7A21--VISN 8 - Clinical Documentation Improvement (CDI) Pro | 675-23-1-5900-0001 (VA-23-00001174)

VISIN 8 CDI PRO TAC Number: Page 14 of 33 Product DescriptionTemplate_JAN_04_2019 Product Description Template_JAN_04_2019 PRODUCT DESCRIPTION (PD) TEMPLATE DEPARTMENT OF VETERANS AFFAIRS VA Sunshine Healthcare Network (VISN 8) VISN 8 Business Development Office Clinical Documentation Improvement (CDI) Pro Date: 7/01/2022 TAC- PD Version Number: 1.0 Contents 1.0 PRODUCT REQUIREMENTS 6 1.1 (Add additional items as needed) 6 1.2 GRAY MARKET GOODS 6 2.0 NOTICE OF THE FEDERAL ACCESSIBILITY LAW AFFECTING ALL INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) PROCUREMENTS (SECTION 508) 7 2.1 SECTION 508 INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) STANDARDS 7 2.2 COMPATABILITY WITH ASSISTIVE TECHNOLOGY 8 2.3 ACCEPTANCE AND ACCEPTANCE TESTING 8 3.0 INFORMATION TECHNOLOGY USING ENERGY-EFFICIENT PRODUCTS 8 4.0 SYSTEM ACCEPTANCE (PRE-PRODUCTION) TESTING 10 5.0 SHIPMENT OF HARDWARE OR EQUIPMENT 10 5.1 SPECIAL SHIPPING INSTRUCTIONS 11 5.2 NATIONAL ACQUISITIONS 11 6.0 GENERAL REQUIREMENTS 13 6.1 VA TECHNICAL REFERENCE MODEL 13 6.2 POSITION/TASK RISK DESIGNATION LEVEL(S) 13 ADDENDUM B VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE 20 PRODUCT REQUIREMENTS The required brand name Nuance Clintegrity 360 VA Clinical Documentation Improvement (CDI Pro) is a software product which interfaces with the medical record (CPRS) and VistA. The product is currently used by VISN 8 Business Development Program to effectively support and enhance effective, efficient CDI programs throughout VISN 8. Clinical Documentation Improvement is a process where the health record is manually reviewed either concurrently or retrospectively for ambiguous, conflicting, incomplete, or nonspecific provider documentation. The Department of Veterans Affairs VISN 8 requires the following items for a period of service of a Base + 4 Option Years. Period of Performance Base Year 11/18/2022 11/17/2023 Option Year 1 11/18/2023 11/17/2024 Option Year 2 11/18/2024 11/17/2025 Option Year 3 11/18/2025 11/17/2026 Option Year 4 11/18/2026 11/17/2027 Part no. Description Qty Gainesville QVA-CDI-LG- SVC Clintegrity 360 | VA CDI Pro, Term, Annual IP Admissions Lic. (10K-20K). Facility Annual License - up to 6 concurrent user licenses. Include SKU QVA CDI-LG-TRM when ordering. 1 NOTE NOTE: # Admissions based on FY21 VSSC: Gainesville: 10,294   Tampa, Orlando, Bay Pines, Miami, West Palm Beach, San Juan QVA-CDI-MD- SVC Clintegrity 360 | VA CDI Pro, Term, Annual IP Admissions Lic. (2,001K-10K). Facility Annual License - up to 4 concurrent user licenses. Include SKU QVA-CDI-MD-TRM when ordering. 6 NOTE NOTE: # Admissions based on FY21 VSSC: Tampa: 9,430, Bay Pines: 8,629, Miami: 4,697, West Palm Beach: 5,099, San Juan: 7,016, Orlando: 7,266   QVA-CDI-USR- SVC Clintegrity | 360 VA CDI Pro, Term, Annual User Lic. (single facility) 1 NOTE 1 additional VISN license to support concurrent usage beyond base facility license - for Tampa   Continued Professional Services All VISN 8 Facilities (count: 7) NOTE Includes 10% discount on Current CDI Solution Pro Services   CDI Program Ongoing Support Package VACDI-PIMPL- PRO VA CDI Pro Post Implementation Professional Services 7 NOTE VA CDI Pro Support Package includes: access to Web Based Didactic Training, Program Management Tools, CDI Physician Advisor, Physician Service   NOTE Includes: Direct Support from a Nuance CDI Specialists to provide monthly completion of ProTrak workbook with feedback on any identification of workflow, bottleneck issues, or other areas of improvement, quarterly analysis upon request of up to three records on CDI scenarios with written responses   Part no. Description Qty Quarterly Inpatient CDI Audit per quarter, per CDIS to include 25 retrospective and 5 concurrent reviews NOTE Quarterly IP CDI Audit per qrtr/per IP CDIS. Includes 25 retrospective & 5 concurrent reviews conducted during 1 week, summary analysis and webcast briefing x 1 inpatient CDI Specialist/facility. Recommended once per quarter per CDIS performing inpatient reviews.   NOTE Line item below are quoted at qty of 5 days per site per qtr. If not all sites require this service, qty may be adjusted for individual site purchase (5 days/site) and line item may be split into multiple lines items if needed to exercise this option.   