Department of Veterans Affairs Network Contracting Office (NCO) 16 Request For Information (RFI) DISCLAIMER: THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS SYNOPSIS IS NOT A REQUEST FOR QUOTE, PROPOSAL, OR BID. This notice is not a solicitation as defined by FAR 2.101, therefore it shall not be construed as a commitment by the Government to enter into a contract, nor does it restrict the Government to an acquisition approach. All information contained in this Request for Information (RFI) is preliminary as well as subject to amendment and is in no way binding on the Government. Information submitted in response to this notice is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. The Government is requesting that restrictive or proprietary markings not be used in response to this notice. If a solicitation is released, it will be synopsized in the Federal Contract Opportunities website or GSA. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this RFI. Preventive Maintenance Software Support for Instrument Manager A Lab Information System (LIS) Department of Veterans Affairs (VA) Veterans Health Administration (VHA) PURPOSE Veterans Affairs requires a Contractor to provide Preventive Maintenance and Support (PM) Services, remotely and on-site as needed, for government-owned lab middleware, Instrument Manager, in accordance with this Statement of Work (SOW), with the intent of ensuring the software maintains currency and function as the manufacturer intended, operating on a continuous basis without interruption to Laboratory services, while contributing to the VA Mission. Services are required for a one-year Base Period of Performance from November 1, 2023 to October 31, 2024 and 4 - one-year option periods of performance at the location outlined in this contract. This Contract will be a non-personal services contract. The Contractor, its employees, agents and subcontractors shall not be considered government employees for any purpose. Contractor shall furnish all labor, materials, parts, equipment, tools, transportation, insurances, licenses, certifications and supervision necessary to provide services in accordance with this Statement of Work (SOW). Background Information: Instrument Manager ( software ) Lab Information System (LIS) software was originally manufactured by Data Innovations and JResultNet was originally manufactured by Dawning Technologies, which has been acquired by Data Innovations. Instrument Manager provides connectivity between these laboratory instruments: VISTA LIS Beckman Coulter Remisol 2000 (2-DXC 860i) Diagnostica Stago STA MAX (2) TOSOH G8 HPLC Beckman Coulter DXH 800 (2) Beckman Coulter Immage IQ200, Velocity & IChem 100 Cepheid GeneXpert GX16 (2) Polymedco OC-Auto 80 Abbott Alinity Bio-Rad QC ISYS DEFINITIONS Refer to end of SOW CONTRACTING TASKS AND REQUIREMENTS The contractor is responsible for providing the following services to the VA for the software as follows: Preventive Maintenance (PM) Services: Perform PM Services to the level required in the Purpose above, and in compliance with this SOW and the Conformance Standards, inclusive of labor. Services include the following: For emergencies, customer access to toll-free phone support 24 hours per day, 7 days per week, year round For non-emergencies, customer access to toll-free phone support between 7:30 AM and 6:00 PM (EST) Alternate customer support via email and customer web portals Opportunities for users to maintain currency via contractor web-based knowledge platforms or portals as well as contractor provided email notifications. Availability of patches, updates, enhancements, and new versions of the software covered under a Software Version Protection (SVP) product. Access to the driver download web page for updated and new drivers, individual username and password access to customer web porter, allow creation and tracking of support requests, Access to web based knowledge base, opportunity to join any of the email notification services. Provide Software Version Protection (SVP) product. Periodically provide releases new software updates and versions for the core software application as well as Instrument Interface Modules, Host Interface Modules and other optional modules. The Software version Protection product provides the following: All released software updates and version upgrades to the software already owned by each individual site. All remote labor required to implement and configure software updates and version upgrades. Provide notification of all technical advisories/recalls/alerts prior to simultaneous with field alerts. Provide most recent interface technology and any/all available product/ software updates at no additional charge to the Government. The contractor will not be held responsible to delivering remote technical support services in the event that remove access is lost. Quality: The Contractor is responsible for performing quality control procedures in accordance industry standards and in accordance with this SOW, such as the following: Testing Software for accuracy in meeting the Purpose of this SOW and documenting such tests on the respective Service Report. Diagnosing, documenting and educating the COR on results of Software PM and Support Services following completion of services. Communicating with the COR on all service tasks to be performed Deliverables: The following list of Deliverables is required by the contractor as part of the services. Refer to this SOW and the Contract clauses for more details Service Reports provided to the COR upon return of equipment to the COR, following completion of each service. Timely and accurate Invoices in accordance with the contract clauses Inspection and Acceptance of Services The only individual authorized