6515--PORTABLE ECMO HEART-LUNG MACHINE

This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does not obligate the Government to award a contract. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research, to make appropriate acquisition decisions, and to gain knowledge of potential qualified businesses capable of providing the following: Portable Heart Lung Machine for Columbia VAMC *** See Statement of Requirement below for details *** If this is within your capability, please respond with the information below: Company Name Address Point of Contact Phone, Fax, and Email UEI number GSA Contract (as applicable) Capability Statement that clearly and convincingly identifies your ability to fulfill this requirement. Brochures of products being offered to include specifications. Meet the Buy American statute FAR 52.225-1, where the product is manufactured. Authorized service provider letter from OEM Interested firms are reminded that in accordance with FAR 4.12, prospective contractors shall complete electronic annual representations and certifications to be considered for award. In addition, FAR 4.11 states that prospective contractors shall be registered in the System for Award Management (www.SAM.gov) database. All Service-Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) shall be verified in VetCert at https://veterans.certify.sba.gov Point of Contact for this Sources Sought is: contact@example.gov Department of Veterans Affairs Network Contracting Office -15 3450 S. 4th Street Trafficway Leavenworth, KS. 66048 STATEMENT OF REQUIREMENTS GENERAL INFORMATION 1.0 Scope of Work: Harry S Truman VA Hospital (HSTVA) needs new life saving equipment. This equipment is a heart bypass machine. HSTVA current Maquet Cardiohelp lung support systems are more than 10 years old and need to be replaced. HSTVA is requiring two new portable cardio lung supports systems to replace the Cardiohelp Maquet system. The component of the cardio lung supports systems need to include a pump, oxygenator, heat exchanger, cannulas, and tubing. 2.0 Background: The current system in place is a Cardiohelp Maquet System and the need for a new system to replace it is greatly needed. The new system MUST be FDA approved and not have any current recalls. CONTRACTOR REQUIREMENTS 3.0 Technical Requirements/Tasks: The system must be able to do the following: An ECMO machine primarily consists of a mechanical blood pump, a membrane oxygenator (artificial lung), a heat exchanger to regulate blood temperature, and tubing connecting to cannulas (large tubes) that are inserted into the patient's veins and arteries, allowing the machine to draw blood out, oxygenate it, remove carbon dioxide, and then return it to the body; essentially acting as a temporary replacement for the heart and lungs when they cannot function adequately. The ECMO machine must include: Pump: This component forcefully pushes the patient's blood through the circuit. Oxygenator (membrane lung): This is where gas exchange occurs, adding oxygen and removing carbon dioxide from the blood. Heat exchanger: Ensures the blood is warmed to the patient's body temperature before being returned. Cannulas: Large tubes inserted into the patient's blood vessels, one to draw blood out and another to return oxygenated blood. Tubing: Connects the cannulas to the pump and oxygenator, allowing blood to flow through the circuit. 4.0 Salient Characteristics: The Cart must be compact and able to fit through any doorway. Cart must be able to fit into an OR room or normal patient room on the floor such as ICU. (Intensive Care Unit). It must be easily portable to move and transport patients from hospital to any ambulatory transportation. Battery Life must be least 90 mins when fully charged. The unit must include an LED speed indicator integrated into the top of the console to display the speed independently of the touchscreen. The console must have a weight bearing carrying handle on top of the console that includes an integrated holder that must accept the emergency hand crank. The console must have a safety bar to protect the console and the attached disposable. The console must have a pump drive capable of accepting the centrifugal pump of the HLS Set 7.0 or 5.0 disposable circuit The console must have a combined flow/bubble sensor for flow measurement and arterial bubble monitoring. The console must have the capability and expandability to add a bubble sensor for venous bubble monitoring if desired. The console must have a venous probe to measure the venous blood parameters of SV O2, Hb, Hct and temperature. This probe must be able to attach to the Venous Cell of the HLS Set 7.0 or 5.0 disposable circuit. The console must have an emergency hand crank used in emergency situations to manually drive the HLS Set 7.0 or 5.0 disposable circuit. The console must have an emergency mode button that can be activated in the event of failure of the touchscreen or other components to operate the disposable and control its speed directly via the rotary knob. The console must have a Zero Flow mode during which the system must aim at a flow of 0 l/min by controlling the pump accordingly. In this way, both forward and backward flow can be prevented The console must have backflow prevention to detect and respond to a backflow of blood. The console must monitor the blood flow, display any alarms and activate the zero-flow mode automatically to prevent any backflow. The console must have bubble detection to monitor for arterial bubbles. It must have the ability to trigger an intervention and/or an alarm when bubbles are detected. With a user activated intervention, the detection of bubbles by the flow/ bubble sensor must trigger a pump stop. The console must have the ability to provide Offline Recording to record data in an internal memory and later exported to a USB drive if desired by the user. The console must have a rotary knob to enable the clinician to change the setpoint speed or the setpoint flow The console s user interface must be a touch screen and could display: Flow and LPM Pressure Internal, Pressure Arterial, Pressure Venous and Dela P Arterial Temperature and Venous Temperature SVO2, HB, HCT Visual Alarms System Lock status Battery Status The console s user interface must also include a separate Keypad next to the touch screen with: Lock/Unlock LED & button On/Off LED & button Zero Flow Mode LED & button Safety LED button Battery status LED The clinician must have the ability to set both alarms and interventions for: LPM or RPM Pressure Venous, Pressure Arterial and Pressure Internal. Arterial bubble sensor Venous bubble sensor 5.0 Deliverables / Schedule: Deliverables of this system must be shipped to 800 Hospital Dr Columbia MO 65201. ATT: Warehouse foreman, All equipment and components must be shipped together. All equipment and components must be tracked upon shipment and tracking number given to the POC. Federal Holidays Observed by the VA Medical Center New Year's Day Labor Day Martin Luther King, Jr. Day Columbus Day President's Day Veterans Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day - and any other day specifically designated by the President of the United States. 6.0 Training: Travel for training and install must be done by vendor after the delivery receipt of the equipment. No additional fees must be incurred outside the quote. Any fees must be identified in the quote of the procurement not noted later. The vendor must handle all traveling to meet the needs of installation and training. Vendor must provide training and installation of equipment with local Biomedical rep from HSTVA to ensure equipment is working properly. 7.0 Data Rights: All rights and admin privileges must be handed over to HSTVA upon install of equipment.