6515--New Requirement: VISN 15 Natus EMG Upgrades (STL/KC/CO), 491-23-2-1025-0007 (VA-23-00025480)
This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise because of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort. The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract based on this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) DUNS number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below Work to be performed: PLEASE NOTE: VENDORS MUST PROVIDE AUTHORIZATION LETTERS/AGREEMENTS FROM THE OEM NATUS. SUBMISSIONS WILL NOT BE CONSIDERED WITHOUT PROOF OF AUTHORIZATION. Veterans Integrated Services Network (VISN) 15, Heartland Network s facilities are in need of upgrading their Natus electromyography (EMG) equipment to replace their legacy software and operating systems with current software and supported operating systems. The sites that need this requirement are Kansas City Veterans Affairs Medical Center (VAMC), Columbia Missouri VAMC, and Saint Louis VAMC. Current EMG equipment is running on older versions of Microsoft Windows that are no longer supported by the manufacturer and are in need or replacement to be compliant with current Office of Information Technology (OIT) policies. As part of updating equipment hardware, software, and operating systems, there is also a need to set up test environments for Kansas City and Saint Louis. These test environments and supported operating systems are required to be in place prior to integrating into the Cerner Electronic Medical Record (EMR) system that VISN 15 will complete in the near future. Equipment Specifications Requirements Item # Description/Part Number* Qty A Saint Louis MO A 1 EDX Desktop WIN-10 PC UPG/ 017606 STL 3 2 Software Upgrade from v22 to ELITE Software/033418 STL 4 3 HL7 Gateway Upgrade/018857 STL 1 4 HL7 Test Environment/018854 STL 1 5 HL7 EMG IMPL Labor-Basic/018858 STL 1 6 Installation Included/SVC800INSTALL 1 7 Training Included/SVC800TRAIN 1 8 Customer Location 2 Day Neuro POS Training/701-446200 1 9 FS and PS Labor Daily Rate/701-579006 1 A Kansas City MO A 10 Software Upgrade from v22 to ELITE Software/033418 2 11 HL7 Gateway Upgrade/018857 1 12 HL7 Test Environment/018854 1 13 HL7 EMG IMPL Labor-Basic/018858 1 14 Installation Included/SVC800INSTALL 1 15 Training Included/SVC800TRAIN 1 16 Customer Location EMG 1 Day Training/019927 1 A Columbia MO A 17 US Configuration/US-CONFIG 3 18 EDX US Base Unit/982A0597 3 19 EDX Windows 10 DSKTP/842-689700 3 20 MS Office PRO + 2016/021223 3 21 NA Power Cord/842-678300 3 22 Natus Viking Software/033416 3 23 Viking EDX CTL Panel/842-689400 3 24 EDX 5 Channel AMPL/842-692000 2 25 EDX 2 Channel AMPL/515-016000 1 26 WR50 Comfort + Probe/515-018800 3 27 Nicolet Headphone/842-202700 2 28 2015 Visual Stimulator/842-648300 2 29 NCS/828-060900 3 30 EMG/828-060800 3 31 Reference Help/828-060700 3 32 Single Fiber EMG/828-061200 2 33 Multi-MUP Analysis/828-060600 2 34 EP(3 Modality)/828-061600 2 35 UB4 Cart/842-690100 3 36 UB4 Cart Monitor Arm/842-691200 3 37 EDX AMPL Holder & Arm/515-018500 3 38 Nicolet 115V ISOBOX/842-670400 3 39 21.5" LCD Monitor/842-664600 3 40 120V Laser Printer/842-117700 3 41 Single Footswitch/222-448101 3 42 Installation Included/SCV800INSTALL 1 43 Training Included/SVC800TRAIN 1 44 Customer Location ADD/TL EMG Training 1 Day/019927 1 Software Vendor shall ensure all software operating on the device provided is supported by the original manufacturer at time of delivery. For example, vendor shall not provide VISN 15 a device/workstation utilizing the Windows XP or Windows 7 operating system as they are no longer Microsoft supported. Proprietary software systems are acceptable so long as vendor supports the version provided to VISN 15 and it is the newest version at time of delivery. Access to all software shall be provided to VISN 15 in situations where re-installation is necessary. Software shall be provided to VISN 15 with unlimited perpetual licensing for the supported life of the device. In cases where vendor insists on utilizing a licensing fee model this should be noted in the bid provided for VISN 15 consideration. Network Security The vendor will be required to fill out VA Security Forms if their equipment regarding connecting equipment to the VA network. The forms will be provided with the RFQ. If these forms are not completed and submitted with the bid package the vendor can be disqualified from the bidding process. Oracle Cerner Compatibility All vendors providing a bid to this requirement shall provide a Oracle Cerner compatibility statement from the OEM of the equipment that they are proposing to the VISN 15 Office. This statement will include an OEM attestation that the product proposed is Oracle Cerner verified and provide a list of healthcare organizations that have deployed the project with the Oracle Cerner EHR. The statement will also include any relevant information as to what data can be transmitted to Oracle Cerner. This statement will be dated within 60 days of the quote being provided to ensure it is recent and accurate. The statement will provide an OEM point of contact who can be reached to further discuss any questions or concerns over Cerner compatibility. If the device/system being proposed does not connect to the network or medical record the vendor shall note this in their proposal. Vendor bids that do not include a Oracle Cerner compatibility statement directly from the OEM will be discarded from consideration. Installation and Assembly Vendor shall be responsible for assembly and installation of systems after notification from VISN 15 Biomedical Engineering that it has been delivered to station. Installation shall include implementation and testing of all purchased interfaces to VA electronic systems in coordination with Clinical Staff, Biomedical Engineering staff, OIT