General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C25623Q1542 Posted Date: September 20, 2023 Response Due Date/Time: September 26, 2023 / 12:00 PM (CST) Product or Service Code: DA10 Set Aside: None (Sole Source) NAICS Code: 541519 Size Standard: $34.0 Million Point of Contact: Justin Clark- Email: Justin.clark2@va.gov Contracting Office Address Department of Veterans Affairs Galleria Financial Center Network Contracting Office 16 5075 Westheimer Rd., Ste. 750 Houston, TX 77056 Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, in conjunction with FAR Part 13.5 for Certain Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-05 (effective 09/07/2023). This solicitation is being issued as a Sole Source requirement. The associated North American Industrial Classification System (NAICS) code for this procurement is 541519, with a small business size standard of $34 Million. Contractor is required to be actively registered in the System for Award Management (SAM). Quote may be considered non-compliant and rejected if the Contracting Officer is unable to verify active registration status. PRICE/COST SCHEDULE: Item # Description of Supplies Qty Unit Unit Price Amount 1 Document Control: 250 users [Federal] 1 EA 2 InspectionProof - up to ten CLIA numbers [Federal] 1 EA 3 Compliance & CE: 250 users [Federal] 1 EA 4 Personnel Documentation: 250 users [Federal] 1 EA 5 Compass: 250 users [Federal] 1 EA 6 Histology Compliance & CE: 25 users [Federal] 1 EA 7 IQE - CAPA: 10-14 CLIA Licenses, 30 forms [Federal] 1 EA 8 Exam Simulator (Group price) 125 EA 9 Phlebotomy Exam Simulator (Group price) 60 EA 10 NSH + LabCE Histology Exam Simulator 14 EA 11 White Blood Cell Differential Simulator: 25 users 1 EA 12 Advanced White Blood Cell Differential Simulator: 25 users 1 EA 13 Red Blood Cell Morphology Case Simulator: 25 users 1 EA 14 Body Fluid Case Simulator: 25 users 1 EA 15 Urinalysis Case Simulator: 25 users 1 EA 16 Single sign-on connection 1 EA 17 Premium Support 1 EA GRAND TOTAL $ STATEMENT OF WORK SCOPE: The Pathology and Laboratory Medicine Service Line (PLMS) at the Michael E DeBakey VA Medical Center (MEDVAMC) is procuring a Cloud-Based Laboratory network software platform and the associated laboratories located within the MEDVAMC s Community Based Outpatient Clinics (CBOCs) requires a document control system to warehouse, catalog, manage, as well as provide employee access to standard operating procedures and related documents. This procurement will be a base year (1 12-month period) with four (12-month option periods). The vendor shall provide all labor, personnel, equipment, tools, materials, supervision, and other items necessary to provide installation and training within 30 days of award. BACKGROUND: Joint Commission (JC) regulations state that all Pathology & Laboratory policies and procedures used by PLMS and associated CBOC Laboratories must be continually updated, easy to access, capable of maintaining staff competencies, laboratory inspection preparedness, continuing education for laboratory personnel, link policies and procedures and be able to be reviewed by laboratory staff, at all locations, on an ongoing basis. The MediaLab system shall have at least five (5) permission levels, personnel documents file, capable of creating forms for action reports, and keep track of corrective actions reports. The new document control package shall replace the current outdated manual systems as electronic document control is critical and necessary for maintaining effective compliance with industry standards. This will ensure that all laboratory testing sites that perform Veteran testing, within the MEDVAMC PLMS and associated CBOCs are in compliance with Association for the Advancement of Blood Biotherapies (AABB), College of American Pathologists (CAP), Food and Drug Administration (FDA), Environmental Protection Agency (EPA), ISO 15189, 21 CFR Part 11 standard, VHA Handbook 1106.01, Clinical Laboratory Improvement Amendments (CLIA) regulations, and JC accreditation standards, as well as meeting VHA Patient Safety and Quality initiatives. REQUIREMENTS: The vendor shall install to manufacturer s specifications maintaining Federal, and local safety standards. The installation must be completed within 90 days after contract is awarded. All work shall be completed between 7:30a.m. and 4 p.m. Monday Friday. All federal holidays, excluded. Federal holidays are available at the Federal Holiday OPM Site. If there is an operational conflict with installation, night or weekend installation can be an option. Government will provide a 72 hours' notice of change of installation hours. Vendor shall provide an implementation plan, with timelines, and coordinate the initial conversion of all documents into the system. The vendor shall provide initial training via WebEx or any form of online training and continued support for all system users at different levels. A. General 1. Internet/Cloud-based laboratory network document control system with single sign-on connection. 2. Unlimited access for any computer 24/7/365; production environment 15 minutes to 2 hours maximum time to acknowledge for Priority 1 severity, and for mean time to resolve. 3. 99% Annual operational uptime and complete data retrieval capability, and backup solution in case of catastrophic failure. Provide system server backup and contingency to ensure access to documents during planned or unplanned downtime. 