to officially accept services is the COR. While inspection of services may be delegated by the COR and a shared responsibility with departmental management staff, the COR is ultimately the only authorized individual to approve and accept services on behalf of the VA. Services failing inspection criteria, following completion, will be require the Contractor perform Rework or Remedy, per the QASP, and in accordance with this SOW. QUALITY Conformance Standards Contractor shall ensure that their services, staff and equipment used in the performance of this contract conform and comply with the latest industry service standards, information, guidance, regulations and publications of the following: US FDA US Food and Drug Administration ASQ American Society for Quality UL Underwriters Laboratories OSHA Occupational Safety and Health Administration Safety The Contractor must perform services in accordance with: local, state and federal Occupational Safety and Health guidelines and legislation, to include Occupational Safety and Health Administration (OSHA), the American National Standards Institute (ANSI) safety guidelines, and any VA Medical Center Directives; local, state and federal Fire and Safety legislation and guidelines, to include VA Medical Center directives and legislation on Fire and Safety; all other Conformance Standards identified in this SOW Medical Center Policies Each VA Medical Center has policies that are updated from time to time. The COR can provide more detailed information to the contractor of these upon commencement of the contract and throughout the term of the contract, as needed, especially policies regarding, parking, possession of weapons, cell phone use and photography as well as smoking on VA property. Violations of such policies may result in individual fines or citation answerable in the United States (Federal) District Court. Remedy or Rework Rework or Remedy is defined as performing the Service again until the Purpose of this SOW is achieved in full. This involves less than Satisfactory Service by the Contractor and as noted by the COR. Rework or Remedy must occur within 3 business days of the notice of the rework or remedy requirement from the COR and at no additional cost to the Government. Payment will be withheld until all services are performed to the satisfactory level in accordance with this SOW and as documented by the COR. The Government reserves the right to inspect and test services in accordance with this Contract. GOVERNMENT FURNISHED EQUIPMENT / PROPERTY (GFE / GFP) The Government shall furnish the following property (GFP) and equipment (GFE). The Contractor shall be responsible for the protection of Government Property. Government Property is any real property at the VAMC accessed by the Contractor in the performance of services in accordance with the SOW. Storage Storage for Contractor equipment is not provided at the VAMC. The Contractor is responsible for the security of its equipment. The Government is not responsible for the security of Contractor equipment. DELIVERABLES Service Report (SR) Contractor is responsible for providing Service Reports for every service. A Service Report is required for all: outgoing serviced equipment with an inventory of all equipment collected by the contractor, and incoming serviced equipment with an inventory of all equipment completely serviced and delivered by the contractor and with the Service Report provided to the COR at the time of delivery of serviced equipment. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, each Service Report shall, at a minimum, document the following data legibly and in complete detail: Name of contractor and contract number. Name of Field Technician who performed services. Contractor s Service Report number/log number. Date and time (arrival and departure) of Field Technician on-site at VA collecting and delivering equipment VA purchase order number Description of problem reported by COR. Details of Equipment serviced: Equipment set numbers Device name, instrument type Serial number Any other manufacturer's identification numbers. PM and Service description Total Cost to be billed Signatures: Field Technician performing services described. COR acceptance signature Service Reports (Engineers Service Report - Service Report) When the service is completed, the Field Technician shall document services rendered on a legible Service Report(s). During Check In/Check Out procedures with the COR, the Field Technician must provide the COR with the Service Report(s) for that service visit. All Service Reports shall be submitted to the COR for an "acceptance signature". If the COR is unavailable, a signed copy of the Service Report shall be sent to the Contractor after the work can be reviewed (if requested or noted on the Service Report). PERSONNEL STANDARDS AND REQUIREMENTS At all times during performance of Services, in accordance with this SOW, the Contractor must ensure Contractor personnel: Be able to function professionally amongst the general public in a hospital and health care environment. Where possible, a warm-natured and humane approach is preferred. Be able to read, understand and apply printed rules, detailed orders, and instructions Be familiar with and compliant with this SOW and Contractual requirements. Be displaying VA Identification badges and Contractor-issued name tags, clearly visible to the general public Be directly and personally escorted by the Contractor s on-site Supervisor when Contractor personnel are not displaying VA Identification badges and Contractor-issued name tags Maintain a neat, clean, professional appearance Be properly attired in Contractor-issued uniforms which clearly display Contractor branding, keeping in accordance with