Q522– Dublin Mobile MRI Services

Notice Type: Combine Solicitation

Posted Date: 28-JUL-20

Office Address: Veterans Affairs, Department of; VETERANS AFFAIRS, DEPARTMENT OF; 247-NETWORK CONTRACT OFFICE 7 (36C247); AUGUSTA, GA 30904

Subject: Q522-- Dublin Mobile MRI Services

Classification Code: Q - Medical services

Solicitation Number: 36C24720Q0951

Contact: Chaz D. Bowling

Setaside: Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)

Place of Performance (address): Department of Veterans AffairsCarl Vinson VA Medical Center 1826 Veterans Blvd Dublin GA

Place of Performance (zipcode): 31021

Place of Performance Country: USA

Description: Veterans Affairs, Department of

VETERANS AFFAIRS, DEPARTMENT OF

247-NETWORK CONTRACT OFFICE 7 (36C247)

COMBINED SYNOPSIS/SOLICITATIONGENERAL INFORMATIONDocument Type:Combined Solicitation/SynopsisSolicitation Number:36C24720Q0951Posted Date:07/28/2020Original Response Date:08/17/2020 11:00 AM ESTProduct of Service Code:Q522NAICS Code:621512Contracting Office AddressNetwork Contracting Officer (NCO) 7ATTN: Chaz D. BowlingDepartment of Veterans Affairs501 Greene StreetHatcher Building Suite 2Augusta, GA 30901DescriptionThis is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued.This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-07 / 07-02-2020.The associated North American Industrial Classification System (NAICS) code for this procurement is 621512, with a small business size standard of $15.0 Million.The Network Contracting Office 7 is seeking to Mobile Magnetic Resonance Imaging (MRI) Services for the Dublin Veterans Affairs (VA) Medical Center.All questions regarding this RFQ must be in writing and may be sent by e mail to [email protected]. Questions must be received no later than August, 05 2020 at 9:30 AM EST. No further questions will be accepted after that date and time.You are reminded that representatives from your company SHALL NOT contact any VA Medical Center employees to discuss this RFQ during this RFQ process. All questions and concerns regarding this RFQ shall be directed to the Contracting Officer (CO).All interested companies shall provide quotation(s) for the following:CLIN(s)DescriptionQTYMeasureUnit $Total $0001Mobile MRI Services Including all pricing to provide the service and personnel 8:00 AM EST 5:00 PM ESTPOP: 09/23/2020 09/22/202112MO0002Mobile MRI Services Including all pricing to provide the service and personnel 5:00 PM 7:00 PM EST (Daily Rate)POP: 09/23/2020 09/22/2021150EASubtotal Base Year1001Mobile MRI Services Including all pricing to provide the service and personnel 8:00 AM EST 5:00 PM EST POP: 09/23/2021 09/22/202212MO1002Mobile MRI Services Including all pricing to provide the service and personnel 5:00 PM 7:00 PM EST (Daily Rate)POP: 09/23/2021 09/22/2022150EASubtotal Option One2001Mobile MRI Services Including all pricing to provide the service and personnel 8:00 AM EST 5:00 PM ESTPOP: 09/23/2022 09/22/202312MO2002Mobile MRI Services Including all pricing to provide the service and personnel 5:00 PM 7:00 PM EST (Daily Rate)POP: 09/23/2022 09/22/2023150EASubtotal Option Two3001Mobile MRI Services Including all pricing to provide the service and personnel 8:00 AM EST 5:00 PM ESTPOP: 09/23/2023 09/22/202412MO3002Mobile MRI Services Including all pricing to provide the service and personnel 5:00 PM 7:00 PM EST (Daily Rate)POP: 09/23/2023 09/22/2024150EASubtotal Option Three4001Mobile MRI Services Including all pricing to provide the service and personnel 8:00 AM EST 5:00 PM ESTPOP: 09/23/2024 09/22/202512MO4002Mobile MRI Services Including all pricing to provide the service and personnel 5:00 PM 7:00 PM EST (Daily Rate)POP: 09/23/2024 09/22/2025150EASubtotal Option FourTotal Contract Pricing$STATEMENT OF WORK STATEMENT Radiology ServicesMobile MRI scanner services are required by the Carl Vinson VA Medical Center (VAMC), Dublin, GA. Contractor shall furnish all personnel, equipment, materials, supplies, supervision and equipment necessary to provide MRI scanner services as detailed in the schedule of Supplies/services and Price/cost, all in accordance with the Statement of Work, terms and conditions of this solicitation. Mobile MRI scanner shall be located at the VAMC, Dublin, GA. Mobile MRI scanner shall be outfitted with changing area and locker for patient use and a ramp or lifting device for non-walking patientsSPECIFICATIONS (MOBILE MRI):The Contractor shall provide a mobile magnetic resonance imager (mobile MRI) to perform the following examinations:Head (including brain, posterior fossa, temporomandibular Joint (TMJ), pituitary gland, and acoustic nerve)Cervical spine (including spinal cord)Thoracic spine (including spinal cord)Lumbar spine (including spinal cord)SpineExtremities (single coil)Abdomen (single coil)PelvisMobile Equipment:The provider will deliver on each scan day a clean well-maintained state-of-the-art mobile MRI unit with a minimum or a 1.5 tesla magnet system designed to perform body, abdominal, neurological, vascular, and extremity and joint imaging. The provider will have available, at provider expense, surface coils for performance or all imaging studies. The provider will be responsible for maintenance of all connectivity cables from the unit to the fixed connectivity ports. The Dublin VAMC will provide well maintained fixed connectivity ports. The provider will be responsible for connecting and disconnecting power, phone, and