documentation: Kits built for VistA Interfaces Patch descriptions Test scripts Installation guides Implementation and back out plans Configure the pre-operative events display information including: Work with the VHA clinical staff to document pre-operative milestones and process flow for each of the milestones. Map VistA/CPRS data elements to pre-operative milestones and document milestone completion criteria. Document criteria for marking a patient ready for transport to Operating Room for planned surgical procedure. Setup alert conditions and appropriate notification mechanism. Setup access control for access to Pre-Op milestone completion. Identify locations where read-only Pre-Op dashboard displayed for use by perioperative staff. Configure the Operating Room events display information including: Work with the VHA clinical staff to document clinical process flow Verify mapping of VistA/CPRS data elements to display board. Verify mapping of Anesthesia data elements to display board. Configure display board to accept data from physiological monitors Configure site-specific checklists. Configure the Scheduling events display information including: Work with hospital s perioperative staff to configure site-specific color key Identify locations where read only OR-Schedule dashboard will be displayed for use by perioperative staff Define dashboard configuration for each of the locations. Define access control list for users who can modify the day of surgery schedule Define application URL and mechanism to deploy URL for use by authorized users. Configure the Family Waiting display information including: Work with hospitals perioperative staff to configure Identify locations where display monitor will be located for use by patients loved ones. Define display board workstation configuration for each of the locations. Configure the Analytics Package: Configure predefined reports Configure analytic cube to host data for above reports Define access control list for users who can access these reports Define application deployment method for authorized users. 9) Integrate software solution: a) VistA integration is required INTEGRATION WITH VISTA. The Contractor s solution shall be integrated with VistA using the Health Level Seven (HL7) interface engine. HL7 interface engine transmits information from VistA to the Contractor s solution based on HL7 events. The HL7 framework shall also enable the Contractor s solution to send vendor-selected HL7 data to VistA. �The Contractor s solution shall not store data. VistA data accessed shall be stored in the Veterans Health Information Systems and Technology Architecture (VistA) only. TESTING. The Contractor shall provide test plans/procedures (TPP) document that includes procedures for testing each system requirement/salient characteristic and coordinate with the sites to and perform a User Acceptance Testing (UAT). The Contractor shall perform testing of the system prior and consider testing successful and the product ready for UAT when the test procedures demonstrate that the system meets the salient characteristics/requirements of section 1.1. TRAINING. The Contractor shall provide onsite training for the system approximately 21 days before the UAT. Training shall include: Clinical applications training for super-users, nurses, physicians, and other clinical staff shall be provided onsite during go-live Training shall be provided on the user interface, application, and its features Training shall provide super-users and end-users with the capability of being self-sufficient in operating the system by the end of the training session. Provide quick notes or reference guides during on-site training during the Go Live Training. Technical Training on an as-needed basis during the life of the contract. Provide technical training for maintenance and service for technical personnel at each site/regional OI&T and/or Biomedical personnel. Training shall include the following topics: Commissioning and preventative maintenance Troubleshooting Server maintenance and backup procedures Provide technical training for configuration of each interface Provide technical training for configuration of each type of display board Workstation WARRANTY. The Contractor shall provide a standard 12-month warranty that covers the system for any hardware/software issues that arise within the warranty period. MAINTENANCE. The Contractor shall provide maintenance for eight VAMC s total (five listed above and three existing (Tampa, Orlando, and Miami) where LiveData Periop is currently installed) of the system to include any hardware, hosting environment, and any software updates, upgrades, and new releases. The Contractor shall provide a help desk phone number for VA to call to notify the Contractor of any issues with the system. The Contractor shall respond within two hours of receipt of VA s call. The Contractor shall complete troubleshooting and repair of the issue(s), making the system once again available to VA users, within 4 hours of receipt of VA call. ITEM 1 SALIENT CHARACTERISTICS The Contractor shall provide a surgical workflow planning system that meets the following salient characteristics: Collect procedure specific data (start/stop times, anesthesia times, room open/room closed, first case starts, turnaround time, OR utilization, OR block time, overtime, out of block utilization, surgeon/anesthesia arrival time). Collect data from the OR, e.g. "Time Out ". Collect data required by the VA's National Surgery Office (VASQIP). Data will be collected by the system but then reported by VA in to SCIP and VASQIP. Example data includes: Prophylactic antibiotic received within 1 hour prior to surgical incision and Prophylactic antibiotic selection for surgical patients. Display overall information on the perioperative process and progress of the patient through the processing the OR on multiple screens (OR desk, SPS, patient s family waiting room, Chief of Surgery's office, OR nurse manager's office, Surgery suite, etc.) and for multiple audiences in order to maintain privacy requirements when/where necessary. Have the capability to schedule patients for surgery. Have the ability for HL7 bi-directional integration with VistA. Have a schedule board view and allow for drag and drop to reschedule patients on any day of surgery. Have an appointment book view that can display if a given surgery schedule block is at capacity or not. Have a means to allocate and track surgery services scheduling block by day of the week and by operating room. Have a means to edit master block schedule to maximize utilization of operating rooms. 