J065--Anesthesia Unit Equipment Maintenance Services

THIS IS A SOURCES SOUGHT NOTICE ONLY  The purpose of this Sources Sought is to conduct market research to procure to implement a Full Service agreement on 16 GE/OHMEDA Anesthesia units and 16 compact airway monitors located at the Omaha VA, along with trace gas testing. Service agreement must provide a minimum of 2 scheduled preventive maintenance (PM) inspections to include parts replacement as described in the original manufacturer s service manual for the covered model. Base coverage period from 1 Nov 2026-31 Oct 2027, with 4 option years. Work includes, but is not limited to, periodically performing preventive maintenance, thoroughly inspecting and testing the GE Ohmeda anesthesia units at Omaha, making adjustments to, effecting repairs and replacing parts and keeping existing system software current with manufacturers recommendations. Semi-annual PMs are due in Nov and May of each year. PMs should normally be scheduled off-hours or as convenient to the surgery/anesthesia managers at the Omaha VA, so as not to interrupt patient care. Contractor must have access to all GE Healthcare maintenance bulletins and maintain the unit to meet Food and Drug Administration s approval under 510K. The medical equipment covered by this contract may contain electronic patient health information (EPHI). The vendor shall not remove/copy/delete any of the EPHI. If a computer hard drive needs to be replaced, the old hard drive must be turned-in to biomedical engineering for destruction. The vendor will not receive compensation for the hard drive. This notice serves to survey the market to ascertain whether-or-not sources are capable of providing the requested supply/services.  This notice also allows potential contractors/vendors to submit a non-binding statement of interest and documentation demonstrating their capability. Please review the DRAFT Statement of Work (SOW) to compare your supply/service to what is requested. Complete the line-items below and submit any documentation supporting your product/service for consideration. Network Contracting Office 23 (NCO 23) is requesting responses from qualified business concerns; the qualifying NAICS code for this effort is 811210 - Electronic and Precision Equipment Repair and Maintenance. The Small Business Administration (SBA) Size Standard for this request is $34M.   This Sources Sought is to gain knowledge of potential qualified sources and their size classification(s) (Service Disabled/Veteran Owned Small Business (SD/VOSB), Hub zone, 8(a), small, small disadvantaged, woman owned small business, or large business) relative to NAICS 332311. Responses to this notice, will be used by the Government to make appropriate acquisition decisions. After review of the responses to this notice, a solicitation announcement may be published. Responses to this notice are not considered adequate responses to any corresponding solicitation announcement.  All interested offerors are requested to respond to this notice but are required to respond to the official solicitation announcement in order to be awarded the contract.   INSTRUCTIONS:    RESPONSES MUST INCLUDE THE FOLLOWING INFORMATION:   Primary Information:   Company Name:    Point of Contact (POC) name:   Email address:   Phone number:  Unique Entity ID No. listed in the System of Awards Management (SAM):  Business Size: (Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Small Business Other, Small Business, or Large Business) for the NAICS code 811210.   Please indicate whether you hold a GSA Federal-Supply-Schedule or Indefinite Delivery/Indefinitely Quantity (IDIQ) contract that covers this type of request. If so, please provide the Schedule contract number.  Must have an Authorized Distributor Letter issued from the manufacture if not the manufacture.   The attached SOW is a draft and is NOT finalized.  If any portions are unclear, prohibited, and/or you are unsure about the draft description of the requirement please list your comments and/or concerns in your response so they can be addressed.    Response is due by 09/01/2026, at 1300 Central Standard Time.  Please submit e-mail responses to Ms. Mariah Delaney, Contract Specialist, at email address: mariah.delaney-mack@va.gov. Please place Anesthesia Unit Equipment Maintenance Services in the subject line of your email. This notice is to assist the Department of Veterans Affairs in determining qualified sources only.     NOTES: Issuance of this notice does not constitute any obligation whatsoever on the part of the Government to procure these supplies and/or services, or to issue a solicitation, nor to notify respondents of the results of this notice. No solicitation documents exists at this time; however, in the event the acquisition strategy demonstrates that GSA is a viable option for procuring a solution, the RFQ shall be posted to GSA eBuy where only those firms who currently hold a GSA Schedule with the applicable SIN will be able to respond. The Department of Veterans Affairs is neither seeking quotes nor accepting unsolicited quotes, and responses to this notice cannot be accepted as offers. Any information the vendor considers proprietary should be clearly marked as such. The U.S. Government will not pay for any information or administrative costs incurred in response to this Sources Sought notice.  DESCRIPTION/SPECIFICATIONS/WORK STATEMENT 1. Scope of Work: 1.1. The contractor will furnish all labor, transportation, original equipment manufacturer (OEM) parts, test equipment, tools, and expertise necessary to implement a Full Service agreement on 16 GE/OHMEDA Anesthesia units and 16 compact airway monitors located at the Omaha VA, along with trace gas testing. Service agreement must provide a minimum of 2 scheduled preventive maintenance (PM) inspections to include parts replacement as described in the original manufacturer s service manual for the covered model. Base coverage period from 1 Nov 2026-31 Oct 2027, with 4 option years. 