Dräger Perseus A500

CUI Control Number: CUI Source Selection Information - See FAR 2.101 and 3.104-4 NOV 2024 Sole Source Justification (SSJ) for Requirements under the Simplified Acquisition Threshold 1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA), DHA Contracting Activity (DHACA), Healthcare Contracting Division (HCD) – Southeast 2. Description of Action: ☒ New Requirement ☒ Purchase Order Contract Type ☒ Fixed Price 3. Description of Services and Estimated Value: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform preventative maintenance and troubleshooting as defined in this Performance Work Statement (PWS) for Anesthesia located at Naval Medical Center Camp Lejeune, 100 Brewster Blvd, NH100, Camp Lejeune, NC, 28547. Period Period of Performance Estimated Value Type of Funding Base Period 10/01/2026 -09/30/2027 $ O&M Option Period 1 10/01/2027 – 09/30/20278 $ O&M Option Period 2 10/01/2028 – 09/30/2029 $ O&M Total $ O&M 4. Authority: ☒ FAR 12.102, Restricting Competition: For purchases not exceeding the simplified acquisition threshold, only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand- name, or industrial mobilization). 5. Reason for Authority Cited: Competition is restricted to the original equipment manufacturer (OEM), Drager, for maintenance and repair of Drager Anesthesia Devices. These devices are life-sustaining and are used during surgery and critical care when patients are most vulnerable. Any malfunction or improper servicing presents an unacceptable risk of serious patient harm, including death. To ensure patient safety and equipment reliability, services must be performed exclusively by Drager factory-trained technicians who maintain current, device-specific manufacturer authorization. Drager does not authorize or certify third-party service providers. Drager requires the exclusive use of original, factory-validated OEM parts when servicing its devices. Servicing by non-Drager personnel or the use of non-OEM parts increases the risk of equipment failure, degraded performance, and patient harm, and may invalidate the manufacturer’s warranty. Because no -- 1 of 3 -- CUI Control Number: CUI Source Selection Information - See FAR 2.101 and 3.104-4 NOV 2024 other source can meet the required manufacturer training, authorization, and OEM parts requirements, restricting competition to Drager is necessary to protect patient safety, maintain warranty coverage, and support uninterrupted clinical operations. 6. Market Research: Market research was conducted in accordance with FAR requirements, and all mandatory sources were reviewed to identify potential vendors capable of meeting this requirement. The research resulted in no successful alternative sources. Due to the nature of the requirement and the critical need for OEM parts and manufacturer-authorized personnel for the Drager Perseus A500 anesthesia system, competition is restricted to the original equipment manufacturer, Drager. To ensure patient safety and equipment reliability, services must be performed exclusively by Drager factory-trained technicians with current, device-specific manufacturer authorization. Drager does not authorize or certify third-party service providers. As a result, this requirement will be sole sourced to Drager. Notice of Intent to sole source will be posted prior to award. 7. Other Facts: a. Procurement History: (1) Is this a new requirement? Yes (2) If 6.a.(1) is No, was the action just prior to this one competed? N/A (3) If 6.a.(2) is Yes, what has changed where this action cannot be completed? N/A 8. Technical Certification: I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. 9. Requirements Certification: I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. __________________________________ 10. Fair and Reasonable Cost Determination: -- 2 of 3 -- CUI Control Number: CUI Source Selection Information - See FAR 2.101 and 3.104-4 NOV 2024 I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable. Basis for Determination: __________________________________ 11. Contracting Officer Determination: I certify this justification is accurate and complete to the best of my knowledge and belief. __________________________________ -- 3 of 3 --