network connections during each visit. The MRI acquisition environment will have a means of redundant backup of all patient data.Communication with MRI workstation technology & Radiology service medical printers. The Dublin VAMC Radiology Service presently has Lexmark printers. The provider will ensure that all software and licenses necessary to have full Digital Imaging Communications in Medicine (DICOM) communication between the MRI workstation technology and Dublin VAMC Radiology service medical printers are acquired and installed.Communication between MRI systems & Radiology service Picture Archiving and Communication System (PACS). Provider will ensure that a convenient and robust means of DICOM transfer of MRI studies to the VAMC Radiology Service PACS is operational. The provider will obtain and provide to VAMC any technology necessary to ensure that MRI studies can be conveniently read on the existing VAMC PACS display technology. Any peripherals that the VAMC does not have but that are needed to insure convenient and timely display of MRI studies in the Dublin VAMC Radiology service will be obtained by the provider, be installed and maintained by the provider, and become the property of the VAMC. Such technology will be retained by the VAMC so that at future dates the archived studies can be reviewed. Each MRI study will be transferred to the VAMC PACS immediately following acquisition of the study so that it can, if necessary, be reviewed before the patient leaves the mobile MRI.The equipment shall have the capabilities necessary to perform the following:Dedicated imaging protocols for head and spine applicationsOptimum water or fat selective excitation imaging, in multi-slice or 3D volume techniquePre-pulses that achieve suppression of blood signal for optimum myocardial and lumen visualization in cardiac and vascular imagingDedicated imaging protocols for orthopedic applicationsHigh quality imaging for assessment of lesions in all anatomical areasComplete clinical studies that are selectable at a single touchPerformance of automatic planning method based on flexibility to choose three anatomical landmarksCopying of all examination parameters from any previous scan to a new acquisitionSelection of image matrix sizes freely up to 1024 X 1024Dynamic studies with all imaging methods allowing entire scans to be repeated multiple timesManual start controlled from the gantry or operator s consoleVarious motion and artifact reduction techniquesSpin echoFast field echoTurbo field echoTurbo spin echoEcho planar imagingInversion recoveryTime of flight imagingPhase contrast imagingQuantitative flow studiesImaging using 3D k-space shutterPre-pulses (pre-saturation, magnetization transfer contrast, fat saturation)Movie for sequential display of up to 24 slices or dynamics/phasesRapid T2 Weighted MR ImagingThe MRI shall be capable of performing 1mm thick scan imagesUtilities and Government Furnished Materials:Fiber reinforced concrete padPower outlet located approximately 25 feet from the pad [The contractor must provide the needed power requirements. An example of power requirements would be 480 volts, 3 phase, 150 amps, 112 kVA.]Water for MRI unit, if neededOne (1) telephone line located near the power outlet One computer terminal with Dublin VAMC Radiology PACS network accessTelephone instruments as needed for the mobile unit(s)Restroom facilities within a reasonable walking distanceProvide all supplies, including basic consumables and linens, required to perform the MRI examinationsSupplies:The Contractor will be responsible for providing all necessary cryogen.The Contractor will provide a clean mobile MRI and dispose of trash in a responsible manner.TASKSContractor will provide mobile MRI services utilizing equipment meeting the minimum specifications listed in section 1.Contractor will available and provide patient exams five (5) days per week, excluding Federal Holidays listed in section 7.3;Contractor will perform arrival and departure such that the mobile MRI operates full days (8AM-7PM EST);Contractor to verify that equipment is used for federal government contract work only;Contractor will be solely responsible for all driver-staffing issues related to the mobile MRI;Contractor will perform arrival, set-up, take-down, and departure of mobile MRI in a manner that results in limited or no disruption to normal operations of the Dublin VAMC;Contractor will perform an estimated fifteen to sixteen (15-16) MRI studies per day;Contractor will provide an accurate screening form for each patient;Contractor will provide an Average patient scan time of thirty (30) minutes;Contractor will provide a system that is compatible with VistA Imaging;Contractor will transfer images to VistA Imaging immediately on completion of each scan via network connection;Contractor will abide by all VA hospital rules and regulations, to include all VA Information and Security guidelines.Contractor will maintain all training, licenses, and certifications to perform this service and provide technologist that meet the qualifications in section 3.1;Contractor will be solely responsible for all technologist and other staffing issues related to operation of the mobile MRI;Contractor will provide each day a clean mobile MRI and dispose of trash in a responsible manner;Contractor will adhere to all Health Insurance Portability and Accountability Act (HIPPA) and Occupational