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VA Pittsburgh Healthcare System (VAPHS) SCOPE OF WORK AND GENERAL SPECIFICATIONS FOR Bladder Scanner Replacement Background VAPHS Critical Care Service Line owns four bladder scanners that are reachin... VA Pittsburgh Healthcare System (VAPHS) SCOPE OF WORK AND GENERAL SPECIFICATIONS FOR Bladder Scanner Replacement Background VAPHS Critical Care Service Line owns four bladder scanners that are reaching the end of their lifecycle and need to be replaced. Project Scope VAPHS requires the purchase of 4 Bladder Scanner units. Critical Care plans to purchase one bladder scanner, mobile stand, probe, for each unit (3A-SICU; 3E-CCU; 4E-MICU; and 5A-SDU), as well as 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. Specifications Device must be FDA approved Quantity: 4 General Characteristics: The unit must have a bladder scan measurement capacity of 0-999 mL Minimum Accuracy: 0-100 mL accuracy is +/- 10mL Greater than 100 mL accuracy is +/- 10% Taking a bladder scan is not to be contraindicated in patients who are pregnant or obese. Unit Power Requirements Must have a rechargeable battery Must be lithium-ion batteries Minimum 12-hour battery life Assuming an average operation of 4 x 1-minute scans per hour Storage/Memory Ability to store at least 600 scans Portability Each bladder scanner must come on portable stand Stands must have the ability to store ultrasound gel, probes, and cleaning supplies The portable stand must have locking casters The portable stand must be able to be adjusted for height Probe/Scanning Head The bladder scanner must have a wired probe Wireless probes and/or hand-held scanners are not acceptable. The bladder scanner probe must be a solid-state probe (not containing moving parts) Display Simultaneous display of image and numerical values on screen The unit must display ultrasound imagery 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. The unit must be able to provide pubic bone detection for easy identification and guidance The unit must have a colored LCD Screen Minimum display dimensions 43 square inches. Feedback Mechanisms The unit must have both auditory and visual feedback mechanisms The feedback mechanism must direct staff toward a more optimal probe placement The unit must be able to provide explanations for improper errors/misplacement associated with a failed bladder scan Cleanability Unit must be able to be cleaned with PDI Wipes and sodium hypochlorite bleach wipes Upgradeability The unit must be capable of upgrading to other functions like ultrasound and vascular imaging. Training Vendor must be available to provide 8-hours of clinical training The training would be broken down over two days and could be subject to varying shift times. The unit must have onboard training showing proper use of the product Maintenance The system must require no annual preventative maintenance according to the manufacturers specifications. Warranty The system must have at minimum a 5-year warranty Assembly The contractor/vendor will assemble all the units upon delivery of the units at no additional cost Delivery Location Attn: 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. 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 COR. 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. 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 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. 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. 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 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. 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, Logistics, and/or COR staff and provide a contact for a replacement.