SPECIAL NOTICE
65 -- INTENT TO SOLE SOURCE. Brand Name Only. SAVI Scout Console and Scout Radiology Verification Console. Reference 36C24422Q0504 in the email subject. This is NOT a Request for Quote.
- Notice Date
- 3/9/2022 9:59:14 AM
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
- ZIP Code
- 15215
- Solicitation Number
- 36C24422Q0504
- Archive Date
- 03/19/2022
- Point of Contact
- David Santiago, Contracting Specialist, Phone: 412-822-3746
- E-Mail Address
-
david.santiago2@va.gov
(david.santiago2@va.gov)
- Awardee
- null
- Description
- SAVI Scout Console and Scout Radiology Verification Console Statement of Need Background: The Lebanon VA Medical Center (LVAMC) has a brand name requirement for one (1) SAVI-SCOUT Console and accessory Cart and one (1) Scout Check Radiology Verification Console. Scope of Work: The SAVI Scout Console and The Scout Radiology Verification Console work in conjunction with each other to precisely identify Breast Tumor Location and depth. Salient Characteristics of the brand name SAVI SCOUT Console and accessory Cart: Precisely Identifies Tumor Location & Depth 60mm detection range3 Permits cosmetically preferred incision Actual distance measurement allows real-time planning of anterior margin Helps Optimize Surgical Goals 360 detection with ± 1mm accuracy3 Instant response guides dissection path, eliminating guesswork Predictable specimen with real-time margin definition Optimizes Breast Conservation Strategy Confirms planned surgical margins relative to reflector location Accurate depth measurement when patients are in supine position The system employs micro-impulse radar and infrared (IR) light technology to detect the presence of the SCOUT Reflector, which is placed into soft tissue of biopsy site prior to the procedure. Provides the Radar signal to the Handpiece along with power for the infrared light source. Multiple-use Handpiece delivers the Radar signal and IR light into the soft tissue or biopsy site and in turn receives signals reflected back from the SCOUT Reflector. Processes the reflected Radar signals to provide the physician with an audible and visual indication when the SCOUT Reflector is detected. Intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SCOUT System) the SCOUT Reflector is located and surgically removed with the target tissue. Intended only for the non-imaging detection and localization of the SCOUT Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal. Salient Characteristics of the brand name SCOUT Check Radiology Verification Console: The SCOUT Check Radiology Verification Console: is a medical device that provides control operations for verifying functionality of the SCOUT Reflector within soft tissue or biopsy site. employs micro-impulse radar and infrared (IR) light technology to detect the presence of the SCOUT Reflector, which is placed into soft tissue or biopsy site prior to the procedure. provides the micro-impulse Radar signal to the Handpiece along with power for the infrared light source. The SCOUT Check Handpiece delivers the micro-impulse Radar signal and IR light into the soft tissue or biopsy site and in turn receives signals reflected back from the SCOUT Reflector. processes the reflected Radar signals to provide the physician with an audible indication when the SCOUT Reflector is detected. is intended to be used to confirm detection of the SCOUT Reflector subsequent to percutaneous placement in Radiology. intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or a soft tissue site intended for surgical removal. is intended only for the non-imaging detection and localization of the SCOUT Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal. Delivery: Delivery shall be within thirty (30) days from the time of award. SCOUT Console and accessory Cart and the SCOUT Check Radiology Verification Console shall be delivered to the Lebanon VAMC located at 1700 S. Lincoln Ave., Lebanon, PA 17042; Attn; Warehouse. BioMedical Engineering will need to perform a safety check and enter the equipment into the system for annual Preventive Maintenance (PM) checks. Placement in the LVAMC clinic shall be coordinated through the Contracting Officer Representative. Delivery should be coordinated with the COR of the contract prior to shipping of any equipment The Contractor must comply and provide all necessary information to the Lebanon VAMC, otherwise the delivery may be refused and require redelivery at no additional cost to the government. 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 Training Any training scheduled should be coordinated with the COR and VA staff. Additional Charges There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts or installation. There will be no additional charges for time spent assembling the equipment. There will be no additional charges for any time spent on-site provided training to either clinical or technical staff. There will be no additional charges with the waste management protocol listed in section 8. Packaging Waste management Contractor shall remove packaging materials and all shipping debris from site and dispose of at appropriate recycling facilities. Contractor shall collect and separate for disposal all paper, plastic, polystyrene, corrugated cardboard, packaging material in appropriate bins for recycling on site if available. Contract shall fold metal and plastic banding, flatten and place in designated areas for trash. 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 the Lebanon VAMC. 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 follows VHA Directive 1192. 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. Tobacco All VA Pittsburgh property is tobacco free. Contractor personnel will comply with the Lebanon VAMC tobacco and smoking policies. Violations will result in a warning and possible citation. COVID-19 Related Policies Upon entering VAPHS, 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 the Lebanon VAMC. 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. Vendor Credentialing Vendor access to the VAPHS is by appointment only and requires credentialing through our vendor credentialing partner, Symplr at https://vcsdatabase.com/login Symplr registration is at cost to the vendor only and the Lebanon VAMC is not responsible for this. All vendors are required to check-in at the Symplr kiosk using their smart phone or desktop check-in with Symplr login and obtain a day badge, which will include date, time, and location of approved appointment. Company badge with photo ID is also required to be worn while onsite at the Lebanon VAMC site. Vendors are only permitted to visit the location identified on their Symplr generated badge and must exit the facility promptly, checking out via their smart phone once the scheduled appointment has ended. Instructions The information identified above is intended to be descriptive, of the Brand Name Only SAVI Scout Console and Scout Radiology Verification Console for Radiology needs 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 david.santiago2@va.gov no later than, 4 PM Eastern Standard Time (EST) on March 16, 2022. This notice will help the VA in determining available potential sources only. Reference 36C24422Q0504 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 e-mail 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.
- Web Link
-
SAM.gov Permalink
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- Record
- SN06261543-F 20220311/220309230101 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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