Safety and Health Administration (OSHA) requirements and regulations;Contractor will communicate effectively with radiologist and other physicians;Contractor will provide excellent customer service to all patients and staff and;Contractor will provide back-up MRI technologists when needed to limit any downtime.QUALIFICATIONSMRI Technologist:Must be registered under the American Registry of Radiologic Technologists (ARRT);Must be Basic Life Support (BLS) certified;Must be Cardiopulmonary Resuscitation (CPR) certified and;Preferably at least three (3) years experienceAll training and certifications must be up to date and maintained through the life of the contract.SPECIAL REQUIREMENTS:Resources:The resources specified in this contract may be charged only by written modification by the assigned Veterans Integrated Service Network (VISN) 7 VA Contracting Officer.The MRI services to be performed by the Contractor will be under the direction of the Chief, Radiology Service, Dublin VAMC. The resulting contract is a non-personnel services contract under which the personnel rendering services are not subject, either by the contract terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.Term of Contract:The contract is effective for one (1) year base period and four (4) 12-month option periods. See section 7.Funds for option period will be subject to the availability of funds. Service will not be performed by the Contractor after the ending date of this contract, until the Contracting Officer authorizes such services in writing.Mobile Unit Staffing:The Contractor will be solely responsible for hiring, training, and compensating the MRI technologists and assistants needed to perform MRI examinations. It is required that staffing levels be such that the mobile units operate competently, professionally, and efficiently. All technologists will have all credentials necessary to work as such within the VA system. All technologists will have current certifications in basic life support procedures. All technologists will maintain all immunizations required of practicing medical professionals. All technologists will adhere to all relevant radiation safety practices and relevant magnetic safety practices. All technologists will always work in a professional manner.Study Quality:The Contractor will provide the Dublin VAMC a study-quality standard (a binder and/or CD of data and studies) that reflects the quality of the studies the provider is prepared to insure will be maintained throughout the duration of the contract. Examples of most, if not all, study types to be performed will be included in the study-quality standard.Quality Control:The Contractor will have a documented quality assurance program and provide the Dublin VAMC copies of quality assurance documents. The program will comply with all relevant The Joint Commission (TJC) and HIPPA standards. The Contractor will have readily available several phantoms that can be used to determine MRI parameters. Phantom studies will be conducted as needed to test and ensure study quality.Site Maintenance:The Dublin VAMC will be responsible for maintenance of a concrete pad appropriate for support and location of the mobile units. The Dublin VAMC will be responsible for maintenance of connectivity ports appropriate for linking the mobile units to power, computer network, and local-access phone/modem/fax as needed. The telephone technology will include one line dedicated for direct access to the code emergency response line in the Dublin VAMC. The emergency phone line must be a dedicated sole use line. The Dublin VAMC will be responsible for connectivity from within the Dublin VAMC to connectivity ports located outside the Dublin VAMC facility at the site of the pad. The Contractor will be responsible for connectivity from within the mobile units to the connectivity ports of the Dublin VAMC.Pre-operation Contractor/ Dublin VAMC Tests of Mobile Units:The Contractor and Dublin VAMC personnel will conduct tests of the mobile units when they are first located. The tests will be performed to ensure the units are working properly, to insure all needed/desired connectivity s are functioning properly, and to ensure functionality is such that the conditions of this contract are met prior to the date of award.Service Contracts:The Contractor will have, throughout the period of the contract, a service contract with the vendors of the mobile units. These service contracts will include service on the MRI, and on any peripherals required to insure connectivity to the Dublin VAMC Radiology Service PACS. No routine maintenance will be scheduled or performed such that it conflicts with the imaging schedules of the mobile MRI. No maintenance will be scheduled or performed during scheduled scanning hours except to address emergency failures of the mobile units. Service response time to emergency failures should be within two hours.Medical Records:Clinical and/or other medical records, including images in DICOM form, of VA beneficiaries treated by the Contractor will be forwarded to the Dublin VAMC and shall remain the property of the US Government. The Dublin VAMC will own solely the data/images of the examinations and studies performed on the mobile unit.Insurance:The Contractor will provide proof of liability and workers compensation, a certificate of insurance providing evidence of liability coverage including the name of the insurance