1.2. Work includes, but is not limited to, periodically performing preventive maintenance, thoroughly inspecting and testing the GE Ohmeda anesthesia units at Omaha, making adjustments to, effecting repairs and replacing parts and keeping existing system software current with manufacturers recommendations. Semi-annual PMs are due in Nov and May of each year. PMs should normally be scheduled off-hours or as convenient to the surgery/anesthesia managers at the Omaha VA, so as not to interrupt patient care. Contractor must have access to all GE Healthcare maintenance bulletins and maintain the unit to meet Food and Drug Administration s approval under 510K. 1.3. The medical equipment covered by this contract may contain electronic patient health information (EPHI). The vendor shall not remove/copy/delete any of the EPHI. If a computer hard drive needs to be replaced, the old hard drive must be turned-in to biomedical engineering for destruction. The vendor will not receive compensation for the hard drive. 1.4. Normal service requirements under this contract consist of scheduled preventive maintenance inspections, adjustments and repairs, as specified herein, along with scheduled contractor maintenance in response to service calls made by VA Omaha to the contractor due to a partial or complete system or subsystem failure which requires the contractor to respond within a specified time frame to make needed repairs/adjustments to the system. Software updates shall be included and consist of any error correction or modification that maintains existing software features and functionality and are made generally available to GE Healthcare s customer installed base. Provide on-site support within twenty-four (24) hours of notification by Customer or detection of any error or malfunction. Vendor shall perform testing at the final path to patient after any adjustment, modification, or repair and document it on the service report with wording such as tested, meets manufacturer s specifications, ready for patient use. . 1.5. Within 24 hours of award of contract, the contractor shall provide, in writing to the Contracting Officer the name, title, address, and telephone number of the contractor s representative. The contractor shall provide a single point of contact for all maintenance support required under this contract. The contractor will also provide a list of parts to keep on hand for the equipment. When this individual is on leave of any kind, the contractor shall provide an alternate point of contact. 2. Equipment: 2.1. The equipment to be serviced/maintained includes: GE HEALTHCARE ANESTHESIA UNITS EQUIPMENT SERIAL # AESTIVA MRI AMTT02022 AISYS CS2 APWW01439 AISYS CS2 APWZ01651 AISYS CS2 APWZ01652 AISYS CS2 APWZ01849 AISYS CS2 APWZ01850 AISYS CS2 APWZ01851 AISYS CS2 APWZ02697 AISYS CS2 APWZ02698 AISYS CS2 APWZ02699 AISYS CS2 APWZ02700 AISYS CS2 APWZ02701 AISYS CS2 APWZ02702 AISYS CS2 APWZ02703 AISYS CS2 APWZ02704 AISYS CS2 APWZ02705 AISYS CS2 APWZ02706 E-SCAIO-00, Gas Module SGV17170108HA E-SCAIO-00, Gas Module SGV20190224HA E-SCAIO-00, Gas Module SGV20200002HA E-SCAIO-00, Gas Module SGV20220050HA E-SCAIO-00, Gas Module SGV20220084HA E-SCAIO-00, Gas Module SGV20220191HA E-SCAIO-00, Gas Module SGV20270064HA E-SCAIO-00, Gas Module SGV20310129HA E-SCAIO-00, Gas Module SGV20310180HA E-SCAIO-00, Gas Module SGV20310181HA E-SCAIO-00, Gas Module SGV20320123HA E-SCAIO-00, Gas Module SGV20320143HA E-SCAIO-00, Gas Module SGV20320179HA E-SCAIO-00, Gas Module SGV20320182HA E-SCAIO-00, Gas Module SGV20320184HA E-SCAIO-00, Gas Module SGV20330043HA 3. Definitions/Acronyms: 3.1. Omaha VA: 4101 Woolworth Ave, Omaha NE 68105 (ph 402.995.3040) 3.2. CO Contracting Officer, VA Omaha/Purchasing and Contracting Division, Bldg 6, Room 103, telephone number 402 346-8800 ext 4505. 3.3. COR Contracting Officer s Representative. 3.4. IAW In Accordance With 3.5. PM Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions. 3.6. FSE Field Service Engineer. A person who is authorized by the contractor 3.7. ESR Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract. 3.8. Acceptance Signature Signature of VA Omaha employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR. 3.9. Authorization Signature COR s signature; indicates COR accepts work status as stated in ESR. 3.10. OSHA Occupational Safety and Health Administration. 3.12. BESS Biomedical Equipment Support Specialist. VA employee responsible vendor coordination of maintenance for VA owned medical equipment. 4. Conformance Standards: 4.1. Contract service shall ensure that the equipment/system functions in conformance with the latest published edition of NFPA-99, OSHA, manufacturer s Network Equipment/System upgrades/updates shall be installed in strict accordance with manufacturer s specifications and must operate within manufacturer s specifications and must operate within manufacturer s specified parameters. 5. Hours of Coverage: The contractor will respond by phone at no additional charge, within the normal business hours (7:00 AM to 7:00 PM (CST) M-F). 5.2. All scheduled service/repairs shall be performed during these normal hours of coverage unless one of the following conditions exist: 5.2.1 The contractor wishes to perform such maintenance at a time that is outside of the normal hours of coverage, at no additional cost to the Government, and the contractor submits a request to the COR prior to the proposed start of the maintenance and the request is approved by the COR before work is begun. 5.2.1.1 The COR directs that the scheduled maintenance be performed at a time that is outside the normal hours of coverage and the additional cost is recommended by the COR and authorized by the CO. 5.3. Scheduled maintenance shall be performed in accordance at the manufacturer s recommended intervals and should be scheduled/completed during the month the VA requests. Changes in this periodicity will occur only when approval is granted by the COR. 5.4. Scheduling for unscheduled maintenance requirements outside of normal hours shall be coordinated with and require the approval of the COR. 5.6. Federal holidays observed by VA Omaha are: New Years Day Labor Day Juneteenth Martin Luther King Day Columbus Day President s Day Veteran s Day Memorial Day Thanksgiving Day Independence Day Christmas Day and any other day specifically designated by the President of the United States. 