staff, and others identified as needed. Install shall include unboxing and transportation of equipment to final use location. Assembly and install shall occur within 30 days of delivery to station. Vendor shall provide all necessary accessories, cables, adaptors, etc. to deliver a fully functional clinical device. Training Vendor shall provide two (2) days of on-site clinical/applications training for relevant VISN 15 site staff members. Vendor shall provide introductory system/maintenance training to VISN 15 Biomedical Engineering staff or local site Biomedical Engineering during installation. Vendor shall include all costs for travel to provide this training in their proposal. Vendor shall coordinate all installation and training dates with VISN 15 specified Biomedical Engineering POC who will communicate internally with clinical staff. Warranty and Service Service and Operator Manuals The vendor shall provide the following documentation for the proposed system: Two (2) copies of operator's instruction manuals per unit purchased Two (2) copies of complete technical service manuals including detailed troubleshooting guides, necessary diagnostic software, service keys, schematic diagrams, parts lists, and any other resources available to the manufacturer s service technicians. Two (2) copies of a system manager s manual outlining back-up procedures, managing privilege group limits, routine tasks, etc. Warranty The system, all accessories, and all software shall be covered under the manufacturer s warranty and shall include all parts and labor for at least one year following acceptance by the VAMC. A manufacturer s factory-trained Field Service Engineer shall perform installation and maintenance during the warranty period. The warranty period shall not begin until after the VISN 15 Biomedical Engineering POC has accepted the products delivery, installation, and functionality. The warranty shall include all manufacturer recommended Preventive Maintenance procedures for its duration. All available software updates and security patches will be made available to the VISN 15 during the warranty period. Vendor shall provide response to applications and technical calls within 8 hours. Vendor shall ship replacement parts within 48 hours of identifying necessity by VISN 15 Biomedical Engineering staff. Other Features Value added features in the vendor s proposal that will be considered include but are not limited to: Options for Trade-in of existing equipment shall be proposed in bid package Extended Warranty options shall be outlined in bid package Service and Biomedical training options shall be outlined in bid package Options for this training should include all registration, travel, and lodging costs when possible Hours of Operation Normal hours of coverage are Monday tough Friday, 8:00 AM to 4:30 PM Central Standard Time excluding national holidays. Vendor on-site visits will be coordinated with the VISN 15 Biomedical Engineering POC before being scheduled or conducted. Vendor representatives will check in with the VISN 15 Biomedical Engineering POC when they arrive on-site and check out upon completion of work each day. All services shall be performed during normal hours unless otherwise scheduled with the VISN 15 Biomedical Engineering POC. Vendor staff shall always be professional and shall take all necessary precautions to maintain a safe environment for the occupants. This includes, as necessary, coordinating access and closures for sensitive areas of the Medical Center. Vendor shall be responsible for cleaning all work areas after completion of tasks. This includes removal of packaging and a clean sweep/mop of the area as required by work type. Vendor staff shall minimize noise as much as possible while working in all buildings. Vendor is responsible for providing all PPE necessary for their work. Note: Hardware/software update/upgrade installations, where applicable, may be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the VISN 15 Biomedical Engineering POC). Federal Holidays observed by VISN 15 are: New Year s Day Labor Day Martin Luther King Day Columbus Day President s Day Veterans Day Memorial Day Thanksgiving Day Juneteenth Cistmas Day Independence Day Delivery Vendor shall deliver purchased equipment within 30 business days of receiving completed Contracting package from the VISN 15 Contracting Officer. If delivery delays occur vendor shall notify the Contracting Officer and the VISN 15 Biomedical Engineering POC. Delivery will be to the four (4) VISN 15 main campuses listed below. Vendor shall coordinate exact delivery location with the Contracting Officer and VISN 15 Biomedical Engineering POC at the time of the purchase. Vendor will ensure that equipment is sent to the Attention of Biomedical Engineering and will include the VISN 15 PO Number on the shipping label. Delivery of oversized, palletized orders or orders that contain a large number of components will be coordinated with the appropriate VISN 15 site Biomedical Engineering POC who will communicate internally with Warehouse Staff. VISN 15 Medical Center Delivery Locations Harry S. Truman Memorial Veterans Hospital Kansas City VA Medical Center 800 Hospital Drive 4801 Linwood Boulevard Columbia, MO 65201 Kansas City, MO 64128 ATTN: Biomedical Engineering ATTN: Biomedical Engineering PO Number for Order PO Number for Order Jefferson Barracks John Cocan 1 Jefferson Barracks Drive 915 North Grand Blvd St. Louis, MO 63125 Saint Louis, MO 63106 ATTN: Biomedical Engineering ATTN: Biomedical Engineering PO Number for Order PO Number for Order VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS 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 tough 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, 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 Contracting Officer 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 Contracting Officer 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 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). 