Page 11 of 11 This is a combined synopsis/solicitation for commercial products prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This is a Brand Name or Equal To Request for Quote (RFQ), and the solicitation number is 36C26024Q0916. The Government anticipates awarding a firm-fixed price service order from this solicitation. This is a solicitation for Bayer© Contrast Dose Management Radimetrics Enterprise Platform. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-06 Effective August 29, 2024. This solicitation is 100% set-aside for SDVOSB. The associated North American Industrial Classification System (NAICS) code for this procurement is 541512, with a small business size standard of $34 Million and the PSC is DH10. All interested companies shall provide quotations that are Brand Name or Equal To for the following: Equipment Needed: BRAND NAME or EQUAL (Bayer ® Healthcare, LLC. All interested parties shall quote the following: Base-included in original award: period to begin September 23, 2024 Base year to include the following list of required items Option Year 1 Option Year 2 Option Year 3 Option Year 4 Item Description Qty ME-84219851 CDM App, Tier 2 7 ME-84220388 CDM-Outbound PACS Interface, Tier 2 6 ME-84219576 CDM-Outbound HL7 Interface, Tier 2 7 ME-84220299 CDM-Outbound SR Interface 7 ME-87008762 INFORMATICS STARTER PACKAGE SW FLEX 6 ME-84219843 CDM App, Tier 1 3 ME-84220396 CDM-Outbound PACS Interface Tier 1 4 ME-84220264 CDM-Outbound HL7 Interface Tier 1 4 ME-84220302 CDM-Outbound SR Interface Tier 1 4 ME-87008630 CDM-Informatics Starter Package SW MRX 4 ME-84856496 INSTALLATION - INFORMATICS 10 ME-59941260 SERVICES, CERTEGRA INTEGRATION 10 ME-84219584 Implementation Services 1 ME-81923167 EXP-Travel and Lodging 1 Salient Characteristics: Contrast Dose Management Bayer proprietary software that allows administrative access to evaluate contrast injection history PACS Outbound Interface Bayer proprietary interface that enables a Dicom secondary capture to be transferred to PACS systems (i.e. Carestream) HL7 Outbound Interface Bayer proprietary interface that enables contrast injection details to be transferred to RIS and HER systems (i.e. VISTA/CERNER) POC Informatics Starter Packages Bayer proprietary software that automates documentation details of patient demographics and exam details Speech Reporting Interface Bayer proprietary interface that auto-populates contrast injection details into speech reporting systems Note: Above solutions require Medrad Stellant and Medrad Stellant Flex CT injectors with Certegra Workstation or Medrad MRXperion MR injection system. Competitive injectors are not compatible with these configurations. CDM will be installed on the Radimetrics Enterprise Platform. VA Portland has already established a server which is currently used for Radiation Dose Management. Contrast Dose Management will also live on this same server. See full Statement of Work for additional system requirements and details Statement of Work VA Portland HCS Radiology Service Addition of Contrast Dose Management Software Purpose: The VA Portland HCS has many Bayer contrast injectors to support care in MRI (qty 4), CT (qty 4), and Angio (qty 2) imaging suites. This new request is for the installation of dose management software that was not included in the original sales order. The injectors have medical software that interfaces with the contrast management software. The CMS system ties injection information to patient demographics obtained through HL7 messaging that is sent from the PACS system. All information remains within the VAMC. WORK STATEMENT Scope: The Contractor will provide Contrast Dose Management System Software designed for continuity in patient dose management and data. Contractor shall: Deliver, install, and set up all data feeds from injector to the patient record. Provide technical support and guidance. Provide basic and advanced operator training. Location: The injectors are located at VA Portland HCS, 3710 SW US Veterans Hospital Rd, Portland, OR 97239, and VA Portland HCS-Vancouver Campus 1601 E Fourth Plain Blvd, Vancouver, WA 98661. Minimal onsite work is required. Performance Requirements: The following are required: Radimetrics Contrast Dose Management System - Bayer Part Number Description Qty 84219851 CDM App, Tier 2 7 84220388 CDM-Outbound PACS Interface, Tier 2 6 84219576 CDM-Outbound HL7 Interface, Tier 2 7 84220299 CDM Outbound SR Interface 7 87008762 Informatics Starter Package SW Flex 6 84219843 CDM App Tier 1 3 84220396 CDM Outbound PACS interface Tier 1 4 84220264 CDM Outbound HL7 Interface Tier 1 4 84220302 CDM Outbound SR Interface Tier 1 4 87008630 CDM Informatics Starter Package SW MRX 4 84856496 Installation-Informatics 10 59941260 Services, Certegra integration 10 84219584 Implementation services 1 81923167 EXP Travel and Lodging 1 System Requirement: Point of Care software PACS Outbound Interface RIS Outbound Interface Speech Reporting Outbound Interface Imaging System (CT and MRI) Interfacing Display Requirements: Able to be used on current workstation for injector and existing workstations in the scanning room. System Functions: Fine-Tuned Performance, a contrast dose management solution can speed things up by eliminating manual process through interfacing. Automated Documentation Accuracy, easy access to accurate study reporting and accelerate report turnaround times. Facilitates compliance aids in meeting requirements surrounding contrast use and documentation required by The Joint Commission (TJC). Quality management, contrast dose management automates technologist workflows for accurate CT contrast-injection documentation at the point of care and throughout the post-procedure workflow. Radiation dose management streamlines compliance through automated dose reporting. Safety The Contractor shall immediately notify VAPORHCS of any changes in supplies, procedure modification, recall notification, or any changes that will affect the performance of the equipment or procedure according to FDA regulations. Prioritized messages and alerts for end user Connectivity Requirements: All network connections shall match the Enterprise Risk Assessment completed by Bayer and the VA. Any changes to the topology shall be communicated to the VA and shall not proceed