Corporal Michael J. Crescenz VA Medical Center Nuclear Medicine Service NeuWave Ablation System Statement of Work Contract Title Procurement for NeuWave Ablation System with Ct Bed Rail Mount. Objective The Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) intends to procure a Brand Name or Equal to the Ethicon NeuWave Certus 140 microwave ablation system for the facilities Interventional Radiology department. This statement of work will highlight the technical and functional specifications and services being requested by the facility for consideration towards purchase of this system. Under this proposal, the specified vendor shall provide all equipment and accessories, installation services, and project management support. Justification The intended procurement for the Brand Name or Equal to the ETHICON NeuWave Certus 140 microwave ablation system and ablation probes are requested by the clinical team to provide the highest level of care for veterans with cancer or benign tumors. This specific system is a device that offers a minimally invasive option for veterans with inoperable cancer or benign tumors. The ETHICON NeuWave Certus 140 is a full-featured soft tissue ablation system that uses small diameter ablation probes, a single microwave source, a CO2 based cooling system and power distribution module. Microwave energy is applied to the target tissue via the ablation probe, heating the tissue to achieve necrosis. This technology will provide physicians with the ability to offer a non-surgical option to treat, and in certain cases, cure, various soft tissue lesions using a minimally invasive approach as an alternative to open surgery. This minimally invasive procedure is typically performed under conscious sedation and often allows patients to go home the same day. The ETHICON NeuWave Certus 140 allows for multiple ablation needles to be used simultaneously and allows for tissue lock targeted lesions which is a unique feature of this system that is critical to ensure consistent positioning of the ablation probes. Specifically, the locking feature prevents probes from migrating after they have already been positioned and when the veteran enters and exits the CT gantry for additional imaging or when multiple probes need to be placed. This microwave ablation system allows up to three probes to be used at a single time providing the ability to target larger lesions and expanding the range of lesions that can be targeted. Our current system at the CMCVAMC only allow 1 probe to be used in a single setting and does not have a tissue locking feature limiting the breadth of Veterans that can be treated as well as the safety profile of the procedure. The ablation probes used for the procedure are consumable items which would be a recurring cost (as needed) but are a required component. The requested product has been specifically identified by the clinical team to provide an optimal solution for the treatment of Veterans with tumors amendable to ablative therapy. This device is intended for use by highly trained Interventional Radiologists. The Interventional Radiologists use these products under CT guidance or ultrasound guidance to perform procedures under sterile conditions in a surgical/vascular suite. Interventional Radiologists here at the CMCVAMC have done extensive research on this product and compared it to numerous other systems leading to the identification of the ETHICON NeuWave Certus 140 microwave ablation system as a critical component for the augmentation to our existing microwave ablation capabilities. Requirements The Microwave Ablation system must allow for multiple ablation needles to be used simultaneously. Must allow for 3 or more probes to be used simultaneously The Microwave Ablation system must have a tissue locking feature to prevent probes from migrating once they have been positioned. The Microwave Ablation system must have a C02 based cooling system and power distribution module. Equipment Specifications System Dimensions Width: 23 (58.4 cm) Depth: 28 (71.1 cm) Height with Monitor: 52 (132 cm) Min, 59 (150 cm) Max Weight: ~250 lbs (113 kg) Environmental Specifications Operating Conditions: Temperature: 18 to 28°C, Humidity: 10 to 90% RH, non-condensing Altitude: 106 to 70kPa (-440 to 3040 m reference) Storage/Shipping Conditions: Temperature: -22 to 60°C, Humidity: 10 to 90% RH, non-condensing Altitude: 106 to 50kPa (-440 to 5860 m reference) Electrical Specifications Operating Range 100-120 VAC, 12 A, 220-230 VAC, 6 A, 50 Hz-60 Hz In the US, plug the Certus 140 Ablation System into only 120 VAC outlets. Leakage currents are within limits of Class BF equipment per IEC 60601-1 System is designed for continuous use. System functionality Imaging Guidance such as CT or Ultrasound is utilized to target the lesion. Once the lesion has been identified, target ablation to the identified lesion, involves placing a probe into the substantial target and then ablating for up to several minutes until the target tissue is necrotic. Depending on the size of the lesion, the attending physician determines how many probes need to be utilized and the duration of treatment. Delivery Microwave Ablation system will be delivered to Michael J. Crescenz VAMC, 3900 Woodland Avenue, Philadelphia PA 19104, Building 2, 3rd Floor, room 3A176. Deliver material to job in manufacturers original sealed container with brand name marked thereon or maintain coverings in place and in good repair. PO# must be on the outside of the shipping box for easy identification. Delivery Days are Monday through Friday during normal business hours which are defined as 7:30am to 3:00pm. National Holidays are excluded. Any delivery service performed for emergency orders may be delivered other than normal business work hours and must be approved. The Contractor is not required to provide delivery services on the following National Holidays, nor shall the Contractor be paid for these Holidays and any other declared national holiday by the President. HOLIDAY New Year s Day Martin Luther King s Birthday President s Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Other special requirements or situations: If for any reason the scheduled time for a deliverable cannot be met, the contractor is required to formally explain (include the original deliverable due date) in writing to the COR (Contracting Officer Representative) and CO (Contracting Officer) the justification for late delivery. The formal document shall include a firm commitment of when the work shall be completed. This notice to the COR and CO shall cite the reasons for the delay, and the impact on the overall project. The CO will then review the facts and issue a response in accordance with the FAR. WARRANTY Vendor provides a warranty to protect its customers from defects in product workmanship or production materials. The warranty covers all products manufactured by the vendor. The vendor warrants that the equipment purchased will be from defects in material and/or workmanship under normal operating conditions for a period of 24 months from the date of shipment. For warranty accessories the vendor is an approved reseller of the devices as listed within this quotation. All device originals manufacturer s warranty is passed through to the customer as offered by the device manufacture. Additional support, service and extended warranties can be purchased directly from the device provider. CUSTOMER SUPPORT The contract covers technical support by e-mail or telephone, downloads of QTM software upgrades, support on issues with all vendor hardware and upgrades on firmware. Vendor undertaking does not include any installation or implementation services in connection with supply of patches, upgrades/new release or any other services or cost, related to installation procedures or use of hardware or software. Additional documentation is available on contracts. CHANGES TO STATEMENT OF WORK Any changes to this SON shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of contractor s staff, sub-contractors, and all other parties other than the CO shall be the responsibility of the contractor. Smoking All VA Philadelphia property is smoke-free. Contractor personnel will comply with VA Philadelphia smoking policies. Violations will result in a warning and possible citation. COVID-19: Upon entering CMCVAMC, per CDC and federal regulations, all personnel must wear the required PPE while on-site; at a minimum this includes a cloth mask. PPE will not be provided by CMCVAMC. All individuals are required to enter through the main entrance for temperature screening. If Contractor s temperature exceeds the designated threshold, they will be asked to leave. In the event of an FSE being forced to vacate the premises, they shall notify the necessary Biomedical Engineering staff and provide a contact for a replacement. INSTRUCTIONS TO VENDORS: The information identified above is intended to be descriptive of the Brand Name or Equal to the ETHICON NeuWave Certus 140 microwave ablation system and ablation probes, 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? (4) 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 e-mail to
[email protected], no later than, 4 PM Eastern Standard Time (EST) on May 31, 2024. This notice will help the VA in determining available potential sources only. Reference 36C24424Q0998 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 Contract 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 this Sources Sought Notice 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 e-mail to Contract Specialist at
[email protected] 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.