6515--Equipment, SONOSITE ULTRASOUND SYSTEM, Columbus

36C25024Q0913 Intent to Sole Source Sonosite Ultrasound PX System The Department of Veterans Affairs, The Chalmers P. Wylie Ambulatory Care Center, 420 North James Road, Columbus, Ohio 43219 intends to solicit and negotiate with only one source under the authority of FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements. The VA intends to solicit and negotiate with the Original Equipment Manufacturer (OEM), FujiFilm Sonosite Inc. at 21919 30th Dr. SE, Bothell, WA 98021, and their Service-Disabled Veteran-Owned Small Business (SDVOSB) authorized distributors: SDVOSB, Bravo, Inc. at 1811 S.E. 5th Ave., Cape Coral, FL 33990; SDVOSB, DGA Medical, LLC at 13236 N. 7th Street, Suite 4246, Phoenix, AZ 85022 and SDVOSB, Fidelis Healthcare, LLC at 4424 Jackson Avenue Apt 512, Austin, Texas 78731. The Department of Veterans Affairs, Network Contracting Office 10, is soliciting quotes from OEM, FujiFilm Sonosite Inc. and their SDVOSB authorized distributors to supply the Women s Health Clinic at the Chalmers P. Wylie Ambulatory Care Center with the FujiFilm Sonosite Ultrasound PX system. This system will be replacing the Toshiba FAMIO 8 Ultrasound System, EE4754 which has reached end of life. Respondents to this solicitation must fully demonstrate their capability by supplying detailed quote information, along with any other documents necessary to support the requirements below. OEM, Fujifilm Sonosite offers the only Enterprise Risk Assessment (ERA) system on the market. However, we believe only OEM, Fujifilm Sonosite or their SDVOSB authorized distributors are able to provide this requirement. Description of services/supplies being requested: ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 1.00 EA SONOSITE PX ULTRASOUND SYSTEM LOCAL STOCK NUMBER: L25100 Funding/Req. Number: 1 757-24-3-096-0376 0002 1.00 EA TRANSDUCER C5-1 LOCAL STOCK NUMBER: L23119 Funding/Req. Number: 1 $ 757-24-3-096-0376 0003 1.00 EA TRANSDUCER IC10-3 LOCAL STOCK NUMBER: L23121 Funding/Req. Number: 1 757-24-3-096-0376 0004 1.00 EA SONOSITE PX STAND LOCAL STOCK NUMBER: L25110 Funding/Req. Number: 1 757-24-3-096-0376 0005 1.00 EA PRINTER B&W HYBRID GRAPHIC SONY UP-X898MD LOCAL STOCK NUMBER: L25200 Funding/Req. Number: 1 757-24-3-096-0376 0006 1.00 EA USER GUIDE SONOSITE PX ENGLISH LOCAL STOCK NUMBER: P21894 Funding/Req. Number: 1 757-24-3-096-0376 0007 1.00 EA SONOSITE PX SERIVCE MANUAL LOCAL STOCK NUMBER: P25393 Funding/Req. Number: 1 757-24-3-096-0376 0008 1.00 EA SONOSITE PX SERVICE MANUAL LOCAL STOCK NUMBER: P25393 Funding/Req. Number: 1 757-24-3-096-0376 GRAND TOTAL The Government believes that only these businesses can satisfy the agency requirements and intends to negotiate with only one source under the authority of FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements. Other persons may identify their interest and capability to respond to this requirement by Tuesday, August 13, 2024, at 5:00PM EST. Such capabilities information will be used solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. All information shall be furnished at no cost or obligation to the Government. A determination by the Government not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government. No solicitation is available at this time. All inquiries must be submitted by email to DeJanee R. Evans at contact@example.gov. Enter RFQ 36C25024Q0913: Sonosite Ultrasound PX System in the email subject line. STATEMENT OF WORK (SOW) Contract Number: Task Order Number: IFCAP Tracking Number: 757-24-3-096-0376 Follow-on to Contract and Task Order Number: PROGRAM REQUESTOR/MANAGER) Name: Andrew Blanford Section: Healthcare Technology Management Address: 420 N James Rd, Columbus, Ohio 43219 Phone Number: Fax Number: 2.Contract Title. Replacement of Women s Health Ultrasound System. 3.Background Women s Health Clinic is in the need of the FujiFilm Sonosite Ultrasound PX System for their clinical workflow to improve the patient care outcomes and provide the best care to women veterans. 4. Scope. Vendor to provide the FujiFilm ultrasound PX system. This system will be replacing the already turned in Toshiba FAMIO 8 ultrasound system (US), EE4754 which has reached end of life. 5. Specific Tasks. 5.1 Task 1 FujiFilm Inc will provide Sonosite Ultrasound PX system. 5.2 Task 2 Provide training and installation for the system and DICOM configuration on the Sonosite PX Ultrasound System. This includes an overview of the product and accessories purchased, including the features, functions, user interface, and system care/maintenance. 