J065--482-24-2-759-0005 VISN 5 Consolidated Cepheid GeneXpert Maintenance (VA-24-00029660)
Statement of Work Cepheid GeneXpert Maintenance and Support GENERAL Scope of Services: The purpose of this requirement is to provide full-service maintenance and repair for twelve (12) Cepheid GeneXpe... Statement of Work Cepheid GeneXpert Maintenance and Support GENERAL Scope of Services: The purpose of this requirement is to provide full-service maintenance and repair for twelve (12) Cepheid GeneXpert laboratory analyzer systems across the Veterans Integrated Service Network (VISN) 5 medical centers. The requirement includes the scheduled maintenance and corrective maintenance according to the manufacturer s recommendations/procedures. The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. A firm-fixed price contract is anticipated. Locations: Beckley VA Medical Center, 200 Veterans Ave, Beckley WV 25801-6444 Hershel "Woody" Williams VA Medical Center, 1540 Spring Valley Drive, Huntington WV 25704 Louis A. Johnson VA Medical Center, 1 Medical Center Drive, Clarksburg WV 26301 Martinsburg VA Medical Center, 510 Butler Avenue, Martinsburg WV 25405 VA Maryland Healthcare System, 10 N Greene St, Baltimore, MD 21201 Washington DC VA Medical Center, 50 Irving Street, NW, Washington DC 20422 WORK HOURS Hours of Operation: Normal business hours are Monday through Friday, 8:00 a.m. to 4:30 p.m., excluding holidays. Should the Contractor require work afterhours, the Contractor shall arrange in advance with the Contracting Officer s Representative (COR). Delivery Hours: The Warehouse is open to receive deliveries Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding holidays. National Holidays: The holidays observed by the Federal Government are: New Year s Day, Martin Luther King Day, President s Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran s Day, Thanksgiving Day, and Christmas Day and any other day specifically declared by the President of the United States to be a national holiday. Contractor may work on holidays with prior communication and coordination. PERIOD OF PERFORMANCE Base Year March 23, 2024 March 22, 2025 1st Option Period March 23, 2025 March 22, 2026 2nd Option Period March 23, 2026 March 22, 2027 3rd Option Period March 23, 2027 March 22, 2028 4th Option Period March 23, 2028 March 22, 2029 EQUIPMENT EE# Serial # Manufacturer Model #/Name LOCATION 544496 808373 Cepheid GENEXPERT INFINITY-48S Baltimore, MD 32749 110004114 Cepheid GENEXPERT IV Beckley, WV 35406 120001412 Cepheid GENEXPERT XVI Beckley, WV 36204 110019557 Cepheid GENEXPERT XVI Clarksburg, WV 34528 110016198 Cepheid GENEXPERT XVI Clarksburg, WV 62866 110019089 Cepheid GENEXPERT XVI Huntington, WV 49996 803748 Cepheid GENEXPERT XVI Martinsburg, WV 75393 110020210 Cepheid GENEXPERT XVI Martinsburg, WV 1291876 802387 Cepheid GENEXPERT XVI Washington DC 1327503 110001056 Cepheid GENEXPERT IV Washington DC SPECIFICATIONS Preventative Maintenance This contract shall include all preventative maintenance of the equipment according to manufacturer s recommendations/procedures in the equipment manual. All tasks in the manufacturer s procedures shall be completed at the manufacturer s listed frequencies. Calibration-- Contractor will guarantee proper calibration specification (for all included equipment) will meet standards for one full year or until next required calibration. Contractor shall provide certificate of calibration for the equipment. Corrective Maintenance The contract shall include all corrective (unplanned) maintenance/repair of the equipment in accordance with the manufacturer s manual. Recalls & Alerts-- Contractor shall perform all remediation actions needed for product alerts and recalls issued for the equipment. Parts/Materials/Tools/Labor All parts and materials to complete the maintenance shall be included as a part of this contract. All parts and materials for maintenance and repair shall meet current manufacturer standards. Contractor shall provide their own tools to complete the maintenance. All labor (including travel) to complete the maintenance is included in the contract. Updates/Patching Contractor shall complete available updates to the software at the discretion of Biomedical Engineering. Contractor shall complete all patching according to manufacturer s specifications. Response Time Contractor shall respond to trouble phone calls within thirty minutes. Contractor shall perform all scheduled and unscheduled services (including emergencies) on-site, during normal business hours to include repair, labor and travel at no additional cost. Contractor shall maintain an uptime guarantee of 98% or better Check in/Out Contractor personnel arriving on-site to perform work shall report to the Biomedical Engineering Department. Contractor personnel shall sign in using the department s vendor sign in sheet, filling out all required information. Contractor personnel s tool bags are subject to inspection by the Biomedical Engineering department upon arrival and upon departure. Contractor personnel shall sign out upon completion of visit. Prior to departure, Contractor personnel are required to, at a minimum, verbally report any issues with the equipment to the Biomedical Engineering department, especially noting if the system is still down or