10 Have the ability to create a surgery case by entering in specific patient, procedure, staff and operating room data. Have a means to create surgical patients pre-operative work up and track its completion. Anonymize patient information and align with HIPAA regulations. Include a report generator that documents: Pre-operative events. Total time to complete Pre-Op prep/checklist process Total length of stay in Pre-Op Order in which the Pre-Op prep/checklist was completed Time to complete each Pre-Op Checklist item Time Patient occupied Pre-Op bed/bay after Pre-Op checklist was completed Operating room events. Time into OR / Time out of OR Total Anesthesia time (Induction to time out of OR) Operative Time (Incision time to close time) Turnover time OR Block Utilization by Surgeon (Percentage of OR time utilized as compared to OR time allocated/blocked for a given surgeon) OR Block Utilization by Service (Ortho, Urology, General, etc...) Time out procedure time (Time safety checklist is started to time safety checklist has been completed). Scheduled events. Total number of ORs anticipated and actually running each day Total number of patients on the surgery waiting list Provide capability for users to generate/create ad-hoc user reports. The reports would use the measures listed in item 13 but be customizable by the facilities. No additional measures, other than those listed above are required to be included in the ad-hoc reports. OPTIONAL TASK There is an optional task that may be exercised for surgical workflow planning systems proposed by industry other than LiveData PeriOp. If a solution other than LiveData PeriOp is proposed and awarded for the five sites listed, the Contractor shall incorporate that solution and perform all tasks listed under 1.0 at the following existing three VAMC sites: Tampa, Orlando, and Miami. GRAY MARKET GOODS The Contractor must provide only new equipment and new parts for the required products described herein; no used, refurbished, or remanufactured equipment or parts shall be provided under any circumstances. Absolutely no Gray Market Goods or Counterfeit Electronic Parts shall be provided. Gray Market Goods are defined as genuine branded goods intentionally or unintentionally sold outside of an authorized sales-territory or by non-authorized dealers in an authorized territory. All equipment shall be accompanied by the Original Equipment Manufacturers (OEM s) warranty. Counterfeit Electronic Parts are defined as unlawful or unauthorized reproduction, substitution, or alteration that has been knowingly mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified electronic part from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitution includes used electronic parts represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics. NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) PROCUREMENTS �(SECTION 508) On January 18, 2017, the Architectural and Transportation Barriers Compliance Board (Access Board) revised and updated, in a single rulemaking, standards for electronic and information technology developed, procured, maintained, or used by Federal agencies covered by Section 508 of the Rehabilitation Act of 1973, as well as our guidelines for telecommunications equipment and customer premises equipment covered by Section 255 of the Communications Act of 1934. The revisions and updates to the Section 508-based standards and Section 255-based guidelines are intended to ensure that information and communication technology (ICT) covered by the respective statutes is accessible to and usable by individuals with disabilities. SECTION 508 INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) STANDARDS The Section 508 standards established by the Access Board are incorporated into, and made part of all VA orders, solicitations and purchase orders developed to procure ICT. These standards are found in their entirety at: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines. A printed copy of the standards will be supplied upon request. � Federal agencies must comply with the updated Section 508 Standards beginning on January 18, 2018. The Final Rule as published in the Federal Register is available from the Access Board: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule. The Contractor shall comply with 508 Chapter 2: Scoping Requirements for all electronic ICT and content delivered under this contract. Specifically, as appropriate for the technology and its functionality, the Contractor shall comply with the technical standards marked here: E205 Electronic Content (Accessibility Standard -WCAG 2.0 Level A and AA Guidelines) E204 Functional Performance Criteria E206 Hardware Requirements E207 Software Requirements E208 Support Documentation and Services Requirements COMPATIBILITY WITH ASSISTIVE TECHNOLOGY The standards do not require installation of specific accessibility-related software or attachment of an assistive technology device. Section 508 requires that ICT be compatible with such software and devices so that ICT can be accessible to and usable by individuals using assistive technology, including but not limited to screen readers, screen magnifiers, and speech recognition software. ACCEPTANCE AND ACCEPTANCE TESTING Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the Section 508 Chapter 2: Scoping Requirements standards identified above. The Government reserves the right to test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon Deliverables resulting from this solicitation will be accepted based in part on satisfaction of the Section 508 Chapter 2: Scoping Requirements standards identified above. The Government reserves the right to test for Section 508 Compliance before delivery. The Contractor shall be able to demonstrate Section 508 Compliance upon delivery. INFORMATION TECHNOLOGY USING ENERGY-EFFICIENT PRODUCTS The Contractor shall comply with Sections 524 and Sections 525 of the Energy Independence and Security Act of 2007; Section 104 of the Energy Policy Act of 2005; Executive Order 13834, Efficient Federal Operations, dated May 17, 2018; Executive