to be implemented until approval is granted. A copy of the Enterprise Risk Assessment can be provided upon request. Maintenance: N/A Technical Support: Support Personnel will be available during business hours each business day, and live representatives via the Contractor s message center will be available by telephone at all other times. Technical support shall be available via telephone during business days (and by message center after hours) to provide troubleshooting assistance or to answer testing inquiries. All remote support shall occur within 2 hours of initial notification of the issue On-site technical support shall be available for escalations within 48 hours. On-site Repairs: For issues that the Contractor determines to require on-site support, the Contractor shall dispatch one or more Support Personnel within 48 business hours after documentation. The Contractor shall submit a detailed work report to include all required materials. The Contractor shall provide all parts and materials at no additional cost to the government. The Contractor shall remove all parts, equipment or materials replaced, or upgraded by the Contractor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the government. The contractor shall check in and out with Biomedical Engineer or designee upon arrival and departure if onsite work is required. Biomedical Engineering staff is located in B1D106-100-P. Training: The contractor shall provide the following: Initial training for end users One additional on-site or off-site Basic Operator class per year. Handouts and training materials in sufficient quantity for each participant. These are off-the-shelf courses. The contractor shall provide lesson plan, course materials and media (DVD s, CD s, videos, etc. if required), and editable procedures at no additional cost. Additional on-site training as requested by VAPORHCS at no additional charge. Period of Performance: Contractor shall provide the complete order to the facility within 90 days of purchase. Any delays in delivery shall be communicated to the Contracting Officer. FOB: Destination Option Years: shall be as follows for software support Base-included in original award: period to begin September 23, 2024 Option Year 1 Option Year 2 Option Year 3 Option Year 4 Deliverables and Supplies: This contract is for licensing and software support of interfaces to the RIS and PACS systems. The Contractor shall deliver all and not limited to operational, maintenance, troubleshooting, small repairs, specifications, and test manuals. The Contractor shall install the equipment and perform verification according to manufacturer specification and regulatory requirements. If requested supplies are on back-order, Contractor is to provide information as to the estimated time of availability. The Contractor shall deliver all invoices for review according to the established contract at the end of each billing cycle. All items not contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost. All modifications, upgrades, patches to the interfaces and software shall be communicated to VAPORHCS Biomedical Engineering staff prior to implementation. Any changes will require written concurrence from a member of the VA. Any changes in modifications shall be immediately disclosed by the Contractor electronically, and detailed guidance for implementation within twenty-four hours of its application. Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to outsourcing, transportation, and or any other additional cost shall be covered by the Contractor at no additional charge to the government. Contractor Security Contract Requirements: This Contractor requires no access to VAPOR HCS or any VA information system. There will be no access to the LIS. There will be supervised access when the Contractor is present for technical support, service calls, and scheduled preventative maintenance. NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA. NARA Records Management Language for Contracts (May 2017) 1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. 2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. 3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. 4. [FACILITY] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [FACILITY] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [FACILITY]. The agency must report promptly to NARA in accordance with 36 CFR 1230. 5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [FACILITY] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). 6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [FACILITY] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. 7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [FACILITY] policy. 8. The Contractor shall not create or maintain any records containing any non-public [FACILITY] information that are not specifically tied to or authorized by the contract. 9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. 10. The [FACILITY] owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [FACILITY] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. 11. Training.  All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers, and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. VA Sensitive Information 1. 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. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information is 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. c. 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. d. 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. e. 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. 3. VA INFORMATION CUSTODIAL LANGUAGE a. 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). b. 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. c. 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. d. 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. e. 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. f. 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. g. 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. h. 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. i. 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. j. 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. k. 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. l. 