4. Simple and intuitive, menu-driven, customizable portal or user interface. 5. Multiple roles or group-based permission levels that enable different levels of user access. 6. The system should enable easy addition and removal of user and level of access. 7. Total traceability tracks who performed what steps of task or approval. 8. Easy management of the entire life cycle of a document (create, edit, approve, issue and archive). 9. Set priority tasks and reminders. Assign to self or other users. 10. Customizable workflows based on department or level of importance. 11. Document Viewer module or capability 12. Ability to create customizable reports. 13. Ability to download full back-ups on demand 14. Generates site usage reports allowing some determination of system effectiveness. 15. Fast supported implementation 16. Modular software that components can be added or removed without requiring major upgrades or changing the functionality of the system. 17. Upgrade/Updates: a. provides updates to the service software in order to maintain the integrity of the system and the state-of the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. b. system updates that enhance the model of service being offered, i.e., new version of software, correction of software defect, update offered to commercial customers at no additional charge, upgrade to replace model of service no longer vendor supported, etc. This does not refer to replacing the original piece of service provided under the contract; however, it does refer to significant changes in the hardware operational capability. 18. Secure documents, passwords and personal information using encryption and Secure Sockets Layer (SSL). System has the compatible with PIV card. 19. Middleware system must be compliant with all Office of Information and Technology and information Security Directive. Must be SaaS compliance with all VA security. 20. If required, any vendor selected must undergo One-VA Technical Reference Model (TRM) approval. It is also expected that the selected vendor would assist in creating and agree to a Memorandum of Understanding MOU-ISA. 21. Key Features Required: a. Document Control The document control system must: 1) Allow documents to be uploaded as Word Docs, Excel files, Power Point files, or PDF files 2) Track all changes made to uploaded documents. 3) Allow the creation of approval processes. 4) Send automatic notifications to approving officials and to employees when documents need to be signed. 5) Send notifications to supervisors if employees do not sign documents within established timelines. 6) Record annual or biennial review with electronic signatures. 7) Allow users to flag documents that need revision. 8) Use hashing, encryption, and SSL so that documents, passwords, and personal information stays secure. 9) Have the ability to archive or retire old versions of documents. b. Inspection Proof The Inspection Preparedness system must: 1) Allow users to upload inspection checklists. 2) Allow users to link policies and procedures to checklist items. 3) Allow administrators to delegate checklists or items to other users. 4) Allow for on-site, self-inspections, mock inspections. 5) Allow administrators to approve or reject checklist responses. 6) Allow capture and respond to identified deficiencies 7) Allow checklists responses to copied to the next year s checklists. c. Compliance & Continuing Education (CE) The compliance and CE system must: 1) User Friendly 2) 24/7 Availability for employees 3) Include OHSA safety courses covering bloodborne pathogens, chemical hygiene, electrical and fire safety, and formaldehyde. 4) Include continuing education courses in hematology, chemistry, phlebotomy, and quality control. 5) Allow users to print certificates of completion. 6) Allow users to print reports of training history. 7) Allow administrators to create custom continuing education courses. 8) Allow administrators to assign courses with due dates. d. Personnel Documentation The personnel documentation file system must: 1) Allow administrators to assign, store, and retrieve employee information and documentation. 2) Allow administrators review and audit readiness of employee s documentations. 3) Allow administrators to track CLIA requirement for employees. e. Compass The competency assessment system must: 1) Allow administrators to build custom competency assessments and customize templates 2) Allow administrators to track competency with online quizzes, observation checklists, document reviews, repeat sample activities. 3) Allow administrators to delegate functions to leaders. 4) Allow administrators to assign six-month and annual assessments automatically. 5) Allow to send customized email notifications for new and incomplete training. f. Histology Compliance & CE The histology must: 1) Include continuing education course in histology and cover special stains, Immunohistochemistry, and Fluorescence in Situ Hybridization (FISH). 2) Include formaldehyde safety and ergonomics courses. 3) Allow users to print certificates of completion. 4) Allow users to print reports of training history. 5) Allow administrators to create custom continuing education courses 6) Allow administrators to assign courses with due dates. 7) User Friendly 8) 24/7 Availability for employees g. Intelligent Quality Engine (IQE) Corrective Action and Preventive Action (CAPA) The IQE and CAPA must: 1) Eliminate paper-based, manual investigation 2) Allow to follow corrective and preventive actions standard online. 