36C24824Q1006.docx

SUBJECT*

Heart-Lung Support Systems

GENERAL INFORMATION

13000 Bruce B. Downs Blvd.

Tampa FL

CONTACT INFORMATION

Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy Suite 160 Tampa FL 33637

POINT OF CONTACT*

Contract Specialist David Griganavicius david.griganavicius@va.gov 813-972-2000 x2819

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Pre-Solicitation This is a Pre-Solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. THIS PRE-SOLICITATION NOTICE IS NOT A REQUEST FOR A QUOTE (RFQ). VENDORS SHOULD NOT SUBMIT FORMAL QUOTES UNTIL THE RFQ IS POSTED ON THIS WEBSITE. This notice is not to be construed as a commitment by the Government, nor will the Government pay for the information resulting from this posting.

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), Heart-Lung Support Systems. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing (1,250 employees) Size Standard.

See attached SON.

The actual Solicitation #36C24824Q1006 is anticipated to be posted to the https://sam.gov website on or about 5/08/2024, closing date of 5/15/2024 @4:30pm EST. Quoters should continue to monitor https://sam.gov for the RFQ and any subsequent amendments to that RFQ. All Quoters must be registered in the System for Award Management (SAM) database; see https://www.sam.gov for complete online Reps and Certs. SDVOSBs must be certified and verified in VetCert.

Presolicitation Notice Presolicitation Notice The point of contact is David Griganavicius, Contract Specialist, email: David.griganavicius@va.gov.

Presolicitation Notice

STATEMENT OF NEED

1. GENERAL: James A. Haley Veterans’ Hospital, 13000 Bruce B. Downs Blvd, Tampa, Florida 33612, has a requirement for two (2) Heart-lung support systems. These systems are needed in the operating room to assist with surgical cases.

2. BACKGROUND: James A. Haley Veterans’ Hospital currently uses the Cardiohelp unit in the operating room. Two additional Cardiopulmonary support system/Circulatory Support System units are requested. These additional units are necessary to ensure veteran patient care in the event the current unit stops working or is otherwise in use. The system is a form of an Extracorporeal Membrane Oxygenation (ECMO) in addition to being a Ventricular Assist Device and or Bridge-To-Transplant device. It is ideally designed for use in the intensive care unit, operating room, cardiac catheterization lab, emergency room, and or operating room. The compact and functional design of the system gives maximum flexibility and easy handling of the device. It is a system used to restore and stabilize the patient’s cardiopulmonary functions so the clinician can gain valuable time to save patients’ lives.

3. PURPOSE: The system is a portable heart-lung support system designed to treat and transport patients needing extended respiratory and/or circulatory support, the system is used in the operating room and intensive care units. The system should be highly portable, the system can be rapidly deployed to transport patient within and between hospitals. The system is used to restore and stabilize the patient’s cardiopulmonary functions so clinicians can gain valuable time to save patients’ lives. These types of systems are proven to be an effective mechanical life support system. It has a compact and functional design with intuitive software that optimizes several specific areas of applications.

4. SCOPE: The Cardiopulmonary support system/Circulatory Support System shall be functional for use in limited space areas and be capable of facilitate transport to another hospital by helicopter or ambulance, if needed.

5. PHYSICAL CHARACTERISTICS: The system is a compact perfusion system, with which an extracorporeal circulation can be driven, controlled, monitored, and recorded. The system consists of the following components:

5.1 Cardiopulmonary support system / Circulatory Support System Characteristics:

· Intuitive control in an emergency: Intuitive control in emergency situations allows for the Perfusionist to take over functions and make necessary adjustments to meet the emergent needs of the patient to improve survival via physiological manipulation as warranted in coordination with cardiothoracic surgeon.

· Integrated sensor technology: With integrated sensor technology, enables continuous monitoring of patient’s critical blood parameters pressures and bubble detection (can be detrimental or even fatal to patient survival). The sensor technology shall also minimize the hazards of air embolism, stagnant zones, clotting, and cavitation from the use of external pressure sensors.

· A minimum 90-minute battery supply when fully charged.

· Emergency Drive Holder: The emergency drive holder of the system can be rapidly deployed for transport of patients needing further treatment outside of VA capabilities (TGH, Advent, etc.) such as Bridge-to-Transplant; Mechanical Assist Device, et., requiring respiratory and or circulatory support. This includes intra-hospital patient transport between departments such as Cath Lab to Surgical Suite. In addition, the system can be run a special Emergency Mode.

· Touch Screen Control Panel

· Rotary knob for (Ability for) adjustment of flow and speed

· Connections-Alarm output for data export to memory stick and for data recording system. Equipotential bonding connection-DC device Socket

· Emergency Mode button

· Main power supply-together with the DC device socket, the device can be used with common voltages and current worldwide. No additional changes need to be performed by Biomed and or hospital engineers to allow for setup in operating rooms, Hybrid, and or Cath Lab to power the device. Thus, the current power supply /voltage will support the system.

· Venous Probe to measure venous oxygen saturation, hemoglobin, hematocrit, and venous temperature.

· Four external pressure sensors: The external sensors allow for the patient’s blood parameters to be accessed by continuous inline measurement including temperature, hemoglobin, hematocrit, and venous saturation all critical to maintaining patient on extracorporeal circulation.

· Bubble sensor: The Bubble sensors alerts Perfusionist to volume levels and bubbles that may enter the system allowing for quick corrective action to protect the patient from the impact of entrained air into the closed system.

5.2 Cart Characteristics:

· An XL Cart must be on casters or wheels that allows easy movement of the system:

· An XL Cart must also provide storage for:

· Infusion Pole

· Gas bottle holder

· Drawer-slide for hyperthermia devices

This request is brand name or equal. The salient characteristics are listed above. The OEM is Getinge USA and the basis of design for the above listed characteristics is:

1. LUSCARDIOHELPBUND Cardiohelp & Sprinter Cart Bundle

2. 701072780 CARDIOHELP-i Description: CARDIOHELP-i incl. Emergency Drive, Flow-/bubble sensor, Venous Probe, Connection cable disposable

3. 701054184 SPRINTER CART XL Description: SPRINTER CART XL Base unit

4. 701053386 Top shelf kit for Cardiohelp (XL) Description: TOP SHELF KIT FOR CARDIOHELP (SPRINTER CART XL)

5. 701054144 Drawer slide for hyperthermia devices Description: SHELF KIT FOR HYPERTHERMIA DEVICES (SPRINTER CART XL)

6. 701033599 INFUSION POLE Description: Old Material Number: 1033599

7. 701040809 GAS BOTTLE HOLDER Description: Old Material Number: 1040809

8. 701048006 CARDIOHELP Emergency Drive Holder, Mast Description: CARDIOHELP Emergency Drive holder for mast system

9. 701052902 70105.2902#CARDIOHELP Country Kit Engl US Description: CARDIOHELP Country Kit English US incl. User's manual and Power supply cord

6. SOFTWARE: No software.

7. TRAINING: No training needed.

8. WARRANTY OF EQUIPMENT: MFG Standard warranty.

9. DELIVERY SCHEDULE: All items to be delivered and or installed within 15 days after receipt of order.

10. PLACE OF DELIVERY: James A. Haley Veterans’ Hospital, 13000 Bruce B. Downs Blvd., Tampa, FL 33612.

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