36C25026P0644_1.docx

Special Notice Special Notice

GENERAL INFORMATION

Network Contracting Office 10 3140 Governors Place Blvd Suite 210 Kettering OH 45409-1337

POINT OF CONTACT*

Contracting Officer Michele R. Bartelt Michele.Bartelt@va.gov 734.845.5623 Not Applicable

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Intent to Sole Source

The Department of Veterans Affairs, LTC Charles S. Kettles VA Medical Center, Biomedical Engineering (138be), 2215 Fuller Road, Ann Arbor, MI 48105-2303, in accordance with FAR 6.302.1 Only one (1) Responsible Source and No Other Supplies or Services will satisfy Agency Requirements and Intends to Negotiate on a Sole Source Basis with the following vendor:

LivaNova USA, Inc., provides Preventative Maintenance for the Essenz Perfusion Systems. The Essenz Heart-Lung Machine is intended to perform, control, monitor and support extracorporeal blood circulation replacing the mechanical pumping function of the heart, monitoring and regulating physiologic parameters during procedures requiring extracorporeal circulation.

Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. Essenz ILBM is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures for up to six hours.

The Essenz Patient Monitor software is modularly structured software program package that is exclusively used with LivaNova heart-lung machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass procedures as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually. The LivaNova Perfusion System Monitor is a panel PC intended to be exclusively used with LivaNova heart lung machines as a base and user interface for the Essenz Patient Monitor software.

This is proprietary to the Original Equipment Manufacturer (OEM) LivaNova USA, Inc. and currently the organization does not allow 3rd Party Service Providers to conduct Preventative Maintenance and Services to the cardiac surgery equipment that is currently utilized at the LTC Charles S. Kettles VA Medical Center.

All services provided under this contract must be performed in conformance with the National Fire Protection Agency (NFPA), Occupation Safety and Health Administration (OSHA), and OEM standards and specifications. Vendor Certified Technician and Engineers shall have the National Association of Special Equipment Distributors (NASED).

LivaNova USA, Inc. is the only firm capable of providing the supplies and services above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.”

NAICS Code 811210 applies to this Procurement. This Notice of Intent is not a request for competitive proposals. It is not a solicitation or request for offers. No solicitation package is available. A determination not to compete is solely within the discretion of the Government. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses must clearly indicate and show proof that they are a Certified Technician by the Original Equipment Manufacturer. Responses must also show proof that they can perform Preventative Maintenance and Services on the Essenz Perfusion System Equipment while following all local, state, and federal regulations at a fair and reasonable price. Responses must also clearly indicate they can provide these services and possess the proper certification.

Responses must be emailed to Michele.Bartelt@va.gov Responses must be received no later than 12:00 PM Eastern Standard Time on May 02, 2026. No email or telephone inquiries with questions will be accepted.

Special Notice