VHA Dress Policies. Compliant with VA Safety and OSHA regulations throughout the VA Medical Center, as well as VA Medical Center policies. Compliant with parking requirements at the VAMC and park only in the designated parking areas as assigned by the COR. Maintain Decorum at all times. During the performance of services care and consideration must be given to VA visitors and staff. All Services must be performed with minimal disturbance or hindrance to VA Medical Center visitors and staff, specifically maintaining the requirements identified in the Purpose of this SOW. Contractor shall not be considered government employees for any purpose. SECURITY PROCEDURES AND OPERATING HOURS Check In/Out Procedures Prior to commencement of services, and when visiting the VA Medical Center, the Contractor or Contractor s authorized Field Technician, must check in and out with the COR as well as obtain a visitors badge from the VA Police. Only individual departmental management staff, as delegated by the COR, can coordinate check in and check out procedures for the Contractor in the absence of the COR. Due to heightened security requirements, the Contractor or their authorized service representative will be required to wear an ID Badge which will be signed for upon arrival and turned in when leaving. All Badges must be worn at or above the waist and facing forward. This Badge must be turned in before leaving the premises; otherwise the person signing for it will be required to pay for the unreturned ID Badge. Standard Business Hours and Federal Holidays: Contract performance should occur between 8:00am to 4:30pm Monday-Friday excluding Federal holidays, except by special alternate arrangement, coordinated and authorized by the COR. Contractor must coordinate all services with the COR The Federal Government observes the following days as holidays. New Year s Day January 1st * Martin Luther King s Birthday Third Monday in January Presidents Day Third Monday in February Memorial Day Last Monday in May Independence Day July 4th * Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11th * Thanksgiving Day Fourth Thursday in November Christmas Day December 25th * *Holidays that fall on Saturday are observed on the preceding Friday. Holidays that fall on Sunday are observed on the following Monday. In addition to the days designated as holidays, the Government observes the following days: Any other day designated by Federal Statute Any other day designated by Executive Order Any other day designated by the President of the United States to be a Federal holiday CONTACT POINTS Contractor Point of Contact (POC) The Contractor shall specify an individual who shall serve as a single point of contact for all contract issues (POC). Contractor must provide the COR and Contracting Office with the POC contact details, to include cell phone and email, as a minimum: Within 5 business days of contract award, Within 5 business days after Extension of Services, if applicable, and Within 5 business days prior to a change in the POC by the Contractor. The POC must be easily accessible by phone and return COR calls within 48hours of a voice message left by the COR. Contracting Officer s Representative (COR) Upon contract commencement, the Contracting Officer will notify the Contractor in writing as to the COR assigned to this contract, and upon reassignment of a new COR, as applicable. Contractor shall only respond to requests for service from the COR or the CO. If service is requested from any source, other than the COR or the CO, the Contractor is to advise the individual of this requirement and refuse to respond. Any billing resulting from unauthorized service will not be paid by the government. The COR will evaluate the contractor s performance through review of the Contractor s Quality Control Procedures and in accordance with FAR clause 52.246-1 and this SOW. Authority of the COR The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract. In the event the Contractor affects any changes at the direction of any person other than the Contracting Officer, the changes will be considered to have been made without authority and no adjustment will be made in the contract price or schedule to cover any increase in costs incurred as a result thereof. The Contracting Officer shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract, and/or modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer. Government Alternate Points of Contact (POC) Emergencies Only The COR will identify Alternate Points of Contact (POC) to be used only for instances of emergencies when the COR is not easily contactable. These will be individuals in supervisory or managerial roles within the applicable department using the service. The contractor will be provided this information within 5 days after contract award and within 48 hours of a change to this information. An Alternate POC does not replace the COR nor do they replace the Contracting Officer during the performance and administration of this contract, nor does it relinquish or diminish the Contractor s requirements in relation to the performance of this Contract. LIABILITIES AND INSURANCES Protection from Damage Contractor shall provide all labor, materials, and equipment necessary for protection of VAMC personnel, furnishings, equipment and buildings from damage, and shall replace or repair any damage due to work performed under this contract equal to its original construction and finish. Liability Insurance Contractor must provide the COR and the CO with written confirmation that Contractor has adequate insurance protection against negligent work and other forms of liability. DEFINITIONS Acceptance Signature - COR's signature; indicates COR accepts work status as stated in Service