6. Unscheduled Maintenance: 6.1. Contractor shall maintain the equipment in accordance with Conformance Standards. 6.2. The contractor shall provide repair service, which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and installing parts. 6.3. All parts will be covered in this agreement. 6.4. The Contracting Officer, COR and designated Alternate have the authority to approve/request a service call from the contractor. 6.5. Response time: 6.5.1. Contractor s FSE shall respond by phone during normal business hours. 6.5.2. If the problem cannot be corrected by phone or by remote diagnostics the contractor will dispatch a technician to arrive not later than the next business day (24hrs) after the call is placed. 7. Scheduled Maintenance: 7.1. Contractor shall perform PM service to ensure that equipment listed in the schedule performs in accordance with the manufacturers recommendations as published in the Manufacturer s Maintenance Manuals for the system. 7.2. Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable) provided to the COR at the completion of the PM. 7.3. PM services shall include, but need not be limited to, the following: 7.3.1. Cleaning of equipment to include filters, gearing, and other parts. 7.3.2. Reviewing operating system software diagnostics to ensure that the system is operating as specified by the manufacturer s specifications. 7.3.3. Calibrating and lubricating the equipment. 7.3.4. Performing remedial maintenance of non-emergent nature. 7.3.5. Performing electrical safety inspection IAW NFPA 99. 8. Parts: 8.1 The Contractor will provide all replacement parts needed to keep the system in operating condition as originally designed by the manufacturer. 8.2 Parts may be repaired or replaced, as the contractor deems appropriate. No used parts will be used to repair this equipment. 9. Service Manuals: 9.1. VA will not provide service manuals of service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSEs all operational and technical documentation, (such as: operational and service manuals, schematics, and parts list), which are necessary the meet the performance requirements of this contract. 9.2. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the Contracting Officer upon request. 10. Documentation/Reports: 10.1. Documentation shall include detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices required to maintain the equipment in accordance with performance requirements. 10.2. Any additional charges claimed will be approved by the CO via the COR before service is completed. 11. Reporting Requirements: 11.1. Upon arrival at VA Omaha the contractor shall be required to log in with Biomed in room B556 in Omaha, room C09 in Grand Island or room 7-3-LN in Lincoln. This log in is mandatory as well as wearing the contractor badge issued upon log in. Contractor s FSE(s) shall wear visible identification at all times while on the premises of the VA. Identification shall include, as a minimum, the employee s name, position, and the contractor s trade name. In addition, the contractor shall submit fingerprints through the VA police for issuance of a VA identification badge that shall be worn at all time while working at a VA facility. 11.2. When service is completed, the FSE shall document services rendered on a legible ESR(s) and submit to the BESS who set-up the service. The ESR can be submitted when logging out with Biomed, via an internet web site or e-mail. ESRs should be submitted not later than 5 business days after service is complete. Preferred method of delivery is via email to NWIHCSBiomedicalStaff@va.gov 11.4. In those cases when the Biomed office is closed, contractor personnel will log in and/or out via the VA police and after-hours service shall be prearranged with the BESS. 12. Services Beyond the Contract Scope: 12.1. Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence of the development of any defects in, or repairs required to, the scheduled equipment which the contractor considers he/she is not responsible for under the terms of the contract. 12.2. Contactor shall furnish the COR with a written estimate of the cost to make necessary repairs. 13. Condition of Equipment: 13.1. The contractor accepts responsibility for the equipment described in as is condition. 13.2. Failure to inspect the equipment prior to contract award shall not relieve the contractor from performance of the requirements of this contract. 14. Test Equipment: 14.1. Test equipment calibration shall be traceable to National Institutes of Standard Technology standards and teste equipment used for calibration shall be listed on service report by Manufacturer, Model, Serial Number, and date due calibration. 15. Identification, Parking, Smoking, and VA Regulations: 15.1. Contractor s FSE(s) shall wear visible identification at all times while on the premises of the VA. Identification shall include, as a minimum, the employee s name, position, and the contractor s trade name. 15.2. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from VA Police Service. VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions. 15.3. Smoking is prohibited inside all VA buildings. 15.4. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. 15.5. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state or municipal court. 16. Contractor Qualifications: 16.1. Contractor must have full time staff that is fully qualified FSE and a fully qualified FSE who will serve as the backup for the equipment identified in this solicitation. 16.2. Fully qualified is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program for the equipment identified in this solicitation as required by the manufacturer. 