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STATEMENT OF NEED Ultrasound Machine (Sonosite Edge II) GENERAL INFORMATION Title: Ultrasound Machine for WVAMC s - Pain Management, Opioid Safety, and Prescription Drug Monitoring Program (PMOP) Back... STATEMENT OF NEED Ultrasound Machine (Sonosite Edge II) GENERAL INFORMATION Title: Ultrasound Machine for WVAMC s - Pain Management, Opioid Safety, and Prescription Drug Monitoring Program (PMOP) Background: The WVAMC is requesting to purchase one (1) Brand Name Only -Sonosite Edge II Ultrasound System with supporting parts and materials, to monitor and treat specific issues concerning Pain Management. This unit will be used at the Wilmington Veterans Administration Medical Center (WVAMC), Bldg. 1, to support the Pain Management Initiative within the Pain Management, Opioid Safety and Prescription Drug Monitoring Program (PMOP). Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this Statement of Need (SON), except as may otherwise be specified. Ultrasound machines are needed to treat certain pain conditions. The contractor will provide replacement products of equivalent or better condition or loaner products delivered via overnight delivery to be used by the WVAMC s PMOP during warranty service for items covered in warranty. Brand Name Only. Point of Care Visualization Tools Item Quantity Needed SONOSITE'S TECHNOLOGY DRIVEN 5 YEAR STANDARD WARRANTY COVERAGE ON SYSTEMS AND TRANSDUCERS INCLUDED P29241 - COVID-19 Point-of-Care Ultrasound Guide - FDA 510K Cleared 1 L21822 - Sonosite Edge II Ultrasound System SonoSite EdgeII Ultrasound System has been designed around every detail and demand of its users. The SonoSite Edge II ultrasound system is a general-purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. The system is used with a transducer attached and is powered either by battery or by AC electrical power. The clinician is positioned beside the patient and places the transducer onto (or into for invasive procedures) the patient s body where needed to obtain the desired ultrasound image. The system transmits ultrasound energy into the patient s body to obtain ultrasound Images. You can assess the liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, and surrounding anatomical structures for the presence or absence of pathology transabdominally. With advanced image clarity aided by a new family of transducers and proprietary speckle reduction technology, it gives clinicians an unparalleled level of confidence for diagnostic and procedural applications. The user interface combines touch panel and physical buttons, for most-used functions, to help clinicians improve efficiency, while its adaptable horizontal to vertical work surface positions allow for ideal bedside ergonomics and optimal access to patients. 1 P21609 - Steep Needle Profiling Technology (SNP) The SNP control turns on Steep Needle Profiling technology, a proprietary and patented software algorithm. SNP enhances needle visualization within a selected angle range while maintaining striking image quality of the target and surrounding anatomy. SNP can aid with in-plane needle guidance without additional hardware, equipment, or special needles. For curved array transducers, SNP technology can help identify the direction of the needle, although only segments of the needle shaft may show in the image. Use of movement and fluid injection help verify the needle-tip location. The SNP control is available in 2D full-screen imaging. 1 P21593 - Color Application Package, Sonosite EDGE II Color power Doppler (CPD) is used to visualize the presence of detectable blood flow. Color is used to visualize the presence, velocity, and direction of blood flow in a wide range of flow states 1 P07691 - L25X / 13-6 MHZ Transducer Transverse Biopsy Compatible Arterial, Lung, Musculoskeletal, Nerve, Ophthalmic, Venous This device transforms one form of energy into another form of energy. Ultrasound transducers contain piezoelectric elements, which when excited electrically, emit acoustic energy. When the acoustic energy is transmitted into the body, it travels until it encounters an interface, or change in tissue properties. At the interface, an echo is formed that returns to the transducer, where this acoustic energy is transformed into electrical energy, processed, and displayed as anatomical information. 1 L12830 - Powerpark System Exclusive to Sonosite, PowerPark cordless charging station allows clinicians to dock a Sonosite system in a convenient, central location while the battery charges for cord-free use. Focus on your patients instead of searching for an outlet or worrying about battery life. Benefits: Park your system in a convenient, central location Keep the system fully charged for optimum battery life Cord-free use eliminates power cords dragging on the floor No power cords to clean and disinfect Eliminate the hassle of twisting and bending to find a power outlet Specifications: Width: 8.6 inches (21.8 cm) Length: 15 inches (38.1 cm) Height: 4.8 inches (12.2 cm) Weight: 20 lbs. (9 kg) 1 L15800 - EDGE Stand This small-footprint, lightweight, and sturdy stand is ideal for transporting Sonosite Edge II point-of-care ultrasound systems to the bedside, allowing you to easily maneuver through crowded hospital corridors. Benefits: Four transducer holders provide convenient space for extra transducers not in use Adjustable height for optimal ergonomics Cable hooks ensure the transducer cables are kept off the floor Storage baskets can be placed on the front or back and are easily removed for cleaning AC cord retainer attachment secures the cord firmly in place, preventing an accidental disconnect Specifications: Width: 20.25 inches (51.4 cm) Depth: 22 inches (55.9 cm) Height: Min: 33 inches (83.8 cm) Max: 45 inches (114.3 cm) Pneumatic height range: 12 inches (30.5 cm) Weight: 40 lbs. (18.1 kg) . 