carrier, limits of liability and type of coverage (Ref: VAAR 852.237-7, Indemnification and Medical Liability Insurance).Standard requirement for $200,000 per person and $500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage as well.Medical Emergencies:The Contractor will provide to the Dublin VAMC written emergency plans addressing emergencies such as patient codes, personal injury, fire, and disruptive behavior.A crash cart will be appropriately located within the Dublin VAMC. All emergencies will be handled by the Dublin VAMC code Team. The mobile provider will provide to the Dublin VAMC written emergency plans addressing emergencies such as patient coded, personal injury, fire, and disruptive behavior.Regulatory Adherence:The Contractor is responsible for adhering to all relevant regulations regarding patient care, medical practice, use of contract agents, use of radiopharmaceuticals, operation of PET technology, CT technology, and MRI technology. Examples of relevant regulations are those of National Health Physics Program (NHPP), Occupational Safety and Health Administration (OSHA), TJC, National Research Council (NRC), VHA, and various other federal agencies.Quality and Contract Monitoring:The Contractor will be monitored through a variety of mechanisms appropriate to VA regulations and policies.The Contracting Officers Technical Representative (COR) (114) will be responsible for monitoring the quality of services provided under this contract.QUALITY ASSURANCE SERVEILANCE PLAN (QASP)Performance:The contractor is responsible for performance of ALL terms and conditions of the contract. CORs will provide contract progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined.Performance standards define desired services. The Government performs surveillance to determine the level of Contractor performance to these standards.Incentives / Deducts:The Government shall use exercise of option period and past performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards. Methods of Surveillance:DIRECT OBSERVATION - The COR and/or his designee will regularly observe the work performance of the vendor or vendor s employee during normal work hours and at dates and times consistent with operational efficiency.PERIODIC INSPECTION - The COR and/or his designee will perform periodic inspection of equipment service reports and other standard documentation of all maintenance performed on the bird cage and birds. PATIENT/CUSTOMER COMPLAINTS - The COR and/or his designee will review and investigate as necessary any staff patient or visitor s complaints, with results to be discussed with vendor as required.Performance Standards:TaskIndicatorStandardAcceptable Quality LevelSurveillanceMethodRatingIncentive \ DisincentiveProvide personnel in the work area and available for work at appointed times2.1Daily>98%Direct observationEXCEPTIONAL96% 100 % UptimeSATISFACTORY90 - 95% UptimeUNSATISFACTORY0% - 89% UptimeA positive or negative performance will be documented in past performance reports (CPARS), and/or contract termination.Adhere to HIPPA requirements2.1.16Daily>100%Inspection by COR and Radiology managementEXCEPTIONAL96% 100 % UptimeSATISFACTORY90 - 95% UptimeUNSATISFACTORY0% - 89% UptimeA positive or negative performance will be documented in past performance reports (CPARS), and/or contract terminationComplete a screening form accurately for each patient2.1.8Daily>95%Periodic InspectionEXCEPTIONAL96% 100 % UptimeSATISFACTORY90 - 95% UptimeUNSATISFACTORY0% - 89% UptimeA positive or negative performance will be documented in past performance reports (CPARS), and/or contract terminationProvide properly cleaned equipment in working order2.1.16Within acceptable medical standards100%Direct observation/periodic inspectionEXCEPTIONAL96% 100 % UptimeSATISFACTORY90 - 95% UptimeUNSATISFACTORY0% - 89% UptimeA positive or negative performance will be documented in past performance reports (CPARS), and/or contract terminationComplete scheduled exams daily2.1.22.1.7Complete all scheduled exams>98%Direct observationEXCEPTIONAL96% 100 % UptimeSATISFACTORY90 - 95% UptimeUNSATISFACTORY0% - 89% UptimeA positive or negative performance will be documented in past performance reports (CPARS), and/or contract terminationPAYMENTThe Contractor will be paid monthly, in arrears, upon receipt of a properly prepared invoice. The invoice shall include at a minimum: invoice number, invoice amount, Contract s name and address, contract number, purchase order number and period of performance. The Contractor will provide backup document to COR for verification of amount invoiced. Backup document shall include invoice number, Contractor s name and address, the contract number, purchase order number, date of exam, type of exam, referring physician s name, invoice amount and any additional cases. Invoices will be reconciled with VA record prior to disbursement of payments.The Contractor shall submit all invoices to the following address:FSC VA (667)PO BOX 149971Austin, TX 78714-8971If provider is unable to have on site for standard operational day (0800 to 1900) an operational system for all hours of operation, then payment shall be prorated to reflect hours the system did operate. Provider will include a prorated charge schedule indicting charges to the VAMC if system is operational on site for less than the 9 hours) an operational system for all hours of operation, then payment shall be