3) Allow to create forms, customize workflows, collaborations, approve request, and reports. 4) Allow administrators to assign roles to employees based on job title and description (Intelligent Access Control). 5) Allow reporting for tracking and trending of event statuses. 6) Allow the laboratory to monitor their metrics in real-time reports. 7) Allow for the integration across management platform (document control, inspectionProof, and compliance & CE systems) to annotate changes to Standard Operating Procedures (SOP) and policies and provide training updates to employees. h. Exam Simulators The Exam simulator must: 1) Include medical laboratory scientist (MLS) and medical laboratory technician (MLT) exams 2) Include histotechnology (NSH) + LabCE Histology exams 3) Include Phlebotomy exam i. Case Simulators The Case simulator must: 1) Red Blood Cell Morphology Case simulator 2) White Blood Cell Differential Case Simulator 3) Advanced White Blood Cell Differential Case Simulator 4) Body Fluid Case Simulator 5) Urinalysis Case Simulator j. System Support and Maintenance 1) Support (phone, email) must be available weekdays during normal business hours. 2) Minimal server maintenance. 3) Document backups available to staff during downtimes. 4) Advance notification during server updates or down times. 5) Storage capacity to archive all document types and workflow histories for at least 5 years after removal from use to meet the more stringent transfusion medicine and quality documents requirement is preferred. Alternatively, a minimal storage capacity is needed for archiving transfusion service documents and review/approval histories for 5 years, and other laboratory section records for 2 years. The MEDVAMC PLMS is modernizing and standardizing service to improve efficiencies and patient safety. Brand name only is being requested in order to standardize across main lab (MEDVAMC PLMS) and associated labs (CBOCs). B. Assessment, Authorization, and Continuous Monitoring 1. The information system solution selected by the Vendor shall comply with the Federal Information Security Management Act (FISMA) and have a current VA authorization. 2. MediaLab shall comply with Federal Risk and Authorization Management Program (FedRAMP) requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement. 3. MediaLab shall, where applicable, assist with the VA Authority to Operate (ATO) Sustainment Process to help maintain health and quality of agency authorization of the cloud service or migrated application. 4. MediaLab shall provide access to FedRAMP authorized and VA authorized environment. 5. MediaLab shall afford VA access to the MediaLab and Cloud Service Provider s (CSP) facilities, installations, technical capabilities, operations, documentation, records, and databases. 6. If new or unanticipated threats or hazards are discovered by either VA or the MediaLab, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party in accordance with the security addendum B. 7. MediaLab shall not release any data without the consent of VA in writing. All requests for release must be submitted in writing to the Contracting Officer s Representative (COR)/Contracting Officer (CO). 8. In order for live VA data to be used in this system, access must be provided to the FedRAMP Authorized and Agency Authorized environment. 9. Under the existing ATO, the MediaLab shall only allow VA customers to purchase MediaLab Federal Licenses. 10. MediaLab shall restrict VA customers from purchasing licenses that are not MediaLab Federal unless there is sign-off from VA Executive Leadership or DTC modifies the current ATO use case. Deliverables: A. Dates for current ATO expiration, due before award B. Monthly POAM (Plan of Action and Milestones) finding reports C. Participation in monthly Agency and FedRAMP Sustainment meetings D. Participation in continuous monitoring and reoccurring security artifacts C. Security Requirement for Cloud Services 1. Per the Office of Management Budget (OMB), any cloud services that hold federal data must be authorized by the Federal Risk and Authorization Management Program (FedRAMP). All Federal data must be stored on a FedRAMP authorized systems, and loss of FedRAMP authorization is equivalent to the inability to house federal data via a cloud service. FedRAMP authorization applies to all third parties and sub-vendors that the vendor uses to store federal data. Proof of FedRAMP authorization must be provided, and the vendor must disclose where all data is stored. If any data is stored by a third party and/or sub-vendor, the vendor must provide proof of FedRAMP authorization for these third parties and sub-vendors. FedRAMP authorization must always be maintained by the vendor and all third parties and subcontractors the vendor uses to store federal data. 2. All cryptographic modules and hardware security modules (HSMs) must be FIPS 140-2 certified. The vendor must provide proof of FIPS 140-2 certification via a NIST approved validator. The operating platform upon which the FIP 140-2 certification was obtain must be maintained. D. VA Information and Information System Security/Privacy 1. General Information: Vendors, vendor personnel, sub-vendors, and sub- vendor 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 vendor/sub-vendor shall