QCONSU-CON1 Consulting Fee, daily rate, 1 consultant 35 NOTE Quarter 1 Option/facility   QCONSU-CON1 Consulting Fee, daily rate, 1 consultant 35 NOTE Quarter 2 Option/facility   QCONSU-CON1 Consulting Fee, daily rate, 1 consultant 35 NOTE Quarter 3 Option/facility   QCONSU-CON1 Consulting Fee, daily rate, 1 consultant 35 NOTE Quarter 4 Option/facility   Quarterly Outpatient CDI Audit per quarter, per CDIS to include 30 retrospective reviews/facility NOTE Quarterly Outpatient CDI Audit per facility. Includes 30 retrospective reviews (up to 10 of which can be ambulatory surgery charts) conducted during one week, summary analysis and webcast briefing per quarter x 1 outpatient CDI Specialists per facility   NOTE Line item below are quoted at qty of 2 days per site per qtr. If not all sites require this service, qty may be adjusted for individual site purchase (2 days/site) and line item may be split into multiple lines items if needed to exercise this option.   QCONSU-CON1 Consulting Fee, daily rate, 1 consultant 14 NOTE Quarter 1 Option/facility   Part no. Description Qty QCONSU-CON1 Consulting Fee, daily rate, 1 consultant 14 NOTE Quarter 2 Option/facility   QCONSU-CON1 Consulting Fee, daily rate, 1 consultant 14 NOTE Quarter 3 Option/facility   QCONSU-CON1 Consulting Fee, daily rate, 1 consultant 14 NOTE Quarter 4 Option/facility   New Proposed CDI Solutions NOTE Includes 10% discount on VA CDI Pro IP Continuing Education and IP CDI Peer-to-Peer Education Refresher   VA CDI Pro Inpatient Continuing Education QCONSU-CON1 Consulting Fee, daily rate, 1 consultants 42 NOTE Unit price includes 5% VISN contract discount   NOTE VA CDI Pro Post Implementation Continuing Education Services (42 consulting days (estimated 6 days x 7 VAMCs))   NOTE Designed to meet VAMC needs include, but not limited to: Coding Clinic quarterly updates, CDI Challenging Scenarios Topic Education, Clinical Rotation (1-1 reviews of CDI workflow processes using Clintegrity VA CDI Pro software with live record reviews), VA CDI Pro IP new CDI user or refresher training (i.e., VA CDI Pro Reports/CDI Trak Reports, DRG Reconciliation training with case reviews, imports   NOTE Additional topics: VERA CDI and PSI Training, query tracking with query compliance, best practices, and live case(s), software best practices, introduction and best practices for Nuance University (Strategy Academy, Didactic, program resources, etc.), additional CDI audits beyond quarterly CDI audits in quote   Part no. Description Qty Peer-to-Peer Monthly Physician Training PHY-PP-CONS Physician Peer to Peer Consulting Services (Per Hour) 156 QHIMBO-SCON HIM/Business Office Senior Consultant, per hour 208 NOTE Supports 12 monthly one-hour VISN-wide Physician CDI Topic Education sessions over webcast, conducted two separate times and one quarterly single facility session for each of the seven VISN 8 VAMCs delivered by the Nuance Physician / CDI Consultant team delivered over a one-year period of performance. Content typically includes 30-40 minutes of content with additional time for questions.   NOTE CDI topics may include: general CDI importance (IP and OP), HCCs, diagnostic topics such as: sepsis, pneumonia, respiratory failure, HF, Afib, renal failure, cerebral compression/edema, diabetes, deep tissue pressure injuries, social determinants of health, E&M   NOTE Includes development of session content, integration of VAMC's statistics and sample clarifications for quarterly VAMC sessions, and delivery via webcast.   NOTE Planning call with VA CDI leadership conducted at the start of the project and throughout with Nuance team of Physician Consultant, VA Outpatient CDI Consultant, VA Inpatient CDI Consultant, and Project Manager, which must take place a minimum of 3 weeks prior to first education session to define VISN monthly topics and schedule VISN and VAMC dates and times.   NOTE Each session may be billed upon delivery. Pricing reflects entire VISN purchase.   NOTE Signed Authorization/Release form must be received and processed 4 weeks in advance of scheduled education visit if VAMC plans to record any session.   