Report. ANSI - American National Standards Institute ASQ - American Society for Quality ASQ-CQI ASQ Certified Quality Inspector CO - Contracting Officer Consumables may be items, such as but not limited to, water additive chemicals, HV lubricants (grease, oil), batteries, air filters, water filters, cleaning chemicals/materials Contractor Employees has the same meaning as Contractor Personnel Contractor Personnel - has the same meaning as Contractor Employees COR Contracting Officer s Representative FDA - Food and Drug Administration (U.S. Department Of Health And Human Services) Field Technician - a person who is authorized by the contractor to perform PM services on VA premises. Also known as Technically Trained Personnel. ISO - International Organization for Standardization Labor refer to Technically Trained Personnel, also Field Technician O.E.M. or OEM Original Equipment Manufacturer. The actual manufacturer and point of origin of the equipment. The OEM provides schematics and standards for maintenance and repair of the equipment and equipment shall be maintained in accordance with these practices. Original Equipment Manufacturer OEM OSHA Occupational Safety and Health Administration PMI - Preventive Maintenance Inspection Preventive Maintenance (PM) -- Services that 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. SDS - Safety Data Sheet Service Report - a documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract. Services includes Preventive Maintenance and Repair for equipment and components listed in this SOW and in accordance with this SOW SR Service Report Technically Trained Personnel are personnel and/or employees who shall be suitably knowledgeable in the field related to the services in this SOW in order to satisfactorily perform services in accordance with the SOW. The contractor shall provide personnel experienced and qualified to perform the required services in accordance with industry practices and standards. Also known as Field Technician. For example, this could mean German-trained technicians, certified technicians etc. Technically Trained Personnel are also known as Contractor Personnel or Contractor Employees or Technicians. UL Underwriters Laboratories US FDA US Food and Drug Administration VAMC Veterans Affairs Medical Center VA Mission Statement: To fulfill President Lincoln's promise To care for him who shall have borne the battle, and for his widow, and his orphan by serving and honoring the men and women who are America s Veterans. VHA - Veterans Health Administration QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) Task Standard Acceptable Quality Level (AQL) Surveillance Method Incentives Deduction Penalty Rework Fully completed Service Reports Fully completed Service Reports for all incoming serviced equipment with an inventory of all equipment completely serviced and delivered by the contractor and with the Service Report provided to the COR at the time of delivery of serviced equipment. No more than 1 Service Report per month may be submitted to the COR later than the specified time period Receipt and review of Service Reports by COR within the required timeframe. Failure to satisfy this requirement after the 2nd request from the COR/CO, FAR clause 52.249-8(a)(2) will be actioned Refer to section titled: QASP (continued) Past Performance Documentation Satisfactory service and tasks per the SOW and Rework or Remedy Minimum desired level is 90% satisfactory service and tasks. Maximum desired level is 100% satisfactory service and tasks. Rework or Remedy must occur within 2 business days of the notice from the COR of less than satisfactory services. Rework or remedy to occur at no additional cost to the Government. No more than 1 Remedy or Rework request per month may be delinquent outside the required timeframe. Receipt by COR of all remedied equipment within the required time. Visual Inspections and Testing Rework or Remedy must occur within 3 business days of the notice of the rework or remedy requirement from the CO/COR Failure to satisfy this requirement after the 2nd request from the COR/CO, FAR clause 52.249-8(a)(2) will be actioned. Refer to section titled: QASP (continued) Past Performance Documentation QASP (continued) Past Performance Documentation Contractor performance on this contract, be it less than, greater than or equal to satisfactory performance on this contract, will be documented by the COR and CO, for use as past performance indicators to support any interest or bids the contractor makes in future government requirements and solicitations. Security:   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 3. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR 5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the 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. b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. d. The contractor/subcontractor s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA s POA&M management process. The contractor/subcontractor must use VA s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the 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. f. VA prohibits the installation and use of personally-owned or contractor/subcontractorowned 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 VAapproved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE. g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: (1) Vendor must accept the system without the drive; (2) VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase (4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; (a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and (b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract. (c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. 