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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 ... 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...