16.3. Contractor must provide, upon request, evidence of appropriate training of any FSE(s) providing services under terms of the contract. Subcontracting of any ensuing award of this solicitation will not be allowed without written permission of the Contracting Officer. Quality Assurance Surveillance Plan Performance Objective SOW Para Performance Threshold Unscheduled Maintenance 6.1 No more than ONE 1 COR write-up per quarter. Repeat complaints/ discrepancies for the same area/ facility will result in an unacceptable rating for the month. Scheduled Maintenance 7.1 No more than 1 COR write-up per quarter. Repeat complaints/ discrepancies for the same area/ facility will result in an unacceptable rating for the month. Reporting Requirements 11.2 No more than 1 COR write-up per quarter. Repeat complaints/ discrepancies for the same area/ facility will result in an unacceptable rating for the month. Test Equipment 14.1 No more than 1 COR write-up per quarter. Repeat complaints/ discrepancies for the same area/ facility will result in an unacceptable rating for the month. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. VA INFORMATION CUSTODIAL LANGUAGE Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. INFORMATION SYSTEM DESIGN AND DEVELOPMENT Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default program files directory and silently install and uninstall. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties. The contractor/subcontractor agrees to: Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies: The Systems of Records (SOR); and The design, development, or operation work that the contractor/subcontractor is to perform; Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and Include this Privacy Act clause, including this subparagraph (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. Operation of a System of Records means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records. Record means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph. System of Records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as Systems ), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, 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. 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 7 days. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 30 days. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. The contractor/subcontractor s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA s POA&M management process. The contractor/subcontractor must use VA s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. VA prohibits the installation and use of personally-owned or contractor/subcontractor owned equipment or software on VA s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: Vendor must accept the system without the drive; VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. SECURITY INCIDENT INVESTIGATION 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 COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. 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. LIQUIDATED DAMAGES FOR DATA BREACH Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. Each risk analysis shall address all relevant information concerning the data breach, including the following: Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: date of occurrence; data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; Number of individuals affected or potentially affected; Names of individuals or groups affected or potentially affected; Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; Amount of time the data has been out of VA control; The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); Known misuses of data containing sensitive personal information, if any; Assessment of the potential harm to the affected individuals; Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to 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: Notification; One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; Data breach analysis; Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; One year of identity theft insurance with $50,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day s notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. TRAINING All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; Successfully complete the appropriate VA privacy training and annually complete required privacy training; and Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [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.] The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. RECORDS MANAGEMENT OBLIGATIONS A.  Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.   B.  Definitions Federal record as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.   The term Federal record: Includes Department of Veteran Affairs records.  does not include personal materials. applies to records created, received, or maintained by Contractors pursuant to their Department of Veteran Affairs contract. may include deliverables and documentation associated with deliverables. C.  Requirements 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.  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.  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.  [Agency] 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 Department of Veteran Affairs 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 [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230. 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 Department of Veteran Affairs 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). 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 Department of Veteran Affairs guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Department of Veteran Affairs policy.  The Contractor shall not create or maintain any records containing any non-public Department of Veteran Affairs information that are not specifically tied to or authorized by the contract.  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.  The Department of Veteran Affairs 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 Department of Veteran Affairs 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. Training.  All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.  [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]  D.  Flowdown of requirements to subcontractors The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.  Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.