request logical (technical) or physical access to VA information and VA information systems for their employees, sub-vendors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b) All vendors, sub-vendors, 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 vendors 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 vendor/sub-vendor 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. Additionally, the Contracting Officer Representative will consult with the Information Security Officer regarding any software development and/or outsourced operations considered for utilization that are not within the continental U.S. The Contracting Officer Representative will get approval from the Information Security Officer prior to utilization of any software, product, and outsourced operation outside the continental U.S. Prior approval from the Information Security Officer must be Location within the U.S. may be an evaluation factor. e) The vendor or sub-vendor 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 vendor or sub-vendor's employ. The Contracting Officer must also be notified immediately by the vendor or sub-vendor prior to an unfriendly termination. 3. VA Information Custodial Language: a) Information made available to the vendor or sub-vendor by VA for the performance or administration of this contract or information developed by the vendor/sub-vendor 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 vendor/sub-vendor'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 vendors/sub-vendor'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 vendor 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 onsite inspections of vendor and sub-vendor 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, vendor/ sub-vendor must not destroy information received from VA, or gathered/ created by the vendor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a vendor/sub-vendor 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 vendor 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 vendor/sub-vendor 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 vendor/sub-vendor 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 vendor/sub-vendor electronic storage media for restoration in case any electronic equipment or data used by the vendor/sub-vendor 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 vendor 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 vendor 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 vendor/sub-vendor 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 vendor/sub-vendor'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 vendor/sub-vendor 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 vendor/sub-vendor 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 vendor/sub-vendor 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 vendor/sub-vendor is in receipt of a court order or other requests for the above-mentioned information, that vendor/sub-vendor 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 vendor/sub-vendor must complete a Vendor 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 Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. b) The vendor/sub-vendor 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 vendor/sub-vendor 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 vendor/sub-vendor 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 vendor/sub-vendor 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 vendor/sub-vendor 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 two 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 two 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, vendors/sub-vendors 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 vendor'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 (Vendor facility, Vendor equipment or Vendor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the Vendor 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) Vendor-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 Vendor/sub vendor 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 Vendor/sub vendor 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. Vendor/sub vendor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with Vendor/sub vendor 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 Vendor/sub vendor 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 Vendor/sub vendor. The Vendor/sub vendor 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 Vendor / sub vendor 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 Vendor/sub vendor or any person acting on behalf of the Vendor/sub vendor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Vendors/sub vendors that contain VA information must be returned to the VA for sanitization or destruction or the Vendor/sub vendor 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: i. Vendor must accept the system without the drive. ii. 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 iii. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. iv. 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. 1. 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 2. 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. 3. 