Order 13221, Energy-Efficient Standby Power Devices, dated August 2, 2001; and the Federal Acquisition Regulation (FAR) to provide ENERGY STAR �, Federal Energy Management Program (FEMP) designated, low standby power, and Electronic Product Environmental Assessment Tool (EPEAT) registered products in providing information technology products and/or services. The Contractor shall ensure that information technology products are procured and/or services are performed with products that meet and/or exceed ENERGY STAR, FEMP designated, low standby power, and EPEAT guidelines. The Contractor shall provide/use products that earn the ENERGY STAR label and meet the ENERGY STAR specifications for energy efficiency. Specifically, the Contractor shall: Provide/use ENERGY STAR products, as specified at www.energystar.gov/products (contains complete product specifications and updated lists of qualifying products). Provide/use the purchasing specifications listed for FEMP designated products at https://www4.eere.energy.gov/femp/requirements/laws_and_requirements/energy_star_and_femp_designated_products_procurement_requirements. The Contractor shall use the low standby power products specified at http://energy.gov/eere/femp/low-standby-power-products. Provide/use EPEAT registered products as specified at www.epeat.net. At a minimum, the Contractor shall acquire EPEAT � Bronze registered products. EPEAT registered products are required to meet the technical specifications of ENERGY STAR, but are not automatically on the ENERGY STAR qualified product lists. The Contractor shall ensure that applicable products are on both the EPEAT Registry and ENERGY STAR Qualified Product Lists. The Contractor shall use these products to the maximum extent possible without jeopardizing the intended end use or detracting from the overall quality delivered to the end user. The following is a list of information technology products for which ENERGY STAR, FEMP designated, low standby power, and EPEAT registered products are available: Computer Desktops, Laptops, Notebooks, Displays, Monitors, Integrated Desktop Computers, Workstation Desktops, Thin Clients, Disk Drives Imaging Equipment (Printers, Copiers, Multi-Function Devices, Scanners, Fax Machines, Digital Duplicators, Mailing Machines) Televisions, Multimedia Projectors This list is continually evolving, and as a result is not all-inclusive. GENERAL REQUIREMENTS VA TECHNICAL REFERENCE MODEL The Contractor shall support the VA enterprise management framework. In association with the framework, the Contractor shall comply with OI&T Technical Reference Model (VA TRM). The VA TRM is one component within the overall Enterprise Architecture (EA) that establishes a common vocabulary and structure for describing the information technology used to develop, operate, and maintain enterprise applications. Moreover, the VA TRM, which includes the Standards Profile and Product List, serves as a technology roadmap and tool for supporting OI&T. Architecture & Engineering Services (AES) has overall responsibility for the VA TRM. POSITION/TASK RISK DESIGNATION LEVEL(S) Position Sensitivity and Background Investigation Requirements by Service Task/Item Number Service Task/ Item Number Tier1 / Low Risk Tier 2 / Moderate Risk Tier 4 / High Risk 1.1 1.2 1.3 The Tasks identified above and the resulting Position Sensitivity and Background Investigation requirements identify, in effect, the Background Investigation requirements for Contractor individuals, based upon the tasks the particular Contractor individual will be working. The submitted Contractor Staff Roster must indicate the required Background Investigation Level for each Contractor individual based upon the tasks the Contractor individual will be working, in accordance with their submitted proposal. INFORMATION SECURITY CONSIDERATIONS: The Assessment and Authorization (A&A) requirements do not apply and a Security Accreditation Package is not required All VA sensitive information shall be protected at all times in accordance with local security field office System Security Plans (SSP s) and Authority to Operate (ATO) s for all systems/LAN s accessed while performing the tasks detailed in this Product Description. A prohibition on unauthorized disclosure: Information made available to the Contractor or Subcontractor by VA for the performance or administration of this contract or information developed by the Contractor/Subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the Contractor/Subcontractor s rights to use data as described in Rights in Data General, FAR 52.227-14(d).(1). A requirement for data breach notification: Upon discovery of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the Contractor/Subcontractor has access, the Contractor/Subcontractor shall immediately notify the COR and simultaneously, the designated ISO, and Privacy Officer for the contract. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. See VA Handbook 6500.6, Appendix C, paragraph 6.a. A requirement to pay liquidated damages in the event of a data breach: In the event of a data breach or privacy incident involving SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals. However, it is the policy of VA to forgo collection of liquidated damages in the event the Contractor provides payment of actual damages in an amount determined to be adequate by the agency. Based on the determinations of the independent risk analysis, the Contractor shall be responsible for paying to VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification; One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; Data breach analysis; Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs A requirement for annual security/privacy awareness training: Before being granted access to VA information or information systems, all Contractor employees and Subcontractor employees requiring such access shall complete on an annual basis either: (i) the VA security/privacy awareness training (contains VA security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA s security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the Contractor. If the Contractor provides their own training that conforms to VA s requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in VA s contract have received their annual security/privacy training that meets VA s requirements