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 COR. 4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT a. 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 Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. b. 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 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. c. 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. d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges. e. 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. f. 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 ), throughout 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 _10_ 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. 5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE a. 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 s network involving VA information must be reviewed and approved by VA prior to implementation. b. 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. c. 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. d. 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, and Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. e. 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. f. 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. g. 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. h. 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: (1) Vendor must accept the system without the drive; (2) 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 (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. (4) 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; (a) 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 (b) 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. (c) 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. 6. SECURITY INCIDENT INVESTIGATION a. 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. b. 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. c. 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. d. 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. 7. LIQUIDATED DAMAGES FOR DATA BREACH a. 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. b. 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. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) 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. d. 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 $_37.50_ 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. PRIVACY a. Contractors and any subcontractors must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996. This includes both the Privacy and Security Rules published by the Department of Health and Human Services (HHS). b. As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities, Veterans Health Administration (VHA). In accordance with HIPAA, the contractor may be required to enter into a Business Associate Agreement (BAA) with VHA. c. Business associates must follow VHA privacy policies and practices when applicable. All contractors and business associates must receive privacy training annually. d. For contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS Standards for Privacy of Individually Identifiable Health Information as determined by VHA. e. For contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training. Proof of training is required upon request. 9. TRAINING a. 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: (1) 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; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) 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 contracting officer 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.] b. The contractor shall provide to the contracting officer and/or the COR 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. c. 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. This User Agreement contains rights and authorizations regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the Department of Veterans Affairs (VA). This User Agreement covers my access to all VA data whether electronic or hard copy ("Data"), VA information systems and resources ("Systems"), and VA sites ("Sites"). This User Agreement incorporates Rules of Behavior for using VA, and other information systems and resources under the contract. The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html http://www.va.gov/oal/library/vaar/index.asp The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Products ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL 52.252-1 Provisions Incorporated by Reference (FEB 1998) 52.204-7 System for Award Management (OCT 2018) 52.204-16 Commercial and Government Entity Code Reporting (AUG 2020) 52.204-20 Predecessor of Offeror (AUG 2020) 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021) 52.204-29 Federal Acquisition Supply Chain Security Act Orders Representation and Disclosures (DEC 2023) 52.211-6 Brand Name or Equal (AUG 1999) 52.214-21 Descriptive Literature (APR 2002) 52.233-2 Service of Protest (SEPT 2006) VAAR Provisions 852.239-71 Information System Security Plan and Accreditation (FEB 2023) 852.239-75 Information and Communication Technology Notice (FEB 2023) 852.252-70 Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008) (a) Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e., replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable. (b) Offeror shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e., replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. (c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items. (d) Any award made as a result of this solicitation will be made on an All or Nothing Basis. (e) Offerors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contractors, the offeror making such contact may be excluded from award considerations. (f) All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments, or the like, not specifically required by this solicitation, such will count against the Offeror s page limitations unless otherwise indicated in the specific volume instructions below. (g) All information shall be confined to the appropriate file. The offeror shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote. (End of Addendum to 52.212-1) FAR 52.212-2, Evaluation-Commercial Items : The Government may award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. In accordance with FAR 9.104-2, the special standards of responsibility described below apply to this procurement. Offerors who fail to meet any special standards of responsibility will not be eligible to receive contract award. The following factors shall be used to evaluate offers: Special Standards of Responsibility: (Per FAR 9.104-2) The following special standards of responsibility apply to this procurement: SP1: Offeror must be a manufacturer authorized provider for the items provided. A letter from the manufacturer stating such must be included with any response to this solicitation. Price (a) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offeror's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. FAR 52.213-3 Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer if has not been completed on SAM.gov. Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. All Service-Disabled Veteran Owned Businesses or Veteran Owned Businesses must be registered/certified with the U.S Small Business Administration at Veteran Small Business Certification Veteran Small Business Certification (sba.gov). The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Products (OCT 2018) ADDENDUM to FAR 52.212-4 The following clauses are included as a part of the addendum: http://www.acquisition.gov/far/index.html (FAR) http://www.va.gov/oal/library/vaar/index.asp (VAAR 52.204-9 Personal Identity Verification of Contractor Personnel (JAN 2011) 52.204-13 System for Award Management Maintenance (OCT 2018) 52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020) 52.217-8 Option to Extend Services (NOV 1999) 52.217-9 Option to Extend the Term of the Contract (MAR 2000) 52.223-5 Pollution Prevention and Right-to-Know Information (MAY 2024) 52.223-23 Sustainable Products and Services (MAY 2024) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) 52.233-3 Protest After Award (AUG 1996) 52.252-2 Clauses Incorporated by Reference (FEB 1998) NOTE: For this requirement: It is within the government s best interest to include the FAR clause 52.217 8, Option to Extend Services and 52.217-9 Option to Extend the Term of the Contract. The contract period will be cover 5 years (Base plus four options). FAR 52.217-8 option to extend the contract term is being evaluated as part of the initial evaluation, so that any resultant exercise of this option is within scope of the pending contract. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed six (6) months. If conditions warrant the exercise of FAR 52.217-8, the price(s) for the continued performance under this clause shall be at the same price(s) as the prior performance period. VAAR Clauses: 852.203-70 Commercial Advertising (MAY 2018) 852.204-70 Personal Identity Verification of Contractor Personnel (MAY 2020) 852.212-71 Gray Market and Counterfeit Items (FEB 2023) 852.219-73 VA Notice of Total Set-Aside for Certified Service-Disabled Veteran-Owned Small Business (JAN 2023) 852.219-75* VA Notice of Limitations on Subcontracting Certificate for Services and Construction (JAN 2023) 852.232-72 Electronic Submission of Payment Requests (NOV 2018) 852.239-70 Security Requirements for Information Technology Resources (FEB 2023) 852.239-73 Information System Hosting, Operation, Maintenance, or Use (FEB 2023) 852.239-74 Security Controls Compliance Testing (FEB 2023) 852.239-76 Information and Communication Technology Accessibility (FEB 2023) 852.242-71 Administrative Contracting Officer (OCT 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products (MAY 2024) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services: (1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E. Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)). (2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kapersky Lab Covered Entities (DEC 2023) (Section 1634 of Pub. L. 115-91). (3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021) Section 889(a)(1)(A) of Pub. L. 115-232). (4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015). (5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801). (6) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (7) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78) (19 U.S.C. 3805 note)). The following subparagraphs of FAR 52.212-5 are applicable and incorporated by reference: 52.203-17 52.204-10 52.204-27 Contractor Employee Whistleblower Rights (NOV 2023) Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note) Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117-328) 52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (NOV 2021) (31 U.S.C. 6101 note) 52.219-6 52.219-28 Notice of Total Small Business Set-Aside (NOV 2020) Post Award Small Business Program Representation (MAR 2023) (15 U.S.C 632(a)(2)) 52.222-3 52.222-19 Convict Labor (JUN 2003) (E.O. 11755) Child Labor Cooperation with Authorities and Remedies (NOV 2023) (E.O. 13126) 52.222-21 Prohibition of Segregated Facilities (APR 2015) 52.222-26 Equal Opportunity (SEP 2016) (E.O. 11246) 52.222-36 Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793) 52.222-50 Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627) 52.225-1 Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83) 52.225-13 Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury) 52.226-8 52.232-33 Encouraging Contractor Policies to Ban Text Messaging While Driving (MAY 2024) Payment by Electronic Funds Transfer System for Award Management (Jul 2018) (31 U.S.C. 3332) All quoters shall submit according to the following: Quotes must be emailed to Maureen.Sundstrom@va.gov and received no later than 4:00 PM PST on 09/10/2024. Quotes may be submitted on this document or the vendor s own form, and if not the manufacturer, an authorized distributor letter, and the completed Certificate of Compliance for Services and Construction at VAAR 852.219-75, attached. Any offer that does not provide the supporting documentation may be considered non-responsive. Required Supporting Documentation: VAAR Certificate of Compliance for Services and Construction VAAR 852.219-75 Authorized Distributor Letter if not the manufacturer Certification that equipment meets/exceeds the salient characteristics of the desired brand above Delivery date The Government intends to make award without discussions. For information regarding the solicitation, please contact Maureen Sundstrom at Maureen.Sundstrom@va.gov.