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 vendor/sub-vendor 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 vendor/sub-vendor has access. b) To the extent known by the vendor/sub-vendor, the vendor/sub- vendor'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 vendor/sub-vendor 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 vendor/sub-vendor 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 vendor, its employees, and its sub-vendors 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 vendor/sub-vendor 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 vendor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the vendor/sub-vendor processes or maintains under this contract. b) The vendor/sub-vendor 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. Vendor 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: i. Nature of the event (loss, theft, unauthorized access). ii. Description of the event, including: 1. Date of occurrence. 2. Data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code. iii. Number of individuals affected or potentially affected. iv. Names of individuals or groups affected or potentially affected. v. 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. vi. Amount of time the data has been out of VA control. vii. The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons). viii. Known misuses of data containing sensitive personal information, if any. ix. Assessment of the potential harm to the affected individuals. x. Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate: and xi. 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 vendor shall be responsible for paying to the VA liquidated damages in the amount of per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: i. Notification. ii. One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports. iii. Data breach analysis. iv. Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution. v. One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and vi. Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 8. 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 vendor under the clauses contained within the contract. With 10 working-days notice, at the request of the government, the vendor 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. 9. Training: a) All vendor employees and sub-vendor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: i. Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Vendor Rules of Behavior, Appendix E relating to access to VA information and information systems. ii. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training. iii. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and iv. 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 vendor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Vendor 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. E. Nara Records Management Language for Contracts 1. Vendor 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, Vendor 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. Michael E DeBakey Veterans Affairs Medical Center and its Vendors 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 Michael E DeBakey Veterans Affairs Medical Center 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, Vendor must report to Michael E DeBakey Veterans Affairs Medical Center. The agency must report promptly to NARA in accordance with 36 CFR 1230. 5. The Vendor 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 Vendor 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 Vendor 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 Michael E DeBakey Veterans Affairs Medical Center control, or the Vendor 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 Vendor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-vendor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Vendor (and any sub-vendor) is required to abide by Government and Michael E DeBakey Veterans Affairs Medical Center guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. 7. The Vendor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Michael E DeBakey Veterans Affairs Medical Center policy. 8. The Vendor shall not create or maintain any records containing any non-public Michael E DeBakey Veterans Affairs Medical Center information that are not specifically tied to or authorized by the contract. 9. The Vendor 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 Michael E DeBakey Veterans Affairs Medical Center 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 Michael E DeBakey Veterans Affairs Medical Center shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Vendor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. 11. Training. All Vendor 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 #10176, Privacy and Information Security, Rules of Behavior. The Vendor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. CONTRACTING OFFICER S REPRESENTATIVE (COR): The following personnel will be the primary and alternate Contracting Officer s Representative (COR): Primary Alternate Bernita Hudson Peter Basten Management and Program Analyst Business ager/Deputy Executive Pathology and Laboratory Medicine Pathology and Laboratory Medicine Service Line Service Line Phone: 713-794-7256 Phone: 713-791-1414 Extension 24392 Email: Bernita.Hudson@va.gov Email: Peter.Basten@va.gov "No Government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification. The COR will provide contact information for the Laboratory Manager post award. The COR will provide any order changes, via electronic transmission, within a week when needed. The MEDVAMC and all CBOCs will be awarded and managed by the COR. "