prorated to reflect hours the system did operate. Provider will include a prorated charge schedule indicating charges to the VAMC if system is operational on site for less than the 9 hours. This only applies if we are billing by scheduled days and not by number of scheduled procedures.ADMINISTRATION OF CONTRACT:The Contractor shall contact the Contracting Officer on all matters pertaining to the administration of this contract. Only the Contracting Officer is authorized to make changes that will affect the price, quantity, quality, or delivery terms of this contract.CONFLICT OF INTEREST:The Contractor shall not employ any person who is an employee of the United States Government if the employment of that person would create a conflict of interest. The Contractor shall not employ any person who is an employee of the Department of Veterans Affairs. Nor shall the Contractor employ any person who is a member of the immediate family of a VA employee, if the employment of that family member would create a conflict of interest, or the appearance of a conflict of interest, particularly with regard to influencing the contract negotiations, terms of the contract or the work carried out under the contract. In any such case VA must review the matter and give its approval in accordance with agency ethics rules.CONTRACT MONITORING PROCEDURES:At the time of contract award, the Contracting Officer will appoint a Contracting Officer Technical Representative (COR) to assist with the contract monitoring requirements. The COR will monitor such items as quality of service, timeliness of performance, customer service, cost control business relations. In accordance with FAR 1.601 (a) Contracts may be entered into and signed on behalf of the Government only by contracting officers. A COR is not authorized to modify the stated terms of the contract, including extending the length of the contract period. Quality of service will be monitored through a continuous review of requested studies vs. performed studies, the appropriateness of images produced and morbidity and mortality figures. These factors will be rated by a consensus of radiologists interpreting the MRI studies and through a radiologist or resident in the MRI unit setting protocols for scan and observing patients and procedures through the study process. Timeliness of performance will be measured through daily workload counts compared to daily number of studies ordered. Customer service will be monitored through periodic unannounced visits to the MRI unit and through patient satisfaction surveys completed by MRI patients. Cost control will be monitored through a comparison of overtime hours worked and the type and number of studies completed per day. Appropriate regulatory and accrediting standards will apply, and all adverse events will be reported in accordance with medical center and other applicable guidelines.The delegated COR will notify the Contracting Officer of any non-compliance immediately upon his/her gaining knowledge of any such situation or incident. Initial communication of such may be communicated by telephone. After such communication, the COR will provide a written statement to the Contracting Officer along with any supporting documentation regarding the performance failure noticed.Upon receipt of a proper invoice, the COR shall certify that the services identified have been performed. Once certification has been made, the invoice will be forward through the proper billing channels and payment shall be made to the Contractor.Both parties shall jointly conduct a review of Contractor s performance to evaluate if services being provided are in accordance with the contract terms and if payments and billings are being properly handled. This review shall include but is not limited to analysis of all billings, payments, costs, administrative issues, patient satisfaction, quality of care and other related documentation that identifies that services have been received. Any concerns need to be brought to the Contractor/COR s attention at the time noted rather than an agreement reached prior to the expiration of services provided and consideration being received are satisfactory.Upon conclusion of the initial contract period and all option periods, and in coordination with the Contracting Officer, the using service shall provide a statement to the Contracting Officer providing a summary of Contractor s actions and a statement that all requirements of the contract were fulfilled as agreed. This information shall be forwarded by the COR to the Contracting Officer at least 90 days prior to the end of base period and each option period if option periods are included.LOCATIONS AND PERIOD OF PERFORMANCE:The Dublin VA Medical Center, including the Radiology Service is located at:Department of Veterans Affairs1826 Veterans BlvdDublin, GA 31021Period of Performance (POP): Base Year09/23/2020 09/22/2021Option One (1)09/23/2021 09/22/2022Option Two (2)09/23/2022 09/22/2023Option Three (3)09/23/2023 09/22/2024Option Four (4)09/23/2024 09/22/2025Hours of Operation:The contractor will provide the service during the hours of operation Monday Friday, 8:00 AM 7:00 PM eastern standard time (EST) and is subject to change depending on the Governments need. Weekends may be added through contract modification if funds permit. Unless otherwise specified the Government observes the following holidays:New Year s DayJanuary 1Martin Luther King s BirthdayThird Monday in FebruaryPresident s DayThird Monday in FebruaryMemorial DayLast Monday in MayIndependence DayJuly 4Labor DayFirst Monday in SeptemberColumbus Day Second Monday in October Veterans Day November 11Thanksgiving DayFourth Thursday in NovemberChristmas Day December 25Any other date specifically declared by the President of The United States to be a national holiday will also be observed.