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 s information is returned to the 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 the 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 Contracting Officer 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 the 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 BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, 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 s 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 s 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 contracting officer 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 contracting officer for response. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an 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 COTR. 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 Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. The contractor/subcontractor shall certify to the COTR 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 the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) 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, 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. g. The contractor/subcontractor agrees to: (1) 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: (a) The Systems of Records (SOR); and (b) The design, development, or operation work that the contractor/subcontractor is to perform. (2) 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 (3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR. h. 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. (1) 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. (2) 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. (3) 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. i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as Systems ), toughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, 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. j. 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 _30___ days. k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the 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 __30__ days. l. 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 contracting officer 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 COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation. 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 certification and accreditation (authorization) (C&A) of the contractor s systems in accordance with VA Handbook 6500.3, Certification and Accreditation 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 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 contracting officer and the ISO for entry into VA s POA&M management process. The contractor/subcontractor must use VA s 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 C&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, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&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 COTR. 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 VA s 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 the 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 the 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 pre-approved 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.A 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 COTR 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. A5725, 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. 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: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) 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; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate: and (11) 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 the VA liquidated damages in the amount of $__35__ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification. (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) 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 Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; Successfully complete the appropriate VA privacy training and annually complete required privacy training; and Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. Failure to complete the mandatory annual training and 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. EQUIPMENT REQUIREMENTS If this device connects to the VA secure wireless network, then the unit must utilize a FIPS 140-2 certified compliant connection compatible with the VA network. Contractor to provide information for VA Form 6550 appendix A at time of RFQ submission. Important information: The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this source sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to an acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Currently a total set-aside for Service-Disabled Veteran Owned Small Business firms is anticipated based on the Veterans Administration requirement with Public Law 109-461, Section 8127 Veterans Benefit Act. However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open. Any response to this source selection from Interested parties must be received NLT 02/09/2023, 12:00 PM CST. Attention: Michael Murphy, Contracting Specialist. Email: michael.murphy7@va.gov Please reference 36C255-23-Q-0163 in the subject line. Please provide your Unique Entity ID so that your organization can be identified in SAM.GOV and VetBiz if organization is claiming SDVOSB preference. Only organizations with an active SAM.GOV account can be considered. Utilize this link to either start a new registration or to renew the organization s registration. https://sam.gov/content/home
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