6515--Pronova-O2 Automated Prone Therapy System - Pulmonary Critical Care Sleep Service (PCCSS)

40 Please submit your capabilities regarding the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes. " Responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract or agreement. This notice shall not be construed as a commitment by the Government to issue a solicitation, or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. All interested party shall submit a capabilities statement and other documentation demonstrating clear and convincing capabilities to satisfy the requirement listed above to the Contract Specialist contact@example.gov no later than 04/23/2025 at 11:00 AM EST. Disclaimer and Important Notes: 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. IAW FAR 15.201(e), 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. Statement of Work GENERAL: Contractor shall provide all labor, material, tools, parts, equipment, operating and/or technical/maintenance manuals, training, delivery/removal, and accessories necessary to furnish and install the Pronova-O2 Automated Prone Therapy System. This is a request for Pronova-O2 Automated Prone Therapy System that will not connect to the network and will not store PHI/PII. The device will be used in the Critical Care/Intensive Care Unit. "The Authorization requirements do not apply, and that a Security Accreditation Package is not required." DELIVERABLES: EQUIPMENT/SERVICE IDENTIFICATION IS AS FOLLOWS: Product Unit of Issue Quantity Unit Price Estimated Cost Base Year: Pronova-O2 Automated Prone Therapy System RENTAL - Includes InteliDerm Powered Skin Protection Kit (Disposable, 1 per pt) Month 12 Base Year: InteliDerm Disposable Kit (Chest, Face, Abdomen, Critical Care Line Manager) 1 each Each 12 Option Year 1: Pronova-O2 Automated Prone Therapy System RENTAL - Includes InteliDerm Powered Skin Protection Kit (Disposable, 1 per pt) Month 12 Option Year 1: InteliDerm Disposable Kit (Chest, Face, Abdomen, Critical Care Line Manager) 1 each Each 12 Option Year 2: Pronova-O2 Automated Prone Therapy System RENTAL - Includes InteliDerm Powered Skin Protection Kit (Disposable, 1 per pt) Month 12 Option Year 2: InteliDerm Disposable Kit (Chest, Face, Abdomen, Critical Care Line Manager) 1 each Each 12 Option Year 3: Pronova-O2 Automated Prone Therapy System RENTAL - Includes InteliDerm Powered Skin Protection Kit (Disposable, 1 per pt) Month 12 Option Year 3: InteliDerm Disposable Kit (Chest, Face, Abdomen, Critical Care Line Manager) 1 each Each 12 Option Year 4: Pronova-O2 Automated Prone Therapy System RENTAL - Includes InteliDerm Powered Skin Protection Kit (Disposable, 1 per pt) Month 12 Option Year 4: InteliDerm Disposable Kit (Chest, Face, Abdomen, Critical Care Line Manager) 1 each Each 12 SALIENT CHARACTERISTICS: The system must be fully Automated and allow a single caregiver to safely prone a patient at the touch of a button. The system must provide Prone Therapy which is considered standard of care and has been clinically demonstrated to improve oxygenation, reduce ventilator induced lung injury, and decrease mortality. The system must provide advanced continuous lateral rotation therapy up to 65 degrees in either the prone or supine positions. The system must have a powered skin protection system consisting of a single-patient-use face pack and chest wedge that uses positive pressure to help reduce pressure injuries by managing the microclimate of the skin. The system must accommodate a patient weight up to 400 lb. The system surface must be a minimum of 37 in. The system must have a hand control that allows one caregiver to monitor lines and tubes during rotation to and from the prone position and allows CPR to be performed by using the hand control at the head of the unit. The system must have integrated surface components with limited removable parts for nurse protection and infection control. The system must have an intubation lever to position the head for ease of intubation and access to critical lines. The system must contain radiolucent panels that allow for imaging and critical bedside procedures. The system must have an occiput panel for access to critical lines, heat dissipation and pressure relief. The system must support a max reverse Trendelenburg angle of l 6° to help improve oxygenation, ventilation, and offload pressure. The weight of the entire system must not exceed 800 lb. The system must have a single-patient-use critical line management system to aid in avoiding dislodgement of lines and tubes. The system must include a single-patient-use Abdominal Sling comprised of breathable material that provides support for the abdomen when the patient is placed in the prone position. The system must offer Central Locking brakes for safety and convenience and Steer Lock to increase mobility and reduce drift. The system must have Digital Therapy Meters to allow caregivers to easily track daily and cumulative therapy time. The system must have a Built in Digital Scale for weighing patients without transfer and that is accurate to +/- 2% for weight greater than l 00 lb. and +/- 2 lb. for weight less than l 00 lb. The system must perform CPR Functions from a Touch Screen or Manually to allow a patient to be rapidly returned to supine position for CPR or to the prone position if the patient is prone dependent. DEFINITIONS/ACRONYMS: A. CO - Contracting Officer B. COTR - Contracting Officer's Technical Representative C. Contractor and/or Supplier/Installer - Company performing work under this contract. D. NFPA - National Fire Protection Association. E. VAMC - Department of Veterans Affairs Medical Center F. JACHO - Joint Commission on Accreditation of Healthcare Organizations G. FSE - Field Service Engineer/Technician H. UL -Underwriters Laboratories I. OSHA Occupational, Safety and Health Administration K. OEM Original Equipment Manufacturer EQUIPMENT REQUIREMENTS: Specifications of component equipment as set forth in this section are minimum specifications, unless otherwise stated, and shall not be construed as limiting the overall quality, quantity