and the total number of employees trained. See VA Handbook 6500.6, Appendix C, paragraph 9. A requirement to sign VA s Rules of Behavior: Before being granted access to VA information or information systems, all Contractor employees and Subcontractor employees requiring such access shall sign on annual basis an acknowledgement that they have read, understand, and agree to abide by VA s Contractor Rules of Behavior which is attached to this contract. See VA Handbook 6500.6, Appendix C, paragraph 9, and Appendix D. Note: If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor s designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA s information and information systems. ADDENDUM B VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE APPLICABLE PARAGRAPHS TAILORED FROM: THE VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE, VA HANDBOOK 6500.6, APPENDIX C, MARCH 12, 2010 GENERAL Contractors, Contractor personnel, Subcontractors, and Subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS A Contractor/Subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, Subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. All Contractors, Subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for Contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates (e.g. Business Associate Agreement, Section 3G), the Contractor/Subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. The Contractor or Subcontractor must notify the CO immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the Contractor or Subcontractor s employ. The CO must also be notified immediately by the Contractor or Subcontractor prior to an unfriendly termination. VA INFORMATION CUSTODIAL LANGUAGE Information made available to the Contractor or Subcontractor by VA for the performance or administration of this contract or information developed by the Contractor/Subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of VA. This clause expressly limits the Contractor/Subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). VA information should not be co-mingled, if possible, with any other data on the Contractors/Subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the Contractor must ensure that VA information is returned to VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on site inspections of Contractor and Subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. Prior to termination or completion of this contract, Contractor/Subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this contract without prior written approval by VA. Any data destruction done on behalf of VA by a Contractor/Subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA CO within 30 days of termination of the contract. The Contractor/Subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. The Contractor/Subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on Contractor/Subcontractor electronic storage media for restoration in case any electronic equipment or data used by the Contractor/Subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. If VA determines that the Contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the Contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. If a VHA contract is terminated for cause, the associated Business Associate Agreement (BAA) must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.05, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. The Contractor/Subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. The Contractor/Subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA minimum requirements. VA Configuration Guidelines are available upon request. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the Contractor/Subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA prior written approval. The Contractor/Subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA CO for response. Notwithstanding the provision above, the Contractor/Subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the Contractor/Subcontractor is in receipt of a court order or other requests for the above mentioned information, that Contractor/Subcontractor shall immediately refer such court orders or other requests to the VA CO for response. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require Assessment and Authorization (A&A) or a Memorandum of Understanding-Interconnection Security Agreement (MOU-ISA) for system interconnection, the Contractor/Subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR. INFORMATION SYSTEM DESIGN AND DEVELOPMENT Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference VA Handbook 6500, Risk Management Framework for VA Information Systems Tier 3: VA Information Security Program, and the TIC Reference Architecture). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6508, Implementation of Privacy Threshold Analysis and Privacy Impact Assessment. The Contractor/Subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or VA. This includes Internet Explorer 11 configured to operate on Windows 7 and future versions, as required. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default program files directory and silently install and uninstall. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Risk Management Framework for VA Information Systems Tier 3: VA Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle. The Contractor/Subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties. The Contractor/Subcontractor agrees to: Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies: The Systems of Records (SOR); and The design, development, or operation work that the Contractor/Subcontractor is to perform; Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and Include this Privacy Act clause, including this subparagraph (c), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the Contractor/Subcontractor is considered to be an employee of the agency. Operation of a System of Records means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records. Record means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph. System of Records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as Systems ), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hot fixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than _____days. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within _____ days. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the CO and the VA Assistant Secretary for Office of Information and Technology. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, Contractors/Subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The Contractor s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA network involving VA information must be in accordance with the TIC Reference Architecture and reviewed and approved by VA prior to implementation. For Cloud Services hosting, the Contractor shall also ensure compliance with the Federal Risk and Authorization Management Program (FedRAMP). Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. Outsourcing (Contractor facility, Contractor equipment or Contractor staff) of systems or network operations, telecommunications services, or other managed services requires A&A of the Contractor s systems in accordance with VA Handbook 6500.3, Assessment, Authorization and Continuous Monitoring of VA Information Systems and/or the VA OCS Certification Program Office. Government-owned (Government facility or Government equipment) Contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection security agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. The Contractor/Subcontractor s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA CO and the ISO for entry into the VA POA&M management process. The Contractor/Subcontractor must use the VA POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the Government. Contractor/Subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with Contractor/Subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the A&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, and Contingency Plan). The Certification Program Office can provide guidance on whether a new A&A would be necessary. The Contractor/Subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The Government reserves the right to conduct such an assessment using Government personnel or another Contractor/Subcontractor. The Contractor/Subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. VA prohibits the installation and use of personally-owned or Contractor/Subcontractor owned equipment or software on the VA network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for Government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the Contractor/Subcontractor or any person acting on behalf of the Contractor/Subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/Subcontractors that contain VA information must be returned to VA for sanitization or destruction or the Contractor/Subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: Vendor must accept the system without the drive; VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for VA to retain the hard drive, then; The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. SECURITY INCIDENT INVESTIGATION The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The Contractor/Subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the Contractor/Subcontractor has access. To the extent known by the Contractor/Subcontractor, the Contractor/Subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the Contractor/Subcontractor considers relevant. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. 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 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. LIQUIDATED DAMAGES FOR DATA BREACH Consistent with the requirements of 38 U.S.C. �5725, a contract may require access to sensitive personal information. If so, the Contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the Contractor/Subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the Contractor provides payment of actual damages in an amount determined to be adequate by the agency. The Contractor/Subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. Each risk analysis shall address all relevant information concerning the data breach, including the following: Nature of the event (loss, theft, unauthorized access); Description of the event, including: date of occurrence; data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; Number of individuals affected or potentially affected; Names of individuals or groups affected or potentially affected; Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; Amount of time the data has been out of VA control; The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); Known misuses of data containing sensitive personal information, if any; Assessment of the potential harm to the affected individuals; Data breach analysis as outlined in 6500.2 Handbook, Management of Breaches Involving Sensitive Personal Information, as appropriate; and Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. Based on the determinations of the independent risk analysis, the Contractor shall be responsible for paying to VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification; One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; Data breach analysis; Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the Contractor under the clauses contained within the contract. With 10 working-day s notice, at the request of the Government, the Contractor must fully cooperate and assist in a Government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The Government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. TRAINING All Contractor employees and Subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Information Security Rules of Behavior, updated version located at https://www.voa.va.gov/DocumentView.aspx?DocumentID=4848, relating to access to VA information and information systems; Successfully complete the VA Privacy and Information Security Awareness and Rules of Behavior course (TMS #10176) and complete this required privacy and information security training annually; Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the CO for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] The Contractor shall provide to the CO and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 2 days of the initiation of the contract and annually thereafter, as required.Failure to complete the mandatory annual training and electronically sign the Rules of Behavior annually, within the timeframe required, 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 training and documents are complete.
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