6515--Bladder Scanners

THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION ONLY. This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. No solicitation exists. Therefore, do not request a copy of a solicitation. The Department of Veterans Affairs (VA), VISN 4, Network Contracting Office 4 (NCO 4), is seeking information and potential qualified sources capable of meeting the following minimum requirements and salient characteristics below: VA Pittsburgh Healthcare System (VAPHS) SCOPE OF WORK AND GENERAL SPECIFICATIONS FOR Bladder Scanner Replacement Biomed Representative: contact@example.gov Logistics Representative: contact@example.gov Facility Point of Contact (contact@example.gov): 1. Background VAPHS owns several bladder scanners that are reaching the end of their lifecycle and need to be replaced. The bladder scanners will be replaced in groups in order to prevent all the bladder scanners from reaching the end of their lifecycle in the future. 2. Project Scope VAPHS requires the purchase of 3 Bladder Scanner units. Patient care services requires one unit for 4W, 5W, and 6W. The purchase will include 3 bladder scanners, mobile stands, probes, clinical and technical training, labor required to assemble the units and any other accessories associated with the product to make it a fully functional unit. 3. Specifications a. Device must be FDA approved b. Quantity: 3 c. General Characteristics: i. The unit must have a bladder scan measurement capacity of 0-999 mL ii. Minimum Accuracy: 1. 0-100 mL accuracy is +/- 10mL Greater than 100 mL accuracy is +/- 10% iii. Taking a bladder scan is not to be contraindicated in patients who are pregnant or obese. d. Unit Power Requirements i. Must have a rechargeable battery Must be lithium-ion batteries ii. Minimum 12-hour battery life Assuming an average operation of 4 x 1-minute scans per hour e. Storage/Memory i. Ability to store at least 600 scans f. Portability i. Each bladder scanner must come on portable stand ii. Stands must have the ability to store ultrasound gel, probes, and cleaning supplies iii. The portable stand must have locking casters iv. The portable stand must be able to be adjusted for height g. Probe/Scanning Head i. The bladder scanner must have a wired probe Wireless probes and/or hand-held scanners are not acceptable. ii. The bladder scanner probe must be a solid-state probe (not containing moving parts) h. Display i. Simultaneous display of image and numerical values on screen ii. The unit must display ultrasound imagery iii. The unit must be able to display the outline of the bladder for easy identification and guidance The user must be able to edit/adjust the bladder outline for further accuracy. iv. The unit must be able to provide pubic bone detection for easy identification and guidance v. The unit must have a colored LCD Screen 1. Minimum display dimensions 43 square inches. i. Feedback Mechanisms i. The unit must have both auditory and visual feedback mechanisms ii. The feedback mechanism must direct staff toward a more optimal probe placement iii. The unit must be able to provide explanations for improper errors/misplacement associated with a failed bladder scan j. Cleanability i. Unit must be able to be cleaned with PDI Wipes and sodium hypochlorite bleach wipes k. Upgradeability i. The unit must be capable of upgrading to other functions like ultrasound and vascular imaging. Training i. Vendor must be available to provide 36-hours of clinical training The training would be broken down over two days and could be subject to varying shift times. ii. Technical training must be provided to Biomedical Engineering Staff 1. At least 2 copies of the user manual/instructions-for-use will be proved to the Biomedical Engineering department. iii. The unit must have onboard training showing proper use of the product m. Maintenance i. The system must require no annual preventative maintenance according to the manufacturers specifications. n. Warranty i. The system must have at minimum a 5-year warranty o. Assembly i. The contractor/vendor will assemble all the units upon delivery of the units at no additional cost 4. Evaluation Team a. Jacob Frankenfield b. Austin Hampton c. Nicole Salerno d. Ruth Morsillo 5. Delivery Location Attn: (Jacob Frankenfield) VA Pittsburgh Healthcare System University Drive C Building 1 Pittsburgh, PA 15240-1001 Prior to delivery, Contracting Officer Representative and/or Business Manager shall receive shipping information from Contractor and forward to Logistics and Biomed using the emails listed above. The Contractor must comply and provide all necessary information to VAPHS. Otherwise, the delivery may be refused and require redelivery at no additional cost to the government. 6. Safety Data Sheet (SDS) Contractor shall provide three (3) copies of each Safety Data Sheet for every product, chemical, etc. used on this project. SDS sheets shall be provided for any material on the same day those materials arrive on VA property. At no time shall the contractor have, or permit subcontractors to have, materials on station without SDS sheets. All instructions for use shall be followed. Products will not be used until SDS's are submitted to the facility points of contact. The contractor shall maintain a current, green in color, loose-leaf notebook on the job site at all times, which is readily available for viewing by the COR or VA Safety Officer. 7. Delivery Coordination 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 8. 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 bladder scanners. 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. 9. 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. 10. Estimates In the quotes, vendors will indicate whether their solution has MET, NOT MET or MET WITH QUALIFICATIONS for each line item in this document (MET WITH QUALIFICATIONS will require a detailed listing of non-compliance). In addition, vendors will complete the Instructions to Offertory s (ITO) and respond in detail to each question. Vendors are required to respond to each item individually in both documents. Include the specification/question number and text in your response document to facilitate review. 10. 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 VAPHS. 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. 11. 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. RUBELLA TESTING: Contractor shall provide proof of immunization for all contract personnel for measles, mumps, rubella or a rubella titer of 1.8 or greater. If the titer is less than 1.8, a rubella immunization shall be administered with follow-up documentation to the COR. Please provide a signed memo stating that: (number of assigned Key Personnel) assigned to VA Contract #___________ have tested negative for tuberculosis within the past 365 days. (number of assigned Key Personnel) assigned to VA Contract #___________ have been immunized for measles, mumps, rubella or a rubella titer of 1.8 or greater. 12. 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. 13. Tobacco All VA Pittsburgh property is tobacco free. Contractor personnel will comply with VA Pittsburgh tobacco and smoking policies. Violations will result in a warning and possible citation. 14. COVID-19 Related Policies a. 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 VAPHS. b. 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 The information identified above is intended to be descriptive, not restrictive and 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) 423450 (size standard of 1000 employees). Please answer the following questions: (1) 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.)? (2) Is your company considered small under the NAICS code identified under this RFI? (3) 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) 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? (6) 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 sub contracted work and completion of job. (7) 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. (8) 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? (9) 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 in regard to the salient characteristics detailed above and any information pertaining to equal to items to establish capabilities for planning purposes? (11) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. (12) Please provide your DUNS number. *** Submissions addressing number (10) should show clear, compelling and convincing*** evidence that all equal to items" meet all the salient characteristics. This Request for Information will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Telephone responses will not be accepted. Responses must be received via e-mail to contact@example.gov no later than, 03:00 PM Eastern Standard Time (EST) on August 7, 2020. Reference the Request for Information number in the subject of the email 36C24420Q0915.This notice will help the VA in determining available potential sources only. 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, Walida Moore. 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 or General Services Administration e-Buy (GSA) web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. 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 Officer at contact@example.gov reference the Request for Information number in the subject of the email 36C24420Q0915. 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 Request for Information. End of Document