1 P20516 - Sonosite EDGE II Ultrasound System User Guide English included P21828 - Sonosite EDGE II Ultrasound System Service Manual included Sonosite Institute for Point-of-Care Ultrasound: Exclusive access to over 100 hours of education including courses, videos, webinars, quizzes, certificates and additional resources. Accessible via desktop, tablet or phone included Performance Period: The contractor shall complete the work required under this SON in 30 calendar days or less from date of award, unless otherwise directed by the Contracting Officer (CO). If the contractor proposes an earlier completion date, and the Government accepts the contractor s proposal, the contractor s proposed completion date shall prevail. [Time and materials] The work shall begin within 30 calendar days of award, unless otherwise specified. [Both] Work at the Government site shall not take place on Federal holidays or weekends unless directed by the CO. Normal business hours for acceptance of deliveries are 8:00am-3:30pm, Monday thru Friday excluding Federal Holidays. Deliveries must be coordinated in advance with COR once a ship date is established. The COR, Biomedical Engineering and/or Logistics Representative shall be the only VA entity signing for freight received on this requirement. The VA-issued purchase order number must be included in the packing slip. All items included in the requirement shall be shipped and delivered to site at same time. If deliveries must be broken into several shipments due to size, this must be coordinated in advance with the COR. Failure the coordinate shipment with COR, may result in failure to deliver on site and cause re-scheduling of delivery/freight at no charge to the government. The packing slip must include the VA-issued purchase order number. Federal Holidays observed by the VAMC are: New Years Day Labor Day Martin Luther King Day Columbus Day Presidents Day Veterans Day Memorial Day Thanksgiving Day Independence Day Christmas Day Type of Contract: Firm Fixed Price Major Requirements: The Contractor/ Vendor must complete the following tasks to meet the needs of this acquisition: Deliver and provide training. Coordinating delivery with COR and or facility. Deliver equipment to: Wilmington VA Medical Center 1601 Kirkwood Hwy Wilmington, DE 19805 The Government and the Contractor understand and agree that the services to be delivered under this contract by the Contractor to the Government are non-personal services and the parties recognize and agree that no employer-employee or master-servant relationships exist or will exist under the contract between the Government and the Contractor s employees. Government Furnished Information or Material: This acquisition does not include Government-furnished property (GFP), identify in the Statement of Work all available information on GFP to be provided, including the make, model, bar code number and serial number, if available, of all accountable assets with an acquisition cost of $500 or more. This acquisition does not include Contractor-acquired property (CAP). Repair and Maintenance: Manufacturer will provide troubleshooting manual. The WVAMC Bio-Medical Department shall manage the service and repair contract on the equipment. Mandatory Value-Added Characteristics: These characteristics are mandatory and will be considered in the best-value determination. Value added characteristics include, but are not limited to: Provide utility requirements (electrical, media disposal, etc.) which should include all necessary SDS documents. Provide environmental requirements (heat/cool, humidity, light, etc.) and recommendations for instrument and testing material storage. The manufacturer should define maintenance requirements and indicate what maintenance is performed by the user. Symplr: The vendor will be required to register on the Symplr website https://www.symplr.com/. Symplr will be used to monitor vendor compliance with vaccination and HIPPA requirements listed below. All on-site contractor representatives agree to follow VA Policy LD-073 medical center policy (MCP) Vendor Access. This includes all on-site contractor representatives shall be greenlighted in VA s Vendor Credentialing System Symplr which includes an up-to-date flu vaccination, Tb test, Covid-19 vaccine, and HIPPA certification at a minimum. The government shall not provide any additional compensation for cost to register staff in Symplr. Vendor shall follow most updated guidelines from the Occupational Safety & Health Administration (OSHA), Center for Disease Control (CDC), and Food & Drug Administration (FDA). If onsite work is necessary, contractor shall notify Biomedical Engineering and the Police service when they arrive on site. Failure to do so more than twice will result in permanent denial of access to facility. Influenza Vaccination VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at WVAMC. Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation: - Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination. - Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine. The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer s Representative (COR) that all contract staff performing services at VA facilities is in compliance with VHA Directive 1192. Tuberculosis Prevention Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually. COVID 19 Contractor shall provide evidence of vaccination records or a negative COVID testing result within 72 hours of planned onsite visitation. This is to include installation, training, maintenance, and repairs. Emergency repairs will be evaluated on a case-by-case situation. HIPAA Training Certificates If Contractor will be working onsite for installation and activation of equipment, all HIPAA training completion documentation must be provided to the COR listed in the awarded contract. Smoking All VA Pittsburgh property is smoke-free. Contractor personnel will comply with VA Pittsburgh smoking policies. Violations will result in a warning and possible citation. Instructions The information identified above is intended to be descriptive of the Sonosite Edge II Ultrasound System to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 339112. Please answer the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). (5) Describe how your small business takes ownership of the equipment in the manufacturing, assembly, or delivery process. (6) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (7) If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job. (8) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number. (9) If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (10) Please submit your capabilities regarding the brand name equipment. (11) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Responses must be received via email to david.santiago2@va.gov no later than, 4 PM Eastern Standard Time (EST) on Friday June 24, 2022. This notice will help the VA in determining available potential sources only. Reference 36C24422Q0840 in the subject of the email response. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, David Santiago. All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award. If a solicitation is issued, information will be posted on the beta.Sam web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for a set-aside. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by email to Contracting Specialist at david.santiago2@va.gov DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.