6. Performance Monitoring Contractor shall provide a field service report upon completion of the work. 7. Security Requirements Service & Maintenance will follow the security requirements as per VA s Medical Device Protection Program (MDPP) which protects VA s medical devices through a comprehensive security initiative that encompasses pre-procurement assessments, medical device isolation architecture (MDIA), communication, validation, scanning, access control list remediation, patching, and secure remote connectivity. General Security Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. Access to VA Information and VA Information Systems A contractor/subcontractor 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. The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured. 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. A BI is not required per VA Information and Information System Security/Privacy Requirements for IT Contracts dated August 2008 if the following exception applies: Contract Personnel with limited and intermittent access to equipment connected to facility networks on which limited VA sensitive information may reside, including medical equipment contractors who install, maintain, and repair networked medical equipment such as CT scanners, EKG systems, ICU monitoring, etc. In this case, Veterans Health Administration facilities must have a duly executed VA Business Associate Agreement (BAA) in place with the vendor in accordance with VHA Handbook 1600.1, Business Associates, to assure compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in addition to the contract. Contract personnel, if on site, should be escorted by VA IT Staff. Training All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. VA Information Custodial Language Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). 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. Information Systems Hosting, Operations, Maintenance, or Use Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: Vendor must accept the system without the drive. VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then. The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. SECURITY INCIDENT INVESTIGATION 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. 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. LIQUIDATED DAMAGES FOR DATA BREACH Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification. One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports. Data breach analysis. Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution. One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. SYSTEM INTERCONNECTION Any VA External Computer System interconnections between VA Systems on the VA Network and VA Business Partner Systems residing outside the VA Network if required will require a signed Memorandum of Understanding (MOU) and Interconnection Security Agreement (ISA) collectively known as MOU ISA between the VA and the VA Business Partner. 8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). NA 9. Other Pertinent Information or Special Considerations. NA a. Identification of Possible Follow-on Work. b. Identification of Potential Conflicts of Interest (COI). c. Identification of Non-Disclosure Requirements. d. Packaging, Packing and Shipping Instructions. e. Inspection and Acceptance Criteria. 10. Place of Performance. All work will be performed at the main facility: Chalmers P. Wylie VA Center 420 N James Road, Columbus, Ohio 43219 DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID: 36C250-24-AP-3783 Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10, located at 3140 Governor s Place Boulevard Suite 210, Kettering OH 45409-1337, in support of VISN 10 VA Health Care System at 420 North James Road, Columbus, OH 43219-1834, using Transaction #: 757-24-3-096-0376. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Chalmers P. Wylie Ambulatory Care Center requests the Fujifilm Sonosite PX ultrasound system for Women s Health Clinic. This new ultrasound system will be replacing the existing Toshiba FAMIO 8 ultrasound system, EE4754 which has reached end of life. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: OEM, FujiFilm Sonosite is the sole source and direct distributor for new Sonosite point-of-care equipment in the US. Therefore, no re-seller or third-party distributor will be able to offer the Sonosite PX ultrasound system, transducers, and its accessories. OEM, FujiFilm is the only Enterprise Risk Assessment (ERA) system for the VA currently being offered on the market. The competing systems do not have the ERA approved software suite. The Chalmers P. Wylie Ambulatory Care Clinic currently has 4 FujiFilm Sonosite ultrasounds that are being used in UCC, Urology, and Surgery. Description of market research conducted and results or statement why it was not conducted: The Original Equipment Manufacturer (OEM), FujiFilm Sonosite limits the sale of the FujiFilm Sonosite PX ultrasound systems. OEM, Fujifilm Sonosite does utilize the following Service-Disabled Veteran-Owned Small Business to further their products: Bravo Inc, DGA Medical, and Fidelis Healthcare. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. ___________________________ Gina P. Crank Contracting Officer Network Contracting Office 10