not fully repaired. The VA campus is non-smoking. Contractor personnel are required to comply with this policy. Parking. It is the responsibility of the Contractor to park in the appropriate desig nated park ing areas. Reporting Contractor shall provide a copy of the service report, complete with test data, to the contract COR within five working days after completion of any services. Service reports shall include identifying information about the equipment, all services provided during the service visit, any issues found during the visit, the technician/engineer names of the personnel performing work, and the date service was provided. Remote Support The Contractor shall provide a telephone line available 24/7 for technical support. Contractor shall also provide a phone number for VA staff to call to dispatch Contractor field service engineers/technicians. If remote support via site-to-site virtual private network (VPN) is required, Contractor shall work with the COR and the facility Information Security Officer (ISO) to meet the requirements prior to connection. A National Site to Site MOU/ISA is the preferred way to complete this connection. Patient Health Information The Contractor shall safeguard patient health information. The Contractor shall report to the Biomedical Engineering Department any issues with disclosed or unsecure patient health information. Contractor shall note remove any hard drives, storage devices, or anything containing patient health information from the site. Contractor Requirements All Contractor personnel performing services on the equipment shall have factory training and experience in the maintenance and repair of the equipment. Contractor shall provide copies of training certificates for the Contractor personnel performing work on-site upon the request of the Government. Safety and Security Contractor shall follow all Occupational Safety and Health Administration (OSHA) laws and regulations. The Contractor is responsible for reporting any hazards they come across to their point of contact. Contractor shall follow all local procedures concerning infection control. Should the Contractor be unsure of the requirements, the COR can provide the specific information and procedures. Contractor personnel shall wear visible identification at all times while on VA property. Contract personnel are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. Property Damage The contractor shall take all necessary precautions to prevent damage to any Government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken. Any damaged material (i.e., trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the Government, upon approval of the Contracting Officer. Chemical Use Prior to performance of any work, the Contractor will be required to furnish the Contracting Officer with the trade names (if any) and chemical names of all chemicals to be used, along with a label showing contents, the use strength of the chemical as applied, and the antidote thereto. Contractor shall furnish the same information each time a change is made to the chemicals or products used in the performance of this contract. This information is required for emergency treatment in the event of ingestion or and/or contact with the material by humans. QUALITY ASSURANCE End-users, Biomedical Engineering, and/or the contract COR shall perform system verification tests to ensure the system is fully functional following service/repairs. Issues with the quality of the Contractor s work will be communicated through the Contracting Officer to the Contractor point of contact for resolution. Documentation with be completed in the Government systems. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/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. b. 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. c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 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. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. 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 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 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 (3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR. h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency. 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 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 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 vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. The contractor/subcontractor s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA s POA&M management process. The contractor/subcontractor must use VA s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. VA prohibits the installation and use of personally-owned or contractor/subcontractor- owned equipment or software on VA s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA- approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: Vendor must accept the system without the drive; VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre- approved and described in the purchase order or contract. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. SECURITY INCIDENT INVESTIGATION The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensi...
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