or performance characteristics of items furnished in the system. The Contractor Furnished Equipment (CFE) shall meet or exceed the minimum requirements and contractor shall be held responsible for the supply, performance, and overall quality of the contractor s furnished equipment. All equipment to be supplied under this specification shall be new and the current model of a standard product of a manufacturer of record. A manufacturer of record shall be defined as a company whose main occupation is the manufacturer for sale and lease of the items of equipment and which: Maintains a factory production line. Maintains a stock of replacement parts for the item. Maintains engineering drawings, specifications, operating manuals and maintenance manuals. Has published and distributed descriptive literature and equipment specifications on the equipment. Contractor shall configure the system proposed to meet those functional requirements. The list of equipment provided shall not be considered all-inclusive but shall serve as a guide for developing a complete system. INSTALLATION: It is agreed upon and understood that the contractor will do a complete installation of the equipment. TESTING AND CERTIFICATION Upon completing installation of the system, the Contractor shall pretest the entire system. After pretesting the system, the Contractor shall notify the COTR that the system is ready for acceptance testing, and that it meets all requirements as specified. Submission of this notification of system readiness shall be accomplished by the contractor prior to the beginning of the scheduled Government Acceptance Test. ACCEPTANCE TESTING The system shall be tested, in the presence of the COTR for proof-of-performance. Acceptance Testing shall be performed at a mutually agreed upon date and time. TRAINING: Contractor shall provide training on the use and operations of the equipment. Cost for training is included in the contract price and shall be conducted at the facility at the discretion of the COTR. Training shall include on-site orientation and training of using personnel in operation and care of the equipment furnished, as well as an actual demonstration of the operation of the equipment. Contractor shall provide guidance on completing any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action will in no way jeopardize the Government's rights under contract guarantee clause. Only qualified Contractor s personnel will give this training. HOURS OF OPERATION: Normal hours of operations at the Memphis VAMC are Monday through Friday from 8:00 am to 4:30 pm, excluding holidays. All work will be performed during normal hours of coverage unless requested or approved by COTR or his designee. 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 Juneteenth Independence Day Christmas Day PERIOD OF PERFORMANCE: This will be a base plus four (4) Option year contract beginning October 01, 2025, and ends September 30, 2030. Base year from October 01, 2025, to September 30, 2026 Option year 1 from October 01, 2026, to September 30, 2027 Option year 2 from October 01, 2027, to September 30, 2028 Option year 3 from October 01, 2028, to September 30, 2029 Option year 4 from October 01, 2029, to September 30, 2030 LOCATION: Lt. Col. Luke J. Weathers Jr. VAMC MICU/Pulmonary Services 116 N. Pauline Street Memphis TN 38105 GUARANTEE/WARRANTY: The Contractor warrants that the system will be free from defects from materials and workmanship under normal use for a period of not less than one (1) year for equipment defined herein. Contractor will replace or repair equipment if necessary to the satisfaction of the Government. Contractor shall provide a copy of the written warranty upon delivery of the equipment. RESPONSE TIME FOR EMERGENCY REAPIR SERVICE AND/OR WARRANTY REPAIRS: The COTR or designated alternate is the Contractor s reporting and contact official for all service calls required. Warranty repairs shall be completed during normal operating hours. Response Time: Contractor's FSE must respond with a phone call to the COTR or his/her designee within one (1) hour after receipt of telephoned notification. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) without within twenty-four (24) hours of receipt of the first notification or as approved by the COTR. All required repairs shall commence without undue delay. CONFORMANCE STANDARDS: All work shall be performed, and equipment shall function in conformance with all VA safety standards, manufacturer's/industry standards, the latest published edition of NFPA 99, FDA, OSHA, JCAHO, ISO 9000, UL, and other applicable state, local, national and industry standards. Equipment meets EMS (Electromagnetic Compatibility) for EIC 601-1-2 CE, CSA, ETL Approved to U.L. 2601-1, second edition. PRODUCT MODIFICATION, REMOVAL OR RECALL: If any product awarded under this solicitation requires modification, is removed, or recalled by the Contractor or manufacturer, or if any required modification, removal, or recall is suggested or mandated by a regulatory or official agency, the following steps will immediately be taken by the Contractor or manufacturer: Notify the Contracting Officer, in writing, by the most expeditious manner possible. Provide two copies of the notification which shall include, but not be limited to the following: Complete item description and/or identification, order numbers from customers, and the contract number assigned as a result of an award on this solicitation. Reasons for modifications, removal, or recall. Necessary instructions for return for credit, replacement, or corrective action. b. Provide the above information to all agencies and VA Facilities who purchased the product. The Contracting Officer shall be provided a copy of the notification in b. above, and a list of all agencies and/or VA facilities notified. c. Contractor shall be responsible for any costs associated with the above. OPERATING/MAINTENANCE MANUALS: In addition to the electronic copy of the operating/maintenance manual (if available), Contractor shall provide two (2) copies of the Operating and/or Maintenance manuals.