Added: May 17, 2019 2:21 pm
This is NOT a solicitation announcement. The Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN 8), James A. Haley Veterans Hospital (JAHVH), Tampa, FL, intends to issue a Request for Quote (RFQ) for Heart-Lung Bypass Machines and Perfusion Charting System in accordance with the attached Statement of Need. Requesting LivaNova brand name or equal.
Ship to address: James A. Haley Veteran s Hospital
13000 Bruce B. Downs Blvd.
Tampa, Fl 33612
NAICS 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing is applicable to this procurement.
RFQ solicitation 36C24819Q0771 will be posted to the Federal Business Opportunities (FBO) website www.fbo.gov. on or about 17 May 2019.
All solicitation packages and amendments must be accessed on line. All amendments issued to this solicitation will also be available at www.fbo.gov and will not be mailed. Offerors are advised that they are responsible for obtaining amendments.
100% SERVICE DISABLED VETERAN-OWNED SMALL BUSINESS (SDVOSB) SET-ASIDE
Point of contact: Daniel Speed Contract Specialist Daniel.Speed@va.gov.
Attachment: Statement of Need
STATEMENT OF NEED
Heart-Lung Machines (2)
GENERAL: The Cardio Thoracic Section of Surgical Service at the James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd, Tampa, Florida 33612, has an immediate requirement for 2 Heart-Lung Machines. Heart-Lung Machines are critical equipment necessary for use during surgeries involving life-saving open-heart procedures including those performed in the Cardio-Thoracic Surgical Suite, Hybrid Operating Room, and or Cardiac Catherization Lab.
BACKGROUND: A cardiopulmonary bypass machine (CBM) is commonly known as a heart-lung bypassÂ machine. It is a device that does the work of providing blood (and oxygen) to the bodyÂ when the heart is stopped for a surgical procedure. In most cases, the machine is used to perform serious procedures that require the heart to be stopped. Â Patients are on the pump only if it takes to stop the heart from beating, complete open-heart surgeryÂ or a procedure on the lungs,Â and restart the heart.
To stop the heart without harming the patient, oxygenated blood must continue to circulate through the body during surgery without stopping. The cardiopulmonary bypass pump does the work of the heart, pumping blood through the body, and making sure that the tissues of the body get the oxygen they need. The machine also adds oxygen to the blood while taking over the pumping action of the heart, replacing the function of the lungs.
SCOPE: The centrifugal pump must be user friendly with flexibility. It must be less cumbersome to move throughout the hospital by perfusion staff and help decrease the risk of injury to staff. The mast assembly should configure in that it saves space due to limited storage space in the operating room and OR Suite. Thus, no additional space should be needed to configure the console for the needs of James A. Haley VA Hospital. The overall system should be delivered complete with drive unit, control panel, connection cable, sensor module for flow measurement, flow sensor and emergency system. The emergency system (ERC) should close the arterial line in a fraction of a second if an alarm is triggered (e.g. retrograde flow, level or bubble alarm), keeping the danger of air delivery to a minimum and thus adding an additional measure of safety to our veteran population. Quoted solutions must be considered Brand Name or Equal to the LivaNova S5 Perfusion System.
SPECIFIC NEED/ SALIENT CHARACTERISTIC S
QUANTITY: 2 x Heart-Lung Machines (Brand Name or Equal to LivaNova S5 Perfusion System)
Integrated perfusion circuit to interface with anesthesia data management and patient records.
Multiple configuration options needed for the varying procedures we provide our patient population without the need drastically undue current configuration in emergent challenging situations and environments (Hybrid OR suite, or non-cardiac OR)
Safety features including automated venous occluder, air-detector, level-alarm sensors, pressure sensors.
Need for a system that can be operated at patient bedside including in our SICU unit rooms, Cardiac Cath Lab, EP Suites, etc.
Easy maneuverability is a must to decrease and or prevent injury during moving of pumps including the ability to swivel to accommodate older OR suites and patient rooms with limited space.
Automated Venous Occluder per HR/Dept of Labor/ Workers Comp for increased patient safety and to decrease re-injury to current employees.
Data-Management System for paperless charting to align with current VA standards of patient data management.
Upgradeable as case complexity and advances in open-heart procedures
Clearly structured, intuitive and descriptive menu system eliminates guesswork, and one-touch accessibility improves user convenience.
Memory chips within the various modules instead of centrally in a CPU which will ensure that each component functions as intended and in real-time.
Each module should be interchangeable and replaceable without the need to replace entire system.
No boot time required after power-up the system should be ready for operation within 3 seconds
The perfusionist should be able to access all control elements.
The pump should be angled and enhance ergonomic flexibility to decrease personal injury to operator.
The motor of the roller pumps should be quiet or noiseless as not to distract the Perfusionist and or surgeon.
The weight should be the lightest and maneuverability is extremely important as the pumps are relocated where needed throughout the hospital. Thus, mounting of system should be able to be configured vertically and horizontally.
High resolution displays so that Perfusionist can easily view displayed values from greater distances and at an angle at varying dependent on location (Cath-Lab, patient bedside, OR suite)
Paperless Perfusion Charting System (Brand Name or Equal to LivaNova Connect System)
Manages all case data in one central database
Provides retrospective data analysis
Generates and exports electronic medical records
Allows full customization
Recorder to record alarm activity and actions taken
Collects and visualizes data from HLM and other external devices such as HMS (ACT-ABG); SAT/HCT monitor; Anesthesia Monitors
Single-touch event entries at any time
PLACE OF PERFORMANCE: James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd, Cardio Thoracic Section Main OR, Bldg 1, Tampa, FL 33612.
DELIVERY SCHEDULE: All items to be delivered and installed within 30 days of purchase order processing and order placement. FOB destination pricing.
WARRANTY OF EQUIPMENT: Contractor must provide manufacturer(s) warranty on all provided supplies.