Notice of Intent to Sole Source Vitrolife HT942525Q0630

The Defense Health Agency (DHA) U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to award a Firm Fixed Price sole source contract on behalf of the Naval Medical Center San Diego (NMSCD) to Vitrolife, Inc., under the authority FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name, or industrial mobilization). This requirement is for a Viscosity Treatment System, Enhance-S Plus Set, Sperm Wash Medium and the 20 um, 2-chamber MicroCell for fertility testing. These reagents and supplies required provide pre-chemotherapy screening and comprehensive infertility investigation for NMCSD patients. Vitrolife, Inc. is the only vendor able to provide the reagents and supplies that can meet the current needs of NMCSD. Use of Vitrolife Inc. reagents and supplies will ensure the continuity of testing for the investigation of current conditions and or functions of existing systems. Any change to the product necessitates thorough investigation, assessment and approval of individual components utilized in the testing procedure in accordance with the Clinical and Laboratory Standards Institute (CLSI) and College of American Pathologist (CAP) accreditation requirements. Current Vitrolife system components in use are FDA approved, have been assessed, validated and approved for use, hence ready for use and require no further assessment for continued use beyond applicable accreditation requirements. Other reagents are available, however the methodology, kit/reagent complexity and/or protocols will require reassessment and revalidation if introduced. Modification of procedures will result in delays and/or necessity to refer patients to outside networks for service. This is a notice of intent to issue a contract on a Sole Source basis. This notice of intent is NOT a request for quotations (RFQ). Any other firms desiring consideration must fully identify their interest and capability to provide these services to the individual listed below. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Interested persons may identify their interest in writing, to the Government point of contact. Responses to this notice must be received no later than 2:00 PM Eastern Standard Time, 15 July 2025. The point of contact for this action is James Cheng, james.cheng1.civ@health.mil. No telephone requests will be honored.