6. SECURITY INCIDENT INVESTIGATION a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the 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. 7. LIQUIDATED DAMAGES FOR DATA BREACH a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons) (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs 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 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:  A. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training. (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] B. The contractor shall provide to the contracting officer and/or the 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. 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. NARA Records Management Language Clause: 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 while 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. G.V. Sonny Montgomery VAMC (GVSMVAMC) 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 [Agency] 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. Contractor personnel shall sign VA Form 10-0708 Employee Clearance from Indebtedness before resigning or termination from Contractor working for GVSMVAMC and Facility Records Officer must sign form. A copy of completed signed VA Form 10-0708 (Contractor personnel and Facility Records Officer signatures) shall be place in each competency folder. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [Agency] 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 [Agency] 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 GVSMVAMC policy. The Contractor shall not create or maintain any records containing any non-public GVSMVAMC 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 GVSMVAMC 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 GVSMVAC 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. TMS (Talent Management System) course VA 4192704: Records Management for Everyone [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] Flow-down 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. The anticipated Small Business Administration (SBA) size standard for the North American Industry Classification System (NAICS) code _ 541519__________ is _150___________ (employees or dollars). 3. Responses Requested: The following questions must be answered in response to this RFI. Answers that are not provided shall be considered non-responsive to the RFI: a. Where are the requested items/equipment manufactured? Vendor must attach documentation of this information to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice b. Are the requested items/equipment manufactured by a Small or Large business? Is the potential vendor in compliance with the Non-Manufacturer Rule (NMR)? Vendor must attach documentation of this to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice c. Is the Vendor an authorized distributor with access to Original Equipment Manufacturer (OEM) parts which may be required in performance of this requirement? The VA does not accept grey market items and therefore the Vendor must attach evidence of this access (Authorized Distributor letter) to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice. d. Name of potential Contractor that possess the capability to fulfill this requirement. Contractors shall also provide the following: Point(s) of contact name: _______________________________________________ Address: ___________________________________________________ Telephone number: ___________________________________________ Email address: _______________________________________________ Company's business size: ________________________________________________ Data Universal Numbering System (DUNS) #: _______________________________ e. Is your company considered a small business concern, SB, SDVOSB, VOSB, HUBZone, or 8A concern, with the requisite __________________ NAICS code? Please provide proof of qualifications. f. Is your company available under any Government Wide Agency Contract (GWAC), General Services Administration (GSA) Schedule, Indefinite Delivery Indefinite Quantity (IDIQ), and/or Blanket Purchase Agreement (BPA)? If so, please identify the contract number for the Government to review as part of this Market Research. 4. Opportunity/Market Pricing: The Jackson VAMC is seeking information from potential vendors on their ability to provide the required items/equipment. THIS IS A SOURCES SOUGHT REQUEST FOR INFORMATION (RFI) ONLY. Small Business Concerns are encouraged to provide responses to this RFI in order to assist the Jackson VAMC in determining potential levels of competition and general market pricing available in the industry. Therefore, vendors are requested to submit estimated market research pricing along with their responses to the above. The estimated pricing will be considered when determining the procurement strategy for the forthcoming solicitation. 5. Instructions and Response Guidelines: Questions regarding this RFI shall be submitted no later than 14:00 (CST), October 10, 2023 via email to reginald.clark@va.gov RFI responses are due by 14:00 (CST), Monday, October 10 , 2023; size is limited to 8.5 x 11 inches, 12-point font, with 1-inch margins in Microsoft Word format via email to reginald.clark@va.gov The subject line shall read: Preventive Maintenance Software Support. NO SOLICITATION EXISTS AT THIS TIME. There is no page limitation on subparagraphs 3(a) - 3(f). Please provide the information you deem relevant in order to respond to the specific inquiries of the RFI. Information provided will be used solely by Jackson VAMC as Market Research and will not be released outside of the MEDVAMC Purchasing and Contract Team. 7. Contact Information: Reggie Clark Reginald.clark@va.gov Your response to this notice is greatly appreciated!