===========================================================================INFORMATION SECURITY:a. IT access: All Contractor personnel accessing Veterans Health Information and Technology architecture (VISTA, etc.) system will be required to sign and abide by all VA security policies and applicable confidentiality statues and the privacy act.b. Patient confidentiality: Contractor to maintain the confidentiality of patient records in accordance with the Privacy Act. HIPAA and all VHA Privacy regulations.c. Security requirements: Contractor shall insure the confidentiality of all patient and employee information and are subject to the completion of all mandatory training specified by the VHA.d. Employee Background Checks: Contractor(s) are required to have background investigations initiated; to include fingerprints, PRIOR to start of contract. Contractor(s) will have completed VA Information Security and Privacy along with Rules of Behavior from the following link https://www.ees-learning.net/librix/loginhtml.asp v=librix prior to start of contract and will compete on an annual basis, before the expiration of previous training. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS:a. A contractor/sub-contractor 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 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.f. 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:(01) 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;(02) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;(03) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and(04) 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.]g. The contractor shall provide to the Contracting Officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.h. 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 the training and documents are complete.i. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media).The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST s Web site at: http://checklists.nist.gov/. To ensure appropriate security controls are in place, contractors must follow the procedures set forth in VA Information and Information System Security/Privacy Requirements for IT Contracts located at the following Web site: http://www.iprm.oit.va.gov/ (852.273-75, Security Requirements for Unclassified Information Technology Resources).The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.VA INFORMATIONAL CUSTODIAL TERMS: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 Federal Information Processing Standards (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. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE:a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation.b. Adequate security controls for collecting, processing, transmitting, and storing of personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.d. The contractor/subcontractor s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA s POA&M management process. The contractor/subcontractor must use VA s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.e. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.f. VA prohibits the installation and use of personally owned or contractor/subcontractor-owned equipment or software on VA s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:(01) Vendor must accept the system without the drive;(02) 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(03) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.(04) 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 pre-approved 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.SECURITY INCIDENT INVESTIGATION:a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA Office of Inspector General and VA 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: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:(01) Nature of the event (loss, theft, unauthorized access);(02) 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;(03) Number of individuals affected or potentially affected;(04) Names of individuals or groups affected or potentially affected;(05) Ease of logical data access to the lost, stolen or improperly accessed data considering the degree of protection for the data, e.g., unencrypted, plain text;(06) Amount of time the data has been out of VA control;(07) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);(08) Known misuses of data containing sensitive personal information, if any;(09) 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 TBD per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:(01) Notification;(02) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;(03) Data breach analysis;(04) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;(05) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and(06) 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 the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working days 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.(End of Statement of Work)

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