Part no. Description Qty Inpatient CDI Peer-to-Peer Physician Education Refresher PHY-PP-CONS Physician Peer to Peer Consulting Services (Per Hour) 112 NOTE Unit price includes 5% VISN contract discount   NOTE 2 day remote refresher Inpatient CDI Peer-to-Peer Physician Education sessions   NOTE Up to 4 general sessions per day (including leadership and HIMS/CDI meetings); 30-45 minute general sessions with 15 minute Q&A sessions; delivered by one Physician Consultant   NOTE Remote learning materials/content development of custom CDI training with outpatient focus and project management included in cost above.   Outpatient CDI Workflow Process (Optimization) QWFA-RIP-LCON Workflow Analysis, Revenue Improvement Professional Services/Product Utilization Enhancement Project, limited 7 NOTE Outpatient CDI audit retrospective review process assessment (current practices) and workflow training using VA tools based on OP CDI staff at that facility for key, targeted focus areas   NOTE Estimated 3-4 days delivered remotely plus additional remote analysis and support   Workflow Analysis QWFA-RI-PROS Workflow Analysis, Revenue Improvement Professional Services/Product Utilization Enhancement Project 7 NOTE Includes review of four service areas: e.g. - Same Day Surgery, Radiology Package, PACT, Cardiology (may substitute different service areas). Typically two four-day weeks remote face-to-face and approximately two additional off site weeks, conducted remotely.   VA CDI Pro Outpatient Software License / Services VACDI-OP-TERM Nuance Clintegrity VA CDI Pro Outpatient; annual term license; on premise 7 NOTE 7 VISN 8 VAMCs QCONSU-CON1 Consulting Fee, daily rate, 1 consultant 21 NOTE VA CDI Pro OP Implementation Training, 3 days remote implementation training per 7 VAMCs Part no. Description Qty QIMP-TRN1 Implementation and Training Fee, daily rate, 1 instructor 1 NOTE Installation and Configuration fee - 1 day will cover all facilities Outpatient Peer-to-Peer CDI Education for Physicians QWFA-RIP-LCON Workflow Analysis, Revenue Improvement Professional Services/Product Utilization Enhancement Project, limited 7 NOTE Remote delivery of 2 days of custom CDI training with outpatient focus for approximately 200 physicians to extend physician training under the VA CDI Pro implementation services x 7 facilities.   NOTE Up to 4 general sessions per day (including leadership and HIMS/CDI meetings); 30-45 minute general sessions with 15 minute Q&A sessions; delivered by one Physician Consultant and one VA CDI/HIMS Consultant   NOTE Remote learning materials/content development of custom CDI training with outpatient focus and project management included in cost above.   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 COMPATABILITY 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. 3.0 SCHEDULE FOR DELIVERABLES Place of Performance: Bay Pines VA Healthcare System    10000 Bay Pines Boulevard  Bay Pines, FL 33744    Miami VA Healthcare System    1201 N.W. 16th Street  Miami, FL 33125    James A Haley Veterans Hospital/Tampa VAMC  13000 Bruce B. Downs Boulevard  Tampa, FL 33612    North Florida/ South Georgia VA Healthcare System  1601 SW Archer Road  Gainesville, FL 32608    Lake City VAMC  619 Marion Ave  Lake City, FL  32025    Orlando VAMC   13800 Veterans Way  Orlando, FL 32827    West Palm Beach VAMC  7305 N. Military Triangle  Riviera Beach, FL 33410    VA Caribbean Healthcare System  10 Casia Street  San Juan, PR  00921  Ship To and Mark For: All deliveries will be electronic to: Name: Jonathan Esteban Address: 140 Fountain Pkwy, Suite 600, St. Petersburg, FL 33716 Voice: (813) 560-6477 Email: jonathan.esteban@va.gov 4.0 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. POINTS OF CONTACT VA Program Manager: Name: Shella Miller Address: 140 Fountain Pkwy, Suite 600, St. Petersburg, FL 33716 Voice: (813) 407-7819 Email: shella.miller@va.gov Contracting Officer s Representative: Name: Jonathan Esteban Address: 140 Fountain Pkwy, Suite 600, St. Petersburg, FL 33716 Voice: (813) 560-6477 Email: jonathan.esteban@va.gov Contracting Officer: Name: Matthew Newell Address: 23 Christopher Way, Eatontown, NJ, 07724 Voice: 848-377-5170 Email: Matthew.Newell@va.gov Contract Specialist: Name: Magda Reyes Address: 23 Christopher Way, Eatontown, NJ, 07724 Voice: 848-377-5260 Email: Magda.Reyes2@va.gov 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, based upon the severity of the incident. 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 based upon the requirements identified within the contract. 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.