SAM #50626315270039

Sole Source Preventative Maintenance for LivaNova Essenz Perfusion Systems at LTC Charles S. Kettles VA Medical Center

This opportunity involves a sole source contract for preventative maintenance services on LivaNova Essenz Perfusion Systems at the LTC Charles S. Kettles VA Medical Center in Ann Arbor, MI. - Department of Veterans Affairs (VA) is the procuring agency, with Network Contracting Office 10 managing the contract. - Services cover the Essenz Heart-Lung Machine and associated patient monitoring software and hardware. - Only LivaNova USA, Inc., the Original Equipment Manufacturer (OEM), is authorized to provide these services; third-party providers are not permitted. - Maintenance must be performed by vendor-certified technicians and engineers with NASED certification. - All work must comply with NFPA, OSHA, and OEM standards, as well as local, state, and federal regulations. - The procurement falls under NAICS code 811210 (Electronic and Precision Equipment Repair and Maintenance). - No specific product quantities or part numbers are listed; this is a service contract for proprietary medical equipment. - Place of performance is LTC Charles S. Kettles VA Medical Center, Ann Arbor, MI. - Contracting offices are located in Dayton and Kettering, OH. - Commercial competitors are limited due to OEM restrictions, but other medical device manufacturers with similar systems include Medtronic, Terumo, and Getinge. - Estimated contract value is likely in the $20,000-$100,000 range, based on typical annual maintenance for specialized medical equipment.

Technical and Business Highlights: - Sole source justification: Only LivaNova can provide maintenance due to proprietary restrictions. - Compliance requirements: NFPA, OSHA, OEM standards, and NASED certification. - No competitive bidding unless clear evidence of advantage is provided. - Federal facility delivery and performance location specified. - Contract covers preventative maintenance, not equipment purchase. - Opportunity is not open for competition unless a qualified alternative is demonstrated.

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. 100 Cyberonics Blvd. Suite 600 Houston, Texas 77058-2017

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 1:00 PM Eastern Standard Time on May 02, 2026. No mail or telephone inquiries with questions will be accepted.
Additional Links:Department of Veterans Affairs Home Page

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